Docstoc

Ensuring the appropriateness of topical over-the-counter

Document Sample
Ensuring the appropriateness of topical over-the-counter Powered By Docstoc
					Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).




  Ensuring the appropriateness of topical over-the-counter
  antifungal agents for clients with self-diagnosed vaginal
                          thrush (the TAFT Project).




This project was funded by the Australian Government Department of Health
and Ageing as part of the Third Community Pharmacy Agreement”




Chief investigators
Mr Peter Tenni, School of Pharmacy, Curtin University.
Mr Jeff Hughes, School of Pharmacy, Curtin University.
Dr Jenny McCloskey, Department of Sexual Health, Royal Perth Hospital.


Project pharmacist
Ms Samantha Hilmi, Department of Pharmacy, Royal Perth Hospital.




                                           -1-
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

Table of Contents

1.      EXECUTIVE SUMMARY.............................................................................. - 11 -
2.      INTRODUCTION .......................................................................................... - 14 -
     2.1.     Literature review ..................................................................................... - 14 -
        2.1.1.       Vaginal candidiasis .............................................................................................. - 15 -
        2.1.2.       Signs, symptoms, physical and laboratory findings in vaginitis.............................. - 16 -
        2.1.3.       Studies looking at self-diagnosis of VVC .............................................................. - 18 -
        2.1.4.       Existing diagnostic guidelines .............................................................................. - 20 -
  2.2. Project aims ............................................................................................ - 21 -
  2.3. Project objectives.................................................................................... - 21 -
  2.4. Study hypotheses.................................................................................... - 21 -
  2.5. Likely benefits of the research project..................................................... - 22 -
3. METHODS.................................................................................................... - 23 -
     3.1.     Clinical setting......................................................................................... - 23 -
     3.2.     Patient eligibility and recruitment ............................................................ - 23 -
     3.3.     Stakeholders meeting ............................................................................. - 25 -
     3.4.     Pharmacist training and reimbursement.................................................. - 25 -
        3.4.1.       Pharmacist’s role ................................................................................................. - 25 -
     3.5.     General Practitioner’s training and reimbursement ................................. - 27 -
        3.5.1.       General Practitioner’s role.................................................................................... - 27 -
     3.6.     Patient’s questionnaire structure............................................................. - 28 -
        3.6.1.       Demographic information ..................................................................................... - 28 -
        3.6.2.       Medical conditions ............................................................................................... - 29 -
        3.6.3.       Signs and symptoms............................................................................................ - 29 -
        3.6.4.       Personal hygiene factors...................................................................................... - 29 -
        3.6.5.       Sexual history ...................................................................................................... - 29 -
        3.6.6.       Use of other medications ..................................................................................... - 29 -
        3.6.7.       Contraceptive methods ........................................................................................ - 30 -
     3.7.     Piloting of questionnaire.......................................................................... - 30 -
     3.8.     Doctor’s assessment questionnaire ........................................................ - 30 -
     3.9.     Laboratory Investigations........................................................................ - 30 -
        3.9.1.       Genital specimens ............................................................................................... - 31 -
        3.9.2.       Microscopy .......................................................................................................... - 31 -
        3.9.3.       Wet preparation ................................................................................................... - 32 -
        3.9.4.       Gram stain........................................................................................................... - 32 -
        3.9.5.       Culture examination............................................................................................. - 32 -
     3.10.        Statistical analysis ............................................................................... - 33 -
        3.10.1.      Initial sample size determination .......................................................................... - 33 -
        3.10.2.      Data analysis....................................................................................................... - 34 -
     3.11.        Evaluation methodology and preparation of diagnostic tool / flowchart- 35 -
        3.11.1.      Preparation and validation of diagnostic flowchart ................................................ - 35 -
     3.12.        Economic analysis............................................................................... - 37 -
     3.13.        Change in methodology from original study proposal.......................... - 38 -
        3.13.1.      Sample size and validation of diagnostic flowchart ............................................... - 38 -
        3.13.2.      Economic analysis ............................................................................................... - 38 -
     3.14.  Ethics................................................................................................... - 39 -
4.      RESULTS..................................................................................................... - 40 -
     4.1.     Demographics......................................................................................... - 40 -
        4.1.1.       Age...................................................................................................................... - 40 -
        4.1.2.       Ancestry .............................................................................................................. - 40 -



                                                                 -2-
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

     4.1.3.        Marital status ....................................................................................................... - 41 -
     4.1.4.        Sexual history ...................................................................................................... - 42 -
     4.1.5.        Weight and body mass index (BMI)...................................................................... - 46 -
     4.1.6.        Menopausal status............................................................................................... - 47 -
  4.2.      Medical history ........................................................................................ - 48 -
     4.2.1.    Sexually transmitted diseases (STD).................................................................... - 49 -
     4.2.2.    History of allergies ............................................................................................... - 50 -
     4.2.3.    Immunodeficiency and diabetes ........................................................................... - 50 -
     4.2.4.    Bleeding disorders ............................................................................................... - 51 -
     4.2.5.    Urinary tract infection (UTI) .................................................................................. - 51 -
     4.2.6.    Skin disorders...................................................................................................... - 51 -
     4.2.7.    Current use of antibiotics, immunosuppressants, blood sugar level (BSL) lowering
     agents and hormonal agents (‘VVC predisposing drugs’) ...................................................... - 52 -
  4.3.      Laboratory and other findings ................................................................. - 55 -
     4.3.1.        pH ....................................................................................................................... - 55 -
     4.3.2.        Vaginal and vulval swabs: Culture and Gram stain results.................................... - 55 -
     4.3.3.        Leucocytes .......................................................................................................... - 57 -
     4.3.4.        Lactobacilli........................................................................................................... - 57 -
     4.3.5.        Group B streptococcus ........................................................................................ - 58 -
     4.3.6.        Mid-stream urine samples: Urinary tract infection ................................................. - 59 -
     4.3.7.        Sexually Transmitted Diseases (STD).................................................................. - 59 -
  4.4.      Patient’s questionnaire: Vulvovaginal signs and symptoms .................... - 60 -
     4.4.1.        Vaginal discharge ................................................................................................ - 63 -
     4.4.2.        Vaginal pruritus.................................................................................................... - 66 -
     4.4.3.        Vulval pruritus...................................................................................................... - 68 -
     4.4.4.        Vulval tenderness ................................................................................................ - 68 -
     4.4.5.        Vulval erythema................................................................................................... - 69 -
     4.4.6.        Vulval oedema..................................................................................................... - 70 -
     4.4.7.        Dysuria ................................................................................................................ - 71 -
     4.4.8.        Dyspareunia ........................................................................................................ - 72 -
     4.4.9.        Postcoital bleeding............................................................................................... - 75 -
     4.4.10.       Previous vulvovaginal signs and symptoms.......................................................... - 76 -
  4.5.      Doctors’ assessment: Vulvovaginal signs and symptoms ....................... - 80 -
     4.5.1.        Vaginal discharge ................................................................................................ - 83 -
     4.5.2.        Vulval pruritus...................................................................................................... - 86 -
     4.5.3.        Vulval appearance ............................................................................................... - 87 -
     4.5.4.        Vulval erythema................................................................................................... - 88 -
     4.5.5.        Vulval oedema..................................................................................................... - 90 -
     4.5.6.        Dysuria ................................................................................................................ - 91 -
     4.5.7.        Genital ulcers....................................................................................................... - 93 -
     4.5.8.        Evidence of scratching......................................................................................... - 93 -
     4.5.9.        Genital warts and pediculosis pubis ..................................................................... - 94 -
  4.6. Comparative summary of findings from patients’ versus doctors’
  questionnaires ................................................................................................... - 94 -
     4.6.1.        Vaginal discharge characteristics: Patients’ and Doctors’ questionnaires.............. - 97 -
  4.7.      Personal hygiene factors....................................................................... - 100 -
     4.7.1.        Use of personal hygiene products ...................................................................... - 100 -
     4.7.2.        Tight clothing / synthetic materials...................................................................... - 103 -
  4.8. Contraceptive methods ......................................................................... - 104 -
  4.9. Patients’ criteria or reasons for self-diagnosis of VVC .......................... - 108 -
  4.10.  Patients’ reasons for not seeing a doctor .......................................... - 109 -
  4.11.  Doctor’s questionnaire: Presumptive diagnosis and treatment
  recommendations ............................................................................................ - 111 -
     4.11.1.       Presumptive diagnosis....................................................................................... - 111 -
     4.11.2.       Treatment recommendations ............................................................................. - 113 -
  4.12.         Proposed set of ‘key’ questions based on study findings .................. - 115 -
  4.13.         Economic analysis............................................................................. - 119 -


                                                                -3-
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

5.      DISCUSSION ............................................................................................. - 130 -
     5.1. Self-diagnosis of VVC ........................................................................... - 131 -
     5.2. Signs, symptoms, physical and laboratory findings in VVC and other causes
     of vaginitis........................................................................................................ - 132 -
        5.2.1.         Vaginal discharge .............................................................................................. - 132 -
        5.2.2.         Vaginal discharge characteristics ....................................................................... - 132 -
        5.2.3.         Vaginal discharge components: Laboratory findings........................................... - 133 -
        5.2.4.         Vulval and vaginal pruritus ................................................................................. - 133 -
        5.2.5.         Inflammatory and other signs ............................................................................. - 134 -
        5.2.6.         History of same symptoms................................................................................. - 134 -
        5.2.7.         Candida speciation ............................................................................................ - 135 -
        5.2.8.         Other infective causes of vaginitis ...................................................................... - 135 -
        5.2.9.         Bacterial vaginosis............................................................................................. - 135 -
        5.2.10.        Group B streptococcus ...................................................................................... - 135 -
     5.3.      Risk factors for VVC.............................................................................. - 136 -
        5.3.1.         Menopausal status............................................................................................. - 136 -
        5.3.2.         Medical history................................................................................................... - 136 -
        5.3.3.         Diabetes ............................................................................................................ - 137 -
        5.3.4.         Sexual history .................................................................................................... - 137 -
        5.3.5.         Use of medications ............................................................................................ - 137 -
        5.3.6.         Contraceptive methods used.............................................................................. - 138 -
        5.3.7.         Non-infective conditions and associated risk factors........................................... - 138 -
     5.4.      Other findings of importance ................................................................. - 139 -
        5.4.1.     Patients’ reasons for self-diagnosis, not seeing a doctor and sources of information for
        self-diagnosis ..................................................................................................................... - 139 -
        5.4.2.     Concordance of presumptive diagnoses and treatment recommendations.......... - 140 -
        5.4.3.     Other serious disorders not to be missed ........................................................... - 141 -
     5.5.      Economic analysis ................................................................................ - 141 -
     5.6.      Proposed diagnostic flowchart .............................................................. - 142 -
     5.7.      Study recommendations ....................................................................... - 143 -
     5.8.      Areas requiring further research ........................................................... - 144 -
     5.9.      Limitations of the study ......................................................................... - 144 -
        5.9.1.         Small sample size.............................................................................................. - 144 -
        5.9.2.         Risk of bias........................................................................................................ - 144 -
        5.9.3.         Economic analysis ............................................................................................. - 146 -
6.      ISSUES RELATING TO RECRUITMENT – LESSONS LEARNED ........... - 146 -
7.      CONCLUSION............................................................................................ - 148 -
8.      ACKNOWLEDGEMENTS .......................................................................... - 148 -
9.      REFERENCES / BIBLIOGRAPHY............................................................. - 149 -
10. APPENDICES ............................................................................................ - 152 -
Appendix 1 – TAFT Project: Patient Information ........................................... - 152 -
Appendix 2 – TAFT Project: Patient Consent Form ...................................... - 154 -
Appendix 3 – TAFT Project: Pharmacist Information Form.......................... - 155 -
Appendix 4 – TAFT Project: Patient Recruitment List................................... - 160 -
Appendix 5 – TAFT Project: Doctor’s Information Form............................... - 161 -
Appendix 6 – TAFT Project: Microbiology Collection Kit and Test Instructions ..-
165 -



                                                                   -4-
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

Appendix 7 – TAFT Project: Doctor’s History, Examination and Assessment
data collection forms ....................................................................................... - 167 -
Appendix 8 – TAFT Project: Patient Survey................................................... - 175 -




                                                     -5-
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

List of Figures
Figure 1 Ancestry of Study Participants ................................................................ - 41 -
Figure 2 Marital Status of Study Participants......................................................... - 42 -
Figure 3 Candida species on vaginal cultures....................................................... - 56 -
Figure 4 Candida species on vulval cultures ......................................................... - 56 -
Figure 5 Description of previous diagnosis............................................................ - 78 -
Figure 6 Sources of Previous Treatment Recommendations................................ - 80 -
Figure 7 Use of Hygiene Products....................................................................... - 101 -
Figure 8 Proposed diagnostic tool / flowchart to assist pharmacists in ensuring
    appropriate use of OTC antifungals ............................................................. - 118 -
Figure 9 Cost analysis – Scenario one................................................................ - 122 -
Figure 10 Cost analysis – Scenario two .............................................................. - 123 -
Figure 11 Cost analysis – Scenario three............................................................ - 124 -
Figure 12 Cost analysis – Scenario four (a) ........................................................ - 125 -
Figure 13 Cost analysis – Scenario four (b) ........................................................ - 126 -
Figure 14 Cost analysis – Scenario four (c)......................................................... - 127 -




                                                  -6-
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

List of Tables
Table 1 Features of the most common causes of vaginitis.................................... - 15 -
Table 2 Sample size determination ....................................................................... - 33 -
Table 3 Mean and range of age for those women who were confirmed to be either
    negative or positive for candidal infection....................................................... - 40 -
Table 4 Sexual activity of subjects over selected periods ..................................... - 43 -
Table 5 Number of different sexual partners over the last 3 months versus VVC by
    culture ............................................................................................................ - 44 -
Table 6 Number of different sexual partners over the last 12 months versus VVC by
    culture ............................................................................................................ - 44 -
Table 7 Number of lifetime sexual partners for subjects........................................ - 45 -
Table 8 Number of lifetime sexual partners versus VVC by culture....................... - 45 -
Table 9 Weight of subjects .................................................................................... - 46 -
Table 10 BMI of subjects....................................................................................... - 46 -
Table 11 BMI category .......................................................................................... - 46 -
Table 12 BMI category versus VVC by culture...................................................... - 47 -
Table 13 Menopausal status versus VVC by culture............................................. - 48 -
Table 14 Medical histories of interest and their reported frequencies ................... - 49 -
Table 15 History of diabetes versus VVC by culture ............................................. - 50 -
Table 16 History of allergies, skin disorders and asthma versus VVC by culture.. - 52 -
Table 17 Frequency of use of ‘VVC predisposing drugs’ in our study cohort ........ - 53 -
Table 18‘VVC predisposing drugs’ versus VVC by culture.................................... - 54 -
Table 19 Combined use of ‘VVC predisposing drugs’ versus VVC by culture....... - 54 -
Table 20 Vaginal pH versus vaginal candidiasis by culture................................... - 55 -
Table 21 Presence of leucocytes versus VVC by culture...................................... - 57 -
Table 22 Presence of lactobacilli versus VVC by culture ...................................... - 58 -
Table 23 Group B streptococcus isolated from vulval and vaginal swabs............. - 58 -
Table 24 Proportion of MSU samples where bacterial growth and UTI confirmed - 59 -
Table 25 Causative bacteria of UTIs ..................................................................... - 59 -
Table 26 Cases of STD ......................................................................................... - 60 -
Table 27 VVC according to vaginal and vulval culture .......................................... - 61 -
Table 28 Total frequency of occurrence of vulvovaginal signs and symptoms and
    validity of screening tests for diagnosis of VVC.............................................. - 62 -
Table 29 Presence of vaginal discharge versus vaginal candidiasis confirmed by
    culture ............................................................................................................ - 64 -
Table 30 Presence of vaginal discharge versus vulval candidiasis confirmed by
    culture ............................................................................................................ - 64 -
Table 31 Presence of vaginal discharge versus VVC confirmed by vaginal and vulval
    culture swabs ................................................................................................. - 65 -
Table 32 Vaginal discharge odour versus vaginal candidiasis by culture.............. - 66 -
Table 33 Vaginal discharge odour versus vulval candidiasis by culture................ - 66 -
Table 34 Vaginal pruritus versus vaginal candidiasis by culture............................ - 67 -
Table 35 Vaginal pruritus versus vulval candidiasis by culture.............................. - 67 -
Table 36 Vulval pruritus versus vulval candidiasis by culture................................ - 68 -
Table 37 Vulval tenderness versus vulval candidiasis by culture .......................... - 69 -
Table 38 Vulval erythema versus vulval candidiasis by culture............................. - 70 -
Table 39 Vulval oedema versus vulval candidiasis by culture............................... - 71 -
Table 40 Dysuria specified versus vulval candidiasis by culture ........................... - 72 -



                                                         -7-
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

Table 41 Dysuria combined versus vulval candidiasis by culture .......................... - 72 -
Table 42 Dyspareunia specified tested against vaginal candidiasis by culture ..... - 73 -
Table 43 Dyspareunia categories combined tested against vaginal candidiasis by
    culture ............................................................................................................ - 74 -
Table 44 Dyspareunia combined tested against vulval candidiasis by culture ...... - 74 -
Table 45 Dyspareunia combined tested against combined vaginal and vulval
    candidiasis by culture..................................................................................... - 75 -
Table 46 Postcoital bleeding and combined vaginal and vulval candidiasis by culture -
    76 -
Table 47 Vulvovaginal signs and symptoms experienced in the past versus combined
    vaginal and vulval candidiasis by culture........................................................ - 77 -
Table 48 Women who had previously experienced the same vulvovaginal symptoms
    which had been diagnosed by a doctor as VVC versus current combined vaginal
    and vulval candidiasis by culture.................................................................... - 79 -
Table 49 Total frequency of reported vulvovaginal signs and symptoms and validity of
    screening tests for diagnosis of VVC ............................................................. - 82 -
Table 50 Vaginal discharge versus culture proven vaginal candidiasis................. - 84 -
Table 51 Vaginal discharge versus vulval candidiasis by culture .......................... - 84 -
Table 52 Vaginal discharge versus VVC by culture............................................... - 85 -
Table 53 Vaginal discharge odour versus vaginal candidiasis by culture.............. - 86 -
Table 54 Vulval pruritus versus vaginal candidiasis by culture.............................. - 87 -
Table 55 Vulval appearance versus vulval candidiasis by culture......................... - 88 -
Table 56 Vulval erythema versus vulval candidiasis by culture............................. - 89 -
Table 57 Different extents of vulval erythema combined versus vulval candidiasis by
    culture ............................................................................................................ - 90 -
Table 58 Vulval oedema versus vulval candidiasis by culture............................... - 91 -
Table 59 Different extents of vulval oedema combined versus vulval candidiasis by
    culture ............................................................................................................ - 91 -
Table 60 Dysuria versus vaginal candidiasis by culture ........................................ - 92 -
Table 61 Dysuria versus vulval candidiasis by culture .......................................... - 92 -
Table 62 Genital ulcers versus vulval candidiasis by culture................................. - 93 -
Table 63 Evidence of scratching versus vulval candidiasis by culture................... - 94 -
Table 64 Comparative summary of findings from patients’ versus doctors’
    questionnaires................................................................................................ - 95 -
Table 65 Doctor’s questionnaire: Discharge consistency versus VVC by culture.. - 98 -
Table 66 Patient’s questionnaire: Discharge consistency versus VVC by culture. - 98 -
Table 67 Doctor’s questionnaire: Discharge colour versus VVC by culture........... - 99 -
Table 68 Patient’s questionnaire: Discharge colour versus VVC by culture.......... - 99 -
Table 69 Doctor’s questionnaire: Discharge odour versus VVC by culture ......... - 100 -
Table 70 Patient’s questionnaire: Discharge odour versus VVC by culture......... - 100 -
Table 71 Frequency table for use of personal hygiene products......................... - 101 -
Table 72 Use of personal hygiene products tested against proven VVC by culture..... -
    102 -
Table 73 Tampon use versus vaginal and vulval candidiasis by culture ............. - 103 -
Table 74 Frequency table for regular wearing of constrictive clothing................. - 103 -
Table 75 Regular wearing of constrictive clothing made of synthetic material tested for
    association against laboratory proven VVC.................................................. - 104 -
Table 76 Any form of contraceptive use versus VVC by culture.......................... - 105 -
Table 77 Frequency of use of specific methods of contraception........................ - 106 -
Table 78 Use of the OCP versus VVC by culture................................................ - 107 -


                                                         -8-
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

Table 79 Use of the OCP, diaphragm and IUD versus VVC by culture............... - 108 -
Table 80 Patients’ criteria or reasons for self-diagnosis of VVC.......................... - 109 -
Table 81 Patients’ reasons for not seeing a doctor ............................................. - 110 -
Table 82 Doctors’ presumptive diagnosis versus vaginal candidiasis by culture. - 111 -
Table 83 Doctors’ presumptive diagnosis versus vulval candidiasis by culture... - 112 -
Table 84 Doctors’ presumptive diagnosis versus VVC by culture ....................... - 112 -
Table 85 Presumptive diagnosis versus treatment recommended by doctor ...... - 114 -
Table 86 Microbiologically proven VVC versus treatment recommended by doctor..... -
    114 -
Table 87 Microbiologically proven VVC versus assessment of treatment
    recommendation .......................................................................................... - 115 -
Table 88 Summary table of variables used to develop diagnostic flowchart ....... - 117 -
Table 89 Average retail costs for products of interest ......................................... - 120 -




                                                     -9-
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

List of Abbreviations
Abbreviation                                        Phrase

OTC                Over-the-counter
VVC                Vulvovaginal candidiasis
IUD                Intrauterine device
OCP                Oral contraceptive pill
STD                Sexually transmitted disease
BV                 Bacterial vaginosis
UTI                Urinary tract infection
BMI                Body mass index
RR                 Relative risk
SD                 Sample standard deviation
PPV                Positive predictive value
NPV                Negative predictive value




Glossary

       Terminology                                       Meaning

2 (1), 0.0020 (P = 0.9647)    Chi-square value = 0.0020, with 1 degree of freedom
P                              Probability value associated with the statistical test




                                          - 10 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

1. EXECUTIVE SUMMARY

Genital problems are associated with fear and embarrassment in the general public.
In the era of over-the-counter antifungals, women have been empowered to treat their
own suspicions of vulvovaginal candidiasis. The concern is whether they are
perpetuating the problem through incorrect self-diagnosis, as the majority of them
regard any vulvovaginal symptom as “thrush”. Community pharmacists are in a
position to assist women in ensuring that the ease of availability of self-treatment
does not end up disadvantaging them through mismanagement and delays in
obtaining appropriate treatment.


Project aims: The main aims were to demonstrate a) that the use of a structured
questionnaire or diagnostic flowchart can assist pharmacists to identify patients for
whom OTC vaginal antifungal therapy is appropriate based on their symptoms; and b)
the cost-benefits of allowing pharmacists to sell such products.


Methods: To assess the association between specific signs and symptoms, risk
factors and past medical history as described by women with a presenting complaint
of VVC with the diagnosis of culture proven vulvovaginal candidiasis, we performed a
cross-sectional cohort study over a 13-month period. All women who presented to
participating community pharmacies within a nominated metropolitan division of
general practice, who wished to purchase a topical antifungal product for their
personal treatment of presumed vulvovaginal candidiasis were invited to participate in
the study. Participants included 94 symptomatic women, aged between 19 to 79
years who were evaluated by clinical examination by nominated general practitioners
within the division along with relevant laboratory tests. Study participants completed a
detailed questionnaire addressing demographic data, their presenting signs and
symptoms, risk factors for vulvovaginal candidiasis and / or past medical history. The
data were initially explored using frequency distributions for categorical variables and
summary statistics for continuous variables. Chi-square test for association was
performed for univariate comparisons of potential risk factors among those women
with laboratory proven candidiasis versus those without. Sensitivity and specificity for
each of the relevant variables, along with the positive and negative predictive values


                                          - 11 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

where appropriate were calculated to determine which variables were suitable for
inclusion in the diagnostic tool / flowchart.


Results:
Our study showed that only 41 out of the 88 women (47%), who had vaginal and / or
vulval swabs and cultures taken were confirmed to have VVC. The remaining 47
(53%) of women either had another cause of infection (4 cases of urinary tract
infection, 2 cases of bacterial vaginosis, 2 cases of chlamydia and 2 cases of genital
herpes were diagnosed) or their symptoms were not secondary to an infectious
cause. We also identified that 63% of presumptive diagnoses made by GPs were
concordant with clinical examination and laboratory proven diagnoses.


We identified seven key questions of clinical importance and/or high sensitivity
(>75%) which were incorporated into our final diagnostic tool proposed for use by
pharmacists to identify women with likely VVC with an overall expected positive
predictive value of approximately 60%. These key questions which related to such
factors as menopausal status, presence of vaginal discharge, presence of vaginal
and / or vulval itch, use of hygiene products and history of same symptoms were
included in our proposed diagnostic tool. Use of ‘VVC predisposing drugs’ was also
included based on the statistical significance and literature evidence found for its
association with VVC. Based on the clinical importance of checking for appropriate
management of diabetes, the question of diabetic status was also included in our final
diagnostic flowchart. The presence of post-coital or abnormal bleeding was also
included to help identify those women who may potentially be at risk of having serious
disorders which should not be missed.


The final proposed diagnostic flowchart was not designed to be an exhaustive list of
questions identifying all risk factors but rather to recognise and serve the need for a
valid, yet easily utilised tool to assist pharmacists in more accurately and promptly
identifying those women who should receive treatment with an OTC antifungal based
on the likelihood of them having VVC. Due to difficulties in patient recruitment, the
proposed diagnostic flowchart was not able to be validated.




                                          - 12 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

Additional findings of interest included the fact that only 5% of women avoided
seeking medical advice for the management of VVC due to embarrassment.
The most common reasons provided highlighted the fact that the majority of our study
cohort had previously experienced the same symptoms, which may have been
diagnosed by a doctor as VVC in the past, and consequently they felt confident in
self-diagnosing VVC for subsequent episodes. Other key reasons included issues
relating to convenience, they were unwilling or not able to wait to see a doctor, or
even questioned the benefit in seeking medical advice, or the fact that vaginal
antifungals were now available over the counter which meant ready and prompt
access, something they were in favour of.


Conclusion: We determined that women who self-diagnose VVC do so poorly. We
obtained enough data to develop a structured diagnostic flowchart composed of key
questions of clinical importance and/or high sensitivity (>75%). Though unable to be
validated in our study, the flowchart has the potential to assist community
pharmacists in improving the management of VVC, especially important in light of the
ease of obtaining OTC vaginal antifungals. By actively being involved in this
diagnostic process, pharmacists are not only fulfilling their professional obligations,
but are also potentially providing significant cost savings to the community.




                                          - 13 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

2. INTRODUCTION
It is quite evident that genital problems are associated with fear and embarrassment
in the general public. The recent down-scheduling of topical antifungal agents has
increased the number of non-prescription options for management of vaginal
symptoms. In the era of over-the-counter (OTC) antifungals, women have been
empowered to treat their own suspicions of one such problem, vulvovaginal
candidiasis (VVC). The concern however, is whether they are perpetuating the
problem through incorrect self-diagnosis, as the majority of them regard any
vulvovaginal symptom as “thrush”.1


Community pharmacists are in a position to assist women in ensuring that the ease of
availability of self-treatment does not end up disadvantaging them through
mismanagement and delays in obtaining appropriate treatment, especially
considering that as little as only one third of women who self-diagnose VVC do so
correctly. What is even more alarming, is that women with a previous clinically based
diagnosis of thrush have been found to be no more accurate in self-diagnosis.2



2.1.    Literature review
Vulvovaginitis is a common gynaecological diagnosis and vaginal discharge
represents one of the top 25 reasons why women seek advice.3 However, although
candidiasis is a common cause of vulvovaginal discomfort, contact dermatitis is one
of the most common causes, along with bacterial vaginosis, genital warts and
psoriasis.1,4,5 Patients with infectious vaginitis frequently complain of vaginal
discharge, foul odour, itching, dysuria or dyspareunia. Infectious organisms may be
fungal (Candida albicans or glabrata), bacterial (Gardnerella vaginalis, Mobiluncus
spp, Mycoplasma hominis or Peptostreptococcus spp), protozoan (Trichomonas spp)
or viral (Human papillomavirus, Herpes simplex virus).6


The literature contains an array of research addressing the features and associated
risk factors for vulvovaginitis. Table 1 outlines the features of the most common
causes of vaginitis,6 which may not always be clearly evident and consequently, can
make diagnosis difficult even for medical practitioners.



                                          - 14 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

   Table 1 Features of the most common causes of vaginitis


Basis of              Bacterial vaginosis     VVC                  Trichomoniasis
diagnosis

Signs and             Thin, off-white         Thick, white         Copious, malodorous,
symptoms              discharge               (‘cottage cheese’)   yellow-green (or
                                              discharge with no    discoloured) discharge
                      Unpleasant ‘fishy’      odour
                      odour, with odour                            Pruritus
                      increasing after        Pruritus
                      sexual intercourse                           Vaginal irritation
                                              Dysuria
                                                                   No symptoms in 20 to
                                              Dyspareunia          50% of affected women

Physical              Usually normal          Vulvar and vaginal   Vulvar and vaginal
examination           appearance of           erythema, oedema     erythema and oedema
(may be noted by      tissue                  and fissures
presenting woman)
                      Discharge may           Discharge may
                      adhere to vaginal       adhere to vaginal
                      walls                   walls

Information adapted from Egan ME, Lipsky MS. Diagnosis of vaginitis. Am Fam Physician
2000;62:1095-104.



2.1.1.      Vaginal candidiasis
Candida is an opportunistic organism present in as many as 50% of asymptomatic
women that can become pathogenic in given circumstances.7,8 While the associated
risk factors for VVC remain difficult to fully ascertain, alteration in the acidic pH of the
vagina has been implicated in the pathogenesis, which is maintained by normal
vagina flora (primarily lactobacilli). This may occur secondary to premenarchal and
postmenopausal       changes,     medication        (immunosuppressants,      antibiotics,    oral
contraceptive pills), douching, foreign bodies, spermicides, and various diseases
(especially diabetes, but also other diseases that affect immunological function).3
Other risk factors include age at first intercourse, frequency of intercourse (more than
four times per month) and receptive oral sex.6,9 There is the potential for candidiasis
to be sexually transmitted, though this remains controversial.3,6 Male partners of
women with culture-proven VVC may carry candida in their oral or rectal cavities and
ejaculate.3 The risk may also be increased in women who are pregnant.3,6,7




                                           - 15 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

Approximately 75% of women have at least one episode of vaginal candidiasis at
some time in their lives and 5% have recurrent episodes, where recurrent VVC is
defined as at least four discrete episodes over a twelve month period or at least three
episodes in the same period which are not related to antibiotic therapy.6, 7, 10 Of
patients with vaginal symptoms, approximately 60% will later be confirmed with a
diagnosis of vaginal candidiasis.11



2.1.2.     Signs, symptoms, physical and laboratory findings in
           vaginitis

2.1.2.1.   Vaginal discharge

For many women, vaginal discharge leads to significant concern and the need to
seek medical advice.3 It is a difficult area to address in particular where the problem is
recurrent or persistent and for the medical practitioner needing to make a proper
diagnosis, they need to differentiate between abnormal or normal (physiological)
discharge. The observed features of vaginal secretions are also influenced by such
factors as age, phase of the menstrual cycle, use of contraceptive methods such as
the oral contraceptive pill (OCP) and intrauterine devices, and pregnancy.12 In
women with VVC, the discharge is usually described as being white, floccular and
highly viscous. Most women will however have a normal looking vaginal discharge.13

The female genitalia is inhabited by complex microbial flora which varies with site,
age and hormonal background12 and in addition the normal vaginal discharge is
comprised of a number of other components, including epithelial cells and white blood
cells (WBCs). White blood cells are not present in abundance among women with a
physiological discharge and where a large number of WBCs is observed,
trichomoniasis or cervicitis should be suspected. They have also been found to be
absent in women who have only candidiasis or non-specific vaginitis.
Clue cells comprise 2 – 50% of the vaginal epithelial cells and some correlation has
been found with the presence or absence of bacterial vaginosis (G. vaginalis) though
the correlation may be poor.13,14




                                          - 16 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

2.1.2.2.   pH of discharge

Large gram-positive rods are found in the normal vaginal flora and in normal
discharge as well as in the discharge of women with candidiasis.3,13 These rods
generally represent the presence of lactobacilli which maintain the normal vaginal pH
at less than 4.5.3 Therefore it is expected that the vaginal pH of women with VVC
would be less than 4.5.


2.1.2.3.   Other causes of vaginitis

Bacterial vaginosis (BV)

Bacterial vaginosis is a common cause of vaginal discharge, which has been
described as abnormal, thin, greyish-white, occasionally frothy and
homogeneous.12,14 Other key differentiating features from VVC are identified in Table
1.6 Vaginal pH is usually elevated above 4.5 and other diagnostic features include a
positive amine test and presence of clue cells.12,14 The significance of BV continues to
unfold and has been identified as a risk factor in:
      Preterm labour / late miscarriage;
      Ascending infection of the female genital tract;
      Endometritis following caesarean section;
      Vaginal cuff cellulitis following abdominal hysterectomy; and
      Neonatal sepsis.12
New evidence has also implicated BV as increasing the risk of acquiring sexually
transmitted diseases and Human Immunodeficiency virus (HIV) infection and of
transmitting HIV infection.15

Trichomoniasis

The third most common cause of vaginitis may be attributed to the protozoan
Trichomonas vaginalis, and has been implicated in 10 to 25 percent of vaginal
infections. There are potentially serious consequences of missing this diagnosis
including the possible increased rate of transmission of the human immunodeficiency
virus, and other venereal diseases. Risk factors associated with trichomoniasis
include use of an intrauterine device (IUD), cigarette smoking and multiple sexual
partners. Refer to Table 1 for key differentiating features from VVC. 6



                                          - 17 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

Allergic vulvovaginitis

Another differential diagnosis to be considered is allergic vulvovaginitis. In an
extensive review article by Moraes et al.5, the many allergens that have been
implicated in provoking allergic reactions in the female genital tract are discussed.
The human vaginal basal lamina contains IgG- and IgA-producing plasma cells and
lymphocytes associated to an accessible pathway to the lumen, which has led to the
conclusion that the vagina may be able to mount a mucosal immune response.5
Allergic reactions affecting the vulva and vagina have been associated with a number
of possible causes, including inhalants, foods and drugs, semen, latex, spermicides,
contact dermatitis including textile dermatitis, topical medications, K-Y jelly (a
lubricant containing propylene glycol), perfumes and other hygiene products including
soaps and detergents, sanitary napkins and finally Candida albicans itself.5


Group B streptococcus in vaginitis

Group B streptococci (GBS) are known to colonise the genital tract in 4 – 18% of
healthy women. Its causal role in vulvovaginal symptoms has not been well
researched 16 and some authors have proposed that GBS at high multiplicity may
produce vulvovaginitis.16,17,18 The primary symptoms are considered to be a persistent
non-offensive discharge, which may result in maceration and irritation of the vulval
skin leading to burning or pain.17,18 The aetiological relevance of GBS isolation is
often considered when alternative explanations for vaginitis symptoms cannot be
found.16



2.1.3.       Studies looking at self-diagnosis of VVC
In a study of 105 women with self-diagnosed recurrent yeast infections who were
referred to a vaginitis specialty centre,2 the most common diagnoses were:
         Vulvovaginal candidiasis (27.6%);
         Vulvar vestibulitis (17.1%);
         Irritant dermatitis (15.2%); and
         Bacterial vaginosis (10.5%).
There are therefore a range of possible diagnoses for patients with vaginal
symptoms, many of which are not effectively treated with antifungal medications.


                                            - 18 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



Ferris et.al. 19 found that when women were given descriptions of various vaginal
infections, only 28% accurately diagnosed vaginal candidiasis and only 4% could
recognise bacterial vaginosis. In another study, Chaponis et.al.11 demonstrated that
of 54 women who presented with a self-diagnosed initial episode of candidiasis, only
59% (33) actually had this condition. Of 100 women who had prior candidiasis, the
accuracy of self-diagnosis of recurrent episodes was 82%. Furthermore, the use of
topical antifungal agents in patients with irritant dermatitis (up to 15% of patients with
vaginal symptoms) may exacerbate the condition.11 A more recent study by Ferris et.
al. 2 showed that only 32 of 95 patients (34%) who self-diagnosed vaginal candidiasis
were correct, with bacterial vaginosis (19%), mixed vaginitis (21%) and other
conditions making up the majority of cases. Further, women who had previously had
an episode of clinically diagnosed vaginal candidiasis were no more accurate in their
diagnosis than women without previous episodes.


In non-fungal vaginal conditions, the use of topical antifungal agents is not only
ineffective, but may also delay diagnosis and appropriate management of the true
problem. There is no Australian data to compare to this most recent American study,
however, given a similar demographic group, we could expect similar results. If this is
the case, approximately two thirds of patients who self diagnose vaginal candidiasis
are incorrect.


Critical factors in determining which vaginal condition is present include:
      The frequency of symptoms (particularly differentiating whether the episode is
       the first or a recurrent episode)20
      Associated antibiotic use (note that some antibiotics may cause dermatitis not
       candidiasis)21
      Age of the patient (candidiasis is extremely rare in postmenopausal patients
       who are not taking hormone replacement therapy or do not have a diagnosis of
       diabetes)22
      Contraceptive method used (may also be associated with marital status and
       sexual history)23




                                          - 19 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

        Concurrent illnesses (especially diabetes, but also other diseases that affect
         immunological function)10
Access to the over-the-counter antifungal products without confirmation of diagnosis
may therefore be associated with wasted financial resources, unfulfilled expectations
and a delay in the correct diagnosis for up to two thirds of women who perceive they
have vaginal candidiasis.



2.1.4.       Existing diagnostic guidelines
There are limited guidelines or diagnostic tools available in the literature for use by
pharmacists to optimise non-prescription treatment of VVC. Most guidelines or
flowcharts looking at diagnosis of vulvovaginal conditions are developed with the
physician in mind.6,13 Watson et al.7 developed a set of evidence based guidelines for
the treatment of VVC in the community pharmacy setting. Their proposed guidelines
are fairly comprehensive and may involve both the pharmacist and patient or patient
alone in the diagnostic process. The flowchart of their main recommendations is
based primarily on signs and symptoms of VVC. In the development of our diagnostic
flowchart we aim to test the reliability of patients’ identification of signs and symptoms
and only incorporate those variables which prove to be reliably identified and are of
high sensitivity.




                                          - 20 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).




2.2.    Project aims
The main aims of this cross-sectional cohort study were to demonstrate a) that the
use of a structured questionnaire or diagnostic flowchart can assist pharmacists to
identify patients for whom OTC vaginal antifungal therapy is appropriate based on
their symptoms; and b) the cost-benefits of allowing pharmacists to sell such
products.



2.3.    Project objectives
The objectives of the study were to prepare a patient’s questionnaire which included
questions on symptoms, risk factors and past history and to test the validity of each
module and individual questions, by establishing the specificity and selectivity, within
this structured questionnaire against the eventual laboratory proven diagnosis. The
validity information would then be used to design a structured set of questions of high
specificity that would be recommended for ongoing use by pharmacists.


Secondary objectives included application of a separate doctors’ questionnaire
addressing some duplicated questions from the patients’ questionnaire to allow for
comparative assessment of patients’ ability to identify markers of VVC. Concordance
of doctors’ presumptive diagnoses and prescribing practices were to be determined
for use in the cost avoidance analyses. Other objectives included collection and
analysis where possible, of any additional laboratory data of interest which have been
suggested as possible markers of VVC.


The final objective of the study was to present a series of case scenarios with their
associated cost implications to demonstrate the economic benefits in utilising the
proposed structured set of questions by community pharmacists.



2.4.    Study hypotheses
The null hypotheses tested were:



                                          - 21 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

   1. The diagnosis of vulvovaginal candidiasis as determined by the isolation of
       candida from vulval and / or vaginal swabs is not related to specific signs or
       symptoms, risk factors and / or past medical history as described by women
       with a presenting complaint of VVC.
   2. The use of a structured questionnaire to assist pharmacists in identifying
       patients for whom OTC vaginal antifungal therapy is appropriate based on their
       presenting features will not result in any likely cost benefits.



2.5.    Likely benefits of the research project
   1. Production of a questionnaire to assist pharmacists in ensuring the appropriate
       use of vaginal antifungal products;
   2. The ability to identify patients requiring referral for further assessment of
       potential non-fungal vaginal conditions;
   3. Prevention or unnecessary and / or inappropriate use of antifungal
       medications;
   4. Early identification and effective treatment of non-fungal vaginal condition with
       potentially serious sequelae; and
   5. Reduction in health care costs related to unnecessary doctor referrals,
       laboratory investigation and / or complications of delayed diagnosis and / or
       treatment of potentially serious non-fungal vaginal disorders.




                                          - 22 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).




3. METHODS

3.1.    Clinical setting
A number of community pharmacies within the Osborne Division of General Practice,
in the Perth metropolitan area were approached to participate in the study. The aim
was to recruit a minimum of 20 pharmacies, a number which was deemed appropriate
in considering the likely recruitment rate of patients based on average sales figures of
OTC vaginal antifungals. In addition the practicalities of monitoring recruitment
progress and distribution of resources had to be taken into consideration. A total of 21
pharmacies in the elected division agreed to participate. Two additional pharmacies
were included outside of the nominated Division, subsequent to the initial recruitment
of pharmacies due to the interest generated, thus allowing recruitment of patients not
otherwise able to attend pharmacies within the nominated Division. The staff of these
pharmacies received the same instructions as was given to the other pharmacies to
avoid any deviations from the proposed recruitment process.

3.2.    Patient eligibility and recruitment
All females who presented to the nominated community pharmacies who wished to
purchase a topical antifungal product for their personal vaginal use were invited to
participate in the study. The initial target sample size was 220 patients, based on
preliminary statistical power calculations (see Statistical Analysis). Inclusion started in
May 2003 and was terminated at the end of June 2004.


The aims and structure of the study were explained to each of the female clients by a
pharmacist and through the provision of a pamphlet outlining details of the study. The
pamphlet included an explanation on the women’s involvement and potential benefits.
On agreeing to participate in the project, clients were asked to provide written
informed consent (see Appendix 1 – TAFT Project: Patient Information’ and Appendix
2 – ‘TAFT Project: Patient Consent Form’).


Clients were not eligible to participate in the project if they:




                                          - 23 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

      had been referred by a general practitioner or other doctor and directed to
       purchase the product;
      were unable to communicate effectively in oral or written English to such an
       extent that they were unable to understand the patient information form or
       complete the informed consent form; and
      had recently completed or had commenced on treatment for VVC.


As a compensation for participation in the study, clients were informed that the cost of
their initial doctor’s consultation would be billed to the study, as would the cost of the
microbiological testing. Further, the cost of treatment of their vaginal condition would
be covered to a maximum cost of $25.00 (this payment was made directly to the
pharmacy).


During the recruitment period, a brief article and a total of three notices alerting
women to the existence of the study were placed in the ‘Health Watch’ section of the
West Australian newspaper, at various times. This was done in an effort to improve
the recruitment rate. This is discussed further under the section titled ‘Change in
methodology from original study proposal’.

The process used to select those women who answered the advertisements and
were deemed appropriate for referral for recruitment through the participating
pharmacies involved questioning the women specifically to ascertain if they were
confident that they had thrush at the time of answering the advertisement. They were
questioned so as to avoid providing any prompts or hints of the signs and symptoms
which would suggest possible thrush. They had to convince the investigator taking the
phone call that they would indeed have gone to a pharmacy having self-diagnosed
thrush and they were also questioned as to the treatment they would have chosen
from the pharmacy, thereby further indicating to the investigator that they had self-
diagnosed their condition. If they indicated or suggested that it was a chronically
recurring problem but that they were not infected at the time of interview, they were
not considered appropriate for recruitment, but were advised they could contact an
investigator at a subsequent time when they considered themselves to be suffering
from thrush. They were not provided with details on the expected signs and
symptoms of thrush nor were they advised on possible treatments.


                                          - 24 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).




3.3.     Stakeholders meeting
Pharmacists and General Practitioners (GPs) from the Division were invited to an
information/education evening, where the study and background were outlined by the
investigating pharmacists and Sexual Health Physician. Those GPs in the area that
did not attend the meeting and indicated their willingness to participate in the study
were mailed detailed information on the study and relevant GP requirements.



3.4.     Pharmacist training and reimbursement
Pharmacists were provided with all the relevant background information and
documentation processes for the study during the initial education evening, as well as
upon ‘activation’ for recruitment by the project pharmacist. Pharmacies that chose to
participate in the study were provided with a total payment of $85 for each patient
enrolled to cover both the initial cost of the therapy used as well as the professional
fee for recruitment. Further, participating pharmacies would receive Continuous
Quality Improvement (CQI) credit points at a rate of one point for every 10 hours
involvement in the research project (approximately one point for every 10 patients
recruited).



3.4.1.        Pharmacist’s role
(See Appendix 3 – ‘TAFT Project: Pharmacist Information Form’)
Each participating pharmacist was instructed to complete the following steps with
respect to the enrolment of patients:
1. Provide each eligible patient with both the TAFT Project Patient Information and
    Consent Forms. Once the patient had volunteered to participate in the study, the
    Consent Form had to be completed and signed in the pharmacy and a photocopy
    made. The copy was to be given to the patient and the original kept for collection
    by a member of the research team. A copy of the Survey had to then be provided,
    the majority of which could be completed by the patient at home.




                                          - 25 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

2. An appointment was to be made with a doctor of the patient’s choice or if they
    didn’t have a preferred doctor, one was to be chosen for them. Contact details of
    all the participating GPs in the Osborne Division were provided for this purpose to
    all participating Pharmacies. Where a patient nominated their own doctor, and if
    that doctor was unfamiliar with the study, a thorough explanation of the role of the
    GP was to be provided and their ability to participate in the study was to be
    determined by the pharmacist. Appointments were to be made within 24 hours of
    recruitment of the patient, in an effort to minimise any delays in commencement
    of treatment.


3. Once patient’s had completed the survey, they were instructed to give the survey
    to their GP and after review by their GP as part of their consultation, the GP had
    been instructed to place it into the envelope provided, seal it and mail all
    completed documents to one of the research team.


4. The product they intended to purchase was to be recorded on the log sheet (see
    below) and was to be provided labelled as per the pharmacy’s usual practice and
    placed in a click seal bag, sealed with a tamper proof sticker (provided by the
    investigators) and given free of charge to the patient. The patients were to be
    instructed that they could only commence treatment after they had seen their
    doctor and the treatment had been approved. The importance of delaying
    commencement of treatment was to be explained, so that their test results were
    not affected. Where the patient was unwilling to wait to commence treatment, they
    were not to be recruited into the study.


5. A “Doctor’s Pack” as prepared by the investigators and previously supplied to
   participating pharmacies, were to be supplied to the patient. It contained some
   documentation and consumables which the doctor would need in order to carry
   out the appropriate tests, so the patient was to be instructed to take this with them
   when they went for their doctor’s appointment.




                                          - 26 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

6. The results of the tests went back to their doctor and where the patient’s treatment
   required changing, the appropriate treatment as prescribed by their GP was to be
   supplied, charged as per usual practice, to the patient.


In addition, pharmacists were instructed to enter full details of all enrolled patients as
well as limited details of those women who declined, but would otherwise have been
eligible to participate in the study, thus providing the researchers with a denominator
for selection. A log sheet was provided for this purpose, which also served as a
check-list for the pharmacist in the enrolment process (see Appendix 4 – ‘TAFT
Project : Patient Recruitment List’).



3.5.     General Practitioner’s training and reimbursement
GPs were provided with all the relevant background information and documentation
processes for the study during the initial education evening, as well as via mail, and
upon contact by a community pharmacist at the time of organising an appointment for
each enrolled patient as required. GPs participating in the study received a payment
of $100 per patient once the results of the investigations and the confirmed diagnosis
were provided to the study team. This payment covered the cost of the long
consultation required that would not be covered by Medicare.



3.5.1.     General Practitioner’s role
(See Appendix 5 – ‘TAFT Project: Doctor’s Information Form’)
GPs were required to conduct a series of tests and investigations that were based on
current best-practice as outlined by Dr Jenny McCloskey, Department of Sexual
Health, Royal Perth Hospital (see Appendix 6 – ‘TAFT Project: Microbiology
Collection Kit and Test Instructions’).


Assessment of the patient and completion of the enclosed ‘TAFT Project: Doctor’s
History, Examination and Assessment’ data collection forms (see Appendix 7) were to
be made and consequently assessment of the appropriateness of the initial treatment.
If the GP’s presumptive diagnosis indicated a need for change in the initial therapy,



                                          - 27 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

then the patient was to re-present to the enrolling pharmacist for any necessary
modifications to treatment.


All laboratory investigations were undertaken by St John of God Pathology services,
following pick up and transport of samples to the laboratory. Results of the laboratory
investigations were reported to both the project pharmacists and GP concurrently.
Where alteration of initial treatment was deemed to be appropriate, based on
laboratory results, the patient was required to attend a second follow-up visit. The
cost of any follow-up consultations and treatment(s) prescribed were not research
funded, and both the patient and GP were informed of the need for cover to be
arranged by the usual means.



3.6.     Patient’s questionnaire structure

The patient’s questionnaire was designed with a number of modules, each of which
contained questions addressing a specific area or variable. These specific variables
which had previously been implicated or proposed as possible risk factors for VVC
were identified following a review of the literature. The patients’ and doctors’
responses to questions related to each variable was then correlated with the eventual
diagnosis, establishing a range of questions that are expected to be more sensitive
for the presence or absence of candida vaginitis and consequently to the likely
responsiveness to OTC antifungal preparations (see Appendix 8 – ‘TAFT Project:
Patient Survey’). Information collected by the questionnaire included general
demographic information as well as those targeted at identifying signs, symptoms and
risk factors for VVC or other potential causes of vaginitis:




3.6.1.     Demographic information
Details of age, menopausal and marital status, weight and height were requested.




                                          - 28 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

3.6.2.     Medical conditions
Identification of medical conditions such as diabetes, obesity, pregnancy, auto-
immune conditions or conditions requiring regular use of antibiotics, steroids or other
immunosuppressive agents were made.6,10



3.6.3.     Signs and symptoms
Presence, nature and frequency of vaginal discharge, foul odour, itching, dysuria or
dyspareunia were determined.13



3.6.4.     Personal hygiene factors
The use of vaginal douching, tampons, antibacterial soaps, perfumes, or detergents,
as well as any other “feminine hygiene” products was elicited.3,13 The regular wearing
of tight and/or constrictive synthetic garments such as leotards, pantyhose, and
bathing suits which is also associated with an increased frequency of vaginal
candidiasis was determined.10



3.6.5.     Sexual history
The fact that a woman has two or more different sexual partners in the previous 12
months has been associated with an increased likelihood of vaginal candidiasis, as
such sexual history was questioned.6,9



3.6.6.     Use of other medications
Any previous management for and vaginal problems, including any alternative
medicine medications or techniques as well as previous conventional antifungal
therapy, was included in the questionnaire. Use of hormone replacement therapy in
postmenopausal patients and recent use of antibiotics or other immunosuppressive
agents was also included.10,13,24,25




                                          - 29 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

3.6.7.      Contraceptive methods

Some methods of contraception are more likely to result in candidiasis. These include
IUDs, cervical caps and diaphragms, combination oestrogen/progesterone pills, and
depot Provera® injections, therefore the use of any form of contraception was
determined.6,10


3.7.     Piloting of questionnaire

The questionnaire was pre-tested on eight women who attended a metropolitan
sexual health clinic prior to the recruitment period in order to determine the ease of
interpretation of the study questions and time for completion of the questionnaire. All
women confirmed that the questionnaire was simple to follow and that it took an
average of 10 minutes to complete.


3.8.     Doctor’s assessment questionnaire
Aside from the laboratory investigations, a standard assessment questionnaire for
doctors’ use was prepared. This incorporated duplicated questions from the ‘Patient’s
questionnaire’ as well as additional questions aimed at identifying diagnoses other
than VVC. The questions were based on the review of the literature and advice from a
consultant Sexual Health Physician.

3.9.     Laboratory Investigations
All laboratory investigations undertaken on each patient were based on current best
practice for diagnosis of vaginal conditions and included:
    1. vaginal pH (using narrow range pH test strips; Merck Spezialindikator pH 4.0
         to 7.0)
    2. urine dipstick analysis
    3. mid-stream urine culture and susceptibilities
    4. vulval fungal microscopy and culture (speciation)
    5. vaginal fungal microscopy and culture (speciation)
    6. vaginal trichomonas culture
    7. endocervical microscopy, culture and PCR for Chlamydia
    8. urethral microscopy, culture and PCR for Chlamydia



                                          - 30 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

Item 1 was undertaken and results recorded by the GP at the time the patients
underwent their initial examination. Items 2 to 8 were undertaken by St John of God
Pathology service (Nedlands, Western Australia) for a price of $80 per set of tests.
This price included all consumables for the tests as well as pickup and transport of
samples to the laboratory.



3.9.1.      Genital specimens
Specimens from genital sites were collected (at the GP visit) for the detection of
organisms from females presenting with clinical syndromes such as pelvic
inflammatory disease, cervicitis, vulvo-vaginitis, urethritis, bacterial vaginosis,
salpingitis, endometritis and genital ulcers. Acute diagnosis of genital infections is
dependent upon separating any possible pathogenic organisms from the normal
genital flora.13,15 The female genital tract is normally colonised by a large range of
microorganisms.
Swab sites included:          Vaginal
                              Endocervical
                              Vulval
                              Urethral
                              Vulval ulcer(s)


All swabs for bacterial culture were required to be collected into transport medium
(Transwabs) to allow for transportation to the laboratory.



3.9.2.      Microscopy
A wet preparation was prepared from the genital specimen to examine for yeasts and
motile Trichomonas vaginalis. A Gram stain was then examined for leucocytes,
epithelial cells (especially clue cells associated with bacterial vaginosis), yeasts and
bacteria.




                                          - 31 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

3.9.3.             Wet preparation
         i)         Collected material from swab/aspirate was placed on a slide and
                    overlayed with a coverslip.
         ii)        Examined for the presence of Trichomonas, and yeasts using phase-
                    contrast microscopy.



3.9.4.             Gram stain
              i)    Material from swab/aspirate was placed onto a slide.
              ii) Slide was placed onto heating block to dry.
              iii) Gram stain performed and then examined for leucocytes, epithelial cells,
                    clue cells, yeasts and bacteria under light microscopy.



3.9.5.             Culture examination
Plates were examined after 24 hours and 48 hours incubation. Any potential
pathogens were identified and appropriate antibiotic sensitivity testing performed.



3.9.5.1.           Polymerase chain reaction technique (PCR)

Urethral and cervical PCR were performed to test for the presence of C. trachomatis
and N. gonorrhoeae and herpes simplex virus (HSV) PCR (if ulceration was present)
was performed to detect for HSV Type 1 and Type 2 and varicella zoster.



3.9.5.2.           Processing of urine specimens

This involved the following:
   Specimen reception;
   Testing with Multistix 8 dipsticks read on the Clinitek 500;
   Microscopic examination;
   Culture;
   Identification and susceptibility testing of significant isolates; and
   Reporting of results.



                                              - 32 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

3.9.5.3.     Microscopic examination of urine


Procedure

Urine was examined microscopically using Kova slide.
For those urines which flagged positive with any of the following parameters, full
culture and sensitivity testing were performed:

     Those which had a leucocyte count of >30;
     Those urines in which bacteria had been seen; and
     For specimens other than urine collected aseptically from urinary tract.



3.10. Statistical analysis

3.10.1.      Initial sample size determination
An estimated prevalence of VVC of 32%, an estimated sensitivity of 80% and
specificity of 90% was used in the sample size calculation. Based on the study by
Ferris et. al.2 which demonstrated a 34% accuracy of self-diagnosis of candidiasis, a
sample size of 220 patients was calculated as outlined in the table below. This
sample size was expected to provide a sensitivity of approximately 79% and a
specificity of approximately 90% for the questionnaire.


      Table 2 Sample size determination

                               Laboratory Tests          Laboratory Tests
                              Positive for Candida      Negative for Candida         Total
                                    vaginitis                 vaginitis
    Questionnaire Tests
    Positive for Candida                  56                    15                     71
    vaginitis
    Questionnaire Tests
    Negative for Candida                  15                    134                   149
    vaginitis
    Total
                                          71                    149                   220


Sensitivity and specificity are proportions and, like any other proportion, their degree
of precision (width of 95% confidence interval) when measured in a study of
diagnostic tests depends upon the size of the sample to which the tests are applied.


                                               - 33 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

The sample size calculation suggests that 220 women are required to detect a
sensitivity of around 80% with a 20% width for the 95% confidence interval, and
specificity of about 90% with a 10% width for the 95% confidence interval. These
estimates are based on the study by Ferris et al.2, 26,27,28



3.10.2.    Data analysis
Data analysis was conducted using SAS software and analysed according to
commonly accepted statistical principles. The data were initially explored using
frequency distributions for categorical variables and summary statistics for continuous
variables. Chi-square test for association was performed for univariate comparisons
of potential risk factors among those women with laboratory proven candidiasis
versus those without. All chi-square 2 x 2 tables show proportions calculated by
column, except where relative risk is also determined, in which case, proportions are
calculated by row. Where the expected frequency was less than five, Fisher’s exact
test was performed. Measures of association between the variables were reported as
the relative risk, and the corresponding 95% confidence interval found and reported to
test for significance.29


Relative risks were generally calculated where a statistically significant association
was found. In certain circumstances based on clinical judgement, previous literature
evidence or proposed theoretical risks, relative risk was calculated to identify any
possible trends, despite a lack of statistical association being found.


A more complex statistical analysis such as logistic regression was not performed
due to the final sample size of the study being too small.



3.10.2.1. Doctors’ assessment

There is an expectation of consistency between the doctor’s examination and their
presumptive diagnosis and actual laboratory findings. Based on the clinical
importance of this, analyses of the doctors’ presumptive diagnoses and treatment
recommendations, and results of the laboratory testing will be performed. The
accuracy of the presumptive diagnoses and treatment recommendations made by the


                                          - 34 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

GPs will be assessed against the laboratory findings and review of questionnaires by
the participating Sexual Health Physician in the study.



3.11. Evaluation methodology and preparation of diagnostic tool /
          flowchart

3.11.1.     Preparation and validation of diagnostic flowchart
With recruitment of 220 patients, all completed data sets (patients’ and corresponding
doctors’ questionnaires and laboratory results) were to be randomly divided into two
groups of 110 patients each. The intention was for the first group’s data to be utilised
to develop the diagnostic flowchart by selecting questions of high sensitivity (see
below). The second group’s data would have served as an independent sample to
validate the diagnostic tool by determining its sensitivity, specificity, positive predictive
value (PPV) and negative predictive value (NPV). Whilst the first part was achieved,
the second was not, and is discussed further under the section ‘Change in
methodology from original study proposal’.


The order of the questions in the diagnostic flowchart was based on clinical logic and
in consideration of the sensitive nature of the questions. Questions would be
arranged as far as reasonably possible in order of ‘least potential to cause
embarrassment’ to ‘greatest potential to cause embarrassment’. This allows the
asking of the latter type of questions only upon establishing a better rapport between
the pharmacist and the patient.


The questions included in the flowchart also have to be appropriate for the pharmacist
to ask. Whilst those variables identified by the doctor or through laboratory evaluation
may be deemed clinically and / or statistically significant with respect to association
with VVC, they would not be appropriate questions for the pharmacist, since the
women may not be able to identify these factors for themselves.




                                          - 35 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

3.11.1.1. Sensitivity, specificity, PPV and NPV

The goal was to select from the patient questionnaire, variables that were
independently diagnostic for VVC. This was done by calculating the sensitivity and
specificity for each of the relevant variables, along with the positive and negative
predictive values where appropriate. Selected variables were included in the
diagnostic tool / flowchart aimed at assisting community pharmacists in treating VVC.
It is anticipated that use of the flowchart will lead to fewer false positives and false
negatives when women with a possible diagnosis of VVC present to a pharmacy for
assistance in treating the condition.


Sensitivity and specificity are properties of a test (or questions in this case) that are
used when deciding whether or not to carry out the test (eg. if the sensitivity or
specificity is low, one might decide not to do the test). However, once the results of a
diagnostic test are available (either positive or negative) the clinician needs to know
whether or not the patient has the disease, given the results of the test. This is
determined by the predictive value of the diagnostic test: the positive predictive value
being the probability of disease in a patient with a positive test result. Sensitivity and
specificity should be used for deciding which questions to include in the flowchart,
whereas PPV is more appropriate for the final flowchart (which is the diagnostic
tool).27 PPV is calculated after validating the final flowchart.


It would be difficult to find a diagnostic question that has high sensitivity and high
specificity. Therefore, sensitivity was chosen as the more important value to assist in
the independent selection of questions to include in the diagnostic tool. Sensitivity
was chosen because there would be a greater penalty for not treating a woman with
VVC (related to the false negative proportion, and hence to sensitivity) than there
would for treating a woman who does not have VVC (related to the false positive
proportion, and hence to specificity). Therefore, variables were selected from the
patient questionnaire that had a sensitivity of 75% or greater. Women were classified
as positive or negative for candidiasis based on the combined results of vaginal and
vulval culture, and this was used as the ‘gold standard’ test to calculate sensitivity and
specificity for relevant variables from the patient questionnaire.




                                          - 36 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

Calculation of PPV and NPV were only performed where the sensitivity was
sufficiently high (>75%), or where a statistically significant association was found,
thereby qualifying the variable for inclusion in the diagnostic flowchart as described
above. PPV was necessary in these instances to allow the calculation of an average
PPV as an estimated parameter for our economic analysis models.


The diagnostic tool that was developed by the above method requires validation in a
follow-up study to calculate its sensitivity, specificity, positive predictive value and
negative predictive value.



3.12. Economic analysis
The following costs were recorded: the cost of the doctor’s consultations (based on
Medicare rebates); the laboratory tests; and the medication prescribed.


The economic benefit of providing OTC vaginal antifungal products through
pharmacies was originally to be assessed in the following way:


Cost Avoided (CA) = Number of study patients for whom the questionnaire predicted
                     vaginal candidiasis proven microbiologically) x Total Costs minus
                     Number of patients for whom the questionnaire predicted vaginal
                     candidiasis not proven microbiologically x Total Costs


Where Total Costs = consultation fees + the cost laboratory tests + difference in
treatment costs between the agent requested by the patient and prescribed by the
doctor and the
overall cost savings = No. patients requesting vaginal antifungals x CA
                         No. patients requesting vaginal antifungals


This data was then to be used to predict cost savings per 100 consultations. This was
amended as described under the following section.




                                          - 37 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

3.13. Change in methodology from original study proposal

3.13.1.    Sample size and validation of diagnostic flowchart
Significant problems with the recruitment of patients for this study were encountered.
Due to the lack of value seen in continuing with a very slow accrual rate that would
require a significant extension of time to achieve the original target number of 220
patients, despite efforts to improve enrolment via published advertising, the
curtailment of the project was proposed and approved.


Since the planned 220 patients were unable to be recruited, it was not possible to
split the data to allow for the validation of the diagnostic flowchart using the second
group of patients as originally planned, since splitting the total number of data sets
would have meant using data from only 38 patients. If we had split the 77 complete
sets of data that were collected, there would have been insufficient power to develop
the diagnostic flowchart.



3.13.2.    Economic analysis
The method of analysing the economic benefit of providing OTC vaginal antifungal
products through pharmacies was amended slightly by calculating the direct cost
avoidance, thereby excluding the cost to the patient of the doctor’s visits in terms of
transportation and time, as was estimation of other health care savings made based
on epidemiological data on cost of delay in the management of other non-fungal
vaginal conditions. The analysis was made based on economic models, presented as
four differing scenarios looking at the process of diagnosis and associated expenses.
The resultant differences in total cost per 100 women presenting with suspected VVC
was used to demonstrate the theoretical economic benefit of providing OTC vaginal
antifungal products with appropriate pharmacists’ input and use of our proposed
diagnostic flowchart. It must be highlighted that the final economic analysis was
theoretical and based on an estimate of the PPV. The estimated PPV was calculated
by taking an average of the PPV of variables included in the flowchart. The limitations
associated with this type of economic analysis are discussed under ‘Limitations of the
study’.



                                          - 38 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).




3.14. Ethics
The study was conducted according to the principles set out by the National
Statement on Ethical Conduct in Research Involving Humans. The Curtin University
of Technology Human Research Ethics Committee had reviewed and approved the
study. Written informed consent was obtained from each subject. Patients were free
to withdraw from the study at any time for any reason, without effect on their medical
care. If subjects wished to discuss the study with someone who was not directly
involved in it (for example, about the information they had received, the conduct of the
study or their rights as a participant, or to make a complaint), they were informed that
they could contact the Curtin University Human Research Ethics Committee
Secretariat.




                                          - 39 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

4. RESULTS


Between May 2003 and end of June 2004, 103 women were enrolled in the study. Of
these, complete sets of data were available for 77 women whereby both the doctors’
and patients’ questionnaires and all requested laboratory tests had been completed
and returned to the investigators. However in total, 94 completed doctors’ and
patients’ questionnaires had been returned to the investigators and a total of 88 sets
of laboratory data (not necessarily complete for all parameters under investigation)
had been collected. A total of nine patients withdrew from the study, not having
completed any of the questionnaires or laboratory investigations.



4.1.      Demographics

4.1.1.       Age
The mean age of those subjects who presented with a self-diagnosis of VVC and
completed details pertaining to their date of birth in our study population was 39
years, and the range was 19 to 79 years. Further to this, the mean age of those
women who were confirmed by laboratory investigation to be positive for vulvovaginal
candidiasis, was determined to be 36 years (Table 3).


      Table 3 Mean and range of age for those women who were confirmed to be either negative
               or positive for candidal infection

                                                                         Age range (years)
                                   Mean
 Variable      Candida     n      (years)            SD        SE       Minimum      Maximum

Age          Negative       45              43            14        2           21             79
Age          Positive       39              36            13        2           19             71
Age          Diff (1-2)                      7            13        3



4.1.2.       Ancestry
Out of the 94 subjects who indicated their ancestry, the majority (62%) were
Australian, the second largest group being of European decent (31%), Asians



                                            - 40 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

comprised 5% of the study population and the remainder were as displayed in Figure
1. Note that the percentages were calculated based on a sample population of 94,
and some subjects indicated belonging to more than one ancestry group.


   Figure 1 Ancestry of Study Participants




              70
                                                              Australian
             60                                               European
             50                                               Asian
           % 40                                               New Zealander
             30                                               Other Ancestry Stated
                                                              British
             20
                                                              African
             10
                                                              Canadian
              0
                                  Ancestry




4.1.3.     Marital status
On the matter of marital status, 89 subjects identified the relevant category to which
they belonged. Of these 25% were single or never married, 58% were married or in a
defacto relationship, and 17% were divorced, separated or widowed (Figure 2).




                                          - 41 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



   Figure 2 Marital Status of Study Participants




                      17%
                                            25%

                                                                Single (never married)

                                                                Married / defacto

                                                                Divorced / separated /
                                                                widowed


                          58%




4.1.4.     Sexual history
The reported median number of sexual partners that our study population had over
both the last 3- and 12-month periods was one, and over their lifetime was four. The
corresponding means for these periods were skewed due to one female subject, with
a stated number of lifetime sexual partners of 1000, see Table 4.




                                          - 42 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



    Table 4 Sexual activity of subjects over selected periods

                                                                          Range
Number of different
 sexual partners          n      Mean         Median      SD        Minimum       Maximum

Last 3 months             93             1            1         5             0           50

Last 12 months            93             2            1    10                 0          100


Lifetime                  92            18            4    104                1        1000


Lifetime (with outlier    91             8            4    13                 1          100
excluded)




Table 5 indicates that of those subjects who tested positive for candida from both
vaginal and vulval swab results, 10% had no sexual partners, 85% had one sexual
partner and 5% had at least 2 sexual partners over the last three-month period, prior
to enrolment into the study. The number of sexual partners that our study cohort had
over this period of sexual activity was tested for any statistical association with
laboratory proven VVC. Chi-square analysis revealed no statistically significant
association between the number of sexual partners in the 3 month period and VVC
confirmed by culture, 2 (2), 5.7578 (P = 0.0562).




                                             - 43 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



    Table 5 Number of different sexual partners over the last 3 months versus VVC by culture

                           Combined vaginal and vulval candidiasis
  Number of sexual
                                        by culture                                 Total (%)
 partners over last 3
       months                 Negative (%)               Positive (%)

                       0                    14 (30)                 4 (10)                  18 (20)
                       1                    30 (64)                35 (85)                  65 (74)
                     ≥2                       3 (6)                  2 (5)                       5 (6)
Total                                    47 (100)                 41 (100)                 88 (100)

Statistic                                       df                  Value                            P
Chi-Square                                       2                 5.7578                    0.0562
Proportions calculated by column.
N=88, missing data=6.
[Source information: Curtin University of Technology, TAFT Project Doctor’s Questionnaire 2004
(Computer File)]


Similarly, Table 6 explored the data relating to the number of sexual partners of each
subject over the last 12 month period. Of those subjects who tested positive for
candida, 85% had one partner, 5% had two and 10% had at least 3 sexual partners
over this period. Chi-square analysis again revealed no statistically significant
association between the number of sexual partners in the 12 month period and VVC
confirmed by culture, 2 (2), 1.6441 (P = 0.4395).


    Table 6 Number of different sexual partners over the last 12 months versus VVC by culture

   Number of sexual partners over               Combined vaginal and vulval
          last 12 months                          candidiasis by culture                 Total (%)
                                              Negative (%)          Positive (%)

                                        1               28 (76)               33 (85)      61 (80)
                                        2                5 (13)                  2 (5)           7 (9)
                                      ≥3                 4 (11)                 4 (10)       8 (11)
  Total                                                37 (100)              39 (100)     76 (100)

  Statistic                                                  df                 Value               P
 Chi-Square                                                  2                 1.6441       0.4395
Proportions calculated by column.
N = 76, missing data = 18.
[Source information: Curtin University of Technology, TAFT Project Doctor’s Questionnaire 2004
(Computer File)]




                                              - 44 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

Finally the influence of the number of lifetime partners on VVC was investigated.
Table 7 firstly indicates that of those 82 women who provided data for the number of
lifetime sexual partners, the majority (65% of this subset of our total study cohort)
admitted to having between one to five sexual partners in their lifetime. Table 8 shows
that 67% of those subjects who tested positive for candida had one to five sexual
partners in their lifetime, a similar proportion (62%) who had the same number of
sexual partners had tested negative for candida, in comparison to the remaining
groups in each column. Chi-square analysis showed that the number of lifetime
sexual partners had no influence on the disease outcome, 2 (4), 3.9088 (P = 0.4185).


   Table 7 Number of lifetime sexual partners for subjects

   Number of lifetime sexual
          partners                                   n                             %

1-5                                                               53                               65
6 - 10                                                            15                               18
11 - 15                                                            5                                6
16 - 20                                                            2                                2
> 20                                                               7                                9
Total                                                             82                             100


   Table 8 Number of lifetime sexual partners versus VVC by culture

                                Combined vaginal and vulval
                                  candidiasis by culture                          Total (%)
 Number of lifetime
  sexual partners            Negative (%)                Positive (%)

                  1-5                   25 (62)                   25 (67)                     50 (65)
                 6 - 10                   6 (15)                   7 (19)                     13 (17)
               11 – 15                    4 (10)                    1 (3)                        5 (6)
               16 – 20                     2 (5)                    0 (0)                        2 (3)
                  > 20                     3 (8)                   4 (11)                        7 (9)
Total                                  40 (100)                 37 (100)                   77 (100)

Statistic                                     df                   Value                            P
Chi-Square                                     4                  3.9088                      0.4185
Proportions calculated by column.
N = 77, missing data = 13.
[Source information: Curtin University of Technology, TAFT Project Doctor’s Questionnaire 2004
(Computer File)]



                                            - 45 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).




4.1.5.          Weight and body mass index (BMI)
Tables 9 and 10 indicate that the average weight and calculated BMI of the 86
women who responded to the relevant questions in the questionnaire were 65kg and
24kg/m2 respectively. The BMIs were grouped30 and each category assessed further,
the details of which are presented in Table 11. In performing the chi-square test for
association between BMI category and candidal infection determined by culture, the
observed value of 2 (3), was determined to be 2.605 (P = 0.457), see Table 12.
These figures indicate a lack of association between BMI category and VVC proven
by culture. Consequently the proportions of subjects compared between BMI groups
within each column of disease outcome were similar (see Table 12). Interestingly
100% of those subjects who were ‘underweight’ tested positive for candida.


     Table 9 Weight of subjects

                                                                                  Weight range (kg)

 n        Mean weight (kg)       Median weight (kg)          SD              Minimum       Maximum

     86                   65.2                   63.0                 11.4          49.0         100.0


     Table 10 BMI of subjects

                                   Analysis Variable : BMI (kg/m2)
     n          Mean      Median          SD                Minimum                    Maximum

          83       23.8          23.0           4.1                      18.1                     39.1


     Table 11 BMI category

               Status                    BMI                      n                        %

Extremely obese                                       ≥40                     0                        0
Obese                                     ≥30.0 – <40                         7                       8.4
Overweight                              ≥25.0 – <30.0                        13                   15.7
Normal                                    ≥18.5 - <25                        61                   73.5
Underweight                                       <18.5                       2                       2.4
Total                                                                        83                  100.0
N = 83, missing data = 11



                                               - 46 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



   Table 12 BMI category versus VVC by culture

                            Combined vaginal and vulval candidiasis by
                                             culture
     BMI category                 Negative (%)               Positive (%)             Total (%)

Obese                                            3 (7)                     3 (9)                  6 (8)
Overweight                                      7 (17)                    6 (17)              13 (17)
Normal                                         32 (76)                   24 (68)              56 (65)
Underweight                                      0 (0)                     2 (6)               2 (10)
Total                                        42 (100)                  35 (100)            77 (100)

Statistic                               df                       Value                    P
Chi-Square                                            3                   2.605                0.457
Proportions calculated by column.
N = 77, missing data = 17.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]

4.1.6.      Menopausal status
Of our study population, 88 women identified their menopausal status, out of which
20% were post-menopausal and 80% were pre-menopausal. From those who were
identified as pre-menopausal, 54% tested positive for disease outcome (VVC), 46%
tested negative for VVC. In contrast, of those who were post-menopausal 28% were
positive for candida and 72% were negative for candida (see Table 13). Based on the
observations outlined in Table 13, chi-square test for association showed 2 (1),
3.8465 (P = 0.0498), this supports a possible statistical association between
menopausal status and culture proven VVC. The relative risk (RR) calculated to
estimate the relationship between the two different menopausal status’ with having
confirmed vulvovaginal candidiasis was found to be 0.5147, 95% confidence interval
(CI) 0.2362, 1.1217. Based on the calculated RR, the results suggest that post-
menopausal women in our study population are about half as likely to have laboratory
confirmed VVC compared to the pre-menopausal cohort, though the CI indicates no
statistical significance in relation to the RR. Of note is that all the post-menopausal
subjects in our analysis were on hormone replacement therapy.




                                             - 47 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



   Table 13 Menopausal status versus VVC by culture

                                      Combined vaginal and vulval
                                        candidiasis by culture
    Menopausal status              Negative (%)             Positive (%)            Total (%)

            Post-menopausal                  13 (72)                    5 (28)             18 (22)
            Pre-menopausal                   29 (46)                  34 (54)              63 (78)
Total                                       42 (100)                 39 (100)             81 (100)

Statistic                                         df                   Value                      P
Chi-Square                                            1               3.8465               0.0498

                        Estimates of the Relative Risk (Row1/Row2)
Type of Study                          Value                            95% CI
Cohort (Column 2 Risk)                       0.5147                   0.2362               1.1217

Sensitivity (%)                                   87          Specificity (%)                     31
Positive predictive value                         56      Negative predictive                     72
(%)                                                                 value (%)
Proportions calculated by column.
N = 81, missing data = 13.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]



4.2.     Medical history
Of the ninety-four women who completed questionnaires addressing their medical
histories, Table 14 lists the medical histories of particular interest and their respective
frequencies of occurrence. Note that the percentages are calculated based on a
sample size of 94 for each medical condition, and more than one medical condition
may have been selected by subjects.




                                             - 48 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).




   Table 14 Medical histories of interest and their reported frequencies


         Medical History                           n                           %

Allergies                                          36                          38
     Hayfever                                     28                          30
     Food                                          5                           5
     Drugs                                        11                          12
     Animal Dander                                 2                           2
Asthma                                             12                          13
Anaemia                                            13                          14
Arthritis                                           4                           4
Bleeding Disorder                                   1                           1
Cancer                                              3                           3
Diabetes                                            3                           3
Eating Disorder                                     2                           2
Sexually Transmitted Disease                       19                          20
     Chlamydia                                     4                           4
     Genital Herpes                                9                          10
     Genital Warts                                 7                           7
     HPV on PAP Smear                              2                           2
Skin Disorders                                     22                          23
     Dermatitis                                   11                          12
     Eczema                                        7                           7
     Psoriasis                                     1                           1
     Other                                         2                           2
Urinary Tract Infection (in the last
year)                                              23                          24
     UTI 0                                         7                           7
     UTI 1 – 3                                    14                          15
     UTI 4 – 6                                     1                           1
     UTI > 6                                       1                           1
Vaginal bleeding                                    9                          10
Percentages calculated on N = 94


4.2.1.      Sexually transmitted diseases (STD)
Out of our study cohort who had completed and returned their questionnaires (94
women), 20% reported a history of at least one of the following sexually transmitted
diseases: gonorrhoea; chlamydia; genital herpes; genital warts; and human
papillomavirus (HPV) confirmed on PAP smear. Where the particular disease was
specified, the frequency and percentage determined for each is listed in Table 14.
The numbers indicate that some women had a history of more than one STD.




                                          - 49 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).


4.2.2.      History of allergies
A total of 38% of the women reported a history of allergies of at least one type, which
included hayfever, food, drugs and animal dander (Table 14 indicates the breakdown
in frequencies). Again, some women suffered from multiple sources of allergies. The
associated risk of having a documented history of allergies along with other possible
inflammatory conditions and a current laboratory proven episode of VVC was
assessed and the data presented in Table 16, see after ‘Skin disorders’.

4.2.3.      Immunodeficiency and diabetes
With respect to any disorder caused by or possibly resulting in immunosuppression
eg as a consequence of treatment, the following were the frequencies reported:
arthritis 4%; cancer 3%; diabetes 3%; and eating disorders 2%.


Table 15 looks at those women who listed a history of diabetes against their candidal
status, showing that 5% of those women who were confirmed to have vulvovaginal
candidiasis by culture had a diagnosed history of diabetes (2% of our diabetic cohort
did not). The sample size was too small for further statistical analysis. It is interesting
to note that one of the women who presented with self-diagnosed VVC was
subsequently diagnosed with diabetes as a result of recruitment into this study.


   Table 15 History of diabetes versus VVC by culture

                         Combined vaginal and vulval candidiasis by
                                          culture                                  Total (%)
   Diabetic status           Negative (%)               Positive (%)

                    No                    43 (98)                   35 (95)                78 (96)
                  Yes                       1 (2)                      2 (5)                   3 (4)
Total                                   44 (100)                  37 (100)                81 (100)

Sensitivity (%)                                 5 Specificity (%)                                 98
Positive predictive                            67 Negative predictive                             55
value (%)                                         value (%)
Proportions calculated by column.
N = 81, missing data = 13.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]




                                             - 50 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).


4.2.4.     Bleeding disorders
Of the women reporting some form of bleeding disorder, anaemia was reported in
14%, bleeding disorder unspecified in 1%, and vaginal bleeding other than normal
menstruation in 10% (Table 14).

4.2.5.     Urinary tract infection (UTI)
In our study cohort, a total of 23 (24%) of women who completed the questionnaire
reported a history of urinary tract infection(s). Out of these 16 (70%) reported
suffering at least one UTI in the preceding twelve months. The various frequencies of
occurrence with respect to numbers of infection are listed in Table 14.



4.2.6.     Skin disorders
A total of 23% of women reported suffering some form of skin disorder in the past.
Integumentary defects such as eczema and dermatitis which may be associated with
a primary immunodeficiency disorder 31 were reported in 7% and 12% of our study
cohort respectively.


In testing to see if an association existed between having a documented history of at
least one of the following: allergies and / or a predisposition to allergies (eg with
asthmatics); skin disorders; and the occurrence of VVC, chi-square analysis was
performed, see Table 16. No association could be found, 2 (1), 0.0020 (P = 0.9647).
Not surprisingly, the comparative proportions within each of the columns for disease
outcome (candida positive or negative) were very similar.




                                          - 51 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



    Table 16 History of allergies, skin disorders and asthma versus VVC by culture

                                Combined vaginal and vulval
 History of allergies
                                  candidiasis by culture                         Total (%)
+/- skin disorders +/-
       asthma                Negative (%)             Positive (%)

                    No                  20 (45)                  17 (46)                    37 (46)
                   Yes                  24 (55)                  20 (54)                    44 (54)
Total                                  44 (100)                37 (100)                   81 (100)

Statistic                                     df                  Value                           P
Chi-Square                                     1                 0.0020                      0.9647

Sensitivity (%)                              54         Specificity (%)                           45
Proportions calculated by column.
N = 81, missing data = 6.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]

4.2.7.      Current use of antibiotics, immunosuppressants, blood
            sugar level (BSL) lowering agents and hormonal agents
            (‘VVC predisposing drugs’)
Certain medications have been implicated in predisposing women to VVC.21,23 From
Table 17 it is evident that the main class of drugs which fit into this category, and
which were being taken by 60% of our subset of women who indicated that they were
on at least one medication (n = 50), were the hormonal agents which included
primarily the OCP. Table 18 indicates that of those women who were on a hormonal
agent, 71% tested positive for candida and 29% tested negative for candida. When
analysed as individual classes tested for association against current episode of
culture proven VVC, no statistically significant association was found, Fisher’s exact P
= 0.0539, see Table 18. However, when they were combined as a group and tested
for association, there was a statistically significant association found, 2 (1), 6.1025 (P
= 0.0135), see Table 19.


The data in Table 19 shows that of those subjects who were on at least one of these
‘predisposing drugs’, 74% tested positive for candida and 26% tested negative for
candida. On the other hand, of those subjects not taking a ‘predisposing drug’, 41%
tested positive for candida as opposed to 59% who tested negative for candida. The



                                             - 52 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

RR was approximately 1.8 (95% CI, 1.1893, 2.7503), indicating a statistically
significant, almost two-fold increased risk in our subjects of having VVC, when
concurrently taking an agent from one of these classes of drugs. The test was also
determined to have a positive predictive value of 74%, indicating that there is a
relatively high probability of having VVC given that a woman is taking a ‘predisposing
drug’.


Since some of the women in our analysis were on multiple agents, those who were on
any concurrent drugs and / or alternative therapies that were considered even
remotely likely to ‘prevent’ VVC (eg dietary supplements, acidophilus culture
supplements etc) were excluded in our data analysis. Even without the exclusion of
these confounders, a statistically significant association was still evident (data not
presented).


   Table 17 Frequency of use of ‘VVC predisposing drugs’ in our study cohort

                                                                              %
       Drug class                       n                            (Based on n = 50)
Antibiotics                                            1                                           2
BSL lowering agents                                    2                                           4
Hormonal agents                                       30                                          60
Immunosuppressants                                     3                                           6
Total                                                 50                                          100
Notes:
        Only systemic agents were considered.
        ‘Hormonal agents’ included OCP / contraceptive implants and HRT.


N = 50.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]




                                             - 53 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



    Table 18‘VVC predisposing drugs’ versus VVC by culture

                                     Combined vaginal and vulval
                                       candidiasis by culture                        Total (%)
‘VVC predisposing drug
        class’                    Negative (%)               Positive (%)

                Antibiotics                   1 (100)                      0 (0)            1 (100)
         Hormonal agents                       7 (29)                17 (71)               24 (100)
    BSL lowering agents                        1 (50)                  1 (50)               2 (100)
   Immunosuppressants                         2 (100)                      0 (0)            2 (100)
Total                                         11 (38)                18 (62)               29 (100)

Statistic                                             df              Value                       P
Chi-Square                                             3              5.8159                 0.1209
Fisher’s Exact test                                                                          0.0539
Proportions calculated by row.
N = 29, missing data = 96.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]


    Table 19 Combined use of ‘VVC predisposing drugs’ versus VVC by culture

                                     Combined vaginal and vulval
                                       candidiasis by culture                        Total (%)
‘VVC predisposing drug’
          use                     Negative (%)               Positive (%)

                         No                   32 (59)                22 (41)               54 (100)
                        Yes                    5 (26)                14 (74)               19 (100)
Total                                         37 (51)                36 (49)               73 (100)

Statistic                                             df              Value                       P
Chi-Square                                             1              6.1025                 0.0135

                        Estimates of the Relative Risk (Row2/Row1)
Type of Study                         Value                                 95% CI
Cohort (Column 2 Risk)                        1.8086                  1.1893                 2.7503

Sensitivity (%)                                       39 Specificity (%)                          86

Positive predictive value                             74 Negative                                 59
(%)                                                      predictive value
                                                         (%)
Proportions calculated by row.
N = 73, missing data = 5.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]



                                             - 54 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).




4.3.       Laboratory and other findings

4.3.1.       pH
The pH of the vagina was cross-tabulated with the candida status on vaginal culture
and statistically analysed (Table 20). It was determined that of those women who had
a normal pH, 53% were confirmed as candida positive and 47% as candida negative
on vaginal culture. No statistical significance was found for this cohort. Allowing for
the likelihood that a higher pH may be expected in subjects who’d had sexual
intercourse in the last 24 hours, and which could consequently act as a confounder,
analysis was performed excluding these subjects but still failed to show any
statistically significant association between pH and VVC proven microbiologically
(data not presented).


   Table 20 Vaginal pH versus vaginal candidiasis by culture

                pH                    Vaginal candidiasis by culture               Total (%)
                                     Negative (%)           Positive (%)

              pH ≤ 4.5 (normal)                 23 (47)              26 (53)             49 (100)
             pH > 4.5 (elevated)                21 (58)              15 (42)             36 (100)
 Total                                          44 (52)              41 (48)             85 (100)

 Statistic                                           df                Value                     P
Chi-Square                                            1               1.0791               0.2989
Proportions calculated by row.
N = 85, missing data = 9.
[Source information: Curtin University of Technology, TAFT Project Doctor’s Questionnaire 2004
(Computer File)]



4.3.2.       Vaginal and vulval swabs: Culture and Gram stain results

4.3.2.1.     Candida by speciation

Figure 3 and Figure 4 present the different species of candida that were isolated from
each of the swab sites, vaginal and vulval. While the majority of isolates were
determined to be Candida albicans (approximately 79% on vaginal and 80% on vulval
cultures), a total of approximately 8% (potentially 21% including those not identified)


                                            - 55 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

on vaginal and 7% (potentially 20% including those not identified) on vulval cultures
were determined to be cases of non-albicans. The numbers isolated for each species
of candida were too small to conduct further analysis to assess for an association
between species of candida and specific vulvovaginal signs and symptoms.


   Figure 3 Candida species on vaginal cultures




                               13%
                          5%
                        3%                                              Albicans
                                                                        Glabrata
                                                                        Non-albicans
                                                                        Not Identified

                                              79%




   Figure 4 Candida species on vulval cultures




                               12%
                          5%
                         2%                                             Albicans
                                                                        Glabrata
                                                                        Non-albicans
                                                                        Not Identified

                                              81%




                                          - 56 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

4.3.3.       Leucocytes
Whether the presence of leucocytes was associated with laboratory confirmed VVC
was tested. Table 21 shows that 2 (1), 0.8357 (P = 0.3606) results indicate no
association found in our study cohort. Even when tested against the varying levels of
leucocyte count there was no association found (data not presented). The validity of
the test (sensitivity and specificity) are also shown, clearly identifying an acceptable
sensitivity (88%), but a poor specificity (7%). The positive and negative predictive
values of the test are also highlighted (47% and 38% respectively), indicating that
leucocyte count as a diagnostic marker for VVC by culture based on our study
findings is not of a high predictive value.


    Table 21 Presence of leucocytes versus VVC by culture

                            Combined vaginal and vulval candidiasis
                                         by culture                                Total (%)
        Presence of
        leucocytes             Negative (%)             Positive (%)

                      No                    3 (7)                    5 (12)                    8 (9)
                      Yes                43 (93)                    36 (88)                79 (91)
Total                                   46 (100)                  41 (100)                87 (100)

Statistic                                      df                    Value                          P
Chi-Square                                      1                   0.8357                 0.3606

Sensitivity (%)                               88           Specificity (%)                          7

Positive predictive                           46     Negative predictive                         38
value (%)                                                      value (%)
Proportions calculated by column.
N = 87, missing data = 16.
[Source information: Curtin University of Technology, TAFT Project Laboratory Data 2004 (Computer
File)]



4.3.4.       Lactobacilli
Laboratory data for the isolation of lactobacilli from the vulval and vaginal swabs were
recorded in only a total of 40 samples. This data was tested for association with VVC
proven microbiologically and chi-square analysis as outlined below showed no
association, 2 (1), 0.2963 (P = 0.5862), see Table 22.




                                            - 57 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

     Table 22 Presence of lactobacilli versus VVC by culture

                                  Combined vaginal and vulval
                                    candidiasis by culture                       Total (%)
        Presence of
        lactobacilli             Negative (%)         Positive (%)

                       No                23 (92)                  13 (87)                    36 (90)
                       Yes                  2 (8)                  2 (13)                     4 (10)
Total                                   25 (100)                 15 (100)                 40 (100)

Statistic                                       df                 Value                            P
Chi-Square                                       1                0.2963                     0.5862

Sensitivity (%)                                 13     Specificity (%)                           92
Proportions calculated by column.
N = 40, missing data = 47.
[Source information: Curtin University of Technology, TAFT Project Laboratory Data 2004 (Computer
File)]



4.3.5.       Group B streptococcus
The relation of group B streptococcus (GBS) isolated from vulval and vaginal swabs
and its association to vulvovaginal symptoms is unclear.16,17 GBS was isolated in only
10 (11.4%) of our 88 suitable swab results, see Table 23, which also specifies the
level of growth determined for GBS in our vulval and vaginal swab samples.
Unfortunately this was too small a sample size to permit any further meaningful
statistical analyses to assess for association with the data collected on vulvovaginal
symptoms in our study cohort.


     Table 23 Group B streptococcus isolated from vulval and vaginal swabs

            Group B streptococcus                            n                        %

No                                                                     78                           89
Yes                      Light growth                                   3                            3
                         Moderate growth                                4                            5
                         Heavy growth                                   3                            3
                         Total                                         88                       100
Percentages calculated based on N = 88.




                                            - 58 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

4.3.6.       Mid-stream urine samples: Urinary tract infection
The number of women in our cohort who had a mid-stream urine sample collected
and analysed was 82. From this, four (5%) had a culture proven urinary tract
infection. Table 25 lists the causative bacteria, 25% of the infections were secondary
to Klebsiella and 75% to E. coli. Three out of these four episodes of UTI had not been
diagnosed as such by the consulting doctors and an alternative diagnosis had been
made. In the remaining patient, the doctor chose to await the results before deciding
on the final diagnosis.



     Table 24 Proportion of MSU samples where bacterial growth and UTI confirmed

Bacterial growth detected
        from MSU                            n                               %

No                                                      78                                    95
Yes                                                      4                                     5
Total                                                   82                                    100




     Table 25 Causative bacteria of UTIs

 Causative bacteria of UTI                  n                               %

Klebsiella                                               1                                    25
E. coli                                                  3                                    75
Total                                                    4                                    100



4.3.7.       Sexually Transmitted Diseases (STD)
Table 33 outlines the confirmed cases of chlamydia (two cases) and genital herpes
(two cases) based on the PCR results. Note that one patient had both HSV Type 1
and HSV Type 2 isolated, therefore bringing the total number of subjects with
confirmed genital herpes infection to two. PCR was not performed for all subjects in
the study cohort, in particular with respect to HSV, since only those subjects in whom
genital ulcers were identified were suitable candidates for HSV PCR swabs. The
percentages reflect the proportion of subjects who were confirmed to have the listed
STD based on the corresponding number of PCRs performed to detect that particular


                                           - 59 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

STD. All were newly diagnosed cases of STD, i.e. none of the four subjects had
indicated a past history of either chlamydial or herpetic infections in their medical
history.


   Table 26 Cases of STD



                                                     Total no. of PCRs
                                                    performed to detect
               STD                     n            corresponding STD             %

Chlamydia trachomatis positive              2                         79                       2
Herpes Simplex Type 1 detected              1                         20                       5
Herpes Simplex Type 2 detected              2                                                 10
Total number of patients                    4

NOTE:
   1. One patient tested positive for HSV1 and HSV2.
   2. Percentages calculated based on column 3 (total number of PCRs)


Other significant diagnoses
Apart from the UTI and STD cases outlined above, other significant diagnoses that
were confirmed microbiologically included two cases of bacterial vaginosis and as
previously mentioned one newly diagnosed case of diabetes. Therefore, from the 86
subjects able to be assessed and diagnosed by laboratory means, 13% of our study
population had some other significant diagnoses identified.



4.4.       Patient’s questionnaire: Vulvovaginal signs and symptoms
While all the women who were recruited suspected and consequently self-diagnosed
VVC based on the signs and symptoms they were experiencing, Table 27 indicates
how accurate they had been in their self-diagnosis in accordance with the results of
the vaginal and vulval cultures. Only 41 out of the 88 women (47%), who had vaginal
and vulval swabs taken were confirmed microbiologically to have a candidal infection.
The remaining 53% of women either had another type of infection or did not have an
infection at all.




                                           - 60 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

   Table 27 VVC according to vaginal and vulval culture

            VVC by culture                             n                           %

Candida negative                                                  47                           53
Candida positive                                                  41                           47
N = 88, missing data = 6.
[Source information: Curtin University of Technology, TAFT Project Laboratory Data 2004 (Computer
File)]


The subsequent tables detail and assess the various vulvovaginal signs and
symptoms experienced and reported by the women which led them to their self-
diagnosis of VVC. From the 94 women who completed and returned their
questionnaires, Table 28 identifies the frequency of occurrence of each of the
vulvovaginal signs and symptoms that were reported (in order of descending
frequency), with the exclusion of all negative answers and answers that indicated any
uncertainty. The percentage frequency was determined based on a total sample size
of 94. It is evident from the results that the four most frequently identified signs or
symptoms were vaginal discharge (70%), vulval pruritus (76%), vaginal pruritus (68%)
and vulval tenderness (58%). Table 28 also includes the validity of each of the
screening tests (the sensitivity and specificity) in diagnosing VVC, obtained from the
data presented in the subsequent corresponding tables.




                                            - 61 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

    Table 28 Total frequency of occurrence of vulvovaginal signs and symptoms and validity of
             screening tests for diagnosis of VVC

Sign / Symptom identified as
                                      n               %       Sensitivity (%)      Specificity (%)
          present

Vaginal discharge                     66              70
      vaginal candidiasis                                           88                   29
      vulval candidiasis                                            89                   32
      combined vaginal /                                            89                   31
       vulval
Vulval pruritus                       71              76
      vulval candidiasis                                            82                   23
Vaginal pruritus                      64              68
      vaginal candidiasis                                           77                   34
      vulval candidiasis                                            76                   35
Vulval tenderness                     55              58             61                   40
Dyspareunia
      During                         11              12
      After                          5               5
      Both                           24              26

      Unspecified                    4               4

Total dyspareunia                     44              47             64                   53
Vulval erythema                       43              46             72                   42
Vaginal discharge odour               41              44
      vaginal candidiasis                                           71                   28
      vulval candidiasis                                            74                   28
Dysuria
      Vulva                          11              12
      Urethra                        5               5
      Both                           13              14
      Unspecified                    7               7

Total dysuria                         36              38             39                   60
Vulval oedema                         32              34             44                   53
Postcoital bleeding                   8               8              13                   95
Percentages in column 3 calculated based on N = 94
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]



                                             - 62 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).




4.4.1.     Vaginal discharge
Table 29 and Table 30 contain details of the assessment for the association between
having vaginal discharge and confirmation of candidiasis either by vaginal or vulval
culture. According to the analysis of the data presented in Table 29, 48% of those
women who claimed to have a vaginal discharge tested positive for candida on
vaginal swabs, as opposed to 52% who tested negative for candida. Of those who
indicated an absence of vaginal discharge, 24% tested positive for disease outcome
(candida), versus 76% who did not. When analysed against vulval candidiasis by
culture (Table 30), similar corresponding proportions were found. Chi-square test for
association showed 2 (1), 3.1404 (P = 0.0764) for data in Table 29, and for data in
Table 23, 2 (1), 4.7266 (P = 0.0297). These results indicate a statistically significant
association between vaginal discharge and vulval candidiasis, but our sample size
lacked power to show any statistical significance for the association between vaginal
discharge and laboratory proven vaginal candidiasis. In combining the data to analyse
the association between presence of vaginal discharge and having laboratory proven
VVC based on both vaginal and vulval swabs, chi-square test results reflect that there
is an overall association 2 (1), 4.4772 (P = 0.0343), see Table 31. The RR was found
to be 2.2297, (95% CI 0.9159, 5.4259), further indicating that those women in our
study cohort who identified having a vaginal discharge were twice as likely to have
microbiologically proven VVC, though the CI does not support a statistical
significance with the results.




                                          - 63 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



    Table 29 Presence of vaginal discharge versus vaginal candidiasis confirmed by culture

                                  Vaginal candidiasis by culture                   Total (%)
  Presence of vaginal
      discharge                Negative (%)             Positive (%)

                       No                 13 (76)                    4 (24)                 17 (100)
                      Yes                 32 (52)                  29 (48)                  61 (100)
Total                                     45 (58)                  33 (42)                  78 (100)

Statistic                                       df                  Value                          P
Chi-Square                                       1                 3.1404                    0.0764

Sensitivity (%)                            88 Specificity (%)                                     29
NB: Excludes the 5 patients with ‘Unknown’ presence of discharge.
Proportions calculated by row.
N = 78, missing data = 16.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]


    Table 30 Presence of vaginal discharge versus vulval candidiasis confirmed by culture

                                  Vulval candidiasis by culture                     Total (%)
  Presence of vaginal
      discharge                Negative (%)             Positive (%)

                       No                 13 (76)                    4 (24)                 17 (100)
                      Yes                 28 (47)                  32 (53)                  60 (100)
Total                                     41 (53)                  36 (47)                  77 (100)

Statistic                                       df                  Value                          P
Chi-Square                                       1                 4.7266                      0.0297

Sensitivity (%)                                89         Specificity (%)                         32
Proportions calculated by row.
N = 77, missing data = 17.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]




                                             - 64 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



    Table 31 Presence of vaginal discharge versus VVC confirmed by vaginal and vulval culture
             swabs

                                   Combined vaginal and vulval
                                     candidiasis by culture
  Presence of vaginal
      discharge                 Negative (%)            Positive (%)               Total (%)

                        No                13 (76)                   4 (24)                  17 (100)
                       Yes                29 (48)                  32 (52)                  61 (100)
Total                                     42 (54)                  36 (46)                  78 (100)

Statistic                                      df                   Value                         P
Chi-Square                                      1                  4.4772                    0.0343

                         Estimates of the Relative Risk (Row2/Row1)
Type of Study                       Value                               95% CI
Cohort (Column 2 Risk)                    2.2297                   0.9159                    5.4259

Sensitivity (%)                                89         Specificity (%)                         31

Positive predictive                            52 Negative predictive                             76
value (%)                                                   value (%)
Proportions calculated by row.
N = 78, missing data = 16.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]



4.4.1.1.    Vaginal discharge odour

Of those subjects who tested positive for vaginal candidiasis proven by culture, 71%
identified the presence of a vaginal discharge odour and the remaining 29% did not.
These were similar to the corresponding proportions reported for those subjects who
tested negative for candida (Table 32). The data presented in Table 33 did not differ
much from that in Table 32, which looked at the presence or absence of vaginal
discharge odour in association with vulval candidiasis proven by culture. Chi-square
test for both sets of data indicated no association was found in our sample population
between the presence of vaginal discharge odour and culture proven VVC from both
vaginal and vulval swabs, 2 (1), 0.0162 (P = 0.8988), and 2 (2), 0.2482 (P = 0.8833)
respectively.




                                             - 65 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



    Table 32 Vaginal discharge odour versus vaginal candidiasis by culture

                                 Vaginal candidiasis by culture                     Total (%)
  Presence of Odour            Negative (%)              Positive (%)

                     No                     8 (28)                   7 (29)                  15 (28)
                    Yes                   21 (72)                   17 (71)                  38 (72)
Total                                    29 (100)                 24 (100)                  53 (100)

Statistic                                       df                   Value                        P
Chi-Square                                       1                  0.0162                   0.8988

Sensitivity (%)                                 71 Specificity (%)                                28
Proportions calculated by column.
N = 53, missing data = 41.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]


    Table 33 Vaginal discharge odour versus vulval candidiasis by culture

                                  Vulval candidiasis by culture                      Total (%)
 Presence of Odour             Negative (%)              Positive (%)

                     No                     7 (24)                    7 (21)                  14 (23)
             Unknown                        4 (14)                    6 (18)                  10 (16)
                    Yes                   18 (62)                    20 (61)                  38 (61)
Total                                    29 (100)                   33 (100)                62 (100)

Statistic                                       df                    Value                        P
Chi-Square                                       2                   0.2482                   0.8833

Sensitivity (%)                                74          Specificity (%)                        28
NB: No change to chi-square statistics after excluding ‘unknown’.
Sensitivity and specificity calculated with exclusion of ‘unknowns’.
Proportions calculated by column.
N = 62, missing data = 32.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]


4.4.2.       Vaginal pruritus
Similarly, the data presented in Table 34 and Table 35 demonstrate no statistically
proven association between the presence of vaginal pruritus and culture proven
candidiasis, irrespective of the swab site, i.e. vaginal or vulval, 2 (1), 1.2124 (P =
0.2709), and 2 (1), 1.2135 (P = 0.2706) respectively.


                                              - 66 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



    Table 34 Vaginal pruritus versus vaginal candidiasis by culture

                                  Vaginal candidiasis by culture                     Total (%)
 Presence of vaginal
      pruritus                 Negative (%)               Positive (%)

                      No                  16 (34)                      8 (23)                24 (29)
                     Yes                  31 (66)                     27 (77)                58 (71)
Total                                    47 (100)                   35 (100)                82 (100)

Statistic                                       df                     Value                      P
Chi-Square                                       1                    1.2124                 0.2709

Sensitivity (%)                                77            Specificity (%)                      34

Positive predictive                            47      Negative predictive                        67
value (%)                                                        value (%)
Proportions calculated by column.
N = 82, missing data = 12.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]




    Table 35 Vaginal pruritus versus vulval candidiasis by culture

                                    Vulval candidiasis by culture                    Total (%)
  Presence of vaginal
       pruritus                Negative (%)               Positive (%)

                       No                 15 (35)                      9 (24)                24 (30)
                      Yes                 28 (65)                     29 (76)                57 (70)
Total                                    43 (100)                   38 (100)                81 (100)

Statistic                                       df                     Value                      P
Chi-Square                                       1                    1.2135                 0.2706

Sensitivity (%)                                76            Specificity (%)                      35

Positive predictive                            51      Negative predictive                        62
value (%)                                                        value (%)
Proportions calculated by column.
N = 81, missing data = 13.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]
NB: No significance found in combining vaginal and vulval candidiasis.




                                             - 67 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

4.4.3.         Vulval pruritus
The data presented in Table 36 shows that where the subjects had microbiologically
proven vulval candidiasis, 82% and 18% had reported the presence or absence of
vulval pruritus, respectively. Alternatively, of those who were negative for vulval
candidiasis, 77% had reported the presence and 23% the absence of vulval pruritus.
The data illustrates that no statistically significant association could be determined
between vulval pruritus as described by the subjects and microbiologically proven
vulval candidiasis, 2 (1), 0.284 (P = 0.594). Though the data is not presented here, no
association was found with VVC by culture either.


       Table 36 Vulval pruritus versus vulval candidiasis by culture

                                   Vulval candidiasis by culture                    Total (%)
  Presence of vulval
       pruritus                Negative (%)              Positive (%)

                       No                 10 (23)                      7 (18)                 17 (21)
                      Yes                 33 (77)                   31 (82)                   64 (79)
Total                                    43 (100)                  38 (100)                  81 (100)

Statistic                                      df                      Value                         P
Chi-Square                                      1                      0.284                      0.594

Sensitivity (%)                                82          Specificity (%)                          23

Positive predictive                            48      Negative predictive                          59
value (%)                                                        value (%)
Proportions calculated by column.
N = 81, missing data = 13.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]



4.4.4.         Vulval tenderness
The data presented in the table below (Table 37) shows that there was a similar
proportion of women within the candida positive group (61% versus 39%) compared
with those within the candida negative group (60% versus 40%) who identified the
presence of vulval tenderness compared with those who did not, respectively. The
chi-square analysis consequently indicated no statistically proven association
between the presence of vulval tenderness and culture proven vulval candidiasis, 2
(1),   0.0000 (P = 0.9955).


                                              - 68 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



    Table 37 Vulval tenderness versus vulval candidiasis by culture

                                   Vulval candidiasis by culture                    Total (%)
  Presence of vulval
     tenderness                Negative (%)              Positive (%)

                      No                  17 (40)                   15 (39)                   32 (40)
                     Yes                  26 (60)                   23 (61)                   49 (60)
Total                                   43 (100)                   38 (100)                 81 (100)

Statistic                                      df                     Value                        P
Chi-Square                                      1                    0.0000                   0.9955

Sensitivity (%)                                61          Specificity (%)                        40
Proportions calculated by column.
N = 81, missing data = 13.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]
NB: Not significant for either vaginal candidiasis or combined vaginal and vulval candidiasis.



4.4.5.       Vulval erythema
Similarly Table 38 outlines the data and chi-square statistics for the association
between vulval erythema and vulval candidiasis, 2 (2), 2.4524 (P = 0.2934) which
indicates that the reporting of vulval erythema by our subjects has no statistically
proven association with the diagnostic outcome of having vulval candidiasis in our
study cohort. It is interesting to note that almost one third (34%) of those subjects who
were positive for vulval candidiasis were unable to specify whether they had vulval
erythema or not.




                                             - 69 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



    Table 38 Vulval erythema versus vulval candidiasis by culture

                                   Vulval candidiasis by culture                    Total (%)
  Presence of vulval
      erythema                 Negative (%)              Positive (%)

                      No                  14 (33)                     7 (18)                 21 (26)
                 Unsure                   10 (23)                    13 (34)                 23 (28)
                     Yes                  19 (44)                    18 (47)                 37 (46)
Total                                    43 (100)                   38 (100)                81 (100)

Statistic                                       df                    Value                       P
Chi-Square                                       2                   2.4524                  0.2934

Sensitivity (%)                                72          Specificity (%)                        42
Proportions calculated by column.
Sensitivity and specificity calculated with exclusion of ‘unsures’.
N = 81, missing data = 13.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]
NB: Not significant for either vaginal candida or combined vaginal and vulval candida.




4.4.6.       Vulval oedema
Table 39 outlines the chi-square statistics for assessing the association between
vulval oedema and vulval candidiasis, 2 (2), 0.7383 (P = 0.6913). Once again data
collected from our sample population showed no association between the reporting of
this factor by our subjects and vulval candidiasis proven by culture. The proportions
within each column of disease outcome were comparative and again, almost a third of
the subjects who tested positive for candida were unsure of whether there was a
presence of vulval oedema or not.




                                             - 70 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



    Table 39 Vulval oedema versus vulval candidiasis by culture

                                  Vulval candidiasis by culture                     Total (%)
 Presence of vulval
      oedema                  Negative (%)               Positive (%)

                     No                   18 (42)                   15 (39)                   33 (41)
                Unsure                      9 (21)                  11 (29)                   20 (25)
                    Yes                   16 (37)                   12 (32)                   28 (35)
Total                                    43 (100)                  38 (100)                 81 (100)

Statistic                                       df                    Value                        P
Chi-Square                                       2                   0.7383                   0.6913

Sensitivity (%)                                44          Specificity (%)                        53
Proportions calculated by column.
Sensitivity and specificity calculated with exclusion of ‘unsures’.
N = 81, missing data = 13.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]
NB: Not significant for either vaginal candida or combined vaginal and vulval candida.




4.4.7.       Dysuria
The data presented in Table 40 and in particular Table 41 show that there were
virtually identical proportions of women within each of the disease outcome groups,
candida positive compared with those within the candida negative group who
identified the presence of dysuria compared with those who did not. Whether our
sample population of women identified dysuria being noted specifically in the vulval,
urethral or both areas, individual and combined analyses of dysuria versus
candidiasis yielded no association, see Table 42 and Table 43, 2 (4), 0.7974 (P =
0.9388) and 2 (1), 0.0000 (P = 0.9955) respectively.




                                             - 71 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



    Table 40 Dysuria specified versus vulval candidiasis by culture

                                         Vulval candidiasis by culture                Total (%)
     Presence of dysuria               Negative (%)            Positive (%)

                              No                  26 (59)                23 (61)              49 (60)
            Yes – not specified                        4 (9)               2 (5)                  6 (7)
   Yes – both vulva & urethra                         6 (14)              5 (13)              11 (13)
                  Yes – urethra                        3 (7)               2 (5)                  5 (6)
                    Yes – vulva                       5 (11)              6 (16)              11 (13)
Total                                            44 (100)              38 (100)             82 (100)

Statistic                                                df               Value                      P
Chi-Square                                                4              0.7974               0.9388
Proportions calculated by column.
N = 82, missing data = 12.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]



    Table 41 Dysuria combined versus vulval candidiasis by culture

                                         Vulval candidiasis by culture                Total (%)
     Presence of dysuria               Negative (%)            Positive (%)

                              No                  26 (60)                23 (61)              49 (60)
                             Yes                  17 (40)                15 (39)              32 (40)
Total                                            43 (100)              38 (100)             81 (100)

Statistic                                                df               Value                      P
Chi-Square                                                1              0.0000               0.9955

Sensitivity (%)                                          39     Specificity (%)                     60
Proportions calculated by column.
N = 81, missing data = 13.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]
NB: Not significant for either vaginal candida or combined vaginal and vulval candida.



4.4.8.       Dyspareunia
Table 42, Table 43, Table 44 and Table 45 address the data concerning dyspareunia,
either broken down by specific timing of dyspareunia in relation to sexual intercourse
or combined and assessed against vaginal, vulval or combined candidiasis by culture.



                                             - 72 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

From Table 45, it can be seen that 64% of those subjects who listed dyspareunia as a
symptom were candida positive (from vaginal and vulval swabs) compared with 36%
who were positive but denied dyspareunia. In those who were negative for VVC
based on swab results, there was almost an even split between those who identified
dyspareunia to those who did not. Chi-square test for association between
dyspareunia and culture proven VVC (vaginal, vulval and combined swab results)
also showed a lack of association in our study population, both for dyspareunia where
the timing in relation to sexual intercourse was specified and for the combined
positive responses to dyspareunia regardless of timing in relation to sexual
intercourse, (refer to Tables for the resultant 2 and P values).


    Table 42 Dyspareunia specified tested against vaginal candidiasis by culture

                                        Vaginal candidiasis by culture                 Total (%)
  Presence of dyspareunia              Negative (%)            Positive (%)

                              No                  20 (49)                13 (39)              33 (45)
   Yes – details not specified                         1 (2)               3 (9)                   4 (5)
              Yes – during sex                        5 (12)              4 (12)                  9 (12)
                Yes – after sex                       4 (10)               1 (3)                   5 (7)
     Yes – both after & during                    11 (27)                12 (36)              23 (31)
                          sex
Total                                            41 (100)              33 (100)             74 (100)

Statistic                                                df               Value                       P
Chi-Square                                                4              3.6168               0.4603
Proportions calculated by column.
N = 74, missing data = 20.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]




                                             - 73 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



    Table 43 Dyspareunia categories combined tested against vaginal candidiasis by culture

                                      Vaginal candidiasis by culture                  Total (%)
 Presence of dyspareunia            Negative (%)             Positive (%)

                           No                  20 (49)                  13 (39)              33 (45)
                          Yes                  21 (51)                  20 (61)              41 (55)
Total                                         41 (100)                33 (100)              74 (100)

Statistic                                             df                 Value                    P
Chi-Square                                             1                0.6520               0.4194

Sensitivity (%)                                       61       Specificity (%)                    49
Proportions calculated by column.
N = 74, missing data = 20.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]




    Table 44 Dyspareunia combined tested against vulval candidiasis by culture

                                       Vulval candidiasis by culture                  Total (%)
 Presence of dyspareunia            Negative (%)             Positive (%)

                           No                  20 (54)                  13 (36)              33 (45)
                          Yes                  17 (46)                  23 (64)              40 (55)
Total                                         37 (100)                36 (100)              73 (100)

Statistic                                             df                 Value                    P
Chi-Square                                             1                2.3716               0.1236

Sensitivity (%)                                       64       Specificity (%)                    54
Proportions calculated by column.
N = 73, missing data = 20.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]




                                             - 74 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



    Table 45 Dyspareunia combined tested against combined vaginal and vulval candidiasis by
             culture

                                       Combined vaginal and vulval
                                         candidiasis by culture                       Total (%)
 Presence of dyspareunia            Negative (%)             Positive (%)

                           No                   20 (53)                13 (36)               33 (45)
                          Yes                   18 (47)                23 (64)               41 (55)
Total                                          38 (100)               36 (100)              74 (100)

Statistic                                             df                 Value                    P
Chi-Square                                             1                2.0420               0.1530

Sensitivity (%)                                       64       Specificity (%)                    53
Proportions calculated by column.
N = 74, missing data = 20.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]




4.4.9.       Postcoital bleeding
Table 46 presents the data collected on whether there was a presence or absence of
postcoital bleeding and the relevant chi-square test results for an association with
VVC. It is evident that the majority of subjects positive for candida (87%) denied
postcoital bleeding compared to 5% who acknowledged the presence of this
symptom. Chi-square analysis indicates a lack of association between postcoital
bleeding and culture proven VVC in our study cohort, 2 (2), 3.3321 (P = 0.1890).




                                             - 75 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



    Table 46    Postcoital bleeding and combined vaginal and vulval candidiasis by culture

                            Combined vaginal and vulval candidiasis
                                         by culture                                 Total (%)
    Presence of
 postcoital bleeding           Negative (%)               Positive (%)

                      No                    35 (90)                  33 (87)                 68 (88)
        Not applicable                        2 (5)                     0 (0)                     2 (3)
                    Yes                       2 (5)                   5 (13)                      7 (9)
Total                                     39 (100)                  38 (100)                77 (100)

Statistic                                        df                   Value                          P
Chi-Square                                        2                  3.3321                  0.1890

Sensitivity (%)                                  13 Specificity (%)                                 95

Positive predictive                              71 Negative predictive                             51
value (%)                                           value
Proportions calculated by column.
N = 77, missing data = 17.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]
Sensitivity and specificity calculated with exclusion of ‘not applicables’.
Even with exclusion of the two “not applicable” patients, no significance was found (P = 0.72).


4.4.10.      Previous vulvovaginal signs and symptoms
Table 47 shows that from a total of 83 women out of our study cohort who identified
their current symptoms as being same or similar to those previously experienced, a
total of 46% were confirmed to have VVC proven by culture for their current episode,
as opposed to 54% who said they had experienced similar symptoms before, and
were found to be negative for candida on vaginal and vulval swabs. Within the group
who claimed to have experienced the same or similar symptoms previously, 47%
tested positive for candida, and 53% were negative for candida. In contrast, within the
group who claimed not to have experienced the same or similar symptoms previously,
25% were positive for candida and 75% were negative for candida, based on vaginal
and vulval swabs. The data represented no statistical association between having
identified similar symptoms in the past and having a current episode of VVC based on
culture results, 2 (1), 0.7313 (P = 0.3925).




                                             - 76 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

    Table 47 Vulvovaginal signs and symptoms experienced in the past versus combined
             vaginal and vulval candidiasis by culture

                                       Combined vaginal and vulval
                                         candidiasis by culture                       Total (%)
Symptoms experienced in
       the past                     Negative (%)             Positive (%)
                           No                   3 (75)                   1 (25)              4 (100)
                          Yes                  42 (53)                  37 (47)             79 (100)
Total                                          45 (54)                  38 (46)             83 (100)

Statistic                                             df                 Value                    P
Chi-Square                                             1                0.7313               0.3925

Sensitivity (%)                                       97       Specificity (%)                     7

Positive predictive value                             47 Negative predictive                      75
(%)                                                                value (%)
Proportions calculated by row.
N = 83, missing data = 11.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]




This data was further analysed to identify those 73 women who had specified whether
they had previously obtained a medical diagnosis based on these same or similar
signs and symptoms experienced during a prior episode. The resultant two groups of
subjects were then tested against culture proven VVC based on swabs from this
current episode, to see whether there was any association between a prior diagnosis
of VVC by a doctor and a current diagnosis of VVC by culture (see Figure 5 and
Table 48). It was determined that 60 out of the 73 women had obtained a previous
medical diagnosis out of which 89% had stipulated a previous diagnosis of ‘thrush’ or
VVC. Another 8% had been told by their doctors that the symptoms were a result of
VVC and possibly some other infection or cause, and 3% had been told that the
symptoms were altogether due to some other infection or cause other than VVC.


When these women, along with those who had not previously sought a medical
diagnosis despite experiencing the same or similar symptoms were cross-tabulated
with confirmed current episode of VVC based on culture results, it was determined
that 45% of those who had previously been diagnosed with VVC were positive for
candida as opposed to 55%, who were not. By comparison, in the group who had not
received a previous doctor’s consult at all or had received an alternative diagnosis


                                             - 77 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

other than VVC, 33% tested positive while 67% tested negative for candida. There
proved to be no statistical association between disease outcome and prior diagnosis
of VVC, 2 (2), 0.5896 (P = 0.4426). It was also determined that the RR for a subject
who’d previously been diagnosed with VVC and was now positive for candida versus
those who’d not been diagnosed at all or not been diagnosed with VVC and was now
positive for candida was approximately 1.4 (95% CI 0.5823, 3.1928). So although not
statistically significant, there appears to be a possible trend to suggest that those
women who’d previously experienced the same symptoms and had been diagnosed
by a doctor as having ‘thrush’ were 1.4 times more likely to have a current laboratory
proven episode of VVC than those who hadn’t been previously diagnosed with VVC.

   Figure 5 Description of previous diagnosis




                  8%      3%

                                                               VVC
                                                               VVC & other
                                                               Other

                                     89%




                                          - 78 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



    Table 48 Women who had previously experienced the same vulvovaginal symptoms which
             had been diagnosed by a doctor as VVC versus current combined vaginal and
             vulval candidiasis by culture

                                        Combined vaginal and vulval
                                          candidiasis by culture                      Total (%)
History of same symptoms:             Negative (%)            Positive (%)

           But not previously                      8 (67)                4 (33)             12 (100)
    diagnosed by a doctor or
       diagnosed with ‘other’
             infection/cause
   Previous same symptoms                         30 (55)               25 (45)             55 (100)
          diagnosed as VVC
Total                                             38 (57)               29 (43)             67 (100)

Statistic                                              df                Value                    P
Chi-Square                                              1               0.5896                0.4426

                         Estimates of the Relative Risk (Row2/Row1)
Type of Study                             Value                              95% CI
Cohort (Column 2 Risk)                            1.3637                0.5823                3.1928

Sensitivity (%)                                       86       Specificity (%)                    21

Positive predictive value                             45            Negative                      67
(%)                                                          predictive value
                                                                          (%)
Proportions calculated by row.
N = 67, missing data = 11.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]




Sources of information for diagnosis and treatment recommendation
Out of 80 women who responded to having experienced similar symptoms in the past
as compared to their current suspected episode of VVC, and where treatment had
been previously recommended to them, Figure 6 lists the various sources of their
treatment recommendations. Some identified more than one source eg ‘doctor and
pharmacist’, hence the reason for the total frequency exceeding 80. A naturopath was
also identified by one of the women as another source of treatment recommendation.


The results indicate that a substantial proportion of women in our study cohort had
received treatment advice for similar symptoms in the past from a healthcare


                                             - 79 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

provider, i.e. doctor = 59 (74%) and pharmacist = 28 (35%). The remainder, 25
(31%), 5 (5%) and 2 (2%) of our study population had relied on either their own
devices, a friend’s or another non-medical professional’s advice in deciding on the
appropriate treatment, respectively.


     Figure 6 Sources of Previous Treatment Recommendations

                      Other

                      Friend
    Sources




              Self-Prescribed

                  Pharmacist

                      Doctor

                                0   10   20       30      40   50    60      70
                                              Number of subjects


NB: N = 80, more than one source of information may have been selected by some women.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]



4.5.            Doctors’ assessment: Vulvovaginal signs and symptoms
The subsequent tables detail and present the analysis of the various vulvovaginal
signs and symptoms as risk factors for VVC, based on the doctors’ reports following
their examinations of our study cohort. From the 94 doctors who completed and
returned their assessment forms, Table 49 identifies the frequency of occurrence of
each of the vulvovaginal signs and symptoms that were reported in order of
descending frequency, excluding all negative answers and answers that indicated any
uncertainty in the reporter’s mind in relation to the question(s). The percentage
frequency was determined based on a total sample size of 94. Some key points are:
              That the majority of subjects with suspected VVC experienced vulval pruritus
               (80%) and vaginal discharge (74%);
              Of those who experienced vaginal discharge only 4.3% were attributed to
               having an excessive amount, while the remainder were almost equally divided
               between slight and moderate amounts of discharge (41.4% and 30.9%
               respectively); and



                                                 - 80 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

      Most also had a normal appearing vagina (67%) and almost half had a normal
       appearing vulva (54.3%).


Table 49 also includes the validity of the screening tests (the sensitivity and
specificity) in diagnosing VVC in accordance with the data presented in the
subsequent corresponding tables.




                                          - 81 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



   Table 49 Total frequency of reported vulvovaginal signs and symptoms and validity of
            screening tests for diagnosis of VVC

  Sign / Symptom identified as
                                           n            %           Sensitivity       Specificity
            present

Vulval pruritus                            75           80               82                19
Vaginal discharge
       Slight                             39           41
       Moderate                           29           31
       Excessive                           4            4
Total vaginal discharge                    70           74               84                30
Normal vaginal appearance                  63           67               NA               NA
Normal vulval appearance                   51           54               49                29
Vaginal erythema                           42           45               NA               NA
Vulval erythema                            39           42               66                74
Vaginal discharge odour                    36           38               47                69
Dysuria
       Vulva                              10           11
       Urethra                            12           13
       Both                                5            5
       Unspecified                         1            1

Total dysuria                              28           30               32                76
Vulval oedema                              17           18               29                86
Evidence of scratching                     10           11               11                86
Genital ulcers                              6            6                5                93

Vaginal ulceration                          2            2               NA               NA
Genital warts                               0            0               NA               NA
Pediculosis pubis                           0            0               NA               NA
Percentages in column 3 calculated based on N = 94
[Source information: Curtin University of Technology, TAFT Project Doctor’s Questionnaire 2004
(Computer File)]




                                            - 82 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).




4.5.1.     Vaginal discharge
Table 50, Table 51 and Table 52 contain little difference in the data with respect to
the number of subjects identifying the presence or absence of vaginal discharge
versus their candidal status, either based on vaginal, vulval or results from both
swabs. So in looking at the data presented in Table 50, of those subjects who
identified the presence of vaginal discharge, 52% were positive for candida and 48%
were negative for candida. In the group who claimed not to have any discharge, 29%
had a positive disease outcome and 71% did not. Table 50 indicates that there
remained a lack of association between the presence of vaginal discharge, as
reported by the consulting doctors’ and the laboratory confirmed diagnosis of vaginal
candidiasis, 2 (1), 2.400 (P = 0.121), these findings being consistent with the findings
from the patients’ questionnaires.


Similarly in analysing the data to ascertain whether an association exists between
vaginal discharge and vulval candidiasis, the results of the chi-square test showed a
lack of association, 2 (1), 3.825 (P = 0.050), this however differed from the
corresponding analysis based on the data from the patients’ questionnaires in which a
statistically significant association was found, see Table 51 and Table 29 respectively.
In analysing for an association between the presence of vaginal discharge and having
laboratory proven VVC based on both vaginal and vulval swabs, chi-square test
results reflect that there isn’t an association 2 (1), 3.599 (P = 0.058), see Table 45.
The RR was found to be 1.8282, (95% CI 0.8953, 3.7313), suggesting a possible
trend (though not statistically significant) in our study cohort with vaginal discharge, to
be almost twice as likely to have VVC proven by culture, see Table 51. Again this
differed from the results based on data from the patients’ questionnaires whereby a
statistically significant RR of greater than two was found, see Table 30.




                                          - 83 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



    Table 50 Vaginal discharge versus culture proven vaginal candidiasis

                                    Vaginal candidiasis by culture                    Total (%)
  Presence of vaginal
      discharge                  Negative (%)               Positive (%)

                        No                    15 (71)                     6 (29)            21 (100)
                      Yes                     35 (52)                   32 (48)             67 (100)
Total                                         50 (57)                   38 (43)             88 (100)

Statistic                                          df                    Value                       P
Chi-Square                                             1                  2.400                   0.121

Sensitivity (%)                                    84          Specificity (%)                      30
Proportions calculated by row.
N = 88, missing data = 6.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]




    Table 51 Vaginal discharge versus vulval candidiasis by culture

                                     Vulval candidiasis by culture                    Total (%)
  Presence of vaginal
      discharge                   Negative (%)               Positive (%)

                        No                    15 (71)                     6 (29)            21 (100)
                      Yes                     31 (47)                   35 (53)             66 (100)
Total                                         46 (53)                   41 (47)             87 (100)

Statistic                                              df                Value                       P
Chi-Square                                             1                  3.825                   0.050

                         Estimates of the Relative Risk (Row2/Row1)
Type of Study                         Value                               95% CI
Cohort (Column 2                               1.8553                   0.9091               3.7879
Risk)

Sensitivity (%)                                        85      Specificity (%)                      33
Proportions calculated by row.
N = 87, missing data = 7.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]




                                              - 84 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



    Table 52 Vaginal discharge versus VVC by culture

                                    Combining vaginal and vulval
                                       candidiasis by culture                       Total (%)
   Presence of vaginal
       discharge                 Negative (%)            Positive (%)

                         No                 15 (71)                  6 (29)                 21 (100)
                        Yes                 32 (48)                 35 (52)                 67 (100)
Total                                       47 (53)                 41 (47)                 88 (100)

Statistic                                        df                  Value                           P
Chi-Square                                        1                  3.599                        0.058

                         Estimates of the Relative Risk (Row2/Row1)
Type of Study                        Value                               95% CI
Cohort (Column 2 Risk)                      1.8282                  0.8953                   3.7313

Sensitivity (%)                                  85        Specificity (%)                          32

Positive predictive                              52 Negative predictive                             71
value (%)                                                     value (%)
Proportions calculated by row.
N = 88, missing data = 6.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]




4.5.1.1.     Vaginal discharge odour

The data in Table 53 indicate that of those women who tested positive for vaginal
candidiasis, 47% identified a vaginal odour as opposed to 53% who did not, by
contrast, of those who were negative for candida, 30% said ‘yes’ to the presence of
odour, 68% said ‘no’ and the remaining 2% admitted to being unsure. The presence
or absence of vaginal discharge odour as assessed by the consulting doctors was
analysed by chi-square analysis, and showed no association between this marker
and vaginal candidiasis confirmed on culture results, 2 (1), 3.3279 (P = 0.1894), see
table below.




                                             - 85 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



       Table 53 Vaginal discharge odour versus vaginal candidiasis by culture

                                    Vaginal candidiasis by culture                 Total (%)
       Presence of odour           Negative (%)            Positive (%)

                           No                34 (68)                 20 (53)                54 (61)
                      Unsure                    1 (2)                  0 (0)                     1 (1)
                          Yes                15 (30)                 18 (47)                33 (38)
Total                                       50 (100)               38 (100)                88 (100)

Statistic                                             df              Value                         P
Chi-Square                                             2             3.3279                 0.1894

Sensitivity (%)                                       47    Specificity (%)                        69
Proportions calculated by column.
N = 88, missing data = 6.
Sensitivity and specificity calculated excluding ‘unsures’.
[Source information: Curtin University of Technology, TAFT Project Doctor’s Questionnaire 2004
(Computer File)]
NB:       Not significant for combined vaginal and vulval candida.



4.5.2.         Vulval pruritus
From the data in Table 54 , similar proportions in each column relating to disease
outcome were found corresponding to the presence or absence of vulval pruritus. No
association between vulval pruritus and vaginal candidiasis by culture was evident, 2
(1),   0.0015 (P = 0.9689), see Table 54, nor for combined VVC confirmed by culture
(analysed but data not presented).




                                             - 86 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



    Table 54 Vulval pruritus versus vaginal candidiasis by culture

                                  Vaginal candidiasis by culture                   Total (%)
  Presence of vulval
       pruritus                 Negative (%)             Positive (%)

                       No                    9 (19)                  7 (18)                 16 (19)
                      Yes                  39 (81)                 31 (82)                  70 (81)
Total                                     48 (100)                38 (100)                 86 (100)

Statistic                                        df                 Value                        P
Chi-Square                                        1                0.0015                    0.9689

Sensitivity (%)                                 82        Specificity (%)                        19

Positive predictive                             44 Negative predictive                           56
value (%)                                                    value (%)
Proportions calculated by column.
N = 86, missing data = 8.
[Source information: Curtin University of Technology, TAFT Project Doctor’s Questionnaire 2004
(Computer File)]
NB: Not significant for combined vaginal and vulval candidiasis by culture.



4.5.3.       Vulval appearance
Based on the doctors’ physical examinations for vulval appearance and reported
findings, Table 55 shows that where the doctors identified the subjects’ vulval
appearance to be normal, 62% were confirmed by vulval culture to be negative for
candidiasis, while 38% were not. By contrast in those subjects who were reported as
having an abnormal vulval appearance, 61% were found to have vulval candidiasis
compared to 39% who were free from candidal infection. Chi-square analysis showed
that there was a statistically significant association between this physical finding and
laboratory confirmed vulval candidiasis, 2 (1), 4.2813 (P = 0.0385). The RR = 1.6155
(95% CI, 0.9852, 2.6455) suggesting that those women with a normal appearing
vulva were approximately 1.6 times more likely to be negative for vulval candidiasis
based on culture results (not statistically significant). Alternatively it can be stated that
the positive predictive value determined indicates that 61% of those women who
tested positive for vulval candidiasis had an abnormal appearing vulva. See Table 55.




                                             - 87 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



    Table 55 Vulval appearance versus vulval candidiasis by culture

                                  Vulval candidiasis by culture                     Total (%)
 Vulval appearance
      normal?                  Negative (%)              Positive (%)

                     No                    12 (39)                   19 (61)               31 (100)
                    Yes                    30 (62)                   18 (38)               48 (100)
Total                                      42 (53)                   37 (47)               79 (100)

Statistic                                       df                    Value                      P
Chi-Square                                       1                   4.2813                  0.0385

                          Estimates of the Relative Risk (Row2/Row1)
Type of Study                      Value                                95% CI
Cohort (Column 1                           1.6155                    0.9852                  2.6455
Risk)

Sensitivity (%)                                 49 Specificity (%)                               29

Positive predictive                             38    Negative predictive                        39
value (%)                                                       value (%)
Proportions calculated by row.
N = 79, missing data = 15.
[Source information: Curtin University of Technology, TAFT Project Doctor’s Questionnaire 2004
(Computer File)]




4.5.4.       Vulval erythema
From the doctors’ physical examinations, vulval erythema of varying extent was found
to be present in 39 and absent in 46 out of the 94 women assessed. Out of these
women, 80 had laboratory data available for cross-tabulation of erythema against
vulval candidiasis. The results presented in Table 56 and Table 57 show the
outcome. Of most important note is that of those subjects who had moderate degree
of vulval erythema, 88% were positive for candida compared to 12% who were not
and of those who had extensive degree of vulval erythema 80% were positive for
candida compared to 20% who were not. The difference between outcome groups
was less for those with a minimal extent of vulval erythema. For those who had an
absence of vulval erythema, 30% were positive for candida as opposed to 70% who
were negative. Chi-square analysis showed that there was a statistically significant
association between vulval erythema and vulval candidiasis confirmed by culture, 2


                                             - 88 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

(1),   12.6397 (P = 0.0004), see Table 57 (combining extent of vulval erythema).
Assessment of the RR (= 2.3502, 95% CI = 1.4182, 3.8956) indicated that in our
study cohort, women with physician reported vulval erythema were more than twice
as likely to have laboratory proven vulval candidiasis compared to those who did not
(statistically significant findings).




       Table 56 Vulval erythema versus vulval candidiasis by culture

                                 Vulval candidiasis by culture                      Total (%)
Presence of vulval
    erythema                  Negative (%)              Positive (%)

                    No                    31 (70)                   13 (30)                44 (100)
        Yes – Minimal                      9 (39)                   14 (61)                23 (100)
       Yes – Moderate                      1 (12)                      7 (88)                8 (100)
       Yes – Extensive                     1 (20)                      4 (80)                5 (100)
Total                                     42 (52)                   38 (48)                80 (100)

Statistic                                      df                      Value                      P
Chi-Square                                      3                  14.5871                   0.0022
Proportions calculated by row.
N = 80, missing data = 14.
[Source information: Curtin University of Technology, TAFT Project Doctor’s Questionnaire 2004
(Computer File)]




                                             - 89 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



       Table 57 Different extents of vulval erythema combined versus vulval candidiasis by culture

                                      Vulval candidiasis by culture                  Total (%)
       Presence of vulval
           erythema                 Negative (%)              Positive (%)

                            No                  31 (70)                 13 (30)            44 (100)
                         Yes                    11 (31)                 25 (69)            36 (100)
Total                                           42 (53)                 38 (47)            80 (100)

Statistic                                             df                 Value                   P
Chi-Square                                             1               12.6397               0.0004

                          Estimates of the Relative Risk (Row2/Row1)
Type of Study                           Value                             95% CI
Cohort (Column 2 Risk)                          2.3502                  1.4182               3.8956

Sensitivity (%)                                       66       Specificity (%)                   74

Positive predictive value                             69   Negative predictive                   70
(%)                                                                  value (%)
Proportions calculated by row.
N = 80, missing data = 14.
[Source information: Curtin University of Technology, TAFT Project Doctor’s Questionnaire 2004
(Computer File)]




4.5.5.         Vulval oedema
Both Table 58 and Table 59 outline the data on subjects with or without vulval
oedema and their disease outcome. Of those subjects who were positive for candida,
29% had a documented presence of vulval oedema and 71% did not. Conversely,
vulval oedema was absent in 86% and present in 14% of those who were negative for
candida. No association was found following chi-square analysis between vulval
oedema and vulval candidiasis in our study cohort, 2 (2), 3.8686 (P = 0.1445) and 2
(1),   2.7349 (P = 0.0982) respectively, based on the data from the doctors’
examinations.




                                             - 90 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



    Table 58 Vulval oedema versus vulval candidiasis by culture

                                 Vulval candidiasis by culture                      Total (%)
Presence of vulval
     oedema                  Negative (%)                Positive (%)

                  No                      37 (86)                    27 (71)                 64 (79)
      Yes – Minimal                         6 (14)                     9 (24)                15 (18)
    Yes – Moderate                           0 (0)                      2 (5)                    2 (2)
Total                                    43 (100)                   38 (100)               81 (100)

Statistic                                       df                     Value                        P
Chi-Square                               2                   3.8686                          0.1445
Note: No women were noted as having extensive vulval oedema.
Proportions calculated by column.
N = 81, missing data = 13.
[Source information: Curtin University of Technology, TAFT Project Doctor’s Questionnaire 2004
(Computer File)]




    Table 59 Different extents of vulval oedema combined versus vulval candidiasis by culture

                                 Vulval candidiasis by culture                      Total (%)
Presence of vulval
     oedema                  Negative (%)                Positive (%)

                  No                      37 (86)                    27 (71)                 64 (79)
                 Yes                        6 (14)                   11 (29)                 17 (21)
Total                                    43 (100)                   38 (100)               81 (100)

Statistic                                       df                     Value                        P
Chi-Square                                       1                    2.7349                 0.0982

Sensitivity (%)                                29           Specificity (%)                        86
Proportions calculated by column.
N = 81, missing data = 13.
[Source information: Curtin University of Technology, TAFT Project Doctor’s Questionnaire 2004
(Computer File)]




4.5.6.       Dysuria
Data pertaining to dysuria and vaginal or vulval candidiasis by culture are presented
in Table 60 and Table 61 respectively, both showing very similar results. Chi-square
test showed no association between dysuria documented by the doctors, and


                                             - 91 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

laboratory proven vaginal candidiasis, 2 (1), 0.6253 (P = 0.4291), see Table 53, nor
for dysuria versus vulval candidiasis (Table 61), 2 (1), 1.1076 (P = 0.2926). Analysis
using results from both vaginal and vulval swabs did not yield statistically significant
results either (not presented).




    Table 60 Dysuria versus vaginal candidiasis by culture

                                    Vaginal candidiasis by culture                   Total (%)
         Dysuria                 Negative (%)               Positive (%)

                       No                     38 (76)                  26 (68)               64 (73)
                      Yes                     12 (24)                  12 (32)               24 (27)
Total                                        50 (100)                 38 (100)             88 (100)

Statistic                                             df                Value                     P
Chi-Square                                             1               0.6253                0.4291

Sensitivity (%)                                       32      Specificity (%)                    76
Proportions calculated by column.
N = 88, missing data = 6.
[Source information: Curtin University of Technology, TAFT Project Doctor’s Questionnaire 2004
(Computer File)]


    Table 61 Dysuria versus vulval candidiasis by culture

                                    Vulval candidiasis by culture                    Total (%)
        Dysuria                  Negative (%)               Positive (%)

                      No                      36 (78)                  28 (68)               64 (74)
                     Yes                      10 (22)                  13 (32)               23 (26)
Total                                        46 (100)                 41 (100)             87 (100)

Statistic                                             df                Value                     P
Chi-Square                                             1               1.1076                0.2926

Sensitivity (%)                                       32      Specificity (%)                    78
Proportions calculated by column.
N = 87, missing data = 7.
[Source information: Curtin University of Technology, TAFT Project Doctor’s Questionnaire 2004
(Computer File)]
NB: Not significant dysuria versus combined vaginal and vulval candidiasis.




                                             - 92 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

4.5.7.       Genital ulcers
According to the results presented in Table 62 , 95% of subjects who were positive for
vulval candidiasis had no genital ulcers present versus 5% who did and similarly 93%
of subjects who tested negative for candida had no genital ulcers compared to 7%
who did. Statistical analysis of documented presence of genital ulcers against
laboratory proven vulval candidiasis yielded no association between the two
parameters, 2 (1), 0.1023 (P = 0.7491), see below.


    Table 62 Genital ulcers versus vulval candidiasis by culture

                                   Vulval candidiasis by culture                     Total (%)
 Presence of genital
       ulcers                  Negative (%)                Positive (%)

                    No                     40 (93)                     36 (95)              76 (94)
                   Yes                        3 (7)                       2 (5)                  5 (6)
Total                                     43 (100)                    38 (100)             81 (100)

Statistic                                        df                     Value                       P
Chi-Square                                        1                    0.1023                0.7491

Sensitivity (%)                                   5           Specificity (%)                      93
Proportions calculated by column.
N = 81, missing data = 13.
[Source information: Curtin University of Technology, TAFT Project Doctor’s Questionnaire 2004
(Computer File)]




4.5.8.       Evidence of scratching
Table 63 outlines the data and corresponding chi-square analysis related to
documented evidence of scratching in our study cohort and vulval candidiasis. Similar
proportions of women within each column of disease outcome were reported with
either observed evidence of scratching or not. The information indicate that no
statistically significant association was evident based on our findings, 2 (1), 0.2190 (P
= 0.6398).




                                             - 93 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



    Table 63 Evidence of scratching versus vulval candidiasis by culture

                                  Vulval candidiasis by culture                     Total (%)
    Evidence of
    scratching               Negative (%)                 Positive (%)

                  No                       37 (86)                    34 (89)               71 (88)
                 Yes                        6 (14)                     4 (11)               10 (12)
Total                                    43 (100)                   38 (100)               81 (100)

Statistic                                       df                     Value                     P
Chi-Square                                       1                    0.2190                 0.6398

Sensitivity (%)                                 11           Specificity (%)                     86
Proportions calculated by column.
N = 81, missing data = 13.
[Source information: Curtin University of Technology, TAFT Project Doctor’s Questionnaire 2004
(Computer File)]




4.5.9.        Genital warts and pediculosis pubis
None of the women recruited into the study were reported by the consulting doctors
as having any evidence of genital warts or pediculosis pubis.



4.6.      Comparative summary of findings from patients’ versus
            doctors’ questionnaires
Table 64 summarises the comparative finding from the two questionnaires used in the
study. It highlights some of the statistically significant findings which will be
considered for incorporation into the diagnostic flowchart.




                                             - 94 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



    Table 64 Comparative summary of findings from patients’ versus doctors’ questionnaires
                           Findings from patients’                    Findings from doctors’
                               questionnaires                             questionnaires

                     Table #     P         RR         Sig.   Table        P         RR         Sig.
Test description                        (95% CI)               #                 (95% CI)
Vaginal              Table     0.076        -         NS      Table     0.121        -         NS
discharge vs VaC      29                                       50

Vaginal              Table     0.030        -          S      Table     0.050        -         NS
discharge vs VuC      30                                       51

Vaginal              Table     0.034      2.230        S      Table     0.058      1.828       NS
discharge vs          31                 (0.916,               52                 (0.895,
VVC                                      5.426)                                   3.731)


Vaginal odour vs     Table     0.899        -         NS      Table     0.189        -         NS
VaC                   32                                       53

Vaginal odour vs     Table     0.883        -         NS       NA          -         -          -
VuC                   33

Vaginal odour vs         Not presented but found NS               Not presented but found NS
VVC
Vaginal pruritus     Table     0.271        -         NS       NA          -         -          -
vs VaC                34

Vaginal pruritus     Table     0.271        -         NS       NA          -         -          -
vs VuC                35

Vaginal pruritus         Not presented but found NS            NA          -         -          -
vs VVC

Vulval pruritus vs    NA         -          -          -      Table     0.969        -         NS
VaC                                                            54

Vulval pruritis vs   Table     0.594        -         NS       NA          -         -          -
VuC                   36
Vulval pruritus vs       Not presented but found NS               Not presented but found NS
VVC
Vulval               Table     0.996        -         NS       NA          -         -          -
tenderness vs         37
VuC
Normal vulval         NA         -          -          -      Table     0.039      1.616        S
appearance vs                                                  55                 (0.985,
VuC                                                                               2.646)




                                          - 95 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).


                             Findings from patients’                  Findings from doctors’
                                 questionnaires                           questionnaires

                     Table      P         RR        Sig.     Table        P          RR         Sig.
Test description       #               (95% CI)                #                  (95% CI)
Vulval erythema          Not presented but found NS           NA           -          -              -
vs VaC
Vulval erythema      Table      0.293        -         NS     Table     0.0004      2.350        S
(combined) vs         38                                       57                  (1.418,
VuC                                                                                3.896)
Vulval erythema           Not presented but found NS             NA        -          -              -
vs VVC
Vulval oedema        Table      0.691        -         NS     Table     0.098         -         NS
(combined) vs         39                                       59
VuC
Dysuria                 NA        -          -         -      Table     0.429         -         NS
(combined) vs                                                  60
VaC
Dysuria              Table      0.996        -         NS     Table     0.293         -         NS
(combined) vs         41                                       61
VuC
Dyspareunia          Table      0.419        -         NS        NA        -          -              -
(combined) vs         43
VaC

Dyspareunia          Table      0.124        -         NS        NA        -          -              -
(combined) vs         44
VuC

Dyspareunia          Table      0.153        -         NS        NA        -          -              -
(combined) vs         45
VVC
Postcoital           Table      0.189        -         NS        NA        -          -              -
bleeding vs VVC       46
Genital ulcers vs     NA          -          -         -      Table     0.749         -         NS
VuC                                                            62
Evidence of             NA        -          -         -      Table     0.640         -         NS
scratching vs                                                  63
VuC
Key                     VaC                                     Vaginal candidiasis
                        VuC                                     Vulval candidiasis
                        VVC                                     Combined vaginal and vulval
                                                                  candidiasis
                        Sig.                                    Significance
                                                                 Not significant / No association
                        NS                                      Significant / Association exists
                        S




                                           - 96 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).


4.6.1.     Vaginal discharge characteristics: Patients’ and Doctors’
           questionnaires
The descriptions for consistency, colour and odour of vaginal discharge were further
analysed using the data collected from both the patients’ and doctors’ questionnaires,
to determine if any particular characteristics relating to the vaginal discharge was
associated with microbiologically proven VVC. As might be expected, the frequencies
of the various descriptions for each of the signs varied little between the two methods
of data collection.


Of particular note relating to the description of the discharge consistency (Table 65
and Table 66) was that there was a greater proportion where the consistency was
identified as ‘thick’ (doctors’ questionnaire: 48%, patients’ questionnaire: 55%)
compared to ‘thin’ (doctors’ questionnaire: 42%, patients’ questionnaire: 39%) for
candida positive subjects and a greater proportion identifying ‘thin’ (doctors’
questionnaire: 55%, patients’ questionnaire: 55%) compared to ‘thick’ (doctors’
questionnaire: 26%, patients’ questionnaire: 34%) for candida negative subjects. No
statistical association was found for discharge consistency and VVC by culture.


With respect to discharge colour, in the doctors’ questionnaire, 52% of the candida
positive subjects had their discharge colour identified as ‘white’ compared to 39% as
‘off-white’, 3% as ‘other / non-specific’ and 6% as ‘yellow-green’, whereas in the
patients’ questionnaire the corresponding proportions were 55% for ‘white’, 32% for
‘off-white’, 3% as ‘other / non-specific’ and 10% as ‘yellow-green’. For the candida
negative group, the greater majority of subjects were identified as having a discharge
that was ‘off-white’ in both the doctors’ and patients’ survey groups (58% and 52%
respectively). No statistical association was found for discharge colour and VVC by
culture.


With respect to the odour of the discharge, in the doctors’ questionnaire, 58%
compared to 42% were identified with a ‘yeasty’ odour as opposed to some ‘other’
odour respectively in the candida positive group. In the corresponding candida
positive group in the patients’ questionnaire, it was 62% versus 38% for the ‘yeasty’



                                          - 97 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

versus ‘other’ groups respectively. ‘Yeasty’ was also identified in the majority of the
candida negative subjects in both surveys, doctors’ was 62% and patients’ was 58%.
Again, no statistical association was found for discharge odour and VVC by culture.
See Tables for chi-square analysis data.




    Table 65 Doctor’s questionnaire: Discharge consistency versus VVC by culture

                           Combined vaginal and vulval candidiasis by
                                            culture                                  Total (%)
       Discharge
      consistency              Negative (%)               Positive (%)

  Other / Non-specific                      6 (19)                       3 (9)                   9 (14)
                   Thick                    8 (26)                    16 (48)                24 (38)
                    Thin                   17 (55)                    14 (42)                31 (48)
Total                                     31 (100)                   33 (100)               64 (100)

Statistic                                       df                     Value                         P
Chi-Square                                       2                    3.8983                 0.1424
Proportions calculated by column.
N = 64, missing data = 4.
[Source information: Curtin University of Technology, TAFT Project Doctor’s Questionnaire 2004
(Computer File)]




    Table 66 Patient’s questionnaire: Discharge consistency versus VVC by culture

                           Combined vaginal and vulval candidiasis by
                                            culture                                  Total (%)
       Discharge
      consistency              Negative (%)               Positive (%)

  Other / Non-specific                      3 (10)                       2 (6)                    5 (8)
                   Thick                   10 (34)                    17 (55)                27 (45)
                    Thin                   16 (55)                    12 (39)                28 (47)
Total                                     29 (100)                   31 (100)               60 (100)

Statistic                                       df                     Value                         P
Chi-Square                                       2                    2.5224                 0.2833
Proportions calculated by column.
N = 60, missing data = 5.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]




                                             - 98 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



    Table 67 Doctor’s questionnaire: Discharge colour versus VVC by culture

                           Combined vaginal and vulval candidiasis by
                                            culture                                  Total (%)
  Discharge colour              Negative (%)               Positive (%)

               Off-white                    18 (58)                   13 (39)                31 (48)
  Other / Non-specific                        3 (10)                      1 (3)                   4 (6)
                  White                       8 (26)                  17 (52)                25 (39)
            Yellow-green                       2 (6)                      2 (6)                   4 (6)
Total                                      31 (100)                  33 (100)               64 (100)

Statistic                                         df                    Value                        P
Chi-Square                                         3                   4.9888                 0.1726
Proportions calculated by column.
N = 64, missing data = 4.
[Source information: Curtin University of Technology, TAFT Project Doctor’s Questionnaire 2004
(Computer File)]




    Table 68 Patient’s questionnaire: Discharge colour versus VVC by culture

                           Combined vaginal and vulval candidiasis by
                                            culture                                  Total (%)
  Discharge colour              Negative (%)               Positive (%)

               Off-white                    15 (52)                   10 (32)                25 (42)
  Other / Non-specific                         0 (0)                      1 (3)                   1 (2)
                  White                     12 (41)                   17 (55)                29 (48)
            Yellow-green                       2 (7)                    3 (10)                    5 (8)
Total                                      29 (100)                  31 (100)               60 (100)

Statistic                                         df                    Value                        P
Chi-Square                                         3                   2.9987                 0.3918
Proportions calculated by column.
N = 60, missing data = 5.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]




                                             - 99 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



    Table 69 Doctor’s questionnaire: Discharge odour versus VVC by culture

                           Combined vaginal and vulval candidiasis by
                                            culture                                  Total (%)
   Discharge odour              Negative (%)               Positive (%)

                  Yeasty                      8 (62)                  11 (58)                 19 (59)
            Yes – other                       5 (38)                    8 (42)                13 (41)
Total                                      13 (100)                  19 (100)               32 (100)

Statistic                                         df                   Value                       P
Chi-Square                                         1                  0.0425                  0.8367

Sensitivity                                      58               Specificity                     38
Proportions calculated by column.
N = 32, missing data = 2.
[Source information: Curtin University of Technology, TAFT Project Doctor’s Questionnaire 2004
(Computer File)]




    Table 70 Patient’s questionnaire: Discharge odour versus VVC by culture

                           Combined vaginal and vulval candidiasis by
                                            culture                                  Total (%)
   Discharge odour              Negative (%)               Positive (%)

                  Yeasty                    11 (58)                   14 (70)                 25 (64)
            Yes – other                       8 (42)                    6 (30)                14 (36)
Total                                      19 (100)                  20 (100)               39 (100)

Statistic                                         df                   Value                       P
Chi-Square                                         1                  0.6205                  0.4309

Sensitivity                                      70               Specificity                     42
Proportions calculated by column.
N = 39, missing data = 3.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]



4.7.      Personal hygiene factors

4.7.1.       Use of personal hygiene products
Table 71 indicates that of the 89 women who specified whether they were in the habit
of using at least one personal hygiene product or not, 79% identified that they did.


                                             - 100 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

Figure 7 details the percentage frequency of use of different hygiene products in the
vaginal and vulval areas, including those cases where multiple selections were made.
‘Other products’ included baby wipes, lubricants, moisturisers, perfumes, shaving
cream and talcum powder.


     Table 71 Frequency table for use of personal hygiene products

     Use of hygiene product                    n                               %

No                                                          19                                21
Yes                                                         70                                79
Total                                                       89                                100


     Figure 7 Use of Hygiene Products

                                                                     Antibacterial Soaps

                            4%      7%
                                          5%                         Body & Other Washes

                                               8%                    Other Soaps &
                                                                     Detergents
                                                                     Other Products
                                                    12%
                                                                     Sanitary Pads
              58%
                                             6%                      Tampons

                                                                     Vaginal Douches




Out of those subjects who identified that they used personal hygiene product(s), 48%
were positive for VVC and 52% were negative for VVC by culture. In those who did
not use any personal hygiene product(s), slightly more were negative for candida
(61%) compared to the candida positive subjects (39%). The use of personal hygiene
products was found not to influence the disease outcome of laboratory proven
candida, 2 (1), 0.4401 (P = 0.5071) in our study population, see Table 72.




                                          - 101 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



    Table 72 Use of personal hygiene products tested against proven VVC by culture

                           Combined vaginal and vulval candidiasis by
                                            culture                                  Total (%)
    Use of hygiene
       product                  Negative (%)               Positive (%)

                      No                    11 (61)                     7 (39)              18 (100)
                     Yes                    34 (52)                   31 (48)               65 (100)
Total                                       45 (54)                   38 (46)               83 (100)

Statistic                                        df                     Value                     P
Chi-Square                                        1                    0.4401                0.5071

Sensitivity (%)                                  82 Specificity (%)                               24

Positive predictive                              48 Negative predictive                           61
value (%)                                           value (%)
Proportions calculated by row.
N = 83, missing data = 6.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]


The most frequently used feminine hygiene product was the tampon, and in
investigating any possible association with its frequency of use and VVC, it was
determined that no association could be found based on the data from our study
population, as the chi-square test for association showed 2 (1), 2.5421 (P = 0.1108).
The RR was determined to be 1.5163, 95% CI = 0.8919, 2.5780, suggesting a
possible trend towards women who regularly use tampons having a 1.5-fold
increased risk of having VVC, though the CI indicates no statistical significance with
these findings, see Table 73.




                                             - 102 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



     Table 73 Tampon use versus vaginal and vulval candidiasis by culture

                              Combined vaginal & vulval candidiasis by
                                             culture                                  Total (%)
        Tampon use                 Negative (%)              Positive (%)

                         No                     28 (68)                 13 (32)             41 (100)
                        Yes                     27 (52)                 25 (48)             52 (100)
Total                                           55 (59)                 38 (41)             93 (100)

Statistic                                               df               Value                     P
Chi-Square                                               1              2.5421               0.1108

                         Estimates of the Relative Risk (Row2/Row1)
Type of Study                          Value                               95% CI
Cohort (Column 2 Risk)                           1.5163                 0.8919               2.5780

Sensitivity (%)                                         66      Specificity (%)                   51
Proportions calculated by row.
N = 93, missing data = 24.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]



4.7.2.       Tight clothing / synthetic materials
Wearing of fitted, tight or constrictive clothing such as leotards, panty-hose, bathing
suits, tight jeans etc on a regular basis was noted in about half (51%) of our study
cohort, see Table 74.

     Table 74 Frequency table for regular wearing of constrictive clothing

   Regular wearing of
  constrictive clothing                   n                                   %

No                                                      44                                        49
Yes                                                     45                                        51
Total                                                   89                                        100


Of these women, those who indicated that they wore constrictive clothing regularly,
defined as daily or more than three times per week, and also specified that these
items of clothing were made of synthetic materials such as nylon, polyester, or lycra
etc, further assessment revealed that 62% tested positive for VVC by culture as
opposed to 38% who were negative for candida, and in the group that denied regular


                                              - 103 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

wearing of such clothing, 43% were positive and 57% were negative for candida. Chi-
square test did not show a statistically significant association between this risk factor
and VVC, 2 (1), 3.1404 (P = 0.0764), see Table 75. The RR assessment suggested a
possible tendency for these women to be almost one-and-a-half times (RR = 1.4368)
more likely to be positive for VVC, though the 95% CI (0.7831, 2.6316) does not
indicate a statistical significance.



    Table 75 Regular wearing of constrictive clothing made of synthetic material tested for
             association against laboratory proven VVC

   Regular wearing of         Combined vaginal and vulval candidiasis
  constrictive clothing                    by culture
                                                                                      Total (%)
   made of synthetic
        material                  Negative (%)              Positive (%)

                         No                   16 (57)                   12 (43)             28 (100)
                        Yes                     5 (38)                   8 (62)             13 (100)
Total                                         21 (51)                   20 (49)             41 (100)

Statistic                                           df                   Value                    P
Chi-Square                                             1                3.1404               0.0764

                         Estimates of the Relative Risk (Row2/Row1)
Type of Study                         Value                               95% CI
Cohort (Column 2 Risk)                        1.4368                    0.7831               2.6316

Sensitivity (%)                                    40          Specificity (%)                    76
Proportions calculated by row.
N = 41, missing data = 53.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]



4.8.      Contraceptive methods
From the 88 women who answered the question relating to contraceptive methods,
38 (43%) identified that they used some method of contraception and the remaining
50 (57%) denied use of any form of contraception. Of those subjects who did use
some form of contraception 57% were positive for disease outcome as opposed to
43% who were not, and of those who denied the use of any contraceptive methods,
62% were negative versus 38% who were positive for candida. Chi-square test for
association showed no statistical association between those women who used some


                                             - 104 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

method of contraception and those who were positive for VVC, 2 (1), 2.8651 (P =
0.0905). The RR was 1.4921, suggesting a tendency for women in our study
population who used some form of contraception to be about 1.5 times more likely to
have laboratory proven VVC, however 95% CI = 0.9395, 2.3697, indicating no
statistical significance with respect to the RR, see Table 76.


    Table 76 Any form of contraceptive use versus VVC by culture

                               Combined vaginal & vulval candidiasis
                                           by culture                               Total (%)
      Any form of
    contraceptive use              Negative (%)            Positive (%)

                          No                   29 (62)               18 (38)                47 (100)
                         Yes                   15 (43)               20 (57)                35 (100)
Total                                          44 (54)               38 (46)                82 (100)

Statistic                                          df                 Value                       P
Chi-Square                                             1             2.8651                  0.0905

                         Estimates of the Relative Risk (Row2/Row1)
Type of Study                          Value                              95% CI
Cohort (Column 2 Risk)                         1.4921                0.9395                  2.3697

Sensitivity (%)                                    53       Specificity (%)                       66
Proportions calculated by row.
N = 82, missing data = 12.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]




Table 77 indicates the usage of the various forms of contraception, some women
having selected multiple forms. The two most frequently used forms being the OCP
(63%) and the condom (29%).




                                             - 105 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



   Table 77 Frequency of use of specific methods of contraception

      Method of contraception                         n                        %


OCP                                                           24                              63
Condom                                                        11                              29
Diaphragm                                                      1                               3
Progestogen implant (Implanon®)                                3                               8
Intrauterine device (IUD)                                      1                               3
Other                                                          1                               3
Total number of women                                         38                              100
indicating use of at least one
form of contraception
NB: Percentage calculated based on N = 38


Further analysis was performed looking in particular at selected forms of
contraception. Firstly those women who used the oral contraceptive pill were
assessed for risk of having VVC. Table 78 shows that out of the subjects who used
the OCP, 73% tested positive for candida while 27% were negative. It was
determined that in our study population, there was a statistically significant
association between use of an oral contraceptive pill and having laboratory proven
VVC, 2 (1), 5.3145 (P = 0.0211), and the RR was statistically significant and
determined to be 1.8 (95% CI, 1.1900, 2.7450) suggesting that these women were
almost twice as likely to have VVC as a result of using the OCP.




                                            - 106 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



    Table 78 Use of the OCP versus VVC by culture

                              Combined vaginal and vulval candidiasis
                                           by culture
         OCP use                  Negative (%)              Positive (%)             Total (%)

                         No                   41 (59)                 28 (41)               69 (100)
                        Yes                     4 (27)                11 (73)               15 (100)
Total                                         45 (54)                 39 (46)               84 (100)

Statistic                                           df                 Value                      P
Chi-Square                                             1              5.3145                  0.0211

                         Estimates of the Relative Risk (Row1/Row2)
Type of Study                         Value                                95% CI
Cohort (Column 2 Risk)                         1.8070                 1.1900                  2.7450

Sensitivity (%)                                    28 Specificity (%)                             91

Positive predictive                                73 Negative                                    59
value (%)                                             predictive value
                                                      (%)
Proportions calculated by row.
N = 84, missing data = 6.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]


Combining the use of the OCP, the diaphragm and the IUD and assessing for an
association with VVC yielded no statistically significant association, 2 (1), 0.4484 (P =
0.5031), see below.




                                             - 107 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

    Table 79 Use of the OCP, diaphragm and IUD versus VVC by culture

                              Combined vaginal and vulval candidiasis
                                           by culture                                Total (%)
       Use of OCP,
     diaphragm, IUD               Negative (%)             Positive (%)

                         No                     6 (38)                 6 (27)                12 (32)
                        Yes                   10 (62)                 16 (73)                26 (68)
Total                                        16 (100)               22 (100)                38 (100)

Statistic                                           df                 Value                      P
Chi-Square                                             1              0.4484                 0.5031

Sensitivity (%)                                    73 Specificity (%)                             38
Proportions calculated by column.
N = 38, missing data = 52.
[Source information: Curtin University of Technology, TAFT Project Patient’s Questionnaire 2004
(Computer File)]



4.9.      Patients’ criteria or reasons for self-diagnosis of VVC
Our study population of women were also asked to provide reasons as to why they
thought they had VVC. Table 80 summarises the reasons provided by 88 of the
women, arranged in order of descending frequency and note that some of the
subjects provided more than one reason. ‘Presence of itch’ and ‘presence and / or
appearance of vaginal discharge’ were the most frequently provided reasons for self-
diagnosis of VVC (given by 47% and 34% of the women respectively). ‘Previous
experience’ and ‘sensation of soreness’ were also fairly common reasons.
Interestingly 8% were unsure of the reasons as to why they thought they had VVC
and 3% of the women named their partners as the reason they suspected having
VVC.




                                             - 108 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



   Table 80 Patients’ criteria or reasons for self-diagnosis of VVC

 Criteria / reason for self-diagnosis of               n                        %
                  VVC

Presence of itch                                                 41                           47
Presence / appearance of discharge                               30                           34
Previous experience                                              16                           18
Sensation of soreness                                            16                           18
General discomfort                                                8                            9
Presence of redness                                               7                            8
Unsure                                                            7                            8
Sensation of burning                                              5                            6
Other specified                                                   5                            6
Taking antibiotics                                                4                            5
Presence of swelling                                              4                            5
Partner                                                           3                            3
Presence of odour                                                 3                            3
Presence of abnormal bleeding                                     2                            2
Unspecified                                                       1                            1
Total number of women who provided                               88
at least one reason for self-diagnosis
of VVC
NB: Percentages calculated based on N = 88




4.10. Patients’ reasons for not seeing a doctor
There were a number of different reasons why 84 of the subjects in our study cohort
chose not to see a doctor and instead chose to self-diagnose and go directly to a
pharmacy to obtain treatment. Table 81 outlines these reasons (summarised) in
descending order of frequency. Some subjects provided multiple reasons for not
seeing a doctor. It is clear that the most commonly identified reasons provided by
almost half of the subjects (48%) were that they felt confident in their knowledge of
being able to recognise that they had VVC, based on either their past experiences, or
past episodes of VVC which had been previously diagnosed by a practitioner or even
based on the prior recommendation of a doctor to self-diagnose subsequent episodes
of VVC. A substantial number (42%) identified that ready access to treatments for


                                             - 109 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

VVC, which now no longer require prescriptions, meant convenience and promptness
in being able to obtain and self-treat their suspected episode of VVC. It was also
interesting to note that only 5% identified that the reason for not consulting a doctor
was because they wanted to avoid any examinations due to discomfort in seeing
them about this medical matter. More commonly they identified negative reasons
such as a perceived difficulty and lack of confidence in seeing a doctor (23%).
Financial reasons in consulting a doctor were also identified (8%).




    Table 81 Patients’ reasons for not seeing a doctor

    Reasons for not seeing doctor                        n                      %


Confident of self-diagnosis / previous                          40                            48
experience / previous diagnosis / on
doctor's advice
Convenience / prompt access to                                  35                            42
treatment / treatment now OTC / no
script required
Can't wait or difficult to see doctor / no                      19                            23
benefit seen in seeing doctor
Financial                                                        7                             8
Study advertisement                                              6                             7
Condition common / not serious enough                            5                             6
Avoid examinations / uncomfortable                               4                             5
seeing doctor
Reason unspecified / unclear                                     4                             5
Friend's recommendation                                          2                             2
Total number of women who provided                              84                            100
at least one reason for self-diagnosis
of VVC
NB: Percentages calculated based on N = 84




                                             - 110 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).




4.11. Doctor’s questionnaire: Presumptive diagnosis and treatment
          recommendations


4.11.1.      Presumptive diagnosis
The accuracy of the presumptive diagnoses made by the GPs following examination
of the subjects was assessed by cross-tabulating the presumptive diagnosis of either
candida positive or negative, against the results of each of the cultures performed, i.e.
from vaginal, vulval and combined swabs, then assessing the agreement between the
latter and the diagnosis (see Table 82, Table 83 and Table 84 respectively). Table 84
indicates that there is a statistically significant association between the presumptive
diagnosis and the laboratory proven diagnosis of VVC, 2 (1), 12.0662 (P = 0.0005). In
addition, the positive predictive value calculated means that the probability that a
woman has VVC if the doctor makes a presumptive diagnosis is 63%. Alternatively,
the negative predictive value means that the probability that a woman does not have
VVC if the GP makes a negative presumptive diagnosis for VVC is 75%. In assessing
the sensitivity and specificity, and corresponding false negative (Fn) and false positive
(Fp) values, the fact that Fp (41%) > Fn (22%) suggests that GPs are over diagnosing
VVC (see Table 84).


    Table 82 Doctors’ presumptive diagnosis versus vaginal candidiasis by culture

                                  Vaginal candidiasis by culture                   Total (%)
      Presumptive
       diagnosis               Negative (%)              Positive (%)

      Candida negative                    28 (78)                    8 (22)                36 (100)
        Candida positive                  21 (41)                   30 (59)                51 (100)
Total                                     49 (56)                   38 (44)                87 (100)

Sensitivity (%)                                79 Specificity (%)                                57
Proportions calculated by row.
N = 87, missing data = 7.
[Source information: Curtin University of Technology, TAFT Project Doctor’s Questionnaire 2004
(Computer File)]




                                            - 111 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



    Table 83 Doctors’ presumptive diagnosis versus vulval candidiasis by culture

                                   Vulval candidiasis by culture                   Total (%)
      Presumptive
       diagnosis               Negative (%)              Positive (%)

      Candida negative                    27 (75)                    9 (25)                 36 (42)
        Candida positive                  18 (36)                   32 (64)                 50 (58)
Total                                     45 (52)                   41 (48)                86 (100)

Sensitivity (%)                                78 Specificity (%)                                60
Proportions calculated by row.
N = 86, missing data = 8.
[Source information: Curtin University of Technology, TAFT Project Doctor’s Questionnaire 2004
(Computer File)]




    Table 84 Doctors’ presumptive diagnosis versus VVC by culture

                                     Combined vaginal & vulval
                                       candidiasis by culture                      Total (%)
  Presumptive diagnosis           Negative (%)           Positive (%)

            Candida negative                 27 (75)                9 (25)                 36 (100)
            Candida positive                 19 (37)               32 (63)                 51 (100)
Total                                        46 (53)               41 (47)                 87 (100)

Statistic                                           df              Value                         P
Chi-Square                                          1             12.0662                    0.0005

Sensitivity (%) [Fn (%)]                                                                     78 [22]
Specificity (%) [Fp (%)]                                                                     59 [41]

Positive predictive value (%)                                                                    63
Negative predictive value (%)                                                                    75
Proportions calculated by row.
N = 87, missing data = 7.
[Source information: Curtin University of Technology, TAFT Project Doctor’s Questionnaire 2004
(Computer File)]


Based on the above findings, little difference was noted between the results
determined from the two swab sites in assessing for infection with candida in our
study cohort.




                                            - 112 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

4.11.2.    Treatment recommendations
The following four tables present the data with respect to the treatment that was
recommended by the doctors. The recommended treatment was firstly cross-
tabulated with presumptive diagnosis (Table 85) and as one would expect, there was
a clear statistical association between the two, 2 (2), 28.2471 (P < 0.0001), since the
GPs would be expected to recommend treatment in accordance with their
presumptive diagnosis. Interestingly, in 29% of those patients who had a presumptive
diagnosis of something other than VVC, the treatment recommendation was to
continue using the OTC antifungal, while 42% had their treatment changed and in the
remaining 29% treatment was ceased altogether. Table 85 looks at the association
between confirmed VVC by culture and the treatment that was recommended by the
GPs and a statistically significant association was also found here, 2 (2), 11.8629 (P =
0.0027), so the treatment recommended was associated with a confirmed laboratory
proven diagnosis of VVC. Based on this data, it is evident that there was an over-
prescribing of OTC antifungals, where 44% of those subjects confirmed as negative
for candidal infection, had been told to continue their OTC antifungal.


The various treatments that were recommended were then assessed by a Sexual
Health Physician as to whether they were concordant with the examination and
laboratory findings. The assessment was divided into three categories, ‘concordant’
pertaining to those treatment recommendations that were in keeping with the final
laboratory proven diagnosis, ‘not concordant’ where they were not and ‘partially
concordant’ where the treatment recommendation was appropriate in part, eg where
the OTC antifungal treatment was ceased and an alternative treatment was
commenced for a presumptive diagnosis of atrophic vaginitis in keeping with the
subject’s demographics and clinical presentation, but subsequent microbiology results
confirmed a diagnosis of VVC.


These three assessment categories were then tested against microbiologically proven
VVC (Table 87), and a statistically significant association was found, 2 (2), 8.5185 (P
= 0.0141). In looking at specific points of interest, it is evident again that there is a
degree of over-diagnosis of VVC (see Table 87) leading to a greater proportion of ‘not
concordant’ treatment recommendations (41%) in association with a presumptive


                                         - 113 -
    Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
    self-diagnosed vaginal thrush (the TAFT Project).

    diagnosis of ‘candida negative’, versus 50% for ‘concordant’ and 9% for ‘partially
    concordant’. In the candida positive group, 75% of treatment recommendations were
    ‘concordant’, 12% ‘not concordant’ and 12% ‘partially concordant’. Hence the GPs
    tended to provide more appropriate treatment recommendations for the candida
    positive subjects than they did for the candida negative subjects.




        Table 85 Presumptive diagnosis versus treatment recommended by doctor

                                      Treatment recommended by doctor
    Presumptive            Continue OTC            Change medication       No medication
     diagnosis              product (%)                   (%)                  (%)             Total (%)

  Candida negative                      10 (29)                 15 (42)             10 (29)       35 (100)
   Candida positive                     47 (84)                    5 (9)               4 (7)      56 (100)
Total                                   57 (63)                 20 (22)             14 (15)       91 (100)

Statistic                                                             df             Value                 P
 Chi-Square                                                           2            28.2471        <0.0001
Proportions calculated by row.
N = 91, missing data = 3.
[Source information: Curtin University of Technology, TAFT Project Doctor’s Questionnaire 2004 (Computer
File)]


        Table 86 Microbiologically proven VVC versus treatment recommended by doctor

 Confirmed vaginal                   Treatment recommended by doctor
   and/or vulval
  candidiasis by           Continue OTC            Change medication       No medication
      culture               product (%)                   (%)                  (%)             Total (%)

  Candida negative                      20 (44)                 14 (31)             11 (24)       45 (100)
   Candida positive                     33 (80)                  5 (12)                3 (7)      41 (100)
Total                                   53 (62)                 19 (22)             14 (16)       86 (100)

Statistic                                                             df             Value                 P
 Chi-Square                                                           2            11.8629          0.0027
Proportions calculated by row.
N = 86, missing data = 8.
[Source information: Curtin University of Technology, TAFT Project Doctor’s Questionnaire 2004 (Computer
File)]




                                                  - 114 -
    Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
    self-diagnosed vaginal thrush (the TAFT Project).



        Table 87 Microbiologically proven VVC versus assessment of treatment recommendation

 Confirmed vaginal                Assessment of treatment recommendation
   and/or vulval
  candidiasis by                                                            Partially
      culture             Concordant (%)         Not concordant (%)      concordant (%)        Total (%)

   Candida negative                    22 (50)                18 (41)                  4 (9)      44 (100)
    Candida positive                   30 (75)                  5 (12)                5 (12)      40 (100)
Total                                  52 (62)                23 (27)                 9 (11)      84 (100)

Statistic                                                           df                Value                P
 Chi-Square                                                          2               8.5185         0.0141
Proportions calculated by row.
N = 84, missing data = 10.
[Source information: Curtin University of Technology, TAFT Project Doctor’s Questionnaire 2004 (Computer
File)]




    4.12. Proposed set of ‘key’ questions based on study findings

    Based on our study findings presented in the ‘Results’ section we can reject the null
    hypothesis that the diagnosis of vulvovaginal candidiasis as determined by the
    isolation of candida from vulval and / or vaginal swabs is not related to specific signs
    or symptoms, risk factors and / or past medical history as described by women with a
    presenting complaint of VVC.


    Along with our results and those previously established in the literature as significant
    markers of VVC, a set of ‘key’ questions formatted as a diagnostic flowchart for use
    by community pharmacists to identify those women presenting with self-diagnosis of
    or suspected VVC has been proposed (see Figure 8). Table 88 summarises the
    variables with a high specificity (>75%) used to identify these ‘key’ questions as
    previously mentioned. We also included three other variables for statistical and / or
    clinical reasons. Question 4 of the flowchart identifying use of drugs which may
    predispose a woman to VVC was included because this variable was found to have a
    statistically significant association with VVC in our study and in other studies, as
    outlined in our literature review. Question 5 and Question 7 in the flowchart were
    included purely for clinical reasons. They were deemed important not for statistical


                                                 - 115 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

reasons, but because a positive response to these questions could highlight a
potentially serious medical condition which may be detrimental if missed by the
pharmacist. The assessment of the critical nature of these questions was made by
our consultant Sexual Health Physician.


Table 88 also includes other variables such as vulval appearance and vulval
erythema as determined by the doctor, which were statistically significantly
associated with VVC, and the presence of leucocytes in the laboratory results which
was highly sensitive, but they were deemed to be inappropriate questions for the
pharmacist, since the women may not be able to identify these factors for themselves.




                                         - 116 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



   Table 88 Summary table of variables used to develop diagnostic flowchart


                                Data from Patients’ Questionnaire
                           (high sensitivity +/- statistically significant)

Variable                             P               Sensitivity       Specificity   PPV   NPV
Menopausal status                    0.0498          87                31            56    72
Vaginal discharge                    0.0343          89                31            52    76
Vaginal pruritus                     0.2709          77                34            47    67
Vulval pruritus                      0.594           82                23            48    59
Symptoms experienced in the          0.3925          97                7             47    75
past
History of same symptoms             0.4426          86                21            45    67
diagnosed by doctor as VVC
Use of personal hygiene              0.5071          82                24            48    61
products
                                  Data from Patients’ Questionnaire
                              (low sensitivity +/- statistically significant)

Variable                             P               Sensitivity       Specificity   PPV   NPV
VVC Predisposing Drug Use            0.0135          39                86            74    59
OCP use                              0.0211          28                91            73    59
History of diabetes                  N/A             5                 98            67    55
Post-coital bleeding                 0.1890          13                95            71    51
Average PPV                                                                          57

                                Data from Doctors’ Questionnaire
                           (high sensitivity +/- statistically significant)

Variable                             P               Sensitivity       Specificity   PPV   NPV
Vaginal discharge (Doctor’s          0.058           85                32         52       71
questionnaire)
Vulval pruritus (Doctor’s            0.9689          82                19         44       56
questionnaire)
                     Data from Doctors’ Questionnaire and Laboratory Results
                          (high or low sensitivity +/- statistically significant)

Variable                             P               Sensitivity       Specificity   PPV   NPV
Vulval appearance (Doctor’s          0.0385          49                29            38    39
questionnaire)
Presence of vulval erythema          0.0004          66                74            69    70
(Doctor’s questionnaire)
Leucocytes                           0.3606          88                7             46    38




                                               - 117 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

   Figure 8 Proposed diagnostic tool / flowchart to assist pharmacists in ensuring appropriate
            use of OTC antifungals

                                Woman presenting with suspected VVC


                                         Q1: Signs & symptoms of VVC
                     Is there a vaginal discharge?
                     Is there vaginal itch?
                     Is there vulval itch?



                   YES                                                       NO
       At least two features present                           Signs & symptoms suggestive of
                                                                       other pathology

         Q2 (a): Same signs /           NO
         symptoms as before
       (previously diagnosed as
                VVC)?                   Q3

             YES
                                                     Recurrent
     Q2 (b): > 2 episodes in last six   YES          VVC
                months?                              requiring
                                                                                REFER TO
                                                     assessment                 DOCTOR

              NO

      Q3: Post-menopausal not on         YES
                HRT?                              May be atrophic
                                                  vaginitis

              NO
                                         NO
      Q4: On any of the following –
           OCP, antibiotics?
                                         Q5
             YES                                     Assessment of
                                                     underlying disease
       Q5: Predisposing medical         YES          required
        condition eg diabetes /                                                      Potentially
        immunosuppression &                                                          serious
       appropriately controlled?                                                     ‘other’
                                                                                     diagnosis
                                                                  May be             eg STD,
             NO                                          YES      dermatitis         cancer

     Q6: Regular use of personal hygiene products
     (douches, tampons, feminine washes etc?
                                                                                       YES
                                                               NO

     VVC LIKELY. REFER IF                                                 Q7: Any post-coital or
                                                  NO                       abnormal bleeding?
     SYMPTOMS PERSIST.




                                               - 118 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).




4.13. Economic analysis
In order to demonstrate the potential cost savings through the use of a questionnaire
which targets key symptoms highly predictive of VVC by community pharmacists,
thereby improving the diagnostic process of VVC, four main case scenarios will be
discussed. Each case scenario will look at the potential cost of managing 100 women
with suspected or proven VVC in various ways. Table 89 outlines the average retail
costs of treating vulvovaginal candidiasis and other possible diagnoses.


The economic analysis is theoretical and based on an estimate of the PPV. The PPV
was calculated by taking an average of the variables included in the flowchart, as
previously described from the results presented in Table 88. It is recognized that this
is an estimate, so two additional case scenarios (scenarios four (b) and (c)) have
been included assessing the outcome of varying the PPV value from 40% to 80% to
demonstrate that the conclusion does not change.




                                         - 119 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



   Table 89 Average retail costs for products of interest
Treatment of vulvovaginal candidiasis and other possible diagnoses

Preparation                                                     Average retail cost ($)

Average cost for all OTC products available for treating VVC
eg:
Clotrimazole products such as:
     1% vaginal cream (35g) with 6 applicators
     100mg pessary (6)
     2% vaginal cream (20g) with 3 applicators
     500mg pessary (1)
Nystatin products:                                              $15.00
     100 000units/5g (75g) vaginal cream
     100 000units pessary (15)
Miconazole products:
     1200mg ovule & 2% cream (9g)
     4% cream (25g)
     4% prefilled applicators (3) & 2% cream (9g)
     2% cream (45g)
Fluconazole 150mg (1)                                           $35.00
Other antifungal treatments requiring prescription:
    Intraconazole 100mg oral (15)
    Ketoconazole 200mg oral (10)                               $60.00


Cost of treating alternative diagnoses such as:
    Bacterial vaginosis
    Chlamydia                                                  $24.00
    Atrophic vaginitis
    UTIs
Treatments require prescription.
Cost of treating alternative diagnoses such as:
    Herpes                                                     $130.00

NB: Prescription cost = $24.00, but total average cost of
treatment options = $130.00, not including mark-up.


Other costs for purposes of analyses:
Doctor’s consult fees:
      Average cost of 10 to 15 minute consult (short-consult) = $40.00 (Medicare
       rebate = $25.70)
      Average cost of 20 to 30 minute consult (long-consult) = $70.00 (Medicare
       rebate = $48.75)




                                          - 120 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

Laboratory fees for work-up (includes vaginal and vulval swabs, cervical and urethral
PCR, MSU and HSV PCR):
      $122.00 (Medicare rebate = $92.00)
      Even with exclusion of HSV PCR, cost remains at $122.00 for each work-up.
References for costs:
      Cost of pharmaceutical products provided by randomly selected pharmacies.
      Doctor’s consult fees and Medicare rebate provided by randomly selected GP
       practices and averaged.
      Laboratory fees provided by CliniPath Main Laboratory, West Perth, Western
       Australia. Fees charged for general practice from study laboratory not
       available.




                                         - 121 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

Scenario one: All presenting women who have self-diagnosed VVC without
intervention by community pharmacist.
From our study cohort, 47% self-diagnosed VVC correctly and 53% did not, based on
microbiologically proven VVC.


   Figure 9 Cost analysis – Scenario one


                                  Women self-diagnosing VVC
                                       (see Table 27)




               47% VVC                                                  53% not VVC



                                                                    53 x $15.00 for OTC
           47 x $15.00 for OTC                                      antifungals expected
          antifungals expected to                                    not to be of benefit
                be of benefit.                                            = $855.00
                 = $705.00


                                                      Expect possible treatment failure and
                                                     doctor’s consult required. Long-consult
                                                       with laboratory work-up since VVC
                                                            treatment already trialled.
                                                          53 x $70.00 + 53 x $122.00 =
                                                                   $10,176.00




                         Expect appropriate treatment based on results.
                           53 x $15.00 - $24.00 = $795.00 - $1,272.00
               (allowing for cost of possible re-trial of VVC treatment if laboratory
                           proven & cost of treating other diagnoses).



    Total potential cost for scenario one = $12,531.00 - $13,008.00 per 100 women




                                           - 122 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

   NB: Have not included full cost of treatment such as for herpes or use of oral
   antifungals such as fluconazole with potentially greater costs, since each scenario
   will be dealt with in the same manner with respect to drug costs.


Scenario two: All presenting women who have self-diagnosed VVC without screening
by community pharmacist, are referred on for long-consult and full laboratory work-up
(similar to present study conditions).




   Figure 10 Cost analysis – Scenario two


                                            100 women self-
                                            diagnosing VVC




                        100 x doctor’s long-consult = 100 x $70.00 = $7,000.00
                        100 x laboratory work-up = 100 x $122.00 = $12,200.00

                Based on our study cohort, if treatment could not wait until results were
                           available (for majority of cases), see Table 85:
                            63 continued OTC = 63 x $15.00 = $945.00
                 22 changed medication = 22 x $15.00 - $24.00 = $330.00 - $528.00
                                       15 did not treat = $0.00

                                  Subtotal = $20,475.00 - $20,673.00




                         Once results available, expect treatment to be modified
                    accordingly. Based on our study, initial treatment was concordant
                      in 62% (see Table 87), therefore expect treatment potentially
                                      changed in 38% of patients.

                                38 x $15.00 - $24.00 = $570.00 - $912.00




         Total potential cost for scenario two = $21,045.00 - $21,585.00 per 100 women




                                         - 123 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

Scenario three: All presenting women who have self-diagnosed VVC without
screening by a community pharmacist are referred on to a doctor for initial
assessment and treatment.




   Figure 11 Cost analysis – Scenario three


        All women with suspected VVC referred to doctor, receives short-consult, no
                      laboratory work-up @ 100 x $40.00 = 4,000.00

      Based on our study results, 62% of treatment recommendations were concordant
                 with microbiological &/or clinical findings (see Table 87)



           62% concordant                                            38% not concordant



           62 x $15.00 - $24.00 =                   Potential treatment costs = 38 x $15.00 -
            $930.00 - $1,488.00                     $24.00 = $570.00 - $912.00

           Treatment either OTC
           antifungal or for other                      Expect possible treatment failure and
                 diagnoses.                            further doctor’s consult required. Long-
                                                        consult with laboratory work-up since
                                                       previous treatment not concordant, and
                                                                potentially ineffective.

                                                       38 x $70.00 + 38 x $122.00 = $7,296.00




                         Expect appropriate treatment based on results.
                            38 x $15.00 - $24.00 = $570.00 - $912.00
               (allowing for cost of possible re-trial of VVC treatment if laboratory
                           proven & cost of treating other diagnoses).



   Total potential cost for scenario three = $13,366.00 - $14,608.00 per 100 women




                                          - 124 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

Scenario four (a): All presenting women who have self-diagnosed VVC receive
intervention by a community pharmacist, using statistically significant or highly
indicative key questions identified in the use and analysis of the current questionnaire
targeted at predicting likelihood of having true VVC. Based on assessment of these
key questions, the overall positive predictive value is calculated to be approximately
60%.

   Figure 12 Cost analysis – Scenario four (a)


      All women with suspected VVC screened by a pharmacist using key questions,
        based on our study results, expect at least 60% positive predictive value of
    questions, expect 60% of women identified as being suitable for continued treatment
                     with OTC antifungal, 40% for referral to a doctor.



            60% concordant                             40% referred to doctor,
                                           receives short-consult, no laboratory work-up @
                                                       40 x $40.00 = 1,600.00

   60 x $15.00 = $900.00
                                                   Potential treatment costs = 40 x $15.00 -
    Treatment with OTC                             $24.00 = $600.00 - $960.00
        antifungal.

                                  Based on our study 62% of treatment recommendations
                                  were concordant with microbiological &/or clinical findings
                                                       (see Table 87).
                                    Expect possible treatment failure and further doctor’s
                                   consult required. Long-consult with laboratory work-up
                                  since previous treatment not concordant, and potentially
                                                         ineffective.



                                      38% of 40 = 15 x $70.00 = $1,050.00 for long consult
  Expect appropriate treatment                & 15 x $122.00 = 1,830.00 for laboratory
   based on results in 62% of          investigations & expect appropriate treatment based
  40 = 25. No further treatment       on results, 15 x $15.00 - $24.00 = $225.00 - $360.00
      or follow-up required.          (allowing for cost of possible re-trial of VVC treatment
                                            if laboratory proven & cost of treating other
                                                             diagnoses).
                                          Total additional cost = $3,105.00 – $3,240.00




    Total potential cost for scenario four (a) = $6,205.00 - $6,700.00 per 100 women


Scenario four (b): Recalculating ‘Scenario four (a)’ using a PPV of 40%.


                                         - 125 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



   Figure 13 Cost analysis – Scenario four (b)


      All women with suspected VVC screened by a pharmacist using key questions,
        based on our study results, expect at least 40% positive predictive value of
    questions, expect 40% of women identified as being suitable for continued treatment
                     with OTC antifungal, 60% for referral to a doctor.



            40% concordant                             60% referred to doctor,
                                           receives short-consult, no laboratory work-up @
                                                       60 x $40.00 = 2,400.00

   40 x $15.00 = $600.00
                                                   Potential treatment costs = 60 x $15.00 -
    Treatment with OTC                             $24.00 = $900.00 - $1440.00
        antifungal.

                                  Based on our study 62% of treatment recommendations
                                  were concordant with microbiological &/or clinical findings
                                                       (see Table 87).
                                    Expect possible treatment failure and further doctor’s
                                   consult required. Long-consult with laboratory work-up
                                  since previous treatment not concordant, and potentially
                                                         ineffective.



                                      38% of 60 = 23 x $70.00 = $1,610.00 for long consult
  Expect appropriate treatment                & 23 x $122.00 = 2,806.00 for laboratory
   based on results in 62% of          investigations & expect appropriate treatment based
  60 = 37. No further treatment       on results, 23 x $15.00 - $24.00 = $345.00 - $552.00
      or follow-up required.          (allowing for cost of possible re-trial of VVC treatment
                                            if laboratory proven & cost of treating other
                                                             diagnoses).
                                          Total additional cost = $4,761.00 – $4,968.00




    Total potential cost for scenario four (b) = $8,661.00 - $9,408.00 per 100 women




                                         - 126 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

Scenario four (c): Recalculating ‘Scenario four (a)’ using a PPV of 80%.


   Figure 14 Cost analysis – Scenario four (c)


      All women with suspected VVC screened by a pharmacist using key questions,
        based on our study results, expect at least 80% positive predictive value of
    questions, expect 80% of women identified as being suitable for continued treatment
                     with OTC antifungal, 20% for referral to a doctor.



            80% concordant                             20% referred to doctor,
                                           receives short-consult, no laboratory work-up @
                                                        20 x $40.00 = 800.00

        80 x $15.00 =
         $1,200.00                                 Potential treatment costs = 20 x $15.00 -
                                                   $24.00 = $300.00 - $480.00
    Treatment with OTC
        antifungal.
                                  Based on our study 62% of treatment recommendations
                                  were concordant with microbiological &/or clinical findings
                                                       (see Table 87).
                                    Expect possible treatment failure and further doctor’s
                                   consult required. Long-consult with laboratory work-up
                                  since previous treatment not concordant, and potentially
                                                         ineffective.



                                       38% of 20 = 8 x $70.00 = $560.00 for long consult &
  Expect appropriate treatment         8 x $122.00 = 976.00 for laboratory investigations &
   based on results in 62% of           expect appropriate treatment based on results, 8 x
  20 = 12. No further treatment                  $15.00 - $24.00 = $120.00 - $192.00
      or follow-up required.          (allowing for cost of possible re-trial of VVC treatment
                                            if laboratory proven & cost of treating other
                                                             diagnoses).
                                          Total additional cost = $1,656.00 – $1,728.00




    Total potential cost for scenario four (c) = $3,956.00 - $4,208.00 per 100 women




                                         - 127 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

Based on the four scenarios illustrated, there is little difference between the expenses
incurred in scenario one compared to three. Scenario two would be considered the
ideal situation where all women receive a full diagnostic work-up and medical
assessment and is also clearly the most costly of the four in relation to direct medical
costs. However, provision of better health-care with more acceptable direct economic
outcomes would be expected in having community pharmacists screen those women
who are self-diagnosing VVC, with the use of an appropriate diagnostic aide, such as
a series of highly predictive questions targeted at identifying VVC or other significant
medical conditions. This would ensure an improved rate of identifying those with
microbiologically proven VVC to an expected rate of at least 60%, an improvement on
the 47% associated with women self-diagnosing VVC, as found in our study and
consequently potentially reducing the rate of treatment failures and requirement for
follow-up consultation by a medical practitioner, as demonstrated in scenario four. In
addition and more importantly, the appropriate screening process would aid in the
prompt referral of those women with potentially more serious medical conditions other
than VVC, which in our study population equated to 13% of women.


The cost savings based on the difference between the expenses calculated for
scenario one and scenario four (a) is suggestive of what the potential financial gain
would be in using a questionnaire as proposed by our study with a PPV of 60%,
which is a savings of approximately $6,300.00 per 100 women with suspected VVC.
Considering sales of OTC antifungals are possibly in the magnitude of at least one
product per day per pharmacy (personal communication from one community
pharmacy in our study), the potential for direct cost savings as well as potentially
improved healthcare for women with VVC is considerable. Based on the conservative
assumption that the rate of sale of vaginal antifungal products is one product per
week per pharmacy in the whole of Australia (4,910 community pharmacies in
Australia as at 30 June 2004, data provided by the Health Insurance Commission of
Australia), the potential direct savings based on our cost analysis is approximately
$16 million per year. Calculated as follows:
      Potential direct cost savings from use of diagnostic flowchart, based on a PPV
       of 60%, i.e. average difference between scenario one and scenario four (a) =
       $6,300 per 100 women, which equates to $63.00 per woman assessed



                                         - 128 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

      If one woman presents to purchase an OTC product and is assessed each
       week, this equates to 52 women per year per pharmacy
      Therefore 4,910 x 52 x $63.00 = approximately $16 million per year for all
       pharmacies in Australia.
If the same calculation was performed using the average differences in cost between
scenario one and scenarios four (b) and (c) respectively, there is still the potential for
substantial savings from the use of the flowchart. These savings are as follows:
      Based on a PPV of 40% for the flowchart = 4,910 x 52 x $40.82 =
       approximately $10 million per year for all pharmacies in Australia.
      Based on a PPV of 80% for the flowchart = 4,910 x 52 x $90.34 =
       approximately $23 million per year for all pharmacies in Australia.
There are clearly limitations to these relatively simplistic economic models which are
discussed in the next section, however they do demonstrate the potential for cost
savings with the use of a validated diagnostic flowchart, even if it’s positive predictive
value is as low as 40% and not the currently expected 60% as based on the study
findings.




                                         - 129 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



5. DISCUSSION

Vulvovaginitis is a common affliction for many women with both infectious and / or
non-infectious causes being associated with the disorder.32 To some degree the
prevalence and causes are uncertain due to the fact that the condition is often self-
diagnosed and managed without medical assistance. Often the condition is also
asymptomatic or may be secondary to multiple causes. It has been noted that up to
90 percent of vulvovaginitis cases may be due to bacterial vaginosis, VVC and
trichomoniasis, while the non-infectious causes include vaginal atrophy, allergies and
chemical irritation.6


With as high as 75 percent of pre-menopausal women being estimated to have VVC
at some time in their life, out of which 5% of women go on to have recurrent episodes,
the implications of inaccurate self-diagnosis and self-treatment in the era of over-the-
counter antifungals is more critical than ever. It is imperative that healthcare providers
are equipped with the appropriate assessment tools to assist women in ensuring that
the ease of availability of self-treatment does not end up disadvantaging them through
mismanagement and delays in obtaining appropriate treatment.


Our study set out to test two null hypotheses and to identify and validate a series of
questions on signs, symptoms, risk factors and past history of high sensitivity which
could be incorporated into a structured questionnaire that pharmacists could use as a
diagnostic tool to minimise the adverse implications of inaccurate self-management of
VVC by women. Based on our findings we were able to reject both null hypotheses.
We also identified five key questions of high sensitivity (>75%) which were
incorporated into our final diagnostic tool proposed for use by pharmacists to identify
women with likely VVC with an overall expected positive predictive value of
approximately 60%. These five key questions which related to menopausal status,
presence of vaginal discharge, presence of vaginal and / or vulval itch, use of hygiene
products and history of same symptoms, confirmed what has been previously
identified in the literature as predictive features and risks of VVC. What differed from
the literature was in that we only found a statistically significant association between



                                         - 130 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

the following questions tested and laboratory proven VVC: the presence of vaginal
discharge; normal vulval appearance; vulval erythema; menopausal status; and use
of ‘VVC predisposing drugs’ including OCP use. Many of the other features or risk
factors such as description of the vaginal discharge, dysuria, dyspareunia, vulval
oedema, presence of fissures, past medical history of eg diabetes etc were found not
be associated with laboratory proven VVC as would have been expected based on
the literature. 3,6,13 This was probably due to our small sample size and other
limitations which will be discussed later. As such, though the sensitivity of the
question relating to ‘VVC predisposing drugs’ was <75%, based on the statistical
significance, significant relative risk, and literature support,10,24,25 the use of these
drugs was included as a question in our diagnostic flowchart.



5.1.    Self-diagnosis of VVC
Our study showed that only 41 out of the 88 women (47%), who had vaginal and / or
vulval swabs and cultures taken were confirmed to have a candidal infection. The
remaining 47 (53%) of women either had another cause of infection or their
symptoms were not secondary to an infectious cause. Hence, little less than half of
the women who had self-diagnosed VVC in our sample population had laboratory
proven VVC. Our study showed a different rate of correct self-diagnosis of VVC
compared to those women in the study by Ferris et al2 where only 32 of 95 patients
(34%) who self-diagnosed vaginal candidiasis were correct. However in comparison
to the study by Chaponis et.al11 where it was demonstrated that 59% of women who
presented with a self-diagnosed initial episode of candidiasis, and 82% who
presented with a self-diagnosed recurrent episode of VVC were accurate in their
assessment, our sample population did not compare as well. Our data concurs in
that there is a poor rate of self-diagnosis of VVC by women in Australia, even in those
with recurrent episodes.




                                         - 131 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

5.2.     Signs, symptoms, physical and laboratory findings in VVC
         and other causes of vaginitis

5.2.1.     Vaginal discharge
In most women with VVC, the discharge is usually normal in appearance though it is
also described as being white, floccular and highly viscous.13 In our study cohort, a
statistically significant association was observed between those women who had
identified the presence of vaginal discharge and laboratory proven vaginal or vulval
candidiasis based on the patients’ response to this question. This was not confirmed
by the data from the doctors’ questionnaires. However the sensitivity of this question
(89%) and the fact that the final diagnostic flowchart is intended to be used by the
pharmacists in questioning the women directly, inclusion of this question in the final
diagnostic flowchart was considered appropriate. One possible explanation for the
difference between the results obtained from the patients’ versus the doctors’
responses may be as a result of a small number of women opting to present for the
doctors’ examination a few days after being recruited (due to convenience). This may
have resulted in a slight delay and therefore possible difference in the presenting
features between the initial self-assessment by the women upon recruitment and
assessment by the doctors. Where this delay occurred the women had to be prepared
and were instructed to wait before commencing treatment, so commencement of
antifungal treatment was not considered a likely reason for the difference. The
presence of vaginal discharge can also be a somewhat subjective assessment and
could be another reason for the difference.



5.2.2.     Vaginal discharge characteristics
No statistical association was found based on the data from our study cohort for any
of the analyses performed looking at vaginal discharge characteristics and laboratory
confirmed diagnosis of VVC, so no definite conclusions may be drawn from our data
as to whether any one particular description relating to the consistency (eg thick or
thin), the colour (eg white, off-white, yellow-green), and / or the odour (eg yeasty or
other), of the vaginal discharge could be used definitively to aid in the diagnosis of
VVC. What is important to note here is that 55 out of 67 women (82%) in our study



                                         - 132 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

had identified their presenting symptoms as being the same or similar to what they’d
previously experienced, and which had been diagnosed by a doctor at the time as
VVC. Since the appearance of the vaginal discharge of acute candidiasis is
uncommon in recurrent VVC,8 and the previous point might suggest the possibility
that the majority of our study cohort were women suffering from recurrent VVC, this
may explain why our data on vaginal discharge characteristics showed no statistical
association with laboratory proven VVC. We cannot be certain on this point since the
frequency of occurrence of these likely episodes of VVC was not determined from our
questionnaires, however from the numerous general comments made by the women
illustrating the frustration and alluding to the frequent nature of occurrence of these
symptoms, there may be some merit to this reasoning.



5.2.3.     Vaginal discharge components: Laboratory findings
As previously discussed in the literature review, the normal vaginal discharge is
comprised of a number of other components, including epithelial cells and white blood
cells or leucocytes.13,14 Where a large number of WBCs is observed, trichomoniasis
or cervicitis should be suspected and where they are found to be absent candidiasis
or non-specific vaginitis may be suspected. 13 Some correlation between the
presence of clue cells and bacterial vaginosis (G. vaginalis) has been found.13,14
Lactobacilli are also found in the vaginal discharge of women with candidiasis and
consequently maintains the pH at less than 4.5.3,13 In our study cohort, neither the
absence of WBCs or clue cells or presence of lactobacilli and associated vaginal pH
were associated with laboratory proven VVC. Only two women were identified as
having bacterial vaginosis, both of whom had clue cells present. Based on our limited
data, no conclusions may be drawn for the association between the laboratory
findings and VVC. This information was collected and analysed to allow for
comparisons with the existing evidence in the literature, but clearly does not serve as
useful data in the design of our final diagnostic flowchart.



5.2.4.     Vulval and vaginal pruritus
No significant association between vulval and / or vaginal pruritus was found with
VVC based on our study findings. However, since the absence of either or both of


                                         - 133 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

these variables have been previously determined as decreasing the likelihood of
candidal infection 33 and based on the high sensitivity of these variables determined
from our analyses, they were included in our diagnostic flowchart.



5.2.5.     Inflammatory and other signs
Presence of inflammatory signs such as vulval and / or vaginal oedema, erythema,
fissures, or excoriations and other signs including dysuria and dyspareunia have been
previously assessed and analysed as having an association with candidiasis. 6,33 We
found no association based on our data, except with ‘normal vulval appearance’ and
vulval erythema against culture proven vulval candidiasis. What’s interesting to note
here is that with respect to vulval erythema (vulval appearance was not included in
the patient’s questionnaire), no association was found based on the patients’
responses to their self-assessment of this variable, but the association was evident
based on the doctors’ data. In fact 28% of women were unsure as to whether there
was any vulval erythema present (specified as ‘redness’ in their questionnaire for
ease of interpretation). This identifies an important point in that, while many signs in
particular may previously have been identified as significant indicators of VVC, these
have been based primarily on clinician assessment and not patient assessment, and
based on our findings, patient assessment of some signs and symptoms may prove
unreliable in diagnosing VVC. This leads on to another important discussion point
which is addressed below.



5.2.6.     History of same symptoms
Our data included women who had specified that they had been instructed to self-
diagnose when there was a recurrence of VVC symptoms, which suggests that at
least in some instances, the women may have been better able to identify signs and
symptoms of VVC appropriately. Even so, previous studies have identified that prior
clinician-based diagnosis of VVC does not improve women’s ability to properly self-
diagnose this condition.2 We set out to determine whether the fact that women who
had previously been diagnosed with VVC by a doctor, based on same or similar
symptoms, were better able to self-diagnose subsequent episodes of VVC. We found
no association between a ‘history of same symptoms diagnosed as VVC’ and current


                                         - 134 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

episode of culture proven VVC, confirming the findings by Ferris et al regarding
women’s ability to self-diagnose stated previously. 2 However the sensitivity of this
variable was high (86%) and as such was included in our diagnostic flowchart.



5.2.7.     Candida speciation
Our findings concurred with the literature in that at least 8% of our cases of
vulvovaginal candidiasis were due to non-albicans yeast species.34,35 The clinical
presentation of C. glabrata vaginitis is reported to differ from that caused by C.
albicans.35 Also with the increasing use of OTC antifungals, the risk of emerging
resistance and chronic vaginitis due to C. glabrata has been proposed, which requires
further study.34,35 The isolated number of cases of C. glabrata from our study was too
small to conduct further analysis to add to the currently available literature evidence.



5.2.8.     Other infective causes of vaginitis

5.2.9.     Bacterial vaginosis
As previously mentioned, two of the women from our study cohort had bacterial
vaginosis according to their laboratory findings, one of whom had specified a sexual
preference for women. Bacterial vaginosis has been found more commonly in women
who have a sexual preference for other women, though this could not be proven
statistically from our limited study numbers.36



5.2.10.    Group B streptococcus
Vulvovaginitis due to group B streptococcus remains controversial and while its
causal role in vulvovaginal symptoms has been argued by some authors, it remains
an area requiring further research. 16,17 We were unable to provide any further
evidence towards its causal role in vaginitis, as there were only 10 cases where GBS
was isolated and reported from our study cohort.




                                         - 135 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

5.3.     Risk factors for VVC

5.3.1.     Menopausal status
Of our study population, from those who were post-menopausal, 13 out of 18 women
(72%) did not have vulvovaginal candidiasis based on culture results. Statistical
analysis suggests a possible association between menopausal status and culture
proven VVC and we found that those women who were post-menopausal are about
half as likely to have culture proven VVC compared to those who are pre-
menopausal. Based on the literature women who have low levels of oestrogen due to
menopause may develop vulvovaginal symptoms attributable to vaginal atrophy,18
hence post-menopausal women who are not on hormone replacement therapy and
who do not have a diagnosis of diabetes rarely suffer from VVC, 32 which differs from
our findings in that all of our post-menopausal women were on HRT and none had
identified a history of diabetes. Despite this, an association (though significance was
borderline) was still found between menopausal status and VVC. The sensitivity of
the question as a test for VVC was 87% and based on these findings and previous
literature support,22 menopausal status was included in our final diagnostic flowchart.
However, this question as a test for VVC should be further validated, with a larger
sample size and tested against a control group of post-menopausal women on HRT
with no history of diabetes versus post-menopausal women not on HRT with no
history of diabetes.



5.3.2.     Medical history
We included in our patient’s questionnaire a range of medical conditions which could
either predispose women to VVC or suggest other possible causes of
vaginitis. 5,13,15,18,37 None of the medical histories of relevance proved to be suitable
variables for inclusion in our diagnostic flowchart based on findings from statistical
analyses and sensitivity values calculated. However, the following were of particular
interest and are briefly discussed.




                                         - 136 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

5.3.3.     Diabetes
Three of the women in our study cohort claimed a history of diabetes, from which 2
(67%) were confirmed to have vulvovaginal candidiasis by culture. Our sample size
was not large enough to show any significant association between a history of
diabetes and risk of VVC. However while our sample size lacked the power to test for
the significance of diabetic status as an appropriate question for our final diagnostic
flowchart, based on the literature support 10,13,32 and clinical importance of checking
for appropriate management of this condition, the question of diabetic status was
included in our final diagnostic flowchart.



5.3.4.     Sexual history
Our study did not specifically look at sexual activity or behaviour which has been
implicated as risk factors for VVC.9 We only addressed the numbers of sexual
partners our study population had over three specified periods of time (3- and 12-
month periods and lifetime). Knowing the sexual partner a shorter period of time has
also been identified as an independent risk factor for VVC.9 Our study findings did not
concur with the literature evidence with respect to this factor. This was probably due
to our small sample size.
Since our intention was to determine the significance of sexual history as a variable
for potential inclusion into the diagnostic flowchart, we had all questions relating to
sexual history being addressed by the doctor in recognition of the sensitive nature of
this issue. However as to whether the question if addressed by a pharmacist in a
potentially busy pharmacy which is less conducive to privacy, would result in an
accurate assessment of this variable remains to be determined. As far as we could
determine, no existing literature guidelines for use specifically by pharmacists
appears to include this as a variable to address.7



5.3.5.     Use of medications
Certain medications such as broad-spectrum antibiotics and immunosuppressant
medications causing immunodeficiency would be expected to and have been shown
to be risk factors for VVC.10, 24,25 From our study population only four cases were



                                         - 137 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

identified where at least one of these drugs were used. In our assessment of ‘VVC
predisposing drugs’ we also included all hormonal agents, including hormone
replacement therapy as well as those patients on blood-sugar lowering medications
(insulin) as a secondary indicator for potentially poorly managed diabetes. Our
analysis found a significant association between use of at least one of these agents
and VVC, with a significant relative risk of 1.8. We included this as a variable in our
diagnostic flowchart despite the low sensitivity (39%) based on the reasons outlined
previously, but because we suspected that the results were influenced primarily by
OCP use (discussed below), instead of addressing ‘hormonal agents’ in general, we
specified ‘OCP use’ in the diagnostic flowchart for this variable. Due to the lack of
power and low sensitivity based on our study findings, further validation of this
variable is recommended.



5.3.6.        Contraceptive methods used
As alluded to previously, OCP use was found to be a significant variable as a risk
factor for VVC. The sensitivity of the question relating to OCP use was 28%, but
based on the statistical significance, significant relative risk, and some literature
support, 10 OCP use was included as a question in our diagnostic flowchart.
Assessment of other contraceptive methods (diaphragm and intrauterine device
usage) in addition to OCP use as risk factors for VVC did not yield significant results
although the sensitivity of this variable was reasonably high (73%). Despite literature
support in identifying these additional contraceptive methods as risk factors for VVC
6,10
       since there were only two patients identified who used either the diaphragm or
intrauterine device, use of OCP appeared to be the more significant variable to
include in our diagnostic flowchart.



5.3.7.        Non-infective conditions and associated risk factors

5.3.7.1.      History of skin disorders and allergies and allergy associated
              disorders

Non-infective conditions such as dermatitis, psoriasis or a predisposition to allergies
are possible differential diagnoses, which could make the diagnosis of VVC more


                                         - 138 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

difficult. These were assessed for possible inclusion into our final diagnostic flowchart
for VVC, but as alluded to before, analysis of statistical association and sensitivity and
specificity for validity of the test did not support the inclusion of this question.



5.3.7.2.     Use of feminine hygiene products

No association between any one particular hygiene product, including the most
commonly used item (tampon), and the occurrence of VVC was found. The literature
has reported that these products have been implicated in allergic or irritant
vulvovaginitis. 5,18 The sensitivity of this variable in identifying those women who used
these products and were unlikely to have VVC, but were instead more likely to have
allergic vulvovaginitis and hence in need of medical referral was high and
consequently, this question was included in the diagnostic flowchart.



5.4.       Other findings of importance

5.4.1.       Patients’ reasons for self-diagnosis, not seeing a doctor
             and sources of information for self-diagnosis
It may be argued that lack of privacy and customer embarrassment are the reasons
why women avoid seeking professional advice for the management of VVC. We
questioned our study cohort on why they chose to self-diagnose rather than seek
medical advice, something which appears not to have been addressed previously in
the literature.


Interestingly in our study population, only 5% identified that they wanted to avoid any
examinations due to discomfort in seeing a doctor about this matter. The most
common reasons provided highlighted the fact that the majority of our study cohort
had previously experienced the symptoms, which may have been diagnosed by a
doctor as VVC in the past, and consequently they felt confident in self-diagnosing
VVC for subsequent episodes. Other key reasons included issues relating to
convenience, they were unwilling or not able to wait to see a doctor, or even
questioned the benefit in seeking medical advice, or the fact that vaginal antifungals



                                         - 139 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

were now available over the counter meant ready and prompt access which they
were in favour of.


The identification of these reasons for self-diagnosis is important as they help health-
professionals to recognise the expectation that women have in managing their
episodes of VVC. The perception that women are embarrassed in discussing this
health issue, may in itself lead pharmacists to not address women as appropriate to
aid in the diagnostic process. This possible factor was observed by one of the
investigators of this study during the recruitment of pharmacies to participate in the
study. Some pharmacists voiced their concern at having to approach women about
this sensitive issue. A study conducted by Ralph et al. identified that almost 25% of
community pharmacists who responded in their study were uncomfortable discussing
genitourinary problems with a member of the opposite sex.38 Which leads to the
question that if health-professionals who have an obligation to assist women in better
managing their health concerns are unwilling to do so for fear of embarrassment
(from either party), what steps can and should be taken to counter-act these issues to
promote better health-care? We expect that utilisation of our diagnostic flowchart will
in part assist to answer this question.


What is reassuring to some degree is that the main sources of information identified
by women utilised to assist in their self-diagnosis of VVC were the ‘doctor’ and
‘pharmacist’ as opposed to other, most likely non-healthcare providers. This
reinforces the fact that community pharmacists have the potential to assist in the
diagnostic process of VVC.



5.4.2.     Concordance of presumptive diagnoses and treatment
           recommendations
The accuracy of the presumptive diagnoses and treatment recommendations made
by the GPs was also assessed against the laboratory findings and review of
questionnaires by the participating Sexual Health Physician in our study. It was
determined that the probability that a woman had VVC where a GP made a positive
presumptive diagnosis of VVC was 63%. This suggests that while GPs are clearly



                                          - 140 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

better at diagnosing VVC compared to the women in the study (47% of women
accurately self-diagnosed VVC), there is not a great deal of difference between the
two groups. This may provide some explanation as to why the women in our study
identified a perceived lack of benefit in seeking medical advice.


In assessing the false positives (41%) and false negatives (22%) in relation to the
presumptive diagnoses, the results showed that GPs tended to err on the side of
caution in diagnosing VVC. These findings were reflected in the treatment
recommendations where the rate of complete concordance of the treatment
recommendations to the diagnosis based on laboratory and examination findings was
62%.


Considering that a number of GPs received specialist instruction in diagnosing VVC
at the outset of the study, these rates of concordance for presumptive diagnosis and
treatment recommendations suggest potential for improvement. One issue to be
borne in mind is that not all the GPs received specialist instruction, this will be further
addressed under ‘study limitations’.



5.4.3.     Other serious disorders not to be missed
A number of disorders should not be missed due to their potential serious nature.
These include STDs such as chlamydia and genital herpes and in particular
carcinoma of the vagina or cervix.37 While the community pharmacist may not be in a
position to readily identify these as potential differential diagnoses, the question
concerning presence of post-coital or abnormal bleeding was included in the
diagnostic flowchart to help identify those women who may potentially be at risk of
having these disorders, and thus requiring prompt medical referral.7
Urinary tract infections should also be borne in mind as a possible differential
diagnosis. We isolated four cases in our study cohort which had been missed.



5.5.     Economic analysis
The cost analysis performed in our study illustrates the potential for significant
savings throughout Australia over a one year period if all community pharmacies were


                                         - 141 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

to utilise a highly sensitive diagnostic tool for VVC. We acknowledge that our cost
analysis only considers direct medical costs and that it does not include travel /
transport costs or cost of lost time and other outcome measures which could be
associated with indirect costs.


A number of assumptions were also made with respect to diagnosis and treatment.
The main assumptions were that in each of the “diagnostic arms” in the four
scenarios, including where laboratory investigations may or may not have been
performed, the final diagnosis would be accurate and resultant treatment curative.
The potential for multiple concurrent treatments, use of more expensive oral
antifungals and total cost (not just prescription costs) for some treatments eg for the
management of HSV (see Table 89), were not included in the analyses.



5.6.    Proposed diagnostic flowchart
The final proposed diagnostic flowchart is not designed to be an exhaustive list of
questions identifying all risk factors (as was more closely done in our study
questionnaire) but rather to recognise and serve the need for a valid, yet easily
utilised tool to assist pharmacists in more accurately and promptly identifying those
women who should receive treatment with an OTC antifungal based on the likelihood
of them having VVC.


While the issue of seeking medical help for the management of suspected VVC by
many women may remain an area of some sensitivity and frustration as indicated by
the women in our study, the professional obligations of the pharmacist come to the
fore as they are now the primary health-care provider who is in the position of
ensuring appropriate use of OTC vaginal antifungals. These are particularly important
considerations in designing a diagnostic tool that is quick to execute, fulfils the
requirements as a valid diagnostic aide and addresses the need for sensitivity in the
nature of the questions thus ensuring minimal embarrassment for the women
concerned.




                                         - 142 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

5.7.    Study recommendations
Our recommendations are that community pharmacists should receive training and
education with respect to genitourinary problems and to use our proposed diagnostic
flowchart as a tool in providing better healthcare and advice to women who present
with suspected VVC. Community pharmacists should also receive training in areas of
good interpersonal skills so that they may feel more confident in addressing sensitive
health issues with the potential to cause embarrassment.


As our proposed diagnostic tool was developed based primarily on questions that had
a high sensitivity due to the greater penalty for not treating a woman with VVC than
there would be for treating a woman who does not have VVC, we also recommend
that it be validated in a follow-up study to calculate not only its sensitivity, but also
specificity, positive predictive value and negative predictive value. In conjunction to
the validation of our diagnostic flowchart, we recommend a full cost-benefit analysis,
looking at potential savings in both direct and indirect costs as well as costs related to
outcome.


We would also recommend ongoing training by specialist physicians in the area of
women’s health be provided for GPs so that the rate of presumptive diagnoses in
relation to women’s sexual health is improved and faith possibly restored in women in
relation to the likely benefits of obtaining medical advice.




                                         - 143 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).


5.8.      Areas requiring further research
   1. While we have stated a recommendation for community pharmacists to receive
         training to better equip them in dealing with sensitive health issues based on
         our observation that some community pharmacists appeared reluctant to
         approach women with suspected VVC, along with findings in a previous study
         also identifying this as an issue 38, research into how competently Australian
         community pharmacists deal with genitourinary problems would be of use.
         Such a study may serve to elucidate existing perceptions and expectations of
         both the healthcare provider and of their customers in managing genitourinary
         problems which could be used to educate and train community pharmacists to
         better serve their customers.


   2. Since controversy remains in the causal role of group B streptococcus in
         vaginitis, well designed studies addressing this issue in an effort to provide
         some answers would be desirable.


   3. The feasibility and cost-benefits of using self-testing kits for VVC, in
         conjunction with appropriate health-care advice.



5.9.      Limitations of the study

5.9.1.       Small sample size
We recognise that our study was limited by a somewhat small sample size and that
our initial intention of recruiting 220 patients was not fulfilled. The difficulties in
recruitment are addressed below. Consequently our study lacked the power to
analyse all risk factors since some variables contained only a very few number of
subjects. We were also unable to validate the diagnostic flowchart as planned.



5.9.2.       Risk of bias
In addition, incomplete response rates to questionnaires may introduce selection bias.
Recall bias and social desirability bias which are well recognised in sexual health


                                          - 144 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

surveys may also have been introduced in our study.36 We used convenience
sampling, through both pharmacies and secondarily through advertisements so our
results may not be generalised to all Australian women.


There was a risk for selection and information bias through use of advertisements,
however the women were questioned specifically to ascertain if they were confident
that they had thrush at the time of answering the advertisement. Since they were not
provided any prompts or hints of the signs and symptoms of thrush and since the
investigator taking the phone call only referred the women to a pharmacy for
recruitment once satisfied that they had self-diagnosed their condition, the risk of
selection bias was expected to be minimal. The women were not provided with details
on the expected signs and symptoms of thrush nor were they advised on possible
treatments (before they had a bout of vaginitis), so the risk for information bias was
minimised. The process of recruitment through the advertisements was considered
not to vary greatly from the situation where women self-diagnosing thrush would
present to a pharmacy of their choice. The only difference was that they were directed
by the screening investigator to a pharmacy participating in the study for further
provision of information and possible inclusion of the women into the study.


We acknowledge that since the patients were made aware that they would receive
the OTC antifungal medication product for free when they consented to the study
there was the potential to bias their responses to the questionnaire. However only
those patients who were requesting a vaginal antifungal product were approached by
pharmacists, or those who answered the advertisement indicating that they were
intending to go to a pharmacy to purchase a vaginal antifungal as a result of self-
diagnosing thrush were considered appropriate for recruitment. Therefore we
consider that since the product which they intended to purchase would be provided
free of charge irrespective of their responses to the questionnaire, there was a
minimal risk for information bias. If the situation was such that the patients were
required to complete the questionnaire first, and if only then they were eligible to a
free product based on their responses to the questionnaire, then we would expect
there to be a risk of bias in their responses. In addition all pharmacists involved were
instructed not to question the women about the specifics of the signs and symptoms,



                                         - 145 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

thus avoiding any likely influence on their subsequent responses to these questions in
the questionnaire.


Not all GPs attended the information session prior to commencement of recruitment,
which could have introduced bias in their technique in sampling and conducting the
various tests. At the same time, attendance at the information session could
potentially have biased our results on accuracy of presumptive diagnoses, where GPs
who attended may have improved their rate of accuracy in diagnosis through being
better informed than those who did not. Bias would still have existed due to the use of
multiple investigators with differing techniques in observation, interviewing and
analysing data.



5.9.3.     Economic analysis
Our cost analysis was a very simplistic theoretical one and only considered direct
medical costs. In addition, as briefly discussed before, a number of assumptions were
made with respect to diagnoses and treatment. The performance and practices of
GPs throughout Australia may differ, therefore the expected cost savings based on
our economic models are also likely to differ in ‘real’ practice.


6. ISSUES RELATING TO RECRUITMENT – LESSONS
     LEARNED
As mentioned previously, our study was limited by the small sample size, which was
approximately half the number of subjects we originally intended to recruit. Due to a
recruitment rate which was significantly slower than what would have been expected
from the average sales figures for OTC antifungals in the community pharmacies
involved, the allocated time of recruitment for our study proved to be inadequate to
fulfil our needs. The recruitment rate fell significantly from the end of 2003. The
primary problem was the number of potential patients not approached in pharmacies
as a result of significant loss of enthusiasm by the pharmacists involved. We
recommend to other investigators who intend on conducting a study of a similar
nature to take into consideration the difficulties in sustaining enthusiasm in study




                                         - 146 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

participants (the pharmacists in this case), especially if the study is conducted for any
length of time beyond a few months and involves a considerable number of sites.
One of the other key difficulties identified by a participating pharmacy was the
difficulty in allocating the necessary time towards recruiting patients when working in
a busy pharmacy. While a busy pharmacy undoubtedly encounters a greater number
of potentially suitable subjects for recruitment, evidently the pharmacists were not
able to devote the necessary time beyond their usual professional obligations,
towards recruitment of subjects. Therefore another key lesson in identifying suitable
sites for recruitment is that it may be better to target those pharmacies with a more
appropriate balance between sales activity and available staff time for dedication to
recruitment activities.




                                         - 147 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

7. CONCLUSION
We determined that women who self-diagnose VVC do so poorly. We obtained
enough data to develop a structured diagnostic flowchart of high sensitivity which has
the potential to assist community pharmacists in improving the management of VVC,
especially important in light of the ease of obtaining OTC vaginal antifungals. By
actively being involved in this diagnostic process, pharmacists are not only fulfilling
their professional obligations, but are also potentially providing significant cost
savings to the community. Further research is needed into validating our proposed
diagnostic flowchart, along with establishing effective and efficient means of
implementing its use throughout Australia. An economic analysis with ‘real’ data
following the validation of the flowchart also needs to be performed.



8.   ACKNOWLEDGEMENTS
This project was funded by the Australian Department of Health and Ageing as part of
the Third Community Pharmacy Agreement and administered by the Pharmacy Guild
of Australia.
The authors thank colleagues in their respective departments for their support and in
particular Mr Frank Sanfilippo for support and advice on statistical matters.
Thanks also to all the community pharmacists and general practitioners who
volunteered to assist with the study.




                                         - 148 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

9. REFERENCES / BIBLIOGRAPHY
1. Bradford J. Is it really thrush? Management of vulvo-vaginal discomfort in
   pharmacy practice. Aust Pharm 2001;20(4):223-4.
2. Ferris DG, Nyirjesy P, Sobel JD, Soper D, Pavletic A, Litaker MS. Over-the-
   Counter Antifungal Drug Misuse Associated with Patient-Diagnosed Vulvovaginal
   Candidiasis. Obstet Gynecol 2002;99:419-425.
3. Ponte CD. Infectious vulvovaginitis: Current trends in management. J Pharm
   Technol 2000;16:92-7.
4. Kamarashev JA, Vassileva SG. Dermatological diseases of the vulva. Clin
   Dermatol 1997;15(1):53-65.
5. Moraes PS, Taketomi EA. Allergic vulvovaginitis. Ann Allergy Asthma Immunol
   2000;85(4):253-65.
6. Egan ME, Lipsky MS. Diagnosis of vaginitis. Am Fam Physician 2000;62:1095-
   104.
7. Watson MC, Bond CM. Evidence-based guidelines for non-prescription treatment
   of vulvovaginal candidiasis (VVC). Pharm World Sci 2003;25(4):129-134.
8. Welsh BM, Berzins KN, Cook KA, et al. Management of common vulval
   conditions. MJA 2003;178:391-5.
9. Reed BD, Gorenflo DW, Gillespie BW, Pierson CL, Zazove P. Sexual behaviours
   and other risk factors for candida vulvovaginitis. J Women’s Health Gender-based
   Med 2000;9(6):645-55.
10. Ringdahl EN. Treatment of recurrent vulvovaginal candidiasis. Am Fam Physician
   2000;61:3306-12, 3317.
11. Chaponis RJ, Bresnick PA, Weiss RR, Edwards LD. Candida vaginitis: Signs and
   symptoms aid women’s self-recognition. J Clin Res Drug Dev 1993;7:17-23.
12. Macsween KF, Ridgway GL. The laboratory investigation of vaginal discharge. J
   Clin Pathol 1998;51:564-7.
13. Eschenbach DA. Vaginal infection. Clin Obstet Gynecol 1983;26(1):186-202.
14. Baldson MJ. Gardnerella vaginalis and its clinical syndrome. Eur J Clin Microbiol
   1982;1(5):288-93.
15. Miller KE, Ruiz DE, Graves JC. Update on the prevention and treatment of
   sexually transmitted diseases. Am Fam Physician 2003;67:1915-22.




                                         - 149 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

16. Shaw C, Mason M, Scoular A. Group B streptococcus carriage and vulvovaginal
   symptoms: causal or casual? A case-control study in a GUM clinic population. Sex
   Transm Infect 2003;79:246-8.
17. Monif GRG. Semiquantitative bacterial observations with group B streptococcal
   vulvovaginitis. Infect. Dis. Obstet. Gynecol 1999;7:227-9.
18. Fischer G. Treatment of vaginitis and vulvitis. Aust Prescr 2001;24:59-61.
19. Ferris DG, Deckle C, Litaker MS. Women’s use of over the counter antifungal
   medications for gynaecological symptoms. J Fam Pract 1996;42:595-600.
20. Rodgers CA, Beardhall AJ. Recurrent vulvovaginal candidiasis: why does it occur?
   Int J STD AIDS 1999;10(7):435-9.
21. Spinillo A, Capuzzo E, Acciano S, DeSantolo A, Zara F. Effect of antibiotic use on
   the prevalence of symptomatic vulvovaginal candidiasis. Am J Obstet Gynecol
   1999;180(1):14-7.
22. Fivozinsky KB, Laufer MR. Vulvar disorders in adolescents. Adolesc Med
   1999;10(2):305-19.
23. Spinillo A, Capuzzo E, Nicola S, Baltaro F, Ferrari A, Monaco A. The impact of
   oral contraception on vulvovaginal candidiasis. Contraception 1995;51(5):293-7.
24. Pirotta MV, Gunn JM, Chondros P. “Not thrush again!” Women’s experience of
   post-antibiotic vulvovaginitis. MJA 2003;179:43-6.
25. Spinillo A, Capuzzo E, Acciano S, De Santolo A, Zara F. Effect of antibiotic use on
   the prevalence of symptomatic vulvovaginal candidiasis. Am J Obstet Gynecol
   1999;180:14-7.
26. Patrick DM. Sample size and diagnostic test evaluations. Sex Transm Infect 1998;
   74(1):78.
27. Fletcher RH, Fletcher SW, Wagner EH. Clinical epidemiology: the essentials. 3rd
   ed. Baltimore: Williams & Wilkins, 1996, p43-74.
28. Simel DL, Samsa GP, Matchar DB. Likelihood ratios with confidence: sample size
   estimation for diagnostic test studies. J Clin Epidemiol 1991; 44(8): 763-70.
29. Dawson B, Trapp RG. Basic & clinical biostatistics. Sydney: McGraw-Hill, 2001
30. Haslett C, Chilvers ER, Boon NA, Colledge NR, Hunter JAA eds. Davidson’s
   principles and practice of medicine, 19th edn. Sydney: Churchill Livingstone, 2002.
31. Beers MH, Berkow R, eds. The merck manual of diagnosis and therapy. New
   Jersey: Merck Research Laboratories, 1999.



                                         - 150 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

32. Dennerstein G. The treatment of candida vaginitis and vulvitis. Aust Prescr
   2001;24:62-4.
33. Anderson MR, Klink K, Cohrssen A. Evaluation of vaginal complaints. JAMA
   2004;291:1368-79.
34. Walker PP, Reynolds MT, Ashbee HR, Brown C, Evans EGV. Vaginal yeasts in
   the era of “over the counter” antifungals. Sex Transm Inf 2000;76:437-8.
35. Sobel JD. Vulvovaginitis due to Candida glabrata. An emerging problem. Mycoses
   1998;41(2):18-22.
36. Bailey JV, Farquhar C, Owen C, Mangtani P. Sexually transmitted infections in
   women who have sex with women. Sex Transm Infect 2004;80:244-6.
37. Murtagh J. Vaginal discharge. Aust Fam Physician 1991;20(2):207-13.
38. Ralph SG, Preston A, Clarke J. Over-the-counter advice for genital problems: the
   role of the community pharmacist. Int J STD AIDS 2001;12:513-5.
39. Katz D, Baptista J, Azen SP, Pike MC. Obtaining confidence intervals for the risk
   ratio in cohort studies. Biometrics. 1978;34:469-74.




                                         - 151 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

.

10. APPENDICES

Appendix 1 – TAFT Project: Patient Information

Title of Project
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

Chief Investigators
Mr Peter Tenni, School of Pharmacy, Curtin University.
Mr Jeff Hughes, School of Pharmacy, Curtin University.
Dr Jenny McCloskey, Department of Sexual Health, Royal Perth Hospital.

PROJECT PHARMACIST
Ms Samantha Hilmi, Department of Pharmacy, Royal Perth Hospital.

EC REFERENCE NO.
HR 230/2002.

Patient Information

You have been asked to participate in this study looking at the treatment and diagnosis of
vaginitis (thrush). Many women self-diagnose thrush and can now purchase appropriate
over-the-counter preparations for the treatment of thrush. In most cases, the treatment is
effective and does not cause any further problems to the condition. However in some cases,
the diagnosis of thrush is incorrect, and the cause of the vaginitis is not Candida (the
common causative organism of thrush). This means that the treatment that is used is not
appropriate and will usually not work. Often the problem may persist and may eventually lead
to a doctor’s visit to get the problem sorted out properly.

In this study we are asking all women who think they have thrush to visit their doctor and
undergo testing to determine the cause of their symptoms. The results of the test will
determine the exact cause of the problem and if the treatment that was originally chosen is
not appropriate this will be changed accordingly. If you choose to participate in this project,
you will be asked to complete a survey that asks you questions related to a number of factors
that may cause different types of vaginitis. By looking at the results of the tests and the
results of the survey we hope to identify which types of vaginitis are associated with
particular answers in the survey. Eventually this will allow pharmacists to identify patients
who are more likely to be at a greater risk of non-Candida vaginitis.

The process will be as follows:

    7. You need to complete both the consent form (must be completed in the pharmacy) and
       the survey (most of it may be completed at home).

    8. An appointment will be made with a doctor of your choice or if you haven’t got a
       preferred doctor, one will be chosen for you. You will be required to see your doctor
       within 24 hours from now, so that you do not have to wait too long before starting your
       chosen treatment.



                                            - 152 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

9. The survey will also require information regarding your doctor’s visit (travel time, waiting
   and consultation time etc), so it should be completed once you’ve seen your doctor.
   Once you have completed the survey place it into the envelope provided, seal it and
   give it to your doctor’s receptionist after your appointment, it will then be collected by one
   of the research team.

10. The product you intended to purchase will be provided to you free of charge in a sealed
    bag, and you may start using the treatment only after your doctor has approved its use. It
    is important that you do not start using the treatment before you see your doctor, as this
    may affect the test results.

11. You will be given a “Doctor’s Pack” by your pharmacist. It will contain some
    documentation and equipment which your doctor will need in order to carry out the
    appropriate tests, so you will need to take this with you when you go to see your doctor.

12. You need to visit your doctor at the appointed time and they will carry out the necessary
    tests and confirm that the treatment you have been provided is appropriate. The results
    of the tests will go back to your doctor and they will contact you if your treatment needs to
    be changed.

13. A member of the research team will contact you in two weeks time to confirm that the
    symptoms have been relieved.

Your participation in this study is entirely voluntary. You may withdraw from the study at any
time without explanation and your future treatment will not be affected. Please be assured
that even if you decide that you do not wish to participate in this study, you will still be able to
purchase whatever over the counter treatment you require. If you do decide to participate in
the study, you will not incur any cost, nor will you receive any payment for participating in this
study. All treatment for your symptoms will be provided free of charge, including your doctor’s
visit (Medicare funds will not be used) and any treatment that is prescribed as a result of this
initial visit. If you do decide to withdraw from the study, please return the unused “Doctor’s
Pack” to your pharmacist.

The study records will be de-identified once information pertaining to your particular case is
recorded. This means that in the future it will not be possible to identify any particular
information from the overall group information. All information obtained during the study
will be kept confidential. The original records will only be available to the primary
investigator and co-investigators of this study.

This study will be carried out in a manner according to the principles set out by the National
Statement on Ethical Conduct in Research Involving Humans. The Curtin University of
Technology Human Research Ethics Committee has reviewed and approved the study. If
you have any questions or concerns now or at any time regarding the study you should
contact any of the investigators at the numbers listed below:

          Samantha Hilmi              Mobile Phone: 0402 111 694

          Peter Tenni                 Mobile Phone: 0439 850 086

If you wish to discuss the study with someone who is not directly involved in it (for example,
about the information you have received, the conduct of the study or your rights as a
participant, OR to make a complaint), you can contact the Curtin University Human Research
Ethics Committee Secretariat on 9266 2784.




                                            - 153 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).



Appendix 2 – TAFT Project: Patient Consent Form
                                      TAFT Project
                                 Patient Consent Form
                         (Original retained by the Pharmacist)

I agree to participate in the above study. I have read and understand the information
provided regarding this study and I have retained a copy of the signed document. I have
been given the opportunity to ask questions about the study by the investigators. I
understand that I may withdraw from the study at any time without affecting any future
medical treatment.


Signed:                              ………………………………………………………


Name of patient:                     ………………………………………………………
(BLOCK Letters)

Date:                                ………………………………………………………



Signature of Investigator/Pharmacist:        ………………………………………………………




                                         - 154 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).




Appendix 3 – TAFT Project: Pharmacist Information Form
TITLE OF PROJECT
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

CHIEF INVESTIGATORS
Mr Peter Tenni, School of Pharmacy, Curtin University.
Mr Jeff Hughes, School of Pharmacy, Curtin University.
Dr Jenny McCloskey, Department of Sexual Health, Royal Perth Hospital.

PROJECT SUPERVISOR
Ms Samantha Hilmi, Department of Pharmacy, Royal Perth Hospital.

EC REFERENCE NO.
HR 230/2002.

Aims of the Study
The aims of this study are to demonstrate:
    That the use of a structured questionnaire can assist pharmacists to identify patients
       for whom OTC vaginal antifungal therapy is appropriate based on their symptoms and
       consequently when referral to a General Practitioner is warranted; and
    The cost-benefits of allowing pharmacists to sell such products.

Background and Significance of the Study

The Research Problem
The recent down-scheduling of topical antifungal agents has increased the number of non-
prescription options for management of vaginal symptoms. This has also meant that there is
increased scope for self-diagnosis by women, the majority of whom regard any vulvo-vaginal
symptom as “thrush”. 1

Context of the Research Problem: Non-Fungal Vaginal Conditions
Vulvo-vaginitis is a common gynaecological diagnosis and vaginal discharge represents one
of the top 25 reasons why women seek advice.2 However, although candidiasis is a common
cause of vulvo-vaginal discomfort, contact dermatitis is one of the most common causes,
along with bacterial vaginosis, genital warts and psoriasis.1,3,4 Patients with infectious
vaginitis frequently complain of vaginal discharge, foul odour, itching, dysuria or dyspareunia.
Infectious organisms may be fungal (Candida albicans or glabrata), bacterial (Gardnerella
vaginalis, Mobiluncus spp, Mycoplasma hominis or Peptostreptococcus spp), protozoan
(Trichomonas spp) or viral (Human papillomavirus, Herpes simplex virus). 5
Approximately 75% of women have at least one episode of vaginal candidiasis at some time
in their lives and 5% have recurrent episodes.5 Of patients with vaginal symptoms,
approximately 60% will later be confirmed with a diagnosis of vaginal candidiasis.7 In a study
of 105 women with self-diagnosed recurrent yeast infections who were referred to a vaginitis
specialty centre,8 the most common diagnoses were:
      Vulvovaginal candidiasis (27.6%);
      Vulvar vestibulitis (17.1%);
      Irritant dermatitis (15.2%); and


                                          - 155 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

      Bacterial vaginosis (10.5%).

There is therefore a range of possible diagnoses for patients with vaginal symptoms,
many of which are not effectively treated with antifungal medications.

Context of the Research Problem: Poor Accuracy of Self-Diagnosis
Ferris et al6 found that when women were given descriptions of various vaginal infections,
only 28% accurately diagnosed vaginal candidiasis and only 4% could recognise bacterial
vaginosis. In another study, Chaponis et al7 demonstrated that of 54 women who presented
with a self-diagnosed initial episode of candidiasis, only 59% actually had this condition. Of
100 women who had prior candidiasis, the accuracy of self-diagnosis of recurrent episodes
was 82%. Furthermore, the use of topical antifungal agents in patients with irritant dermatitis
(up to 15% of patients with vaginal symptoms) may exacerbate the condition.7 A more recent
study by Ferris et al8 showed that only 32 of 95 patients (34%) who self-diagnosed vaginal
candidiasis were correct, with bacterial vaginosis (19%), mixed vaginitis (21%) and other
conditions making up the majority of cases. Further, women who had previously had an
episode of clinically diagnosed vaginal candidiasis were no more accurate in their diagnosis
than women without previous episodes.
In non-fungal vaginal conditions, the use of topical antifungal agents is not only ineffective,
but may also delay diagnosis and appropriate management of the true problem. There is no
Australian data to compare to this most recent American study, however, given a similar
demographic group, we could expect similar results. If this is the case, approximately two
thirds of patients who self-diagnose vaginal candidiasis are incorrect.
Critical factors in determining which vaginal condition is present include:
     The frequency of symptoms (particularly differentiating whether the episode is the first
         or a recurrent episode);9
     Associated antibiotic use (note that some antibiotics may cause dermatitis not
         candidiasis);10
     Age of the patient (candidiasis is extremely rare in postmenopausal patients who are
         not taking hormone replacement therapy or do not have a diagnosis of diabetes);11
     Contraceptive method used (may also be associated with marital status and sexual
         history);12 and
     Concurrent illnesses (especially diabetes, but also other diseases that affect
         immunological function).
Access to the over the counter antifungal products without confirmation of diagnosis
may therefore be associated with wasted financial resources, unfulfilled expectations
and a delay in the correct diagnosis for up to two thirds of women who perceive they
have vaginal candidiasis.

The Research Project
A structured questionnaire concerning the patient’s signs, symptoms and history has been
prepared, which all patients enrolled in the study are required to complete, place in a sealed
envelope and forward to their GP’s receptionist, which then will be subsequently collected by
a member of the research team. The patient needs to be referred to their GP (or if they
haven’t got one, a GP in the Osborne Division of General Practice) for definitive examination
and for relevant laboratory testing. All necessary documentation and test equipment,
included in the “Doctor’s Packs” previously supplied to all participating pharmacies must be
given to each patient prior to their doctor’s appointment.

This project aims to test the validity of each module and the individual questions answered
by the patient within the structured questionnaire, against the eventual laboratory proven
diagnosis. The validity information will ultimately be used to structure a set of questions of
high specificity that will be recommended for ongoing use by pharmacists.


                                         - 156 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).


Likely Benefits of the Research Project
          A questionnaire to assist pharmacists to ensure the appropriate use of vaginal
           antifungal products
          The ability to identify patients requiring referral for further assessment of potential
           non-fungal vaginal conditions
          Prevention or unnecessary and/or inappropriate use of antifungal medications
          Early identification and effective treatment of non-fungal vaginal conditions with
           potentially serious sequelae
          Reduction in health care costs related to unnecessary doctor referrals, laboratory
           investigation and/or complications of delayed diagnosis and/or treatment of
           potentially serious non-fungal vaginal disorders

Methods
All community pharmacies and GPs within the Osborne Division of General Practice have
been approached to participate in the study.

Patient Eligibility and Recruitment
All females who present to participating community pharmacies wishing to purchase a topical
vaginal antifungal product for their personal use and who voluntarily agree to participate in
the study will be enrolled. The aims and structure of the study will be explained to the patient
via an information form and they are required to provide written informed consent. A copy of
the signed consent form needs to be made by the pharmacist and supplied to the patient for
their records and for GP perusal if required.

As a compensation for participation in the study, patients have been informed that the cost of
their initial doctor’s consultation will be billed to the study, as will the cost of the
microbiological testing. Further, the cost of treatment of their vaginal condition will be
covered (this payment will be made directly to the pharmacy). Any further examinations or
consultations if deemed necessary, should be funded through the usual system.

Stakeholder Meetings/Clarification of Information
All Pharmacists from the Division have, prior to commencement of the study been invited to
an information/education evening, where the study and background information (as similarly
outlined in this information form) was presented. If further information is required to be
disseminated in the future, the Division will be informed of any planned meetings, or the
information posted to participating GP practices as warranted. Alternatively, any of the
investigators may be contacted on the following numbers for clarification of any of the details
of this study.

          Samantha Hilmi     Mobile Ph: 0402 111 694

          Peter Tenni        Mobile Ph: 0439 850 086

If you wish to discuss the study with someone who is not directly involved in it (for example,
about the information you have received, the conduct of the study or your rights as a
participant, OR to make a complaint), you can contact the Curtin University Human Research
Ethics Committee Secretariat on 9266 2784.

Ethical Issues
This study will be carried out in a manner according to the principles set out by the National
Statement on Ethical Conduct in Research Involving Humans. The Curtin University of
Technology Human Research Ethics Committee has reviewed and approved the study.


                                          - 157 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).


The study records will be de-identified once information pertaining to each particular case
has been recorded. All information obtained during the study will be kept confidential. The
original records will only be available to the primary investigator and co-investigators of this
study.

Pharmacist’s Role
    You need to provide each eligible patient with both the TAFT Project Patient Information
     and Consent Forms. Once the patient has volunteered to participate in the study, the
     Consent Form must be completed and signed in the pharmacy and a photocopy made.
     The copy should be given to the patient and the original kept for collection by a member
     of the research team. A copy of the Survey must then be provided, the majority of which
     may be completed by the patient at home.

    An appointment will need to be made with a doctor of the patient’s choice or if they
     haven’t got a preferred doctor, one needs to be chosen for them. Contact details of all the
     participating GPs in the Osborne Division has been provided for this purpose to all
     participating Pharmacies.

     Once patient’s have completed the survey, and after review by their GP as part of their
     consultation, they have been instructed to place it into the envelope provided, seal it and
     give it to their doctor’s receptionist after their appointment, it will then be collected by one
     of the research team.

     The product they intended to purchase will need to be provided labelled as per your
     usual pharmacies practice and placed in a click seal bag, sealed with a tamper proof
     sticker (provided by the investigators) and given free of charge to the patient. They have
     been instructed that they may only commence treatment after they have seen their doctor
     and the treatment has been approved. It is important that they do not commence
     treatment before then, as this may affect their test results.

    A “Doctor’s Pack” as prepared by the investigators and previously supplied to
     participating pharmacies, will need to be supplied to the patient. It will contain some
     documentation and equipment which the doctor will need in order to carry out the
     appropriate tests, so the patient will need to take this with them when they go for their
     doctor’s appointment.

    The results of the tests will go back to their doctor and the patient’s treatment may need
     changing, in which case the appropriate treatment as prescribed by their GP will need to
     be supplied, however this should be charged as per usual practice, to the patient.

Reimbursement
Pharmacies participating in the study will receive a payment of $85 per patient enrolled (this
includes cover for the cost of the initial therapy supplied). Further, participating pharmacies
will receive Continuous Quality Improvement (CQI) credit points at a rate of one point for
every 10 hours involvement in the research project (approximately one point for every 10
patients recruited).


References/Bibliography
1.   Bradford J. Is it really thrush? Management of vulvo-vaginal discomfort in pharmacy practice. Aust Pharm 2001;20(4):223-
     4.
2.   Ponte CE. Infectious vulvovaginitis: Current trends in management. J Pharm Technol 2000;16:92-7.
3.   Kamarashev JA, Vassileva SG. Dermatological diseases of the vulva. Clin Dermatol 1997;15(1):53-65.




                                                       - 158 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

4.  Moraes PS, Taketomi EA. Allergic vulvovaginitis. Ann Allergy Asthma Immunol 2000;85(4):253-65.
5.  Egan ME, Lipsky MS. Diagnosis of vaginitis. Am Fam Physician 2000;62:1095-104.
6.  Ferris DG, Deckle C, Litaker MS. Women’s use of over the counter antifungal medications for gynaecological symptoms. J
    Fam Pract 1996;42:595-600.
7. Chaponis RJ, Bresnick PA, Weiss RR, Edwards LD. Candida vaginitis: Signs and symptoms aid women’s self-recognition.
    J Clin Res Drug Dev 1993;7:17-23.
8. Ferris DG, Nyirjesy P, Sobel JD, Soper D, Pavletic A, Litaker MS. Over-the-Counter Antifungal Drug Misuse Associated
    with Patient-Diagnosed Vulvovaginal Candidiasis. Obstet Gynecol 2002;99:419-425.
9. Rodgers CA, Beardhall AJ. Recurrent vulvovaginal candidiasis: why does it occur? Int J STD AIDS 1999;10(7):435-9.
10. Spinillo A, Capuzzo E, Acciano S, DeSantolo A, Zara F. Effect of antibiotic use on the prevalence of symptomatic
    vulvovaginal candidiasis. Am J Obstet Gynecol 1999;180(1):14-7.
11. Fivozinsky KB, Laufer MR. Vulvar disorders in adolescents. Adolesc Med 1999;10(2):305-19.
12. Spinillo A, Capuzzo E, Nicola S, Baltaro F, Ferrari A, Monaco A. The impact of oral contraception on vulvovaginal
    candidiasis. Contraception 1995;51(5):293-7.




                                                     - 159 -
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with self-diagnosed vaginal thrush (the TAFT Project).



Appendix 4 – TAFT Project: Patient Recruitment List
INSTRUCTIONS FOR PHARMACISTS
    The following is required to be completed for ALL patients who present complaining of vaginal thrush and request an OTC product for treatment and are
     subsequently approached regarding the TAFT Project, including those who choose not to participate. Patient details may be omitted for those not enrolled
     in the study.
    For each patient enrolled, a fixed reimbursement fee will be provided to the Pharmacy to cover any treatment costs and administration time incurred.
    Please maintain patient confidentiality at all times.

     PATIENT NAME &             OTC PRODUCT             ENROLLED IN STUDY?               FOR THOSE PATIENTS ENROLLED IN THE STUDY                PHARMACIST’S
     PHONE NUMBER                PURCHASED                                                  – TICK TO CONFIRM TASK COMPLETED                        NAME

    (DETAILS REQUIRED                                           YES OR IF               PATIENT     DOCTOR’S APPOINT.        LAB        OTC
     ONLY FOR THOSE                                     NO - GIVE BRIEF REASON            INFO &     MADE (FOR WITHIN       TEST     PRODUCT
     ENROLLED IN THE                                             WHY NOT                 SURVEY       24 HOURS, GIVE         KIT      PACKED
          STUDY)                                       (eg patient certain they have   PROVIDED &        DETAILS)           GIVEN        IN
                                                         thrush, or time issue etc)     CONSENT                                       SEALED
                                                                                           FORM                                        BAG
                                                                                         SIGNED
                                                        YES          NO                           GP Name:

                                                                                                    GP Phone:

                                                                                                    Appt Date/Time:


                                                        YES          NO                           GP Name:

                                                                                                    GP Phone:

                                                                                                    Appt Date/Time:



                  Please fax form at the end of the day for patient follow-up (fax number 9224 2939). Thank you for your assistance.




                                             - 160 -
                           TAFT PROJECT
     Data Sheet – Doctor’s History, Examination and Assessment
                       (Please return to investigators in the envelope provided)




Appendix 5 – TAFT Project: Doctor’s Information Form
TITLE OF PROJECT
Ensuring the appropriateness of topical over-the-counter antifungal agents for clients with
self-diagnosed vaginal thrush (the TAFT Project).

CHIEF INVESTIGATORS
Mr Peter Tenni, School of Pharmacy, Curtin University.
Mr Jeff Hughes, School of Pharmacy, Curtin University.
Dr Jenny McCloskey, Department of Sexual Health, Royal Perth Hospital.

PROJECT PHARMACIST
Ms Samantha Hilmi, Department of Pharmacy, Royal Perth Hospital.

EC REFERENCE NO.
HR 230/2002.

Aims of the Study
The aims of this study are to demonstrate:
    That the use of a structured questionnaire can assist pharmacists to identify patients
       for whom OTC vaginal antifungal therapy is appropriate based on their symptoms and
       consequently when referral to a General Practitioner is warranted; and
    The cost-benefits of allowing pharmacists to sell such products.

Background and Significance of the Study

The Research Problem
The recent down-scheduling of topical antifungal agents has increased the number of non-
prescription options for management of vaginal symptoms. This has also meant that there is
increased scope for self-diagnosis by women, the majority of whom regard any vulvo-vaginal
symptom as “thrush”. 1

Context of the Research Problem: Non-Fungal Vaginal Conditions
Vulvo-vaginitis is a common gynaecological diagnosis and vaginal discharge represents one
of the top 25 reasons why women seek advice.2 However, although candidiasis is a common
cause of vulvo-vaginal discomfort, contact dermatitis is one of the most common causes,
along with bacterial vaginosis, genital warts and psoriasis.1,3,4 Patients with infectious
vaginitis frequently complain of vaginal discharge, foul odour, itching, dysuria or dyspareunia.
Infectious organisms may be fungal (Candida albicans or glabrata), bacterial (Gardnerella
vaginalis, Mobiluncus spp, Mycoplasma hominis or Peptostreptococcus spp), protozoan
(Trichomonas spp) or viral (Human papillomavirus, Herpes simplex virus). 5
Approximately 75% of women have at least one episode of vaginal candidiasis at some time
in their lives and 5% have recurrent episodes.5 Of patients with vaginal symptoms,
approximately 60% will later be confirmed with a diagnosis of vaginal candidiasis.7 In a study
of 105 women with self-diagnosed recurrent yeast infections who were referred to a vaginitis
specialty centre,8 the most common diagnoses were:
      Vulvovaginal candidiasis (27.6%);
      Vulvar vestibulitis (17.1%);
      Irritant dermatitis (15.2%); and
TAFT Project – Data Sheet Doctor’s Examination & Assessment
                                             Page - 161 -
                              TAFT PROJECT
        Data Sheet – Doctor’s History, Examination and Assessment
                       (Please return to investigators in the envelope provided)

        Bacterial vaginosis (10.5%).

There is therefore a range of possible diagnoses for patients with vaginal symptoms,
many of which are not effectively treated with antifungal medications.

Context of the Research Problem: Poor Accuracy of Self-Diagnosis
Ferris et al6 found that when women were given descriptions of various vaginal infections,
only 28% accurately diagnosed vaginal candidiasis and only 4% could recognise bacterial
vaginosis. In another study, Chaponis et al7 demonstrated that of 54 women who presented
with a self-diagnosed initial episode of candidiasis, only 59% actually had this condition. Of
100 women who had prior candidiasis, the accuracy of self-diagnosis of recurrent episodes
was 82%. Furthermore, the use of topical antifungal agents in patients with irritant dermatitis
(up to 15% of patients with vaginal symptoms) may exacerbate the condition. 7 A more recent
study by Ferris et al8 showed that only 32 of 95 patients (34%) who self-diagnosed vaginal
candidiasis were correct, with bacterial vaginosis (19%), mixed vaginitis (21%) and other
conditions making up the majority of cases. Further, women who had previously had an
episode of clinically diagnosed vaginal candidiasis were no more accurate in their diagnosis
than women without previous episodes.
In non-fungal vaginal conditions, the use of topical antifungal agents is not only ineffective,
but may also delay diagnosis and appropriate management of the true problem. There is no
Australian data to compare to this most recent American study, however, given a similar
demographic group, we could expect similar results. If this is the case, approximately two
thirds of patients who self-diagnose vaginal candidiasis are incorrect.
Critical factors in determining which vaginal condition is present include:
     The frequency of symptoms (particularly differentiating whether the episode is the first
         or a recurrent episode);9
     Associated antibiotic use (note that some antibiotics may cause dermatitis not
         candidiasis);10
     Age of the patient (candidiasis is extremely rare in postmenopausal patients who are
         not taking hormone replacement therapy or do not have a diagnosis of diabetes);11
     Contraceptive method used (may also be associated with marital status and sexual
         history);12 and
     Concurrent illnesses (especially diabetes, but also other diseases that affect
         immunological function).
Access to the over the counter antifungal products without confirmation of diagnosis
may therefore be associated with wasted financial resources, unfulfilled expectations
and a delay in the correct diagnosis for up to two thirds of women who perceive they
have vaginal candidiasis.

The Research Project
A structured questionnaire concerning the patient’s signs, symptoms and history has been
prepared, which the patient has been instructed to complete, place in a sealed envelope and
forward to your receptionist, which then will be subsequently collected by a member of the
research team. The patient has been referred to yourself for definitive examination and for
relevant laboratory testing. All necessary documentation and test equipment has been
included in this pack to allow completion of this phase of the study.

This project aims to test the validity of each module and the individual questions answered
by the patient within the structured questionnaire, against the eventual laboratory proven
diagnosis. The validity information will ultimately be used to structure a set of questions of
high specificity that will be recommended for ongoing use by pharmacists.
TAFT Project – Data Sheet Doctor’s Examination & Assessment
                                             Page - 162 -
                           TAFT PROJECT
     Data Sheet – Doctor’s History, Examination and Assessment
                       (Please return to investigators in the envelope provided)



Likely Benefits of the Research Project
           A questionnaire to assist pharmacists to ensure the appropriate use of vaginal
            antifungal products
           The ability to identify patients requiring referral for further assessment of potential
            non-fungal vaginal conditions
           Prevention or unnecessary and/or inappropriate use of antifungal medications
           Early identification and effective treatment of non-fungal vaginal conditions with
            potentially serious sequelae
           Reduction in health care costs related to unnecessary doctor referrals, laboratory
            investigation and/or complications of delayed diagnosis and/or treatment of
            potentially serious non-fungal vaginal disorders

Methods
All community pharmacies and GPs within the Osborne Division of General Practice have
been approached to participate in the study.

Patient Eligibility and Recruitment
All females who present to these community pharmacies wishing to purchase a topical
vaginal antifungal product for their personal use and who voluntarily agree to participate in
the study have been enrolled. The aims and structure of the study have been explained to
the patient and they have been asked to provide written informed consent. A copy of the
signed consent form has been supplied to the patient by the enrolling pharmacy, for GP
perusal if required.

As a compensation for participation in the study, patients have been informed that the cost of
their initial doctor’s consultation will be billed to the study, as will the cost of the
microbiological testing. Further, the cost of treatment of their vaginal condition will be
covered (this payment will be made directly to the pharmacy). Any further examinations or
consultations if deemed necessary, should be funded through the usual system.

Stakeholder Meetings/Clarification of Information
All GPs from the Division have, prior to commencement of the study been invited to an
information/education evening, where the study and background information (as similarly
outlined in this information form) was presented. If further information is required to be
disseminated in the future, the Division will be informed of any planned meetings, or the
information posted to participating GP practices as warranted. Alternatively, any of the
investigators may be contacted on the following numbers for clarification of any of the details
of this study.

           Samantha Hilmi       Mobile Ph: 0402 111 694

           Peter Tenni          Mobile Ph: 0439 850 086

If you wish to discuss the study with someone who is not directly involved in it (for example,
about the information you have received, the conduct of the study or your rights as a
participant, OR to make a complaint), you can contact the Curtin University Human Research
Ethics Committee Secretariat on 9266 2784.

Ethical Issues
TAFT Project – Data Sheet Doctor’s Examination & Assessment
                                             Page - 163 -
                            TAFT PROJECT
      Data Sheet – Doctor’s History, Examination and Assessment
                        (Please return to investigators in the envelope provided)

This study will be carried out in a manner according to the principles set out by the National
Statement on Ethical Conduct in Research Involving Humans. The Curtin University of
Technology Human Research Ethics Committee has reviewed and approved the study.
The study records will be de-identified once information pertaining to each particular case
has been recorded. All information obtained during the study will be kept confidential. The
original records will only be available to the primary investigator and co-investigators of this
study.

General Practitioner’s Role
GPs are required to conduct a series of tests and investigations that are based on current
best-practice as outlined by Dr Jenny McCloskey, Department of Sexual Health, Royal Perth
Hospital.
Assessment of the patient and completion of the enclosed “Doctor’s History, Examination
and Assessment” data collection forms will need to be made and consequently assessment
of the appropriateness of the initial treatment. If the GP’s presumptive diagnosis indicates a
need for change in the initial therapy, then the patient needs to re-present to the enrolling
pharmacist for any necessary modifications to treatment.
All laboratory investigations will be undertaken by St John of God Pathology services,
following pick up and transport of samples to the laboratory. This will be done if the GP’s
practice is on the SJOG Pathology services’ usual courier run, however if not, then it will be
necessary for the GP to arrange pick-up by ringing 9284 8194 (direct courier line).

Results of the laboratory investigations will be reported to both the project pharmacists and
GP concurrently. Where alteration of initial treatment is deemed to be appropriate, based on
laboratory results, the patient will be required to attend a second follow-up visit. Note that the
cost of any follow-up consultations and treatment(s) prescribed will not be research funded,
and will need to be covered by the usual means.

Reimbursement
GPs participating in the study will receive a payment of $100 per patient once the results of
the investigations and the confirmed diagnosis are provided to the study team. This payment
covers the cost of the long consultation required that will not be covered by Medicare.

References/Bibliography
1.  Bradford J. Is it really thrush? Management of vulvo-vaginal discomfort in pharmacy practice. Aust Pharm
    2001;20(4):223-4.
2. Ponte CE. Infectious vulvovaginitis: Current trends in management. J Pharm Technol 2000;16:92-7.
3. Kamarashev JA, Vassileva SG. Dermatological diseases of the vulva. Clin Dermatol 1997;15(1):53-65.
4. Moraes PS, Taketomi EA. Allergic vulvovaginitis. Ann Allergy Asthma Immunol 2000;85(4):253-65.
5. Egan ME, Lipsky MS. Diagnosis of vaginitis. Am Fam Physician 2000;62:1095-104.
6. Ferris DG, Deckle C, Litaker MS. Women’s use of over the counter antifungal medications for gynaecological
    symptoms. J Fam Pract 1996;42:595-600.
7. Chaponis RJ, Bresnick PA, Weiss RR, Edwards LD. Candida vaginitis: Signs and symptoms aid women’s
    self-recognition. J Clin Res Drug Dev 1993;7:17-23.
8. Ferris DG, Nyirjesy P, Sobel JD, Soper D, Pavletic A, Litaker MS. Over-the-Counter Antifungal Drug Misuse
    Associated with Patient-Diagnosed Vulvovaginal Candidiasis. Obstet Gynecol 2002;99:419-425.
9. Rodgers CA, Beardhall AJ. Recurrent vulvovaginal candidiasis: why does it occur? Int J STD AIDS
    1999;10(7):435-9.
10. Spinillo A, Capuzzo E, Acciano S, DeSantolo A, Zara F. Effect of antibiotic use on the prevalence of
    symptomatic vulvovaginal candidiasis. Am J Obstet Gynecol 1999;180(1):14-7.
11. Fivozinsky KB, Laufer MR. Vulvar disorders in adolescents. Adolesc Med 1999;10(2):305-19.
12. Spinillo A, Capuzzo E, Nicola S, Baltaro F, Ferrari A, Monaco A. The impact of oral contraception on
    vulvovaginal candidiasis. Contraception 1995;51(5):293-7.


TAFT Project – Data Sheet Doctor’s Examination & Assessment
                                             Page - 164 -
                              TAFT PROJECT
        Data Sheet – Doctor’s History, Examination and Assessment
                       (Please return to investigators in the envelope provided)



Appendix 6 – TAFT Project: Microbiology Collection Kit and
Test Instructions

CONTENTS

3 x PCR SWABS (URETHRA, CERVIX, ULCER)
2 x TRANSWABS (VULVA, HIGH VAGINA)
1 x STERILE SALINE TUBE
1 x STERILE URINE COLLECTION CONTAINER – YELLOW LID
1 x pH PAPER
1 x 1L LOOP

INSTRUCTIONS ON USE

        Label swabs as indicated below

1) VULVAL FUNGAL SWAB
    Dip cotton transwab in saline and rub on inner and outer lips of labia majora
     bilaterally
    Place in transwab medium and label “vulval swab”


2) HSV PCR SWAB IF ULCER(S) PRESENT
    Dip thin swab into saline and rub firmly on ulcer
    Place in dry transport container and label “herpes PCR”


3) URETHRAL PCR SWAB
    Dip thin swab into saline
    Insert into urethra and rotate 360
    Place in dry PCR container and label “urethral PCR/swab


4) VAGINAL pH TEST
    Insert speculum
    Use pH test paper provided
    Take a sample of vaginal discharge from the middle third of the vagina (using
     a 1L loop) making sure the cervix or cervical discharge is not sampled
    Press the discharge in the loop onto the pH paper
    Wait 30 seconds and read the pH
    Record result on “Doctor’s History, Examination and Assessment” form (page
     6) or on SJOG Pathology standard report forms (pH to be added as free text
     comment)

5) VAGINAL SWAB
    Take a sample of vaginal secretion from posterior fornix and wipe down left
     and right sides of vaginal walls
    Place in transwab medium and label “vaginal swab”


6) CERVIX PCR SWAB
TAFT Project – Data Sheet Doctor’s Examination & Assessment
                                             Page - 165 -
                              TAFT PROJECT
        Data Sheet – Doctor’s History, Examination and Assessment
                       (Please return to investigators in the envelope provided)

        Insert thin cotton swab into endocervix and rub vigorously
        Place in dry PCR container and label “endocervix swab”

7) MID-STREAM URINE CULTURES AND SUSCEPTIBILITIES
    Collect as for routine micro culture and susceptibility


TRANSPORT

Transport specimens in the biohazard bag to the laboratory immediately. If transport
is likely to be delayed store the SWABS AT ROOM TEMPERATURE and
REFRIDGERATE THE URINE.

NOTE

After the collection of all specimens, a bimanual examination should be performed
using the lubricant gel.




TAFT Project – Data Sheet Doctor’s Examination & Assessment
                                             Page - 166 -
                           TAFT PROJECT
     Data Sheet – Doctor’s History, Examination and Assessment
                       (Please return to investigators in the envelope provided)



Appendix 7 – TAFT Project: Doctor’s History, Examination
and Assessment data collection forms
PATIENT DETAILS:

NAME:           ________________________________________________

ADDRESS:        ________________________________________________

DOB:            ________________________________________________

MEDICAL PRACTITIONER’S DETAILS:

NAME:           ________________________________________________

BUSINESS
ADDRESS:        ________________________________________________

BUSINESS
PHONE:          ________________________________________________


PATIENT HISTORY
Preview copy of Patient Survey.



Comments:




TAFT Project – Data Sheet Doctor’s Examination & Assessment
                                             Page - 167 -
                           TAFT PROJECT
     Data Sheet – Doctor’s History, Examination and Assessment
                       (Please return to investigators in the envelope provided)



PATIENT HISTORY

VULVOVAGINAL SYMPTOMS
1. Discharge

        1.1     Does the patient have a history of vaginal discharge?
                 Yes
                 No

        1.2     How much discharge does the patient complain of?
                 Slight
                 Moderate
                 Excessive

2. Pruritis

        2.1     Does the patient have itching of the vulva?
                 Yes
                 No

3. Dysuria

        3.1     Does the patient have dysuria?
                 Yes
                 No

        3.2     If yes, is it urethral or vulval?
                 Urethral
                 Vulval

4. Odour

        4.1     Has the patient noticed a vaginal odour?
                 Yes
                 No


PATIENT HISTORY - SEXUAL HISTORY

5. Sexual history

        5.1     Has the patient had unprotected sexual intercourse in the last 24 hours?
                 Yes
                 No

        5.2     Has the patient been sexually active over the last 12 months?
                 Yes
                 No – go to question 5.5

TAFT Project – Data Sheet Doctor’s Examination & Assessment
                                             Page - 168 -
                           TAFT PROJECT
     Data Sheet – Doctor’s History, Examination and Assessment
                       (Please return to investigators in the envelope provided)

        5.3     If yes, how many different sexual partners have they had over the last 12
                months?

                 Number___________


PATIENT HISTORY - SEXUAL HISTORY CONT…
        5.4     How many different sexual partners have they had over the last 3 months?

                 Number___________

        5.5     How many lifetime sexual partners have they had?

                 Number___________

        5.6     What is the patient’s sexual preference?
                 Men
                 Women
                 Both men and women




TAFT Project – Data Sheet Doctor’s Examination & Assessment
                                             Page - 169 -
                           TAFT PROJECT
     Data Sheet – Doctor’s History, Examination and Assessment
                       (Please return to investigators in the envelope provided)




PHYSICAL EXAMINATION
6.   Vulval Examination

        6.1     Does the vulva appear normal?
                 Yes
                 No

        6.2     Is there vulval erythema?
                 Yes (circle extent of erythema         +      ++      +++)
                 No

        6.3     Is there vulval swelling?
                 Yes (circle extent of oedema           +      ++      +++)
                 No

        6.4     Are there genital ulcers?
                 Yes
                 No

        6.5     If yes, are these discrete ulcers or fissures?
                 Discrete
                 Fissures

        6.6     Are there genital warts?
                 Yes
                 No

        6.7     Is there evidence of the patient having scratched themselves?
                 Yes
                 No

        6.8     Are there pediculosis pubis?
                 Yes
                 No




TAFT Project – Data Sheet Doctor’s Examination & Assessment
                                             Page - 170 -
                             TAFT PROJECT
       Data Sheet – Doctor’s History, Examination and Assessment
                       (Please return to investigators in the envelope provided)

PHYSICAL EXAMINATION CONT…
6.    Vulval Examination cont…

     6.9 Please draw on diagram below to illustrate any of the previous points as required and
         add any other comments.




PHYSICAL EXAMINATION CONT…




7.    Vaginal Examination

         7.1    What are the characteristics of the vaginal discharge if present?
                 Thin, off-white
                 Thick, white (“cottage cheese”)
                 Copious, yellow-green (discoloured)
                 Frothy
                 Other (specify)_______________________________________________
                 Not applicable

         7.2    How does the patient describe the odour of the discharge?
                 Fishy
                 Yeasty
                 Other (please specify)_______________________________________
                 Not applicable
TAFT Project – Data Sheet Doctor’s Examination & Assessment
                                             Page - 171 -
                           TAFT PROJECT
     Data Sheet – Doctor’s History, Examination and Assessment
                       (Please return to investigators in the envelope provided)


        7.3     Does the vagina appear normal?
                 Yes
                 No

        7.4     Is there vaginal erythema?
                 Yes (circle extent of erythema         +      ++      +++)
                 No

        7.5     Is there vaginal ulceration?
                 Yes (circle extent of fissures          +     ++       +++)
                 No

        7.6     Other comments___________________________________________

                ______________________________________________________________

                ______________________________________________________________

                ______________________________________________________________

                ______________________________________________________________

                ______________________________________________________________




TAFT Project – Data Sheet Doctor’s Examination & Assessment
                                             Page - 172 -
                            TAFT PROJECT
      Data Sheet – Doctor’s History, Examination and Assessment
                        (Please return to investigators in the envelope provided)




PHYSICAL EXAMINATION CONT…
8.   PV Examination

        8.1       Is there evidence of cervical tenderness?
                   Yes (circle extent of tenderness +           ++       +++)
                   No

        8.2       Is there evidence of forniceal tenderness?
                   Yes (circle extent of tenderness +       ++           +++)
                   No

9.   Other Relevant Clinical Findings and Comments

     _______________________________________________________________________

     _______________________________________________________________________

     _______________________________________________________________________

     _______________________________________________________________________


TESTS (AS PER INSTRUCTIONS PROVIDED IN EXAMINATION KIT)
10. Tests (to be sent to SJOG Pathology except vaginal pH - to be performed by GP)

         Vulval fungal swab

         HSV PCR if ulcers present

         Urethral PCR dry swab

         Vaginal pH
                 Actual pH measured______________
                 Assessment:
                   Normal ( 4.5)
                   Elevated (> 4.5)

         High vaginal swab

         Cervical PCR dry swab

         Bimanual

         Mid-stream urine culture and susceptibilities




TAFT Project – Data Sheet Doctor’s Examination & Assessment
                                             Page - 173 -
                           TAFT PROJECT
     Data Sheet – Doctor’s History, Examination and Assessment
                       (Please return to investigators in the envelope provided)




FINAL COMMENTS, DIAGNOSIS AND OTHER FINDINGS
11. Presumptive Diagnosis

           Candida
           BV
           Herpes
           Other (please
            specify)____________________________________________________

12. Comments and Other Findings

    ______________________________________________________________________

    ______________________________________________________________________

    ______________________________________________________________________

    ______________________________________________________________________

    ______________________________________________________________________



TREATMENT RECOMMENDED
     To continue with self-prescribed OTC product
                _______________________________

     Change treatment to
                ______________________________________________________




                                        END OF REPORT

                                            THANK YOU




TAFT Project – Data Sheet Doctor’s Examination & Assessment
                                             Page - 174 -
                           TAFT PROJECT
     Data Sheet – Doctor’s History, Examination and Assessment
                       (Please return to investigators in the envelope provided)




Appendix 8 – TAFT Project: Patient Survey
CHIEF INVESTIGATORS:
Ms Samantha Hilmi, Department of Pharmacy, Royal Perth Hospital.
(Mobile Phone: 0402 111 694)
Mr Peter Tenni, School of Pharmacy, Curtin University. (Mobile Phone: 0439 850 086)
Mr Jeff Hughes, School of Pharmacy, Curtin University. (Ph: 9266 7367)
Dr Jenny McCloskey, Department of Sexual Health, Royal Perth Hospital.

INSTRUCTIONS FOR COMPLETING THE SURVEY:
 To indicate a positive response, please mark boxes like this .
 If you make a mistake simply cross it out and continue.
 Where a written response is required, please print legibly.
 Please answer ALL the questions, and if you require clarification or assistance, feel free
   to contact any of the above investigators.
 Your doctor will need to read your completed survey as part of your consultation so that
   they can confirm that the treatment you have been provided is appropriate.
 Please return ALL pages of the survey as instructed in the envelope provided.

NOTE:           This survey is STRICTLY CONFIDENTIAL, and will be de-identified once
                patient follow-up has been completed. See “Patient Information” form.



PATIENT DETAILS

Please complete the following details, which are essential in allowing us to contact
you regarding your laboratory test results where necessary.

Full Name:
       ________________________________________________________________

Address:
      ________________________________________________________________

Phone:
         ________________________________________________________________



DEFINITIONS & DIAGRAMS

Please refer to the last two pages for clarification of the terms below, which may help you in
answering some of the questions in this survey:

   Vagina
   Vulva
   Urethra

TAFT Project – Data Sheet Doctor’s Examination & Assessment
                                             Page - 175 -
                           TAFT PROJECT
     Data Sheet – Doctor’s History, Examination and Assessment
                       (Please return to investigators in the envelope provided)




PERSONAL HISTORY

Demographic Information

        1.1     What is your date of birth?

                ___ ___ / ___ ___ / ___ ___ ___ ___
                 D D       M M       Y Y Y Y

        1.2     How tall are you?

                ________cm OR

                ________ft______inches

        1.3     How much do you weigh?

                ________Kg OR

                ________Ibs

        1.4     What is your marital status?
                 Single (never married)
                 Married / Defacto relationship
                 Divorced / separated / widowed

        1.5     What is your ancestry?
                 Australian
                 European
                 Asian
                 African
                 Indigenous Australian or Torres Strait Islander
                 Other (please state)____________________

        1.6     What is your menopausal status?
                 Pre-menopausal
                 Post-menopausal




TAFT Project – Data Sheet Doctor’s Examination & Assessment
                                             Page - 176 -
                           TAFT PROJECT
     Data Sheet – Doctor’s History, Examination and Assessment
                       (Please return to investigators in the envelope provided)




PERSONAL HISTORY CONT…

Medical History and Information

        2.1     Do you have a history of any of the following? (Select as many as appropriate)

                 Abnormal pap test – Date (please state if known)______________
                 Abnormal pelvic exam -
        Please circle whichever applies - ovarian cyst, uterine fibroids, uterine/vaginal abnormality,
        other (please state)___________________________________________
                 Allergies -
                    Please circle whichever applies – hayfever, others
                    (specify)_______________
                   Anaemia
                   Asthma
                   Bleeding disorder
                   Blood transfusion
                   Cancer (please state type if known)_______________________
                   Cryotherapy, laser or LEEP treatment of cervix –
                    Year in which treatment received (please state if
                    known)________________
                   Depression
                   Diabetes
                   Eating disorder
                   Endometriosis
                   HIV / AIDs
                   Kidney disease
                   Liver disease
                   Pelvic inflammatory disease
                   Sexually transmitted disease -
        Please circle whichever applies - gonorrhoea, chlamydia, genital herpes, genital warts, HPV
        on PAP smear
                 Skin disorders –
        Please circle whichever applies – psoriasis, eczema, dermatitis,

        other (please specify)__________________________________________
                   Thyroid disorder
                   Urinary tract infection - number in the past year__________
                   Vaginal bleeding (other than your normal period)
                   Other significant
                    illness/disease______________________________________

                    ___________________________________________________________




TAFT Project – Data Sheet Doctor’s Examination & Assessment
                                             Page - 177 -
                           TAFT PROJECT
     Data Sheet – Doctor’s History, Examination and Assessment
                       (Please return to investigators in the envelope provided)




PERSONAL HISTORY CONT…

2.   Medical History and Information cont…

        2.2     Are you currently pregnant?
                 Yes
                 No
                 Possibly

        2.3     Have you been in hospital recently?
                 Yes
                 No – go to question 2.5

        2.4     If yes, how long ago were you in hospital?

                __________months __________days

        2.5     Are you on any medication(s) currently?
                 Yes
                 No – go to question 2.7

        2.6     If yes, please list ALL medications that you currently take (include medications
                taken for any of the previous medical conditions selected, any hormone
                replacement therapy and natural or alternative therapies).

                ____________________________                     __________________________

                ____________________________                     __________________________

                ____________________________                     __________________________

                ____________________________                     __________________________

        2.7     Have you stopped any medications recently (within the last few weeks)?
                 Yes
                 No – go to question 2.9

        2.8     If yes, please list ALL medications that were recently stopped (include
                medications that may have been taken for other conditions, not just for those
                listed in question 2.1).

                ____________________________                     __________________________

                ____________________________                     __________________________

                ____________________________                     __________________________



TAFT Project – Data Sheet Doctor’s Examination & Assessment
                                             Page - 178 -
                           TAFT PROJECT
     Data Sheet – Doctor’s History, Examination and Assessment
                       (Please return to investigators in the envelope provided)




PERSONAL HISTORY CONT…


Current Vulvovaginal Signs and Symptoms

        3.1     Is there a vaginal discharge?
                 Yes
                 No           ) go to question 3.9
                 Unsure       )

        3.2     If yes, which of the following do you think best describes its appearance?
                    Thin, off-white
                    Thick, white (like “cottage cheese”)
                    Copious (plentiful), yellow-green (or discoloured)
                    Frothy
                    Other (please specify)_____________________________________

        3.3     Is there a smell to the discharge?
                 Yes
                 No             ) go to question 3.9
                 Unsure         )

        3.4     If yes, which of the following do you think best describes the smell?
                 Unpleasant “fishy”
                 Yeasty
                 Other (please describe)______________________________________

        3.5     Does the smell seem to be worse at certain times of the day?
                 Yes
                 No          ) go to question 3.7
                 Unsure      )

        3.6     If yes, when does the smell seem to be worse?
                 After sexual intercourse
                 When standing or walking after sitting
                 Other (please specify)________________________________________




TAFT Project – Data Sheet Doctor’s Examination & Assessment
                                             Page - 179 -
                           TAFT PROJECT
     Data Sheet – Doctor’s History, Examination and Assessment
                       (Please return to investigators in the envelope provided)




PERSONAL HISTORY CONT…

3.   Current Vulvovaginal Signs and Symptoms cont…

        3.7     Does the smell seem to be worse at certain times related to your periods?
                 Yes
                 No – go to question 3.9

        3.8     If yes, when in relation to your periods is it worse?
                 Before
                 During
                 After

        3.9     Is there any vaginal itching present?
                 Yes
                 No

        3.10    Is there any vulval itching present?
                 Yes
                 No

        3.11    Is there any vulval soreness present?
                 Yes
                 No

        3.12    Have you noticed any redness of the vulva?
                 Yes
                 No
                 Unsure

        3.13    Have you noticed any swelling of the vulva?
                 Yes
                 No
                 Unsure

        3.14    Do you feel any burning, pain and/or discomfort when you go to pass urine?
                 Yes – please circle where this is felt - vulva, urethra or both
                 No

        3.15    Do you feel any pain at any time in relation to sexual intercourse?
                 Yes - please circle whichever is appropriate – during sex, after sex, or
                   both
                 No

        3.16    Is there any bleeding after sexual intercourse?
                 Yes
                 No


TAFT Project – Data Sheet Doctor’s Examination & Assessment
                                             Page - 180 -
                           TAFT PROJECT
     Data Sheet – Doctor’s History, Examination and Assessment
                       (Please return to investigators in the envelope provided)




PERSONAL HISTORY CONT…

Previous Vaginal Problems

        4.1     Have you experienced any of the above symptoms in the past?
                 Yes
                 No – go to question 5.1

        4.2     If yes, was it ever diagnosed by a doctor?
                 Yes
                 No – go to question 4.4

        4.3     If yes, please state in your own words what the diagnosis was.

                __________________________________________________________

        4.4     Did you obtain treatment for it?
                 Yes
                 No – go to question 5.1

        4.5     If yes, who recommended it?
                 Doctor
                 Pharmacist
                 Nurse
                 Friend
                 Self-prescribed (you decided on the treatment)
                 Other
                     (please specify)____________________________________________

        4.6     If it was self-prescribed, what helped you to decide on the treatment? (Select
                as many as appropriate).
                 Health magazine/information pamphlet
                 Woman’s magazine (eg Woman’s Day, New Idea etc)
                 What a friend, family member said in the past
                 Information on the Internet (specify site)__________________________
                 Medical book
                 Other (please specify)________________________________________

        4.7     What was the treatment?

                ____________________________________________________________




TAFT Project – Data Sheet Doctor’s Examination & Assessment
                                             Page - 181 -
                           TAFT PROJECT
     Data Sheet – Doctor’s History, Examination and Assessment
                       (Please return to investigators in the envelope provided)




PERSONAL HISTORY CONT…

Personal Hygiene Factors

        5.1     Do you use any of the following products in the vaginal area? (Select as many
                as appropriate).
                 Vaginal douches
                 Tampons
                 Antibacterial soaps
                 Perfumes
                 Detergents
                 Other “feminine hygiene” products (please specify)

                     _________________________________________

        5.2     Do you wear fitted, tight or constrictive clothing (eg leotards, panty-hose,
                bathing suits, tight jeans etc) on a regular basis?
                 Yes
                 No – go to question 6.1

        5.3     If yes, how frequently do you wear them?
                 Regularly (daily or more than 3 times per week)
                 Occasionally (1-3 times a week)
                 Rarely (1-3 times per month)

        5.4     Are they made of synthetic material (eg nylon, polyester, lycra etc)?
                 Yes
                 No
                 Unsure

Method of Contraception

        6.1     Do you use any methods of contraception?
                 Yes
                 No – go to question 7.1

        6.2     If yes, which of the following methods do you use? (Select as many as
                appropriate).
                 Intrauterine device (IUD)
                 Cervical cap
                 Diaphragm
                 Combination oestrogen / progesterone pills (oral contraceptive pill)
                 Depot Provera® injections
                 Other (please specify)___________________________________




TAFT Project – Data Sheet Doctor’s Examination & Assessment
                                             Page - 182 -
                           TAFT PROJECT
     Data Sheet – Doctor’s History, Examination and Assessment
                       (Please return to investigators in the envelope provided)




PERSONAL HISTORY CONT…

Current Diagnosis

        7.1     Please state the reason(s) why you think you have vaginal thrush.


    ___________________________________________________________________


    ___________________________________________________________________


    ___________________________________________________________________

        7.2     Please state the reason(s) why you went to your pharmacy first instead of
                your doctor about your suspected vaginal thrush.

                ______________________________________________________________

                ______________________________________________________________

                ______________________________________________________________



GENERAL COMMENTS

Comments

        8.1     If you have any comments to add, please write them below.


    ___________________________________________________________________


    ___________________________________________________________________


    ___________________________________________________________________


    ___________________________________________________________________


    ___________________________________________________________________


    ___________________________________________________________________

TAFT Project – Data Sheet Doctor’s Examination & Assessment
                                             Page - 183 -
                            TAFT PROJECT
      Data Sheet – Doctor’s History, Examination and Assessment
                       (Please return to investigators in the envelope provided)



                                       END OF SURVEY
    Please be assured that the information you have provided will be kept confidential.

 Please place ALL 11 pages of the survey into the envelope provided and hand it over
           to your doctor’s receptionist when you go for your appointment.

             THANK YOU FOR PARTICIPATING IN THIS STUDY.

DEFINITIONS & DIAGRAMS

   Vagina
    The vagina is a muscular tube that leads from the vaginal opening. It is a narrow tunnel
    that usually measures between three and six inches in length extending from the
    vestibule to
    the uterus.
Fig 10.3
 Vulva
    The vulva is a collective term used to describe the visible external genital organs which
    surround the entrance to the vagina, extending from the mons pubis (the soft fatty tissue
    covered with pubic hair, which lies on top of the pubic bone) to the perineum. The
    external genitalia includes the clitoris and clitoral hood, and the labia majora (the two
    large folds of skin) and labia minora (the two delicate folds of skin).

    Urethra
     The urethra is a short tube connected to the bladder that transports urine to the urethral
     opening. This opening can be seen as a very small, v-shaped dimple below the clitoris.




TAFT Project – Data Sheet Doctor’s Examination & Assessment
                                             Page - 184 -
                           TAFT PROJECT
     Data Sheet – Doctor’s History, Examination and Assessment
                       (Please return to investigators in the envelope provided)

The Female Internal Genital Organs




The Female External Genital Organs




TAFT Project – Data Sheet Doctor’s Examination & Assessment
                                             Page - 185 -

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:16
posted:6/13/2011
language:English
pages:185
ghkgkyyt ghkgkyyt
About