Title of systematic review protocol Quality of life tools for by hjkuiw354


									Title of systematic review protocol
Quality of life tools for adult patients with cancer undergoing
chemotherapy: a systematic review

Centre conducting review
Singapore National University Hospital Centre for Evidence Based
Nursing: Joanna Briggs Collaborating Centre for Evidence Review

Primary reviewer
Name: Siti Zubaidah Mordiffi
Telephone: 65 67725137
Facsimile: 65 67724032
Email: Siti_ZUBAIDAH@nuhs.edu.sg

Secondary reviewer
Name: Yip Wai Kin
Telephone: 65 67724665
Facsimile: 65 67724032
Email: Wai_Kin_YIP@nuhs.edu.sg

Associate reviewer
Name: Emily Ang NK
Telephone: 65 67724819
Email: Emily_NK_ANG@nuhs.edu.sg

Name: Kamala Devi
Telephone: 65-65167792
Facsimile: 65-67767135
Email:     nurmkd@nus.edu.sg

Name: Chow Ying Leng
Telephone: 9756 3383
Facsimile: 6772 5829
Email: ying_leng_chow@nuhs.edu.sg

Name: Lee Yee Mei
Telephone: 65 92369997
Facsimile: 65 67722958
Email: yee_mei_lee@nuhs.edu.sg

Commencement date: July 2009
Expected completion date: April 2010


The use of chemotherapeutic agents for treatment of cancer has expanded
widely with multiple potent agents being administered at higher but more
tolerable doses. The majority of these patients received several cycles of
chemotherapy over a period of months,1 resulting in a toxic physiologic
environment that causes adverse effects including fatigue, alopecia, and
potentially life-threatening neutropenia.2,3,4 The incidence of adverse effects will
continue to increase as more aggressive chemotherapy continues to be used
more frequently.5 These adverse effects of chemotherapy can be severe and
may lead to a significant impact on the patients’ quality of life (QoL).6 The
concept of QoL refers to how patients are feeling about their health status, which
includes individual perception of their illness-specific symptoms. QoL
encompasses four core domains of individual functioning being physical,
psychological, social and spiritual. 7

Although clinicians have long recognised the impact of chemotherapy on
patient’s QoL, the literature reports incorporating QoL measurements into routine
clinical practice is a relatively new practice. Moreover, most oncology clinicians
believe that if an appropriate tool exists, domains of the patient’s QoL can be
collected on a routine basis.8 Being able to clinically evaluate the QoL of patients
not only provides information about the impact of cancer and its treatment
outcome, the information could be used to direct patient care, education, and
counseling in order to optimise patients’ physical and psychological well-being.9

The number of published articles reporting QoL instruments used to evaluate
patients with cancer on chemotherapy has grown exponentially.11,12 These
instruments range from short estimates of the patients’ general status through
non-validated ad-hoc instruments, to more comprehensive measurements using
standardized validated instruments.13 Despite the amount of information
regarding QoL instruments available in the literature, no analysis has been
conducted that examines the evidence using a systematic approach. This
systematic review aims to fill that gap. In this effort, we hope to help busy
practising clinicians in making a decision of selecting a valid and reliable tool for
use in clinical practice. In addition, the instruments selected must be easy to use
and interpret whilst not being a burden to busy clinicians or patients.11

The objective of this review is to critically analyse the literature and present the
best available evidence related to QoL questionnaires, which can be used to
assess patients with cancer on chemotherapy.
Specific questions to be answered are:
   1. What are the available QoL tools that can be used to assess cancer
      patients undergoing chemotherapy?
   2. What are the reliability and validity of identified QoL tools for cancer
      patients undergoing chemotherapy?
   3. What is the optimal frequency of assessment using identified QoL tools?
   4. What is the feasibility of the use of identified QoL tools by busy clinicians?

Criteria for considering studies for this review
For studies to be included in the systematic review, they must meet all the
inclusion criteria.

Types of studies
This review will consider any randomised control trials (RCTs) related to QoL
tools used for cancer chemotherapy. In the absence of, or limited RCTs, other
research designs, such as non-randomised trials, before and after studies, cohort
studies, case control studies and observational studies without control group will
be considered for inclusion.

Types of participants
This systematic review will include all adults with cancer over the age of 18 years
who have undergone chemotherapy and clinicians (physicians and nurses) who
have used the tools.

Types of interventions
There is no single intervention of interest. This review will consider studies of
QoL tools used in conjunction with cancer chemotherapy.

Types of outcome measures
The primary outcomes will include:
    • Number of QoL tools used in conjunction with cancer chemotherapy
    • Validity and reliability of the QoL tools
    • The types of measures or scale used
The secondary outcomes will include frequency of assessment, and the
suitability of the quality of life tool for use in clinical setting. The suitability of the
tools to be included are to fulfil the following characteristics11:
    • Short
   •   Easy to use
   •   Multidimensional
   •   Prospective design
   •   Not burdensome
   •   Easy to score and interpret
   •   Clearly defined endpoints
   •   Sensitive to changes in patient’s health status
   •   Capable of international and cross-cultural standardization
   •   Contain global questions regarding the cancer experience
   •   Captures cancer-specific morbidity
   •   Captures cancer treatment-specific morbidity
   •   Self-administered
   •   Standardised, reliable and valid
   •   Measures distress in addition to frequency and degree
   •   Captures baseline status and can be administered longitudinally

Search strategy for identification of studies
Prior to commencing of this systematic review, the Cochrane Library, Joanna
Briggs Institute Library of Systematic Review, MEDLINE and the Database of
Abstracts and Review were searched and no previous systematic review on this
topic was identified.

The search strategy aims to find both published and unpublished studies. A
search strategy was developed to guide the systematic review. A three-step
search strategy will be utilized in each component of this review. An initial search
of MEDLINE and CINAHL will be undertaken followed by analysis of the text
words contained in the title and abstract, and the text terms used to describe the
article. A second search strategy using all the identified keywords and the index
terms will then be undertaken across all included databases. Thirdly, the relevant
list of all identified reports and articles will be searched for additional studies.
The databases to be searched from 1998-2009 include:
   •   CINAHL
   •   Complete Biomedical Collection
   •   MEDLINE
   •   Embase
   •   Expanded Academic Index
   •   PsycINFO
   •   PsycARTICLES
   •   APAIS Health
   •   Current Contents
   •   Digital Dissertations
   •   Social Science Citation Index
   •   Sociological Abstracts
   •   Cochrane Central Register of Controlled Trials (CENTRAL)
   •   AustHealth
   •   EBM Reviews
The grey literature search included:

          •   Conference Proceedings

          •   MEDNAR

          •   PsycEXTRA

          •   Australian Centre for Evidence Based Clinical Practice

          •   Clinical Medicine Netprints Collection,

Every electronic database has its own indexing terms, and although many of the
term used will be the same, individual search strategies will be developed for
each database. During the process of conducting the search, consideration will
be given to the diverse terminology used and the spelling of keywords as it may
influence the identification of relevant studies. In addition, reports of expert
committees and guidelines will be reviewed and their reference lists and
bibliography searched to identify further primary search. Extensive hand
searches of relevant journals will also be undertaken. Experts will be contacted to
elicit further information relevant to this review.

Methods of the review
The titles and abstracts identified from the search will be identified independently
by two reviewers against the inclusion criteria and full text of the studies will be
obtained. If the title and abstracts are inconclusive, full reports will be retrieved
and thorough evaluation against the inclusion criteria will be undertaken. The
reference lists of all retrieved articles will be further searched for additional
references. The decision to include or exclude the study will be undertaken by
two independent reviewers. All references will be entered into the bibliographic
software package Endnote.

If any data is missing from the trial report, attempts will be made to obtain the
data by contacting the authors. Papers that have been published in duplicate will
be included only once. Decision for study eligibility will be made by two reviewers
and will be checked by the third, who is an expert in the field.

Assessment of methodological quality
The papers selected for retrieval will be assessed by two independent reviewers
for methodological validity prior to inclusion in the review using standardized
critical appraisal instruments from the Joanna Briggs Institute Meta Analysis of
Statistical Assessment and Review Instrument (JBI-MAStARI). (Appendix I) Any
disagreements that arise between the reviewers will be resolved through
discussion, or with a third reviewer.

Data extraction
Data will be extracted from papers included in the review using the standardised
data extraction tool from JBI-MAStARI. (Appendix II) The data extracted will
include specific details about the authors, study design, population, QoL
instrument, validity and reliability of the instrument, type of measure or scale, and
frequency of assessment related to the review questions.

Data synthesis
The papers will, where possible be pooled in statistical meta-analysis using the
JBI-MAStARI. All results will be subjected to double data entry. Odds ratio or
relative risk (for categorical data) and weighted mean differences (for continuous
data) and their 95% confidence intervals will be calculated for analysis.
Heterogeneity will be assessed using the standard Chi-square. Where statistical
pooling is not possible the findings will be presented in narrative form.

We would like to thank Ms Goh Mien Li for performing the initial literature search
to enable this review protocol to be written.

Potential conflict of interests
The primary, secondary and associate reviewers have no potential conflicts of
  1. Bow, E J. Infection risk and cancer chemotherapy: the impact of the
     chemotherapeutic regimen in patients with lymphoma and solid tissue
     malignancies. Journal of Antimicrobial Chemotherapy. 1998; 41 (suppl
  2. Ropka, M., & Padilla, G. Quality of life and chemotherapy-induced
     neutropenia. Cancer Nursing. 2005; 28(3):167-171.
  3. Sitzia, J., Hughes, J., Sobrido, L. A study of patients’ experiences of side
     effects associated with chemotherapy: a pilot stage report. International
     Journal of Nursing Studies. 1995; 32 580-600.
  4. Can, G., Durna,Z., Aydiner,A. Assessment of fatigue in and care needs of
     Turkish women with breast cancer. Cancer Nursing. 2004;27;153-161.
  5. Kerryann, L-J., Carey,M., Jefford,M., Schofield, P., Charleson,C.,
     Aranda,S. Non-pharmacologic strategies for managing common
     chemotherapy adverse effects: a systematic review. Journal of Clinical
     Oncology. 2008; 26(34); 5618-5628.
  6. Michael Micheal, MB., Tannock, I F. Measuring health-related quality of
     life in clinical trials that evaluate the role of chemotherapy in cancer
     treatment. Canadian Medical Association.1998; 158 (13); 1727-1734.
  7. Garratt, A.,Schmidt, L., Mackintosh, A., Fitzpatrick, R. Quality of life
     measurement: bibliographic study of patient-assessed health outcome
     measures. British Medical Journal. 2002; 324:1417-1421.
  8. Lindbald, A.K., Ring, L., Glimelius, B., Hansson, M.G. Focus on the
     individual-quality of life assessment in oncology. Acta Oncologica, 41.
  9. Conroy, T., Uwer, L., Malthilde, D. Health-related quality-of-life
     assessment in gastro-intestinal cancer: are results relevant for clinical
     practice? Current Opinion in Oncology. 2007; 19: 401-408.
 10.   King CR, Haberman M, Berry DL et al. Quality of life and the cancer
       experience: the state of knowledge. Oncology Nursing Forum. 1997;

 11. King, C. Advances in how clinical nurses can evaluate and improve quality
     of life for individuals with cancer. Oncology Nursing Forum. 2006; 33 (1,
     Suppl.), 5-12.
12.    Ropka, M., & Padilla, G. Assessment of neutropenia-related quality of life
      in a clinical setting. Oncology Nursing Forum. 2007.34(2), 403-409.

13. Gunnars, B., Nygren, P., Glimelius, B. Assessment of quality of life during
    chemotherapy. Acta Oncologica. 2007.40 (2/3), 175-181.
Appendix I: JBI Critical Appraisal Checklist for Experimental Studies
Reviewer ___________________            Date __________

Author _____________________           Year __________     Record Number ______

                                                              Yes    No     Unclear

1. Was the assignment to treatment groups truly random?

2. Were participants blinded to treatment allocation?

3. Was allocation to treatment groups concealed from the


4. Were the outcomes of people who withdrew described

and included in the analysis?

5. Were those assessing outcomes blind to the treatment


6. Were the control and treatment groups comparable at


7. Were groups treated identically other than for the named


8. Were outcomes measured in the same way for all groups?

9. Were outcomes measured in a reliable way?

10. Was appropriate statistical analysis used?

Overall appraisal:           Include          Exclude          Seek further info.

Comments (Including reasons for exclusion)
JBI Critical Appraisal Checklist for Comparable Cohort/ Case Control
Reviewer ___________________           Date __________

Author _____________________           Year __________       Record Number ______

                                                             Yes    No     Unclear

1. Is sample representative of patients in the

population as a whole?

2. Are the patients at a similar point in the course

of their condition/illness?

3. Has bias been minimised in relation to selection

of cases and of controls?

4. Are confounding factors identified and strategies

to deal with them stated?

5. Are outcomes assessed using objective criteria?

6. Was follow up carried out over a sufficient time


7. Were the outcomes of people who withdrew

described and included in the analysis?

8. Were outcomes measured in a reliable way?

9. Was appropriate statistical analysis used?

Overall appraisal:      Include        Exclude         Seek further info

Comments (Including reason for exclusion)
      JBI Critical Appraisal Checklist for Descriptive/ Case Series

Reviewer ___________________             Date __________

Author _____________________             Year __________      Record Number ______

                                                              Yes    No     Unclear

1. Was study based on a random or pseudo-

random sample?

2. Were the criteria for inclusion in the sample

clearly defined?

3. Were confounding factors identified and strategies

to deal with them stated?

4. Were outcomes assessed using objective criteria?

5. If comparisons are being made, was there

sufficient descriptions of the groups?

6. Was follow up carried out over a sufficient time period?

7. Were the outcomes of people who withdrew

described and included in the analysis?

8. Were outcomes measured in a reliable way?

9. Was appropriate statistical analysis used?

Overall appraisal:     Include           Exclude        Seek further info

Comments (Including reason for exclusion)
                      Appendix II: Data Extraction Form
                   For Experimental/Observational Studies

Reviewer________    Date __________    Record No____

Author___________________________                      Year________

Study Method        RCT                Quasi RCT  Longitudinal 

                    Retrospective      Observational       Other 




Sample size

Intervention1________ Intervention 2__________ Intervention 3___________




Intervention 3

Clinical Outcome Measures

          Outcome Description                          Scale/measure

Study results

Dichotomous data
            Outcome        Intervention ( )       Intervention ( )

                           Number/total number    Number/total number

Continuous data

            Outcome        Intervention ( )       Intervention ( )

                           Mean and SD (number)   Mean and SD (number)

Author conclusions

Reviewer conclusions /comments


Include       Exclude    Seek further info

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