The effectiveness of self-management educational interventions for

Document Sample
The effectiveness of self-management educational interventions for Powered By Docstoc
					CAHE          The effectiveness of self-management educational interventions for osteoarthritis of the knee




       The effectiveness of
        self-management
           educational
        interventions for
       osteoarthritis of the
              knee

         Systematic Review
                                  PROTOCOL


Centre for Allied Health Evidence (CAHE)
University of South Australia
Adelaide
SA 5000
CAHE             The effectiveness of self-management educational interventions for osteoarthritis of the knee


Table of contents


EVALUATORS                                                                                   Page     1

GENERAL INFORMATION
AIM OF THE PROTOCOL                                                                                   2

INTRODUCTION
BACKGROUND AND RATIONALE FOR ASSESSMENT                                                               2
INTERVENTIONS                                                                                         3

OBJECTIVE
ASSESSMENT OBJECTIVE                                                                                  3
RESEARCH QUESTIONS                                                                                    3

INCLUSION CRITERIA
PATIENTS                                                                                              3
INTERVENTIONS                                                                                         3
OUTCOMES                                                                                              3
ELIGIBLE STUDY DESIGNS                                                                                3
LANGUAGE                                                                                              4

SEARCH STRATEGY
LITERATURE SOURCES                                                                                    4
Bibliographic databases
Internet
General                                                                                               4
Hand Searching
Pearling

SEARCH STRATEGY                                                                                       5

VALIDITY ASSESSMENT                                                                                   5
LEVEL OF EVIDENCE                                                                                     5
QUALITY OF EVIDENCE                                                                                   5

DATA EXTRACTION AND ANALYSIS                                                                          6

REFERENCES                                                                                            7

APPENDIX 1                                                                                            8
APPENDIX 2                                                                                            8
APPENDIX 3                                                                                            9
CAHE               The effectiveness of self-management educational interventions for osteoarthritis of the knee



Centre conduction review
Name: Centre for Allied Health Evidence, University of South Australia, Adelaide


Contact for review
Telephone: Prof. Karen Grimmer
Facsimile: (08) 8302 2766
Email: karen.grimmer@unisa.edu.au

Review panel: Primary reviewer(s)
Name: Caroline Smith
Telephone: 0419 390 755
Facsimile 08 8362 4664
Email: caroline.smith@unisa.edu.au

Secondary reviewer
Name: Saravana Kumar
Telephone: 8302 2085
Facsimile 8302 2766
Email Saravana.kumar@unisa.edu.au


Commencement date
November 2005

Expected completion date
February 2005


Reference Panel

Dr. Nadine Pelling,
Dr. Nicola Massey-Westropp




                                                     1
CAHE                 The effectiveness of self-management educational interventions for osteoarthritis of the knee



Aim of the Protocol
The aim of the protocol is to outline the methodology involved with undertaking this systematic review to
identify the effectiveness of self-management education interventions for osteoarthritis of the knee.

Background
        Procedure
        Purpose of systematic review
        Clinical need and reflection of available evidence
        Existing treatment modalities

Approach to assessment
        Review of literature
        Level of evidence to be assessed
        Appraisal tools

Results of assessment
          Effectiveness
          Appropriateness
          Safety
          Conclusion
          Recommendations

Introduction

Background and rationale for assessment
Osteoarthritis (OA) is a common cause of pain and disability, and is the most common form of arthritis in
the Western world. It is characterised by loss of articulate cartilage and marginal and new central bone
formation. The most common joint to be affected is the knee. It is estimated that 10% of people aged
over 55 are affected by OA of the knee, with a quarter being severely disabled (Peat 2001). Women have
twice the risk of developing bilateral OA of the knee compared to men, whilst men are at greater risk of
developing unilateral OA. The cause of OA is multifactorial and includes ageing, obesity, genetics,
mechanical factors such as trauma, occupation, and recreational usage (Felson 2000 and Cooper et al
2000).

Osteoarthritis of the knee is associated with symptoms of pain and functional disability. Together the
pain and functional disability can lead further to reduced quality of life and increase the risk of further
morbidity. A report by the World Health Organisation (WHO) on the global burden of disease suggests
OA of the knee is likely to become the fourth most important global cause of disability in women and the
eighth most common in men (Murray and Lopez 1997). The impact of OA can be significant on
individuals. People with OA have difficulty performing and taking longer to perform activities of daily
living. They also have less time for leisure activities, are dependent on assistance from family and friends
and spend more money on health care than age matched and sex matched peers in the general population
(Gabriel, Crowson, Campion and O’Fallon 1997, Yelin and Callahan 1995). OA of the knee accounts for
more dependence in walking, stair climbing and lower limb extremity task than any other disease
(Creamer, Lethbridge-Cejku and Hochberg 2000).

The economic impact of OA on society and health care resources is also significant. In Australia it is
estimated that direct medical costs to the Australian healthcare budget attributed to OA between 1993-4
were $624 million (Mathers and Penn 1999). Greater costs were attributed to hospitalisation, visits to
general practitioners and specialists, prescription and over the counter medication and allied health
services.

Current treatments aim to educate patients about the management of OA, reduce pain, improve function,
decrease disability and to prevent or reduce the progression of the disease and it’s consequences. These
include non pharmacological treatments such as education, exercise and lifestyle changes, and


                                                       2
CAHE                 The effectiveness of self-management educational interventions for osteoarthritis of the knee


pharmacological treatments such as topical treatments, paracetamol and non-steroidal anti-inflammatory
drugs, and invasive treatments such as intra-articular injections, lavage and arthroplasty.

Patient education with a focus on self-education has a long standing history. Education with clients has
been described as a set of planned educational activities designed to improve patients health behaviours
and/or health status (Lorig 1992). The purpose of self-education is to maintain or improve health, or, in
some cases, to slow deterioration by increasing participant’s perception of self efficacy defined as an ability
to control or manage various aspects of OA. The focus of programes working with individuals with
osteoarthritis is to teach patients to adjust their daily living activities as dictated daily by disease symptoms,
decreasing pain and reducing depressed mood. Arthritis self-management programes are frequently
comprised of several modalities including education about arthritis, an overview of self-management
principles, exercise, cognitive symptom management, guided imagery, visualisation, nutrition, dealing with
depression, communication with family and health professionals and goal setting.

To date, there is no systematic review of the literature undertaken to identify the effectiveness of self-
management educational activities for osteoarthritis of the knee.

Objective
Assessment Objective
The objective of this systematic review is to evaluate the effectiveness of self-management educational
interventions on improved function and quality of life for adult subjects with OA of the knee.

Research questions
How effective is-self management education in patients with OA of the knee with:
   1. improving function, and
   2. improving the quality of life of subjects.

Inclusion criteria
Types of studies
To determine the effectivenss of an intervention, randomised controlled trials (RCTs) will be the method
of choice. However, in the absence of RCTs, controlled trials will also be considered. Other research
designs such as systematic reviews, other experimental trials, observational studies/descriptive studies,
case studies will be excluded.

Participants
Subjects are adults aged over 18 years with a diagnosis of primary or secondary osteoarthritis of the knee.
The diagnosis should be supported by history taking, and physical examination which is confirmed where
necessary by laboratory investigation, radiological or arthroscopic examination, irrespective of gender,
race, or nationality.

Interventions
Education on self-management is defined as an education intervention that includes formal structured
instruction on osteoarthritis and on ways to manage arthritis symptoms. Studies that used modern psycho-
behavioural methods to promote changes in health behaviours will also be included. As a complement to
an instructional component, interventions could include exercise, nutritional advice or psychosocial
supports.

Interventions delivered by any of the following health care providers will be included, physician, general
practitioner, nurse, physiotherapist, occupational therapist, counselor/psychologist or care provider. No
minimum time period for the intervention will be included.

Studies will be excluded in which the intervention was only behavioural (e.g. biofeedback) without an
educational component, or was only social support.




                                                        3
CAHE                 The effectiveness of self-management educational interventions for osteoarthritis of the knee


Outcomes
   1. Disability and function measuring activities of daily living, using scales such as the Western
      Ontario and McMaster Universities Osteoarthritis (WOMAC) index of pain and physical
      function, or the Arthritis Impact Measurement Scale.
    2.   Health status measures: average change on any scale at the end of the intervention, for example
         the Short Form 12/36.

Language
Searches will include all English and foreign language publications. Assessment for inclusion of foreign
language publication will be based on the English language abstract, where available.

Search Strategy

Literature Sources
In an initial search all years available in each database will be covered to evaluate the amount of research
done in this area, as well as to indicate any trends or changes over the years.

Bibliographic Databases –

    •    Academic search elite                    1985-present
    •    Allied and complementary medicine        1985 to present
    •    AMI Australasian medical index.          1968 to present
    •    AUSThealth                               1968 to present
    •    BioMed Central gateway                   since inception
    •    Blackwell Synergy                        since inception
    •    BMJ.com                                  1988 to present
    •    CINAHL database                          1937 to present
    •    Cochrane library                         since inception
    •    Digital Dissertations                    since inception
    •    Health source consumer edition.          1985 to present
    •    Health source nursing/academic edition. 1975 to present
    •    HighWire Press                           1997 to present
    •    Ingenta Connect                          since inception
    •    MEDLINE                                  1966 to present
    •    NLM Gateway                              1953 to present
    •    PEDro                                    1952 to present
    •    ScienceDirect                            since inception
    •    Social services abstracts                1980 to present
    •    PsycArticles                             1985 to present
    •    PsycInfo                                 1800s to present
    •    PubMed                                   since inception
    •    Web of science                           1993 to present

Hand Searching
Handsearching will include relevant conference proceedings and journals which were not indexed in
electronic databases and were therefore available to the reviewers.

Unpublished literature
To limit publication bias, postgraduate and doctoral dissertations will be identified and searched for
additional literature. These will include Dissertations Abstracts International and Proceedings First.

Content experts
Content experts would also be contacted in order to provide other alternatives for securing relevant
literature.

Pearling

                                                       4
CAHE                  The effectiveness of self-management educational interventions for osteoarthritis of the knee


All included literature will have their reference lists searched for additional relevant source material.

Search Strategy
The following search strategy has been designed for MEDLINE but will also be applied similarly in other
mentioned databases.

The search will be undertaken using a combination of keyword 1 and the following terms. All studies
identified in the search will be reviewed regarding their title, abstract and descriptive terms for meeting the
inclusion criteria.


Keyword 1           Osteoarthritis
1. Arthritis
2. health promotion
3. patient education
4. behaviour therapy
5. occupational therapy
6. self care
7. psychological adaptation
8. counseling.
9. exercise therapy
10. nutrition
11. clinical trial.pt.
12. randomised controlled trial.pt.
13. random allocation/
14. exp clinical trials/
15. exp longitudinal studies/
16. double-blind method/
17. single-blind method/
18. placebos/
19. random$.tw.
20. placebos/
21. (control or controls or controlled).tw

Validity assessment
The evidence of the retrieved studies will be assesses using the Joanna Briggs Institute scale of level of
evidence (Table 1).
         Table 1      Levels of Evidence : Effectiveness
          Levels       of   Effectiveness E (1-4)
          evidence
          I                 Systematic review (with homogeneity) of experimental studies (eg RCT with
                            concealed allocation)

          II                Quasi experimental studies (eg without randomisation)

          III               3a Cohort studies (with control group)
                            3b Case controlled
                            3c Observational studies without control groups

          IV                Expert opinion without explicit critical appraisal, or based on physiology,
                            bench research or consensus

Quality of evidence


                                                        5
CAHE                 The effectiveness of self-management educational interventions for osteoarthritis of the knee


To evaluate the quality of evidence, each study will be critically appraised by two independent reviewers
(CS and SK). A third reviewer (NM-W) will be consulted if there is a disagreement between the reviewers..
The appraisal tool to be used will be the JBI Critical Appraisal of evidence effectiveness (see Appendix
1).

This appraisal tool used is a modification of the ‘PEDro’ (1999) and the ‘Law et al’ (1998) tool. PEDro
(1999) has been proven to have good reliability (Maher et al 2003) and the amendments made simply
added additional information derived from the Law tool (1998). Blinding and concealment was removed
from the scale on account of not being adequate to the reviewed literature. Consequently, the adapted
version is, equal the original versions of PEDro (1999) and the Law (1998), a critical review form for
quantitative studies. It contains 11 points, equally weighted, each answered by yes or no, where yes will be
allocated one, and no zero point. With this modification an adequate and valuable assessment of the
methodological quality of the reviewed literature was aimed to achieve.

Data Collection and Storage

All included articles will be recorded in a data storage sheet giving the information about title, author,
source, location and which database they were retrieved from (see Appendix 2).

Data Extraction

Data will be extracted in a separate extraction sheet (adapted from JBI), providing a profile of each study,
whereby following data will be collected (see Appendix 3):
   • demographic information about the subjects in the study
   • study method
   • descriptions of the intervention (s)
   • description of the outcome measure(s)
   • results of data analysis

Data Synthesis
If two or more comparable studies are identified, data will be pooled in a meta-analysis, using Review
Manager, to determine the effectiveness of the particular intervention. Studies will be considered
comparable if they have drawn subjects from comparable populations, used similar interventions and had
comparable outcome measures. Double data entry will be used to minimise the risk of data entry errors.

We will test for statistical heterogeneity between trials using a standard chi squared test. In the presence
of significant heterogeneity, random effects meta-analysis will be used. Causes of heterogeneity will be
examined by pre specified subgroup analysis and sensitivity analysis. Where possible sub group analyses
will explore the effects of treatment in people of different ages (less <65 years and > 65 years), type of
hprovider or gender.

The meta-analysis approach used will be determined by the type of data. An odds ratio will be used as the
summary measure of effect for dichotomous data. Either weighted mean difference or standardised mean
differences will be used for continuous data as appropriate. Confidence intervals (95%) will be calculated
for all data. If statistical pooling of results is not appropriate the findings will be summarised in a narrative
form.




                                                       6
CAHE                 The effectiveness of self-management educational interventions for osteoarthritis of the knee


References

Bellamy N, Buchanan W, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: A health
status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug
therapy in patients with osteoarthritis of the hip or the knee. J Rheumatol. 1988;15:1833–40

Cooper C, Snow S, McAlindon TE, Kellingray S, Stuart B, Coggon D et al. Risk factors for the incidence
and progression of radiographic knee osteoarthritis. Arthritis Rheum 2000:43:995-1000.

Creamer P, Lethbridge-Cejku M, Hochberg MC. Factors associated with functional impairment in
symptomatic knee osteoarthritis. Rheumatology (Oxford) 2000;39:490-496.

Felson DT. Osteoarthritis new insights. Part 1: the disease and its risk factors. Ann Intern Med
2000;133:637-9.

Gabriel SE, Crowson CS, Campion ME, O’Fallon WM. Indirect and non medical costs among people
with rheumatoid and osteoarthritis compared with non arthritic controls. J Reheumatol 1997;24:43-48.

Law M, Stewart D, Letts L, Pollock N, Bosch J & Westmorland M (1998): Critical Review Form –
Qualitative Studies. McMaster University. In Grimmer K (2004): Incorporating health research methods
and biostatistics and evidence-based research. Research Summer School (Ed.) Course Workbook
University of South Australia.

Lorig K.Common sense patient education.Ivanhoe, Victoria, Australia:Fraser Publications,1992.

Maher CG, Sherrington C, Herbert RD, Moseley AM, Elkins M (2003). Reliability of the PEDro scale for
rating quality of randomized controlled trials. Physical Therapy, 83(8):713-21.

Mathers C, Penn R. Health system costs of injury, posioning and musculo-skeletal disorders in Australia
1993-4. (Health and Welfare Expenditure Series no. 6). Canberra: Australian Institue of health and
Welfare, 1999.

Meenan RF, Gertman PM, Mason JH. Measuring health status in arthritis: The Arthritis Impact
Measurement Scale. Arthritis & Rheumatism 23, 146–152, 1980.

Murray CJL, Lopez AD. The global burden of disease. Geneva: World Health Organisation, 1997.

Peat G, McCarney R, Croft P. Knee pain and osteoarthritis in older adults: a review of community
burden and current use of health care. Ann Rheum Dis 2001;60:91-7.

Ware JE, Sherbourne CD. . The MOS 36 Item Short Form Health Survey (SF-36) Conceptual CD
framework and item selection. Med Care 1992;30: 473-483.

Yelin E, Callahan LF. The economic cost and social and psychological impact of muscul-skeletal
conditions. National Arthritis Dat Work Groups. Arthritis Rheum 1995:38:1351-1362.

.




                                                       7
CAHE                 The effectiveness of self-management educational interventions for osteoarthritis of the knee


APPENDIX 1
Critical appraisal of evidence of effectiveness
CITATION:



Reviewer


                                         Yes                 No                   Unclear           N/A
Was the assignment to treatment
groups random
Were participants blinded to
treatment allocation
Was allocation to treatment
groups concealed from the
allocator
Were the outcomes of people
who withdrew described and
included in the analysis?
Were those assessing the
outcomes blind to the treatment
allocation?
Were the treatment and control
group comparable at entry?
Were outcomes measured in the
same way for all groups?
Were outcomes measured in a
reliable way?
Was there adequate follow up
(>80%)?
Was appropriate statistical
analysis used?

Overall appraisal

Include

Exclude

Seek further information

Comments including reasons for exclusions:


Appendix 2

Data Storage

 ID              Title                      Source                   Author             Database        Location




                                                       8
CAHE                The effectiveness of self-management educational interventions for osteoarthritis of the knee


Appendix 3

Data extraction sheet (based on JBI)


Author                                                 Record Number

Journal

Year

Reviewer


Method         __________________________________________________________________
               __________________________________________________________________

Setting

               ________________________________________________


Participants
               __________________________________________________________________

Number of Participants

Group A                                                         Group B


Interventions -
Group A
               __________________________________________________________________




Group B

Intervention

               __________________________________________________________________
               __________________________________________________________________

Were the intervention adequately described

yes                     no                         not clear


Outcome Measures

                                                      9
CAHE               The effectiveness of self-management educational interventions for osteoarthritis of the knee



Definition
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________

Other Outcomes Measures

             Outcome Description                                    Scale / Measure




                                                    10
CAHE               The effectiveness of self-management educational interventions for osteoarthritis of the knee


Results
Dichotomous Data
        Outcome                         Control Group                      Treatment Group
                                     number / total number               number / total number




Continuous Data
         Outcome                       Control Group                      Treatment Group
                                     mean & SD (number)                  mean & SD (number)




Authors Conclusions
____________________________________________________________________________
____________________________________________________________________________


Comments
____________________________________________________________________________




                                                    11