Accepted Manuscript A systematic review of guidelines for the physical management of osteoarthritis Peter J. Larmer, DHSc, MPH, FNZCP Nicholas David Reay, BBS Elizabeth Richmond Aubert, BSc Paula Kersten, PhD, MSc, BSc PII:
S0003-9993(13)01105-2
DOI:
10.1016/j.apmr.2013.10.011
Reference:
YAPMR 55636
To appear in:
ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION
Received Date: 14 June 2013 Revised Date:
26 August 2013
Accepted Date: 8 October 2013
Please cite this article as: Larmer PJ, Reay ND, Aubert ER, Kersten P, A systematic review of guidelines for the physical management of osteoarthritis, ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION (2013), doi: 10.1016/j.apmr.2013.10.011. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Title: A systematic review of guidelines for the physical management of osteoarthritis.
Additional authors:
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Nicholas David Reay BBS Department of Physiotherapy Faculty of Health and Environmental Sciences AUT University Private Bag 92006 Auckland 1142 New Zealand
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Peter J. Larmer DHSc, MPH, FNZCP Head, School of Rehabilitation and Occupation Studies Faculty of Health and Environmental Sciences AUT University Private Bag 92006 Auckland 1142 New Zealand Ph;64-9-9219999 x 7322 Fax:64-9-9219620 Email:
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Contact person and primary author:
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Elizabeth Richmond Aubert BSc Department of Physiotherapy Faculty of Health and Environmental Sciences AUT University Private Bag 92006 Auckland 1142 New Zealand
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Paula Kersten PhD, MSc, BSc Associate Professor Person Centred Research Centre School of Rehabilitation and Occupation Studies Faculty of Health and Environmental Sciences AUT University New Zealand
Authors contributions All authors participated in the conception and design of the study, revision of the manuscript, acquired and interpreted the data, and drafted the manuscript. All authors read and approved the final manuscript. Acknowledgements The authors would like to acknowledge Andrew South, a library technician at the Auckland University of Technology, for his assistance with designing the literature search criteria.
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Keywords: Osteoarthritis, Guideline, Rehabilitation, Critical appraisal
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A systematic review of guidelines for the physical management of osteoarthritis.
2 Abstract
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Objective: To undertake a systematic critical appraisal of guidelines to provide a summary of
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recommendations for the physical management of Osteoarthritis (OA).
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Data Sources: The Cochrane Library, MEDLINE, CINAHL, SPORTDiscuss with Full Text, Scopus, ScienceDirect, PEDro and Google Scholar databases were searched (2000 to 2013)
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to identify all guidelines, protocols and recommendations for the management or treatment of
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osteoarthritis. In addition internet searches of all relevant arthritis organisations were
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undertaken. All searches were performed between July 2012 and end of April 2013.
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Guidelines that included only pharmacological, injection therapy or surgical interventions
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were excluded. Only guidelines published in English were retrieved.
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Study Selection: Osteoarthritis guidelines developed from evidence based research,
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consensus and/or expert opinion were retrieved. There were no restrictions on severity or site
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of OA, gender or age. Nineteen guidelines were identified for evaluation.
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Data Extraction: The quality of all guidelines was critically appraised using the AGREE II
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instrument. Each guideline was independently reviewed. All relevant recommendations for
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the physical management of OA were synthesised, graded and ranked according to available
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evidence.
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Data Synthesis: Seventeen guidelines with recommendations on the physical management of
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OA met the inclusion criteria and underwent a full critical appraisal. There were variations in
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the interventions, levels of evidence and strength of recommendations across the guidelines.
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Forty different interventions were identified. Recommendations were graded from ‘strongly
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recommended’ to ‘unsupported’. Exercise and education were found to be strongly
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recommended by most guidelines.
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Conclusion: Exercise and education were key recommendations supporting the importance
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of rehabilitation in the role in the physical management of OA. This critical appraisal can
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assist health care providers who are involved in the management of people with OA.
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Keywords: Osteoarthritis, Guideline, Rehabilitation, Critical appraisal
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Abbreviations:
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OA Osteoarthritis
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SOR strength of recommendation
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MA meta-analysis
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RCT randomised controlled trials
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TENS transcutaneous electrical nerve stimulation
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Osteoarthritis (OA) is the most common form of arthritis and is identified as one of the
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leading cause of pain and disability worldwide (1, 2). By the year 2020 the prevalence of OA is
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expected to double (3). The risk factors associated with OA include: age, gender, genetics,
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occupation, past injuries and, obesity (4). Hip and knee pain associated with OA often leads to
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inactivity and loss of mobility resulting in deconditioning, weight gain, loss of independence
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and decreased quality of life (5). There are substantial personal and societal costs associated
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with OA (1). Personal costs may include the inability to participate in work, sport, hobbies or
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caring for others due to pain. Societal costs may include visits to the doctor, medication costs
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and assistance equipment. Joint replacement is an effective intervention to alleviate pain and
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improve quality of life for those with advanced OA. However, despite a growing number of
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joint replacements undertaken each year many people are still placed on a waiting list often
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for a considerable time (6, 7). In order to reduce the burden of OA, safe and effective health
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services, involving a range of non surgical treatments options are required. These services
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must be effective with respect to intervention and cost as well as meet the affected person’s
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needs.
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Evidence based clinical guidelines are developed to assist the practitioner, patient and/or
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policy-maker to make informed clinical decisions (8). Guidelines are valuable resources that
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play an integral role in improving treatment and management of various health conditions. 3
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They can be used by health practitioners and people suffering with OA seeking information
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to determine how their disease can best be managed. A preliminary search of the literature
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identified many international guidelines developed for the management of OA. The
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preliminary search identified that the guidelines included evidence and recommendations for
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a number of interventions including: pharmacological, non-pharmacological, surgical and
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injections therapies, physical management and lifestyle changes for the management of OA.
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However, due to adverse side effects, patients and health care providers may pursue physical
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management options rather than surgery, pharmacology, or injection based therapy. A
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number of guidelines highly recommend exercise as an intervention for OA. However, Gill
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et al (9) in a recent systematic review concluded that while exercise interventions were
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beneficial for those people awaiting hip replacement, this was not the case for those awaiting
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knee replacement. It was also noted that there were variations across the guidelines in the
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recommendations made. Currently there is no critical appraisal of international guidelines
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that has synthesised, graded and comprehensively presented all the relevant recommendations
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for the physical management of OA. Therefore, a systematic critical appraisal of international
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OA guidelines was undertaken to comprehensively present all the relevant evidence based
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recommendations on the physical management of OA.
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83 Methods
Electronic database searches
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A systematic literature search was performed. The Cochrane Library, MEDLINE, CINAHL,
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SPORTDiscuss with Full Text, Scopus, ScienceDirect, PEDro and Google Scholar databases 4
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were searched (2000 to 2013) to identify all guidelines, protocols and recommendations for
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the management or treatment of osteoarthritis. An experienced health science librarian
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assisted with the development of the search strategy. MEDLINE, CINAHL, SPORTDiscuss
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with Full Text databases were searched using key word proximity searches to identify
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guidelines or recommendations for the management of osteoarthritis ((osteoarthrit* N5
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guideline*) OR (osteoarthrit* N5 evidence*) OR (osteoarthrit* N5 recommend) OR
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(osteoarthrit* N5 best*)). Scopus and ScienceDirect databases used the same proximity
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search logic but with the appropriate syntax. PEDro and The Cochrane Libraries were
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searched using ((osteoarthriti* and guideline) AND (osteoarthriti* and protocol)). A manual
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search was conducted on reference lists found in relevant guidelines, systematic reviews and
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meta-analysis, which returned additional resources.
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102 Internet searches
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A thorough internet search was conducted to identify international arthritis organisations and
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guideline clearinghouses. The names of organisations were also found during the process of
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reviewing guidelines and recommendations identified during the electronic database searches.
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The websites of these organisations were reviewed and any relevant guidelines were
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included. A list of these organisations is shown in Appendix 1.
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Eligibility Criteria
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The primary source of literature for this review is recommended guidelines developed from
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evidence based research, consensus and/or expert opinion. Guidelines that included only
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pharmacological, injection therapy or surgical interventions were excluded. There were no 5
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restrictions on severity or site of OA, gender or age. The search was confined to papers
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published in English and available electronically between the period of 2000 and end of April
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2013. Animal based studies were not included. If there had been updates to guidelines, only
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the latest version of the guideline was reviewed.
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Selection of guidelines
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All titles and/or abstracts were reviewed to determine if they met the eligibility criteria of this
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critical appraisal. When citations met the criteria, the full text articles were retrieved and
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reviewed. Nineteen guidelines were identified for evaluation. The details of results returned
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are shown in Figure 1.
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Quality appraisal
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The Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool was used to
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critique the guidelines (10). AGREE II is a guideline quality appraisal tool that has been found
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to have high construct validity (11). The AGREE II consists of 23 items arranged into six
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domains: scope and purpose (3 items), stakeholder involvement (3 items), rigour of
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development (8 items), clarity of presentation (3 items), applicability (4 items) and editorial
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independence (2 items). Each item is scored between strongly agree (4) to strongly disagree
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(1). The items scores within a domain were then added and calculated as a percentage. A
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domain was determined to be effectively addressed if its score was ≥ 60%, as has been used
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in other critical appraisals of arthritis guidelines (12, 13). Prior to a full critique of the guidelines
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all members of the research team undertook a training review process to ensure consistency
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and reliability in grading. All guidelines were then reviewed independently to ensure
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sufficient reliability as suggested by previous authors (11). Differences in scoring were
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resolved through discussions and consensus between all four authors. Where guidelines were
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not clear, the identified author was contacted for clarification if possible. Finally, based on
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their overall domain scores, the guidelines received an overall assessment from the research
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team of either ‘recommended’, ‘recommended with modifications’, or ‘not recommended’
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(10)
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Synthesis of Recommendations
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Following the AGREE II appraisal of the guidelines, recommendations that were specific to
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the physical management of OA were identified for data extraction. This analysis involved
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categorising recommendations by intervention (e.g. exercise, education) with their associated
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level of evidence (LOE) and strength of recommendation (SOR). For the purposes of this
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review the interventions have been grouped for similarity into twelve interventions. For each
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guideline recommendation, the associated interventions were scored on a +4 to -4 individual
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weighting scale (Table 1) based on their LOE and SOR values. The levels of the scale were
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derived from LOE and SOR values found in each guideline. There was variation in how
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individual guidelines provided grading scales for both LOE and SOR. A list of individual
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guideline scales is provided in Appendix 2. Guidelines based on meta-analysis (MA),
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systematic reviews (SR) and definitive randomised controlled trials (RCTs) that were
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strongly recommended were weighted highest (individual weighting = 4) while expert
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opinion with a weak strength of recommendation was weighted low (individual weighting =
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1). Where a guideline provided a recommendation against an intervention this was weighted
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negatively (individual weighting = -1 - -4). There were two exceptions to this process. Firstly,
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the recommendations from the National Health and Medical Research Council (NHMRC)
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guideline (14) were already graded on a 4-point scale based on LOE and SOR. Secondly, the
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NICE guideline (1) provided extensive level one evidence (MA, SR, and RCTs) throughout
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the paper. However, it did not present recommendations with a LOE or SOR. Due to the
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support of a high level of evidence we have graded each of the NICE recommendations with
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a weighting of four.
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Overall recommendation scores of interventions were determined by the median value of the
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specific interventions individual weightings. Table 2 illustrates how the overall intervention
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recommendations were then grouped based on their median score into strongly
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recommended, recommended, recommended with caution, and unsupported. For example,
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knee bracing is recommended by five guidelines with weighted scores of 4, 3, 4, 4 and 2
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resulting in a median score of 4 and grading of strongly recommended.
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Results
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The systematic literature search yielded 19 guidelines. One (15) was excluded as there were
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no stated methods for evidence gathering or developing recommendations, recommendations
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were not clear and no method for grading recommendations was stated. One (16) was excluded 8
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because no conclusive recommendations were provided for the physical management of
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glenohumeral joint OA. This resulted in 17 guidelines available for full data extraction.
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189 AGREE II appraisal results
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Table 3 presents the 17 guidelines AGREE II domain scores with an overall quality
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assessment rating and a comment on weaknesses of the specific guideline. There was
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variability in the domains that were effectively addressed by the guidelines. Of the 17
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guidelines, two effectively addressed four of the six AGREE II domains (14, 17), nine
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effectively addressed three domains (18-26), and six effectively addressed at least two domains
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(1, 5, 27-30)
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28)
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in any guideline. Six guidelines can be recommended without modifications (14, 17, 20, 24-26).
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Eleven guidelines (1, 5, 18, 19, 21-23, 27-30) were recommended with modifications.
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. Stakeholder involvement was effectively addressed by six guidelines (1, 14, 17, 18, 26,
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, editorial independence in one guideline (22) and applicability was not effectively addressed
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Interventions
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Forty interventions were identified across the guidelines. Table 4 presents the grouped
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interventions covered by the 17 guidelines. The grouped interventions are listed in
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descending order with the number of guidelines that recommended them: exercise (16
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guidelines), education (13 guidelines), equipment (11 guidelines), weight loss/diet (11
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guidelines), taping, heat/ice (9 guidelines), electrical based therapy (7 guidelines), self-
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management (7 guidelines), acupuncture (5 guidelines), manual therapy (5 guidelines),
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psychosocial interventions (5 guidelines) and balneotherapy/spa therapy (2 guidelines).
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Balneotherapy, refers to the passive relaxation in mineral or thermal water whereas
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hydrotherapy refers to therapeutic methods (e.g. exercise) that take advantage of the physical
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properties of water. All guidelines except the NICE guideline stated grading scales for their
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recommendations, either using level of evidence (LOE), strength of recommendation (SOR),
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or both. The grading criteria used by guideline developers varied among guidelines.
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The median weighting of the specific interventions across guidelines was calculated and then
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given an overall recommendation. These are presented as strongly recommended (Table 5),
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recommended (Table 6), recommended with caution (Table 7), unsupported (Table 8) and not
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recommended (Table 9).
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Strongly recommended interventions included: unspecified types of education (n=11(where
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n= recommended by number of guidelines)), combined modalities of exercise or exercise of
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an unspecified type (n=11), wedged insoles for knee OA (n=10), weight loss (n=10),
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strengthening exercise (n=9), aerobic exercise (n=8), self-management (n=7), aquatic/hydro
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therapy (n=6), transcutaneous electrical nerve stimulation (TENS) (n=6), knee bracing for
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knee OA (n=5) and appropriate footwear (n=4). Yoga, manual therapy with supervised
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exercise, manipulation and stretching, land based exercise and balneotherapy/spa therapies
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were also graded as strongly recommended interventions. However, only three or fewer
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guidelines provided recommendations for each of these interventions. Extensive research in
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regards to specific forms of education and diet strategies were described by two of the Ottawa
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Panel guidelines (18, 27) warranting their interventions to be strongly recommended. With
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respect to exercise, there were few studies that investigated individualised or tailored
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exercise, however nine guidelines (1, 14, 20-24, 26, 29) indicated that this should be an important
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consideration when prescribing exercise.
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Recommended interventions included: thermal based therapy (n=7), taping (n=6), and
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walking aides (n=6), and telephone support (n=5). Tai chi, electrical stimulation, devices to
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assist with activities of daily living, acupuncture, multi modal physical therapy and adherence
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strategies were also graded as recommended interventions. However, only three or fewer
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guidelines provided recommendations for each of these interventions.
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Two interventions, ultrasound and hand splints, were recommended with caution.
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Interventions reported as unsupported recommendations were laser therapy, magnetic
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bracelets, Chinese acupuncture, massage therapy, psychosocial interventions, and cognitive
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behavioural therapy.
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One intervention, electro acupuncture, was explicitly not recommended by one guideline (1)
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(Table 9). While there were a number of interventions that were either unsupported or not
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recommended by their authors, there were no interventions that were specified as harmful.
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Discussion 11
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256 257 This review is the first published critical appraisal of guidelines for the physical management
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of OA. Of the 19 guidelines that we identified, two were excluded. Firstly, the South Africa
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Arthritis Foundation guideline (15) was not included because recommendations were not
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clearly stated. Secondly, the recommendations from the American Academy of Orthopaedic
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Surgeons (AAOS) glenohumeral OA guideline (16) was not included as the focus of the
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guideline was surgical and pharmacological, with no conclusive recommendations provided
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for the physical management of OA. It was also noted that there were no allied health
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members (physiotherapists or occupational therapists) on the guideline development group.
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The group consisted entirely of medical doctors. In the future, patients with glenohumeral
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OA may be better served if the working group included individuals from all relevant health
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professional groups.
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The AGREE II instrument was used to assess the methodological quality of the remaining 17
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guidelines. When reviewing the AGREE II domain scores, the authors chose to use 60% as
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the value that represented adequate coverage of the criteria in a particular domain. The same
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approach was also used in other critical appraisals of arthritis guidelines (12, 13). This allowed
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comparisons of the domains amongst the 17 guidelines and recommendations to be made on
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the areas that could be improved in future development of guidelines. In this appraisal the
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domains of scope and purpose, rigour of development, and clarity of presentation were
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addressed effectively by the majority of guidelines. However, there were three domains that
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were consistently weak or unfulfilled by most guidelines: stakeholder involvement,
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applicability and editorial independence. Reviewing previous appraisals on clinical practice
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guidelines it became apparent that the same three domains have consistently scored poorly (12,
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31, 32)
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strong AGREE II scores add to the credibility of the recommendations.
. While AGREE II scores have no bearing on the actual content of the recommendations,
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283 Stakeholder involvement was only adequately addressed by six of the seventeen guidelines
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and improvement is needed within this domain. It requires the inclusion of all relevant
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information pertaining to the authors involved, target users clearly identified, and the views
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of the target population considered when developing guidelines. Guyatt and Rennie (33)
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reported that patient’s values need to be considered when developing evidence based
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literature. A failure in doing so is likely to overlook the person’s lived experience of OA and
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what is important to them. The applicability domain addresses resource implications,
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facilitators and barriers as well as advice on the implementation of the recommendation.
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None of the guidelines fulfilled the criteria for this domain. These elements play a role in
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decision making for the consumer, and these should be addressed within the guideline.
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Editorial independence adds to the rigour of the guideline. Only one guideline fulfilled this
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criterion. Guideline developers are required to declare the funding body and any competing
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interests. However, it is important that authors not only declare the funding body and
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competing interests, but also clearly state editorial independence. When this is omitted, the
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reader is unsure if there is actually a conflict of interest or if it was simply not mentioned.
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While this may be taken for granted, it is an important statement that adds to the rigour of the
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guideline. Improving all these areas of guideline development will allow the consumer to
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have more confidence in the recommendations made within the guideline.
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The method used to determine our overall combined intervention recommendations is novel
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and untested. We calculated a median score in an attempt to provide a balance on individual 13
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guideline’s LOE and SOR. The variability across guidelines made any attempt at aggregating
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recommendations difficult. It is also important to note that while some interventions were
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strongly recommended, some were based on only one or two guidelines. Balneotherapy was
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based on two guidelines (22, 29), whilst, land based exercise (14), yoga (28), and diet (18) were
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only based on one guideline. By comparison, other intervention recommendations were
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supported by many guidelines and therefore provide greater confidence in recommending that
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intervention.
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There were some inconsistencies found among the guidelines. Peter et al. (30) specifically
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recommended not to use massage therapy, electrical stimulation, laser therapy and
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ultrasound, while ultrasound was recommended by Brand et al. (14), Tuncer et al. (22), and
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Zhang et al. (24). Electrical stimulation was recommended by Brand et al. (14) and Tuncer et al.
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(22)
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opinion (14). Consumers of evidence based literature should be aware that there may be
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conflicting evidence among the research. This critical appraisal has assisted the user by
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identifying these inconsistencies and by providing a balanced interpretation.
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, and massage therapy and laser therapy received a recommendation based on expert
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The Ottawa group’s four guidelines (5, 18, 27, 28), while very comprehensive, failed to provide
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specific recommendations for the management of OA. The group provided extensive
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evidence of the research. However, the papers were presented in a PICOT (population,
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intervention, comparator, outcome and timeframe) format for different comparisons of
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interventions, making it difficult for consumers to take recommendations from the paper. The
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Ottawa panel was contacted and responded to questions surrounding the usability of the
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recommendations. The panel replied that a Cochrane Collaboration methodology was utilised
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and directed us to an Arthritis Society of Canada website. The Ottawa group report on highly
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relevant information concerning the physical management of OA. However, it would assist
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the guideline user if the group synthesised the data and presented key recommendations in an
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easily identifiable summarised box or grouped together in one section.
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The NICE guidelines are very comprehensive, with extensive evidence supporting the use of
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non-pharmacological interventions. The three core recommendations from the guideline were
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for strength and aerobic fitness, education, and weight loss if overweight. However, there are
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several user issues with the NICE guidelines. The guideline provided evidence statements in
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tables throughout the guideline. However, it did not grade the evidence, instead it referred the
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reader to an online link. Unfortunately the webpage was no longer available. After
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corresponding with the author, we were informed that their recommendations were no longer
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graded and it was advised to use the language in the recommendation as a guide. Although
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they provided strong evidence, without grading the levels of evidence and strength of
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recommendations it was difficult to interpret the recommendations. The authors have
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endeavoured to use a consistent methodology when grading the NICE guideline
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recommendations. While it is not mandatory to use a grading system for the strength of
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recommendations, it provides the reader with valuable information. Finally, the layout of the
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NICE recommendations was very difficult to follow. The guideline provided 36
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recommendations (18 non-pharmacological recommendations). These were dispersed
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throughout the document making it very difficult to locate all of the recommendations. It
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would assist the reader if the recommendations were presented in an easily identifiable box
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summarising the recommendations or presenting them grouped together at the beginning of
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the document.
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353 Exercise and education were found to be amongst the strongest interventions recommended
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throughout the guidelines. While the exercise recommendations ranged from very specific
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(aerobic, strength training, or hydrotherapy) to very general (exercise of unspecified type),
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the message was clear that exercise in all its forms is strongly recommended for OA, most
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specifically for knee OA. The important benefits of exercise include an improvement in pain
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and function, which are the main complaints reported by OA sufferers. Exercise is a low cost
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option in the management of OA, which makes it accessible to all OA sufferers. Education
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was also considered a strong recommendation. Education was found to reduce pain, increase
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coping skills and result in fewer visits to primary care practitioners in knee OA (5, 20, 29).
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Additionally, although the supporting evidence concerning tailored exercises was sparse, the
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consensus from nine guidelines recommended prescribing individualised patient exercise and
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education and these are key components of rehabilitation.
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Study Limitations
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This critical appraisal has two key limitations. Firstly, a new grading scale to grade the
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overall strength of each recommendation was developed. This was a non-standardised
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grading system and requires further testing. Secondly, only guidelines published in English
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were reviewed leading to a potential publication bias. This criterion may misrepresent the
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amount of research that has been conducted on the physical management of OA globally.
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Conclusions
377 378 The objective of this appraisal was to review the available guidelines and present the
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treatment recommendations for the physical management of OA in a format that was useful
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to the user. Throughout the research, there is strong evidence to support aspects of the use of
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exercise, electrical based therapy, equipment, education, diet and weight loss, manual therapy
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and self management. Laser therapy, magnetic bracelets, Chinese acupuncture, massage
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therapy, aspects of psychosocial based therapy and electro acupuncture were either
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unsupported or not recommended. With the prevalence of OA expected to double by 2020
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and the personal and societal costs associated with OA being substantial, it is important to
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establish the best strategy to manage and treat OA. As exercise and education were found to
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be among the strongest recommendations within the guidelines and can be relatively cost
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effective to provide, there is an opportunity for those engaged in rehabilitation to move into a
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leading role in the management of OA.
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In this critical appraisal we have taken a unique approach. Not only have we appraised the
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quality of the guidelines but also synthesised, graded and comprehensively presented all the
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relevant recommendations for the physical management of OA. It is hoped that this will
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inform health care providers on the best evidence interventions available for the physical
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management of OA.
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References
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1.
National Collaborating Centre for Chronic Conditions. Osteoarthritis: National
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Appendix 1 Arthritis related organisations
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Organisation name 3e Initiative in Rheumatology African League of Associations for Rheumatology American Academy of Orthopaedic Surgeons
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American College of Rheumatology American Geriatrics Society
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American Pain Society Arthritis New Zealand Arthritis Research UK Arthritis Society - Canada
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Arthritis.com
Asia Pacific League of Associations for Rheumatology Assessment of SpondyloArthritis International Society
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Brazilian Society of Rheumatology
British Paediatric Rheumatology Group
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British Society for Rheumatology Canadian Medical Association Clinical Guidelines Canadian Rheumatology Association Centers for Disease Control and Prevention Guidelines Cochrane Review - Osteoarthritis European League Against Rheumatism Group for Research in Psoriasis and Psoriatic Arthritis
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Hong Kong Society of Rheumatology Institute for Clinical Systems Improvement International League of Association for Rheumatology
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Italian Society of Rheumatology Medical Journal of Australia Clinical Guidelines National Guidelines Clearinghouse
National Institute of Clinical Excellence
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New South Wales Therapeutic Assessment Group
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National Health and Medical Research Council
New Zealand Guidelines Group (completed voluntary liquidation mid-2012) Orthopedic Research Society
Osteoarthritis Research Society International Ottawa Panel Evidence
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Panamerican League of Associations for Rheumatology Queensland University Clinical Practice Guidelines Royal Dutch Society for Physical Therapy
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Scottish Intercollegiate Guidelines Network South Africa Arthritis Foundation
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Therapeutic Goods Administration Therapeutic Guidelines
Turkish League Against Rheumatism U.S. Agency for Healthcare Research & Quality
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Appendix 2
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Levels of evidence and strengths of recommendation scales Author. Criteria for levels of evidence/recommending grading AAOS(17)
ACR(19) Strong recommendation to use Weak (or conditional) recommendation to use No recommendation Weak (or conditional) recommendation not to use Strong recommendation not to use.
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Study Type: Systematic reviews, high quality RCTs Poor quality RCTs, prospective or retrospective comparative studies, case control Case series, expert opinion
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Level of Evidence: Level I Level II or III Level IV or V None or Conflicting
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Grading the Recommendations: A Good evidence (Level I Studies with consistent finding) for or against recommending intervention B Fair evidence (Level II or III Studies with consistent findings) for or against recommending intervention. C Poor quality evidence (Level IV or V) for or against recommending intervention. I There is insufficient or conflicting evidence not allowing a recommendation for or against intervention.
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Strong recommendations: mean that most informed patients would choose the recommended management and that clinicians can structure their interactions with patients accordingly. Conditional recommendations: mean that the majority of informed patients would choose the recommended management but many would not, so clinicians must ensure that patients’ care is in keeping with their values and preferences. BSR(21) Strength of recommendation: A Directly based on category 1 evidence B Directly based on category 2 evidence or extrapolated recommendation from category 1 evidence C Directly based on category 3 evidence or extrapolated recommendation from category 1 or 2 evidence
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EULAR(20, 23, 24, 26, 29) Strength of recommendation: Category 1 evidence A B Category 2 evidence or extrapolated recommendation from category 1 evidence C Category 3 evidence or extrapolated recommendation from category 1 or 2 evidence D Category 4 evidence or extrapolated recommendation from category 2 or 3 evidence
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Categories of evidence: Ia Meta-analysis of RCT Ib At least one RCT IIa At least one CT without randomization IIb At least one type of quasi-experimental study III Descriptive studies (comparative, correlation, case–control) IV Expert committee reports/opinions and/or clinical opinion of respected authorities
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Author. Criteria for levels of evidence/recommending grading D Directly based on category 4 evidence or extrapolated recommendation from category 1, 2 or 3 evidence
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Categories of evidence: Ia Meta-analysis or RCT's Ib At least one RCT IIa At least one controlled study without randomisation IIb At least one quasi-experimental study III Descriptive studies, such as comparative, correlation or case-control studies IV Expert committee reports or opinions and/or clinical experience of respected authorities
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NHMRC(14) Grade of recommendations: A Body of evidence can be trusted to guide practice B Body of evidence can be trusted to guide practice in most situations C Body of evidence provides some support for recommendation(s) but care should be taken in its application D Body of evidence is weak and recommendation must be applied with caution Note: A recommendation cannot be graded A or B unless the volume and consistency of evidence components are both graded either A or B. Levels of evidence: I Evidence obtained from a systematic review of all relevant randomised controlled trials. II Evidence obtained from at least one properly designed randomised controlled trial.
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Author. Criteria for levels of evidence/recommending grading III-1 Evidence obtained from well designed pseudo randomised controlled trials (alternate allocation or some other method). III-2 Evidence obtained from comparative studies with concurrent controls and allocation not randomised (cohort studies), case control studies, or interrupted time series with a control group. III-3 Evidence obtained from comparative studies with historical control, two or more single arm studies, or interrupted time series without a parallel control group. IV Evidence obtained from case series, either post-test or pre-test and post-test.
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NICE(1) Grading the evidence statements: High-quality meta-analyses (MA), systematic reviews of RCTs, or RCTs with a very low risk of bias. 1++ 1+ Well-conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias. 1– Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias.* 2++ High-quality systematic reviews of case-control or cohort studies. High-quality case-control or cohort studies with a very low risk of confounding, bias or chance and a high probability that the relationship is causal. 2+ Well-conducted case-control or cohort studies with a low risk of confounding, bias or chance and a moderate probability that the relationship is causal. 2Case-control or cohort studies with a high risk of confounding, bias or chance and a significant risk that the relationship is not causal.* 3 Non-analytic studies (for example case reports, case series). 4 Expert opinion, formal consensus.
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*Studies with a level of evidence ‘–’ are not used as a basis for making a recommendation OARSI (22, 25) Strength of Recommendation: VAS Scale (0-100%)
Ottawa Panel(5, 18, 27, 28) Grade: A (strongly recommended) B (recommended)
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Evidence hierarchy: Ia Meta-analysis of randomized controlled trials Ib At least one randomized controlled trial At least one well-designed controlled study, but without randomisation IIa IIb At least one well-designed quasi-experimental study III At least one non-experimental descriptive study (comparative, correlation or case-controlled study) IV Expert committee reports, opinions and/or experience of respected authorities
Clinical Importance (%): >=15 >=15
Statistical Significance: