ࡱ> q ;bjbjt+t+ %fAA7],,,,,,,@@@@8xl@$$(LLLLLL$FҚ,LLLLLҚ< ,,LL$< < < L,,L,L@@,,,,L< L< *  ,,L,@ @@x ڙ Design & method introduction The main question which forms the basis for this project, is: What are the effects of aquatic therapy for people with rheumatoid arthritis, osteoarthritis and ankylosing spondylitis on pain, ADL-functioning and Health-Related Quality of Life? To answer this question a decision was made to do this by conducting a literature review. The Cochrane collaboration has provided a comprehensive manual for conducting literature reviews in a systematic way. The use of systematic methods in reviews are designed to limit bias (systematic errors) and reduce chance effects, thus providing more reliable results upon which to draw conclusions and make decisions (see 1.5). Shortly described, the approach to develop systematic reviews involves 7 steps (46): Developing the protocol (FLP-format). Formulating the problem (main question) Locating and selecting studies Quality assessment of studies Collecting data Analysing and presenting results Interpreting results Developing the protocol ( FLP-format) The initial research proposal can be found in appendix I. This proposal contains a problem description, and information regarding the objectives of the project, proposed activities, end products and estimated costs of the project. The FLP format can be found in appendix II. This contains more specific information regarding the project. Especially the methodological approach is described in detail here, with a comprehensive timetable for the whole project period. Formulating the problem ( main question) The main question is formulated in 2.1. A focused question leads to clear decisions about what research to include and how to summarise it. A focused question should specify the patient population, type of intervention and types of outcome measures (39). For this particular review the following components were investigated: patient population: people diagnosed with rheumatoid arthritis, osteoarthritis or ankylosing spondylitis; Intervention: aquatic therapy; and outcome measures of interest were pain, ADL-functioning and health Related Quality of Life. For more information regarding the components of the main question of this project see sections 2.3.2 2.3.4 Type of study designs Studies were eligible if they were randomised controlled trials (RCTs), or clinically controlled trials (CCTs) comparing effects of aquatic therapy with any other, or no intervention, on pain, ADL-functioning and/or Health Related Quality of Life for people with rheumatoid arthritis, osteoarthritis or ankylosing spondylitis. Type of participants The patient populations of interest for this review are people diagnosed with rheumatoid arthritis, osteoarthritis and ankylosing spondylitis. See tables 1.1, 1.2 and 1.3 for information regarding the aetiology, pathology, diagnosis, clinical signs and prevalence of these disorders. Type of interventions The intervention of interest for this project is aquatic therapy. There are several terms being used more or less interchangeably for this intervention., e.g. balneotherapy (28), hydrotherapy (4), immersion (4) , floatation spa (17) and aquaerobics (9). All studies dealing with the combined effect of immersion and exercise were potentially eligible for this review, no matter which terms were being used for the intervention. The exercises being given in the different studies will be specified further into their duration in time, frequency of sessions, length of sessions, intensity, and nature of activity. Type of outcome measures Pain, ADL-functioning and Health Related Quality of Life was selected as outcome measures to be investigated in this review. At least one of these outcome had to be key outcome measures in eligible trials. These outcome measures were selected on the basis of what the World Health Organisation (WHO) and the International League Against Rheumatism (ILAR) have determined to be the most important endpoints in clinical trials concerning patients with chronic rheumatic disease (28). See 1.4 for definitions of these outcome measures, and further justification for why they were selected for this review. Locating and selecting studies 2.4.1 Data base search Databases that were searched included Medline, PEDro, Cinahl and the Cochrane Library (see 1.6.1). For identifying trials on Medline, use was made of a search filter developed by Robinson and Dickersin for locating studies on the Pubmed database (27). This filter consist of the search terms and Boolean operators listed below (see 1.6.1). This filter is divided into three phases: Phase one: (randomized controlled trial [pt] OR controlled clinical trial [pt] OR randomized controlled trials [mh] OR random allocation [mh] OR double-blind method [mh] OR single-blind method [mh]) NOT (animal [mh] NOT human [mh]) Phase two: (randomized controlled trial [pt] OR controlled clinical trial [pt] OR randomized controlled trials [mh] OR random allocation [mh] OR double-blind method [mh] OR single-blind method [mh] OR clinical trial [pt] OR clinical trials [mh] OR ("clinical trial" [tw]) OR ((singl* [tw] OR doubl* [tw] OR trebl* [tw] OR tripl* [tw]) AND (mask* [tw] OR blind* [tw])) OR ("latin square" [tw]) OR placebos [mh] OR placebo* [tw] OR random* [tw] OR research design [mh:noexp]) NOT (animal [mh] NOT human [mh]) Phase three: (randomized controlled trial [pt] OR controlled clinical trial [pt] OR randomized controlled trials [mh] OR random allocation [mh] OR double-blind method [mh] OR single-blind method [mh] OR clinical trial [pt] OR clinical trials [mh] OR ("clinical trial" [tw]) OR ((singl* [tw] OR doubl* [tw] OR trebl* [tw] OR tripl* [tw]) AND (mask* [tw] OR blind* [tw])) OR ("latin square" [tw]) OR placebos [mh] OR placebo* [tw] OR random* [tw] OR research design [mh:noexp]) OR comparative study [mh] OR evaluation studies [mh] OR follow-up studies [mh] OR prospective studies [mh] OR cross-over studies [mh] OR control* [tw] OR prospective* [tw] OR volunteer* [tw]) NOT (animal [mh] NOT human [mh]) Phase 1 was the most specific filter, providing 254118 findings on Medline. Phase 2 was more sensitive, providing 515226 findings on Medline. Phase 3 was the most sensitive filter, providing 2620430 findings on Medline. Search terms that was AND-ed together with the search filters presented above, are displayed in table 2.1. The search terms used were OR-ed or AND-ed together, enclosed within parentheses, then AND-ed with these search filters. These search terms were sorted according to whether they were population-, intervention-, or outcome specific ( see sections 2.1.2-2.1.4). The search strategy was modified for differences in the search engines provided by the different databases. Table 2.1: Search terms used in the database searching. (*) = Truncation, see 1.6.1. Search termsPopulation specificIntervention specificOutcome SpecificRheum* RA Ankylosing spondylitis AS Bechterew Osteoarthritis OA Arthritis Gout Adults Juvenile Hydro therapy Hydro* aqua* Balneotherapy Balneo Immersion Swim* Activit* Exercis* Water Sea Pool Therap* Outcome* Effect* Pain VAS Self report Activies of Daily living Function* Walking Health-related quality of life Quality of life Life satisfaction  The method used when developing an effective search strategy was this combination of search terms and search filters: (Populations terms (OR-ed)) AND (Intervention terms (OR-ed)) AND (outcome terms (OR-ed)) AND (search filter) Here is an example of a search filter that was fairly effective and provided in total 302 findings, including several eligible studies, on Medline: ((aquatic therapy OR aquatic OR spa OR hydrotherapy[mh] OR exercise therapy[mh] OR exercise OR Swimming OR Activities in water OR aqua OR pool therapy ) AND (Outcome OR outcomes OR effects OR effectiveness OR Pain OR VAS OR Questionnaire* OR selfreport* OR self-report* OR ADL OR Activites of Daily living OR Function OR functioning OR Walking OR Health-related quality of life OR Quality of life OR HRQL OR quality OR Life satisfaction) AND (Rheumatic OR rheumatoid arthritis OR rheumatoid or RA OR Ankylosing spondylitis OR AS OR Osteoarthritis OR OA OR Arthritis)) AND (randomized controlled trial [pt] OR controlled clinical trial [pt] OR randomized controlled trials [mh] OR random allocation [mh] OR double-blind method [mh] OR single-blind method [mh] OR clinical trial [pt] OR clinical trials [mh] OR ("clinical trial" [tw]) OR ((singl* [tw] OR doubl* [tw] OR trebl* [tw] OR tripl* [tw]) AND (mask* [tw] OR blind* [tw])) OR ("latin square" [tw]) OR placebos [mh] OR placebo* [tw] OR random* [tw] OR research design [mh:noexp]) NOT (animal [mh] NOT human [mh]) When searching databases, the first criterion for identifying eligible studies was by words in the titles of studies. A study was excluded if it failed to mention two of the following components of the study in its title: A relevant Patient population, relevant intervention or relevant outcomes (see sections 2.3.2-2.3.4). Studies that were included after this first criterion, were then assessed by their abstracts and key words. Studies were given the benefit of the doubt if it was unclear from their title if they were eligible or not. The Picarta database (43) was used to locate the full text articles of the potentially eligible studies. Reference checking Reference checking was conducted at the time of retrieval of full-text articles. This was performed in such a way that references of retrieved studies were screened twice. Any additional studies that seemed eligible was retrieved and assessed according to title, abstract and key words. Personal communication with experts To retrieve any additional studies that might have been missed, four experts in research and/or aquatic therapy were contacted: Dr. Rob deBie, convenor of Cochrane Collaborations field of rehabilitation and related fields. Dr.Arianne Verhagen, lead author on Cochrane Collaborations review on balneotherapy, one of the developers of the Delphi Scale for methodological assessment of clinical trials. Dr.Maria Judd, co-ordinator of Cochrane Collaborations musculoskeletal review group Prof.Jefferson Cardoso, lead author of Cochrane Collaborations review on aquatic therapy for RA The project groups correspondence with Prof. Cardoso , Arianne Verhagen and Maria Judd is included in the appendix personal communication regarding retrieval of additional literature. Quality assessment of studies Methodological quality assessments were conducted on all eligible studies. Though sometimes recommended (39), it was thought to be of little value to assess studies for quality while being blinded to authors, sources or results. For the purpose of methodological assessment, use was made of the PEDro scale, which is a modification of the Delphi scale (see 1.6.2 for descriptions of the two scales). To get familiar with the scale and ensure reliability when assessing methodological quality, several studies that had already been rated by official PEDro raters were assessed. After consensus was made within the group, the official PEDro scores were obtained to compare the groups findings with the actual PEDro ratings. These official ratings were considered the golden standard. The remaining studies were assessed for methodological quality twice. The scores given to the studies were then compared within the group, and any discrepancies were discussed and a consensus regarding the scores were obtained (see 3.2 for methodological quality of included trials). Collecting data A form was produced to collect only relevant data from the included studies. The original data collection form (see FLP-format in appendix II) was pilot tested, and any necessary alteration was made. The revised data collection form that was used for all articles is presented here: DATA COLLECTION FORMStudy:Author, year, titleMethod:Type of trial: Groups: PEDro score: Participants:Number of participants: Age: Sex ratio(m:f): Diagnosis & Diagnostic criteria: How long diagnosed. Eligibility criteria: Intervention:Characteristics: treatment length, frequency of sessions, duration of sessions, type of activity and intensity of activity. Control intervention: Setting:Outcomes:Measurements: When were they taken Outcome measures: Outcome measurement tool results (incl. Significance values) Notes: The results from the data collection can be seen in the table 3.1. 2.7 Analysing and presenting results Results were analysed and presented according to five basic questions provided in the Cochrane Collaborations reviewers manual (47): What comparisons should be made? What study results should be used in each comparison? Are the results of studies similar within each comparison? What is the best summary of effect for each comparison? How reliable are those summaries? The first step in addressing these questions was to decide which comparisons to make (see 3.1). The next step was to prepare tabular summaries of the characteristics and results of the studies that were included in each comparison (see table 3.1 and table 3.3 ). It may then be possible in a systematic way to derive estimates of effect across studies, to conclude how much confidence should be placed in those estimates and to investigate differences among studies (39). In chapter three these questions will be specified according to the objective of this review. 2.8 Interpreting results The results from the studies were interpreted in relation to the methodological quality of the studies. The following elements are discussed in chapter 4: Methodological quality of the included studies, as measured by the PEDro scale is discussed in 4.2.1. The applicability (external validity) of the included studies is discussed in 4.2.2. Interpretation of the effects of aquatic therapy on pain, ADL-functioning and HRQL is discussed in 4.3. In 4.4 a conclusive answer to the main question of this review will be provided. Implications for future practice and future research are discussed in 4.5. 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