ࡱ> 8:567q bjbjt+t+ %nAA]&&&&8^d&2"   e e e $֬ʮZ˫e C "e e e ˫#  72###e   &&e ##%  N#&&)`ת APPENDICES: I.Graduation project proposalp. 51 II.FLP formatp. 52 III.Notes on administration of the PEDro scalep. 62 IV.Personal communication with expertsp. 63 a.Communication regarding retrieval of additional literaturep. 63 b.Communication regarding dispute of quality rating of PEDro rated studies  p. 66  Appendix I: Graduation project proposal 1.Title: Aquatic therapy for people with rheumatic disorders 2. Responsibility for proposal: David deLouw, Monica Veeger 3. Problem description: Reumasol Centre, specialised in the treatment of people with rheumatic disorders, is using aquatic therapy as one of it s main therapeutic means. A project about aquatic therapy for rheumatic patients will be used as an education material for the different physiotherapists working at the centre. Many physiotherapist working here (including ourselves) have not received formal training about exercise therapy in water , and feel the need for additional educational material. Practical problems are encountered at Reumasol when it comes to aquatic therapy because of the difference in functional abilities among rheumatic patients. Main question: What would be the most suitable way for Reumasol to treat patients in water according to their different functional levels? 4. Objectives: Description of the best way for Reumasol to treat rheumatic patients using aquatic therapy considering their initial functional abilities. Educational material for Reumasols physiotherapy departement. 5. Proposed activities: Literature research to find out what would be the most suitable way to treat rheumatic patients in water according to their different functional levels using internet, books and journals; Survey among the PTs at Reumasol to find their opinions and expectations regarding our project and the end product we will present; Observation and interviews of other PTS working in other centres specialized in exercise therapy for rheumatic patients. Judge data by means of a checklist. Analysing data. 6. Product: Endproduct report A video and a reader. 7. Globally estiamted costs: Depending on the outcome of the survey and the product chosen. 8. Participating students: Kim Grana Gilles Jarret Kristian Kulvik Appendix II: FLP - format PROJECT: 0.1 TITLE OF PROJECT: Effects of exercising in water for patients with the rheumatoid arthritis , osteoarthrtitis and ankylosing spondylitis on pain, ADL-functioning and Health-Related Quality of Life (HRQL). 0.2 PARTICIPATING STUDENTS: - Kim Grana : HYPERLINK "/cgi-bin/compose?mailto=1&msg=MSG1010752018.67&start=405115&len=49983&src=&type=x&to=Kimgrana%40hotamail%2ecom&cc=&bcc=&subject=&body=&curmbox=F000000001&a=080e57da8c215c1898eb5d2fb4d13391"Kimgrana@hotmail.com - Kristian Kulvik : HYPERLINK "/cgi-bin/compose?mailto=1&msg=MSG1010752018.67&start=405115&len=49983&src=&type=x&to=kristiankulvik%40hotmail%2ecom&cc=&bcc=&subject=&body=&curmbox=F000000001&a=080e57da8c215c1898eb5d2fb4d13391"kristiankulvik@hotmail.com - Gilles Jarret : HYPERLINK "/cgi-bin/compose?mailto=1&msg=MSG1010752018.67&start=405115&len=49983&src=&type=x&to=gjarret%40hotmail%2ecom&cc=&bcc=&subject=&body=&curmbox=F000000001&a=080e57da8c215c1898eb5d2fb4d13391"gjarret@hotmail.com - Project mail address : HYPERLINK "/cgi-bin/compose?mailto=1&msg=MSG1010752018.67&start=405115&len=49983&src=&type=x&to=reumaproject%40hotmail%2ecom&cc=&bcc=&subject=&body=&curmbox=F000000001&a=080e57da8c215c1898eb5d2fb4d13391"reumaproject@hotmail.com DATE: 31/01/2002: Concept FLP 1 08/02/2002: Concept FLP 2 27/03/2002: Concept FLP 3 04/04/2002: Concept FLP 4 09/04/2002: Concept FLP 5 10/04/2002: Concept FLP 6 11/04/2002: Concept FLP 7 1. PROJECT LEADER, COMMISSIONER. RESPONSIBLE COMMISSIONER Peter Ardon, Sjefsfysioterapeut Reumasol senter 1.2 SUPERVISORY TEACHERS: - General Supervisor: Monica Veeger:  HYPERLINK mailto:M.veeger@fontys.nl M.veeger@fontys.nl - Methodological Supervisor: David De Louw: HYPERLINK "/cgi-bin/compose?mailto=1&msg=MSG1010752018.67&start=405115&len=49983&src=&type=x&to=D%2edelouw%40fontys%2enl&cc=&bcc=&subject=&body=&curmbox=F000000001&a=080e57da8c215c1898eb5d2fb4d13391"D.delouw@fontys.nl , ph: 00 31 877 878 870. - Graduation proj. coordinator:Annelies Simons: HYPERLINK "/cgi-bin/compose?mailto=1&msg=MSG1010752018.67&start=405115&len=49983&src=&type=x&to=A%2esimonsad%40fontys%2enl&cc=&bcc=&subject=&body=&curmbox=F000000001&a=080e57da8c215c1898eb5d2fb4d13391"A.simonsad@fontys.nl , ph: 00 31 877 878 928. - Address school: Fontys Paramedische Hogeschool, postbus 347, 5600 Eindhoven. 2. DEFINITION OF THE PROBLEM. 2.1 PREVIOUS HISTORY: The 3 participating students have fulfilled one of their final year clinical affiliations at Reumasol Center in Spain. Reumasol Center, run by the Norsk Revmatiker Forbund (NRF - the Norwegian Rheumatologic Association) is using Exercice Therapy ( E.T.) in water as one of its main therapeutic means for the treatment/rehabilitation of its patients. Practical problems are encountered at Reumasol when it comes to exercise therapy in water. The wide difference in functional abilities among rheumatic patients create difficulties when selecting patients into groups so that a tailor made program in water can be implemented. A previous unformal proposal for this project was therefore to design a tool helping the physiotherapists working at Reumasol to assess the functional levels of the patients, as well as to produce a literature review about exercise therapy in water for rheumatic patients. The physiotherapy department at Fontys suggested however that it would be more realistic to focus on the literature review, considering the time allocated for this project. Using water for remedial purposes can be dated back to antiquity (Jackson 1990). Many different terms are used for treatment in water, including hydrotherapy, balneotherapy, spa therapy, medical hydrology, et cetera. Kinebalneotherapy signifies a more active form of therapy in water (Verhagen 2000). Nowadays exercise therapy is a popular method for treating rheumatic patients, and the combination of exercise and the physical properties of water is widely used. It is our experience that the patients at Reumasol valued exercise therapy in water highly. The physical therapists working there also have positive experiences with their patients being treated this way. These are subjective opinions based on clinical experience, and not valid in a scientific way. Reviewing literature on the subject to find out if there are any documented objective effects from this treatment form is therefore interesting. What can be said about the effects of exercise therapy in water in terms of physiological, psychological and social levels. Three outcomes influenced by rheumatic diseases will be considered: pain, ADL functioning and health related quality of life. The aim was that the outcomes would cover the whole range of the movement continuum (Cott 1968) where an individual can be considered on a biological, personal or social level. All of those outcomes except strength figure on a functional scale designed by rheumatologists when asked what functional measures were important to use in evaluation of patients with rheumatic diseases (Hicks 1993). Osteoarthritis (OA) , rheumatoid arthritis (RA) and ankylosing spondylitis represent a large percentage of the patient population at Reumasol . Therefore the focus will be on these three conditions in this research. 2.2 SOCIAL AND SCIENTIFIC RELEVANCY: Reumasol is using exercise therapy in water as one of its main therapeutic means. This project will systematically review literature on the subject, to find out if there are any objective evidence on the effects of this treatment form. It will this way bring an extra source of information to the rheumatologymodule for the physiotherapy students at Fontys Hogescholen. This review of studies and its deducted suggestions for further research could also be a consultation source for centers specialized in rehabilitation of rheumatic patients using exercise therapy in water. MAIN QUESTION: What are the documented effects of exercising in water for patients with rheumatoid arthritis , osteoarthrtitis and ankylosing spondylitis on pain, ADL-functioning and Health-Related Quality of Life (HRQL)? 2.5 WORKING DEFINITIONS: Rheumatic patients: People who have been diagnosed medically by use of international criteria (e.g. New York criteria for RA 1968, Modified N.Y. criteria for AS, The revised American Rheumatism Association (ARA) criteria of 1987) as being affected by OA, AS or RA (Walton 1986). Rheumatoid arthritis: A chronic and often progressive polyarthropathy of unknown aetiology, affecting primarily joint synovial membranes, though other tissues and organs may also be involved. There may be extensive deformitites and corresponding disability in advanced cases. There is evidence that a disordered immune system plays a part in the pathogenesis (Walton 1986). Osteoarthritis: A chronic degenerative non-inflammatory condition of joints. Some degree of OA is almost universal in older age groups and may be regarded as the inevitable result of the wear-and-tear of a lifetime; When severe , however, it is an important cause of disability. Genetic factors probably influence the rate and degree of degenerative change, as do abnormal stresses on joints, for example the weightbearing joints in obesity (Walton 1986). Ankylosing spondylitis: An inflammatory condition of the spine, which occurs predominantly in young males. It usually begins with inflammation of the sacroiliac joints, and in those cases which progress the spine eventually becomes completely rigid (poker back) with X-ray appearances aptly described as bamboo spine. Peripheral jonts may also be involved, and other associated features may include iridocyclitis, cardiac conduction defects, aortic valve incompetence, pulmonary fibrosis, ulcerative colitis, and amyloidosis (Walton 1986). Exercise therapy in water: Activities in water , supervised or unsupervised by physiotherapists, directed towards improving or maintaining physical, psychological and social patient variables. Health related quality of live (HRQL): This is a broad term encompassing all health related factors contributing to the overall quality of a persons life. 3. OBJECTIVES: A report dealing with the effects of exercise therapy in water for patients with rheumatoid arthritis, osteoarthritis and ankylosing spondylitis on pain, ADL- functioning and health related quality of life (HRQL). 4. METHOD: Systematic review: The systematic review will be conducted independently by the three members of the group. Data bases to be searched include: Medline, Cochrane Library, Cinahl and PEDro. Specialized journals and books in rheumatology and hydrotherapy by using search engines at libraries in: - Netherlands: Fontys library, Eindhoven, Library of the free university of Amsterdam/Den Haag (NIWI), Library of university of Utrecht, library of Amersfoort; - Norway: Library at Hoeyeskolen i Trondheim - France: Library at ecole de Kinesiologie-St try/Seine. In the first phase each group member will select studies which seem eligible from their titles and abstracts, using the in- and exclusion criteria mentioned below. The predetermined eligible studies will be compared . Disagreement regarding which studies to include in the second phase of searching will be solved by consensus. If consensus is not reached, the majority decides which studies to include. In the second phase of searching, the full text articles of the included studies be will sought after at their location in Dutch libraries, as listed in Picarta. In the early data extraction phase, the methodological quality of each study will be evaluated independently by two members of the group, to find out which studies are truely eligible for inclusion. For this purpose the 11 items on the PEDro scale ( see appendix ) will be used. The next phase of searching will consist of reference checking, independently by the three group members, to find any studies overlooked in earlier search phases. Any new studies found at this point, will have to go through phase one and two before inclusion can be decided. Contact will then be taken with experts and researchers for finding any other information sources, and input regarding the following phases of analysis and synthesis: Dr. Rob de Bie, Convenor of Cochrane Rehabilitation and Related Therapies Field : HYPERLINK "mailto:ra.debie@epid.unimaas.nl"ra.debie@epid.unimaas.nl Maria Judd, Coordinator of Cochrane Musculoskeletal Group : HYPERLINK "mailto:mjudd@uottawa.ca"mjudd@uottawa.ca Mrs Arianne Verhagen, Dept. Of General Practice, Erasmus University Rotterdam :  HYPERLINK mailto:verhagen@hag.fgg.eur.nl verhagen@hag.fgg.eur.nl Inclusion criterias: Types of studies: Controlled trials, randomized and non-randomized, which compares effects of activities in water for one group, with another group which receives no intervention or another intervention, will be included. Types of participants: The participants in the study must be diagnosed with either RA, OA or AS by internationally accepted criteria, for example the New York criteria for RA 1968, Modified N.Y. criteria for AS, or The revised American Rheumatism Association (ARA) criteria of 1987. Types of intervention: Activities in water has to be the intervention being studied, compared with no treatment or another treatment form. Types of outcome measures: Studies must measure at least one of the three relevant outcomes; Pain, ADL-functioning and/or Health Related Quality of Life. Language: In order to be able to assess the methodological quality appropriately, only articles written in English, Norwegian or French will be considered. Exclusion criterias: Type of studies: - Studies which do not discuss at least one of the three relevant outcomes for RA, OA and/or AS for this review will be excluded. - Case studies will be excluded. Studies where one group receives activities in water and the other group receives activities in water plus another treatment form will be excluded (i.e. studies where activities in water is not the dependent variable). Studies where water is being used as a passive treatment form ( e.g. taking mineral baths ) will be excluded. Keywords: English key words: Rheumatoid arthritis Osteoarthritis ankylosing spondylitis - rheumatic - exercise therapy - water - hydro aqua balneo spa heated pool - outcome effect comparing pain ADL HRQL - Norwegian key words: Trening terapi vann basseng revmatisk effekt revmatoid artritt artrose bechterew smerte hydro aqua balneo spa oppvarmet ADL livskvalitet - French key words: Hydrotherapie eau exercice spondylarthrite anky-losante arthrite osteoarthrite rhumatisme bassin - activite hydro aqua balneo spa douleur - qualite de vie. Data extraction: Data will be extracted from included studies by use of a data extraction form. Below is the provisional data extraction form. A pilot testing of this form will be conducted by the three group members extracting data from one study. Modifications of this form will be decided through consensus, so that only relevant information will be extracted from the included studies. If consensus is not reached, the majority will decide the modifications. 1. Method2.Participants3.Intervention4.Outcomes5.Results6.Additional notes-Pedro score -study duration -Type of trial -no. Of drop outs and cross-overs -cointerventions and other potential confounders -Any validity criteria used -ethnicity -age -sex -education level -setting of intervention (ho-spital,office,clin-ic,nursing home) -geographical region. -diagn. Criteria -how long diagn. - pre treatment -Type of activity. -duration -frequency -intensity -number of sessions - co interventions -controll group interventions Differences in: -pain -mobility -strength -ADL-functioning -HRQL -measurement tool -subgroup outcomes -outcomes at different times -Side effects. -Any relevant analyses of the significance of the outcomes. Data analysis and synthesis: Meta analysis will attempt to make comparisons between for example the outcomes of the interventions for OA, RA and AS, and long-term versus short term intervention duration. After data extraction attempts will be made to synthezise data so relevant comparisons can be made between any clear sub groups that come out of the different studies. PROJECT PRODUCT: A research report. Three individual evaluation reports (process report) Title of the project and a short summary of the content of the project, for the benefit of the verbal presentation. Oral presentation. TIME: week 1: from 01/04/2002 to 05/04/2002.week 2: from 08/04/2002 to 12/04/2002.week 3: from 15/04/2002 to 19/04/2002.week 4: from 22/04/2002 to 26/04/2002.week 5: from 29/04/2002 to 03/05/2002.week 6: from 06/05/2002 to 10/05/2002.week 7: from 13/05/2002 to 17/05/2002.week 8: from 20/05/2002 to 24/05/2002.week 9: from 27/05/2002 to 31/05/2002.week 10: from 03/06/2002 to 07/06/2002.week 11: from 10/06/2002 to 14/06/2002. Project activitiesPreparation phase/WeekNAMEFirst meeting with methodological supervisor and general supervisor for revision of FLP draft 3.02/04/2002David, Monica, Kim, Kristian, Gilles.Extraction and evaluation of PEDro methodological validity assessment scale.02/04/2002Kristian.Research books Rheumatism/hydrotherapy in studylandskap.Week 1Gilles.Week 2: Writing and sending FLP draft 4 to General supervisor, after feedback.03/04/2002.Kristian, Gilles.Writing and sending FLP draft 5 to General supervisor, after feedback.Week 2.Kristian, Gilles.Dividing tasks internet research English sites.Week 2.Kristian, Kim, Gilles.Internet research English sites.Week 2.Kristian, Kim, Gilles.Internet research Scandinavian sites.Week 2.Kristian, Kim.Internet research French sites.Week 2.Gilles.Meeting with Bernadette Smetsers in search for expert consultation.10/04/2002.Bernadette, Kim, Gilles.Making overview of experts to be contacted.Week 2.Kim, Gilles.Making overview of Rheuma. Associations to be contacted.Week 2.Kristian, Kim.Writing and sending FLP draft 6 to general supervisor, after feedback.10/04/2002.Kristian, Gilles.Fortnightly report to General supervisor.12/04/2002.Kim.Fortnightly report to Peter Ardon/Reumasol.12/04/2002.Gilles.Data collection: first phase: deciding which studies are eligible for phase 2: use of in-exclusion criterias.12/04/2002.Kristian, Kim,Gilles.Writing and sending FLP draft 7 (final) to general supervisor.12/04/2002.Kim, Gilles.Week 3: Realisation phase:Continuation of internet research (3 languages).Week 3.Kristian, Kim, Gilles.Data collection: phase 2: Checking of availability of selected studies in Dutch libraries using Picarta.15/04/2002.Kristian, Kim.Visit to Amsterdam library to find full text articles of included studies.17/04/2002.Kristian, Kim, Gilles.Data extraction: evaluation of methodological quality of collected full text studies by PEDro scale.18/04 to 19/04/2002.Independently: Kristian, Kim, Gilles.Data extraction: reference checking of selected studies.18/04/2002.Kristian, Kim.Data extraction: studies overlooked in earlier search phases gets evaluated (PEDro scale).19/04/2002.Kristian, Kim, Gilles.Pilot testing of 1 article using the data extraction formWeek 3Kristian, Kim, GillesModification of data extraction form after pilot testing.Week 3Kristian, Kim, GillesData extraction: summary of found articles in tables.Week 3.Kristian, Kim, Gilles.Taking contact with experts and rheuma associations (E.mail) to find out other information sources.Week 3.Kim, Gilles.Week 4:Continuation internet article research.Kristian, kim, Gilles.Continuation extraction data (tables) .Kristian, Kim, Gilles.Deviding tasks data analysis.26/04/2002.Kristian,Kim, Gilles.Data analysis, compare articles (meta analysis).Kristian, Kim, Gilles.Fortnightly report to general supervisor.26/04/2002.Kristian.Fortnightly report to Peter Ardon/Reumasol.26/04/2002.Kim.Week 5:Continuation data analysis.Kristian, Kim, Gilles.Meeting with general supervisor before synthesis.Monica, Kristian, Kim, Gilles.Dividing of tasks for data synthesis.Kristian, Kim, Gilles.Data synthesis.Kristian, Kim, Gilles.Writing of data synthesis.Kristian, Kim, Gilles.Updating and writing og referanse list.Kim.Week 6Final completion end product: data synthesis writing.Kristian, Kim, Gilles.Fortnightly report to general supervisor.10/05/2002.Gilles.Fortnightly report to Peter Ardon/Reumasol.10/05/2002Kristian.Week 7:Continuation completion end product.Kristian, Kim, gilles.Continuation writing individual report.All, seperatly.Writing title and short summary of end report.Kristian, Kim, Gilles.Week 8:Writing individual reportsAll separatelyContinuation completion end product.Kristian, kim, Gilles.Continuation completion individual report.All, seperatly.Deliver title and short description (email/floppy) to Project coordinator Annelies Simmons.23/05/2002 before 12.am: deadline.Fortnightly report to general supervisor.Kim.Fortnightly report to Peter Ardon/Reumasol.Gilles.Assessment of report readabilityBlind assessorModification after feedback from blind assessorKristian, Kim, GillesWeek 9:Making copies and binding of end product.Kristian, Kim, Gilles.Sending one copy to reumasol centre.Deliver end product (3 copies) to project coordinator Annelies Simmons.30/05/2002 before 12.am: deadline. Week 10:Presentation rehearsal with general supervisor. Monica, Kristian, Kim, Gilles.Deliver individual report to general supervisor Monica Weber.06/06/2002 before 12.am: deadline.All, seperatly.Appointments with general supervisor for individual discussion.Between 07/06/2002 and 12/06/2002.Monica with kristian, kim, Gilles, seperatly.Week 11:Assessment of end product12/06/2002.General and methodological supervisors.Presentation graduation project.13/06/2002.All.Delivering of grades.13 or 14/06/2002. Supervision: No agreements have been made with Reumasol by Physical therapy dept. about supervision, tasks, invested powers or other matters. ESTIMATED COSTS: Copying Printing Travelling costs Phone calls + Presents to helpful people = All in all we expect to use 200-300,- Euro. QUALITY REQUIREMENTS: The end product chosen is a systematic review. Functional demands: Volume: 40-60 pages (not including apendices), Lay out: typed work on A 4 paper, word 98, Fonts: Times New Roman, size 10, pages numbered, explanation and title next to tables and diagrams. Project will be binded. - Operational demands: - In English, -Simple enough so that the reader (who may not be English) can understand (high school level), Citations will be left "as is", as well as necessary professional language. Design limitations: "Expected to go wrong": - Respect of the first few deadlines. - FLP format and writing of data synthesis. Boundery conditions: litterature study, following the format as listed under 6.4.1 in the graduation project reader. PROVISIONAL LITERATURE: David C, Lloyd J. Rheumatological physiotherapy. Mosby International Limited; 1998 Hicks JE, Gerber LH. Rehabilitation of the patient with arthritis and connective tissue disease. In: DeLisa JA, editor. Rehabilitation medicine:principles and practice. 2nd ed. Philadelphia: Lippincott Company; 1993. P. 1054-55 Simon L, Blotman F. Exercise therapy and hydrotherapy in the treatment of the rheumatic diseases. Clin in Rheum Diseases 1981; 7: 337-47 Verhagen AP, de Vet HCW, de Bie, Kessels AGH, Boers M, Knipschild PG. Balneotherapy for rheumatoid arthritis and osteoarthritis (Cochrane review) . In: The Cochrane Library, Issue 1, 2000. Oxford: update software. Walton J, Beeson PB, Scott RB. The Oxford companion to medicine. Volume I A-M. New York: Oxford university press; 1986 Walton J, Beeson PB, Scott RB. The Oxford companion to medicine. Volume II N-Z. New York: Oxford university press; 1986 FLP-appendix: The Pedro (methodological validity assessment) Scale PEDro the PEDro scale  PEDro Scale (last modified March, 1999) PRIVATE1. Eligibility criteria were specified. no / yes 2. subjects were randomly allocated to groups (in a crossover study, subjects were randomly allocated an order in which treatments were received). no / yes3. allocation was concealed. no / yes 4. the groups were similar at baseline regarding the most important prognostic indicators. no / yes 5. there was blinding of all subjects. no / yes 6. there was blinding of all therapists who administered the therapy. no / yes 7. there was blinding of all assessors who measured at least one key outcome. no / yes 8. measures of at least one key outcome were obtained from more than 85% of the subjects initially allocated to groups. no / yes9. all subjects for whom outcome measures were available received the treatment or control condition as allocated or, where this was not the case, data for at least one key outcome was analysed by "intention to treat". no / yes10. the results of between-group statistical comparisons are reported for at least one key outcome. no / yes 11. the study provides both point measures and measures of variability for at least one key outcome. no / yes  Appendix III: Notes on administration of the PEDro scale PRIVATEAll criteriaPoints are only awarded when a criterion is clearly satisfied. If on a literal reading of the trial report it is possible that a criterion was not satisfied, a point should not be awarded for that criterion.Criterion 1This criterion is satisfied if the report describes the source of subjects and a list of criteria used to determine who was eligible to participate in the study. Criterion 2A study is considered to have used random allocation if the report states that allocation was random. The precise method of randomisation need not be specified. Procedures such as coin-tossing and dice-rolling should be considered random. Quasi-randomisation allocation procedures such as allocation by hospital record number or birth date, or alternation, do not satisfy this criterion. Criterion 3Concealed allocation means that the person who determined if a subject was eligible for inclusion in the trial was unaware, when this decision was made, of which group the subject would be allocated to. A point is awarded for this criteria, even if it is not stated that allocation was concealed, when the report states that allocation was by sealed opaque envelopes or that allocation involved contacting the holder of the allocation schedule who was "off-site". Criterion 4At a minimum, in studies of therapeutic interventions, the report must describe at least one measure of the severity of the condition being treated and at least one (different) key outcome measure at baseline. The rater must be satisfied that the groups outcomes would not be expected to differ, on the basis of baseline differences in prognostic variables alone, by a clinically significant amount. This criterion is satisfied even if only baseline data of study completers are presented. Criteria 4, 7-11Key outcomes are those outcomes which provide the primary measure of the effectiveness (or lack of effectiveness) of the therapy. In most studies, more than one variable is used as an outcome measure. Criterion 5-7Blinding means the person in question (subject, therapist or assessor) did not know which group the subject had been allocated to. In addition, subjects and therapists are only considered to be "blind" if it could be expected that they would have been unable to distinguish between the treatments applied to different groups. In trials in which key outcomes are self-reported (eg, visual analogue scale, pain diary), the assessor is considered to be blind if the subject was blind. Criterion 8This criterion is only satisfied if the report explicitly states both the number of subjects initially allocated to groups and the number of subjects from whom key outcome measures were obtained. In trials in which outcomes are measured at several points in time, a key outcome must have been measured in more than 85% of subjects at one of those points in time. Criterion 9An intention to treat analysis means that, where subjects did not receive treatment (or the control condition) as allocated, and where measures of outcomes were available, the analysis was performed as if subjects received the treatment (or control condition) they were allocated to. This criterion is satisfied, even if there is no mention of analysis by intention to treat, if the report explicitly states that all subjects received treatment or control conditions as allocated. Criterion 10A between-group statistical comparison involves statistical comparison of one group with another. Depending on the design of the study, this may involve comparison of two or more treatments, or comparison of treatment with a control condition. The analysis may be a simple comparison of outcomes measured after the treatment was administered, or a comparison of the change in one group with the change in another (when a factorial analysis of variance has been used to analyse the data, the latter is often reported as a group time interaction). The comparison may be in the form hypothesis testing (which provides a "p" value, describing the probability that the groups differed only by chance) or in the form of an estimate (for example, the mean or median difference, or a difference in proportions, or number needed to treat, or a relative risk or hazard ratio) and its confidence interval. Criterion 11A point measure is a measure of the size of the treatment effect. The treatment effect may be described as a difference in group outcomes, or as the outcome in (each of) all groups. Measures of variability include standard deviations, standard errors, confidence intervals, interquartile ranges (or other quantile ranges), and ranges. Point measures and/or measures of variability may be provided graphically (for example, SDs may be given as error bars in a Figure) as long as it is clear what is being graphed (for example, as long as it is clear whether error bars represent SDs or SEs). Where outcomes are categorical, this criterion is considered to have been met if the number of subjects in each category is given for each group.  Appendix IV: Personal communication with experts Communication regarding retrieval of additional literature This e-mail was sent on Wednesday 24th of april 2002 to Dr. Rob de Bie, Maria Judd and Mrs Arianne Verhagen regarding retrieval of additional litterature. The same e-mail was subsequently sent to Mr.Jefferson Cardoso PRIVATE Hello, We are three students studying Physical therapy at Fontys Hogescholen in the Netherlands. We are currently working on our final project which will lead up to bachelors degree, as accredited by APTA. This project is a systematic review, and the question we are trying to answer is is: What are the effects of exercising in water for patients with rheumatoid arthritis(RA) , osteoarthrtitis(OA) and ankylosing spondylitis(AS) on pain, ADL-functioning and Health-Related Quality of Life (HRQL). To find an answer to our question, we have searched Medline, PEDro, Cinahl and Cochrane collaborations databases. We have retrieved eligible studies, checked reference lists and retrieved additional studies. To assess the methodological quality of theses studies we used the PEDro scale The reason we send you this email is that we are now in a phase of our project where we ask external experts for input regarding any additional litterature we may have missed, or which is not published at the present time. Attached to this email you will find a Word-document with our litterature list of included, as well as excluded studies. Most excluded studies were excluded because they lacked controll groups, or because they involved passive treatment in water. In general we included all controlled studies dealing with active hydrotherapy for patients with OA,RA and AS. We are hoping for a reply from you. Sincerely, Kim Grana Gilles R.E. Jarret Kristian M. Kulvik  - Replies receieved on the 25th of April 2002: PRIVATEFrom :  PRIVATE"Maria Judd" To : reumaproject@hotmail.com>, ,  PRIVATEDear Kim, Gilles, and Kristian As you are aware Arianne Verhagen is the lead author on the Cochrane Balenotherapy review so she is a good person to ask! I will also copy this email to Jefferson Cardoso, the lead author developing a Cochrane review on aquatic therapy for RA. Best wishes for completing your review and completing your degree. Sincerely, Maria Judd  PRIVATEFrom :  PRIVATE"A. P. Verhagen" To : reumaproject@hotmail.com PRIVATEDear Gilles, Kim and Kristian, Thank very much for your mail!. Maria already gave you the address of Jefferson. He is probably the best man to answer your question at the moment! He performs a Cochrane review on 'aquatic therapy' which involves exercises in water. I think he has already performed an extensive search strategy and may be you can correspond with him about the included studies. I read in your mail you were planning to use the PEDro scale for quality assessment. The PEDro scale is based on the Delphi list, and I would recommend to use the Delphi instead of the PEDro for two reasons: 1. The Delphi is one of the few validated quality assessment instruments and therefore recommended by the Dutch Cochrane Centre 2. The PEDro added two statistical items to the Delphi, and I am not very happy with that decision, because now the relative weight of the statistical items in the overall quality score increases at the expense of the weight of the internal validity items. Hope this will help you! If there are any questions, please do not hesitate to email me! Yours, Arianne  Reply receieved from Mr. Jefferson Cardoso on the 9th of May 2002: PRIVATEFrom :  PRIVATE"jefferson Cardoso" To : reumaproject@hotmail.com  PRIVATEDear Students, Please, give me a couple of days to answer properly. I'm too busy in my PhD program and I promisse until Tuesday I will make the comments. I can forward some inputs right now, without reading the project. I'm already doing an official Cochrane SR (protocol published in the Issue 2, 2002) about effects of aquatic therapy exercises for RA. Why don't you make the effects of aquatic therapy exercises on OA and AS? Or even better, answer the research question separately, one for OA and afterwards for AS? Why don't you try to make it an official Cochrane SR? Well, hope to help you with more comments soon as well as Dr. Ariane (who conducted a SR with RA and Balneotherapy) Sincerely, Prof. Jefferson Cardoso, PT, MSc (Maastricht University), PhD student (UNIFESP) State University of Londrina  Communication regarding dispute of quality rating of PEDro rated studies: PRIVATEFrom : PRIVATE reumaproject@hotmail.comTo : pedro@fhs.usyd.edu.au, reumaproject@hotmail.com  PRIVATEHi, We are three physical therapy students at Fontys Hogescholen in Eindhoven, The Netherlands, who are currently working on our graduation project. This project is a systematic review regarding the effects of exercising in water (active hydrotherapy ) for patients with rheumatoid arthritis, ostoarthritis and ankylosing spondylitis on pain, ADL-functioning and Health-Related Quality of Life. During our review of relevant literature we have used your PEDro scale to assess trials included in our study. Blind to the scores given by you in trials in your database,three members of our group have independently rated these trials, compared with each other and then used your ratings as a "golden standard". However, on some occasions we have disagreed with your quality ratings, and will therefore dispute some of these. The details are listed below. In addition, there seem to be unclaritites with regard to the use of some items on the PEDro scale, especially item no.7: "Blinding of all assessors who measured at least one outcome". In the notes on administration of the PEDro scale we found on the PEDro website, it is stated that in case of self-report key outcomes, the assessor is considered to be blind if the subject was blind. The unclarity here is that due to the nature of the intervention being studied here (hydrotherapy), it is highly unlikely that subjects will be blind to this form of intervention. Hence, on any self-reported key outcome measures ( which is the only option regarding outcomes like pain and Health Related Quality of Life) , the assessor is not to be considered blind. It has been the case on several trials that you have indeed given a point for blind assesors, even though subjects were not blinded to therapy, and key outcomes were measured using self-report scales. We have to mention that objective measurements were often taken as well ( range of motion, strength testing), but all studies used self report for some key outcomes. We hope you can shed some light on our difficulties using your scale. Details regarding disputed quality ratings of trials: 1.Author: Nguyen M, Revel M, Dougados M Title: Prolonged effects of 3 week therapy in a spa resort on lumbar spine, knee and hip osteoarthritis: follow-up after 6 months. A randomized controlled trial. Source: British Journal of Rheumatology 1997 Jan;36(1):77-81 Notes: Items we are disputing here are: 7:blinded assessors: you gave a point to this item. However, though it is stated on p.78 1st col,from line 22 under the clinical assessments"-section that an independent physician made other clinical assessments, you can see that the measure-ment tools were Visual Analogue scale (pain measurement), revised Arthritis Impact measurement Scale (AIMS2) for measuring quality of life, which are selfreport. Subjects were not blind to therapy, and therefore, with such important outcomes being measured using self report, can only suggest that assessors cannot be considered blinded. 9.intention to treat: see p.78, 2nd col, 1st line under response to treatment section. Here intention to treat analysis is mentioned as the method used for analyses. You did not give a point for this item, although it is stated in your notes on administration of the scale that this point should be given if there is mentioning of intention to treat, or if it is explicitly stated that all subjects received treatment or control condition as allocated. 2.Author: Helliwell PS, Abbott CA, Chamberlain MA Title: A randomised trial of three different physiotherapy regimes in ankylosing spondylitis. Source: Physiotherapy 82(2):85-90, 1996 Feb. Notes: We dispute your rating on item 8 (adequate follow up ) in this trial. On page 87, col 2, line 6: "Furthermoreattended for assessment". This number of subjects are less than 85 % of the total number of subjects initially allocated to groups. However, they analysed improvement in groups by means of an anlysis of covariance using the initial measurements as the covariate. Is this sufficient to obtain a point for this criterion? In addition we dispute the point given to these trials for item 7: blinding of assessors, due to the fact that key outcome measures have been measured by selfreport ( VAS-scales, questionnaires), when patients are not blind to therapy. 3.Author: Hall J, Skevington SM, Maddison PJ, Chapman K Title: A randomized and controlled trial of hydrotherapy in rheumatoid arthritis. Source: Arthritis Care & Research 1996 Jun;9(3):206-15 Method: clinical trial 4.Author: Smith SS, MacKay-Lyons M, Nunes-Clement S Title: Therapeutic benefit of aquaerobics for individuals with rheumatoid arthritis. Source: Physiotherapy Canada 50(1):40-6, 1998 Winter. Method: clinical trial 5.Author: Sylvester KL Title: Investigation of the effect of hydrotherapy in the treatment of osteoarthritic hips. Source: Clinical Rehabilitation 1990;4:223-228 Method: clinical trial Sincerely, Kim Grana Gilles R.E. Jarret Kristian M. Kulvik  Reply received on the 4th of May 2002 from Dr. Rob Herbert of the Centre of Evidence-Based Physiotherapy regarding the disputed ratings: PRIVATEFrom :  PRIVATERob Herbert To :   PRIVATEDear Kim, Gilles, and Kristian, Greetings from Sydney. Thank you very much for your message about methodological rating of trials on the PEDro database. Your interest and assistance is greatly appreciated. We acknowledge that not all ratings on the database are "correct" (even the "confirmed" ratings, the majority view of three raters, are ocasionally incorrect). But we expect this with an imperfect rating tool, particularly when there are many trials. Even when the PEDro scale has been applied accurately there is sometimes room for disagreement because the criteria do not always allow raters to know wheteher to score "yes" or "no". You may be interested to know that we have conducted two studies of the reliability of PEDro ratings. In the first study (reported in abstract form at the Rome Cochrane Colloquium) we asked 20 raters to rate 20 randomly selected trials independently. We found overall moderate reliability, although some scale items had quite low reliability. We have just analysed data from a more much thorough assessment (comparing independent consensus ratings of two sets of three raters on 100 randomly selected trials) which essentially concurs with that finding. Overall, the reliability is OK, and probably at least as good as with other scales. The message is that the ratings are moderately reliable, but not perfect. We have to live with a degree of ambiguity and inaccuracy, but we try to keep that to a minimum. I have responded to your specific comments below. Nguyen M, Revel M, Dougados M Items we are disputing here are: 7:blinded assessors: you gave a point to this item. However, though it is stated on p.78 1st col,from line 22 under the clinical assessments"-section that an independent physician made other clinical assessments, you can see that the measure-ment tools were Visual Analogue scale (pain measurement), revised Arthritis Impact measurement Scale (AIMS2) for measuring quality of life, which are selfreport. Subjects were not blind to therapy, and therefore, with such important outcomes being measured using self report, can only suggest that assessors cannot be considered blinded. I think I would side with your ratings here as I agree that mobility measures should not be considered to be key outcomes. Of course that is a subjective decision; the two PEDro raters must have decided mobility was a key outcome. 9.intention to treat: see p.78, 2nd col, 1st line under response to treatment section. Here intention to treat analysis is mentioned as the method used for analyses. You did not give a point for this item, although it is stated in your notes on administration of the scale that this point should be given if there is mentioning of intention to treat, or if it is explicitly stated that all subjects received treatment or control condition as allocated. You are, of course, correct. The raters must have missed this. Helliwell PS, Abbott CA, Chamberlain MA We dispute your rating on item 8 (adequate follow up ) in this trial. On page 87, col 2, line 6: "Furthermore attended for assessment". This number of subjects are less than 85 % of the total number of subjects initially allocated to groups. However, they analysed improvement in groups by means of an anlysis of covariance using the initial measurements as the covariate. Is this sufficient to obtain a point for this criterion? At the end of column 2, p 87, it states "all patients diaries were returned fully completed. No further diaries were requested after the initial six-week period". I think the raters may have interpreted this as meaning there was complete diary data at six weeks (I agree this is arguable, but I don't think it's unreasonable), even though there clearly was substantial loss to follow up by six months. So there is a case for saying that follow-up was adequate at six weeks. In addition we dispute the point given to these trials for item 7: blinding of assessors, due to the fact that key outcome measures have been measured by selfreport ( VAS-scales, questionnaires), when patients are not blind to therapy. This item is scored "No" on PEDro, so we agree. Hall J, Skevington SM, Maddison PJ, Chapman K Title: A randomized and controlled trial of hydrotherapy in rheumatoid arthritis. Source: Arthritis Care & Research 1996 Jun;9(3):206-15 Method: clinical trial 4.Author: Smith SS, MacKay-Lyons M, Nunes-Clement S Title: Therapeutic benefit of aquaerobics for individuals with rheumatoid arthritis. Source: Physiotherapy Canada 50(1):40-6, 1998 Winter. Method: clinical trial 5.Author: Sylvester KL Title: Investigation of the effect of hydrotherapy in the treatment of osteoarthritic hips. Source: Clinical Rehabilitation 1990;4:223-228 Method: clinical trial Thank you again for your interest and assistance. If you find any RCTs that are not on the PEDro database, we would appreciate if you could let us know of them. Dr Rob Herbert Centre for Evidence-Based Physiotherapy  PAGE  PAGE 50  4=MV VWa/4 C  &  ! 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