Author's response to reviews A pragmatic randomised controlled trial of hydrotherapy and land exercises on overall well being and Title: quality of life in rheumatoid arthritis Authors:

Background p2) .....We report a randomised controlled trial in which we compared the effects of hydrotherapy with exercises on land on overall response to treatment, improvement in health physical function and quality of life in patients with rheumatoid arthritis. Abstract (Methods p2) Our primary outcome was a self-rated global impression of health change a measure of treatment effect on a 7-point scale ranging from 1(very much worse) to 7 (very much better) assessed immediately on completion of treatmentMethods p2) Our primary outcome was a self-rated global impression of health change a measure of treatment effect on a 7-point scale ranging from 1(very much worse) to 7 (very much better) assessed immediately on completion of treatment Abstract (Conclusion p3-4) Patients with RA treated with hydrotherapy are more likely to report feeling much better or very much better than those treated with land exercises immediately on completion of the treatment programme.Conclusion p3-4) Patients with RA treated with hydrotherapy are more likely to report feeling much better or very much better than those treated with land exercises immediately on completion of the treatment programme. Conclusion (p20) Our study clearly shows that RA patients who attend hospital clinics are more likely to report feeling much better or very much better if they are treated with hydrotherapy than if they are treated with exercises on land. This benefit was reported immediately after completing treatment. 3. I apologize for this remark, which unjustly suggested that I thought the authors were led by false intentions. By my remark I meant to rhetorically refer to the type of critical questions I try to teach my students to have in the back of their head. However, I remain that the paper does not provide a clear justification for measuring the secondary but not the primary outcome measures after three months. The problem of recall bias is now mentioned in the discussion, but not that recall bias is more likely to affect transitional outcome measures (the primary) than status measures (the secondary). This should be included in the discussion. Apology accepted. We are not able to go back and measure our primary outcome at a later time point. Recall is an essential component of a transitional outcome measure. Patients are being asked how things have changed. This is quite different from health status measures which seek to determine how things are. We do not know of any evidence supporting the reviewer’s contention that recall bias is ‘more likely to affect transitional outcome measures (the primary) than status measures (the secondary).’ 6. That patients report feeling better is undisputed. Whether they actually felt better depends on the validity of the measure. (In your conclusion and abstract you do use the more prudent formulation.) We believe that the changes highlighted above deal with this point. 13. The term “co” in “co-morbidity” refers to “other than RA”. Therefore, to me, “other” seems to refer to pregnancy. Accepted, we have deleted ‘other’ as follows: Methods (Participants p8) Also excluded were: pregnant women; patients with other co-morbid conditions which, in the opinion of the assessing physiotherapist, prevented safe use of hydrotherapy.... 16. I do not understand the response. I can only see both sentences as consistent if you consider “self-reported improvement” as not necessarily “relevant to patients”. The reviewer’s original comments were: ‘Pages 16 and 17: on page 16 you state that the EQ-5D has been shown to be highly responsive to selfreported improvement, yet on page 17 you state that your data underscores concerns about the relevance of measures such as the EQ-5D. Both statements seem contradictary.’ EQ-5D has been shown to be highly responsive to self reported change in other studies, not ours. We merely make the point that self-reported change, in our study, was not being captured by EQ-5D and cited other work which raises concerns about quality of life measures such as EQ-5D. 17. In my opinion it is not justified to make recommendations in the conclusion of the paper, if you have previously mentioned those in the preceding part of the paper. Moreover, to me it is unclear what you mean by community initiatives. No recommendation is being made. Our conclusion raises some questions about hospital provision (as opposed to out of hospital, or community provision) of hydrotherapy. A citation, which discusses community hydrotherapy provision in detail, is shown. Page 9, line 11: “change in self-rated ...” should be “self-rated change in ...” This has been altered as below: Outcome Measures (p10) The primary outcome was a change in self-rated overall effect of treatment global impression of health, measured once; on the day treatment was completed. This validated measure of treatment effect has previously been used in clinical trials of exercise in fibromyalgia and chronic fatigue syndrome [9,10,11]. Effect of treatment is measured as change on a 7-point scale....