Patient Perceptions of Glucocorticoid Side Effects: a Cross-Sectional Survey of Users in an Online Health Community

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Patient Perceptions of Glucocorticoid Side Effects: a Cross-Sectional Survey of Users in an Online Health Community PEER REVIEW HISTORY BMJ Open: first published as 10.1136/bmjopen-2016-014603 on 3 April 2017. Downloaded from BMJ Open publishes all reviews undertaken for accepted manuscripts. Reviewers are asked to complete a checklist review form (http://bmjopen.bmj.com/site/about/resources/checklist.pdf) and are provided with free text boxes to elaborate on their assessment. These free text comments are reproduced below. ARTICLE DETAILS TITLE (PROVISIONAL) Patient perceptions of glucocorticoid side effects: a cross-sectional survey of users in an online health community. AUTHORS Costello, Ruth; Patel, Rikesh; Humphreys, Jennifer; McBeth, John; Dixon, Will VERSION 1 - REVIEW REVIEWER Russell, Anthony Univ Alberta,Canada REVIEW RETURNED 14-Oct-2016 GENERAL COMMENTS An interesting approach with unexpected answers. REVIEWER Michele Iudici Past address: Rheumatology Unit Second University of Naples, Italy REVIEW RETURNED 15-Nov-2016 http://bmjopen.bmj.com/ GENERAL COMMENTS The authors report an online cross-sectional survey aiming to identify the GC-related adverse events most important to patients. They analyzed data from 604 patients and reported the ranks for each side effect, without providing any additional analysis that can make the paper more interesting and appealing for the readers. For example they do have data on the number and time of pills intake on October 1, 2021 by guest. Protected copyright. per day. It would be interesting to investigate if patient's perception of some AEs could be related to these parameters (evening intake and sleep disturbances...intake during meals and digestive symptoms...). Moreover, authors could also in deepen analyze how the experience of an AEs impacts on patient's perception. I wuold be prone to think that the experience of a vertebral fracture could absolutely change my point of view on this AE and the same can happens for the others. So, I would suggest to make a subanalysis taking into account the patient's history of GC-AEs occurrence. Another point I think the authors should underline is that this kind of exercise could be flawed by difference in patient's educational levels. They should acknowledge this in the text. REVIEWER Adrian Loerbroks BMJ Open: first published as 10.1136/bmjopen-2016-014603 on 3 April 2017. Downloaded from University of Düsseldorf, Germany REVIEW RETURNED 21-Nov-2016 GENERAL COMMENTS Costello and colleagues examined which potential side effects of glucocorticoid (GC) use may matter most to patients. Doing so, they conducted an online survey among individuals reporting current or recent GC use. The most important side effects from patients’ perspectives were weight gain, insomnia and a “moon face”. Overall, this study provides interesting findings as it illustrates how patient perceptions of the salience of GC side effects may differ from those of clinicians. Further, the authors adopted a novel approach to data collection (i.e. recruitment through a social online network). The study suffers from a number of limitations though, which the authors partly acknowledged, but which should be presented more explicitly in my view. Also, additional analyses may be of interest. Those points and additional suggestions are detailed below. Specific comments: 1. I recommend adding to the introduction why your research aim matters. You mention this in the discussion (e.g. patient perceptions of side effects will likely affect adherence), but I would do so early on. 2. Does you study make a novel contribution in light of what is currently known (study 8-10)? 3. In my view your findings could be affected by selection bias in at least two ways: 1) selection due to imperfect participation (as you acknowledged and as reflected by the very low response rate) and 2) selection due to your sampling choice (e.g. even if 100% had participated, those http://bmjopen.bmj.com/ using such social networks may differ from patients who do not). I suggest acknowledging in particular the latter selection process more explicitly. 4. It would be of interest to learn how exactly you obtained and used clinicians’ and patients’ feedback in the construction of the questionnaire measuring potential GC side effects. Especially, the approach to account for patient views needs to be presented in greater detail, because I wondered whether you had been able to on October 1, 2021 by guest. Protected copyright. identify and consider potential patient misconceptions about GC side effects. In the field of asthma research, it has been observed for instance that patients may be concerned about developing „tolerance“ /addiction with regard to some drugs (e.g. Hyland et al., Clnical Therapeutics 2004). Possibly, the same holds true for GC, but has not been measured. 5. What was the distribution of responses to the items in block 6? 6. As the authors stated, the ranking of the importance of side effects may partly reflect their prevalence. It would be of interest, in this context, to re-run analyses while excluding those individuals who report to actually suffer from the respective symptom (item set #6 in your questionnaire). In my view, such analyses would be a more valid representation of real life scenarios related to the prescription of GC: Patients may decide not to use GC because of concerns about potential and anticipated side-effects (that are thus not yet experienced). 7. Another shortcoming of your study is that you only inquired after conditions and symptoms that are attributed to GC use. As a result, it remains elusive what proportion of the sample suffered from BMJ Open: first published as 10.1136/bmjopen-2016-014603 on 3 April 2017. Downloaded from particular complaints irrespectively of GC treatment. For instance, a reasonable proportion of your respondents (aged 50+) may have suffered for hypertension and may therefore have ranked this side effect unimportant. However, these cases are probably only partly captured by the items in block #6, which related hypertension to GC treatment. I suggest mentioning this limitation in the discussion section. VERSION 1 – AUTHOR RESPONSE Response to reviewers Thank you to the reviewers for their helpful comments. We have responded to each of the reviewer’s comments below: Reviewer 2: The authors report an online cross-sectional survey aiming to identify the GC-related adverse events most important to patients. They analyzed data from 604 patients and reported the ranks for each side effect, without providing any additional analysis that can make the paper more interesting and appealing for the readers. For example they do have data on the number and time of pills intake per day. It would be interesting to investigate if patient's perception of some AEs could be related to these parameters (evening intake and sleep disturbances...intake during meals and digestive symptoms...). Moreover, authors could also in deepen analyze how the experience of an AEs impacts on patient's perception. I wuold be prone to think that the experience of a vertebral fracture could absolutely change my point of view on this AE and the same can happens for the others. So, I would suggest to make a subanalysis taking into account the patient's history of GC-AEs occurrence. Another point I think the authors should underline is that this kind of exercise could be flawed by difference in patient's educational levels. They should acknowledge this in the text. http://bmjopen.bmj.com/ Response: Thank you for your helpful suggestions. Although we have the usual time per day of steroid administration, we do not have the number of pills per day so we did not feel we could conduct any additional analysis around this, though it is an interesting area. We have added stratification of scores by both experience and community group. Thank you for the suggestion to look at the impact of prior experience of GC-associated side effects and how this influenced scoring. We had in fact done this analysis for a conference presentation post-submission and it revealed some interesting on October 1, 2021 by guest. Protected copyright. findings. Prior experience of a side effect did increase the importance of that side effect to respondents. The results are tabulated in table 4, with the following text summarising the results on page 11: “When stratified by prior experience, participants who had previously experienced the side effect of interest reported higher median scores, with smaller IQRs. The side effects most important to those who had experienced them were diabetes, eye disease and CVD, all scoring a median of 10. The side effects most important to those who had not experienced them were reduced bone strength, CVD and eye disease (Table 4, figure S2). Although weight gain had the highest rank overall, it was ranked only fourth in those who had and who hadn’t experienced it prior to completing the survey, with median scores and IQRs of 9 (7-10) and 6 (2-9), respectively. The most commonly experienced side effects were, in order, weight gain, round face, insomnia, changes in mood, skin changes and indigestion, all of which were experienced by over half of the 604 respondents.” We added stratification by community to give an indication of the effect of dose on the perception of side effects and this showed community rankings were mainly similar except for the PMR/GCA community. The results are tabulated in Table 3, with the following text at the bottom of page 9: “When stratified by community group the rankings remained similar to the overall rankings for all BMJ Open: first published as 10.1136/bmjopen-2016-014603 on 3 April 2017. Downloaded from communities except the PMRGCAUK community group, where the side effects most important to respondents were eye disease, CVD and insomnia, with weight gain fourth (Table 3).” The reasons for the difference by prior experience and by community are discussed in the first paragraph of the discussion (page 12): “It is known that oral GCs have many side effects, but few studies have investigated which matter the most to patients.
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