How effective is a blended web-based rehabilitation for improving pain, physical activity, and knee function of patients with knee osteoarthritis? Study protocol for a randomized control trial

Maria Moutzouri; Georgios Gioftsos

doi:10.1371/journal.pone.0268652

Peer Review History

Original SubmissionSeptember 22, 2021
15 Mar 2022 Decision Letter - Jose María Blasco, Editor PONE-D-21-28366 How effective is a blended web-based rehabilitation for improving pain, physical activity, and knee function of patients with knee osteoarthritis?” PLOS ONE Dear Dr. Moutzouri, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. You may find the comments of one of the reviewers appended to this email. In addition, since this is a study protocol with no published results, this should be stated in the title. Please submit your revised manuscript by Apr 15 2022 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. 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"We noticed you have some minor occurrence of overlapping text with the following previous publication(s), which needs to be addressed: - https://www.oarsijournal.com/article/S1063-4584(16)30486-1/fulltext - https://viewer.joomag.com/paramedics-paramedics-health-promotion-program/0389408001492717768?page=60 - https://link.springer.com/article/10.1186/1471-2474-13-129?code=e67f92a2-7839-42a8-823d-b3cf43ce3416&error=cookies_not_supported - https://www.nivel.nl/sites/default/files/bestanden/e-Exercise_proefschrift_Corelien_Kloek.pdf - https://onlinelibrary.wiley.com/doi/abs/10.1002/acr.20642 In your revision ensure you cite all your sources (including your own works), and quote or rephrase any duplicated text outside the methods section. Further consideration is dependent on these concerns being addressed. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions? The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field. Reviewer #1: Yes ******** 2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses? The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory. Reviewer #1: Yes ****** 3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable? Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible. Reviewer #1: No ****** 4. Have the authors described where all data underlying the findings will be made available when the study is complete? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes ****** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics. You may also provide optional suggestions and comments to authors that they might find helpful in planning their study. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: Thanks for the opportunity given to me to review the article tittled: “How effective is a blended web-based rehabilitation for improving pain, physical activity, and knee function of patients with knee osteoarthritis?” Please, find the comments on the attached document ****** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: Yes:** Fernando Dominguez-Navarro [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. Attachments Attachment Submitted filename: Review_Blended web-based rehabilitation for knee osteoarthritis patients..docx https://doi.org/10.1371/journal.pone.0268652.r001
Revision 1
3 Apr 2022 Author Response Dear Editor, Re: submission of an original article for consideration for publication Please find enclosed a manuscript for consideration for publication in the Medicine for the titled: “How effective is a blended web-based rehabilitation for improving pain, physical activity, and knee function of patients with knee osteoarthritis?” Study protocol for a randomized control trial. Thank you for taking the time to review our manuscript and for all constructive feedback offered. We have considered all comments made by the Academic Editor and the Reviewer and we believe they have all helped the manuscript to move forward. Regarding the comments made by the Academic Editor 1.We have ensured that your manuscript meets PLOS ONE's style requirements, including those for file naming. 2. We have corrected the information regarding grant numbers for the awards we received for our study in the ‘Funding Information’ section. 3. We have added “No competing interests.” in our cover letter. Thank you for changing the online submission form on our behalf. 4. Regarding the repository information if the manuscript is accepted for publication, we have not understood exactly what was exactly expected. Any data asked by the Academic Editor or Reviewers can be offered upon request. However, no storage file is needed and the since the manuscript is a study protocol the data file is now being processed. If you still consider that to be essential please let us know how we can proceed to create the repository information. We have ticked the relevant box saying that we will need help for the creating a DOI. Please update our Data Availability statement to reflect this information. 5.We have included a title page within our main document and have listed all authors and all affiliations as per our author instructions. 6. We have amended our authorship list in our manuscript file to include author’s names. 7. We have amended our manuscript to include our abstract after the title page. 8. We have deleted the Ethics information from any other section apart from the Methods. 9. We have included captions for our Supporting Information files at the end of our manuscript and have updated in-text citations to match accordingly. 10. We have included our tables as part of our main manuscript and removed the individual files. 11. We have shown caution and addressed to the minor occurrence of overlapping text with other previous publication(s). We apologise for that. In our revision we have ensured proper citation of all sources, and quoted or rephrased any duplicated text outside the methods section. Regarding the specific comments made by the Reviewer: Introduction Line 20. Another important limitation of the exercise-focused programs is the low degree of adherence that subjects with KOA tend to show. For this reason, other measures (motivational talks, calls, etc.) are often necessary to improve compliance with these programs. We agree with comment and have added the statement in the paragraph. Line 26. There are examples of studies carried out on subjects with KOA that have used a website or an electronic application as a support for teaching physical exercise. It would be appropriate for this paragraph of the introduction to include some reference to these studies, as well as note the possible effects it may have on subjects with KOA por increasing PA. In this way, this paragraph could be more targeted to the condition being studied. We have added the relevant references in the section. Material and methods Line 52: What does it mean "exploratory" in this context? Is this concept necessary? You are right it is not necesseary in this context since relevat research has been made up to a point, so we have removed the term. Line 81: If the level of physical activity performed by each subject prior to the start of the intervention has not been assessed, this should appear as a limitation, or at least be mentioned in the discussion. The level of physical activity will be assessed at baseline with the Baecke scale and UCLA. However, will not be assessed objectively, so we have added it as a limitation in the discussion, lines 290-1. Line 95: You mention that both groups receive the introductory session, but please also specify that the control phone calls are also received by both groups. We have added the observation for the phone calls. Line 104: Please, add the reference The reference has been added. Line 126: During the introduction, the need for a blended intervention of physical activity and behavioral programs has been mentioned. However, when it comes to explaining the intervention of the experimental group, this structure is not so clear. I suggest that the authors partially rewrite this paragraph in such a way that the blended structure and how each of the components is worked on is clearer, so that the use of the term "blended" can be justified. The paragraph has been partly re-written to clarify the blended component (lines 106-128). Usual care paragraph: To my understand, the walking journey that perform subjects in usual care group is also mutually agreed during the initial session, as explained before. Am I right? However, it is not clear if they receive any explanation on how to make the walking journey, with what parameters and what factors were used to establish these characteristics, as was detailed in the experimental group. If they simply receive the advice to walk, please specify. Any justification of why control group performed journey route 5 times per week and the experimental only 3 times? Yes you are right, the same parameters and characteristics were explained for both groups. The observation has been added to offer the clarification. The frequency was more (5 times per week versus 3 times per week in the experiment group) in the usual care group so as to sustain the dosage equal between groups. In this way both groups will have activity/ exercise for 5 times per week. Lines 154-155: It is already explained. Please, remove this sentence. Thank you, it has been removed. Discussion Lines 172-176: If pain was already assessed by the specific domain of the KOOS scale, is there any compelling reason to assess it with the NPRS week Average knee pain as well? Please, explain if it the case. NPRS has been shown to have high reliability, specifically in elderly and less educated patients, and is useful for the assessment of chronic pain. Moreover, it can be used as a quick marker for patients to easily understand and monitor their progress whereas KOOS is more complex and needs more sophisticated scoring. Pleas let us know if you feel we need to add a referenced explanation in the manuscript. Lines 245-249: I also understand that one of the objectives is whether this type of intervention contributes to increasing physical activity levels in people with KOA. Yes, thank you for the observation. We have added the relevant objective. Please feel free to contact me by telephone or via email, if you have any questions regarding the manuscript. I look forward to hearing for your reply. Yours sincerely, Maria Moutzouri Attachments Attachment Submitted filename: Response to Reviewers.doc https://doi.org/10.1371/journal.pone.0268652.r002
5 May 2022 Decision Letter - Jose María Blasco, Editor How effective is a blended web-based rehabilitation for improving pain, physical activity, and knee function of patients with knee osteoarthritis? Study protocol for a randomised controll trial. PONE-D-21-28366R1 Dear Dr. Moutzouri, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Jose María Blasco, Ph.D. Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0268652.r003
Formally Accepted
12 May 2022 Acceptance Letter - Jose María Blasco, Editor PONE-D-21-28366R1 How effective is a blended web-based rehabilitation for improving pain, physical activity, and knee function of patients with knee osteoarthritis? Study protocol for a randomized control trial Dear Dr. Moutzouri: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Jose María Blasco Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0268652.r004

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