The use of a patch to augment rotator cuff surgery – A survey of UK shoulder and elbow surgeons

M. J. Baldwin; N. S. Nagra; N. Merritt; J. L. Rees; A. J. Carr; A. Rangan; M. Thomas; D. J. Beard; C. Cooper; L. Kottam; J. A. Cook

doi:10.1371/journal.pone.0230235

Peer Review History

Original SubmissionSeptember 3, 2019
15 Oct 2019 Decision Letter - Chunfeng Zhao, Editor PONE-D-19-24794 The use of a patch to augment rotator cuff surgery – a survey of UK shoulder and elbow surgeons. PLOS ONE Dear Dr Baldwin, 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 can see that reviewers have divided decision. However, I do think this manuscript has provided some clinical and meaningful information regarding the rotator cuff augmentation, which may help shoulder surgeons to understand current status regarding this treatment. I suggest you fully address the reviewers' concerns including the reasons for the rejection decision that one reviewer has made. We would appreciate receiving your revised manuscript by Nov 29 2019 11:59PM. 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We will update your Data Availability statement on your behalf to reflect the information you provide. 7. Please include your tables as part of your main manuscript and remove the individual files. Please note that supplementary tables (should remain/ be uploaded) as separate "supporting information" files [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes Reviewer #2: Partly ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: No ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). 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 Reviewer #2: No ****** 4. 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 Reviewer #2: Yes ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: Patch has been increasingly used in rotator cuff repair, especially for large/massive rotator cuff tear. But there are limited epidemiologic studies about the choice of patch. This paper focused to survey the current UK practice and opinion relating to the factors that influence choice of path, current patient selection and willingness to assist with generation of improved evidence. This study was well performed and provided the panorama of patch uses in the UK. Here are some questions for the authors. 1. Why the authors choose the 6 months as one time point in the survey contents? 2. The date was collected from different surgeons. So please clarify how to validate these date. 3. Why did you preclude the ages less than 50 in the survey contents? 4. Arthroscopic rotator cuff repairs accounted for 66%, but this was not according with the data in Table 2. 5. Clarify the meaning of “Number of patches implanted” in Table 2. Does that mean the number of patch used in one surgery or the total number of patch used by one surgeon? Reviewer #2: Dear Authors, Thank you for submitting this manuscript. In this paper, you presented a survey of UK shoulder and elbow surgeons, summarizing the patches which have been used in rotator cuff repair surgeries. This paper is well written and well thought out. However, there is no evidence-based data to contribute to clinical practice. Also, the conclusion of this study is irrelevant and inconclusive. Therefore, this manuscript is not suitable for publication. ****** 6. 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: No Reviewer #2: No [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 to be viewed.] 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 us at figures@plos.org. Please note that Supporting Information files do not need this step. Attachments Attachment Submitted filename: Review comments.docx https://doi.org/10.1371/journal.pone.0230235.r001
Revision 1
28 Nov 2019 Author Response Following consideration of the reviewer’s comments, appropriate changes have now been incorporated into the article and are summarised below. Referee 1 Comments to Author: 1. Why the authors choose the 6 months as one time point in the survey contents? Respondents were asked if they had used a patch to augment the surgical repair of the rotator cuff within the last 6 months. This question was designed to understand current patch usage rather than total career patch use. Given recent concerns over patch safety and an increasingly large array of patches available we felt this was an important consideration. During survey design we felt that a short time period would minimise recall bias, but that this also needed to be of long enough during to capture ‘events’ i.e. the use of rotator cuff repair. A six-month duration, whilst arbitrary, was felt by the authors to best balance these considerations. 2. The date was collected from different surgeons. So please clarify how to validate these date. Data collected from each surgeon was not validated. Whilst this may have been possible, for example through access to the operative log-book for each surgeon, these records are themselves often incomplete. It is also likely that any such strategy would have significantly impacted upon survey uptake. However, we have added the following sentence to acknowledge this methodological limitation; ‘No attempt was made to validate individual responses’ 3. Why did you preclude the ages less than 50 in the survey contents? Previous work has shown that over 90% of rotator cuff tears occur in the over 50s (Yamamoto et al. J Shoulder Elbow Surg (2010) 19, 116-120). Those under the age of 50 are more likely to be of a different aetiology e.g. traumatic tears. We sought to characterise patch usage for the ‘general’ rotator cuff tear and not for specific clinical indications e.g. trauamatic vs degenerative, superior cuff vs anterior tendon tears. 4. Arthroscopic rotator cuff repairs accounted for 66%, but this was not according with the data in Table 2. Many thanks for pointing out this important typographical error in Table 2. This has now been corrected. 5. Clarify the meaning of “Number of patches implanted” in Table 2. Does that mean the number of patch used in one surgery or the total number of patch used by one surgeon? The number of patches implanted refers to the total number of patches used by each respondent during their career to date. The table legend has now been amended to reflect this: “n refers to the number of respondents. Total number of patches refers to the total number of patches used during each respondents surgical career to date.” Reviewer 2 Questions: It is difficult to response to the second reviewers’ concerns, as few reasons for their recommended rejection of the paper were provided. We would however raise that while the reviewer has cited statistical concerns, that the final author is an experienced academic statistician. We would thank the reviewer for their comment that “This paper is well written and well thought out”. However, would disagree that “there is no evidence-based data to contribute to clinical practice”. For the first time we have provided data on patch usage and patch choice within a public healthcare system. Understanding the clinical practice of our colleagues is directly relevant to current clinical practice, and vital in the planning of future clinical trials that seek to comprehensively assess and evidence our clinical and surgical decisions during rotator cuff repair. Academic Editors points: 1. PLOS style requirement – The manuscript has been re-formatted to meet the requirements of the various style templates (main body/tables and authors affiliations) 2. Include captions for supporting information – A caption for the supplementary files has been provided 3. Please provide additional details regarding participant consent – The following sentence has been added into the methods section: “This was a voluntary survey of health care professionals therefore formal ethical review was not sought. However, the survey was approved by the BESS committee. A formal consenting process was not undertaken, rather completion of the survey was taken as implied consent.” 4. Please remove any instances of 'unpublished data' or 'data not shown' in your manuscript – Completed as requested 5. Thank you for stating in the manuscript: "This was a voluntary survey of health care professionals therefore formal ethical review was not sought. However, the survey was approved by the BESS committee." Please amend your current ethics statement to include the full name of the ethics committee/institutional review board(s) that approved your specific study. – Changed from ‘BESS’ to ‘British Elbow and Shoulder Society’ 6. We note that you have indicated that data from this study are available upon request - Anonymised dataset has been provided as a supplementary file (S2_Dataset) 7. Please include your tables as part of your main manuscript and remove the individual files – Completed as requested https://doi.org/10.1371/journal.pone.0230235.r002
26 Feb 2020 Decision Letter - Chunfeng Zhao, Editor The use of a patch to augment rotator cuff surgery – a survey of UK shoulder and elbow surgeons. PONE-D-19-24794R1 Dear Dr. Baldwin, We are pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it complies with all outstanding technical requirements. Within one week, you will receive an e-mail containing information on the amendments required prior to publication. When all required modifications have been addressed, you will receive a formal acceptance letter and your manuscript will proceed to our production department and be scheduled for publication. Shortly after the formal acceptance letter is sent, an invoice for payment will follow. To ensure an efficient production and billing process, please log into Editorial Manager at https://www.editorialmanager.com/pone/, click the "Update My Information" link at the top of the page, and update your user information. 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 enable them to help maximize its impact. If they will be preparing press materials for this manuscript, you must inform our press team as soon as possible and 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. With kind regards, Chunfeng Zhao, MD Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #2: All comments have been addressed ******** 2. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #2: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #2: Yes ****** 4. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). 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 #2: 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 #2: Yes ****** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #2: (No Response) ****** 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 #2: No https://doi.org/10.1371/journal.pone.0230235.r003
Formally Accepted
5 Mar 2020 Acceptance Letter - Chunfeng Zhao, Editor PONE-D-19-24794R1 The use of a patch to augment rotator cuff surgery – a survey of UK shoulder and elbow surgeons. Dear Dr. Baldwin: I am 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 notify them about your upcoming paper at this point, to enable them to help maximize its impact. If they will be preparing press materials for this manuscript, 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. For any other questions or concerns, please email plosone@plos.org. Thank you for submitting your work to PLOS ONE. With kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Chunfeng Zhao Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0230235.r004

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