Peer Review History
| Original SubmissionAugust 6, 2021 |
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PONE-D-21-25531Clinical Improvement after Surgery for Degenerative Cervical Myelopathy; a Comparison of Patient-Reported Outcome Measures during 12-Month Follow-UpPLOS ONE Dear Dr. Mjåset, 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. Please submit your revised manuscript by Nov 12 2021 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. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript:
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Fehlings Academic Editor PLOS ONE Journal requirements: When submitting your revision, we need you to address these additional requirements. 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and [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: No Reviewer #2: Yes ********** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: No 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: No Reviewer #2: Yes ********** 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: The authors present a retrospective review of prospectively-collected data in an attempt to determine the ability of the listed patient reported outcomes to produce a significant clinical improvement (termed “Minimal Important Change”) after surgery for degenerative cervical myelopathy (DCM). These results are based on national registry data, and the outcomes of NDI, NRS for arm and neck, the EQ-5D and the European Myelopathy Score. The data collection methods are clearly presented, and the response to follow up at 12 months is acceptable (70%). Unfortunately, this article suffers from a number of major flaws, including (but not limited to) the interpretation of the currently available literature on the topic, the selected methodology, the inclusion criteria, as well as the interpretation and representation of the results. These are explained in detail below, however due to the combination of these flaws and lack of novelty, I am unable to support publication of this article. 1 – Introduction – I agree DCM is a progressive disorder, however surgery should not be presented as the ‘standard treatment’. The surgical treatment recommendations varies depending on the severity of myelopathy, judged on a functional outcome assessment such as the Modified Japanese Orthopedic Association score (MJOA). This is a recommendation from the international clinical practice guidelines published in 2017 (Fehlings et al). The references 4 & 5 presented in the article refer to a mixture of quality of life as well as functional outcome measures after surgery specifically after ACDF surgery, in small numbers – there are more appropriate articles to cite regarding outcomes after surgery for DCM (i.e. the CSM-North America and CSM-International studies). 2- Throughout the article the authors refer to the “Minimal Important Change” which I suggest is a misnomer for “Minimum Clinically Important Difference” or “MCID”. The MCID is often cited in literature when discussing patient reported outcome measures, particularly with DCM. 3- The authors state repeatedly that the MCID has not been reported for DCM patients – when there are multiple works that have explored this exact fact- Tetreault et al 2015 for the MJOA, Badhiwala et al 2018 for the SF-36 to name a couple. 4- The authors refer to ‘percentage change score’ and present this as a novel finding, when in fact the ‘Delta’ value (change from baseline) is a more common modality when discussing PROMs in spine surgery and should therefore be used. 5- The authors excluded combined anterior/posterior surgery – with no explanation 6- The authors present a table of demographics for patients initially enrolled (n=614) but not for the patients who were actually followed up at 12 months (n=430). 7- The authors report a high number of Tobacco smokers in both anterior and posterior groups – and at no point is this fact addressed, adjusted for, or even commented on when it comes to the results and discussion. 8- It is not stated the proportion of patients undergoing disc arthroplasty vs ACDF – I would argue the use of arthroplasty is not internationally substantiated in the treatment of DCM. 9-The statistical analysis is incorrect – the use of T tests when attempting to report the potential outcomes of PROMs standardized to a binary outcome is not going to produce reliable results. Odds ratios and, at the very least, linear regression modelling is the best initial modality to interrogate the data and represents the most suitable first approach. Multiple regression analysis should then be employed to adjust for confounders such as smoking, gender, number of operated levels, age – all of which have been consistently demonstrated to affect the outcomes after surgery for DCM. All of this should be performed and validated before any attempt at AUC analysis. 10- Given the above – none of the AUC analysis is accurate. 11- No attempt was made to internally validate the data presented. 12- The authors state the sample size (417) is large. ROC and AUC analysis require significantly larger sample sizes to produce reliable results. See this recent article: Wilson et al 2020 Frailty Is a Better Predictor than Age of Mortality and Perioperative Complications after Surgery for Degenerative Cervical Myelopathy: An Analysis of 41,369 Patients from the NSQIP Database 2010–2018 Reviewer #2: Page 3 Line 4 Clarify this sentence please- surgery is recommended in moderate-severe at the moment by the AO, however evidence suggests that mild cases benefit too. Line 9: Comment on OPLL please Line 12: What incidence of patient report an improvement. Line 17: Its not more correct, perhaps could be more representative or easier to interpret. Page 4 line 2: Why was mJOA not evaluated? Line 9: what was the distribution ACDF/ ACDA? Page 7 Line 1 How did the authors check for normality? Page 15 Line 5: More accurate needs to be qualified more comprehensively please Page 16 Line 15: How do you discriminate between the effects of ant/post approach and age? Summarise here please ********** 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: Yes: Jamie R F Wilson 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.] 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. |
| Revision 1 |
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Clinical Improvement after Surgery for Degenerative Cervical Myelopathy; a Comparison of Patient-Reported Outcome Measures during 12-Month Follow-Up PONE-D-21-25531R1 Dear Dr. Mjåset, 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, Michael G. Fehlings 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: No ********** 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: A much improved manuscript which is clearer in its aims and in its conclusions. The authors defend their manuscript in the response to reviewers. There remains several typographical and grammatical errors, otherwise the report is satisfactory at this stage. ********** 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 |
| Formally Accepted |
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PONE-D-21-25531R1 Clinical Improvement after Surgery for Degenerative Cervical Myelopathy; a Comparison of Patient-Reported Outcome Measures during 12-Month Follow-Up Dear Dr. Mjåset: 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. Michael G. Fehlings Academic Editor PLOS ONE |
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