Preoperative exercise training for adults undergoing elective major vascular surgery: A systematic review

Garry A. Tew; Kim Caisley; Gerard Danjoux

doi:10.1371/journal.pone.0263090

Peer Review History

Original SubmissionOctober 13, 2021
6 Dec 2021 Decision Letter - Athanasios Saratzis, Editor PONE-D-21-32818Preoperative exercise training for adults undergoing elective major vascular surgery: A systematic reviewPLOS ONE Dear Dr. Tew, 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 Jan 20 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. 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. 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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 https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf. 2. Thank you for stating the following in the Competing Interests section: [I have read the journal's policy and the authors of this manuscript have the following competing interests: GT and GD were investigators on one of the included trials (Tew 2017).] Please confirm that this does not alter your adherence to all PLOS ONE policies on sharing data and materials, by including the following statement: "This does not alter our adherence to PLOS ONE policies on sharing data and materials.” (as detailed online in our guide for authors http://journals.plos.org/plosone/s/competing-interests). If there are restrictions on sharing of data and/or materials, please state these. Please note that we cannot proceed with consideration of your article until this information has been declared. Please include your updated Competing Interests statement in your cover letter; we will change the online submission form on your behalf. 3. Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. Additional Editor Comments: Thank you for submitting this interesting article. Some comments have been made by the expert Reviewers. Please address the comments raised if you are considering a re-submission. [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: Yes ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: Yes ****** 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: 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: For transparency to the authors i have already reviewed this document and provided feedback which i believe has mainly been addressed. However i did not see the previous response to reviewer document. Some further considerations for review: 1. With regard to the RoB tool, i would consider an external reviewer as some of the papers are the authors own. 2. Consider a secondary search as the current one is nearing 8 months post completion. 3. This review only included 3 studies but a recently published Cochrane - identifies 4 (https://pubmed.ncbi.nlm.nih.gov/34236703/) please consider whether the missing study should be included in this review? 4. Regarding the complications in the Baraket paper these were found to be surgery specific OPEN vs EVAR, it would be good to demonstrate this in the results section. 5. Page 15 lines 222-223 & 227-228 are repeats. 6. Please discuss the discrepancy between the RoB reported here as low but reported as very high in the Cochrane review. 7. Due to the lack of studies found in PAD and carotid disease, this review does have an overlap with the published Cochrane review. Is there consideration to expand your review to non-RCTs to include more data, although acknowledging that this is not as "high level evidence". Reviewer #2: This is well-conducted systematic review of the published evidence regarding pre-habilitation exercise programmes prior to major vascular surgery (AAA, Lower limb bypasses and Carotid endarterectomy). Unfortunately there were only 3 RCTs which fulfilled the inclusion criteria, however this reflects the current lack of evidence in this area. The manuscript is well-written, however could benefit from shortening of the discussion section, where there seems to be a repetition of some of the findings in the results section ****** 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.] 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. https://doi.org/10.1371/journal.pone.0263090.r001
Revision 1
7 Dec 2021 Author Response Response to Reviewers Preoperative exercise training for adults undergoing elective major vascular surgery: A systematic review Journal 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 https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf. We have reformatted the headings and updated the figure citations and file names for figures. Supporting information has been uploaded separately as individual files. Postal codes have been removed from affiliations. 2. Thank you for stating the following in the Competing Interests section: [I have read the journal's policy and the authors of this manuscript have the following competing interests: GT and GD were investigators on one of the included trials (Tew 2017).] We have re-named this section as “Competing interests” and inserted the following variant of what has been suggested: “The authors of this manuscript have the following competing interests: GT and GD were investigators on one of the included trials (Tew 2017).” Please confirm that this does not alter your adherence to all PLOS ONE policies on sharing data and materials, by including the following statement: "This does not alter our adherence to PLOS ONE policies on sharing data and materials.” (as detailed online in our guide for authors http://journals.plos.org/plosone/s/competing-interests). If there are restrictions on sharing of data and/or materials, please state these. Please note that we cannot proceed with consideration of your article until this information has been declared. We have included that statement in the Competing Interests section. Please include your updated Competing Interests statement in your cover letter; we will change the online submission form on your behalf. The updated statement has been included in our cover letter. 3. Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. We have reviewed the reference list and believe it to be complete and correct. Additional Editor Comments: Thank you for submitting this interesting article. Some comments have been made by the expert Reviewers. Please address the comments raised if you are considering a re-submission. We are glad that you think our article is interesting. We have addressed all review comments. 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: Yes 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: Yes 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: 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: For transparency to the authors i have already reviewed this document and provided feedback which i believe has mainly been addressed. However i did not see the previous response to reviewer document. Some further considerations for review: We appreciate the time you have taken to review our manuscript and thank you for the thoughtful and helpful comments. 1. With regard to the RoB tool, i would consider an external reviewer as some of the papers are the authors own. The risk of bias assessments were conducted independently by two reviewers. One of the reviewers (KC) was not involved in the any of the included studies. There were no discrepancies in two reviewers’ judgements, so we are confident that our assessments are appropriate and unbiased. 2. Consider a secondary search as the current one is nearing 8 months post completion. We performed a rerun of the database searches on December 7, 2021. No further relevant RCTs were identified. 3. This review only included 3 studies but a recently published Cochrane - identifies 4 (https://pubmed.ncbi.nlm.nih.gov/34236703/) please consider whether the missing study should be included in this review? We think that the reviewer is referring to the following pilot study of Richardson and colleagues: https://clinicaltrials.gov/ct2/show/NCT02845167. This study was excluded during our screening process because the intervention involved exercise sessions on three consecutive days. For inclusion in our review, the training duration needed to be at least one week. 4. Regarding the complications in the Baraket paper these were found to be surgery specific OPEN vs EVAR, it would be good to demonstrate this in the results section. We have added the procedure-specific complication rates to Table 3, as well as the following sentence: “An exploratory (i.e., underpowered) sub-group analysis indicated that the effect was procedure-specific, with a greater risk reduction being observed in patients undergoing open surgical repair rather than endovascular repair.” 5. Page 15 lines 222-223 & 227-228 are repeats. These sentences are worded similarly, but both are relevant and worthy of inclusion as they relate to different outcomes. The first sentence refers to how we handled the mortality data. The second sentence refers to how we handled the complications data. 6. Please discuss the discrepancy between the RoB reported here as low but reported as very high in the Cochrane review. The Cochrane review of Fenton et al. (2021) used version 1 of the Cochrane RoB tool, whereas we used version 2, so the RoB results are not directly comparable. We can however comment on some apparent discrepancies. First, we did not consider there to be high risk of bias due to selective reporting because data were presented for the outcome measures that we were interested in. Second, Fenton et al. gave the study of Tew et al. a rating of ‘high risk’ for incomplete outcome data, stating that attrition was >20% and ITT analysis wasn’t used. Both these statements are incorrect. Third, in ‘other potential sources of bias’, Fenton et al. gave a high risk of bias rating to the study of Tew et al. for it being underpowered. This goes against Cochrane guidance that criteria related to precision should not be assessed within this domain (https://handbook-5-1.cochrane.org/chapter_8/8_15_2_assessing_risk_of_bias_from_other_sources.htm). Finally, we would like to note that that RoB results in the NICE evidence review (reference #17) are in keeping with our results. 7. Due to the lack of studies found in PAD and carotid disease, this review does have an overlap with the published Cochrane review. Is there consideration to expand your review to non-RCTs to include more data, although acknowledging that this is not as "high level evidence". Quasi-RCTs were eligible for inclusion, however no such studies were found. We decided not to include uncontrolled studies because they provide little insight into the quantitative effect of prehabilitation on post-operative outcomes. Limiting the inclusion of studies to RCTs also reflects the approach used in evidence syntheses to inform clinical guidelines (i.e., to focus on “high-level evidence). Reviewer #2: This is well-conducted systematic review of the published evidence regarding pre-habilitation exercise programmes prior to major vascular surgery (AAA, Lower limb bypasses and Carotid endarterectomy). Unfortunately there were only 3 RCTs which fulfilled the inclusion criteria, however this reflects the current lack of evidence in this area. The manuscript is well-written, however could benefit from shortening of the discussion section, where there seems to be a repetition of some of the findings in the results section. Thank you for reviewing our manuscript. We have carefully reviewed the discussion section and would prefer not to shorten it. This is because we think that all the content is valuable and most of it is new (i.e., not repeated). For example, the discussion around implications for policy, practice and research and the strengths and limitations, which makes up most of the text, is all unique to this section. Also, at 1,828 words, the size of this section is in keeping with the rest of the manuscript. Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0263090.r002
12 Jan 2022 Decision Letter - Athanasios Saratzis, Editor Preoperative exercise training for adults undergoing elective major vascular surgery: A systematic review PONE-D-21-32818R1 Dear Dr. Tew, 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, Athanasios Saratzis 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: N/A ****** 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.0263090.r003
Formally Accepted
17 Jan 2022 Acceptance Letter - Athanasios Saratzis, Editor PONE-D-21-32818R1 Preoperative exercise training for adults undergoing elective major vascular surgery: A systematic review Dear Dr. Tew: 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. Athanasios Saratzis Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0263090.r004

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