Comparison of patient-reported outcomes at one year after injury between limb salvage and amputation: A prospective cohort study

Taketo Kurozumi; Takahiro Inui; Yuhei Nakayama; Akifumi Honda; Kentaro Matsui; Keisuke Ishii; Takashi Suzuki; Yoshinobu Watanabe

doi:10.1371/journal.pone.0274786

Peer Review History

Original SubmissionMarch 4, 2022
9 May 2022 Decision Letter - Arezoo Eshraghi, Editor PONE-D-22-06485Comparison of patient-reported outcomes at one year after injury between limb salvage and amputation: A prospective cohort studyPLOS ONE Dear Dr. KUROZUMI, 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 Jun 23 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. Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. 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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. In your Data Availability statement, you have not specified where the minimal data set underlying the results described in your manuscript can be found. PLOS defines a study's minimal data set as the underlying data used to reach the conclusions drawn in the manuscript and any additional data required to replicate the reported study findings in their entirety. All PLOS journals require that the minimal data set be made fully available. For more information about our data policy, please see http://journals.plos.org/plosone/s/data-availability. Upon re-submitting your revised manuscript, please upload your study’s minimal underlying data set as either Supporting Information files or to a stable, public repository and include the relevant URLs, DOIs, or accession numbers within your revised cover letter. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. Any potentially identifying patient information must be fully anonymized. Important: If there are ethical or legal restrictions to sharing your data publicly, please explain these restrictions in detail. Please see our guidelines for more information on what we consider unacceptable restrictions to publicly sharing data: http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. Note that it is not acceptable for the authors to be the sole named individuals responsible for ensuring data access. We will update your Data Availability statement to reflect the information you provide in your cover letter. 3. Thank you for stating the following financial disclosure: “No. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.” At this time, please address the following queries: a) Please clarify the sources of funding (financial or material support) for your study. List the grants or organizations that supported your study, including funding received from your institution. b) State what role the funders took in the study. If the funders had no role in your study, please state: “The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.” c) If any authors received a salary from any of your funders, please state which authors and which funders. d) If you did not receive any funding for this study, please state: “The authors received no specific funding for this work.” Please include your amended statements within your cover letter; we will change the online submission form on your behalf. 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. [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 ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: I Don't Know ****** 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 ****** 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 ****** 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: Summary: The authors present a small cohort study of patients with severe lower limb fractures, an uncommon but profoundly disabling injury. Deciding on the optimal treatment (salvage or amputation) for patients with these injuries is recognised as one of the most difficult decisions a surgeon can face. The results of this study advance understanding of patient centered outcomes following these injuries, and will contribute to the literature aiding decision-making between amputation and limb salvage. Major issues: Introduction & Discussion: 1) The Lower Extremity Assessment Project (LEAP) was a multi-centre, prospective cohort study between 1994 and 1997 that investigated the topic of this paper, and followed patients up at 2 (Bosse, NEJM) and 7 (MacKenzie, JBJS) years. The results of the LEAP study are now probably dated, and differ from the results of this study - however, the authors should report the key background knowledge on this topic in the introduction, and discuss their findings in the content of this previous work. Indeed, the authors suggest in the introduction that "prospective studies based on patient reported outcomes are extremely rare", yet the LEAP study is just this, and has provided the largest body of knowledge on the topic. Methods: 1) Consider using the Strobe reporting guideline for cohort studies Minor issues: Introduction: 1) The introduction is short, well written and highlights a clear rationale for the study and potential knowledge gap. However, there are few references. Please could the authors consider referencing more of the statements if possible. Results: 1) The magnitude of the functional disability in both groups is substantial, this in itself is an important finding, that is not highlighted. Could the authors consider showing this in graphical format (before - after LEFS scores)? And place in context what a LEFS score of 33 (average for amputees) means - on average moderate to quite a bit of difficulty with all activities of daily living! Discussion: 1) Consider discussing the possible reasons for the considerable impact these injuries have on mental health ( a key finding of this paper) ****** 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 [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.0274786.r001
Revision 1
10 Jun 2022 Author Response Response to Reviewers 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 https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf Response: Thank you for the information. We have made the required changes. 2. In your Data Availability statement, you have not specified where the minimal data set underlying the results described in your manuscript can be found. PLOS defines a study's minimal data set as the underlying data used to reach the conclusions drawn in the manuscript and any additional data required to replicate the reported study findings in their entirety. All PLOS journals require that the minimal data set be made fully available. For more information about our data policy, please see http://journals.plos.org/plosone/s/data-availability. Upon re-submitting your revised manuscript, please upload your study’s minimal underlying data set as either Supporting Information files or to a stable, public repository and include the relevant URLs, DOIs, or accession numbers within your revised cover letter. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. Any potentially identifying patient information must be fully anonymized. Important: If there are ethical or legal restrictions to sharing your data publicly, please explain these restrictions in detail. Please see our guidelines for more information on what we consider unacceptable restrictions to publicly sharing data: http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. Note that it is not acceptable for the authors to be the sole named individuals responsible for ensuring data access. We will update your Data Availability statement to reflect the information you provide in your cover letter. Response: Thank you for the information. We have added the following to the title page. Request can be made to the Japanese Society for Fracture Repair secretariat (1-8-6, Shintomi Chuoku Tokyo 104-0041 Japan) or to jsfr@jsfr.jp and those who meet the criteria for access to anonymized patient level data will be granted data access. 3. Thank you for stating the following financial disclosure: “No. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.” At this time, please address the following queries: a) Please clarify the sources of funding (financial or material support) for your study. List the grants or organizations that supported your study, including funding received from your institution. b) State what role the funders took in the study. If the funders had no role in your study, please state: “The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.” c) If any authors received a salary from any of your funders, please state which authors and which funders. d) If you did not receive any funding for this study, please state: “The authors received no specific funding for this work.” Please include your amended statements within your cover letter; we will change the online submission form on your behalf. Response: We have added the following to the cover letter and it has been added to the Title page. The authors received no specific funding for this work. Comments to the Author 5. Review Comments to the Author Reviewer #1: Summary: The authors present a small cohort study of patients with severe lower limb fractures, an uncommon but profoundly disabling injury. Deciding on the optimal treatment (salvage or amputation) for patients with these injuries is recognised as one of the most difficult decisions a surgeon can face. The results of this study advance understanding of patient centered outcomes following these injuries, and will contribute to the literature aiding decision-making between amputation and limb salvage. Response: Thank you for understanding our arguments. Major issues: Introduction & Discussion: 1) The Lower Extremity Assessment Project (LEAP) was a multi-centre, prospective cohort study between 1994 and 1997 that investigated the topic of this paper, and followed patients up at 2 (Bosse, NEJM) and 7 (MacKenzie, JBJS) years. The results of the LEAP study are now probably dated, and differ from the results of this study - however, the authors should report the key background knowledge on this topic in the introduction, and discuss their findings in the content of this previous work. Indeed, the authors suggest in the introduction that "prospective studies based on patient reported outcomes are extremely rare", yet the LEAP study is just this, and has provided the largest body of knowledge on the topic. Response: Thank you for this suggestion. We have added its content in the background and discussion. Page 3, Line 65-71; Page 14, Lines 288-290 Methods: 1) Consider using the Strobe reporting guideline for cohort studies Response: Thank you for your suggestion. We have rewritten some of them to conform to the guidelines. Page 3, Lines 79, 81; Page 4, Lines 86, 89. Minor issues: Introduction: 1) The introduction is short, well written and highlights a clear rationale for the study and potential knowledge gap. However, there are few references. Please could the authors consider referencing more of the statements if possible. Response: Thank you very much. We have added some additional references and background information there. Page 3, Lines 65, 66, 68, 71. Results: 1) The magnitude of the functional disability in both groups is substantial, this in itself is an important finding, that is not highlighted. Could the authors consider showing this in graphical format (before - after LEFS scores)? And place in context what a LEFS score of 33 (average for amputees) means - on average moderate to quite a bit of difficulty with all activities of daily living! Response: Thank you for this suggestion. We have added its content in the result and discussion. Pages 10-11, Lines 176-206; 217-218 Discussion: 1) Consider discussing the possible reasons for the considerable impact these injuries have on mental health ( a key finding of this paper) Response: Thank you for this insightful comment. We have added a discussion around this topic to the discussion section. Page 13, Lines 275-278 Attachments Attachment Submitted filename: 22.06.08Response_to_Reviewers.docx https://doi.org/10.1371/journal.pone.0274786.r002
1 Jul 2022 Decision Letter - Arezoo Eshraghi, Editor PONE-D-22-06485R1Comparison of patient-reported outcomes at one year after injury between limb salvage and amputation: A prospective cohort studyPLOS ONE Dear Dr. KUROZUMI, 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 Aug 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. 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: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols. We look forward to receiving your revised manuscript. Kind regards, Arezoo Eshraghi, Ph.D. Academic Editor PLOS ONE Journal Requirements: 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. [Note: HTML markup is below. Please do not edit.] 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 #1: (No Response) ******** 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 #1: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: I Don't Know ****** 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 #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. 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: Minor issue: Thank you for including reference to the LEAP study body of work. This was a large multi-centre, prospective observational study, that took place between 1994 and 1997, and remains one of the most important civilian studies on the topic. In the revised introduction, the sentence "Moreover, many previous investigations on this topic are retrospective cohort studies or meta-analyses on retrospective studies, such as the LEAP study, whereas prospective cohort studies based on patient-reported outcomes are extremely rare [1-3]." implies that the LEAP study is a retrospective cohort study or a meta-analysis of retrospective studies, which it is neither. Please consider rewording to something like: "Moreover, many previous investigations on this topic are retrospective cohort studies or meta-analyses on retrospective studies, whereas prospective cohort studies based on patient-reported outcomes, such as the LEAP study, are extremely rare [1-3]." ****** 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: 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.0274786.r003
Revision 2
3 Jul 2022 Author Response 6. Review Comments to the Author Reviewer #1: Minor issue: Thank you for including reference to the LEAP study body of work. This was a large multi-centre, prospective observational study, that took place between 1994 and 1997, and remains one of the most important civilian studies on the topic. In the revised introduction, the sentence "Moreover, many previous investigations on this topic are retrospective cohort studies or meta-analyses on retrospective studies, such as the LEAP study, whereas prospective cohort studies based on patient-reported outcomes are extremely rare [1-3]." implies that the LEAP study is a retrospective cohort study or a meta-analysis of retrospective studies, which it is neither. Please consider rewording to something like: "Moreover, many previous investigations on this topic are retrospective cohort studies or meta-analyses on retrospective studies, whereas prospective cohort studies based on patient-reported outcomes, such as the LEAP study, are extremely rare [1-3]." Response: Thank you for this suggestion. We have made the required changes. Page 5, Line 68-69 Attachments Attachment Submitted filename: 22.07.03Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0274786.r004
6 Sep 2022 Decision Letter - Alvan Ukachukwu, Editor Comparison of patient-reported outcomes at one year after injury between limb salvage and amputation: A prospective cohort study PONE-D-22-06485R2 Dear Dr. Kurozumi, 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, Alvan Ukachukwu, MD, MSc.GH Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0274786.r005
Formally Accepted
9 Sep 2022 Acceptance Letter - Alvan Ukachukwu, Editor PONE-D-22-06485R2 Comparison of patient-reported outcomes at one year after injury between limb salvage and amputation: A prospective cohort study Dear Dr. Kurozumi: 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. Alvan Ukachukwu Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0274786.r006

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