Volar locking plate versus external fixation for unstable dorsally displaced distal radius fractures–A 3-year cost-utility analysis

Jenny Saving; Emelie Heintz; Hans Pettersson; Anders Enocson; Cecilia Mellstrand Navarro

doi:10.1371/journal.pone.0240377

Peer Review History

Original SubmissionMarch 31, 2020
10 Jun 2020 Decision Letter - Daniel Ribeiro, Editor PONE-D-20-09180 Volar Locking Plate versus External Fixation for Unstable Dorsally Displaced Distal Radius Fractures – A 3-year Cost-Utility Analysis PLOS ONE Dear Dr. Mellstrand Navarro, 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 Jul 25 2020 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: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols We look forward to receiving your revised manuscript. Kind regards, Daniel Ribeiro 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 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: The authors have declared that no competing interests exist. We note that one or more of the authors are employed by a commercial company: Capio Artro Clinic. a. Please provide an amended Funding Statement declaring this commercial affiliation, as well as a statement regarding the Role of Funders in your study. If the funding organization did not play a role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript and only provided financial support in the form of authors' salaries and/or research materials, please review your statements relating to the author contributions, and ensure you have specifically and accurately indicated the role(s) that these authors had in your study. You can update author roles in the Author Contributions section of the online submission form. 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Please also provide an updated Competing Interests Statement declaring this commercial affiliation along with any other relevant declarations relating to employment, consultancy, patents, products in development, or marketed products, etc. Within your Competing Interests Statement, please confirm that this commercial affiliation 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 this adherence statement is not accurate and 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 both an updated Funding Statement and Competing Interests Statement in your cover letter. We will change the online submission form on your behalf. Please know it is PLOS ONE policy for corresponding authors to declare, on behalf of all authors, all potential competing interests for the purposes of transparency. PLOS defines a competing interest as anything that interferes with, or could reasonably be perceived as interfering with, the full and objective presentation, peer review, editorial decision-making, or publication of research or non-research articles submitted to one of the journals. Competing interests can be financial or non-financial, professional, or personal. Competing interests can arise in relationship to an organization or another person. Please follow this link to our website for more details on competing interests: http://journals.plos.org/plosone/s/competing-interests Additional Editor Comments (if provided): Thank you for your submission. The reviewers provided excellent feedback to improve the quality and clarity of your reporting. They have also identified important areas that need revision. I would like to highlight the following: - Please ensure you adhere to the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement (this was also raised by Reviewer #2). - Table 1: needs formatting, it is not formatted as table. [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: 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: I will focus on methods and reporting. The abstract is well written and balanced. The use of the ICER is appropriate as far as I can tell. Methods are appropriate. Graphs are informative. Major 1) the sample size, for which the authors cannot do much. But they can tone down the certainty of their findings and conclusions, especialyl in the abstract. 2) Linked to that there is no power calculation. Was there for the original study? It is worth saying that there was, to detect what (if there was), and then go on to say that you are underpowered to detect anything but very large effects. A post-hoc power calculation is meaningless. 2) missing data - why is a complete case approach selected? Why don't the authors use multiple imputation, for example? Minor 1) Introduction was a bit short and did not give a comprehensive picture of the issue. 2) I appreciate this is an old trial and the information is avaialble elsewhere, but the authors could expand a bit on the randomisation process at least since it is quite important. Reviewer #2: This is a generally well-conducted study, and the authors' interpretations and conclusions are supported by the results, although should perhaps be softened somewhat given the wide uncertainty evident in the cost-effectiveness results. The reporting is generally clear, although some minor grammatical issues should be addressed by careful language/copy-editing throughout. I have a few further concerns that should be addressed before the manuscript is suitable for publication: 1. The cost-perspective is probably best described as a partial societal perspective, as the only non-healthcare costs considered are production loss due to sick leave (i.e. many other societal costs, such as other out-of-pocket patient costs, caregiver time, travel, etc. are not included) 2. Reporting a health care sector perspective in additional to the (partial) societal perspective would be useful (e.g. the dual reference cases recommended by the 2nd panel on cost-effectiveness in health & medicine). This would likely also give more precise results, given how much the productivity losses contribute to the overall uncertainty 3. Would be good to see a completed CHEERS checklist to ensure the manuscript conforms to reporting guidelines for health economic evaluations 4. The authors have stated that 'All relevant data are within the manuscript and its Supporting Information files.' If the complete data have been uploaded as Supporting Information, I do not seem to have access to them as a reviewer, and there is no list of supporting information included 5. There are a lot of figures & tables included, some of which could probably be moved to an Appendix (e.g. Table 4) or combined (e.g. Figures 4 & 5) ****** 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.0240377.r001
Revision 1
31 Jul 2020 Author Response Dear PLOS One, Please consider our resubmission of PONE-D-20-09180 Volar Locking Plate versus External Fixation for Unstable Dorsally Displaced Distal Radius Fractures – A 3-year Cost-Utility Analysis PLOS ONE All our comments are provided below in italics. We hope that our efforts are sufficient. Do not hesitate to contact us for further clarifications or modifications of our submission. Sincerely yours, Cecilia Mellstrand Navarro and co-authors • 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'. 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 https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf We have checked all style requirements to the best of our abilities. 2. We note that one or more of the authors are employed by a commercial company: Capio Artro Clinic. a. Please provide an amended Funding Statement declaring this commercial affiliation We have added a “funding statement declaration” to the cover letter clarifying the affiliation of author JS, and the roles of our funder. b. Please also provide an updated Competing Interests Statement declaring this commercial affiliation along with any other relevant declarations relating to employment, consultancy, patents, products in development, or marketed products, etc. We have added this information in the cover letter. Additional Editor Comments (if provided): Thank you for your submission. The reviewers provided excellent feedback to improve the quality and clarity of your reporting. They have also identified important areas that need revision. I would like to highlight the following: - Please ensure you adhere to the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement (this was also raised by Reviewer #2). A Cheers statement has been added as supporting information S1. - Table 1: needs formatting, it is not formatted as table. Table 1 has been formatted as a table. 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: No The data availability has been clarified in the online submission form. ________________________________________ 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: I will focus on methods and reporting. The abstract is well written and balanced. The use of the ICER is appropriate as far as I can tell. Methods are appropriate. Graphs are informative. Major 1) the sample size, for which the authors cannot do much. But they can tone down the certainty of their findings and conclusions, especialyl in the abstract. The abstract has been modified. 2) Linked to that there is no power calculation. Was there for the original study? It is worth saying that there was, to detect what (if there was), and then go on to say that you are underpowered to detect anything but very large effects. A post-hoc power calculation is meaningless. The power calculation has been clarified in the method section and the small study size mentioned as a limitation in the discussion section. 2) missing data - why is a complete case approach selected? Why don't the authors use multiple imputation, for example? All imputation methods basically invent data in a more or less true way and only works under the assumption that data are missing at random. Multiple imputation would be the preferred way to impute data. However, because we did not have much partially missing data, we decided that it would be most transparent to only use data that was complete rather than use multiple imputation to impute a few more data points (113 were analyzed as complete cases out of 140 included patients). A clarifying note has been added in the methods section. Minor 1) Introduction was a bit short and did not give a comprehensive picture of the issue. This is a matter of personal preferences. We think we have defined the need for the study: equal clinical effects of different surgical procedures and a lack of previous studies. We think that it is preferable to keep the introduction short. No changes have been performed. 2) I appreciate this is an old trial and the information is avaialble elsewhere, but the authors could expand a bit on the randomisation process at least since it is quite important. A description of the randomization process has been added to the methods section. Reviewer #2: This is a generally well-conducted study, and the authors' interpretations and conclusions are supported by the results, although should perhaps be softened somewhat given the wide uncertainty evident in the cost-effectiveness results. The conclusions have been modified to a more moderate wording in the abstract and conclusion sections. The reporting is generally clear, although some minor grammatical issues should be addressed by careful language/copy-editing throughout. We are not native English speakers and would appreciate identification of grammatical issues by the editorial process. I have a few further concerns that should be addressed before the manuscript is suitable for publication: 1. The cost-perspective is probably best described as a partial societal perspective, as the only non-healthcare costs considered are production loss due to sick leave (i.e. many other societal costs, such as other out-of-pocket patient costs, caregiver time, travel, etc. are not included) The description of the perspective has been modified as requested. 2. Reporting a health care sector perspective in additional to the (partial) societal perspective would be useful (e.g. the dual reference cases recommended by the 2nd panel on cost-effectiveness in health & medicine). This would likely also give more precise results, given how much the productivity losses contribute to the overall uncertainty 3. Would be good to see a completed CHEERS checklist to ensure the manuscript conforms to reporting guidelines for health economic evaluations A CHEERS checklist has been added as supporting information. 4. The authors have stated that 'All relevant data are within the manuscript and its Supporting Information files.' If the complete data have been uploaded as Supporting Information, I do not seem to have access to them as a reviewer, and there is no list of supporting information included The statement has been modified. All data is available upon request from the corresponding author. 5. There are a lot of figures & tables included, some of which could probably be moved to an Appendix (e.g. Table 4) or combined (e.g. Figures 4 & 5) We think that figures and tables are valuable to make the results clear to our readers. If requested by the editorial office, we will change relevant figures / tables to appendices. ________________________________________ 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. All figures have been uploaded through your PACE system, and are provided as TIF files. https://doi.org/10.1371/journal.pone.0240377.r002
26 Aug 2020 Decision Letter - Daniel Ribeiro, Editor PONE-D-20-09180R1 Volar Locking Plate versus External Fixation for Unstable Dorsally Displaced Distal Radius Fractures – A 3-year Cost-Utility Analysis PLOS ONE Dear Dr. Mellstrand Navarro, 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 Oct 10 2020 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: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols We look forward to receiving your revised manuscript. Kind regards, Daniel Ribeiro Academic Editor PLOS ONE Additional Editor Comments (if provided): Thank you for your revised manuscript. Can I please ask you to address the comments raised by the reviewers? [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: All comments have been addressed Reviewer #2: (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: Partly Reviewer #2: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes 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 #1: Yes 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 #1: Yes 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 #1: I am happy with the authors' responses in general. The argument against multiple imputation is rather weak, especially considering the small sample size. So including another 20 people or so in small study like this would be quite beneficial I think. Yes multiple imputation invents data out of thin air and it comes with assumptions, but it is still the best approach irrespective of the underlying mechanism: https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/s12874-016-0281-5 Reviewer #2: The responses the authors have provided are fine, but there does not appear to be any response or action taken in regard to my comment #2. Reporting both a health system and societal perspective would be in line with guidelines for the conduct of cost-effectiveness analyses (e.g. Sanders et al., JAMA 2016, doi:10.1001/jama.2016.12195), and the health system-only perspective would likely reduce some of the uncertainty associated with the estimation of productivity costs. If the authors do not believe this analysis is required, this should be justified (but since they have the data required to do this, it seems an easy way to improve the reporting & interpretability of the paper). ****** 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 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.0240377.r003
Revision 2
4 Sep 2020 Author Response Stockholm 2 September 2020 Response to reviewers Rebuttal letter Thank you for your response regarding our revision of PONE-D-20-09180R1 Volar Locking Plate versus External Fixation for Unstable Dorsally Displaced Distal Radius Fractures – A 3-year Cost-Utility Analysis PLOS ONE Please see below our answers to reviewers’ comments: Additional Editor Comments (if provided): Thank you for your revised manuscript. Can I please ask you to address the comments raised by the reviewers? [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author ________________________________________ 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: I am happy with the authors' responses in general. The argument against multiple imputation is rather weak, especially considering the small sample size. So including another 20 people or so in small study like this would be quite beneficial I think. Yes multiple imputation invents data out of thin air and it comes with assumptions, but it is still the best approach irrespective of the underlying mechanism: https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/s12874-016-0281-5 We understand your point of view. A larger sample would have been optimal. Since our study population size is limited by our RCT patients (out of which 113/140, i e 81% were analyzed) we still consider our choice of complete case analysis be adequate. Reviewer #2: The responses the authors have provided are fine, but there does not appear to be any response or action taken in regard to my comment #2. Reporting both a health system and societal perspective would be in line with guidelines for the conduct of cost-effectiveness analyses (e.g. Sanders et al., JAMA 2016, doi:10.1001/jama.2016.12195), and the health system-only perspective would likely reduce some of the uncertainty associated with the estimation of productivity costs. If the authors do not believe this analysis is required, this should be justified (but since they have the data required to do this, it seems an easy way to improve the reporting & interpretability of the paper). ________________________________________ . 2. Reporting a health care sector perspective in additional to the (partial) societal perspective would be useful (e.g. the dual reference cases recommended by the 2nd panel on cost-effectiveness in health & medicine). This would likely also give more precise results, given how much the productivity losses contribute to the overall uncertainty Thank you for your suggestion! We agree that this would increase transparency and improve the paper. We have now clarified the differences between the health care and (partial) societal perspective by adding information in table 7, where costs at 1 and 3 years, plus ICER for the respective perspectives have been presented. The total costs for both perspectives are also described in table 5, where standard deviations are presented. We have modified the methods section and discussion in line with your comments. We hope you find these changes satisfying. When editing this revision we identified a calculation error: in table 7 the ICER for the one year perspective was wrong, and it has been corrected. The erroroneous number was not used in any other calculation or analyses in this paper. https://doi.org/10.1371/journal.pone.0240377.r004
25 Sep 2020 Decision Letter - Daniel Ribeiro, Editor Volar Locking Plate versus External Fixation for Unstable Dorsally Displaced Distal Radius Fractures – A 3-year Cost-Utility Analysis PONE-D-20-09180R2 Dear Dr. Mellstrand Navarro, 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, Daniel Ribeiro 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: (No Response) ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #2: (No Response) ****** 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: (No Response) ****** 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 Response) ****** 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.0240377.r005
Formally Accepted
29 Sep 2020 Acceptance Letter - Daniel Ribeiro, Editor PONE-D-20-09180R2 Volar Locking Plate versus External Fixation for Unstable Dorsally Displaced Distal Radius Fractures – A 3-year Cost-Utility Analysis Dear Dr. Mellstrand Navarro: 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. Daniel Ribeiro Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0240377.r006

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