Venous leg ulcer healing as a determinant of quality of life in patients treated with unna boot: A quasi-experimental study

Mário Lins Galvão de Oliveira; Felipe León-Morillas; Isadora Costa Andriola; Carmelo Sergio Gómez Martínez; Bruno Araújo da Silva Dantas; Gilson de Vasconcelos Torres

doi:10.1371/journal.pone.0314490

Peer Review History

Original SubmissionMarch 5, 2024
2 Oct 2024 Decision Letter - Kathleen Finlayson, Editor PONE-D-24-08769Venous leg ulcer healing as a determinant of quality of life in patients treated with unna boot: a quasi-experimental studyPLOS ONE Dear Dr. Dantas, 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 consider the additional information required as per the reviewers' comments below, to allow a full clinical picture of your participants for the reader. As your inclusion criteria re ulcer duration indicates you only included chronic venous leg ulcers, be sure to specify this when discussing your sample. A review of grammar and language is needed. Please submit your revised manuscript by Nov 16 2024 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, Kathleen Finlayson 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 financial disclosure: This study was funded by the National Council for Scientific and Technological Development (Brazil) through the CNPq/MCTI/FNDCT call, grant number 408535/2021-0 and document nº 18/2021 - Tier B, for consolidated groups. The grant was awarded to researcher Dr. Gilson de Vasconcelos Torres, from the Federal University of Rio Grande do Norte, Brazil (Level PQ1D Researcher). Please state what role the funders took in the study. If the funders had no role, please state: ""The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript."" If this statement is not correct you must amend it as needed. Please include this amended Role of Funder 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. [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: No Reviewer #2: No ****** 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: Dear Authors Thank you for the opportunity to read the research results. I suggest making the following corrections/additions: - in Introduction - population 1% - outdated data ... - during treatment - how was the progress of ulcer healing assessed? what tool...? - inclusions criteria - only age? nothing else?, gender, other data? - what were the recommendations for patients undergoing compression therapy treatment (we have 1 year of observation here) - what treatment was provided apart from Unna boot? (pharmacology, dressings?() - I suggest English Native Speaker correction Reviewer #2: Dear Author, The manuscript is technically sound piece of scientific research with data that supports the conclusions. Clinical study has been conducted rigorously, with appropriate controls, replication, and sample sizes. statistical analysis is adequate and optimum. Data is presented well. English and grammar needs improvement. Thanks With Best Regards ****** 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.0314490.r001
Revision 1
8 Oct 2024 Author Response Dear Reviewers, On behalf of the authors, I would like to extend my greetings and express our gratitude for the thoughtful comments and requests regarding the submitted manuscript. I am confident that they have helped improve the quality of the work to which we have been so dedicated. Below, I have provided point-by-point responses to each of your comments. I hope these answers satisfactorily address the concerns you raised. 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: No Reviewer #2: No ________________________________________ 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: Dear Authors Thank you for the opportunity to read the research results. I suggest making the following corrections/additions: - in Introduction - population 1% - outdated data ... Response: We found a meta-analysis published in 2023 that reports a prevalence of 0.32% and an incidence of 0.17%. We have replaced the theoretical reference accordingly. The study is described as follows: Probst, S., Saini, C., Gschwind, G., Stefanelli, A., Bobbink, P., Pugliese, M. T., Cekic, S., Pastor, D., & Gethin, G. (2023). Prevalence and incidence of venous leg ulcers—A systematic review and meta-analysis. International Wound Journal, 20(9), 3906–3921. https://doi.org/10.1111/iwj.14272 - during treatment - how was the progress of ulcer healing assessed? what tool...? Response: At each dressing change appointment at the service, a new evaluation was conducted by the healthcare professional. The evaluation focused on the same aspects, including the size and width of the wound, the appearance of its edges and interior, as well as the presence and characteristics of exudate. We have added this information to the methodology to make it clearer. - inclusions criteria - only age? nothing else?, gender, other data? Response: In addition to age as a requirement, the participant had to be registered with the primary care service in the study setting and not with other services. Furthermore, the venous ulcer had to be considered active, meaning it should not have healed. Even when covered by thin layers of skin, a wound could still be confused with an active venous ulcer. We have added a clarification in the methods section to better explain this point. - what were the recommendations for patients undergoing compression therapy treatment (we have 1 year of observation here) Response: Patients were routinely instructed on how to care for their dressings at home, such as protecting them during bathing to avoid getting them wet, following a healthy diet, and elevating the leg above heart level. All these instructions are in line with the conduct manual adopted as a theoretical reference cited in the manuscript. We have added a description of these instructions in the methodology to make it clearer. - what treatment was provided apart from Unna boot? (pharmacology, dressings?() Response: The treatment primarily consisted of an Unna boot covered by a secondary dressing (over the boot). Only in cases suggestive of wound infection did the physician implement antibiotic treatment before starting compression therapy. This is because infectious processes contraindicate the use of compression therapy. We have described this in the methodology. - I suggest English Native Speaker correction Response: We conducted a thorough revision of the English language with the assistance of a native speaker. The revision was both grammatical, and we aimed to make the language more fluid for better comprehension. Reviewer #2: Dear Author, The manuscript is technically sound piece of scientific research with data that supports the conclusions. Clinical study has been conducted rigorously, with appropriate controls, replication, and sample sizes. statistical analysis is adequate and optimum. Data is presented well. English and grammar needs improvement. Thanks With Best Regards Response: Thank you for your comments and observations. We have conducted a thorough revision of the English language with the help of a native speaker. The revision focused on grammar, and we have worked to improve the fluidity of the language for better understanding. Attachments Attachment Submitted filename: Response to Reviewers.pdf https://doi.org/10.1371/journal.pone.0314490.r002
12 Nov 2024 Decision Letter - Kathleen Finlayson, Editor Venous leg ulcer healing as a determinant of quality of life in patients treated with unna boot: a quasi-experimental study PONE-D-24-08769R1 Dear Dr. Dantas, 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 will be generated when your article is formally accepted. Please note, if your institution has a publishing partnership with PLOS and your article meets the relevant criteria, all or part of your publication costs will be covered. Please make sure your user information is up-to-date by logging into Editorial Manager at Editorial Manager® and clicking the ‘Update My Information' link at the top of the page. If you have any questions relating to publication charges, 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, Kathleen Finlayson Academic Editor PLOS ONE Additional Editor Comments: Thank you for addressing the reviewers' suggestions, the manuscript now is clearer and provides further details on your methods. There are a couple of remaining areas requiring some additional detail or clarification as follows: - firstly, how was the status of 'healed' ulcer defined? - in Table 5 (logistic regression), could you specify the outcome variable here? was it healed or unhealed? if so, I would change the title of the table description to reflect that the regression was on all participants, looking at factors associated with healing (rather than only including those who healed? https://doi.org/10.1371/journal.pone.0314490.r003
Formally Accepted
14 Nov 2024 Acceptance Letter - Kathleen Finlayson, Editor PONE-D-24-08769R1 PLOS ONE Dear Dr. Dantas, I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now being handed over to our production team. At this stage, our production department will prepare your paper for publication. This includes ensuring the following: * All references, tables, and figures are properly cited * All relevant supporting information is included in the manuscript submission, * There are no issues that prevent the paper from being properly typeset If revisions are needed, the production department will contact you directly to resolve them. If no revisions are needed, you will receive an email when the publication date has been set. At this time, we do not offer pre-publication proofs to authors during production of the accepted work. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few weeks to review your paper and let you know the next and final steps. Lastly, 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 customercare@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. Kathleen Finlayson Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0314490.r004

Open letter on the publication of peer review reports

PLOS recognizes the benefits of transparency in the peer review process. Therefore, we enable the publication of all of the content of peer review and author responses alongside final, published articles. Reviewers remain anonymous, unless they choose to reveal their names.

We encourage other journals to join us in this initiative. We hope that our action inspires the community, including researchers, research funders, and research institutions, to recognize the benefits of published peer review reports for all parts of the research system.

Learn more at ASAPbio .