Virtual triage and outcomes of diabetic foot complications during Covid-19 pandemic: A retro-prospective, observational cohort study

Ashu Rastogi; Priya Hiteshi; Anil Bhansali A.; Edward B. Jude

doi:10.1371/journal.pone.0251143

Peer Review History

Original SubmissionFebruary 24, 2021
8 Apr 2021 Decision Letter - Kanhaiya Singh, Editor PONE-D-21-06327 Virtual Triage and Outcomes of Diabetic Foot Complications during COVID-19 Pandemic: A Retro-Prospective, Observational cohort study PLOS ONE Dear Dr. Rastogi, 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 May 23 2021 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. 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Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent. b) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings as either Supporting Information files or to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. Please see http://www.bmj.com/content/340/bmj.c181.long for guidelines on how to de-identify and prepare clinical data for publication. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. We will update your Data Availability statement on your behalf to reflect the information you provide. Additional Editor Comments: Please expand the table and figure legends including details like how data was represented (e.g. mean +/- standard deviation). Please provide values of statistical tests in addition to p value (e.g. odds ratio or other values). What was the power of study? Please also provide details about the human subject research approval of the study in the method part including the approval number and/or a statement indicating approval of this research. Also, the exclusion criteria of the patients should be presented as a separate section. [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: The authors have submitted an interesting study wherein they have shown that teleconsultation with video call for visual inspection of the ulcers is very helpful in the care of Diabetic patients with foot ulcers or those who are at risk during the lockdown period necessitated by the Corona pandemic. They have shown that outcomes and wound healing rates were similar to a cohort of patients who had physical follow-ups in the same period a year earlier i,e. pre-lockdown. The authors have also discussed the limitations of this study because it would be applicable in a select subset of patients. Reviewer #2: The Manuscript “Virtual Triage and Outcomes of Diabetic Foot Complications during COVID-19 Pandemic: A Retro-Prospective, Observational cohort study” by Dr. Rastogi et al, Compares the care provided to patients with diabetic foot by virtual consultation during the COVID 19 pandemic and face-to-face care provided to the diabetic patients. It mainly focuses on the outcomes of diabetic foot and developing complications like foot ulcers in patients provided tele-consultations with those who attended foot clinic consultations in the pre-pandemic period. This research tried to elucidate the benefits of remote consultations over in-clinic consultations. Allocation of patients in each group is appropriate for the study. Size of both groups is large enough for efficient statistical comparison of the treatment. Patient follow-up and wound assessment were performed by a single investigator, and trained personnel, would decrease the subjective error in the study. Because of the limitation due to COVID-19, investigations like difference in foot temperature and other DFU estimations are done by trained personnel at patients’ resident. Visual estimation of wound infection and wound healing, without appropriate investigations may limit the study but, author tried to address these limitations and overcome it by using the appropriate methods. Though the study duration is less, long enough to address the significance of the study. It would be more appropriate for author to include the parameters like HbA1c, FBG, PPBG and other complications like HTN and nephropathy at the end of the study. These parameters will reflect the patient’s compliance to diabetic treatment and give us the actual outcome of the foot ulcers. This is manuscript is technically sound enough and the statistically significant data supports it. I recommend that this paper be accepted. ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: Yes:** Sanjeev Kumar Gupta 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.0251143.r001
Revision 1
16 Apr 2021 Author Response Sir, I would like to thank you for your time during the ongoing COVID-19 pandemic giving an opportunity to revise the manuscript. I sincerely thank the editor and reviewers for their suggestions and constructive comments. We have revised the article as per your suggestions and provided the changes highlighted BLUE in the revised manuscript. Editor Comments: Please expand the table and figure legends including details like how data was represented (e.g. mean +/- standard deviation). Please provide values of statistical tests in addition to p value (e.g. odds ratio or other values). What was the power of study? Please also provide details about the human subject research approval of the study in the method part including the approval number and/or a statement indicating approval of this research. Also, the exclusion criteria of the patients should be presented as a separate section. Reply: The table and figure legends are expanded as detailed. Odds ratio were not calculated for independent group comparisons. This was an observational retro-prospective study during the present ongoing COVID19 pandemic. Power of the study was not obtained. Statement about research approval is provided in the revised manuscript (Method section) Exclusion criteria are provided in separate section as suggested (Method section) 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 Reply: We thank you for your comments ________________________________________ 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes Reviewer #2: Yes Reply: We thank you for your comments ________________________________________ 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 Reply: We thank you for your comments ________________________________________ 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 Reply: We thank you for your comments ________________________________________ 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: The authors have submitted an interesting study wherein they have shown that teleconsultation with video call for visual inspection of the ulcers is very helpful in the care of Diabetic patients with foot ulcers or those who are at risk during the lockdown period necessitated by the Corona pandemic. They have shown that outcomes and wound healing rates were similar to a cohort of patients who had physical follow-ups in the same period a year earlier i,e. pre-lockdown. The authors have also discussed the limitations of this study because it would be applicable in a select subset of patients. Reply: We thank you for your comments Reviewer #2: The Manuscript “Virtual Triage and Outcomes of Diabetic Foot Complications during COVID-19 Pandemic: A Retro-Prospective, Observational cohort study” by Dr. Rastogi et al, Compares the care provided to patients with diabetic foot by virtual consultation during the COVID 19 pandemic and face-to-face care provided to the diabetic patients. It mainly focuses on the outcomes of diabetic foot and developing complications like foot ulcers in patients provided tele-consultations with those who attended foot clinic consultations in the pre-pandemic period. This research tried to elucidate the benefits of remote consultations over in-clinic consultations. Allocation of patients in each group is appropriate for the study. Size of both groups is large enough for efficient statistical comparison of the treatment. Patient follow-up and wound assessment were performed by a single investigator, and trained personnel, would decrease the subjective error in the study. Because of the limitation due to COVID-19, investigations like difference in foot temperature and other DFU estimations are done by trained personnel at patients’ resident. Visual estimation of wound infection and wound healing, without appropriate investigations may limit the study but, author tried to address these limitations and overcome it by using the appropriate methods. Though the study duration is less, long enough to address the significance of the study. It would be more appropriate for author to include the parameters like HbA1c, FBG, PPBG and other complications like HTN and nephropathy at the end of the study. These parameters will reflect the patient’s compliance to diabetic treatment and give us the actual outcome of the foot ulcers. This is manuscript is technically sound enough and the statistically significant data supports it. I recommend that this paper be accepted. Reply: We thank you for your comments. The detailed evaluation regarding nephropathy and hypertension was not possible during lockdown for patients in group 1 were provided virtual teleconsultations. FBG and PPBG values were provided on home based self-monitoring of blood glucose in the revised manuscript. HbA1c was not possible due to same reasons for lack of clinic visit. We hope that the revised manuscript may be considered for publication. Sincerely, Ashu Rastogi Attachments Attachment Submitted filename: Reply to Reviewers April 10.docx https://doi.org/10.1371/journal.pone.0251143.r002
21 Apr 2021 Decision Letter - Kanhaiya Singh, Editor Virtual Triage and Outcomes of Diabetic Foot Complications during COVID-19 Pandemic: A Retro-Prospective, Observational cohort study PONE-D-21-06327R1 Dear Dr. Rastogi, 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, Kanhaiya Singh, Ph.D Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0251143.r003
Formally Accepted
26 Apr 2021 Acceptance Letter - Kanhaiya Singh, Editor PONE-D-21-06327R1 Virtual triage and outcomes of diabetic foot complications during Covid-19 pandemic: A retro-prospective, observational cohort study Dear Dr. Rastogi: 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. Kanhaiya Singh Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0251143.r004

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