Development and validation of risk prediction model for diabetic neuropathy among diabetes mellitus patients at selected referral hospitals, in Amhara regional state Northwest Ethiopia, 2005–2021

Negalgn Byadgie Gelaw; Achenef Asmamaw Muche; Adugnaw Zeleke Alem; Nebiyu Bekele Gebi; Yazachew Moges Chekol; Tigabu Kidie Tesfie; Tsion Mulat Tebeje

doi:10.1371/journal.pone.0276472

Peer Review History

Original SubmissionOctober 26, 2022
16 Jan 2023 Decision Letter - Jacopo Sabbatinelli, Editor PONE-D-22-27723Prediction of the risk for diabetic neuropathy among diabetes mellitus patients at selected referral hospitals, in Amhara regional state Northwest Ethiopia, January, 2005- December 2021; Development and validation of risk prediction modelPLOS ONE Dear Dr. Gelaw, 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 Mar 02 2023 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. 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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. Please provide additional details regarding participant consent. In the ethics statement in the Methods and online submission information, please ensure that you have specified (1) whether consent was informed and (2) what type you obtained (for instance, written or verbal, and if verbal, how it was documented and witnessed). If your study included minors, state whether you obtained consent from parents or guardians. If the need for consent was waived by the ethics committee, please include this information. 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Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: 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 ****** 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: Negalgn Byadgie Gelaw et al. investigated the prediction of the risk for diabetic nephropathy in Ethiopia. In multivariable logistic regression, glycemic control, physical activity, hypertension, alcohol drinking, type of treatment, white blood cells and red blood cells count were statistically significant. Nomogram and mobile based tool were developed and AUC, discrimination performance by bootstrapping method, and classification and regression performance by machine learning were 73.2%, 71.7%, and 70.2%, respectively. Major comments 1. In lines 241-246, the complete diagnostic criteria should be presented. The thresholds of each diagnostic component should be shown. How many items should be positive for the diagnosis of diabetic neuropathy? What was the diagnostic criteria for the description of diabetic neuropathy in medical record? 2. In lines 161-179, the design of clinical study design is not well described. Since the authors predict the risk for diabetic neuropathy, they should perform the retrospective cohort study. The authors should describe the exposures and observation periods. 3. In page 10 and Table 1, the authors should describe the definition and thresholds of “rural vs urban”, “alcohol drinking”, “physical activity” and “unhealthy diet”. 4. In page 11 and Table 2, did the patients receive the GLP-1 receptor agonists? GLP-1 receptor agonists may be beneficial for the diabetic neuropathy. 5. In lines 408-411, the formula can be applied for the subjects with normal glucose tolerance (NGT), impaired fasting glucose (IFG), and impaired glucose tolerance (IGT)? The authors should use the continuous values rather than descreted values for the clinical parameters. Minor comments 1. In lines 79, 97, and 138, “burdon” should be “burden”. ****** 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.0276472.r001
Revision 1
17 Feb 2023 Author Response 1. . In lines 241-246, the complete diagnostic criteria should be presented. The thresholds of each diagnostic component should be shown. How many items should be positive for the diagnosis of diabetic neuropathy? What was the diagnostic criteria for the description of diabetic neuropathy in medical record? Authors response; we modified as your comment in revised manuscripit in line 241-246 the complete diagnostic criteria for diabetic neuropathy was different corrected in operational definition. We use clinical criteria and confirmed by different tests, since different type of neuropathies. The typical clinical sign and symptoms is numbness on hands and feet’s, pain, tingling, paraesthesia , gait ataxia and confirmed by pinprick and temperature examination, touch sensation by 10g monofilament, vibration sense by biothesiometer and ankle reflex In medical records, the medical doctors written as diabetic neuropathy after they took detailed clinical history, physical examination with advanced imaging technology. 2. In lines 161-179, the design of clinical study design is not well described. Since the authors predict the risk for diabetic neuropathy, they should perform the retrospective cohort study. The authors should describe the exposures and observation periods. Authors response; We were correct as in line 161-169 the design of the study is retrospective follow up study since our interest is follow the exposed groups (Diabetes mellitus patients) for 16 years to identify who is at risk of developing diabetic neuropathy and develop clinical model based on the data got from 808 DM patients for early diagnosis and applying early intervention to prevent further complication and death 3. In page 10 and Table 1, the authors should describe the definition and thresholds of “rural vs urban”, “alcohol drinking”, “physical activity” and “unhealthy diet”. Authors response; The operation definition and threshold of alcohol drinking, physical activity and unhealthy diet were correct and written in operational definition section 4.In page 11 and Table 2, did the patients receive the GLP-1 receptor agonists? GLP-1 receptor agonists may be beneficial for the diabetic neuropathy Authors response; After diagnosing DM, the patients took GLP-1 agonists medication to prevent diabetic neuropathy and other DM complication such as; retinopathy, nephropathy 5. In lines 408-411, the formula can be applied for the subjects with normal glucose tolerance (NGT), impaired fasting glucose (IFG), and impaired glucose tolerance (IGT)? The authors should use the continuous values rather than descreted values for the clinical parameters. Authors response; The clinical model formula used for all confirmed/diagnosed Diabetes mellitus patients with or without normal glucose tolerance to identify low or high risk of DM patients to develop diabetic neuropathy. If low risk, then counsel to try to keep their health condition or if high risk to try to improve their health condition by taking drugs accordingly , avoid eating fat contain foods, do physical exercise. Therefore, the formula is very important for all DM patients to predict diabetic neuropathy. Using clinical parameters as continuous is recommended to prevent loss of information but fore sake of developing mobile based tool and easily applicability, we categorized based on the standard criteria. Thank you!!! Attachments Attachment Submitted filename: Point by point response for editors.docx https://doi.org/10.1371/journal.pone.0276472.r002
20 Feb 2023 Decision Letter - Jacopo Sabbatinelli, Editor PONE-D-22-27723R1 Prediction of the risk for diabetic neuropathy among diabetes mellitus patients at selected referral hospitals, in Amhara regional state Northwest Ethiopia, January, 2005- December 2021; Development and validation of risk prediction model PLOS ONE Dear Dr. Gelaw, 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 Apr 06 2023 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, Jacopo Sabbatinelli, MD, PhD 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: 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 #1: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: 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 ****** 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: No ****** 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: Authors response: After diagnosing DM, the patients took GLP-1 agonists medication to prevent diabetic neuropathy and other DM complication such as; retinopathy, nephropathy. Please describe the percentage of the patients treated with the GLP-1 receptor agonists in Table 2. ****** 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.0276472.r003
Revision 2
10 Jul 2023 Author Response Dear Editors Manuscript ID: PONE-D-22-27723R1 First of all I would like thank for your expertfull comments to be eligible our work manuscript in your journal and I have one publication by other area and familiar with your PLOS ONE journal policies. Response to editors; As your request to amend the title either in the manuscript or online submission form. The title was amend in the manuscript which is identical in the original manuscript and revised manuscript with track changes as" Development and validation of risk prediction model for diabetic neuropathy among diabetes mellitus patients at selected referral hospitals, in Amhara regional state Northwest Ethiopia, 2005-2021" The other comments was corrected as response to reviewers and updated to be eligible as PLOS ONE journal guideline I was amend in the manuscript at all pages Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0276472.r004
24 Jul 2023 Decision Letter - Jacopo Sabbatinelli, Editor Development and validation of risk prediction model for diabetic neuropathy among diabetes mellitus patients at selected referral hospitals, in Amhara regional state Northwest Ethiopia, 2005-2021. PONE-D-22-27723R2 Dear Dr. Gelaw, 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, Jacopo Sabbatinelli, MD, PhD Academic Editor PLOS ONE Additional Editor Comments: Extensive language editing is recommended during the proofreading stage. https://doi.org/10.1371/journal.pone.0276472.r005
Formally Accepted
1 Aug 2023 Acceptance Letter - Jacopo Sabbatinelli, Editor PONE-D-22-27723R2 Development and validation of risk prediction model for diabetic neuropathy among diabetes mellitus patients at selected referral hospitals, in Amhara regional state Northwest Ethiopia, 2005-2021 Dear Dr. Gelaw: 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. Jacopo Sabbatinelli Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0276472.r006

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