Stepping forward: A study protocol for developing and validating a Malaysian diabetic foot self-care practice assessment instrument

Divya Nair Narayanan; Samsiah Awang

doi:10.1371/journal.pone.0337754

Peer Review History

Original SubmissionApril 10, 2025
5 May 2025 Decision Letter - Yee Gary Ang, Editor Dear Dr. Nair Narayanan, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. ============================== Please submit your revised manuscript by Jun 19 2025 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. 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, Yee Gary Ang, MBBS MPH 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. We note that the grant information you provided in the ‘Funding Information’ and ‘Financial Disclosure’ sections do not match. When you resubmit, please ensure that you provide the correct grant numbers for the awards you received for your study in the ‘Funding Information’ section. 3. Your ethics statement should only appear in the Methods section of your manuscript. If your ethics statement is written in any section besides the Methods, please move it to the Methods section and delete it from any other section. Please ensure that your ethics statement is included in your manuscript, as the ethics statement entered into the online submission form will not be published alongside your manuscript. 4. We note that you have indicated that there are restrictions to data sharing for this study. For studies involving human research participant data or other sensitive data, we encourage authors to share de-identified or anonymized data. However, when data cannot be publicly shared for ethical reasons, we allow authors to make their data sets available upon request. For information on unacceptable data access restrictions, please see http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. Before we proceed with your manuscript, please address the following prompts: a) If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially identifying or sensitive patient information, data are owned by a third-party organization, etc.) and who has imposed them (e.g., a Research Ethics Committee or Institutional Review Board, etc.). 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 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 recommended repositories, please see https://journals.plos.org/plosone/s/recommended-repositories. You also have the option of uploading the data as Supporting Information files, but we would recommend depositing data directly to a data repository if possible. Please update your Data Availability statement in the submission form accordingly. 5. In the online submission form, you indicated that data used in this study is not publicly available due to confidentiality restrictions. However, data can be accessed upon reasonable request and subject to approval from the corresponding author or the Head of Centre for Biostatics & Data Repository, National Institutes of Health, Ministry of Health Malaysia on reasonable grounds for the request and with the permission from the Director General of Health, Malaysia. All PLOS journals now require all data underlying the findings described in their manuscript to be freely available to other researchers, either 1. In a public repository, 2. Within the manuscript itself, or 3. Uploaded as supplementary information. This policy applies to all data except where public deposition would breach compliance with the protocol approved by your research ethics board. If your data cannot be made publicly available for ethical or legal reasons (e.g., public availability would compromise patient privacy), please explain your reasons on resubmission and your exemption request will be escalated for approval. [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions 1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions? Reviewer #1: Yes ******** 2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses??> Reviewer #1: Partly ****** 3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable??> Reviewer #1: No ****** 4. Have the authors described where all data underlying the findings will be made available when the study is complete??> The PLOS Data policy Reviewer #1: No ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English??> Reviewer #1: Yes ****** Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics. You may also provide optional suggestions and comments to authors that they might find helpful in planning their study. Reviewer #1: I see ethical problems with the use of items from other global scales and, worse, with the adaptation and modification of items from these scales without prior authorization from the authors of the original scales. I suggest taking the best scale and, with the authorization of the authors of the original scale, translating it into the language of your country. I recommend TO REFUSE to publish this article in its current form. ****** 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: THEREZA MARIA MAGALHÃES MOREIRA ******** [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.0337754.r001
Revision 1
19 May 2025 Author Response 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf Response: Thank you for the guidance. Where applicable and required, the manuscript has been reformatted to align with the PLOS ONE style requirements. 2. We note that the grant information you provided in the ‘Funding Information’ and ‘Financial Disclosure’ sections do not match. When you resubmit, please ensure that you provide the correct grant numbers for the awards you received for your study in the ‘Funding Information’ section. Response: Thank you for highlighting the discrepancy. • I have amended the ‘Funding Information’ as instructed to ensure it is accurate to reflect the following: This research is funded by the Ministry of Health Malaysia Research Grant [Grant reference number: KKM.400-4/2/30 Jld.2 (52)]. The funding body is not involved in the study design, data collection and analysis, publication decision, or manuscript preparation. • Nevertheless, I am unable to amend the 'Financial Disclosure' section, as I no longer have access to it, possibly because the journal has not granted permission for further edits to that section. 3. Your ethics statement should only appear in the Methods section of your manuscript. If your ethics statement is written in any section besides the Methods, please move it to the Methods section and delete it from any other section. Please ensure that your ethics statement is included in your manuscript, as the ethics statement entered into the online submission form will not be published alongside your manuscript. Response: Thank you for highlighting this important aspect. • We have now ensured that the full ethics statement is included exclusively in the “Methods” section (lines 377–389: marked up version), as advised. 4. We note that you have indicated that there are restrictions to data sharing for this study. For studies involving human research participant data or other sensitive data, we encourage authors to share de-identified or anonymized data. However, when data cannot be publicly shared for ethical reasons, we allow authors to make their data sets available upon request. For information on unacceptable data access restrictions, please see http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. Before we proceed with your manuscript, please address the following prompts: a) If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially identifying or sensitive patient information, data are owned by a third-party organization, etc.) and who has imposed them (e.g., a Research Ethics Committee or Institutional Review Board, etc.). b) Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent. c) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. d) 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 recommended repositories, please see https://journals.plos.org/plosone/s/recommended-repositories. e) You also have the option of uploading the data as Supporting Information files, but we would recommend depositing data directly to a data repository if possible. Please update your Data Availability statement in the submission form accordingly. Response: Thank you for your detailed guidance on data sharing requirements. • As this is a study protocol, no data have been generated or analysed at this stage. However, we acknowledge the importance of data availability and have updated the “Data Availability Statement” section in the manuscript and submission form to reflect the following: • As this is a study protocol, no datasets have been generated or analysed at this stage. Upon completion and publication of the study, de-identified relevant research data will be made available upon reasonable request from the corresponding author or the Head of Centre for Biostatics & Data Repository, National Institutes of Health, Ministry of Health Malaysia, and subject to approval by the Director General of Health, Malaysia. (as elaborated from lines 370-376: marked up version) 5. Reviewer #1: I see ethical problems with the use of items from other global scales and, worse, with the adaptation and modification of items from these scales without prior authorization from the authors of the original scales. I suggest taking the best scale and, with the authorization of the authors of the original scale, translating it into the language of your country. I recommend TO REFUSE to publish this article in its current form. Response: Thank you for your valuable feedback. We understand and appreciate your concerns regarding the use and adaptation of existing global instruments. • In response, we have carefully reconsidered our approach and have revised the protocol accordingly. • The proposed study will no longer involve the adoption or adaptation of any existing scales; instead, we intend to develop a new Malaysian-specific instrument. • To inform/guide this development, the comprehensive literature review will examine the strengths and limitations of previously established instruments. • Insights gained from this review will guide the design of our instrument, aligning it with the specific needs of Malaysian stakeholders while also ensuring internationally recognised constructs to support cross-cultural comparability. • We are also mindful of potential proprietary and licensing issues that may arise from using established tools. For example, the Morisky Medication Adherence Scale, which was previously adopted and adapted in our country, later required licensing fees that became too costly for sustained national use and was eventually discontinued. • Developing a contextually relevant instrument from the outset will help us avoid such challenges and ensure broader accessibility for future nationwide implementation. • We remain committed to ethical research practices and will ensure that content drawn from existing instruments are appropriately acknowledged and cited. • Additionally, we have expanded the methodological section to provide greater detail on our instrument development process. This is intended to enhance transparency and support replicability of the study by researchers in other countries with similar contextual needs. • Amended in manuscript (marked up version) in the following lines: � 28-31 � 92-95 � 97-99 � 120-125 � 147-151 � 158-165 � 174-178 � 256-257 � 312-315 � 321-322 � 326-328 � 391-392 � 421-423 6. Have the authors described where all data underlying the findings will be made available when the study is complete? Reviewer #1: No Response: Thank you for highlighting this important point. • As this is a study protocol, no datasets have been generated or analysed at this stage. • However, we have revised the manuscript under the “Data Availability Statement” clarifying that, upon completion and publication of the study, de-identified relevant data will be made available upon reasonable request from the corresponding author or the Head of the Centre for Biostatistics & Data Repository, National Institutes of Health, Ministry of Health Malaysia, and subject to approval by the permission from the Director General of Health, Malaysia. (as elaborated from lines 370-376: marked up version) 7. 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. Response: Thank you for the instructions. • All figure files have been uploaded to the Preflight Analysis and Conversion Engine (PACE) and have passed the required checks. • We have ensured that the figures meet PLOS formatting requirements. • Fig 1, Fig 2 and Fig 3 have been uploaded as .tif files, labelled accordingly (label of figure). Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0337754.r002
2 Jun 2025 Decision Letter - Yee Gary Ang, Editor Dear Dr. Nair Narayanan, 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. We only managed to find one reviewer Please make the changes and consider resubmitting Please submit your revised manuscript by Jul 17 2025 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. 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 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, Yee Gary Ang, MBBS MPH 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. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions? Reviewer #2: Yes ******** 2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses??> Reviewer #2: Partly ****** 3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable??> Reviewer #2: Yes ****** 4. Have the authors described where all data underlying the findings will be made available when the study is complete??> The PLOS Data policy Reviewer #2: Yes ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English??> Reviewer #2: Yes ****** Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics. You may also provide optional suggestions and comments to authors that they might find helpful in planning their study. Reviewer #2: The aim of this study protocol is describe the development and validation of a Malaysian diabetic foot self-care practice assessment instrument. In this revised version, the recommendations previously made have been taken into account and the manuscript has been improved, and I have only some minor comments. 1) At the end of the introduction, the aim and/or objectives of the study should be clearly defined. As the proposed study will first develop and then validate a national instrument, both aspects should also be mentioned in the objectives. As the authors have changed the structure of the study compared to the first version of the manuscript, they should also change the title. 2) Study type and design – please clearly state that the first stage is the development of the instrument and the second is the validation study. 3) Patients will be involved in the second phase of the study - validation through a cross-sectional study. However, the new instrument will be self-administered by the patients, so the patients should be involved already in the development process - from the definition of the topics/items of the instrument and the content validation, patients should be involved in the expert group, in addition it may be appropriate to conduct a qualitative survey among patients. ****** 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 ******** [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 https://doi.org/10.1371/journal.pone.0337754.r003
Revision 2
17 Jul 2025 Author Response Journal Requirements / Editor’s Comments: 1. Your ethics statement should only appear in the Methods section of your manuscript. If your ethics statement is written in any section besides the Methods, please delete it from any other section. Response: • Thank you for your attention to this detail. • I have carefully reviewed the entire manuscript to ensure that the ethics statement appears only in the Methods section. • The manuscript’s main sections are: Abstract, Introduction, Methods, Discussion, Conclusion, Acknowledgment, Supporting Information, and References. • Within the Methods section, the subheadings are: Study Type & Design, Phase 1: Development of the Malaysian Instrument, Phase 2: Validation of the Instrument, Study Population and Sampling, Statistical Analysis Plan, Data Management and Oversight, Data Availability Statement, and Ethical Approval & Study Registration. • I confirm that the ethics statement appears only under the Ethical Approval & Study Registration subheading within the Methods section and does not appear elsewhere in the manuscript. 2. • 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. Response: • We thank the reviewer for this important reminder. • In response, we undertook a thorough review of the entire reference list to ensure that every source cited is complete, verifiable, and fully compliant with PLOS ONE’s rigorous publication standards. • We confirm there were no retracted articles in the reference list. • Nevertheless, 3 references were removed as they may not meet the required standards for robust peer-review, retrievability, or scientific credibility: a. Goweda et al. (2017) was removed because it is not widely indexed and its content is sufficiently covered by stronger, peer-reviewed sources already included in the manuscript. b. AHS et al. (2018) was removed due to lack of indexing and unclear peer-review status. - To uphold the scientific foundation of this section, we actively replaced it with a more credible, peer-reviewed source (Sulistyo et al., 2018, Journal of Research in Nursing), which reports on the same instrument and context. c. Quadri et al. (2013) was removed as it is a conference abstract only, with no peer-reviewed full-text version available, and therefore does not meet PLOS ONE’s citation requirements. • By carefully verifying, removing, and replacing these references, we have taken deliberate steps to strengthen the scholarly rigor and integrity of the manuscript. • We have ensured that all references meet the journal’s expectations for transparency, retrievability, and quality. Reviewer’s Comments: 1. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses? The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory. Reviewer #2: Partly Response: • We have addressed these methodological aspects through our responses to the specific comments provided and have revised the manuscript accordingly to ensure sufficient detail, clarity, and transparency. 2. Review Comments to the Author: The aim of this study protocol is describe the development and validation of a Malaysian diabetic foot self-care practice assessment instrument. In this revised version, the recommendations previously made have been taken into account and the manuscript has been improved, and I have only some minor comments. Response: • We thank the reviewer for acknowledging the improvements and appreciate the constructive feedback provided throughout the review process. • We will address the remaining minor comments accordingly to further strengthen the manuscript. 3. Review Comments to the Author: • At the end of the introduction, the aim and/or objectives of the study should be clearly defined. • As the proposed study will first develop and then validate a national instrument, both aspects should also be mentioned in the objectives. Response: • We thank the reviewer for this valuable suggestion. • In response, we have revised the study objectives in both the Abstract and Introduction sections to explicitly state that the study involves both the development and validation of the national instrument. - Lines 23, 25, 26 (Abstract) - Line 130 (Introduction) • We believe this amendment clarifies the full scope of the study as intended. 4. Review Comments to the Author: As the authors have changed the structure of the study compared to the first version of the manuscript, they should also change the title. Response: • We thank the reviewer for this constructive suggestion. We concur that the revised structure of the study should be clearly reflected in the title. • Accordingly, we have amended the title to: “Stepping Forward: A Study Protocol for Developing and Validating a Malaysian Diabetic Foot Self-care Practice Assessment Instrument” and the short title to “Developing and validating a Malaysian diabetic foot self-care practice assessment instrument” • These revised titles more accurately represent the comprehensive scope of the study, which now encompasses both the development and validation phases of the proposed national instrument. 5. Review Comments to the Author: Study type and design - please clearly state that the first stage is the development of the instrument and the second is the validation study. Response: • We thank the reviewer for this helpful suggestion. • We have revised the manuscript to clearly state that Phase 1 involves the development of the instrument and Phase 2 involves its validation through a cross-sectional study design. - Lines 144-146 - Lines 383-386 6. Review Comments to the Author: • Patients will be involved in the second phase of the study - validation through a cross-sectional study. • However, the new instrument will be self-administered by the patients, so the patients should be involved already in the development process - from the definition of the topics/items of the instrument and the content validation, patients should be involved in the expert group, in addition it may be appropriate to conduct a qualitative survey among patients. Response: • We sincerely thank the reviewer for highlighting this important point. • We agree that incorporating patient perspectives is crucial to ensure that the instrument is clear, relevant, and practical for its intended users. • In Phase 1, the domains and items will be systematically drafted based on established national diabetic foot care guidelines and robust international evidence. • This initial version will undergo expert content validation by a panel of healthcare professionals with extensive experience in diabetic foot care to ensure clinical relevance and accuracy. • To ensure that the instrument also meets patient needs and expectations, patients will be involved in the face validity process in Phase 1 through pre-testing and cognitive debriefing. • This will include: - A short, structured feedback form for patients - Cognitive debriefing interviews to gather in-depth feedback on wording, cultural appropriateness, and ease of use • We will carefully analyse this feedback to refine the instrument before proceeding to piloting and field-testing in Phase 2 : Lines 216–232 • This multi-step approach ensures that the instrument content is evidence-based, clinically sound, and meaningfully co-shaped by patient input, hence maximizing its practical usability and cultural appropriateness. Attachments Attachment Submitted filename: Response to Reviewers (Cycle 2).docx https://doi.org/10.1371/journal.pone.0337754.r004
14 Nov 2025 Decision Letter - Yee Gary Ang, Editor Stepping forward: A study protocol for developing and validating a Malaysian diabetic foot self-care practice assessment instrument PONE-D-25-16530R2 Dear Dr. Nair Narayanan, 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. For questions related to billing, please contact billing support . 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, Yee Gary Ang, MBBS MPH Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions? Reviewer #2: Yes Reviewer #3: Yes ******** 2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses??> Reviewer #2: Yes Reviewer #3: Yes ****** 3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable??> Reviewer #2: Yes Reviewer #3: Yes ****** 4. Have the authors described where all data underlying the findings will be made available when the study is complete??> The PLOS Data policy Reviewer #2: Yes Reviewer #3: Yes ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English??> Reviewer #2: Yes Reviewer #3: Yes ****** Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics. You may also provide optional suggestions and comments to authors that they might find helpful in planning their study. Reviewer #2: In this revised version, the recommendations previously made have been taken into account and the manuscript has been improved, and I have no further suggestions. Reviewer #3: The revision is clear and practical, and the steps are easy to follow for replication. The study idea fits well with current work in this area. I don’t see major problems. I think this protocol can be accepted for publication. ****** 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: Yes: Kaja Põlluste Reviewer #3: No ******** https://doi.org/10.1371/journal.pone.0337754.r005
Formally Accepted
Acceptance Letter - Yee Gary Ang, Editor PONE-D-25-16530R2 PLOS One Dear Dr. Nair Narayanan, 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 You will receive further instructions from the production team, including instructions on how to review your proof when it is ready. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few days 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. You will receive an invoice from PLOS for your publication fee after your manuscript has reached the completed accept phase. If you receive an email requesting payment before acceptance or for any other service, this may be a phishing scheme. Learn how to identify phishing emails and protect your accounts at https://explore.plos.org/phishing. 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. Yee Gary Ang Academic Editor PLOS One https://doi.org/10.1371/journal.pone.0337754.r006

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 .