https://orcid.org/0009-0004-8766-0358
Peer Review History
| Original SubmissionJuly 17, 2023 |
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PONE-D-23-20966Prevalence and monitoring utility of glycated albumin among diabetic patients attending clinic in tertiary hospitals in Dodoma, Tanzania: A cross-sectional study protocolPLOS ONE Dear Dr. Mkumbi, 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 Nov 11 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:
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, Fredirick Lazaro mashili, MD, PhD 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 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 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. If you are reporting a retrospective study of medical records or archived samples, please ensure that you have discussed whether all data were fully anonymized before you accessed them and/or whether the IRB or ethics committee waived the requirement for informed consent. If patients provided informed written consent to have data from their medical records used in research, please include this information. 3. 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. 4. In your Data Availability statement, you have not specified where the minimal data set underlying the results described in your manuscript can be found. PLOS defines a study's minimal data set as the underlying data used to reach the conclusions drawn in the manuscript and any additional data required to replicate the reported study findings in their entirety. All PLOS journals require that the minimal data set be made fully available. For more information about our data policy, please see http://journals.plos.org/plosone/s/data-availability. Upon re-submitting your revised manuscript, please upload your study’s minimal underlying data set as either Supporting Information files or to a stable, public repository and include the relevant URLs, DOIs, or accession numbers within your revised cover letter. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. Any potentially identifying patient information must be fully anonymized. Important: If there are ethical or legal restrictions to sharing your data publicly, please explain these restrictions in detail. Please see our guidelines for more information on what we consider unacceptable restrictions to publicly sharing data: http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. Note that it is not acceptable for the authors to be the sole named individuals responsible for ensuring data access. We will update your Data Availability statement to reflect the information you provide in your cover letter. Additional Editor Comments: The authors present a protocol of a planned study aimed at determining the prevalence and monitoring utility of glycated albumin among diabetic patients attending clinic in tertiary hospitals in Dodoma, Tanzania. The study is relevant, and the document provides a clear outline of the study's intent, methodology, and expected outcomes. The research seems well-thought-out, with comprehensive planning around data analysis and ethical considerations. Enhancements can be made in clarifying certain sections and ensuring that all potential limitations and implications are thoroughly addressed as follows. 1. A range of statistical techniques have been listed, indicating a comprehensive plan to thoroughly analyze the data. However, the authors have mentioned calculating a percentage for demographic variables (e.g., gender, place of residence). They should be cautious with smaller sample sizes as percentages may not provide a true representation. Actual counts or proportions might be more informative in such cases. 2. The inclusion of Cronbach's alpha to assess data reliability is a strong addition. 3. The research plan has clearly laid out the ethical considerations and approvals needed. It's good to see the references to consent and the process for withdrawing from the study. For completeness and clarity, the authors should consider having a plan to handle any adverse events or complications that might arise from the blood draw. 4. The timeline is straightforward. However, depending on the sample size, two months for data collection and only one month for analysis might be tight, especially if unforeseen issues arise. If that is the case the authors can consider amending their protocol based on realistic timelines and add in the protocol some of the comments raised here. 5. Comparison of GA and HbA1c is an essential part of this work. Ensure that the benefits and limitations of each are clearly demarcated and not mixed. Additionally, while the authors have addressed the clinical implications of HbA1c and GA, it may be worth briefly mentioning any cost or accessibility differences between the two, if relevant. 6. It's commendable that they have addressed potential study limitations, but consideration to adding a dedicated "Limitations" section will improve clarity. 7. The conclusion neatly sums up the relevance of the study. However, considerations to add potential implications for policy or clinical practice based on expected findings will add value. 8. The conclusion mentions the "current gold standard marker." However, a reader unfamiliar with the topic might benefit from clarifying that HbA1c is that standard marker. 9. Consider adding a statement about the potential for presenting findings at conferences or symposiums, if applicable. 10. While the hospitals and participants have been acknowledged the authors should also consider acknowledging any funding or grants that supported this work, if applicable. 11. Consider registering the study to one of clinical research data bases like clinical trial.gov 12. Lastly, they should ensure a thorough proofreading for grammatical and typographical errors before the final submission. [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? The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field. Reviewer #1: No 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? 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 #1: Yes Reviewer #2: Yes ********** 3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable? Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible. Reviewer #1: Yes 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 requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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: No Reviewer #2: No ********** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes Reviewer #2: No ********** 6. Review Comments to the Author 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. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: 1. The manuscript is written in the future tense while the study has already been conducted, additionally the manuscript reads like a research proposal. 2. Although there is a discussion section there are no results to be discussed. 3. Manuscript arrangement needs to follow standard journal format 4. Results and conclusion seem to be missing from abstract 5. Key references are needed, for example: “Additionally, it is suitable for individuals’ undergoing hemodialysis and its levels are unaffected by anaemia or haemolytic processes. GA is preferable to fructosamine because it is not impacted differently by different serum proteins” Reviewer #2: GENERAL COMMENTS 1. I would advise thoroughly checking any typos and grammatical problems throughout the study protocol. This will make the proposal more comprehensible and professional-looking. For instance, glycosylated and glycated hemoglobin are mixed in various locations. 2. There are some repetitions of similar explanations in the paragraphs. This repetition can be confusing for the reader and can make the study protocol not appealing and seem less polished. Authors should thoroughly revise the whole document and make sure they remove/paraphrase wordy sentences and descriptions recurring in different sections. For example, The explanations about data collection by the use of questionnaires have been repeated several times in the text. 3. Why were other factors that may affect glycemic control like physical activity, and diet not considered.? 4. Authors should define all abbreviations the first time they are used. Also, abbreviations should be used consistently throughout the study proposal. 5. Under the Discussion section, authors should revise thoroughly and provide a reference for the applicability of cross-sectional studies in studying the Validity of diagnostic tests. SECTIONS COMMENTS. 1. Introduction Add a section describing the prevalence of poor glycemic control in Tanzania 2. Sample size estimation. Can the authors provide any justification for using the cited reference from Uganda with a prevalence of 84.3%? There are a number of published studies conducted in Tanzania with a lower prevalence of poor glycemic control which would be a better choice than the one used. 3. Exclusion and Inclusion criteria How will you identify these patients? “Patients who are at risk of receiving or donating blood” Will the study not consider specific types of diabetic patients? E.g Type 1, type 2, autoimmune diabetes e.t.c? 4. Clinical examination The names, brands and models, and city of manufacture of the equipment and machines should be written in brackets. For example, you write: "A blood pressure (BP) reading will be taken using an automated digital machine (AD Medical Instruments, Beijing, China)." Revise this throughout the manuscript. 5. Data collection methods. Revise the dates for the commencement of data collection and, pilot study In this section, it is stated that BP will be measured using a Mercury sphygmomanometer while in contrast to the previous section (clinical examination), it is clearly explained that BP will be gauged using an automated digital BP machine. To make it clear why is this so? 6. Independent variables Revise the paragraph describing Glycemic control. what you describe is not related to the description of glycemic control as the independent variable. The paragraph is poorly organized, incoherent and congested with unnecessary explanations. 7. Ethical issues Give a concise elaboration. Don't repeat explanations from the methodology sections. 8. Discussion Provide a reference for the use of HbA1c a Gold standard method. A number of studies recommend OGTT as the Gold standard method. Add more limitations of the study. 9. Dissemination of the findings The statement “different peer-review journals for publication” should be revised. Duplicate or Salami publication is unethical in research. Manuscript should be submitted to only one peer-reviewed journal. After the previous submission's editorial decision has been made, resubmissions are permitted. . ********** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #2: Yes: Oscar Mbembela ********** [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. |
| Revision 1 |
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PONE-D-23-20966R1PREVALENCE OF POOR GLYCEMIC CONTROL AND THE MONITORING UTILITY OF GLYCATED ALBUMIN AMONG DIABETIC PATIENTS ATTENDING CLINIC IN TERTIARY HOSPITALS IN DODOMA, TANZANIA: A CROSS-SECTIONAL STUDY PROTOCOLPLOS ONE Dear Dr. Mkumbi, 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 address the comments raised by one of the reviewers
Please submit your revised manuscript by Mar 09 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:
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, Fredirick Lazaro mashili, 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. Additional Editor Comments: Please address the comments raised by one of the reviewers [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? The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field. 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? 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: Yes Reviewer #3: Yes ********** 3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable? Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible. 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 requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #2: Yes Reviewer #3: 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 #2: Yes Reviewer #3: Yes ********** 6. Review Comments to the Author 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. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #2: Extensive revisions have been made by the authors as it was suggested. I would therefore recommend accepting the manuscript for publication Reviewer #3: REVIEWER COMMENTS The authors intend to determine the prevalence of poor glycemic control and the utility of serum glycated albumin (GA) as an index of glycemic control in diabetic patients. The proposed study is important since GA appears to be of great potential in diagnostic efficiency, relatively less costly and the possibility of GA equipment automation. In turn, GA as biomarker for glycemic control will be useful in limited resource settings such as Tanzania. Nevertheless, the authors need to address the following comments; 1. It is not clear why the authors will screen for eligibility among patients diagnosed with diabetes mellitus for over six months. What was the basis for using 6 months as a cut-f point for eligibility to participate in the study? 2. The authors intend to conduct an interview and self-administer the questionnaire among those would wish to do so. In addition, those wishing to self-administer the question will be given a Swahili version questionnaire. How is this likely to affect the study findings? 3. The authors describe that they will perform physical examinations and/or obtain information such as blood pressure, body mass index and electrocardiogram. However, the relationship between such parameters and the validity of GA in glycemic control is not clearly described in the introduction and methods section such as in the analysis section. ********** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #2: Yes: Oscar Mbembela Reviewer #3: 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.
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| Revision 2 |
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PREVALENCE OF POOR GLYCEMIC CONTROL AND THE MONITORING UTILITY OF GLYCATED ALBUMIN AMONG DIABETIC PATIENTS ATTENDING CLINIC IN TERTIARY HOSPITALS IN DODOMA, TANZANIA: A CROSS-SECTIONAL STUDY PROTOCOL PONE-D-23-20966R2 Dear Dr. Mkumbi, 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, Fredirick Lazaro mashili, MD, PhD Academic Editor PLOS ONE Additional Editor Comments (optional): The authors have sufficiently addressed all the comments raised by the reviewers. 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? The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field. 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? 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 #3: Yes ********** 3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable? Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible. 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 requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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 #3: 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 #3: Yes ********** 6. Review Comments to the Author 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. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #3: The manuscript is well written and the methodology is valid. Nevertheless, the authors have responded that... "The six-month period has no meaning and was chosen arbitrarily just to exclude new and unstable diabetic patients from participating in the study while targeting stable anti-diabetic medication clients that have been at least on medication for some time and are assumed to have a set regimen that they adhere to. This aligns with the goal of the study to estimate glycemic control and suggest a better test, rather than to diagnose the disease." Therefore, it is my opinion that such reasoning needs to be incorporated in the discussion section to enable the readers understand why the cut-off point for inclusion was set to be six months, and possibly state how this is likely to or not affect the study findings. ********** 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 #3: Yes: Alexander Mtemi Tungu ********** |
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