PONE-D-22-16726Self-Management in Pregnancy and Breastfeeding in Women with Type 2

Diabetes Mellitus from Thailand: A Convergent Parallel Mixed-Methods Study ProtocolPLOS ONE

Dear Dr. Phonyiam,

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 Jan 08 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.

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We look forward to receiving your revised manuscript.

Kind regards,

Ai Theng Cheong

Academic Editor

PLOS ONE

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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: Yes

Reviewer #2: Partly

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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: Partly

Reviewer #2: Partly

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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: No

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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: Yes

Reviewer #2: Yes

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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

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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: In general, this study seems feasible to be done. However, there are some comments that is needed to be clarified by the author. Kindly see the attached comments for full review.

Reviewer #2: Title:

The term 'breastfeeding' is rather broad. Suggest to write 'breastfeeding experiences' in parallel with the study objectives.

Abstract:

This study has two Major outcomes/ dependant variables which does not seem to be related, as these outcomes are rather major and encompasses many aspects on its own. Suggest to focus on one major outcome, i.e breastfeeding.

"Data will be collected from 20 pregnant women with preexisting type 2 diabetes mellitus in Thailand who are either primigravida or multigravida, aged 20-44 years old, speak the Thai language, and provide consent."- Provide consent- can be stated in methods, not in abstract.

"Using interviews and questionnaires data will be collected two times. The first time is during pregnancy where data on a woman’s diabetes self-management, breastfeeding confidence, and breastfeeding intention will be collected. The second time is 4-6 weeks postpartum and is about her breastfeeding experiences. Maternal health outcomes"- grammatical error.

"The first time is during pregnancy where data on a woman’s diabetes self-management, breastfeeding confidence, and breastfeeding intention will be collected. The second time is 4-6 weeks postpartum and is about her breastfeeding experiences.It is not clear on how data collection is going to be conducted during these two time-points."- Suggest to briefly elaborate which outcome will be assessed using quantitative and qualitative data respectively.

What ‘health outcomes’ in particular? Suggest to state briefly in abstract.

"This proposed study is significant because the findings will have a potential impact on improving two generations' health across a lifespan. Health care providers will apply the findings to deliver holistic care to women with type 2 diabetes mellitus."-There is lack of strong justification provided by author. Suggest to rephrase to highlight the unique contribution of this study.

Introduction

The introduction should not be presented with detailed statistics as such. Suffice to briefly elaborate the complications with appropriate citations.

"These adverse outcomes can be minimized with proper diabetes self-management during pregnancy."- citation needed.

"An appreciation of the cultural influences on how Thai persons with diabetes view their condition facilitated self-management [7], which in turn, may improve maternal and fetal health."- I don’t quite understand this statement.

"Mothers with T2DM are less likely to establish exclusive breastfeeding at hospital discharge (OR 0.4; 95% CI 0.2, 0.8; p = 0.006), compared to women without T2DM [12]."- Refer to my earlier comment on presentation of detailed statistics in introduction which is unnecessary.

"Further, the number of feedings in the first 24 hours was an independent positive predictor of breastfeeding four months postpartum (OR 1.158; 95% CI 1.021–1.314, p = 0.022), while maternal body mass index was a negative predictor (OR 0.848; 95% CI: 0.779–0.922, p < 0.001) [11]."- This statement seemed to be disjointed. Suggest to add on/ elaborate on other breastfeeding challenges that mothers with T2DM may face (rather than highlighting on the number of feeds and BMI which seemed to be irrelevant.

"The six-month EBF rate in Thailand is still far from optimal. Little is known about how diabetes affects a woman’s confidence and intention to breastfeed her infant and her breastfeeding experiences. Gaining a better understanding of Thai women’s diabetes management experiences during pregnancy and breastfeeding practices postpartum will inform evidence‐based clinical approaches to enhance the health of women with T2DM and their children in Thailand."- This paragraph seems to be disjointed. The earlier statement highlights the rate of EBM inThailand, which followed by ‘little is known about how diabetes affects woman’s confidence…’. Suggest to improve the flow of writing with better connections and relevance between statements.

Material and Methods

The aims of the study should be placed prior to the methods section.

With reference to my prior comment, I highly suggest that the research questions on diabetes self-management and breastfeeding are separated into two different studies.

Study Design

"...because we will discover the who, what, and where of diabetes management and breastfeeding experiences by gaining insights from women with T2DM."- Rephrasing needed (grammatical error).

Descriptive design? I am not sure if this is a common/usual term to be used to describe a quantitative study design. Do you mean to say cross-sectional study design?

Participant eligibility and recruitment

What if the women are diagnosed with T2DM but lack of experienced in T2DM self-management? Will these participants be eligible?

"Participants will be excluded if they have any significant complications such as blindness or life-threatening illnesses such as myocardial infarction."- Suggest to rephrase to more academically appropriate terms.

"These interest criteria were derived from the literature focused on pregnant women who will have various experiences on diabetes self-management in pregnancy [23, 24]."- I don’t quite understand this statement. Suggest to rephrase.

Ethical considerations

"Participants' rights to participate or withdraw from the study without any effect on care will be emphasized. The PI will give the women a chance to ask questions before deciding to participate in this study."- Redundant phrases as this is typically stated in patient information sheet.

"All participants will receive a signed copy of the consent form, which includes the PI’s study office number. They will be encouraged to call with any questions or concerns and the phone numbers for the offices of human subject protection for any questions they may have regarding their rights as study participants."- With reference to my prior comment, this statement typically stated in the participant information sheet/ consent form, hence not necessary to be elaborated in detailed in the manuscript.

Sample Size

"...conducting approximately 20 semi-structured interviews"- Do you have any literatures/ references as to why you chose 20 as your approximate sample size?

Interview Guide

"The interview guide lists open-ended and follow-up questions..."- Need to briefly elaborate the content of the interview guide, what aspects does it cover?

Physiological measures

It is not clear as to the purpose of acquiring these physiological measures as it is not stated as one of the study objectives.

Data Collection

"We will give the women a chance to ask questions before deciding whether to participate."- This is a redundant statement as it is not necessary to state in manuscript.

Time 2 data collection

"A mother’s fasting plasma glucose will be measured at the 4-6 weeks postpartum visit."- As per my previous comment, it is not clear as to the indication of this measurement as it is not included in the study objectives.

Data management

"All data will be kept in a locked file cabinet or computer behind a locked door."- This may not be necessary to be reported in a protocol.

Quantitative data

What do the authors meant by ‘inconsistent and abnormal values’?

Discussion

Will be good to elaborate further on this, on how the findings of this study may have an impact on patient-centred care.

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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: 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.

Attachments

Attachment

Submitted filename: PONE-D-22-16726 .pdf

Attachment

Submitted filename: PLOS ONE Manuscript PSJK review.docx

PONE-D-22-16726R1Self-management of type 2 diabetes mellitus in pregnancy and breastfeeding experiences among women in Thailand: Study protocolPLOS ONE

Dear Dr. Phonyiam,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

Please submit your revised manuscript by May 26 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,

Ai Theng Cheong

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.

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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: Yes

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: Yes

Reviewer #2: 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: Yes

Reviewer #2: 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 #1: The authors have addressed most of concern in the first review. There are still minor things to be improved. For further detail please refer attachment.

Reviewer #2: Overall, the authors have managed to address the feedback/ comments. However, I think the whole manuscript still needs to be proof read for minor grammatical correction. For example. in Line 60 and 62, the author wrote as 'a woman will complete questionnaires', 'a woman will be interviewed', this statements give the impression that only one woman will complete the questionnaire or will be interviewed (instead the authors could modify the statement by stating 'study participants will complete questionnaires', or 'eligible participants will be interviewed..' (suggestion).

Otherwise, the authors managed to revise the manuscript based on the comments and suggestions satisfactorily.

**********

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: 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.

Attachments

Attachment

Submitted filename: PONE-D-22-16726 (Post revision Review).docx

Self-management of type 2 diabetes mellitus in pregnancy and breastfeeding experiences among women in Thailand: Study protocol

PONE-D-22-16726R2

Dear Dr. Phonyiam,

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.

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Kind regards,

Ai Theng Cheong

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments: