PONE-D-22-07048Prospective longitudinal study with treated hypertensive patients in Northern-Bangladesh (PREDIcT-HTN) to understand uncontrolled hypertension and adverse clinical events: A protocol for 5-years follow-upPLOS ONE

Dear Dr. Ahmed Hossain,

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Professor Hafiz T.A. Khan, Ph.D, CStat

Academic Editor

PLOS ONE

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- https://www.nature.com/articles/s41598-018-27377-2

- https://bmccardiovascdisord.biomedcentral.com/articles/10.1186/s12872-019-1091-6

- https://pubmed.ncbi.nlm.nih.gov/29447174/

The text that needs to be addressed involves the Introduction

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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

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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: Yes

Reviewer #2: Yes

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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: Yes

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4. Have the authors described where all data underlying the findings will be made available when the study is complete?

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Reviewer #1: Yes

Reviewer #2: Yes

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Reviewer #1: Yes

Reviewer #2: Yes

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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: Abstract:

• Method:

o What does it mean by “treated hypertensive patients”? A little more clarification in the abstract would be great.

o “The participant will be right censored if the patient develops MACE or death due to any cause, lost to follow-up or at end of the study”. – Is this an extra “Or” in this sentence?

Introduction:

• Why is this study important? We already know most of the risk factors of hypertension or CVD now. The authors can add some additional justifications in the Introduction - what is so unique about the study? And why do they want to conduct search research in Bangladesh?

Methods:

•Study design and setting:

o Is there any justification for – why you want to follow up with the enrolled participants 12 monthly? The gap between the follow-up periods is long, but there will also be more recall bias, death, and loss to follow-up (refuse, absent, etc.). How will you be going to manage all of these?

o Please mention in the write up clearly – who will be excluded from the study? Figure 1 has all the details, but better to mention them in the write-up.

• Rationale for planned sample size:

o What percentage did the authors consider for the loss to the follow-up group?

Informed Consent form:

•Did the author plan to collect informed consent in every follow-up visit? If not, then the author should clearly mention the number of follow-up visits and how many years the participants will be followed-up?

Reviewer #2: Thank you for submitting your proposal to conduct this important research in northern Bangladesh. Certainly, there is a dearth of data regarding the hypertension control status and major adverse events in this part of the country as well as in Bangladesh. There are a few issues to be addressed to improve the quality and robustness of the study and make it more lucid.

There are a few instances where it is written that it will be done. However, what I believe is that these stages have already been done as per the time line set in the proposal. For example, in the abstract, it is written that the baseline data will be retrieved. Likewise, the participants have already given their consent and will not provide it. Please find these and correct them.

The first objective of the study stated must include the aim of investigating the 5-year incidence of MACE (Major Adverse Clinical Events).

3. An additional value could be added by taking the rate of attrition (not having a final visit at 12 months) and rates of several categories of attrition (mortality, withdrawal from the study, transfer to non-study clinics, and loss to follow-up without identifiable cause) into consideration as a secondary outcome. Please include it in the analysis plan as well.

As per the follow-up design of the study, the death of the participant shall be recorded based on the death certificate or through telephonic conversation with the patient’s attendance. It might not be robust, but it will surely be a transparent and executable study plan.

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Reviewer #1: No

Reviewer #2: No

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A prospective longitudinal study with treated hypertensive patients in Northern Bangladesh (PREDIcT-HTN) to understand uncontrolled hypertension and adverse clinical events: A protocol for 5-years follow-up

PONE-D-22-07048R1

Dear Authors,

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.

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Kind regards,

Hafiz T.A. Khan, Ph.D, CStat

Academic Editor

PLOS ONE

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Reviewers' comments: