PONE-D-20-10140

Ten-years cardiovascular risk among the Bangladeshi population using non-laboratory-based risk chart of the World Health Organization: findings from a nationally representative survey

PLOS ONE

Dear Dr. Hanif,

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Giuseppe Vergaro, M.D., Ph.D.

Academic Editor

PLOS ONE

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Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Yes

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: No

Reviewer #2: Yes

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3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

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4. Is the manuscript presented in an intelligible fashion and written in standard English?

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Reviewer #1: Yes

Reviewer #2: Yes

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5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: In this paper, Abu Abdullah Mohammad Hanif and colleagues have addressed the estimation of CVD in Bangladeshi population based on non-laboratory-based charts.

This paper explores the topic of estimation and prevention of CVD in low income countries and it is therefore of interest for publication. It is a well displayed work with reasonable methodological section and interesting results.

I have nonetheless several issues to be addressed

Methods section

- In the “sample size and sampling techniques” section the Authors state that a sample size of 62 individuals from each cluster for each group was sampled. However, the age groups should be defined in the Methods section.

- In the Statistical analysis section the Authors state that they imputed missing values. However, imputation analysis might affect the results. A per protocol assessment of the results should also be performed.

- In the Statistical analysis section, the Authors have stated to have performed a bivariable logistic regression analysis. The variables enlisted should be declared. Why did the Authors choose a bivariable approach rather than a two step univariable-multivariable logistic regression analysis?

- In the variables considered to be relevant for CVD risk, family history is missing. The Authors further address the issue of genetics in the limitations section of the manuscript; however, family history is a relatively easy information to acquire. Can the Authors comment on this issue and add the family history data, if available?

Results section

- A CONSORT diagram would help the reader understanding the estimation of the population addressed, going from 30005 participant enrolled to 7757 actual data.

- The percentage 189% in line 294 is wrong and should be revised.

- The sentence in lines 294-296 is hard to understand and should be rephrased.

- In Table 1, the Authors enlist the general sociodemographic, behavioral and biological characteristics of the population. However, an analysis based on sex has also being carried on. Why did the Authors choose to stratify the population according to sex rather than other variables included in the WHO chart (i.e. Blood pressure)? The p-values addressed in the table are for multivariable comparisons? If so, sub-analyses for significantly different variables should also be performed.

- A figure on the prevalence of CVD and the prevalence of a risk>10% can help the reader focus on the main result of the paper.

- A Table assessing each variable of the WHO chart per risk category should also be performed to understand which risk factors account for the general CVD risk and on which it is possible to intervene (for example, diabetes or blood pressure rather than sex).

- What are the multivariable analysis adjusted for? Which is the covariate? Why did the Authors decide to stratify the population according to gender?

Discussion

- The sentence in lines 352-353 in difficult to understand and should be rephrased.

- Did the Authors consider to perform a lab-based analysis in a subgroup of their population? This could have validated their non-lab-based approach. Otherwise, the conclusions contained in lines 363-365 are too strong and should be rephrased.

- The paragraph between lines 389-396 is too general. Consider rephrasing.

- The intervention on CVD by primary physicians based on non-lab-based charts can only be hypothesized with this study, as follow up data were not collected. Therefore, the conclusions driven in lines 401-404 should be referred to as hypothetical.

References

- Ref 6,7, 15 and 19 are incomplete.

Reviewer #2: In the present paper, Abu Abdullah Mohammad Hanif and Colleagues aimed to investigate the role of a non-laboratory based cardiovascular disease (CVD) risk chart, recently developed by the World Health Organization (WHO)1, in assessing the prevalence of ten years CVD burdenamong Bangladeshi population aged 40-74 years.Parameters used in the risk algorithm were age, sex, smoking status, body mass index and systolic bloodpressure.They obtain six groups based on the calculated risk score:no risk (<5%), low risk (5% to <10%), moderate risk (10% to <20%), high risk (20% to <30%) and very high risk (≥30%).Then Authors listed potential factors associated with elevated CVD risk (defined as CVD risk ≥10%) among the subjects studied,based on literature review andconsidering data availability from this survey.Sociodemographic variables included place of residence (rural, non-slum urban, and slum), education, household income, marital status and religion; among the behavioralvariables were physical activity, sedentary time,fruits and vegetable consumption, and smokeless tobacco consumption status.So the study deals with an interestingissue concerning resource optimization topic; in low income countriesanon-laboratory based chart couldhelp the health care workers in screening, primary management counseling and referral of patients at higher risk of cardiovascular eventsto further evaluation. On the other hand, there aresome methodological limitations that could weak the strength of these findings,in particular data accuracy and poor method description.

Major points

-In the method session about sample size and sampling techniques,Authors have selectedpatients according to origin area: rural, urban and slum zone. For each cluster research assistants listed households based onage groups; could author clarify age range and better defined it (year of age or age range as listed in table 1?). Moreover,it could be interesting screening patients also by genderin order to have balanced groups of the same age

-In the method session authorsrecorded “self-reported diabetes”if subjects had declared this comorbidity; it could be useful regarding the elevated risk of CVD in this cluster of patients also checking old blood chemistry exams, when available.

-Method session need furtherexplanation; authors refer toa non-laboratorybasedCVD risk chart, recently developed by the World Health Organization1; but in the aforementioned model were included participants without a known baseline history of cardiovascular disease; this aspect isnot clarified in the study. Moreover,there are a lot of relevant parameters that are associated to an elevated risk of CVD, such as family history, chronic renal disease, carotid atherosclerosis,that have not been reported. All these variables are easily obtainable through an interview and have a significantly weight in the selection of clusters of subjects at higher risk of adverse events.

-In the “explanatory variables” session Authors defined outcome variable as elevated CVD risk if the total CVD risk score was ≥10% and CVD risk if the risk score was <10%; how they establish this cut-off?This choice needs further explanation.

-In the Statistical analysis section Authors carry out bivariate logistic regression analysis, but they don’t itemize thevariables sorted. Why did Authors employ a bivariable approach rather than a two-step univariable-multivariable logistic regression analysis?

-In the result section Authors state that they extracted data of 7,757 males and females aged from 40 to 74 years old as the WHO CVD risk chart is only applicable for this age groups, please clarify this content, since in the referral model1 were included participants aged 40-80 years old.

-An explicative graphic of the study design could be helpful in evaluating patient screening from the initial 17,323 households to the effective 7,757 subjects studied.

-In Table 1, are p-values referred tomultivariable comparisons? Probably in this situation asub-analysisfor significantly different variables should be performed.

-Could authors explain why in table 2 they considered only sociodemographic characteristics? -All results are itemizedin fourtables;this presentation method could make occult some relevant data; afigure about the prevalence of CVD in the different risk categories could focus on thetopic of the paper.

-Could authors explain whatare the multivariable analysis adjusted for and which is the covariate?

-In the discussion session Authors state “this analysis revealed that without even any laboratory procedures, the primary health care worker would be able to assess the CVD risk of the population and initiate management/referral procedure following national protocols for the CVD risk”(lines 363-365); without follow-up data and in the absence of a comparison witha lab-based analysis (also in a subgroup of their sample size) they could not sentencing this content.

-In the discussion session the assertion: “insufficient physical activity may cause overweight, high blood pressure, and increase the level of bad cholesterol; tobacco can damage and narrow the blood vessels with harmful substances and, high blood sugar levels can damage the blood vessels, and all of these eventually cause CVDs”(lines 393-396) is too generic; please reward.

-Finally,considerationsabout the usefulness of a nonlab-based algorithm adopted byphysicians for implementing subsequent prevention and management options (line 397-399) can only be hypothesized, since follow-up data are missing.

Minor points

-Please correct line 294 where we read 189% vs. 16%

-References are to be corrected

-Please grammatically correct line 295 where probably verb is missing

-Please correct line 317: “,)”

-Please correct line 339: a bracket is missing

References

1) Kaptoge S, Pennells L, BacquerDD, Cooney MT, Kavousi M, Stevens G, et al. World Health Organization cardiovascular disease risk charts: revised models to estimate risk in 21 global regions. The Lancet Global Health. 2019;7(10):e1332-e45

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Reviewer #1: No

Reviewer #2: No

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Attachments

Attachment

Submitted filename: revision bangladeshi.pdf

PONE-D-20-10140R1

Ten-years cardiovascular risk among the Bangladeshi population using non-laboratory-based risk chart of the World Health Organization: findings from a nationally representative survey

PLOS ONE

Dear Dr. Mridha,

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 all the minor points raised during the review process.

Please submit your revised manuscript by May 30 2021 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: http://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,

Giuseppe Vergaro, M.D.

Academic Editor

PLOS ONE

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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. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

Reviewer #2: All comments have been addressed

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2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Partly

Reviewer #2: Yes

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3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

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: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: The Authors have reviewed extensively the paper and answered appropriately to the comments made by the Reviewers.

I have still two minor issues: the p values in the tables should be mentioned and not eliminated at all, now that the Tables have been clarified for the reader.

Also, in the Methods section, an effect size of 1.6 is mentioned, which is very wide. The sample size calculated might therefore be misleading. Please clarify.

Reviewer #2: The authors have adequately addressed my concerns. The study deals with an interesting issue regarding resource optimization topic. A non-laboratory based chart could help health care workers in screening, primary management counseling and referral of patients at higher risk cardiovascular events to further evaluation

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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.

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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.

Ten-years cardiovascular risk among the Bangladeshi population using non-laboratory-based risk chart of the World Health Organization: findings from a nationally representative survey

PONE-D-20-10140R2

Dear Dr. Mridha,

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,

Giuseppe Vergaro, M.D.

Academic Editor

PLOS ONE