PONE-D-22-31768

Sexually Transmitted Infections among Key Populations in India: A Protocol for Systematic Review

PLOS ONE

Dear Dr. Biswas,

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.

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Kind regards,

Addisu Melese Dagnaw, MSc

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: Yes

Reviewer #3: No

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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

Reviewer #3: No

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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

Reviewer #3: 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

Reviewer #3: No

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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

Reviewer #3: 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: This protocol is well written, with a clear objective to get a better insight in the prevalence of four major sexually transmitted infections in India. I have only some minor comments to further improve the manuscript.

Minor comments and editorials

Introduction

-In line 9 is mentioned that ‘almost half of them are much younger of age’. This is not comprehensive. Half of what? Younger than who? Please clarify and adjust this sentence.

-Line 14: In this line STIs and HIV is written. Hiv infection actually is an STI. Please adjust.

-Line 29: please remove the comma between ‘STIs’ and ‘are’.

-Line 44: Please add ‘probably’ before ‘much higher’, since the STI prevalences are the subject of this study.

-Line 45: It is mentioned that ‘there is limited literature’ which is indeed why this review will be performed, but of course there are still relevant studies available. It would be good to already refer to some major studies here.

-In line 48 reference 9 is given. It suggests that this will refer to key populations in India but that is not the case in ref 9. Please adjust.

Objective

-Line 61: please add ‘the’ before ‘present’.

-Line 70: Please remove the hard return.

Methods

-Lines 147-154: please consider to add a ‘snowballing strategy’ (=use references within references)

-Line 181: please rewrite to ‘will be included’

Strengths and limitations

-Line 233-234: ‘moreover, future included…’: this sentence is not comprehensive; please rewrite.

Conclusions

-Line 243: Actually there are no conclusions yet. Maybe rename this paragraph ‘Discussion’? Also in the abstract?

-Line 248: ‘NACP’ should probably be ‘NACO’?

-Line 250: Please adjust to ‘systematic’

Reviewer #2: 1. Methodology

i. This review may include studies that use different methods for diagnosing STIs, such as the Nucleic Acid Amplification Test (NAAT) – the gold standard test for N. gonorrhea, C. trachomatis, and T. vaginalis – as well as those that rely on clinical examination instead of laboratory investigations.

What strategy will be utilized for this issue (as it will have an impact on the pooled prevalence; varying sensitivity specificity of diagnosis methods)? This must be mentioned in the method section.

ii. Is there any operational definition for the 'geographical region' mentioned in the protocol? This may be clearly stated as it is not clear how the data will be pooled/analyzed/presented in later stages. e. g. Does the geographical region mean physical divisions of Indian Geography ? or state-wise division or zone-wise?

iii. Though from the protocol it appears that authors will be considering only observational designs, it makes it more convenient for all readers if the types of study designs, to be included, are mentioned clearly at the outset.

2. Data extraction:

Suggestion: i. You may consider enumerating a few details of the extraction form. Some of them may be sample size, setting, urban/rural, duration of the study, completeness of follow-up, enumeration of variables that are adjusted in the included study, and other factors that may influence the validity of the results. Also, administrative details like: study author, year, place, published/unpublished status

3. Data analysis:

i. The software to be used doing the meta-analysis (Individual and/or cumulative pooled prevalence )may be mentioned.

ii. Suggestion: Consideration for subgroup analysis e.g. based on categories chosen: MSM, TGs, IV drug users, and FSWs; Based on the state's population and size; per capita. income; state categorization based on the health index (NITI Aayog)

iii. Few details on how the assessment of heterogeneity will be done needs to mentioned.

iv. Do the authors plan to conduct sensitivity analyses in cases of substantial heterogeneity?

v. How the missing data will be dealt?

4. Abstract of the protocol:

i. There is literature from India substantiating the high STI prevalence among the sub-population considered for this review ( e.g. Syphilis prevalence, was reported to be 13% among MSM in Mumbai in a study published in 2009) hence assuming word in the abstract i.e., "assumed that STI prevalence is much higher among subpopulations practicing high-risk behavior", may be modified.

ii. Please specify the tools to be used for risk of bias, and quality assessment mentioned in the abstract. Please clarify the role of the Funnel plot.

iii. The authors have taken on an intriguing topic for this review, however, their abstract conclusion is not adequately supported. Therefore, the conclusion may be rephrased in a manner that emphasizes and highlights the unique contributions that this review makes to the existing body of literature.

Reviewer #3: Thank you for the opportunity to review this protocol. Overall, this protocol requires a major revision before it could be submitted for the consideration. This will also require an English editing before resubmission.

Specific comments:

Abstract:

- Background could be shortened.

- For objective, recommend to only include the main objective of the study rather than providing the rationale behind it, which could be part of a background section.

-Need to elaborate the methods section. What would be the inclusion criteria for the selection of articles (e.g., time period, language etc.)? What key words will be used?

Introduction:

- Page 2, Line 8: How is the information on young age relevant to the context of this study?

-Page 2, Line 13 and 16: Spell out the abbreviations when using for the first time in the text.

- Page 2, Line 30: Needs citation.

- Needs more concrete rationale/justification for the conduct of this systematic review.

- Objective could be included in the last paragraph of the introduction section.

- Objective A: Isn't synthesis part of a systematic review? In systematic review, we synthesize study findings from the relevant articles.

Materials and Methods:

- Requires overall revision of this section.

- Page 3, Line 75: Authors have specified "A study protocol (published)". This indicates that the protocol is already published. If it's already published, why is there a need of publishing the protocol again?

- What geographical divisions will be sued by the authors?

- Page 3, Line 97: What's the reason behind selecting the given timeline is not clear.

- Authors should consider writing methods section in paragraph rather than in bullet points.

- Strengths and limitations section needs to be more developed as well as paraphrased.

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If you choose “no”, your identity will remain anonymous but your review may still be made public.

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Reviewer #1: Yes: Sylvia M. Bruisten

Reviewer #2: Yes: Dr. Ranadip Chowdhury, Dr. Barsha Pathak

Reviewer #3: No

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Sexually Transmitted Infections among Key Populations in India: A Protocol for Systematic Review

PONE-D-22-31768R1

Dear Dr. Biswas,

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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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,

Addisu Melese Dagnaw, MSc

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?

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: All comments were answered to satisfaction and the paper is now acceptable for publication.

Please still check all grammar carefully. For example, 'Discussion' not 'discussions'. The results of the systematic review will be interesting.

Reviewer #2: The authors have addressed all comments adequately. I have no further comments. The manuscript can be accepted.

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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: Yes: Sylvia Bruisten

Reviewer #2: Yes: Ranadip Chowdhury

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