PONE-D-22-22130Protocol for a systematic review of long-term physical sequelae and financial burden of multidrug resistant and extensively drug resistant tuberculosisPLOS ONE

Dear Dr. Akalu,

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 Mar 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:

• 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,

Jinsoo Min

Academic Editor

PLOS ONE

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When submitting your revision, we need you to address these additional requirements.

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2. Thank you for stating the following financial disclosure:

“No funding”

At this time, please address the following queries:

a)        Please clarify the sources of funding (financial or material support) for your study. List the grants or organizations that supported your study, including funding received from your institution.

b)        State what role the funders took in the study. If the funders had no role in your study, please state: “The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.”

c)        If any authors received a salary from any of your funders, please state which authors and which funders.

d)        If you did not receive any funding for this study, please state: “The authors received no specific funding for this work.”

Please include your amended statements within your cover letter; we will change the online submission form on your behalf.

3. Please include captions for your Supporting Information files at the end of your manuscript, and update any in-text citations to match accordingly. Please see our Supporting Information guidelines for more information: http://journals.plos.org/plosone/s/supporting-information.

Additional Editor Comments (if provided):

Please, find the attached reviewer's comments.

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. We may reject papers that do not meet these standards.

[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: Partly

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: Partly

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?

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: 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: This is a systematic review protocol on a very relevant phenomenon in Public Health based on the high impact of tuberculosis and resistance to drugs to treat this disease, to which it must be added that this reality is strongly increased in the countries of the Global South, contributing to increasing social inequalities in health. However, in order to accept this manuscript, I suggest that a number of issues be incorporated:

1. Introduction:

a. Citation number 1 appears to be from the WHO Global TB report, but the 2022 report is available, so the data should be updated. This raises the concern that the numbering of the references does not correspond to the number of the citation in the text, so all citations should be checked to ensure that they correspond to the references. Citation 3 appears before citation 2. The data in the current citation 2 should also be updated with the WHO 2022 report.

b. On lines 54 to 59: Are these the three sentences of reference 4? Even so, they do not seem to correspond because reference 4 alludes to data from an American Indian population.

c. In terms of study objectives, meta-analysis is a statistical technique, not a type of study like a systematic review, which cannot always be carried out, depending on the data found in the selected studies. Therefore, meta-analysis should be removed from the objectives.

2. Methods:

a. A 2015 version of PRISMA is cited, but should be replaced by the latest version in 2020.

b. Within the Search Strategy, Central (trials) from the Cochrane Library and other grey literature sources (Medicines/Drug Agencies). For strategy number 3 (Table 1), it is recommended to introduce more search terms, such as: ("Cost of Illness" OR "Cost of Sickness" OR "Financial Stresses” OR "Financial Stress" OR "financial pressure*" OR "Financial Hardship" OR "Financial Hardships" OR "Financial Challenges" OR "Economic Burden" OR "Financial toxicity" OR "Financial Impact" OR "health economics" OR "Financial Distress").

c. Within the Quality Assessment section, the Cochrane Handbook for Systematic Reviews of Interventions (Version 6.3, 2022) should be incorporated to assess the risk of bias in randomised and non-randomised studies of interventions. In addition, the Newcastle-Ottawa Scale (NOS), the Meta-analysis Of Observational Studies in Epidemiology (MOOSE) statement and the Grading of Recommendation Assessment, Development, and Evaluation (GRADE) need references.

3. Related to Data Availability: As this is a systematic review protocol, no data is currently available in an open access repository, but it would be advisable that the search strategies launched in the different bibliographic databases, as well as the RIS files of the retrieved documents, could be made available once the protocol has been executed.

Reviewer #2: - Line 46-48: I recommend using the recent (2022) global TB report for reporting some figures such as the global and local burden of TB. Almost all the estimates in the introduction should be updated using recent reports.

- In the first search term, I recommend including “Totally drug-resistant tuberculosis” as one of the search terms

- In the third search term, financial sequel, it is better to add “catastrophic health expenditure”, as one of the search terms

- In the fourth search terms, I recommend including terms such as “sequels” and “effect”

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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

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[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.

PONE-D-22-22130R1Protocol for a systematic review of long-term physical sequelae and financial burden of multidrug resistant and extensively drug resistant tuberculosisPLOS ONE

Dear Dr. Akalu,

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 Apr 28 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,

Jinsoo Min

Academic Editor

PLOS ONE

Additional Editor Comments:

Major revisions

(1) Find other reviews' comments and revise accordingly.

(2) Introduction section is too long. Please, modify the introduction section and reduce to two or three paragraphs. Remnant contents could be moved to the discussion section.

(3) Please, summarize the "methods and materials" and insert a new paragraph immediately after the "Discussion" heading.

(4) Write a new paragraph of 3-4 sentences at the end of the manuscript summarizing all the manuscript as a conclusion.

(5) Try to avoid unnecessary use of the abbreviation, which was only used for once or twice.

page 3 line 45 : COVID-19

page 4 line 84 : DS

page 11 line 205 : COPD

(6) Insert the full term when the abbreviation was first used in the manuscript.

page 2 line 30: RR

page 3 line 59 : DR-TB

page 11 line 221 : PRISMA ?? -> this abbreviation was used elsewhere in the manuscript before.

(7) others

page 9 line 164 : change "diabetes" to "Diabetes" (Use capital letter)

page 11 line 215 : Please, delete sub-heading, "strengths and limitations".

(8) Please, check and correct the all the grammatical errors.

page 5 line 93 : aim -> aims

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. We may reject papers that do not meet these standards.

If the language of a paper is difficult to understand or includes many errors, we may recommend that authors seek independent editorial help before submitting a revision. These services can be found on the web using search terms like “scientific editing service” or “manuscript editing service.

[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: 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: Although the authors use PRISMA-P (2015) for the systematic review protocol reporting items, for the supplementary file (S1 Table: Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) flow diagram for the summary of systematic review study selection process) they should use PRISMA 2020 (flow diagram for new systematic reviews which included searches of databases, registers and other sources (http://www.prisma-statement.org/PRISMAStatement/FlowDiagram))

Reviewer #2: Authors addressed all my comments on the manuscript. Hence, I recommend this protocol to be published.

**********

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.

Protocol for a systematic review of long-term physical sequelae and financial burden of multidrug resistant and extensively drug resistant tuberculosis

PONE-D-22-22130R2

Dear Dr. Akalu,

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 for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, 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,

Jinsoo Min

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Dear Dr. Akalu,

Thank you for your hard work on revising the manuscript. I am sorry that process of the review system took a long time.

I wish you great success in your future research.

Best regards,

Jinsoo Min

Reviewers' comments: