PONE-D-23-18845Evaluation of radiological capacity and usage in paediatric TB diagnosis: Protocol of a comparative study in Mozambique, South Africa and SpainPLOS ONE

Dear Dr. Munyangaju,

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ACADEMIC EDITOR: Please insert comments here and delete this placeholder text when finished. 

Please take your time to read and respond to the reviewers comments. In particular it is important to discuss potential limitations of this project.

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PLOS ONE

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“We acknowledge support from the grant CEX2018-000806-S funded by MCIN/AEI/ 10.13039/501100011033, and support from the Generalitat de Catalunya through the CERCA Program. Isabelle Munyangaju the support of a fellowship from “la Caixa” Foundation (ID 100010434). The fellowship code is LCF/BQ/DI21/11860045. Role of the funding sources: None of the funding sources had a role in the study’s design, conduct and reporting.”

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Additional Editor Comments (if provided):

Please take your time to read and respond to the reviewers comments. In particular it is important to discuss potential limitations of this project.

[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

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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: 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

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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: The proposed study is interesting and ambitious; it will likely require a significant amount of effort to complete, collate and then to extract accurate findings. Obviously estimates of access to care will be major challenges in Mozambique and South Africa.

A few key comments:

1. First author has superscript (17) but no corresponding institution (17) is listed.

2. The "individual" level is better described as the "institutional" level. "Multi-country" is probably better described as "multi-national".

3. The use of "clinical and radiological human resources" is vague; e.g. compare line 176 with line 204. It seems that clinical medical physicists working in radiology are excluded entirely from this study and this may impact on the integrity of the data collection and analysis to estimate "cumulative radiation dose exposure".

4. Specific Objective No. 1: surely this is "...in Mozambique, South Africa and Spain by mapping the number and distribution of CXR units...."?

5. Clarification is required on Specific Objective No. 3. The inclusion (or not) of South African data does not consistent/clear in the manuscript, and is best described in lines 223 - 230. South Africa should be mentioned in Table 1 under this objective.

6. The study also does not seem to handle dosimetry across the sites in a consistent way, which means that data analysis could be become very complex, i.e. use of NCI software is only possible for 2 institutions. It may be better to rather use dose indicators or surrogates like image size, mAs and kVp for CXR, and mAS, scan length, scan thickness and pitch for CT, for example. Sub-analysis by age (number of exams and repeat imaging of individuals with more than one contact/episode) will be necessary if all patients under the age of 16y are to be included.

7. Line 178: please define, clarify or remove the phrase "radiological diagnostics".

8. The term "radiation protection (awareness)" is very broad, as this could imply that elements like radiation shielding, e.g. line 178. Consider using another term like optimization.

9. For patient records extracted over a number of years (Mozambique and Spain) one assumes that repeat episodes in the patient once they are over the age of 16y, are excluded from the study and will not count towards cumulative dose?

Reviewer #2: This protocol paper outlines a study that will address the capacity for radiological diagnosis of paediatric TB in low-and middle-income countries with a high TB burden. The methods appear rigorous. The strengths and anticipated limitations need to be stated more clearly.

Comments

1. Please make reference to the "mixed methods" design in the title for further clarification.

2. Please provide more up-to-date references 2023 in the background section i.e., Global TB report 2023 https://www.who.int/publications/i/item/9789240083851

3. Please clearly state the study outcomes for each objective in a table similar to Table 1 (or even in the same table).

4. Since adolescents are involved in the study, I think assent forms from those older than 12 or 13, depending on national regulations, are also necessary; however, the protocol makes no mention of this. Could you please elaborate?

5. Please include the current study status in the methods section.

6. Line 172: Could you please specify how many site operation managers are intended to receive the survey?

7. Please include a risk/benefit analysis in the protocol.

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Reviewer #1: No

Reviewer #2: No

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Evaluation of radiological capacity and usage in paediatric TB diagnosis: a mixed-method protocol of a comparative study in Mozambique, South Africa and Spain

PONE-D-23-18845R1

Dear Dr. Munyangaju,

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,

Fran

Francis John Gilchrist

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

**********

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

**********

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

**********

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

**********

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

**********

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 the track changes version, line 172 has a repeat in the word "protection".

Thank you for the due consideration and implementation of the suggested changes.

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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

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