PONE-D-24-24627Assessing Antimicrobial Use Patterns in Christian Health Association of Malawi (CHAM) Health Facilities: A Cross-Sectional Study ProtocolPLOS ONE

Dear Dr. Chirambo,

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.

In addition to few minor things, this research protocol has some confusions regarding sampling procedure, which needs to be addressed at this stage. Please see the detailed comments below for further suggestions.

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We look forward to receiving your revised manuscript.

Kind regards,

Muhammad Farooq Umer, PhD Epidemiology and Health Statistics

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: 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

Reviewer #3: Partly

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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: 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

Reviewer #3: 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: It is a well thought out and well written research proposal on a very important topic (AMR) in a location where little is known about the problem.

The research when completed will contribute to the current knowledge on the topic.

The proposal is for a prospective study and proposed period of study is January 2024 to December 2025. However, the ethics approval for the study was only obtained on May 15, 2024. The study period therefore needs to be revised.

Typo error on line 162, the words 'Ninety percent' were repeated in the sentence.

Reviewer #2: Check minor editorial corrections on pages 14 and 16

Line 200 – are these facilities to be excluded? Please state that clearly

Line 202 – replace with (included) - otherwise the statement is not clear

Line 262 - Where the data from the multiple sources are contradictory, how will this be resolved?

Reviewer #3: Line 160: Authors should take out 'in the' as used as the last words in the line

Line 162: ninety-percent has been repeated in the same line

Authors should come clear on the sampling procedure. Is 194 the total CHAM facilities of it was sampled? If it was sampled then how did the arrive at 194? If it's the former then the sentence should be as specific as possible to clear any ambiguity. Also, if WHO recommends 3000 for the prescribing indicator, then how did authors arrive at 104 for withdrawal of consent and incomplete responses? What factor was used in this case?

Patient indicator sample size has been indicated as 274 with an excess of 113 for consent withdrawal and incomplete responses yet it is not clear how authors has authors arrived at the 113. That being said, authors went ahead to indicate that they will collect data from 2 patients per facility to make the sample size 388 which is very clear and understandable. If authors want to do 2 respondents per facility they should stick to that approach instead of complicating matters by trying to calculate a sample size using a formula with unexplained factors. I suggest authors delete the sample size calculation and rather maintain the 2 interviews per facility

Grammar check, line 218-219

Grammar check, line 223

In the safety plan, authors should provide some PPEs for data collection team to prevent risk of contamination considering they will be engaging patients on admission and reviewing records that might have travelled throughout the hospital environment

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Reviewer #1: No

Reviewer #2: Yes: Prof. Tanimola Makanjuola Akande

Reviewer #3: Yes: George Akowuah

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Attachments

Attachment

Submitted filename: PONE-D-24-24627_reviewer.pdf

Assessing Antimicrobial Use Patterns in Christian Health Association of Malawi (CHAM) Health Facilities: A Cross-Sectional Study Protocol

PONE-D-24-24627R1

Dear Dr. Chirambo,

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,

Muhammad Farooq Umer, PhD Epidemiology and Health Statistics

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 #3: 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 #3: 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 #3: 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 #3: 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 #3: 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 #3: The manuscript has indeed undergone a major transformation since the last review. I am very impressed with the level of detail and clarity in the current manuscript.

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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 #3: Yes: George Akowuah

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