PONE-D-23-11849A multi-dimensional incomplete stepped-wedge trial design to estimate the impact of standards-based auditPLOS ONE

Dear Dr. Sarah Ann White

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PLOS ONE

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Reviewers' comments:

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Reviewer #1: Yes

Reviewer #2: Yes

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

Reviewer #1: Yes

Reviewer #2: N/A

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Reviewer #1: Yes

Reviewer #2: Yes

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Reviewer #1: Yes

Reviewer #2: Yes

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5. Review Comments to the Author

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Reviewer #1: Well written and fairly explained. Just I would like to know more about considerations after those limitation points. For example, you have mentioned in line 502 (the covariate maybe considered) and that (in my opinion) will let the reader be thrilled and imagining what will these improvements do next?

Overall, Nice article

Reviewer #2: This study is highly intriguing as it employs a complex research design to investigate the impact of standards-based audits. The design incorporates multiple dimensions and utilizes a stepped-wedge trial approach. In this approach, the application of the intervention (standards-based audits) varies across different clusters, rather than being uniform. The primary objective is to estimate the effects of these audits on specific outcomes.

The study introduces an innovative trial design that avoids the common pitfalls associated with the use of before-after designs in clinical audits, which often lead to biased impact estimations. However, there are certain aspects that, in my opinion, the authors should carefully contemplate before proceeding with the publication of their work in your journal.

Neither in the introduction nor in the discussion sections did the authors clearly explain why they believe the chosen design would be more advantageous when compared to existing approaches (such as before and after designs). I would appreciate it if the authors could offer readers a comprehensive justification for the trial design and elaborate on its distinctions from the before-after design used in clinical audits. What limitations of the before-after design have influenced their preference for the trial design?

In the body text, I recommend placing tables immediately after their corresponding citations. This approach not only adheres to the journal's guidelines but also enhances the reader's comprehension flow.

I am of the opinion that there are certain writing issues that should be addressed on a line-by-line basis. For instance, in line number 115 of the manuscript, the in-text citation format appears inconsistent with other citations, and information source for Table 1 is labeled as "source:2".

Overall, this is a commendable piece of work with significant novelty, and it deserves support. If published, it has the potential to benefit numerous researchers and contribute to the ongoing improvement of our audit practices, particularly in developing countries.

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Reviewer #1: No

Reviewer #2: No

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A multi-dimensional incomplete stepped-wedge trial design to estimate the impact of standards-based audit

PONE-D-23-11849R1

Dear Dr. Sarah Ann White

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,

Mergan Naidoo, PhD

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments: