PONE-D-23-41107Standards-based audit to improve quality of maternal and newborn care – a stepped-wedge cluster randomised trial in MalawiPLOS ONE

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Mergan Naidoo, PhD

Academic Editor

PLOS ONE

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Reviewers' comments:

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Comments to the Author

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Reviewer #1: Partly

Reviewer #2: Yes

Reviewer #3: Partly

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

Reviewer #1: Yes

Reviewer #2: I Don't Know

Reviewer #3: I Don't Know

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Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: No

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5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: A stepped-wedge cluster randomized trial was conducted at 44 healthcare facilities which aimed to assess clinical standards-based audits in improving maternal and newborn health as measured by compliance rates. Audited compliance standards improved significantly.

Minor revisions:

1- Line 312: Provide a measure of dispersion for the mean of 20.6.

2- Table 1: Define all abbreviations.

3- Indicate if an effect for the repeated measures from individual patients was included in the logistic regression. These correlated measures need to be accounted for in the models.

4- Line 378: The common abbreviation for standard deviation is SD.

5- Cite the statistical software used for the analysis.

Reviewer #2: Standards-based audit to improve quality of maternal and newborn care – a stepped- wedge cluster randomised trial in Malawi

Summary of the Research

Audit is a quality improvement approach used in maternal and newborn health. The objective of the study was to introduce the practice of standards-based audit at healthcare facility level, and to examine if this would improve compliance with standards of care developed and agreed with healthcare providers. The focus was on emergency obstetric and newborn care in a low resource setting. A multidimensional incomplete stepped-wedge cluster randomised trial with 8 steps (months) was conducted in 44 healthcare facilities in Malawi. A total of 25 standards were developed. Each facility had two consecutive audit cycle periods in each of which one (health centres) or two standards (hospitals) were audited in each period. Each audit cycle consisted of five steps: (i) agree the standard to be audited, (ii) measure compliance with standard, (iii) review findings and identify what changes are required to increase compliance (iv) implement changes, (v) re-measure compliance. For steps ii) and v), compliance with a standard was to be assessed for 25 women. Multilevel mixed effects logistic regression models were used to analyse data for all standards.

Standards-based audit was an effective method to improve the quality of care. The crude overall compliance rate rose from 45% in the control phase (pre-action in audit cycle) to 63% in the intervention phase (post-action). There was a statistically significant improvement in compliance for standards audited: the adjusted (for standard, facility type, month, and healthcare facility by month clustering) OR (95% CI) was 2.80 (1.65,4.76). The most frequently taken actions to improve compliance with standards included: i) providing support to improve staff performance to better carry out clinical duties and improve general conduct through re-orientation and staff meetings as well as improved supervision, and, ii) ensuring basic equipment and consumables were available on site (thermometers, rapid diagnostics, partograph).

Areas for improvement

Title:

The authors should write specific and concise title reflecting the study. I think no need to mention cluster randomized trial, they can add cross sectional study.

Abstract:

The authors should revise the language to improve readability.

The authors should select appropriate key words.

The authors should make sure that the abstract don’t exceed 300 words.

The authors should use IMRaD format to write the abstract.

Introduction:

The authors should revise introduction section for grammar issues and language to improve readability.

The authors used statistics in first paragraph of introduction section, they should mention from where this statistics came, which mean from which country.

The authors should join some related paragraphs together.

The authors should mention the gap clearly to the reader and the need for the study.

Overall

Material and Methods:

Study design, the authors should mention clearly the designed used and the important of the study design.

Trial intervention, clear.

Trial outcome, clear.

Study setting, The authors should revise the language to improve readability.

Developing of standards, clear.

Training on standards based audit, The authors should revise the language to improve readability.

Assigning standards, the authors should revise the language to improve readability and complete the missing information.

Data collection, the authors should mention if they used any tool to collect data. For the tool used in this study, they authors should mention from where they obtained this tool? Is it adopted or developed by the authors. If developed by authors how they check the validity and reliability of the tool?

Sample size, clear.

Data analysis, The authors should revise the langue to improve readability.

Ethical consideration, clear.

Results:

The authors should follow appropriate labelling of the title of each table in the manuscripts according to the journal’s guidelines. While the study appears to be sound, the language is unclear, making difficult to follow. Thus, the authors should work with a writing editor to improve readability of the text. The results section is clear.

References:

The authors should revise all references according to the guidelines provided.

Reviewer #3: The paper presented an interesting and important topic. However, the author needs to do some major revision.

- Can the description of Malawi level of health care delivery be included in the introduction? Emergency obstetric care take place at the secondary and tertiary level. The write up did not tell us at which level.

- The analysis also did not tell us what the adherence to this standard was at these two levels.

- The introduction also did not tell us whether both private and public facilities were used. Mission hospital was later mentioned (Line 290). This shows a mixed of the hospital types.

- How does the standard relate to the WHO quality of care (QoC) standards? Were any indicators adopted from the WHO QoC measurement?

- The table illustrating the 25 standards should have been added to the main document.

- The standard should have been categorized with relatable descriptive terms. This would have made the analysis easy to read and relate to.

- Under result, mentioning the standard that health facilities audited would have made the segment clear. (Line 269 -268). Line 362 -363 should be moved to the beginning of the analysis. It has basic information that would make the analysis clear.

- Line 309 mentioned all 12 standards. This contradict the 25 standard that was mentioned in line 29 -20.

- Line 415 – 434. The discussion did not adequately explain the analysis

- Line 427 -429 (The statement is not clear)

the author should review and rewrite the analysis and discussion.

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Reviewer #1: No

Reviewer #2: Yes: Zalikha Khamis Al-Marzouqi

Reviewer #3: No

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Standards-based audit to improve quality of maternal and newborn care – a stepped-wedge cluster randomised trial in Malawi

PONE-D-23-41107R1

Dear Dr. 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

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