PONE-D-19-24170

Improving skin-to-skin practice for babies in Kangaroo Mother Care in Malawi through the use of a customized baby wrap

PLOS ONE

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Reviewers' comments:

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Comments to the Author

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Reviewer #1: Yes

Reviewer #2: Partly

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

Reviewer #1: Yes

Reviewer #2: No

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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: This is an important and original piece of research addressing an understudied area, namely how the type of wrapper affects KMC delivery and assessment of skin-to-skin practices in the community, post facility discharge.

It is generally a very well written manuscript with a logical and easy to follow structure. The methodology is clear and concise although it would benefit from more detail about randomisation and allocation processes to ensure methods were robust and selection / allocation bias was minimized. There is clear description of the eligibility criteria and well described setting, enabling generalisability of the results. Discussion was relevant and gave a detailed exploration of current evidence base for use of different wrappers and KMC duration data. The article did an excellent job of putting KMC in Malawi into context, with a description of implementation history, showcasing the context of advanced KMC implementation in Malawi, which is not typical of many countries in Sub-Saharan Africa. There was also good discussion of the limitations of self-reporting for KMC duration data although from the supplemental maternal it is clear that direct observation of KMC duration was conducted, yet this is not adequately reported. It would be highly beneficial to expand this section with direct observation data compared with maternal reported data, if possible. Otherwise, issues around missing data and potential ascertainment bias are well described.

The text box on ensuring sustainability and local production is particularly helpful and a novel addition to the study, but would benefit from more detailed description of how the cost per wrapper was derived.

Specific feedback / suggestions for improvement:

Suggest to include study design in the title to make it easier for readers to identify this was a RCT

1. Check the statistics quoted for KMC in the background section. According to Cochrane 2016, mortality risk at 40 – 41 weeks post menstrual age is reduced by 40% (RR0.6) and mortality at latest follow up is reduced by 33% (RR0.67), which is different to what is stated in this article.

2. The primary and secondary outcomes are not clear. It is stated at one stage that the primary outcome is rate of weight gain and then later mentioned that wrap acceptability, duration of STS contact, feeding support and other support were outcomes, with no mention of weight gain. This becomes clearer in the results and discussion when the issue of missing weight outcome data is explained, but for ease of reading it would be beneficial to explain this earlier in the manuscript rather than in the supplemental material.

3. A more detailed description of the statistical analysis would be helpful - What values were considered significant ? Also including 95% confidence intervals is advised.

4. Please give more detail about the randomisation / allocation process – how was the randomisation sequence generated and was this blinded and kept secure? Was allocation concealed and if so, how was it concealed ? What were the timelines involved in screening, allocation and baseline data collection and were they consistent with avoiding selection bias ?

5. It is not clear if the outcome assessors were blinded to the allocation arm, especially for assessing the acceptability outcome. It is possible that unconscious bias may influence how the questions were asked.

6. There are a large (n=75) number of ineligible babies in the “other”: category – in the interests of transparency please provide details of why these babies were excluded.

7. The discussion mentions that data quality issues also affected the results, but it is not clear what this is referring to (? Weight outcome). Please clarify

8. It would be beneficial to include more detail about the pre-enrolment care these babies received, as average age at admission to KMC ward was 1.5 days this suggests they had a short period of stabilization on NICU and then were transferred to KMC. Also, 20% of babies become unwell whilst on KMC ward and it would be informative to know if there is any statistically significant difference between the 2 types of wrappers used, as a marker of safety. Although this information is available in the supplemental material (Table 3a) it is not mentioned in the main manuscript and should be highlighted to the reader.

Reviewer #2: Title: Improving Skin-to-Skin Practice for Babies in Kangaroo Mother Care in Malawi Through the Use of a Customized Baby Wrap

Overall note: Thank you for the opportunity to review this manuscript. It was very well-written and I enjoyed reading the paper as well as learning about this innovative intervention. I believe it is an important contribution to the literature. However, I have several concerns. First, I do not believe the statistical analysis is entirely appropriate; further, critical details are omitted from the methodology section. Some of the text could be organized a little differently to help justify the paper as well. Please see detailed comments below.

Major comments

Abstract

1) Consider adding in that the study was among low birthweight dyads

Introduction

2) To motivate the need for the customized wrap, swap paragraph that starts on line 73 with the one that starts on 64.

3) Ensure that objectives align with outcomes (include breastfeeding, feeding support, family support) and that these outcomes are justified. Why these objectives/outcomes specifically? Acceptability, duration of skin to skin and breastfeeding outcomes make sense (perhaps note that more comfort encourages more use which could mean better outcomes?), but what is the justification for family and social support for KMC and why would that differ by type of wrap (especially food, chores, child-care, etc)?

a. After reading the discussion, there is a need for family support – suggest moving lines 300-304 to intro

Methods

4) Consider noting in study population section that study included multiple births/twins

5) Mention that analyses conducted at two time points- pre and post discharge

6) Please add more detail about how each outcome was assessed. Even if the info is in supplemental file, the outcome variables should be defined up front here, including listing response options.

7) After reviewing supplementary file, it appears the “acceptability” outcomes are binary. The analysis would then be testing the difference in proportion satisfied between the two study groups whereas a t-test is meant to compare the difference in means between groups. Why not use chi-square tests? Similarly, duration of skin-to-skin is reported in categories and the use of a T test is also questionable.

Results

8) Lines 143-146 (first few sentences of the results section) seem to belong in the methods as it is the final sample size.

9) Line 213- were family members’ training part of the study? If so, this should be included in the methods

10) Throughout the text, the ergonomic carrier is called “CarePlus” but in the tables it is “Customized”- consider using “CarePlus” in tables, too.

11) Weight gain is mentioned as the primary outcome of interests, but there is no mention of it until the discussion /limitations. Consider including a line similar to 338 (e.g., “Weight gain results are not included in this study”) then adding some from the supplemental text (lines 27-31) in the results section.

Discussion

12) Line 277-78: there aren’t results related to male involvement in the results section so this statement isn’t supported by the analysis presented. Suggest either adding more to analysis/results, or remove from discussion.

13) Lines 305-311: Suggest moving to results section

a. Also, this is interesting. I suggest finding different headings- it looks too close to an abstract of something that should be an independent paper. Suggest head each paragraph with more simple/plain text-style headings or even questions, e.g. “What was the sustainability assessment?” “What did it show”

14) Lines 321-22: What is the reason to mention that the sample size was based on weight gain in the limitations—this isn’t clear how it could be a limitation. Also, what indications do you have about data quality? This needs more explanation as well.

15) Mention the limitation of generalizability—within Malawi, regionally, etc..

Minor comments

1. (Abstract) Line 31-32: I think the ‘more’ is misplaced. I would suggest saying, “Women using the customized wrap reported being comfortable […] more often than women using the chitenje”

2. Line 50: define/explain “early” discharge

3. Line 53: no apostrophe needed after weeks’; consider adding parentheses around (corrected gestational age)

4. Is there a reference for sentence on line 74-75

5. Figure 3 title add in time point (Day 3)

6. Line 166: delete space between Care and Plus

7. Line 172: restate post-discharge time period/days.

8. Line 188-I don’t see these results specified anywhere- if not, please add “results not shown”

9. Line 189: Reported daily duration – should duration be practice?

10. Supplemental table 3a, please add % to item/variable labels to differentiate from mean (e.g., Without a label, I wasn’t sure at first if died meant number of deaths or %)

11. Table 3: Please add a title for facility based KMC for first few lines. Please add results of provider support to table 3 and also briefly summarize the results that are there.

12. Line 206-07: “frequency of duration of breastfeeding" – I don’t know what this refers to? Are there results to include in the table?

13. Lines 242-249: How similar are other wraps to CarePlus? How similar are traditional wraps in those countries?

14. Line 295: when was the first follow-up visit?

15. Line 298-300: 2013 was several years ago now and much has evolved in newborn/KMC care since then. I would suggest either discussing these findings couched as how things have improved over time or not mentioning it.

16. Line 316-17: I don’t think that is necessary to include (“We had planned…”)

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Reviewer #1: No

Reviewer #2: Yes: Lindsay Mallick

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Improving Skin-to-Skin Practice for babies in Kangaroo Mother Care in Malawi through the use of a customized baby wrap: a randomized control trial

PONE-D-19-24170R1

Dear Dr. Chavula,

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Jennifer Yourkavitch

Academic Editor

PLOS ONE

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Reviewers' comments: