Unpacking the null: a post-hoc analysis of a cluster-randomised controlled trial of the WHO Safe Childbirth Checklist in Uttar Pradesh, India (BetterBirth)

Megan Marx Delaney,Kate A Miller,Lauren Bobanski,Shambhavi Singh,Vishwajeet Kumar,Ami Karlage,Danielle E Tuller,Atul A Gawande,Katherine E A Semrau

doi:10.1016/s2214-109x(19)30261-x

Abstract

SummaryBackgroundA coaching-based implementation of the WHO Safe Childbirth Checklist in Uttar Pradesh, India, improved adherence to evidence-based practices, but did not reduce perinatal mortality, maternal morbidity, or maternal mortality. We examined facility-level correlates of the outcomes, which varied widely across the 120 study facilities.MethodsWe did a post-hoc analysis of the coaching-based implementation of the WHO Safe Childbirth Checklist in Uttar Pradesh. We used multivariable modelling to identify correlations between 30 facility-level characteristics and each health outcome (perinatal mortality, maternal morbidity, or maternal mortality). To identify contexts in which the intervention might have had an effect, we then ran the models on data restricted to the period of intensive coaching and among patients not referred out of the facilities.FindingsIn the multivariable context, perinatal mortality was associated with only 3 of the 30 variables: female literacy at the district level, geographical location, and previous neonatal mortality. Maternal morbidity was only associated with geographical location. No facility-level predictors were associated with maternal mortality. Among facilities in the lowest tertile of birth volume (<95 births per month), our models estimated perinatal mortality was 17 (95% CI 11·7–24·8) per 1000 births in the intervention group versus 38 (31·6–44·8) per 1000 in the control group (p<0·0001).InterpretationMortality was not directly associated with measured facility-level indicators but was associated with general risk factors. The absence of correlation between expected predictors and patient outcomes and the association between improved outcomes and the intervention in smaller facilities suggest a need for additional measures of quality of care that take into account complexity.FundingBill & Melinda Gates Foundation.

Highlights

We understand the need for improving the quality of care delivered by health-care systems worldwide
Study design In this study we did a post-hoc analysis of the results of the BetterBirth trial, which is registered at ClinicalTrials.gov, number NCT02148952
The BetterBirth trial[4,5,7,8,9] was a matched-pair, cluster-randomised controlled trial testing the effect of a coaching-based WHO Safe Childbirth Checklist programme on a composite outcome of perinatal death, maternal death, and maternal severe morbidity in primary and community health centres in Uttar Pradesh, India

Summary

Introduction

We understand the need for improving the quality of care delivered by health-care systems worldwide. In 2016, of the 8·6 million people who died of conditions amenable to health care in lower-income and middle-income countries, 5 million (58%) presented for care but received poor-quality care.[1] increasing access to these health-care systems will not improve patient outcomes; the systems’ ability to deliver highquality care appropriately and consistently needs to be improved. Designed for use during childbirth, the Checklist reminds birth attendants of 28 evidence-based practices that can prevent complications, identify emergencies early, and ensure a base of high-quality care.[2] Studies have demonstrated that using the Checklist can increase birth attendants’ adherence to evidence-based practices,[3] but until 2017, there was no evidence about the effect of the Checklist on maternal and neonatal outcomes

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Results

Conclusion