Evidence map›Paper›PMID 31303296›Full record

Trial reportThe Lancet. Global health2019

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

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in The Lancet. Global health, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Megan Marx DelaneyAriadne Labs, Boston, MA, USA.
Kate A MillerAriadne Labs, Boston, MA, USA.
Lauren BobanskiAriadne Labs, Boston, MA, USA.
Shambhavi SinghCommunity Empowerment Lab, Lucknow, India.
Vishwajeet KumarCommunity Empowerment Lab, Lucknow, India.
Ami KarlageAriadne Labs, Boston, MA, USA.
Danielle E TullerAriadne Labs, Boston, MA, USA.
Atul A GawandeAriadne Labs, Boston, MA, USA; Brigham and Women's Hospital, Boston, MA, USA; Harvard T H Chan School of Public Health, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.
Katherine E A SemrauAriadne Labs, Boston, MA, USA; Brigham and Women's Hospital, Boston, MA, USA; Harvard T H Chan School of Public Health, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address: ksemrau@ariadnelabs.org.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA 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.

Indexed as

ChecklistEvidence-Based PracticeGuideline AdherenceParturitionWorld Health OrganizationAdultCluster AnalysisCounselingDelivery, ObstetricFemaleHumansIndiaInfant, NewbornMaternal MortalityPerinatal MortalityPregnancy

Identifiers

PMID31303296
PMCPMC6639352

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.