Implementation and results of an integrated data quality assurance protocol in a randomized controlled trial in Uttar Pradesh, India.

ABSTRACT:

Background

There are few published standards or methodological guidelines for integrating Data Quality Assurance (DQA) protocols into large-scale health systems research trials, especially in resource-limited settings. The BetterBirth Trial is a matched-pair, cluster-randomized controlled trial (RCT) of the BetterBirth Program, which seeks to improve quality of facility-based deliveries and reduce 7-day maternal and neonatal mortality and maternal morbidity in Uttar Pradesh, India. In the trial, over 6300 deliveries were observed and over 153,000 mother-baby pairs across 120 study sites were followed to assess health outcomes. We designed and implemented a robust and integrated DQA system to sustain high-quality data throughout the trial.

Methods

We designed the Data Quality

SUBMITTER: Gass JD 

PROVIDER: S-EPMC5590237 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature