Journal Article

Background: Effective, scalable strategies to improve maternal, fetal, and newborn health and reduce preventable morbidity and mortality are urgently needed in low- and middle-income countries. Building on the successes of previous checklist-based programs, the World Health Organization (WHO) and partners led the development of the Safe Childbirth Checklist (SCC), a 28-item list of evidence-based practices linked with improved maternal and newborn outcomes. Pilot-testing of the Checklist in Southern India demonstrated dramatic improvements in adherence by health workers to essential childbirth-related practices (EBPs). The BetterBirth Trial seeks to measure the effectiveness of SCC impact on EBPs, deaths, and complications at a larger scale.

Methods: This matched-pair, cluster-randomized controlled, adaptive trial will be conducted in 120 facilities across 24 districts in Uttar Pradesh, India. Study sites, identified according to predefined eligibility criteria, were matched by measured covariates before randomization. The intervention, the SCC embedded in a quality improvement program, consists of leadership engagement, a 2-day educational launch of the SCC, and support through placement of a trained peer “coach” to provide supportive supervision and real-time data feedback over an 8-month period with decreasing intensity. A facility-based childbirth quality coordinator is trained and supported to drive sustained behavior change after the BetterBirth team leaves the facility. Study participants are birth attendants and women and their newborns who present to the study facilities for childbirth at 60 intervention and 60 control sites. The primary outcome is a composite measure including maternal death, maternal severe morbidity, stillbirth, and newborn death, occurring within 7 days after birth. The sample size (n = 171,964) was calculated to detect a 15% reduction in the primary outcome. Adherence by health workers to EBPs will be measured in a subset of births (n = 6000). The trial will be conducted in close collaboration with key partners including the Governments of India and Uttar Pradesh, the World Health Organization, an expert Scientific Advisory Committee, an experienced local implementing organization (Population Services International, PSI), and frontline facility leaders and workers

Discussion: If effective, the WHO Safe Childbirth Checklist program could be a powerful health facilitystrengthening intervention to improve quality of care and reduce preventable harm to women and newborns, with millions of potential beneficiaries.

Trial registration: BetterBirth Study Protocol dated: 13 February 2014; ClinicalTrials.gov: NCT02148952; Universal Trial Number: U1111-1131-5647. 

The vast majority of social science research presently uses small (MB or GB scale) data sets. These fixed-scale data sets are commonly downloaded to the researcher's computer where the analysis is performed locally, and are often shared and cited with well-established technologies, such as the Dataverse Project (see Dataverse.org), to support the published results.  The trend towards Big Data -- including large scale streaming data -- is starting to transform research and has the potential to impact policy-making and our understanding of the social, economic, and political problems that affect human societies.  However, this research poses new challenges in execution, accountability, preservation, reuse, and reproducibility. Downloading these data sets to a researcher’s computer is infeasible or not practical; hence, analyses take place in the cloud, require unusual expertise, and benefit from collaborative teamwork and novel tool development. The advantage of these data sets in how informative they are also means that they are much more likely to contain highly sensitive personally identifiable information. In this paper, we discuss solutions to these new challenges so that the social sciences can realize the potential of Big Data.

"Robust standard errors" are used in a vast array of scholarship to correct standard errors for model misspecification. However, when misspecification is bad enough to make classical and robust standard errors diverge, assuming that it is nevertheless not so bad as to bias everything else requires considerable optimism. And even if the optimism is warranted, settling for a misspecified model, with or without robust standard errors, will still bias estimators of all but a few quantities of interest. The resulting cavernous gap between theory and practice suggests that considerable gains in applied statistics may be possible. We seek to help researchers realize these gains via a more productive way to understand and use robust standard errors; a new general and easier-to-use "generalized information matrix test" statistic that can formally assess misspecification (based on differences between robust and classical variance estimates); and practical illustrations via simulations and real examples from published research. How robust standard errors are used needs to change, but instead of jettisoning this popular tool we show how to use it to provide effective clues about model misspecification, likely biases, and a guide to considerably more reliable, and defensible, inferences. Accompanying this article is open source software that implements the methods we describe. 

Data are being collected on human behaviour in cities such as London, New York, Singapore and Shanghai, with a view to meeting city dwellers' needs more effectively. Incorporating decision-making theory into analyses of the data from these 'urban observatories' would yield further valuable information.