Learning before leaping: integration of an adaptive study design process prior to initiation of BetterBirth, a large-scale randomized controlled trial in Uttar Pradesh, India.

BACKGROUND: Pragmatic and adaptive trial designs are increasingly used in quality improvement (QI) interventions to provide the strongest evidence for effective implementation and impact prior to broader scale-up. We previously showed that an on-site coaching intervention focused on the World Health Organization Safe Childbirth Checklist (SCC) improved performance of essential birth practices (EBPs) in one facility in Karnataka, India. We report on the process and outcomes of adapting the intervention prior to larger-scale implementation in a randomized controlled trial in Uttar Pradesh (UP), India. METHODS: Initially, we trained a local team of physicians and nurses to coach birth attendants in SCC use at two public facilities for 4-6 weeks. Trained observers evaluated adherence to EBPs before and after coaching. Using mixed methods and a systematic adaptation process, we modified and strengthened the intervention. The modified intervention was implemented in three additional facilities. Pre/post-change in EBP prevalence aggregated across facilities was analyzed. RESULTS: In the first two facilities, limited improvement was seen in EBPs with the exception of post-partum oxytocin. Checklists were used <25 % of observations. We identified challenges in physicians coaching nurses, need to engage district and facility leadership to address system gaps, and inadequate strategy for motivating SCC uptake. Revisions included change to peer-to-peer coaching (nurse to nurse, physician to physician); strengthened coach training on behavior and system change; adapted strategy for effective leadership engagement; and an explicit motivation strategy to enhance professional pride and effectiveness. These modifications resulted in improvement in multiple EBPs from baseline including taking maternal blood pressure (0 to 16 %), post-partum oxytocin (36 to 97 %), early breastfeeding initiation (3 to 64 %), as well as checklist use (range 32 to 88 %), all p < 0.01. Further adaptations were implemented to increase the effectiveness prior to full trial launch. CONCLUSIONS: The adaptive study design of implementation, evaluation, and feedback drove iterative redesign and successfully developed a SCC-focused coaching intervention that improved EBPs in UP facilities. This work was critical to develop a replicable BetterBirth package tailored to the local context. The multi-center pragmatic trial is underway measuring impact of the BetterBirth program on EBP and maternal-neonatal morbidity and mortality. CLINICAL TRIALS IDENTIFIER: NCT02148952 .

Narrowing of sex differences in infant mortality in Massachusetts.

OBJECTIVES: To examine whether the improved survival of preterm infants has influenced the known male excess in infant mortality. STUDY DESIGN: We analyzed sex-specific infant mortality using linked birth and death certificates for all 619,811 live born infants in Massachusetts between 1989 and 1995. RESULTS: Between 1989 and 1995 the male excess in infant mortality decreased by 50%, from 1.6/1000 to 0.8/1000 live births (LB). This narrowing resulted primarily from a more rapid decline in neonatal mortality among male infants (1.5/1000 LB) than among female infants (0.9/1000 LB). The largest declines in the male excess in neonatal mortality occurred among very premature infants (GA < or = 30 weeks) and resulted primarily from a more rapid decrease in male deaths from respiratory distress syndrome. CONCLUSIONS: The narrowing of the sex difference in mortality between 1989 and 1995 suggests that newer treatments like antenatal steroids, and surfactants may have differentially benefited male infants.

Developing a quality and safety curriculum for fellows: lessons learned from a neonatology fellowship program.

Formal training in health care quality and safety has become an important component of medical education at all levels, and quality and safety are core concepts within the practice-based learning and system-based practice medical education competencies. Residency and fellowship programs are rapidly attempting to incorporate quality and safety curriculum into their training programs but have encountered numerous challenges and barriers. Many program directors have questioned the feasibility and utility of quality and safety education during this stage of training. In 2010, we adopted a quality and safety educational module in our neonatal fellowship program that sought to provide a robust and practical introduction to quality improvement and patient safety through a combination of didactic and experiential activities. Our module has been successfully integrated into the fellowship program's curriculum and has been beneficial to trainees, faculty, and our clinical services, and our experience suggests that fellowship may be particularly well suited to incorporation of quality and safety training. We describe our module and share tools and lessons learned during our experience; we believe these resources will be useful to other fellowship programs seeking to improve the quality and safety education of their trainees.