description): The purpose of this Midcareer Investigator Award in Patient-Oriented Research is to provide Dwight J. Rouse, Associate Professor of Obstetrics and Gynecology in the School of Medicine at the University of Alabama at Birmingham (UAB) with sufficient protected time to: 1) continue and expand his ongoing patient oriented research activities including serving as protocol chairman of a jointly funded NINDS and NICHD randomized clinical trial and as principal investigator of a funded RO1 randomized clinical trial of intrapartum chlorhexidine vaginal cleansing, and through the continued performance of decision and cost-effectiveness analyses of obstetric screening technologies and practices; 2) to enhance his activities and capabilities as a mentor, especially through the UAB NIH Women's Reproductive Health Research Center Career Development Program, and 3) to develop new patient oriented research skills. For this award, his new skill acquisition will be focused on """"""""pragmatic"""""""" clinical trials, i.e., trials in which the intervention to be tested is overlaid on the background of local usual clinical practice, with a minimum of study-related practice constraints, liberal inclusion and few exclusion criteria The design and conduct of these pragmatic clinical trials poses distinct challenges, from devising an implementable intervention to coordinating communication across centers often not otherwise organized into a formal research network. Through formal epidemiologic (and economic analysis) training (obtaining an M.P.H.) and planned visits to internationally-renowned trial coordinating units, he will substantially enhance his abilities as a perinatal clinical trialist (and his ability to conduct economic analyses alongside clinical trials), especially in the area of pragmatic, multi-centered national and international trials which, for at least three reasons, are likely to take on increasing importance in defining optimal obstetric care. First, the declining patient populations of many academic obstetric units in this country make it difficult to conduct single center trials with adequate sample sizes and expeditious patient accrual. Second, the incidence of some severe but preventable obstetric outcomes (e.g., eclampsia) is quite low, but even for such low incidence conditions, it is often desirable to evaluate interventions which may offer only modest protection. Thus, to achieve adequate statistical power, large sample sizes are necessary. Finally, the effectiveness of an intervention (how it would perform under conditions of actual clinical practice) is an attribute that, in many situations, is as important as its efficacy (how it performs under ideal conditions).
