MIDCAREER AWARD IN PATIENT ORIENTED OBSTETRIC RESEARCH

描述（改编自申请人的描述）：本申请的目的 以患者为导向的研究中的职业中期研究者奖将为德怀特提供 J. Rouse，妇产科副教授， 医学在伯明翰的亚拉巴马大学（UAB）， 受保护的时间：1）继续和扩大他正在进行的以病人为导向的 研究活动，包括担任联合资助的 NINDS和NICHD随机临床试验，并作为一项 RO1资助的分娩期氯己定阴道给药的随机临床试验 清洁，并通过继续执行决定和 产科检查技术和做法的成本效益分析; 2)加强他作为导师的活动和能力，特别是通过 UAB NIH妇女生殖健康研究中心职业发展 计划，和3）发展新的病人为导向的研究技能。为此 奖，他的新技能收购将集中在“务实”的临床 试验，即，试验中，要测试的干预措施覆盖在 当地常规临床实践背景，至少与研究相关 实践限制，自由纳入和少数排除标准 这些实用的临床试验的进行带来了不同的挑战， 制定一项可实施的干预措施， 这些中心通常没有组织成一个正式的研究网络。通过 正式的流行病学（和经济分析）培训（获得M.P.H.） 并计划访问国际知名的审判协调单位， 将大大提高他作为围产期临床试验者的能力（和 他在临床试验的同时进行经济分析的能力）， 特别是在务实、多中心的国家和国际合作领域， 至少有三个原因，审判可能会越来越多， 确定最佳产科护理的重要性。第一，病人的衰落 在这个国家，许多学术产科单位的人口使其难以 以足够的样本量进行单中心试验， 患者累积。二是一些发病严重但可预防的 产科结果（例如，子痫）是相当低的，但即使如此低， 在发病条件下，通常需要评估干预措施， 只能提供适度的保护。因此，为了获得足够的统计功效， 需要较大的样本量。最后，一个 干预（在实际临床条件下如何执行） 实践）是一个属性，在许多情况下，与其 功效（在理想条件下的表现）。

DESCRIPTION (Adapted from applicant's 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).