MIDCAREER AWARD IN PATIENT ORIENTED OBSTETRIC RESEARCH

描述(改编自申请人的描述)：本报告的目的 以患者为中心的研究中的职业生涯中期研究员奖是为Dwight提供 J·劳斯，麻省理工学院妇产科副教授 阿拉巴马大学伯明翰分校(UAB)的医学 受保护的时间：1)继续并扩展其持续的以患者为中心 研究活动包括担任联合资助的 NINDS和NICHD随机临床试验和作为 产程中用洗必泰阴道给药的RO1随机临床试验 清洗，并通过继续执行决定和 产科筛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 美国国立卫生研究院妇女生殖健康研究中心职业发展 计划，以及3)发展新的以患者为中心的研究技能。为了这个 获奖后，他获得的新技能将专注于“务实”的临床 试验，即将被测试的干预措施覆盖在 有当地的临床实践背景，至少有相关的研究 实践限制、自由包容和较少的排除标准设计 而进行这些务实的临床试验带来了明显的挑战，来自 设计可实施的干预措施，以协调 中心通常不会以其他方式组织成正式的研究网络。穿过 正规流行病学(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，他 将大大增强他作为围产期临床试验人员的能力(和 在进行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领域 至少出于三个原因，试验可能会越来越多 在确定最佳产科护理方面的重要性。首先，衰弱的病人 在这个国家，许多学术产科单元的人口使这一点变得困难 以足够的样本量和快速的速度进行单中心试验 病人应计费用。第二，一些严重但可以预防的发病率 产科结局(例如，子痫)相当低，但即使如此低 在发病情况下，通常需要评估以下干预措施 可能只会提供适度的保护。因此，为了实现足够的统计能力， 大样本量是必要的。最后，一个有效的 干预(在实际临床条件下如何实施 实践)是一种属性，在许多情况下，它与它的 功效(它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).