Limited Competition: Clinical Centers for Completion of Ongoing MFMU Network Protocols (UG1 Clinical Trial Optional)Activity Code

有限竞争：临床中心完成正在进行的 MFMU 网络协议（UG1 临床试验可选）活动代码

• 批准号: 10379322
• 负责人: Suneet P Chauhan
• 金额: $ 30.3万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-01 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10379322
• 关键词: Address; Appointment; Area; Birth; COVID-19; Cesarean section; Child; Clinical; Clinical Trials; Code; Computerized Medical Record; Data; Enrollment; Ensure; Ethnic Origin; Faculty; Family; Fellowship; Fetal Growth; Foundations; Funding; Future; Guidelines; Health; Hemorrhage; Home visitation; Hospital Administration; Hospitals; Hour; House Staffs; Hypertension; Individual; Institution; Institutional Review Boards; Longterm Follow-up; Maternal complication; Maternal-Fetal Medicine Units Network; Measures; Minority Recruitment; Mothers; Narcotic Abuses; Newborn Infant; Participant; Peer Review; Performance; Persons; Pregnancy; Premature Birth; Productivity; Protocols documentation; Publications; Publishing; Race; Randomized; Randomized Clinical Trials; Research; Research Personnel; Research Training; Retrospective Studies; Risk; Schedule; Secondary to; Site; Societies; System; Telephone; Texas; Time; Underrepresented Minority; United States National Institutes of Health; Universities; Visit; adverse outcome; base; career development; clinical center; data quality; design; disability; double-blind placebo controlled trial; ethnic diversity; expectation; experience; fetal; follow-up; high risk; improved; infant morbidity; member; obstetric outcomes; offspring; pandemic disease; pregnancy disorder; prescription opioid; prevent; prospective; racial diversity; recruit; secondary analysis; social media; treatment effect; uptake

Project Summary Irrespective of whether the pregnancy is high- or low-risk, the national guidelines influencing the management of upwards of 3.7 million births in the US annually are often based on retrospective data. Hence, the need for prospectively collected data from multiple-centers or, whenever feasible, randomized clinical trials (RCT), with unbiased treatment effect. For the last 19 years University of Texas-Houston (UTH) has been a vital part of Maternal-Fetal Medicine Units (MFMU) Network to garner unbiased data. The UTH research team consists of 11 people, with combined experience of 84 years conducting research and over 100 years of working on labor and delivery. Prioritizing participation in the Network is ingrained in our Division. Our Chair and the MFM Fellowship Director have both served as Network PI and alternate PI. Within our Division we have a combined experience of being PI or alternate PI for 37 years. For the current 4 RCT, out of the 12 Network centers, our recruitment of eligible people ranks between 1st and 4th and, our ranking for the number of people randomized to these trials is between 2nd and 5th. The people we recruit for the Network trials deliver at 3 hospitals, with upwards of 11,000 combined births annually. The majority of the individuals we manage are racially and ethnically diverse, so over 85% of those recruited for the ongoing MFMU studies are underrepresented minorities. Our follow-up rates have been consistently greater 90%, except for the follow-up of ALPS children. We have taken several measures to increase follow-up rates. We are attempting to contact the families after hours or on weekends, offering Saturday appointments for study visits, and increasing our use of social media. We continue to refine our strategies to optimize follow-up rates. To be a valuable member of the Network, the center must have evidence of academic productivity. Since, 2016, we have published over 260 peer-reviewed articles, which were congruent with the aims of the MFMU Network. In the last 5 years, UTH faculty and Fellows have published 14 RCT, with 11 trials (78%) being multi-centered. If the Network is to upend the national guidelines' reliance on retrospective studies, centers must encourage and engage Fellows and junior faculty to undertake hypothesis generating secondary analyses and RCT. Independent of the Network, we recently published 12 secondary analyses, and our MFM Fellows are conducting 6 RCT, which do not compete with MFMU trials. It's notable that a nidus for the upcoming Network trial—Prescription After Cesarean Trial—was an RCT published by a recent graduate of our fellowship (Dinis J et al. Am J Obstet Gynecol. 2020). We remain committed to ensuring proper conduct of the studies, maintaining our performance ranks in the top-half of all aspects, including rate of eligible people randomized, follow-up and data quality merits.

项目概要 无论妊娠是高危还是低危，国家指南都会影响妊娠 美国每年对超过 370 万新生儿的管理通常基于回顾性数据。 需要从多中心前瞻性收集数据，或者在可行的情况下进行随机临床试验 (RCT)，在过去 19 年里，德克萨斯大学休斯顿分校 (UTH) 一直是一个具有公正治疗效果的研究。 母胎医学单位 (MFMU) 网络的重要组成部分，用于收集公正的数据。 UTH 研究团队由 11 人组成，拥有 84 年的研究经验 优先参与该网络是 100 多年的研究和工作经验。 我们的主席和 MFM 奖学金主任都曾担任网络 PI 和 在我们部门，我们担任 PI 或候补 PI 的综合经验已有 37 年。 目前的4个RCT，在12个网络中心中，我们的招募合格人员排名在第1到第4位之间 而且，我们对随机参加这些试验的人数的排名在第二到第五之间。 网络试验的招募人员在 3 家医院分娩，每年总共分娩超过 11,000 例。 我们管理的大多数人都是不同种族和民族的，因此超过 85% 的人员是为 正在进行的 MFMU 研究针对的是代表性不足的少数群体。 除 ALPS 儿童的随访外，我们的随访率始终高于 90%。 我们已采取多项措施来提高随访率，我们正在尝试在下班后联系家属。 或者在周末，提供周六的考察访问预约，并增加我们对社交媒体的使用。 继续完善我们的策略以优化随访率。 要成为网络的有价值的成员，中心必须拥有学术生产力的证据。 自 2016 年以来，我们已发表了 260 多篇同行评审文章，这些文章与 MFMU 网络。在过去 5 年中，UTH 教师和研究员发表了 14 项随机对照试验，其中 11 项试验 (78%)。 如果该网络要颠覆国家指南对回顾性研究的依赖， 中心必须鼓励和吸引研究员和初级教师进行假设生成二次 独立于网络的分析和 RCT，我们最近发表了 12 项二次分析以及我们的 MFM。 研究员正在进行 6 项随机对照试验，这些试验不与 MFMU 试验竞争。值得注意的是，该试验存在一个病灶。 即将进行的网络试验——剖腹产试验后的处方——是一项随机对照试验，由我们的一名应届毕业生发表 奖学金（Dinis J 等人 Am J Obstet Gynecol. 2020）。 我们仍然致力于确保研究的正确进行，保持我们的表现排名 上半部分是各个方面的内容，包括符合条件的人随机化率、随访情况以及数据质量优劣。