Comparing Two Gestational Diabetes Screening Methods: A Pragmatic Outpatient RCT

比较两种妊娠期糖尿病筛查方法：实用的门诊随机对照试验

• 批准号: 8631835
• 负责人: TERESA A HILLIER
• 金额: $ 65.5万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-12-01 至 2018-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8631835
• 关键词: Address; Adopted; Advisory Committees; Affect; American; Carbohydrates; Child; Clinical; Clinical Trials; Cohort Studies; Collaborations; Communities; Computerized Medical Record; Consensus; Diabetes Mellitus; Diagnosis; Discipline of obstetrics; Eligibility Determination; Environment; Ethnic Origin; Funding; Gestational Diabetes; Glucose; Gynecology; Hawaii; Health Planning; Health Policy; Heating; Light; Manuscripts; Methods; Mothers; Neonatal; OGTT; Outcome; Outpatients; Participant; Patients; Perinatal; Population; Population Heterogeneity; Population Study; Pregnancy; Pregnancy in Diabetics; Pregnant Women; Prevalence; Preventive; Protocols documentation; Publishing Peer Reviews; Race; Randomized; Recommendation; Recruitment Activity; Regional Health Planning; Research; Risk; Sampling; Services; System; Test Result; Testing; Time; Translating; United States National Institutes of Health; Weight; Weight Gain; Woman; base; clinical care; clinical practice; cohort; college; computerized; cost; cost effective; design; fetal; forging; head-to-head comparison; high risk; improved; innovation; prospective; public health relevance; randomized placebo controlled trial; randomized trial; screening; socioeconomics; symposium; volunteer

PROJECT SUMMARY/ABSTRACT: Two recent randomized placebo-controlled trials show that gestational diabetes (GDM) treatment (vs. none) improves maternal and perinatal outcomes, based on diagnosis with a 2- step screening strategy. Also, a large multi-center prospective cohort study showed a linear relationship with glucose and maternal and perinatal outcomes, based on screening with a single 75g oral glucose tolerance test (OGTT). Based on this large cohort's findings, the American Diabetes Association recommended that clinical practice adopt the 1-step 75g screening approach for diagnosing GDM. The American College of Obstetrics & Gynecology took the opposite stance, recommending the traditional 2-step screening: because it alone has RCT outcome evidence. What is urgently needed in 2013 to best inform clinical practice and health policy is not an additional GDM treatment vs. control trial, but a pragmatic RCT testing the 2 recommended clinical strategies. To pragmatically address this critical research gap, we propose to randomize an estimated 17,626 diverse women to GDM screening (2-step vs. 75g OGTT) as part of their clinical care in the Kaiser Permanente Northwest (KPNW) and Hawaii (KPH) regional health plans. We will use the plans' electronic medical record (EMR) system at the time of GDM screening to randomize the women. Both KPNW and KPH regions universally screen for GDM at 24-28 weeks gestation, and they will cover the costs of randomizing women to the two approaches, as well as treatment per standard protocol, as part of clinical care. Importantly, our team will also leverage the strong partnerships we forged with both regions' OB/GYN departments to carry out our current project that evaluates the Impact of Early Gestational Diabetes Screening in High-Risk Populations (R01 HD058015). By randomizing GDM screening in the context of clinical care, we specifically propose: to compare GDM prevalences (Aim 1) and differences in maternal and perinatal outcomes between screening strategies (Aim 2). We also propose to determine the concordance of the 75g OGTT with GDM diagnosed by 2-step, among a recruited sub-sample of 1,000 pregnant women at KPNW and KPH. With our combined expertise in the GDM field and strong regional partnerships to support randomizing current universal GDM screening in KPNW and KPH as part of clinical care, we are exceptionally poised to fill the important research gap about these 2 screening strategies (2-step vs. 75g OGTT). Additionally, because of our KP health plan collaborations, we offer an extraordinary capacity to track and evaluate the impact of these screening strategies on outcomes in over 35,000 participants (>17,500 mother-child pairs). This proposal also offers the design advantage of testing aims in a "real-world" clinical setting. Results from our proposed pragmatic RCT truly have enormous potential to fundamentally and quickly transform clinical practice.

项目概要/摘要：最近两项随机安慰剂对照试验显示，妊娠期 糖尿病（GDM）治疗（与无治疗相比）可改善孕产妇和围产期结局，基于2- 逐步筛选策略。此外，一项大型多中心前瞻性队列研究显示， 基于单次75 g口服葡萄糖耐量筛查的血糖与孕产妇和围产期结局 OGTT试验。根据这一大型队列的研究结果，美国糖尿病协会建议， 临床实践采用一步75 g筛查法诊断GDM。The American College of 妇产科采取了相反的立场，建议传统的两步筛查：因为它 只有RCT结果证据。2013年迫切需要什么来最好地告知临床实践和健康 这项政策不是一项额外的GDM治疗与对照试验，而是一项务实的RCT， 临床策略 为了务实地解决这一关键的研究差距，我们建议随机分配估计17，626个不同的 作为Kaiser Permanente临床护理的一部分，女性接受GDM筛查（2步vs. 75 g OGTT） 西北（KPNW）和夏威夷（KPH）地区卫生计划。我们将使用该计划的电子医疗记录 (EMR)系统在GDM筛查时对妇女进行随机分组。KPNW和KPH区域 在妊娠24-28周时普遍筛查GDM，他们将支付随机分配妇女的费用， 这两种方法，以及按照标准方案进行治疗，作为临床护理的一部分。重要的是，我们的团队 我们还将利用我们与两个地区的妇产科部门建立的强大伙伴关系， 目前正在进行的一个项目，评估早期糖尿病筛查对高危人群的影响 (R01 HD058015）。 通过在临床护理背景下对GDM筛查进行随机化，我们特别提出： 患病率（目标1）和筛查策略之间的孕产妇和围产期结局差异（目标2）。 我们还建议确定75 g OGTT与GDM诊断的一致性， 在KPNW和KPH招募了1，000名孕妇的子样本。 凭借我们在GDM领域的综合专业知识和强大的区域合作伙伴关系， 作为临床护理的一部分，我们特别准备在KPNW和KPH中进行GDM筛查， 关于这2种筛查策略的重要研究差距（2步与75 g OGTT）。此外，由于我们的 KP健康计划的合作，我们提供了一个非凡的能力来跟踪和评估这些影响， 对35 000多名参与者（> 17 500对母婴）的结果进行筛查。该提案还 提供了在“真实世界”临床环境中测试目标的设计优势。我们提出的结果 实用RCT确实具有从根本上迅速改变临床实践的巨大潜力。