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: 8969684
• 负责人: TERESA A HILLIER
• 金额: $ 62.28万
• 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/8969684
• 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; Health Planning; Health Policy; Heating; Light; Manuscripts; Methods; Mothers; Neonatal; OGTT; Outcome; Outpatients; Participant; Patients; Population; Population Heterogeneity; Pregnancy; Pregnancy in Diabetics; Pregnant Women; Prevalence; Preventive service; Protocols documentation; Publishing Peer Reviews; Race; Randomized; Recommendation; Recruitment Activity; Regional Health Planning; Research; Risk; Sampling; 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; gestational weight gain; head-to-head comparison; high risk; improved; improved outcome; innovation; perinatal outcomes; prospective; randomized placebo controlled trial; randomized trial; screening; socioeconomics; study population; symposium; volunteer

DESCRIPTION (provided by applicant): 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 tria, 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 partnership 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 prevalence's (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.

描述（由申请人提供）：最近的两项随机安慰剂对照试验表明，妊娠糖尿病（GDM）治疗（相对于无）可以改善产妇和围产期结果，并基于具有2台阶筛查策略的诊断。此外，基于单个75G口服葡萄糖耐受性测试（OGTT）的筛查，一项大型多中心前瞻性队列研究显示，与葡萄糖，孕产妇和围产期结局的线性关系。根据这一大型队列的发现，美国糖尿病协会建议临床实践采用1步75G筛查方法来诊断GDM。美国妇产科学院采取了相反的立场，推荐了传统的2步筛查：因为仅它就有RCT结果证据。 2013年迫切需要为临床实践和卫生政策提供最大程度的信息，这不是GDM治疗与控制三角素的额外治疗，而是对两种推荐的临床策略进行务实的RCT测试。为了务实地解决这一关键研究差距，我们建议将估计的17,626名不同女性随机地在GDM筛查（2步vs. 75G OGTT）中，作为其在Kaiser Permanente Northwest（KPNW）和夏威夷（KPH）（KPH）地区健康计划中的临床护理的一部分。我们将在GDM筛查时使用计划的电子病历（EMR）系统来随机使女性。 KPNW和KPH区域均在妊娠24-28周都普遍筛选GDM的筛查，作为临床护理的一部分，她们将涵盖将妇女随机分配给两种方法的成本，以及根据标准方案的治疗。重要的是，我们的团队还将利用我们与两个地区的OB/GYN部门建立的强大合作伙伴关系，以进行当前的项目，以评估早期妊娠糖尿病筛查在高风险人群中的影响（R01 HD058015）。通过在临床护理的背景下随机对GDM筛查进行随机化，我们特别建议：比较GDM患病率（AIM 1）以及筛查策略之间的母体和围产期结果的差异（AIM 2）。我们还建议在KPNW和KPH的1,000名孕妇的招募子样本中确定75G OGTT与GDM的一致性。凭借我们在GDM领域和强大的区域合作伙伴关系方面的综合专业知识，以支持KPNW和KPH中的当前通用GDM筛查，作为临床护理的一部分，我们非常准备填补有关这两种筛查策略的重要研究差距（2步vs. 75G OGTT）。此外，由于我们的KP健康计划合作，我们提供了非同寻常的能力，可以跟踪和评估这些筛选策略对35,000多名参与者的结果的影响（> 17,500个母子对）。该建议还为“现实世界”临床环境中的测试目标提供了设计优势。我们拟议的务实RCT的结果确实具有从根本和快速改变临床实践的巨大潜力。