Comparing Two Gestational Diabetes Screening Methods: A Pragmatic Outpatient RCT

描述（由申请人提供）：最近的两项随机安慰剂对照试验表明，基于两步筛查策略的诊断，妊娠期糖尿病（GDM）治疗（与无治疗相比）改善了孕产妇和围产期结局。此外，一项大型多中心前瞻性队列研究显示，基于单次75克口服葡萄糖耐量试验（OGTT）的筛查，葡萄糖与孕产妇和围产期结局呈正相关。基于这一大型队列研究结果，美国糖尿病协会建议临床实践采用1步75克筛查方法诊断GDM。美国妇产科学院（American College of Obstetrics & Gynecology）采取了相反的立场，推荐传统的两步筛查：因为它本身就有RCT结果证据。2013年迫切需要为临床实践和卫生政策提供最佳信息的不是一项额外的GDM治疗与对照试验，而是一项实用的随机对照试验，对两种推荐的临床策略进行测试。为了切实解决这一关键的研究缺口，我们建议在Kaiser Permanente西北（KPNW）和夏威夷（KPH）地区健康计划中随机选取约17,626名不同类型的女性进行GDM筛查（两步对照75克OGTT），作为其临床护理的一部分。我们将在GDM筛查时使用该计划的电子医疗记录（EMR）系统随机分配妇女。KPNW和KPH地区普遍在妊娠24-28周筛查GDM，作为临床护理的一部分，他们将承担随机分配妇女使用这两种方法的费用，以及按标准方案进行治疗的费用。重要的是，我们的团队还将利用我们与这两个地区的妇产科建立的牢固伙伴关系来开展我们目前的项目，评估妊娠早期糖尿病筛查对高危人群的影响（R01 HD058015）。通过在临床护理中随机进行GDM筛查，我们特别提出：比较GDM患病率（目标1）和筛查策略之间孕产妇和围产期结局的差异（目标2）。我们还建议在KPNW和KPH招募的1000名孕妇的子样本中，确定75g OGTT与两步诊断的GDM的一致性。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，我们支持在KPNW和KPH中随机进行目前普遍的GDM筛查，作为临床护理的一部分，我们特别准备填补这两种筛查策略（2步vs 75克OGTT）的重要研究空白。此外，由于我们的KP卫生计划合作，我们提供了非凡的能力来跟踪和评估这些筛查战略对35000多名参与者（17500对母婴）结果的影响。该建议还提供了在“现实世界”临床环境中测试目标的设计优势。我们提出的实用RCT的结果确实具有从根本上迅速改变临床实践的巨大潜力。

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.