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，妊娠期糖尿病（GDM）治疗（与无）改善孕产妇和围产期结局，基于诊断与2步筛查策略。此外，一项大型多中心前瞻性队列研究显示，基于单次75 g口服葡萄糖耐量试验（OGTT）筛查，血糖与孕产妇和围产期结局呈线性关系。基于这一大型队列研究的结果，美国糖尿病协会建议临床实践采用一步75克筛查方法诊断GDM。美国妇产科学院采取了相反的立场，推荐传统的两步筛查：因为它本身就有RCT结果证据。2013年迫切需要最好地告知临床实践和卫生政策的不是额外的GDM治疗与对照试验，而是一项务实的RCT测试2种推荐的临床策略。为了务实地解决这一关键的研究差距，我们建议将估计17，626名不同的妇女随机分配到GDM筛查（2步与75 g OGTT），作为Kaiser Permanente Northwest（KPNW）和夏威夷（KPH）区域健康计划中临床护理的一部分。我们将在GDM筛查时使用计划的电子病历（EMR）系统对女性进行随机分组。KPNW和KPH地区都普遍在妊娠24-28周筛查GDM，他们将支付将妇女随机分配到这两种方法的费用，以及作为临床护理的一部分，按照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两个地区的妇产科部门建立的强大合作伙伴关系，开展我们目前的项目，评估早期糖尿病筛查对高危人群的影响（R 01 HD 058015）。通过在临床护理背景下随机进行GDM筛查，我们特别提出：比较GDM患病率（目的1）和筛查策略（目的2）之间的孕产妇和围产期结局差异。我们还建议在KPNW和KPH招募的1，000名孕妇子样本中确定75 g OGTT与通过2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，支持将KPNW和KPH中目前普遍的GDM筛查随机化作为临床护理的一部分，我们非常愿意填补这两种筛查策略的重要研究空白（2步与75 g OGTT）。此外，由于我们的KP健康计划合作，我们提供了非凡的能力来跟踪和评估这些筛查策略对35，000多名参与者（> 17，500对母婴）结果的影响。该建议还提供了在“真实世界”临床环境中测试目标的设计优势。我们提出的务实随机对照试验的结果确实具有从根本上快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.