Comparing Two Gestational Diabetes Screening Methods: A Pragmatic Outpatient RCT

项目摘要/摘要：最近两项随机安慰剂对照试验表明，妊娠期 糖尿病(GDM)治疗(与不治疗相比)改善了孕产妇和围产儿的结局，这是基于2- 阶梯式筛选策略。此外，一项大型多中心前瞻性队列研究显示， 基于单一75g口服葡萄糖耐量筛查的血糖与孕产妇和围产儿结局 测试(OGTT)。根据这一大群人的发现，美国糖尿病协会建议 临床采用一步75G筛查法诊断妊娠期糖尿病。美国理工学院 妇产科采取了相反的立场，推荐传统的两步筛查：因为它 仅此一项就有RCT结果证据。2013年迫切需要什么来最好地为临床实践和健康提供信息 政策不是额外的GDM治疗与对照试验，而是2个推荐的务实的RCT测试 临床策略。 为了务实地解决这一关键的研究差距，我们建议将估计的17,626个不同的 作为Kaiser Permanente临床护理的一部分，妇女接受GDM筛查(2步VS 75g OGTT) 西北(KPNW)和夏威夷(KPNW)区域健康计划。我们将使用这些计划的电子病历 (EMR)系统在妊娠期糖尿病筛查时随机选择妇女。KPNW和KPh区 普遍在怀孕24-28周进行妊娠期糖尿病筛查，他们将支付将妇女随机分配到 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 还将利用我们与这两个地区的OB/GYN部门建立的牢固合作伙伴关系来执行我们的 评估早期妊娠糖尿病筛查对高危人群影响的当前项目 (R01 HD058015)。 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(目标1)和不同筛查策略的孕产妇和围产儿结局的差异(目标2)。 我们还建议确定75g OGTT与两步法诊断的GDM的一致性，其中 在KPNW和KPH招募了1,000名孕妇的子样本。 凭借我们在全球需求管理领域的综合专业知识和强大的区域伙伴关系，支持当前的随机化 作为临床护理的一部分，我们特别准备在KPNW和KPH进行普遍的GDM筛查 关于这两种筛查策略的重要研究差距(2步与75g OGTT)。此外，由于我们的 KP健康计划协作，我们提供非凡的能力来跟踪和评估这些 对35,000多名参与者(17,500对母子)的结果进行筛选的策略。这项提议还包括 在“真实世界”的临床环境中提供测试目标的设计优势。我们建议的结果 务实的RCT确实具有从根本上快速改变临床实践的巨大潜力。

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.