The ROSE Scale-Up Study: Informing a decision about ROSE as universal postpartum depression prevention

项目总结/摘要 产后抑郁症（PPD）是一种常见的和有影响力的公共卫生问题，可以有严重的 对母亲和婴儿，有时是整个家庭造成持久的后果。The Reach Out，Stand 强，新妈妈的必需品（ROSE）计划是一个以证据为基础的干预，防止一半的 产后抑郁症的病例，是美国预防医学会推荐的两种干预措施之一。 2019年的服务工作队。ROSE和其他推荐的PPD预防的所有有效性试验 干预措施只包括低收入妇女，这是一个使产后抑郁症发病率加倍的单一风险因素。因此 现有的PPD预防证据基础主要由PPD风险增加的妇女组成。基于 来自PI当前ROSE实施研究（R 01 MH 114883）的数据，许多医疗保健和社区 在这项实施试验中，78%的机构认为向每个人提供ROSE更可行， 妇女作为其标准工作流程的一部分（即，提供它作为普遍预防），而不是创建一个 对高危妇女的筛查和转诊程序（即，有针对性或有选择性的预防措施）。在 除了对各机构更可行外，普遍预防也可能是有利的，因为成本 筛查假阴性（导致可预防的PPD病例; 32，000美元）的费用远远超过ROSE的费用 分娩（50 - 300美元/妇女）。已知ROSE在有PPD风险的低收入妇女中的有效性 (ROSE预防约50%的PPD病例）。告知有关使用ROSE作为通用与 选择性或指示性预防，我们需要确定ROSE在一般人群中的有效性 包括PPD风险筛查阴性的女性（以各种方式定义）。因此，该项目将 在2，320例样本中评估不同PPD风险水平和不同预防方法的ROSE有效性 来自一个大型区域卫生系统（总部设在密歇根州底特律）的妇女。每一个提议的目标都收集了一部分 缺乏指导关于ROSE作为普遍预防的决策所需的信息。 我们将从以下方面评估ROSE作为普遍性、选择性和适应症预防的作用：（1）ROSE的有效性 相对于预防PPD和改善功能的每种预防方法的控制;（2）成本- 结果，（3）公平，（4）每种预防方法的可扩展性;（5）ROSE效应的机制 PPD风险水平。我们将整合结果，建议将ROSE作为普遍预防。这个决定性的 PPD预防试验将显示如何最好地为那些需要它的人提供循证计划 他们通过解决一个实用而新颖的问题（ROSE应该是普遍的吗 预防？）以及审查普遍预防办法与其他预防办法的公平性和成本-结果。

Project Summary/Abstract Postpartum depression (PPD) is a common and impactful public health problem, which can have severe and lasting consequences for the mother and infant, and sometimes the entire family. The Reach Out, Stand Strong, Essentials for New Mothers (ROSE) program is an evidence-based intervention that prevents half of cases of postpartum depression and was one of two interventions recommended by the US Preventive Services Task Force in 2019. All effectiveness trials of ROSE and of the other recommended PPD prevention intervention included only low-income women a single risk factor that doubles incidence of PPD. Thus, the existing evidence base for PPD prevention consists primarily of women at increased risk for PPD. Based on data from the PIs’ current implementation study of ROSE (R01 MH114883), many healthcare and community agencies in this implementation trial (78%) find it is more feasible for them to provide or offer ROSE to every woman as part of their standard work flow (i.e., provide it as universal prevention), than it is to create a screening and referral process for at risk women (i.e., an indicated or selective prevention approach). In addition to being more feasible for agencies, universal prevention may also be advantageous because the cost of a screening false negative (resulting in a preventable case of PPD; $32,000) far exceeds the cost of ROSE delivery ($50-$300/woman). Effectiveness of ROSE among low-income women at risk for PPD is known (ROSE prevents ~50% of PPD cases). To inform a recommendation about using ROSE as universal vs. selective or indicated prevention, we need to determine the effectiveness of ROSE among general populations of women, including women screening negative for PPD risk (defined in various ways). Thus, this project will assess ROSE effectiveness across PPD risk levels and across prevention approaches in a sample of 2,320 women from a large regional health system (based in Detroit, MI). Each proposed aim gathers a piece of information missing that is needed to guide decision-making about ROSE as universal prevention. We will assess ROSE as universal, selective, and indicated prevention in terms of: (1) ROSE effectiveness relative to a control for each prevention approach in preventing PPD and improving functioning; (2) cost- outcome, (3) equity, and (4) scalability of each prevention approach; and (5) mechanisms of ROSE effects across PPD risk levels. We will integrate results to advise about ROSE as universal prevention. This definitive PPD prevention trial will show how best to get an evidence-based program to those who need it in settings where they receive perinatal care by addressing a pragmatic and novel question (should ROSE be universal prevention?) and by examining equity and cost-outcome of universal vs. other prevention approaches.