Study protocol for the ROSE Scale-Up Study: Informing a decision about ROSE as universal postpartum depression prevention.
Study protocol for the ROSE Scale-Up Study: Informing a decision about ROSE as universal postpartum depression prevention.
复制标题
ROSE 扩大研究的研究方案：告知有关 ROSE 作为通用产后抑郁症预防的决定。
DOI：
10.1016/j.cct.2023.107297
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发表时间：
2023
影响因子：
2.2
通讯作者：
Zlotnick,Caron
中科院分区：
文献类型：
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作者：
Johnson,JenniferE;Loree,AmyM;Sikorskii,Alla;Miller,TedR;Carravallah,Laura;Taylor,Brandon;Zlotnick,Caron
目的探讨“伸出手，保持坚强，新生儿母亲必需品”（ROSE）产后抑郁症预防（PPD）项目作为普遍预防与选择性或指示性预防的有效性、成本-结果、公平性、可扩展性和机制。美国预防服务工作组（USPSTF）目前建议有PPD风险的孕妇预防PPD（即选择性/指示性预防）。然而，普遍预防可能更具可扩展性、公平性和成本效益。ROSE在高危人群中预防PPD的设计有效性是已知的。为了评估ROSE作为普遍预防，我们需要确定ROSE在所有孕妇中的有效性，包括那些PPD风险筛查阴性的孕妇。我们将招募2320名孕妇，用常用的PPD风险预测工具对她们进行评估，将每个人随机分配到ROSE或常规强化护理，并在以下方面评估ROSE作为普遍、选择性和指示性预防：(1)有效性（PPD预防和功能），(2)成本效益，(3)公平性（通过普遍预防预防的PPD病例，在少数族裔与非西班牙裔白人的选择性/指出下无法预防），(4)可扩展性的定量和定性测量（来自98个先前实施ROSE的机构），(5)跨风险级别的ROSE机制。我们将综合结果，概述三种预防方法（即普遍、选择性、指示性）的利弊。这将是第一个评估普遍与选择性/指示性PPD预防的试验。试验设计说明了一种新颖、有效的方法来进行这些比较。该试验是迄今为止规模最大的PPD预防试验，将检验可扩展性，这是实施科学的一个尚未充分研究的领域。
PurposeTo examine the effectiveness, cost-outcome, equity, scalability, and mechanisms of the Reach Out, Stay strong, Essentials for mothers of newborns (ROSE) postpartum depression prevention (PPD) program as universal versus selective or indicated prevention.BackgroundThe United States Preventive Services Task Force (USPSTF) currently recommends PPD prevention for pregnant people at risk of PPD (i.e., selective/indicated prevention). However, universal prevention may be more scalable, equitable, and cost-beneficial.DesignEffectiveness of ROSE for preventing PPD among people at risk is known. To assess ROSE as universal prevention, we need to determine the effectiveness of ROSE among all pregnant people, including those screening negative for PPD risk. We will enroll 2320 pregnant people, assess them with commonly available PPD risk prediction tools, randomize everyone to ROSE or enhanced care as usual, and assess ROSE as universal, selective, and indicated prevention in terms of: (1) effectiveness (PPD prevention and functioning), (2) cost-benefit, (3) equity (PPD cases prevented by universal prevention that would not be prevented under selective/indicated for minority vs. non-Hispanic white people), (4) quantitative and qualitative measures of scalability (from 98 agencies previously implementing ROSE), (5) ROSE mechanisms across risk levels. We will integrate results to outline pros and cons of the three prevention approaches (i.e., universal, selective, indicated).ConclusionThis will be the first trial to assess universal vs. selective/indicated PPD prevention. Trial design illustrates a novel, efficient way to make these comparisons. This trial, the largest PPD prevention trial to date, will examine scalability, an understudied area of implementation science.