Do Patients at Sites With High RCT Enrollment Propensity Have Better Outcomes?
Do Patients at Sites With High RCT Enrollment Propensity Have Better Outcomes?
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具有高 RCT 入组倾向的地点的患者是否有更好的结果？
DOI：
10.1097/mlr.0000000000000429
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发表时间：
2015
期刊：
影响因子：
3
通讯作者：
Busch,AlisaB
中科院分区：
文献类型：
--
作者：
O'Malley,AlistairJ;Zelevinsky,Katya;He,Yulei;Busch,AlisaB
背景：对随机对照试验（RCT）普遍性的关注通常集中在RCT患者参与者的特征上。可能有RCT研究中心的特征，将RCT结果与非RCT环境中预期的结果区分开来。目的：检查研究中心对RCT招募的倾向是否与患者的恢复结果相关，以及参与RCT的患者与仍处于观察（OBS）治疗环境中的患者之间的相关性是否不同。数据：来自双相情感障碍急性抑郁药物治疗系统治疗增强计划RCT（N= 337）和OBS治疗组（N= 1581）的急性双相抑郁研究参与者。方法：一项纵向OBS研究，比较了RCT与OBS组的恢复可能性，允许根据研究中心高RCT入组倾向进行效应修改（定义为>中位数）和其他预测因素。结果：在RCT入组倾向高的研究中心接受治疗的非RCT受试者从双相情感障碍中恢复的概率更高。抑郁发作与低倾向性研究中心的参与者相比[比值比（95%置信区间）= 2.13（1.28-3.55）]。RCT入组倾向与RCT受试者的恢复结局无关[1.03（0.35-3.03）]。结论：在RCT中具有高入组倾向的研究中心似乎具有未观察到的特征，这些特征对非RCT患者的结局起着重要作用。对于低入组研究中心的RCT参与者，可能是禁止护理提供和监测的RCT方案减弱了这种影响。这些结果对未来的研究，以改善在非研究护理环境的结果。
Background:Concerns about randomized controlled trial (RCT) generalizability typically center on characteristics of RCT patient participants. Possibly there are RCT site characteristics that distinguish RCT outcomes from those that can be expected in non-RCT settings.Objectives:To examine whether site propensity toward RCT enrollment is associated with recovery outcomes for patients and whether the association differs between patients who participate in a RCT compared with those who remain in an observational (OBS) treatment environment.Data:Study participants with acute bipolar depression from The Systematic Treatment Enhancing Program for Bipolar Disorder acute depression pharmacotherapy RCT (N= 337) and OBS treatment arm (N= 1581).Methods:A longitudinal OBS study comparing the likelihood of recovery in the RCT to the OBS arm, allowing effect modification by site high RCT enrollment propensity (defined as> the median) and other predictors over a 6-month follow-up period.Results:Non-RCT participants who received care in sites with high RCT enrollment propensity had a higher probability of recovering from their bipolar-depression episode compared with participants from low propensity sites [odds ratio (95% confidence interval)= 2.13 (1.28–3.55)]. RCT enrollment propensity was not associated with recovery outcomes for RCT participants [1.03 (0.35–3.03)].Conclusions:Sites with high propensity to enroll patients in RCTs appear to have unobserved characteristics, which play a significant role in outcomes for non-RCT patients. For RCT participants in low-enrollment sites, possibly RCT protocols, which proscribe care delivery and monitoring, attenuate this effect. These results have implications for future research to improve outcomes in nonresearch care settings.