Division of Critical Care Medicine, St. Michael's Hospital, Toronto, Ontario, Canada.
Am J Respir Crit Care Med. 2013 Jun 1;187(11):1212-8. doi: 10.1164/rccm.201208-1537OC.
Limited cross-sectional data exist to characterize the challenges of enrolling critically ill patients into research studies.
We aimed to describe recruitment practices, document factors that impact recruitment, and identify factors that may enhance future research feasibility.
We conducted a prospective, observational study of all critically ill adults eligible to participate in research studies at 23 Canadian intensive care units. We characterized eligibility events into one of five consent outcomes, identified reasons why opportunities to recruit were missed or infeasible, and documented decision maker's rationale for providing or declining consent.
Patients made decisions for themselves in 8.9% of encounters. In 452 eligibility events, consent was not required in 14 (3.1%), missed in 130 (28.8%), infeasible due to operational reasons in 129 (28.5%), obtained in 140 (31.0%), and declined in 39 (8.6%). More than half (57.3%) of all opportunities to recruit patients were missed or infeasible, largely because of research team workload, limited availability, narrow time windows for inclusion, difficulties in contacting families, nonexistent substitute decision makers (SDMs), physician refusals, and protocols prohibiting coenrollment. The rationale for providing consent differed between patients and SDMs. Greater research coordinator experience and site research volume and broader time windows for inclusion were significant predictors of fewer declined consents.
A large gap exists between eligibility and the frequency with which consent encounters occur in intensive care unit research. Recruitment is susceptible to design and procedural inefficiencies that hinder recruitment and to personnel availability, given the need to interact with SDMs. Current enrollment practices may underrepresent potential study populations.
目前仅有有限的横断面数据可用于描述将重症患者纳入研究的挑战。
我们旨在描述招募实践，记录影响招募的因素，并确定可能增强未来研究可行性的因素。
我们对 23 个加拿大重症监护病房符合研究条件的所有成年重症患者进行了一项前瞻性、观察性研究。我们将符合条件的事件分为 5 种同意结果之一，确定了错失或不可行的招募机会的原因，并记录了决策制定者提供或拒绝同意的理由。
8.9%的情况下患者自己做出决定。在 452 个符合条件的事件中，14 个（3.1%）不需要同意，130 个（28.8%）被错过，129 个（28.5%）因操作原因不可行，140 个（31.0%）获得同意，39 个（8.6%）被拒绝。超过一半（57.3%）的所有招募患者的机会被错过或不可行，主要是由于研究团队工作量大、可利用资源有限、纳入的时间窗口狭窄、与家属联系困难、不存在替代决策人、医生拒绝和协议禁止共同纳入。提供同意的理由在患者和替代决策人之间存在差异。研究协调员经验更丰富、研究站点数量更多、纳入时间窗口更宽是同意率降低的显著预测因素。
在重症监护病房研究中，符合条件与同意发生的频率之间存在很大差距。由于需要与替代决策人互动，招募容易受到设计和程序效率低下以及人员可用性的影响。目前的招募实践可能会低估潜在的研究人群。
