School of Medicine, Cardiff University, Cardiff, UK.
Centre for Trials Research, Cardiff University, Cardiff, UK.
Clin Trials. 2021 Aug;18(4):436-448. doi: 10.1177/1740774520988678. Epub 2021 Feb 2.
Critical care trials are limited by problems with participant recruitment, and little is known about the most effective ways to enhance trial participation. Despite clinical research improving in the past decades within intensive care, participant recruitment remains a challenge. Not all eligible patients are identified, and opportunities for enrolment into clinical trials are often missed. Interventions to facilitate recruitment need to be identified to improve trial conduct in the critical care environment. Therefore, we aimed to establish the effectiveness of recruitment strategies in critical care trials in order to inform future research practice.
Databases including MEDLINE, Embase, CINAHL and PsycINFO were searched for English language papers from inception to February 2020. The objectives were to: (1) establish the effectiveness of recruitment strategies and (2) recommend how effective recruitment strategies can inform research practice. Two reviewers independently assessed papers for inclusion and critically appraised the quality of the studies. Discrepancies were discussed within the research team. Relevant data were extracted and thematically coded into five overarching themes using a narrative synthesis approach. The review was prospectively registered on PROSPERO (CRD42019160519).
The search resulted in 2509 initially identified articles, with 15 that met the inclusion criteria. Articles reported a combination of quantitative, mixed methods and qualitative studies and a range of low-, moderate- and high-quality studies. Although, in-keeping with narrative synthesis approaches, none were excluded based on methodological quality. Five themes were identified relating to: patient eligibility identification, who provides information and seeks consent, resource limitations, research culture or environment and the consent model used. The relative success of recruitment strategies was dependent upon the experience and availability of the staff involved in the approach, trial design, the application of the strategy to the specific intensive care environment, the acceptability of the recruitment and consent models used, and the efficiency of the recruitment procedures. Opportunities for consent were missed in a proportion of eligible patients in most studies, suggesting that clinicians may avoid recruiting more complex patients or in more complex situations and that further development of strategies is needed.
More effective recruitment strategies are required to enhance recruitment and the representativeness of the patient sample obtained in critical care trials, in order to expand the evidence base for treatments in this field. Greater focus is needed on assessing the performance of different recruitment strategies within different types of studies and critical care research environments. Future research should explore key stakeholders' experiences of, and attitudes towards, recruitment and establish the most important and feasible modifiable barriers to recruitment.
重症监护试验受到参与者招募问题的限制，对于增强试验参与度的最有效方法知之甚少。尽管过去几十年来，重症监护领域的临床研究取得了进步，但参与者招募仍然是一个挑战。并非所有符合条件的患者都被识别出来，临床试验的入组机会经常错过。需要确定促进招募的干预措施，以改善重症监护环境中的试验实施。因此，我们旨在确定重症监护试验中招募策略的有效性，以便为未来的研究实践提供信息。
从开始到 2020 年 2 月，在 MEDLINE、Embase、CINAHL 和 PsycINFO 等数据库中搜索英文文献。目的是：（1）确定招募策略的有效性，（2）提出有效的招募策略如何为研究实践提供信息。两名审查员独立评估纳入标准的论文，并对研究质量进行批判性评估。研究小组内部讨论了差异。使用叙述性综合方法，将相关数据提取并主题编码为五个总体主题。该综述已在 PROSPERO（CRD42019160519）上进行了前瞻性注册。
搜索结果产生了 2509 篇最初确定的文章，其中 15 篇符合纳入标准。这些文章报告了定量、混合方法和定性研究的组合，以及一系列低、中、高质量的研究。尽管与叙述性综合方法一致，没有一篇文章因方法学质量而被排除。确定了五个与以下内容相关的主题：患者资格认定、谁提供信息并寻求同意、资源限制、研究文化或环境以及使用的同意模式。招募策略的相对成功率取决于参与该方法的工作人员的经验和可用性、试验设计、将策略应用于特定的重症监护环境、所使用的招募和同意模式的可接受性以及招募程序的效率。在大多数研究中，都有一部分符合条件的患者错过了同意的机会，这表明临床医生可能会避免招募更复杂的患者或在更复杂的情况下进行招募，并且需要进一步开发策略。
需要更有效的招募策略来提高重症监护试验的招募率和代表性，以扩大该领域治疗方法的证据基础。需要更加关注在不同类型的研究和重症监护研究环境中评估不同招募策略的表现。未来的研究应该探索关键利益相关者对招募的经验和态度，并确定招募的最重要和最可行的可修改障碍。
