The Perspectives Study: From Evidence to Guidance on Patient Recruitment to Clinical Research in Intensive Care Units, 2016-2019

Data collection was conducted across three workstreams.
In workstream (WS) 1, 17 ICU clinicians/researchers, and eight patient and public involvement (PPI) contributors with experience of working on ICU studies, took part in semi-structured telephone interviews about the problems and potential solutions in recruitment and consent to ICU studies. This informed the development of the survey for WS2.
In WS2, 1453 participants from 14 ICUs in England took part in the survey, which explored experiences and views of ICU research recruitment and consent process. Forty-four surveys were either duplicates or had substantial missing data so 1409 surveys were included in the analysis. Of these, 333 surveys were from ICU patients, 488 from family members (of whom 63 were bereaved) and 588 were from healthcare practitioners. Thirty five percent (115/333) of patient surveys and 32% (157/488) of family member surveys were from individuals who reported having been approached about research in the ICU, while 44% (260/588) of healthcare practitioner surveys were from those who indicated they had a role in research.
For WS3, a purposive sample of 60 participants, 54 of whom had completed the WS2 survey, took part in semi-structured interviews to explore their survey responses and their wider perspectives on ICU research in more depth. This included 13 patients, 30 family members (of whom 4 were bereaved before completing the survey, and 5 were bereaved since they or another family member completed the survey), and 17 healthcare practitioners. Of interviewed patients and family members, 25 had been approached about a study while in the ICU. Of healthcare practitioners, 12 had research roles at the time of their interview (3 doctors, 7 research nurses and 2 pharmacists).
The six additional interviewees comprised: four family members of surveyed patients where the family member had visited the patient’s during their ICU stay; two ICU patients whose family members had completed a survey. Although these six interviewees had not completed the WS2 survey, the protocol permitted interviews with such individuals if they had close ties to WS2 participants.<p>Clinical research in intensive care units (ICUs) is essential for improving treatments for critically ill patients. However, invitations to participate in clinical research in this situation pose numerous challenges. ICU studies frequently take place within a narrow time window and patients will often be unconscious and unable to consent. Consent must, therefore, be sought from representatives or proxies of a patient, usually the patient's relatives. Conversations about research participation in this setting will be difficult, as relatives are often overwhelmed and some will feel uneasy about making decisions on behalf of their loved ones. In some circumstances, legislation allows doctors act as representatives so patients can be enrolled in research. Despite these and other distinctive practices in recruitment and consent to ICU research, prior to the Perspectives study there was little good quality evidence and guidance on stakeholders’ perspectives to inform how recruitment and consent is carried out in ICU studies. Knowledge of stakeholder perspectives was needed to avoid basing recruitment and consent processes on presumptions about peoples’ experience of ICU research.
The Perspectives study explored the views of stakeholders with recent first-hand experience of ICU treatment and research to inform approaches to recruitment and consent. Established social science methods and empirical ethics were employed to balance the interests of the various stakeholders and justify recommendations. The findings were used to inform good practice guidance on recruitment and consent to future ICU studies. Researchers and an expert Advisory Group of key stakeholders (including patients, relatives, ICU doctors, nurses and research regulators) contributed throughout the process of developing the guidance bringing different viewpoints to interpreting the evidence and informing the guidance.</p>

本数据集的收集工作共覆盖三个工作流（Workstream, WS）。
在工作流1（WS1）中，17名重症监护病房（Intensive Care Unit, ICU）临床医师/研究者，以及8名具备ICU研究参与经验的患者与公众参与（Patient and Public Involvement, PPI）参与者，参与了针对ICU研究招募与知情同意环节存在的问题及潜在解决方案的半结构化电话访谈。本次访谈为WS2的问卷开发提供了依据。
在WS2中，来自英格兰14家ICU的1453名参与者参与了本次问卷调研，旨在了解其对ICU研究招募与知情同意流程的体验与看法。其中44份问卷为重复提交或存在大量缺失数据，最终纳入分析的有效问卷共1409份。细分来看，有效问卷包括333份ICU患者问卷、488份家属问卷（其中63名家属为丧亲者）以及588份医疗从业人员问卷。在受访者中，35%（115/333）的患者、32%（157/488）的家属均表示曾在ICU期间被邀请参与研究；而44%（260/588）的医疗从业人员问卷受访者表明其自身参与过研究相关工作。
在WS3中，研究采用目的性抽样选取了60名参与者，其中54名曾完成WS2的问卷调研，他们参与了半结构化访谈，以更深入地探讨其问卷反馈及对ICU研究的更广泛看法。本次访谈对象包括13名患者、30名家属（其中4名在完成问卷前已丧亲，另有5名在自身或其他家属完成问卷后丧亲）以及17名医疗从业人员。在接受访谈的患者与家属中，25人曾在ICU住院期间被邀请参与研究；在医疗从业人员中，12人在访谈时承担研究相关职责（包括3名医师、7名研究护士及2名药剂师）。另有6名额外访谈对象：4名曾在患者ICU住院期间探视的受访患者家属，以及2名家属完成了WS2问卷的ICU患者。尽管这6名受访者未完成WS2问卷，但研究方案允许与WS2参与者有密切关联的此类人员进行访谈。

重症监护病房（Intensive Care Unit, ICU）的临床研究对于改善危重症患者的治疗方案至关重要。然而，在此场景下邀请受试者参与临床研究面临诸多挑战。ICU研究的开展往往时间窗口狭窄，且患者常处于昏迷状态，无法自行完成知情同意。因此，研究人员需向患者的代理人或授权代表（通常为患者家属）寻求知情同意。在此场景下开展研究参与相关沟通难度极大，因为家属往往承受着巨大的精神压力，部分家属甚至会因替至亲做出决策而感到不安。在部分场景中，法律法规允许医师作为代理人，使患者能够被纳入研究。尽管ICU研究的招募与知情同意存在上述及其他特殊流程，但在本视角研究（Perspectives study）开展前，鲜有高质量的证据与指南能基于利益相关方的视角，指导ICU研究的招募与知情同意工作。研究人员需要了解利益相关方的真实看法，以避免将招募与知情同意流程建立在对人们ICU研究体验的主观假设之上。
本视角研究（Perspectives study）旨在调研具备近期ICU治疗与研究亲历经历的利益相关方的看法，为优化招募与知情同意流程提供依据。研究采用成熟的社会科学方法与经验伦理学框架，以平衡各利益相关方的利益，并为研究建议提供合理性支撑。研究结果被用于制定未来ICU研究招募与知情同意的最佳实践指南。在指南开发的全过程中，研究者与由核心利益相关方组成的专家咨询组（包括患者、家属、ICU医师、护士及研究监管人员）共同参与，通过整合多元视角解读研究证据并完善指南内容。