Department of Childhood, Youth and Education Studies, Manchester Metropolitan University, Manchester, UK
Department of Public Health, Policy and Systems, University of Liverpool, Liverpool, UK.
BMJ Open. 2022 Nov 14;12(11):e066149. doi: 10.1136/bmjopen-2022-066149.
Obtaining informed consent from patients in intensive care units (ICUs) prior to enrolment in a study is practically and ethically complex. Decisions about the participation of critically ill patients in research often involve substitute decision makers (SDMs), such as a patient's relatives or doctors. We explored the perspectives of different stakeholder groups towards these consent procedures.
Mixed-methods study comprising surveys completed by ICU patients, their relatives and healthcare practitioners in 14 English ICUs, followed by qualitative interviews with a subset of survey participants. Empirical bioethics informed the analysis and synthesis of the data. Survey data were analysed using descriptive statistics of Likert responses, and analysis of interview data was informed by thematic reflective approaches.
Analysis included 1409 survey responses (ICU patients n=333, relatives n=488, healthcare practitioners n=588) and 60 interviews (ICU patients n=13, relatives n=30, healthcare practitioners n=17). Most agreed with relatives acting as SDMs based on the perception that relatives often know the patient well enough to reflect their views. While the practice of doctors serving as SDMs was supported by most survey respondents, a quarter (25%) disagreed. Views were more positive at interview and shifted markedly depending on particularities of the study. Participants also wanted reassurance that patient care was prioritised over research recruitment. Findings lend support for adaptations to consent procedures, including collaborative decision-making to correct misunderstandings of the implications of research for that patient. This empirical evidence is used to develop good practice guidance that is to be published separately.
Participants largely supported existing consent procedures, but their perspectives on these consent procedures depended on their perceptions of what the research involved and the safeguards in place. Findings point to the importance of explaining clearly what safeguards are in place to protect the patient.
在将患者纳入研究之前，从重症监护病房（ICU）的患者处获得知情同意在实践和伦理上都非常复杂。关于危重患者参与研究的决策通常涉及替代决策者（SDM），例如患者的亲属或医生。我们探讨了不同利益相关者群体对这些同意程序的看法。
混合方法研究包括在 14 家英国 ICU 中对 ICU 患者、其亲属和医疗保健从业者进行的调查，随后对调查参与者的一部分进行了定性访谈。实证生物伦理学为数据分析和综合提供了信息。使用李克特量表的描述性统计分析对调查数据进行分析，并且通过主题反映方法对访谈数据进行了分析。
分析包括 1409 份调查回复（ICU 患者 n=333，亲属 n=488，医疗保健从业者 n=588）和 60 次访谈（ICU 患者 n=13，亲属 n=30，医疗保健从业者 n=17）。大多数人同意亲属作为 SDM，因为他们认为亲属通常非常了解患者，足以反映他们的观点。虽然大多数调查受访者支持医生作为 SDM，但有四分之一（25%）的人不同意。在访谈中，观点更加积极，并且根据研究的特殊性有明显变化。参与者还希望确保优先考虑患者护理，而不是研究招募。研究结果为同意程序的调整提供了支持，包括合作决策以纠正对研究对该患者影响的误解。这些实证证据被用于制定将单独发布的良好实践指南。
参与者在很大程度上支持现有的同意程序，但他们对这些同意程序的看法取决于他们对研究内容和已采取的保障措施的看法。研究结果表明，明确解释已采取哪些保障措施来保护患者非常重要。
