O'Grady Heather K, Bhimani Zahra, Dalziel Sandra, Dolanjski Barbara, Sandhu Gyan, Santos Marlene, Smith Kathy, Murthy Srinivas, Marshall John C, Kho Michelle E
Faculty of Health Sciences, School of Rehabilitation Sciences, McMaster University, Hamilton, Ontario, Canada.
St. Michael's Hospital Unity Health Toronto, Toronto, Ontario, Canada.
Pilot Feasibility Stud. 2023 Apr 13;9(1):58. doi: 10.1186/s40814-023-01290-6.
Informed consent is critical to the ethical conduct of clinical research and requires understanding of a trial including its purpose, process, potential risks and benefits, and alternatives to participation. This can be challenging for complex trials, such as platform trials, and in high-stress environments, such as the intensive care unit (ICU). REMAP-CAP (randomized, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia) is a platform trial which studies treatments for ICU patients with community-acquired pneumonia, including COVID-19. Patient/family partners (PFP) identified challenges during the REMAP-CAP consent process.
This is a patient-centred co-design study to refine and test an infographic to supplement current REMAP-CAP consent documents. Infographic prototypes were developed by patients, substitute decision-makers (SDMs), and researchers with lived experience in the ICU or with ICU research. We will apply a two-phase exploratory sequential, mixed-methods research design. In phase 1, we will conduct focus groups with ICU patients, SDMs, and research coordinators (RCs). We will use inductive content analysis to inform infographic refinement, to be pilot tested in phase 2. Phase 2 is a prospective study within a trial (SWAT) at ≤ 5 REMAP-CAP sites. We will collect self-reported data from patients/SDMs and RCs. The primary outcome is feasibility (eligible consent encounters, receipt of infographic, consent to follow-up, completion of follow-up surveys). Data will be integrated to understand if/how quantitative results build upon the qualitatively informed infographic.
Phase 1 results will be used to co-design an infographic, directly informed by the perspectives of patients, SDMs, and RCs involved in ICU research consent discussions. Results from phase 2 will determine the feasibility of infographic implementation in REMAP-CAP consent encounters. These feasibility data will inform a larger SWAT to evaluate our consent infographic. If successful, use of a co-designed infographic to support REMAP-CAP consent documents may improve the experience of consent for patients, SDMs, and RCs.
The Northern Ireland Hub for Trials Methodology Research SWAT Repository (SWAT no. 176).
知情同意对于临床研究的伦理行为至关重要，需要受试者理解一项试验，包括其目的、过程、潜在风险和益处以及参与试验的替代方案。对于复杂的试验，如平台试验，以及在高压力环境中，如重症监护病房（ICU），这可能具有挑战性。REMAP-CAP（社区获得性肺炎随机、嵌入式、多因素、适应性平台试验）是一项平台试验，研究针对包括新型冠状病毒肺炎（COVID-19）在内的社区获得性肺炎ICU患者的治疗方法。患者/家属合作伙伴（PFP）在REMAP-CAP的知情同意过程中发现了一些挑战。
这是一项以患者为中心的协同设计研究，旨在完善和测试一份信息图表，以补充当前的REMAP-CAP知情同意文件。信息图表原型由患者、替代决策者（SDM）以及有ICU实际经验或ICU研究经验的研究人员共同开发。我们将采用两阶段探索性序列混合方法研究设计。在第1阶段，我们将对ICU患者、SDM和研究协调员（RC）进行焦点小组访谈。我们将使用归纳性内容分析为信息图表的完善提供依据，并在第2阶段进行预试验。第2阶段是在≤5个REMAP-CAP试验点进行的试验内前瞻性研究（SWAT）。我们将收集患者/SDM和RC的自我报告数据。主要结局是可行性（符合条件的知情同意接触、收到信息图表、同意随访、完成随访调查）。将整合数据以了解定量结果是否以及如何基于定性信息图表得出。
第1阶段的结果将用于协同设计一份信息图表，该图表直接基于参与ICU研究知情同意讨论的患者、SDM和RC的观点。第2阶段的结果将确定在REMAP-CAP知情同意接触中实施信息图表的可行性。这些可行性数据将为一项更大规模的SWAT提供信息，以评估我们的知情同意信息图表。如果成功，使用协同设计的信息图表来支持REMAP-CAP知情同意文件可能会改善患者、SDM和RC的知情同意体验。
北爱尔兰试验方法研究中心SWAT储存库（SWAT编号176）。
