What did trial participants in REMAP-CAP Japan experience during the COVID-19 pandemic? A qualitative study

Overview

This qualitative study examined the experiences of critically ill patients in Japan who participated in the anticoagulation domain of REMAP-CAP during the COVID-19 pandemic. The research addressed a gap in the literature regarding participant experiences in randomized controlled trials of acute and critical care, with particular attention to informed consent processes under pandemic conditions. Ten ICU patients with severe COVID-19 who had been deemed competent and provided prospective informed consent were recruited; data saturation was achieved within this sample.

Methods and approach

Conventional content analysis was applied to semi-structured interview data collected from trial participants. Participants were required to have been hospitalized in a Japanese ICU for severe COVID-19, deemed competent at enrollment, and to have provided prospective informed consent to trial participation. The methodological approach allowed for systematic identification and categorization of themes related to participants' understanding of and engagement with the trial.

Results

Three primary categories emerged from analysis: trial participation without awareness or adequate understanding, interpretation of trial participation experience with reference to personal circumstances, and emotions and thoughts evoked by trial participation. Across the sample, understanding of trial details and interventions was substantially limited. Several participants were unaware they had consented to trial participation. Regarding future engagement with clinical research, some participants expressed interest in subsequent trials, while others remained uncertain about their previous trial involvement.

Implications

The findings indicate that critically ill patients experience significant barriers to comprehension during informed consent processes, particularly in the context of acute care settings and health emergencies. These barriers suggest a disconnect between the procedural completion of informed consent and participants' meaningful understanding of trial participation. The research highlights structural vulnerabilities in informed consent practices within acute care settings that warrant institutional attention.