ArticleResearch involvement and engagement2025
Co-designing and pilot-testing an infographic to support the consent process in an adaptive platform trial for adults in ICU with community-acquired pneumonia or COVID-19: a mixed methods study within a trial (SWAT).
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Abstract
backgroundInformed consent documents educate patients and families about research participation and alternatives. However, given their length and complexity, consent documents can be challenging to understand, particularly in high-stress environments such as the Intensive Care Unit (ICU) and for complex study designs such as platform trials.
methodsThis is an exploratory sequential mixed methods study-within-a-trial (SWAT) of REMAP-CAP (Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia). Phase 1: We conducted focus groups with individuals with lived experience, including ICU survivors, substitute decision makers (SDMs) and research coordinators (RCs) to refine an infographic to augment a priori REMAP-CAP consent encounters. We analyzed data using inductive content analysis. Phase 2: We piloted the infographic with patients/SDMs approached a priori to participate in REMAP-CAP, who could communicate in English, at five sites in Ontario, Canada. We assessed implementation according to 1) eligible consent encounters (number of patients/SDMs eligible for SWAT / approached for REMAP-CAP), 2) receipt of infographic (number of patients/SDMs who received the infographic / eligible consent encounters), 3) consent to participation in this SWAT by patients/SDMs (number of patients/SDMs who consented / those approached), and 4) feedback questionnaire completion (number of patients/SDMs who completed the questionnaire / those who received it).
resultsPhase 1: We conducted two, two-hour focus groups with 5 participants (10 participants total). Participants identified important infographic design considerations (visual presentation, language) and content (study details, participation in research). Integration: Results from Phase 1 were used to develop a final consent infographic. Phase 2: Sixty-three patients were eligible for REMAP-CAP during the study period; 21 were eligible (33%) for the SWAT. Of these, 18 patients/SDMs (86%) received the infographic, 17 consented to the SWAT (94%) and 15 (88%) completed questionnaires. RCs completed case report forms for each consent encounter (n = 18, 100%).
conclusionsWe engaged individuals with lived experience to co-design a consent infographic. We achieved three of four pre-specified feasibility objectives during pilot testing of the infographic for a priori REMAP-CAP consent encounters. Although there were fewer eligible consent encounters than anticipated, we identified acceptable rates of infographic delivery, consent to SWAT participation and questionnaire completion.
trial registrationThe Northern Ireland Hub for Trials Methodology Research SWAT Repository (SWAT #176).
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