Measuring and evaluating participant understanding of consent processes in clinical trials: a systematic review
Discuss this preprint
Start a discussion What are Sciety discussions?Listed in
This article is not in any list yet, why not save it to one of your lists.Abstract
Background Informed consent (IC) is essential for maintaining participant autonomy in clinical trials by ensuring participants are fully informed. However, inconsistent oversight of spoken information provision and participant comprehension can lead to significant gaps in participant understanding and recall of critical trial details. This systematic review (SR) evaluates existing tools or approaches that measure participant understanding during the IC process. This review will encompass both quantitative and qualitative approaches, specifically focusing on tools or approaches which assess comprehension during recruitment discussions or through subsequent self-reported participant recall. It will further focus on the quality of data regarding the validity and reliability of these methods. Methods With an information specialist support, relevant primary studies were identified through searching MEDLINE, EMBASE, PsycINFO, and CINAHL from inception to March 2023. Studies included adults who had undergone the IC process for research. Excluded studies reported on understanding to consent to medical procedures outside of a research context, or involving adults without capacity and children. Following screening, data extraction was performed using a customised Microsoft Excel template, focusing on characteristics including validity, reliability, and participant involvement in development. Narrative synthesis developed an initial description of results and explored relationships between studies. Results Of the 6526 records screened, 261 studies were retrieved for full-text screening and a total of 148 studies were included in the review. Among these studies, 103 were quantitative, 24 were mixed methods, and only 20 were qualitative studies. Based on the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) criteria, three tools/measures demonstrated high validity and reliability: the Deaconess Informed Consent Comprehension Questionnaire (DICCQ), the Participatory and Informed Consent (PIC) tool, and the Process and Quality of Informed Consent (P-QIC). Conclusions This SR identified variability across approaches used in clinical trials to measure participant understanding of IC. Very few among these demonstrated rigour in their psychometric properties. The findings highlight the need for standardisation in assessment approaches and the need for an enhanced methodological approach in tool/measure development and its validation. This review also emphasises the importance of incorporating patient and public perspectives in designing these tools. Registration: PROSPERO ID: CRD42023407715