Improving communication when seeking informed consent: a randomised controlled study of a computer‐based method for providing information to prospective clinical trial participants

Abstract

Objective: To assess the efficacy, with respect to participant understanding of information, of a computer‐based approach to communication about complex, technical issues that commonly arise when seeking informed consent for clinical research trials. Design, setting and participants: An open, randomised controlled study of 60 patients with diabetes mellitus, aged 27–70 years, recruited between August 2006 and October 2007 from the Department of Diabetes and Endocrinology at the Alfred Hospital and Baker IDI Heart and Diabetes Institute, Melbourne. Intervention: Participants were asked to read information about a mock study via a computer‐based presentation (n = 30) or a conventional paper‐based information statement (n = 30). The computer‐based presentation contained visual aids, including diagrams, video, hyperlinks and quiz pages. Main outcome measures: Understanding of information as assessed by quantitative and qualitative means. Results: Assessment scores used to measure level of understanding were significantly higher in the group that completed the computer‐based task than the group that completed the paper‐based task (82% v 73%; P = 0.005). More participants in the group that completed the computer‐based task expressed interest in taking part in the mock study (23 v 17 participants; P = 0.01). Most participants from both groups preferred the idea of a computer‐based presentation to the paper‐based statement (21 in the computer‐based task group, 18 in the paper‐based task group). Conclusions: A computer‐based method of providing information may help overcome existing deficiencies in communication about clinical research, and may reduce costs and improve efficiency in recruiting participants for clinical trials.

Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials

“…Data regarding rates of participant satisfaction were tracked for eleven interventions. Preferences between interventions and controls were either insignificant or showed that participants significantly preferred the interventions [19,27,29,32,35,43,47,52-54]. Accrual rates, tracked for trials with real parent studies, were also reported as improved or unchanged by interventions in all categories [13,23,29,43,52,55,56], with one exception [46].…”

A randomized study of multimedia informational aids for research on medical practices: Implications for informed consent

“…However, there is no clear standard for how much of an improvement in understanding is needed to justify the cost of developing a multimedia aid, and reviews of the literature have shown these efforts to have mixed results. 18–19 In some studies, multimedia aids have improved participant understanding, 20–21 while others have shown no significant improvement in knowledge despite participants’ reports that they found them worthwhile. 22 None of these studies have addressed understanding of research on medical practices specifically.…”

Development and preliminary evaluation of an animation (simplifyKDPI) to improve kidney transplant candidate understanding of the Kidney Donor Profile Index

“…Strategies included limiting animation length, focusing on a relevant and practical topic, using simple and familiar language, visually reinforcing content, and using active voice with conversational style. 11,12 Animation-based education is quickly gaining an evidence base and offers great opportunity to overcome literacy barriers 13 by visually underscoring the message and improving comprehension, 10,14 recall, 14,15 and satisfaction with information delivery. 14,[16][17][18] In this paper, we review the patient-engaged development process for the animation and report preliminary evidence of its feasibility and acceptability from pilot testing the animation with kidney transplant candidates.…”