Aims: Gaining informed consent from participants is a vital but challenging aspect of conducting clinical research. We did a systematic review to describe interventions designed to support patients with communication and decision making about whether to take part in health research.
Methods: Eligible papers were peer-reviewed journal articles reporting any study design focusing on an intervention for adult patients capable of deciding about their participation in health research. Eligible interventions aimed to improve decision quality by enabling users to address their own information needs (e.g. question prompt list) and/or incorporate their values into decision making (e.g. decision aid). We searched 5 databases (1990–2022), Google Scholar, and reference lists of included papers and related reviews.
Results: We included 15 studies (13 in cancer) of which 9 were randomised trials (all in cancer). In 5 papers, resources addressed participation in a specific study (3 in cancer); the other 10 were generic but focused on clinical trials (all in cancer). 7 tools were on paper; 8 were computer- or web-based, which facilitated greater interactivity and/or tailoring. About half the papers cited a relevant health psychology or decision making theory, model, framework or standards. Studies assessed various measures of patient engagement; the most commonly used outcome was knowledge.
Conclusions: While the reviewed literature highlights the potential utility of tools to support patients considering health-related research participation, we identified some gaps. Future interventions should address study types other than clinical trials, settings other than cancer, and important emerging areas like genomics and precision medicine.