Aids to improve understanding of statistical risk in patients consenting for surgery and interventional procedures: A systematic review

Background: Informed consent is an essential process in clinical decision-making, through which healthcare providers educate patients about benefits, risks, and alternatives of a procedure. Statistical risk information is difficult to communicate and the effectiveness of aids aimed at supporting this type of communication is uncertain. This systematic review aims to study the impact of risk communication adjuncts on patients' understanding of statistical risk in surgery and interventional procedures. Methods: A systematic search was performed across Medline, Embase, PsycINFO, Scopus, and Web of Science until July 2021 with a repeated search in September 2022. RCTs and observational studies examining risk communication tools (e.g., information leaflets and audio-video) in adult (age >16) patients undergoing a surgical or interventional procedure were included. Primary outcomes included the objective assessment of statistical risk recall. Secondary outcomes included patient attitudes with respect to statistical information. Due to the study heterogeneity, a narrative synthesis was performed. Results: A total of 4348 articles were identified, and following abstract and full-text screening 14 articles, including 9 RCTs, were included. The total number of adult patients was 1513. The most common risk communication tool used was written information (n = 7). Most RCTs (7/9, 77.8%) showed statistically significant improvements in patient understanding of statistical risk in the intervention group. Quality assessment found some concerns with all RCTs. Conclusion: Risk communication tools appear to improve recall of statistical risk. Additional prospective trials comparing various aids simultaneously are warranted to determine the most effective method of improving understanding.