Aids to Improve Statistical Risk Communication in Patients Consenting for Surgery and Interventional Procedures: a Systematic Review

Abstract

Objective: Evaluate the effect of risk communication tools on the understanding of statistical risk of complications occurring in patients undergoing a surgical or interventional procedure. Summary Background Data: Informed consent is an essential process in clinical decision-making, through which healthcare providers educate patients about the benefits, risks and alternatives of a procedure. Numerical risk information is by nature probabilistic and difficult to communicate. Aids which support statistical risk communication and studies assessing their effectiveness are needed. Methods: A systematic search was performed across Medline, Embase, PsycINFO, Scopus and Web of Science until July 2021. Studies examining risk communication tools (e.g. informative leaflets, audio-video) in adults (age>16) patients undergoing a surgical or interventional procedure were included. Both randomised control trials (RCTs) and observational studies were included. Cochrane risk-of-bias and the Newcastle-Ottawa Scale were used to assess the quality of studies. Due to heterogeneity of the studies, a narrative synthesis was performed (PROSPERO ID: CRD42022285789). Results: A total of 4348 articles were identified and following abstract and full-text screening a total of 11 articles were included. 8 studies were RCTs and 3 were cross-sectional. The total number of adult patients was 1030. The most common risk communication tool used was additional written information (n=7). Of the 8 RCTs, 5 showed statistically significant improvements in the intervention group in outcomes relating to recall of statistical risk. Quality assessment of RCTs found some concerns with all studies. Conclusions: Risk communication tools appear to improve recall of statistical risk. Additional prospective trials are warranted which can compare various aids and determine the most effective method of improving patient understanding.