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

ObjectiveEvaluate 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 DataInformed 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. MethodsA systematic search was performed across Medline, Embase, PsycINFO, Scopus and Web of Science until July 2021 with a repeated search in September 2022. Studies examining risk communication tools (e.g. informative leaflets, audio-video) in adults (age>16) patients undergoing a surgical or interventional procedure were included. Studies only assessing understanding of non-statistical aspects of the procedure were excluded. 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). ResultsA 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. ConclusionsRisk 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.