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 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).
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.
Competing Interest Statement
The authors have declared no competing interest.
Clinical Protocols
https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=285789
Funding Statement
This study did not receive any funding
Author Declarations
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Yes
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Yes
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Yes
Footnotes
Data Availability
All data produced in the present study are available upon reasonable request to the authors