WP6.11 - Systematic Review and Meta-Analysis of Written Interventions Used In the Informed Consent Process

Abstract Aim Written interventions are the earliest and most prevalent mode of information provided to patients in clinical practice. They are used as an adjunct to the verbal discussions between clinician and patients during the informed consent process. This review aimed to assess the effects of these interventions. Method This was a subgroup analysis from a larger systematic review and meta-analysis conducted according to the predefined protocol developed and registered on PROSPERO (CRD42023380406). . Five databases were searched using pre-defined search criterion in December 2022 for randomised trials of written interventions designed to improve the informed consent process. Adults > 18 years with the capacity to consent were included. The Cochrane risk of Bias (RoB) tool was used to assess study quality. Effect measurements were assessed using standardised mean differences and risk ratios for continuous variables and dichotomous variables respectively. Results 35 studies (37 intervention arms) contributing 3600 patients met the inclusion criteria. All but one study were conducted in an elective setting across a variety of surgical, radiological, endoscopic, oncological, and medical disciplines. Statistically significant improvement was demonstrated, in short (SMD 0.88, 95% CI 0.29 to 1.47, I2 = 81%) and long-term knowledge (SMD 0.38, 95% CI 0.14 to 0.62, I2 = 66%). There was no difference in immediate knowledge, satisfaction, or anxiety with the informed consent process. Conclusions This review provides a global overview of the impact of written interventions which has demonstrated improvement in short and long-term knowledge. These readily accessible intervention types should be considered as an adjunct during informed consent consultations to better inform decision making.