WP8.7 - Systematic review and meta-analysis of interventions to improve the informed consent process for patients undergoing invasive interventions Free

This systematic review and meta-analysis aimed to assess the impact of various information based interventions used during the informed consent process for adults (over 18 years) with capacity undergoing invasive procedures.

The systematic review was conducted according to the predefined protocol developed and registered on PROSPERO (CRD42023380406). The Cochrane risk of Bias (ROB) tool was used to assess study quality. Effect measurements were assessed using standard mean differences and risk ratios for continuous variables and dichotomous variables respectively. Meta- analyses were performed using Review Manager (RevMan) version 5.4.

127 studies contributing 15022 patients met the inclusion criteria from 22 countries. 120 studies were conducted in an elective setting across a variety of surgical, radiological, endoscopic, oncological, and medical disciplines. Statistically significant improvement was demonstrated in objective (SMD 0.45, (95% CI 0.14 to 0.77) I²=86% and subjective understanding (SMD 0.62, (95% CI 0.28 to 0.96) I²=74%, immediate (SMD 0.68 (95% CI 0.53 to 0.83) I²=81%, short (SMD 0.70, (95% CI 0.43 to 0.97) I²=83% and long-term knowledge (SMD 0.57, (95% CI 0.30 to 0.84) I²=82% and satisfaction with the informed consent process (SMD 0.32, (95% CI 0.19 to 0.45) I²=78%.

This review provides a global overview of the impact of various intervention modalities employed to enhance the informed consent process with demonstrable improvement in a variety of outcomes measures. Where available, consideration should be given by clinicians to the use of such adjuncts during the informed consent process.