Impact of video -based incentive on patient willingness to read the informed consent form with comprehension before minimally-invasive surgery: a randomized controlled trial.

Abstract

Introduction: The purpose of the informed consent (IC) form is to enable patients to make a conscious choice based on complete and comprehensible information about a planned surgical procedure, its risks, benefits, and alternative treatment methods. Obtaining information about other therapeutic options is particularly important in the case of laparoscopic surgeries which are becoming increasingly popular. Unfortunately, as the literature indicates, most patients do not read the IC form.

Aim: The aim of this study was to evaluate the impact of video material on encouraging patients to thoroughly read the IC form.

Materials and methods: This parallel design study comprised 102 patients referred for elective laparoscopic surgical procedures. The participants were randomized in a 1:1 ratio. The block randomization consisted of alternating, weekly assignment of patients to the intervention (video) group and the control group. Anxiety levels were evaluated using a translated version of the Amsterdam Preoperative Anxiety and Information Scale (APAIS).

Results: The patients in the video group were more likely to read the entire IC form (83.67%) than those in the control group (33.96%; P = 0.003). However, according to the APAIS scale, reading the IC form had no impact on the level of anxiety (P = 0.72) and information demand (P = 0.9). The most frequently given reason for not reading the IC form was its excessive length (32.61% of the responses).

Conclusions: Video materials demonstrate a remarkable potential in enhancing the awareness of the IC process importance and should be increasingly implemented into everyday medical practice.