A Video-Based Consent Tool: Development and Effect of Risk–Benefit Framing on Intention to Randomize

Writing Group for the CODA Collaborative

Research output: Contribution to journalArticlepeer-review

Abstract

Introduction: Nearly 75% of clinical trials fail to enroll enough participants, and cohorts often fail to reflect the clinical and demographic diversity of at-risk populations. Effective recruitment strategies are critically important for successful clinical trials. Framing treatment risks are known to affect medical decision-making for both physicians and patients but has not been rigorously studied in surgical trials. We sought to examine the impact of a high-quality video-based consent tool and the effect of risk–benefit framing on patient willingness to participate in a surgical clinical trial. Methods: A standardized video consent was shown to all potential participants in the Comparison of Outcomes of antibiotic Drugs and Appendectomy (CODA) trial, a randomized controlled trial comparing antibiotics and surgery for acute appendicitis. We report (1) differences in recruitment between two versions of a video-based tool that differed in production quality and (2) the impact of risk–benefit framing on participant randomization rates. The reasons for declining randomization were also assessed. Results: Of 4697 eligible patients approached to participate in the CODA trial, 1535 (33% [95% confidence interval (CI): 31%-34%]) agreed to randomization; this did not change from video version 1 to version 2. There was no difference in participation between positively framed videos (32% [95% CI: 30%-34%]) versus negatively framed videos (33.0% [95% CI: 30.8-35.2]). The most common reason for declining participation was treatment preference (72% for surgery and 18% for antibiotics). Conclusions: Neither the change from video 1 to video 2 nor the positive versus negative framing affected participant willingness to randomize. The stakeholder-informed video-based consenting tool used in CODA was an effective strategy for the recruitment of a heterogeneous patient population within the proposed study period.

Original languageEnglish
Pages (from-to)357-367
Number of pages11
JournalJournal of Surgical Research
Volume283
DOIs
StatePublished - Mar 2023
Externally publishedYes

Keywords

  • Appendicitis
  • Comparison of Outcomes of antibiotic Drugs and Appendectomy
  • Gender and race recruitment disparities
  • Inclusion
  • Patient recruitment
  • Randomization rates
  • Randomized clinical trial
  • Risk–benefit framing
  • Video consent tool

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