Factors Influencing Willingness to Participate in Clinical Studies in Pediatric Anesthesia (FILIPPA): A vignette-based, structured interview study

Clemens Miller; Jan Scholand; Johannes Wieditz; Carlo Pancaro; Hendrik Rosewich; Marcus Nemeth

doi:10.1111/pan.14922

Factors Influencing Willingness to Participate in Clinical Studies in Pediatric Anesthesia (FILIPPA): A vignette-based, structured interview study

Paediatr Anaesth. 2024 May 17. doi: 10.1111/pan.14922. Online ahead of print.

Authors

Clemens Miller^{1

2}, Jan Scholand², Johannes Wieditz^{2

3}, Carlo Pancaro⁴, Hendrik Rosewich⁵, Marcus Nemeth²

Affiliations

¹ Neurosurgical Critical Care Unit, Department of Neurosurgery, Medical University Innsbruck, Innsbruck, Austria.
² Department of Anesthesiology, University Medical Center Goettingen, Goettingen, Germany.
³ Department of Medical Statistics, University Medical Center Goettingen, Goettingen, Germany.
⁴ Department of Anesthesiology, University of Michigan Health, Ann Arbor, Michigan, USA.
⁵ Department of Pediatrics and Adolescent Medicine, University Hospital Tuebingen, Tuebingen, Germany.

PMID: 38757570
DOI: 10.1111/pan.14922

Abstract

Background: Informed consent is a relevant backdrop for conducting clinical trials, particularly those involving children. While several factors are known to influence the willingness to consent to pediatric anesthesia studies, the influence of study design on consenting behavior is unknown.

Aims: To quantify the impact of study complexity on willingness to consent to pediatric anesthesia studies.

Methods: We conducted a vignette-based interview study by presenting three hypothetical studies to 106 parents or legal guardians whose children were scheduled to undergo anesthesia. These studies differed in level of complexity and included an example of a prospective observational study, a randomized controlled trial, and a phase-II-pharmacological study. Primary outcome was the willingness to consent, using a 5-point Likert scale ranging from "absolutely consent" to "absolutely decline". Secondary outcomes were the effects of child-related (such as sex, age, previous anesthesia, research exposure) and proxy-related factors.

Results: Response probabilities for "absolute consent" were 90.9% [95% CI 85.3-96.5] for the observational study, 48.6% [95% CI 38.3-58.9] for the randomized controlled trial, and 32.7% [95% CI 23.9-41.6] for the phase-II-pharmacological study. Response probabilities for "absolutely decline" were 1.6% [95% CI 0.3-2.8], 14.4% [95% CI 8.3-20.5], and 24.7% [95% CI 16.6-32.7], respectively. Significant effects were found for previous research exposure (OR = 0.486 [95% CI 0.256-0.923], p = .027), older age (OR = 0.963 [95% CI 0.927-0.999], p = .045) and the gender of the parent or legal guardian, as mothers were less willing to consent (OR = 0.234 [95% CI 0.107-0.512], p < .001).

Conclusions: Willingness to consent decreased with increasing level of study complexity. When conducting more complex studies, greater efforts need to be made to increase the enrollment of pediatric patients.

Keywords: clinical trial design; pediatric anesthesia; study enrolment; study type complexity; willingness to consent.