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Factors Influencing Willingness to Participate in Clinical Studies in Pediatric Anesthesia (FILIPPA): A

Clemens Miller1,2, Jan Scholand2, Johannes Wieditz2,3

  • 1Neurosurgical Critical Care Unit, Department of Neurosurgery, Medical University Innsbruck, Innsbruck, Austria.

Paediatric Anaesthesia
|May 17, 2024
PubMed

Insights

Study complexity significantly impacts parental consent for pediatric anesthesia trials. More complex study designs, like randomized controlled trials, show lower consent rates, highlighting the need for enhanced recruitment strategies.

Area of Science:

  • Pediatric Anesthesiology
  • Clinical Trial Design
  • Informed Consent Research

Background:

  • Informed consent is crucial for pediatric clinical trials.
  • Factors influencing consent for pediatric anesthesia studies are known, but study design impact is unclear.

Purpose of the Study:

  • To quantify the impact of study complexity on parental willingness to consent to pediatric anesthesia studies.

Main Methods:

  • A vignette-based interview study involved 106 parents/guardians.
  • Hypothetical studies varied in complexity: observational, randomized controlled trial, and phase-II-pharmacological.
  • Willingness to consent was measured using a 5-point Likert scale.

Main Results:

  • Consent probability decreased with increasing study complexity (observational: 90.9%, RCT: 48.6%, phase-II: 32.7%).
  • Higher complexity correlated with increased "absolutely decline" responses.
  • Previous research exposure, older child age, and maternal gender influenced consent decisions.

Conclusions:

  • Parental willingness to consent to pediatric anesthesia studies declines as study complexity increases.
  • Greater efforts are needed to enhance pediatric patient enrollment in more complex research designs.
Abstract

Keywords:
clinical trial designpediatric anesthesiastudy enrolmentstudy type complexitywillingness to consent

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