Neurosurgical Critical Care Unit, Department of Neurosurgery, Medical University Innsbruck, Innsbruck, Austria.
Department of Anesthesiology, University Medical Center Goettingen, Goettingen, Germany.
Paediatr Anaesth. 2024 Aug;34(8):800-809. doi: 10.1111/pan.14922. Epub 2024 May 17.
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.
To quantify the impact of study complexity on willingness to consent to pediatric anesthesia studies.
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.
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).
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.
知情同意是进行临床试验的重要背景，特别是涉及儿童的临床试验。虽然有几个因素被认为会影响儿童对麻醉研究的同意意愿，但研究设计对同意行为的影响尚不清楚。
定量研究复杂性对儿童麻醉研究同意意愿的影响。
我们通过向 106 名计划接受麻醉的儿童的父母或法定监护人呈现三个假设研究，进行了基于案例的访谈研究。这些研究在复杂性方面有所不同，包括前瞻性观察性研究、随机对照试验和 II 期药理学研究的示例。主要结局是使用 5 分李克特量表从“绝对同意”到“绝对拒绝”的同意意愿。次要结局是儿童相关（如性别、年龄、以前的麻醉、研究暴露）和代理相关因素的影响。
对观察性研究的“绝对同意”的应答概率为 90.9% [95%置信区间 85.3-96.5]，对随机对照试验为 48.6% [95%置信区间 38.3-58.9]，对 II 期药理学研究为 32.7% [95%置信区间 23.9-41.6]。“绝对拒绝”的应答概率分别为 1.6% [95%置信区间 0.3-2.8]、14.4% [95%置信区间 8.3-20.5]和 24.7% [95%置信区间 16.6-32.7]。先前的研究暴露（OR=0.486 [95%置信区间 0.256-0.923]，p=0.027）、年龄较大（OR=0.963 [95%置信区间 0.927-0.999]，p=0.045）和父母或法定监护人的性别存在显著影响，母亲的同意意愿较低（OR=0.234 [95%置信区间 0.107-0.512]，p<0.001）。
随着研究复杂性的增加，同意意愿降低。在进行更复杂的研究时，需要付出更大的努力来增加儿科患者的入组。
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