背景:知情同意是进行临床试验的相关背景,特别是涉及儿童的。虽然已知有几个因素会影响同意儿科麻醉研究的意愿,研究设计对同意行为的影响是未知的。
目的:量化研究复杂性对同意儿科麻醉研究意愿的影响。
方法:我们进行了一项基于小插图的访谈研究,向106名父母或法定监护人提供了三项假设研究,他们的孩子被安排接受麻醉。这些研究的复杂程度不同,包括一个前瞻性观察研究的例子,一项随机对照试验,和II期药理学研究。主要结果是同意的意愿,使用5点李克特量表,范围从“绝对同意”到“绝对拒绝”。次要结果是儿童相关的影响(如性别,年龄,以前的麻醉,研究暴露)和代理相关因素。
结果:观察性研究的“绝对同意”反应概率为90.9%[95%CI85.3-96.5],随机对照试验的48.6%[95%CI38.3-58.9],第二阶段药理学研究为32.7%[95%CI23.9-41.6]。“绝对下降”的响应概率为1.6%[95%CI0.3-2.8],14.4%[95%CI8.3-20.5],和24.7%[95%CI16.6-32.7],分别。以前的研究暴露有显著影响(OR=0.486[95%CI0.256-0.923],p=.027),年龄较大(OR=0.963[95%CI0.927-0.999],p=.045)和父母或法定监护人的性别,由于母亲不太愿意同意(OR=0.234[95%CI0.107-0.512],p<.001)。
结论:同意意愿随着研究复杂性的增加而降低。当进行更复杂的研究时,需要做出更大的努力来增加儿科患者的登记.
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.
OBJECTIVE: 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.