Clemens Miller, Jan Scholand, Johannes Wieditz, Carlo Pancaro, Hendrik Rosewich, Marcus Nemeth
{"title":"Factors Influencing Willingness to Participate in Clinical Studies in Pediatric Anesthesia (FILIPPA): A vignette-based, structured interview study.","authors":"Clemens Miller, Jan Scholand, Johannes Wieditz, Carlo Pancaro, Hendrik Rosewich, Marcus Nemeth","doi":"10.1111/pan.14922","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Aims: </strong>To quantify the impact of study complexity on willingness to consent to pediatric anesthesia studies.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":19745,"journal":{"name":"Pediatric Anesthesia","volume":null,"pages":null},"PeriodicalIF":1.7000,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pediatric Anesthesia","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/pan.14922","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/5/17 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"ANESTHESIOLOGY","Score":null,"Total":0}
引用次数: 0
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.
期刊介绍:
Devoted to the dissemination of research of interest and importance to practising anesthetists everywhere, the scientific and clinical content of Pediatric Anesthesia covers a wide selection of medical disciplines in all areas relevant to paediatric anaesthesia, pain management and peri-operative medicine. The International Editorial Board is supported by the Editorial Advisory Board and a team of Senior Advisors, to ensure that the journal is publishing the best work from the front line of research in the field. The journal publishes high-quality, relevant scientific and clinical research papers, reviews, commentaries, pro-con debates, historical vignettes, correspondence, case presentations and book reviews.