Distribution of Patient Diagnosis.

The goal of this study was to determine the difference in participant understanding, satisfaction, timing and, preference between video consent and written informed consent in a pediatric rheumatology research setting. Participants were randomized to receive either video consent or written informed consent for a registry study. After completing the first consent method, they completed a comprehension and satisfaction questionnaire. Then they received the alternate consent method and completed a second set of questionnaires. Bayesian non-parametric tests determined the difference in comprehension, satisfaction, timing and preference between video consent and written informed consent. Ninety-nine caregivers and 76 patients were randomized into video consent (n = 88) and written informed consent (n = 87) groups. Comprehension (Max = 12) and satisfaction (Max = 5) were high in both groups. There was moderate evidence supporting no difference in comprehension (medianvideo consent = 11 and medianwritten informed consent = 10) and satisfaction (medianvideo consent = 4 and medianwritten informed consent = 5) between video consent and written informed consent (BF10 = 0.225 and 0.32, respectively). The median time to complete video consent and written informed consent was 408 (95% Credible Interval (CrI): 397–412) and 360 (95% CrI: 329–391) seconds, respectively. There was decisive evidence that video consent increased the time of consent (in our sample by 48 seconds) compared to written informed consent (BF10 = 713). There was decisive evidence for participants preferring video consent over written informed consent (BF10 = 2.307x1011) as they thought it was easier to follow. Overall, participant understanding and satisfaction were comparable between video consent and written informed consent. Even though video consent was slightly less time efficient compared to written informed consent, video consent was highly preferred by caregivers and patients, supporting its use to obtain informed consent.

本研究旨在明确儿科风湿病学研究场景下，视频知情同意（video consent）与书面知情同意（written informed consent）在受试者理解程度、满意度、完成耗时及偏好方面的差异。受试者被随机分配至视频知情同意组或书面知情同意组，参与一项登记研究（registry study）。受试者完成首种知情同意方式后，需填写理解度与满意度调查问卷；随后接收另一种知情同意方式，并完成第二套调查问卷。本研究采用贝叶斯非参数检验（Bayesian non-parametric tests），分析两类知情同意方式在上述维度的差异。最终共纳入99名照护者与76名患者，随机分为视频知情同意组（n=88）与书面知情同意组（n=87）。两组受试者的理解度（满分12分）与满意度（满分5分）均处于较高水平。贝叶斯因子（Bayes Factor, BF10）分别为0.225与0.32，存在中等强度证据表明，两类知情同意方式在理解度（视频组中位数为11，书面组中位数为10）与满意度（视频组中位数为4，书面组中位数为5）上无显著差异。视频知情同意与书面知情同意的完成耗时中位数分别为408秒（95%可信区间（95% Credible Interval, CrI）：397~412）与360秒（95% CrI：329~391）。贝叶斯因子BF10=713，存在决定性证据表明，相较于书面知情同意，视频知情同意会增加知情同意流程耗时（本研究样本中多耗时48秒）。贝叶斯因子BF10=2.307×10^11，存在决定性证据表明受试者更偏好视频知情同意，因其被认为更易于遵循。总体而言，两类知情同意方式在受试者理解度与满意度上表现相当。尽管视频知情同意的时间效率略低于书面知情同意，但照护者与患者均高度偏好视频知情同意，这支持其可用于获取知情同意。