Mwaturura Tinashe Cynthia, Simms Victoria, Dauya Ethel, Shrestha Som Kumar, Ferrand Salmaan, Shavani Talent, Dziva Chikwari Chido, Mackworth-Young Constance R S, Bandason Tsitsi, Mavodza Constancia, Tembo Mandikudza, Kranzer Katharina, Bernays Sarah, Ferrand Rashida Abbas
The Health Research Unit Zimbabwe, Biomedical Research and Training Institute, Harare, Zimbabwe
The Health Research Unit Zimbabwe, Biomedical Research and Training Institute, Harare, Zimbabwe.
BMJ Glob Health. 2025 Jan 19;10(1):e014481. doi: 10.1136/bmjgh-2023-014481.
Obtaining informed consent for research includes the use of information sheets, which are often long and may be difficult for participants to understand. We conducted a trial to investigate whether consent procedures using a study information video coupled with electronic consent were non-inferior to standard consent procedures using participant information sheets (PIS) among youth aged 18-24 years in Zimbabwe.
The trial was nested within an endline population-based survey for a cluster-randomised trial from October 2021 to June 2022. Randomisation of participants to video or paper-based consent was at household level. We assessed non-inferiority in comprehension of the study using a questionnaire. The video method was accepted as non-inferior to standard consent procedures if the 95% CIs of the mean difference did not fall below the prespecified margin of 1.98. Thematic analysis was conducted on brief qualitative discussions with randomly selected youth to explore the acceptability of video and PIS within consent methods.
Overall, 921 participants were enrolled (54% female). The median age was 20 (IQR 18-24) years. The mean comprehension score was 25.4/30 in both arms. The mean difference in comprehension between arms was -0.02 (95% CI -0.51 to 0.47) showing non-inferiority of the intervention in comprehension of study information. Youth (N=90) described both consent methods as interactive and inclusive. Those in the video consent arm felt it was exciting and youth focused. The use of imagery to explain procedures strengthened the perceived trustworthiness of the research. However, the high volume of information in both arms reduced acceptability.
Comprehension of study information using an information video is non-inferior to a paper-based consent method. Using information videos for consent processes shows promise as a person-centred and context-sensitive approach to enhance the informed consent process and should be encouraged by ethics committees.
获取研究的知情同意包括使用信息表，而信息表通常很长，参与者可能难以理解。我们进行了一项试验，以调查在津巴布韦18至24岁的年轻人中，使用研究信息视频并结合电子同意书的同意程序是否不劣于使用参与者信息表（PIS）的标准同意程序。
该试验嵌套在2021年10月至2022年6月进行的一项基于人群的整群随机试验的终期调查中。在家庭层面将参与者随机分为视频同意组或纸质同意组。我们使用问卷评估对研究的理解方面的非劣效性。如果平均差异的95%置信区间不低于预先设定的1.98的界限，则视频方法被认为不劣于标准同意程序。对与随机选择的年轻人进行的简短定性讨论进行了主题分析，以探讨视频和PIS在同意方法中的可接受性。
总体而言，共招募了921名参与者（54%为女性）。中位年龄为20岁（四分位间距18 - 24岁）。两组的平均理解得分均为25.4/30。两组之间理解的平均差异为 -0.02（95%置信区间 -0.51至0.47），表明干预措施在研究信息理解方面不劣于标准程序。90名年轻人将两种同意方法都描述为具有互动性和包容性。视频同意组的人认为它令人兴奋且以年轻人为重点。使用图像来解释程序增强了对研究的可信度。然而，两组中大量的信息都降低了可接受性。
使用信息视频对研究信息的理解不劣于纸质同意方法。在同意过程中使用信息视频作为一种以人为主且因地制宜的方法来加强知情同意过程显示出前景，伦理委员会应予以鼓励。
