Medical Research Council Midland Hub for Trials Methodology Research, University of Birmingham, Birmingham, United Kingdom ; Cancer Research UK Clinical Trials Unit, School of Cancer Science, University of Birmingham, Birmingham, United Kingdom.
PLoS One. 2013 Oct 3;8(10):e76435. doi: 10.1371/journal.pone.0076435. eCollection 2013.
To assess: 1) the feasibility of electronic information provision; 2) gather evidence on the topics and level of detail of information potential research participant's accessed; 3) to assess satisfaction and understanding.
Observational study with an embedded randomised controlled trial.
Low risk intervention study based in primary care.
White British & Irish, South Asian and African-Caribbean subjects aged between 40-74 years eligible for a blood pressure monitoring study.
PDF copy of the standard paper participant information sheet (PDF-PIS) and an electronic Interactive Information Sheet (IIS) where participants could choose both the type and level of detail accessed.
1160 participants were eligible for the study. Of these, 276 (24%) provided an active email address, of whom 84 did not respond to the email. 106 responded to the email but chose not to access any electronic information and were therefore ineligible for randomisation. 42 were randomised to receive the PDF-PIS and 44 to receive the IIS (with consent rates of 48% and 36%, respectively; odds ratio 0.6, 95% confidence interval 0.25 to 1.4). Electronic observation of information accessed by potential participants showed 41% chose to access no information and only 9% accessed the detail presented on the Research Ethics Committee approved participant information sheet before booking to attend a recruitment clinic for the intervention study. 63 of the 106 participants (59%) who chose not to access any electronic information also booked an appointment.
Current written information about research may not be read, emphasising the importance of the consent interview and consideration of new ways of presenting complex information.
评估：1）电子信息提供的可行性；2）收集潜在研究参与者访问的信息主题和详细程度的证据；3）评估满意度和理解度。
观察性研究，嵌入随机对照试验。
基于初级保健的低风险干预研究。
40-74 岁之间符合血压监测研究条件的白种英国人和爱尔兰人、南亚人和非裔加勒比人。
标准纸质知情同意书（PDF-PIS）的 PDF 副本和电子互动信息表（IIS），参与者可以在其中选择访问的类型和详细程度。
1）提供电子邮件地址并访问电子信息的参与者比例；2）是否愿意参加招募诊所；3）IIS 上访问的信息类型和深度；4）参与者的满意度和理解度。
共有 1160 名参与者符合研究条件。其中，276 名（24%）提供了有效的电子邮件地址，其中 84 名未回复电子邮件。106 名回复了电子邮件，但选择不访问任何电子信息，因此不符合随机分组条件。42 名被随机分配到 PDF-PIS 组，44 名被随机分配到 IIS 组（同意率分别为 48%和 36%，优势比 0.6，95%置信区间 0.25 至 1.4）。对潜在参与者访问的信息进行电子观察显示，41%的人选择不访问任何信息，只有 9%的人在预约参加干预研究的招募诊所之前访问了经研究伦理委员会批准的知情同意书上提供的详细信息。在选择不访问任何电子信息的 106 名参与者中，有 63 名（59%）也预约了就诊。
目前关于研究的书面信息可能未被阅读，这强调了同意访谈的重要性，并需要考虑呈现复杂信息的新方法。
