Miller L, Hart A, Cléirigh-Büttner F, Arundel C, Hamborg T, McGuinness S, Moss-Morris R, Parker A, Relton C, Stagg I, Sweeney L, Wileman V, Zenasni Z, Norton C
Unit for Social and Community Psychiatry, Centre for Psychiatry and Mental Health (CPMH), Wolfson Institute of Population Health, Queen Mary University of London, Yvonne Carter Building, 58 Turner Street, London, E1 2AB, UK.
St Mark's Hospital, Acton Lane, Central Middlesex, London, NW10 7NS, UK.
Trials. 2025 Jun 18;26(1):211. doi: 10.1186/s13063-025-08931-6.
Participant Information Leaflets (PILs) are lengthy and increasingly complex, and could deter research participation. A shortened PIL may be more appealing as it is likely to provide a more a manageable volume of information. Previous research has found that shortened PILs are no less effective for recruitment outcomes, and we deemed it useful to replicate this in an online setting. We also decided to compare retention rates, given the potential for more information to increase participants' motivation.
To evaluate the efficacy of a shortened vs standard-length PIL on trial recruitment and retention rates.
This two-arm study within a trial (SWAT) was embedded in a host randomised controlled trial (RCT)-IBD-BOOST. Potential participants were randomised to receive a standard-length or shortened PIL electronically for recruitment to the host RCT. An ethics committee approved potential participants being blinded to this randomisation.
The percentage of SWAT participants receiving the shortened vs standard PIL who were recruited to the RCT.
Four thousand two hundred one participants were randomised to the standard-length (n = 2099) and shortened (n = 2102) PIL arms. Thirty-four email queries were received about the PILs-18 from those who received the standard and 16 from those receiving the shortened. Seven hundred eight SWAT participants were recruited to the RCT-333 (15.86%) who received the standard-length PIL and 375 (17.84%) who received the shortened (OR = 1.15, (95%CI = 0.98, 1.35), p = 0.09). Retention rates in the RCT were not statistically different between groups.
We did not find evidence of a significant difference between RCT recruitment and retention rates in participants randomised to the standard-length PIL compared with the shortened. It may be that a shortened PIL has the same effect on recruitment and retention outcomes, providing that the trial does not require extensive information for other reasons (e.g. safety). Therefore, it could be argued that researchers have a choice about how long to make PILs, perhaps with a link to more detail. Alternatively, given that there was no benefit of the shortened PIL, it may be worth comparing written PILs with other methods of conveying information to determine optimal means of encouraging participation and retention in decentralised trials.
A randomised controlled trial of supported, online, self-management for symptoms of fatigue, pain and urgency/incontinence in people with inflammatory bowel disease: the IBD-BOOST trial (ISRCTN71618461 on ISRCTN registry).
受试者信息手册（PILs）篇幅冗长且日益复杂，可能会阻碍人们参与研究。缩短后的PILs可能更具吸引力，因为其信息量可能更易于管理。先前的研究发现，缩短后的PILs在招募效果方面并不逊色，我们认为在在线环境中重复这一研究很有意义。鉴于更多信息可能会增强受试者的积极性，我们还决定比较留存率。
评估缩短版与标准版PILs对试验招募和留存率的效果。
这项试验中的双臂研究（SWAT）嵌入了一项主要的随机对照试验（RCT）——IBD-BOOST。潜在受试者被随机分配，以电子方式接收标准版或缩短版PILs，以招募其参与主要的RCT。伦理委员会批准对潜在受试者隐瞒这种随机分配。
被招募到RCT的SWAT受试者中，接收缩短版PIL与标准版PIL的受试者的百分比。
4201名受试者被随机分配到标准版（n = 2099）和缩短版（n = 2102）PIL组。收到了34封关于PILs的电子邮件询问——18封来自收到标准版的受试者，16封来自收到缩短版的受试者。708名SWAT受试者被招募到RCT——333名（15.86%）收到标准版PIL的受试者和375名（17.84%）收到缩短版PIL的受试者（比值比=1.15，95%置信区间=0.98，1.35，p = 0.09）。两组在RCT中的留存率无统计学差异。
我们没有发现证据表明，随机分配到标准版PIL的受试者与缩短版PIL的受试者在RCT招募率和留存率上存在显著差异。可能是缩短版PIL在招募和留存结果上具有相同的效果，前提是试验不需要因其他原因（如安全性）提供大量信息。因此，可以认为研究人员可以选择PILs的长度，或许可以链接到更详细的内容。或者，鉴于缩短版PIL没有优势，可能值得将书面PILs与其他信息传达方法进行比较，以确定在分散式试验中鼓励参与和留存的最佳方式。
一项针对炎症性肠病患者疲劳、疼痛和尿急/尿失禁症状的支持性在线自我管理随机对照试验：IBD-BOOST试验（ISRCTN注册中心的ISRCTN71618461）
