Whiteside Katie, Flett Lydia, Mitchell Alex, Fairhurst Caroline, Cockayne Sarah, Rodgers Sara, Torgerson David
York Trials Unit, Department of Health Sciences, University of York, York, YO10 5DD, UK.
F1000Res. 2019 Mar 21;8:315. doi: 10.12688/f1000research.18300.1. eCollection 2019.
: Meeting recruitment targets for randomised controlled trials is challenging. This trial evaluated the effectiveness of including a pen within the trial invitation pack on the recruitment of older adults into a randomised controlled trial. : This trial was embedded within the Occupational Therapist Intervention Study, a falls-prevention randomised controlled trial. Potential participants (n = 1862), who were posted an invitation pack from two General Practitioner practices, were randomised to either not receive a pen (n = 1295) or receive a pen (n = 648) with their invitation pack, using a 2:1 ratio. The primary outcome was the likelihood of being randomised, and therefore fully recruited, to the host trial. To be randomised to the host trial, participants had to: return a consent form and screening form; be eligible on their screening form; and return a baseline questionnaire and a monthly falls calendar. Secondary outcomes were: the likelihood of returning (and time to return) a screening form; being eligible for the host trial; and remaining in the trial for at least 3 months. : The likelihood of being randomised to the host trial did not differ between the pen group (4.5%) and no pen group (4.3%; odds ratio 1.04; 95% confidence interval: 0.65 to 1.67; = 0.86). There were marginal differences in secondary outcomes in favour of the pen group, particularly in screening form return rates, though these differences were not statistically significant. : Pens may not be an effective incentive for the recruitment of older adults into randomised controlled trials, though future trials are required. ISRCTN22202133; SWAT 37.
实现随机对照试验的招募目标具有挑战性。本试验评估了在试验邀请包中包含一支笔对招募老年人参与随机对照试验的有效性。：本试验嵌入了职业治疗师干预研究，一项预防跌倒的随机对照试验。从两家全科医生诊所收到邀请包的潜在参与者（n = 1862），以2:1的比例随机分为不收到笔（n = 1295）或收到笔（n = 648）的邀请包组。主要结果是被随机分配到主试验并因此完全招募的可能性。要被随机分配到主试验，参与者必须：返回同意书和筛查表；筛查表符合条件；并返回基线问卷和每月跌倒日历。次要结果包括：返回（及返回时间）筛查表的可能性；符合主试验条件；以及在试验中至少保留3个月。：笔组（4.5%）和无笔组（4.3%；优势比1.04；95%置信区间：0.65至1.67；P = 0.86）被随机分配到主试验的可能性没有差异。次要结果在有利于笔组方面存在微小差异，特别是在筛查表返回率方面，尽管这些差异没有统计学意义。：笔可能不是招募老年人参与随机对照试验的有效激励措施，不过未来还需要进行试验。ISRCTN22202133；SWAT 37。
