Investigating modifications to participant information materials to improve recruitment into a large randomized trial
Investigating modifications to participant information materials to improve recruitment into a large randomized trial
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DOI：
10.1186/s13063-019-3779-4
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发表时间：
2019-12-05
期刊：
影响因子：
2.5
通讯作者：
Armitage, Jane
中科院分区：
文献类型：
--
作者：
Haynes, Richard;Chen, Fang;Armitage, Jane
背景：大型随机试验是检验预期具有中等效果的治疗的有效性和安全性的最佳方法。我们观察到一个显着下降，潜在的参与者的响应邮寄邀请参加这样的试验超过10年的时间，并调查这背后的可能原因和潜在的修改邀请过程，以减轻it. Methods：参与者拒绝参加HPS 2-THRIVE试验被要求给出一个理由。举行了正式的焦点小组讨论会，以探讨潜在参与者可能不参加的原因。此外，在这项大型随机试验招募期间，围绕提供完整受试者信息说明书（PIL）的时间及其风格进行了两项嵌入式随机比较。HPS 2 THRIVE在ClinicalTrials.gov（NCT 00461630）上注册。结果：拒绝邀请的最常见原因与流动性和交通有关（尽管提供旅费）。焦点小组和拒绝邀请的潜在参与者都表示担心治疗的副作用（如PIL中所示），这是拒绝邀请的原因。延迟提供完整的PIL直到潜在参与者参加试验诊所，或修改PIL的类型，都不会改善潜在参与者进入试验的比例：比值比（OR）分别为1.05（95%置信区间（CI）0.94-1.17）和1.10（95% CI 0.94-1.28）。然而，修改PIL的样式确实增加了参加筛选预约的参与者比例（OR 1.17，95% CI 1.03-1.33）。结论：许多不参加试验的理由对个别试验来说是不容易处理的。然而，PIL的修改确实显示出适度提高参与的潜力。如果进一步的试验可以确定类似的简单干预措施是有益的，其净效应可以大大提高试验参与率，并促进招募到大型试验。
Background: Large randomized trials are the best method to test the efficacy and safety of treatments expected to have moderate effects. We observed a significant decline in potential participants' response to mailed invitations to participate in such trials over a 10-year period and investigated possible reasons behind this and potential modifications to the invitation process to mitigate it. Methods: Participants who declined to participate in the HPS2-THRIVE trial were asked to give a reason. Formal focus groups were conducted to explore the reasons that potential participants might have for not participating. In addition, two embedded randomized comparisons around the timing of provision of the full participant information leaflet (PIL) and its style were conducted during recruitment into this large randomized trial. HPS2THRIVE is registered at ClinicalTrials.gov (NCT00461630). Results: The commonest reason given for declining invitations related to mobility and transportation (despite the offer of travel expenses). Both the focus groups and potential participants who declined their invitation indicated concern about side-effects of the treatment (as presented in the PIL) as a reason for declining the invitation. Neither delaying provision of the full PIL until the potential participant attended the trial clinic, nor modifying the style of the PIL improved the proportion of potential participants entering the trial: odds ratio (OR) 1.05 (95% confidence interval (CI) 0.94-1.17) and 1.10 (95% CI 0.94-1.28), respectively. However, modifying the style of the PIL did increase the proportion of participants attending screening appointments (OR 1.17, 95% CI 1.03-1.33). Conclusions: Many reasons given for not participating in trials are not tractable to individual trials. However, modification of the PIL does show potential to modestly improve participation. If further trials could identify similar simple interventions that were beneficial, their net effects could substantially improve trial participation and facilitate recruitment into large trials.