Université de Paris, Centre of Research Epidemiology and Statistics, Inserm, Paris, France.
Department of Public Health, Policy and Systems, Institute of Population Health, University of Liverpool, Liverpool, United Kingdom.
J Med Internet Res. 2022 Feb 1;24(2):e29691. doi: 10.2196/29691.
Patients' participation is crucial to the success of randomized controlled trials (RCTs). However, recruiting and retaining patients in trials remain a challenge.
This study aims to describe patients' preferences for the organization of RCTs (visits on- site or remotely) and evaluate the potential impact of fulfilling preferences on their willingness to participate in a clinical trial.
This was a vignette-based survey. Vignettes were case scenarios of real clinical trials assessing pharmacological treatments. These RCTs evaluated 6 prevalent chronic diseases (ie, osteoporosis, osteoarthritis, asthma, cardiovascular diseases, diabetes, and endometriosis). Each vignette described (1) the RCT and characteristics of the treatment tested (ie, doses, administration routes) and (2) the trial procedures and different options (on-site or remotely) for how the trial was organized for informed consent, follow-up visits, and communication of results when the trial was completed. We recruited 628 participants from ComPaRe (www.compare.aphp.fr), a French e-cohort of patients with chronic diseases. The outcomes were the participants' preferences for the way the trial was organized (on-site or remotely) and their willingness to participate in the trial.
Of the 628 participants who answered the vignettes, 491 (78.2%) were female (median age 55 years), with different chronic diseases ranging from endometriosis in 59 of 491 (12%) patients to asthma in 133 of 628 (21.2%) patients. In addition, 38 (6.1%) participants wanted to provide informed consent and all trial visits on-site, 176 (28%) wished to participate in the trial entirely remotely, and 414 (65.9%) wanted to combine remote-based and hospital-based visits. Considering the trial as a whole, when the trial was organized in a way that the patients preferred, the median (Q1-Q3) likelihood of participation in the trial was 90% (80-100) versus 60% (30-80) if the trial followed the patients' nonpreferred model. Furthermore, 256 (40.8%) patients responded to open-ended questions expressing their experience with trial participation and visits to the hospital and providing suggestions for improvement. The patients emphasized the need to personalize the way a trial is organized according to each patient's needs and conditions.
There was a significant diversity in the participants' preferences. Most participants preferred hybrid organization involving both on-site and remote visits. Participants were more likely to participate in a trial organized according to their preferences.
患者的参与对于随机对照试验（RCT）的成功至关重要。然而，招募和留住试验中的患者仍然是一个挑战。
本研究旨在描述患者对 RCT 组织方式（现场或远程就诊）的偏好，并评估满足这些偏好对其参与临床试验意愿的潜在影响。
这是一项基于案例的调查。案例是评估药物治疗的真实临床试验的案例场景。这些 RCT 评估了 6 种常见的慢性疾病（即骨质疏松症、骨关节炎、哮喘、心血管疾病、糖尿病和子宫内膜异位症）。每个案例描述了（1）RCT 和所测试治疗的特征（即剂量、给药途径），以及（2）试验程序和不同选项（现场或远程），用于组织知情同意、随访和试验完成时结果的沟通。我们从 ComPaRe（www.compare.aphp.fr）招募了 628 名患有慢性疾病的法国电子队列患者。结果是参与者对试验组织方式（现场或远程）的偏好以及他们参与试验的意愿。
在回答案例的 628 名参与者中，491 名（78.2%）为女性（中位数年龄 55 岁），患有不同的慢性疾病，从 491 名患者中的 59 名（12%）子宫内膜异位症到 628 名患者中的 133 名（21.2%）哮喘不等。此外，38 名（6.1%）参与者希望现场提供知情同意和所有试验就诊，176 名（28%）希望完全远程参与试验，414 名（65.9%）希望结合远程和医院就诊。考虑到整个试验，如果试验按照患者偏好的方式进行组织，参与试验的可能性中位数（Q1-Q3）为 90%（80-100），而如果试验遵循患者不偏好的模式，则为 60%（30-80）。此外，256 名（40.8%）患者对开放式问题做出了回应，表达了他们参与试验和就诊医院的经验，并提出了改进建议。患者强调需要根据每个患者的需求和条件个性化试验的组织方式。
参与者的偏好存在显著差异。大多数参与者更喜欢同时包括现场和远程就诊的混合组织方式。参与者更有可能参与按照他们偏好组织的试验。
