■开发针对常染色体显性多囊肾病的新疗法需要有效地进行临床试验。在这项研究中,本研究调查了一项为期3年的常染色体显性遗传性多囊肾病随机对照试验的参与者招募和保留的影响因素.
■定性研究。
■邀请所有参与者(N=187)在主要试验的最终研究访问中完成16项问卷。招募参与者根据年龄进行有目的的抽样,以完成半结构化的访谈,自我报告的性别,和随机化组。
■描述性统计数据用于人口统计数据和问卷调查。面试笔录经过归纳主题编码。
■187名随机参与者(79%)中的146人完成了试验后问卷,187名参与者中有31名(21%)完成了面试。大多数参与者(94%)将他们对试验的总体满意度评为高(10分中有8分或更多)。利他主义,知识增益,获得新的治疗是招募的主要动机。考虑退出研究的主要原因是对干预风险以及家庭或工作问题的担忧。有利于保留的策略包括参加不同研究地点的灵活性,时间表的灵活性,员工互动,和停车和提醒的实际支持。主要负担是失去工资的工作时间,以及与磁共振成像扫描和24小时尿量收集相关的负担。
■研究人群仅限于一项非药物临床试验的参与者,结果可能受到选择和可能的社会期望偏差的影响。
■参与者报告了高水平的满意度,这是试验参与者期望的函数。此外,保留是感知的利益和参与负担之间的平衡。在未来临床试验的设计中考虑这些观点将提高其效率和行为。
■常染色体显性多囊肾病(ADPKD)临床实践的进展要求受影响的个体自愿参与长期多中心随机对照试验(RCT)。在这项对ADPKD水摄入量增加的3年RCT的定性事后研究中,利他主义,知识增益,获得非药物治疗对志愿者的决定产生了积极的影响。通过在研究方案中建立灵活性和工作人员在研究访问期间优先考虑参与者的需求,可以实现持续参与。尽管参与者完成了所需的测试,大多数被认为是繁重的。这项研究强调了将方案灵活性纳入试验设计的重要性;对具有低不良反应风险的干预措施的偏好;以及迫切需要强大的替代非侵入性生物标志物以使ADPKD中的RCTs更短。
UNASSIGNED: The development of new therapies for autosomal dominant polycystic kidney disease requires clinical trials to be conducted efficiently. In this study, the factors affecting the recruitment and retention of participants enrolled in a 3-year randomized controlled
trial in autosomal dominant polycystic kidney disease were investigated.
UNASSIGNED: Qualitative
study.
UNASSIGNED: All participants (N=187) were invited to complete a 16-item questionnaire at the final study visit of the primary
trial. Participants were recruited to complete a semistructured interview using purposeful sampling according to age, self-reported gender, and randomization group.
UNASSIGNED: Descriptive statistics were used for demographic data and questionnaires. The interview transcripts underwent inductive thematic coding.
UNASSIGNED: One hundred and forty-six of the 187 randomized participants (79%) completed the post-trial questionnaire, and 31 of the 187 participants (21%) completed the interview. Most participants (94%) rated their global satisfaction with the trial as high (a score of 8 or more out of 10). Altruism, knowledge gain, and access to new treatments were the main motivators for recruitment. The main reasons for considering leaving the study were concerns about the risk of intervention and family or work issues. Strategies that favored retention included flexibility in attending different study sites, schedule flexibility, staff interactions, and practical support with parking and reminders. The main burden was time away from work with lost wages, and burden associated with magnetic resonance imaging scans and 24-hour urine output collections.
UNASSIGNED: The study population was restricted to participants in a single nondrug clinical trial, and the results could be influenced by selection and possible social desirability bias.
UNASSIGNED: Participants reported high levels of satisfaction that occurred as a function of the trial meeting participants\' expectations. Furthermore, retention was a balance between the perceived benefits and burden of participation. Consideration of these perspectives in the design of future clinical trials will improve their efficiency and conduct.
UNASSIGNED: Advances in the clinical practice of autosomal dominant polycystic kidney disease (ADPKD) require affected individuals to voluntarily participate in long-term multicenter randomized controlled trials (RCTs). In this qualitative post hoc study of a 3-year RCT of increased water intake in ADPKD, altruism, knowledge gain, and access to a nondrug treatment positively influenced the decision to volunteer. Ongoing participation was enabled by building flexibility into the study protocol and staff prioritizing a participant\'s needs during
study visits. Although participants completed the required tests, most were considered burdensome. This
study highlights the importance of incorporating protocol flexibility into
trial design; the preference for interventions with a low risk of adverse effects; and the urgent requirement for robust surrogate noninvasive biomarkers to enable shorter RCTs in ADPKD.