Randomised controlled trials (RCTs) are the gold standard for demonstrating the efficacy of new therapies. However, issues of external validity often affect result application to real-world settings. Using registries to conduct RCTs is a reasonably new practice, but is appealing because it combines the benefits of both observational studies and RCTs. There is limited literature on patient motivators, barriers, and consent to registries for conducting RCTs. The purpose of our study was to establish the factors that motivate and/or inhibit patients from joining a registry for RCTs and to determine what information matters to patients when making an enrolment decision to participate in such a registry. We conducted a cross-sectional questionnaire-based study at a dialysis centre in Southwest Ireland representing a catchment patient population of approximately 430,000. Quantitative data were coded and analysed in SPSS (v16). Descriptive statistics were produced, and open-ended questions were analysed by thematic analysis. Eighty-seven patients completed the questionnaire. Reasons for participation in a registry included personal and altruistic benefits. Barriers to participation were time and travel requirements associated with registry participation, data safety concerns, risks, side effects, and concerns that registry participation would impact current treatment. Although 29.8% of patients expressed concern regarding their data being stored in a registry, 79.3% were still willing to consent to have their data uploaded and stored in a registry for conducting RCTs. It was important to patients to have their GP (general practitioner) involved in the decision to participate, despite little day-to-day contact with their GP for renal dialysis management. Challenges to recruitment to registries for RCTs exist, but addressing the identified concerns of potential participants may aid patients in making a more informed enrolment decision and may improve recruitment to registries, and by extension, to RCTs conducted using the registry.

中文翻译：

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患者对肾脏随机试验登记处招募挑战的看法：一项基于问卷的试点研究

随机对照试验 (RCT) 是证明新疗法疗效的金标准。然而，外部有效性问题通常会影响结果在现实世界中的应用。使用注册中心进行 RCT 是一种相当新的做法，但很有吸引力，因为它结合了观察性研究和 RCT 的好处。关于患者动机、障碍和对注册进行 RCT 的同意的文献有限。我们研究的目的是确定激励和/或抑制患者加入 RCT 登记的因素，并确定在做出登记决定参加此类登记时哪些信息对患者很重要。我们在爱尔兰西南部的一个透析中心进行了一项基于问卷调查的横断面研究，该研究代表了大约 430,000 的学区患者群体。定量数据在 SPSS (v16) 中进行编码和分析。产生了描述性统计数据，并通过主题分析分析了开放式问题。87 名患者完成了问卷调查。参与登记的原因包括个人利益和利他利益。参与的障碍是与注册参与相关的时间和旅行要求、数据安全问题、风险、副作用以及注册参与会影响当前治疗的担忧。尽管 29.8% 的患者对他们的数据存储在注册表中表示担忧，但 79. 3% 仍然愿意同意将他们的数据上传并存储在注册表中以进行 RCT。对于患者来说，让他们的 GP（全科医生）参与参与的决定很重要，尽管他们很少与 GP 进行日常接触以进行肾透析管理。RCT 注册登记的招募存在挑战，但解决潜在参与者已确定的担忧可能有助于患者做出更明智的招募决定，并可能改善注册登记的招募，进而改善使用注册进行的 RCT 的招募。