Clinical Trials and Statistics Unit (ICR-CTSU), The Institute of Cancer Research, London, UK.
Independent Patient Representative, London, UK.
BMJ Open. 2023 Sep 21;13(9):e073817. doi: 10.1136/bmjopen-2023-073817.
Patient-reported outcomes (PRO) are currently collected from trial participants using paper questionnaires by the Clinical Trials and Statistics Unit at The Institute of Cancer Research (ICR-CTSU). Streamlining PRO collection using electronic questionnaires (ePRO) may improve data collection and patient experience. Here, we outline our protocol for a Study within a trial of electronic versus paper-based Patient-Reported oUtcomes CollEction (SPRUCE), which investigates the acceptability of ePRO in oncology clinical trials.
SPRUCE was developed alongside patient and public contributors. SPRUCE runs in multiple host trials with a partially randomised patient preference design, allowing participants to be randomised or choose their preference of electronic or paper questionnaires. Questionnaires are scheduled in accordance with host trial follow-up. The primary objective will assess differences in return rates (compliance) between ePRO and paper PROs at the first timepoint post-host trial intervention in the randomised group. Paper PRO compliance is expected to be 90%. 244 randomised participants are required to exclude ≤80% compliance rates with ePRO (10% non-inferiority margin, with 80% power and one-sided alpha=0.05). SPRUCE aims to assess acceptability of ePRO in oncology clinical trials, establish whether ePRO is acceptable to ICR-CTSU trial participants and can capture complete PRO data, consistent with paper PROs.
The SPRUCE protocol (ICR-CTSU/2021/10074) was approved by the Coventry and Warwick Central Research Ethics Committee (21/WM/0223) on 21 October 2021. Results will be disseminated via presentations, publications and lay summaries. No participant identifiable data will be included.
SWAT169.
目前，癌症研究所临床试验和统计学部门（ICR-CTSU）通过纸质问卷收集试验参与者的患者报告结局（PRO）。使用电子问卷（ePRO）简化 PRO 收集可能会改善数据收集和患者体验。在这里，我们概述了一项电子与纸质患者报告结局收集研究（SPRUCE）的试验内研究方案，该研究调查了电子 PRO 在肿瘤临床试验中的可接受性。
SPRUCE 是与患者和公众贡献者共同开发的。SPRUCE 在多个宿主试验中运行，采用部分随机患者偏好设计，允许参与者随机分配或选择电子或纸质问卷。问卷按照宿主试验随访进行安排。主要目标将评估随机组在宿主试验干预后的第一个时间点电子 PRO 和纸质 PRO 的回复率（依从性）之间的差异。预计纸质 PRO 的依从率为 90%。需要 244 名随机参与者排除电子 PRO 的依从率≤80%（10%非劣效性边际，80%效力和单侧 alpha=0.05）。SPRUCE 旨在评估电子 PRO 在肿瘤临床试验中的可接受性，确定电子 PRO 是否被 ICR-CTSU 试验参与者接受，并且能够与纸质 PRO 一致地捕获完整的 PRO 数据。
SPRUCE 方案（ICR-CTSU/2021/10074）于 2021 年 10 月 21 日获得考文垂和沃里克中央研究伦理委员会（21/WM/0223）的批准。结果将通过演讲、出版物和通俗摘要进行传播。不会包含任何可识别参与者的个人数据。
SWAT169。
