Mastellos Nikolaos, Andreasson Anna, Huckvale Kit, Larsen Mark, Curcin Vasa, Car Josip, Agreus Lars, Delaney Brendan
Department of Primary Care and Public Health, School of Public Health, Imperial College London, 3rd Floor Reynolds Building, St Dunstan's Road, London W6 8RP, UK.
Implement Sci. 2015 Feb 3;10:15. doi: 10.1186/s13012-015-0207-3.
Opportunistic recruitment is a highly laborious and time-consuming process that is currently performed manually, increasing the workload of already busy practitioners and resulting in many studies failing to achieve their recruitment targets. The Translational Medicine and Patient Safety in Europe (TRANSFoRm) platform enables automated recruitment, data collection and follow-up of patients, potentially improving the efficiency, time and costs of clinical research. This study aims to assess the effectiveness of TRANSFoRm in improving patient recruitment and follow-up in primary care trials.
METHODS/DESIGN: This multi-centre, parallel-arm cluster randomised controlled trial will compare TRANSFoRm-supported with standard opportunistic recruitment. Participants will be general practitioners and patients with gastro-oesophageal reflux disease from 40 primary care centres in five European countries. Randomisation will take place at the care centre level. The intervention arm will use the TRANSFoRm tools for recruitment, baseline data collection and follow-up. The control arm will use web-based case report forms and paper self-completed questionnaires. The primary outcome will be the proportion of eligible patients successfully recruited at the end of the 16-week recruitment period. Secondary outcomes will include the proportion of recruited patients with complete baseline and follow-up data and the proportion of participants withdrawn or lost to follow-up. The study will also include an economic evaluation and measures of technology acceptance and user experience.
The study should shed light on the use of eHealth to improve the effectiveness of recruitment and follow-up in primary care research and provide an evidence base for future eHealth-supported recruitment initiatives. Reporting of results is expected in October 2015.
EudraCT: 2014-001314-25.
机会性招募是一个极其费力且耗时的过程，目前依靠人工操作，这增加了本就忙碌的从业者的工作量，导致许多研究无法实现招募目标。欧洲转化医学与患者安全（TRANSFoRm）平台能够实现患者的自动招募、数据收集和随访，有可能提高临床研究的效率、节省时间并降低成本。本研究旨在评估TRANSFoRm在改善初级保健试验中患者招募和随访方面的有效性。
方法/设计：这项多中心、平行组群随机对照试验将比较TRANSFoRm支持的招募方式与标准机会性招募方式。参与者将是来自欧洲五个国家40个初级保健中心的全科医生和胃食管反流病患者。随机分组将在护理中心层面进行。干预组将使用TRANSFoRm工具进行招募、收集基线数据和随访。对照组将使用基于网络的病例报告表和纸质自填问卷。主要结局将是在16周招募期结束时成功招募的符合条件患者的比例。次要结局将包括招募患者中具有完整基线和随访数据的比例以及退出或失访的参与者比例。该研究还将包括一项经济评估以及技术接受度和用户体验的测量。
该研究应阐明电子健康在提高初级保健研究中招募和随访有效性方面的应用，并为未来电子健康支持的招募举措提供证据基础。预计将于2015年10月报告结果。
EudraCT：2014 - 001314 - 25。
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