de Groot Saskia, van der Linden Naomi, Franken Margreet G, Blommestein Hedwig M, Leeneman Brenda, van Rooijen Ellen, Koos van der Hoeven J J M, Wouters Michel W, Westgeest Hans M, Uyl-de Groot Carin A
Institute of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, The Netherlands; Institute for Medical Technology Assessment, Erasmus University Rotterdam, Rotterdam, The Netherlands.
Institute of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, The Netherlands.
Value Health. 2017 Apr;20(4):627-636. doi: 10.1016/j.jval.2016.02.007. Epub 2016 Apr 6.
The aim of this article was to provide practical guidance in setting up patient registries to facilitate real-world data collection for health care decision making.
This guidance was based on our experiences and involvement in setting up patient registries in oncology in the Netherlands. All aspects were structured according to 1) mission and goals ("the Why"), 2) stakeholders and funding ("the Who"), 3) type and content ("the What"), and 4) identification and recruitment of patients, data handling, and pharmacovigilance ("the How").
The mission of most patient registries is improving patient health by improving the quality of patient care; monitoring and evaluating patient care is often the primary goal ("the Why"). It is important to align the objectives of the registry and agree on a clear and functional governance structure with all stakeholders ("the Who"). There is often a trade off between reliability, validity, and specificity of data elements and feasibility of data collection ("the What"). Patient privacy should be carefully protected, and address (inter-)national and local regulations. Patient registries can reveal unique safety information, but it can be challenging to comply with pharmacovigilance guidelines ("the How").
It is crucial to set up an efficient patient registry that serves its aims by collecting the right data of the right patient in the right way. It can be expected that patient registries will become the new standard alongside randomized controlled trials due to their unique value.
本文旨在为建立患者登记系统提供实用指导，以促进为医疗保健决策收集真实世界数据。
本指导基于我们在荷兰建立肿瘤患者登记系统的经验和参与情况。所有方面按照以下内容进行构建：1）使命和目标（“为何”），2）利益相关者和资金（“何人”），3）类型和内容（“何事”），以及4）患者识别与招募、数据处理和药物警戒（“如何做”）。
大多数患者登记系统的使命是通过提高患者护理质量来改善患者健康；监测和评估患者护理通常是主要目标（“为何”）。使登记系统的目标保持一致，并与所有利益相关者就清晰且实用的治理结构达成共识非常重要（“何人”）。在数据元素的可靠性、有效性和特异性与数据收集的可行性之间往往需要权衡（“何事”）。应谨慎保护患者隐私，并遵守（国际和）当地法规。患者登记系统可能会揭示独特的安全信息，但遵守药物警戒指南可能具有挑战性（“如何做”）。
建立一个高效的患者登记系统至关重要，该系统通过以正确的方式收集正确患者的正确数据来实现其目标。由于其独特价值，预计患者登记系统将与随机对照试验一起成为新标准。
