van Bragt Job J M H, Hansen Susanne, Djukanovic Ratko, Bel Elisabeth H D, Ten Brinke Anneke, Wagers Scott S, Maitland-van der Zee Anke H, Porsbjerg Celeste
Dept of Respiratory Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.
Center for Clinical Research and Disease Prevention, Bispebjerg and Frederiksberg Hospital, The Capital Region, Copenhagen, Denmark.
ERJ Open Res. 2021 Apr 19;7(2). doi: 10.1183/23120541.00064-2021. eCollection 2021 Apr.
Real-world evidence is important to help unravel unanswered problems in severe asthma and is valuable to better understand the patient experience and common clinical practice. The Severe Heterogeneous Asthma Registry, Patient-centred (SHARP) Clinical Research Collaboration is created as a network of national registries and severe asthma centres that work together to perform registry based real-world research and clinical studies on a pan-European scale. Such collaboration requires a new, innovative design to overcome the many issues that arise with large-scale data collection across national borders. SHARP has developed a platform that offers a federated analysis approach where national registry data are transformed and integrated into a common data model (CDM). The CDM then allows a local analysis of de-identified patient data and subsequent aggregate (meta-)analysis. To facilitate an easily accessible way to set up new registries, SHARP enables new registries to take part in a central database, based on already proven technology. Next to being economical, this linkage ensures data from different SHARP central members to be comparable. Technological advancements lead to an ever-expanding rate of patient data that will be collected; with the collective effort of the pan-European severe asthma research community SHARP hopes to ensure that they are well equipped to enter a new era of medical research, with the ultimate goal to positively impact the lives of patients with severe asthma.
真实世界证据对于帮助解决重度哮喘中尚未解决的问题很重要，对于更好地了解患者体验和常见临床实践也很有价值。以患者为中心的重度异质性哮喘注册研究协作组（SHARP）临床研究合作网络是由国家注册研究机构和重度哮喘中心组成的，它们共同合作，在泛欧洲范围内开展基于注册研究的真实世界研究和临床研究。这种合作需要一种全新的创新设计，以克服跨国界大规模数据收集过程中出现的诸多问题。SHARP开发了一个平台，该平台提供了一种联邦分析方法，将国家注册研究数据进行转换并整合到一个通用数据模型（CDM）中。然后，CDM允许对去识别化的患者数据进行本地分析以及后续的汇总（元）分析。为了便于以一种易于访问的方式建立新的注册研究，SHARP使新的注册研究能够基于已被证明的技术参与到一个中央数据库中。除了经济实惠之外，这种关联还确保了来自SHARP不同中央成员的数据具有可比性。技术进步导致收集到的患者数据量不断增加；通过泛欧洲重度哮喘研究界的共同努力，SHARP希望确保他们能够做好充分准备，进入医学研究的新时代，最终目标是对重度哮喘患者的生活产生积极影响。
