Advancing the Real-World Evidence for Medical Devices through Coordinated Registry Networks.
Advancing the Real-World Evidence for Medical Devices through Coordinated Registry Networks.
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DOI：
10.1136/bmjsit-2021-000123
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发表时间：
2022
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生成和使用真实世界证据（RWE）是评估卫生技术的实用解决方案。RWE被监管机构、卫生技术评估人员、临床医生和制造商认可为支持其决策的有效信息来源。设计良好的登记处可以提供RWE，并在与协调登记网络（CRN）中的电子健康记录和管理数据库链接时变得更加强大。我们的目标是创建一个CRN和登记系统成熟度的框架，从而指导它们的开发和资金的优先顺序。我们邀请了来自不同背景的52名利益相关者，包括患者倡导团体、学术、临床、行业和监管专家，参与德尔菲调查。在受邀者中，有42人参与了调查，以提供关于CRN和登记系统成熟度框架的反馈。一个专家小组审查了答复，以完善框架，直到达到80%的目标共识。于二零二零年七月至八月及于二零二零年十月至十一月，两轮德尔菲已透过Qualtrics线上平台分销。CRN和登记研究成熟度框架的共识包括7个领域（唯一器械识别、有效数据收集、数据质量、产品生命周期方法、管理和可持续性、质量改进和患者报告结局），每个领域有5个成熟度水平。在52名受邀专家中，41名（79.9%）对第一轮作出了答复;所有41名对第二轮作出了答复;在大多数领域达成了共识。专家小组解决了分歧，最终的共识估计范围为七个领域的80.5%至92.7%。我们开发了一个强大的框架来评估任何CRN（或注册中心）的成熟度，以提供可靠的RWE。这一框架将促进不同学科和卫生系统的RWE生成方法的统一。随着新的解决方案的出现，域及其级别可能会随着时间的推移而演变。
Generating and using real-world evidence (RWE) is a pragmatic solution for evaluating health technologies. RWE is recognized by regulators, health technology assessors, clinicians, and manufacturers as a valid source of information to support their decision-making. Well-designed registries can provide RWE and become more powerful when linked with electronic health records and administrative databases in coordinated registry networks (CRNs). Our objective was to create a framework of maturity of CRNs and registries, so guiding their development and the prioritization of funding. We invited 52 stakeholders from diverse backgrounds including patient advocacy groups, academic, clinical, industry and regulatory experts to participate on a Delphi survey. Of those invited, 42 participated in the survey to provide feedback on the maturity framework for CRNs and registries. An expert panel reviewed the responses to refine the framework until the target consensus of 80% was reached. Two rounds of the Delphi were distributed via Qualtrics online platform from July to August 2020 and from October to November 2020. Consensus on the maturity framework for CRNs and registries consisted of seven domains (unique device identification, efficient data collection, data quality, product life cycle approach, governance and sustainability, quality improvement, and patient-reported outcomes), each presented with five levels of maturity. Of 52 invited experts, 41 (79.9%) responded to round 1; all 41 responded to round 2; and consensus was reached for most domains. The expert panel resolved the disagreements and final consensus estimates ranged from 80.5% to 92.7% for seven domains. We have developed a robust framework to assess the maturity of any CRN (or registry) to provide reliable RWE. This framework will promote harmonization of approaches to RWE generation across different disciplines and health systems. The domains and their levels may evolve over time as new solutions become available.