Cardiology Division, Johns Hopkins University, Baltimore, Maryland.
OM1, Inc., Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts.
Heart Rhythm. 2019 Jan;16(1):e3-e16. doi: 10.1016/j.hrthm.2018.09.021. Epub 2018 Nov 16.
Atrial fibrillation (AF) affects an estimated 33 million people worldwide, leading to increased mortality and an increased risk of heart failure and stroke. Many AF patient registries exist, but the ability to link and compare data across registries is hindered by differences in the outcome measures collected by each registry and a lack of harmonization.
The purpose of this project was to develop a minimum set of standardized outcome measures that could be collected in AF patient registries and clinical practice.
AF patient registries were identified through multiple sources and invited to join the workgroup and submit outcome measures. Additional measures were identified through literature searches and reviews of consensus statements. Outcome measures were categorized using the Agency for Healthcare Research and Quality's supported Outcome Measures Framework (OMF). A minimum set of broadly relevant measures was identified. Measure definitions were harmonized through in-person and virtual meetings.
One hundred twelve outcome measures, including those from thirteen registries, were curated according to the OMF and then harmonized into a minimum set of measures in the OMF categories of survival (3 measures), clinical response (3 measures), events of interest (9 measures), patient-reported outcomes (2 measures), and resource utilization (3 measures). The harmonized definitions build on existing consensus statements.
The harmonized measures represent a minimum set of outcomes that are relevant in AF research and clinical practice. Routine and consistent collection of these measures in registries and in other systems would support creation of a research infrastructure to efficiently address new questions and improve patient outcomes.
心房颤动（AF）影响全球约 3300 万人，导致死亡率增加，心力衰竭和中风风险增加。存在许多 AF 患者登记处，但由于每个登记处收集的结果衡量标准存在差异以及缺乏协调，因此难以在登记处之间进行链接和比较数据。
本项目旨在制定一套标准化的最小结果衡量标准，可在 AF 患者登记处和临床实践中收集。
通过多种来源确定 AF 患者登记处，并邀请他们加入工作组并提交结果衡量标准。通过文献检索和共识声明的审查，确定了其他措施。使用美国医疗保健研究与质量局（Agency for Healthcare Research and Quality）支持的结果衡量标准框架（OMF）对结果衡量标准进行分类。确定了一组最小但广泛相关的措施。通过面对面和虚拟会议协调衡量标准的定义。
根据 OMF 对 112 种结果衡量标准进行了策展，其中包括来自 13 个登记处的衡量标准，然后将其协调为 OMF 类别中生存（3 个衡量标准）、临床反应（3 个衡量标准）、关注事件（9 个衡量标准）、患者报告的结果（2 个衡量标准）和资源利用（3 个衡量标准）中的一组最小措施。协调后的定义建立在现有共识声明的基础上。
协调后的措施代表了在 AF 研究和临床实践中相关的最小结果集。在登记处和其他系统中常规且一致地收集这些措施将支持创建一个研究基础设施，以有效地解决新问题并改善患者的结果。
