Biedermann Patricia, Ong Rose, Davydov Alexander, Orlova Alexandra, Solovyev Philip, Sun Hong, Wetherill Graham, Brand Monika, Didden Eva-Maria
Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123, Allschwil, Switzerland.
Odysseus Data Services, Inc., Cambridge, MA, USA.
BMC Med Res Methodol. 2021 Nov 2;21(1):238. doi: 10.1186/s12874-021-01434-3.
The Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) can be used to transform observational health data to a common format. CDM transformation allows for analysis across disparate databases for the generation of new, real-word evidence, which is especially important in rare disease where data are limited. Pulmonary hypertension (PH) is a progressive, life-threatening disease, with rare subgroups such as pulmonary arterial hypertension (PAH), for which generating real-world evidence is challenging. Our objective is to document the process and outcomes of transforming registry data in PH to the OMOP CDM, and highlight challenges and our potential solutions.
Three observational studies were transformed from the Clinical Data Interchange Standards Consortium study data tabulation model (SDTM) to OMOP CDM format. OPUS was a prospective, multi-centre registry (2014-2020) and OrPHeUS was a retrospective, multi-centre chart review (2013-2017); both enrolled patients newly treated with macitentan in the US. EXPOSURE is a prospective, multi-centre cohort study (2017-ongoing) of patients newly treated with selexipag or any PAH-specific therapy in Europe and Canada. OMOP CDM version 5.3.1 with recent OMOP CDM vocabulary was used. Imputation rules were defined and applied for missing dates to avoid exclusion of data. Custom target concepts were introduced when existing concepts did not provide sufficient granularity.
Of the 6622 patients in the three registry studies, records were mapped for 6457. Custom target concepts were introduced for PAH subgroups (by combining SNOMED concepts or creating custom concepts) and World Health Organization functional class. Per the OMOP CDM convention, records about the absence of an event, or the lack of information, were not mapped. Excluding these non-event records, 4% (OPUS), 2% (OrPHeUS) and 1% (EXPOSURE) of records were not mapped.
SDTM data from three registries were transformed to the OMOP CDM with limited exclusion of data and deviation from the SDTM database content. Future researchers can apply our strategy and methods in different disease areas, with tailoring as necessary. Mapping registry data to the OMOP CDM facilitates more efficient collaborations between researchers and establishment of federated data networks, which is an unmet need in rare diseases.
观察性医学结局合作组织（OMOP）通用数据模型（CDM）可用于将观察性健康数据转换为通用格式。CDM转换允许跨不同数据库进行分析，以生成新的真实世界证据，这在数据有限的罕见病中尤为重要。肺动脉高压（PH）是一种进行性、危及生命的疾病，有诸如肺动脉高压（PAH）等罕见亚组，生成真实世界证据具有挑战性。我们的目标是记录将PH注册数据转换为OMOP CDM的过程和结果，并突出挑战及我们的潜在解决方案。
三项观察性研究从临床数据交换标准协会研究数据列表模型（SDTM）转换为OMOP CDM格式。OPUS是一项前瞻性、多中心注册研究（2014 - 2020年），OrPHeUS是一项回顾性、多中心病历审查（2013 - 2017年）；两者均纳入美国新接受马昔腾坦治疗的患者。EXPOSURE是一项前瞻性、多中心队列研究（2017年至今），研究欧洲和加拿大新接受司来帕格或任何PAH特异性治疗的患者。使用了带有最新OMOP CDM词汇表的OMOP CDM版本5.3.1。定义并应用了缺失日期的插补规则以避免数据被排除。当现有概念没有提供足够的粒度时引入了自定义目标概念。
在三项注册研究的6622名患者中，6457条记录被映射。为PAH亚组（通过组合SNOMED概念或创建自定义概念）和世界卫生组织功能分级引入了自定义目标概念。根据OMOP CDM惯例，关于事件未发生或信息缺失的记录未被映射。排除这些非事件记录后，4%（OPUS）、2%（OrPHeUS）和1%（EXPOSURE）的记录未被映射。
来自三个注册机构的SDTM数据被转换为OMOP CDM，数据排除有限且与SDTM数据库内容的偏差较小。未来的研究人员可以根据需要进行调整，在不同疾病领域应用我们的策略和方法。将注册数据映射到OMOP CDM有助于研究人员之间更高效的合作以及建立联合数据网络，这是罕见病领域尚未满足的需求。
