What does this research mean for the field?

The choice of common data model (OMOP vs. ConcePTION) significantly alters real-world evidence study results, as evidenced by DOACs showing reduced cardiovascular risk compared to VKAs in OMOP data but no difference in ConcePTION data. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

This research aims to evaluate the impact of different common data models on outcomes related to anticoagulant use.

March 8, 2026

Implementation of OMOP and ConcePTION Common Data Models in CPRD GOLD: Risk of Bleeding and Cardiovascular Outcomes From Anticoagulant Use.

Key Result

DOACs showed no cardiovascular risk difference vs VKAs in ConcePTION data (HR 0.99) but reduced risk in OMOP data (HR 0.82), with similar stroke and bleeding risks.

Key Points

This research aims to evaluate the impact of different common data models on outcomes related to anticoagulant use.
Mapped CPRD GOLD data to OMOP and ConcePTION CDMs.
Compared incidence rates and Cox proportional hazards ratios for DOACs versus VKAs.
Analyzed bleeding and cardiovascular outcomes in patients with non-valvular atrial fibrillation.
No differential risk of cardiovascular disease (CVD) associated with DOACs in ConcePTION data (HR 0.99).
Protective effect of DOACs on CVD found in OMOP data (HR 0.82).
Similar increase in stroke risk was observed in both models, with ConcePTION HR 1.19 and OMOP HR 1.10.
No increased major bleeding risk identified in either CDM (ConcePTION HR 0.97; OMOP HR 0.90).

Structured PICO

Does the choice of common data model (OMOP vs ConcePTION) alter the estimated effect of DOACs versus VKAs on bleeding and cardiovascular outcomes in patients with non-valvular atrial fibrillation?

Population

Patients with non-valvular atrial fibrillation from the CPRD GOLD database (OMOP mapped n=80,701; ConcePTION mapped n=76,726).

Intervention

Direct oral anticoagulants (DOACs)

Comparator

Vitamin K antagonists (VKAs)

Outcome

Cardiovascular (CVD) outcomes, stroke, and major bleedinghard clinical

The choice of Common Data Model (OMOP vs ConcePTION) can significantly alter real-world evidence study results, such as the estimated cardiovascular benefits of DOACs versus VKAs.

Main Result

Absolute Event Rate: 0% vs 0%

Abstract

The impact of the choice of common data model (CDM) approach on the study results in a real-world evidence (RWE) study is unknown. We aimed to determine potential differences in the results of an RWE study when data were mapped to two different CDMs, ConcePTION and OMOP. With the same instance of CPRD GOLD, data were mapped to both CDMs. Using the same programming steps, we estimated the risk of direct oral anticoagulants (DOACs) vs. vitamin K antagonists (VKAs) on bleeding and cardiovascular (CVD) outcomes in patients with non-valvular atrial fibrillation. Baseline characteristics, incidence rates, and Cox proportional hazards ratios were compared between the analyses. OMOP and ConcePTION mapped study populations included 80,701 (93,350 person-years) and 76,726 exposed persons (100,135 person-years), respectively. DOACs showed no differential risk of CVD compared to VKAs in ConcePTION mapped data (HR 0.99, 95% CI 0.91; 1.08), but protective effects in OMOP (HR 0.82, 95% CI 0.74; 0.90). DOACs had a similar increase in risk of stroke (ConcePTION HR 1.19, 95% CI 1.02; 1.37; OMOP HR 1.10, 95% CI 0.96; 1.26). No increased risk of major bleeding was identified (ConcePTION HR 0.97, 95% CI 0.84; 1.13; OMOP HR 0.90, 95% CI 0.78; 1.04). OMOP gave lower effect estimates for CVD and equivalent risks of stroke and bleeding associated with DOACs use. This study highlights the challenges in repeating the same analysis across the two data CDMs. Differences potentially stem from the cohort construction, the identification of phenotypes in the different CDMs, and the use of imputed variables defined during mapping processes, such as drug exposure duration.

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