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Comparability of Event Adjudication Versus Administrative Billing Claims for Outcome Ascertainment in the DAPT Study:
Kamil F Faridi1,2, Hector Tamez2, Neel M Butala3
1Section of Cardiovascular Medicine, Department of Medicine, Yale School of Medicine, New Haven, CT (K.F.F., J.P.C.).
Insights
Administrative claims data offer an efficient method for endpoint ascertainment in cardiovascular clinical trials. While mortality is accurately captured, further monitoring is needed for other events like bleeding and stroke.
Area of Science:
- Cardiovascular Medicine
- Health Informatics
- Clinical Trials
Background:
- Administrative claims data present a potential efficient alternative for endpoint ascertainment in clinical trials.
- The accuracy of claims data compared to clinical events committee adjudication in cardiovascular trials remains uncertain.
Purpose of the Study:
- To evaluate the concordance between adjudicated clinical trial endpoints and administrative claims data for cardiovascular events.
- To assess the efficiency and accuracy of using Medicare claims for endpoint ascertainment in clinical trials.
Main Methods:
- 1336 patients aged ≥65 undergoing percutaneous coronary intervention were matched from the DAPT Study with Medicare claims via the CathPCI Registry (EXTEND Study).
- Adjudicated trial endpoints were compared to International Classification of Diseases, Ninth Revision codes in Medicare claims using time-to-event analyses, sensitivity, specificity, positive and negative predictive values, and kappa statistics.
Main Results:
- Major adverse cardiovascular and cerebrovascular events showed similar cumulative incidence between adjudicated events and claims data (7.9% vs. 7.2%, P=0.50) at 21-month follow-up.
- Bleeding rates were significantly lower in adjudicated events (5.0%) compared to claims data (8.6%, P<0.001).
- Sensitivity and positive predictive values for myocardial infarction, stroke, and bleeding varied, with high specificity (93.7%-99.5%) and equivalent identification of all deaths.
Conclusions:
- Medicare claims data demonstrated moderate agreement for myocardial infarction and high specificity for bleeding and stroke, but poor agreement for stroke.
- Claims data accurately identified all deaths, suggesting efficiency for mortality assessment in Medicare patients.
- While claims data can aid in detecting outcomes, additional monitoring is recommended for precise event assessment in clinical trials.
Background:
Data from administrative claims may provide an efficient alternative for end point ascertainment in clinical trials. However, it is uncertain how well claims data compare to adjudication by a clinical events committee in trials of patients with cardiovascular disease.
Methods:
We matched 1336 patients ≥65 years old who received percutaneous coronary intervention in the DAPT (Dual Antiplatelet Therapy) Study with the National Cardiovascular Data Registry CathPCI Registry linked to Medicare claims as part of the EXTEND (Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data) Study. Adjudicated trial end points were compared with Medicare claims data with International Classification of Diseases, Ninth Revision codes from inpatient hospitalizations using time-to-event analyses, sensitivity, specificity, positive predictive value, negative predictive value, and kappa statistics.
Results:
At 21-month follow-up, the cumulative incidence of major adverse cardiovascular and cerebrovascular events (combined mortality, myocardial infarction, and stroke) was similar between trial-adjudicated events and claims data (7.9% versus 7.2%, respectively; P=0.50). Bleeding rates were lower using adjudicated events compared with claims (5.0% versus 8.6%, respectively; P<0.001). The sensitivity and positive predictive value of comprehensive billing codes for identifying adjudicated events were 65.6% and 85.7% for myocardial infarction, 61.5% and 47.1% for stroke, and 76.8% and 39.3% for bleeding, respectively. Specificity and negative predictive value for all outcomes ranged from 93.7% to 99.5%. All 39 adjudicated deaths were identified using Medicare data. Kappa statistics assessing agreement between events for myocardial infarction, stroke, and bleeding were 0.73, 0.52, and 0.49, respectively.
Conclusions:
Claims data had moderate agreement with adjudication for myocardial infarction and poor agreement but high specificity for bleeding and stroke in the DAPT Study. Deaths were identified equivalently. Using claims data in clinical trials could be an efficient way to assess mortality among Medicare patients and may help detect other outcomes, although additional monitoring is likely needed to ensure accurate assessment of events.
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