Validation of a claims-based algorithm identifying eligible study subjects in the ADAPTABLE pragmatic clinical trial
| Autor: | W. Schuyler Jones, Jade Dinh, Amanda Marshall, Rebecca Merkh, Ezra Fishman, Holly Robertson, John Barron, Kevin Haynes |
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| Rok vydání: | 2018 |
| Předmět: |
medicine.medical_treatment
Computable phenotype Acute myocardial infarction 030204 cardiovascular system & hematology Article Coronary artery disease 03 medical and health sciences 0302 clinical medicine medicine 030212 general & internal medicine Myocardial infarction Real-world evidence Pharmacology lcsh:R5-920 Aspirin business.industry Medical record Percutaneous coronary intervention General Medicine Cardiovascular disease medicine.disease Confidence interval Clinical trial Conventional PCI Current Procedural Terminology lcsh:Medicine (General) business Algorithm |
| Zdroj: | Contemporary Clinical Trials Communications, Vol 12, Iss, Pp 154-160 (2018) Contemporary Clinical Trials Communications |
| ISSN: | 2451-8654 |
| Popis: | Objective: Validate an algorithm that uses administrative claims data to identify eligible study subjects for the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) pragmatic clinical trial (PCT). Materials and methods: This study used medical records from a random sample of patients identified as eligible for the ADAPTABLE trial. The inclusion criteria for ADAPTABLE were a history of acute myocardial infarction (AMI) or percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), or other coronary artery disease (CAD), plus at least one of several risk-enrichment factors. Exclusion criteria included a history of bleeding disorders or aspirin allergy. Using a claims-based algorithm, based on International Classification of Diseases, 9th Edition, Clinical Modification (ICD-9-CM) and 10th Edition (ICD-10) codes and Current Procedural Terminology (CPT) codes, we identified patients eligible for the PCT. The primary outcome was the positive predictive value (PPV) of the identification algorithm: the proportion of sampled patients whose medical records confirmed their ADAPTABLE study eligibility. Exact 95% confidence limits for binomial random variables were calculated for the PPV estimates. Results: Of the 185 patients whose medical records were reviewed, 168 (90.8%; 95% Confidence Interval: 85.7%, 94.6%) were confirmed study eligible. This proportion did not differ between patients identified with codes for AMI and patients identified with codes for PCI or CABG. Conclusion: The estimated PPV was similar to those in claims-based identification of drug safety surveillance events, indicating that administrative claims data can accurately identify study-eligible subjects for pragmatic clinical trials. Keywords: Cardiovascular disease, Aspirin, Real-world evidence, Acute myocardial infarction, Computable phenotype |
| Databáze: | OpenAIRE |
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