دورية أكاديمية
Validation of a claims-based algorithm identifying eligible study subjects in the ADAPTABLE pragmatic clinical trial
| العنوان: | Validation of a claims-based algorithm identifying eligible study subjects in the ADAPTABLE pragmatic clinical trial |
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| المؤلفون: | Ezra Fishman, John Barron, Jade Dinh, W. Schuyler Jones, Amanda Marshall, Rebecca Merkh, Holly Robertson, Kevin Haynes |
| المصدر: | Contemporary Clinical Trials Communications, Vol 12, Iss , Pp 154-160 (2018) |
| بيانات النشر: | Elsevier, 2018. |
| سنة النشر: | 2018 |
| المجموعة: | LCC:Medicine (General) |
| مصطلحات موضوعية: | Medicine (General), R5-920 |
| الوصف: | 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 |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | English |
| تدمد: | 2451-8654 00340448 |
| Relation: | http://www.sciencedirect.com/science/article/pii/S2451865418301182; https://doaj.org/toc/2451-8654 |
| DOI: | 10.1016/j.conctc.2018.11.001 |
| URL الوصول: | https://doaj.org/article/cf7eef6af00340448634d942e525f302 |
| رقم الأكسشن: | edsdoj.f7eef6af00340448634d942e525f302 |
| قاعدة البيانات: | Directory of Open Access Journals |
Full Text via ClinicalKey 
Full Text Finder | تدمد: | 24518654 00340448 |
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| DOI: | 10.1016/j.conctc.2018.11.001 |