| アブストラクト | INTRODUCTION: A multinational post-authorization safety study assessed cardiovascular safety in initiators of prucalopride for chronic constipation compared with a matched cohort of polyethylene glycol 3350 initiators. The primary safety outcome was major adverse cardiovascular events (MACE), a composite of hospitalization for acute myocardial infarction, stroke, or in-hospital cardiovascular death. We report the validation process for MACE endpoints in United Kingdom (UK) data sources: Clinical Practice Research Datalink (CPRD GOLD), The Health Improvement Network (THIN), and the Information Services Division (ISD) Scotland. METHODS: Modified electronic algorithms from prior research identified potential MACE cases. Validation followed a common protocol, adapted for each database, with all information anonymized: (1) direct confirmation via linkage to hospital records (CPRD GOLD); (2) requests for additional clinical information through questionnaires (CPRD GOLD), free-text (THIN), or abstraction of hospital records (ISD); (3) manual review of electronic records of potential events retrieved by the algorithm (CPRD GOLD/THIN); and (4) event adjudication by three clinicians, blinded to exposure, for all remaining events. RESULTS: Electronic algorithms identified 260 potential MACE cases: 38 confirmed via linkage to hospital records (CPRD GOLD), 56 ruled out as non-cardiovascular death cases (THIN), and three unavailable for review (ISD), leaving 163 potential cases. After manual review with additional information (steps 2 and 3), 45 were considered noncases (CPRD GOLD/THIN). Upon final adjudication (step 4), remaining potential events were adjudicated as definite (n = 62), probable (n = 10), possible (n = 13), or noncases (n = 33). CONCLUSIONS: Given the limitations of relying solely on computer algorithms to identify cardiovascular outcomes, validation with clinical review is essential to guide interpretation. |
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| ジャーナル名 | Drug safety |
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| Pubmed追加日 | 2021/2/20 |
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| 投稿者 | Ruigomez, Ana; Plana, Estel; Gilsenan, Alicia; Fortuny, Joan; Cainzos-Achirica, Miguel; Flynn, Robert W V; MacDonald, Thomas M; Garcia-Rodriguez, Luis; Ziemiecki, Ryan; Andrews, Elizabeth B |
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| 組織名 | Centro Espanol de Investigacion Farmacoepidemiologica (CEIFE), Madrid, Spain.;RTI Health Solutions, Barcelona, Spain.;RTI Health Solutions, 3040 Cornwallis Rd, Research Triangle Park, NC, 27709, USA.;agilsenan@rti.org.;Division of Cardiovascular Prevention and Wellness, Department of Cardiology,;Houston Methodist DeBakey Heart and Vascular Center, Houston, TX, USA.;Center for Outcomes Research, Houston Methodist, Houston, TX, USA.;University of Dundee, Dundee, Scotland. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/33606202/ |
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