| アブストラクト | OBJECTIVES: Electronic health records (EHR) provide a valuable resource for assessing drug side-effects, but treatments are not randomly allocated in routine care creating the potential for bias. We conduct a case study using the Prior Event Rate Ratio (PERR) Pairwise method to reduce unmeasured confounding bias in side-effect estimates for two second-line therapies for type 2 diabetes, thiazolidinediones, and sulfonylureas. STUDY DESIGN AND SETTINGS: Primary care data were extracted from the Clinical Practice Research Datalink (n = 41,871). We utilized outcomes from the period when patients took first-line metformin to adjust for unmeasured confounding. Estimates for known side-effects and a negative control outcome were compared with the A Diabetes Outcome Progression Trial (ADOPT) trial (n = 2,545). RESULTS: When on metformin, patients later prescribed thiazolidinediones had greater risks of edema, HR 95% CI 1.38 (1.13, 1.68) and gastrointestinal side-effects (GI) 1.47 (1.28, 1.68), suggesting the presence of unmeasured confounding. Conventional Cox regression overestimated the risk of edema on thiazolidinediones and identified a false association with GI. The PERR Pairwise estimates were consistent with ADOPT: 1.43 (1.10, 1.83) vs. 1.39 (1.04, 1.86), respectively, for edema, and 0.91 (0.79, 1.05) vs. 0.94 (0.80, 1.10) for GI. CONCLUSION: The PERR Pairwise approach offers potential for enhancing postmarketing surveillance of side-effects from EHRs but requires careful consideration of assumptions. |
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| ジャーナル名 | Journal of clinical epidemiology |
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| 投稿日 | 2020/3/21 |
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| 投稿者 | Rodgers, Lauren R; Dennis, John M; Shields, Beverley M; Mounce, Luke; Fisher, Ian; Hattersley, Andrew T; Henley, William E |
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| 組織名 | Institute of Health Research, University of Exeter Medical School, Exeter, UK.;Electronic address: L.R.Rodgers@exeter.ac.uk.;NIHR Exeter Clinical Research Facility, University of Exeter Medical School,;Exeter, UK.;IQVIA, London UK.;Department of Diabetes and Endocrinology, Royal Devon and Exeter NHS Foundation;Trust, Exeter, UK. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/32194148/ |
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