| アブストラクト | BACKGROUND: Temporal pattern discovery (TPD) is a method of signal detection using electronic healthcare databases, serving as an alternative to spontaneous reporting of adverse drug events. Here, we aimed to replicate and optimise a TPD approach previously used to assess temporal signals of statins with rhabdomyolysis (in The Health Improvement Network (THIN) database) by using the OHDSI tools designed for OMOP data sources. METHODS: We used data from the Truven MarketScan US Commercial Claims and the Commercial Claims and Encounters (CCAE). Using an extension of the OHDSI ICTemporalPatternDiscovery package, we ran positive and negative controls through four analytical settings and calculated sensitivity, specificity, bias and AUC to assess performance. RESULTS: Similar to previous findings, we noted an increase in the Information Component (IC) for simvastatin and rhabdomyolysis following initial exposure and throughout the surveillance window. For example, the change in IC was 0.266 for the surveillance period of 1-30 days as compared to the control period of - 180 to - 1 days. Our modification of the existing OHDSI software allowed for faster queries and more efficient generation of chronographs. CONCLUSION: Our OMOP replication matched the we can account forwe can account for of the original THIN study, only simvastatin had a signal. The TPD method is a useful signal detection tool that provides a single statistic on temporal association and a graphical depiction of the temporal pattern of the drug outcome combination. It remains unclear if the method works well for rare adverse events, but it has been shown to be a useful risk identification tool for longitudinal observational databases. Future work should compare the performance of TPD with other pharmacoepidemiology methods and mining techniques of signal detection. In addition, it would be worth investigating the relative TPD performance characteristics using a variety of observational data sources. |
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| 投稿日 | 2022/2/5 |
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| 投稿者 | Lavallee, M; Yu, T; Evans, L; Van Hemelrijck, M; Bosco, C; Golozar, A; Asiimwe, A |
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| ジャーナル名 | BMC medical informatics and decision making |
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| 組織名 | Former Bayer Healthcare Pharmaceutical Inc, Whippany, NJ, USA.;lavalleema@vcu.edu.;Virginia Commonwealth University, Richmond, VA, USA. lavalleema@vcu.edu.;LTS Computing LLC, West Chester, PA, USA. lavalleema@vcu.edu.;LTS Computing LLC, West Chester, PA, USA.;Translational Oncology & Urology Research (TOUR), King's College London, London,;UK.;Bayer AG, Berlin, Germany. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/35115001/ |
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