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Pharmacovigilance evidence investigation Workgroup
Objective: The objective of this workgroup (WG) is to establish an open-source standardized knowledge base for the effects of medical products and an efficient procedure for maintaining and expanding it. For a complete overview, please see the paper Bridging islands of information to establish an integrated knowledge base of drugs and health outcomes of interest. In 2015/16 the WG contributed LAERTES (Largescale Adverse Effects Related to Treatment Evidence Standardization) – a system that integrates several sources of evidence investigating the association of drugs and health into a single system. The first staging release of LAERTES occurred last year and is reported in https://jbiomedsem.biomedcentral.com/articles/10.1186/s13326-017-0115-3.
One of the primary use cases for the WG has been the creation of negative controls. Members of the WG published a paper reporting on the accuracy of automated negative control generation using machine learning and the merged evidence base: http://dx.doi.org/10.1016/j.jbi.2016.12.005
The current efforts of the WG are focused on improving the process of creating and maintaining the merged evidence base, providing better support in OHDSI tools for negative control generation, and developing user friendly methods for using the merged evidence base to investigate pharmacovigilance signals. Other use cases are also being discussed. The new merged evidence base is called the Common Evidence Model and is accessible by requesting data from the project leads. The WG plans to make the data accessible from the OHDSI Web API by April 2018 (see https://goo.gl/1m6NcB).
Project Lead: Erica Voss, MPH
Project Co-Lead: Richard D. Boyce, PhD
Members:
Start Date: 6/10/2014
Repository: https://github.com/OHDSI/CommonEvidenceModel
WG Minutes: WG Minutes
WG Agendas: WG Agendas
Publications: E.A. Voss, R.D. Boyce, P.B. Ryan, J. van der Lei, P.R. Rijnbeek, M.J. Schuemie, Accuracy of an Automated Knowledge Base for Identifying Drug Adverse Reactions, Journal of Biomedical Informatics, Available online 16 December 2016, ISSN 1532-0464, http://dx.doi.org/10.1016/j.jbi.2016.12.005.
Boyce, RD., Voss, E., Huser, V., Evans, L., Reich, C., Duke, JD., Tatonetti, NP., Lorberbaum, T., Dumontier, M., Hauben, M., Wallberg, M., Peng, L., Dempster, S., He, O., Sena, A., Koutkias, V., Natsiavas, P., Ryan, P. (Knowledge Base workgroup of the Observational Health Data Sciences and Informatics (OHDSI) collaborative). Large-scale adverse effects related to treatment evidence standardization (LAERTES): an open scalable system for linking pharmacovigilance evidence sources with clinical data. J Biomed Semantics. 2017 Mar 7;8(1):11. doi: 10.1186/s13326-017-0115-3. Available at: https://jbiomedsem.biomedcentral.com/articles/10.1186/s13326-017-0115-3. PubMed PMID: 28270198; PubMed Central PMCID: PMC5341176.
Boyce. RD., Ryan. PB., Noren. N., et al., Bridging islands of information to establish an integrated knowledge base of drugs and health outcomes of interest. Drug Safety. 2014. Volume 37, Issue 8 (2014), Page 557-567. DOI: 10.1007/s40264-014-0189-0, PubMed PMID: 24985530. PMCID: PMC4134480. http://link.springer.com/article/10.1007%2Fs40264-014-0189-0
Meetings (Telecon Info)
Schedule: - All team call once per month on the 4th Wednesday of each month at 9-10 Eastern. - Touch point call on the 2nd Wednesday of each month 9-10 Eastern
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Discussions
Search for “LAERTES” on http://forums.ohdsi.org/
GitHub Issues
Active members List (add or delete your name if you see an omission or error)
Erica A. Voss, Janssen Research & Development, LLC, Titusville, NJ, EVoss3@its.jnj.com
Richard D. Boyce, University of Pittsburgh, Pittsburgh, PA, rdb20@pitt.edu
Lee Evans, LTS Computing LLC, West Chester, PA, levans@ltscomputingllc.com
Anthony G. Sena, Janssen Research & Development, LLC, Titusville, NJ, asena5@its.jnj.com
Vassilis Koutkias, Institute of Applied Biosciences, Center for Research & Technology Hellas, Thermi, Thessaloniki, Greece, vkoutkias@certh.gr
Pantelis Natsiavas, Institute of Applied Biosciences, Center for Research & Technology Hellas, Thermi, Thessaloniki, Greece, pnatsiavas@certh.gr
Manfred Hauben, MD. MPH, Pfizer Inc, New York University Medical Center, New York, NY, manfred.hauben@pfizer.com
Patrick B. Ryan, Janssen Research & Development, LLC, Titusville, NJ, ryan@ohdsi.org
