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Erica Voss edited this page Feb 23, 2020 · 7 revisions

Welcome to the CommonEvidenceModel wiki!

Introduction

The CommonEvidenceModel (CEM) leverages work previously performed within LAERTES, also known as the OHDSI Knowledgebase. However, the focus here is building infrastructure to update the incoming raw sources as well as the post processing of finding Negative Controls.

CEM Process Flow

This project is an offshoot of the OHDSI Knowledgebase which more information can be found here:

  • https://github.com/OHDSI/KnowledgeBase
  • Boyce RD, Ryan PB, Norén GN, Schuemie MJ, Reich C, Duke J, Tatonetti NP, Trifirò G, Harpaz R, Overhage JM, Hartzema AG, Khayter M, Voss EA, Lambert CG, Huser V, Dumontier M. Bridging islands of information to establish an integrated knowledge base of drugs and health outcomes of interest. Drug Saf. 2014 Aug;37(8):557-67. doi: 10.1007/s40264-014-0189-0. PubMed PMID: 24985530; PubMed Central PMCID: PMC4134480.
  • Voss EA, Boyce RD, Ryan PB, van der Lei J, Rijnbeek PR, Schuemie MJ. Accuracy of an automated knowledge base for identifying drug adverse reactions. J Biomed Inform. 2017 Feb;66:72-81. doi: 10.1016/j.jbi.2016.12.005. Epub 2016 Dec 16. PubMed PMID: 27993747; PubMed Central PMCID: PMC5316295.
  • 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. PubMed PMID: 28270198; PubMed Central PMCID: PMC5341176.

Release Information

There are two parts of release identification which are documented in the SOURCE table

  • SOURCE.DATE = date data is released
  • SOURCE.VERSION = code release version

Data Status

CEM v1.0

source_id description provenance contributor_organization contact_name creation_date coverage_start_date coverage_end_date version_identifier
AEOLUS Spontaneous reports and signals from FDA Adverse Event Reporting System (FAERS) based on the paper Banda, J. M. et al. A curated and standardized adverse drug event resource to accelerate drug safety research. Sci. Data 3:160026 doi: 10.1038/sdata.2016.26 (2016). AEOLUS Center for Biomedical Informatics Research, Stanford University Lee Evans (LTS Computing LLC) 2016-04-22 2004-01-01 2015-06-01 V1
MEDLINE_COOCCURRENCE Co-occurrence of a drug and condition MeSH tag on a publication pulled from MEDLINE. MEDLINE Janssen R&D Erica Voss 1900-01-01 1900-01-01 1900-01-01 V1
MEDLINE_AVILLACH Co-occurrence of a drug and condition MeSH tag on a publication with the qualifiers adverse effects and chemically induced respectively. Based on publication Avillach P, Dufour JC, Diallo G, Salvo F, Joubert M, Thiessard F, Mougin F, Trifiro G, Fourrier-Reglat A, Pariente A, Fieschi M. Design and validation of an automated method to detect known adverse drug reactions in MEDLINE: a contribution from the EU-ADR project. J Am Med Inform Assoc. 2013 May 1;20(3):446-52. doi: 10.1136/amiajnl-2012-001083. Epub 2012 Nov 29. PubMed PMID: 23195749; PubMed Central PMCID: PMC3628051. MEDLINE Janssen R&D Erica Voss 1900-01-01 1900-01-01 1900-01-01 V1
MEDLINE_PUBMED Co-occurrence of a drug and condition MeSH tag or found in the Title of Abstract of a publication. Leverages Pubmed. PUBMED Janssen R&D Erica Voss 1900-01-01 1900-01-01 1900-01-01 V1
MEDLINE_WINNENBURG Winnenburg R, Sorbello A, Ripple A, Harpaz R, Tonning J, Szarfman A, Francis H, Bodenreider O. Leveraging MEDLINE indexing for pharmacovigilance - Inherent limitations and mitigation strategies. J Biomed Inform. 2015 Oct;57:425-35. doi: 10.1016/j.jbi.2015.08.022. Epub 2015 Sep 2. PubMed PMID: 26342964; PubMed Central PMCID: PMC4775467. MEDLINE Janssen R&D Erica Voss 1900-01-01 1900-01-01 1900-01-01 V1
SEMMEDDB Semantic Medline uses natural language processing to extract semantic predictions from titles and text. H. Kilicoglu et al., Constructing a semantic predication gold standard from the biomedical literature, BMC Bioinformatics 12 (2011) 486. SEMMEDDB National Institutes of Health National Institutes of Health 2016-12-31 1865-01-01 2016-12-31 V30
SPLICER Adverse drug reactions extracted from the Adverse Reactions or Post Marketing section of United States product labeling. Based on publication J. Duke, J. Friedlin, X. Li, Consistency in the safety labeling of bioequivalent medications, Pharmacoepidemiol. Drug Saf. 22 (3) (2013) 294?301. SPLICER Regenstrief Institute Jon Duke 1900-01-01 1900-01-01 1900-01-01 V
SHERLOCK --- --- --- --- --- --- --- ---
EU_PL_ADR From the PROTECT ADR database, this provided a list of ADRS on Summary of Product Characteristics (SPC) of products authorized in the European Union. Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT), Adverse Drug Reactions Database, [webpage] (2015.05.07), Available from: http://www.imi-protect.eu/adverseDrugReactions.shtml EU_PL_ADR PROTECT PROTECT 2015-05-30 1900-01-01 2015-05-30 20150630

CEM v2.0

source_id description provenance contributor_organization contact_name creation_date coverage_start_date coverage_end_date version_identifier
AEOLUS "Spontaneous reports and signals from FDA Adverse Event Reporting System (FAERS) based on the paper Banda, J. M. et al. A curated and standardized adverse drug event resource to accelerate drug safety research. Sci. Data 3:160026 doi: 10.1038/sdata.2016.26 (2016)." AEOLUS "Center for Biomedical Informatics Research, Stanford University" Lee Evans (LTS Computing LLC) 6/1/2019 1/1/2004 3/31/2019
COMMONEVIDENCEMODEL CommonEvidenceModel (CEM) is the infrastructure to pull together public sources of information on drugs and conditions and standardize their format and vocabularies. COMMONEVIDENCEMODEL OHDSI Erica Voss 2/26/2020 01/01/1865 1/23/2020 V2.0.0
EU_PL_ADR "From the PROTECT ADR database, this provided a list of ADRS on Summary of Product Characteristics (SPC) of products authorized in the European Union. Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT), Adverse Drug Reactions Database, [webpage] (2015.05.07), Available from: http://www.imi-protect.eu/adverseDrugReactions.shtml" EU_PL_ADR PROTECT PROTECT 12/31/2019 1/1/1900 6/30/2017 20170630
MEDLINE_AVILLACH "Co-occurrence of a drug and condition MeSH tag on a publication with the qualifiers ""adverse effects"" and ""chemically induced"" respectively. Based on publication Avillach P, Dufour JC, Diallo G, Salvo F, Joubert M, Thiessard F, Mougin F, Trifir? G, Fourrier-R?glat A, Pariente A, Fieschi M. Design and validation of an automated method to detect known adverse drug reactions in MEDLINE: a contribution from the EU-ADR project. J Am Med Inform Assoc. 2013 May 1;20(3):446-52. doi: 10.1136/amiajnl-2012-001083. Epub 2012 Nov 29. PubMed PMID: 23195749; PubMed Central PMCID: PMC3628051." MEDLINE Janssen R&D Erica Voss 2/9/2020 1/1/1900 5/28/2018
MEDLINE_PUBMED Co-occurrence of a drug and condition MeSH tag or found in the Title of Abstract of a publication. Leverages Pubmed. PUBMED Janssen R&D Erica Voss 2/19/2020 1/1/1900 5/28/2018
MEDLINE_WINNENBURG "Winnenburg R, Sorbello A, Ripple A, Harpaz R, Tonning J, Szarfman A, Francis H, Bodenreider O. Leveraging MEDLINE indexing for pharmacovigilance - Inherent limitations and mitigation strategies. J Biomed Inform. 2015 Oct;57:425-35. doi:10.1016/j.jbi.2015.08.022. Epub 2015 Sep 2. PubMed PMID: 26342964; PubMed Central PMCID: PMC4775467." MEDLINE Janssen R&D Erica Voss 2/19/2020 1/1/1900 5/28/2018
OMOP_VOCABULARY OMOP Vocabulary VOCABULARY OHDSI Odysseus 12/2/2019 12/19/2019 1/26/2018 v5.0 02-DEC-19
SEMMEDDB "Semantic Medline uses natural language processing to extract semantic predictions from titles and text. ""H. Kilicoglu et al., Constructing a semantic predication gold standard from the biomedical literature, BMC Bioinformatics 12 (2011) 486.""" SEMMEDDB National Institutes of Health National Institutes of Health 6/1/2019 01/01/1865 12/8/2018 semmedVER40_R
SHERLOCK "ClinicalTrials.gov publicly makes available information about clinical trials and is maintained by the U.S. National Library of Medicine (NLM) and the U.S. National Institutes of Health (NIH). Each trial, however, comes as an individual eXtensible Markup Language (XML) file which is difficult for summarizing information across trials. Instead of using the XMLs we leverage a tool called Sherlock which downloads trial information from ClinicalTrials.gov, and then parses and organizes that data for analysis. For more information on Sherlock: Cepeda, M.S., V. Lobanov, and J.A. Berlin, Use of ClinicalTrials.gov to estimate condition-specific nocebo effects and other factors affecting outcomes of analgesic trials. J Pain, 2013. 14(4): p. 405-11." SHERLOCK Janssen R&D Erica Voss 1/27/2020 6/1/1931 1/23/2020
SPLICER "Adverse drug reactions extracted from the Adverse Reactions or Post Marketing section of United States product labeling. Basd on publication J. Duke, J. Friedlin, X. Li, Consistency in the safety labeling of bioequivalent medications, Pharmacoepidemiol. Drug Saf. 22 (3) (2013) 294?301." SPLICER Georgia Tech Jon Duke 12/8/2019 12/1/1990 12/8/2019

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