MedDRA® automated term groupings using OntoADR: evaluation with upper gastrointestinal bleedings

ABSTRACT Objective: To propose a method to build customized sets of MedDRA terms for the description of a medical condition. We illustrate this method with upper gastrointestinal bleedings (UGIB). Research design and methods: We created a broad list of MedDRA terms related to UGIB and defined a gold standard with the help of experts. MedDRA terms were formally described in a semantic resource named OntoADR. We report the use of two semantic queries that automatically select candidate terms for UGIB. Query 1 is a combination of two SNOMED CT concepts describing both morphology ‘Hemorrhage’ and finding site ‘Upper digestive tract structure’. Query 2 complements Query 1 by taking into account MedDRA terms associated to SNOMED CT concepts describing clinical manifestations ‘Melena’ or ‘Hematemesis’. Results: We compared terms in queries and our gold standard achieving a recall of 71.0% and a precision of 81.4% for query 1 (F1 score 0.76); and a recall of 96.7% and a precision of 77.0% for query 2 (F1 score 0.86). Conclusions: Our results demonstrate the feasibility of applying knowledge engineering techniques for building customized sets of MedDRA terms. Additional work is necessary to improve precision and recall, and confirm the interest of the proposed strategy.

[1]  B. Stricker,et al.  Spironolactone and risk of upper gastrointestinal events: population based case-control study , 2006, BMJ : British Medical Journal.

[2]  F. D. de Abajo,et al.  Pharmacoepidemiology and Prescription , 2022 .

[3]  M. E. Leerdam Epidemiology of acute upper gastrointestinal bleeding. , 2008 .

[4]  A. Pariente,et al.  Performance of the Standardised MedDRA® Queries for Case Retrieval in the French Spontaneous Reporting Database , 2014, Drug Safety.

[6]  Samy Suissa,et al.  Drug–drug interactions between antithrombotic medications and the risk of gastrointestinal bleeding , 2007, Canadian Medical Association Journal.

[7]  Marie-Christine Jaulent,et al.  Computational Approaches for Pharmacovigilance Signal Detection: Toward Integrated and Semantically-Enriched Frameworks , 2015, Drug Safety.

[8]  B. Levin,et al.  Screening and surveillance for the early detection of colorectal cancer and adenomatous polyps, 2008: a joint guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology. , 2008, Gastroenterology.

[9]  Marie-Christine Jaulent,et al.  Automatic Generation of MedDRA terms Groupings using an Ontology , 2012, MIE.

[10]  I. Ralph Edwards,et al.  Principles of Signal Detection in Pharmacovigilance , 1997, Drug safety.

[11]  Marius Fieschi,et al.  A Semantic Approach for the Homogeneous Identification of Events in Eight Patient Databases: A Contribution to the European eu-ADR Project , 2009, MIE.

[12]  R. Hunt,et al.  International Consensus Recommendations on the Management of Patients With Nonvariceal Upper Gastrointestinal Bleeding , 2010, Annals of Internal Medicine.

[13]  David Madigan,et al.  Influence of the MedDRA® hierarchy on pharmacovigilance data mining results , 2009, Int. J. Medical Informatics.

[14]  Alan Ruttenberg,et al.  The Logic of Surveillance Guidelines: An Analysis of Vaccine Adverse Event Reports from an Ontological Perspective , 2014, PloS one.

[15]  J. Tijssen,et al.  Acute upper GI bleeding: did anything change? Time trend analysis of incidence and outcome of acute upper GI bleeding between 1993/1994 and 2000. , 2003, The American journal of gastroenterology.

[16]  P. Mozzicato MedDRA , 2020, Pharmaceutical Medicine.

[17]  Marie-Christine Jaulent,et al.  Formalizing MedDRA to support semantic reasoning on adverse drug reaction terms , 2014, J. Biomed. Informatics.

[18]  Cui Tao,et al.  OAE: The Ontology of Adverse Events , 2014, J. Biomed. Semant..

[19]  H. Sørensen,et al.  COX‐2‐selective inhibitors and the risk of upper gastrointestinal bleeding in high‐risk patients with previous gastrointestinal diseases: a population‐based case–control study , 2004, Alimentary pharmacology & therapeutics.

[20]  M. Cappell,et al.  Initial management of acute upper gastrointestinal bleeding: from initial evaluation up to gastrointestinal endoscopy. , 2008, The Medical clinics of North America.

[21]  L. G. García Rodríguez,et al.  Variability among nonsteroidal antiinflammatory drugs in risk of upper gastrointestinal bleeding. , 2010, Arthritis and rheumatism.

[22]  Patrice Degoulet,et al.  Building an ontology of adverse drug reactions for automated signal generation in pharmacovigilance , 2006, Comput. Biol. Medicine.

[23]  A. Pariente,et al.  Data mining on electronic health record databases for signal detection in pharmacovigilance: which events to monitor? , 2009, Pharmacoepidemiology and drug safety.

[24]  A. Pariente,et al.  Cardiovascular and Gastrointestinal Safety of NSAIDs: A Systematic Review of Meta‐Analyses of Randomized Clinical Trials , 2011, Clinical pharmacology and therapeutics.

[25]  A. Venot,et al.  Appraisal of the MedDRA Conceptual Structure for Describing and Grouping Adverse Drug Reactions , 2005, Drug safety.

[26]  R Menguy,et al.  Diagnosis and management of upper gastrointestinal bleeding. , 1976, Southern medical journal.

[27]  F. D. de Abajo,et al.  Antidepressants and risk of upper gastrointestinal bleeding. , 2006, Basic & clinical pharmacology & toxicology.

[28]  S. Hernández-Díaz,et al.  Steroids and risk of upper gastrointestinal complications. , 2001, American journal of epidemiology.

[29]  J. Lei,et al.  Risk of upper gastrointestinal bleeding from different drug combinations. , 2014, Gastroenterology.

[30]  Marie-Christine Jaulent,et al.  Evaluation of automated term groupings for detecting anaphylactic shock signals for drugs , 2012, AMIA.

[31]  Taxiarchis Botsis,et al.  Application of Information Retrieval Approaches to Case Classification in the Vaccine Adverse Event Reporting System , 2013, Drug Safety.

[32]  P. Maisonneuve,et al.  Screening and surveillance for the early detection of colorectal cancer and adenomatous polyps. , 2008, Gastroenterology.

[33]  Marie-Christine Jaulent,et al.  Ci4SeR - Curation Interface for Semantic Resources - Evaluation with Adverse Drug Reactions , 2014, MIE.