Abstract
We conducted a cohort study of acute, noninfectious liver injury among oral antimicrobial users. Potential cases were identified in the HealthCore Integrated Research Database (HIRDSM) population between July 1, 2001, and March 31, 2009, using ICD-9-CM codes primarily for acute and subacute necrosis of the liver, hepatic coma, and unspecified hepatitis.
Liver test results were used to confirm case status according to published criteria. Two physician reviewers experienced in studying acute liver injury (blinded to study drug exposures) evaluated data abstracted from hospital and emergency department records to validate potential cases. Of 715 potential cases having claims associated with any of the primary screening codes, 312 (44%) were valid cases, 108 (15%) were not cases, and 295 (41%) were of uncertain status (records inadequate for validation). Among potential cases with adequate medical records, the PPV for presence of any of the primary codes was 74% (95% CI, 70%-78%). The highest PPV for a single code was for acute and subacute necrosis of the liver (84%; 95% CI, 77%-90%).
Evaluation of cases of noninfectious liver injury using hospital and emergency department medical records continues to represent the preferred approach in studies using insurance claims data.
Keywords: Antimicrobials, cohort, liver injury, nested case-control, validation.
Current Drug Safety
Title:Validation of Acute Liver Injury Cases in a Population-Based Cohort Study of Oral Antimicrobial Users
Volume: 9 Issue: 1
Author(s): Christine L. Bui, James A. Kaye, Jordi Castellsague, Brian Calingaert, Lisa J. McQuay, Nuria Riera-Guardia, Catherine W. Saltus, Scott C. Quinlan, Crystal N. Holick, Peter M. Wahl, Kiliana Suzart, Kenneth J. Rothman, Mari-Ann Wallander and Susana Perez-Gutthann
Affiliation:
Keywords: Antimicrobials, cohort, liver injury, nested case-control, validation.
Abstract: We conducted a cohort study of acute, noninfectious liver injury among oral antimicrobial users. Potential cases were identified in the HealthCore Integrated Research Database (HIRDSM) population between July 1, 2001, and March 31, 2009, using ICD-9-CM codes primarily for acute and subacute necrosis of the liver, hepatic coma, and unspecified hepatitis.
Liver test results were used to confirm case status according to published criteria. Two physician reviewers experienced in studying acute liver injury (blinded to study drug exposures) evaluated data abstracted from hospital and emergency department records to validate potential cases. Of 715 potential cases having claims associated with any of the primary screening codes, 312 (44%) were valid cases, 108 (15%) were not cases, and 295 (41%) were of uncertain status (records inadequate for validation). Among potential cases with adequate medical records, the PPV for presence of any of the primary codes was 74% (95% CI, 70%-78%). The highest PPV for a single code was for acute and subacute necrosis of the liver (84%; 95% CI, 77%-90%).
Evaluation of cases of noninfectious liver injury using hospital and emergency department medical records continues to represent the preferred approach in studies using insurance claims data.
Export Options
About this article
Cite this article as:
Bui L. Christine, Kaye A. James, Castellsague Jordi, Calingaert Brian, McQuay J. Lisa, Riera-Guardia Nuria, Saltus W. Catherine, Quinlan C. Scott, Holick N. Crystal, Wahl M. Peter, Suzart Kiliana, Rothman J. Kenneth, Wallander Mari-Ann and Perez-Gutthann Susana, Validation of Acute Liver Injury Cases in a Population-Based Cohort Study of Oral Antimicrobial Users, Current Drug Safety 2014; 9 (1) . https://dx.doi.org/10.2174/15748863113086660051
DOI https://dx.doi.org/10.2174/15748863113086660051 |
Print ISSN 1574-8863 |
Publisher Name Bentham Science Publisher |
Online ISSN 2212-3911 |
- Author Guidelines
- Graphical Abstracts
- Fabricating and Stating False Information
- Research Misconduct
- Post Publication Discussions and Corrections
- Publishing Ethics and Rectitude
- Increase Visibility of Your Article
- Archiving Policies
- Peer Review Workflow
- Order Your Article Before Print
- Promote Your Article
- Manuscript Transfer Facility
- Editorial Policies
- Allegations from Whistleblowers
Related Articles
-
Bedtime Hypertension Chronotherapy: Concepts and Patient Outcomes
Current Pharmaceutical Design Endothelin and Subarachnoid Hemorrhage-Induced Cerebral Vasospasm: Pathogenesis and Treatment
Current Medicinal Chemistry Structure, Production and Function of Erythropoietin: Implications for Therapeutical Use in Cardiovascular Disease
Current Medicinal Chemistry Antioxidant Effects of Coumarins Include Direct Radical Scavenging, Metal Chelation and Inhibition of ROS-Producing Enzymes
Current Topics in Medicinal Chemistry Editorial (Thematic Issue: Treating Major Age-Related Diseases in Older and Oldest Old Patients)
Current Pharmaceutical Design Medication Adherence and Associated Factors among Chronic Heart Failure Clients on Follow Up Oromia Region, West Ethiopia
Cardiovascular & Hematological Agents in Medicinal Chemistry Secondary Hypertension: The Ways of Management
Current Vascular Pharmacology The Metabolomic Strategy in Tuberculosis Therapy
Combinatorial Chemistry & High Throughput Screening DNA Microarrays: Tools for the 21st Century
Combinatorial Chemistry & High Throughput Screening Channel-Like Functions of the 18-kDa Translocator Protein (TSPO): Regulation of Apoptosis and Steroidogenesis as Part of the Host-Defense Response
Current Pharmaceutical Design A Validated UPLC Method Used for the Determination of Trandolapril and its Degradation Products as per ICH Guidelines
Current Pharmaceutical Analysis The Woman’s Heart: Insights into New Potential Targeted Therapy
Current Medicinal Chemistry Brain Excitatory/Inhibitory Circuits Cross-Talking with Chromogranin A During Hypertensive and Hibernating States
Current Medicinal Chemistry The Role of Amino Acids in the Modulation of Cardiac Metabolism During Ischemia and Heart Failure
Current Pharmaceutical Design Effects of Physical Exercise on Inflammatory Markers of Atherosclerosis
Current Pharmaceutical Design Cigarette Smoke-Induced Proteostasis Imbalance in Obstructive Lung Diseases
Current Molecular Medicine Thiazolidinediones and Type 2 Diabetes: From Cellular Targets to Cardiovascular Benefit
Current Drug Targets Innovative Strategy in Treating Angina Pectoris with Chinese Patent Medicines by Promoting Blood Circulation and Removing Blood Stasis: Experience from Combination Therapy in Chinese Medicine
Current Vascular Pharmacology A2A Adenosine Receptor and its Modulators: Overview on a Druggable GPCR and on Structure-Activity Relationship Analysis and Binding Requirements of Agonists and Antagonists
Current Pharmaceutical Design Effects of Transport Medium Composition on In vitro Drug Permeation Across Excised Pig Intestinal Tissue
Drug Delivery Letters