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
-
Pharmacological Approaches in an Experimental Model of Non-Small Cell Lung Cancer: Effects on Tumor Biology
Current Pharmaceutical Design Impact of Exercise Training on Physiological Measures of Physical Fitness in the Elderly
Current Aging Science Selection of Antithrombotic Therapy in Patients with Atrial Fibrillation and Percutaneous Coronary Intervention
Current Pharmaceutical Design Soluble Forms of RAGE in Human Diseases: Clinical and Therapeutical Implications
Current Medicinal Chemistry Nanotechnology Platforms; An Innovative Approach to Brain Tumor Therapy
Medicinal Chemistry HHT in Childhood: Screening for Special Patients
Current Pharmaceutical Design Clinical Studies with Sirolimus, Zotarolimus, Everolimus and Biolimus A9 Drug- Eluting Stent Systems
Current Pharmaceutical Design Management of Massive Obstetric Haemorrhage
Current Women`s Health Reviews New Look at Therapeutic Strategies for Blocking Costimulatory Signal in Experimental and Pre-Clinical Transplantation
Current Drug Safety Association of Common Variants in the IL-33/ST2 Axis with Ischemic Stroke
Current Neurovascular Research Effects of Nucleotides and Nucleotide Analogue Inhibitors of HIV-1 Reverse Transcriptase in a Ratchet Model of Polymerase Translocation
Current Pharmaceutical Design Heart Failure Epidemiology: European Perspective
Current Cardiology Reviews Dexmedetomidine Use in General Anaesthesia
Current Drug Targets Treatment of Hypertensive Left Ventricular Hypertrophy
Current Pharmaceutical Design Effects of Oral L-Citrulline Supplementation on Lipoprotein Oxidation and Endothelial Dysfunction in Humans with Vasospastic Angina
Immunology, Endocrine & Metabolic Agents in Medicinal Chemistry (Discontinued) Asymmetric Dimethylarginine (ADMA): A Promising Biomarker for Cardiovascular Disease?
Current Topics in Medicinal Chemistry Sleep Apnea and Coronary Heart Disease: From Dusk Till Dawn and Further
Current Respiratory Medicine Reviews Marine Natural Products as a Promising Source of Therapeutic Compounds to Target Cancer Stem Cells
Current Medicinal Chemistry Blockade of Ser16-Hsp20 Phosphorylation Attenuates Neuroprotection Dependent Upon Bcl-2 and Bax
Current Neurovascular Research Natural Polyphenols and Cardioprotection
Mini-Reviews in Medicinal Chemistry