Chart validation of inpatient ICD-9-CM administrative diagnosis codes for acute myocardial infarction (AMI) among intravenous immune globulin (IGIV) users in the Sentinel Distributed Database

Eric M Ammann; Marin L Schweizer; Jennifer G Robinson; Jayasheel O Eschol; Rami Kafa; Saket Girotra; Scott K Winiecki; Candace C Fuller; Ryan M Carnahan; Charles E Leonard; Cole Haskins; Crystal Garcia; Elizabeth A Chrischilles

doi:10.1002/pds.4398

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Chart validation of inpatient ICD-9-CM administrative diagnosis codes for acute myocardial infarction (AMI) among intravenous immune globulin (IGIV) users in the Sentinel Distributed Database

Journal article

Peer reviewed

Chart validation of inpatient ICD-9-CM administrative diagnosis codes for acute myocardial infarction (AMI) among intravenous immune globulin (IGIV) users in the Sentinel Distributed Database

Eric M Ammann, Marin L Schweizer, Jennifer G Robinson, Jayasheel O Eschol, Rami Kafa, Saket Girotra, Scott K Winiecki, Candace C Fuller, Ryan M Carnahan, Charles E Leonard, …

Pharmacoepidemiology and drug safety, Vol.27(4), pp.398-404

04/2018

DOI: 10.1002/pds.4398

PMCID: PMC6410350

PMID: 29446185

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Abstract

The Sentinel Distributed Database (SDD) is a large database of patient-level administrative health care records, primarily derived from insurance claims and electronic health records, and is sponsored by the US Food and Drug Administration for medical product safety evaluations. Acute myocardial infarction (AMI) is a common study endpoint for drug safety studies that rely on health records from the SDD and other administrative databases. In this chart validation study, we report on the positive predictive value (PPV) of inpatient International Classification of Diseases, Ninth Revision, Clinical Modification AMI administrative diagnosis codes (410.x1 and 410.x0) in the SDD. As part of an assessment of thromboembolic adverse event risk following treatment with intravenous immune globulin, charts were obtained for 103 potential post-intravenous immune globulin AMI cases. Charts were abstracted by trained nurses and physician-adjudicated based on prespecified diagnostic criteria. Acute myocardial infarction status could be determined for 89 potential cases. The PPVs for the inpatient AMI diagnoses recorded in the SDD were 75% overall (95% CI, 65-84%), 93% (95% CI, 78-99%) for principal-position diagnoses, 88% (95% CI, 72-97%) for secondary diagnoses, and 38% (95% CI, 20-59%) for position-unspecified diagnoses (eg, diagnoses originating from separate physician claims associated with an inpatient stay). Of the confirmed AMI cases, demand ischemia was the suspected etiology more often for those coded in secondary or unspecified positions (72% and 40%, respectively) than for principal-position AMI diagnoses (21%). The PPVs for principal and secondary AMI diagnoses were high and similar to estimates from prior chart validation studies. Position-unspecified diagnosis codes were less likely to represent true AMI cases.

Predictive Value of Tests

Myocardial Infarction - epidemiology

Thromboembolism - chemically induced

Humans

Middle Aged

Immunoglobulins, Intravenous - adverse effects

Child, Preschool

Hospitalization - statistics & numerical data

Infant

Male

Thromboembolism - epidemiology

Young Adult

Myocardial Infarction - therapy

Aged, 80 and over

Adult

Female

Product Surveillance, Postmarketing - methods

Child

Myocardial Infarction - etiology

Autoimmune Diseases - drug therapy

Infant, Newborn

Myocardial Infarction - diagnosis

International Classification of Diseases

Clinical Coding - statistics & numerical data

Databases, Factual - statistics & numerical data

Pharmacovigilance

Electronic Health Records - statistics & numerical data

Administrative Claims, Healthcare - statistics & numerical data

Adolescent

Thromboembolism - complications

Aged

Details

Title: Subtitle: Chart validation of inpatient ICD-9-CM administrative diagnosis codes for acute myocardial infarction (AMI) among intravenous immune globulin (IGIV) users in the Sentinel Distributed Database
Creators: Eric M Ammann - College of Public Health, University of Iowa, Iowa City, IA, USA
Marin L Schweizer - University of Iowa Hospitals and Clinics, Iowa City, IA, USA
Jennifer G Robinson - Carver College of Medicine, University of Iowa, Iowa City, IA, USA
Jayasheel O Eschol - University of Iowa Hospitals and Clinics, Iowa City, IA, USA
Rami Kafa - University of Iowa Hospitals and Clinics, Iowa City, IA, USA
Saket Girotra - Carver College of Medicine, University of Iowa, Iowa City, IA, USA
Scott K Winiecki - Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA
Candace C Fuller - Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA
Ryan M Carnahan - College of Public Health, University of Iowa, Iowa City, IA, USA
Charles E Leonard - Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA
Cole Haskins - Medical Scientist Training Program, University of Iowa, Iowa City, IA, USA
Crystal Garcia - Harvard Medical School
Elizabeth A Chrischilles - College of Public Health, University of Iowa, Iowa City, IA, USA
Resource Type: Journal article
Publication Details: Pharmacoepidemiology and drug safety, Vol.27(4), pp.398-404
DOI: 10.1002/pds.4398
PMID: 29446185
PMCID: PMC6410350
NLM abbreviation: Pharmacoepidemiol Drug Saf
ISSN: 1099-1557
eISSN: 1099-1557
Publisher: England
Grant note: T32 GM007337 / NIGMS NIH HHS HHSF223200910006I / FDA HHS U54 TR001356 / NCATS NIH HHS
Language: English
Date published: 04/2018
Academic Unit: Pharmacy; Epidemiology; Cardiovascular Medicine; Injury Prevention Research Center; General Internal Medicine; Internal Medicine
Record Identifier: 9983995058302771

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