Validity of ICD‐10‐CM diagnoses to identify hospitalizations for serious infections among patients treated with biologic therapies
| Autor: | Dena M. Carbonari, Judith C. Maro, Adee Kennedy, Jolene Damon, Gaia Pocobelli, Vincent Lo Re, Lauren E. Parlett, Michael D. Nguyen, Charles E. Leonard, David J. Graham, Jerry Jacob, Vinit P. Nair, Esther H. Zhou, Jennifer G. Lyons, Mano S. Selvan, Yunping Zhou, Nicole Haug, William R. Short, Cheryl N. McMahill-Walraven |
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| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Databases Factual Epidemiology 030226 pharmacology & pharmacy Inflammatory bowel disease 03 medical and health sciences 0302 clinical medicine International Classification of Diseases Internal medicine Humans Medicine Pharmacology (medical) 030212 general & internal medicine Medical diagnosis Infectious disease (athletes) business.industry Pharmacoepidemiology Medical record ICD-10 Emergency department medicine.disease Confidence interval Biological Therapy Hospitalization business |
| Zdroj: | Pharmacoepidemiology and Drug Safety. 30:899-909 |
| ISSN: | 1099-1557 1053-8569 |
| DOI: | 10.1002/pds.5253 |
| Popis: | Purpose Identifying hospitalizations for serious infections among patients dispensed biologic therapies within healthcare databases is important for post-marketing surveillance of these drugs. We determined the positive predictive value (PPV) of an ICD-10-CM-based diagnostic coding algorithm to identify hospitalization for serious infection among patients dispensed biologic therapy within the FDA's Sentinel Distributed Database. Methods We identified health plan members who met the following algorithm criteria: (1) hospital ICD-10-CM discharge diagnosis of serious infection between July 1, 2016 and August 31, 2018; (2) either outpatient/emergency department infection diagnosis or outpatient antimicrobial treatment within 7 days prior to hospitalization; (3) inflammatory bowel disease, psoriasis, or rheumatological diagnosis within 1 year prior to hospitalization, and (4) were dispensed outpatient biologic therapy within 90 days prior to admission. Medical records were reviewed by infectious disease clinicians to adjudicate hospitalizations for serious infection. The PPV (95% confidence interval [CI]) for confirmed events was determined after further weighting by the prevalence of the type of serious infection in the database. Results Among 223 selected health plan members who met the algorithm, 209 (93.7% [95% CI, 90.1%-96.9%]) were confirmed to have a hospitalization for serious infection. After weighting by the prevalence of the type of serious infection, the PPV of the ICD-10-CM algorithm identifying a hospitalization for serious infection was 80.2% (95% CI, 75.3%-84.7%). Conclusions The ICD-10-CM-based algorithm for hospitalization for serious infection among patients dispensed biologic therapies within the Sentinel Distributed Database had 80% PPV for confirmed events and could be considered for use within pharmacoepidemiologic studies. |
| Databáze: | OpenAIRE |
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