Validity of ICD-10-CM diagnoses to identify hospitalizations for serious infections among patients treated with biologic therapies
Published in Pharmacoepidemiology and Drug Safety, July 1, 2021 | Online publication on April 22, 2021
Authors:
Vincent Lo Re 3rd, Dena M Carbonari, Jerry Jacob, William R Short, Charles E Leonard, Jennifer G Lyons, Adee Kennedy, Jolene Damon, Nicole Haug, Esther H Zhou, David J Graham, Cheryl McMahill-Walraven
, Lauren E Parlett, Vinit Nair, Mano Selvan, Yunping Zhou, Gaia Pocobelli, Judith C Maro, Michael D Nguyen
DOI: 10.1002/pds.5253 | Pubmed ID: 33885214
Abstract
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.
Keywords: ICD-10-CM; infection; pharmacoepidemiology; validation.
© 2021 John Wiley & Sons Ltd.
Tags
Analytic: case algorithm validation
Data Source: No tags set.
Research Focus: No tags set.
Study Design: medical record review
Funding Transparency
This work was possible through:
- Contract
Additional details:
- Platt - FDA - HHSF223201400030I : Sentinel 2014
Conflict of interest statement at time of publication:
This activity was funded by the United States Food and Drug Administration. The project's sponsors approved the protocol and had the right to provide non-binding comments on this manuscript, but were excluded from all analyses. C.E.L. is an Executive Committee Member of the University of Pennsylvania's Center for Pharmacoepidemiology Research and Training. The Center receives funds from Pfizer and Sanofi to support pharmacoepidemiology education. C.E.L. recently received honoraria from the American College of Clinical Pharmacy Research Institute and the University of Florida College of Pharmacy. G.P. received funding from research grants awarded to the Kaiser Permanente Washington Health Research Institute from Jazz Pharmaceuticals and Amgen. C.N.M.W. is employed by Aetna, a CVS Health company. Aetna receives funding for public health and distributed research projects as a subcontractor from Harvard Pilgrim Health Care Institute for FDA Sentinel, Managed Care Pharmacy's Biologics and Biosimilars Collective Intelligence Collaborative, Pfizer, and GlaxoSmithKline and as a contractor from the Patient-Centered Outcomes Research Institute, Reagan-Udall's Foundation Innovation in Medical Evidence Development and Surveillance, and Pfizer. S.D., E.Z., D.J.G., and M.D.N are employees of the Food and Drug Administration. All other authors report no other relevant potential conflicts of interest related to this manuscript.
Entry last updated (DMY): 14-12-2024.