Overview of global real-world data sources for pediatric pharmacoepidemiologic research.

Autor: Wharton GT; Office of Pediatric Therapeutics, US Food and Drug Administration, Silver Spring, Maryland, USA., Becker C; Basel Pharmacoepidemiology Unit, Division of Clinical Pharmacy & Epidemiology, Department of Pharmaceutical Sciences, University Basel, Basel, Switzerland., Bennett D; Global Evidence and Outcomes, Safety Pharmacoepidemiology, Takeda Development Center Americas, Inc., Cambridge, Massachusetts, USA.; Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA., Burcu M; Department of Epidemiology, Merck & Co., Inc., Rahway, New Jersey, USA., Bushnell G; Department of Biostatistics and Epidemiology, Rutgers School of Public Health, New Brunswick, NJ, USA; Rutgers Center for Pharmacoepidemiology and Treatment Science, Institute for Health, Health Care Policy and Aging Research, New Brunswick, New Jersey, USA., Ferrajolo C; Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Naples, Italy.; Department of Experimental Medicine, Section of Pharmacology, 'L. Donatelli', University of Campania 'Luigi Vanvitelli', Naples, Italy., Kaplan S; Department Pharmacoepidemiology, Teva Pharmaceutical Industries Ltd, Netanya, Israel., McMahon AW; Office of Pediatric Therapeutics, US Food and Drug Administration, Silver Spring, Maryland, USA., Movva N; EpidStrategies, A Division of ToxStrategies Inc, Rockville, Maryland, USA., Raman SR; Department of Population Health Sciences, Duke University School of Medicine, Durham, North Carolina, USA., Scholle O; Department of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany., Suh M; EpidStrategies, A Division of ToxStrategies Inc, Rockville, Maryland, USA., Sun JW; Safety Surveillance Research, Pfizer Inc., New York, New York, USA., Horton DB; Department of Biostatistics and Epidemiology, Rutgers School of Public Health, New Brunswick, NJ, USA; Rutgers Center for Pharmacoepidemiology and Treatment Science, Institute for Health, Health Care Policy and Aging Research, New Brunswick, New Jersey, USA.; Department of Pediatrics, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA.
Jazyk: angličtina
Zdroj: Pharmacoepidemiology and drug safety [Pharmacoepidemiol Drug Saf] 2024 Jan; Vol. 33 (1), pp. e5695. Date of Electronic Publication: 2023 Sep 10.
DOI: 10.1002/pds.5695
Abstrakt: Purpose: Given limited information available on real-world data (RWD) sources with pediatric populations, this study describes features of globally available RWD sources for pediatric pharmacoepidemiologic research.
Methods: An online questionnaire about pediatric RWD sources and their attributes and capabilities was completed by members and affiliates of the International Society for Pharmacoepidemiology and representatives of nominated databases. All responses were verified by database representatives and summarized.
Results: Of 93 RWD sources identified, 55 unique pediatric RWD sources were verified, including data from Europe (47%), United States (38%), multiregion (7%), Asia-Pacific (5%), and South America (2%). Most databases had nationwide coverage (82%), contained electronic health/medical records (47%) and/or administrative claims data (42%) and were linkable to other databases (65%). Most (71%) had limited outside access (e.g., by approval or through local collaborators); only 10 (18%) databases were publicly available. Six databases (11%) reported having >20 million pediatric observations. Most (91%) included children of all ages (birth until 18th birthday) and contained outpatient medication data (93%), while half (49%) contained inpatient medication data. Many databases captured vaccine information for children (71%), and one-third had regularly updated data on pediatric height (31%) and weight (33%). Other pediatric data attributes captured include diagnoses and comorbidities (89%), lab results (58%), vital signs (55%), devices (55%), imaging results (42%), narrative patient histories (35%), and genetic/biomarker data (22%).
Conclusions: This study provides an overview with key details about diverse databases that allow researchers to identify fit-for-purpose RWD sources suitable for pediatric pharmacoepidemiologic research.
(© 2023 John Wiley & Sons Ltd.)
Databáze: MEDLINE
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