TY - JOUR

T1 - Epidemiological surveillance of drug safety using cumulative sequential analysis in electronic healthcare data

AU - Aakjær, Mia

AU - De Bruin, Marie Louise

AU - Andersen, Morten

N1 - Publisher Copyright: © 2023 The Authors. Basic & Clinical Pharmacology & Toxicology published by John Wiley & Sons Ltd on behalf of Nordic Association for the Publication of BCPT (former Nordic Pharmacological Society).

PY - 2024

Y1 - 2024

N2 - Background: Methods for safety signal detection in electronic healthcare data analysing data sequentially are being developed to meet the limitations of spontaneous reporting systems. Objectives: This study aims to provide an overview of the literature on sequential analysis of electronic healthcare data and describe the development and testing of a novel epidemiological surveillance system. Methods: We searched Medline, Embase, PubMed, Scopus, Web of Science, and the Cochrane Library applying similar in- and exclusion criteria as those of a previous systematic review. The proposed system consisted of repeated cohort studies and was tested in an emulated prospective setting. Two signal evaluations were performed with several sensitivity analyses and a target trial emulation. Findings: In the literature, 11 studies analysed the data sequentially of which two applied traditional epidemiological methods. Epidemiological surveillance of several exposures and outcomes can be successfully conducted with the newly proposed sequential analysis of electronic healthcare data. Signal evaluation studies confirmed the results of the system. Conclusions: Very few studies in the literature analysed data at multiple time points, although this seems to be a prerequisite for testing the methods in a realistic setting. We demonstrated the feasibility of a sequential surveillance system using electronic healthcare data.

AB - Background: Methods for safety signal detection in electronic healthcare data analysing data sequentially are being developed to meet the limitations of spontaneous reporting systems. Objectives: This study aims to provide an overview of the literature on sequential analysis of electronic healthcare data and describe the development and testing of a novel epidemiological surveillance system. Methods: We searched Medline, Embase, PubMed, Scopus, Web of Science, and the Cochrane Library applying similar in- and exclusion criteria as those of a previous systematic review. The proposed system consisted of repeated cohort studies and was tested in an emulated prospective setting. Two signal evaluations were performed with several sensitivity analyses and a target trial emulation. Findings: In the literature, 11 studies analysed the data sequentially of which two applied traditional epidemiological methods. Epidemiological surveillance of several exposures and outcomes can be successfully conducted with the newly proposed sequential analysis of electronic healthcare data. Signal evaluation studies confirmed the results of the system. Conclusions: Very few studies in the literature analysed data at multiple time points, although this seems to be a prerequisite for testing the methods in a realistic setting. We demonstrated the feasibility of a sequential surveillance system using electronic healthcare data.

KW - adverse drug reactions

KW - pharmacoepidemiology

KW - pharmacovigilance

KW - postmarketing surveillance

U2 - 10.1111/bcpt.13955

DO - 10.1111/bcpt.13955

M3 - Review

C2 - 37897140

AN - SCOPUS:85176446153

VL - 134

SP - 129

EP - 140

JO - Basic and Clinical Pharmacology and Toxicology

JF - Basic and Clinical Pharmacology and Toxicology

SN - 1742-7835

IS - 1

ER -