SynthesisPharmacoepidemiology and drug safety2020
Quality of reporting of drug exposure in pharmacoepidemiological studies.
Synthesis in Pharmacoepidemiology and drug safety, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
6 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Quality of reporting of drug exposure in pharmacoepidemiological studies.Pharmacoepidemiology and drug safety · 2020Pooled it
- Drug exposure definitions reported in real-world evidence studies on oncology medicines in patients with colorectal cancer: a scoping review.ESMO real world data and digital oncology · 2026Review
- Pharmacoepidemiology unpacked: a roadmap for junior researchers.Frontiers in pharmacology · 2026Review
- Estimation of the Duration of Antihypertensive Prescriptions: Validation of a Data-Driven Approach Using Rotterdam Study Data.Pharmacoepidemiology and drug safety · 2025Article
- A data-informed approach using individualised dispensing patterns to estimate medicine exposure periods and dose from pharmaceutical claims data.Pharmacoepidemiology and drug safety · 2023Article
- New-user and prevalent-user designs and the definition of study time origin in pharmacoepidemiology: A review of reporting practices.Pharmacoepidemiology and drug safety · 2021Review
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeExposure definitions vary across pharmacoepidemiological studies. Therefore, transparent reporting of exposure definitions is important for interpretation of published study results. We aimed to assess the quality of reporting of exposure to identify where improvement may be needed.
methodWe systematically reviewed observational pharmacoepidemiological studies that used routinely collected health data, published in 2017 in six pharmacoepidemiological journals. Reporting of exposure was scored using 11 items of the ISPE-ISPOR guideline on reporting of pharmacoepidemiological studies.
resultsOf the 91 studies included, all studies reported the type of exposure (100%), while most reported the exposure risk window (85%) and the exposure assessment window (98%). Operationalization of the exposure window was described infrequently: 16% (14/90) of the studies explicitly reported the presence or absence of an induction period if applicable, 11% (5/47), and 35% (17/49) reported how stockpiling and gaps between exposure episodes were handled, respectively, and 35% (17/49) explicitly mentioned the exposure extension. Switching/add-on was reported in 62% (50/81). How switching between drugs was dealt with and specific drug codes were reported in 52 (57%) and 24 (26%) studies, respectively.
conclusionPublications of pharmacoepidemiological studies frequently reported the type of exposure, the exposure risk window, and the exposure assessment window. However, more details on exposure assessment are needed, especially when it concerns the operationalization of the exposure risk window (eg, the presence or absence of an induction period or exposure extension, handling of stockpiling and gaps, and specific codes), to allow for correct interpretation, reproducibility, and assessment of validity.
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