SynthesisEuropean journal of clinical pharmacology2025
The quantity, reliability, transparency, reporting, and interpretation of pharmacovigilance signal detection studies in pregnancy: a meta-epidemiological study.
Synthesis in European journal of clinical pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Who cites it
1 citing paper in PubMed.
Corrections and comments
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Authors and funding
12 authors.
Funding
Abstract
purposeTo systematically review the characteristics of the available pharmacovigilance signal detection studies in pregnancy, and comprehensively assess the reliability, transparency, reporting, and interpretation of these studies.
methodsWe searched five databases from inception to February 2024 to identify the available pharmacovigilance signal detection studies in pregnancy. We extracted three aspects of information (basic information, data processing modes, signal detection analyses) to assess the reliability, transparency, and reporting of each study. Moreover, we adopted the criteria of Mouffak et al.'s study to assess the misinterpretation of signal detection results in these studies.
resultsA total of 33 pharmacovigilance signal detection studies in pregnancy were identified. Among them, there were great methodological heterogeneities in the data processing modes (restriction to the population, comparator, standardization of drug names and adverse event names, the assigned roles of drugs, counting unit, etc.) and signal detection analyses (signal detection method, sensitivity analysis, subgroup analysis, adjustment for confounding factors, etc.). Moreover, 13 (39%) studies had at least one type of inappropriate interpretation and/or extrapolation of signal detection results.
conclusionOur results reveals that the quantity of pharmacovigilance signal detection studies in pregnancy is relatively limited. Furthermore, the reliability, transparency, reporting, and interpretation of the existing studies are less optimistic. The main issues existing in the available pharmacovigilance signal detection studies in pregnancy consist of two aspects: (1) great methodological heterogeneities exist in the data processing modes and signal detection analyses among different studies and (2) inappropriate interpretation and extrapolation of signal detection results are frequent.
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Registered trials
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