ArticleDrug safety2017
Diverging Conclusions from the Same Meta-Analysis in Drug Safety: Source of Data (Primary Versus Secondary) Takes a Toll.
Article in Drug safety, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.
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
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
4 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Prevalence of systemic antibacterial use during pregnancy worldwide: A systematic review.PloS one · 2024Pooled it
- Bias in pharmacoepidemiologic studies using secondary health care databases: a scoping review.BMC medical research methodology · 2019Article
- Primary versus secondary source of data in observational studies and heterogeneity in meta-analyses of drug effects: a survey of major medical journals.BMC medical research methodology · 2018Article
- Summarising the Evidence for Drug Safety: A Methodological Discussion of Different Meta-Analysis Approaches.Drug safety · 2017Article
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionMeta-analyses of observational studies represent an important tool for assessing efficacy and safety in the pharmacoepidemiologic field. The data from the individual studies are either primary (i.e., collected through interviews or self-administered questionnaires) or secondary (i.e., collected from databases that were established for other purposes). So far, the origin of the data (primary vs. secondary) has not been systematically assessed as a source of heterogeneity in pharmacoepidemiologic meta-analyses.
objectiveThe aim was to assess the impact of considering the source of exposure data as a criterion in sensitivity and subgroup analysis on the conclusions of drug safety meta-analyses.
methodsWe selected meta-analyses published between 2013 and 2015 in which the intake of frequently used over-the-counter medicines was either the main exposure or a concomitant treatment and the outcome had short latency and induction periods. We stratified the results by origin of data (primary vs. secondary) and compared the new results to those presented originally in the meta-analyses.
resultsWe used four meta-analyses that fulfilled our criteria of inclusion. The results were selective serotonin reuptake inhibitors and upper gastrointestinal bleeding: original estimate odds ratio (OR) = 1.71 [95% confidence interval (CI) 1.44-2.04], OR primary data = 1.19 (95% CI 0.90-1.58), OR secondary data = 1.81 (95% CI 1.50-2.17); proton pump inhibitors and cardiac events: original estimate hazard ratio (HR) = 1.35 (95% CI 1.18-1.54), HR primary data = 1.05 (95% CI 0.87-1.26), HR secondary data = 1.43 (95% CI 1.23-1.66); non-aspirin non-steroidal anti-inflammatory drugs and myocardial infarction: original estimate risk ratio (RR) = 1.08 (95% CI 0.95-1.22), RR primary data = 0.57 (95% CI 0.34-0.96), RR secondary data = 1.15 (95% CI 1.03-1.28); paracetamol during pregnancy and childhood asthma: original estimate OR = 1.32 (95% CI 1.14-1.52), OR primary data = 1.23 (95% CI 1.06-1.42), OR secondary data = 1.53 (95% CI 1.33-1.75).
conclusionsThe results after stratification are considerably modified. It is crucial to explore the origin of the data, either primary or secondary, as a source of heterogeneity in pharmacoepidemiologic meta-analyses to avoid misleading conclusions.
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