ArticleAnnals of translational medicine2021
Surgical clinical trials with non-inferiority design: a cross-sectional bibliometric analysis.
Article in Annals of translational medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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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Authors and funding
8 authors.
Funding
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Abstract
backgroundWide-spread concerns have been raised about possible bias in published surgical non-inferiority trials. Therefore, we performed a comprehensive bibliometric analysis to identify the existence of bias, and provided recommendations for future non-inferiority trials.
methodsDatabases including MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials were systematically searched (last update on 27 April 2020) to include published phase II and phase III non-inferiority surgical trials. We collected general information and parameters associated with trial design. The association between extracted factors and establishment of non-inferiority was then analyzed.
resultsA total of 347 trials were included in this study. Only 13 (3.7%) trials reported the pre-specified non-inferiority margin in registration, and 99 (28.5%) trials justified margin selection in ultimate trial publications. A significant association was found between industry funding and increased odds of achieving non-inferiority [odds ratio (OR): 1.17, 95% confidence interval (CI): 1.06 to 1.30, P=0.001]. Moreover, trials which had been presented in conferences were less likely to claim non-inferiority (OR: 0.83, 95% CI: 0.69 to 0.99, P=0.035).
conclusionsOur study was the first quantitative analysis revealing the presence of biases in findings of existing surgical non-inferiority trials, which could possibly mislead surgeons' clinical decision making. We suggest improving reporting of detailed study design especially funding sources as well as margin justification for future trials. We also encourage conference presentation of ongoing trials prior to the ultimate publication.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.