ArticleJournal of the American College of Surgeons2013
Are surgical trials with negative results being interpreted correctly?
Article in Journal of the American College of Surgeons, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pooled it
- Big Data vs. Clinical Trials in HPB Surgery.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2020Review
- Biopsy vs. extensive resection for first recurrence of glioblastoma: is a prospective clinical trial warranted?BMC research notes · 2015Article
Corrections and comments
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Authors and funding
6 authors.
Funding
Abstract
backgroundMany published accounts of clinical trials report no differences between the treatment arms, while being underpowered to find differences. This study determined how the authors of these reports interpreted their findings. STUDY
designWe examined 54 reports of surgical trials chosen randomly from a database of 110 influential trials conducted in 2008. Seven that reported having adequate statistical power (β ≥ 0.9) were excluded from further analysis, as were the 32 that reported significant differences between the treatment arms. We examined the remaining 15 to see whether the authors interpreted their negative findings appropriately. Appropriate interpretations discussed the lack of power and/or called for larger studies.
resultsThree of the 7 trials that did not report an a priori power calculation offered inappropriate interpretations, as did 3 of the 8 trials that reported an a priori power < 0.90. However, we examined only a modest number of trial reports from 1 year.
conclusionsNegative findings in underpowered trials were often interpreted as showing the equivalence of the treatment arms with no discussion of the issue of being underpowered. This may lead clinicians to accept new treatments that have not been validated.
Indexed as
Identifiers
What OpenQuestion holds
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.