ArticlePloS one2021
Reporting of statistical sample size calculations in publications of trials on age-related macular degeneration, glaucoma and cataract.
Article in PloS one, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed, 7 citations in OpenAlex.
- Review
- A descriptive study of samples sizes used in agreement studies published in the PubMed repository.BMC medical research methodology · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTransparent and complete publications of randomised controlled trials (RCT) ought to comply with the guidelines of the CONSORT Statement, which stipulates sample size calculation as an important aspect of trial planning. The objective of this study was to analyse and compare the reporting of statistical sample size calculations in RCT papers on the treatment of age-related macular degeneration (AMD), glaucoma and cataract published in 2018. MATERIAL AND
methodsThis study comprises a total of 113 RCT papers (RCT-P) published in 2018 (AMD: 14, glaucoma: 28, cataract: 71), in English or German, and identified through an internet-based literature search in PubMed and EMBASE. The primary outcome measure of the study was the number of trials providing a complete description of the underlying sample case calculation on the basis of the variables required (significance level, expected outcomes, power, and resulting sample size).
resultsOf the RCTs reviewed, 64% (AMD), 61% (glaucoma) and 31% (cataract) provided a justification of the number of patients included. A complete description of the described studies' sample size calculation including all the necessary values (primary outcome measure of this study) was described by 21% of the AMD, 29% of the cataract and 18% of the glaucoma RCT publications (in total: 24 of 113 (21%) at a confidence interval of 95%: [13%; 29%]).
conclusionAll three treatment areas analysed lacked reporting quality regarding the justification of the number of patients included in a clinical trial based on a sample size calculation required for ethical reasons. More than half of all RCT publications reviewed did not provide all of the required information on statistical sample size calculation, and thus lacked transparency and completeness. It is therefore urgently required to involve methodologists in a study's planning and publishing processes to ensure that methodology descriptions are transparent and of high quality.
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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.