Sample size calculations for randomized clinical trials published in anesthesiology journals: a comparison of 2010 versus 2016

Chow, Jeffrey; Turkstra, Timothy P.; Yim, Edmund; Jones, Philip M.

doi:10.1007/s12630-018-1109-z

Cited by 14 publications

(17 citation statements)

References 20 publications

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“…Literature, however, demonstrates that this tendency is by far not AMD specific. The findings of this investigation are in line with the results of other studies that have examined the quality and accuracy of the descriptions of sample size calculations in publications 4–9. One study analysed sample size calculations in publications, which had appeared in six high impact between 2005 and 2006: a total of 95% of all publications analysed in this study provided information on the calculation of the sample size, whereas of these, 43% did not report all necessary information 4.…”

Section: Discussionsupporting

confidence: 85%

“…In other reviews, 78% (66% complete)6 and 91.7% (80.3% complete)7 of anaesthesia publications reported sample size calculations. In RCT publications from the field of dentistry and orthodontics, descriptions of sample size calculations were found in only 29.3%8 and 29.5%,9 respectively.…”

Section: Discussionmentioning

confidence: 99%

“…Despite the availability of both RCT reporting standards for longer than two decades, several investigations4–9 identified clinical trials which either do not provide any information on sample size calculation or incorrect sample sizes in their publication. Bearing these findings in mind, the aim of this study was to examine whether publications of RCTs on age-related macular degeneration (AMD) treatment reported complete and correct sample size calculations: It is expected that RCTs on invasive and drug therapies for severe diseases will be monitored with the highest standard of care.…”

Section: Introductionmentioning

confidence: 99%

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Validity of sample sizes in publications of randomised controlled trials on the treatment of age-related macular degeneration: cross-sectional evaluation

et al. 2019

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ObjectiveThe aim of this cross-sectional study was to examine the completeness and accuracy of the reporting of sample size calculations in randomised controlled trial (RCT) publications on the treatment of age-related macular degeneration (AMD).MethodsA sample of 97 RCTs published between 2004 and 2014 was reviewed for the calculation of their sample size. It was examined whether a (complete) description of the sample size calculation was presented. Furthermore, the sample size was recalculated, whenever possible based on the published details, in order to verify the reported number of patients.Primary outcome measureThe primary endpoint of this cross-sectional investigation was a described sample size calculation that was reproducible, complete and correct (maximum tolerated deviation between reported and replicated sample size ±2 participants per trial arm).ResultsA total of 50 publications (52%) did not provide any information on the justification of the number of patients included. Only 17 publications (18%) provided all the necessary parameters for recalculation; 8 of 97 (8%, 95%-CI: 4% to 16%) publications achieved the primary endpoint. The median relative deviation between reported and recalculated sample sizes was 1%, with a range from −43% to +66%.ConclusionAlthough a transparent sample size legitimation is a crucial determinant of an RCT’s methodological validity, more than half of the RCT publications considered failed to report them. Furthermore, reported sample size legitimations were often incomplete or incorrect. In summary, clinical authors should pay more attention to the transparent reporting of sample size calculation, and clinical journal reviewers may opt to reproduce reported sample size calculations.SynopsisMore than half of the analysed RCT publications on the treatment of AMD did not report a transparent sample size calculation. Only 8% reported a complete and correct sample size calculation.

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Section: Discussionsupporting

confidence: 85%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Validity of sample sizes in publications of randomised controlled trials on the treatment of age-related macular degeneration: cross-sectional evaluation

et al. 2019

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“…In the current issue of the Journal, Chow et al 1 report the results of a survey of the quality of sample size calculations for two-arm, parallel group, superiority, randomized clinical trials (RCTs) published in six high-impact-factor anesthesiology journals. Trials reporting continuous or binary outcomes published in 2010 and 2016 were included.…”

mentioning

confidence: 99%

“…Dans ce numéro du Journal, Chow et coll. 1 Ces constatations correspondent également à ce qu'on devrait attendre pour des ECR. Au moment du calcul de la taille de l'échantillon, les chercheurs sont habituellement incertains quant à l'ampleur attendue de l'effet thérapeutique.…”

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