Quality of Sample Size Estimation in Trials of Medical Devices: High-Risk Devices for Neurological Conditions as Example

Olberg, Britta; Perleth, Matthias; Felgentraeger, Katja; Schulz, Sandra; Busse, Reinhard

doi:10.1017/s0266462317000265

Cited by 2 publications

(1 citation statement)

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“…In addition, it could be shown that there were also discrepancies between sample sizes in publications and protocols 14. Another study documented that only 31 out of 71 studies (protocol/publication) provided information on how the sample size was calculated (26 complete descriptions) 15…”

Section: Discussionmentioning

confidence: 99%

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: Discussionmentioning

confidence: 99%