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- Chloe Jacklin, Jeremy N Rodrigues, Joanna Collins, Jonathan Cook, and Conrad J Harrison.
- Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
- Br J Surg. 2022 Feb 1; 109 (2): 178-181.
AbstractSample size calculations from high-profile surgical RCTs that used a patient-reported outcome measure as primary outcome were reviewed systematically against Difference ELicitation in TriAls (DELTA2) standards, with a focus on target differences. In this sample of trials, there was frequent use of suboptimal methods to determine the target difference, and sample size calculations were generally not reported to DELTA2 standards. This risks over-recruitment and/or erroneous trial conclusions, which clinicians should be aware of when interpreting published trials.© The Author(s) 2021. Published by Oxford University Press on behalf of BJS Society Ltd. All rights reserved. For permissions, please email: journals.permissions@oup.com.
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