Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Department of Plastic Surgery, Stoke Mandeville Hospital, Buckinghamshire Healthcare NHS Trust, Aylesbury, UK.
Br J Surg. 2022 Feb 1;109(2):178-181. doi: 10.1093/bjs/znab421.
Sample 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.
对使用患者报告结局测量作为主要结局的高影响力外科随机对照试验的样本量计算进行了系统审查，重点是目标差异。在本试验样本中，经常使用次优方法来确定目标差异，并且通常未按照 DELTA2 标准报告样本量计算。这存在过度招募和/或错误试验结论的风险，临床医生在解释已发表的试验时应注意这一点。
