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.

中文翻译：

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使用患者报告的结果指标进行备受瞩目的外科试验中的样本量计算：系统评价

使用患者报告的结果测量作为主要结果的备受瞩目的外科 RCT 的样本量计算，根据 TriAls 差异诱导 (DELTA2) 标准进行了系统审查，重点关注目标差异。在此试验样本中，经常使用次优方法来确定目标差异，并且样本量计算通常不符合 DELTA2 标准。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。