Harvard Medical School, Boston, MA.
Department of Surgery, University of Toronto, Toronto, Canada.
Ann Surg. 2024 Jun 1;279(6):907-912. doi: 10.1097/SLA.0000000000006250. Epub 2024 Feb 23.
To determine the prevalence of clinical significance reporting in contemporary comparative effectiveness research (CER).
In CER, a statistically significant difference between study groups may or may not be clinically significant. Misinterpreting statistically significant results could lead to inappropriate recommendations that increase health care costs and treatment toxicity.
CER studies from 2022 issues of the Annals of Surgery , Journal of the American Medical Association , Journal of Clinical Oncology , Journal of Surgical Research , and Journal of the American College of Surgeons were systematically reviewed by 2 different investigators. The primary outcome of interest was whether the authors specified what they considered to be a clinically significant difference in the "Methods."
Of 307 reviewed studies, 162 were clinical trials and 145 were observational studies. Authors specified what they considered to be a clinically significant difference in 26 studies (8.5%). Clinical significance was defined using clinically validated standards in 25 studies and subjectively in 1 study. Seven studies (2.3%) recommended a change in clinical decision-making, all with primary outcomes achieving statistical significance. Five (71.4%) of these studies did not have clinical significance defined in their methods. In randomized controlled trials with statistically significant results, sample size was inversely correlated with effect size ( r = -0.30, P = 0.038).
In contemporary CER, most authors do not specify what they consider to be a clinically significant difference in study outcome. Most studies recommending a change in clinical decision-making did so based on statistical significance alone, and clinical significance was usually defined with clinically validated standards.
确定当代比较效果研究（CER）中临床意义报告的流行情况。
在 CER 中，研究组之间的统计学显著差异可能具有临床意义，也可能没有。错误解释统计学显著结果可能导致不适当的建议，从而增加医疗保健成本和治疗毒性。
由 2 名不同的研究者对 2022 年《外科学纪事》、《美国医学会杂志》、《临床肿瘤学杂志》、《手术研究杂志》和《美国外科医师学会杂志》的 CER 研究进行了系统回顾。主要观察结果是作者是否在“方法”部分指定了他们认为的临床显著差异。
在 307 项综述研究中，162 项为临床试验，145 项为观察性研究。作者在 26 项研究（8.5%）中指定了他们认为的临床显著差异。25 项研究使用临床验证标准定义临床意义，1 项研究主观定义。有 7 项研究（2.3%）建议改变临床决策，所有这些研究的主要结果都达到了统计学意义。其中 5 项（71.4%）研究未在方法中定义临床意义。在具有统计学显著结果的随机对照试验中，样本量与效应量呈负相关（r=-0.30，P=0.038）。
在当代 CER 中，大多数作者并未在研究结果中指定他们认为的临床显著差异。大多数建议改变临床决策的研究仅基于统计学意义，并且临床意义通常使用临床验证标准定义。
