Department of Surgery, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.
Department of Surgery, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.
J Pediatr Surg. 2020 Jul;55(7):1173-1179. doi: 10.1016/j.jpedsurg.2019.05.007. Epub 2019 May 16.
BACKGROUND/PURPOSE: Determining the appropriate sample size is an integral component of any well-designed research study, grant application, or scientific manuscript. Surgeons intuitively understand the concept of statistical power, but have limited knowledge in how to go about performing the calculations correctly. Our goal is to provide a strategy for pediatric surgeons to use when planning a study to determine the sample sizes required for detecting a clinically meaningful effect, which is important for interpreting and validating their results. METHODS: We present a general 5-step approach for performing a sample size justification and statistical power analysis, and illustrate this approach using several surgical research examples. The 5 steps are: 1) Define the primary outcome of interest, 2) Define the magnitude of the effect or effect size and power desired, 3) Determine the appropriate statistics and statistical test that will be considered, 4) Perform the calculations to estimate the required sample size using software or a reference table, 5) Write the formal power and sample size statement for the manuscript, grant application, or project proposal. CONCLUSIONS: Understanding sample size considerations and statistical power in the surgical research community will improve the quality of published articles. This primer can be used by pediatric surgeons in the process of determining the appropriate sample sizes for detecting a clinically meaningful effect with sufficient statistical power. Virtually all research studies in pediatric surgery should include a justification of sample size based on a power calculation as this leads to more meaningful inferences from the data and analysis. TYPE OF STUDY: Review article. LEVEL OF EVIDENCE: N/A.
背景/目的:确定适当的样本量是任何精心设计的研究、资助申请或科学手稿的一个组成部分。外科医生直观地理解统计功效的概念,但在如何正确进行计算方面知之甚少。我们的目标是为儿科外科医生提供一种策略,用于规划研究以确定检测临床有意义效果所需的样本量,这对于解释和验证他们的结果很重要。
方法:我们提出了一种用于进行样本量论证和统计功效分析的通用 5 步方法,并使用几个外科研究示例来说明这种方法。这 5 个步骤是:1)定义感兴趣的主要结果,2)定义所需的效果或效应大小和功效大小,3)确定将考虑的适当统计数据和统计检验,4)使用软件或参考表进行计算以估计所需的样本量,5)为手稿、资助申请或项目建议书撰写正式的功效和样本量说明。
结论:了解外科研究界的样本量考虑因素和统计功效将提高已发表文章的质量。本指南可用于儿科外科医生确定检测临床有意义效果的适当样本量,以获得足够的统计功效。实际上,儿科外科学的所有研究都应包括基于功效计算的样本量论证,因为这可以从数据和分析中得出更有意义的推论。
研究类型:综述文章。
证据水平:无。
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