Beyond Parametric and Nonparametric Tests: A Practical Guide to Table 1 in Clinical Research.

IF 3.4 Q2 EMERGENCY MEDICINE
Jongkyeong Kang, Sook-Young Woo, Han Zo Choi
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引用次数: 0

Abstract

In many clinical research reports, Table 1 presents the baseline or general characteristics of study participants and helps readers understand the study population and observed between-group differences. Despite its apparent simplicity, constructing and interpreting Table 1 requires several distinct decisions, including whether formal between-group inference is scientifically justified, how variables should be summarized, and how observed differences should be interpreted. Routine significance testing of baseline characteristics is generally discouraged in randomized trials and often provides limited information in observational studies, where group differences may reflect treatment selection, exposure patterns, disease severity, or other systematic mechanisms. We propose a purpose-first framework in which investigators first clarify the intended role of Table 1, consider the study design, and determine whether a comparison addresses a prespecified and scientifically meaningful inferential question. They should then identify the variable type, evaluate distributional shape, influential observations, and clinical interpretability, and select appropriate summary statistics. For descriptive applications, transparent group-specific summaries should be emphasized, with observed absolute or standardized differences added when useful and without routine p-values. Confidence intervals should be reported when a population-level estimation objective has been defined. When formal inference is justified, investigators should define the target quantity or estimand and select a statistical method according to the variable type, data structure, distributional characteristics, and model assumptions. Effect estimates and confidence intervals should receive greater emphasis than isolated p-values. This framework distinguishes description from inference and promotes transparent, statistically coherent, and clinically meaningful construction and interpretation of Table 1.

超越参数和非参数检验:临床研究中表1的实用指南。
在许多临床研究报告中,表1给出了研究参与者的基线或一般特征,帮助读者了解研究人群和观察到的组间差异。尽管表1看起来很简单,但构建和解释表1需要几个不同的决定,包括组间的正式推断是否科学合理,变量应该如何总结,以及观察到的差异应该如何解释。在随机试验中通常不鼓励对基线特征进行常规显著性检验,并且在观察性研究中通常提供有限的信息,其中组间差异可能反映治疗选择、暴露模式、疾病严重程度或其他系统机制。我们提出了一个目的优先的框架,在这个框架中,研究者首先澄清表1的预期作用,考虑研究设计,并确定比较是否解决了预先指定的和科学上有意义的推理问题。然后,他们应该确定变量类型,评估分布形状,有影响的观察结果和临床可解释性,并选择适当的汇总统计。对于描述性应用,应强调透明的群体特定摘要,在有用时添加观察到的绝对或标准化差异,而不需要常规p值。当确定了总体水平的估计目标时,应报告置信区间。在证明形式推理是合理的情况下,研究者应根据变量类型、数据结构、分布特征和模型假设来定义目标数量或估计,并选择统计方法。效果估计和置信区间应该比孤立的p值得到更大的重视。该框架将描述与推理区分开来,并促进表1的透明、统计连贯和临床有意义的构建和解释。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
2.80
自引率
10.50%
发文量
59
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