Levitt S H, Aeppli D M, Potish R A, Lee C K, Nierengarten M E
Department of Therapeutic Radiology-Radiation Oncology, University of Minnesota, Minneapolis 55455.
Cancer. 1993 Oct 1;72(7):2075-82. doi: 10.1002/1097-0142(19931001)72:7<2075::aid-cncr2820720704>3.0.co;2-#.
Inadvertent random and systemic errors introduced into data sets and manipulation of data are well-defined sources of discrepancies in statistical evaluation of clinical trials. In this study, the authors show the influence of errors on the widely used statistical result, P values.
Using data from a retrospective study of patients with Hodgkin disease treated at the University of Minnesota between 1970 and 1984 and observed to 1988, we introduced various errors into the data to study the impact on results.
Inadvertent random and systemic errors affect statistical results. Data entry and transcription errors, vague definitions of endpoints and prognostic factors, and the omission and selection of patients are examples of frequent errors that affect statistical evaluation.
The results and inferences of many studies are sensitive to systemic errors and data manipulation. Great care must be given to the clear definitions of terms, exclusion and inclusion criteria, group assignments, treatment protocols, and the subgroups on which statistical analysis is performed. Clinicians and statisticians must work together to improve the performance and interpretation of clinical trials.
引入数据集的无意随机误差和系统误差以及数据处理是临床试验统计评估中差异的明确来源。在本研究中,作者展示了误差对广泛使用的统计结果P值的影响。
利用明尼苏达大学1970年至1984年治疗的霍奇金病患者的回顾性研究数据,并观察至1988年,我们在数据中引入各种误差以研究其对结果的影响。
无意随机误差和系统误差会影响统计结果。数据录入和转录错误、终点和预后因素的模糊定义以及患者的遗漏和选择是影响统计评估的常见误差示例。
许多研究的结果和推论对系统误差和数据处理很敏感。必须非常谨慎地明确术语定义、排除和纳入标准、分组、治疗方案以及进行统计分析的亚组。临床医生和统计学家必须共同努力以提高临床试验的性能和解释。