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目的调查我国主要肿瘤专业期刊所发表论著中生存分析方法的应用现状,评价生存分析的报告质量,总结存在的问题,以提高生存分析相关统计方法的应用水平和报告质量。方法选择《中华肿瘤杂志》、《中华肿瘤防治杂志》、《中华放射肿瘤学杂志》和《中国肿瘤临床》2013年所发表的1 492篇论著,纳入使用了生存分析方法的研究,对其生存分析方法的应用情况和报告质量进行评价。结果共纳入242篇使用了生存分析方法的研究,其中Kaplan-Meier法、寿命表法、Log-rank检验、Breslow检验及Cox比例风险模型的使用率分别为91.74%、3.72%、78.51%、0.41%和46.28%。112篇论文进行了多因素分析,且均使用Cox比例风险模型。纳入研究共包含396个终点,有10种不同类型的生存时间,223篇(92.15%)报告了总生存时间,103篇(42.56%)的158个(39.90%)终点对生存时间进行了明确定义。155篇(64.05%)论文报告了随访率,随访率<80%的论文有4篇,最低为75.25%,其余均>80%,55篇随访率为100%。本研究发现的主要问题有:使用Cox比例风险模型的论文中没有论文报告比例风险假定检验情况,没有论文使用参数方法进行生存分析,130篇(53.72%)论文未进行多因素分析,139篇(57.44%)论文未定义生存时间,存在失访的100篇论文中仅11篇报告了对失访的处理情况,没有论文报告样本量的计算方法,没有论文报告删失率。结论我国肿瘤专业期刊论文对生存分析的使用率较低,报告质量尚存在不足。建议制订生存分析类研究的报告指南,鼓励吸纳统计学专业人员参与相关研究的设计、分析和报告,以提高论文质量。
Objective To investigate the application status of survival analysis in the treatises published in the major oncology journals in China, evaluate the quality of survival analysis and summarize the existing problems so as to improve the application level and quality of the statistical methods related to survival analysis. Methods A total of 1 492 articles published in Chinese Journal of Oncology, Chinese Journal of Cancer Prevention and Treatment, Chinese Journal of Radiation Oncology and Chinese Journal of Oncology in 2013 were included in the study using survival analysis method, The application of the analytical method and the quality of the report. Results A total of 242 studies using survival analysis were included. The Kaplan-Meier method, life table method, Log-rank test, Breslow test and Cox proportional hazard model were 91.74%, 3.72%, 78.51%, 0.41 % And 46.28%. 112 papers were multivariate and Cox proportional hazards models were used. A total of 396 endpoints were included in the study, with 10 different types of survival times, 223 (92.15%) reported overall survival, and 103 (42.56%) 158 (39.90%) endpoints defined survival time explicitly . A total of 155 papers (64.05%) reported follow-up rates. There were 4 papers with a follow-up rate of <80%, the lowest was 75.25%, the others were> 80% and the 55 follow-up rates were 100%. The main problems found in this study are: no papers reported in the paper using the Cox proportional hazards model to test the proportional hazards assumed test, no papers used parametric methods for survival analysis, 130 papers (53.72%) did not perform multivariate analysis, 139 papers 57.44%) The essay did not define the survival time. Only 11 out of 100 papers with lost-to-follow-up reported the treatment of lost-of-treatment. There was no calculation method for the sample size of papers and no censorship rate. Conclusion The utilization rate of survival analysis in Chinese journal of oncology specialty is low, and the quality of the report is still insufficient. It is suggested that a guideline should be drawn up for the study of survival analysis to encourage the participation of statisticians in the design, analysis and reporting of relevant research in order to improve the quality of the paper.