Chai-Adisaksopha Chatree, Iorio Alfonso, Hillis Christopher, Lim Wendy, Crowther Mark
Departments of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada ; Departments of Medicine, McMaster University, Hamilton, Canada.
Departments of Medicine, McMaster University, Hamilton, Canada ; Departments of Oncology, McMaster University, Hamilton, Canada.
BMC Hematol. 2016 Jun 8;16:17. doi: 10.1186/s12878-016-0055-7. eCollection 2016.
Survival analysis is commonly used to determine the treatment effect among acute lymphoblastic leukemia (ALL) patients who undergo allogeneic stem cell transplantation (allo-SCT) or other treatments. The aim of this study was to evaluate the use and reporting of survival analyses in these articles.
We performed a systematic review by searching the MEDLINE, EMBASE and Cochrane library databases from inception to April 2015. Clinical trials of patients with ALL comparing allo-SCT compared to another treatment were included. We included only studies that used survival analysis as a part of the statistical methods.
There were 14 studies included in the review. Sample size estimation was described in 4 (29 %) studies. Only 4 (29 %) studies reported the list of covariates assessed in the Cox regression and 6 (43 %) studies provided a description of censorship. All studies reported survival curves using the Kaplan-Meier method. The comparisons between groups were investigated using the log-rank test and Wilcoxon test. Crossing survival curves were observed in 11(79 %) studies. The Cox regression model was incorporated in 10 (71 %) studies. None of the studies assessed the Cox proportional hazards assumption or goodness-of-fit.
The use and reporting of survival analysis in adult ALL patients undergoing allo-SCT have significant limitations. Notably, the finding of crossing survival curves was common and none of the studies assessed for the proportional hazards assumption. We encourage authors, reviewers and editors to improve the quality of the use and reporting of survival analysis in the hematology literature.
生存分析常用于确定接受异基因干细胞移植（allo-SCT）或其他治疗的急性淋巴细胞白血病（ALL）患者的治疗效果。本研究旨在评估这些文章中生存分析的使用和报告情况。
我们通过检索MEDLINE、EMBASE和Cochrane图书馆数据库，从数据库建立至2015年4月进行了一项系统评价。纳入比较allo-SCT与其他治疗的ALL患者的临床试验。我们仅纳入将生存分析作为统计方法一部分的研究。
该评价纳入了14项研究。4项（29%）研究描述了样本量估计。仅有4项（29%）研究报告了Cox回归中评估的协变量列表，6项（43%）研究提供了删失情况的描述。所有研究均使用Kaplan-Meier方法报告生存曲线。使用对数秩检验和Wilcoxon检验研究组间比较。11项（79%）研究观察到生存曲线交叉。10项（71%）研究纳入了Cox回归模型。没有研究评估Cox比例风险假设或拟合优度。
接受allo-SCT的成人ALL患者生存分析的使用和报告存在显著局限性。值得注意的是，生存曲线交叉的情况很常见，且没有研究评估比例风险假设。我们鼓励作者、审稿人和编辑提高血液学文献中生存分析使用和报告的质量。
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