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检验 Cox 回归中比例风险假设及处理全关节置换研究中潜在的非比例性:方法学视角与综述。

Testing the proportional hazards assumption in cox regression and dealing with possible non-proportionality in total joint arthroplasty research: methodological perspectives and review.

机构信息

Mikkeli Central Hospital, Porrassalmenkatu, 35-37 50100, Mikkeli, Finland.

University of Eastern Finland, School of Medicine, Yliopistonranta 1, 70210, Kuopio, Finland.

出版信息

BMC Musculoskelet Disord. 2021 May 28;22(1):489. doi: 10.1186/s12891-021-04379-2.

Abstract

BACKGROUND

Survival analysis and effect of covariates on survival time is a central research interest. Cox proportional hazards regression remains as a gold standard in the survival analysis. The Cox model relies on the assumption of proportional hazards (PH) across different covariates. PH assumptions should be assessed and handled if violated. Our aim was to investigate the reporting of the Cox regression model details and testing of the PH assumption in survival analysis in total joint arthroplasty (TJA) studies.

METHODS

We conducted a review in the PubMed database on 28th August 2019. A total of 1154 studies were identified. The abstracts of these studies were screened for words "cox and "hazard*" and if either was found the abstract was read. The abstract had to fulfill the following criteria to be included in the full-text phase: topic was knee or hip TJA surgery; survival analysis was used, and hazard ratio reported. If all the presented criteria were met, the full-text version of the article was then read. The full-text was included if Cox method was used to analyze TJA survival. After accessing the full-texts 318 articles were included in final analysis.

RESULTS

The PH assumption was mentioned in 114 of the included studies (36%). KM analysis was used in 281 (88%) studies and the KM curves were presented graphically in 243 of these (87%). In 110 (45%) studies, the KM survival curves crossed in at least one of the presented figures. The most common way to test the PH assumption was to inspect the log-minus-log plots (n = 59). The time-axis division method was the most used corrected model (n = 30) in cox analysis. Of the 318 included studies only 63 (20%) met the following criteria: PH assumption mentioned, PH assumption tested, testing method of the PH assumption named, the result of the testing mentioned, and the Cox regression model corrected, if required.

CONCLUSIONS

Reporting and testing of the PH assumption and dealing with non-proportionality in hip and knee TJA studies was limited. More awareness and education regarding the assumptions behind the used statistical models among researchers, reviewers and editors are needed to improve the quality of TJA research. This could be achieved by better collaboration with methodologists and statisticians and introducing more specific reporting guidelines for TJA studies. Neglecting obvious non-proportionality undermines the overall research efforts since causes of non-proportionality, such as possible underlying pathomechanisms, are not considered and discussed.

摘要

背景

生存分析和协变量对生存时间的影响是研究的重点。Cox 比例风险回归仍然是生存分析的金标准。Cox 模型依赖于不同协变量之间比例风险(PH)的假设。如果违反了假设,应该评估和处理 PH 假设。我们的目的是调查在全关节置换术(TJA)研究中的 Cox 回归模型细节报告和 PH 假设检验。

方法

我们于 2019 年 8 月 28 日在 PubMed 数据库中进行了一项综述。共确定了 1154 项研究。筛选这些研究的摘要中是否包含“cox 和”“hazard*”这两个词,如果找到这两个词之一,则阅读摘要。如果摘要满足以下标准,则将其纳入全文阶段:主题为膝关节或髋关节 TJA 手术;使用生存分析,报告风险比。如果满足所有呈现的标准,则阅读文章的全文版本。如果 Cox 方法用于分析 TJA 生存,则纳入全文。在访问全文后,有 318 篇文章被纳入最终分析。

结果

在纳入的研究中,有 114 项(36%)提到了 PH 假设。281 项(88%)研究使用了 KM 分析,其中 243 项(87%)以图形方式呈现了 KM 曲线。在 110 项(45%)研究中,KM 生存曲线在至少一个呈现的图表中相交。最常见的检验 PH 假设的方法是检查对数-对数图(n=59)。时间轴划分方法是 Cox 分析中最常用的校正模型(n=30)。在纳入的 318 项研究中,只有 63 项(20%)符合以下标准:提到 PH 假设、检验 PH 假设、命名 PH 假设的检验方法、提及检验结果以及校正 Cox 回归模型(如果需要)。

结论

髋关节和膝关节 TJA 研究中 PH 假设的报告和检验以及对非比例性的处理受到限制。需要提高研究人员、评论员和编辑对所用统计模型背后假设的认识和教育,以提高 TJA 研究的质量。这可以通过与方法学家和统计学家更好地合作以及为 TJA 研究引入更具体的报告指南来实现。忽视明显的非比例性会破坏整体研究工作,因为未考虑和讨论非比例性的原因,例如可能存在的潜在发病机制。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3b4f/8161573/73793aef52ef/12891_2021_4379_Fig1_HTML.jpg

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