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使用新的合并症指数进行目标试验模拟提供的风险估计与随机试验相当。

Target trial emulation using new comorbidity indices provided risk estimates comparable to a randomized trial.

机构信息

Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.

Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.

出版信息

J Clin Epidemiol. 2024 Oct;174:111504. doi: 10.1016/j.jclinepi.2024.111504. Epub 2024 Aug 17.

DOI:10.1016/j.jclinepi.2024.111504
PMID:39159770
Abstract

OBJECTIVES

To quantify the ability of two new comorbidity indices to adjust for confounding, by benchmarking a target trial emulation against the randomized controlled trial (RCT) result.

STUDY DESIGN AND SETTING

Observational study including 18,316 men from Prostate Cancer data Base Sweden 5.0, diagnosed with prostate cancer between 2008 and 2019 and treated with primary radical prostatectomy (RP, n = 14,379) or radiotherapy (RT, n = 3,937). The effect on adjusted risk of death from any cause after adjustment for comorbidity by use of two new comorbidity indices, the multidimensional diagnosis-based comorbidity index and the drug comorbidity index, were compared to adjustment for the Charlson comorbidity index (CCI).

RESULTS

Risk of death was higher after RT than RP (hazard ratio [HR] = 1.94; 95% confidence interval [CI]: 1.70-2.21). The difference decreased when adjusting for age, cancer characteristics, and CCI (HR = 1.32, 95% CI: 1.06-1.66). Adjustment for the two new comorbidity indices further attenuated the difference (HR 1.14, 95% CI 0.91-1.44). Emulation of a hypothetical pragmatic trial where also older men with any type of baseline comorbidity were included, largely confirmed these results (HR 1.10; 95% CI 0.95-1.26).

CONCLUSION

Adjustment for comorbidity using two new indices provided comparable risk of death from any cause in line with results of a RCT. Similar results were seen in a broader study population, more representative of clinical practice.

摘要

目的

通过与随机对照试验(RCT)结果的靶向试验模拟进行基准测试,量化两种新合并症指数调整混杂因素的能力。

研究设计和设置

这是一项观察性研究,纳入了来自瑞典前列腺癌数据库 5.0 的 18316 名男性,这些男性在 2008 年至 2019 年间被诊断为前列腺癌,并接受了根治性前列腺切除术(RP,n=14379)或放射治疗(RT,n=3937)。比较两种新的合并症指数,多维基于诊断的合并症指数和药物合并症指数,在调整了合并症后对任何原因死亡的调整风险的影响,与调整 Charlson 合并症指数(CCI)的效果进行了比较。

结果

与 RP 相比,RT 后死亡风险更高(风险比 [HR] = 1.94;95%置信区间 [CI]:1.70-2.21)。当调整年龄、癌症特征和 CCI 时,差异会减小(HR = 1.32,95% CI:1.06-1.66)。调整这两种新的合并症指数进一步减弱了差异(HR 1.14,95% CI 0.91-1.44)。模拟一个假设的实用试验,其中还包括基线有任何类型合并症的老年男性,这在很大程度上证实了这些结果(HR 1.10;95% CI 0.95-1.26)。

结论

使用两种新指数调整合并症可以提供相当的任何原因死亡风险,与 RCT 结果一致。在更广泛的代表性更强的临床实践的研究人群中,也观察到了类似的结果。

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