Purpose Whether the ASCO Value Framework and the European Society for Medical Oncology (ESMO) Magnitude of Clinical Benefit Scale (MCBS) measure similar constructs of clinical benefit is unclear. It is also unclear how they relate to quality-adjusted life-years (QALYs) and funding recommendations in the United Kingdom and Canada. Methods Randomized clinical trials of oncology drug approvals by the US Food and Drug Administration, European Medicines Agency, and Health Canada between 2006 and August 2015 were identified and scored using the ASCO version 1 (v1) framework, ASCO version 2 (v2) framework, and ESMO-MCBS by at least two independent reviewers. Spearman correlation coefficients were calculated to assess construct (between frameworks) and criterion validity (against QALYs from the National Institute for Health and Care Excellence [NICE] and the pan-Canadian Oncology Drug Review [pCODR]). Associations between scores and NICE/pCODR recommendations were examined. Inter-rater reliability was assessed using intraclass correlation coefficients. Results From 109 included randomized clinical trials, 108 ASCOv1, 111 ASCOv2, and 83 ESMO scores were determined. Correlation coefficients for ASCOv1 versus ESMO, ASCOv2 versus ESMO, and ASCOv1 versus ASCOv2 were 0.36 (95% CI, 0.15 to 0.54), 0.17 (95% CI, -0.06 to 0.37), and 0.50 (95% CI, 0.35 to 0.63), respectively. Compared with NICE QALYs, correlation coefficients were 0.45 (ASCOv1), 0.53 (ASCOv2), and 0.46 (ESMO); with pCODR QALYs, coefficients were 0.19 (ASCOv1), 0.20 (ASCOv2), and 0.36 (ESMO). None of the frameworks were significantly associated with NICE/pCODR recommendations. Inter-rater reliability was good for all frameworks. Conclusion The weak-to-moderate correlations of the ASCO frameworks with the ESMO-MCBS, as well as their correlations with QALYs and with NICE/pCODR funding recommendations, suggest different constructs of clinical benefit measured. Construct convergent validity with the ESMO-MCBS did not increase with the updated ASCO framework.

中文翻译：

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美国临床肿瘤学会价值框架和欧洲肿瘤内科学会临床获益量表衡量的临床获益结构是否相同？

目的 ASCO 价值框架和欧洲肿瘤内科学会 (ESMO) 临床获益量表 (MCBS) 是否衡量类似的临床获益结构尚不清楚。目前还不清楚它们与英国和加拿大的质量调整生命年 (QALY) 和资助建议之间的关系。方法 2006 年至 2015 年 8 月美国食品药品监督管理局、欧洲药品管理局和加拿大卫生部批准的肿瘤药物随机临床试验使用 ASCO 版本 1 (v1) 框架、ASCO 版本 2 (v2) 框架进行识别和评分，和 ESMO-MCBS 由至少两名独立审查员进行。计算 Spearman 相关系数以评估结构（框架之间）和标准有效性（针对来自国家健康与护理卓越研究所 [NICE] 和泛加拿大肿瘤药物审查 [pCODR] 的 QALY）。检查了分数与 NICE/pCODR 建议之间的关联。使用组内相关系数评估评分者间的可靠性。结果 从 109 项随机临床试验中，确定了 108 项 ASCOv1、111 项 ASCOv2 和 83 项 ESMO 评分。ASCOv1 与 ESMO、ASCOv2 与 ESMO 以及 ASCOv1 与 ASCOv2 的相关系数分别为 0.36（95% CI，0.15 至 0.54）、0.17（95% CI，-0.06 至 0.37）和 0.50（95% CI，0.65） ， 分别。与NICE QALYs相比，相关系数分别为0.45（ASCOv1）、0.53（ASCOv2）和0.46（ESMO）；使用 pCODR QALY，系数为 0.19 (ASCOv1)、0.20 (ASCOv2) 和 0.36 (ESMO)。没有一个框架与 NICE/pCODR 建议显着相关。所有框架的评分者间可靠性都很好。结论 ASCO 框架与 ESMO-MCBS 的弱到中等相关性，以及它们与 QALYs 和 NICE/pCODR 资助建议的相关性，表明测量的临床益处的不同结构。ESMO-MCBS 的构建收敛效度并没有随着更新的 ASCO 框架而增加。以及它们与 QALYs 和 NICE/pCODR 资助建议的相关性，建议测量不同的临床获益结构。ESMO-MCBS 的构建收敛效度并没有随着更新的 ASCO 框架而增加。以及它们与 QALYs 和 NICE/pCODR 资助建议的相关性，建议测量不同的临床获益结构。ESMO-MCBS 的构建收敛效度并没有随着更新的 ASCO 框架而增加。