ESMO-Magnitude of Clinical Benefit Scale version 2.0 (ESMO-MCBS v2.0).

This paper describes the development of ESMO-MCBS v2.0.

本文描述了ESMO-MCBS v2.0的开发过程。

methodology

The revision process incorporates nine steps: (i) review of critiques and suggestions and identification of problems in the application of ESMO-MCBS v1.1; (ii) identification of shortcomings for revision in the upcoming version; (iii) drafting solutions addressing identified shortcomings; (iv) field-testing of solutions; (v) preparation of a near-final revised version for peer review for reasonableness by members of the ESMO Faculty and ESMO Guidelines Committee; (vi) amendments based on peer review for reasonableness; (vii) near-final review by members of the ESMO-MCBS Working Group; (viii) final amendments; (ix) final review and approval by members of the ESMO-MCBS Working Group and the ESMO Executive Board.

修订过程包含九个步骤：(i) 回顾批评和建议并识别ESMO-MCBS v1.1应用中的问题；(ii) 确定即将版本修订中的不足之处；(iii) 起草解决已识别不足的方案；(iv) 方案的实地测试；(v) 准备一个接近最终修订版本，供ESMO学院和ESMO指南委员会成员进行合理性同行评审；(vi) 根据合理性同行评审进行修订；(vii) ESMO-MCBS工作组成员进行接近最终的审查；(viii) 最终修订；(ix) ESMO-MCBS工作组和ESMO执行董事会成员进行最终审查和批准。

Results

Seventeen issues for revision or amendment were considered, and 13 amendments were formulated to address identified shortcomings.

考虑了十七条修订或修改的问题，并制定了13项修订方案以解决已识别的不足。

In the curative setting, studies evaluated based on disease-free survival now credit improved time without treatment or disease even when overall survivalis not significantly improved, and studies with small absolute gain in disease-free survival are credited more conservatively.

在治愈性治疗环境中，基于无病生存期评估的研究现在认可了即使总生存没有显著改善，治疗或疾病无进展的时间也有所延长，而对于无病生存期绝对获益较小的研究则更加保守地予以评价。

Additionally, acute and persistent toxicity annotations are added.

此外，还增加了急性与持续性毒性注释。

In the non-curative setting, the approach to crediting a difference in the tail of overall survivaland progression-free survivalcurves is more statistically valid, and the toxicity evaluation has been revised.

在非治愈性治疗中，对总生存和无进展生存曲线尾部差异的评估方法更为统计有效，毒性评估也已修订。

In peer review all amendments were found to be either reasonable or mostly reasonable.

在同行评审中，所有修订都被认为是合理的，或者大多数是合理的。

The amendments changed the scoring of 85/353 of evaluated studies.

修订后，对85/353项评估研究的评分进行了更改。

Conclusions

The amendments incorporated into ESMO-MCBS v2.0 change the scores of 13.6% of evaluated studies (10.5% downgraded, 3.1% upgraded) and add toxicity annotations to 45.5% of the studies in the curative setting, and improve its discriminatory capacity and utility.

纳入ESMO-MCBS v2.0的修订改变了13.6%评估研究的评分（其中10.5%降级，3.1%升级），并且为45.5%的治愈性研究增加了毒性注释，从而提高了其区分能力和实用性。