Fundación ECO (Excelencia y Calidad en Oncología), Madrid, Spain.
Centro de Investigación Biomédica en Red de Cáncer, Spain.
JCO Oncol Pract. 2020 Mar;16(3):e298-e305. doi: 10.1200/JOP.19.00487.
Several frameworks have been developed to define and quantify the value of oncologic therapies and to support decision making; however, they define treatment value mainly in terms of clinical benefit. As part of its mission to improve oncologic care, the ECO Foundation (Excellence and Quality in Oncology) directed this pilot study aimed at developing a reflective multicriteria decision analysis (MCDA)-based framework for evaluating and positioning oncologic drugs in the clinical setting.
The framework was developed following Evidence and Value: Impact on Decision-Making methodology, and literature was reviewed to identify relevant criteria. The selected criteria were then presented to a group of experts composed of 9 clinical oncologists who assessed each criterion for inclusion in the framework and suggested modifications in their definition and/or response scale. The framework was tested in 2 case studies (abemaciclib for advanced or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer and TAS-102 for metastatic colorectal cancer) to validate the proposed framework; this was followed by a discussion of the results.
Eight of the 15 criteria presented to the experts were included in the framework: disease severity, unmet needs, comparative efficacy, comparative safety/tolerability, treatment intent, comparative treatment cost, comparative other medical costs, and quality of evidence. Framework validation in 2 drug cases resulted in similar value scores, although they were based on different contributing criteria and resulted in different clinical recommendations.
We developed and validated a reflective MCDA framework for the assessment and positioning of oncologic therapies in Spain. Additional work is needed to create a manual for practical decision making in the clinical setting.
已经开发了几个框架来定义和量化肿瘤治疗的价值，并为决策提供支持；然而，它们主要根据临床获益来定义治疗价值。为了改善肿瘤治疗，ECO 基金会（肿瘤学卓越与质量）指导了这项试点研究，旨在开发一个基于反思性多准则决策分析（MCDA）的框架，用于评估和定位临床环境中的肿瘤药物。
该框架是按照证据和价值：对决策的影响方法开发的，并对文献进行了回顾，以确定相关标准。然后将选定的标准提交给由 9 名临床肿瘤学家组成的专家组，这些专家评估每个标准是否纳入框架，并提出对其定义和/或响应量表的修改建议。该框架在 2 个案例研究（晚期或转移性激素受体阳性、人表皮生长因子受体 2 阴性乳腺癌的 abemaciclib 和转移性结直肠癌的 TAS-102）中进行了测试，以验证所提出的框架；随后对结果进行了讨论。
向专家介绍的 15 个标准中有 8 个被纳入框架：疾病严重程度、未满足的需求、比较疗效、比较安全性/耐受性、治疗意图、比较治疗成本、比较其他医疗成本和证据质量。在 2 个药物案例中的框架验证产生了相似的价值评分，尽管它们基于不同的贡献标准，并产生了不同的临床建议。
我们开发并验证了一个用于评估和定位西班牙肿瘤治疗的反思性 MCDA 框架。需要进一步的工作来创建一个在临床环境中进行实际决策的手册。
