DataSheet1_Framework Development for Clinical Comprehensive Evaluation of Drugs–a Study Protocol Using the Delphi Method and Analytic Hierarchy Process.docx

Measuring the value of drugs to help make health-care decisions is a complex process which involves confronting trade-offs among multiple objectives. Although guidelines have been released for clinical comprehensive evaluation of drugs, refinement is required when considering a specific drug used in a specific disease. In this study, a two-level framework for clinical comprehensive evaluation of drugs will be developed. Six first-level indicators, including safety, efficacy, costs/cost-effectiveness, novelty, suitability, and accessibility will be evaluated according to the Chinese Guideline for Clinical Comprehensive Evaluation of Drugs. The second-level components involved in the framework will be first validated by the Delphi method and subsequently compared with one another to get the index weight based on the Analytic Hierarchy Process (AHP). The scoring criteria of each component in the framework will also be determined by the Delphi method and AHP. The scoring criteria of components representing therapeutic effects will involve both score of therapeutic effects and score of evidence quality. With the evidence of the drug to be evaluated, the score of each component will be obtained according to the established scoring criteria, and the overall comprehensive score value of the drug will be calculated, which will assist the evidence-based decision making.

助力医疗决策的药物价值评估是一项复杂工作，需统筹多目标间的权衡取舍。尽管已有药物临床综合评价（Clinical Comprehensive Evaluation of Drugs）指南发布，但针对特定疾病中应用的特定药物时，仍需对该指南进行细化调整。本研究将构建一套药物临床综合评价的二级框架体系。依据《中国药物临床综合评价指南》，将对安全性、有效性、成本/成本效益、创新性、适宜性及可及性这6项一级指标开展评价。框架内涉及的二级指标，将首先通过德尔菲法（Delphi method）进行效度验证，随后基于层次分析法（Analytic Hierarchy Process, AHP）对各指标进行两两比较以确定其权重。框架内各指标的评分标准，同样将通过德尔菲法与层次分析法共同确定。其中代表治疗效应的指标评分标准，需同时涵盖治疗效应得分与证据质量得分。结合待评价药物的相关证据，根据既定评分标准即可得到各指标的得分，并计算得到该药物的综合总评分，从而为循证决策提供辅助支持。