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目的:确定需要纳入大剂量甲氨蝾呤临床用药指南的临床问题与结局指标.方法:草拟临床问题与结局指标初稿,应用三轮德尔菲法进行专家咨询,并计算积极系数、变异系数、协调系数等进行质量控制.结果:共形成23个临床问题和12个结局指标.其中,15个临床问题必须在指南中形成推荐意见,4个结局指标为关键结局.回收率98％,德尔菲法第一轮与第三轮的协调系数分别为临床问题0.276与0.293、结局指标0.367与0.373.结论:通过德尔菲法确定了大剂量甲氨蝶呤临床用药指南需要纳入的临床问题和结局指标,对指南的后续制定工作有重要指导意义.“,”Objective:To choose and confirm the clinical questions and outcomes included in the Practice Guideline for Clinical Use of High-dose Methotrexate.Methods:Drawing up the draft form of guideline questions and outcomes,then three rounds of the Delphi method was adopted to consult experts.Enthusiasm index,variation index and coordination coefficient were calculated for quality control.Results:23 questions and 12 outcomes were defined.Reccomendations of 15 questions must be involved in the guideline.Four outcomes were ranked as “critical outcome”.Enthusiasm index was 100％.Coordination coefficient was 0.630 and 0.388 respectively in first round and third round of the Delphi method.Conclusion:Through Delphi method,questions and outcomes involved in the Practice Guideline for Clinical Use of Highdose Methotrexate were confirmed,which is of great significance to guideline further development.