偏头痛基于患者报告的结局评价量表初稿的研制

Development of First Draft of PRO Scale of Migraine

目的:研制偏头痛基于患者报告的结局(Patients-reported outcomes,PRO)评价量表。方法:参照美国FDA发布的PRO量表研制说明,遵照量表学原理,经临床病例与医案的症状筛选、患者访谈、研究小组讨论确定量表条目池。经专家咨询与问卷调查确定量表条目,依据专家对条目重要性的评分确定条目权重。结果:临床病例与医案症状筛选、患者访谈以及研究小组讨论后确定了33个条目组成条目池。两轮专家问卷调查后确定了偏头痛PRO量表的12个条目,各条目权重相当,视作等权。结论:偏头痛PRO量表条目来源于医案、临床病例和患者本身,经两轮专家问卷调查后筛选出的量表条目代表性好,条目分布与构建的量表阈体系一致,由上述条目编制的偏头痛PRO量表科学性强,是对偏头痛临床疗效评价体系的有益补充。

Objective ： To develop the patients - reported outcomes （PRO） scale of migraine. Methods ： According to the specific instructions of PRO research issued by the U. S. FDA and the principle and requirement of scale, we confirmed the item - banks of PRO scale through choosing symptoms from medical records and clinical cases with patients and group discussion and refining. After expert consultation and questionnaire survey, items of the PRO scale were determined. And the weights of all items were determined according to the score of importance of items. Results ： Based on screening results from medical records and clinical cases and patient interview and group discussion, 33 symptoms used for the clinical efficacy evaluation about migraine were preliminarily determined. Through two rounds of experts questionnaire, 12 items were integrated, and there was few difference among 12 items so we regard each item equally-weighted. Conclusions ： Items of PRO scale of migraine came from medical records and clinical cases have good representatives, so the PRO scale of migraine consist of the above items is scientific and good supplement for migraine clinical efficacy evaluation system.