针刺治疗偏头痛核心结局指标集的建立

目的 目前,偏头痛的临床疗效评价指标多样,而中医治疗偏头痛结局指标缺乏全面、统一的标准,严重制约其临床疗效的精准评价。本团队针对上述问题,建立针刺治疗偏头痛核心结局指标集,旨在客观、多维反映中医的临床疗效。方法 首先,通过系统评价及半结构化访谈构建偏头痛结局指标条目池;其次,通过专家和患者德尔菲调查,并引入层次分析法明确各项结局指标的权重评级;最后,召开专家共识会议对结局指标达成共识,形成核心结局指标集。结果 针刺治疗偏头痛核心结局指标集包含7个类别的16个结局指标,主要类别：1.临床症状;2.生活质量;3.伴随症状;4.心理健康状态;5.理化指标;6.用药情况;7.患者自我评估。结论 通过建立针刺治疗偏头痛的核心结局指标集,为中医治疗偏头痛的临床研究提供可参考的评价方法,有助于提高临床研究的同质性,减少资源浪费,规范、客观地对针刺治疗偏头痛的临床疗效进行多维、精准评价。

The Development of a Core Outcome Set (COS) about Clinical Effect of Migraine in Acupuncture Treatment

Objective At present, there are various indicators of clinical efficacy of migraine, but lack comprehensive and unified of outcome indicators for migraine in Traditional Chinese Medicine(TCM) treatment, which seriously restricts the exact evaluation of clinical efficacy. To solve the problems, we established a core outcome set(COS) for migraine in acupuncture treatment, aiming to objectively and multidimensional reflects the clinical efficacy of TCM.Methods Firstly, through systematic assessments and semi-structured interviews to construct an item of migraine in acupuncture treatment; secondly, through leads in Delphi survey of experts and patients, analytic hierarchy process (AHP) to clarify the weight ratings of each outcome indicator; finally, through held an expert consensus meeting to reach consensus on the outcome indicators and form a COS.Result The COS of acupuncture treatment for migraine included 16 outcome indicators of 7 categories, the main categories were: (1) the pain symptom of migraine, (2) the quality of life, (3) accompanying symptoms, (4) psychological health state, (5) indictors of clinical application, (6) conditions of drug application, and (7) patient self-assessment.Conclusion By establishing the COS of migraine in acupuncture treatment, we can provide a referential evaluation method for the clinical research of TCM treatment for migraine, help to improve the homogeneity of clinical research, reduce the waste of resources, standardize and objectively evaluate the clinical efficacy of acupuncture treatment for migraine in a multi-dimensional and accurate way.