指南更新：《国际头痛学会儿童和青少年偏头痛预防性治疗对照试验指南》（第一版）——基于经验的更新。
Guidelines Update: Guidelines of the International Headache Society for controlled trials of preventive treatment of migraine in children and adolescents, 1st edition - An experience-based update.
机构信息
Paediatric Neurosciences Uit, Royal Hospital for Children, Glasgow, UK.
Department of Pediatrics and Neurology, Cincinnati Children's Hospital, University of Cincinnati, College of Medicine, Cincinnati, OH, USA.
出版信息
Cephalalgia. 2023 May;43(5):3331024231178239. doi: 10.1177/03331024231178239.
BACKGROUND
Recent experience in designing and running clinical trials on new medications for the prevention of migraine in children and adolescents highlighted the need for revision of the 1st edition of the International Headache Society Guidelines for clinical trials of preventive treatment of migraine in children and adolescents which were published in 2019.
METHODS
The authors of the 1st edition of the guidelines formed an informal focus group with aims of appraising the performance of the guidelines, clarifying any ambiguity and providing improvements, where needed, based on personal experience and expert analysis.
RESULTS
This review and the following update were able to address issues related to the classification of migraine, the duration of migraine attacks, the age groups of children and adolescents, the use of electronic diaries, the assessment of outcome measures, the need for an interim analysis and the issues related to placebo response.
CONCLUSIONS
This update provides necessary clarifications of the guidelines in order to enable better design and running of future clinical trials for the preventive treatment of migraine in children and adolescents.
背景
最近在设计和开展预防儿童和青少年偏头痛新药临床试验方面的经验突显了修订 2019 年发布的《国际头痛学会儿童和青少年偏头痛预防性治疗临床试验指南》第 1 版的必要性。
方法
指南第 1 版的作者组成了一个非正式焦点小组，旨在评估指南的表现，根据个人经验和专家分析澄清任何歧义，并在需要时进行改进。
结果
本次审查和以下更新能够解决与偏头痛分类、偏头痛发作持续时间、儿童和青少年年龄组、电子日记的使用、结局评估、中期分析的必要性以及与安慰剂反应相关的问题。
结论
本次更新对指南进行了必要的澄清，以便更好地设计和开展未来预防儿童和青少年偏头痛的临床试验。
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