Guidelines of the International Headache Society for controlled trials of preventive treatment of migraine in children and adolescents, 1st edition
Guidelines of the International Headache Society for controlled trials of preventive treatment of migraine in children and adolescents, 1st edition
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DOI：
10.1177/0333102419842188
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发表时间：
2019-06-01
期刊：
影响因子：
4.9
通讯作者：
Tassorelli, Cristina
中科院分区：
文献类型：
--
作者：
Abu-Arafeh, Ishaq;Hershey, Andrew D.;Tassorelli, Cristina
背景由于研究治疗的临床试验结果影响监管政策、处方模式和临床实践中的使用，高质量的试验是偏头痛证据基础的重要组成部分。自1991年以来，国际头痛协会已经发布了成人偏头痛临床试验指南。随着偏头痛儿童和青少年特有的多重问题，以及药物、生物制剂、设备和行为干预方面新的试验设计和进展的出现，有必要对偏头痛儿童和青少年临床试验的特定问题提供指导。目的这些指南的目标是提供一种现代的、标准化的和基于证据的方法来设计、实施和报告儿童和青少年偏头痛预防治疗的良好控制的临床试验。这些建议是以证据为基础的，只要有可能。这一过程包括各委员会之间的磋商，利益相关者(非专业人士和制药行业)之间的圆桌讨论，以及与IHS成员就最终草案进行公开磋商。建议得到了循证实践和有效方法的支持。结论在设计和进行儿童和青少年偏头痛预防治疗的临床试验时，应参考和使用这些指南。
Background Because the results of clinical trials of investigational treatments influence regulatory policy, prescribing patterns, and use in clinical practice, high quality trials are an essential component of the evidence base for migraine. The International Headache Society has published guidelines for clinical trials in adults with migraine since 1991. With multiple issues specific to children and adolescents with migraine, as well as the emergence of novel trial designs and advances in pharmaceuticals, biologics, devices, and behavioural interventions, there is a need for guidance focusing on issues specific to the conduct of clinical trials in children and adolescents with migraine.Objectives The objective of these guidelines is to provide a contemporary, standardized, and evidence-based approach to the design, conduct, and reporting of well-controlled clinical trials of preventive treatment of migraine in children and adolescents.Methods The development of these guidelines was based on guidelines previously published by the International Headache Society and regulatory bodies. The recommendations are evidence-based, where available. The process included consultations among various committees, roundtable discussions among stakeholders (lay people and the pharmaceutical industry), and open consultation with the IHS membership on the final draft.Results A series of recommendations addressing the major issues in clinical trials in children and adolescents with migraine is provided. Recommendations are supported by evidence-based practice and validated methodologies, where available. Supporting comments are provided to clarify ambiguities.Conclusions These guidelines should be consulted and used in designing and conducting clinical trials of preventive treatments in children and adolescents with migraine.