PDF(Pubmed)
Abstract：
Clinic-based headache registries collect data for a wide variety of purposes including delineating disease characteristics, longitudinal natural disease courses, headache management approaches, quality of care, treatment safety and effectiveness, factors that predict treatment response, health care resource utilization, clinician adherence to guidelines, and cost-effectiveness. Registry data are valuable for numerous stakeholders, including individuals with headache disorders and their caregivers, healthcare providers, scientists, healthcare systems, regulatory authorities, pharmaceutical companies, employers, and policymakers. This International Headache Society document may serve as guidance for developing clinic-based headache registries. Use of registry data requires a formal research protocol that includes: 1) research aims; 2) methods for data collection, harmonization, analysis, privacy, and protection; 3) methods for human subject protection; and 4) publication and dissemination plans. Depending upon their objectives, headache registries should include validated headache-specific questionnaires, patient reported outcome measures, data elements that are used consistently across studies (i.e., \"common data elements\"), and medical record data. Amongst other data types, registries may be linked to healthcare and pharmacy claims data, biospecimens, and neuroimaging data. Headache diagnoses should be made according to the International Classification of Headache Disorders diagnostic criteria. The data from well-designed headache registries can provide wide-ranging and novel insights into the characteristics, burden, and treatment of headache disorders and ultimately lead to improvements in the management of patients with headache.
摘要：
以诊所为基础的头痛登记处收集各种目的的数据，包括描绘疾病特征，纵向自然疾病病程，头痛管理方法，护理质量,治疗的安全性和有效性，预测治疗反应的因素，卫生保健资源利用，临床医生遵守指南，和成本效益。书记官处的数据对许多利益攸关方来说都很有价值，包括头痛患者和他们的照顾者，医疗保健提供者，科学家,医疗保健系统,监管机构,制药公司,雇主,和政策制定者。该国际头痛学会文件可作为开发基于临床的头痛登记处的指导。使用注册数据需要正式的研究协议，包括：1）研究目标；2）数据收集方法，协调,分析,隐私,和保护；3）保护人类受试者的方法；和4）出版和传播计划。根据他们的目标，头痛登记处应包括经过验证的头痛特异性问卷，患者报告的结果指标，在研究中一致使用的数据元素(即，“通用数据元素”)，和医疗记录数据。在其他数据类型中，登记册可能与医疗保健和药房索赔数据相关联，生物标本,和神经影像数据。头痛诊断应根据国际头痛疾病分类诊断标准进行。来自精心设计的头痛登记处的数据可以提供对这些特征的广泛和新颖的见解，负担，和治疗头痛疾病，并最终导致改善头痛患者的管理。
