TY - JOUR

T1 - Guidelines of the International Headache Society for Clinic-Based Headache Registries, 1st edition

AU - Schwedt, Todd J.

AU - Tassorelli, Cristina

AU - Silberstein, Stephen D.

AU - Szperka, Christina L.

AU - Kurth, Tobias

AU - Pozo-Rosich, Patricia

AU - Amin, Faisal Mohammad

AU - Lipton, Richard B.

AU - Dodick, David W.

AU - Ashina, Messoud

AU - Diener, Hans-Christoph

AU - Terwindt, Gisela M.

N1 - Publisher Copyright: © International Headache Society 2022.

PY - 2022

Y1 - 2022

N2 - 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.

AB - 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.

KW - biobank

KW - biorepository

KW - common data elements

KW - database

KW - Headache

KW - migraine

KW - patient reported outcomes

KW - real world evidence

KW - registry

U2 - 10.1177/03331024221099035

DO - 10.1177/03331024221099035

M3 - Journal article

C2 - 35514209

AN - SCOPUS:85139386329

VL - 42

SP - 1099

EP - 1115

JO - Cephalalgia

JF - Cephalalgia

SN - 0800-1952

IS - 11-12

ER -