Guidelines of the International Headache Society for Clinic-Based Headache Registries, 1st edition
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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.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Cephalalgia |
| Vol/bind | 42 |
| Udgave nummer | 11-12 |
| Sider (fra-til) | 1099-1115 |
| Antal sider | 17 |
| ISSN | 0333-1024 |
| DOI | |
| Status | Udgivet - 2022 |
Bibliografisk note
Funding Information:
PPR: within the last 24 months, PPR has received honoraria as a consultant and/or speaker for AbbVie, BCNPeptides, Biohaven, Chiesi, Eli Lilly, Lundbeck, Medscape, Neurodiem, Novartis, Pharvaris, Praxis, and Teva Pharmaceuticals. Her research group has received research grants from AGAUR, EraNet Neuron, FEDER (RIS3CAT), la Caixa foundation, International Headache Society, Instituto Investigación Carlos III, AbbVie, Novartis, Teva Pharmaceuticals; and has received funding for clinical trials from AbbVie, Amgen, Biohaven, Eli Lilly, Lundbeck, Novartis and Teva. PPR serves as an Associate Editor for Cephalalgia, Headache, Frontiers in Neurology, Neurologia and Revista de Neurologia. PPR is the Honorary Secretary of the International Headache Society and serves as a member of the Clinical Trials Committee and the Scientific Committee of the IHS. She is the founder of www.midolordecabeza.org. PPR does not own stocks from any pharmaceutical company.
Funding Information:
CLS has received research/grant support from Miles for Migraine, the National Institutes of Health/National Institute of Neurological Disorders and Stroke (K23 NS102521), and the US Food and Drug Administration (1U18FD006298). CLS or her institution have received compensation for her consulting work for Allergan/AbbVie Inc; Impel NeuroPharma, Inc; Eli Lilly; Lundbeck; Teva Pharmaceutical Industries Ltd; and Upsher-Smith Laboratories, LLC.
Funding Information:
GMT reports consultancy support from Novartis, Allergan, Lilly, and Teva, and has received royalties from UpToDate. She has received independent support from the Dutch Organization for Scientific Research, the Dutch Heart & Brain Foundations, IRRF and Dioraphte.
Funding Information:
CT: Within the last 2 years, CT received fees from Allergan/Abbvie, Eli-Lilly, Lundbeck Novartis, Teva, and WebMD for participating in advisory boards or for lecturing. Her Institute has received income for clinical trials sponsored by Allergan/Abbvie, Eli-Lilly, Lundbeck, Novartis, and Teva. CT has no ownership interest and does not own stocks of any pharmaceutical company. She has received research funding from ERA-NET schemes, Migraine Research Foundation, and the Italian Ministry of Health.
Funding Information:
The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: TJS: Within the prior 24 months, TJS has received personal income from Abbvie, Allergan, Biodelivery Science, Biohaven, Click Therapeutics, Eli Lilly, Equinox, Ipsen, Lundbeck, Novartis, and Satsuma. He holds stock options in Aural Analytics and Nocira and has received royalties from UpToDate. He has received research funding from American Migraine Foundation, Amgen, Henry Jackson Foundation, National Institutes of Health, Patient Centered Outcomes Research Institute, SPARK Neuro, and the United States Department of Defense.
Funding Information:
RBL receives research support from the NIH, FDA as well as the National Headache Foundation and the Marx Foundation. He also receives research support from Allergan/Abbvie, Amgen, Eli Lilly and Electrocore. He receives personal fees as a consultant or advisor from Allergan/Abbvie, Amgen, Biohaven Holdings, Dr. Reddy’s, GlaxoSmithKline, Grifols, Impel NeuroPharma, Novartis, Lundbeck, Merck, and Teva Pharmaceuticals. He holds stock or options in Biohaven Holdings and CtrlM Health.
Funding Information:
HCD received honoraria for participation in clinical trials, contribution to advisory boards or oral presentations from: Lilly, Novartis, Pfizer, Teva and WebMD. The German Research Council (DFG), the German Ministry of Education and Research (BMBF) and the European Union support his headache research. HCD serves on the editorial boards of Cephalalgia and Lancet Neurology. HCD is member of the Clinical Trials Committee of the IHS.
Funding Information:
TK: received outside of the submitted work research grants from the German Joint Committee and the German Ministry of Health; personal compensation form Eli Lilly & Company, Teva, TotalEnergeis and the BMJ.
Publisher Copyright:
© International Headache Society 2022.
ID: 345057681