The study protocol for a multicenter observational headache registry: Brazilian Headache Registry - REBRACEF II
Registro Brasileiro de Cefaleia - REBRACEF II
DOI:
https://doi.org/10.48208/HeadacheMed.2024.35Keywords:
Headache, Epidemiology, real world evidence, Clinical Protocol, Registries, HeadcheAbstract
Objective
This article presents the protocol for the Brazilian Headache Registry (REBRACEF), the first national registry designed to systematically collect real-world data on patients with primary and secondary headaches at specialized centers in Brazil. The main objective is to describe the methods for patient selection, the registry infrastructure, data collection, and the standardized instruments used.
Methodology
REBRACEF is a prospective, observational, multicenter cohort study conducted in real-world settings.
Expected results
This protocol aims to standardize and enable the structuring of the registry, allowing its implementation in other centers across Brazil. It also ensures external feasibility by establishing a robust framework that can be replicated in other national and international healthcare institutions.
Conclusion
The registry protocol provides a standardized framework for the collection of real-world data on patients with primary and secondary headaches, facilitating the improvement of headache management and research in Brazil.
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References
Global Health Estimates [Internet]. [citado 11 de março de 2024]. Disponível em: https://www.who.int/data/global-health-estimates
Feigin VL, Abajobir AA, Abate KH, Abd-Allah F, Abdulle AM, Abera SF, et al. Global, regional, and national burden of neurological disorders during 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet Neurol. 1o de novembro de 2017;16(11):877–97. Doi: 10.1016/S1474-4422(17)30299-5. DOI: https://doi.org/10.1016/S1474-4422(17)30299-5
Lipton RB, Serrano D, Holland S, Fanning KM, Reed ML, Buse DC. Barriers to the diagnosis and treatment of migraine: effects of sex, income, and headache features. Headache. janeiro de 2013;53(1):81–92. Doi: 10.1111/j.1526-4610.2012.02265.x. DOI: https://doi.org/10.1111/j.1526-4610.2012.02265.x
Queiroz LP, Peres MFP, Kowacs F, Piovesan EJ, Ciciarelli MC, Souza JA, et al. Chronic daily headache in Brazil: a nationwide population-based study. Cephalalgia Int J Headache. dezembro de 2008;28(12):1264–9. Doi: 10.1111/j.1468-2982.2008.01670.x. DOI: https://doi.org/10.1111/j.1468-2982.2008.01670.x
Burch R, Rizzoli P, Loder E. The prevalence and impact of migraine and severe headache in the United States: Updated age, sex, and socioeconomic-specific estimates from government health surveys. Headache. janeiro de 2021;61(1):60–8. Doi: 10.1111/head.14024. DOI: https://doi.org/10.1111/head.14024
Mortel D, Kawatu N, Steiner TJ, Saylor D. Barriers to headache care in low- and middle-income countries. eNeurologicalSci. 28 de setembro de 2022;29:100427. Doi: 10.1016/j.ensci.2022.100427. DOI: https://doi.org/10.1016/j.ensci.2022.100427
Dang A. Real-World Evidence: A Primer. Pharm Med. 2023;37(1):25–36. DOI: 10.1007/s40290-022-00456-6. DOI: https://doi.org/10.1007/s40290-022-00456-6
Rudrapatna VA, Butte AJ. Opportunities and challenges in using real-world data for health care. J Clin Invest. 3 de fevereiro de 2020;130(2):565–74. Doi: 10.1172/JCI129197. DOI: https://doi.org/10.1172/JCI129197
EQUATOR Network | Enhancing the QUAlity and Transparency Of Health Research [Internet]. [citado 6 de fevereiro de 2024]. Disponível em: https://www.equator-network.org/
Schwedt TJ, Tassorelli C, Silberstein SD, Szperka CL, Kurth T, Pozo-Rosich P, et al. Guidelines of the International Headache Society for Clinic-Based Headache Registries, 1st edition. Cephalalgia Int J Headache. outubro de 2022;42(11–12):1099–115. Doi: 10.1177/03331024221099035. DOI: https://doi.org/10.1177/03331024221099035
Borges RB, Mancuso ACB, Camey SA, Leotti VB, Hirakata VN, Azambuja GS, et al. Power and sample size for health researchers: uma ferramenta para cálculo de tamanho amostral e poder do teste voltado a pesquisadores da área da saúde. Clin Biomed Res. 2020;247–53. Doi: 10.22491/2357-9730.109542. DOI: https://doi.org/10.22491/2357-9730.109542
ICHD-3-Brazilian-Portuguese. [Internet]. [citado 15 de janeiro de 2024]. Disponível em: https://ihs-headache.org/wp-content/uploads/2021/03/ICHD-3-Brazilian-Portuguese.pdf
Vetvik KG, MacGregor EA. Sex differences in the epidemiology, clinical features, and pathophysiology of migraine. Lancet Neurol. 1o de janeiro de 2017;16(1):76–87. Doi: 10.1016/S1474-4422(16)30293-9. DOI: https://doi.org/10.1016/S1474-4422(16)30293-9
Vanood A, Rangel IC, Starling AJ. Migraine and the Gender Divide. Neurol Clin. 1o de maio de 2023;41(2):231–47. Doi: 10.1016/j.ncl.2023.01.002. DOI: https://doi.org/10.1016/j.ncl.2023.01.002
Fragoso YD. MIDAS (Migraine Disability Assessment): a valuable tool for work-site identification of migraine in workers in Brazil. Sao Paulo Med J. julho de 2002;120:118–21. Doi: 10.1590/s1516-31802002000400006. DOI: https://doi.org/10.1590/S1516-31802002000400006
Wachowska K, Bliźniewska-Kowalska K, Sławek J, Adamczyk-Sowa M, Szulc A, Maes M, et al. Common pathomechanism of migraine and depression. Psychiatr Pol. 30 de abril de 2023;57(2):405–19. Doi: 10.12740/PP/OnlineFirst/143982. DOI: https://doi.org/10.12740/PP/OnlineFirst/143982
Santos IS, Tavares BF, Munhoz TN, Almeida LSP de, Silva NTB da, Tams BD, et al. Sensibilidade e especificidade do Patient Health Questionnaire-9 (PHQ-9) entre adultos da população geral. Cad Saúde Pública. agosto de 2013;29:1533–43. Doi: 10.1590/0102-311X00144612. DOI: https://doi.org/10.1590/0102-311X00144612
de Lima Osório F, Vilela Mendes A, Crippa JA, Loureiro SR. Study of the discriminative validity of the PHQ-9 and PHQ-2 in a sample of Brazilian women in the context of primary health care. Perspect Psychiatr Care. julho de 2009;45(3):216–27. Doi: 10.1111/j.1744-6163.2009.00224.x. DOI: https://doi.org/10.1111/j.1744-6163.2009.00224.x
Tassorelli C, Diener HC, Dodick DW, Silberstein SD, Lipton RB, Ashina M, et al. Guidelines of the International Headache Society for controlled trials of preventive treatment of chronic migraine in adults. Cephalalgia Int J Headache. abril de 2018;38(5):815–32. Doi: 10.1177/0333102418758283. DOI: https://doi.org/10.1177/0333102418758283
Alwhaibi M, Balkhi B, AlRuthia Y. Anxiety and depression and health-related quality of life among adults with migraine: a National Population-Based Study. Front Public Health. 2023;11:1241800. Doi: 10.3389/fpubh.2023.1241800. DOI: https://doi.org/10.3389/fpubh.2023.1241800
Peres MFP, Mercante JPP, Tobo PR, Kamei H, Bigal ME. Anxiety and depression symptoms and migraine: a symptom-based approach research. J Headache Pain. dezembro de 2017;18(1):37. Doi: 10.1186/s10194-017-0742-1. DOI: https://doi.org/10.1186/s10194-017-0742-1
Seo JG, Park SP. Validation of the Generalized Anxiety Disorder-7 (GAD-7) and GAD-2 in patients with migraine. J Headache Pain. 2015;16:97. Doi: 10.1186/s10194-015-0583-8. DOI: https://doi.org/10.1186/s10194-015-0583-8
Spitzer RL, Kroenke K, Williams JBW, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 22 de maio de 2006;166(10):1092–7. Doi: 10.1001/archinte.166.10.1092. DOI: https://doi.org/10.1001/archinte.166.10.1092
Moreno AL, DeSousa DA, Souza AMFLP, Manfro GG, Salum GA, Koller SH, et al. Factor Structure, Reliability, and Item Parameters of the Brazilian-Portuguese Version of the GAD-7 Questionnaire. Temas Em Psicol. 2016;24(1):367–76. Doi: 10.9788/TP2016.1-25 DOI: https://doi.org/10.9788/TP2016.1-25
Vgontzas A, Pavlović JM. Sleep Disorders and Migraine: Review of Literature and Potential Pathophysiology Mechanisms. Headache. julho de 2018;58(7):1030–9. Doi: 10.1111/head.13358. DOI: https://doi.org/10.1111/head.13358
Tiseo C, Vacca A, Felbush A, Filimonova T, Gai A, Glazyrina T, et al. Migraine and sleep disorders: a systematic review. J Headache Pain. 27 de outubro de 2020;21(1):126. Doi: 10.1186/s10194-020-01192-5. DOI: https://doi.org/10.1186/s10194-020-01192-5
Okajima I, Miyamoto T, Ubara A, Omichi C, Matsuda A, Sumi Y, et al. Evaluation of Severity Levels of the Athens Insomnia Scale Based on the Criterion of Insomnia Severity Index. Int J Environ Res Public Health. janeiro de 2020;17(23):8789. Doi: 10.3390/ijerph17238789. DOI: https://doi.org/10.3390/ijerph17238789
Pires AC, Fleck MP, Power M, da Rocha NS. Psychometric properties of the EUROHIS-QOL 8-item index (WHOQOL-8) in a Brazilian sample. Braz J Psychiatry. 26 de março de 2018;40:249–55. Doi: 10.1590/1516-4446-2017-2297. DOI: https://doi.org/10.1590/1516-4446-2017-2297
Risal A, Manandhar K, Holen A, Steiner TJ, Linde M. Comorbidities of psychiatric and headache disorders in Nepal: implications from a nationwide population-based study. J Headache Pain. 2016;17:45. Doi: 10.1186/s10194-016-0635-8. DOI: https://doi.org/10.1186/s10194-016-0635-8
Yu S, Liu R, Zhao G, Yang X, Qiao X, Feng J, et al. The prevalence and burden of primary headaches in China: a population-based door-to-door survey. Headache. abril de 2012;52(4):582–91. Doi: 10.1111/j.1526-4610.2011.02061.x. DOI: https://doi.org/10.1111/j.1526-4610.2011.02061.x
Bond DS, Buse DC, Lipton RB, Thomas JG, Rathier L, Roth J, et al. Clinical Pain Catastrophizing in Women With Migraine and Obesity. Headache. 2015;55(7):923–33. Doi: 10.1111/head.12597. DOI: https://doi.org/10.1111/head.12597
Grazzi L, Montisano DA, Rizzoli P, Guastafierro E, Marcassoli A, Fornari A, et al. A Single-Group Study on the Effect of OnabotulinumtoxinA in Patients with Chronic Migraine Associated with Medication Overuse Headache: Pain Catastrophizing Plays a Role. Toxins. 17 de janeiro de 2023;15(2):86. Doi: 10.3390/toxins15020086. DOI: https://doi.org/10.3390/toxins15020086
Sehn F, Chachamovich E, Vidor LP, Dall-Agnol L, de Souza ICC, Torres ILS, et al. Cross-cultural adaptation and validation of the Brazilian Portuguese version of the pain catastrophizing scale. Pain Med Malden Mass. novembro de 2012;13(11):1425–35. Doi: 10.1111/j.1526-4637.2012.01492.x. DOI: https://doi.org/10.1111/j.1526-4637.2012.01492.x
Polk AN, Protti TA, Smitherman TA. Allodynia and Disability in Migraine: The Mediating Role of Stress. Headache. novembro de 2020;60(10):2281–90. Doi: 10.1111/head.14012. DOI: https://doi.org/10.1111/head.14012
Florencio LL, Chaves TC, Branisso LB, Gonçalves MC, Dach F, Speciali JG, et al. 12 item Allodynia Symptom Checklist/Brasil: cross-cultural adaptation, internal consistency and reproducibility. Arq Neuropsiquiatr. novembro de 2012;70:852–6. Doi: 10.1590/s0004-282x2012001100006. DOI: https://doi.org/10.1590/S0004-282X2012001100006
K B, Wf S. Headache and migraine: a leading cause of absenteeism. Handb Clin Neurol [Internet]. 2015 [citado 4 de janeiro de 2024];131. Disponível em: https://pubmed.ncbi.nlm.nih.gov/26563803/. Doi: 10.1016/B978-0-444-62627-1.00025-1. DOI: https://doi.org/10.1016/B978-0-444-62627-1.00025-1
Lp W, H A, N BP, I C, Yc C, S K, et al. Impact of migraine on workplace productivity and monetary loss: a study of employees in banking sector in Malaysia. J Headache Pain [Internet]. 6 de agosto de 2020 [citado 4 de janeiro de 2024];21(1). Disponível em: https://pubmed.ncbi.nlm.nih.gov/32513174/. Doi: 10.1186/s10194-020-01144-z. DOI: https://doi.org/10.1186/s10194-020-01144-z
Ciconelli RM, Soárez PC de, Kowalski CCG, Ferraz MB. The Brazilian Portuguese version of the Work Productivity and Activity Impairment: General Health (WPAI-GH) Questionnaire. Sao Paulo Med J. novembro de 2006;124:325–32. Doi: 10.1590/s1516-31802006000600005. DOI: https://doi.org/10.1590/S1516-31802006000600005
Bigal ME, Rapoport AM, Bordini CA, Tepper SJ, Sheftell FD, Speciali JG. Burden of migraine in Brazil: estimate of cost of migraine to the public health system and an analytical study of the cost-effectiveness of a stratified model of care. Headache. 2003;43(7):742–54. Doi: 10.1046/j.1526-4610.2003.03132.x. DOI: https://doi.org/10.1046/j.1526-4610.2003.03132.x
Schwedt TJ, Digre K, Tepper SJ, Spare NM, Ailani J, Birlea M, et al. The American Registry for Migraine Research: Research Methods and Baseline Data for an Initial Patient Cohort. Headache J Head Face Pain. 2020;60(2):337–47. Doi: 10.1111/head.13688. DOI: https://doi.org/10.1111/head.13688
Patridge EF, Bardyn TP. Research Electronic Data Capture (REDCap). J Med Libr Assoc JMLA. janeiro de 2018;106(1):142–4. Doi: 10.5195/jmla.2018.319. DOI: https://doi.org/10.5195/jmla.2018.319
Luna F. Informed consent: still a useful tool in research ethics. RECIIS. 8 de dezembro de 2008;2(1):208/184. Doi: 10.3395/reciis.v2.Sup1.208en. DOI: https://doi.org/10.3395/reciis.v2.Sup1.208en
Evidence-Based Medicine Working Group. Evidence-based medicine. A new approach to teaching the practice of medicine. JAMA. 4 de novembro de 1992;268(17):2420–5. Doi: 10.1001/jama.1992.03490170092032. DOI: https://doi.org/10.1001/jama.268.17.2420
Lyu S, Zhang CS, Zhang AL, Sun J, Xue CC, Guo X. Migraine patients visiting Chinese medicine hospital: Protocol for a prospective, registry-based, real-world observational cohort study. PloS One. 2022;17(3):e0265137. Doi: 10.1371/journal.pone.0265137. DOI: https://doi.org/10.1371/journal.pone.0265137
Ashina M, Buse DC, Ashina H, Pozo-Rosich P, Peres MFP, Lee MJ, et al. Migraine: integrated approaches to clinical management and emerging treatments. Lancet Lond Engl. 17 de abril de 2021;397(10283):1505–18. Doi: 10.1016/S0140-6736(20)32342-4. DOI: https://doi.org/10.1016/S0140-6736(20)32342-4
Ruscheweyh R, Klonowski T, Goßrau G, Kraya T, Gaul C, Straube A, et al. The headache registry of the German Migraine and Headache Society (DMKG): baseline data of the first 1,351 patients. J Headache Pain. 1o de julho de 2022;23(1):74. Doi: 10.1186/s10194-022-01447-3. DOI: https://doi.org/10.1186/s10194-022-01447-3
Barbanti P, Egeo G, Aurilia C, Fiorentini G, Proietti S, Tomino C, et al. The first report of the Italian Migraine Registry (I-GRAINE). Neurol Sci Off J Ital Neurol Soc Ital Soc Clin Neurophysiol. setembro de 2022;43(9):5725–8. Doi: 10.1007/s10072-022-06214-5. DOI: https://doi.org/10.1007/s10072-022-06214-5
Martelletti P, Schwedt TJ, Lanteri-Minet M, Quintana R, Carboni V, Diener HC, et al. My Migraine Voice survey: a global study of disease burden among individuals with migraine for whom preventive treatments have failed. J Headache Pain. 27 de novembro de 2018;19(1):115. Doi: 10.1186/s10194-018-0946-z. DOI: https://doi.org/10.1186/s10194-018-0946-z
Buse DC, Reed ML, Fanning KM, Bostic RC, Lipton RB. Demographics, Headache Features, and Comorbidity Profiles in Relation to Headache Frequency in People With Migraine: Results of the American Migraine Prevalence and Prevention (AMPP) Study. Headache J Head Face Pain. novembro de 2020;60(10):2340–56. Doi: 10.1111/head.13966. DOI: https://doi.org/10.1111/head.13966
Adams AM, Serrano D, Buse DC, Reed ML, Marske V, Fanning KM, et al. The impact of chronic migraine: The Chronic Migraine Epidemiology and Outcomes (CaMEO) Study methods and baseline results. Cephalalgia. junho de 2015;35(7):563–78. Doi: 10.1177/0333102414552532. DOI: https://doi.org/10.1177/0333102414552532
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Copyright (c) 2024 Jesuély Spieckert de Souza, Marcos Otávio Brum Antunes, Vinícius da Silva Lessa de Oliveira, Jordana Henz Hammes, Lígia Barros, Rebeca Veras de Andrade Vieira, Mauro Eduardo Jurno, Frederico Friedrich, Vanise Grassi (Author)
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