Abstract
Background
This study aimed to validate a semi-quantitative composite score tool, “Headache Gauge” (HG), to monitor the treatment effect in primary headaches in everyday clinic practice, adjustable to any chosen timeframe.
Method
A cohort validation study of HG was performed in primary headache patients, recovering their clinical data and patient-related outcome measures (PROMs) for headache (HIT-6, MIDAS, HURT), work impact (WPAIQ), quality-of-life (SF-12), and mood (STAI, ZUNG). HG score distribution, its relation to clinical variables, its internal consistency, and its convergent validity were determined.
Results
HG was plotted in 233 patients: 90.1% females, age average 37 years, 86% with migraine, 27% with chronic headaches, and 28% with medication overuse. HG ranged from 0.21 to 58.3 in this sample, higher in chronic headaches (HG 16) and medication overuse (HG 15). HG presented good concurrent validity, significantly correlating with HIT-6 (p < 0.0001), SF-12 (p = 0.001), WPAIQ (p < 0.0001), MIDAS (p < 0.0001), and HURT (p < 0.0001). Good sensitivity to change (p < 0.001) and moderate test-retest reliability (p = 0.001) were calculated after reassessment of 147 patients (63.1% of the initial sample).
Conclusions
Headache Gauge is a clinical data-based outcome measure that conceptually translates the percentage of lost time to headache in any given timeframe. It relates to headache impact, therefore bearing the potential to be relevant in real-life clinical monitoring.
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Data availability
Additional data will be made available to interested researchers upon request.
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Acknowledgements
The authors would like to acknowledge the technical help of Alexandre Maia Barbosa for programming the freeware app available on bit.ly/headachegauge.
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Raquel Gil-Gouveia, MD, PhD (Hospital da Luz, Lisboa, Portugal): conception and design of the study, acquisition and analysis of data, drafting a significant portion of the manuscript and figures, editing and approval of the final draft. Inês Brás Marques, MD (Hospital da Luz, Lisboa, Portugal): contributed to study design, acquisition of data, critical review of the manuscript, copy editing and approval of the final draft. Elsa Paixão Parreira, MD (Hospital da Luz, Lisboa, Portugal): contributed to study design, acquisition of data, critical review of the manuscript, copy editing and approval of the final draft. Isabel Pavão Martins, MD, PhD (Hospital de Santa Maria, and University of Lisbon, Portugal): contributed to study design, acquisition of data, critical review of the manuscript, copy editing and approval of the final draft. António Gouveia Oliveira, MD, PhD (Universidade Federal do Rio Grande do Norte, Natal, Brasil): responsible for most of the statistical analysis of data, drafting the manuscript, critical review of the data and manuscript, copy editing and approval of the final draft.
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None of the authors has conflicts of interest to disclose. The authors authorize the use of Headache Gauge freely.
Ethical approval
The study protocol was approved by the Hospital’s Institutional Review Board and local data protection officer and all patients gave written informed consent.
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Gil-Gouveia, R., Marques, I.B., Parreira, E.P. et al. Headache Gauge: a real-life calendar-based tool for headache monitoring. Neurol Sci 42, 4163–4174 (2021). https://doi.org/10.1007/s10072-021-05080-x
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DOI: https://doi.org/10.1007/s10072-021-05080-x