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The patient's perspective as a medical criterion of migraine


The Patient-reported Outcomes (PROs) are tools used in medicine to quantify the disability and impact on the patient’s quality of life, applicable in migraine. In a daily evaluation of the migraine frequency, the pain intensity, the analgesic consumption, and different PROs questionnaires (MSG and PGI-C) before and after the treatment, researchers from the University Hospital and Research Institute Vall d’Hebron and the UAB’s Department of Medicine have concluded that the PROs evaluation after three months of treatment is crucial to contrast the drug’s efficiency and tolerability. The practice and utility of those questionnaires is intended to aid decision-making by facilitating medical evaluation from the patient's perspective.


Patient-reported Outcomes (PROs) are tools used in medicine to quantify the disability and impact on the patient’s quality of life of caused by different conditions. In migraine, many PROs have been used in clinical trials evaluating the preventive treatment with anti-CGRP monoclonal antibodies. However, the application of all of them is difficult in clinical practice, and most doctors do not use them or only some to complement the information on response to treatment determined by the reduction in migraine days.

This study has two parts, prospectively analyzing a cohort of patients with migraine who started treatment with antibodies in the Headache Clinic. The patients completed a daily diary entering the migraine frequency, the pain intensity and the consumption of painkillers. In addition, they completed different PROs before starting treatment and after receiving 3 doses (that is, 3 months). In the first part of the study, we tried to evaluate which PRO reflected a broader improvement in the traditional efficacy measures of response provided by the diary (reduction in migraine days, intensity and consumption of painkillers). In a second part, we aimed to study which PRO was associated with treatment continuation at 3 months.

In the first analysis, we found that the MSQ questionnaire (Migraine-Specific Quality of Life) was correlated with an improvement in all traditional efficacy measures. This questionnaire measures through 14 items divided into 3 domains (restrictive, preventive and emotional) the quality of life of patients with migraine. Specifically, we found that the restrictive domain, which measures how migraines limit daily social and work-related activities, was the only one correlated with all traditional efficacy measures. Furthermore, we found that an improvement in the PGI-C scale (Patient Global Impression of Change), which assesses the patient's perception of their clinical status through a question, was also associated with an improvement in all efficacy measures. In the second analysis, we found that an improvement in the PGI-C scale and in the MSQ questionnaire were predictors of treatment continuation at 3 months.

In this study, we describe for the first time which PRO can help clinicians with decision-making regarding preventive treatment with antibodies in patients with migraine. The evaluation at 3 months is a crucial point where the efficacy and tolerability of these treatments are evaluated, determined to restrictions in their use. Although in some patients the answer is clear, in others a global assessment is mandatory. Therefore, it is a practical and useful approach that aims to help physicians with decision-making in clinical practice from the patient’s perspective, facilitating the evaluation of physicians who treat them.

Alicia Alpuente (1,2), Victor J. Gallardo (2), Edoardo Caronna (1,2), Marta Torres-Ferrus PhD (1,2), Patricia Pozo-Rosich (1,2)

1.    Headache Unit, Neurology Department, Vall d’Hebron University Hospital 
2.    Headache and Neurological Pain Research Group, Vall d’Hebron Research Institute, Departament de Medicina, UAB


Alpuente, A., Gallardo, V.J., Caronna, E. et al. In search of a gold standard patient-reported outcome measure to use in the evaluation and treatment-decision making in migraine prevention. A real-world evidence study. J Headache Pain 22, 151 (2021). https://doi.org/10.1186/s10194-021-01366-9

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