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

The Journal of Headache and Pain

Marta Torres-Ferrus¹  Edoardo Caronna¹  Alicia Alpuente¹  Patricia Pozo-Rosich²  Victor J Gallardo³ 

[1] Headache Unit, Neurology Department, Vall d’Hebron University Hospital, Barcelona, Spain;Headache and Neurological Pain Research Group, Vall d’Hebron Research Institute, Departament de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain;Headache Unit, Neurology Department, Vall d’Hebron University Hospital, Barcelona, Spain;Headache and Neurological Pain Research Group, Vall d’Hebron Research Institute, Departament de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain;Headache Unit, Neurology Department, Hospital Universitari Vall d’Hebron, 119-129 Passeig de la Vall d’Hebron, 08035, Barcelona, Spain;Headache and Neurological Pain Research Group, Vall d’Hebron Research Institute, Departament de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain;

关键词: Headache;    Migraine;    Outcomes;    Patient-reported outcome;    Health-related quality of life;    Efficacy;    anti-CGRP monoclonal antibodies;   

DOI  :  10.1186/s10194-021-01366-9

来源: Springer

【 摘 要 】

BackgroundPatient-Reported Outcomes (PROs) have been developed to numerically quantify disability, impact and quality of life. They have been widely used in migraine clinical trials. However, we still do not know which PRO more accurately reflects preventive treatment response from a patient’s perspective or which one may help us with treatment decisions in clinical practice. They have been used to enforce the efficacy results in clinical trials and real-world evidence so far. The aim of this study was to analyze which PROM is (1) better correlated with all primary efficacy endpoints and (2) which one is better associated with treatment continuation with CGRP-mAbs at week-12, which is usually the moment when this decision is made.MethodsPatients with migraine who had received 3 administrations of CGRP-mAbs were evaluated in this prospective cohort study. Primary efficacy outcomes considered: a change in migraine days (MMD), headache days (MHD), pain intensity (INT), acute medication days (AMD) and 50% responder rate. The Spearman coefficient (rs) was the measure used for quantify the strength of the correlation between PROMs and treatment efficacy outcomes changes. A stepwise logistic regression identified which PROM was independently associated with treatment continuation at week-12.Results263 patients completed 12 weeks of treatment. The efficacy outcomes and PROMs scores were statistically significantly reduced at week-12 for all patients. The role function-restrictive (RFR) domain of the Migraine-Specific Quality of Life (MSQ) questionnaire was statistically significantly correlated with all primary efficacy outcomes. Relative changes in MSQ total score (OR[95%]: 0.840[0.619-0.973]; p=0.037) and Patient Global Impression of Change (PGIC) scale (OR[95%]: 15.569[6.254-31.533]; p<0.001) were the PROMs associated with treatment continuation as independent factors at week-12.ConclusionsChanges in MSQ questionnaire and PGIC scale at week-12 were the PROMs with higher association with CGRP-mAbs response from a patient’s perspective and medical decision-taking.

【 授权许可】

CC BY