Associations Between Headache-Free Days and Patient-Reported Outcomes Among Migraine Patients: A Cross-Sectional Analysis of Survey Data in Europe

Abstract

IntroductionMigraine imposes a substantial burden on patients, society, and healthcare systems. This study aimed to assess the associations between the number of headache-free days (HFDs) and health-related quality of life (HRQoL), work productivity and activity impairment (WPAI), and healthcare resource utilization (HRU) in patients with migraine in the EU5 (France, Germany, Italy, Spain, and the United Kingdom).MethodsThis retrospective cross-sectional study collected survey responses from adults aged ≥ 18 years from the 2017 National Health and Wellness Survey (N = 62,000). Migraine patients with a physician’s diagnosis of migraine and who had experienced at least 4 monthly headache days in the prior month were included (N = 1569). Number of HFDs was compared with Short-Form 12-Item Survey Instrument, version 2 (SF-12v2) physical and mental component summary scores (PCS and MCS), Short-Form-6D (SF-6D) and EuroQoL-5D (EQ-5D) scores, WPAI, and HRU in migraine patients. Correlation analyses were conducted to test the bivariate associations, whereas generalized linear models were used for multivariable analyses.ResultsAn increase of 1 HFD was associated with average increases of 0.171, 0.306, 0.003, and 0.008 points for MCS, PCS, SF-6D utility score, and EQ-5D index score, respectively (p < 0.001 for all). Extrapolating the results to a tenfold increase in monthly HFDs corresponded to clinically meaningful increases in PCS and EQ-5D scores. An increase of 1 HFD was associated with expected average decreases in absenteeism of 3.9% and presenteeism of 2.1%. Further, an increase of 1 HFD was associated with expected decreases in HCP visits and neurologist visits of 1.0% and 4.7%, respectively.ConclusionAn increase in the number of HFDs was associated with better health-related outcomes in patients suffering from migraine. Further, the results demonstrate a need for more effective treatments that can reduce migraine frequency and thus improve HRQoL, increase work productivity, and reduce both activity impairment and HRU.FundingNovartis Pharma AG, Switzerland.

Changes in headache characteristics with oral appliance treatment for obstructive sleep apnea

“…Although the improvement was majorly in overall headache frequency, severest headache intensity also significantly decreased in the headache responder group. Decrease in headache frequency itself is known to lead to a significant improvement in patient quality of life 27 and based on such observations, headache frequency is also considered an important criterion in evaluating treatment success for headaches 28 . Overall, the patients with headache still had related symptoms after OA treatment but the severity and level of disability due to headaches showed a decrease.…”

Identifying Outcome Measures for Migraine Value‐Based Contracting Using the Delphi Method

“…An individual's self-report of such measures, including migraine frequency and severity, can elucidate the true impact of migraine on a person's quality of life and function. 14,[48][49][50][51] Moreover, patient-reported metrics are vital to understanding the efficacy of therapeutic interventions for migraine. 14,[48][49][50][51] When designing a value-based contract for migraine medications, our survey presents an innovative opportunity to work toward operationalizing the inclusion of patient-reported outcome measures.…”

“…14,[48][49][50][51] Moreover, patient-reported metrics are vital to understanding the efficacy of therapeutic interventions for migraine. 14,[48][49][50][51] When designing a value-based contract for migraine medications, our survey presents an innovative opportunity to work toward operationalizing the inclusion of patient-reported outcome measures. Operationally, one could consider collecting these data through tools such as the Headache Impact Test-6 34,48,52 or Migraine Disability Assessment, 48,53,54 both of which are validated to assess headache-related disability.…”

Demographic and clinical characteristics of prevention-eligible patients with migraine in the US: a linked national survey and administrative claims database study

“…In the few studies that do examine the characteristics and burden of migraine using a cutoff of ≥4 monthly headache days, all outcomes are self-reported [28][29][30]. To our knowledge, no research has combined survey data with closed medical claims and closed pharmacy claims to examine the characteristics and health-related and economic burden of migraine patients.…”

“…Normal weight (18.5 to <25.0 kg/m 2 ) 135 (30) 91 (31) 44 (28) Overweight (25 to <30.0 kg/m 2 ) 109 (24) 64 (22) 45 (28) Obese (30.0 kg/m 2 and above)…”