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Published on: June 2, 2014
Evaluating the relationship between the 4-item migraine interictal burden scale and other patient-reported outcome
Christian Lampl1, Richard B Lipton2,3, Sarah Lipsius4
1Hospital Barmherzige Brüder Linz, Linz, Austria.
Background:
People with migraine report reduced health-related quality of life during ictal and interictal phases. However, most patient-reported outcome measures (PROMs) focus on impact during migraine episodes (ictal) or globally (both ictal and interictal), potentially neglecting interictal burden. This exploratory analysis evaluated correlations between the 4-item Migraine Interictal Burden Scale (MIBS-4) total score and other PROMs in people with migraine.
Methods:
A post hoc analysis was conducted using participant data from a galcanezumab phase 3, placebo-controlled, 3-month study, followed by a 3-month open-label extension in participants with prior treatment failures. Correlations were assessed between baseline MIBS-4 and disease characteristics, baseline MIBS-4 and demographics, and MIBS-4 and other PROMs/monthly migraine headache days at baseline and at Month (M) 6, using Spearman's rank correlation coefficient (rs).
Results:
A total of 462 participants were included (mean age: 45.8 years); 85.9% were female, 58.2% had episodic migraine and 41.8% had chronic migraine. At baseline, highest correlations with MIBS-4 were observed for Migraine Specific Quality of Life Questionnaire (MSQ)-total score, MSQ-Emotional Function (MSQ-EF), and the Patient Health Questionnaire (PHQ-9) score, which measures depressive symptoms (all p < 0.001). Correlation analysis between MIBS-4 and MSQ-total score revealed moderate correlation at baseline (r s:-0.53) that transitioned to moderate-high at M6 (r s:-0.70). MIBS-4 was moderately correlated with PHQ-9 score at baseline (r s:0.55) and M6 (r s:0.55). The Migraine Disability Assessment score transitioned from moderate-low correlation at baseline (r s:0.41) to moderate at M6 (r s: 0.53) and Generalized Anxiety Disorder score had moderate-low correlation at both time points (r s:0.42-0.47). MIBS-4 had moderate-negligible correlation with monthly migraine headache days at baseline (r s:0.21) and low correlation at Month 6 (r s:0.32).
Conclusion:
Interictal burden, as assessed by MIBS-4, was moderately correlated with PROMs like MSQ, PHQ-9, and MIDAS, but moderate-negligible to low correlation was observed with monthly migraine headache days. These results indicate that interictal burden is a unique construct that is correlated with, but not fully captured by, other measures and should be considered when managing people with migraine.
Clinical Trial Registration:
ClinicalTrials.gov identifier NCT03559257.
Insights
The Migraine Interictal Burden Scale (MIBS-4) captures unique aspects of migraine burden beyond typical symptom tracking. This scale is moderately correlated with quality of life and depression measures, highlighting its value in comprehensive migraine management.
Area of Science:
- Neurology
- Psychiatry
- Health Outcomes Research
Background:
- Migraine significantly impacts health-related quality of life during both active episodes and symptom-free periods.
- Existing patient-reported outcome measures (PROMs) often focus on active migraine episodes or overall impact, potentially overlooking the burden experienced between attacks.
- This study explored the correlation of the Migraine Interictal Burden Scale (MIBS-4) with other PROMs to assess its ability to capture interictal migraine burden.
Purpose of the Study:
- To evaluate the correlations between the 4-item Migraine Interictal Burden Scale (MIBS-4) total score and other PROMs in individuals with migraine.
- To determine if MIBS-4 captures a unique aspect of interictal burden not fully represented by other measures.
Main Methods:
- A post hoc analysis of data from a 6-month galcanezumab clinical trial (3 months placebo-controlled, 3 months open-label extension) was performed.
- Spearman's rank correlation coefficient (rs) was used to assess relationships between baseline MIBS-4 scores and demographics, disease characteristics, and other PROMs.
- Correlations were examined at baseline and Month 6, including the Migraine Specific Quality of Life Questionnaire (MSQ), Patient Health Questionnaire (PHQ-9), Migraine Disability Assessment (MIDAS), and Generalized Anxiety Disorder (GAD-7) scores.
Main Results:
- The MIBS-4 showed moderate correlations with MSQ-total score (baseline: rs=-0.53; Month 6: rs=-0.70) and PHQ-9 (baseline & Month 6: rs=0.55).
- Correlations with MIDAS transitioned from moderate-low (baseline: rs=0.41) to moderate (Month 6: rs=0.53), while GAD-7 showed moderate-low correlations (rs=0.42-0.47).
- MIBS-4 demonstrated moderate-negligible to low correlation with monthly migraine headache days (baseline: rs=0.21; Month 6: rs=0.32).
Conclusions:
- The MIBS-4 effectively assesses interictal migraine burden, showing moderate correlations with quality of life, depression, and anxiety measures.
- Interictal burden measured by MIBS-4 is a distinct construct, partially captured by other PROMs but not fully explained by monthly headache frequency.
- The findings support considering MIBS-4 in the comprehensive management of individuals experiencing migraine.