BACKGROUND: The place of health-related quality of life (HRQoL) instruments in clinical research trials and clinical practice as compared to more traditional clinical outcome measures such as headache intensity and frequency is unclear. OBJECTIVES: To review the current status of HRQoL measurement in migraine. METHODS: A literature search was done for HRQoL and migraine. Selected articles dealing with migraine and commonly used HRQoL instruments and HRQoL measures used in recent clinical trials were reviewed. RESULTS: Several general and migraine specific HRQoL instruments can detect changes over time in response to at least major changes in migraine therapy. Both also show a correlation with clinical headache features. However, their sensitivity to detect clinically significant changes over time is not clear. CONCLUSION: The SF-36, a general HRQoL measure and several migraine-specific HRQoL instruments are useful endpoints for migraine clinical trials. Their role in clinical practice is yet to be established.
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Werner J. Becker (2002) studied this question.
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