Patient-centered outcomes for frequent headaches.

Objective: To identify clinical outcomes that headache sufferers consider meaningful.

Background: Several standardized instruments have been developed to assess the severity of headaches and the impact of headaches on an individual's quality of life. To our knowledge, however, little research has been conducted to determine which of these many clinical endpoints are considered by headache sufferers themselves to be most important.

Methods: We conducted 4 focus groups with patients with frequent headaches who had recently participated in a randomized clinical trial. Subjects were informed that the purpose of the focus groups was to help healthcare providers learn how to better recognize if their patients' headache conditions improved or worsened over time.

Results: Five salient topics emerged from the discussions: (1) severity of pain associated with headaches; (2) definition of meaningful symptom relief; (3) uncertainty regarding timing and severity of headaches; (4) devaluation of the impact of headaches on sufferers; and (5) assessments of pain. Participants stated unambiguously that headache pain is one of the most important aspects of their headache experience. Each of the 4 groups agreed that an increase in the number of pain-free days would be meaningful. Participants also reported that daily headache diaries are not overly burdensome to complete and that the diaries helped them identify useful trends over time.

Conclusions: Our findings suggest that severity and frequency of headache pain are important clinical outcomes from patients' perspective, and that headache diaries are a feasible and useful method of assessing meaningful clinical change over time. Although standardized questionnaires that assess functional status, disability, or health-related quality of life may help quantify patients' response to treatment for frequent headaches, participants in this study did not consider such questionnaires particularly informative. Further research is needed to validate headache diaries among patients with headache in the primary care setting.