More than 60% of adolescents felt that it was more important to measure decreases in the frequency and intensity of headaches in terms of severe headaches/spikes rather than total headache days.
In an effort to understand patient-valued outcome measures for headache preventive treatments, new results from a pilot study showed that adolescents care most about outcomes reflecting headache intensity, while the parents of these adolescents value outcomes directed at assessing functional impact.1
The pilot study, led by Cynthia Morris, MD, pediatric neurologist, St. Louis University, included 55 adolescents with an International Classification of Headache Disorders diagnosis of chronic migraine (CM) who had continuous headache and who were being care for at a tertiary pediatric headache clinic, and 60 of their parents. Developed in Research Electronic Data Capture, the final distributed survey questionnaire contained 78 multiple-choice questions covering demographics, headache history, number of previous preventive medication treatment trials, school attendance, and questions on participant’s preferences for measuring treatment outcomes.
Although children and adolescents with CM who have continuous headache may have high levels of headache-related disability, they have been largely excluded from clinical trials. The mean age of the adolescents in this study was 16 years, 82% of whom were female. Among parents, 57% (33 of 58) reported having a history of headaches themselves. Adolescents reported a median of 24 months (IQR, 12-39) of continuous headache and parents reported a median duration of 30 months (IQR, 12-42).
Although adolescents reported a median of 2 prior preventive medication trials (IQR, 0-5), only 13% of them believed their preventive medication was helpful. Regarding functional impact of headaches, adolescents and parents reported missing a median of 10 days of activities per month. Furthermore, adolescents reported missing a median of 3 full days and 0 partial days of school per month, while parents reported a median of 4 full days and 2 partial days of school per month.
When assessing patient-valued outcome measures, headache severity was the most important category for adolescents, while parents valued functional impact of headaches, followed closely by headache frequency and severity. When asked to select the outcome measure most important to them in assessing response to headache treatment, both adolescents and parents selected frequency of severe headaches followed by intensity of background headache. Overall, outcome measures related to characteristics of the headaches themselves—frequency and intensity of headaches—were more highly ranked than those related to functional impact, associated symptoms, or acute medication use.
Morris et al noted that while these findings serve as groundwork for clinicians, "future research is encouraged to build on this work in a broader population with validated surveys that incorporate NIH common data elements and validated instruments such as PedMIDAS for assessing disability, as well as evaluation of specific headache features (eg, length of continuous headache to date) as potential moderators of patient preferences."
Within the respective categories of headache frequency and severity, 61% and 70% of adolescents reported that it was more important to measure both the frequency and intensity of severe headaches rather than the frequency or intensity of background headaches, while parents were more divided. Among outcomes reflecting need for acute intervention, both parents and adolescents felt that improved efficacy of acute medications were more important than decrease in frequency of acute medication use. In total, 75% of parents felt that decrease in frequency of contacting providers was more meaningful than decrease in frequency of emergency room visits (26%), while adolescents valued these measures equally.
The mental or cognitive impact of headaches was rated as the most important outcome by both adolescents and parents when evaluating specific outcomes related to functional impact of headache. The next highest rated outcome in this section was physical impact of headache for adolescents and emotional impact of headache for parents. Among outcomes related to associated symptoms, brain fog was reported as the most important outcome measure by both adolescents and parents.
With regard to how adolescents and parents viewed brain fog, the investigators wrote that “this measure likely reflects the significant cognitive burden continuous headache due to chronic migraine causes in this population, as reflected by evidence that higher frequency of headaches is associated with poorer school performance."