“Migraine attacks can be severely burdensome, intensely painful, and debilitating, often interfering with daily living,” explains Rebecca M. Speck, PhD, MPH. “However, the burden of living with migraine is often not captured. My colleagues and I conducted an investigation of the content validity of the 24-Hour Migraine Quality of Life Questionnaire (24-Hr MOoLQ). The only previously published qualitative research was initially done to support the instrument’s development. We sought to gather more evidence to demonstrate that the instrument is content valid and meaningful to patients.”

For a paper published in Headache, Dr. Speck and colleagues conducted one-on-one interviews with 11 patients with episodic migraine. The interviews—which were audio-recorded, transcribed, and analyzed using the constant comparative method—followed methods appropriate for concept elicitation, cognitive debriefing, and usability testing.

PRO Provides Greater Insight into Burden of Migraine

“While the primary endpoints for acute treatment of migraine in clinical trials are freedom from both pain and the most bothersome symptoms at 2 hours post-dose, patient-reported outcome (PRO) measures can provide more insight into the burden of migraine,” Dr. Speck says. “One of the significant PROs for measuring the health-related quality of life (HRQoL) of patients with migraine is the 24-Hr MQoLQ instrument.”

The instrument, she explains, includes 15 items covering the domains of work functioning, social functioning, energy and vitality, feelings and concerns, and migraine symptoms. It was designed to capture these concepts within 24 hours of treating a migraine attack. For the purpose of this study, the 24-Hr MQoLQ was installed on the ePRO device, an electronic handheld tool about the size of a mobile phone that captures input from subjects and transmits data electronically for analysis.

Facilitating Communication Between Providers & Patients

A key finding, Dr. Speck notes, is that the instrument is content valid in that concepts are relevant and important to patients with migraine. “By assessing the impact that migraine is having on their patients’ lives, clinicians can make appropriate treatment decisions,” Dr. Speck says. “Yet, we know that communication is often lacking between providers and patients. This instrument can help facilitate meaningful dialogue between both parties.”

Dr. Speck and colleagues also observed that the saturation of symptoms was reached, which is indicated by no new symptoms being spontaneously mentioned after the ninth participant interview. (Table) “This demonstrates that the tool was able to adequately capture the symptoms of migraine that are important and relevant,” she says.

The main implication of this study is that physicians have an instrument that measures concepts that are relevant to patients with migraine, according to Dr. Speck. “It can be used in clinical practice to help determine if patients are benefiting from their acute migraine therapies,” she says. “It’s imperative that patient perspective on symptoms and day-to-day impact of migraine be included as part of a physician’s assessment of a patient’s overall well-being. Tools that improve communication between providers and patients can lead to better care. In addition, incorporating PROs that measure the burden of migraine into clinical trials and other research can help paint a better picture of that burden and the effectiveness of treatment.”

Looking Ahead 

As for the study’s small sample of 11 subjects, Dr. Speck explains that for the purposes of this research objective, the sample size was adequate and the concept saturation data support this. Still, she says “it would certainly be a contribution to the literature and further support the use of the 24‐Hr MQoLQ instrument for additional data to be collected from a more racially and culturally diverse patient population. Given that population-based studies show that around two of every five people with migraine are not able to effectively work or spend time with family or friends at least 1 day a week, it is essential that patient perspective on the burden of migraine continue to be studied, Evidence about the psychometric properties needs to be published and that work is in progress with the study team.”