DEVELOPMENT OF A NOVEL PATIENT-REPORTED OUTCOME MEASURE FOR HEADACHE DISORDERS: THE HEADACHE-Q
Manraj Kaur1, Elena Tsangarias2, Merel H. Hazewinkel*3, Sait Ashina4, William G. Austen5, Anne Klassen6, Andrea Pusic2, Lisa Gfrerer3
1Department of Surgery, Patient-Reported Outcomes, Value and Experience (PROVE) Center, Brigham and Women's Hospital, Boston, MA; 2Brigham and Women's Hospital, Harvard Medical School, Boston, MA; 3Department of plastic & Reconstructive surgery, Weill Cornell Medicine, New York City, NY; 4BIDMC Comprehensive Headache Center, Department of Neurology and Department of Anaesthesia, Critical Care and Pain Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Boston, MA; 5Division of Plastic and Reconstructive Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, MA; 6Department of Pediatrics, McMaster University, Hamilton, ON, Canada
A recent systematic review concluded that no single comprehensive, rigorously developed, validated Headache disorders (HD)-specific Patient-reported Outcome Measure (PROM) currently exists. This study fills this gap by developing a HD-specific PROM, called the HEADACHE-Q.
We use a multi-step, mixed methods approach to develop PROMs. This abstract describes the first step which includes the use of qualitative methods to develop content validity of the PROM. In-depth, semi-structured interviews were conducted with adults with HD at the outpatient clinic. Purposive, maximal variation sampling technique was used to ensure representation of diverse age groups, HD diagnosis and treatments. A semi-structured interview guide was used. During the interviews, the participants were asked to describe the impact of HD and the treatments on their Health Related Quality of Life (HRQL). The data were analyzed and constant comparison was used to develop an item pool and a preliminary conceptual framework.
21 interviews (76% females; 48 ± 8 years) were conducted that resulted in an item pool and a preliminary conceptual framework with two top-level domains of HRQL and experience of care. All patients had undergone pharmacologic treatment including CGRP antagonist treatment (80%). All participants described the experience of HD in terms of pain (type, frequency, duration and relieving factors). In terms of impact of HD, most participants described the impact on psychological function (anxiety, worry, frustration), cognitive function (brain fog, memory loss), day-to-day function (selfcare, sleep), work (taking time off work, changing professions), and social life (isolation). Participants also described varying levels of HD relief with treatment(s).
The conceptual framework and the item pool will be used to develop the drafts of HEADACHE-Q scales such that the scales are unidimensional and independently functioning. Following this, we will conduct an international, multi-center study to establish psychometric properties of the HEADACHE-Q.
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