Grants We Funded

Abstract

Project Summary: Current patient reported outcome measures (PROMs) that are used to determine the impact of headache disorders (HD) and HD treatment have significant methodological flaws including lack of representation of all HD types and treatment options, no reliability and validity studies, and failure to include patient interviews. The objective of this project is to develop the HEADACHE-Q, a high quality, clinically meaningful and scientifically sound PROM for patients suffering from HD. This PROM will be the first questionnaire to include patients who undergo surgical management for HD. Inclusion of headache surgery patients is critical for plastic surgeons performing this procedure to allow for objective evaluation of outcomes and comparison of outcome between treatment types. The long- term goal of the HEADACHE-Q is to allow for integration of surgical care into the evidence-based algorithms of HD care across clinical specialties and research settings around the world. PROM instruments are rating scales that measure concepts of interest (COI) to patients such as symptoms, health-related quality-of-life by asking patients directly and measuring what truly matters to individuals suffering from health conditions. In our preliminary work leading up to this proposal, we conducted 21 semi- structures qualitative interviews in a heterogeneous patient sample that included all HD diagnoses and treatment types. The interviews were coded to identify preliminary patient COIs (e.g. pain frequency, absence from work and family, treatment side effects). The aim of the current proposal outlines the next steps of the HEADACHE- Q development. The COIs will be used to develop a conceptual framework, and preliminary scales with items will be generated. We will then conduct cognitive interviews with patients to obtain their feedback on the instructions, response options and items. Further, the scales will be distributed to experts in HD to obtain input. This feedback will be used to revise the scales. Then, we will perform an international field test study to collect data to perform item reduction and to test its psychometric properties (e.g., reliability, validity, and responsiveness to change). We will use these data to refine and validate the Headache-Q scales using Rasch Measurement Theory analysis. We will develop a set of independently functioning scales (no total scores) that are short, easy to understand and complete, clinically meaningful, and psychometrically sound.

Impact Statement: Headache disorders (HD) affect 52% of the population worldwide. Around 40% of patients do not respond to medications adequately. Headache surgery is a field that has been pioneered by plastic surgeons and is proven to be an effective treatment for HD refractory to medication. Access to headache surgery treatment has been limited by barriers in communication between plastic surgeons and nonsurgical providers who triage patients with HD. Plastic surgeons need the HEADACHE-Q to objectively evaluate the impact of HD treatment on patient lives and allow for a scientifically sound comparison of treatment types. This will facilitate a multidisciplinary dialogue towards integration of surgical care into the evidence-based algorithms for HD management.

Biography
I am currently Assistant Professor of Surgery in the Division of Plastic Surgery at Weill Cornell Medicine (WCM). I received my MD degree at the Medical School of Vienna prior to completing a PhD in craniofacial development at the Harvard Stem Cell Institute/MUW. In 2021, I graduated from the Harvard Integrated Plastic Surgery Residency Program and then completed the Advanced Peripheral Nerve and Microsurgery at the Massachusetts General Hospital. My clinical and research focus is peripheral nerve surgery including headache surgery. A big part of my mission is to further our understanding of the impact of headache disorders (HD), as well as HD treatments on patient lives and improve the integration of surgical care into the evidence-based treatment algorithms for HD. As part of this effort, I was very fortunate to collaborate with PRO experts Dr. Andrea Pusic and Dr. Anne Klassen, as well as my colleagues from neurology and headache surgery to initiate the development of the HEADACHE-Q. This multidisciplinary effort using the combined experience of various specialists has led to completion of the qualitative phase of the HEADACHE-Q PRO development. Our exceptional team of experts now hopes to continue this work to complete creation of clinically meaningful and scientifically sound PRO scales that can be used by all practitioners caring for HD patients worldwide in a clinical and research setting.