A patient-centered conceptual model and measurement framework for migraine experience developed by the Migraine...

To develop a comprehensive, evidence-based, patient-centered conceptual model of migraine and to derive a measurement framework for the development or selection of clinical outcome assessments used in clinical trials of treatments for migraine.

Improving ways of assessing the outcomes that matter to people who live with migraine is an important goal for treatment development and evaluation. The Migraine Clinical Outcome Assessment System (MiCOAS) project aimed to gather qualitative data directly from people with migraine and develop a patient-centered core set of outcomes and endpoints for migraine clinical trials. Data gathered by the MiCOAS research team was used to develop a patient-centered conceptual model of migraine and a measurement framework designed to capture outcomes that matter to patients.

A post hoc, pooled secondary interpretive analysis of the results from two MiCOAS qualitative studies (executed in 2020 and 2021 with 71 US adults with migraine) was conducted to develop the conceptual model using iterative diagramming methods to create a visualization. Supporting information exhibits for the visualization were created to record concept definitions and describe their interrelationships. The conceptual model was used to guide development of a measurement framework intended to support the selection or development of patient-reported outcome assessments suitable for regulated clinical trials of both acute and preventive migraine therapies. Input from people with migraine, patient advocates, clinical researchers, and subject matter experts was integrated into the model and the measurement framework.

The comprehensive conceptual model diagram organizes patient-reported experiences into domains for symptoms and impacts of migraine and depicts commonly occurring mediating contextual factors (e.g., perceived pain tolerance) that can affect patients' self-reported disease experiences. The measurement framework identifies concepts that are widely experienced or highly disabling to patients with episodic or chronic migraine but also meet the needs of clinical trial endpoint design (e.g., are cross-culturally relevant and amenable to treatment effect within a 3-month trial period) and are capable of capturing experiences during all phases of migraine, including interictal periods.

The patient-centered conceptual model of migraine provides a concise but comprehensive framework for describing and measuring patient experiences of migraine disease and its treatment, including symptoms, daily functioning, and distal outcomes that result from the aggregation of migraine experiences over time. The measurement framework was developed to support comprehensive endpoint design for migraine clinical trials and has been used to guide the development of the MiCOAS measurement instruments.