Development of a novel patient-reported outcome measure for disseminated coccidioidomycosis (valley fever).

Abstract

Background: Coccidioidomycosis (Valley Fever) is a dimorphic fungal infection endemic to the southwest United States, Mexico, Central and South America, which can lead to chronic debilitating illness and death.

Objectives: This qualitative study was conducted to develop a bespoke patient-reported outcome measure for patients with chronic disseminated coccidioidomycosis to assess health-related quality of life (HRQoL) impacts.

Patients and methods: Online, first-person narratives of patient experiences of disseminated coccidioidomycosis were used to create a patient-centred conceptual model of symptoms and impacts of the condition. Interviews were conducted with expert clinicians, followed by concept elicitation interviews with patients, to generate key symptom and impact concepts from which an initial patient-reported outcome measure was developed. The draft measure was reviewed with clinicians for clinical relevance and further assessed in cognitive debriefing interviews with patients to refine the measure and establish content validity.

Results: A total of 25 patients were interviewed, which identified impacts relating to physical function, activities of daily living, cognitive function, social/role function and emotional function of disseminated coccidioidomycosis. Twenty items were developed simultaneously in English and Spanish to capture the main impacts across these 5 areas. In general, items were clear and well understood by patients, and clinicians found the measure clinically relevant and appropriate for assessing the burden of disseminated coccidioidomycosis on HRQoL.

Conclusions: Once fully validated, the Valley Fever-Patient Reported Outcome measure may be used in interventional studies to assess HRQoL outcomes, and in clinical practice to monitor patients' HRQoL.