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Novel Patient-Reported Outcome Measure Shown Psychometrically Sound in Measuring Disability in Patients with Unilateral Vocal Fold Paralysis

by Linda Kossoff •

Can a psychometrically reliable, valid patient-reported outcome measure (PROM) for unilateral vocal fold paralysis (UVFP)-related disability be developed that is appropriately rigorous for use in clinical trials?

BOTTOM LINE

The CoPE PROM could be a psychometrically sound, comprehensive measure of UVFP-attributed disability suitable for use in clinical and research settings to assess within-person changes.

BACKGROUND: UVFP is a life-changing complication risk of approximately 500,000 head, neck, and chest surgeries performed annually in the United States. UVFP treatments vary widely because the degree of spontaneous recovery and intervention timing also vary. Many clinicians use PROMs and/or physiological measures to gauge these patients’ disability.

STUDY DESIGN: Survey validation study.

SETTING: Department of Biostatistics and Medical Informatics, University of Wisconsin- Madison, Madison, Wis.

SYNOPSIS: Researchers sought to test a conceptual PROM model designed to comprehensively quantify the breadth of UVFP-specific disability, measure patient experience, and track symptoms and treatment effectiveness. They formed the CoPE Collaborative, composed of 34 U.S.-based tertiary care institutions that treat UVFP, and recruited 613 adult, English-speaking patients with UVFP regardless of cause. Patient-reported demographic data related to marital status, income, employment, and race and ethnicity were collected. At baseline time, participants completed 27 candidate PROM items, a comorbidity questionnaire, and several existing PROMs that measure relevant constructs. Subsequently, they completed a disease survey and PROM items every two months (three times). Overall, 555 participants completed surveys for all data collection points. Results showed high internal consistency in the overall 22-item PROM and psychosocial, swallow, and voice subscales. Intraclass correlations for individuals between the baseline and two-week administrations were moderate for the overall score and subscales. Study limitations included the effect of the COVID-19 pandemic on disability during recruitment.

CITATION: Fernandes-Taylor S, Damico-Smith C, Arroyo N, et al. Multicenter development and validation of the vocal cord paralysis experience (CoPE), a patient-reported outcome measure for unilateral vocal fold paralysis-specific disability [published online ahead of print July 7, 2022]. JAMA Otolaryngol Head Neck Surg; doi:10.1001/jamaoto.2022.1545.