Development and Implementation of the Cochlear Implant Quality of Life (CIQOL) Functional Staging System

• Published in: The Laryngoscope 2022-11, Vol.132 (S12), p.S1-S13
• Main Authors: McRackan, Theodore R., Hand, Brittany N., Velozo, Craig A., Dubno, Judy R.
• Format: Article
• Language: English
• Subjects: Adult; Clinical decision making; Cochlear implant; Cochlear Implantation; Cochlear Implants; Communication; functional staging systems; Humans; Laryngoscopy; Longitudinal Studies; patient‐reported outcome measures; patient‐reported outcomes; Prospective Studies; Quality of Life; Quantitative psychology; shared decision making
• ISSN: 0023-852X; 1531-4995
• DOI: 10.1002/lary.30381

Objectives The purpose of this study is to develop and implement a functional staging system using the Cochlear Implant Quality of Life (CIQOL) framework. The CIQOL‐35 Profile was developed and validated following a rigorous research design and found to be more comprehensive and psychometrically sound than previous patient‐reported outcome measures (PROMs) applied to adult CI users. However, interpreting the CIQOL‐35 Profile (and all PROMs) relative to real‐world functioning remains difficult for patients and clinicians, which limits the capacity of PROMs to direct clinical care. To address this limitation, a functional staging system based on PROM scores was developed to provide detailed descriptions of patients' self‐reported abilities (clinical vignettes) without sacrificing the inherent value of the psychometrically derived scores. The current study (1) creates an evidence‐based CIQOL functional staging system using advanced psychometric techniques, (2) confirms the clarity and meaningfulness of the staging system with patients, and (3) implements the staging system to measure CIQOL stage progression using data from a longitudinal study design. Methods Item response theory (IRT) analyses of CIQOL‐35 Profile data from 705 experienced adult CI users and expert opinion were used to determine the cut‐scores that separated adjacent stages for the six CIQOL‐35 domains (communication, emotional, entertainment, environment, listening effort, and social). The research team then created clinical vignettes based on item response patterns for each stage. Semi‐structured key informant interviews were conducted with 10 adult CI users to determine the clarity and meaningfulness of the CIQOL stages and associated clinical vignettes. Finally, we prospectively collected CIQOL‐35 Profile scores from 42 CI users prior to cochlear implantation and then at 3‐ and 6‐months post‐CI activation to measure CIQOL stage progression. Results Psychometric analyses identified five statistically distinct stages for the communication domain and three stages for all other domains. Using IRT analysis results for guidance, research team members independently identified the cut‐scores that represented transitions between the functional stages for each domain with excellent agreement (κ = 0.98 [95% confidence interval 0.96–0.99]). Next, the key informant interviews revealed that CI users found the clinical vignettes to be clear and only minor changes were required. Participants also agreed