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

Abstract

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' selfreported 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 that stage progression represented meaningful improvements in functional abilities. Finally, 88.1% of 42 patients in the prospective cohort (n = 37) improved from pre-CI functional stage by at least one functional stage in one or more domains. The communication domain had the greatest number of patients improve by one or more stages (59.5%) and the social domain the fewest (25.6%). There was also a trend for less improvement at 3-and 6-months post-CI activation for patients at higher pre-CI functional stages, even though higher stages were achievable. Conclusion:...

Understanding Patient Expectations Before Implantation Using the Cochlear Implant Quality of Life–Expectations Instrument

“…Given the established hierarchical ability model, higher CIQOL-communication scores represent better communication in more difficult listening environments, such as a greater ability to communicate with more partners when background noise is present. 18,27 Therefore, the cohort's expectation scores in this domain are consistent with the findings from this previous study. These findings will need to be confirmed in prospective studies in which patients' pre-CI CIQOL-Expectations domain scores are compared with the same patients' post-CI CIQOL-35 Profile domain scores.…”

“…Most (94%) had their expectations met regarding conversation in quiet, but more than half had unfulfilled expectations regarding communication in background noise. Given the established hierarchical ability model, higher CIQOL-communication scores represent better communication in more difficult listening environments, such as a greater ability to communicate with more partners when background noise is present . Therefore, the cohort’s expectation scores in this domain are consistent with the findings from this previous study.…”

Discrepancies Between Expected and Actual Cochlear Implant–Related Functional Outcomes

“…The use of the CIQOL-Expectations instrument and corresponding published normative CIQOL outcome data (12) provides the framework to ensure patients have realistic expectations. Outcome discussions based on real-world examples as used in the CIQOL Functional Staging System are favored by patients over reviewing speech recognition scores (14). Future research by our group aims to explore changes in patient expectations after preoperative counseling during the CI evaluation.…”

“…The staging system was designed to transform psychometrically derived CIQOL scores into detailed descriptions of patients' self-reported abilities, thereby enabling more straightforward interpretation and incorporation into CI counseling. Importantly, patients prefer outcome discussions based on such real-world examples over discussions centered on speech recognition scores (14). By incorporating data-driven functional outcome counseling into the preoperative evaluation, providers can reduce misconceptions regarding potential CI outcomes and ultimately improve shared decision-making.…”

Conditional Minimal Detectable Change for the Cochlear Implant Quality of Life-35 Profile Associated With Improved Functional Abilities 12 Months After Cochlear Implantation

“…The Cochlear Implant Quality of Life-35 (CIQOL-35) Profile is a PROM that evaluates functional abilities across 6 domains (communication, emotional, entertainment, environmental, listening effort, social) as well as a global assessment with scores ranging from 0 (low) to 100 (high). It was created and validated using a thorough mixed-methods approach that included a multi-institution design, stakeholder engagement, and advanced psychometric analyses . These methods, which, to our knowledge have never been used before in CI outcome research, incorporated item response theory (IRT), an advanced psychometric modeling technique with many potential measurement advantages compared with traditional test-level psychometrics used in developing legacy PROMs …”