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

Abstract

ImportancePrevious research suggests that clinicians view realistic patient expectations as the most important nonaudiological factor in the decision to proceed with a cochlear implant (CI). However, clinicians have few data to determine whether patients’ outcome expectations are realistic.ObjectiveTo address this unmet clinical need through the development and psychometric analysis of a new patient-reported outcome measure, the CI Quality of Life (CIQOL) Expectations.Design, Setting, and ParticipantsThis cross-sectional study was conducted at a tertiary CI center from February 26, 2020, to August 31, 2021. First, a team comprising 2 CI audiologists, a CI surgeon, a hearing scientist, and 2 psychometricians with experience in instrument development converted all items from the CIQOL-35 Profile instrument into statements reflecting expected outcomes. Then, cognitive interviews with 20 potential CI users assessed the clarity and comprehensiveness of the new instrument. Next, responses to the CIQOL-Expectations instrument for 131 potential adult CI candidates were psychometrically analyzed using confirmatory factor analysis and item response theory. Finally, degree to which patient expectations changed from before to after and their CI evaluation appointments was measured.InterventionThe CIQOL-Expectations instrument.ResultsOf 178 participants, 85 (47.8%) were female, and there was 1 (0.6%) Asian, 26 (14.6%) Black or African American, 1 (0.6%) Latinx, and 150 (84.3%) White individuals. No major content or grammar changes were identified during the cognitive interviews. Overall, all CIQOL domains demonstrated adequate to strong psychometric properties. Several domains did not meet all a priori established indicators of model fit or ability to separate CI users based on response patterns, but all met most indicators. Potential CI users demonstrated the highest mean (SD) expectation scores for the environment (70.2 [20.8]) and social (68.4 [18.0]) domains. In addition, the entertainment (20 [15.3%]) and environment (31 [24.4%]) domains had the highest percentage of patients with expectation scores of 100. Yet, normative CIQOL-35 Profile data from experienced CI users suggested few patients obtain this high degree of functional benefit after implant.Conclusions and RelevanceThe results of this cross-sectional study suggest that the CIQOL-Expectations instrument may provide an opportunity to assess potential CI users’ expected outcomes using modification of an established CIQOL instrument and a patient-centered framework. The included items and domains reflect real-world functional abilities valued by CI users and may provide opportunities for an evidence-based shared decision-making approach to the CI evaluation process. With this instrument, clinicians can compare individual patients’ pre-CI outcome expectations with established normative data and provide appropriate counseling.

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

“…9,20 The current study provides the evidence necessary to begin the development of a patient-centered shareddecision making approach for adult cochlear implantation. 46 During the CI evaluation, clinicians can present the data in Table IV to demonstrate the percentage of CI users in each functional stage. Then, using the clinical vignettes, patients can be provided real-world examples of the potential improvements in abilities associated with implantation.…”

Why Do Candidates Forgo Cochlear Implantation?

“…Self-reported functional abilities were assessed using the CI Quality of Life Profile (CIQOL-35 Profile) and CI Quality of Life Expectations (CIQOL-Expectations) instruments. 17,18 The CIQOL-35 Profile is an established and psychometrically verified instrument that measures domain-specific QOL across 6 domains (communication, emotional, entertainment, environmental, listening effort, and social) and a global score. 20 The CIQOL-Expectations instrument is a modification of the CIQOL-35 that was previously developed and psychometrically verified to measure patients' expected CI outcomes prior to CI surgery across the same domains.…”

“…20 The CIQOL-Expectations instrument is a modification of the CIQOL-35 that was previously developed and psychometrically verified to measure patients' expected CI outcomes prior to CI surgery across the same domains. 18…”

“…To accomplish this, we utilized two validated patient-reported outcome measures (PROM), the CI Quality of Life Profile (CIQOL-35 Profile) instrument and the CI Quality of Life Expectations (CIQOL-Expectations) instrument and compared scores between eligible CI candidates who did or did not undergo implantation. 17,18…”

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 …”