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

Abstract

ImportanceIt is essential to measure an individual patient’s baseline and follow-up abilities to demonstrate changes in clinical outcomes over time. Inherent in this strategy is interpreting whether the measured change is clinically significant and beyond measurement error. Conditional minimal detectable change (cMDC) values are widely used in many disciplines but have rarely been established for outcome measures in otolaryngology or hearing research, and never in cochlear implantation.ObjectiveTo determine cMDC values for the Cochlear Implant Quality of Life-35 (CIQOL-35) Profile instrument to enhance our understanding of the initial and ongoing changes in functional abilities from cochlear implants (CIs).Design, Setting, and ParticipantsItem response theory analyses of responses from a multi-institutional cohort of 705 CI users at a tertiary CI center were used to derive standard error (SE) values for each possible CIQOL-35 domain score. Using an iterative approach, these SE values were used to calculate cMDC values for every possible pre-CI and post-CI domain score combination. We then compared pre-CI to 12-month post-CI CIQOL-35 domains scores in an independent cohort of 65 adult CI users to determine whether the measured change exceeded error to be clinically significant. The analysis took place on December 14, 2022.InterventionsThe CIQOL-35 Profile instrument and cochlear implantation.ResultsThe cMDC values were smaller for the communication domain, and global measure and cMDC values for all domains were larger at the extremes of the measurement scale. Overall, 60 CI users (92.3%) demonstrated improvement beyond cMDC at 12 months post-CI for at least 1 CIQOL-35 domain, and no patients’ scores declined beyond cMDC for any domain. The percentage of CI users demonstrating improvement beyond cMDC varied by domain, with communication (53 [81.5%]) showing the largest number of CI users improving, followed by global (42 [64.6%]) and entertainment (40 [60.9%]). In general, CI users who demonstrated improvement in CIQOL-35 domains had greater improvement in speech recognition scores than patients who did not, but the strength and significance of these associations greatly varied by domain and speech material.Conclusions and RelevanceThis multistep cohort study found that cMDC values for the CIQOL-35 Profile provided personalized thresholds for detecting real changes in patient self-reported functional abilities over time across multiple domains, which may inform clinical decision-making. Moreover, these longitudinal results reveal the domains with more or less improvement, which may aid in patient counseling.

Listening-Related Fatigue in New and Experienced Adult Cochlear Implant Users

“…Likewise, CI users report significant improvements in self-perceived communication abilities and significant reductions in perceived hearing handicap (Boisvert et al 2020; Buchman et al 2020; Dunn et al 2020). In addition to these hearing-related improvements, cochlear implantation is also associated with broader improvements in quality of life (Boisvert et al 2020; Buchman et al 2020; McRackan et al 2023), including significantly greater socialization and social participation (Orabi et al 2006; McRackan et al 2023). Finally, adult CI recipients report significantly less listening effort following cochlear implantation (McRackan et al 2023).…”

“…In addition to these hearing-related improvements, cochlear implantation is also associated with broader improvements in quality of life (Boisvert et al 2020; Buchman et al 2020; McRackan et al 2023), including significantly greater socialization and social participation (Orabi et al 2006; McRackan et al 2023). Finally, adult CI recipients report significantly less listening effort following cochlear implantation (McRackan et al 2023). Thus, there are many well-known benefits associated with cochlear implantation; however, the impact of CI use on listening-related fatigue remains unknown.…”

“…Also, given evidence for significant postimplantation changes in listening effort, social participation, and hearing handicap (Orabi et al 2006; Boisvert et al 2020; Buchman et al 2020; McRackan et al 2023) and evidence suggesting these constructs are related to listening-related fatigue (Hornsby et al 2016, 2023; Alhanbali et al 2017; Hughes et al 2018), we examined associations between these outcomes over time. Thus, secondary questions of interest focused on the relationship between individual demographic and audiologic variables, psychosocial characteristics (i.e., perceived listening effort, hearing handicap, and social disconnectedness/isolation), and preimplantation and postimplantation listening-related fatigue.…”