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

Importance: It 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. Objective: To 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 Participants: Item 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. Interventions: The CIQOL-35 Profile instrument and cochlear implantation. Results: The 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 Relevance: This 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.

Association of Demographic and Hearing-Related Factors With Cochlear Implant-Related Quality of Life.

Importance: Only limited evidence is available describing the contribution of patient-related factors to quality of life in adults with cochlear implants. Objective: Assess the association between demographic, hearing-related, and cochlear implant-related factors and quality of life by using a new Cochlear Implant Quality of Life (CIQOL) item bank, which was developed to meet rigorous psychometric standards. Design, Setting, and Participants: Multicenter cross-sectional study of adults 18 to 89 years of age who had at least 1 year of cochlear implant use and who were recruited through a consortium of 20 cochlear implant centers in the United States. Using an online format, questionnaires were sent to the first 500 participants who contacted the research team. Of these participants, 371 (74.2%) completed the questionnaire. Demographic, hearing-related, and cochlear implant-related data were obtained along with responses to each of the 81 items in the CIQOL item bank. Multivariable linear regression was used to examine demographic, hearing-related, and cochlear implant-related factors associated with scores in each of the 6 CIQOL domains (communication, emotional, entertainment, environment, listening effort, and social). Main Outcomes and Measures: Association among demographic, hearing-related, and cochlear implant-related factors and CIQOL scores for each of 6 domains. Results: Of the 371 participants who completed the questionnaire, 222 (59.8%) were women, and the mean (SD) age was 59.5 (14.9) years. The CIQOL scores were normally distributed across the 6 domains. Being employed, having higher household income, longer duration of hearing loss prior to cochlear implantation, and having bilateral rather than unilateral cochlear implantation were associated with higher CIQOL scores in 1 or more domains, but the effect size varied widely (ß, 0.1-6.9). Better sentence recognition ability (using AzBio to measure speech recognition) was associated with only a small positive effect size for the communication (ß, 0.0 [95% CI, 0.0-0.1]), entertainment (ß, 0.0 [95% CI, 0.0-0.1]), and environmental (ß, 0.0 [95% CI, 0.0-0.0]) domains. Increased age was associated with lower CIQOL in the entertainment domain (ß, -0.3 [95% CI, -1.5 to -0.4]). The demographic, hearing-related, and cochlear implant-related factors included in the multivariable regression models accounted for only a small percentage of the variance in CIQOL domain scores (R2, 0.08-0.17). Conclusions and Relevance: Several factors were found to predict higher or lower CIQOL scores in specific domains, with speech-recognition ability having only a minimal association. Despite evaluating a large number of demographic, hearing-related, and cochlear implant-related factors, the multivariable models accounted for only a small amount of CIQOL variance. This suggests that patient or other characteristics that contribute to cochlear implant-related quality of life remain largely unknown.

Use of Adult Patient Focus Groups to Develop the Initial Item Bank for a Cochlear Implant Quality-of-Life Instrument.

Importance: No instrument exists to assess quality of life (QOL) in adult cochlear implant (CI) users that has been developed and validated using accepted scientific standards. Objective: To develop a CI-specific QOL instrument for adults in accordance with the Patient Reported Outcomes Measurement Information System (PROMIS) guidelines. Design, Setting, and Participants: As required in the PROMIS guidelines, patient focus groups participated in creation of the initial item bank. Twenty-three adult CI users were divided into 1 of 3 focus groups stratified by word recognition ability. Three moderator-led focus groups were conducted based on grounded theory on December 3, 2016. Two reviewers independently analyzed focus group recordings and transcripts, with a third reviewer available to resolve discrepancies. All data were reviewed and reported according to the Consolidated Criteria for Reporting Qualitative Research. The setting was a tertiary referral center. Main Outcomes and Measures: Coded focus group data. Results: The 23 focus group participants (10 [43%] female; mean [range] age, 68.1 [46.2-84.2] years) represented a wide range of income levels, education levels, listening modalities, CI device manufacturers, duration of CI use, and age at implantation. Data saturation was determined to be reached before the conclusion of each of the focus groups. After analysis of the transcripts, the central themes identified were communication, emotion, environmental sounds, independence and work function, listening effort, social isolation and ability to socialize, and sound clarity. Cognitive interviews were carried out on 20 adult CI patients who did not participate in the focus groups to ensure item clarity. Based on these results, the initial QOL item bank and prototype were developed. Conclusions and Relevance: Patient focus groups drawn from the target population are the preferred method of identifying content areas and domains for developing the item bank for a CI-specific QOL instrument. Compared with previously used methods, the use of patient-centered item development for a CI-specific QOL instrument will more accurately reflect patient experience and increase our understanding of how CI use affects QOL.

Relationship Between Physical Activity and Overweight and Obesity in Children: Findings From the 2012 National Health and Nutrition Examination Survey National Youth Fitness Survey.

OBJECTIVE: This study examined the relationship between childhood obesity and overweight and functional activity and its enjoyment. METHOD: A cross-sectional design was used to analyze data from the 2012 National Health and Nutrition Examination Survey National Youth Fitness Survey. Multivariate logistic regression models were used. RESULTS: Data for 1,640 children ages 3-15 yr were retrieved. Physical activity was negatively associated with risk of obesity (odds ratio [OR] = 0.93; 95% confidence interval [CI] [0.87, 0.98]). Although children who were obese and overweight were more likely to have functional limitations (ORs = 1.58-1.61), their enjoyment of physical activity participation was not significantly different from that of the healthy-weight group. CONCLUSION: Physical activity lowered the risk of obesity. Children who were obese had functional limitations compared with healthy-weight children, but both groups enjoyed physical activity equally. Future studies are needed to determine barriers to participation among these children in recreation and sporting activities.

Psychometrics of the Fitness-to-Drive Screening Measure.

We employed item response theory (IRT), specifically using Rasch modeling, to determine the measurement precision of the Fitness-to-Drive Screening Measure (FTDS), a tool that can be used by caregivers and occupational therapists to help detect at-risk drivers. We examined unidimensionality through the factor structure (how items contribute to the central construct of fitness to drive), rating scale (use of the categories of the rating scale), item/person-level separation (distinguishing between items with different difficulty levels or persons with different ability levels) and reliability, item hierarchy (easier driving items advancing to more difficult driving items), rater reliability, rater effects (severity vs. leniency of a rater), and criterion validity of the FTDS to an on-road assessment, via three rater groups (n = 200 older drivers; n = 200 caregivers; n = 2 evaluators). The FTDS is unidimensional, the rating scale performed well, has good person (> 3.07) and item (> 5.43) separation, good person (> 0.90) and item reliability (> 0.97), with < 10% misfitting items for two rater groups (caregivers and drivers). The intraclass correlation (ICC) coefficient among the three rater groups was significant (.253, p < .001) and the evaluators were the most severe raters. When comparing the caregivers' FTDS rating with the drivers' on-road assessment, the areas under the curve (index of discriminability; caregivers .726, p < .001) suggested concurrent validity between the FTDS and the on-road assessment. Despite limitations, the FTDS is a reliable and accurate screening measure for caregivers to help identify at-risk older drivers and for occupational therapy practitioners to start conversations about driving.

Measurement qualities of a self-report and therapist-scored functional capacity instrument based on the Dictionary of Occupational Titles.

Studies provide convincing arguments to support the development of functional capacity instruments based on the Dictionary of Occupational Titles (DOT). The purpose of this study is to investigate the item-level measurement qualities of a newly developed DOT-based functional capacity instrument for clients undergoing rehabilitation treatment for back pain. Client and therapist ratings were collected on 124 clients from 27 rehabilitation sites using the newly developed Occupational Rehabilitation Data Base (ORDB) functional capacity instrument. Rasch analysis was used to investigate: (1) unidimensionality, (2) hierarchical item difficulty continuum, (3) rater severity, and 4) person-item match. Overall, the functional capacity scale of the ORDB showed good measurement qualities. All items, except the Handling item fit the Rasch measurement model. Because of high fit statistics and loading on factors independent from the remainder of the items, the "handling" item was removed, from further analyses. Separate client-rated and therapist-rated instruments retained good item-level psychometrics. While client and therapist items showed similar item-difficulty hierarchical structures, clients had a tendency to be more severe in their rating and the correlation between client and therapist ratings was relatively low, 0.32. These findings suggest that Handling items should not be included as a DOT measure for clients with back pain. While the above psychometric study supports using client or therapist ratings as independent instruments, the lack of concordance between these ratings requires further investigation.