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Development of the Cochlear Implant Quality of Life Item Bank.

ABSTRACT: OBJECTIVES:Functional outcomes following cochlear implantation have traditionally been focused on word and sentence recognition, which, although important, do not capture the varied communication and other experiences of adult cochlear implant (CI) users. Although the inadequacies of speech recognition to quantify CI user benefits are widely acknowledged, rarely have adult CI user outcomes been comprehensively assessed beyond these conventional measures. An important limitation in addressing this knowledge gap is that patient-reported outcome measures have not been developed and validated in adult CI patients using rigorous scientific methods. The purpose of the present study is to build on our previous work and create an item bank that can be used to develop new patient-reported outcome measures that assess CI quality of life (QOL) in the adult CI population. DESIGN:An online questionnaire was made available to 500 adult CI users who represented the adult CI population and were recruited through a consortium of 20 CI centers in the United States. The questionnaire included the 101 question CIQOL item pool and additional questions related to demographics, hearing and CI history, and speech recognition scores. In accordance with the Patient-Reported Outcomes Measurement Information System, responses were psychometrically analyzed using confirmatory factor analysis and item response theory. RESULTS:Of the 500 questionnaires sent, 371 (74.2%) subjects completed the questionnaire. Subjects represented the full range of age, durations of CI use, speech recognition abilities, and listening modalities of the adult CI population; subjects were implanted with each of the three CI manufacturers' devices. The initial item pool consisted of the following domain constructs: communication, emotional, entertainment, environment, independence, listening effort, and social. Through psychometric analysis, after removing locally dependent and misfitting items, all of the domains were found to have sound psychometric properties, with the exception of the independence domain. This resulted in a final CIQOL item bank of 81 items in 6 domains with good psychometric properties. CONCLUSIONS:Our findings reveal that hypothesis-driven quantitative analyses result in a psychometrically sound CIQOL item bank, organized into unique domains comprised of independent items which measure the full ability range of the adult CI population. The final item bank will now be used to develop new instruments that evaluate and differentiate adult CIQOL across the patient ability spectrum.

SUBMITTER: McRackan TR

PROVIDER: S-EPMC6749825 | biostudies-literature | 2019 Jul/Aug

REPOSITORIES: biostudies-literature

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Project description:ImportanceNo instrument exists to assess quality of life (QOL) in adult cochlear implant (CI) users that has been developed and validated using accepted scientific standards.ObjectiveTo develop a CI-specific QOL instrument for adults in accordance with the Patient Reported Outcomes Measurement Information System (PROMIS) guidelines.Design, setting, and participantsAs 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 measuresCoded focus group data.ResultsThe 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 relevancePatient 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.

Project description:BackgroundPositive mindset (PM) is an important domain of health-related quality of life in Singapore, a multi-ethnic urban city state in Southeast Asia. We therefore developed and calibrated a novel item bank to measure and improve PM.MethodsWe developed an initial candidate pool of 48 items from focus groups, in-depth interviews and existing instruments locally developed and validated for use in Singapore. We administered all items in English to a multi-stage sample stratified for age and gender, of subjects with and without medical conditions recruited from the community and a hospital, and calibrated their responses using Samejima's Graded Response Model. We evaluated a final 36-item bank with respect to Item Response Theory (IRT) model assumptions, model fit, differential item functioning (DIF), concurrent and known-groups validity.ResultsAmong 493 participants (49.3% male, 41.6% above 50 years old, 33% Chinese, Malay and Indian), bifactor model analyses supported unidimensionality: explained common variance of the general factor was 0.86 and omega hierarchical was 0.97. Local independence was deemed acceptable: the average absolute residual correlations were <0.06 and 3.3% of the total item-pair residuals were flagged for local dependence. The overall model fit was adequate and provided good coverage of the PM construct (theta range: -3.6 to +2.4). Five items exhibited DIF with respect to ethnicity and gender, but were retained without modification of scores because they measured important aspects of PM. Scores correlated in the hypothesized direction with a self-reported measure of global health (Spearman's rho = -0.28, p<0.001) and discriminated between groups of participants with and without a self-reported diagnosis of a mood disorder (p = 0.007) adjusting for age, gender, ethnicity, education and marital status.ConclusionThe 36-item PM item bank demonstrated satisfactory psychometric properties for the English-speaking Singaporean population. IRT model assumptions were sufficiently met and scores showed concurrent and known-groups validity. Future studies to evaluate the validity of PM scores when items are administered adaptively are needed.

Project description:ImportanceOnly limited evidence is available describing the contribution of patient-related factors to quality of life in adults with cochlear implants.ObjectiveAssess 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 participantsMulticenter 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 measuresAssociation among demographic, hearing-related, and cochlear implant-related factors and CIQOL scores for each of 6 domains.ResultsOf 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 (β, 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 (β, 0.0 [95% CI, 0.0-0.1]), entertainment (β, 0.0 [95% CI, 0.0-0.1]), and environmental (β, 0.0 [95% CI, 0.0-0.0]) domains. Increased age was associated with lower CIQOL in the entertainment domain (β, -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 relevanceSeveral 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.

Project description: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.

Project description:BackgroundA glaucoma-specific health-related quality of life (HRQoL) item bank (IB) and computerized adaptive testing (CAT) system relevant to Asian populations is not currently available. We aimed to develop content for an IB focusing on HRQoL domains important to Asian people with glaucoma; and to compare the content coverage of our new instrument with established glaucoma-specific instruments.MethodsIn this qualitative study of glaucoma patients recruited from the Singapore National Eye Centre (November 2018-November 2019), items/domains were generated from: (1) glaucoma-specific questionnaires; (2) published articles; (3) focus groups/semi-structured interviews with glaucoma patients (n = 27); and (4) feedback from glaucoma experts. Data were analyzed using the constant comparative method. Items were systematically refined to a concise set, and pre-tested using cognitive interviews with 27 additional glaucoma patients.ResultsOf the 54 patients (mean ± standard deviation [SD] age 66.9 ± 9.8; 53.7% male), 67 (62.0%), 30 (27.8%), and 11 (10.2%) eyes had primary open angle glaucoma, angle closure glaucoma, and no glaucoma respectively. Eighteen (33.3%), 11 (20.4%), 8 (14.8%), 12 (22.2%), and 5 (9.3%) patients had no, mild, moderate, severe, or advanced/end-stage glaucoma (better eye), respectively. Initially, 311 items within nine HRQoL domains were identified: Visual Symptoms, Ocular Comfort Symptoms, Activity Limitation, Driving, Lighting, Mobility, Psychosocial, Glaucoma management, and Work; however, Driving and Visual Symptoms were subsequently removed during the refinement process. During cognitive interviews, 12, 23 and 10 items were added, dropped and modified, respectively.ConclusionFollowing a rigorous process, we developed a 221-item, 7-domain Asian glaucoma-specific IB. Once operationalised using CAT, this new instrument will enable precise, rapid, and comprehensive assessment of the HRQoL impact of glaucoma and associated treatment efficacy.

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Development of the Cochlear Implant Quality of Life Item Bank.

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