Dataset Information

Cochlear Implant Quality of Life (CIQOL): Development of a Profile Instrument (CIQOL-35 Profile) and a Global Measure (CIQOL-10 Global).

ABSTRACT: Purpose Valid, reliable, and efficient patient-reported outcome measures are needed to quantify quality of life (QOL) outcomes after cochlear implantation to supplement information obtained from performance-based outcomes. We previously developed the Cochlear Implant Quality of Life (CIQOL) item bank to serve as the source of items for subsequent instruments. This study reports the development and psychometric properties for 2 of these new instruments, the CIQOL-35 Profile and the CIQOL-10 Global. Method Cochlear implant (CI) users referred from the CIQOL Development Consortium (n = 371), consisting of 20 CI centers across the United States, provided responses to the 81-item CIQOL item bank, which are grouped into 6 QOL domains (communication, emotional, entertainment, environment, listening effort, and social). Responses to the 81 CIQOL items were analyzed using item response theory to determine individual item difficulty, discrimination, and model fit to select the set of items for the profile instrument and global measure that would optimize their measurement characteristics. Results The 35-item CIQOL-35 Profile instrument assesses outcomes represented in the 6 domains of the CIQOL final item pool. The 10-item CIQOL-10 Global measure produces a single, overall QOL score. After ensuring the upper and lower ends of the item difficulty continuum were represented (item difficulty range: -2.48 to 2.47), the items with the highest discrimination ability for each domain were selected for the CIQOL-35 Profile instrument (discrimination range: 0.67-1.37). Items were selected for the CIQOL-10 Global measure in a similar manner. Conclusion The CIQOL-35 Profile and CIQOL-10 Global instruments provide psychometrically sound and efficient measures that can be used to assess QOL in adult CI users in both clinical and research settings. Supplemental Material https://doi.org/10.23641/asha.9745010.

SUBMITTER: McRackan TR

PROVIDER: S-EPMC6808347 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Cochlear Implant Quality of Life (CIQOL): Development of a Profile Instrument (CIQOL-35 Profile) and a Global Measure (CIQOL-10 Global).

McRackan Theodore R TR Hand Brittany N BN Velozo Craig A CA Dubno Judy R JR

Journal of speech, language, and hearing research : JSLHR 20190904 9

Purpose Valid, reliable, and efficient patient-reported outcome measures are needed to quantify quality of life (QOL) outcomes after cochlear implantation to supplement information obtained from performance-based outcomes. We previously developed the Cochlear Implant Quality of Life (CIQOL) item bank to serve as the source of items for subsequent instruments. This study reports the development and psychometric properties for 2 of these new instruments, the CIQOL-35 Profile and the CIQOL-10 Globa ...[more]

PMID: 31479616

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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: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: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.

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:Health-related quality of life (HRQOL) is one of the most important outcome measures to be assessed by medical research. This study aims to develop and validate an instrument called the "health-related quality of life with six domains" (HRQ-6D), which aims to measure an individual's health-related quality of life within a 24 h period of time. This is a questionnaire development study involving five phases, which are (i) to explore the subject matter content for gaining a better understanding of the topic, (ii) to develop the questionnaire, (iii) to assess both its content validity and face validity, (iv) to conduct a pilot study, and finally, (v) to undertake a field testing of the questionnaire. For the field-testing phase, a cross-sectional study involving a self-administered survey for HRQ-6D items was conducted among healthcare workers with various health conditions. Exploratory factor analysis was initially applied to construct the major dimensions of the HRQ-6D. Confirmatory factor analysis was subsequently applied to evaluate the model fit of the overall framework of the HRQ-6D. The clinical utility of this HRQ-6D was also assessed via its association with actual clinical evidence. A total of 406 respondents participated in the survey. Six domains were identified from the analysis, namely "pain", "physical strength", "emotion", "self-care", "mobility", and "perception of future health" comprising two items in each domain. Each domain was reported to have a minimum value of Cronbach's alpha of 0.731, and the model fit for the overall framework of the HRQ-6D was also found to be excellent. Exploratory factor analysis was undertaken for the 12 items of the HRQ-6D. All the domains can be categorized into three major dimensions, namely "health", "body function", and "future perception", with a minimum value for their factor loadings of at least 0.507. A notable finding was that the HRQ-6D was significantly associated with an individual's existing comorbidities and current status of health (p < 0.05). This study successfully validated the HRQ-6D, and we found it to possess both excellent levels of reliability and validity and a satisfactory degree of model fit; it was also significantly associated with actual clinical evidence.

Project description:BackgroundImplant survival and implant success (freedom of biologic complications) are important factors in assessing the success of implant therapy. However, these factors are not the only determinants. Patients' satisfaction also plays a very important role in daily practice. Therefore, the aim of this study was to assess patients' satisfaction regarding function (phonetics, chewing comfort, stability, cleanability) and aesthetics in patients treated with XiVE and Frialite implants in a private periodontal practice ten years after implant placement. Furthermore, oral health-related quality of life (OHRQoL) was evaluated.MethodsPatient-reported outcome measures (PROMs) regarding overall satisfaction, phonetics, chewing comfort, stability, cleanability, and aesthetics were examined on a Visual Analog Scale (VAS) 10 years ± 6 months after implant placement in a cross-sectional survey. OHRQoL and psychological impact were assessed via the Oral Health Impact Profile (OHIP) and Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ). Potential influence of patient-related factors (age, gender, smoking, peri-implantitis, implant position, type of restoration) on VAS, OHRQoL and PIDAQ were investigated using regression analyses.ResultsHigh satisfaction with implant-supported restorations was seen in all 95 patients ten years after implant placement. Mean VAS-score for general satisfaction with implant-supported restoration was 93.0% (SD ± 9.4, median: 96.3%, range 50.0-100%). Mean OHIP score was 11.3 (SD ± 10.8, median: 9.0, range 0-45), mean PIDAQ score 20.5 (SD ± 11.37, median: 17.0, range 0-52). A slight tendency that presence of a moderate/severe peri-implantitis lowers satisfaction could be detected (overall satisfaction: ordinal, p = 0.012, VAS, p = 0.026). Also, the factors age, implant position and type of restoration might have an impact on patient's satisfaction.ConclusionsPatients restored with mostly fixed implant-supported restorations showed a very high patient satisfaction regarding function and aesthetics 10-year after implant placement. The presence of a moderate/severe peri-implantitis showed a slight tendency for influencing patient satisfaction. Due to the cross-sectional design results have to be interpreted with care.

Dataset Information

Cochlear Implant Quality of Life (CIQOL): Development of a Profile Instrument (CIQOL-35 Profile) and a Global Measure (CIQOL-10 Global).

Publications

Cochlear Implant Quality of Life (CIQOL): Development of a Profile Instrument (CIQOL-35 Profile) and a Global Measure (CIQOL-10 Global).

Similar Datasets

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