Dataset Information

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

ABSTRACT:

Importance

Previous 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.

Objective

To 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 participants

This 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.

Intervention

The CIQOL-Expectations instrument.

Results

Of 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 relevance

The 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.

SUBMITTER: McRackan TR

PROVIDER: S-EPMC9372907 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature

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Publications

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

McRackan Theodore R TR Hand Brittany N BN Chidarala Shreya S Dubno Judy R JR

JAMA otolaryngology-- head & neck surgery 20220901 9

<h4>Importance</h4>Previous 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.<h4>Objective</h4>To 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.<h4>Desig ...[more]

PMID: 35951334

Similar Datasets

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:BACKGROUND:Breast implant illness (BII) after aesthetic breast augmentation remains a poorly defined syndrome encompassing a wide spectrum of symptoms. While previously published series have observed overall symptomatic improvement after breast implant removal, there is a lack of studies evaluating changes in specific symptoms over time. The purpose of this study was to gain an understanding of symptoms associated with BII, and to evaluate how these symptoms change after removal of breast implants and total capsulectomy (explantation). We hypothesized that patients presenting with BII would experience both immediate and sustained improvement in constitutional symptoms after explantation. METHODS:A retrospective study of all patients who underwent explantation by a single surgeon over 2 years was conducted. Repeated-measures analysis of variance accounting for dependency was used to compare symptoms before and after surgery. Multivariate analyses and linear regression models were used to examine the impact of patient- and implant-related factors on changes in symptoms. RESULTS:Seven hundred fifty patients met inclusion criteria. Mean preoperative survey score (26.19 ± 11.24) was significantly different from mean postoperative survey score at less than 30 days (9.49 ± 7.56) and greater than 30 days (9.46 ± 7.82, P < 0.001). Patients with a BMI greater than 30 or those with clinically detectable contracture on examination showed greater improvement on their survey scores (P = 0.039, 0.034, respectively). CONCLUSIONS:Although BII encompasses a large range of symptoms, subjects in this study demonstrated significant and sustained improvement in 11 common symptom domains. This improvement was demonstrable within the first 30 days postoperatively and was maintained beyond 30 days. The study demonstrated a strong association of explantation and specific symptom improvement within the patient population studied. Future investigation will further elucidate possible biologic phenomena to better characterize the pathophysiology and mechanism of BII.

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:Cochlear implants are a standard therapy for deafness, yet the ability of implanted patients to understand speech varies widely. To better understand this variability in outcomes, the authors used functional near-infrared spectroscopy to image activity within regions of the auditory cortex and compare the results to behavioral measures of speech perception.The authors studied 32 deaf adults hearing through cochlear implants and 35 normal-hearing controls. The authors used functional near-infrared spectroscopy to measure responses within the lateral temporal lobe and the superior temporal gyrus to speech stimuli of varying intelligibility. The speech stimuli included normal speech, channelized speech (vocoded into 20 frequency bands), and scrambled speech (the 20 frequency bands were shuffled in random order). The authors also used environmental sounds as a control stimulus. Behavioral measures consisted of the speech reception threshold, consonant-nucleus-consonant words, and AzBio sentence tests measured in quiet.Both control and implanted participants with good speech perception exhibited greater cortical activations to natural speech than to unintelligible speech. In contrast, implanted participants with poor speech perception had large, indistinguishable cortical activations to all stimuli. The ratio of cortical activation to normal speech to that of scrambled speech directly correlated with the consonant-nucleus-consonant words and AzBio sentences scores. This pattern of cortical activation was not correlated with auditory threshold, age, side of implantation, or time after implantation. Turning off the implant reduced the cortical activations in all implanted participants.Together, these data indicate that the responses the authors measured within the lateral temporal lobe and the superior temporal gyrus correlate with behavioral measures of speech perception, demonstrating a neural basis for the variability in speech understanding outcomes after cochlear implantation.

Dataset Information

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

Importance

Objective

Design, setting, and participants

Intervention

Results

Conclusions and relevance

Publications

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

Similar Datasets

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