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Health-Related Quality of Life Instruments for Children With Cochlear Implants: Development of Child and Parent-Proxy Measures.

ABSTRACT: OBJECTIVES:Severe to profound hearing loss is associated with worse health-related quality of life (HRQoL), reflecting the wide-ranging effects of deafness on spoken language, cognition, and social/behavioral development. However, there are currently no cochlear implant (CI)-specific HRQoL measures that were developed using the Food and Drug Administration Guidance on patient-reported outcomes. This study developed the first HRQoL instruments (CI-QoL) for children with CIs, ages 6 to 12, and a parent-proxy measure for this age group. DESIGN:Two phases of instrument development were conducted. Phase 1 consisted of a literature review yielding a conceptual framework and discussion guides to elicit information from stakeholder focus groups at CI clinics in Miami and Philadelphia (n = 30; e.g., physicians, speech pathologists). During phase 2, open-ended interviews were conducted with 21 parent-child dyads (M child age = 9.1 years) recruited from these two clinics. Interviews were transcribed, followed by content analysis in NVivo to identify the most frequent and difficult themes. Items were then derived from these themes to form the initial draft instruments. A multimodal approach was used to create the child-report version (i.e., pictorial representations, audio recording of items, written text above the drawings) to maximize comprehension and ease of responding. Both measures were developed to be administered electronically on a tablet device. In phase 3, a new set of parent-child dyads (n = 20; child age M = 9.2 years) completed a cognitive testing protocol to ensure clarity, ease of use, and comprehensiveness. Cognitive testing led to revisions and finalization of the instruments. RESULTS:The final self-report measure contained 33 items across eight domains: Noisy Environments, Academic Functioning, Child Acceptance, Oral Communication, Social Functioning, Fatigue, Emotional Functioning, and Device Management. The final parent-proxy measure included 42 items on nine scales: the same eight scales that appear on the child version, with the addition of Behavior Problems. Correlations between child and parent reports on each scale ranged from r = 0.08 to 0.48. CONCLUSIONS:CI-specific HRQoL instruments have now been developed for school-age children with CIs, with an accompanying parent-proxy version. After a psychometric validation, these CI-specific measures will enable us to track long-term outcomes, evaluate the efficacy of interventions to improve CI use (e.g., single versus bilateral implantation, AV therapy, maternal sensitivity training), and provide a profile of the "whole child's" functioning to facilitate care.

SUBMITTER: Hoffman MF

PROVIDER: S-EPMC6348146 | biostudies-literature | 2019 May/Jun

REPOSITORIES: biostudies-literature

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Health-Related Quality of Life Instruments for Children With Cochlear Implants: Development of Child and Parent-Proxy Measures.

Hoffman Michael F MF Cejas Ivette I Quittner Alexandra L AL

Ear and hearing 20190501 3

<h4>Objectives</h4>Severe to profound hearing loss is associated with worse health-related quality of life (HRQoL), reflecting the wide-ranging effects of deafness on spoken language, cognition, and social/behavioral development. However, there are currently no cochlear implant (CI)-specific HRQoL measures that were developed using the Food and Drug Administration Guidance on patient-reported outcomes. This study developed the first HRQoL instruments (CI-QoL) for children with CIs, ages 6 to 12, ...[more]

PMID: 30059365

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Project description:BackgroundDiscrepancy between self-reports and parent-proxy reports of adolescent health-related quality of life (HRQoL) has been repeatedly acknowledged in the literature as the proxy problem. However, little is known about the extent and direction of this discrepancy. The purpose of this study is to explore to what extent and in what direction HRQoL self-reports of adolescents with chronic conditions and those of their parents differ.MethodsA cross-sectional survey was conducted among adolescents suffering from chronic conditions and their parents. Socio-demographic and disease-related characteristics were collected and information about consequences of the chronic condition was assessed. HRQoL was measured with KIDSCREEN-10 and DISABKIDS condition generic measure (DCGM-10). Agreement was analysed through defining a threshold of agreement based on half of the standard deviation of the HRQoL score with the highest variance. Agreement occurred if the difference between adolescent and parent scores was less than or equal to half of the standard deviation. Intra-class correlation coefficients and Bland-Altman plots were also computed. The characteristics associated with direction of disagreement were statistically tested with one-way ANOVA and Chi-square tests.Results584 paired HRQoL scores were obtained. Ratings from both adolescents and parents were high, compared to European norm data. Differences between adolescents and parents were statistically significant, yet relatively small. Disagreement existed in both directions: in 24.5% (KIDSCREEN-10) and 16.8% (DCGM-10) of the cases adolescents rated their HRQoL lower than did their parent, while in 32.2% (KIDSCREEN-10) and 31.7% (DCGM-10) of the cases the opposite was true. Adolescent's age, educational level and type of education, parent's educational level, number of hospital admissions and several other disease-related factors influenced direction of disagreement.ConclusionsIn a reasonable proportion of cases the adolescent and parent agreed on the adolescent's HRQoL (43-51% of the cases) and most disagreement tended to be minor. Thus, the proxy problem may be smaller than presented in the literature and its extent may differ per population. As adolescents are expected to become partners in their own health care, it is recommended to focus on adolescents' own perceptions of HRQoL.

Project description:BackgroundHearing loss impacts health-related quality of life and general well-being and was identified in a Lancet report as one of the largest potentially modifiable factors for the prevention of age-related dementia. There is a lack of robust data on how cochlear implant treatment in the elderly impacts quality of life. The primary objective was to measure the change in health utility following cochlear implantation in individuals aged ≥ 60 years.MethodsThis study uniquely prospectively recruited a large multinational sample of 100 older adults (mean age 71.7 (SD7.6) range 60-91 years) with severe to profound hearing loss. In a repeated-measures design, pre and post implant outcome measures were analysed using mixed-effect models. Health utility was assessed with the Health Utilities Index Mark III (HUI3). Subjects were divided into groups of 60-64, 65-74 and 75 + years.ResultsAt 18 months post implant, the mean HUI3 score improved by 0.13 (95%CI: 0.07-0.18 p < 0.001). There was no statistically significant difference in the HUI3 between age groups (F[2,9228] = 0.53, p = 0.59). The De Jong Loneliness scale reduced by an average of 0.61 (95%CI: 0.25-0.97 p < 0.014) and the Lawton Instrumental Activities of Daily Living Scale improved on average (1.25, 95%CI: 0.85-1.65 p < 0.001). Hearing Handicap Inventory for the Elderly Screening reduced by an average of 8.7 (95%CI: 6.7-10.8, p < 0.001) from a significant to mild-moderate hearing handicap. Age was not a statistically significant factor for any of the other measures (p > 0.20). At baseline 90% of participants had no or mild depression and there was no change in mean depression scores after implant. Categories of Auditory perception scale showed that all subjects achieved a level of speech sound discrimination without lip reading post implantation (level 4) and at least 50% could use the telephone with a known speaker.ConclusionsBetter hearing improved individuals' quality of life, ability to communicate verbally and their ability to function independently. They felt less lonely and less handicapped by their hearing loss. Benefits were independent of age group. Cochlear implants should be considered as a routine treatment option for those over 60 years with bilateral severe to profound hearing loss.Trial registrationClinicalTrials.gov ( http://www.Clinicaltrialsgov/ ), 7 March 2017, NCT03072862.

Project description:ObjectivesSevere to profound hearing loss is associated with communication, social, and behavioral difficulties that have been linked to worse health-related quality of life (HRQoL) compared to individuals with normal hearing. HRQoL has been identified as an important health outcome that measures functional ability, particularly for chronic conditions and disabilities. The current study developed the QoL-cochlear implant (CI) for early childhood and adolescents using the recommended Food and Drug Administration and European Medicines Agency guidelines on patient-reported outcomes.DesignThree phases of instrument development were conducted for both the early childhood (0 to 5 years old; parent proxy) and adolescent/young adult (13 to 22 years old) versions of the QoL-CI. Phase 1 included the development of our conceptual framework, which informed the discussion guides for stakeholder focus groups (e.g., audiologists, physicians, and therapists) at CI clinics in Miami and Philadelphia (n = 39). Open-ended interviews with parents (N = 18 for early childhood; N = 6 for adolescent/young adult version) and adolescents/young adults using CIs (n = 17) were then completed at both sites during phase 2. All interviews were transcribed and coded to identify common themes, which were then used to draft items for the QoL-CI. Both versions of the QoL-CI were developed using Qualtrics to allow for quick, easy electronic administration of the instruments on a tablet device. Last, phase 3 included cognitive testing in a new sample (N = 19 early childhood, N = 19 adolescent) to ensure that the draft instruments were clear, comprehensive, and easy to use.ResultsParticipant responses obtained via the open-ended interviews yielded an early childhood and adolescent version of the QoL-CI that was reportedly easy to complete and comprehensive. The final QoL-CI Early Childhood instrument yielded 35 questions across eight functional domains (environmental sounds, communication, social functioning, behavior, CI device management and routines, school, CI benefits, and early intervention). Similarly, the final QoL-CI adolescent/young adult version consisted of 46 items across eight domains (noisy environments, communication, CI usage and management, advocacy, social functioning, emotional functioning, acceptance, and independence).ConclusionsThe QoL-CI is a condition-specific QoL instrument that can be used for children ages birth through 22 years. These instruments capture the "whole" child by not only focusing on communication and auditory skills but also academic, social and emotional functioning. Once validated, these CI-specific measures will enable providers to track long-term outcomes and evaluate the efficacy of new interventions to improve overall CI use and QoL for pediatric and young adult users.

Project description:ImportanceChildren who receive a cochlear implant (CI) for early severe to profound sensorineural hearing loss may achieve age-appropriate spoken language skills not possible before implantation. Despite these advances, reduced access to auditory experience may have downstream effects on fundamental neurocognitive processes for some children with CIs.ObjectiveTo determine the relative risk (RR) of clinically significant executive functioning deficits in children with CIs compared with children with normal hearing (NH).Design, setting, and participantsIn this prospective, cross-sectional study, 73 children at a hospital-based clinic who received their CIs before 7 years of age and 78 children with NH, with average to above average mean nonverbal IQ scores, were recruited in 2 age groups: preschool age (age range, 3-5 years) and school age (age range, 7-17 years). No children presented with other developmental, cognitive, or neurologic diagnoses.InterventionsParent-reported checklist measures of executive functioning were completed during psychological testing sessions.Main outcomes and measuresEstimates of the RR of clinically significant deficits in executive functioning (≥1 SDs above the mean) for children with CIs compared with children with NH were obtained based on 2 parent-reported child behavior checklists of everyday problems with executive functioning.ResultsIn most domains of executive functioning, children with CIs were at 2 to 5 times greater risk of clinically significant deficits compared with children with NH. The RRs for preschoolers and school-aged children, respectively, were greatest in the areas of comprehension and conceptual learning (RR [95% CI], 3.56 [1.71-7.43] and 6.25 [2.64-14.77]), factual memory ( 4.88 [1.58-15.07] and 5.47 [2.03-14.77]), attention (3.38 [1.03-11.04] and 3.13 [1.56-6.26]), sequential processing (11.25 [1.55-81.54] and 2.44 [1.24-4.76]), working memory (4.13 [1.30-13.06] and 3.64 [1.61-8.25] for one checklist and 1.77 [0.82-3.83] and 2.78 [1.18-6.51] for another checklist), and novel problem-solving (3.93 [1.50-10.34] and 3.13 [1.46-6.67]). No difference between the CI and NH samples was found for visual-spatial organization (2.63 [0.76-9.03] and 1.04 [0.45-2.40] on one checklist and 2.86 [0.98-8.39] for school-aged children on the other checklist).Conclusions and relevanceA large proportion of children with CIs are at risk for clinically significant deficits across multiple domains of executive functioning, a rate averaging 2 to 5 times that of children with NH for most domains. Screening for risk of executive functioning deficits should be a routine part of the clinical evaluation of all children with deafness and CIs.

Dataset Information

Health-Related Quality of Life Instruments for Children With Cochlear Implants: Development of Child and Parent-Proxy Measures.

Publications

Health-Related Quality of Life Instruments for Children With Cochlear Implants: Development of Child and Parent-Proxy Measures.

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