Abstract
Severe to profound hearing loss is associated with measurable deficits in health-related quality of life (HRQoL), reflecting its concomitant effects on oral language, social and emotional functioning, and academic performance. HRQoL is a multidimensional construct that encompasses four core domains: 1) disease severity and physical symptoms, 2) functional status, 3) emotional/cognitive functioning, and 4) social skills (Aaronson, 1989; Palermo et al., 2008). However, studies of cochlear implantation (CI) have focused on clinical measures of efficacy related to language and communication (e.g., auditory, speech, language skills), and have not captured the implant’s effects on daily functioning. HRQoL measures provide a unique assessment of the effects of a CI on a broad range of outcomes, from the child and family's perspective. To date, there are no CI-specific HRQoL measures for young children (ages 6-12) and their parents (Morettin et al., 2013). This study developed the first HRQoL instruments for children with CIs and their parents, which were created using the FDA measurement process. Phase I included a literature review and focus groups with key stakeholders (e.g., implant surgeons, audiologists; n=30) to identify relevant content and create a conceptual framework. We also conducted open-ended interviews with children with CIs and their parents recruited from two CI centers to understand the impact of childhood deafness on daily functioning (n=21 dyads recruited from The University of Miami and Children’s Hospital of Philadelphia). Interviews were transcribed and coded using content analysis, leading to initial draft instruments. The child-report version utilizes a multimodal approach (i.e., pictorial representations, audio recording of items, written text) to maximize understanding. Both measures are administered digitally. In Phase II, a new set of child-parent dyads (n=20) took part in cognitive testing of the instruments to ensure clarity, ease of use, and comprehensiveness. Based on this feedback, the instruments were finalized. The finalized child-report measure contains 33 items across eight domains: Noisy Environments, Academic Functioning, Child Acceptance, Oral Communication, Social Functioning, Fatigue, Emotional Functioning, and Device Management. The finalized parent-proxy measure includes 42 items and nine scales: the same eight as the child version, plus Behavior Problems. Correlations between child and parent reports on each scale ranged from r=.08-.48. In addition, a nine-item Parenting Stress Module was created to assess common stressors. Following a psychometric validation, these CI-specific measures will enable us to track long-term outcomes, identify specific targets for intervention, assess the efficacy of interventions (e.g., auditory-verbal therapy, social skills) to improve implant use, and provide patient-centered clinical information to improve care.