This is a qualitative research study focused on refining the presentation of outcome scores from the CIQOL-35 instrument by performing key informant interviews. CIQOL-35 patient profiles will be used to develop a preliminary staging system to classify patient outcomes. Interview questions will be developed based on the language and phrasing of the staging system. Clinician and patient participants will be scheduled or recruited to participate in 10 to 25-minute interviews. Participants will consist of pre-implantation patients, post implantation patients, and clinicians that work with CI patients (doctors, audiologists, counselors and rehabilitation staff). Each group will consist of up to 50 subjects answering questions about how well the language and terminology of the CIQOL-35 items and staging system reflect their experiences. Results will be used to develop and refine the language used to describe CI-patient abilities and the CIQOL-35 staging system for describing clinical outcomes.
Patient-reported outcome measures (PROMs) are crucial for understanding the impact of cochlear implants (CIs) on real-world functional abilities and quality of life (QOL) and for monitoring changes over time. However, CI clinical outcome measures traditionally focus solely on CI users' speech recognition ability to evaluate treatment success, which limits our understanding of CI's effects on patients' social isolation, emotional impact, and mental and listening effort related to severe hearing loss. Moreover, patient's speech recognition scores demonstrate low correlations with CI users' real-world communication experiences and QOL. Therefore, there is a critical gap in the measures commonly used to quantify patient outcomes after CI activation. To address this gap, we developed the Cochlear Implant Quality of Life (CIQOL)-35 Profile instrument, which provides a comprehensive, patient-centered assessment of CI-related functional abilities and QOL. However, difficultly in interpreting an individual patient's PROM score is a major barrier for PROM implementation and applications to clinical care. Therefore, additional work is critical for clinicians to appropriately interpret CIQOL-35 Profile scores for individual patients and apply those results to inform intervention decisions and monitor patient progress. In the current study we will longitudinally assess CI users CIQOL scores to help identify CI users with lower functional abilities who may benefit from increased support and allow clinicians to better track functional improvement after implantation for individual patients. This work will inform patient discussions regarding expected outcomes and timeframe for improvement.
The purpose of this study is to evaluate participants Quality of Life (QOL) with their Cochlear implant (CI) through a variety of questionnaires and hearing tests.
There will be a pre-surgical visit as well as 3, 6, and 12 month post-surgery visits. In this study, the participants will take surveys and hearing tests at each visit. He or she will complete surveys on the computer through REDCap and the hearing tests will be completed in sound-attenuating booth using headphones in the Walton Research building on MUSC's campus. The study participation is complete once the participant has completed all 4 study visits.
In the first arm of this study (Pro00063109) we developed a list of questions that will be utilized in a new quality of life questionnaire for cochlear implant users. We developed a survey to be used in the clinical setting based on these questions. We would like to gather data from a large number of implant users in order to validate the questionnaire. In the survey subjects are asked how hearing loss and having a cochlear implant affects their life. Enrolled subjects will complete the combined experimental survey paired with the current gold standard quality of life measures at two time points two weeks apart, greater than a year after receiving cochlear implantation.