American Cochlear Implant Alliance (ACI Alliance)
Funding Opportunity in Quality of Life Outcomes Measures of Cochlear Implantation
Quality of Life after Cochlear Implants
The American Cochlear Implant Alliance invited investigators to submit proposals for a research grant to explore cochlear implant outcomes research. A variety of assessments have been developed to document the impact of cochlear implantation on communication abilities in adults and children with hearing loss. However, our knowledge of the functional outcomes of cochlear implantation remains limited. This funding was meant to result in the development and validation of Quality of Life instruments specifically targeted to cochlear implant recipients.
The ACI Alliance Research Committee reviewed applications using criteria adapted from the NIH Review Criteria that included Significance, Investigator(s), Innovation, Approach, and Environment.
The three-year grant was awarded to Theodore McRacken MD of MUSC Health-University Medical Center of South Carolina for the proposal of Meta-analysis of quality of life improvement after cochlear implantation and association with speech recognition abilities. The start date for the study was 10/1/2017.
April 18, 2018
Development of New Cochlear Implant Quality of Life Instruments for Adults
Ted R. McRackan MD, MSCR, Assistant Professor, Judy R. Dubno PhD, Professor, Director of the Hearing Research Program Department of Otolaryngology—Head and Neck Surgery Medical University of South Carolina (MUSC)
ACI Alliance Calling, April 2018, Vol 6, No.1
|Ted McRackan MD speaking at CI2018 DC
Due to increased numbers of adults with hearing loss and changing cochlear implant (CI) indications, the number of adult CIs performed annually continues to increase. Cochlear implant outcomes are primarily assessed using word and sentence recognition; although important, these measures do not capture the diverse listening and communication experiences of CI users. Clinical protocols remain limited to the same metrics (speech understanding) that have been used for the past 25 years with little advancement. Importantly, outcomes reported using these test batteries are often poorly correlated with CI user self-reports of real-world communication abilities and are characterized by large, unexplained individual differences.
Health-related quality of life (QOL) instruments have become increasingly important in understanding the impact of a medical intervention on a patient’s life. Patient-reported outcome measures (PROMs) are instruments devised to capture a patient’s perspective about their overall health or treatment. The use of PROMs to assess QOL allows direct input from the affected population about how disease processes and interventions impact patients’ lives. The importance of PROMs is perhaps best highlighted by the Center for Medicaid and Medicare Services (CMS) targeting QOL improvement as a primary outcome measure in the Quality Strategy Report and the FDA requirement that PROMs be included in all clinical trials where an intervention seeks FDA approval.
Numerous studies have shown the positive effects of CI on QOL, but there is no universally accepted QOL instrument for CI patients. Some CI studies have used hearing-specific QOL instruments, but these have not been validated in CI patients. Even the few CI-specific QOL instruments available do not meet modern development standards. The NIH established the Patient-Reported Outcomes Measurement Information System (PROMIS) in 2004 to develop, evaluate, and disseminate PROMs that assess well-being from a patient perspective. Since that time, PROMIS has established rigorous and clear guidelines for how PROMs should be developed and validated. No hearing or CI-specific PROM has been developed using these methods.
The development of QOL instruments that meet the above standards is a multiple step process that requires a large numbers of research subjects. We have established the Cochlear Implant Quality of Life Development Consortium to help recruit a diverse sample of patients. The consortium consists of 29 CI centers that represent all regions of the United States. Following the PROMIS guidelines, our team at MUSC has made significant progress in developing new CI-specific QOL instruments for adults, including: systematic literature search, patient focus groups, cognitive interviews, and psychometric evaluation of our item (question) bank. We now have a psychometrically valid item bank with 91 question separated into 6 domains (communication, emotion, entertainment, environment, listening effort, and social). Using this item bank, we have developed a 35-item profile CIQOL instrument with face, content, and construct validity. The next step will be to psychometrically evaluate the profile instrument against legacy QOL measures.
We are also working to develop short form and computer adaptive testing (CAT) CI-QOL instruments. Shortforms are important for routine use in the busy clinical setting where clinicians and patients may not have sufficient time to complete longer instruments. CAT instruments alter the difficulty of subsequent items based on a patient’s responses to previous items, which can minimize floor and ceiling effects and allow greater differentiation of abilities among individual patients.
The results of this research will expand outcome measures related to cochlear implantation beyond speech recognition ability to better understand the communication, social, emotional and other experiences of CI users. In doing so, we aim to improve how CI outcomes are measured and reported. CI-QOL instruments with increased precision and responsiveness will be a valuable measurement tool for future clinical trials involving adult CI patients. We are excited about the future of this work and believe it is the beginning of a more comprehensive and patient-centered era of reporting and understanding CI patient outcomes, which should lead to better interventions for patients with CIs.
Editor’s Note: Dr. McRackan is the PI for a 3-year ACI Alliance grant to develop QOL measures for CI that was awarded to MUSC. He presented at CI2018 DC and will continue to update the membership on the study progress.
To view presentation material on QOL from the CI2018 DC conference: https://www.acialliance.org/page/EmergingIssue1
March 2, 2018
The development of quality of life instruments that meet modern standards is a multiple step process that requires a large numbers of research subjects. The research team at the Medical University of South Carolina established the Cochlear Implant Quality of Life Development Consortium to help recruit a diverse sample of patients. The consortium consists of 25 cochlear implant centers that represent all regions of the United States. Patient recruitment for phase one (development of the cochlear implant quality of life item bank) is complete. Through the consortium, the research team enrolled 500 subjects throughout the United States. The research team is now performing the psychometric analysis to review the themes and domains that were initially identified during focus groups and to ensure that the items are sound and cover the range of ways that adult CI recipients benefit from cochlear implantation.
Ted McRackan, MD, MSCR
Director, Skull Base Center
Department of Otolaryngology - Head and Neck Surgery
Medical University of South Carolina