QUALITY OF LIFE AND COCHLEAR IMPLANTATION

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.

Teddy McRackan, MD MSCR of the Medical University of South Carolina was awarded a grant from the American Cochlear Implant Alliance (10/17-9/20) to improve how cochlear implant outcomes in adults are measured.  His work, highlighted below, has resulted in the development and application of the Cochlear Implant Quality of Life (CIQOL) instrument suite. 

Measuring Patient Expectations as Part of the CI Evaluation

August 12, 2022

QoL Expectations Instruments

The Cochlear Implant Quality of Life (CIQOL) suite of instruments provide a comprehensive assessment of functional abilities in adults with cochlear implants (CI). Using stringent psychometric methods, including factor analysis and item response theory (IRT), and following the Patient-Reported Outcomes Measurement Information System (PROMIS) and Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) methodology, we created the CIQOL item banks, CIQOL-35 Profile instrument, CIQOL-10 Global measure, and the CIQOL-Expectations instrument.   The new CIQOL Functional Staging System enhances the interpretability and clinical application of the CIQOL instruments and associated domain scores.  Our research program has taken a patient-centered approach, including direct engagement with CI users, their families, and CI clinicians, to ensure that all outcomes are meaningful to CI users and to encourage realistic expectations and shared decision-making. 

All CIQOL instruments and scoring manuals are available for free download at https://education.musc.edu/CIQOL.  The instruments have been downloaded over 300 times and have undergone translation/cross-cultural adaptation into French, Arabic, and German with many other languages underway.

CIQOL-35 Profile and CIQOL-10 Global Measure

The Cochlear Implant Quality of Life-35 Profile (CIQOL-35 Profile) includes 35 items and assesses the functional abilities of adult CI users in 6 domains:

• Communication: receptive and expressive communication ability in different situations
• Emotional:impact of hearing ability on emotional well-being
• Entertainment: enjoyment and clarity of TV, radio, and music
• Environmental: ability to distinguish and localize environmental sound
• Listening effort: degree of effort and resulting fatigue associated with listening
• Social: ability to interact in groups and to attend and enjoy social functions

The CIQOL-10 Global measure is an additional patient-reported outcome measure with 10 items from the CIQOL-35 that provides a general overall assessment of quality of life in CI users without domain-specific data.  The CIQOL-10 Global score can be derived from a subset of responses from the CIQOL-35 Profile.

The process to develop the CIQOL-35 Profile instrument and CIQOL-10 Global measure included four main stages: 

1. Focus groups to create the CIQOL item pools
2. Psychometric analyses of the CIQOL item pools to create the CIQOL item banks
3. Selection of items for the CIQOL instruments based on the results of IRT analysis of the CIQOL item bank
4. Validation of the CIQOL instruments

Completion of these stages required participation of over 700 individual adult CI users who were recruited from our CIQOL Development Consortium, which consists of 30 CI centers from all regions of the United States. 

CIQOL-35 Profile and CIQOL-10 Global Normative Outcomes

CIQOL domain-specific and global outcome scores are available for 705 adult CI users from all regions of the United States who met candidacy criteria and have been using their CIs for at least 12 months Patients receiving CIs for single-sided deafness were excluded. These normative data can be found at the reference at the end of this page.

CIQOL-Expectations Instrument

Ensuring patients have realistic outcome expectations prior to cochlear implantation is a key component of the CI evaluation process.  However, clinicians primarily determine patients’ expectations and the extent to which they are realistic using generalized conversations and their own experiences.  Now, availability of the validated CIQOL-Expectations instrument addresses this unmet clinical need.

• The CIQOL-Expectations instrument used the established, patient-centered CIQOL framework using a mixed-methods research design, which included interviews with potential CI users and extensive psychometric analyses.
• A total of 178 potential CI users took part in the development and validation process. Highest mean expectation scores were obtained for the environment (70.2±20.8) and social (68.4±18.0) domains (scale 0-100).
• On average, potential CI users had substantially higher expectations than corresponding normative CIQOL-35 Profile scores (experienced CI users) for all domains other than emotional and social.
• Finally, 28 participants completed the CIQOL-Expectations instrument before and after their CI evaluation to determine whether their expectations changed following discussions during the CI evaluation. Indeed, after the CI evaluation, participants demonstrated large changes in scores (both higher and lower expectations) for all domains.

Use of the CIQOL-Expectations instrument provides an opportunity to assess potential CI users’ expected outcomes among 6 domains that reflect real-world functional abilities valued by CI users.  Moreover, comparing expectations of individual patients to normative CIQOL data from large numbers of experienced CI users (see above) provides clinicians the opportunity for evidence-based counseling with their patients.

The CIQOL Functional Staging System

Functional staging systems directly address a major limitation of many outcome measures, including patient-reported outcome measures and speech recognition scores, which is the inability to provide patients with real-world interpretations of numerical scores.  These staging systems have been used in many fields to provide detailed descriptions of patient-reported abilities (clinical vignettes) without sacrificing the inherent value of the scores themselves.  For the CIQOL functional staging system, each domain has multiple stages that maintain the hierarchic ability structure established during the development process. The functional staging system was based on CIQOL-35 responses from the 705 experienced CI users described earlier.

The number of stages for each domain was determined by the number of statistically distinct groupings, based on ability levels, to which patients can be reliably assigned.  This resulted in 5 stages for the communication domain and 3 stages for the other 5 domains.  Cut scores were then defined to separate CI users into each of these distinct functional stages. Then, based on the item responses for each stage, clinical vignettes were developed that describe the functional abilities for each stage and then validated by adult CI users to confirm that each higher stage represents meaningful improvement in functional abilities. 

There are many potential applications of the CIQOL functional staging system, and several are highlighted below:

• Provide evidence-based understanding of CI users’ real-world functional abilities across 6 domains following implantation
• Allow comparison of patient pre-CI expectations (using the CIQOL-Expectations instrument) and pre-CI functional abilities (using the CIQOL-35 Profile instrument) to normative data
• Monitor individual patient progress following implantation and identify patient and domain-specific barriers that inhibit or facilitate patient progress.

Dr. Teddy McRackan, MD, MSCR was awarded the 2022 Harris P. Mosher Award by the Triological Society for the development and implementation of the CIQOL Functional Staging System.

Acknowledgements:

This research was funded in part by the American Cochlear Implant Alliance and the NIH/NIDCD

WEBINAR

2/27/2019

Ted R. McRackan, M.D. discusses the various ways to measure the quality of life in the cochlear implant population. In addition, data will be presented regarding the quality of life outcomes in adult cochlear implant recipients. Click here to view webinar.