Cochlear Implant Awareness: Development and Validation of a Patient Reported Outcome Measure

Abstract

BackgroundSurgical success of cochlear implantation is usually measured through speech perception and quality of life questionnaires. Although these questionnaires cover a broad spectrum of domains, they do not evaluate the consciousness of wearing a cochlear implant (CI) and how this impacts the daily life of patients. To evaluate this concept we aimed to develop and validate a standardized patient reported outcome measure (PROM) for use in cochlear implant users.MethodsDevelopment and evaluation of the COchlear iMPlant AwareneSS (COMPASS) questionnaire was realized following the COSMIN guidelines in three phases: (1) item generation, (2) qualitative pilot study to ensure relevance, comprehensiveness, comprehensibility, and face validity, and (3) quantitative survey study for the assessment of reliability (test-retest) with 54 participants.ResultsNine domains of CI awareness were identified through literature research and interviews with experts and patients. These resulted in the formulation of 18 items which were tested with a pilot study, after which 3 items were deleted. The final 15-item COMPASS questionnaire proved to have good validity and satisfactory reliability. The intraclass correlation coefficient calculated for items with continuous variables ranged from 0.66 to 0.89 with seven out of eight items scoring above the acceptable level of 0.7. The Cohen’s kappa calculated for items with nominal variables ranged from −0.4 to 0.78 with 11 (sub)items out of 15 scoring above fair to good agreement. Measurement error analysis for items with continuous variables showed a mean difference of −2.18 to 0.22. The calculated 95% limits of agreement for these items revealed no statistically significant difference between the two administered questionnaires. For items with nominal variables, the percentages of agreement calculated, ranged between 0 and 95%, and 83.3 and 96.6% for positive and negative agreement, respectively.ConclusionThe COMPASS questionnaire is a valid and reliable PROM for evaluating the cochlear implant awareness, and it can be easily used in routine clinical practice.

A monocenter, patient-blinded, randomized, parallel-group, non-inferiority study to compare cochlear implant receiver/stimulator device fixation techniques (COMFIT) with and without drilling in adults eligible for primary cochlear implantation

“…The questionnaire used in this study is the validated COchlear iMPlant AwareneSS (COMPASS) survey that assesses patient-experienced burden by wearing the CI in their day-to-day activities [ 41 ]. It contains 15 items, multiple choice as well as visual analog scale items.…”

Evaluating the Clinical Reliability and Reference Values of the International Outcome Inventory for Cochlear Implants in a DOD Population

“…5 For management using cochlear implants (CIs), there are far fewer options for standardized subjective outcome measures. The Cochlear Implant Management Skills (CIMS) 6 evaluates how well the patient can manage their device, the Nijmegen Cochlear Implantation Questionnaire (NICQ) 7 assesses quality of life, and the Cochlear iMPlant AwareneSS (COMPASS) 8 evaluates the awareness the patient has about their CI and the impacts it has on their daily life. Though these questionnaires are useful in their respective category of assessment, there are no consistently used subjective questionnaires that are specifically validated for cochlear implant users' perception of benefit.…”