Sensitivity of EQ-5D-3L, HUI2, HUI3, and SF-6D to changes in speech reception and tinnitus associated with cochlear implantation

Abstract Purpose There is concern that some generic preference based measures (GPMs) of health-related quality of life may be insensitive to interventions that improve hearing. Establishing where sensitivity arises could contribute to the design of improved measures. Accordingly, we compared the sensitivity of four widely-used GPMs to a clinically effective treatment – cochlear implantation – which restores material degrees of hearing to adults with little or no functional hearing. Methods Participants (N=147) received implants in any of 13 hospitals in the UK. One month before implantation and nine months after, they completed the HUI2, HUI3, EQ 5D 3L, and SF-6D questionnaires, together with the EuroQoL visual analogue scale as a direct measure of health, a performance test of speech reception, and a self-report measure of annoyance due to tinnitus. Results Implantation was associated with a large improvement in speech reception and a small improvement in tinnitus. HUI2 and HUI3 were sensitive to the improvement in speech reception through their Sensation and Hearing dimensions; EQ 5D 3L was sensitive to the improvement in tinnitus through its Anxiety/Depression dimension; SF-6D was sensitive to neither. Participants reported no overall improvement in health. Variation in health was associated with variation in tinnitus, not variation in speech reception. Conclusions None of the four GPMs was sensitive to the improvements in both speech reception and tinnitus that were associated with cochlear implantation. To capture fully the benefits of interventions for auditory disorders, developments of current GPMs would need to be sensitive to both the health-related and non-health-related aspects of auditory dysfunction

Comparison of the benefits of cochlear implantation versus contra-lateral routing of signal hearing aids in adult patients with single-sided deafness: study protocol for a prospective within-subject longitudinal trial

Background Individuals with a unilateral severe-to-profound hearing loss, or single-sided deafness, report difficulty with listening in many everyday situations despite having access to well-preserved acoustic hearing in one ear. The standard of care for single-sided deafness available on the UK National Health Service is a contra-lateral routing of signals hearing aid which transfers sounds from the impaired ear to the non-impaired ear. This hearing aid has been found to improve speech understanding in noise when the signal-to-noise ratio is more favourable at the impaired ear than the non-impaired ear. However, the indiscriminate routing of signals to a single ear can have detrimental effects when interfering sounds are located on the side of the impaired ear. Recent published evidence has suggested that cochlear implantation in individuals with a single-sided deafness can restore access to the binaural cues which underpin the ability to localise sounds and segregate speech from other interfering sounds. Methods/Design The current trial was designed to assess the efficacy of cochlear implantation compared to a contra-lateral routing of signals hearing aid in restoring binaural hearing in adults with acquired single-sided deafness. Patients are assessed at baseline and after receiving a contra-lateral routing of signals hearing aid. A cochlear implant is then provided to those patients who do not receive sufficient benefit from the hearing aid. This within-subject longitudinal design reflects the expected care pathway should cochlear implantation be provided for single-sided deafness on the UK National Health Service. The primary endpoints are measures of binaural hearing at baseline, after provision of a contra-lateral routing of signals hearing aid, and after cochlear implantation. Binaural hearing is assessed in terms of the accuracy with which sounds are localised and speech is perceived in background noise. The trial is also designed to measure the impact of the interventions on hearing- and health-related quality of life. Discussion This multi-centre trial was designed to provide evidence for the efficacy of cochlear implantation compared to the contra-lateral routing of signals. A purpose-built sound presentation system and established measurement techniques will provide reliable and precise measures of binaural hearing. Trial registration Current Controlled Trials http://www.controlled-trials.com/ISRCTN33301739 (05/JUL/2013

Plasticity in bilateral superior temporal cortex: effects of deafness and cochlear implantation on auditory and visual speech processing

While many individuals can benefit substantially from cochlear implantation, the ability to perceive and understand auditory speech with a cochlear implant (CI) remains highly variable amongst adult recipients. Importantly, auditory performance with a CI cannot be reliably predicted based solely on routinely obtained information regarding clinical characteristics of the CI candidate. This review argues that central factors, notably cortical function and plasticity, should also be considered as important contributors to the observed individual variability in CI outcome. Superior temporal cortex (STC), including auditory association areas, plays a crucial role in the processing of auditory and visual speech information. The current review considers evidence of cortical plasticity within bilateral STC, and how these effects may explain variability in CI outcome. Furthermore, evidence of audio-visual interactions in temporal and occipital cortices is examined, and relation to CI outcome is discussed. To date, longitudinal examination of changes in cortical function and plasticity over the period of rehabilitation with a CI has been restricted by methodological challenges. The application of functional near-infrared spectroscopy (fNIRS) in studying cortical function in CI users is becoming increasingly recognised as a potential solution to these problems. Here we suggest that fNIRS offers a powerful neuroimaging tool to elucidate the relationship between audio-visual interactions, cortical plasticity during deafness and following cochlear implantation, and individual variability in auditory performance with a CI

Criteria of candidacy for unilateral cochlear implantation in postlingually deafened adults II: cost-effectiveness analysis

Objectives: The objectives of this study were to estimate the cost-effectiveness of unilateral cochlear implantation for postlingually deafened adults; to study the impact on cost-effectiveness of relaxing criteria of candidacy to include patients who benefit from acoustic hearing aids; and to study the further impact of age at implantation and duration of profound deafness before implantation.Design: This prospective cohort study was carried out in 13 hospitals with four groups of severely to profoundly hearing-impaired subjects distinguished by their preoperative ability to identify words in prerecorded sentences when aided acoustically. The groups represent a progressive relaxation of criteria of candidacy: Group I (N = 134) scored 0% correct without lipreading and did not improve their lipreading score significantly when aided; group II (N = 93) scored 0% without lipreading but did improve their lipreading score significantly when aided; group III (N = 53) scored 0% without lipreading when the ear to be given an implant was aided but between 1% and ~50% when the other ear was aided; and group IV (N = 31) scored between 1% and ~50% without lipreading when the ear to be given an implant was aided. Lifetime costs to the UK National Health Service of providing and maintaining a cochlear implant were estimated for each subject. The gain in health utility from cochlear implantation was estimated with the Mark III Health Utilities Index and was combined with life expectancy to estimate the number of quality-adjusted life-years (QALYs) that would be gained from cochlear implantation. Cost/QALY ratios were calculated by means of the Net Benefit technique and were compared with an upper limit of acceptability of [Euro sign]50,000/QALY.Results: Averaged over the whole cohort, the cost of gaining a QALY was [Euro sign]27,142 (95% confidence interval, [Euro sign]24,532 to [Euro sign]30,323); 203 of 311 (67%) of the cohort displayed cost/QALY ratios more favorable than [Euro sign]50,000/QALY. The average cost of gaining a QALY increased from group I ([Euro sign]24,032) to groups II ([Euro sign]27,062) and IV ([Euro sign]27,092) to group III ([Euro sign]39,009). Cost/QALY varied with age at implantation from [Euro sign]19,223 for subjects who were younger than 30 yr of age to [Euro sign]45,411 for subjects who were older than 70 yr of age. Cost/QALY was unacceptable because of minimal gain in health utility for the subset of groups I and II, who were given implants in ears that had been profoundly deaf for more then 40 yr and for the subset of groups III and IV, who were given implants in ears that had been profoundly deaf for more than 30 yr.Conclusions: Cochlear implantation was a cost-effective intervention for the majority of subjects, including the group given implants when older than 70 yr of age. Relaxation of criteria of candidacy for cochlear implantation reduces cost-effectiveness. Prioritization of the provision of cochlear implantation should take duration of profound deafness in the ear to be given an implant into account, as well as preoperative word recognition performance

Criteria of candidacy for unilateral cochlear implantation in postlingually deafened adults I: theory and measures of effectiveness

Objectives: The objectives of this study were to distinguish the equivalent-effectiveness, health-economic, and actuarial approaches to specifying criteria of candidacy for medical interventions; to apply the equivalent-effectiveness approach to unilateral cochlear implantation for postlingually deafened adults; and to determine whether the criterion should take age at implantation and duration of profound deafness into account.Design: The study was designed as a prospective cohort study in 13 hospitals with four groups of severely-profoundly hearing-impaired subjects distinguished by their preoperative ability to identify words in sentences when aided acoustically. The groups represent a progressive relaxation of criteria of candidacy: Group I (N = 134) scored 0% correct without lipreading and did not improve their lipreading score significantly when aided; group II (N = 93) scored 0% without lipreading but did improve their lipreading score significantly when aided; group III (N = 53) scored 0% without lipreading when the to-be-implanted ear was aided but between 1% and ~50% when the other ear was aided. Group IV (N = 31) scored between 1% and ~50% without lipreading when the to-be-implanted ear was aided. Measures of speech intelligibility, health utility, and otologically relevant quality of life were obtained before surgery and 9 mo after surgery from each subject. Measures of effectiveness were calculated as the difference between 9-mo and preoperative scores.Results: Effectiveness differed only slightly between groups. Effectiveness was not strongly associated with age at the time of implantation. Greater effectiveness was associated with implantation in the ear with the shorter duration of profound deafness. Cochlear implantation was least effective when the preoperative audiological status of the better-hearing ear was good and the duration of profound deafness of the implanted ear was long. As a result, effectiveness was not significant for the subsets of groups III and IV, who were given implants in ears that had been profoundly deaf for more than 30 yr.Conclusions: The effectiveness of cochlear implantation differs little between groups of candidates who score zero with acoustic hearing aids before surgery and groups who score up to ~50% correct, thereby justifying a relaxation of the criterion of candidacy to embrace some members of the latter groups. The criterion should be based not only on preoperative speech intelligibility but also on duration of profound deafness in the to-be-implanted ear

Criteria of candidacy for unilateral cochlear implantation in postlingually deafened adults III: prospective evaluation of an actuarial approach to defining a criterion

Objective: Outcomes from unilateral cochlear implantation in postlingually deafened adults are variable and difficult to predict precisely from data gathered before surgery. The objective was to derive and validate a method for specifying criteria of candidacy for implantation that takes this variability into account.Design: Accuracy of identifying words in prerecorded sentences without lipreading was measured in 480 users of unilateral multichannel cochlear implants. These patients had all scored zero before surgery on prerecorded open-set tests of word recognition in sentences with acoustic hearing aids. Statistical models were derived that calculated the odds that a patient would score higher with an implant than a criterion score, given knowledge of the duration of profound deafness in the implanted ear. The accuracy of the models was evaluated prospectively with two new groups of patients who scored between 1% and ~50% correct before surgery in one or both ears with acoustic hearing aids. Group I (N = 53) was implanted in an ear that scored zero. Group II (N = 31) was implanted in an ear that scored above zero. Benefits from implantation, measured as changes in word recognition performance and in health utility, were compared with the odds calculated by the statistical models.Results: The preferred model was based on data from 376 subjects. It made accurate predictions of the proportion of patients in group I, and, disregarding minor exceptions, accurate predictions of the proportion of patients in group II, who improved on their preoperative word recognition score. Benefit from implantation was low for patients implanted with odds less favorable than 4:1 (4 chances out of 5).Conclusions: Adoption of odds of 4:1 as the criterion of candidacy for unilateral cochlear implantation would be likely to maintain acceptable benefit and cost-effectiveness while being explicit and informative for patients, clinicians, and commissioners of health care