A Multinational Cost-Consequence Analysis of a Bone Conduction Hearing Implant System-A Randomized Trial of a Conventional vs. a Less Invasive Treatment With New Abutment Technology.

Background: It is hypothesized that, for patients with hearing loss, surgically placing an implant/abutment combination whilst leaving the subcutaneous tissues intact will improve cosmetic and clinical results, increase quality of life (QoL) for the patient, and reduce medical costs. Here, incremental costs and consequences associated with soft tissue preservation surgery with a hydroxyapatite (HA)-coated abutment (test) were compared with the conventional approach, soft tissue reduction surgery with an all-titanium abutment (control). Methods: A cost-consequence analysis was performed based on data gathered over a period of 3 years in an open randomized (1:1) controlled trial (RCT) running in four European countries (The Netherlands, Spain, France, and Sweden). Subjects with conductive or mixed hearing loss or single-sided sensorineural deafness were included. Results: During the first year, in the Netherlands (NL), France (FR), and Spain (ES) a net cost saving was achieved in favor of the test intervention because of a lower cost associated with surgery time and adverse event treatments [NL €86 (CI -50.33; 219.20), FR €134 (CI -3.63; 261.30), ES €178 (CI 34.12; 97.48)]. In Sweden (SE), the HA-coated abutment was more expensive than the conventional abutment, which neutralized the cost savings and led to a negative cost (SE €-29 CI -160.27; 97.48) of the new treatment modality. After 3 years, the mean cost saving reduced to €17 (CI -191.80; 213.30) in the Netherlands, in Spain to €84.50 (CI -117.90; 289.50), and in France to €80 (CI -99.40; 248.50). The mean additional cost in Sweden increased to €-116 (CI -326.90; 68.10). The consequences in terms of the subjective audiological benefit and Health-related quality of life (HRQoL) were comparable between treatments. A trend was identified for favorable results in the test group for some consequences and statistical significance is achieved for the cosmetic outcome as assessed by the clinician. Conclusions: From this multinational cost-consequence analysis it can be discerned that health care systems can achieve a cost saving during the first year that regresses after 3 years, by implementing soft tissue preservation surgery with a HA-coated abutment in comparison to the conventional treatment. The cosmetic results are better. (sponsored by Cochlear Bone Anchored Solutions AB; Clinical and health economic evaluation with a new Baha® abutment design combined with a minimally invasive surgical technique, ClinicalTrials.gov NCT01796236).

Minimally Invasive Ponto Surgery compared to the linear incision technique without soft tissue reduction for bone conduction hearing implants: study protocol for a randomized controlled trial.

BACKGROUND: Over the last years, less invasive surgical techniques with soft tissue preservation for bone conduction hearing implants (BCHI) have been introduced such as the linear incision technique combined with a punch. Results using this technique seem favorable in terms of rate of peri-abutment dermatitis (PAD), esthetics, and preservation of skin sensibility. Recently, a new standardized surgical technique for BCHI placement, the Minimally Invasive Ponto Surgery (MIPS) technique has been developed by Oticon Medical AB (Askim, Sweden). This technique aims to standardize surgery by using a novel surgical instrumentation kit and minimize soft tissue trauma. METHODS: A multicenter randomized controlled trial is designed to compare the MIPS technique to the linear incision technique with soft tissue preservation. The primary investigation center is Maastricht University Medical Center. Sixty-two participants will be included with a 2-year follow-up period. Parameters are introduced to quantify factors such as loss of skin sensibility, dehiscence of the skin next to the abutment, skin overgrowth, and cosmetic results. A new type of sampling method is incorporated to aid in the estimation of complications. To gain further understanding of PAD, swabs and skin biopsies are collected during follow-up visits for evaluation of the bacterial profile and inflammatory cytokine expression. The primary objective of the study is to compare the incidence of PAD during the first 3 months after BCHI placement. Secondary objectives include the assessment of parameters related to surgery, wound healing, pain, loss of sensibility of the skin around the implant, implant extrusion rate, implant stability measurements, dehiscence of the skin next to the abutment, and esthetic appeal. Tertiary objectives include assessment of other factors related to PAD and a health economic evaluation. DISCUSSION: This is the first trial to compare the recently developed MIPS technique to the linear incision technique with soft tissue preservation for BCHI surgery. Newly introduced parameters and sampling method will aid in the prediction of results and complications after BCHI placement. TRIAL REGISTRATION: Registered at the CCMO register in the Netherlands on 24 November 2014: NL50072.068.14 . Retrospectively registered on 21 April 2015 at ClinicalTrials.gov: NCT02438618 . This trial is sponsored by Oticon Medical AB.

Intrauterine Lipopolysaccharide-Induced Chorioamnionitis in a Sheep: Does It Affect the Auditory System?

BACKGROUND: Fetal exposure to in utero inflammation such as chorioamnionitis is related to central nervous system injury. We hypothesized that chorioamnionitis can provoke inflammatory changes in the perilymph and alter hearing outcome. METHODS: Pregnant ewes were randomized into 2 groups: intrauterine injection with lipopolysaccharide (LPS; n = 19) or saline (n = 21). In the first experiment, fetal perilymph samples were taken for cytokine analysis. In the second experiment, consecutive bone-conducted auditory brain stem responses were obtained from 1 to 7 months after birth. RESULTS: Perilymph samples showed a significant elevation in interleukin 8 in the LPS group. Auditory brain stem response analysis demonstrated higher response thresholds and a prolongation of absolute peak V and interpeak intervals I to V and III to V in the LPS group compared to sham treatment. CONCLUSION: Our study confirms the hypothesis that an intrauterine inflammation by LPS can result in a fetal perilymphatic inflammatory response and functional impaired hearing outcomes after birth in a sheep model.

The Cost-Effectiveness of Different Hearing Screening Strategies for 50- to 70-Year-Old Adults: A Markov Model.

OBJECTIVE: To assess the cost-effectiveness of screening 50- to 70-year-old adults for hearing loss in The Netherlands. We compared no screening, telephone screening, Internet screening, screening with a handheld screening device, and audiometric screening for various starting ages and a varying number of repeated screenings. METHODS: The costs per quality-adjusted life-year (QALY) for no screening and for 76 screening strategies were analyzed using a Markov model with cohort simulation for the year 2011. Screening was deemed to be cost-effective if the costs were less than €20,000/QALY. RESULTS: Screening with a handheld screening device and audiometric screening were generally more costly but less effective than telephone and Internet screening. Internet screening strategies were slightly better than telephone screening strategies. Internet screening at age 50 years, repeated at ages 55, 60, 65, and 70 years, was the most cost-effective strategy, costing €3699/QALY. At a threshold of €20,000/QALY, this strategy was with 100% certainty cost-effective compared with current practice and with 69% certainty the most cost-effective strategy among all strategies. CONCLUSIONS: This study suggests that Internet screening at age 50 years, repeated at ages 55, 60, 65, and 70 years, is the optimal strategy to screen for hearing loss and might be considered for nationwide implementation.

Cost-effectiveness of specialized treatment based on cognitive behavioral therapy versus usual care for tinnitus.

OBJECTIVE: To evaluate the cost-effectiveness of specialized multidisciplinary tinnitus treatment based on cognitive behavioral therapy, compared with care as usual. DESIGN: Randomized controlled trial including an economic evaluation from a health-care and societal perspective, using a one-year time horizon. SETTING: Audiologic center. PATIENTS: A referred sample of 626 patients with tinnitus were eligible for participation. Approximately 492 patients were included in the study. Eighty-six (35%) of 247 patients in the usual care group, and 74 (30%) of 245 patients in the specialized care group were lost to follow-up by month 12. MAIN OUTCOME MEASURES: Quality adjusted life years (QALYs) as measured with the Health Utilities Index Mark III and cost in US dollars. RESULTS: Compared with patients receiving usual care, patients who received specialized care gained on average 0.015 QALYs (95% bootstrapped confidence interval [BCI], -0.03 to 0.06). The incremental costs from a societal perspective are $357 (95% BCI,-$1,034 to $1,785). The incremental cost per QALY from a societal perspective amounted to $24,580. The probability that SC is cost-effective from a societal perspective is 58% for a willingness to pay for a QALY of $45,000. CONCLUSION: Specialized multidisciplinary tinnitus treatment based on cognitive behavioral therapy is cost-effective as compared with usual care. Although uncertainty surrounding the incremental costs and effects is considerable, sensitivity analysis indicated that cost-effectiveness results were robust.

Predictors of hearing acuity: cross-sectional and longitudinal analysis.

BACKGROUND: This study aimed to identify predictors of hearing thresholds (best-ear pure-tone average at 1, 2, and 4 kHz) and hearing deterioration in order to define potential target groups for hearing screening. METHODS: We analyzed data from the Maastricht Aging Study, a Dutch cohort (aged 24-81 years; N = 1,721) that was observed for 12 years. Mixed model analysis was used to calculate each participant's average hearing threshold deterioration rate during the follow-up period. We built ordinary least square linear regression models to predict the baseline threshold and deterioration rate. Potential predictors included in these models were age, gender, type of occupation, educational level, cardiovascular disease, diabetes, systemic inflammatory disease, hypertension, obesity, waist circumference, smoking, and physical activity level. We also examined the relationship between baseline threshold and the deterioration rate. RESULTS: Poorer baseline thresholds were strongly associated with faster hearing deterioration. Higher age, male gender, manual occupation, and large waist circumference were statistically significantly associated with poorer baseline thresholds and faster deterioration, although the effects of occupation type and waist circumference were small. CONCLUSIONS: This study indicates that age and gender must be taken into account when determining the target population for adult hearing screening and that the time interval between repeated screenings should be based either on age or on the hearing thresholds at the first screening.

Qualitative interviews on the beliefs and feelings of adults towards their ownership, but non-use of hearing aids.

OBJECTIVE: Up to a quarter of the adults who own hearing aids never use them. To provide these 'non-users' with the best help, hearing care professionals need to have an in-depth understanding of the non-users' beliefs and feelings with regard to the non-use. This qualitative study explored these beliefs and feelings in order to increase our understanding of hearing aid non-users. DESIGN: Individual face-to-face semi-structured interviews were completed. STUDY SAMPLE: Eleven hearing aid owners (aged 54-80 years) who reported that they never or hardly ever used their hearing aids. RESULTS: The participants expressed a variety of feelings towards their non-use, including indifference, self-annoyance, frustration, powerlessness, shame, and guilt. Their feelings were related to beliefs about: (1) the severity of their hearing handicap with and without hearing aids, (2) whom or what was responsible for the non-use, and (3) the attitudes of significant others towards the non-use. CONCLUSIONS: Hearing-aid non-users differ in their beliefs and feelings towards the non-use. A patient-centred approach is needed.

Functional impairment of the auditory pathway after perinatal asphyxia and the short-term effect of perinatal propofol anesthesia in lambs.

BACKGROUND: Sensorineural hearing loss (SNHL) is a common feature in the postasphyxial syndrome in newborns. Several anesthetic drugs have been proposed to attenuate secondary neuronal injury elicited by hypoxia-ischemia. We hypothesized that propofol anesthesia reduces auditory impairment after perinatal asphyxia in comparison with isoflurane. METHODS: Twenty-three pregnant ewes were randomized to propofol or isoflurane anesthesia and sedation. The lambs underwent in utero umbilical cord occlusion (isoflurane n = 5; propofol n = 7) and were compared with sham-treated animals (isoflurane n = 5; propofol n = 6) at a gestational age of 133 d. For 8 h after delivery by cesarean section, repeated auditory brainstem responses (ABRs) were recorded to obtain hearing thresholds, peak amplitudes, latencies, and interpeak latencies. RESULTS: Significantly elevated mean thresholds, diminished amplitudes, and elevated latencies were observed in the asphyxia group relative to the control group through the observation period. Comparison of anesthetic treatment in the asphyxia group revealed a significantly lower elevation in threshold and less impairment in the ABR amplitudes and latencies during propofol anesthesia as compared with isoflurane anesthesia. CONCLUSION: Our results support the hypothesis that anesthesia with propofol has a preventive effect on the functional changes to the auditory pathway in the event of perinatal asphyxia.

Tinnitus: a cost study.

OBJECTIVES: The aim of this study was to examine the costs of tinnitus in The Netherlands from a health care and a societal perspective. Furthermore, the impact of disease characteristics and demographic characteristics on these costs were examined. METHODS: A bottom-up cost of illness study was performed, using the baseline data on a cost questionnaire of a randomized controlled trial investigating the (cost) effectiveness of an integral multidisciplinary treatment for tinnitus versus care as usual. Mean yearly costs were multiplied by the prevalence figure of tinnitus for the adult general population to estimate the total cost of illness of tinnitus to society. Because cost data usually are not normally distributed, a nonparametric bootstrap resampling procedure with 1000 simulations was performed to determine statistical uncertainty of the cost estimates per category. Several questionnaires measuring disease and demographic characteristics were administered. The impact of disease characteristics and demographics on costs was investigated using a multivariate regression analysis. RESULTS: Total mean societal cost of illness was €6.8 billion (95% confidence interval: €3.9 billion-€10.8 billion). The larger part of total cost of illness was not related to health care. Total mean health care costs were €1.9 billion (95% confidence interval: €1.4 billion-€2.5 billion). Significant predictors of both health care costs and societal costs were tinnitus severity, age, shorter duration of tinnitus, and more severe depression. CONCLUSION: The economical burden of tinnitus to society is substantial, and severity of tinnitus is an important predictor of the costs made by patients.

Evaluation of the Hearing Aid Rehabilitation Questionnaire in Dutch: Examination of its Psychometric Properties and Potential Use as a Screening Instrument.

Items pertaining to hearing and hearing aids from the Hearing Aid Rehabilitation Questionnaire were applied to a heterogeneous sample of Dutch patients aged 55 years and more to evaluate their potential use in hearing screening. Subjects aged 55+ were recruited from a large general practitioners practice to participate. Three groups were formed: a group of 63 persons with a hearing aid, a group of 64 without a hearing aid but with sufficient hearing impairment to qualify for hearing aid reimbursement, and a group of 85 non-hearing impaired persons. Factor and reliability analyses revealed a structure with two scales regarding hearing, namely functionality and social hearing and three scales pertaining to hearing aids, namely hearing aid stigma, pressure to be assessed and not wanting a hearing aid. Scale validity was assessed with pure tone averages over the frequencies 1, 2 and 4 kHz and with a visual analogue scale for subjective hearing. The derived scales can be applied reliably in audiological assessment in an adult hearing screen setting to detect experienced hearing problems as well as attitudes related to hearing and hearing aids.

Screening for hearing loss versus parental concern regarding hearing problems: Subsequent referral and treatment for otitis media in the Netherlands.

OBJECTIVE: The present study investigates whether general practitioner (GP) consultation initiated by failing the population hearing screening at age nine months or GP consultation because of parental concern over ear/hearing problems was more important in deciding on referral and/or surgical treatment of otitis media (OM). DESIGN: A questionnaire covering the history between birth and 21 months of age was used to obtain information on referral after failing the hearing screening, GP consultations for ear/hearing problems, and subsequent referral to a specialist and possible surgical treatment at an ENT department. SETTING: The province of Limburg, the Netherlands. SUBJECTS: Healthy infants invited for the hearing screening at age nine months, who responded in an earlier study called PEPPER (Persistent Ear Problems, Providing Evidence for Referral, response rate 58%). MAIN OUTCOME MEASURES: The odds of a child being surgically treated for OM. RESULTS: The response rate for the present questionnaire was 72%. Of all children tested, 3.9% failed the hearing screening and were referred to their GP. Of all 2619 children in this study, 18.6% visited their GP with ear/hearing problems. Children failing the hearing screening without GP consultation for ear/hearing problems were significantly more often treated surgically for OM than children passing the hearing screening but with GP consultation for ear/hearing problems. CONCLUSION: Objectified hearing loss, i.e. failing the hearing screening, was important in the decision for surgical treatment in infants in the Netherlands.

Specialised treatment based on cognitive behaviour therapy versus usual care for tinnitus: a randomised controlled trial.

BACKGROUND: Up to 21% of adults will develop tinnitus, which is one of the most distressing and debilitating audiological problems. The absence of medical cures and standardised practice can lead to costly and prolonged treatment. We aimed to assess effectiveness of a stepped-care approach, based on cognitive behaviour therapy, compared with usual care in patients with varying tinnitus severity. METHODS: In this randomised controlled trial, undertaken at the Adelante Department of Audiology and Communication (Hoensbroek, Netherlands), we enrolled previously untreated Dutch speakers (aged >18 years) who had a primary complaint of tinnitus but no health issues precluding participation. An independent research assistant randomly allocated patients by use of a computer-generated allocation sequence in a 1:1 ratio, stratified by tinnitus severity and hearing ability, in block sizes of four to receive specialised care of cognitive behaviour therapy with sound-focused tinnitus retraining therapy or usual care. Patients and assessors were masked to treatment assignment. Primary outcomes were health-related quality of life (assessed by the health utilities index score), tinnitus severity (tinnitus questionnaire score), and tinnitus impairment (tinnitus handicap inventory score), which were assessed before treatment and at 3 months, 8 months, and 12 months after randomisation. We used multilevel mixed regression analyses to assess outcomes in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT00733044. FINDINGS: Between September, 2007 and January, 2011, we enrolled and treated 492 (66%) of 741 screened patients. Compared with 247 patients assigned to usual care, 245 patients assigned to specialised care improved in health-related quality of life during a period of 12 months (between-group difference 0·059, 95% CI 0·025 to 0·094; effect size of Cohen's d=0·24; p=0·0009), and had decreased tinnitus severity (-8·062, -10·829 to -5·295; d=0·43; p<0·0001) and tinnitus impairment (-7·506, -10·661 to -4·352; d=0·45; p<0·0001). Treatment seemed effective irrespective of initial tinnitus severity, and we noted no adverse events in this trial. INTERPRETATION: Specialised treatment of tinnitus based on cognitive behaviour therapy could be suitable for widespread implementation for patients with tinnitus of varying severity. FUNDING: Netherlands Organisation for Health Research and Development (ZonMW).

Compensating for deviant middle ear pressure in otoacoustic emission measurements, data, and comparison to a middle ear model.

OBJECTIVE: Deviant middle ear pressure has a negative effect on the forward and backward transmission of stimulus and emissions through the middle ear. Resolving this deviant middle ear pressure is expected to lead to better middle ear transmission and, as a result of this, stronger otoacoustic emissions, which are better detectable. We investigated the effect of compensation o a deviant tympanic peak pressure on click-evoked otoacoustic emissions (CEOAEs). Second, we compared patient data to model predictions made by Zwislocki's middle ear model. SETTING: University Medical Center. PATIENTS: Fifty-nine children aged between 0.5 and 9 years (mean, 4.4 yr). INTERVENTION: Hearing investigations including CEOAE measurements at ambient and at compensated tympanic peak pressure (TPP). MAIN OUTCOME MEASURE: CEOAEs at ambient and compensated TPP. RESULTS: Compensation of TPP resulted in higher emission amplitudes below 2 kHz (increase of 8-11 dB). In addition, the compensated measurement showed an increased phase lag (up to one-fourth cycle). For ears with mild deviations of TPP, Zwislocki's model could describe these changes. Pressure compensation was well described by a compliance increase of the tympanic membrane, the malleus, and the incus. CONCLUSION: Compensating the ear canal pressure for negative tympanic peak pressure increased CEOAE amplitudes below 2 kHz and increased the phase lag. These changes can be predicted from an increase of the compliance of the tympanic membrane, incus, and malleus, as a consequence of the pressure compensation.

Risk factors for failing the hearing screen due to otitis media in Dutch infants.

Hearing loss from otitis media (OM) can affect young children's development. Some children with persistent OM-related hearing loss and associated problems can benefit from treatment, but researchers and clinicians are still unclear on how to identify them best. The present study aims to determine which factors are most related to the hearing loss in OM, as a first step towards an effective case-finding instrument for detecting infants with persistent OM-related hearing loss. The full PEPPER ('Persistent Ear Problems, Providing Evidence for Referral') item pool includes a wide range of risk factors for OM in a single questionnaire, and is easily completed by parents or guardians. The questionnaire was sent to all children invited for the universal hearing screen at age 9 months in Limburg, The Netherlands. Repeatedly failing of the hearing screen was used as outcome marker indicative of OM-related chronic hearing loss. Univariate analyses were conducted to determine statistically significant risk factors predicting 'fail' cases at this hearing screen. Five items were found as individually predictive of hearing screen failure and subsequent referral: 'having severe cold symptoms', 'attending day care with >4 children', 'having siblings', 'severe nasal congestion' and 'male gender'. Suitably worded parental questions document risk factors for OM-related hearing loss in infants, broadly consistent with past general literature on OM risk factors, but more focused. The findings justify further optimising and evaluation of an additive or multiplicative combination of these questions as a means for selecting and routing an infant with diagnosed or suspected OM to further care.

Interventions following hearing screening in adults: a systematic descriptive review.

OBJECTIVE: Adult hearing screening may be a solution to the under-diagnosis and under-treatment of hearing loss in adults. Limited use and satisfaction with hearing aids indicate that consideration of alternative interventions following hearing screening may be needed. The primary aim of this study is to provide an overview of all intervention types that have been offered to adult (≥ 18 years) screen-failures. DESIGN: Systematic literature review. Articles were identified through systematic searches in PubMed, EMBASE, Cinahl, the Cochrane Library, private libraries, and through reference checking. RESULTS: Of the initial 3027 papers obtained from the searches, a total of 37 were found to be eligible. The great majority of the screening programmes (i.e. 26) referred screen-failures to a hearing specialist without further rehabilitation being specified. Most of the others (i.e. seven) led to the provision of hearing aids. Four studies offered alternative interventions comprising communication programme elements (e.g. speechreading, hearing tactics) or advice on environmental aids. CONCLUSIONS: Interventions following hearing screening generally comprised referral to a hearing specialist or hearing aid rehabilitation. Some programmes offered alternative rehabilitation options. These may be valuable as an addition to or replacement of hearing aid rehabilitation. It is recommended that this be addressed in future research.

Frequency shifts with age in click-evoked otoacoustic emissions of preterm infants.

A previous study [Brienesse et al. (1997). Pediatr. Res. 42, 478-483] demonstrated a positive shift with increasing postmenstrual age (PMA) in the frequencies of synchronized spontaneous otoacoustic emissions (SSOAEs) in preterm infants. We used a mixed model approach to describe a shift with PMA in the spectra of click-evoked otoacoustic emissions (CEOAEs) measured in a group of 22 preterm infants. The rate in shift in CEOAE spectral components was found to be frequency dependent, with a mean estimate of 10 Hz/week for frequencies around 2 kHz and 30 Hz/week for frequencies around 4.25 kHz. This rate decreased with increasing PMA. Because SSOAEs are often part of the CEOAE response, a comparison was made between the shifts in SSOAEs and CEOAEs in a sub-group of 16 preterm infants. The results indicate that the shifts found for both types of OAE are similar, which supports a common mechanism for this change in OAE-characteristic. At present it is not clear to what extent developmental processes in the cochlea and the middle ear can account for these frequency shifts in the spectra of CEOAEs and SSOAEs during the preterm period.

Tinnitus interferes with daily life activities: a psychometric examination of the Tinnitus Disability Index.

OBJECTIVES: Tinnitus Disability Index (TDI) is presented as a novel and brief self-report measure for the assessment of the interference of tinnitus with performance in specific daily life activities. We hypothesized that the TDI is a reliable and valid measure and that tinnitus disability is strongly associated with tinnitus severity, subjective tinnitus intensity ratings, and ratings of general health. DESIGN: Six hundred fifteen tinnitus patients from across the Netherlands completed online a number of questionnaires about their tinnitus, their general health, and demographics. Two samples were extracted by a random split: Sample I (N = 311) for exploratory factor analysis and Sample II (N = 304) for confirmatory analysis, using structural equation modeling. One hundred forty-three of the first included respondents repeated assessment after a 2-wk time interval for test/retest analysis. Regression analyses were employed to investigate construct validity. RESULTS: Present analyses reveal that tinnitus disability, as measured with the TDI, might be best understood as a single-component construct, that is, one single underlying factor. The TDI is reliable over time, and tinnitus-related disability, as measured with the TDI, is strongly associated with subjective ratings of tinnitus intensity, negatively associated with quality of life ratings, and distress due to tinnitus. CONCLUSIONS: The TDI is a brief and easily administered index measuring a unique construct, namely the experienced interference of the tinnitus with daily life activities, which is invaluable in the assessment and treatment of tinnitus patients.

Assessment of health state in patients with tinnitus: a comparison of the EQ-5D and HUI mark III.

OBJECTIVES: Expressing the outcomes of treatment in quality-adjusted life years is increasingly important as a tool to aid decision makers concerning the allocation of scarce resources within the health care sector. A quality-adjusted life year is a measure of life expectancy that is weighted by health-related quality of life. These weights are referred to as utility scores and are usually measured by multiattribute utility measures. Several studies found that different utility measures provide different estimates of the same person's level of utility. The aim of this study was to investigate which of two widely used utility measures, the EQ-5D and the HUI mark III, is preferred in a tinnitus population. METHODS: Baseline and follow-up data on EQ-5D and HUI mark III of 429 patients of a randomized controlled clinical trial, investigating cost-effectiveness of usual care versus specialized care of tinnitus, were included. Agreement, discriminative power, and responsiveness of the health state description and the utility scores were examined. RESULTS: Corresponding dimensions of the EQ-5D and HUI mark III showed large correlations; although ceiling effects were more frequently observed in the EQ-5D. Mean utility scores for EQ-5D (0.77; SD 0.22) and HUI mark III (0.64; SD 0.28) were significantly different (Wilcoxon signed ranks test, p < 0.001), and agreement was low to moderate (intraclass correlation coefficient = 0.53). Both health state description and utility scores of both measures discriminated between different severity groups. These groups were based on baseline scores of the Tinnitus Questionnaire. The HUI mark III had a higher ability than the EQ-5D to detect improved patients from randomly selected pairs of improved and unimproved patients. CONCLUSION: This study shows that different utility measures lead to different health state descriptions and utility scores among tinnitus patients. However, both measures are capable of discriminating between clinically different groups. The HUI mark III is more responsive than the EQ-5D, and therefore preferred in a tinnitus population.

Shared care for hearing complaints: guideline effects on patient flow.

RATIONALE, AIMS AND OBJECTIVES: A national guideline was proposed to enable shared care in hearing complaints and therefore to change patient flows. In this study the effect of this guideline is evaluated. METHODS: From a total of 3500 patients with hearing complaints, consulting the Ear Nose and Throat Department of a large non-university hospital in the Netherlands in 2002, a random sample of 1000 patients was selected. Patient flow was simulated according to guideline criteria with as main outcome measures: the effect of the guideline on patient flow. RESULTS: Simulation of the consensus guideline did not really alter patient flow, with 89% to 97% of the patients still being referred to the Ear Nose and Throat specialist or Audiological Centre. Age, ear operations in the past and asymmetric hearing loss are the most important factors determining whether a person is labelled as a patient in need of medical care. CONCLUSION: The present study emphasizes the importance of designing evidence-based guidelines for shared care.