The cost evaluation of day-case compared to inpatient cochlear implantation in adults: subanalysis of a randomized controlled trial.

OBJECTIVE: To investigate the assumption that day-case cochlear implantation is associated with lower costs, compared to inpatient cochlear implantation, while maintaining equal quality of life (QoL) and hearing outcomes, for the Dutch healthcare setting. STUDY DESIGN: A single-center, non-blinded, randomized controlled trial in a tertiary referral center. METHODS: Thirty adult patients with post-lingual bilateral sensorineural hearing loss eligible for unilateral cochlear implantation surgery were randomly assigned to either the day-case or inpatient treatment group (i.e., one night admission). We performed an intention-to-treat evaluation of the difference of the total health care-related costs, hospital and out of hospital costs, between day-case and inpatient cochlear implantation, from a hospital and patient perspective over the course of one year. Audiometric outcomes, assessed using CVC scores, and QoL, assessed using the EQ-5D and HUI3 questionnaires, were taken into account. RESULTS: There were two drop-outs. The total health care-related costs were €41,828 in the inpatient group (n = 14) and €42,710 in the day-case group (n = 14). The mean postoperative hospital stay was 1.2 days (mean costs of €1,069) in the inpatient group and 0.7 days (mean costs of €701) for the day-case group. There were no statistically significant differences in postoperative hospital and out of hospital costs. The QoL at 2 months and 1 year postoperative, measured by the EQ-5D index value and HUI3 showed no statistically significant difference. The EQ-5D VAS score measured at 1 year postoperatively was statistically significantly higher in the inpatient group (84/100) than in the day-case group (65/100). There were no differences in postoperative complications, objective hearing outcomes, and number of postoperative hospital and out of hospital visits. CONCLUSION: A day-case approach to cochlear implant surgery does not result in a statistically significant reduction of health care-related costs compared to an inpatient approach and does not affect the surgical outcome (complications and objective hearing measurements), QoL, and postoperative course (number of postoperative hospital and out of hospital visits).

Health Economic Cost Analysis for Percutaneous Bone Conduction Devices: The Minimally Invasive Ponto Surgery Versus Linear Incision Technique with Tissue Preservation.

OBJECTIVES: To identify differences in mean cost per patient between the Minimally Invasive Ponto Surgery (MIPS) and the linear incision technique with tissue preservation (LITT-P). STUDY DESIGN: Health economic cost analysis. SETTING: The analysis was performed in a randomized multicenter controlled trial cohort. PATIENTS: Adult patients eligible for unilateral bone conduction device surgery. INTERVENTIONS: MIPS versus LITT-P surgery for bone conduction device implantation. MAIN OUTCOME MEASURES: Perioperative and postoperative costs were identified and compared. RESULTS: The difference in mean cost per patient between both techniques was €77.83 in favor of the MIPS after 22 months follow-up. The mean costs per patient were lower in the MIPS cohort for surgery (€145.68), outpatient visits (€24.27), systemic antibiotic therapy with amoxicillin/clavulanic acid (€0.30) or clindamycin (€0.40), abutment change (€0.36), and abutment removal (€0.18). The mean costs per patient were higher for implant and abutment set (€18.00), topical treatment with hydrocortison/oxytetracycline/polymyxine B (€0.43), systemic therapy with azithromycin (€0.09) or erythromycin (€1.15), local revision surgery (€1.45), elective explantation (€1.82), and implant extrusion (€70.42). Additional analysis of scenarios in which all patients were operated under general or local anesthesia or with recalculation when using current implant survival rates showed that differences in mean cost per patient were also in favor of the MIPS. CONCLUSION: The difference between the MIPS and the LITT-P in mean cost per patient was €77.83 in favor of the MIPS after 22 months of follow-up. The MIPS is an economically responsible technique and could be promising for the future.

Self-assessment of unilateral and bimodal cochlear implant experiences in daily life.

OBJECTIVE: The subjective experiences were assessed of cochlear implant (CI) users either wearing or not wearing a hearing aid (HA) at the contralateral ear. DESIGN: Unilateral CI-recipients were asked to fill out a set of daily-life questionnaires on bimodal HA use, hearing disability, hearing handicap and general quality of life. STUDY SAMPLE: Twenty-six CI-recipients who regularly use a contralateral HA (bimodal group) and twenty-two CI-recipients who do not use a HA in the contralateral ear (unilateral group). RESULTS: Comparisons between both groups (bimodal versus unilateral) showed no difference in self-rated disability, hearing handicap or general quality of life. However within the group of bimodal listeners, participants did report a benefit of bimodal hearing ability in various daily life listening situations. CONCLUSIONS: Bimodal benefit in daily life can consistently be experienced and reported within the group of bimodal users.

A retrospective cohort study of adverse event assessment during anesthesia-related procedures for cochlear implant candidacy assessment and cochlear implantation in infants and toddlers.

BACKGROUND: Cochlear implantation in children with sensorineural hearing loss is preferably performed at youngest age because early auditory input is essential to prevent neural plasticity decline. In contrast, the rate of anesthetic adverse events is increased during infancy. Therefore, to provide recommendations regarding an optimal pediatric implantation age, these possible anesthetic risks in infants need to be taken into account. AIMS: This study aimed at assessing the relation between the age at cochlear implant surgery and anesthetic and surgical adverse events. Secondary aims were to evaluate anesthetic and surgical adverse events in relation to (a) the number of preoperative anesthesia-related procedures for cochlear implant candidacy assessment and (b) the anesthetic maintenance agent (total intravenous anesthesia versus inhalation anesthesia) during implantation. METHODS: We executed a retrospective cohort study to evaluate cochlear implantation performed in infants and toddlers between January 2008 and July 2015 in a tertiary pediatric center. We compared anesthetic and surgical adverse events between age-at-implantation (0-12 and 12-24 months of age) groups. Furthermore, we assessed whether anesthetic adverse events occurred during preoperative anesthesia-related procedures for cochlear implant candidacy assessment. RESULTS: Forty-six cochlear implantations were performed in 43 patients requiring 42 preoperative anesthesia-related procedures. Nineteen cochlear implantations (41.3%) were performed during infancy. During implantation, the maintenance agent was either sevoflurane (n = 22) or propofol (n = 24). None of the patients encountered major anesthetic adverse events, whereas minor adverse events occurred during 34 cochlear implantations. Those attributed to surgery occurred following six implantations. Neither the age at implantation nor the anesthetic maintenance agent was significantly related to the occurrence of both types of adverse events. CONCLUSIONS: Adverse events occur independent of the age at implantation, the number of anesthetic preoperative procedures, and the type of anesthetic maintenance agent in patients who received a cochlear implant before 24 months of age.

Healthcare utilisation, follow-up of guidelines and practice variation on rhinosinusitis in adults: A healthcare reimbursement claims study in The Netherlands.

OBJECTIVES: To provide insight into healthcare utilisation of rhinosinusitis, compare data with clinical practice guideline recommendations and assess practice variation. DESIGN: Anonymised data from claims reimbursement registries of healthcare insurers were analysed, from 1 January 2016 until 31 December 2016. SETTING: Secondary and tertiary care in the Netherlands. PARTICIPANTS: Patients ≥18 years with diagnostic code "sinusitis." MAIN OUTCOME MEASURES: Healthcare utilisation (prevalence, co-morbidity, diagnostic testing, surgery), costs, comparison with guideline recommendation, practice variation. RESULTS: We identified 56 825 patients, prevalence was 0.4%. Costs were € 45 979 554-that is 0.2% of total hospital-related care costs (€21 831.3 × 106 ). Most patients were <75 years, with a slight female preponderance. 29% had comorbidities (usually COPD/asthma). 9% underwent skin prick testing, 61% nasal endoscopy, 2% X-ray and 51% CT. Surgery rate was 16%, mostly in daycare. Nearly, all surgical procedures were performed endonasally and concerned the maxillary and/or ethmoid sinus. Seven recommendations (25%) could be (partially) compared to the distribution of claims data. Except for endoscopy, healthcare utilisation patterns were in line with guideline recommendations. We compared results for three geographical regions and found generally corresponding rates of diagnostic testing and surgery. CONCLUSION: Prevalence was lower than reported previously. Within the boundaries of guideline recommendations, we encountered acceptable variation in healthcare utilisation in Dutch hospitals. Health reimbursement claims data can provide insight into healthcare utilisation, but they do not allow evaluation of the quality and outcomes of care, and therefore, results should be interpreted with caution.

Hearing assessment during deep brain stimulation of the central nucleus of the inferior colliculus and dentate cerebellar nucleus in rat.

BACKGROUND: Recently it has been shown in animal studies that deep brain stimulation (DBS) of auditory structures was able to reduce tinnitus-like behavior. However, the question arises whether hearing might be impaired when interfering in auditory-related network loops with DBS. METHODS: The auditory brainstem response (ABR) was measured in rats during high frequency stimulation (HFS) and low frequency stimulation (LFS) in the central nucleus of the inferior colliculus (CIC, n = 5) or dentate cerebellar nucleus (DCBN, n = 5). Besides hearing thresholds using ABR, relative measures of latency and amplitude can be extracted from the ABR. In this study ABR thresholds, interpeak latencies (I-III, III-V, I-V) and V/I amplitude ratio were measured during off-stimulation state and during LFS and HFS. RESULTS: In both the CIC and the CNBN groups, no significant differences were observed for all outcome measures. DISCUSSION: DBS in both the CIC and the CNBN did not have adverse effects on hearing measurements. These findings suggest that DBS does not hamper physiological processing in the auditory circuitry.

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.

Cost-Utility of Bilateral Versus Unilateral Cochlear Implantation in Adults: A Randomized Controlled Trial.

OBJECTIVE: To study the cost-utility of simultaneous bilateral cochlear implantation (CI) versus unilateral CI. STUDY DESIGN: Randomized controlled trial (RCT). SETTING: Five tertiary referral centers. PATIENTS: Thirty-eight postlingually deafened adults eligible for cochlear implantation. INTERVENTIONS: A cost-utility analysis was performed from a health insurance perspective. MAIN OUTCOME MEASURES: Utility was assessed using the HUI3, TTO, VAS on hearing, VAS on general health and EQ-5D. We modeled the incremental cost per quality-adjusted life year (QALY) of unilateral versus bilateral CI over periods of 2, 5, 10, 25 years, and actual life-expectancy. RESULTS: Direct costs for unilateral and bilateral CI were €43,883 ±â€Š€11,513(SD) and €87,765 ±â€Š€23,027(SD) respectively. Annual costs from the second year onward were €3,435 ±â€Š€1,085(SD) and €6,871 ±â€Š€2,169(SD), respectively. A cost-utility analysis revealed that a second implant became cost-effective after a 5- to 10-year period, based on the HUI3, TTO, and VAS on hearing. CONCLUSION: This is the first study that describes a cost-utility analysis to compare unilateral with simultaneous bilateral CI in postlingually deafened adults, using a multicenter RCT. Compared with accepted societal willingness-to-pay thresholds, simultaneous bilateral CI is a cost-effective treatment for patients with a life expectancy of 5-10 years or longer.

Follow-up assessment of vestibular schwannomas: volume quantification versus two-dimensional measurements.

INTRODUCTION: A conservative treatment strategy is often proposed as a primary treatment option in the management of vestibular schwannomas (VS). In this "wait and scan" policy, audiovestibular symptoms are monitored regularly, and VS growth is measured on consecutive magnetic resonance images (MRI). The aim of this study is validation of two-dimensional versus volume MRI assessment in the longitudinal follow-up of VS and to define tumor growth beyond measurement error. METHODS: MRI scans of 68 consecutive patients with VS were analyzed retrospectively. Two-dimensional and volume measurements on contrast enhanced (CE) T1- and T2-weighted images were performed independently by two readers. Smallest detectable differences (SDD) were calculated, and intraclass correlation coefficients (ICCs) were determined for both assessment methods. RESULTS: Two-dimensional and volume measurements both showed best reproducibility on CE T1-weighted images. SDD for differences relative to baseline MRI [SDD (%)] for two-dimensional measurements had a higher interobserver error compared to volume measurements (40% versus 19.7%), which decreases when tumor size increases. The ICC for two-dimensional measurements in three directions was 0.947, 0.974, and 0.978 and for volume measurements 0.999. CONCLUSION: Volume measurements are more accurate compared to two-dimensional measurements for the evaluation of VS growth. These measurements are assessed preferably on CE T1-weighted images. SDD (%) strongly depends on VS size. SDD between consecutive scans exceeds the common clinical applied criterion of 1 or 2 mm growth to define growth.

Decision-analytic modeling to assist decision making in organizational innovation: the case of shared care in hearing aid provision.

OBJECTIVE: To illustrate the use of decision-analytic modeling to assist decision making in organizational innovations. STUDY SETTING/DATA SOURCES: Regarding an organizational innovation (shared care in hearing aid provision) available evidence from different sources was synthesized. STUDY DESIGN: A probabilistic Markov model was constructed. DATA COLLECTION/EXTRACTION: We modeled the long-term cost-effectiveness of different organizational formats of shared care as opposed to the current organization. We assessed the expected value of perfect information (EVPI) for several groups of parameters in the model. PRINCIPAL FINDINGS: The current organization had the highest probability of being cost-effective. Additional research is worthwhile, especially on access to care and safety (sensitivity to detect pathology). CONCLUSIONS: Decision-analytic modeling in an early stage of organizational innovation is a valuable tool to facilitate evidence-based decision making.