Objectives/Hypothesis: To determine if the choice of health utility measure affects the incremental cost‐utility ratio (ICUR) when assessing the cost‐effectiveness of bilateral cochlear implantation (CI).Study Design: A scenario‐based estimate with three scenarios: 1) a patient with severe to profound sensorineural hearing loss with no intervention, 2) the same patient with a unilateral CI with average or better performance, and 3) the same patient with bilateral CIs with average or better performance.Methods: One hundred and forty‐two subjects comprising preimplantees (n = 30), unilateral cochlear implantees (n = 30), bilateral implantees (n = 30), and healthcare professionals (n = 52). The four health utility instruments applied were the Health Utility Index Mark 3 (HUI3), European Quality of Life Questionnaire in 5 Domains (EQ5D), visual analog scale (VAS), and time trade‐off (TTO). Cost for each implant was based on a 25‐year time horizon, 50% discount for the second implant, and a 15% failure rate.Results: Using the HUI3, the utility gain from unilateral to bilateral implantation was 0.035 or 11.5% of the total utility gain. This ratio was higher using the other instruments: EQ5D (22.2%), VAS (35.0%), and TTO (41.4%). For the scenario of bilateral CI compared to no intervention, HUI3 ICUR estimates were the lowest, and for bilateral CI compared to unilateral CI, HUI3 ICUR estimates were the highest.Conclusions: The choice of utility instrument in cost‐utility analysis of bilateral CI heavily influences whether the second implant is deemed cost‐effective. The HUI3 is the utility of choice in CI studies and is the most conservative.Level of Evidence: 4.Laryngoscope, 125:442–447, 2015
5 February 2016 in Cochlear Implants International
Preoperative steroids have been shown to be beneficial in reducing the hearing loss associated with cochlear implantation. This review article discusses the mechanism of action, effects of differing routes of administration, and side effects of steroids administered to the inner ear. Studies on the role of preoperative steroids in animal and human studies are also examined and future directions for research in this area are discussed.
Objectives. To determine if cochlear duct length and cochlear basal diameter, measured using routinely available radiology software, affect hearing outcomes after cochlear implantation with two different length electrodes. Methods. 55 patients who received a Med-El Flex electrode were retrospectively reviewed. 34 patients received the Flex 31 electrode (31mm) and 21 patients received the Flex 28 electrode (28mm). Preoperative high-resolution CT scans of the temporal bone were reformatted in the axial and coronal plane. The basal diameter of the cochlear (A-value) and the outer-wall lengths of the cochlear duct were measured using readily available imaging software. Postoperative plane X-rays were used to determine the degree of electrode insertion and the number of electrodes within the cochlea and speech discrimination scores at 6 months were evaluated. Results. The cochlear metrics obtained were comparable with those previously published in the literature. There was no significant difference in the degree of insertion or speech outcomes between the two electrode lengths. However, when the group who had received the shorter electrode were analysed, there was an association seen between both cochlear duct length and cochlear diameter and speech outcomes. Conclusions. Cochlear size may be a factor in determining speech outcomes that cannot be explained solely by insertion depth or degrees of insertion. Further studies are required to determine if cochlear duct length is an independent predictor of speech outcomes.
1 October 2021 in Drug Design, Development and Therapy
Introduction: In a recent study, in our laboratory, primary unconjugated bile acids, commonly found in humans, chenodeoxycholic acid (CDCA), have been shown to improve stability of nanoencapsulated lipophilic drugs and improve their release profile after oral administration likely via electrokinetic stabilisation. Hence, this study aimed to examine the effects of CDCA on exerting similar effects on hydrophilic drugs. Methods: Various CDCA-based formulations were produced for the orally administered hydrophilic drug, metformin. Analyses of these formulations included electrokinetic potentials, topography, drug and CDCA formulation contents, nano size distribution, heat-induced deformation and outer-core expansion indices, release profiles, shell-resistance ratio, and thermal and chemical indices. With the drug’s main target being pancreatic beta-cells, the formulations’ effects on cell viability, functions and inflammatory profiles were also investigated. Results and Conclusions: CDCA-based metformin formulations exhibited improved stability and release profiles via thermal, chemical and electrokinetic effects, which were formulation-dependent suggesting potential applications of CDCA in the oral targeted delivery of hydrophilic drugs.
Recent studies in our laboratories have shown promising effects of bile acids in ➀ drug encapsulation for oral targeted delivery (via capsule stabilization) particularly when encapsulated with Eudragit NM30D® and ➁ viable-cell encapsulation and delivery (via supporting cell viability and biological activities, postencapsulation). Accordingly, this study aimed to investigate applications of bile acid-Eudragit NM30D® capsules in viable-cell encapsulation ready for delivery. Mouse-cloned pancreatic β-cell line was cultured and cells encapsulated using bile acid-Eudragit NM30D® capsules, and capsules’ images, viability, inflammation, and bioenergetics of encapsulated cells assessed. The capsules’ thermal and chemical stability assays were also assessed to ascertain an association between capsules’ stability and cellular biological activities. Bile acid-Eudragit NM30D® capsules showed improved cell viability (e.g., F1 < F2 & F8; p < 0.05), insulin, inflammatory profile, and bioenergetics as well as thermal and chemical stability, compared with control. These effects were formulation-dependent and suggest, overall, that changes in ratios of bile acids to Eudragit NM30D® can change the microenvironment of the capsules and subsequent cellular biological activities.