BACKGROUND Salvage radiation therapy is often necessary in men who have undergone radical pros-tatectomy and have evidence of prostate-cancer recurrence signaled by a persistently or recurrently elevated prostate-specific antigen (PSA) level. Whether antiandrogen therapy with radiation therapy will further improve cancer control and prolong overall survival is unknown. METHODS In a double-blind, placebo-controlled trial conducted from 1998 through 2003, we assigned 760 eligible patients who had undergone prostatectomy with a lymphadenectomy and had disease, as assessed on pathological testing, with a tumor stage of T2 (confined to the prostate but with a positive surgical margin) or T3 (with histologic extension beyond the prostatic capsule), no nodal involvement, and a detectable PSA level of 0.2 to 4.0 ng per milliliter to undergo radiation therapy and receive either antiandrogen therapy (24 months of bicalutamide at a dose of 150 mg daily) or daily placebo tablets during and after radiation therapy. The primary end point was the rate of overall survival. RESULTS The median follow-up among the surviving patients was 13 years. The actuarial rate of overall survival at 12 years was 76.3% in the bicalutamide group, as compared with 71.3% in the placebo group (hazard ratio for death, 0.77; 95% confidence interval, 0.59 to 0.99; P=0.04). The 12-year incidence of death from prostate cancer, as assessed by means of central review, was 5.8% in the bicalutamide group, as compared with 13.4% in the placebo group (P<0.001). The cumulative incidence of metastatic prostate cancer at 12 years was 14.5% in the bicalutamide group, as compared with 23.0% in the placebo group (P=0.005). The incidence of late adverse events associated with radiation therapy was similar in the two groups. Gynecomastia was recorded in 69.7% of the patients in the bicalutamide group, as compared with 10.9% of those in the placebo group (P<0.001). CONCLUSIONS The addition of 24 months of antiandrogen therapy with daily bicalutamide to salvage radiation therapy resulted in significantly higher rates of long-term overall survival and lower incidences of metastatic prostate cancer and death from prostate cancer than radiation therapy plus placebo. (Funded by the National Cancer Institute and AstraZeneca; RTOG 9601 ClinicalTrials.gov number, NCT00002874.)

Compared with unilateral cochlear implantation, bilateral implantation is associated with better listening skills in severely-profoundly deaf children.

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Groups of adults varying widely in age and life experience perceived sufficient additional quality of life from giving children two implants rather than one to mean that bilateral cochlear implantation is possibly a cost-effective use of healthcare resources in the UK. Wide variation in valuations within the groups of informants means that considerable uncertainty surrounds that conclusion. Further data on the costs and benefits of bilateral implantation are needed to resolve the uncertainty.

ObjectivePrecision medicine allows healthcare interventions to be tailored to groups of patients based on their disease susceptibility, diagnostic or prognostic information, or treatment response. We analysed what developments are expected in precision medicine over the next decade and considered the implications for health technology assessment (HTA) agencies.MethodsWe performed a pragmatic literature search to account for the large size and wide scope of the precision medicine literature. We refined and enriched these results with a series of expert interviews up to 1 h in length, including representatives from HTA agencies, research councils and researchers designed to cover a wide spectrum of precision medicine applications and research.ResultsWe identified 31 relevant papers and interviewed 13 experts. We found that three types of precision medicine are expected to emerge in clinical practice: complex algorithms, digital health applications and ‘omics’-based tests. These are expected to impact upon each stage of the HTA process, from scoping and modelling through to decision-making and review. The complex and uncertain treatment pathways associated with patient stratification and fast-paced technological innovation are central to these effects.DiscussionInnovation in precision medicine promises substantial benefits but will change the way in which some health services are delivered and evaluated. The shelf life of guidance may decrease, structural uncertainty may increase and new equity considerations will emerge. As biomarker discovery accelerates and artificial intelligence-based technologies emerge, refinements to the methods and processes of evidence assessments will help to adapt and maintain the objective of investing in healthcare that is value for money.Electronic supplementary materialThe online version of this article (10.1007/s40273-018-0686-6) contains supplementary material, which is available to authorized users.

Patient preference studies could provide valuable insights to a National Institute for Health and Care Excellence committee into the preferences patients have for different treatment options, especially if the study sample is representative of the broader patient population. We identify three main uses of patient preference studies along a technology's pathway from drug development to clinical use: in early clinical development to guide the selection of appropriate endpoints, to inform benefitrisk assessments carried out by regulators and to inform reimbursement decisions made by health technology assessment bodies. In the context of the National Institute for Health and Care Excellence's methods and processes, we do not see a role for quantitative patient preference data to be directly incorporated into health economic modelling. Rather, we see a role for patient preference studies to be submitted alongside other types of evidence. Examples where patient preference studies might have added value in health technology assessments include cases where two distinctly different treatment options are being compared, when patients have to decide between multiple treatment options, when technologies have important nonhealth benefits or when a treatment is indicated for a heterogenous population.

Children with an unaided four-frequency PTA of 80 dB HL or poorer in both ears should be considered candidates for bilateral cochlear implantation. In cases where a four-frequency PTA cannot be measured, the criterion of candidacy should be a two-frequency PTA of 85 dB HL or poorer in both ears. If adopted by policy-makers, these recommendations would expand the provision of cochlear implants among children in England and Wales.

Modern health services need efficient tools for measuring outcomes from interventions, that is, tools of proven efficacy which make minimal demands on the time of clinicians in learning to administer tests and in interpreting results. This paper describes an apparatus designed to meet those requirements. The apparatus administers performance tests of spatial listening for children and adults with unilateral and bilateral cochlear implants. The apparatus was designed with guidance from clinicians. It possesses three key attributes: it is simple to use; the results of tests are scored automatically and are compared with reference data; the apparatus generates comprehensive personalized reports for individual participants that can be included in clinical notes. This paper describes the apparatus and reports results of a test measuring spatial release from masking of speech which illustrates the compatibility between the new apparatus and an older apparatus with which the reference data were gathered.