[A systematic evaluation of the assessment methods of spasmoidc dysphonia].

To review the available subjective and objective evaluation methods used in the assessment of the spasmodic dysphonia.A systematic literature search was conducted in PubMed,web of science,EBSCO and Ovid database,date limited from 2000 to 2015,language limited English,using the following key words: "spasmodic dysphonia" OR "spastic dysphonia" AND "evaluat*" OR " diagnosis" OR "treatment" OR "assess*".Screening the titles and abstracts,and reading the full text,studies met the inclusion criteria were enrolled.The references of eligible publications were manually searched to identify additional studies.A total of 967 literatures were retrieved.Finally,twenty-three papers were enrolled in the study according to the inclusion criteria.Evaluation methods were mainly divided into subjective and objective,including perception,subjective self-assessment;and aerodynamic,acoustic analysis,respectively.The assessment of spasmodic dysphonia should be multidimensional.

Estimated medical cost reductions for paliperidone palmitate vs placebo in a randomized, double-blind relapse-prevention trial of patients with schizoaffective disorder.

OBJECTIVE: The objective of this economic model was to estimate the difference in medical costs among patients treated with paliperidone palmitate once-monthly injectable antipsychotic (PP1M) vs placebo, based on clinical event rates reported in the 15-month randomized, double-blind, placebo-controlled, parallel-group study of paliperidone palmitate evaluating time to relapse in subjects with schizoaffective disorder. RESEARCH DESIGN AND METHODS: Rates of psychotic, depressive, and/or manic relapses and serious and non-serious treatment-emergent adverse events (TEAEs) were obtained from the long-term paliperidone palmitate vs placebo relapse prevention study. The total annual medical cost for a relapse from a US payer perspective was obtained from published literature and the costs for serious and non-serious TEAEs were based on Common Procedure Terminology codes. Total annual medical cost differences for patients treated with PP1M vs placebo were then estimated. Additionally, one-way and Monte Carlo sensitivity analyses were conducted. RESULTS: Lower rates of relapse (-18.3%) and serious TEAEs (-3.9%) were associated with use of PP1M vs placebo as reported in the long-term paliperidone palmitate vs placebo relapse prevention study. As a result of the reduction in these clinical event rates, the total annual medical cost was reduced by $7140 per patient treated with PP1M vs placebo. One-way sensitivity analysis showed that variations in relapse rates had the greatest impact on the estimated medical cost differences (range: -$9786, -$4670). Of the 10,000 random cycles of Monte Carlo simulations, 100% showed a medical cost difference <$0 (reduction) for patients using PPIM vs placebo. The average total annual medical differences per patient were -$8321 for PP1M monotherapy and -$6031 for PPIM adjunctive therapy. CONCLUSIONS: Use of PP1M for treatment of patients with schizoaffective disorder was associated with a significantly lower rate of relapse and a reduction in medical costs compared to placebo. Further evaluation in the real-world setting is warranted.

A prototypical process for creating evidentiary standards for biomarkers and diagnostics.

A framework for developing evidentiary standards for qualification of biomarkers is a key need identified in the Food and Drug Administration's Critical Path Initiative. This article describes a systematic framework that was developed by Pharmaceutical Research and Manufacturers of America (PhRMA) committees and tested at a workshop in collaboration with the Food and Drug Administration and academia. With some necessary refinements, this could be applied to create an appropriately individualized evidentiary standard for any biomarker purpose.

Clinical and immunological assessment of a candidate Lyme disease vaccine in healthy adults: antibody persistence and effect of a booster dose at month 12.

A candidate Lyme vaccine was administered to 20 adult volunteers following a 0, 1, 2 months vaccination schedule, with a booster at 12 months. An immune response, assessed as 'LA-2 equivalent' antibody titres using an inhibition ELISA, was induced in all vaccinees which persisted until the booster. Titres were increased 25-fold following the booster and persisted through month 24. There was a good correlation between 'LA-2 equivalent' antibody titres and a bactericidal assay (r2 = 0.86). Local symptoms were mild, resolving spontaneously within 72 h, with no reports of rash, arthralgia or other systemic symptoms. This Lyme vaccine was safe, well-tolerated and elicited an antibody response in all volunteers which persisted at least 12 months after the booster.