Background There is evidence for a group of nonclinical individuals with full-blown, persistent psychotic experiences (PEs) but no need-for-care: they are of particular importance in identifying risk and protective factors for clinical psychosis. The aim of this study was to investigate whether reasoning biases are related to PEs or need-for-care. Method Two groups with persistent PEs (clinic...

Neuropathology analyses as end points during nonclinical efficacy and toxicity studies are challenging and require trained personnel and particular equipment to achieve optimal results. Accordingly, many regulatory agencies have produced explicit guidelines for designing and performing neuropathology assessments for nonclinical studies. This compilation of international regulatory guidance for ...

BACKGROUND Health care providers are being pressured to lower the cost of care. Because of the inherent cost variability in providing health care, as reimbursement falls, providers may not be able to cover all costs. Understanding the underlying causes of this wide variability is important in determining optimum pricing. Prior studies on the cost of coronary bypass surgery have determined which...

Comparing the Effectiveness of Acceptance and Commitment Therapy Well-being on Life Expectancy Psychological Health in Elderly Nonclinical Depressed Patients

The Autism-Spectrum Quotient (AQ) is a self-report measure of autistic traits. It is frequently cited in diverse fields and has been administered to adults of at least average intelligence with autism and to nonclinical controls, as well as to clinical control groups such as those with schizophrenia, prosopagnosia, anorexia, and depression. However, there has been no empirical systematic review...

Multidisciplinary approaches that incorporate nonclinical pharmacologic and toxicologic characterization of small-molecule oncology drugs into clinical development programs may facilitate improved benefit-risk profiles and clinical toxicity management in patients. The performance of the current nonclinical safety-testing scheme was discussed, highlighting current strengths and areas for improve...

Risk tolerance is a source of variation in physician decision-making. This variation, if independent of clinical concerns, can result in mistaken utilization of health services. To address such problems, it will be helpful to identify nonclinical factors of risk tolerance, particularly those amendable to intervention-regulatory focus theory suggests such a factor. This study tested whether regu...

BACKGROUND This investigation examined why some elderly women with severe pain symptoms and impairment in health status were not seen in a tertiary care pain center. METHODS Three groups of older (> or = 60 years) women were included in the study: women seeking chronic pain treatment at a multidisciplinary pain center (N = 49), and research volunteers from the same institution with (N = 28) a...

Background. This investigation examined why some elderly women with severe pain symptoms and impairment in health status were not seen in a tertiary care pain center. Methods. Three groups of older ( 60 years) women were included in the study: women seeking chronic pain treatment at a multidisciplinary pain center (N = 49), and research volunteers from the same institution with (N = 28) and wit...

The nonclinical statistics teams in the Center of Drug Review and Research of the Food and Drug Administration (FDA) conduct regulatory reviews, statistical consultation, and statistical methodology development in nonclinical regulations. In this chapter, we provide a brief description of the two teams and provide two examples in statistical research development. In the first example, we descri...