Protocol for a randomized controlled trial examining multilevel prediction of response to behavioral activation and exposure-based therapy for generalized anxiety disorder.

BACKGROUND: Only 40-60% of patients with generalized anxiety disorder experience long-lasting improvement with gold standard psychosocial interventions. Identifying neurobehavioral factors that predict treatment success might provide specific targets for more individualized interventions, fostering more optimal outcomes and bringing us closer to the goal of "personalized medicine." Research suggests that reward and threat processing (approach/avoidance behavior) and cognitive control may be important for understanding anxiety and comorbid depressive disorders and may have relevance to treatment outcomes. This study was designed to determine whether approach-avoidance behaviors and associated neural responses moderate treatment response to exposure-based versus behavioral activation therapy for generalized anxiety disorder. METHODS/DESIGN: We are conducting a randomized controlled trial involving two 10-week group-based interventions: exposure-based therapy or behavioral activation therapy. These interventions focus on specific and unique aspects of threat and reward processing, respectively. Prior to and after treatment, participants are interviewed and undergo behavioral, biomarker, and neuroimaging assessments, with a focus on approach and avoidance processing and decision-making. Primary analyses will use mixed models to examine whether hypothesized approach, avoidance, and conflict arbitration behaviors and associated neural responses at baseline moderate symptom change with treatment, as assessed using the Generalized Anxiety Disorder-7 item scale. Exploratory analyses will examine additional potential treatment moderators and use data reduction and machine learning methods. DISCUSSION: This protocol provides a framework for how studies may be designed to move the field toward neuroscience-informed and personalized psychosocial treatments. The results of this trial will have implications for approach-avoidance processing in generalized anxiety disorder, relationships between levels of analysis (i.e., behavioral, neural), and predictors of behavioral therapy outcome. TRIAL REGISTRATION: The study was retrospectively registered within 21 days of first participant enrollment in accordance with FDAAA 801 with ClinicalTrials.gov, NCT02807480. Registered on June 21, 2016, before results.

Twelve-month outcomes and predictors of very stable INR control in prevalent warfarin users.

BACKGROUND: For patients on warfarin therapy an international normalized ratio (INR) recall interval not exceeding 4 weeks has traditionally been recommended. For patients whose INR values are nearly always therapeutic, less frequent INR monitoring may be feasible. OBJECTIVE: To identify patients with stable INRs (INR values exclusively within the INR range) and comparator patients (at least one INR outside the INR range), compare occurrences of thromboembolism, bleeding and death between groups, and identify independent predictors of stable INR control. METHODS: The study was a retrospective, longitudinal cohort study using data extracted from electronic databases. Patient characteristics and risk factors were entered into multivariate logistic regression models to identify variables that independently predict stable INR status. RESULTS: There were 533 stable and 2555 comparator patients. Bleeding and thromboembolic complications were significantly lower in stable vs. comparator patients (2.1% vs. 4.1% and 0.2% vs. 1.3%, respectively; P < 0.05). Independent predictors of stable INR control were age >70 years, male gender and the absence of heart failure. Stable patients were significantly less likely to have target INR > or =3.0 or chronic diseases. CONCLUSION: A group of patients with exclusively therapeutic INR values over 12 months is identifiable. In general, these patients are older, have a target INR <3.0, and do not have heart failure and/or other chronic diseases. Our findings suggest that many patients whose INR values remain within the therapeutic range over time could be safely treated with INR recall intervals >4 weeks.

Cognitive test performance and crash risk in an older driver population.

This paper reports on the usefulness of five brief tests of cognitive function for identifying older drivers who may be at increased risk of crash involvement; it also examines the broader issue of whether impaired cognitive function is associated with increased crash risk in the older driver population. Data for the study were collected from 3238 drivers aged 65 and older applying for renewal of their North Carolina driver's license. The specific cognitive assessments examined include the Trail Making Test parts A and B, the Short Blessed Orientation-Memory-Concentration test of cognitive impairment, a modification of the American Association of Retired Persons 'Reaction Time' test, and a timed Traffic Sign Recognition test. Information on crash involvements during the 3-year period prior to testing was obtained by linkage with the North Carolina driver history file. Although the individual tests were not found to be particularly effective screening tools for identifying subsets of high risk drivers, cognitive test performance remained significantly associated with crash risk even after controlling for driver age, race and measures of driving exposure. Drivers who scored in the lowest 10% on the cognitive tests were approx. 1.5 times more likely to be in crashes than were drivers who scored in the highest 10%. Implications for the counseling and licensing of older drivers are discussed, along with recommendations for future research.

Comparison of the use of secretory and somatic antigens in an ELISA for the serodiagnosis of hypodermosis.

An antigen was prepared from metabolic products which were produced by maintaining first instar larvae of Hypoderma lineatum in RPMI tissue culture medium for 48 h. Three major proteins were identified in the secretory products and were characterised in terms of their molecular weights and iso-electric points. The antigen compared favourably with a soluble extract of larvae when used in an enzyme-linked immunosorbent assay (ELISA) against a panel of control sera and 2000 bovine sera collected from farms in Andalucia, Spain.

Older driver population and crash involvement trends, 1974-1988.

North Carolina motor vehicle crash data for even-numbered years 1974-1988, inclusive, are analyzed in conjunction with North Carolina population, licensed driver, and mileage data to examine trends in motor vehicle crash involvement by driver age, sex, and race. Crash rates per licensed driver are presented along with crash rates per estimated vehicle miles travelled calculated on the basis of induced exposure. Results focus particularly on older drivers. They show that older drivers' representation in the licensed driver population has increased at a greater rate than their representation in either the census or crash involvement populations. These trends are particularly strong for females and for nonwhites. Furthermore, crash rates have declined more for drivers aged 55 and older than for younger drivers. The greatest declines, both in terms of crashes per licensed driver and crashes per estimated miles travelled, have been experienced by drivers age 65 and older, particularly nonwhites. Males show higher overall crash rates per miles travelled than females, but this effect decreases with age and disappears entirely in the oldest age categories. Results are discussed in light of the changing nature of the overall driving population and the cohort of older drivers in particular.

Family practice residents' prescribing patterns.

Prescription patterns of physicians in a family practice residency office were analyzed retrospectively from the following perspectives: frequency of prescribing for individual drugs and drug categories; effect of the level of postgraduate training on prescribing patterns; and effect of patient payment systems (Medicare-Medicaid, self-pay, third-party insurance) on the number of prescriptions. Antibiotics, antihistamine-decongestants, and antihypertensive medications were the most commonly prescribed medications. Psychotropic medications were used infrequently. An average of 0.70 prescriptions was issued on each office visit. Per office visit, first-year residents averaged 0.59 prescriptions, second-year residents averaged 0.69 prescriptions, third-year residents averaged 0.72 prescriptions, and the faculty averaged 0.98 prescriptions. Patients on Medicare-Medicaid averaged 0.78 prescriptions per office visit, self-pay patients averaged 0.25 prescriptions per visit, and patients with third-party insurance averaged 1.49 prescriptions per visit. The differences in the prescription rates between each payment group were significant.