Randomized trials of alcohol-use interventions with college students and their parents: lessons from the Transitions Project.

BACKGROUND: Matriculation from high school to college is typified by an increase in alcohol use and related harm for many students. Therefore, this transition period is an ideal time for preventive interventions to target alcohol use and related problems. PURPOSE: The purpose of this report is to describe the design and methods used in the Transitions Project, a randomized controlled trial of two interventions designed to prevent and reduce heavy episodic drinking and alcohol-related negative consequences among incoming college students. METHODS: This study used a 2 × 2 factorial design to investigate the effects of a two-session brief motivational intervention delivered to students and a handbook-based parent intervention. Interventions were administered to students and parents. Follow-up assessment took place at 10- and 22-months post-baseline. RESULTS: The Transitions Project successfully recruited and retained participants across a major transition period (i.e., entering college), administered and compared two distinct but complementary interventions, and collected and analyzed highly skewed data. The application of a factorial design and two-part latent growth curve modeling allowed us to examine main and interactive intervention effects in terms of both initiation and growth in heavy drinking and alcohol-related problems. LIMITATIONS: While we conducted successful tests of our primary and secondary study hypotheses over a lengthy follow-up period, our study design did not permit full interpretation of null findings. We suggest that researchers carefully consider assessment timing, tests of assessment reactivity, and ensure objective tests of intervention efficacy when conducting clinical trials of motivational interventions. CONCLUSIONS: The lessons we learned while conducting this trial have the potential to assist other researchers designing and conducting future preventive interventions targeting parents and college students. The data analytic procedures presented can also help guide trials that plan to analyze zero-inflated non-normal outcome data.

Home-based virtual reality for chronic pain: protocol for an NIH-supported randomised-controlled trial.

INTRODUCTION: Chronic pain is highly prevalent and associated with a large burden of illness; there is a pressing need for safe, home-based, non-pharmacological, interventions. Virtual reality (VR) is a digital therapeutic known to be effective for acute pain, but its role in chronic pain is not yet fully elucidated. Here we present a protocol for the National Institute of Health (NIH) Back Pain Consortium (BACPAC) VR trial that evaluates the effectiveness of three forms of VR for patients with chronic lower back pain (cLBP), a highly prevalent form of chronic pain. METHODS AND ANALYSIS: The NIH BACPAC VR trial will randomise 360 patients with cLBP into one of three arms, each administered through a head-mounted display: 1) skills-based VR, a program incorporating principles of cognitive behavioural therapy, mindful meditation and physiological biofeedback therapy using embedded biometric sensors; 2) distraction-based VR, a program using 360-degree immersive videos designed to distract users from pain; and 3) sham VR, a non-immersive program using two-dimensional videos within a VR headset. Research participants will be monitored for 12 weeks using a combination of patient-reported outcomes administered via REDCap (Research Electronic Data Capture), wearable sensor data collected via Fitbit Charge 4 and electronic health record data. The primary outcome will be the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scale. Secondary outcomes will include PROMIS Anxiety, PROMIS Sleep Disturbance, opioid prescription data and Pain Catastrophizing Scale Short Form. A subgroup analysis will explore patient level predictors for VR efficacy. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Institutional Review Board of Cedars-Sinai Health System in April 2020. The results will be disseminated in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT04409353.

Cavernous hemangioma of the spinal cord: report of 2 unusual cases.

We present 2 cases of spinal cord intramedullary cavernous hemangioma; 1 patient is the 1st reported case of multiple spinal cord lesions. Diagnosis is greatly enhanced by the use of MRI.

Acessory nerve function after surgical procedures in the posterior triangle.

Seventeen patients who had undergone surgical procedures in the posterior triangle of the neck were examined between one day and four years after operation. Eleven patients were studied with electromyography. Clinical and electromyographic evidence of 11th cranial nerve paresis was present in 12 patients. Partial nerve injuries and entrapments, as suggested by delayed symptoms and incomplete denervation on electromyographic studies, were frequent. Physiotherapy was effective in restoring a satisfactory, although in many cases an incomplete, return of function. The spinal accessory nerve appears to be vulnerable to injury despite careful preservation during surgical dissection.

Ragged-red fibers. A biochemical and morphological study.

Histochemical, ultrastructural and biochemical studies were performed on muscle biopsy specimens from a 30-year-old man with proximal limb weakness. Modified Gomori trichome stains of anterior tibial muscle revealed accumulations of red-staining material in the subsarcolemmal and intermyofibrillar regions of virtually every fiber (ragged-red fibers); these accumulations were rich in oxidative enzymes. Electron microscopy of this muscle showed that the red-staining areas consisted of large collections of abnormal-appearing mitochondria. Mitochondria isolated from the quadriceps muscle showed lack of respiratory control with alpha-glycerophosphate as substrate. However, the lack of respiratory control with alpha-glycerophosphate must be interpreted with caution since the quadriceps muscle was severely degenerated, and biochemical alterations of mitochondria may occur secondary to muscle degeneration itself. Nevertheless, this is the second reported case of lack of respiratory control with alpha-glycerophosphate in a patient with ragged-red fibers. Further interpretation of this defect and its significance must await more studies to determine whether this muscle mitochondrial abnormality is a common finding in the disorders in which ragged-red fibers are encountered.

Comment on "The employed uninsured and the role of public policy".

Monheit, Hagan, Berk, and Farley, in an earlier issue of this journal, made a major contribution to our understanding of health system problems of access and uncompensated care by correcting the widespread misimpression that lack of health insurance coverage is predominantly related to unemployment. Their research, based on the 1977 National Medical Care Expenditure Survey, indicated that 75% of the uninsured were workers and their dependents. The authors observed that industry, unionization, full- or part-time status, and geographic region are among the interrelated factors that influence the availability of employment-related health insurance coverage. This comment augments their findings through an examination of U.S. employment trends since 1977 as well as projections of future employment.

Cerebral candidiasis: case report of brain abscess secondary to Candida albicans, and review of literature.

A patient with a brain abscess due to Candida albicans is reported. This patient had three episodes of systemic candidiasis in spite of the fact that she had no underlying debilitating disease and had never received prior antibiotic or adrenocortical steroid therapy. A review of the literature reveals 42 cases of central nervous system Candida albicans infection. The salient features of these cases are tabulated and discussed. The clinical features, pathology, pathogenesis, treatment, and aetiology of cerebral candidiasis are also discussed.

Employer-sponsored health insurance: are employers good agents for their employees?

Employers in the United States provide many welfare-type benefits, such as life insurance, disability insurance, health insurance, and pensions, to their employees. Employers can be viewed as performing an agency role in purchasing pension, health, and other welfare benefits for their employees. An exploration of their competence in this role as agents for their employees indicates that large employers are very helpful to their employees in this arena. They seem to contribute to individual employees' welfare by providing them with valued services in purchasing health insurance.

Comparison of a Bayesian program with three microcomputer programs for predicting gentamicin concentrations.

A recently developed Bayesian regression program was compared with three other aminoglycoside pharmacokinetic dosing programs available for clinical use. From 30 adult patients, 152 measured serum gentamicin concentrations (SGC) were evaluated retrospectively (78 peak and 74 trough). Predictive performance was compared for each method by using the first peak and trough SGC pair to predict subsequent serum concentrations, making a total of 92 predictions (48 peak and 44 trough). The two Bayesian programs (Brater and Koup) were further evaluated using only one initial peak or trough SGC to make the same predictions. Mean predicted error (ME), mean absolute error (MAE), and root mean squared error (RMSE) were calculated for each method. Prediction bias and precision were compared statistically, between each method, by calculating the 95% confidence intervals for the delta ME and delta MAE, respectively. No statistically significant differences were found in the MAEs among any of the methods for predicting peak SGCs, with the exception of the Brater program, using a single trough SGC, which was statistically less precise (less than 0.05). There were few statistically significant differences in the MAEs for trough SGCs; however, Koup's Bayesian program using a single trough concentration yielded statistically more precise predictions than the other methods. The ME was found to differ significantly (p less than 0.05) among estimates for peak and trough SGCs provided by some of the predictive methods.(ABSTRACT TRUNCATED AT 250 WORDS)

Neurological and neuropathologic heterogeneity in two brothers with cobalamin C deficiency.

Two adult brothers, one documented to have methylmalonic acidemia with homocystinuria, or cobalamin C deficiency, after autopsy, displayed severe but divergent neurological presentations. One exhibited a myelopathy and the other chronic endocrine problems (Schmidt's syndrome) followed by a neuropsychiatric and dementing disorder owing to cerebral perivascular demyelination. The recognition of cobalamin C deficiency has practical implications because it is one of the few inherited diseases of central white matter that is treatable.