Design and conduct of a randomized controlled feeding trial in a residential setting with mitigation for COVID-19.

BACKGROUND: Evaluating effects of different macronutrient diets in randomized trials requires well defined infrastructure and rigorous methods to ensure intervention fidelity and adherence. METHODS: This controlled feeding study comprised two phases. During a Run-in phase (14-15 weeks), study participants (18-50 years, BMI, ≥27 kg/m2) consumed a very-low-carbohydrate (VLC) diet, with home delivery of prepared meals, at an energy level to promote 15 ± 3% weight loss. During a Residential phase (13 weeks), participants resided at a conference center. They received a eucaloric VLC diet for three weeks and then were randomized to isocaloric test diets for 10 weeks: VLC (5% energy from carbohydrate, 77% from fat), high-carbohydrate (HC)-Starch (57%, 25%; including 20% energy from refined grains), or HC-Sugar (57%, 25%; including 20% sugar). Outcomes included measures of body composition and energy expenditure, chronic disease risk factors, and variables pertaining to physiological mechanisms. Six cores provided infrastructure for implementing standardized protocols: Recruitment, Diet and Meal Production, Participant Support, Assessments, Regulatory Affairs and Data Management, and Statistics. The first participants were enrolled in May 2018. Participants residing at the conference center at the start of the COVID-19 pandemic completed the study, with each core implementing mitigation plans. RESULTS: Before early shutdown, 77 participants were randomized, and 70 completed the trial (65% of planned completion). Process measures indicated integrity to protocols for weighing menu items, within narrow tolerance limits, and participant adherence, assessed by direct observation and continuous glucose monitoring. CONCLUSION: Available data will inform future research, albeit with less statistical power than originally planned.

False negative AUDIT screening results among patients in rural primary care settings.

Purpose: The objective of this study was to examine the incidence of false-negative screening results on a tool measuring alcohol use - the United States Alcohol Use Disorder Identification Test Consumption (US-AUDIT-C).Method: A sample of patients (n = 4,023) in Alabama completed the US-AUDIT-C prior to a medical visit as part of a screening, brief intervention, and referral to treatment (AL-SBIRT) program. We calculated the incidence of false negative US-AUDIT-C screens based on recommendations for safe alcohol consumption.Results: The false negative screening rate on the US-AUDIT-C was 1%. The false negative screening rate for (a) males aged > 65 years in the AL-SBIRT program was 0.64%, (b) males aged 18-65 years was 2.79%, and (c) all females was 2.29%.Discussion & Conclusions: Increasing alcohol-consumption-related health education and reducing the stigma of discussing alcohol consumption habits is an important step toward improving patient health. Clinicians can more accurately screen and provide brief intervention services for alcohol misuse by training on US-AUDIT-C response patterns.

Evaluation of the Effect of Routine Antibiotic Administration after Uterine Artery Embolization on Infection Rates.

PURPOSE: To evaluate the effect of routine administration of post-procedural antibiotics following elective uterine artery embolization (UAE) on infectious complication rates. MATERIALS AND METHODS: The charts of patients who underwent UAE between January 2013 and September 2019 were retrospectively reviewed. Prior to January 15, 2016, all patients received post-procedural antibiotics with 500 mg of ciprofloxacin twice a day orally for 5 days. After January 15, 2016, none of the patients received post-procedural antibiotics. All patients in both groups received pre-procedural intravenous antibiotics. The post-procedural antibiotics group included 217 patients (age, 44.7 ± 6 years); the no-antibiotics group included 158 patients (age, 45.4 ± 5.6 years). Patients in the no-antibiotics group had a significantly higher rate of diabetes mellitus (P = .03) but fewer cases of adenomyosis (P = .048). Otherwise, demographic and fibroid characteristics were similar between the groups. RESULTS: Six infectious complications (6/375, 1.6%) were recorded. No statistically significant difference (P = .66) was observed in the number of infections between the post-procedural antibiotics group (4/217, 1.8%) and the no-antibiotics group (2/158, 1.3%). Three of the 6 infectious complications presented with malodorous vaginal discharge (3/375, 0.8%) and received nominal therapy. The 3 remaining complications (0.8%) were considered major and included 2 patients (0.5%) who underwent hysterectomy and 1 patient (0.3%) who underwent myomectomy. The major infection rate was 0.9% (2/217) in the post-procedural antibiotics group and 0.7% (1/158) in the no-antibiotics group (P = 1). There were no 90-day post-procedural mortalities. CONCLUSIONS: Discontinuation of routine post-procedural antibiotics with ciprofloxacin after elective UAE did not result in increased rates of infectious complications within the first 90 days post procedure.

Effect of vitamin D3 supplementation on insulin resistance and ß-cell function in prediabetes: a double-blind, randomized, placebo-controlled trial.

BACKGROUND: Observational studies have suggested an inverse association between low serum 25-hydroxyvitamin D [25(OH)D] concentrations and development of type 2 diabetes. High-quality trials are required to test the hypothesis that vitamin D is a direct contributor to type 2 diabetes pathogenesis. OBJECTIVE: The purpose of this double-blind randomized placebo-controlled trial was to investigate the effect of vitamin D3 supplementation on insulin resistance (IR) and ß-cell function in people with prediabetes and suboptimal vitamin D status (<50 nmol/L). METHODS: Sixty-six individuals were randomly assigned to receive 3000 IU (75 µg) vitamin D3 or placebo daily for 26 wk. Compliance was monitored by pill count and change in serum 25(OH)D concentration using LC-MS. The primary endpoint was between-group difference in change in IR assessed using a 2-step euglycemic-hyperinsulinemic clamp combined with infusion of tritiated glucose. An oral-glucose-tolerance test was performed pre- and postintervention to calculate indices of ß-cell function. Between-group comparisons were made using ANCOVA. RESULTS: In total, 64 participants completed the study. Baseline serum 25(OH)D concentrations in the vitamin D3 and placebo group were 30.7 and 30.0 nmol/L, with status increasing by 70.5 nmol/L and 5.3 nmol/L, respectively (between-group difference in vitamin D: 65.8 nmol/L; 95% CI: 54.2, 77.3 nmol/L; P < 0.01), after supplementation. There was no difference between groups in measures of whole-body, peripheral, or hepatic IR or in any measure of glycemic control or ß-cell function. CONCLUSION: This study employed a robust assessment of IR and ß-cell function and targeted a high-risk population with low 25(OH)D status at baseline and found that vitamin D3 supplementation had no effect on insulin action in people with prediabetes.This trial was registered on clinicaltrials.gov as NCT01889810.

Case Series: Redefining Severe Grade 5 Vaginismus.

INTRODUCTION: Vaginismus is poorly understood and relatively unknown among health care providers. For those who understand and treat vaginismus, few make an assessment of the severity of this condition. The importance of classifying the severity of vaginismus impacts the clinician's ability to diagnose and treat vaginismus, and understanding of the patient's experience. AIM: The aims of this paper are to identify the distinguishing features of severe grade 5 vaginismus, determine if vaginal spasm is present in severe grade vaginismus, and to establish qualifications for the Pacik grade 5 classification. METHODS: Assessment of 553 referred or self-referred women who were unable to tolerate intercourse completed a comprehensive pretreatment questionnaire. Of those women, 391 underwent a vaginal examination in a certified surgicenter using sedation and anesthesia as needed. MAIN OUTCOME MEASURE: The main outcome measures were to detect the presence of a visceral reaction with an intended or actual gynecologic examination in Grade 5 patients, and to identify vaginal spasm on examination. RESULTS: A visceral response reaction to routine gynecologic examinations, as well as spasm of the bulbocavernosum, occurred in patients with severe vaginismus. CONCLUSION: Severe vaginismus with visceral response manifestations to routine gynecologic examinations, inability to have intercourse, and spasm of the bulbocavernosum is newly defined as severe grade 5 vaginismus. Pacik PT, Babb CR, Polio A, et al. CASE SERIES: Redefining Severe Grade 5 Vaginismus. Sex Med 2019;7:489-497.

Abundance estimates and habitat preferences of bottlenose dolphins reveal the importance of two gulfs in South Australia.

Informed conservation management of marine mammals requires an understanding of population size and habitat preferences. In Australia, such data are needed for the assessment and mitigation of anthropogenic impacts, including fisheries interactions, coastal zone developments, oil and gas exploration and mining activities. Here, we present large-scale estimates of abundance, density and habitat preferences of southern Australian bottlenose dolphins (Tursiops sp.) over an area of 42,438km2 within two gulfs of South Australia. Using double-observer platform aerial surveys over four strata and mark-recapture distance sampling analyses, we estimated 3,493 (CV = 0.21; 95%CI = 2,327-5,244) dolphins in summer/autumn, and 3,213 (CV = 0.20; 95%CI = 2,151-4,801) in winter/spring of 2011. Bottlenose dolphin abundance and density was higher in gulf waters across both seasons (0.09-0.24 dolphins/km2) compared to adjacent shelf waters (0.004-0.04 dolphins/km2). The high densities of bottlenose dolphins in the two gulfs highlight the importance of these gulfs as a habitat for the species. Habitat modelling associated bottlenose dolphins with shallow waters, flat seafloor topography, and higher sea surface temperatures (SSTs) in summer/autumn and lower SSTs in winter/spring. Spatial predictions showed high dolphin densities in northern and coastal gulf sections. Distributional data should inform management strategies, marine park planning and environmental assessments of potential anthropogenic threats to this protected species.

Regulatory and Legislative Disparities With Cannabis Present Challenges to P&T Committees and Health Care Providers.

Increased cannabis use has brought about a sea change in policy and attitudes toward regulation, and a multitude of rules that vary widely between states. The disparity has stymied any effective response to the problems surrounding access to cannabis products for those in need. Health care providers and practitioners, as well as P&T committees, must carefully undertake decisions on rational drug use, whether or not their patients are using cannabis while under their care.

Predictors of surgical intervention following initial surveillance for acute ureteric colic.

PURPOSE: To identify clinical and stone-related factors predicting the need for surgical intervention in patients who were clinically considered appropriate for non-surgical intervention. PATIENTS AND METHODS: We conducted a retrospective review of a contemporary cohort of patients who were selected for surveillance following presentation with acute ureteric colic. Data on patient demographic and stone variables, inpatient management and long-term outcomes were evaluated. Multivariate logistic regression was used to generate a nomogram predicting need for surgical intervention. The accuracy of the nomogram was subsequently validated with an independent cohort of patients presenting with ureteric colic. RESULTS: Of 870 study eligible patients presenting with acute ureteric colic, 527 were initially treated non-surgically and included in the analysis. 113 of these eventually required surgical intervention. Median time from first presentation to acute surgery was 11 (IQR 4-82) days. In our final MVA analysis, duration of symptoms more than 3 days, not receiving alpha-blockers, positive history of previous renal calculi and stone location, burden and density were independent predictors of need for surgical intervention. Patients who required opioid analgesia were more likely to have surgical intervention; however, this did not reach statistical significance. The area under the curve (AUC) of the final model was 0.802. The nomogram was validated with a cohort of 210 consecutive colic patients with AUC of 0.833 (SE 0.041, p < 0.001). CONCLUSIONS: We have identified independent predictors of the need for surgical intervention during an episode of renal colic and formulated a nomogram. Combined with the diligent use of acute ureteroscopy at our centre, this nomogram may have clinical utility when making decisions regarding treatment options with potential healthcare cost savings.

A collaborative university model for employee wellness.

Universities are taking a more active approach in understanding and monitoring employees' modifiable health risk factors and chronic care conditions by developing strategies to encourage employees to start and sustain healthy behaviors. WellBama, the University of Alabama's signature health and wellness program, utilizes a collaborative model in partnership with select colleges and departments to implement strategies to improve employees' health status. The program provides onsite health screenings and assessments, timely health advising sessions, assistance in setting and monitoring individual health goals to promote improved health, and preventive examination referrals.

Force feedback in limb lengthening.

A new variable-rate distraction system using a motorized distractor driven by feedback from the distraction force was designed. The distractor was mounted on a unilateral fixator and attached to the tibiae of 6 sheep that underwent distraction osteogenesis. The sheep were divided equally into 3 groups. In group 1, the forces were recorded but were not used to drive the lengthening rate. In group 2, force feedback was used and the desired distraction force level was set to 300 N and the initial rate was 1 mm/day. Group 3 also underwent force feedback with the desired force limit at 300 N, but the rate change was initiated earlier, at 200 N. The distraction force was recorded at 15 second intervals throughout the distraction phase and stored onboard the distractor.

Utility of an abbreviated questionnaire to identify individuals with ADHD at risk for functional impairments.

OBJECTIVE: To discern whether a subset of items from the 99-item Current Behavior Scale (CBS) of behaviorally defined Executive Function Deficits (EFDs) in adults with Attention-Deficit/Hyperactivity Disorder (ADHD) can identify a group at risk for poor outcome. METHODS: Subjects were 200 adults with ADHD participating in a family study of ADHD in adults. Factor analysis was used to reduce the number of items in the 99-item CBS. RESULTS: The one factor solution provided eight items with factor loadings above 0.70. This abbreviated set of items was highly correlated with the 99-item CBS (0.91) and was similarly related to functional outcomes compared to the 99-item CBS (average correlation of 0.30 versus 0.32). CONCLUSION: For adults with ADHD, a set of eight empirically-derived from the CBS similarly correlated with negative outcomes compared to the 99-item CBS, raising the possibility of utilization as a mechanism for identification of EFDs in adults with ADHD.