Depressive Syndromes in Men with Hypogonadism in the TRAVERSE Trial: Response to Testosterone Replacement Therapy.

CONTEXT: The effect of testosterone on depressive symptoms in men with hypogonadism remains incompletely understood. OBJECTIVE: We assessed the effects of testosterone replacement therapy (TRT) in improving depressive symptoms in hypogonadal men with and without depressive symptoms enrolled in the TRAVERSE cardiovascular safety trial. DESIGN: Randomized, placebo-controlled, double-blind. SETTING: 316 trial sites. PARTICIPANTS: Men, 45 to 80 years, with two fasting testosterone levels <300 ng/dL, one or more hypogonadal symptoms, cardiovascular disease (CVD), or increased risk of CVD. We evaluated three subgroups of participants: 1) men with rigorously defined late-life-onset, low-grade persistent depressive disorder (LG-PDD, previously "dysthymia"); 2) all men with significant depressive symptoms (Patient Health Questionnaire-9 Score >4); and 3) all randomized men. INTERVENTION: 1.62% transdermal testosterone or placebo gel. OUTCOME MEASURES: Proportions of participants 1) meeting criteria for LG-PDD or 2) with significant depressive symptoms; changes in depressive symptoms, energy, sleep quality, and cognition in testosterone- vs. placebo-treated men in the three subgroups. RESULTS: Of 5,204 randomized participants, 2,643 (50.8%) had significant depressive symptoms, but only 49 (1.5%) met rigorous criteria for LG-PDD. Among those with LG-PDD, there was no significant difference in any outcome measure between the TRT and placebo groups, possibly reflecting low statistical power. In men with significant depressive symptoms n=2643) and in all randomized participants (n=5204), TRT was associated with modest but significantly greater improvements in mood and energy but not cognition or sleep quality. CONCLUSIONS: Depressive symptoms are common in middle-aged and older men with hypogonadism, but LG-PDD is uncommon. TRT is associated with small improvements in mood and energy in hypogonadal men with and without significant depressive symptoms. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03518034.

Testosterone Treatment and Fractures in Men with Hypogonadism.

BACKGROUND: Testosterone treatment in men with hypogonadism improves bone density and quality, but trials with a sufficiently large sample and a sufficiently long duration to determine the effect of testosterone on the incidence of fractures are needed. METHODS: In a subtrial of a double-blind, randomized, placebo-controlled trial that assessed the cardiovascular safety of testosterone treatment in middle-aged and older men with hypogonadism, we examined the risk of clinical fracture in a time-to-event analysis. Eligible men were 45 to 80 years of age with preexisting, or high risk of, cardiovascular disease; one or more symptoms of hypogonadism; and two morning testosterone concentrations of less than 300 ng per deciliter (10.4 nmol per liter), in fasting plasma samples obtained at least 48 hours apart. Participants were randomly assigned to apply a testosterone or placebo gel daily. At every visit, participants were asked if they had had a fracture since the previous visit. If they had, medical records were obtained and adjudicated. RESULTS: The full-analysis population included 5204 participants (2601 in the testosterone group and 2603 in the placebo group). After a median follow-up of 3.19 years, a clinical fracture had occurred in 91 participants (3.50%) in the testosterone group and 64 participants (2.46%) in the placebo group (hazard ratio, 1.43; 95% confidence interval, 1.04 to 1.97). The fracture incidence also appeared to be higher in the testosterone group for all other fracture end points. CONCLUSIONS: Among middle-aged and older men with hypogonadism, testosterone treatment did not result in a lower incidence of clinical fracture than placebo. The fracture incidence was numerically higher among men who received testosterone than among those who received placebo. (Funded by AbbVie and others; TRAVERSE ClinicalTrials.gov number, NCT03518034.).

Effect of Testosterone Replacement Therapy on Sexual Function and Hypogonadal Symptoms in Men with Hypogonadism.

CONTEXT: Few long-term randomized trials have evaluated the efficacy of testosterone replacement therapy (TRT) in improving sexual function and hypogonadal symptoms in men with hypogonadism and whether effects are sustained beyond 12 months. OBJECTIVE: The Testosterone Replacement therapy for Assessment of long-term Vascular Events and efficacy ResponSE in hypogonadal men (TRAVERSE) study evaluated the effect of TRT on major adverse cardiovascular events in middle-aged and older men with hypogonadism. The Sexual Function Study, nested within the parent trial, determined testosterone's efficacy in improving sexual activity, hypogonadal symptoms, libido, and erectile function among men reporting low libido. METHODS: Among 5204 men, 45-80 years, with 2 testosterone concentrations <300 ng/dL, hypogonadal symptoms, and cardiovascular disease (CVD) or increased CVD risk enrolled in the TRAVERSE trial, 1161 with low libido were enrolled in the Sexual Function Study (587 randomized to receive 1.62% testosterone gel and 574 to placebo gel for the duration of their participation in the study). Primary outcome was change from baseline in sexual activity score. Secondary outcomes included hypogonadal symptoms, erectile function, and sexual desire. RESULTS: TRT was associated with significantly greater improvement in sexual activity than placebo (estimated mean [95% CI] between-group difference 0.49 [0.19,0.79] and 0.47 [0.11, 0.83] acts per day at 6 and 12 months, respectively; omnibus test P = .011); treatment effect was maintained at 24 months. TRT improved hypogonadal symptoms and sexual desire, but not erectile function, compared with placebo. CONCLUSION: In middle-aged and older men with hypogonadism and low libido, TRT for 2 years improved sexual activity, hypogonadal symptoms, and sexual desire, but not erectile function.

Medical Directors, Facilities, and Finances: Resource Deficiencies in Accredited Paramedic Programs.

BACKGROUND: Initial paramedic education must have sufficient rigor and appropriate resources to prepare graduates to provide lifesaving prehospital care. Despite required national paramedic accreditation, there is substantial variability in paramedic pass rates that may be related to program infrastructure and clinical support. Our objective was to evaluate US paramedic program resources and identify common deficiencies that may affect program completion. METHODS: We conducted a cross-sectional mixed methods analysis of the 2018 Committee on Accreditation of Educational Programs for the Emergency Medical Services Professions annual report, focusing on program Resource Assessment Matrices (RAM). The RAM is a 360-degree evaluation completed by program personnel, advisory committee members, and currently enrolled students to identify program resource deficiencies affecting educational delivery. The analysis included all paramedic programs that reported graduating students in 2018. Resource deficiencies were categorized into ten categories: faculty, medical director, support personnel, curriculum, financial resources, facilities, clinical resources, field resources, learning resources, and physician interaction. Descriptive statistics of resource deficiency categories were conducted, followed by a thematic analysis of deficiencies to identify commonalities. Themes were generated from evaluating individual deficiencies, paired with program-reported analysis and action plans for each entry. RESULTS: Data from 626 programs were included (response rate = 100%), with 143 programs reporting at least one resource deficiency (23%). A total of 406 deficiencies were identified in the ten categories. The largest categories (n = 406) were medical director (14%), facilities (13%), financial resources (13%), support personnel (11%), and physician interaction (11%). The thematic analysis demonstrated that a lack of medical director engagement in educational activities, inadequate facility resources, and a lack of available financial resources affected the educational environment. Additionally, programs reported poor data collection due to program director turnover. CONCLUSION: Resource deficiencies were frequent for programs graduating paramedic students in 2018. Common themes identified were a need for medical director engagement, facility problems, and financial resources. Considering the pivotal role of EMS physicians in prehospital care, a consistent theme throughout the analysis involved challenges with medical director and physician interactions. Future work is needed to determine best practices for paramedic programs to ensure adequate resource availability for initial paramedic education.

Cardiovascular Safety of Testosterone-Replacement Therapy.

BACKGROUND: The cardiovascular safety of testosterone-replacement therapy in middle-aged and older men with hypogonadism has not been determined. METHODS: In a multicenter, randomized, double-blind, placebo-controlled, noninferiority trial, we enrolled 5246 men 45 to 80 years of age who had preexisting or a high risk of cardiovascular disease and who reported symptoms of hypogonadism and had two fasting testosterone levels of less than 300 ng per deciliter. Patients were randomly assigned to receive daily transdermal 1.62% testosterone gel (dose adjusted to maintain testosterone levels between 350 and 750 ng per deciliter) or placebo gel. The primary cardiovascular safety end point was the first occurrence of any component of a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, assessed in a time-to-event analysis. A secondary cardiovascular end point was the first occurrence of any component of the composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization, assessed in a time-to-event analysis. Noninferiority required an upper limit of less than 1.5 for the 95% confidence interval of the hazard ratio among patients receiving at least one dose of testosterone or placebo. RESULTS: The mean (±SD) duration of treatment was 21.7±14.1 months, and the mean follow-up was 33.0±12.1 months. A primary cardiovascular end-point event occurred in 182 patients (7.0%) in the testosterone group and in 190 patients (7.3%) in the placebo group (hazard ratio, 0.96; 95% confidence interval, 0.78 to 1.17; P<0.001 for noninferiority). Similar findings were observed in sensitivity analyses in which data on events were censored at various times after discontinuation of testosterone or placebo. The incidence of secondary end-point events or of each of the events of the composite primary cardiovascular end point appeared to be similar in the two groups. A higher incidence of atrial fibrillation, of acute kidney injury, and of pulmonary embolism was observed in the testosterone group. CONCLUSIONS: In men with hypogonadism and preexisting or a high risk of cardiovascular disease, testosterone-replacement therapy was noninferior to placebo with respect to the incidence of major adverse cardiac events. (Funded by AbbVie and others; TRAVERSE ClinicalTrials.gov number, NCT03518034.).

Paramedic educational program attrition accounts for significant loss of potential EMS workforce.

Objective: Recent concerns for the strength and stability of the emergency medical services (EMS) workforce have fueled interest in enhancing the entry of EMS clinicians into the workforce. However, the educational challenges associated with workforce entry remain unclear. Our objective was to evaluate the educational pathway of entry into the EMS workforce and to identify factors that lead to the loss of potential EMS clinicians. Methods: This is a cross-sectional evaluation of all US paramedic educational programs, with enrolled students, in the 2019 Committee on Accreditation of Educational Programs for the EMS Professions annual report survey. This data set includes detailed program characteristics and metrics including program attrition rate (leaving before completion), and certifying exam pass rates. Descriptive statistics were calculated, and multivariable logistic regression analysis was conducted to evaluate the association between high program attrition rates (>30%) and program specific characteristics. Results: In 2019, 640 accredited programs met inclusion with 17,457 students enrolled in paramedic educational programs. Of these, 13,884 students successfully graduated (lost to attrition, 3,573/17,457 [21%]) and 12,002 passed the certifying exam on the third attempt (lost to unable to certify, 1,882/17,457 [11%]). High program attrition rates were associated with longer programs (>12 months), small class sizes (<12 students), and regional locations. Conclusions: Nearly 1 in 3 paramedic students were lost from the potentially available workforce either owing to attrition during the educational program or failure to certify after course completion. Attrition represented the largest loss, providing an avenue for future targeted research and interventions to improve EMS workforce stability.

Effects of creatine monohydrate timing on resistance training adaptations and body composition after 8 weeks in male and female collegiate athletes.

Background: Limited research is available on the potential impact of creatine monohydrate administration before or after workouts among athletes. This study aimed to investigate the effects of pre- vs. post-exercise creatine monohydrate supplementation on resistance training adaptations and body composition. Methods: In a randomized, double-blind, placebo-controlled, parallel design, 34 healthy resistance-trained male and female athletes were randomly assigned and matched according to fat free mass to consume a placebo, or 5-g dose of creatine monohydrate within 1 h before training, or within 1 h after training for 8 weeks, while completing a weekly resistance training program. Participants co-ingested 25-gram doses of both whey protein isolate and maltodextrin along with each assigned supplement dose. Body composition, muscular strength, and endurance, along with isometric mid-thigh pull were assessed before and after the 8-week supplementation period. A 3 × 2 mixed factorial (group x time) ANOVA with repeated measures on time were used to evaluate differences. Results: All groups experienced similar and statistically significant increases in fat free mass (+1.34 ± 3.48 kg, p = 0.04), upper (+2.21 ± 5.69 kg, p = 0.04) and lower body strength (+7.32 ± 10.01 kg, p < 0.001), and decreases in body mass (-1.09 ± 2.71 kg, p = 0.03), fat mass (-2.64 ± 4.16 kg, p = 0.001), and percent body fat (-2.85 ± 4.39 kg, p < 0.001). Conclusions: The timing of creatine monohydrate did not exert any additional influence over the measured outcomes.

Validity of the Wattbike 3-Minute Aerobic Test: Measurement and Estimation of V̇o2max.

ABSTRACT: Hanson, NJ, Scheadler, CM, Katsavelis, D, and Miller, MG. Validity of the Wattbike 3-minute aerobic test: measurement and estimation of V̇o2max. J Strength Cond Res 36(2): 400-404, 2022-The Wattbike includes a 3-minute aerobic test (3mAT) along with an estimation of V̇o2max. The estimation equation that is used is from a previous study using a different protocol and sedentary subjects. The purpose of this study was to determine whether (a) the 3mAT is able to elicit V̇o2max, and (b) whether this estimation is accurate. Thirteen cyclists (10 men; age: 29.2 ± 10.0 years, height 178.7 ± 8.3 cm, and mass 75.1 ± 12.5 kg) with a range of experience volunteered for this study. At the first visit, a self-paced V̇o2max (SPV) test was performed to obtain the "true" V̇o2max. At the second session, subjects completed the 3mAT. Primary dependent variables included maximal values of oxygen consumption (V̇o2), carbon dioxide production (V̇co2), heart rate (HR), ventilation (VE), and respiratory exchange ratio (RER). A repeated-measures analysis of variance showed no difference (p = 0.367) between V̇o2max values (3mAT estimation: 54.3 ± 9.3 ml·kg-1·min-1, 3mAT measured: 52.5 ± 8.7, SPV: 54.0 ± 9.7). Paired-samples t-tests showed that HR (p = 0.027) was higher in the SPV (184.7 ± 10.6 vs. 180.9 ± 6.3 b·min-1), whereas RER and V̇co2 were both higher in the 3mAT (1.29 ± 0.10 vs. 1.19 ± 0.06 and 4.92 ± 1.01 vs. 4.62 ± 0.98, respectively; both p < 0.05). The intraclass correlation between the V̇o2max measured from the SPV and 3mAT was 0.96 (95% CI: 0.88-0.99, p < 0.001), and between the 3mAT measured and estimated values was 0.91 (95% CI: 0.71-0.97 p < 0.001). If an athlete has access to a Wattbike, they can complete the 3mAT, receive their V̇o2max estimation, and be confident of its accuracy.

The Effects of a Novel Quadrupedal Movement Training Program on Functional Movement, Range of Motion, Muscular Strength, and Endurance.

ABSTRACT: Buxton, JD, Prins, PJ, Miller, MG, Moreno, A, Welton, GL, Atwell, AD, Talampas, TR, and Elsey, GE. The effects of a novel quadrupedal movement training program on functional movement, range of motion, muscular strength, and endurance. J Strength Cond Res 36(8): 2186-2193, 2022-Quadrupedal movement training (QMT) is a form of bodyweight training incorporating animal poses, transitions, and crawling patterns to reportedly improve fitness. This type of training may improve multiple facets of fitness, unfortunately, little evidence exists to support commercial claims and guide practitioners in the best use of QMT. Therefore, the purpose of this study was to assess the impact of a commercially available QMT program on functional movement, dynamic balance, range of motion, and upper body strength and endurance. Forty-two active college-age (19.76 ± 2.10 years) subjects (males = 19, females = 23) were randomly assigned to a QMT ( n = 21) or control (CON) ( n = 21) group for 8 weeks. Quadrupedal movement training consisted of 60-minute classes performed 2×·wk -1 in addition to regular physical activity. Active range of motion, Functional Movement Screen (FMS), Y-Balance Test (YBT), handgrip strength, and push-up endurance were assessed before and after the intervention. The QMT group showed significantly greater improvements than the CON group in FMS composite score (1.62 ± 1.53 vs. 0.33 ± 1.15, p = 0.004) and FMS advanced movements (0.81 ± 0.87 vs. 0.01 ± 0.71, p = 0.002) and fundamental stability (0.57 ± 0.75 vs. 0.05 ± 0.50, p = 0.011), along with hip flexion, hip lateral rotation, and shoulder extension ( p < 0.05). No significant differences between groups were observed for dynamic balance or upper body strength and endurance. Our results indicate that QMT can improve FMS scores and various active joint ranges of motion. Quadrupedal movement training is a viable alternative form of training to improve whole-body stabilization and flexibility.

Effects of long-term testosterone treatment on cardiovascular outcomes in men with hypogonadism: Rationale and design of the TRAVERSE study.

BACKGROUND: Testosterone exerts some effects on the cardiovascular system that could be considered beneficial; some other effects may potentially increase the risk of cardiovascular (CV) events. Neither the long-term efficacy nor safety of testosterone treatment has been studied in an adequately-powered randomized trial. METHODS: The Testosterone Replacement therapy for Assessment of long-term Vascular Events and efficacy ResponSE in hypogonadal men (TRAVERSE) study is a randomized, double-blind, placebo-controlled, parallel group, non-inferiority, multicenter study. Eligible participants are men, 45 to 80 years, with serum testosterone concentration <300 ng/dL and hypogonadal symptoms, who have evidence pre-existing CV disease or increased risk of CV disease. Approximately 6,000 subjects will be randomized to either 1.62% transdermal testosterone gel or a matching placebo gel daily for an anticipated duration of up to 5 years. The primary outcome is CV safety defined by the major adverse CV event composite of nonfatal myocardial infarction, nonfatal stroke, or death due to CV causes. The trial will continue until at least 256 adjudicated major adverse CV event endpoints have occurred to assess whether the 95% (2-sided) upper confidence limit for a hazard ratio of 1.5 can be ruled out. Secondary endpoints include prostate safety defined as the incidence of adjudicated high grade prostate cancer and efficacy in domains of sexual function, bone fractures, depression, anemia, and diabetes. RESULTS: As of July 1, 2021, 5,076 subjects had been randomized. CONCLUSIONS: The TRAVERSE study will determine the CV safety and long-term efficacy of testosterone treatment in middle-aged and older men with hypogonadism with or at increased risk of CV disease.

Transcranial Direct Current Stimulation with the Halo Sport Does Not Improve Performance on a Three-Minute, High Intensity Cycling Test.

Transcranial direct current stimulation (tDCS) uses a weak electrical current that is sent through the cerebral cortex. The Halo Sport headphones are a user-friendly form of tDCS that is implemented by many athletes purportedly to improve performance. The purpose of this study was to determine the effect of tDCS, using the Halo Sport, on performance variables associated with a high-intensity three-minute cycling test. Eighteen healthy, active individuals (ten men, eight women) volunteered for this study. The Halo Sport headphones were worn during a 20-minute warmup before completing a high-intensity three-minute cycling test. A sham treatment was used in addition to the experimental condition. Ratings of perceived exertion (RPE) were assessed every 30 seconds and electromyography (EMG) of the quadriceps muscle group was measured throughout testing. Two-way repeated measures ANOVAs were used to determine the effect of condition and time on mean RPE, heart rate (HR) and power; paired samples t-tests were also used to compare conditions. Mean HR was higher in the experimental condition (p = 0.038). Otherwise, there were no differences between conditions on any of the variables (mean RPE, cadence and speed, mean and peak HR, power, root mean square EMG). Despite the popularity of this new device, our findings do not support an ergogenic effect. However, further research is warranted.

The COVIDome Explorer Researcher Portal.

COVID-19 pathology involves dysregulation of diverse molecular, cellular, and physiological processes. In order to expedite integrated and collaborative COVID-19 research, we completed multi-omics analysis of hospitalized COVID-19 patients including matched analysis of the whole blood transcriptome, plasma proteomics with two complementary platforms, cytokine profiling, plasma and red blood cell metabolomics, deep immune cell phenotyping by mass cytometry, and clinical data annotation. We refer to this multidimensional dataset as the COVIDome. We then created the COVIDome Explorer, an online researcher portal where the data can be analyzed and visualized in real time. We illustrate here the use of the COVIDome dataset through a multi-omics analysis of biosignatures associated with C-reactive protein (CRP), an established marker of poor prognosis in COVID-19, revealing associations between CRP levels and damage-associated molecular patterns, depletion of protective serpins, and mitochondrial metabolism dysregulation. We expect that the COVIDome Explorer will rapidly accelerate data sharing, hypothesis testing, and discoveries worldwide.

Recommendations to Increase Neuromuscular Electrical Stimulation Training Intensity During Quadriceps Treatments for Orthopedic Knee Conditions.

ABSTRACT: Neuromuscular electrical stimulation (NMES) is often used by clinicians as a therapeutic adjunct to improve quadriceps strength deficits following orthopedic knee conditions. The efficacy of NMES treatments is primarily dependent on the NMES training intensity, which is a direct result of NMES-induced torque production. The importance of NMES training intensity is well known, yet adequate NMES training intensities are often difficult to achieve due to a variety of limitations associated with NMES (eg, fatigue and patient discomfort). This article provides recommendations that a clinician can use to increase NMES training intensity when strengthening the quadriceps with NMES for orthopedic knee conditions. These recommendations should allow forceful contractions that can be sustained over a treatment with multiple repetitions without the rapid decline in force that is typically seen when NMES is used.

Testosterone concentrations and risk of cardiovascular events in androgen-deficient men with atherosclerotic cardiovascular disease.

BACKGROUND: Whether androgen deficiency among men increases the risk of cardiovascular (CV) events or is merely a disease marker remains a subject of intense scientific interest. OBJECTIVES: Among male subjects in the AIM-HIGH Trial with metabolic syndrome and low baseline levels of high-density lipoprotein (HDL)-cholesterol who were randomized to niacin or placebo plus simvastatin, we examined the relationship between low baseline testosterone (T) concentrations and subsequent CV outcomes during a mean 3-year follow-up. METHODS: In this post hoc analysis of men with available baseline plasma T concentrations, we examined the relationship between clinical/demographic characteristics and T concentrations both as a continuous and dichotomous variable (<300 ng/dL ["low T"] vs. ≥300 ng/dL ["normal T"]) on rates of pre-specified CV outcomes, using Cox proportional hazards models. RESULTS: Among 2118 male participants in whom T concentrations were measured, 643 (30%) had low T and 1475 had normal T concentrations at baseline. The low T group had higher rates of diabetes mellitus, hypertension, elevated body mass index, metabolic syndrome, higher blood glucose, hemoglobin A1c, and triglyceride levels, but lower levels of both low-density lipoprotein and HDL-cholesterol, and a lower rate of prior myocardial infarction (MI). Men with low T had a higher risk of the primary composite outcome of coronary heart disease (CHD) death, MI, stroke, hospitalization for acute coronary syndrome, or coronary or cerebral revascularization (20.1%) compared with the normal T group (15.2%); final adjusted HR 1.23, P = .07, and a higher risk of the CHD death, MI, and stroke composite endpoint (11.8% vs. 8.2%; final adjusted HR 1.37, P = .04), respectively. CONCLUSIONS: In this post hoc analysis, there was an association between low baseline testosterone concentrations and increased risk of subsequent CV events in androgen-deficient men with established CV disease and metabolic syndrome, particularly for the composite secondary endpoint of CHD death, MI, and stroke. CONDENSED ABSTRACT: In this AIM-HIGH Trial post hoc analysis of 2118 men with metabolic syndrome and low HDL-cholesterol with available baseline plasma testosterone (T) samples, 643 males (30%) had low T (mean: 229 ng/dL) and 1475 (70%) had normal T (mean: 444 ng/dL) concentrations. The "low T" group had a 24% higher risk of the primary 5-component endpoint (20.1%) compared with the normal T group (15.2%); final adjusted HR 1.23, P = .07). There was also a 31% higher risk of the secondary composite endpoint: coronary heart disease death, myocardial infarction, and stroke (11.8% vs. 8.2%, final adjusted HR 1.37, P = .04) in the low vs. normal T group, respectively.

Homeless Shelter Users and Their Experiences as EMS Patients: A Qualitative Study.

Introduction: Patients who are users of homeless shelters interact with EMS and Emergency Departments (ED) as means of accessing the healthcare system. Patients in this population are known to have chronic health conditions as well as being frequent users of EMS. In this study, we researched how patients living at a homeless shelter experienced EMS. Methods: A phenomenological qualitative approach methodology was used to interview individuals at the largest homeless shelter in Omaha, Nebraska in 2017. Data was transcribed then coded for thematic analysis. Results: Eighteen adult individuals participated with four major themes emerging: Frequency and Medical Histories, Perceived Positive Experiences, Perceived Negative Experiences, and Awareness of EMS. Professionalism and being non-judgmental toward a homeless shelter user appeared to best describe the difference between a positive EMS experience from a negative one. Patients of this population have an awareness and appreciation to the role of EMS. They are also aware and recognize overuse of EMS by others and biases from EMS towards patients of this population. There are recognized opportunities to improve the relationship and role of EMS with patients using homeless shelters and services. Conclusion: Support for increased EMS awareness, research, and relationship building with homeless shelter users and shelters is needed.

Advanced Placement Paramedic Education for Health Care Professionals: A Descriptive Evaluation.

INTRODUCTION: The delivery of emergency medical services is primarily performed by emergency medical technicians and paramedics in the United States. More recently, nurses and physicians have become more involved in the delivery of emergency medical services. Advanced placement paramedic education bridging programs have been developed to prepare the workforce, but the success of these programs is unknown. This study evaluated the demographics and performance of nonemergency medical services health care professionals who attended an advanced placement paramedic education program at a Midwestern university. METHODS: This was a retrospective evaluation of student data from 2007 to 2017. Descriptive statistics were used to tabulate demographics, program performance, and individual performance in the National Paramedic Certification Examination. RESULTS: The program admitted 305 students; registered nurses (95%) were the majority of students. Of the 305 admitted students, 271 (88.9%) fulfilled all program requirements and were eligible to take the National Registry of Emergency Medical Technicians paramedic certification examination. Of these 271 eligible students, 201 (74.2%) took the National Paramedic Certification Examination. A total of 195 (97%) obtained certification at the first test attempt, whereas 200 (99.5%) obtained certification within 3 attempts. Of the 200 who passed the test, 175 (88%) successfully demonstrated entry-level competency in paramedic-level psychomotor testing. DISCUSSION: The advanced placement paramedic program evaluated in this study had high rates of successful program completion, as well as high first-time and cumulative passing rates for the National Paramedic Certification Examination. Further research is needed to identify the best practices in determining student requirements and the methodologies in delivering advanced placement paramedic education bridging programs.

Brain activity during self-paced vs. fixed protocols in graded exercise testing.

Electroencephalography research surrounding maximal exercise testing has been limited to male subjects. Additionally, studies have used open-looped protocols, meaning individuals do not know the exercise endpoint. Closed-loop protocols are often shown to result in optimal performance as self-pacing is permitted. The purpose of this study was to compare brain activity during open- and closed-loop maximal exercise protocols, and to determine if any sex differences are present. Twenty-seven subjects (12 males, ages 22.0 ± 2.5 years) participated in this study. A pre-assembled EEG sensor strip was used to collect brain activity from specific electrodes (F3/F4: dorsolateral prefrontal cortex, or dlPFC; and C3/Cz/C4: motor cortex, or MC). Alpha (8-12 Hz) and beta (12-30 Hz) frequency bands were analyzed. Subjects completed two maximal exercise tests on a cycle ergometer, separated by at least 48 h: a traditional, open-loop graded exercise test (GXT) and a closed-loop self-paced VO2max (SPV) test. Mixed model ANOVAs were performed to compare power spectral density (PSD) between test protocols and sexes. A significant interaction of time and sex was shown in the dlPFC for males, during the GXT only (p = 001), where a peak was reached and then a decrease was shown. A continuous increase was shown in the SPV. Sex differences in brain activity during exercise could be associated with inhibitory control, which is a function of the dlPFC. Knowledge of an exercise endpoint could be influential towards cessation of exercise and changes in cortical brain activity.

Atrasentan and renal events in patients with type 2 diabetes and chronic kidney disease (SONAR): a double-blind, randomised, placebo-controlled trial.

BACKGROUND: Short-term treatment for people with type 2 diabetes using a low dose of the selective endothelin A receptor antagonist atrasentan reduces albuminuria without causing significant sodium retention. We report the long-term effects of treatment with atrasentan on major renal outcomes. METHODS: We did this double-blind, randomised, placebo-controlled trial at 689 sites in 41 countries. We enrolled adults aged 18-85 years with type 2 diabetes, estimated glomerular filtration rate (eGFR) 25-75 mL/min per 1·73 m2 of body surface area, and a urine albumin-to-creatinine ratio (UACR) of 300-5000 mg/g who had received maximum labelled or tolerated renin-angiotensin system inhibition for at least 4 weeks. Participants were given atrasentan 0·75 mg orally daily during an enrichment period before random group assignment. Those with a UACR decrease of at least 30% with no substantial fluid retention during the enrichment period (responders) were included in the double-blind treatment period. Responders were randomly assigned to receive either atrasentan 0·75 mg orally daily or placebo. All patients and investigators were masked to treatment assignment. The primary endpoint was a composite of doubling of serum creatinine (sustained for ≥30 days) or end-stage kidney disease (eGFR <15 mL/min per 1·73 m2 sustained for ≥90 days, chronic dialysis for ≥90 days, kidney transplantation, or death from kidney failure) in the intention-to-treat population of all responders. Safety was assessed in all patients who received at least one dose of their assigned study treatment. The study is registered with ClinicalTrials.gov, number NCT01858532. FINDINGS: Between May 17, 2013, and July 13, 2017, 11 087 patients were screened; 5117 entered the enrichment period, and 4711 completed the enrichment period. Of these, 2648 patients were responders and were randomly assigned to the atrasentan group (n=1325) or placebo group (n=1323). Median follow-up was 2·2 years (IQR 1·4-2·9). 79 (6·0%) of 1325 patients in the atrasentan group and 105 (7·9%) of 1323 in the placebo group had a primary composite renal endpoint event (hazard ratio [HR] 0·65 [95% CI 0·49-0·88]; p=0·0047). Fluid retention and anaemia adverse events, which have been previously attributed to endothelin receptor antagonists, were more frequent in the atrasentan group than in the placebo group. Hospital admission for heart failure occurred in 47 (3·5%) of 1325 patients in the atrasentan group and 34 (2·6%) of 1323 patients in the placebo group (HR 1·33 [95% CI 0·85-2·07]; p=0·208). 58 (4·4%) patients in the atrasentan group and 52 (3·9%) in the placebo group died (HR 1·09 [95% CI 0·75-1·59]; p=0·65). INTERPRETATION: Atrasentan reduced the risk of renal events in patients with diabetes and chronic kidney disease who were selected to optimise efficacy and safety. These data support a potential role for selective endothelin receptor antagonists in protecting renal function in patients with type 2 diabetes at high risk of developing end-stage kidney disease. FUNDING: AbbVie.

Increased Rate of Heat Storage, and No Performance Benefits, With Caffeine Ingestion Before a 10-km Run in Hot, Humid Conditions.

PURPOSE: Although the effect of caffeine in thermoneutral or cool environmental conditions has generally shown performance benefits, its efficacy in hot, humid conditions is not as well known. The purpose of this study was to further examine the effect of caffeine ingestion on endurance running performance in the heat. METHODS: Ten trained endurance runners (6 males; mean [SD] age = 26 [9] y, height = 176.7 [5.1] cm, and mass = 72.1 [8.7] kg) came to the lab for 4 visits. The first was a VO2max test to determine cardiorespiratory fitness; the final 3 visits were 10-km runs in an environmental chamber at 30.6°C and 50% relative humidity under different conditions: 3 mg·kg-1 body mass (low caffeine dosage), 6 mg·kg-1 (moderate caffeine dosage), and a placebo. Repeated-measures analyses of variance were used to determine the effect of condition on the 10-km time, heart rate, core temperature, rating of perceived exertion, and thermal sensation. RESULTS: There was no difference in the 10-km time between the placebo (53.2 [8.0] min), 3-mg·kg-1 (53.4 [8.4]), and 6-mg·kg-1 (52.7 [8.2]) conditions (P = .575, ηp2=.060 ). There was not a main effect of average heart rate (P = .406, ηp2=.107 ), rating of perceived exertion (P = .151, ηp2=.189 ), or thermal sensation (P = .286, ηp2=.130 ). There was a significant interaction for core temperature (P = .025, ηp2=.170 ); the moderate-dosage caffeine condition showed a higher rate of rise in core temperature (0.26 [0.08] °C·km-1 vs 0.20 [0.06] and 0.19 [0.10] °C·km-1 in the low-caffeine and placebo conditions, respectively). CONCLUSION: The results support previous research showing a thermogenic effect of caffeine, as the moderate-dosage condition led to a greater rate of heat storage and no performance benefits.

Deception of Ambient Temperature Does Not Elicit Performance Benefits During a 5 km Run in Hot, Humid Conditions.

Hanson, NJ, Carriveau, DM, Morgan, HE, Smith, AR, Michael, TJ, and Miller, MG. Deception of ambient temperature does not elicit performance benefits during a 5 km run in hot, humid conditions. J Strength Cond Res 32(8): 2250-2257, 2018-The purpose of this study was to investigate the effect of deception of ambient temperature on 5 km performance in recreational runners. Eleven participants (6 men, 5 women) each performed three 5 km runs in a random order consisting of a control trial (CON) in temperate conditions (21° C, 43% RH), a hot humid trial (HOT; 31° C, 65% RH) and a deception trial (DEC; 31° C, 65% RH), where participants were told it was 5° C lower than it actually was. Overall completion time was recorded at the end of trials; thermal sensation (TS), rating of perceived exertion (RPE), and core temperature (TC) were recorded each kilometer. Participants completed the 5 km run faster in the CON condition (23:18 ± 2:05; mean ± SD) compared with DEC (p = 0.005) and HOT (p = 0.014). There was no difference in completion time (p = 0.554) between DEC (25:11 ± 2:41) and HOT (24:25 ± 2:47). Similarly, TS was lower in the CON condition (5.7 ± 0.2) compared with DEC and HOT (p < 0.001 and p = 0.016, respectively) and no differences were seen between the DEC (6.4 ± 0.2) and HOT (6.5 ± 0.2) conditions. No differences in RPE (p = 0.115) or rise in TC (p = 0.289) were seen between the 3 conditions. Deception of the environmental conditions did not positively affect 5 km running performance, and no differences were seen in physiological or psychological variables.