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. METHODS: A randomized, placebo-controlled, double-blind study was conducted at 316 trial sites. Participants included men, aged 45 to 80 years, with 2 fasting testosterone levels less than 300 ng/dL, 1 or more hypogonadal symptoms, cardiovascular disease (CVD), or increased risk of CVD. We evaluated 3 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 randomly assigned men. Intervention included 1.62% transdermal testosterone or placebo gel. Outcome measures included the proportions of participants (1) meeting criteria for LG-PDD or (2) with significant depressive symptoms; and changes in depressive symptoms, energy, sleep quality, and cognition in testosterone-treated vs placebo-treated men in the 3 subgroups. RESULTS: Of 5204 randomly assigned participants, 2643 (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 randomly assigned participants (n = 5204), TRT was associated with modest but significantly greater improvements in mood and energy but not cognition or sleep quality. CONCLUSION: 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.

Depression, Anxiety, Energy, and Fatigue Among Nurses Who Cared for Patients During the COVID-19 Pandemic: A Cross-Sectional Study.

Purpose of Study: Nurses around the world have faced challenges during the coronavirus disease 2019 (COVID-19) pandemic. This study examined the association between depression and anxiety and trait energy and trait fatigue, and baseline health status and work characteristics. Design of Study: A cross-sectional study. Methods: A survey was conducted to collect self-reported data from nurses involved in patient care in Northern Virginia. Depression and anxiety were assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) depression and anxiety scales. To measure trait energy and trait fatigue, the Mental and Physical State and Trait Energy and Fatigue Scale (MPSTEFS) was used. Findings: There was a significant association between depression and energy (b=-0.46, t = -1.78, p < .001) and loneliness (b=1.38, t = 4.00, p < .001) and increased alcohol use (b=2.11, t = 2.04, p = .045). We also found that nurses with depression were significantly more likely to seek mental health counseling (b=-2.91, t = 2.54, p = 0.013), which was also the case for anxiety (b=3.13, t = 2.14, p = .036). Conclusions: Our study highlights the mental health burden among nurses who worked in the early phase of the COVID-19 pandemic and its association with increased alcohol use and loneliness. The findings may help healthcare leaders identify early signals of deterioration in nurses' well-being.

Iterative development and pilot testing of an intervention fidelity monitoring plan for the enhanced, electronic health record-facilitated pragmatic clinical trial: Implications for training and protocol integrity.

Fidelity monitoring is the degree to which a clinical trial intervention is implemented as intended by a research protocol. Consistent implementation of research protocols supported with extant fidelity monitoring plans contribute rigor and validity of study results. Fidelity monitoring plans should be comprehensive yet practical to accommodate the realities of conducting research, particularly a pragmatic clinical trial, in dynamic settings with heterogeneous patient populations. The purposes of this paper are to describe the (1) iterative development and implementation of protocols for intervention fidelity monitoring, (2) pilot testing of the fidelity monitoring plan, (3) the identification of interventionist training deficiencies, and (4) opportunities to enhance protocol rigor for a cancer symptom management intervention delivered through the electronic health record patient portal and telephone as part of a complex, multi-component pragmatic clinical trial to uncover training deficits and bolster protocol integrity. The intervention focuses on prominent symptoms reported among medical oncology patients including sleep disturbance, pain, anxiety, depression, low energy (fatigue) and physical function. In this pragmatic trial, the role of interventionist is a registered nurse symptom care manager (RN SCM). A three-part fidelity monitoring plan with checklists audit: Part-1 RN SCM role training activities in research components, clinical training components, and protocol simulation training; Part-2 RN SCM adherence to the intervention core components delivered over the telephone; and Part-3 maintenance of adherence to core intervention components. The goal is ≥ 80% adherence to components of each of the three checklists. An initial pilot test of the fidelity monitoring plan was conducted to evaluate the checklists and the RN SCM adherence to core protocol components. RN SCM skills and training deficits were identified during the pilot phase, as were opportunities to improve protocol integrity. Overall, approximately 50% of the audited RN SCM telephone calls had ≥80% fidelity to the core components. There remains on-going need for RN SCM training and skill building in action planning. The content presented in this paper is intended to begin to fill the gap of fidelity monitoring plans for complex interventions tested in pragmatic clinical trials and delivered remotely in an effort to strengthen protocol integrity.

Comparative Analysis of Fatigue EnergyCharacteristics of S355J2 Steel Subjected toMulti-Axis Loads.

In this study, a novel test system for estimating bending and torsion fatigue under selectable kinematic and dynamic loading modes was constructed. Using S355J2 steel specimens, a series of tests were conducted to determine material sensitivity to different load paths and loading modes. The experimental results were supplemented with the results of numerical analyses, on the basis of which the components of strain and stress tensors for subsequent analyses were determined in the entire working part of the specimen. An original method for determining specific strain energy components was used. The experimental results showed the grouping of data according to the mode of loading chosen. This could signify that the selected fatigue models are sensitive to certain loading scenarios. We performed in- depth data analysis and complex numerical simulations, formulating likely explanations for the observed effect.