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Testosterone treatment of men with low testosterone is common and, although relatively short-term, has raised concern regarding an increased risk of prostate cancer (CaP). We investigated the association between modest-duration testosterone treatment and incident aggressive CaP. Retrospective inception cohort study of male Veterans aged 40 to 89 years with a laboratory-defined low testosterone measurement from 2002 to 2011 and recent prostate specific antigen (PSA) testing; excluding those with recent testosterone treatment, prostate or breast cancer, high PSA or prior prostate biopsy. Histologically-confirmed incident aggressive prostate cancer or any prostate cancer were the primary and secondary outcomes, respectively. Of the 147,593 men included, 58,617 were treated with testosterone. 313 aggressive CaPs were diagnosed, 190 among untreated men (incidence rate (IR) 0.57 per 1000 person years, 95% CI 0.49-0.65) and 123 among treated men (IR 0.58 per 1000 person years; 95% CI 0.48-0.69). After adjusting for age, race, hospitalization during year prior to cohort entry, geography, BMI, medical comorbidities, repeated testosterone and PSA testing, testosterone treatment was not associated with incident aggressive CaP (HR 0.89; 95% CI 0.70-1.13) or any CaP (HR 0.90; 95% CI 0.81-1.01). No association between cumulative testosterone dose or formulation and CaP was observed. Among men with low testosterone levels and normal PSA, testosterone treatment was not associated with an increased risk of aggressive or any CaP. The clinical risks and benefits of testosterone treatment can only be fully addressed by large, longer-term randomized controlled trials.

Background Use of participatory research methods is increasing in research trials. Once partnerships are established with end-users, there is less guidance about processes research teams can use to successfully incorporate end-user feedback. The current study describes the use of a brief reflections process to systematically examine and evaluate the impact of end-user feedback on study conduct. Methods The Comparative Effectiveness of Trauma-Focused and Non-Trauma- Focused Treatment Strategies for PTSD among those with Co-Occurring SUD (COMPASS) study was a randomized controlled trial to determine the effectiveness of trauma-focused psychotherapy versus non-trauma-focused psychotherapy for Veterans with co-occurring posttraumatic stress disorder and substance use disorder who were entering substance use treatment within the Department of Veterans Affairs. We developed and paired a process of “brief reflections” with our end-user engagement methods as part of a supplemental evaluation of the COMPASS study engagement plan. Brief reflections were 30-minute semi-structured discussions with the COMPASS Team following meetings with three study engagement panels about feedback received regarding study issues. To evaluate the impact of panel feedback, 16 reflections were audio-recorded, transcribed, rapidly analyzed, and integrated with other study data sources. Results Brief reflections revealed that the engagement panels made recommended changes in eight areas: enhancing recruitment; study assessment completion; creating uniformity across Study Coordinators; building Study Coordinator connection to Veteran participants; mismatch between study procedures and clinical practice; therapist skill with patients with active substance use; therapist burnout; and dissemination of study findings. Some recommendations positively impact study conduct while others had mixed impact. Reflections were iterative and led to emergent processes that included revisiting previously discussed topics, cross-pollination of ideas across panels, and sparking solutions amongst the Team when the panels did not make any recommendations or recommendations were not feasible. Conclusions When paired with end-user engagement methods, brief reflections can facilitate systematic examination of end-user input, particularly when the engagement strategy is robust. Reflections offer a forum of accountability for researchers to give careful thought to end-user recommendations and make timely improvements to the study conduct. Reflections can also facilitate evaluation of these recommendations and reveal end-user-driven strategies that can effectively improve study conduct. Trial registration ClinicalTrials.gov (NCT04581434) on October 9, 2020; https://clinicaltrials.gov/ct2/show/study/NCT04581434?term=NCT04581434&draw=2&rank=1 .

Anger is a symptom of post-traumatic stress disorder (PTSD) associated with a range of clinical and functional impairments, and may be especially prevalent among veterans with PTSD. Effective anger management therapies exist but may be undermined by poor engagement or lack of treatment availability. Finding ways to engage veterans in anger management therapy or to improve access can be helpful in improving clinical outcomes. This randomized controlled trial compared anger management treatment (AMT) with AMT augmented by a mobile application (app) system, Remote Exercises for Learning Anger and Excitation Management (RELAX). Participants were 58 veterans enrolled in 12 sessions of either AMT alone or AMT with the RELAX system (AMT + RELAX). The RELAX system includes the RELAX app, a wearable heart rate monitor, a remote server, and a web-based therapist interface. RELAX allows the user to practice skills, monitor symptoms, and record physiological data. The server collects data on app use. A web-based interface allows the therapist to access data on between-session practice, and skills use. Measures administered at baseline, post-treatment, and 3-and 6-month follow-up include state and trait anger, dimensions of anger, PTSD, depression, interpersonal functioning, and satisfaction. We used multilevel modeling to account for the nesting of time points within participants and participants within treatment groups. Predictors were Treatment Condition (AMT + RELAX and AMT), Linear Time (baseline, post-treatment, 3-and 6-month follow-up), and Quadratic Time and Treatment Condition × Linear Time interaction. All analyses were conducted using SPSS 21 (Armonk, New York). Approval was obtained from the institutional review board. Across groups, the treatment dropout rate was 13.8%; of those who remained in treatment, 90% received an adequate dose of treatment (10 or more sessions). There were no significant differences between groups on attendance or treatment completion. Participants in both treatments demonstrated statistically significant and clinically meaningful reductions in anger severity and significant post-treatment reductions in PTSD. Veterans did not report significant changes in depression or interpersonal functioning. Veterans in the AMT + RELAX group reported spending significantly less time on homework assignments, and they rated the AMT + RELAX app as helpful and easy to use, with these ratings improving over time. Findings suggest that AMT + RELAX was beneficial in reducing anger symptoms and promoting efficient use of the between-session practice; however, AMT + RELAX did not outperform AMT. This study is an important contribution as it is one of the first randomized controlled trials to study the efficacy of a technology-enhanced, evidence-based psychotherapy for anger management. Findings are limited because of small sample size and modifications to the technology during the trial. However, the results highlight the possible benefits of mobile app-supported treatment, including increasing the accessibility of treatment, lowering therapist workload, reducing costs of treatment, reducing practice time, and enabling new activities and types of treatments. This study presents preliminary evidence that mobile apps can be a valuable addition to treatment for patients with anger difficulties. Future research should evaluate how much therapist involvement is needed to support anger management.

Positive psychological interventions for improving health have received increasing attention recently. Evidence on the impact of such interventions on pain, and racial disparities in pain, is limited. To assess the effects of a positive psychological intervention on pain and functional difficulty in veterans with knee osteoarthritis. The Staying Positive With Arthritis Study is a large, double-blinded randomized clinical trial powered to detect race differences in self-reported pain in response to a positive psychological intervention compared with a neutral control intervention. Data were collected from 2 urban Veterans Affairs medical centers. Participants included non-Hispanic white and non-Hispanic African American patients aged 50 years or older with a diagnosis of osteoarthritis. Mailings were sent to 5111 patients meeting these criteria, of whom 839 were fully screened, 488 were eligible, and 360 were randomized. Enrollment lasted from July 8, 2015, to February 1, 2017, with follow-up through September 6, 2017. The intervention comprised a 6-week series of evidence-based activities to build positive psychological skills (eg, gratitude and kindness). The control program comprised similarly structured neutral activities. Programs were delivered via workbook and weekly telephone calls with interventionists. The primary outcomes were self-reported pain and functional difficulty measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC; range 0-100). Secondary outcomes included affect balance and life satisfaction. The sample included 180 non-Hispanic white patients and 180 non-Hispanic African American patients (mean [SD] age, 64.2 [8.8] years; 76.4% were male). Mean (SD) baseline scores for WOMAC pain and functional difficulty were 48.8 (17.6) and 46.8 (18.1), respectively. Although both decreased significantly over time (pain: χ23 = 49.50, P < .001; functional difficulty: χ23 = 22.11, P < .001), differences were small and did not vary by treatment group or race. Exploratory analyses suggested that the intervention had counterintuitive effects on secondary outcomes. The results of this randomized clinical trial do not support the use of positive psychological interventions as a stand-alone treatment for pain among white or African American veterans with knee osteoarthritis. Adaptations are needed to identify intervention components that resonate with this population, and the additive effect of incorporating positive psychological interventions into more comprehensive pain treatment regimens should be considered. ClinicalTrials.gov Identifier: NCT02223858.

Collaborative chronic care models (CCMs) have extensive randomized clinical trial evidence for effectiveness in serious mental illnesses, but little evidence exists regarding their feasibility or effect in typical practice conditions. To determine the effectiveness of implementation facilitation in establishing the CCM in mental health teams and the impact on health outcomes of team-treated individuals. This quasi-experimental, randomized stepped-wedge implementation trial was conducted from February 2016 through February 2018, in partnership with the US Department of Veterans Affairs (VA) Office of Mental Health and Suicide Prevention. Nine facilities were enrolled from all VA facilities in the United States to receive CCM implementation support. All veterans (n = 5596) treated by designated outpatient general mental health teams were included for hospitalization analyses, and a randomly selected sample (n = 1050) was identified for health status interviews. Individuals with dementia were excluded. Clinicians (n = 62) at the facilities were surveyed, and site process summaries were rated for concordance with the CCM process. The CCM implementation start time was randomly assigned across 3 waves. Data analysis of this evaluable population was performed from June to September 2018. Internal-external facilitation, combining a study-funded external facilitator and a facility-funded internal facilitator working with a designated team for 1 year. Facilitation was hypothesized to be associated with improvements in both implementation and intervention outcomes (hybrid type II trial). Implementation outcomes included the clinician Team Development Measure (TDM) and proportion of CCM-concordant team care processes. The study was powered for the primary health outcome, mental component score (MCS). Hospitalization rate was derived from administrative data. The veteran population (n = 5596) included 881 women (15.7%), and the mean (SD) age was 52.2 (14.5) years. The interviewed sample (n = 1050) was similar but was oversampled for women (n = 210 [20.0%]). Facilitation was associated with improvements in TDM subscales for role clarity (53.4%-68.6%; δ = 15.3; 95% CI, 4.4-26.2; P = .01) and team primacy (50.0%-68.6%; δ = 18.6; 95% CI, 8.3-28.9; P = .001). The percentage of CCM-concordant processes achieved varied, ranging from 44% to 89%. No improvement was seen in veteran self-ratings, including the primary outcome. In post hoc analyses, MCS improved in veterans with 3 or more treated mental health diagnoses compared with others (β = 5.03; 95% CI, 2.24-7.82; P < .001). Mental health hospitalizations demonstrated a robust decrease during facilitation (β = -0.12; 95% CI, -0.16 to -0.07; P < .001); this finding withstood 4 internal validity tests. Implementation facilitation that engages clinicians under typical practice conditions can enhance evidence-based team processes; its effect on self-reported overall population health status was negligible, although health status improved for individuals with complex conditions and hospitalization rate declined. ClinicalTrials.gov Identifier: NCT02543840.

Patients with transient ischemic attack (TIA) are at high risk of recurrent vascular events. Timely management can reduce that risk by 70%; however, gaps in TIA quality of care exist. To assess the performance of the Protocol-Guided Rapid Evaluation of Veterans Experiencing New Transient Neurological Symptoms (PREVENT) intervention to improve TIA quality of care. This nonrandomized cluster trial with matched controls evaluated a multicomponent intervention to improve TIA quality of care at 6 diverse medical centers in 6 geographically diverse states in the US and assessed change over time in quality of care among 36 matched control sites (6 control sites matched to each PREVENT site on TIA patient volume, facility complexity, and quality of care). The study period (defined as the data period) started on August 21, 2015, and extended to May 12, 2019, including 1-year baseline and active implementation periods for each site. The intervention targeted clinical teams caring for patients with TIA. The quality improvement (QI) intervention included the following 5 components: clinical programs, data feedback, professional education, electronic health record tools, and QI support. The primary outcome was the without-fail rate, which was calculated as the proportion of veterans with TIA at a specific facility who received all 7 guideline-recommended processes of care for which they were eligible (ie, anticoagulation for atrial fibrillation, antithrombotic use, brain imaging, carotid artery imaging, high- or moderate-potency statin therapy, hypertension control, and neurological consultation). Generalized mixed-effects models with multilevel hierarchical random effects were constructed to evaluate the intervention associations with the change in the mean without-fail rate from the 1-year baseline period to the 1-year intervention period. Six facilities implemented the PREVENT QI intervention, and 36 facilities were identified as matched control sites. The mean (SD) age of patients at baseline was 69.85 (11.19) years at PREVENT sites and 71.66 (11.29) years at matched control sites. Most patients were male (95.1% [154 of 162] at PREVENT sites and 94.6% [920 of 973] at matched control sites at baseline). Among the PREVENT sites, the mean without-fail rate improved substantially from 36.7% (58 of 158 patients) at baseline to 54.0% (95 of 176 patients) during a 1-year implementation period (adjusted odds ratio, 2.10; 95% CI, 1.27-3.48; P = .004). Comparing the change in quality at the PREVENT sites with the matched control sites, the improvement in the mean without-fail rate was greater at the PREVENT sites than at the matched control sites (36.7% [58 of 158 patients] to 54.0% [95 of 176 patients] [17.3% absolute improvement] vs 38.6% [345 of 893 patients] to 41.8% [363 of 869 patients] [3.2% absolute improvement], respectively; absolute difference, 14%; P = .008). The implementation of this multifaceted program was associated with improved TIA quality of care across the participating sites. The PREVENT QI program is an example of a health care system using QI strategies to improve performance, and may serve as a model for other health systems seeking to provide better care. ClinicalTrials.gov Identifier: NCT02769338.

Objectives. We examined whether a proactive care smoking cessation intervention designed to overcome barriers to treatment would be especially effective at increasing cessation among African Americans receiving care in the Veterans Health Administration. Methods. We analyzed data from a randomized controlled trial, the Veterans Victory over Tobacco study, involving a population-based electronic registry of current smokers (702 African Americans, 1569 Whites) and assessed 6-month prolonged smoking abstinence at 1 year via a follow-up survey of all current smokers. We also examined candidate risk adjustors for the race effect on smoking abstinence. Results. The interaction between patient race and intervention condition (proactive care vs usual care) was not significant. Overall, African Americans had higher quit rates than Whites (13% vs 9%; P < .006) regardless of condition. Conclusions. African Americans quit at higher rates than Whites. These findings may be a result of the large number of veterans receiving smoking cessation services and the lack of racial differences in receipt of these services as well as racial differences in smoking history, self-efficacy, and motivation to quit that favor African Americans.

Background: Statistical models that identify patients at elevated risk of death or hospitalization have focused on population subsets, such as those with a specific clinical condition or hospitalized patients. Most models have limitations for clinical use. Our objective was to develop models that identified high-risk primary care patients. Methods: Using the Primary Care Management Module in the Veterans Health Administration (VHA)'s Corporate Data Warehouse, we identified all patients who were enrolled and assigned to a VHA primary care provider on October 1, 2010. The outcome variable was the occurrence of hospitalization or death during the subsequent 90 days and 1 year. We extracted predictors from 6 categories: sociodemographics, medical conditions, vital signs, prior year use of health services, medications, and laboratory tests and then constructed multinomial logistic regression models to predict outcomes for over 4.6 million patients. Results: In the predicted 95th risk percentiles, observed 90-day event rates were 19.6%, 6.2%, and 22.6%, respectively, for hospitalization, death, and either hospitalization or death, compared with population averages of 2.7%, 0.7%, and 3.4%, respectively; 1-year event rates were 42.3%, 19.4%, and 51.3%, respectively, compared with population averages of 8.2%, 2.6%, and 10.8%, respectively. The C-statistics for 90-day outcomes were 0.83, 0.86, and 0.81, respectively, for hospitalization, death, and either hospitalization or death and were 0.81, 0.85, and 0.79, respectively, for 1-year outcomes. Conclusions: Prediction models using electronic clinical data accurately identified patients with elevated risk for hospitalization or death. This information can enhance the coordination of care for patients with complex clinical conditions.

BackgroundCongress, veterans’ groups, and the press have expressed concerns that access to care and quality of care in Department of Veterans Affairs (VA) settings are inferior to access and quality in non-VA settings.ObjectiveTo assess quality of outpatient and inpatient care in VA at the national level and facility level and to compare performance between VA and non-VA settings using recent performance measure data.Main MeasuresWe assessed Patient Safety Indicators (PSIs), 30-day risk-standardized mortality and readmission measures, and ORYX measures for inpatient safety and effectiveness; Healthcare Effectiveness Data and Information Set (HEDIS®) measures for outpatient effectiveness; and Consumer Assessment of Healthcare Providers and Systems Hospital Survey (HCAHPS) and Survey of Healthcare Experiences of Patients (SHEP) survey measures for inpatient patient-centeredness. For inpatient care, we used propensity score matching to identify a subset of non-VA hospitals that were comparable to VA hospitals.Key ResultsVA hospitals performed on average the same as or significantly better than non-VA hospitals on all six measures of inpatient safety, all three inpatient mortality measures, and 12 inpatient effectiveness measures, but significantly worse than non-VA hospitals on three readmission measures and two effectiveness measures. The performance of VA facilities was significantly better than commercial HMOs and Medicaid HMOs for all 16 outpatient effectiveness measures and for Medicare HMOs, it was significantly better for 14 measures and did not differ for two measures. High variation across VA facilities in the performance of some quality measures was observed, although variation was even greater among non-VA facilities.ConclusionsThe VA system performed similarly or better than the non-VA system on most of the nationally recognized measures of inpatient and outpatient care quality, but high variation across VA facilities indicates a need for targeted quality improvement.

U.S. Army mortuary affairs (MA) soldiers experience stressors of deployment and exposure to the dead, increasing risk for post-traumatic stress and depression. This study examines Troop Education for Army Morale, a postdeployment early intervention based on Psychological First Aid. MA soldiers (N = 126) were randomized to intervention or comparison groups 1-month postdeployment. Intervention sessions were held at 2, 3, 4, and 7 months. Assessments of post-traumatic stress disorder (PTSD), depression, and quality of life (QOL) were conducted at 1, 2, 3, 4, 7, and 10 months for both groups. At baseline, 25.0% of the total sample had probable PTSD (17-item PTSD Checklist M = 35.4, SD = 16.9) and 23.6% had probable depression (9-item Patient Health Questionnaire Depression Scale M = 7.8, SD = 6.9). Over 10 months, PTSD and depression symptoms decreased and QOL improved for the total sample. At study conclusion, intervention and comparison groups were not different. Intervention group males showed a transient symptom increase at 2 to 3 months. Males attended fewer intervention sessions than females. Lower attendance was associated with more symptoms and lower QOL. Higher attendance was associated with greater intervention benefits. Findings highlight the need for better understanding postdeployment interventions and facilitating attendance. Further intervention for MA soldiers is indicated.