The effect of a fermented soy beverage among patients with localized prostate cancer prior to radical prostatectomy.

BACKGROUND: Fermented soy products have shown to possess inhibitory effects on prostate cancer (PCa). We evaluated the effect of a fermented soy beverage (Q-Can®), containing medium-chain triglycerides, ketones and soy isoflavones, among men with localized PCa prior to radical prostatectomy. METHODS: We conducted a placebo-controlled, double-blind randomized trial of Q-Can®. Stratified randomization (Cancer of the Prostate Risk Assessment (CAPRA) score at diagnosis) was used to assign patients to receive Q-Can® or placebo for 2-5 weeks before RP. Primary endpoint was change in serum PSA from baseline to end-of-study. We assessed changes in other clinical and pathologic endpoints. The primary ITT analysis compared PSA at end-of-study between randomization arms using repeated measures linear mixed model incorporating baseline CAPRA risk strata. RESULTS: We randomized 19 patients, 16 were eligible for analysis of the primary outcome. Mean age at enrollment was 61, 9(56.2%) were classified as low and intermediate risk, and 7(43.8%) high CAPRA risk. Among patients who received Q-Can®, mean PSA at baseline and end-of-study was 8.98(standard deviation, SD 4.07) and 8.02ng/mL(SD 3.99) compared with 8.66(SD 2.71) to 9.53ng/mL(SD 3.03), respectively, (Difference baseline - end-of-study, p = 0.36). There were no significant differences in Gleason score, clinical stage, surgical margin status, or CAPRA score between treatment arms (p > 0.05), and no significant differences between treatment arms in end-of-study or change in lipids, testosterone and FACT-P scores (p > 0.05). CONCLUSIONS: Short exposure to Q-Can® among patients with localized PCa was not associated with changes in PSA levels, PCa characteristics including grade and stage or serum testosterone. Due to early termination from inability to recruit, study power, was not achieved.

Facilitation and Preferred Models for Delivering Substance Use Disorder Treatment in HIV Clinics: Results From a Multisite Randomized Trial.

BACKGROUND: Integrated addiction treatment in HIV clinics is associated with improved outcomes, yet it is offered inconsistently and with variable models of care. We sought to evaluate the impact of Implementation Facilitation ("Facilitation") on clinician and staff preference for provision of addiction treatment in HIV clinics with on-site resources (all trained or designated on-site specialist) versus outside resources (outside specialist or refer out). METHODS: From July 2017 to July 2020, surveys assessed clinician and staff preferences for addiction treatment models during control (ie, baseline), intervention, evaluation, and maintenance phases in 4 HIV clinics in the Northeast United States. RESULTS: During the control phase, among 76 respondents (response rate, 58%), the proportions who preferred treatment with on-site resources for opioid use disorder (OUD), alcohol use disorder (AUD), and tobacco use disorder (TUD) were 63%, 55%, and 63%, respectively. Compared with control, there were no significant differences in preferred model during the intervention and evaluation phases except for AUD where there was an increased preference for treatment with on-site resources in the intervention versus control phase. Compared with control, during the maintenance phase, a higher proportion of clinicians and staff preferred providing addiction treatment with on-site resources versus outside resources: OUD, 75% (odds ratio [OR; 95% confidence interval {CI}], 1.79 [1.06-3.03]); AUD, 73% (OR [95% CI], 2.23 [1.36-3.65]), and TUD, 76% (OR [95% CI], 1.88 [1.11-3.18]). CONCLUSIONS: The findings from this study lend support for "Facilitation" as a strategy to enhance clinician and staff preference for integrated addiction treatment in HIV clinics with on-site resources.

Use of an Automated Bilingual Digital Health Tool to Reduce Unhealthy Alcohol Use Among Latino Emergency Department Patients: A Randomized Clinical Trial.

Importance: Alcohol use disorders have a high disease burden among US Latino groups. In this population, health disparities persist, and high-risk drinking has been increasing. Effective bilingual and culturally adapted brief interventions are needed to identify and reduce disease burden. Objective: To compare the effectiveness of an automated bilingual computerized alcohol screening and intervention (AB-CASI) digital health tool with standard care for the reduction of alcohol consumption among US adult Latino emergency department (ED) patients with unhealthy drinking. Design, Setting, and Participants: This bilingual unblinded parallel-group randomized clinical trial evaluated the effectiveness of AB-CASI vs standard care among 840 self-identified adult Latino ED patients with unhealthy drinking (representing the full spectrum of unhealthy drinking). The study was conducted from October 29, 2014, to May 1, 2020, at the ED of a large urban community tertiary care center in the northeastern US that was verified as a level II trauma center by the American College of Surgeons. Data were analyzed from May 14, 2020, to November 24, 2020. Intervention: Patients randomized to the intervention group received AB-CASI, which included alcohol screening and a structured interactive brief negotiated interview in their preferred language (English or Spanish) while in the ED. Patients randomized to the standard care group received standard emergency medical care, including an informational sheet with recommended primary care follow-up. Main Outcomes and Measures: The primary outcome was the self-reported number of binge drinking episodes within the last 28 days, assessed by the timeline followback method at 12 months after randomization. Results: Among 840 self-identified adult Latino ED patients (mean [SD] age, 36.2 [11.2] years; 433 [51.5%] male; and 697 [83.0%] of Puerto Rican descent), 418 were randomized to the AB-CASI group and 422 to the standard care group. A total of 443 patients (52.7%) chose Spanish as their preferred language at enrollment. At 12 months, the number of binge drinking episodes within the last 28 days was significantly lower in those receiving AB-CASI (3.2; 95% CI, 2.7-3.8) vs standard care (4.0; 95% CI, 3.4-4.7; relative difference [RD], 0.79; 95% CI, 0.64-0.99). Alcohol-related adverse health behaviors and consequences were similar between groups. The effect of AB-CASI was modified by age; at 12 months, the relative reduction in the number of binge drinking episodes within the last 28 days in the AB-CASI vs standard care group was 30% in participants older than 25 years (RD, 0.70; 95% CI, 0.54-0.89) compared with an increase of 40% in participants 25 years or younger (RD, 1.40; 95% CI, 0.85-2.31; P = .01 for interaction). Conclusions and Relevance: In this study, US adult Latino ED patients who received AB-CASI had a significant reduction in the number of binge drinking episodes within the last 28 days at 12 months after randomization. These findings suggest that AB-CASI is a viable brief intervention that overcomes known procedural barriers to ED screening, brief intervention, and referral to treatment and directly addresses alcohol-related health disparities. Trial Registration: ClinicalTrials.gov Identifier: NCT02247388.

Consistency between trials presented at conferences, their subsequent publications and press releases.

OBJECTIVE: This study examined the extent to which trials presented at major international medical conferences in 2016 consistently reported their study design, end points and results across conference abstracts, published article abstracts and press releases. DESIGN: Cross-sectional analysis of clinical trials presented at 12 major medical conferences in the USA in 2016. Conferences were identified from a list of the largest clinical research meetings aggregated by the Healthcare Convention and Exhibitors Association and were included if their abstracts were publicly available. From these conferences, all late-breaker clinical trials were included, as well as a random selection of all other clinical trials, such that the total sample included up to 25 trial abstracts per conference. MAIN OUTCOME MEASURES: First, it was determined if trials were registered and reported results in an International Committee of Medical Journal Editors-approved clinical trial registry. Second, it was determined if trial results were published in a peer-reviewed journal. Finally, information on trial media coverage and press releases was collected using LexisNexis. For all published trials, the consistency of reporting of the following characteristics was examined, through comparison of the trials' conference and publication abstracts: primary efficacy endpoint definition, safety endpoint identification, sample size, follow-up period, primary end point effect size and characterisation of trial results. For all published abstracts with press releases, the characterisation of trial results across conference abstracts, press releases and publications was compared. Authors determined consistency of reporting when identical information was presented across abstracts and press releases. Primary analyses were descriptive; secondary analyses included χ2 tests and multiple logistic regression. RESULTS: Among 240 clinical trials presented at 12 major medical conferences, 208 (86.7%) were registered, 95 (39.6%) reported summary results in a registry and 177 (73.8%) were published; 82 (34.2%) were covered by the media and 68 (28.3%) had press releases. Among the 177 published trials, 171 (96.6%) reported the definition of primary efficacy endpoints consistently across conference and publication abstracts, whereas 96/128 (75.0%) consistently identified safety endpoints. There were 107/172 (62.2%) trials with consistent sample sizes across conference and publication abstracts, 101/137 (73.7%) that reported their follow-up periods consistently, 92/175 (52.6%) that described their effect sizes consistently and 157/175 (89.7%) that characterised their results consistently. Among the trials that were published and had press releases, 32/32 (100%) characterised their results consistently across conference abstracts, press releases and publication abstracts. No trial characteristics were associated with reporting primary efficacy end points consistently. CONCLUSIONS: For clinical trials presented at major medical conferences, primary efficacy endpoint definitions were consistently reported and results were consistently characterised across conference abstracts, registry entries and publication abstracts; consistency rates were lower for sample sizes, follow-up periods, and effect size estimates. REGISTRATION: This study was registered at the Open Science Framework (https://doi.org/10.17605/OSF.IO/VGXZY).

Effect of Implementation Facilitation to Promote Adoption of Medications for Addiction Treatment in US HIV Clinics: A Randomized Clinical Trial.

Importance: Medications for addiction treatment (MAT) are inconsistently offered in HIV clinics. Objective: To evaluate the impact of implementation facilitation (hereafter referred to as "facilitation"), a multicomponent implementation strategy, on increasing provision of MAT for opioid use disorder (MOUD), alcohol use disorder (MAUD), and tobacco use disorder (MTUD). Design, Setting, and Participants: Conducted from July 26, 2016, through July 25, 2020, the Working with HIV Clinics to adopt Addiction Treatment using Implementation Facilitation (WHAT-IF?) study used an unblinded, stepped wedge design to sequentially assign each of 4 HIV clinics in the northeastern US to cross over from control (ie, baseline practices) to facilitation (ie, intervention) and then evaluation and maintenance periods every 6 months. Participants were adult patients with opioid, alcohol, or tobacco use disorder. Data analysis was performed from August 2020 to September 2022. Interventions: Multicomponent facilitation. Main Outcomes and Measures: Outcomes, assessed using electronic health record data, were provision of MAT among patients with opioid, alcohol, or tobacco use disorder during the evaluation (primary outcome) and maintenance periods compared with the control period. Results: Among 3647 patients, the mean (SD) age was 49 (12) years, 1814 (50%) were Black, 781 (22%) were Hispanic, and 1407 (39%) were female; 121 (3%) had opioid use disorder, 126 (3%) had alcohol use disorder, and 420 (12%) had tobacco use disorder. Compared with the control period, there was no increase in provision of MOUD with facilitation during the evaluation period (243 patients [27%; 95% CI, 22%-32%] vs 135 patients [28%; 95% CI, 22%-35%]; P = .59) or maintenance period (198 patients [29%; 95% CI, 22%-36%]; P = .48). The change in provision of MAUD from the control period to the evaluation period was not statistically significant (251 patients [8%; 95% CI, 5%-12%] vs 112 patients [13%; 95% CI, 8%-21%]; P = .11); however, the difference increased and became significant during the maintenance period (180 patients [17%; 95% CI, 12%-24%]; P = .009). There were significant increases in provision of MTUD with facilitation during both the evaluation (810 patients [33%; 95% CI, 30%-36%] vs 471 patients [40%; 95% CI, 36%-45%]; P = .005) and maintenance (643 patients [38%; 95% CI, 34%-41%]; P = .047) periods. Conclusions and Relevance: In this randomized clinical trial, facilitation led to increased provision of MTUD, delayed improvements in MAUD, and no improvements in MOUD in HIV clinics. Enhanced strategies, potentially including clinic and patient incentives, especially for MOUD, may be needed to further increase provision of MAT in HIV clinics. Trial Registration: ClinicalTrials.gov Identifier: NCT02907944.

LGBQ-affirmative cognitive-behavioral therapy for young gay and bisexual men's mental and sexual health: A three-arm randomized controlled trial.

OBJECTIVE: Effective Skills to Empower Effective Men (ESTEEM) represents the first intervention to address the psychological pathways through which minority stress undermines young sexual minority men's (SMM's) mental and sexual health using transdiagnostic cognitive-behavioral therapy. This study compared the efficacy of ESTEEM against two existing interventions. METHOD: Participants were young HIV-negative SMM (N = 254; ages = 18-35; 67.2% racial/ethnic minority) experiencing a depression, anxiety, and/or stress-/trauma-related disorder and past-90-day HIV transmission risk behavior. After completing HIV testing and counseling, participants were randomized to receive 10-session ESTEEM (n = 100); 10-session community-based LGBQ-affirmative counseling (n = 102); or only HIV testing and counseling (n = 52). RESULTS: For the primary outcome of any HIV transmission risk behavior at 8 months, ESTEEM was not significantly associated with greater reduction compared to HIV testing and counseling (risk ratio [RR] = 0.89, p = .52). Supportive analyses of the frequency of HIV transmission risk behavior at 8 months showed a nonsignificant difference between ESTEEM compared to HIV testing and counseling (RR = 0.69) and LGBQ-affirmative counseling (RR = 0.62). For secondary outcomes (e.g., depression, anxiety, substance use, suicidality, number of mental health diagnoses) at 8 months, ESTEEM had a larger effect size than the two comparison conditions, but these comparisons did not reach statistical significance when adjusting for the false discovery rate. Observed effect sizes for condition comparisons were smaller than the effect sizes used to power the study. In exploratory analyses, ESTEEM showed promise for reducing comorbidity. CONCLUSIONS: Because the control conditions were associated with stronger effects than anticipated, and given the heterogeneous nature of transdiagnostic outcomes, the study possessed insufficient power to statistically detect the consistently small-to-moderate benefit of ESTEEM compared to the two control conditions. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Social science research to inform solar geoengineering.

What are the benefits and drawbacks, and for whom?.

Antimicrobial Stewardship Optimization in the Emergency Department: The Effect of Multiplex Respiratory Pathogen Testing and Targeted Educational Intervention.

BACKGROUND: Antibacterial agents are often prescribed for patients with suspected respiratory tract infections even though these are most often caused by viruses. In this study, we sought to evaluate the effect of Respiratory Pathogen Panel (RPP) PCR result availability and antimicrobial stewardship education on antibiotic prescription rates in the adult emergency department (ED). METHODS: We compared rates of antibacterial and oseltamivir prescriptions between 2 nonconsecutive influenza seasons among ED visits, wherein the latter season followed the implementation of a comprehensive educational stewardship campaign. In addition, we sought to elucidate the effect of RPP-PCR on antibiotic prescriptions, with focus on result availability prior to the conclusion of emergency department encounters. RESULTS: Antibiotic prescription rates globally decreased by 17.9% in the FS-17/18 cohort compared to FS-14/15 (P < 0.001), while oseltamivir prescription rates stayed the same overall (P = 0.42). Multivariate regression across both cohorts revealed that patients were less likely to receive antibiotics if RPP-PCR results were available before the end of the ED visit or if the RPP-PCR result was positive for influenza. Patients in the educational intervention cohort were also less likely to receive an antibiotic prescription. CONCLUSION: This study provides evidence that RPP-PCR results are most helpful if available prior to the end of the provider-patient interaction. Further, these data suggest that detection of influenza remains an influential result in the context of antimicrobial treatment decision making. In addition, these data contribute to the body of literature which supports comprehensive ASP interventions including leadership and patient engagement.

Exenatide extended release in patients with type 1 diabetes with and without residual insulin production.

AIMS: To test whether a long-acting GLP-1 receptor agonist would improve glucose control in patients with type 1 diabetes (T1D) and to determine whether the presence of residual beta cell function would affect the response. In addition, we sought to determine whether the drug would affect beta cell function. METHODS: We performed a randomized placebo-controlled trial of exenatide extended release (ER) in participants with T1D with and without detectable levels of C-peptide. Seventy-nine participants were randomized to exenatide ER 2 mcg weekly, or placebo, stratified by the presence or absence of detectable C-peptide levels. The primary outcome was the difference in glycated haemoglobin (HbA1c) levels at 24 weeks. Participants were followed for another 6 months off study drug. RESULTS: At week 24, the time of the primary outcome, the least squares (LS) mean HbA1c level was 7.76% (95% confidence interval [CI] 7.42, 8.10) in the exenatide ER group versus 8.0% (95% CI 7.64, 8.35) in the placebo group (P = 0.08). At week 12 the LS mean HbA1c levels were 7.71% (95% CI 7.37, 8.05) in the exenatide ER group versus 8.05% (95% CI 7.7, 8.4) in the placebo group (P = 0.01). The improvement at week 12 was driven mainly by those with detectable levels of C-peptide. Those treated with exenatide ER lost weight at 12 and 24 weeks compared to those treated with placebo (P <0.001 and P = 0.007). The total insulin dose was lower, but not when corrected for body weight, and was not affected by residual insulin production. Adverse events were more frequent with exenatide ER, but hypoglycaemia was not increased. CONCLUSION: Treatment with exenatide ER may have short-term benefits in some individuals with T1D who are overweight or who have detectable levels of C-peptide, but short-term improvements were not sustained.

Quality and Publication of Emergency Medicine Trials Registered in ClinicalTrials.gov

INTRODUCTION: Promoting emergency medicine (EM) clinical trials research remains a priority. To characterize the status of clinical EM research, this study assessed trial quality, funding source, and publication of EM clinical trials and compared EM and non-EM trials on these key metrics. We also examined the volume of EM trials and their subspecialty areas. METHODS: We abstracted data from ClinicalTrials.gov (February 2000 - September 2013) and used individual study National Clinical Trial numbers to identify published trials (January 2007 - September 2016). We used descriptive statistics and chi-square tests to examine study characteristics by EM and non-EM status, and Kaplan-Meier curves and log-rank tests to compare time to publication of completed EM and non-EM studies. RESULTS: We found 638 interventional EM trials and 59,512 non-EM interventional trials conducted in the United States between February 2000 and September 2013, registered on ClinicalTrials.gov. EM studies were significantly less likely than non-EM studies to be National Institutes of Health-funded or to evaluate a drug or biologic. However, EM studies had significantly larger sample sizes, and were significantly more likely to use randomization and blinding. Overall, 34.3% of EM and 26.0% of non-EM studies were published in peer-reviewed journals. By subspecialty, more EM trials concerned medical/surgical and psychiatric/neurological conditions than trauma. CONCLUSION: Although EM studies were less likely to have received federal or industry funding, and the EM portfolio consisted of only 638 trials over the 14-year study period, the quality of EM trials surpassed that of non-EM trials, based on indices such as randomization and blinding. This novel finding bodes well for the future of clinical EM research, as does the higher proportion of published EM than non-EM trials. Our study also revealed that trauma studies were under-represented among EM studies. Periodic assessment of EM trials with the metrics used here could provide an informative and valuable longitudinal view of progress in clinical EM research.

Crowdsourcing hypothesis tests: Making transparent how design choices shape research results.

To what extent are research results influenced by subjective decisions that scientists make as they design studies? Fifteen research teams independently designed studies to answer five original research questions related to moral judgments, negotiations, and implicit cognition. Participants from 2 separate large samples (total N > 15,000) were then randomly assigned to complete 1 version of each study. Effect sizes varied dramatically across different sets of materials designed to test the same hypothesis: Materials from different teams rendered statistically significant effects in opposite directions for 4 of 5 hypotheses, with the narrowest range in estimates being d = -0.37 to + 0.26. Meta-analysis and a Bayesian perspective on the results revealed overall support for 2 hypotheses and a lack of support for 3 hypotheses. Overall, practically none of the variability in effect sizes was attributable to the skill of the research team in designing materials, whereas considerable variability was attributable to the hypothesis being tested. In a forecasting survey, predictions of other scientists were significantly correlated with study results, both across and within hypotheses. Crowdsourced testing of research hypotheses helps reveal the true consistency of empirical support for a scientific claim. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Solar geoengineering to reduce climate change: a review of governance proposals.

Although solar geoengineering (alternatively 'solar radiation management' or 'solar radiation modification') appears to offer a potentially effective, inexpensive and technologically feasible additional response to climate change, it would pose serious physical risks and social challenges. Governance of its research, development and deployment is thus salient. This article reviews proposals for governing solar geoengineering. Its research may warrant dedicated governance to facilitate effectiveness and to reduce direct and socially mediated risks. Because states are not substantially engaging with solar geoengineering, non-state actors can play important governance roles. Although the concern that solar geoengineering would harmfully lessen abatement of greenhouse gas emissions is widespread, what can be done to reduce such displacement remains unclear. A moratorium on outdoor activities that would surpass certain scales is often endorsed, but an effective one would require resolving some critical, difficult details. In the long term, how to legitimately make decisions regarding whether, when and how solar geoengineering would be used is central, and suggestions how to do so diverge. Most proposals to govern commercial actors, who could provide goods and services for solar geoengineering, focus on intellectual property policy. Compensation for possible harm from outdoor activities could be through liability or a compensation fund. The review closes with suggested lines of future inquiry.

Project ESTEEM protocol: a randomized controlled trial of an LGBTQ-affirmative treatment for young adult sexual minority men's mental and sexual health.

BACKGROUND: Young gay and bisexual men disproportionately experience depression, anxiety, and substance use problems and are among the highest risk group for HIV infection in the U.S. Diverse methods locate the source of these health disparities in young gay and bisexual men's exposure to minority stress. In fact, minority stress, psychiatric morbidity, substance use, and HIV risk fuel each other, forming a synergistic threat to young gay and bisexual men's health. Yet no known intervention addresses minority stress to improve mental health, substance use problems, or their joint impact on HIV risk in this population. This paper describes the design of a study to test the efficacy of such an intervention, called ESTEEM (Effective Skills to Empower Effective Men), a 10-session skills-building intervention designed to reduce young gay and bisexual men's co-occurring health risks by addressing the underlying cognitive, affective, and behavioral pathways through which minority stress impairs health. METHODS: This study, funded by the National Institute of Mental Health, is a three-arm randomized controlled trial to examine (1) the efficacy of ESTEEM compared to community mental health treatment and HIV counseling and testing and (2) whether ESTEEM works through its hypothesized cognitive, affective, and behavioral minority stress processes. Our primary outcome, measured 8 months after baseline, is condomless anal sex in the absence of PrEP or known undetectable viral load of HIV+ primary partners. Secondary outcomes include depression, anxiety, substance use, sexual compulsivity, and PrEP uptake, also measured 8 months after baseline. DISCUSSION: Delivering specific stand-alone treatments for specific mental, behavioral, and sexual health problems represents the current state of evidence-based practice. However, dissemination and implementation of this one treatment-one problem approach has not been ideal. A single intervention that reduces young gay and bisexual men's depression, anxiety, substance use, and HIV risk by reducing the common minority stress pathways across these problems would represent an efficient, cost-effective alternative to currently isolated approaches, and holds great promise for reducing sexual orientation health disparities among young men. TRIAL REGISTRATION: Registered October 10, 2016 to ClinicalTrials.gov Identifier: NCT02929069 .

Optimization of Turnaround Time for Group A Streptococcus PCR.

The use of some nucleic acid amplification tests (NAATs) for the diagnosis of group A Streptococcus (GAS) pharyngitis allows laboratories to adopt single-tiered testing without reflex culture. However, centralization may delay the delivery of actionable information to the bedside, particularly in the outpatient setting. We describe two novel workflows at our institution and their effect on in-lab turnaround time (TAT) at a tertiary care microbiology lab. Laboratory records were extracted, and relevant data were analyzed after the implementation of qualitative in vitro diagnostic testing for GAS with the Xpert Xpress Strep A assay, performed using the GeneXpert Infinity-48s. Workflow optimization steps studied included: (i) direct specimen submission to the microbiology laboratory via the pneumatic tube system and (ii) autoverification of GAS NAAT results in the laboratory information system. Between April 2018 and October 2018, 2,595 unique specimens were tested for GAS by PCR. Of these, 2,523 were included in the final analysis. Linear regression established that the total in-lab TAT was significantly reduced by direct specimen submission to the microbiology laboratory, autoverification, and processing during the night shift. We describe two workflow optimization methods that reduced the in-lab TAT for GAS NAAT. Although microbiology labs historically use manual processes, the advent of total laboratory automation and the adoption of on-demand NAATs will allow for more streamlined processing of microbiology specimens. It may be beneficial to consider instrument interfacing and specimen processing optimization during the early phases of implementation planning for NAATs in the microbiology laboratory.

Statin therapy associated with improved thrombus resolution in patients with deep vein thrombosis.

OBJECTIVE: Statin therapy has been associated with a decreased incidence of venous thromboembolism (VTE) in clinical trials and enhanced thrombus resolution in animal models. The effect of statins on thrombus resolution has not been reported clinically. This study investigates the association of statins with thrombus resolution or improvement in patients with deep venous thrombosis (DVT). METHODS: A retrospective study of the electronic medical records of consecutive adult patients presenting with lower extremity DVT was performed. Patients were divided into two groups based on statin therapy (statin group) or lack thereof (nonstatin group). The two groups were compared with respect to demographics, comorbidities, and risk factors for VTE. Initial as well as all subsequent ultrasound reports were reviewed for each patient to determine extent of DVT and subsequent change in thrombus characteristics. Long-term outcomes examined were mortality, VTE recurrence, and thrombus improvement or resolution on follow-up ultrasound examination. Multivariable analysis was used to determine independent predictors of thrombus resolution or improvement, VTE recurrence, and mortality. RESULTS: A total of 818 patients with DVT were identified (statin group, n = 279 [34%]; nonstatin group, n = 539 [66%]). The patients in the statin group were significantly older (P < .001). Patients on statins were more likely to have risk factors for and manifestations of atherosclerosis and to be on antiplatelet therapy (P < .001), whereas those in the nonstatin group were more likely to have a hypercoagulable disorder (P = .009) or prior DVT (P = .033). There was no significant difference in provoked DVT, extent of DVT, or association with pulmonary embolism (PE), but patients on statins were more likely to have high-risk PE (P = .046). There was no difference in patients receiving anticoagulation, type and duration of anticoagulation, inferior vena cava filter placement, or treatment with lytic therapy. There was no difference in thrombus resolution, mortality, or recurrence of DVT, PE, or VTE between the groups. On multivariable analysis, age, proximal DVT, CAD, and cancer were associated with higher mortality, whereas anticoagulation with coumadin and direct oral anticoagulants and antiplatelet therapy were associated with lower mortality. Statin therapy, antiplatelet therapy, and younger age were associated with thrombus resolution or improvement. CONCLUSIONS: Statin therapy is associated with greater thrombus resolution or improvement in patients with DVT. However, statin therapy in this study was not associated with different clinical outcomes of VTE recurrence or mortality.

Clinical trial registration and reporting: a survey of academic organizations in the United States.

BACKGROUND: Many clinical trials conducted by academic organizations are not published, or are not published completely. Following the US Food and Drug Administration Amendments Act of 2007, "The Final Rule" (compliance date April 18, 2017) and a National Institutes of Health policy clarified and expanded trial registration and results reporting requirements. We sought to identify policies, procedures, and resources to support trial registration and reporting at academic organizations. METHODS: We conducted an online survey from November 21, 2016 to March 1, 2017, before organizations were expected to comply with The Final Rule. We included active Protocol Registration and Results System (PRS) accounts classified by ClinicalTrials.gov as a "University/Organization" in the USA. PRS administrators manage information on ClinicalTrials.gov. We invited one PRS administrator to complete the survey for each organization account, which was the unit of analysis. RESULTS: Eligible organization accounts (N = 783) included 47,701 records (e.g., studies) in August 2016. Participating organizations (366/783; 47%) included 40,351/47,701 (85%) records. Compared with other organizations, Clinical and Translational Science Award (CTSA) holders, cancer centers, and large organizations were more likely to participate. A minority of accounts have a registration (156/366; 43%) or results reporting policy (129/366; 35%). Of those with policies, 15/156 (11%) and 49/156 (35%) reported that trials must be registered before institutional review board approval is granted or before beginning enrollment, respectively. Few organizations use computer software to monitor compliance (68/366; 19%). One organization had penalized an investigator for non-compliance. Among the 287/366 (78%) accounts reporting that they allocate staff to fulfill ClinicalTrials.gov registration and reporting requirements, the median number of full-time equivalent staff is 0.08 (interquartile range = 0.02-0.25). Because of non-response and social desirability, this could be a "best case" scenario. CONCLUSIONS: Before the compliance date for The Final Rule, some academic organizations had policies and resources that facilitate clinical trial registration and reporting. Most organizations appear to be unprepared to meet the new requirements. Organizations could enact the following: adopt policies that require trial registration and reporting, allocate resources (e.g., staff, software) to support registration and reporting, and ensure there are consequences for investigators who do not follow standards for clinical research.

Evaluation of a novel 5-group classification system of sepsis by vasopressor use and initial serum lactate in the emergency department.

Prognostication in sepsis is limited by disease heterogeneity, and measures to risk-stratify patients in the proximal phases of care lack simplicity and accuracy. Hyperlactatemia and vasopressor dependence are easily identifiable risk factors for poor outcomes. This study compares incidence and hospital outcomes in sepsis based on initial serum lactate level and vasopressor use in the emergency department (ED). In a retrospective analysis of a prospectively identified dual-center ED registry, patients with sepsis were categorized by ED vasopressor use and initial serum lactate level. Vasopressor-dependent patients were categorized as dysoxic shock (lactate >4.0 mmol/L) and vasoplegic shock (≤4.0 mmol/L). Patients not requiring vasopressors were categorized as cryptic shock major (lactate >4.0 mmol/L), cryptic shock minor (>2.0 and ≤4.0 mmol/L), and sepsis without lactate elevation (≤2.0 mmol/L). Of 446 patients included, 4.9% (n = 22) presented in dysoxic shock, 11.7% (n = 52) in vasoplegic shock, 12.1% (n = 54) in cryptic shock major, 30.9% (n = 138) in cryptic shock minor, and 40.4% (n = 180) in sepsis without lactate elevation. Group mortality rates at 28 days were 50.0, 21.1, 18.5, 12.3, and 7.2%, respectively. After adjusting for potential confounders, odds ratios for mortality at 28 days were 15.1 for dysoxic shock, 3.6 for vasoplegic shock, 3.8 for cryptic shock major, and 1.9 for cryptic shock minor, when compared to sepsis without lactate elevation. Lactate elevation is associated with increased mortality in both vasopressor dependent and normotensive infected patients presenting to the emergency department (ED). Cryptic shock mortality (normotension + lactate >4 mmol/L) is equivalent to vasoplegic shock mortality (vasopressor requirement + lactate <4 mmol/L) in our population. The odds of normotensive, infected patients decompensating is three to fourfold higher with hyperlactemia. The proposed Sepsis-3 definitions exclude an entire group of high-risk ED patients. A simple classification in the ED by vasopressor requirement and initial lactate level may identify high-risk subgroups of sepsis. This study may inform prognostication and triage decisions in the proximal phases of care.

Characteristics of provoked deep venous thrombosis in a tertiary care center.

OBJECTIVE: Provoked deep venous thrombosis (DVT) is precipitated by a specific event. This paper compares the characteristics of provoked DVT in patients with transient risk (TR) factors and patients with continuous risk (CR) factors. METHODS: A retrospective review of records of all consecutive patients diagnosed with DVT between January 2013 and August 2014 was performed. Patients with provoked DVT were included in the TR group if the provoking event resolved in 2 weeks and they did not have ongoing risk of thrombosis. Patients in the CR group had a provoked DVT with ongoing risk of thrombosis due to individual factors deemed to be ongoing risks of thrombosis, such as cancer, hypercoagulable disorder, and prolonged immobilization. Demographics, risk factors, association with pulmonary embolism (PE) and its severity, risk of recurrent venous thromboembolism (VTE), and mortality were compared between the two groups. RESULTS: A total of 838 patients were diagnosed with DVT, and 50.7% (425) were provoked. There were 127 (29.9%) patients with TR and 298 (70.1%) with CR. TR patients were younger (60.4 ± 16.3 vs 65.9 ± 16.0; P = .001). TR was more likely to be provoked by surgery (70.9% vs 55.4%; P = .003), whereas CR was more likely to be provoked by immobilization (21.5% vs 12.6%; P = .032). CR patients were affected by cancer (48.7%) and hypercoagulable disorders (4.4%). TR patients were more likely to have calf DVTs (36.2% vs 26.2%; P = .047). There was a trend toward lower association with PE on presentation in TR (17.3% vs 21.1%; P = .072), but that did not reach statistical significance. However, TR factors were more likely to be associated with low-risk PE compared with CR factors (30.2% vs 54.6%; P = .040). After mean follow-up of 7.2 months, CR had higher risk of recurrent VTE (14.0% vs 6.8%; P = .045) and mortality (23.5% vs 7.1%; P < .0001). CONCLUSIONS: Provoked DVT with CR factors affects older patients and is associated with high recurrence of VTE and mortality compared with provoked DVT with TR factors.

Advancing School and Community Engagement Now for Disease Prevention (ASCEND).

PURPOSE: To compare two intensity levels (standard vs. enhanced) of a nutrition and physical activity intervention vs. a control (usual programs) on nutrition knowledge, body mass index, fitness, academic performance, behavior, and medication use among elementary school students. DESIGN: Quasi-experimental with three arms. SETTING: Elementary schools, students' homes, and a supermarket. SUBJECTS: A total of 1487 third-grade students. INTERVENTION: The standard intervention (SI) provided daily physical activity in classrooms and a program on making healthful foods, using food labels. The enhanced intervention (EI) provided these plus additional components for students and their families. MEASURES: Body mass index (zBMI), food label literacy, physical fitness, academic performance, behavior, and medication use for asthma or attention-deficit hyperactivity disorder (ADHD). ANALYSIS: Multivariable generalized linear model and logistic regression to assess change in outcome measures. RESULTS: Both the SI and EI groups gained less weight than the control (p < .001), but zBMI did not differ between groups (p = 1.00). There were no apparent effects on physical fitness or academic performance. Both intervention groups improved significantly but similarly in food label literacy (p = .36). Asthma medication use was reduced significantly in the SI group, and nonsignificantly (p = .10) in the EI group. Use of ADHD medication remained unchanged (p = .34). CONCLUSION: The standard intervention may improve food label literacy and reduce asthma medication use in elementary school children, but an enhanced version provides no further benefit.

Neuropsychological Impairment in Acute HIV and the Effect of Immediate Antiretroviral Therapy.

OBJECTIVE: To investigate neuropsychological performance (NP) during acute HIV infection (AHI) before and after combination antiretroviral therapy (cART). DESIGN: Prospective study of Thai AHI participants examined at 3 and 6 months after initiation of cART. METHODS: Thirty-six AHI participants were evaluated pre-cART at median 19 days since HIV exposure and 3 and 6 months after cART with the Grooved Pegboard test, Color Trails 1 & 2 (CT1, CT2), and Trail Making Test A. Raw scores were standardized to 251 age- and education-matched HIV-uninfected Thais. To account for learning effects, change in NP performance was compared with that of controls at 6 months. Analyses included multivariable regression, nonparametric repeated measures analysis of variance, and Mann-Whitney U test. RESULTS: Baseline NP scores for the AHI group were within normal range (z-scores range: -0.26 to -0.13). NP performance improved on CT1, CT2, and Trail Making Test A in the initial 3 months (P < 0.01) with no significant change during the last 3 months. Only improvement in CT1 was greater than that seen in controls at 6 months (P = 0.018). Participants who performed >1 SD below normative means on ≥2 tests (n = 8) exhibited higher baseline cerebrospinal fluid HIV RNA (P = 0.047) and had no improvement after cART. CONCLUSIONS: Most AHI individuals had normal NP performance, and early cART slightly improved their psychomotor function. However, approximately 25% had impaired NP performance, which correlated with higher cerebrospinal fluid HIV RNA, and these abnormalities were not reversed by early cART possibly indicating limited reversibility of cognitive impairment in a subset of AHI individuals.