Age-Dependent Heterogeneity in the Efficacy of Prophylaxis With Enoxaparin Against Catheter-Associated Thrombosis in Critically Ill Children: A Post Hoc Analysis of a Bayesian Phase 2b Randomized Clinical Trial.

OBJECTIVES: We explored the age-dependent heterogeneity in the efficacy of prophylaxis with enoxaparin against central venous catheter-associated deep venous thrombosis in critically ill children. DESIGN: Post hoc analysis of a Bayesian phase 2b randomized clinical trial. SETTING: Seven PICUs. PATIENTS: Children less than 18 years old with newly inserted central venous catheter. INTERVENTIONS: Enoxaparin started less than 24 hours after insertion of central venous catheter and adjusted to anti-Xa level of 0.2-0.5 international units/mL versus usual care. MEASUREMENTS AND MAIN RESULTS: Of 51 children randomized, 24 were infants less than 1 year old. Risk ratios of central venous catheter-associated deep venous thrombosis with prophylaxis with enoxaparin were 0.98 (95% credible interval, 0.37-2.44) in infants and 0.24 (95% credible interval, 0.04-0.82) in older children greater than or equal to 1 year old. Infants and older children achieved anti-Xa level greater than or equal to 0.2 international units/mL at comparable times. While central venous catheter was in situ, endogenous thrombin potential, a measure of thrombin generation, was 223.21 nM.min (95% CI, 8.78-437.64 nM.min) lower in infants. Factor VIII activity, a driver of thrombin generation, was also lower in infants by 45.1% (95% CI, 15.7-74.4%). Median minimum platelet count while central venous catheter was in situ was higher in infants by 39 × 103/mm3 (interquartile range, 17-61 × 103/mm3). Central venous catheter:vein ratio was not statistically different. Prophylaxis with enoxaparin was less efficacious against central venous catheter-associated deep venous thrombosis at lower factor VIII activity and at higher platelet count. CONCLUSIONS: The relatively lesser contribution of thrombin generation on central venous catheter-associated thrombus formation in critically ill infants potentially explains the age-dependent heterogeneity in the efficacy of prophylaxis with enoxaparin.

Efficacy of Early Prophylaxis Against Catheter-Associated Thrombosis in Critically Ill Children: A Bayesian Phase 2b Randomized Clinical Trial.

OBJECTIVES: We obtained preliminary evidence on the efficacy of early prophylaxis on the risk of central venous catheter-associated deep venous thrombosis and its effect on thrombin generation in critically ill children. DESIGN: Bayesian phase 2b randomized clinical trial. SETTING: Seven PICUs. PATIENTS: Children less than 18 years old with a newly inserted central venous catheter and at low risk of bleeding. INTERVENTION: Enoxaparin adjusted to anti-Xa level of 0.2-0.5 international units/mL started at less than 24 hours after insertion of central venous catheter (enoxaparin arm) versus usual care without placebo (usual care arm). MEASUREMENTS AND MAIN RESULTS: At the interim analysis, the proportion of central venous catheter-associated deep venous thrombosis on ultrasonography in the usual care arm, which was 54.2% of 24 children, was significantly higher than that previously reported. This resulted in misspecification of the preapproved Bayesian analysis, reversal of direction of treatment effect, and early termination of the randomized clinical trial. Nevertheless, with 30.4% of 23 children with central venous catheter-associated deep venous thrombosis on ultrasonography in the enoxaparin arm, risk ratio of central venous catheter-associated deep venous thrombosis was 0.55 (95% credible interval, 0.24-1.11). Including children without ultrasonography, clinically relevant central venous catheter-associated deep venous thrombosis developed in one of 27 children (3.7%) in the enoxaparin arm and seven of 24 (29.2%) in the usual care arm (p = 0.02). Clinically relevant bleeding developed in one child randomized to the enoxaparin arm. Response profile of endogenous thrombin potential, a measure of thrombin generation, was not statistically different between trial arms. CONCLUSIONS: These findings suggest the efficacy and safety of early prophylaxis that should be validated in a pivotal randomized clinical trial.

Resection of Cavity Shave Margins in Stage 0-III Breast Cancer Patients Undergoing Breast Conserving Surgery: A Prospective Multicenter Randomized Controlled Trial.

OBJECTIVE: Single-center studies have demonstrated that resection of cavity shave margins (CSM) halves the rate of positive margins and re-excision in breast cancer patients undergoing partial mastectomy (PM). We sought to determine if these findings were externally generalizable across practice settings. METHODS: In this multicenter randomized controlled trial occurring in 9 centers across the United States, stage 0-III breast cancer patients undergoing PM were randomly assigned to either have resection of CSM ("shave" group) or not ("no shave" group). Randomization occurred intraoperatively, after the surgeon had completed their standard PM. Primary outcome measures were positive margin and re-excision rates. RESULTS: Between July 28, 2016 and April 13, 2018, 400 patients were enrolled in this trial. Four patients (2 in each arm) did not meet inclusion criteria after randomization, leaving 396 patients for analysis: 196 in the "shave" group and 200 to the "no shave" group. Median patient age was 65 years (range; 29-94). Groups were well matched at baseline for demographic and clinicopathologic factors. Prior to randomization, positive margin rates were similar in the "shave" and "no shave" groups (76/196 (38.8%) vs. 72/200 (36.0%), respectively, P = 0.604). After randomization, those in the "shave" group were significantly less likely than those in the "no shave" group to have positive margins (19/196 (9.7%) vs. 72/200 (36.0%), P < 0.001), and to require re-excision or mastectomy for margin clearance (17/196 (8.7%) vs. 47/200 (23.5%), P < 0.001). CONCLUSION: Resection of CSM significantly reduces positive margin and re-excision rates in patients undergoing PM.

The Researcher-Practitioner Partnership Study (RPPS): Experiences From Criminal Justice System Collaborations Studying Violence Against Women.

The benefits of researcher-practitioner (R-P) collaborations focused on violence against women (VAW) are many. Such projects support researchers and practitioners working together to create uniquely comprehensive projects that have the potential to change practices, policies, and services. Extant literature is limited in that it has (a) focused on the experiences of a very limited number of collaborations, (b) ignored collaborations conducted in the context of the criminal justice system, and (c) excluded as a focus the products that result from the collaborations and their dissemination. Therefore, the goal of this qualitative study is to identify the essential elements to consider for successful R-P collaborations on VAW research in the criminal justice system.

Relationship self-efficacy protects against mental health problems among women in bidirectionally aggressive intimate relationships with men.

Research examining predictors or correlates of mental health problems among women who experience or use aggression in intimate relationships typically assesses factors that confer risk. Such research has primarily examined intimate partner violence (IPV) victimization or aggression frequency or severity as central risk factors for mental health problems. In the general population, one factor demonstrating a protective effect on mental health problems is self-efficacy. Research on self-efficacy among women who experience or use aggression in intimate relationships is nearly absent. The purpose of this study was to determine if self-efficacy specific to a woman's ability to manage various relationship problems (i.e., relationship self-efficacy [RSE]) played a protective role against the severity of posttraumatic stress, depression, and anxiety symptoms among 354 community-residing women who were victimized and used aggression (bidirectional IPV). Regression analyses found that RSE uniquely predicted each mental health outcome above and beyond what was accounted for by the frequency of physical, sexual, and psychological victimization and aggression. Further, RSE fully mediated the relationships between psychological victimization and each mental health outcome. If replicated, and in circumstances where it is determined safe to do so, findings suggest RSE as a promising avenue for future research to improve the health and well-being of women in bidirectionally aggressive relationships.

IS IT THE EXCEPTION OR THE RULE? DAILY CO-OCCURRENCE OF PHYSICAL, SEXUAL, AND PSYCHOLOGICAL PARTNER VIOLENCE IN A 90-DAY STUDY OF SUBSTANCE-USING, COMMUNITY WOMEN.

OBJECTIVE: This study aims to describe the daily co-occurrence of physical, sexual, and psychological intimate partner violence (IPV) among substance-using, community-based women currently experiencing IPV. METHODS: A micro-longitudinal study design was used to collect data daily from 49 women for 90 days. RESULTS: On the majority of days (62%), no IPV occurred; 27% of days were characterized by psychological IPV alone, followed by the co-occurrence of psychological and physical IPV (6% of IPV days). Results of person-level analyses showed comparable sized correlations between the proportion of days with physical and sexual IPV and the proportion of days with physical and psychological IPV. However, results of day-level analyses revealed that the association between physical and psychological IPV was much stronger than the association between physical and sexual IPV; Physical IPV was 64 times more likely to occur on days when psychological IPV occurred. CONCLUSIONS: Results revealed new information about physical, sexual, and psychological IPV experiences and demonstrate the utility of a micro-longitudinal design among this high risk population. Implications for practice, future research, and the development of preventive interventions are noted, underscoring the importance of psychological IPV and the range of IPV experiences among women.

Men's perceptions and knowledge of human papillomavirus (HPV) infection and cervical cancer.

The authors assessed young men's knowledge and perceptions of genital human papillomavirus (HPV) infection to identify factors that predict intention to make positive behavioral changes. Male university students aged 18 to 25 years completed a self-report instrument to assess knowledge and perceptions of genital HPV infection. If diagnosed with HPV, most men (95%) reported that they would use condoms with new partners. The intention to reduce number of sex partners was associated with an understanding that HPV may have severe consequences for women, whereas intention to encourage female sex partners to undergo Pap smear screening was associated with increased general knowledge of HPV infection. The authors concluded that it is important to include men in HPV education and prevention efforts, especially within the context that HPV may lead to cervical cancer in female partners.