Evaluation of the effectiveness and safety of oral vancomycin versus placebo in the prevention of recurrence of Clostridioides difficile infection in patients under systemic antibiotic therapy: a phase III, randomised, double-blind clinical trial.

INTRODUCTION: Clostridioides difficile infection (CDI) is the most prevalent cause of nosocomial bacterial diarrhoea and it is strongly associated with antibiotic use. The recurrence of CDI is a growing medical problem. Data from real-life studies and one open label randomised clinical trial (RCT) suggest that secondary prophylaxis with oral vancomycin (SPV) during subsequent courses of systemic antibiotics is a promising approach for reducing the risk of CDI recurrence. Our aim is to confirm the role of SPV through a double-blind RCT. METHODS AND ANALYSIS: We will perform a phase III, multicentre, placebo-controlled RCT (PREVAN trial) in a 2:1 ratio in favour of SPV (experimental treatment), in four tertiary care hospitals in Spain. Adult patients (≥18 years) with a previous history of CDI in the previous 180 days and with requirement for hospitalisation and systemic antibiotic therapy will be randomly allocated to receive either 125 mg of oral vancomycin or placebo every 6 hours for 10 days. Patients will be followed for 60 days after the end of treatment to verify a reduction in the rate of CDI recurrence in the experimental group. We assume a recurrence rate of 5% in the experimental group versus 25% in the placebo group. Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a two-sided test, 104 subjects will be required in total (68 assigned to the SPV group and 34 to the placebo group). ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Ethic Committee for Research with medicinal products of the University Hospital '12 de Octubre' (AC069/18) and from the Spanish Medicines and Healthcare Product Regulatory Agency (AEMPS, AC069/18), which is valid for all participating centres under existing Spanish legislation. The results will be presented at international meetings and will be made available to patients and funders. TRIAL REGISTRATION NUMBER: NCT05320068.

Brief Report: Participation of Black and African-American Families in Autism Research.

Black and African-American families are underrepresented in research on autism spectrum disorder (ASD) and few studies have explored how to increase their involvement. To address this gap in the literature, this study explored the perspectives of 22 Black families raising children with ASD in order to identify facilitators and barriers to research participation; as well as suggestions to increase their involvement in ASD studies. Facilitators to research involvement included a desire to contribute to ASD research inclusive of Black families; to seek information and support for child and/or caregiver; and, to engage with culturally responsive research team members. Barriers to research involvement included stigma; denial, shame, and/or embarrassment; distrust of the research process; lack of time/interest; and research material inaccessibility or literacy issues.

The Relationship Between Children's Exposure to Intimate Partner Violence and Intellectual and Developmental Disabilities: A Systematic Review of the Literature.

Children exposed to intimate partner violence (IPV) can experience negative social, emotional, behavioral, and academic outcomes. A growing body of research has examined the relationship between intellectual and developmental disabilities (IDD) and IPV exposure. We systematically reviewed the literature for research exploring this relationship and found a limited number of studies meeting inclusion criteria ( N = 11). Over half (64%) identified a significant relationship between IPV and IDD, although the cross-sectional methodologies of the majority of studies (82%) prevented the ability to ascertain directionality. Further, the studies defined and measured IPV and IDD in various ways. Some studies were limited by poor external validity and small sample sizes. More research is needed to understand the intersection between IPV exposure and IDD.

"We Had to Keep Pushing": Caregivers' Perspectives on Autism Screening and Referral Practices of Black Children in Primary Care.

Black children with autism spectrum disorder (ASD) are diagnosed later than their White peers, are more likely to be misdiagnosed, and are less likely to receive early intervention services or a developmental evaluation by three years old. Using a grounded theory approach, we solicited the perspectives of parents and other primary caregivers of Black children with ASD on barriers and facilitators to ASD screening and referrals in primary care. A socioeconomically diverse sample of 22 female caregivers participated. Four themes emerged. First, while some caregivers noted their child's primary healthcare providers facilitated a timely ASD diagnosis, other participants reported these providers ignored early concerns about child developmental delays. Second, many participants felt racial bias negatively impacted caregiver-primary healthcare provider interactions. Third, legal/custodial issues slowed caregivers' abilities to follow up on referrals from their primary healthcare providers. Finally, caregivers described denial, shame, and stigma relating to ASD in the Black community as possible factors for delayed follow up to referrals. Differences based on socioeconomic status are discussed. Efforts to improve family-centered, culturally relevant care for all Black caregivers raising children with or at-risk for ASD are needed, particularly for those families experiencing the multiple effects of poverty.

Interventions for Posttraumatic Stress With Children Exposed to Violence: Factors Associated With Treatment Success.

BACKGROUND: In the past 15 years, there have been a substantial number of rigorous studies examining the effectiveness of various treatments for child trauma and posttraumatic stress disorder (PTSD). Although a number of review articles exist, many have focused on randomized controlled trials or specific treatment methodologies, both of which limit the ability to draw conclusions across studies and the statistical power to test the effect of particular treatment characteristics on treatment outcomes. The current study is a review and meta-analysis of 74 studies examining treatments for children exposed to violence. METHODS: After reviewing the literature, we examined the relationship of a variety of treatment characteristics (e.g., group or individual treatments) and sample characteristics (e.g., average age) on treatment effect sizes. RESULTS: Results indicated that individual therapies and those with exposure paradigms within a cognitive-behavioral therapy or skills-building framework show the most promise, but treatment is somewhat less effective for those with more severe symptomology and for younger children. CONCLUSIONS: Future treatments should consider the developmental and social contexts that may impede treatment progress for young children and consider how best to develop the effectiveness of group interventions that can be readily delivered in settings of mass trauma.