To investigate whether intravenous immunoglobulin (IVIG) improves neurological outcomes in children with encephalitis when administered early in the illness.
Phase 3b multicentre, double-blind, randomised placebo-controlled trial.
Twenty-one hospitals in the UK.
Children aged 6 months to 16 years with a diagnosis of acute or subacute encephalitis, with a planned sample size of 308.
Two doses (1 g/kg/dose) of either IVIG or matching placebo given 24–36 hours apart, in addition to standard treatment.
The primary outcome was a ‘good recovery’ at 12 months after randomisation, defined as a score of≤2 on the Paediatric Glasgow Outcome Score Extended.
The secondary outcomes were clinical, neurological, neuroimaging and neuropsychological results, identification of the proportion of children with immune-mediated encephalitis, and IVIG safety data.
18 participants were recruited from 12 hospitals and randomised to receive either IVIG (n=10) or placebo (n=8) between 23 December 2015 and 26 September 2017. The study was terminated early following withdrawal of funding due to slower than anticipated recruitment, and therefore did not reach the predetermined sample size required to achieve the primary study objective; thus, the results are descriptive. At 12 months after randomisation, 9 of the 18 participants (IVIG n=5/10 (50%), placebo n=4/8 (50%)) made a good recovery and 5 participants (IVIG n=3/10 (30%), placebo n=2/8 (25%)) made a poor recovery. Three participants (IVIG n=1/10 (10%), placebo n=2/8 (25%)) had a new diagnosis of epilepsy during the study period. Two participants were found to have specific autoantibodies associated with autoimmune encephalitis. No serious adverse events were reported in participants receiving IVIG.
The IgNiTE (ImmunoglobuliN in the Treatment of Encephalitis) study findings support existing evidence of poor neurological outcomes in children with encephalitis. However, the study was halted prematurely and was therefore underpowered to evaluate the effect of early IVIG treatment compared with placebo in childhood encephalitis.
Clinical Trials.gov NCT02308982; ICRCTN registry
To: (1) explore current best practices for hospital-acquired pressure injury prevention in high BMI patients; (2) summarize nurses' experiences in preventing and managing them; (3) explore the association between a high BMI and occurrence and severity of pressure injury.
Exploratory.
Scoping review.
Ovid MEDLINE, EBSCO CINAHL Plus, JBI Evidence Synthesis, Scopus, Embase, clinical registries and grey literature (search dates: January 2009 to May 2021).
Overall, 1479 studies were screened. The included studies were published between 2010 and 2022. Five interventional studies and 32 best practice recommendations (Objective 1) reported low-quality evidence. Findings of thematic analysis reported in nine studies (Objective 2) identified nurses' issues as insufficient bariatric equipment, inadequate staffing, weight bias, fatigue, obese-related terminology issues, ethical dilemmas and insufficient staff education in high BMI patients' pressure injury prevention. No association between hospital-acquired pressure injury occurrence and high BMI were reported by 18 out of 28 included studies (Objective 3).
Quality of evidence was low for the interventional studies and best practice recommendations.
Current (2019) International Pressure Injury Guideline to be used despite the low quality of evidence of most best practice recommendations.
This study addressed hospital-acquired pressure injury prevention in high BMI patients. Greater proportion of studies in this review found no association between high BMI and occurrence of hospital-acquired pressure injury. Nurses need educational interventions on pressure injury prevention in high body mass index people, sufficient staffing for repositioning and improved availability of bariatric equipment.
We adhered to relevant EQUATOR guidelines, PRISMA extension for scoping reviews.
No patient or public contribution.
Larger clinical trials are needed on repositioning frequency, support surfaces, prophylactic dressings and risk assessment tools to inform clinical practice guidelines on pressure injury prevention in high BMI people.
Wound Practice and Research (https://doi.org/10.33235/wpr.29.3.133-139).
Existing literature suggests that transgender women (TW) may be at high risk for adverse mental health due to stress attributed to combined experiences of stigma and complex social and structural vulnerabilities. Little research has examined how these co-occurring experiences relate to mental health. We aimed to test a theoretically driven conceptual model of relationships between stigma, social and structural vulnerabilities, and mental health to inform future intervention tailoring.
Partial least square path modeling followed by response-based unit segmentation was used to identify homogenous clusters in a diverse community sample of United States (US)-based TW (N = 1418; 46.2% White non-Hispanic). This approach examined associations between latent constructs of stigma (polyvictimization and discrimination), social and structural vulnerabilities (housing and food insecurity, unemployment, sex work, social support, and substance use), and mental health (post-traumatic stress and psychological distress).
The final conceptual model defined the structural relationship between the variables of interest within stigma, vulnerability, and mental health. Six clusters were identified within this structural framework which suggests that racism, ethnicism, and geography may be related to mental health inequities among TW.
Our findings around the impact of racism, ethnicism, and geography reflect the existing literature, which unfortunately shows us that little change has occurred in the last decade for TW of color in the Southern US; however, the strength of our evidence (related to sampling structure and sample size) and type of analyses (accounting for co-occurring predictors of health, i.e., stigma and complex vulnerabilities, reflecting that of real-world patients) is a novel and necessary addition to the literature. Findings suggest that health interventions designed to offset the negative effects of stigma must include anti-racist approaches with components to reduce or eliminate barriers to resources that contribute to social and structural vulnerabilities among TW. Herein we provide detailed recommendations to guide primary, secondary, and tertiary prevention efforts.
This study demonstrated the importance of considering stigma and complex social and structural vulnerabilities during clinical care and design of mental health interventions for transgender women who are experiencing post-traumatic stress disorder and psychological distress. Specifically, interventions should take an anti-racist approach and would benefit from incorporating social support-building activities.