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BackgroundPatient and public involvement is an integral component of clinical research. A YPAG is group of young people with active involvement in the design and conduct of clinical research aimed at CYP.1 2 Active collaboration with a YPAG can be mutually beneficial and can have a positive impact on study design and conduct.2 3 We report on the involvement of young people, their influence on study design and the perceived benefits to members.MethodA UK secondary school was approached and ten 16–17 year old students agreed to form a YPAG. Three 1-hour sessions were planned involving arts-based activities to explore key challenges, predetermined iteratively by the research team. Activities involved group work to explore and propose solutions for effective CYP recruitment and data collection, produce a study logo and review the plain English summary.ResultsYPAG members produced insightful arts-based posters containing important ideas and concepts that were incorporated into the study design. A study logo was created, diaries and electronic communication methods to collect data were added and a variety of age-based leaflets were added to the recruitment strategy. Members reported several benefits from the sessions, including enhanced creative and problem-solving skills and members enjoyed the teamwork and collaborative approach.ConclusionYPAG involvement resulted in meaningful improvements to research design and members gained new knowledge, transferrable skills and improved confidence. This experience should help inform YPAG involvement in future research.ReferencesNational Institute for Health Research (2021) NIHR resource for public involvement - Involving children and young people as advisors in research. Available at: https://www.learningforinvolvement.org.uk/?opportunity=nihr-involving-children-and-young-people-as-advisors-in-research Accessed 06-Dec-2021Rouncefield-Swales A, Harris J, Carter B, Bray L, Bewley T, et al. (2021) Children and young people’s contributions to public involvement and engagement activities in health-related research: A scoping review. PLOS ONE 16(6): e0252774. https://doi.org/10.1371/journal.pone.0252774Abrehart N, Frost K, the Young Persons Advisory Group. et al. (2021) ‘A little (PPI) MAGIC can take you a long way’ : involving children and young people in research from inception of a novel medical device to multi-centre clinical trial Roald Dahl, James and the Giant Peach (1961). Res Involv Engagem 7, 2 https://doi.org/10.1186/s40900-020-00243-0.Conflict of interestGAW received funding to conduct this project through a post-doctoral bridging fellowship. HT, TB, EM and RT received financial compensation, in line with NIHR/INVOLVE guidelines, for their involvement in the YPAG group.FundingThis project formed part of a post-doctoral bridging fellowship supported by the National Institute for Health Research (NIHR) Applied Research Collaboration East Midlands (ARC EM) and Health Education England. The views expressed in this publication are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.

In a trial involving adults with out-of-hospital cardiac arrest, an intraosseous-first strategy for vascular access did not result in a higher incidence of 30-day survival than an intravenous-first strategy.

The benefit of combined treatment with intravenous thrombolysis before endovascular thrombectomy in patients with acute ischaemic stroke caused by large vessel occlusion remains unclear. We hypothesised that the clinical outcomes of patients with stroke with large vessel occlusion treated with direct endovascular thrombectomy within 4·5 h would be non-inferior compared with the outcomes of those treated with standard bridging therapy (intravenous thrombolysis before endovascular thrombectomy). DIRECT-SAFE was an international, multicentre, prospective, randomised, open-label, blinded-endpoint trial. Adult patients with stroke and large vessel occlusion in the intracranial internal carotid artery, middle cerebral artery (M1 or M2), or basilar artery, confirmed by non-contrast CT and vascular imaging, and who presented within 4·5 h of stroke onset were recruited from 25 acute-care hospitals in Australia, New Zealand, China, and Vietnam. Eligible patients were randomly assigned (1:1) via a web-based, computer-generated randomisation procedure stratified by site of baseline arterial occlusion and by geographic region to direct endovascular thrombectomy or bridging therapy. Patients assigned to bridging therapy received intravenous thrombolytic (alteplase or tenecteplase) as per standard care at each site; endovascular thrombectomy was also per standard of care, using the Trevo device (Stryker Neurovascular, Fremont, CA, USA) as first-line intervention. Personnel assessing outcomes were masked to group allocation; patients and treating physicians were not. The primary efficacy endpoint was functional independence defined as modified Rankin Scale score 0–2 or return to baseline at 90 days, with a non-inferiority margin of –0·1, analysed by intention to treat (including all randomly assigned and consenting patients) and per protocol. The intention-to-treat population was included in the safety analyses. The trial is registered with ClinicalTrials.gov, NCT03494920, and is closed to new participants. Between June 2, 2018, and July 8, 2021, 295 patients were randomly assigned to direct endovascular thrombectomy (n=148) or bridging therapy (n=147). Functional independence occurred in 80 (55%) of 146 patients in the direct thrombectomy group and 89 (61%) of 147 patients in the bridging therapy group (intention-to-treat risk difference –0·051, two-sided 95% CI –0·160 to 0·059; per-protocol risk difference –0·062, two-sided 95% CI –0·173 to 0·049). Safety outcomes were similar between groups, with symptomatic intracerebral haemorrhage occurring in two (1%) of 146 patients in the direct group and one (1%) of 147 patients in the bridging group (adjusted odds ratio 1·70, 95% CI 0·22–13·04) and death in 22 (15%) of 146 patients in the direct group and 24 (16%) of 147 patients in the bridging group (adjusted odds ratio 0·92, 95% CI 0·46–1·84). We did not show non-inferiority of direct endovascular thrombectomy compared with bridging therapy. The additional information from our study should inform guidelines to recommend bridging therapy as standard treatment. Australian National Health and Medical Research Council and Stryker USA.

Neonates with HSV and CNS involvement or skin, eye, and mouth disease were treated with IV acyclovir for 2 to 3 weeks, then acyclovir suppressive therapy or placebo for 6 months. Infants receiving acyclovir suppressive therapy had better neurodevelopmental outcomes. The outcomes of neonatal herpes simplex virus (HSV) disease are dependent on the extent of the disease. 1 Approximately 30% of babies with disseminated disease die, but only 20% of survivors have neurologic sequelae. 2 In contrast, only 6% of babies with central nervous system (CNS) disease die, but approximately 70% have permanent neurologic impairment. 2 Skin, eye, and mouth disease is not associated with death, and neurologic impairment is rare with this manifestation of neonatal herpes. 3 HSV establishes latency in sensory ganglia, with periodic reactivation and recurrence of localized disease. 4 , 5 Whether the virus subclinically reactivates in the brain after neonatal HSV . . .

Ideal dressings of surgical wounds should provide moist, semi‐permeable, and antiseptic environments for optimal wound healing. To maximise patient comfort, surgical dressings must be hypoallergenic, not restrict movement, and allow patients to manage their personal hygiene. From the aspect of health care personnel, dressings should enable visual monitoring of the wound without the need for removing them, thus reducing the number of dressing changes. The active antimicrobial effect of silver cations has been demonstrated by many studies. StopBac is a unique surgical dressing based on the sol‐gel process. Silver cations are bound in a colloidal solution in an organic‐inorganic hybrid organosilicate oligomer. This gel is deposited on a pad using spray atomisation. The result is a polymer nanolayer matrix with prolonged and controlled release of silver ions. This pad forms part of a waterproof hypoallergenic transparent adhesive bandage. The goal of this study was to prospectively evaluate the ability of StopBac to prevent surgical site infections (SSIs) in patients after abdominal surgery. The secondary goal was to compare costs and determine the properties of this new material. A total of 32 patients were included in the study. The patients were followed up until their surgical wounds healed completely. An SSI occurred only in one patient.

Congenital cytomegalovirus (CMV) infection occurs in ∼1% of newborns in the United States. A phase II evaluation was done of ganciclovir for the treatment of symptomatic congenital CMV infection. Daily doses of 8 or 12 mg/kg were administered in divided doses at 12-h intervals for 6 weeks. Clinical and laboratory evaluations sought evidence of toxicity, quantitative virologic responses in urine, plasma drug concentrations, and clinical outcome. A total of 14 and 28 babies received 8 and 12 mg/kg/day, respectively. Five additional babies received ganciclovir on a compassionate plea basis. Significant laboratory abnormalities included thrombocytopenia (≤50,000/mm3) in 37 babies and absolute neutropenia (≤500 mm3) in 29 babies. Quantitative excretion of CMV in the urine decreased; however, after cessation of therapy, viruria returned to near pretreatment levels. Hearing improvement or stabilization occurred in 5 (16%) of 30 babies at 6 months or later, indicating efficacy.

Hurler syndrome is a debilitating genetic disease with a typical life span of 5 to 8 years. Early hematopoietic stem cell transplantation (HSCT) mitigates disease symptoms and improves survival. However, morbidity and mortality associated with HSCT can limit its success. We describe the initial experience with combined use of enzyme replacement therapy (ERT, laronidase) and HSCT in Hurler syndrome. Thirteen transplants were performed in 12 patients. ERT was given at a standard dose of 0.58 mg/kg per week. Transplant conditioning regimen and donor graft source were determined by institutional protocol. The median age at initiation of ERT was 12 months (range, 8 to 18 months). The median duration of pre-HSCT ERT was 12 weeks (range, 4 to 28). All but 1 patient tested showed decrease in urinary GAG excretion during ERT. ERT infusion-related toxicity was limited to mild reactions. Development of antibodies to laronidase did not correlate with infusion reactions or responses in urinary GAG excretion. ERT was given for a median of 7 weeks (range, 3 to 20) after HSCT. After transplantation, eight patients demonstrated complete donor engraftment and four suffered graft failure. Two patients required ventilator support and three developed acute GVHD. Eleven of the 12 patients are surviving with a median follow-up of 3 months (range, 1 to 7 months). In children with Hurler syndrome, ERT with HSCT is feasible and well tolerated. Development of antibodies against exogenous enzyme does not appear to correlate with infusion reactions or response to ERT. A prospective study is needed to determine the effect of concomitant ERT on transplant outcomes.

ABSTRACT As the incidence of violence and potential risks for violence have increased in the health care workplace, the safety of nurses and nursing students has emerged as a critical concern for the profession. This article provides a review of the literature focusing on the incidence of violence toward nurses, factors that contribute to the occurrence of violence, the management of violent or potentially violent situations, and the effects on nurse victims of violence. Additionally, the costs of violence to the health care system and the various ways that violence has been defined are reviewed. The literature on violence occurs primarily in the clinical specialty areas of psychiatricmental health, emergency department, long-term care, and home care nursing. To address the need to prepare students to deal with the issue of violence in the health care setting, strategies for nursing education are presented which include role playing, videotape playbacks, and debriefing sessions. Suggested content consists of student self-awareness, assessment, and diagnosis of violent or potentially violent clients, and nursing care planning, interventions, and evaluation for the immediate situation, as well as long-term treatment goals. The authors emphasize the obligation of nurse educators to prepare students to deal with violence in the health care setting.

Congenital cytomegalovirus (CMV) infection occurs in approximately 1% of newborns in the United States. A phase II evaluation was done of ganciclovir for the treatment of symptomatic congenital CMV infection. Daily doses of 8 or 12 mg/kg were administered in divided doses at 12-h intervals for 6 weeks. Clinical and laboratory evaluations sought evidence of toxicity, quantitative virologic responses in urine, plasma drug concentrations, and clinical outcome. A total of 14 and 28 babies received 8 and 12 mg/kg/day, respectively. Five additional babies received ganciclovir on a compassionate plea basis. Significant laboratory abnormalities included thrombocytopenia (< or = 50,000/mm3) in 37 babies and absolute neutropenia (< or = 500 mm3) in 29 babies. Quantitative excretion of CMV in the urine decreased; however, after cessation of therapy, viruria returned to near pretreatment levels. Hearing improvement or stabilization occurred in 5 (16%) of 30 babies at 6 months or later, indicating efficacy.