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Impact of the COVID-19 pandemic on eating disorder-related hospital and programme admissions in youth

Por: Devoe · D. J. · Holland · K. M. G.

Commentary on: Hartman-Munick SM, Lin JA, Milliren CE, et al. Association of the COVID-19 pandemic with adolescent and young adult eating disorder care volume. JAMA Pediatr. 2022 Dec 1;176(12):1225-1232. doi: 10.1001/jamapediatrics.2022.4346.

Implications for practice and research

  • The current research demonstrates the need to increase staffing and programme capacity for those working with patients with eating disorders (EDs) to ensure adequate care.

  • Future research into how the relationship between ED-related hospitalisations and individual external factors, such as social isolation are needed.

  • Context

    Research has shown that the pandemic greatly impacted worldwide mental health1 and disproportionality impacted those with EDs.2 Those with EDs such as anorexia nervosa, bulimia nervosa and binge ED have seen an increase in hospital admissions and programmes due to the COVID-19 pandemic.2 3 However, there is a lack of nationwide research investigating the increase...

    Implementing a complex mental health intervention in occupational settings: process evaluation of the MENTUPP pilot study

    Por: Tsantila · F. · Coppens · E. · De Witte · H. · Arensman · E. · Aust · B. · Pashoja · A. C. · Corcoran · P. · Cully · G. · De Winter · L. · Doukani · A. · Dushaj · A. · Fanaj · N. · Griffin · E. · Hogg · B. · Holland · C. · Leduc · C. · Leduc · M. · Mathieu · S. · Maxwell · M. · Ni Dhalaigh
    Background

    According to the Medical Research Council (MRC) framework, the theorisation of how multilevel, multicomponent interventions work and the understanding of their interaction with their implementation context are necessary to be able to evaluate them beyond their complexity. More research is needed to provide good examples following this approach in order to produce evidence-based information on implementation practices.

    Objectives

    This article reports on the results of the process evaluation of a complex mental health intervention in small and medium enterprises (SMEs) tested through a pilot study. The overarching aim is to contribute to the evidence base related to the recruitment, engagement and implementation strategies of applied mental health interventions in the workplace.

    Method

    The Mental Health Promotion and Intervention in Occupational Settings (MENTUPP) intervention was pilot tested in 25 SMEs in three work sectors and nine countries. The evaluation strategy of the pilot test relied on a mixed-methods approach combining qualitative and quantitative research methods. The process evaluation was inspired by the RE-AIM framework and the taxonomy of implementation outcomes suggested by Proctor and colleagues and focused on seven dimensions: reach, adoption, implementation, acceptability, appropriateness, feasibility and maintenance.

    Results

    Factors facilitating implementation included the variety of the provided materials, the support provided by the research officers (ROs) and the existence of a structured plan for implementation, among others. Main barriers to implementation were the difficulty of talking about mental health, familiarisation with technology, difficulty in fitting the intervention into the daily routine and restrictions caused by COVID-19.

    Conclusions

    The results will be used to optimise the MENTUPP intervention and the theoretical framework that we developed to evaluate the causal mechanisms underlying MENTUPP. Conducting this systematic and comprehensive process evaluation contributes to the enhancement of the evidence base related to mental health interventions in the workplace and it can be used as a guide to overcome their contextual complexity.

    Trial registration number

    ISRCTN14582090.

    Psychosocial safety climate (PSC) and working conditions, predictors of mental health and antidepressant and opioid use in Australia: a study protocol for longitudinal data linkage

    Por: Crispin · C. N. · Afsharian · A. · Loh · M. Y. · Dollard · M. F. · Dormann · C. · Glozier · N. · Gill · T. · Taylor · A. W.
    Introduction

    Work-related stress is a social determinant of global health that represents a huge cost to workers’ health and reduces work performance. In Australia, mental well-being is a pressing national issue—with one in five Australians experiencing mental disorders. Antidepressants are a first-line medication commonly used to treat mental disorders. Recently, Australia has seen a dramatic increase in the use of prescribed antidepressant medications to treat mental health related illnesses. Australia has also seen a dramatic increase in the use of prescribed opioid analgesics for non-cancer pain including opioid use for psychological distress and social stressors. It is plausible a rise in mental health problems and antidepressant and opioid medication use is partly attributable to the corporate climate for worker mental health (ie, the psychosocial safety climate, PSC). This research aims to identify how PSC and workplace conditions contribute to employee well-being and distress that culminate in antidepressant and opioid medication use.

    Methods/analysis

    Data will be collected through creative data linkage from the Australian Workplace Barometer (AWB), to medication data (via the Pharmaceutical Benefits Scheme, PBS). The participant sample will include 1372 working Australians from the AWB project from 2009 to 2021. Four waves of longitudinal data from 2009 to 2021 will be used to investigate the plausible link between Australia’s high levels of antidepressant and opioid use and distress at work. The project advances theory by probing the role corporate climate plays in work design, distress, mental health problems and antidepressant and opioid use. It will determine if antidepressant and opioid use has led to an underestimation of work stress effects. Proposed theoretical models will be analysed through linked data, using continuous time structural equation modelling, hierarchical linear modelling, logistic regression and cost estimation.

    Ethics and dissemination

    The study has been approved by the Human Research Ethics Committee of the University of South Australia (Ethics Protocol: 203003). Further, approval from the Australian Institute of Health and Welfare Ethics Committee was also granted for linkage of AWB data and PBS data (EthOS Application EO2022/1/1190).

    Results of the study will be disseminated through worldwide keynotes, key international settings, high-impact peer-reviewed journals, industry conference presentations and media outlets to reach managers, workers, and industry partners. Further, UniSA requires publications from public projects to be held in an institutional repository which fulfils the Australian Research Council’s Open Access Policy.

    The Oxford Needle Experience (ONE) scale: a UK-based and US-based online mixed-methods psychometric development and validation study of an instrument to assess needle fear, attitudes and expectations in the general public

    Por: Kantor · J. · Vanderslott · S. · Morrison · M. · Pollard · A. J. · Carlisle · R. C.
    Objectives

    To develop and validate the Oxford Needle Experience (ONE) scale, an instrument to assess needle fear, attitudes and expectations in the general population.

    Design

    Cross-sectional validation study.

    Setting

    Internet-based with participants in the UK and USA.

    Participants

    UK and US representative samples stratified by age, sex, and ethnicity using the Prolific Academic platform.

    Main outcome measures

    Exploratory factor analysis with categorical variables and a polychoric correlation matrix followed by promax oblique rotation on the UK sample for the ONE scale. Confirmatory factor analysis (CFA) with a Satorra-Bentler scaled test statistic evaluating the root mean squared error of approximation (RMSEA), standardised root mean squared residual (SRMR) and comparative fit index (CFI) on the US sample. Reliability as internal consistency using McDonald’s omega. Convergent validity using the Pearson correlation coefficient. Predictive and discriminant validity using logistic regression ORs of association (OR).

    Results

    The population included 1000 respondents, 500 in the UK and 500 in the USA. Minimum average partial correlation and a scree plot suggested four factors should be retained: injection hesitancy, blood-related hesitancy, recalled negative experiences and perceived benefits, yielding a 19-question scale. On CFA, the RMSEA was 0.070 (90% CI, 0.064 to 0.077), SRMR 0.053 and CFI 0.925. McDonald’s omega was 0.92 and 0.93 in the UK and US samples, respectively. Convergent validity with the four-item Oxford Coronavirus Explanations, Attitudes and Narratives Survey (OCEANS) needle fear scale demonstrated a strong correlation (r=0.83). Predictive validity with a single-question COVID-19 vaccination status question demonstrated a strong association, OR (95% CI) 0.97 (0.96 to 0.98), p

    Conclusions

    The ONE scale is a reliable and valid multidimensional scale that may be useful in predicting vaccine hesitancy, designing public health interventions to improve vaccine uptake and exploring alternatives to needles for medical procedures.

    Hospital-based caregiver intervention for people following hip fracture surgery (HIP HELPER): multicentre randomised controlled feasibility trial with embedded qualitative study in England

    Por: Smith · T. O. · Khoury · R. · Hanson · S. · Welsh · A. · Grant · K. · Clark · A. B. · Ashford · P.-A. · Hopewell · S. · Pfeiffer · K. · Logan · P. · Crotty · M. · Costa · M. L. · Lamb · S. · The HIP HELPER Study Collaborators · Clifford · Freeman · Gray · Cunningham · Langford · Baxter
    Objectives

    To assess the feasibility of conducting a pragmatic, multicentre randomised controlled trial (RCT) to test the clinical and cost-effectiveness of an informal caregiver training programme to support the recovery of people following hip fracture surgery.

    Design

    Two-arm, multicentre, pragmatic, open, feasibility RCT with embedded qualitative study.

    Setting

    National Health Service (NHS) providers in five English hospitals.

    Participants

    Community-dwelling adults, aged 60 years and over, who undergo hip fracture surgery and their informal caregivers.

    Intervention

    Usual care: usual NHS care. Experimental: usual NHS care plus a caregiver–patient dyad training programme (HIP HELPER). This programme comprised three, 1 hour, one-to-one training sessions for a patient and caregiver, delivered by a nurse, physiotherapist or occupational therapist in the hospital setting predischarge. After discharge, patients and caregivers were supported through three telephone coaching sessions.

    Randomisation and blinding

    Central randomisation was computer generated (1:1), stratified by hospital and level of patient cognitive impairment. There was no blinding.

    Main outcome measures

    Data collected at baseline and 4 months post randomisation included: screening logs, intervention logs, fidelity checklists, acceptability data and clinical outcomes. Interviews were conducted with a subset of participants and health professionals.

    Results

    102 participants were enrolled (51 patients; 51 caregivers). Thirty-nine per cent (515/1311) of patients screened were eligible. Eleven per cent (56/515) of eligible patients consented to be randomised. Forty-eight per cent (12/25) of the intervention group reached compliance to their allocated intervention. There was no evidence of treatment contamination. Qualitative data demonstrated the trial and HIP HELPER programme was acceptable.

    Conclusions

    The HIP HELPER programme was acceptable to patient–caregiver dyads and health professionals. The COVID-19 pandemic impacting on site’s ability to deliver the research. Modifications are necessary to the design for a viable definitive RCT.

    Trial registration number

    ISRCTN13270387.

    “Like fighting a fire with a water pistol”: A qualitative study of the work experiences of critical care nurses during the COVID‐19 pandemic

    Abstract

    Aim

    To understand the experience of critical care nurses during the COVID-19 pandemic, through the application of the Job-Demand-Resource model of occupational stress.

    Design

    Qualitative interview study.

    Methods

    Twenty-eight critical care nurses (CCN) working in ICU in the UK NHS during the COVID-19 pandemic took part in semi-structured interviews between May 2021 and May 2022. Interviews were guided by the constructs of the Job-Demand Resource model. Data were analysed using framework analysis.

    Results

    The most difficult job demands were the pace and amount, complexity, physical and emotional effort of their work. Prolonged high demands led to CCN experiencing emotional and physical exhaustion, burnout, post-traumatic stress symptoms and impaired sleep. Support from colleagues and supervisors was a core job resource. Sustained demands and impaired physical and psychological well-being had negative organizational consequences with CCN expressing increased intention to leave their role.

    Conclusions

    The combination of high demands and reduced resources had negative impacts on the psychological well-being of nurses which is translating into increased consideration of leaving their profession.

    Implications for the Profession and/or Patient Care

    The full impacts of the pandemic on the mental health of CCN are unlikely to resolve without appropriate interventions.

    Impact

    Managers of healthcare systems should use these findings to inform: (i) the structure and organization of critical care workplaces so that they support staff to be well, and (ii) supportive interventions for staff who are carrying significant psychological distress as a result of working during and after the pandemic. These changes are required to improve staff recruitment and retention.

    Reporting Method

    We used the COREQ guidelines for reporting qualitative studies.

    Patient and Public Contribution

    Six CCN provided input to survey content and interview schedule. Two authors and members of the study team (T.S. and S.C.) worked in critical care during the pandemic.

    Using a novel ambulatory monitoring system to support patient safety on an acute infectious disease ward during an unfolding pandemic

    Abstract

    Aim

    To gain staff feedback on the implementation and impact of a novel ambulatory monitoring system to support coronavirus patient management on an isolation ward.

    Design

    Qualitative service evaluation.

    Methods

    Semi-structured interviews were conducted with 15 multidisciplinary isolation ward staff in the United Kingdom between July 2020 and May 2021. Interviews were audio-recorded, transcribed and analysed using thematic analysis.

    Findings

    Adopting Innovation to Assist Patient Safety was identified as the overriding theme. Three interlinked sub-themes represent facets of how the system supported patient safety. Patient Selection was developed throughout the pandemic, as clinical staff became more confident in choosing which patients would benefit most. Trust In the System described how nurses coped with discrepancies between the ambulatory system and ward observation machines. Finally, Resource Management examined how, once trust was built, staff perceived the ambulatory system assisted with caseload management. This supported efficient personal protective equipment resource use by reducing the number of isolation room entries. Despite these reported benefits, face-to-face contact was still highly valued, despite the risk of coronavirus exposure.

    Conclusion

    Hospital wards should consider using ambulatory monitoring systems to support caseload management and patient safety. Patients in isolation rooms or at high risk of deterioration may particularly benefit from this additional monitoring. However, these systems should be seen as an adjunct to nursing care, not a replacement.

    Implications for the Profession and/or Patient Care

    Nurses valued ambulatory monitoring as a means of ensuring the safety of patients at risk of deterioration and prioritizing their workload.

    Impact

    The findings of this research will be useful to all those developing or considering implementation of ambulatory monitoring systems in hospital wards.

    Reporting Method

    This manuscript follows the Consolidated criteria for Reporting Qualitative Research (COREQ) guidelines with inclusion of relevant SQUIRE guidelines for reporting quality improvement.

    Patient or Public Contribution

    No Patient or Public Contribution.

    Assessment of psychological terror and its impact on mental health and quality of life in medical residents at a reference medical center in Mexico: A cross-sectional study

    by Víctor Manuel Enriquez Estrada, Neftali Eduardo Antonio-Villa, Omar Yaxhemen Bello-Chavolla, Carlos Fredy Cuevas-García, Pedro Luis Vargas Gutiérrez, Irma Sau-Yen Corlay Noriega, Luis Rey García-Cortés

    Background

    Mobbing, particularly in medical residencies, can lead to psychological terror with lasting mental and physical health consequences. Its impact on Mexican residents, however, remains underexplored.

    Aim

    This study aimed to investigate the prevalence and associated factors of psychological terror among medical residents at a medical center in Mexico City.

    Methods

    In a cross-sectional study, medical residents from various specialties were assessed for mobbing domains, quality of life, and anxiety/depression using the Leymann Inventory of Psychological Terror (LIPT), 36-Item Short Form Health Survey, Beck Depression Inventory-II, and Beck Anxiety Inventory, respectively. Psychological terror was defined as a LIPT score ≥ p80. Linear and binomial logistic regression models were used to explore independent predictors of mobbing and psychological terror.

    Results

    Of the 349 participants included (median age: 28; IQR: 27–30 years), 19.5% (95% CI: 15.5%-24.0%) were identified with psychological terror. Furthermore, 39% reported higher-degree trainees as mobbing perpetrators. Women in surgical residencies in their second or fifth year were found to experience higher levels of mobbing. Manifested bullying, workplace stigma, and inappropriate tasks were the most impacted mobbing domains. Anxiety, diminished mental health quality of life, and higher degree of medical specialization were independent predictors of mobbing. Meanwhile, increased anxiety, affiliation to surgical specialties, and being in the second or fifth year of training were identified as predictors of psychological terror.

    Conclusions

    Mobbing and psychological terror are prevalent conditions among medical residents in Mexico. Identification of occupational conditions and adverse psychological stressors can help to improve quality of life and training of medical residents.

    Prevalence of surgical wound infection and related factors in patients after long bone surgery: A systematic review and meta‐analysis

    Abstract

    The goal of this systematic review and meta-analysis is to provide an overview of the prevalence of surgical wound infection and related factors in patients after long bone surgery. A comprehensive, systematic search was conducted in different international electronic databases, such as Scopus, PubMed, Web of Science and Persian electronic databases such as Iranmedex and Scientific Information Database using keywords extracted from Medical Subject Headings such as “Prevalence”, “Surgical wound infection”, “Surgical site infection” and “Orthopedics” from the earliest to the May 1, 2023. The appraisal tool for cross-sectional studies (AXIS tool) evaluates the quality of the included studies. A total of 71 854 patients undergoing long bone surgery participated in 12 studies. The pooled prevalence of surgical wound infection in patients who underwent long bone surgery reported in the 12 studies was 3.3% (95% CI: 1.5%–7.2%; I 2 = 99.39%; p < 0.001). The pooled prevalence of surgical wound infection in male and female patients who underwent long bone surgery was 4.6% (95% CI: 1.7%–11.7%; p < 0.001; I 2 = 99.34%) and 2.6% (95% CI: 1.0%–6.3%; I 2 = 98.84%; p < 0.001), respectively. The pooled prevalence of surgical wound infection in patients with femur surgery sites reported in nine studies was 3.7% (95% CI: 2.1–6.4%; I 2 = 93.43%; p < 0.001). The pooled prevalence of surgical wound infection in open and close fractures was 16.4% (95% CI: 8.2%–30.2%; I 2 = 95.83%; p < 0.001) and 2.9% (95% CI: 1.5%–5.5%; I 2 = 96.40%; p < 0.001), respectively. The pooled prevalence of surgical wound infection in patients with diabetes mellitus (DM), hypertension (HTN) and cardiovascular disease (CVD) was 4.6% (95% CI: 2.3%–8.9%; I 2 = 81.50%; p < 0.001), 2.7% (95% CI: 1.2%–6.0%; I 2 = 83.82%; p < 0.001) and 3.0% (95% CI: 1.4%–6.4%; I 2 = 69.12%; p = 0.006), respectively. In general, the different prevalence of surgical wound infection in patients undergoing surgical treatment after long bone fracture may be caused by underlying factors (gender and co-morbidity) and fracture-related factors (surgery site and type of fracture).

    Self-reported and parent-reported mental health in children from low-income families in Agder, Norway: results from baseline measurements of New Patterns project participants

    Por: Boe · T. · Ostojic · H. A. · Haraldstad · K. · Abildsnes · E. · Wilson · P. · Vigsnes · K. · Molland · E.
    Background

    Poverty may pose risks to child and adolescent mental health, but few studies have reported on this association among children and adolescents in low-income families in Norway.

    Methods

    Based on a sample participating in an intervention for low-income families in Norway, we report data from the survey administered at the start of the intervention. Mental health problems were measured using the Strengths and Difficulties Questionnaire (SDQ; self-report (SR) n = 148; parent/proxy-report (PR) n = 153, mean age = 10.8). Demographic and family characteristics were obtained from parent reported data. Results are presented by gender and migration background. Regression analysis was used to investigate the relative contribution of background factors to mental health symptoms. The distribution of scores is compared to UK norms.

    Results

    Participants reported relatively high scores on the Strengths and Difficulties Questionnaire (SDQ) Total Difficulties Scale (parent/proxy-report, PR mean=10.7; self-report, SR mean=10.1). Participants with non-immigrant backgrounds scored considerably higher on the Total Difficulties Scale (PR mean difference=2.9; SR 5.3) and on most other domains measured with the SDQ compared with their peers with immigration backgrounds. Participants generally scored higher than or equal to UK norms.

    Conclusion

    Participants in the current study had many symptoms of mental health problems, with large differences between those with and without a migrant background. Interventions for low-income families should be based on detailed knowledge about differences in family risks, resources and needs.

    Do community-based singing interventions have an impact on people living with dementia and their carers? A mixed-methods study protocol

    Por: Polden · M. · Hanna · K. · Ward · K. · Ahmed · F. · Brown · H. · Holland · C. · Barrow · H. · Main · J. · Mann · S. · Pendrill · S. · Giebel · C.
    Introduction

    Psychosocial interventions have been shown to improve mood, relieve stress and improve quality of life for people living with dementia (PwD). To date, most evaluations of singing interventions have focused on the benefits for PwD and not their carers. This research aims to evaluate the benefits of dementia singing groups for both PwD and their carers.

    Methods and analysis

    This 2-year project will observe the impact of two different singing intervention services, one combining singing alongside dance and another that includes a sociable lunch. This project will aim to recruit a total of n=150 PwD and n=150 carers across the two singing interventions. Using a mixed-methods approach, the influence of both services will be analysed via the following outcome measures: quality of life, neuropsychiatric symptoms, social isolation, loneliness, cognition, carer burden and depressive symptoms in PwD and their carers using a prestudy/poststudy design. Regression models will be used to analyse the data with time (pre/post) as the exposure variable. Semistructured interviews will be conducted with a subset of people (n=40) to further investigate the impact of singing services with a specific focus on the acceptability of the interventions, barriers to access and prolonged engagement and potential for remote delivery. Interview data will be analysed using Braun and Clarke’s reflexive thematic analysis, and public advisers will assist with coding the transcripts. A social return on investment analysis will be conducted to determine the social impact of the services.

    Ethics and dissemination

    This project has received ethical approval from the University of Liverpool’s Ethics Committee (App ref: 12374) and Lancaster University’s Ethics Committee (App ref: 3442). All participants will provide informed consent to participate. Results will be presented at national and international conferences, published in scientific journals and publicly disseminated to key stakeholders.

    OptiBreech collaborative care versus standard care for women with a breech-presenting fetus at term: A pilot parallel group randomised trial to evaluate the feasibility of a randomised trial nested within a cohort

    by Shawn Walker, Emma Spillane, Kate Stringer, Lauren Trepte, Siân M. Davies, Jacana Bresson, Jane Sandall, Andrew Shennan, the OptiBreech Collaborative

    OptiBreech collaborative care is a multi-disciplinary care pathway for breech presentation at term, with continuity from a breech specialist midwife, including where chosen, for vaginal breech birth (VBB). Pilot randomised trial using unblinded 1:1 parallel group allocation to OptiBreech versus standard care, within a cohort. Participants were women with a breech-presenting fetus > 33 weeks, at four sites in England, January–June 2022. A two-stage consent process was used. Participants consented to undergo random selection to be offered a ‘new care process’, with a choice to accept it, or not. Primary objectives were to identify recruitment, acceptance, and attrition rates. Randomisation procedures and potential primary outcomes for a substantive study were also feasibility-tested. 68 women were randomised between January–June 2022. The consent process was acceptable to participants, but randomisation was unacceptable to women who specifically sought OptiBreech care. Two women withdrew due to concerns about sharing personal information. More women planned a VBB when randomised to OptiBreech Care (23.5% vs 0, p = .002, 95% CI = 9.3%,37.8%). Women randomised to OptiBreech care had: lower rates of cephalic presentation at birth (38.2% vs 54.5%), higher rates of vaginal birth (32.4% vs 24.2%), lower rates of in-labour caesarean birth (20.6% vs 36.4%), lower rates of neonatal intensive care (5.9% vs 9.1%), and lower rates of severe neonatal morbidity (2.9% vs 9.1%). Randomisation was stopped on the advice of the steering committee before the planned sample of 104, as lack of access to VBB within standard care prohibited comparison of outcomes. Demand for VBB is sufficient for a cohort study, but comparison of outcomes by 1:1 randomisation is not feasible. OptiBreech care would be best evaluated using stepped wedge cluster randomisation. Funded by the United Kingdom National Institute for Health and Care Research (NIHR300582). Clinical trial registration: ISRCTN 14521381.

    Salmonella Vaccine Study in Oxford (SALVO) trial: protocol for an observer-participant blind randomised placebo-controlled trial of the iNTS-GMMA vaccine within a European cohort

    Por: Hanumunthadu · B. · Kanji · N. · Owino · N. · Ferreira Da Silva · C. · Robinson · H. · White · R. · Ferruzzi · P. · Nakakana · U. · Canals · R. · Pollard · A. J. · Ramasamy · M. · Vacc-iNTS Consortium · Agyapong · Breghi · Crump · Fiorino · Gordon · Jacobs · Kariuki · Malvolti · Mante
    Introduction

    Invasive non-typhoidal Salmonellosis (iNTS) is mainly caused by Salmonella enterica serovars Typhimurium and Enteritidis and is estimated to result in 77 500 deaths per year, disproportionately affecting children under 5 years of age in sub-Saharan Africa. Invasive non-typhoidal Salmonellae serovars are increasingly acquiring resistance to first-line antibiotics, thus an effective vaccine would be a valuable tool in reducing morbidity and mortality from infection. While NTS livestock vaccines are in wide use, no licensed vaccines exist for use in humans. Here, a first-in-human study of a novel vaccine (iNTS-GMMA) containing S. Typhimurium and S. Enteritidis Generalised Modules for Membrane Antigens (GMMA) outer membrane vesicles is presented.

    Method and analysis

    The Salmonella Vaccine Study in Oxford is a randomised placebo-controlled participant-observer blind phase I study of the iNTS-GMMA vaccine. Healthy adult volunteers will be randomised to receive three intramuscular injections of the iNTS-GMMA vaccine, containing equal quantities of S. Typhimurium and S. Enteritidis GMMA particles adsorbed on Alhydrogel, or an Alhydrogel placebo at 0, 2 and 6 months. Participants will be sequentially enrolled into three groups: group 1, 1:1 randomisation to low dose iNTS-GMMA vaccine or placebo; group 2, 1:1 randomisation to full dose iNTS-GMMA vaccine or placebo; group 3, 2:1 randomisation to full dose or lower dose (dependant on DSMC reviews of groups 1 and 2) iNTS-GMMA vaccine or placebo.

    The primary objective is safety and tolerability of the vaccine. The secondary objective is immunogenicity as measured by O-antigen based ELISA. Further exploratory objectives will characterise the expanded human immune profile.

    Ethics and dissemination

    Ethical approval for this study has been obtained from the South Central—Oxford A Research Ethics Committee (Ethics REF:22/SC/0059). Appropriate documentation and regulatory approvals have been acquired. Results will be disseminated via peer-reviewed articles and conferences.

    Trial registration number

    EudraCT Number: 2020-000510-14.

    Intravenous immunoglobulin treatment in childhood encephalitis (IgNiTE): a randomised controlled trial

    Por: Hill · M. · Iro · M. · Sadarangani · M. · Absoud · M. · Cantrell · L. · Chong · K. · Clark · C. · Easton · A. · Gray · V. · Kneen · R. · Lim · M. · Liu · X. · Pike · M. · Solomon · T. · Vincent · A. · Willis · L. · Yu · L.-M. · Pollard · A. J. · The IgNiTE study team · Pollard · Lim · Solomon
    Objective

    To investigate whether intravenous immunoglobulin (IVIG) improves neurological outcomes in children with encephalitis when administered early in the illness.

    Design

    Phase 3b multicentre, double-blind, randomised placebo-controlled trial.

    Setting

    Twenty-one hospitals in the UK.

    Participants

    Children aged 6 months to 16 years with a diagnosis of acute or subacute encephalitis, with a planned sample size of 308.

    Intervention

    Two doses (1 g/kg/dose) of either IVIG or matching placebo given 24–36 hours apart, in addition to standard treatment.

    Main outcome measure

    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.

    Secondary outcome measures

    The secondary outcomes were clinical, neurological, neuroimaging and neuropsychological results, identification of the proportion of children with immune-mediated encephalitis, and IVIG safety data.

    Results

    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.

    Conclusions

    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.

    Trial registration number

    Clinical Trials.gov NCT02308982; ICRCTN registry ISRCTN15791925.

    Research on missed nursing care during the COVID‐19 pandemic: A scoping review

    Abstract

    Background

    Missed nursing care is defined as care that is delayed, partially completed, or not completed at all. The scenario created by the COVID-19 pandemic may have influenced multifactorial determinants related to the care environment, nursing processes, internal processes, and decision-making processes, increasing missed nursing care.

    Aim

    This scoping review aimed to establish the quantity and type of research undertaken on missed nursing care during the COVID-19 pandemic.

    Methods

    This review was conducted following the Joanna Briggs Institute methodology for scoping reviews. We searched CINAHL, MEDLINE, Scopus, two national and regional databases, two dissertations and theses databases, a gray literature database, two study registers, and a search engine from November 1, 2019, to March 23, 2023. We included quantitative, qualitative, and mixed studies carried out in all healthcare settings that examined missed nursing care during the COVID-19 pandemic. Language restrictions were not applied. Two independent reviewers conducted study selection and data extraction. Disagreements between the reviewers were resolved through discussion or with an additional reviewer.

    Results

    We included 25 studies with different designs, the most common being acute care cross-sectional survey designs. Studies focused on determining the frequency and reasons for missed nursing care and its influence on nurses and organizational outcomes.

    Linking Evidence to Action

    Missed nursing care studies during the COVID-19 pandemic were essentially nurses-based prevalence surveys. There is an urgent need to advance the design and development of longitudinal and intervention studies, as well as to broaden the focus of research beyond acute care. Further research is needed to determine the impact of missed nursing care on nursing-sensitive outcomes and from the patient's perspective.

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