Infection prevention and control (IPC) teams are routinely confronted with intense emotions in their daily work, as they are involved in many change processes with front-line medical staff, for example, when promoting compliance with basic IPC measures. In addition, they are confronted with challenges due to their role as intermediaries. Based on former research, this study aims to empower IPC teams to promote clinicians’ compliance through interventions focusing on the IPC teams’ leadership skills.

The IP-POWER study (Infection Prevention with head and heart: Psychological empowerment of IPC teams), a multicentre, two-arm, non-blinded, cluster-randomised controlled trial with a parallel waiting control group, is planned to be conducted in Germany as of February to November 2024. A group of 10 voluntary hospitals is going to participate in a multistage intervention programme, including 2 days of intense psychological training; 5 hospitals will be randomly assigned to the waiting control group. After the workshops, there will be a 12-week follow-up period during which the contents learnt within the workshops can be applied and internalised into IPC practice. The proposed outcomes (both self-assessed and other-assessed leadership competencies of IPC team members and their task profiles, perceived workload, motivation to act in order to implement IP measures and goal attainment) are going to be collected with an online questionnaire, followed by an analysis with IBM SPSS (Statistics 29 (or later)) using descriptive analyses and multiple linear regressions. Additionally, as external data sources, hand hygiene compliance rates from the study hospitals’ monitoring systems will be analysed using ² tests.

This study was reviewed and approved by the ethics committee of the University of Leipzig (184/23-ek; vote from 4 July 2023). Findings will be disseminated via peer-review publications, and national and international conference presentations.

DRKS00031879.

In critically ill children, pain management is complex owing to cognitive development and the nature of hospitalisation in paediatric intensive therapy units. Although there are many protocols and guidelines for pain control via pharmacological interventions, non-pharmacological practices should also be explored and disseminated for their potential benefit.

A systematic literature search will be performed using the following databases: Academic Search Premier, Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Excerpta Medica Database, Virtual Health Library, Medical Literature Analysis and Retrieval System Online, ScienceDirect, Scopus, Web of Science Core Collection, Theses from Coordenacão de Aperfeicoamento de Pessoal de Nível Superior, Dart Europe, Open Access Theses and Dissertations and grey literature from Google Scholar. The research will consider quantitative and qualitative studies, mixed-method studies, systematic reviews, text articles, opinion articles, letters to editors and editorials in any language and from any database. The following will be eligible for inclusion: (1) newborns, infants, children and adolescents; and (2) non-pharmacological therapies used for pain in paediatric intensive care.

This study does not require ethical approval. The results of this research will be disseminated through social media channels and podcasts about pain in children.

This protocol has been registered with the Open Science Framework (DOI 10.17605/OSF.IO/DZHKT).

To determine the well-being of physicians and nurses in hospital practice in Europe, and to identify interventions that hold promise for reducing adverse clinician outcomes and improving patient safety.

Baseline cross-sectional survey of 2187 physicians and 6643 nurses practicing in 64 hospitals in six European countries participating in the EU-funded Magnet4Europe intervention to improve clinicians’ well-being.

Acute general hospitals with 150 or more beds in six European countries: Belgium, England, Germany, Ireland, Sweden and Norway.

Physicians and nurses with direct patient contact working in adult medical and surgical inpatient units, including intensive care and emergency departments.

Burnout, job dissatisfaction, physical and mental health, intent to leave job, quality of care and patient safety and interventions clinicians believe would improve their well-being.

Poor work/life balance (57% physicians, 40% nurses), intent to leave (29% physicians, 33% nurses) and high burnout (25% physicians, 26% nurses) were prevalent. Rates varied by hospitals within countries and between countries. Better work environments and staffing were associated with lower percentages of clinicians reporting unfavourable health indicators, quality of care and patient safety. The effect of a 1 IQR improvement in work environments was associated with 7.2% fewer physicians and 5.3% fewer nurses reporting high burnout, and 14.2% fewer physicians and 8.6% fewer nurses giving their hospital an unfavourable rating of quality of care. Improving nurse staffing levels (79% nurses) and reducing bureaucracy and red tape (44% physicians) were interventions clinicians reported would be most effective in improving their own well-being, whereas individual mental health interventions were less frequently prioritised.

Burnout, mental health morbidities, job dissatisfaction and concerns about patient safety and care quality are prevalent among European hospital physicians and nurses. Interventions to improve hospital work environments and staffing are more important to clinicians than mental health interventions to improve personal resilience.

The literature presents complex inter-relationships among individual-factors and organisational-factors and barriers to seeking mental health support after deployment. This study aims to quantify longitudinal associations between such factors and barriers to mental health support.

A longitudinal online survey of Canadian Armed Forces (CAF) personnel collected data at 3 months post-deployment (T1), 6 months post-deployment (T2) and 1 year post-deployment (T3).

In 2020, as part of Canada’s response to the COVID-19 pandemic, 2595 CAF personnel deployed on Operation LASER to support civilian long-term care facilities in Québec and Ontario.

All Operation LASER personnel were invited to participate: 1088, 582 and 497 responded at T1, T2 and T3, respectively. Most respondents were young, male, non-commissioned members.

Barriers to mental health support were measured using 25 self-reported items and grouped into theory-based factors, including eight factors exploring care-seeking capabilities, opportunities and motivations; and two factors exploring moral issues. Logistic regressions estimated the crude and adjusted associations of individual and organisational characteristics (T1) with barriers (T2 and T3).

When adjusting for sex, military rank and mental health status, increased meaningfulness of deployment was associated with lower probability of endorsing barriers related to conflicts with career goals and moral discomfort in accessing support at T2. Higher scores in trust in leadership were associated with lower probability of endorsing four barriers at T2, and five barriers at T3.

We identified several modifiable organisational-level characteristics that may help reduce perceived barriers to mental health support in military and other high-risk occupational populations. Results suggest that promoting individuals’ sense of purpose, instilling trust in leadership and promoting relatedness among team members may improve perceptions of access to mental health supports in the months following a domestic deployment or comparable occupational exposure.

Japanese encephalitis virus (JEV) is a mosquito-borne flavivirus that causes encephalitis and other morbidity in Southeast Asia. Since February 2022, geographically dispersed JEV human, animal and vector detections occurred on the Australian mainland for the first time. This study will determine the prevalence of JEV-specific antibodies in human blood with a focus on populations at high risk of JEV exposure and determine risk factors associated with JEV seropositivity by location, age, occupation and other factors.

Samples are collected using two approaches: from routine blood donors (4153 samples), and active collections targeting high-risk populations (convenience sampling). Consent-based sampling for the latter includes a participant questionnaire on demographic, vaccination and exposure data. Samples are tested for JEV-specific total antibody using a defined epitope-blocking ELISA, and total antibody to Australian endemic flaviviruses Murray Valley encephalitis and Kunjin viruses.

Two analytic approaches will occur: descriptive estimates of seroprevalence and multivariable logistic regression using Bayesian hierarchical models. Descriptive analyses will include unadjusted analysis of raw data with exclusions for JEV-endemic country of birth, travel to JEV-endemic countries, prior JEV-vaccination, and sex-standardised and age-standardised analyses. Multivariable logistic regression will determine which risk factors are associated with JEV seropositivity likely due to recent transmission within Australia and the relative contribution of each factor when accounting for effects within the model.

National Mutual Acceptance ethical approval was obtained from the Sydney Children’s Hospitals Network Human Research Ethics Committee (HREC). Local approvals were sought in each jurisdiction. Ethical approval was also obtained from the Australian Red Cross Lifeblood HREC.

Findings will be communicated to participants and their communities, and human and animal health stakeholders and policy-makers iteratively and after final analyses. Understanding human infection rates will inform procurement and targeted allocation of limited JEV vaccine, and public health strategies and communication campaigns, to at-risk populations.

To understand community antibiotic practices and their drivers, comprehensively and in contextually sensitive ways, we explored the individual, community and health system-level factors influencing community antibiotic practices in rural West Bengal in India.

Qualitative study using focus group discussions and in-depth interviews.

Two contrasting village clusters in South 24 Parganas district, West Bengal, India. Fieldwork was conducted between November 2019 and January 2020.

98 adult community members (42 men and 56 women) were selected purposively for 8 focus group discussions. In-depth interviews were conducted with 16 community key informants (7 teachers, 4 elected village representatives, 2 doctors and 3 social workers) and 14 community health workers.

Significant themes at the individual level included sociodemographics (age, gender, education), cognitive factors (knowledge and perceptions of modern antibiotics within non-biomedical belief systems), affective influences (emotive interpretations of appropriate medicine consumption) and economic constraints (affordability of antibiotic courses and overall costs of care). Antibiotics were viewed as essential fever remedies, akin to antipyretics, with decisions to halt mid-course influenced by non-biomedical beliefs associating prolonged use with toxicity. Themes at the community and health system levels included the health stewardship roles of village leaders and knowledge brokering by informal providers, pharmacists and public sector accredited social health activists. However, these community resources lacked sufficient knowledge to address people’s doubts and concerns. Qualified doctors were physically and socially inaccessible, creating a barrier to seeking their expertise.

The interplay of sociodemographic, cognitive and affective factors, and economic constraints at the individual level, underscores the complexity of antibiotic usage. Additionally, community leaders and health workers emerge as crucial players, yet their knowledge gaps and lack of empowerment pose challenges in addressing public concerns. This comprehensive analysis highlights the need for targeted interventions that address both individual beliefs and community health dynamics to promote judicious antibiotic use.

Sudden death resulting from cardiorespiratory arrest carries a high mortality rate and frequently occurs out of hospital. Immediate initiation of cardiopulmonary resuscitation (CPR) by witnesses, combined with automated external defibrillator (AED) use, has proven to double survival rates. Recognising the challenges of timely emergency services in rural areas, the implementation of basic CPR training programmes can improve survival outcomes. This study aims to evaluate the effectiveness of online CPR-AED training among residents in a rural area of Tarragona, Spain.

Quasi-experimental design, comprising two phases. Phase 1 involves assessing the effectiveness of online CPR-AED training in terms of knowledge acquisition. Phase 2 focuses on evaluating participant proficiency in CPR-AED simulation manoeuvres at 1 and 6 months post training. The main variables include the score difference between pre-training and post-training test (phase 1) and the outcomes of the simulated test (pass/fail; phase 2). Continuous variables will be compared using Student’s t-test or Mann-Whitney U test, depending on normality. Pearson’s ² test will be applied for categorical variables. A multivariate analysis will be conducted to identify independent factors influencing the main variable.

This study adheres to the tenets outlined in the Declaration of Helsinki and of Good Clinical Practice. It operated within the Smartwatch project, approved by the Clinical Research Ethics Committee of the Primary Care Research Institute IDIAP Jordi Gol i Gurina Foundation, code 23/081-P. Data confidentiality aligns with Spanish and European Commission laws for the protection of personal data. The study’s findings will be published in peer-reviewed journals and presented at scientific meetings.

NCT05747495.

This article presents the study design of the qualitative part of the VersKiK study (Long-term care, care needs and wellbeing of individuals after cancer in childhood or adolescence: study protocol of a large scale multi-methods non-interventional study) aiming to explore actual follow-up needs of childhood and adolescence cancer survivors and their informal caregivers, gaps in current follow-up care provision and trajectories of cancer survivors’ transition from paediatric to adult healthcare.

We will conduct up to 30 interviews with survivors of childhood and adolescence cancer and their informal caregivers with up to 20 participant observations of follow-up appointments. The results of these will be discussed in up to four focus groups with healthcare professionals and representatives of self-help groups. The study design aims to evaluate follow-up care after childhood cancer considering perspectives from survivors, their informal caregivers as well as healthcare providers. The combination of different data sources will allow us to get an in-depth understanding of the current state of follow-up care after paediatric cancer in Germany and to suggest recommendations for care improvement.

The VersKiK study was approved by the Ethics Committee Otto von Guericke University on 2 July 2021 (103/21), by the Ethics Committee of Johannes Gutenberg University Mainz on 16 June 2021 (2021-16035), by the Ethics Committee University of Lübeck on 10 November 2021 (21-451), by the Ethics Committee University of Hospital Bonn on 28 February 2022 (05/22). For each part of the qualitative study, a separate written informed consent is prepared and approved accordingly by the ethics committees named above.

Registered at German Clinical Trial Register, ID: DRKS00026092.

Conventional prediction models fail to integrate the constantly evolving nature of critical illness. Alternative modelling approaches to study dynamic changes in critical illness progression are needed. We compare static risk prediction models to dynamic probabilistic models in early critical illness.

We developed models to simulate disease trajectories of critically ill COVID-19 patients across different disease states. Eighty per cent of cases were randomly assigned to a training and 20% of the cases were used as a validation cohort. Conventional risk prediction models were developed to analyse different disease states for critically ill patients for the first 7 days of intensive care unit (ICU) stay. Daily disease state transitions were modelled using a series of multivariable, multinomial logistic regression models. A probabilistic dynamic systems modelling approach was used to predict disease trajectory over the first 7 days of an ICU admission. Forecast accuracy was assessed and simulated patient clinical trajectories were developed through our algorithm.

We retrospectively studied patients admitted to a Cleveland Clinic Healthcare System in Ohio, for the treatment of COVID-19 from March 2020 to December 2022.

5241 patients were included in the analysis. For ICU days 2–7, the static (conventional) modelling approach, the accuracy of the models steadily decreased as a function of time, with area under the curve (AUC) for each health state below 0.8. But the dynamic forecasting approach improved its ability to predict as a function of time. AUC for the dynamic forecasting approach were all above 0.90 for ICU days 4–7 for all states.

We demonstrated that modelling critical care outcomes as a dynamic system improved the forecasting accuracy of the disease state. Our model accurately identified different disease conditions and trajectories, with a

Recently published studies support the beneficial effects of consuming fibre-rich legumes, such as cooked dry beans, to improve metabolic health and reduce cancer risk. In participants with overweight/obesity and a history of colorectal polyps, the Fibre-rich Foods to Treat Obesity and Prevent Colon Cancer randomised clinical trial will test whether a high-fibre diet featuring legumes will simultaneously facilitate weight reduction and suppress colonic mucosal biomarkers of colorectal cancer (CRC).

This study is designed to characterise changes in (1) body weight; (2) biomarkers of insulin resistance and systemic inflammation; (3) compositional and functional profiles of the faecal microbiome and metabolome; (4) mucosal biomarkers of CRC risk and (5) gut transit. Approximately 60 overweight or obese adults with a history of noncancerous adenomatous polyps within the previous 3 years will be recruited and randomised to one of two weight-loss diets. Following a 1-week run-in, participants in the intervention arm will receive preportioned high-fibre legume-rich entrées for two meals/day in months 1–3 and one meal/day in months 4–6. In the control arm, entrées will replace legumes with lean protein sources (eg, chicken). Both groups will receive in-person and written guidance to include nutritionally balanced sides with energy intake to lose 1–2 pounds per week.

The National Institutes of Health fund this ongoing 5-year study through a National Cancer Institute grant (5R01CA245063) awarded to Emory University with a subaward to the University of Pittsburgh. The study protocol was approved by the Emory Institutional Review Board (IRB approval number: 00000563).

NCT04780477.

To provide an overview of existing instruments measuring patient-perceived quality of nursing care and to develop and psychometrically evaluate a new multidimensional scale applicable to the German acute care sector.

We conducted a scale development and validation study involving the following phases: (1) performing a structured literature search to identify existing scales, (2) generating an initial pool of items using the results of the literature search and expert interviews, (3) coding/categorising the item pool, (4) organising a peer researcher workshop to select relevant items, (5) drafting the survey questionnaire and conducting cognitive pretesting, (6) pilot testing the survey questionnaire, (7) administering the survey to a large sample of hospital patients and (8) conducting a psychometric evaluation comprising exploratory factor analysis using the survey results, followed by confirmatory factor analysis and reliability and validity assessment of the resulting draft scale.

17 859 recently hospitalised patients discharged from non-intensive care in non-paediatric and non-psychiatric hospital units in Germany between May and October 2019.

We identified 32 instruments comprising 635 items on nursing care quality. Alongside 135 indicators derived from expert interviews, these formed our initial item pool, which we coded into 15 categories. From this pool, 36 items were selected in the peer researcher workshop for pretesting and psychometric evaluation. Based on the results of our exploratory and confirmatory factor analyses, we propose a second-order scale to measure Patients’ Experience of Nursing Quality in Acute Hospitals (PENQuAH), including the two higher-order dimensions ‘patients’ perception of direct nursing care activities’ and ‘patients’ perception of guidance provided by nurses’. The results of various tests suggest the scale has sufficient goodness of fit, reliability and validity.

The PENQuAH scale is promising in terms of its psychometric properties, the plausibility and meaningfulness of its dimensions, and its ease of use.

Critically ill patients are at high risk of acquiring ventilator-associated pneumonia (VAP), which occurs in approximately 20% of mechanically ventilated patients. VAP results either from aspiration of pathogen-contaminated oropharyngeal secretions or contaminated biofilms that form on endotracheal tubes (ETTs) after intubation. VAP results in increased duration of mechanical ventilation, increased intensive care unit and hospital length of stay, increased risk of death and increased healthcare costs. Because of its impact on patient outcomes and the healthcare system, VAP is regarded as an important patient safety issue and there is an urgent need for better evidence on the efficacy of prevention strategies. Modified ETTs that reduce aspiration of oropharyngeal secretions with subglottic secretion drainage or reduce the occurrence of biofilm with a coating of ceragenins (CSAs) are available for clinical use in Canada. In this implementation study, we will evaluate the efficacy of these two types of Health Canada-licensed ETTs on the occurrence of VAP, and impact on patient-centred outcomes.

In this ongoing, pragmatic, prospective, longitudinal, interrupted time, cross-over implementation study, we will compare the efficacy of a CSA-coated ETT (CeraShield N8 Pharma) with an ETT with subglottic secretion drainage (Taper Guard, Covidien). The study periods consist of four alternating time periods of 11 or 12 weeks or a total of 23 weeks for each ETT. All patients intubated with the study ETT in each time period will be included in an intention-to-treat analysis. Outcomes will include VAP incidence, mortality and health services utilisation including antibiotic use and length of stay.

This study has been approved by the Health Sciences Research Ethics Board at Queen’s University. The results of this study will be actively disseminated through manuscript publication and conference presentations.

NCT05761613.

To our knowledge, this study is the first to identify and describe current sepsis policies, clinical practice guidelines, and health professional training standards in Canada to inform evidence-based policy recommendations.

This study will be designed and reported according to the Arksey and O’Malley framework for scoping reviews and the Preferred Reporting Items for Systematic Review and Meta-Analyses Extension for Scoping Reviews. EMBASE, CINAHL, Medline, Turning Research Into Practice and Policy Commons will be searched for policies, clinical practice guidelines and health professional training standards published or updated in 2010 onwards, and related to the identification, management or reporting of sepsis in Canada. Additional sources of evidence will be identified by searching the websites of Canadian organisations responsible for regulating the training of healthcare professionals and reporting health outcomes. All potentially eligible sources of evidence will be reviewed for inclusion, followed by data extraction, independently and in duplicate. The included policies will be collated and summarised to inform future evidence-based sepsis policy recommendations.

The proposed study does not require ethics approval. The results of the study will be submitted for publication in a peer-reviewed journal and presented at local, national and international forums.

Early sepsis treatment in the emergency department (ED) is crucial to improve patient survival. Despite international promulgation, the uptake of the Surviving Sepsis Campaign (SSC) Hour-1 Bundle (lactate measurement, blood culture, broad-spectrum antibiotics, 30 mL/kg crystalloid for hypotension/lactate ≥4 mmol/L and vasopressors for hypotension during/after fluid resuscitation within 1 hour of sepsis recognition) is low across healthcare settings. Delays in sepsis recognition and a lack of high-quality evidence hinder its implementation. We propose a novel sepsis care model (National Early Warning Score, NEWS-1 care), in which the SSC Hour-1 Bundle is triggered objectively by a high NEWS-2 (≥5). This study aims to determine the feasibility of a full-scale type 1 hybrid effectiveness-implementation trial on the NEWS-1 care in multiple EDs.

We will conduct a pilot type 1 hybrid trial and prospectively recruit 200 patients from 4 public EDs in Hong Kong cluster randomised in a stepped wedge design over 10 months. All study sites will start with an initial period of standard care and switch in random order at 2-month intervals to the NEWS-1 care unidirectionally. The implementation evaluation will employ mixed methods guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance framework, which includes qualitative and quantitative data from focus group interviews, staff survey and clinical record reviews. We will analyse the 14 feasibility outcomes as progression criteria to a full-scale trial, including trial acceptability to patients and staff, patient and staff recruitment rates, accuracy of sepsis screening, protocol adherence, accessibility to follow-up data, safety and preliminary clinical impacts of the NEWS1 care, using descriptive statistics.

The institutional review boards of all study sites approved this study. This study will establish the feasibility of a full-scale hybrid trial. We will disseminate the findings through peer-reviewed publications, conference presentations and educational activities.

NCT05731349.

Dexmedetomidine is a promising pharmaceutical strategy to minimise opioid use during surgery. Despite its growing use, it is uncertain whether dexmedetomidine can improve patient-centred outcomes such as quality of recovery and pain.

We will conduct a systematic review and meta-analysis following the recommendations of the Cochrane Handbook for Systematic Reviews. We will search MEDLINE, Embase, CENTRAL, Web of Science and CINAHL approximately in October 2023. We will include randomised controlled trials evaluating the impact of systemic intraoperative dexmedetomidine on patient-centred outcomes. Patient-centred outcome definition will be based on the consensus definition established by the Standardised Endpoints in Perioperative Medicine initiative (StEP-COMPAC). Our primary outcome will be the quality of recovery after surgery. Our secondary outcomes will be patient well-being, function, health-related quality of life, life impact, multidimensional assessment of postoperative acute pain, chronic pain, persistent postoperative opioid use, opioid-related adverse events, hospital length of stay and adverse events. Two reviewers will independently screen and identify trials and extract data. We will evaluate the risk of bias of trials using the Cochrane Risk of Bias Tool (RoB 2.0). We will synthesise data using a random effects Bayesian model framework, estimating the probability of achieving a benefit and its clinical significance. We will assess statistical heterogeneity with the tau-squared and explore sources of heterogeneity with meta-regression. We have involved patient partners, clinicians, methodologists, and key partner organisations in the development of this protocol, and we plan to continue this collaboration throughout all phases of this systematic review.

Our systematic review does not require research ethics approval. It will help inform current clinical practice guidelines and guide development of future randomised controlled trials. The results will be disseminated in open-access peer-reviewed journals, presented at conferences and shared among collaborators and networks.

CRD42023439896.