Acute respiratory distress syndrome (ARDS) is a major public health problem, accounting for 23% of intubated patients and associated with high mortality rates. Although lifesaving, invasive mechanical ventilation can worsen lung injury when ventilator settings are poorly adjusted to lung physiology. We hypothesise that individualising ventilator settings via (1) the bedside assessment of lung recruitability using a one-breath derecruitment manoeuvre and measurement of airway opening pressure to set positive end-expiratory pressure (PEEP), (2) controlling the distending pressure and (3) controlling respiratory drive improves ARDS outcomes.
The CAreful Ventilation In ARDS trial is an investigator-led multicentre (33 centres in eight countries), open-label, randomised controlled basket trial comparing two ventilation strategies in two subpopulations of moderate-to-severe ARDS: induced or not by COVID-19. A total of 740 patients will be randomised (370 in each substudy) in a 1:1 ratio to individualised ventilator settings or to using traditional PEEP to inspired fraction of oxygen tables for PEEP setting. Indications for proning and weaning strategies are similar in both arms. The primary outcome is all-cause mortality at day 60. Secondary outcomes include duration of mechanical ventilation, duration of intensive care unit (ICU) and hospital stay, organ dysfunction, barotrauma and mortality in ICU, at day 28 and in hospital.
Ethics approval has been obtained for all participating centres: Unity Health Toronto Research Ethics Board (for three centres: St Michael’s Hospital, Toronto General Hospital and Toronto Western Hospital); Comité de Ética de Investigación con Medicamentos del Hospital Universitari Vall d’Hebron; Comité de protection des personnes Ile de France III; Comité d'Ética de la Investigatción con Medicamentos de la Fundació de Gestió Sanitària del Hospital de la Santa Creu i Sant Pau; Comitato Etico—Fondazione Policlinico Gemelli; Comitato Etico di Area Vasta Emilia Centro; NYU Langone Health Institutional Review Board; Comité Ético Científico de Ciencias de la Salud; Il Comitato Etico Area 1 dell’Azienda Ospedaliero-Universitaria ‘Ospedali Riuniti’ di Foggia; HIGA ‘Eva Perón’ Comité de Bioética; Comité de Revisión Institucional del Hospital Británico Comité de Ética en Investigación; Complejo Médico Churruca-Visca Comité de Ética Biomédica; Comité de Ética SATI Comité de Ética en Investigación; Comité de Ética en Investigación del CEMIC; Comité de Ética SATI Comité de Ética en Investigación; Medical Research Ethics Committees United. Findings will be disseminated in peer review journals and conference presentations.
Biofilms are a key driver of chronicity and treatment failure in diabetic foot ulcers (DFUs), yet clinical evidence quantifying their impact and management remains fragmented. This systematic narrative review synthesised recent evidence (2015–2025) on the prevalence, diagnostics, and management of biofilm in DFUs. A Systematic Review of the Literature (SRL) was conducted following PRISMA 2020 guidelines across PubMed/MEDLINE, Scopus, Cochrane Library and ScienceDirect. Eligible studies included adults with DFUs reporting biofilm/bioburden metrics or interventions aimed at biofilm disruption. Risk of bias was assessed using RoB 2 for randomised trials and ROBINS-I for non-randomised studies. Data were narratively synthesised by evidence tier (Tier 1 = clinical; Tier 2 = preclinical/mechanistic). Of 600 records screened, 25 studies met inclusion criteria (Tier 1 n = 9; Tier 2 n = 5; reviews n = 11). Over half of bacterial isolates in DFUs were biofilm producers, with multidrug resistance exceeding 90% in several cohorts. Fungi were detected in 31% of ulcers by qPCR but only 9% by culture. Tier 1 clinical evidence supports standard care components—debridement, antiseptics, and negative-pressure wound therapy—for improved healing, though direct antibiofilm outcomes remain limited. Emerging strategies (enzymatic agents, peptides, cold plasma, smart dressings) show promise in vitro but lack clinical translation. Evidence for direct antibiofilm efficacy in DFUs remains scarce. Current data justify maintaining guideline-based care while prioritising trials that integrate validated biofilm endpoints, standardised microbiological methods, and antifungal components. Distinguishing established from experimental approaches is essential to advancing safe, evidence-based biofilm management in DFUs.
Tobacco use is the most significant modifiable risk factor for adverse health outcomes, and early research indicates there are also significant harms associated with vaping. National targets aim to reduce smoking and vaping during pregnancy for Aboriginal and Torres Strait Islander people. While most Aboriginal and Torres Strait Islander people want to quit, cessation is frequently attempted without support, increasing the chance of relapse. Group-based smoking cessation programmes increase quit success by 50%–130% in the general population; however, they have never been evaluated in Aboriginal and/or Torres Strait Islander communities.
The Gulibaa study is an Indigenous-led and community-embedded project that will co-design, implement and evaluate a group-based model of care to support Aboriginal and Torres Strait Islander women to be smoke- and vape-free. Staff of Health Services in New South Wales, Australia, will receive training to deliver a face-to-face group-based smoking and vaping cessation intervention. Aboriginal and/or Torres Strait Islander people who identify as a woman or non-binary, are pregnant or of reproductive age (16 to 49 years), currently smoke or vape at least once per day and are willing to attend the programme are eligible to participate. Up to 500 participants will be recruited. A mixed method evaluation approach will be implemented guided by the RE-AIM framework. Outcomes will include intervention reach, intervention effectiveness (determined primarily by self-reported 7-day point prevalence abstinence at 6 months follow-up), acceptability and feasibility of the intervention, programme fidelity and maintenance and cost effectiveness.
Embedding culturally safe support to quit during pregnancy can result in improved outcomes for both mother and child and immediately improve intergenerational health and well-being. Ethics approval has been provided by the Aboriginal Health and Medical Research Council and the University of Newcastle. Study findings will be disseminated to Aboriginal and Torres Strait Islander communities in ways that are meaningful to them, as well as through Aboriginal health services, key national bodies, relevant state and federal government departments.
ACTRN12625001050448.
This study aimed to examine the psychosocial impact and identify risk factors for poor psychosocial outcomes in healthcare professionals during the Coronavirus disease 2019 (COVID-19) pandemic in Cyprus.
Healthcare professionals are in the forefront of the COVID-19 pandemic facing an unprecedented global health crisis, which can have consequences on their psychosocial health. There is a need to identify risk factors for poor psychosocial outcomes to inform the design of tailored psychological interventions.
Cross-sectional online study.
A total of 1071 healthcare professionals completed self-report questionnaires. Measures included sociodemographic information, COVID-19-related characteristics, quality of life (Brief World Health Organization Quality of Life; WHOQOL-Bref), anxiety (Generalized Anxiety Disorder-7; GAD-7), depression (Patient Health Questionnaire-8; PHQ-8), occupational burnout (Copenhagen Burnout Inventory; CBI), and coping (Brief Coping Orientation to Problems Experienced; Brief COPE). This article follows the STROBE reporting guidelines.
The prevalence of moderate to severe anxiety and clinically significant depression was 27.6% and 26.8%, respectively. Significant risk factors for poor psychological outcomes included being female, being a nurse or doctor (vs non-medical professional), working in frontline units (inpatient, intensive care), perceptions of inadequate workplace preparation to deal with the pandemic, and using avoidance coping. Depression and occupational burnout were significant risk factors for poor quality of life.
The findings suggest several individual, psychosocial, and organisational risk factors for the adverse psychological outcomes observed in healthcare professionals during the COVID-19 pandemic.
This study highlights the urgent need for screening for anxiety and depression and psychological interventions to combat an imminent mental health crisis in healthcare professionals during the COVID-19 pandemic. Pandemic response protocols and public health initiatives aiming to improve and prevent mental health problems in healthcare professionals during the current and future health crises, need to account for the various factors at play.
Type 2 diabetes is a prevalent chronic disease, associated with health complications, premature morbidity and significant healthcare costs. Optimal lifestyle behaviour control and patient self-management are crucial for improving diabetes control; however, they are difficult to achieve in primary care. There is limited research on the use of information from wearable devices to encourage behaviour change. This study will examine the effectiveness and cost-effectiveness of a multi-component health behaviour intervention in achieving clinically significant reductions in haemoglobin A1c (HbA1c) among general practice patients with type 2 diabetes.
The study uses a cluster-randomised controlled design, with general practices randomly assigned to either the Wearables Integrated Technology (WEAR-IT) intervention (n=15) or usual care (n=15). To achieve a sample size of 375 participants, 12–13 patients per practice will be recruited. Patients diagnosed with type 2 diabetes will be eligible to participate if they are aged 18–75 years; have had poorly controlled diabetes (HbA1c≥7.5%), with the cognitive capacity and ability to access the intervention application via an iOS or Android smart device. The WEAR-IT self-management intervention combines information from wearable devices (physical activity, blood glucose and blood pressure) and the electronic medical record, with goal setting and coaching support. The intervention will be primarily delivered by the general practice nurse, with review and confirmation of goals by the general practitioner. Participants attending the usual care practices will receive standard care. Outcome measures, including HbA1c, lipids, blood pressure, quality of life, dietary and exercise behaviours and cost-effectiveness, will be collected at baseline, 6-month (primary endpoint) and 12-month post-randomisation. The primary analysis will compare the change in HbA1c between the intervention and control groups at 6-month follow-up, with long-term outcomes assessed at 12-month post-randomisation.
The study was approved by Bond University (BH00137). Results will be disseminated through peer-reviewed journal publications, conference presentations and summaries to participating sites and patients.
Australian New Zealand Clinical Trials Registry (ACTRN12624000957594).
The objective of the scoping review was to systematise the existing knowledge about skill mix changes among the healthcare workforce during the COVID-19 pandemic.
Scoping review according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Review.
Five databases including CINAHL Ultimate, Web of Science, Medline, Embase and Scopus were searched in August 2024.
The review encompassed original research studies published from January 2020 to August 2024, on the skill mix of healthcare workers during the COVID-19 pandemic. Quantitative and qualitative studies were included without geographical or linguistic restrictions.
Data were independently extracted by two researchers, capturing details such as publication year, study title, country, target population, study purpose and methodology, sample size, analysed variables, results and recommendations.
A total of 13 563 records were identified in the databases of which 3962 remained for abstract review. 32 articles were included in the final analysis. 17 of the 32 papers were from Western and Southern Europe. The healthcare professions which were described in the studies were physicians, nurses, midwives, paramedics, pharmacists, physiotherapists, occupational therapists and medical assistants, of which the majority of the studies were conducted among nurses (n=16), pharmacists (n=11) and physicians (n=6). Most studies (n=9) concerned the adding of new tasks/roles and reallocating tasks in combination with teamwork (n=8). Research covered a range of topics, including psychological aspects of work, patient safety, work reorganisation, training and collaboration. Many studies focused on the challenges related to skill mix, such as the blurring of responsibilities and role ambiguity.
The research summarised in this review demonstrates the impact of implementing skill mix changes on healthcare workers during the COVID-19 pandemic, particularly in the area of mental health. The research highlights the importance of adaptation in response to pressures among healthcare professions and the entire system. Further research is needed to examine the long-term impact of skill mix on healthcare workers across regions and professions in crisis situations.
To explore neonatal survival by type of neonatal complications at birth and referral pattern for these complications by place of delivery.
Bihar, India.
Women aged 15–49 years who had given live birth between July 2020 and June 2021.
Prevalence of neonatal complications at birth, referral pattern by complication and neonatal deaths by type of complication.
Data were available for 6767 (81.8%) newborns including 717 neonatal deaths. The prevalence of at least one neonatal complication at birth was reported for 32.9% (95% CI 32.4 to 33.4) newborns, with the most common complications including difficulty in breathing (21.9%), high fever (20.7%), low birth weight (12.5%) and jaundice (13.2%). A total of 578 (26.6%; 95% CI 25.8 to 27.4) neonates with complications at birth were referred to another health provider, predominantly to private sector (68.1%, 93% and 78.7% from public facility, private facility and home). The complications with high referrals included meconium aspiration syndrome (64.1%; 95% CI: 61.1 to 67.1), inability to pass urine (54.7%; 95% CI: 42.1 to 67.2), difficulty in suckling (49.7%; 95% CI: 46.9 to 52.5), cold to touch (48.5%; 95% CI: 43.5 to 53.6), inability to cry (47.2%; 95% CI: 44.2 to 50.1), pneumonia (45.6%; 95% CI: 42.0 to 49.1), difficulty in breathing (44.0%; 95% CI: 42.5 to 45.6) and lethargy (43.5%; 95% CI: 38.4 to 48.6). Referrals were linked to higher neonatal deaths, in particular, among neonates born at home and referred for complications (84.7%; p
With one-third of the neonates reported to have complications at birth and those referred more likely to die, critical gaps in addressing neonatal complications at birth and improvement in the referral services are urgently needed to reduce neonatal mortality.
Modern healthcare is delivered by an increasingly multidisciplinary team, complicating workforce management. Patient safety inquiries have led to reports such as the Francis and Berwick reports (2013), which consistently emphasise the need for proper staffing to ensure patient safety. While nursing has seen progress with safe staffing guidelines, there remains a significant gap in guidance for medical staff. In the UK, consultants are the senior members of the medical profession who have achieved a Certification of Completion of Training (CCT) and are able to practice independently. The number of required consultants is based on population needs, and future consultant numbers are used to determine the number of doctor training positions. However, this approach often overlooks the specific staffing needs of individual hospitals, particularly regarding patient safety. Although a named consultant is responsible for patient care, the medical workforce that handles day-to-day operations in acute hospitals consists of a diverse group of staff who require varying degrees of supervision based on their competency and seniority. This group includes medical associates, such as physician associates, and resident doctors (formerly known as junior doctors) who themselves are a heterogeneous group needing different levels of oversight. As a result, the previous focus solely on consultant staffing requirements must be broadened to address the realities of patient care. At present, no single resource provides a comprehensive summary of staffing recommendations that includes all groups within the non-consultant medical workforce. This research aims to identify existing guidance for this part of the medical workforce to support healthcare management. The objectives of this study are, therefore, to identify guidance and recommendations for safe staffing levels from a patient safety perspective for non-consultant medical staff in UK acute hospitals.
A scoping literature review was conducted and is reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines.
This used five search strategies: internal website searches, Google Scholar searches, general Google searches, medical database searches via Ovid and a snowballing strategy.
English-language resources published from 2015 to 2024 that provide specific guidance on safe medical staffing levels for National Health Service acute hospitals in the UK.
Thematic analysis was employed to identify patterns in the diverse guidance discovered, using a hybrid approach that combined human and AI methods. The benefits and limitations of this method are discussed.
The review yielded 10 703 resources, of which 10 met all eligibility criteria for analysis. Identified themes include staffing requirements, staffing recommendations and a tiered system approach.
Medical staffing is complex due to the varying roles and competencies involved. While some guidance exists, there is a clear need for more comprehensive recommendations that go beyond specific specialities. Future research should focus on developing a medical safe staffing tool and addressing the barriers to comprehensive guidance, both of which would enhance patient care.
Las enfermeras nos planteamos las diferentes formas con las que podemos comunicarnos con nuestros pacientes, pero quizás deberíamos pro-fundizar cuántas veces somos nosotras mismas las que, prejuzgamos situaciones, y acabamos siendo las que ponemos barreras a la comunica-ción. El relato que a continuación describimos es una historia real, donde su protagonista, tras el seudónimo de Serafín, nos muestra cómo en las últimas horas de su vida, ni su mudez ni la gravedad de su enfermedad limitaron su comunicación con la persona que lo cuidaba y que a su vez era quien realmente lo conocía. En una residencia de mayores cuando las personas precisan cuidados paliativos, se trabaja con las ventajas de poder ejercer un cuidado que va más allá del confort y del alivio de síntomas. En este tipo de instituciones los profesionales han convivido durante años con sus pacientes y en muchas ocasiones, tan solo una mirada puede hacer que la persona muera en paz.