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Gram negative bloodstream infections (GN BSI) are a leading cause of mortality worldwide, and antibiotic treatment approaches remain understudied. BALANCE+ is a perpetual Bayesian adaptive platform trial to test multiple treatment questions for hospitalised patients with GN BSI. The vanguard phase objective was to test the feasibility of the main trial.
Adaptive platform trial with five initial domains of investigation, each with open label 1:1 randomisation.
Ten hospitals across four Canadian provinces.
Individuals admitted to hospital with blood cultures yielding Gram negative bacteria.
The five initial domains of investigation included: antibiotic de-escalation versus no de-escalation; oral transition to beta-lactam versus non-beta-lactam treatment; routine versus no routine follow-up blood cultures (FUBCs); central vascular catheter replacement versus retention; and, ceftriaxone versus carbapenem treatment for low risk AmpC organisms.
Domain-specific recruitment rates and protocol adherence.
During the vanguard phase, 719 patients were screened, of whom 563 (78.3%) were eligible, with 179 (31.8%) enrolled into the platform. The platform recruitment rate was 1.37 patients/site-week. Recruitment varied by domain: routine versus no FUBC domain 1.23 patients/site-week; oral beta-lactam versus non-beta-lactam domain 0.48; de-escalation versus no de-escalation domain 0.28; low risk AmpC domain 0.02; catheter replacement versus retention domain 0.01. Domain specific protocol adherence rates were 145/158 (91.8%) for routine versus no routine FUBC, 53/60 (88.3%) for oral beta-lactam versus non-beta-lactam, 26/33 (78.8%) for de-escalation versus no de-escalation, 3/3 (100%) for low risk AmpC, and 0/1 (0%) for line replacement versus retention. There was complete ascertainment of all study outcomes in hospital 170/170 (100%) and near complete ascertainment at 90 days 162/170 (95.3%).
The vanguard phase demonstrated overall trial feasibility by recruitment rate and protocol adherence, with differences across interventions, leading to a transition to the main BALANCE+ platform trial with minimal protocol modifications.
We reviewed how artificial intelligence has been applied to inform care coordination by identifying and/or intervening in patients' unmet social needs.
Scoping review.
PubMed, CINAHL, PsycInfo, and Scopus databases were searched for articles published by November 2023.
Articles were excluded if they were reviews or protocols, did not explicitly mention artificial intelligence, or did not primarily focus on using it to identify and/or address unmet needs to inform care coordination.
Of 476 articles that underwent title and abstract screening, 102 were assessed for full-text eligibility, and eight were ultimately included. Five articles used both natural language processing and machine learning; two articles used natural language processing; and one article used machine learning. Half (n = 4) of the articles focused on using artificial intelligence to identify/predict social needs, and two each focused on artificial intelligence to examine social resource provision or to indirectly identify social needs or using artificial intelligence to facilitate addressing unmet needs through care coordination.
This review can inform an understanding of facilitators and barriers to the implementation of artificial intelligence in practice, to potentially improve patient care, health outcomes, and population health equity.
Using artificial intelligence to promote care coordination can expand opportunities to identify and intervene on social needs across more patients, with implications for nurses and other health professionals. It can also potentially exacerbate inequities and harm patient trust.
The findings suggest a gap between the practice of incorporating artificial intelligence into integrated care platforms and the available scientific literature. This review can provide healthcare providers and organisations with insights into integrating artificial intelligence into clinical workflows, which may inform decisions about whether or how to implement these technologies in clinical settings.
We followed PRISMA-ScR guidelines.
No Patient or Public Contribution.
Depression and depressive symptoms are common in the elderly population and contribute to a lower quality of life. One change that is common in depression is the disruption of circadian cycles, which are regulated by melatonin and other neurotransmitters. Oral melatonin and melatonin agonists are well tolerated, being the main clinical indication of insomnia. A melatonin agonist is approved as an antidepressant. Thus, the objective of the systematic review will be to provide an up-to-date synthesis of the findings of randomised controlled trials that used melatonin or melatonin agonists as a therapeutic intervention in elderly people with depression.
This systematic review protocol was registered with PROSPERO under the number CRD42023391092. We will conduct a systematic review and possible meta-analysis of the efficacy of melatonin and melatonin agonists in the treatment of depression. Comparators will include placebo and active treatments (eg, antidepressants). We will search international electronic databases, including the Cochrane Library (Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials), EMBASE, PUBMED/MEDLINE and SciELO for published randomised control trial studies, and ongoing work and trials in progress by searching key internet-based relevant databases from inception to April 2025. There will be no restrictions on the language or geography of publication. The Cochrane’s risk of bias tool for randomised trials (RoB2) will be used to appraise the risk of bias, and GRADE tools will be used to evaluate the overall quality of the included studies. A descriptive summary with data tables will be constructed, and if adequate, we will perform a meta-analysis. A random-effects model will be used when substantial heterogeneity is present, otherwise, a fixed-effects model will be considered (I²). The Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist will be followed for reporting.
Since this systematic review will be based only on published and retrievable literature, no ethics approval will be required. A multidisciplinary team has been assembled for this systematic review and will participate in relevant dissemination activities, namely reports, publications and presentations.
CRD42023391092.
Acute hypoxaemic respiratory failure is a common reason for intensive care unit (ICU) admission. Non-invasive respiratory support strategies such as high-flow nasal oxygen (HFNO) and helmet non-invasive ventilation may reduce the need for invasive mechanical ventilation and death. The High-flow nasal Oxygen with or without alternating helmet Non-invasive ventilation for Oxygenation sUpport in acute Respiratory failure pilot trial is designed to compare helmet non-invasive ventilation combined with HFNO vs HFNO alone in patients with acute hypoxaemic respiratory failure and to determine the feasibility of a larger randomised controlled trial.
This is a pragmatic, open-label, multicentre randomised controlled pilot trial enrolling 200 critically ill adults with acute hypoxaemic respiratory failure across 12 Canadian ICUs. Participants are randomised 1 to 1 to receive either helmet non-invasive ventilation plus HFNO or HFNO alone for at least 48 hours. The primary aim is to assess feasibility metrics including recruitment rate, protocol adherence and fidelity to pre-specified intubation criteria. Secondary outcomes include rates of intubation, all-cause mortality, ventilator-free days, ICU length of stay and quality of life at 6 months. Primary and secondary outcomes will be analysed using Bayesian methods.
Ethics approval has been obtained at all participating centres. Findings will inform the feasibility and design of a future full-scale trial and be disseminated through peer review publications and conference presentations.
ClinicalTrials.gov Identifier: NCT05078034.
Eating disorders are complex mental health conditions characterised by pathological behaviours related to food intake, often accompanied by a chronic obsession with weight control. Their prevalence is increasing, with an earlier onset and greater severity among young people. Universal prevention, through multicomponent strategies that tackle modifiable risk factors, has emerged as a promising tool. This paper reports the study protocol designed to assess the effectiveness and cost-effectiveness of the PRETA (Prevención de los Trastornos de la Alimentación) programme in reducing the risk of eating disorders and related modifiable risk factors among preadolescents in the school setting.
The PRETA programme will be assessed by means of an open, community-based, multicentre, controlled trial using 1:1 matched-pairs cluster randomisation at the school level. Schools in Tenerife (Spain) will be assigned to the PRETA programme or a waitlist control group. Participants include 5th- or 6th-grade students (10–13 years old), their parents and teachers. The PRETA programme is a universal, school-based, multicomponent programme designed to reduce eating-disorder risk and modifiable risk factors. Its main component is an interactive online platform called e-PRETA, complemented by training sessions for families and teachers. e-PRETA includes nine 45-minute sessions addressing risk factors, such as dietary habits, beauty standards, media literacy, self-esteem, emotional regulation and social skills. A total of 1068 children from 12 schools will participate. The primary outcome will be the risk of developing eating disorders (Children’s Eating Attitudes Test-26 item version). Secondary outcome measures are body dissatisfaction (Adapted Contour Drawing Rating Scale), eating disorder traits (Eating Disorder Inventory-2), internalisation of appearance ideals (Sociocultural Attitudes Towards Appearance Questionnaire-4) and self-esteem (Rosenberg Self-Esteem Scale). Outcomes will be assessed at baseline and postintervention (3 months). Additional baseline covariates such as electronic device use, parental feeding attitudes, physical activity, sleep duration and screen time will also be collected. Programme effectiveness will be analysed using generalised mixed models. Cost-effectiveness will be assessed by comparing the incremental costs associated with the implementation of the PRETA programme with its estimated effectiveness.
Ethics approval has been obtained from the Ethics Committee for Research with Medicines at the University Hospital of the Canary Islands (CHUC_2021_78). Written informed consent will be obtained from the parents or legal guardians of all participants. Results will be disseminated through scientific publications and conferences.
Inhaled anaesthetics can be used in mechanically ventilated critically ill patients to provide sedation. This approach to sedation potentially improves patient and health system outcomes, but further supportive evidence is needed. The objective of the SAVE-ICU clinical trial is to compare the effectiveness of inhaled versus intravenous sedation in ventilated adults with acute hypoxaemic respiratory failure.
SAVE-ICU is a multicentre, open-label, pragmatic, randomised controlled trial conducted in 15 intensive care units (ICUs) in Canada and the USA. Eligible patients include mechanically ventilated and sedated adults with acute hypoxemic respiratory failure from COVID-19 or non-COVID causes with PaO2/FIO2 ratio 12 hour). A hierarchy of outcomes was identified at the time of trial design, as the trial was launched during the COVID-19 pandemic when study drug shortages, staffing challenges and healthcare system pressures were prevalent and there was a requirement for rapid evidence generation and implementation on this topic. The primary outcome and highest in the hierarchy is hospital mortality (requiring 758 participants). Secondary and lower hierarchical outcomes are ventilator-free days at day 30 (200 patients), quality of life at 3 months (144 participants) and ICU-free days at day 30 (128 participants). Additional secondary outcomes include median daily oxygenation at day 3 (PaO2/FIO2 ratio), need for adjunctive acute respiratory distress syndrome therapies (prone positioning, inhaled nitric oxide, paralysis with a neuromuscular blocking agent and extracorporeal membrane oxygenation) during ICU stay, days alive and free from delirium and coma at day 14, hospital-free days at day 60 and disability score at 3 months and 12 months after enrolment.
The protocol was approved by all hospital ethics committees and by Health Canada. Informed consent will be obtained from substitute decision makers or deferred consent (as permitted by site ethics board). Trial findings will be shared at the end of the study using peer-review publications, conference presentations and social media as part of the trial knowledge translation plan.
Commentary on: Wen, F. H., Prigerson, H. G., Hu, T. H., Huang, C. C., Chou, W. C., Chuang, L. P., Chiang, M. C., & Tang, S. T. (2024). Associations Between Family-Assessed Quality-of-Dying-and-Death Latent Classes and Bereavement Outcomes for Family Surrogates of ICU Decedents. Crit Care Med. Published online February 1, 2024. doi:10.1097/CCM.0000000000006199.
Improving end-of-life (EoL) care in intensive care units is paramount for supporting patients and families. Supporting families with EoL decisions can impact their postbereavement health-related quality of life. Recognising and fostering spiritual self-awareness may enhance the bereavement experience.
Intensive care units (ICUs) exposes both patients and families to an unfamiliar/stressful environment, featuring the urgency for enhanced end-of-life (EoL) care within ICUs.
Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) entails substantial morbidity and mortality, yet no epidemiologic evidence exists on its outcomes in Mexico. This study assessed national hospitalisations (2005–2022) and mortality (2000–2022) related to AAV using data from the General Board of Health Information.
Retrospective, population-based time-trend analysis on administrative health data.
Mexico’s national hospital discharge and mortality registries, covering 1 January 2000 through 31 December 2022.
All individuals aged ≥ 15 years with a primary or secondary International Classification of Diseases, 10th revision, diagnosis of AAV recorded during hospitalisation or on death certificates nationwide.
The study’s primary outcomes were the age-standardised hospitalisation and mortality rates for AAV (expressed per 100 000 population, overall and by sex), with temporal trends in both rates quantified using Joinpoint regression to calculate annual percent change (APC) and average APC (AAPC).
We identified 2804 hospitalisations and 599 deaths. Females accounted for 49.7% of hospitalisations, while males represented 48.7% of deaths. Although the overall age-standardised hospitalisation rate (ASHR) and mortality rate (ASMR) AAPCs were not statistically significant, relevant trends emerged. From 2010 to 2022, ASHR declined significantly (APC: –5.2%; 95% CI –9.7, –0.5; p=0.03), whereas mortality rates remained stable from 2000 to 2022 (AAPC: +3%; 95% CI –4.6, 11.3; p=0.45). Nevertheless, mortality increased among males (APC: +6.4%; 95% CI 0.9, 12.2; p=0.02) and individuals over 45 years (APC: +8.6%; 95% CI 1.7, 16.0; p=0.02) from 2008 onwards.
Overall, these findings indicate no major changes in national rates but reveal a decline in hospitalisations since 2010 and a rise in mortality for specific subgroups since 2008. Targeted interventions, particularly for older adults and men, appear warranted to address this evolving disease burden. Future research should explore underlying risk factors and evaluate tailored strategies to improve clinical outcomes in AAV across Mexico.
This study validates the previously tested Screening for Poverty And Related social determinants to improve Knowledge of and access to resources (‘SPARK Tool’) against comparison questions from well-established national surveys (Post Survey Questionnaire (PSQ)) to inform the development of a standardised tool to collect patients’ demographic and social needs data in healthcare.
Cross-sectional study.
Pan-Canadian study of participants from four Canadian provinces (SK, MB, ON and NL).
192 participants were interviewed concurrently, completing both the SPARK tool and PSQ survey.
Survey topics included demographics: language, immigration, race, disability, sex, gender identity, sexual orientation; and social needs: education, income, medication access, transportation, housing, social support and employment status. Concurrent validity was performed to assess agreement and correlation between SPARK and comparison questions at an individual level as well as within domain clusters. We report on Cohen’s kappa measure of inter-rater reliability, Pearson correlation coefficient and Cramer’s V to assess overall capture of needs in the SPARK and PSQ as well as within each domain. Agreement between the surveys was described using correct (true positive and true negative) and incorrect (false positive and false negative) classification.
There was a moderate correlation between SPARK and PSQ (0.44, p60), SPARK correctly classified 90.5% (n=176/191).
SPARK provides a brief 15 min screening tool for primary care clinics to capture social and access needs. SPARK was able to correctly classify most participants within each domain. Related ongoing research is needed to further validate SPARK in a large representative sample and explore primary care implementation strategies to support integration.
Fatigue is a common and debilitating symptom that is associated with an increased risk of mortality, dialysis initiation and hospitalisation among patients with chronic kidney disease (CKD). The aim of this study was to identify the characteristics, content and psychometric properties of patient-reported outcome measures (PROMs) used to measure fatigue in patients with CKD not requiring kidney replacement therapy (KRT).
Systematic review. The characteristics, dimensions of fatigue and psychometric properties of these measures were extracted and analysed.
We searched MEDLINE, Embase, PsycINFO and CINAHL from database inception to February 2023.
All studies that reported fatigue in patients with CKD stages 1–5 not receiving KRT.
We identified 97 studies (20 (21%) randomised trials, 2 (2%) non-randomised trials and 75 (77%) observational studies). 27 different measures were used to assess fatigue, of which three were author-developed measures. The 36-Item Short Form Health Survey (SF-36) and Kidney Disease Quality of Life – Short Form (KDQOL-SF) were the most frequently used measures (41 (42%) and 24 (25%) studies, respectively). Six (22%) measures were specific to fatigue (Chalder Fatigue Questionnaire, Functional Assessment of Chronic Illness Therapy – Fatigue Scale, Functional Assessment of Cancer Therapy-Fatigue, Fatigue Severity Scale, and author developed Chen & Ku 1998, and Hao et al 2021) while 21 (78%) included a fatigue subscale or item within a broader construct for example, quality of life. Various content domains assessed included tiredness, ability to think clearly, level of energy, muscle weakness, ability to concentrate, verbal abilities, motivation, memory, negative emotions and life participation. Only two measures (Chronic Kidney Disease Symptom Index – Sri Lanka, Kidney Symptom Questionnaire) were developed specifically for CKD, but they were not specific to fatigue. Six measures (Chronic Kidney Disease Symptom Index – Sri Lanka, Functional Assessment of Cancer Therapy – Anemia, Revised Illness Perception Questionnaire, Kidney Symptom Questionnaire, Short Form 6 Dimension and 36-Item Short Form Health Survey) had been validated in patients with CKD not requiring KRT.
PROMs used to assess fatigue in patients with CKD vary in content and few were specific to fatigue in patients with CKD not requiring KRT. Data to support the psychometric robustness of PROMs for fatigue in CKD were sparse. A validated and content-relevant measure to assess fatigue in patients with CKD is needed.
To evaluate the impact of using ‘Situation-Background-Assessment-Recommendation’ method (‘SBAR’) in a palliative care setting.
Effective handover communication is crucial for patient safety. Standardised communication tools, such as the SBAR method, are recommended to reduce errors and improve care coordination, but their use in palliative care is not investigated.
Mixed method study design, adhering to the GRAMMS guideline.
From January to October 2021, a SBAR guide tailored for palliative care was developed using the Delphi method and implemented in a Hospice setting. Data on 150 nurse handovers were collected before and after implementation to assess changes in nursing outcomes, including medication errors, adverse events and the identification of psychological and spiritual needs. Nurses' perceptions on the handover process were gathered through a qualitative survey.
The SBAR guide significantly improved the handovers quality, reducing medication errors and eliminating adverse events postimplementation. The identification of psychological and spiritual needs increased during postimplementation period. Nurses also reported improved clarity, accuracy and completeness of information during handover.
This is the first study to evaluate the impact of SBAR for handover in palliative nursing care. Findings show the added value of using communication tools.
Objetivo. Describir la prevalencia de pacientes con alteración de sueño en presencia de luz y ruidos nocturnos durante su internación en el 6º piso del Hospital Universitario Austral. Material y Métodos. Estudio transversal en una población de pacientes obstétricos y clínicos internados, elegidos mediante muestreo consecutivo. Para la recolección de datos se realizó una encuesta anónima por medio de una herramienta digital. Se incluyeron las variables sociodemográficas y ocho preguntas relacionadas a la satisfacción del descanso y la repercusión de la luz y el ruido de las últimas dos noches. Los datos fueron volcados en un Excel para su posterior análisis. Resultados. La prevalencia de pacientes con alteración del descanso en presencia de luz y de ruido fue del 9% (23). La población analizada fue de 246 pacientes, con una edad promedio de 34 años (DE ± 12); de las cuales 78% (191) fueron mujeres. En cuanto al tipo de paciente, 74% (180) fueron obstétricos y 17% (40) clínicos. Según la ubicación de las habitaciones, 34% (82) se encontraban ubicados cerca del office de enfermería y 66% (160) se encontraban lejos. La alteración del descanso de los pacientes no varía según el tipo de pacientes (obstétricos o clínicos) ni según su cercanía al office de enfermería. Discusión. La prevalencia de la alteración del sueño es muy baja. El instrumento midió la satisfacción con un instrumento corto, rápido, dinámico. Es la única herramienta encontrada en la literatura que responda a la satisfacción y percepción del sueño en relación con el ruido y la luz.
ABSTRACT
Objective. Describe the prevalence of inpatients with sleep alterations due to nocturnal lights and noises during their stay in the 6th floor of the Hospital Universitario Austral. Methodology. A cross-sectional study was conducted on a group of inpatients, either from the obstetric or the general care section, who were selected throughout consecutive sampling. Data recollection was done by an anonymous survey using a digital tool. The survey included socio demographic variables and eight questions about rest satisfaction and the impact of light and noise over rest within the last two nights. This information was transferred to an Excel for its further analysis. Results. The prevalence of patients with rest alteration in presence of light and noise was 9% (23). The study was carried out on a group of 246 patients, with an average age of 34 years old (± 12); 78% of which (191) were women. As regards the kind of patient, 74% (180) were obstetrical patients and 17% (40) were derived from the general care section. As to room location, 34% (82) were near the nurse working station and 66% (160) were far away from it. Sleep alteration in patients is not affected by the type of patient (obstetrical or general) or by their proximity to the nurse working station. Discussion. The prevalence of sleep alteration is very low. Satisfaction was measured with a short, quick and dynamic instrument. This is the only document found in literature which answers to rest satisfaction and perception in relation to light and noise.
Objetivo principal: Conocer la percepción de los profesionales de enfermería sobre la prevención y tratamiento de lesiones en pacientes hospitalizados con enfermedades potencialmente mortales. Metodología: Estudio con enfoque cualitativo y cuantitativo, descriptivo y exploratorio, realizado en unidades clínicas, quirúrgicas, unidad de cuidados intensivos y unidad de urgencias de un hospital del sur de Brasil. Datos recogidos en 2014 mediante entrevistas semiestructuradas con 118 profesionales de enfermería. Resultados principales: Se identificaron tres categorías temáticas: La percepción de la atención; Prevención y tratamiento de lesiones; y Dificultades y estrategias para implementar la atención. Conclusión principal: El escenario de investigación no cuenta con unidad de cuidados paliativos. Realidad de la mayoría de los servicios, aumentando la posibilidad de desconocimiento del tema. Sin embargo, se cree que los resultados de este estudio pueden contribuir a reforzar la necesidad de esta línea de atención.
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