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Unbound cloxacillin plasma concentrations in relation to toxicity and renal function: protocol for a prospective, observational clinical trial in a real-world Staphylococcus aureus bacteraemia population

Por: Damgaard · T. · Hellborg · T. · Larsson · A. · Eliasson · E. · Bonnedahl · J. · Nielsen · E. I. · Schön · T. · Hällgren · A.
Introduction

Staphylococcus aureus bacteraemia (SAB) is a common and severe infection, with a 90-day mortality of 24%–32%. Cloxacillin is regarded as a first-line antibiotic treatment in SAB in Sweden. However, exposure to cloxacillin in real-world hospitalised patients with SAB, most of whom are elderly patients treated outside the intensive care unit, is not well described. There are also limited data on the role of unbound cloxacillin exposure in relation to renal function or drug-induced toxicity.

Methods and analysis

This multicentre, prospective, observational clinical trial will include 95 adult patients with methicillin-susceptible S. aureus bacteraemia, treated with cloxacillin. Patients with endocarditis, polymicrobial bacteraemia or those considered unsuitable for cloxacillin treatment are excluded. Trough and peak total and unbound cloxacillin concentrations will be measured at steady state at days 2 and 7. Blood cultures will be obtained at days 2, 3, 4 and 7 to assess time to negative culture. Renal function will be assessed daily for plasma creatinine and at days 1 and 6 for cystatin C and for 12-hour urine creatinine clearance. In a novel approach to detecting nephrotoxicity, renal tubular damage biomarkers will be measured at days 1 and 6 (KIM-1, N-acetyl-β-D-glucosaminidase, neutrophil gelatinase-associated lipocalin, urine cystatin C, alpha-1-microglobulin). Detection of neurologic symptoms such as confusion, tremor, hallucinations and convulsions, as well as consciousness, will be monitored daily using a structured evaluation form.

We aim to investigate to which extent target attainment (100% of the dosing interval during which the free (unbound) drug concentration exceeds the minimum inhibitory concentration) is achieved with standard dosing of cloxacillin in a real-world cohort of hospitalised patients with SAB, and whether initial renal function can predict who is at risk for underdosing or overdosing. We will also explore whether neurological or renal damage is prevalent and associated with cloxacillin levels.

Ethics and dissemination

Ethics approval has been granted by the Swedish Ethical Review Authority (EUCT 2023-505148-20-00) as part of a low-intervention clinical trial approval according to EU regulation 536/2014. Results will be disseminated in a peer-reviewed journal and at academic conferences.

Trial registration number

EUCT 2023-505148-20-00.

Patients experiences of ward rounds in a Swedish context: a qualitative study

Por: Larsson · E. · Hordiienko · Y. · Fagerström · C. · Almerud-Österberg · S. · Finnbogadottir · H. R. · Persson · C.
Objective

The aim was to explore patients’ experiences of ward rounds in inpatient care.

Design

An exploratory qualitative design was chosen, collecting data with one-to-one semistructured interviews, conducted from March to May 2023. An interview guide was used as a basis for the interviews. Data were analysed using reflexive thematic analysis.

Setting

A medical and a surgical ward at a medium-sized hospital in southern Sweden.

Participants

Purposeful sampling was used to recruit patients aged 18 years or older. 16 patients were recruited with an age range of 38–72 years.

Results

The findings showed that patients’ experiences of ward rounds have a wide range of variation. The main theme was: ‘The ward round as a bridge between patients’ experiences and knowledge and healthcare professionals’. The main theme consisted of two subthemes, reflecting the variation in patients’ experiences: ‘Feeling of togetherness versus loneliness’ and ‘Getting answers or being left in limbo’. The subthemes also highlighted patients’ experiences of factors that enabled satisfactory interactions between patients and healthcare professionals during ward rounds, such as comprehensible detailed information and supportive atmosphere, as well as experiences of factors that obstructed such interactions and caused patients to feel uncertainty.

Conclusions

Ward rounds in inpatient care play an important role for patient care and health, functioning as a bridge between patients and healthcare professionals. It is important for healthcare practitioners and policy-makers to create a model for ward rounds that can contribute to an open and supportive atmosphere as well as sharing comprehensible and detailed information.

Feasibility study of the internet-based intervention 'Strategies for Empowering activities in Everyday life (SEE 2.0) for use by people with chronic diseases and long-term disorders in healthcare: a study protocol

Por: Larsson-Lund · M. · Karlsson Sundbaum · J. · Mansson Lexell · E. · Spinord · L.
Introduction

Proactive and easily accessible interventions are needed to support people with long-term health conditions who experience limitations in activities of everyday life. However, there is a lack of interventions that promote self-management skills that prevent deterioration and improve health. The internet-based programme ‘Strategies for Empowering Activities in Everyday Life’ (SEE) supports people with long-term health conditions in developing self-management skills through knowledge, self-analysis and management strategies, promoting active and healthy daily life. This study protocol aims to evaluate the feasibility of SEE 2.0 and the study design.

Methods and analysis

This feasibility study employs a pretest and post-test design with no control group, embedded within a mixed-method approach. The participants will include 30–40 clients, occupational therapists and managers involved in delivering SEE 2.0 in primary healthcare and hospital-based services. Data will be collected through assessments and forms at baseline, 4 months and 12 months after inclusion. Additionally, qualitative methods will be used to enhance the understanding of participants’ experiences.

Ethics and dissemination

The study was approved by the Swedish Ethical Review Authority. The results will inform the refinement of SEE 2.0 and guide decisions on whether to proceed with planning a full-scale evaluation to assess the intervention’s effect. The results will be published in peer-reviewed scientific journals on websites and presented at conferences and seminars to reach various user groups.

Trial registration number

NCT06484322.

Evaluating the diagnostic accuracy of WHO-recommended treatment decision algorithms for childhood tuberculosis using an individual person dataset: a study protocol

Por: Olbrich · L. · Larsson · L. · Dodd · P. · Palmer · M. · Nguyen · M. H. T. N. · dElbee · M. · Hesseling · A. C. · Heinrich · N. · Zar · H. J. · Ntinginya · N. E. · Khosa · C. · Nliwasa · M. · Verghese · V. · Bonnet · M. · Wobudeya · E. · Nduna · B. · Moh · R. · Mwanga · J. · Mustapha · A. · B
Introduction

In 2022, the WHO conditionally recommended the use of treatment decision algorithms (TDAs) for treatment decision-making in children

Methods and analysis

Within the Decide-TB project (PACT ID: PACTR202407866544155, 23 July 2024), we aim to generate an individual-participant dataset (IPD) from prospective TB diagnostic accuracy cohorts (RaPaed-TB, UMOYA and two cohorts from TB-Speed). Using the IPD, we aim to: (1) assess the diagnostic accuracy of published TDAs using a set of consensus case definitions produced by the National Institute of Health as reference standard (confirmed and unconfirmed vs unlikely TB); (2) evaluate the added value of novel tools (including biomarkers and artificial intelligence-interpreted radiology) in the existing TDAs; (3) generate an artificial population, modelling the target population of children eligible for WHO-endorsed TDAs presenting at primary and secondary healthcare levels and assess the diagnostic accuracy of published TDAs and (4) identify clinical predictors of radiological disease severity in children from the study population of children with presumptive TB.

Ethics and dissemination

This study will externally validate the first data-driven WHO TDAs in a large, well-characterised and diverse paediatric IPD derived from four large paediatric cohorts of children investigated for TB. The study has received ethical clearance for sharing secondary deidentified data from the ethics committees of the parent studies (RaPaed-TB, UMOYA and TB Speed) and as the aims of this study were part of the parent studies’ protocols, a separate approval was not necessary. Study findings will be published in peer-reviewed journals and disseminated at local, regional and international scientific meetings and conferences. This database will serve as a catalyst for the assessment of the inclusion of novel tools and the generation of an artificial population to simulate the impact of novel diagnostic pathways for TB in children at lower levels of healthcare. TDAs have the potential to close the diagnostic gap in childhood TB. Further finetuning of the currently available algorithms will facilitate this and improve access to care.

Feasibility of an online nutrition intervention to improve adherence to healthy and sustainable diets in young Australian adults: protocol for a pilot pre-post intervention study

Por: Lam · B. T. · Szymlek-Gay · E. A. · Larsson · C. · Margerison · C.
Introduction

Current diets which are commonly high in meat and ultra-processed foods are unhealthy and unsustainable and contribute significantly to climate change, environmental degradation and poor health outcomes. Transitioning to healthy and sustainable diets that are rich in plant-based foods and low in animal products could reduce environmental impacts and improve population health. Young Australian adults are a critical target group for dietary intervention as they are motivated towards climate action and have the lowest diet quality out of all adult age groups. As such, this study proposes a digital nutrition intervention to promote healthy and sustainable diets in this population group.

Methods and analysis

A 4-week pilot pre-post intervention will be conducted on the Deakin Wellbeing mobile application between July and August 2025. 32 young adults (18–25 years old; current student and/or staff at Deakin University; consume less than 260 g/week of legumes or 175 g/week nuts, living in Australia) will receive 4 weeks of the intervention to improve their adherence to a healthy and sustainable diet. Primary outcomes include feasibility (retention rate) and acceptability (engagement and user experience). Secondary outcomes include sustainable food literacy, legume and nut intakes, and adherence to a healthy and sustainable diet. Primary outcomes will be reported with descriptive statistics, while changes in secondary outcomes at each study time point will be measured using repeated measures Analysis of Variance, Friedman tests and McNemar’s tests.

Ethics and dissemination

Ethics approval to conduct the study was granted by the Deakin University Human Research Ethics Committee (2024/HE000163). A summary of findings will be disseminated to key stakeholders, for example, Deakin University Student Engagement groups, and will also be presented to the wider research community at conferences and via peer-reviewed publications. A summary of the results will be sent to all participants via email.

Trial registration number

Australian New Zealand Clinical Trials Registry Registration ID: ACTRN12625000335493p, prospectively registered on 22 April 2025. Universal Trial Number: U1111-1319-0745.

School health professionals understanding of culture: a scoping review

Por: Wahlström · E. · Landerdahl Stridsberg · S. · Larsson · C. · Stier · J.
Introduction

Culture underpins social interaction between school health professionals and children. Both practice and research suggest that cultural variations, migration and intercultural interactions pose potential challenges in encounters between school health professionals and children and may relate to the health professionals’ understanding of their own culture as a factor in such encounters. Still, for the school health services (SHS), reviews collating existing research on school health professionals’ understanding of culture are lacking.

Objectives

This review aims to identify, describe and analyse existing research on school health professionals’ (ie, school nurses, school social workers, school doctors and school psychologists) understanding of culture.

Design

A scoping review of peer-reviewed and published scientific articles on school health professionals’ understanding of culture.

Inclusion criteria

Articles published between 2013 and 2024 on culture, SHS and school nurses, school doctors, school social workers or school psychologists.

Methods and analysis

Searches were conducted in October 2023 and September 2024 in 10 databases. Two reviewers independently screened the article titles, abstracts and full texts for inclusion. Extracted data were analysed using descriptive statistics and qualitative content analysis. The qualitative content analysis focused on content related to theoretical considerations, key findings and conceptualisations of culture.

Results

From 1784 screened articles, 100 articles were screened in full text and 21 articles fulfilled the eligibility criteria. After identifying two additional articles through manual searches, a total of 23 articles were included in the review. The findings show that the articles primarily applied a quantitative study design, focused on school psychologists and school nurses and were conducted in the USA and Nordic-Baltic area. Self-understanding was mainly studied using validated instruments, leaving the conceptualisation of culture to the researchers. Still, only about half of all the articles described the theoretical conceptualisation of culture. Studies of intercultural interaction focused on the challenges of encountering ‘diverse’ children and raised concerns about barriers and hindrances to the encounters.

Conclusions

This review shows that SHS professionals’ understanding of culture has mainly been studied within two SHS professions, within a narrow geographical sphere and without a theoretical stance on culture. Thus, more qualitative research, a clearer theoretical conceptualisation of culture and more research on SHS professionals’ practice and self-understanding are needed.

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