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Impact assessment of neonatal care interventions on regional neonatal care capacity: a simulation study based on clinical data in the Netherlands

Por: Wagenaar · J. H. L. · Dietz · A. · Huang · Y. · Reiss · I. K. M. · Been · J. V. · Spaan · J. · Kornelisse · R. F. · Taal · H. R. · Hinrichs-Krapels · S.
Objective

To analyse the impact of selected neonatal care interventions on regional care capacity.

Design

Discrete event simulation modelling based on clinical data.

Setting

Neonatal care in the southwest of the Netherlands, consisting of one tertiary-level neonatal intensive care unit (NICU), four hospitals with high-care neonatal (HCN) wards and six with medium-care neonatal (MCN) wards.

Participants

44 461 neonates admitted to at least one hospital within the specified region or admitted outside of the region but with a residential address inside the region between 2016 and 2021.

Interventions

The impact of three interventions was simulated: (1) home-based phototherapy for hyperbilirubinaemia, (2) oral antibiotic switch for culture-negative early onset infection and (3) changing tertiary-level NICU admission guidelines.

Main outcome measure

Regional neonatal capacity defined as: (1) occupancy per ward level, (2) required operational beds per ward level to provide care to all inside region patients at maximum 85% occupancy, (3) proportion rejected, defined as outside region transfers due to no capacity to provide local care and (4) the weekly rejections in relation to occupancy to provide a combined analysis.

Results

In the current situation, with many operational beds closed due to nurse shortages, occupancy was extremely high at the NICU and HCNs (respectively 91.7% (95% CI 91.4 to 92.0) and 98.1% (95% CI 98.0 to 98.2)). The number of required beds exceeded available beds, resulting in >20% rejections for both NICU and HCN patients. Although the three interventions individually demonstrated effect on capacity, clinical impact was marginal. In combination, NICU occupancy was reduced below the 85% government recommendation at the cost of an increased burden for HCNs, highlighting the need for redistribution to MCNs.

Conclusion

Our model confirmed the severity of current neonatal capacity strain and demonstrated the potential impact of three interventions on regional capacity. The model showed to be a low-cost and easy-to-use method for regional capacity impact assessment and could provide the basis for making informed decisions for other interventions and future scenarios, supporting data-driven neonatal capacity planning and policy development.

Early and late biomarkers as predictors of severe dengue: a comprehensive umbrella review protocol

Por: Gunasekera · K. M. · Seneviwickrama · M. · Ranasinghe · S. · Gamage · K. · Gonapaladeniya · M.
Introduction

Predicting the progression to severe dengue remains a critical yet challenging aspect of patient management. This umbrella review aims to identify biomarkers associated with the development of severe dengue. The primary objective is to determine which biomarkers can predict progression to severe disease in dengue-infected patients. Secondary objectives include identifying (a) early biomarkers (detected on days 1–3 of illness), (b) late biomarkers (detected after day 3), (c) biomarkers requiring further investigation and (d) differences in predictive biomarkers between patients aged

Method and analysis

The review questions were formulated based on the Population, Concept and Context (PCC) framework. This review will follow the Joanna Briggs Institute methodology for umbrella reviews and be reported in accordance with the Preferred Reporting Items for Overviews of Systematic Reviews guidelines. The protocol has been registered in PROSPERO (CRD420251058284). MEDLINE, Embase, CINAHL, Cochrane Database of Systematic Reviews, JBI Evidence Synthesis and DARE databases will be searched from 1/1/1990 to 1/6/2025. The findings are expected to support early risk stratification and guide future biomarker research in dengue infection. The systematic reviews included in this umbrella review may define severe dengue according to either the WHO 1997 or 2009 guidelines.

Ethics and dissemination

Ethical approval is not required since the work involves published documents. The review findings will be communicated to relevant stakeholders through conference presentations and publication in an open-access journal.

Trial registration number

PROSPERO 2025 CRD420251058284. Available from: https://www.crd.york.ac.uk/PROSPERO/view/CRD420251058284.

Evaluation protocol using propensity score matching to assess the impact of Arizonas Health Start Programme on maternal morbidity, chronic disease and mental health outcomes among Medicaid-enrolled mothers

Por: Wightman · P. · Nation · K. M. · Sabo · S. · Asantewaa · S. · Spevak · K. · Celaya · M.
Introduction

In Arizona, chronic diseases, mental health conditions, haemorrhage and infections remain significant causes of severe maternal morbidity (SMM). Community health worker (CHW) interventions address social determinants of health and enhance healthcare access, which is particularly important for improving maternal health among high-risk Medicaid beneficiaries.

Methods and analysis

The Arizona Health Start Programme (HSP), a home-visiting intervention, uses CHWs to improve maternal and child health outcomes through health education, referral support and advocacy services for at-risk pregnant and postpartum women with children up to age 2 years. Over 80% of HSP participants are insured by Medicaid. The goal of this evaluation is to determine if, among Arizona Medicaid beneficiaries, participation in HSP improves (1) the risk of experiencing SMM, (2) the care management of pregnant women diagnosed with chronic conditions (eg, diabetes, hypertension) and (3) the care management of pregnant women diagnosed with depression, compared with pregnant women who did not participate in HSP. To test our hypothesis, we employ a quasi-experimental design using retrospective data and propensity score matching to establish comparison groups using Arizona Medicaid claims and enrolment records spanning the study period (2008–2019).

Ethics and dissemination

No primary data will be collected. This work is supported through an inter-agency contract from Arizona Department of Health Services (ADHS); approved by the ADHS Human Subjects Review Board, Project #17–00010, determined as non-human subjects research. Evaluation of the proposed outcomes will be completed by June 2027, and findings will be disseminated to HSP directors, managers and CHWs, as well as through academic journals and conferences.

Testing psychosocial work adversities as a necessary condition for work-related emotional exhaustion in young workers: a cross-sectional necessary condition analysis on a national general working population-based survey

Por: Schelvis · R. M. C. · van Veen · M. · Tamminga · S. J. · Oude Hengel · K. M. · Nieuwenhuijsen · K. · Boot · C. R. L. · Dul · J.
Objectives

Being exposed to adverse psychosocial working conditions contributes to poor mental health in young workers. This study explores whether psychosocial work adversities are a necessary condition for work-related emotional exhaustion in young workers.

Design

Data from the ‘Netherlands Working Condition Survey 2021’ was used. By applying a novel method called Necessary Condition Analysis, we tested two psychosocial work adversities as necessary conditions for high work-related emotional exhaustion in young workers: (1) a composite score of high job demands and low job resources and (2) a composite score of high job demands. Additionally, we tested whether the threshold for job demands as a necessary condition for high work-related emotional exhaustion differed for young workers with low versus high resources.

Setting

Secondary data analysis on a national working population-based survey.

Participants

The sample included 5791 young workers in the Netherlands (aged

Primary outcome measure

Work-related emotional exhaustion.

Results

A high level of the composite on job demands and job resources is necessary for a high level of work-related emotional exhaustion in young workers (effect size=0.11, p

Conclusions

Both psychosocial work adversities were necessary conditions for high work-related emotional exhaustion in young workers. The necessity threshold for job demands was higher for young workers with high job resources, compared with the group with low resources. This indicates that removing psychosocial work adversities and ensuring the presence of job resources might contribute to the prevention of high work-related emotional exhaustion in young workers.

Examining differences in clinical and demographic characteristics of patients with post-traumatic stress disorder across adult treatment subgroups based on the NeuroBlu database: a non-interventional, retrospective cohort study

Por: Abramsky · S. · St.Rose · S. · Heng · Y. W. · Vance · L. A. · Zhang · L. · Chan · K. M. · Wong · J. G. · Kuah · S. · Low · L. T. · Adamczyk · I.
Background

Post-traumatic stress disorder (PTSD) is a heterogeneous psychiatric disorder, with symptom variation between patients.

Objective

We describe clinical and demographic characteristics of patients with PTSD based on real-world data.

Methods

This non-interventional, retrospective cohort study analysed de-identified electronic health records of patients from the Holmusk NeuroBlu database in the USA. Patients with ≥2 PTSD diagnoses captured in the database within 30 days between 2001 and 2020 were included. The index date was defined as the date of the first recorded PTSD diagnosis. In patients who were aged ≥18 years, demographic and clinical characteristics at baseline (index date ±14 days), in the 6 months prior to baseline and 12 months after baseline were described. Patients were stratified into four mutually exclusive subgroups according to treatment received: psychotherapy only, pharmacotherapy only, psychotherapy and pharmacotherapy, and untreated. Natural language processing models were used to derive PTSD symptoms from unstructured clinician-documented mental state examination data. Data were analysed descriptively.

Findings

A total of 37,449 patients had ≥2 PTSD diagnoses within 30 days between 2001 and 2020; 32,875 patients received care at clinical sites with both inpatient/outpatient units; 25,507 patients received psychotherapy and/or pharmacotherapy as per further prespecified criteria, and 17,234 were ≥18 years old and included in this analysis. Most patients (84.9%) received psychotherapy, pharmacotherapy or both during the first year post-baseline. Mean age (SD) was 37.7 (12.4) years, 73.4% of patients were female and 59.6% were White. At baseline, 98% of patients had ≥1 psychiatric comorbidity; major depressive disorder (42.2%), substance use disorder (35%) and anxiety disorder (30.7%) were most frequently reported. Reported suicidal ideation/attempts were most frequent in the pharmacotherapy only group compared with other subgroups at baseline. The most frequently prescribed drug classes were antidepressants (51.8%), second-generation antipsychotics (29.9%) and anxiolytics (23.3%) at baseline. Trazodone, clonazepam, quetiapine and sertraline were the most frequently prescribed medications.

Conclusion

In the overall study population, most patients were female, with a high prevalence of psychiatric comorbidities. Demographic and clinical characteristics observed in this study varied across treatment subgroups. These insights may support patient-specific treatment planning and inform health-economic decision models in PTSD.

Health effects of street vended fresh cut fruits: A randomized controlled trial in Bangladesh

by F. N. U. Nahiduzzaman, Tasnim Zarin, Chandra Shaker Chouhan, Md. Zaminur Rahman, Mst. Minara Khatun, A. K. M. Anisur Rahman, Md. Ariful Islam, Md Azizul Haque

Foodborne infections, particularly from street-vended fresh-cut fruits, are a growing public health concern in urban settings of developing countries. This study evaluated the gastrointestinal effects of consuming street-vended fruits in a randomized controlled trial (RCT) in Mymensingh, Bangladesh. A total of 300 participants were recruited and randomized into Treatment (n = 150) and Control (n = 150) groups. Treatment participants consumed guava, pineapple, or watermelon purchased from street vendors, while Control participants avoided street-vended fruits. Microbial analysis of fruits included total viable count (TVC), S. aureus, and E. coli. Participants recorded GI symptoms for 4 days post-intervention, with a 10-day follow-up. At least one GI symptom occurred in 41 (27.3%) treatment participants compared with 15 (10%) controls. Nausea affected 20 (13.3%) versus 2 (1.3%) participants (RR = 10, 95% CI: 2.38–42.03, p E. coli (6–10% prevalence) showed the strongest correlations with abdominal cramps, weakness, and diarrhea (ρ = 0.69–0.78, p S. aureus (20–34%) correlated primarily with weakness and abdominal cramps (ρ = 0.44–0.47, p 

Family caregiver burden and associated factors among caregivers of people with mental illness attending outpatient treatment in public hospital in Eastern Ethiopia, Ethiopia: hospital-based cross-sectional study

Por: Leta · F. O. · Genna · K. M. · Ibirahim · M. K. · Dechasa · T. D.
Objective

To assess family caregiver burden and associated factors among caregivers of people with mental illness in Eastern Ethiopia.

Design

Cross-sectional study.

Setting

Three hospitals in Eastern Ethiopia.

Participants

A total of 422 family caregivers of people with mental illness were recruited using systematic random sampling, of whom 417 participated (response rate 98.8%).

Primary outcome measures

Caregiver burden was assessed using the Zarit Burden Interview (ZBI-22). Linear regression was used to measure the associations between dependent and independent variables.

Results

The mean score of the ZBI was 47.971 (SD=14.539). In our study, factors associated with caregiver burden included age of caregivers (β=0.143, p=0.006), sex of the caregiver (β=0.121, p=0.007), time spent in providing care (β=0.194, p=0.006), presence of comorbid medical illness (β=0.309, p0.001), substance use in the last 12 months (β=0.265, p=0.024), perceived stigma (β=0.207, p

Conclusions

89 (22.2%) of caregivers reported severe burden and 220 (52.8%) reported moderate-to-severe burden. Family caregivers play a critical role in the treatment of mental illness; there is a need to establish family caregiver support services, such as group therapy and psychoeducation.

Maximizing Extubation Outcomes Through Educational and Organizational Research (METEOR) Trial: protocol for a batched, stepped-wedge, cluster-randomised, type 2 hybrid effectiveness-implementation trial

Por: Prendergast · N. T. · Kahn · J. M. · Angus · D. C. · Argote · L. · Barnes · B. · Chang · C.-C. H. · Graff · S. · Hess · D. R. · Onyemekwu · C. A. · Rak · K. J. · Russell · J. L. · Seaman · J. B. · Toth · K. M. · Girard · T. D.
Introduction

Many patients who are extubated after receiving mechanical ventilation for acute respiratory failure experience extubation failure (ie, require reintubation hours to days after extubation). High-quality evidence shows that extubating patients directly to non-invasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC), rather than conventional low-flow oxygen, can prevent extubation failure. These guideline-recommended interventions, however, require care coordination involving multiple intensive care unit (ICU) team members and are infrequently used. Interprofessional education (IPE), which teaches members of multiple professions together, could effectively address this implementation gap in complex, team-based, critical care settings, particularly when paired with a customisable protocol.

Methods and analysis

This batched, stepped-wedge, cluster-randomised, type 2 hybrid effectiveness–implementation trial will test three hypotheses: (1) when compared with traditional online education (OE), IPE increases implementation of preventive postextubation respiratory support, (2) the benefits of IPE are increased when paired with a clinical protocol and (3) preventive postextubation NIV for high-risk patients and preventive postextubation HFNC for low-risk patients reduce in-hospital mortality when compared with conventional postextubation oxygen therapy. The trial will recruit 24 clusters made up of one or more ICUs that care for at least 100 mechanically ventilated patients per year in a large multihospital health system in the USA. All clusters will receive OE, IPE and a clinical protocol, with timing determined by randomisation. We will also randomise half of the clusters to education promoting postextubation NIV for patients at high risk of extubation failure and preventive, postextubation HFNC for patients at lower risk, whereas the other half will be randomised to education promoting postextubation HFNC for all eligible patients. We will include all patients who are invasively mechanically ventilated for at least 24 hours. The primary implementation endpoint is the rate of use of postextubation NIV or HFNC among eligible participants. The primary clinical endpoint is in-hospital mortality truncated at 60 days from intubation.

Ethics and dissemination

This study was approved by the institutional review board of the University of Pittsburgh and an independent data safety monitoring board. We describe the methods herein using the Standard Protocol Items for Randomised Trials framework and discuss key design decisions. We will disseminate results to participating healthcare providers, through publication in a peer-reviewed medical journal and via presentations at international conferences.

Trial registration number

NCT05523479.

Outcomes following a behaviour change intervention within hospitals to improve birth registrations and hospital utilisation for Aboriginal and/or Torres Strait Islander infants: a quasi-experimental and cohort study

Por: McAuley · K. · Strobel · N. A. · Christensen · D. · Edmond · K. M. · Jacoby · P. · McAullay · D.
Objectives

The primary objective was to determine whether a behaviour change intervention delivered to hospital staff would (1) improve the proportion of Aboriginal and/or Torres Strait Islander (Aboriginal) babies being registered and (2) reduce hospital admissions and emergency presentations for babies

Design

Quasi-experimental design and cohort study.

Setting

Five tertiary birthing hospitals in WA.

Participants

The intervention was delivered to health service providers who were in the five tertiary birthing hospitals. Outcome data were collected on Aboriginal babies born between 1 January 2016 and 30 June 2018 who were delivered within these hospitals. Babies in the control group (n=226) were born 6 months before the intervention and intervention babies (n=232) were born 6 months following the intervention. For the secondary objective, there were 4573 babies included in the analysis.

Interventions

A behaviour change intervention delivered to hospital staff in five hospitals.

Primary and secondary outcome measures

The primary outcomes were the proportion of babies who were registered and whether a baby had been admitted to hospital or an emergency department by 3 and 6 months old. The secondary outcome was to determine factors that might influence the proportion of registered Aboriginal births in WA (cohort study).

Results

There was evidence of a 38% reduction in emergency presentations within 6 months for babies born to hospitals 6 months following the staff training (OR 0.62, 95% CI 0.42 to 0.91), and little evidence of improvements in birth registrations, hospital admissions within 3 or 6 months of birth or emergency department presentations within 3 months of birth. Of the 4573 babies included in the cohort study, 3769 (82.4%) babies had their births registered and 804 (17.6%) babies did not. Factors that were associated with not having a birth registered included low birth weight babies with a 34% decrease in odds of having a registered birth compared with those with a normal birth weight (adjusted OR (aOR) 0.66, 95% CI 0.51 to 0.86). Timing of first antenatal visit was associated with reduced odds of having a birth registered if this occurred in the second (aOR 0.77, 95% CI 0.64 to 0.93) or third trimester (aOR 0.59, 95% CI 0.45 to 0.77) compared with the first trimester.

Conclusions

Our study identifies the complexities surrounding birth registrations and improved hospital utilisation for Aboriginal babies, the importance of targeted interventions and ongoing efforts needed to address this issue comprehensively.

Trial registration number

ACTRN12615000976583.

Models, frameworks, and strategies used to implement digital interventions targeted to youth mental health: a scoping review protocol

Por: Moss · S. J. · Zuniga Chacon · C. · Hekmati · F. B. · Siddiqui · S. A. · Stelfox · M. · Ahmed · S. B. · Birnie · K. · Halperin · D. · Halperin · S. A. · Tutelman · P. R. · Stelfox · H. T. · Fiest · K. M. · Parsons Leigh · J.
Introduction

The use of digitally enabled technology is considered a promising platform to prevent morbidity and enhance youth mental health as youth are growing up in the digital world and accessing the Internet at increasingly younger age. This scoping review will identify, describe and categorise the models, frameworks and strategies that have been used to study the implementation of digital mental health interventions targeted at youth aged 15–34 years.

Methods and analysis

We will conduct a scoping review following the Arksey-O’Malley five-stage scoping review method and the Scoping Review Methods Manual by the Joanna Briggs Institute. Implementation methods will be operationalised according to pre-established aims: (1) process models that describe or guide the implementation process; (2) evaluation frameworks evaluating or measuring the success of implementation; and (3) implementation strategies used in isolation or combination in implementation research and practice. Primary research studies in all languages will be identified in CINAHL, Cochrane Central Register of Controlled Trials, Embase, ERIC, Education Research Complete, MEDLINE and APA PsycINFO on 6 January 2025. Two reviewers will calibrate screening criteria and the data charting form and will independently screen records and abstract data. We will use the Evidence Standards Framework for Digital Health Technologies by the National Institute for Health and Care Excellence to classify digital interventions based on functions, and a pre-established working taxonomy to synthesise conceptually distinct implementation outcomes. Convergent integrated data synthesis will be performed.

Ethics and dissemination

Ethical approval is not applicable as this scoping review will be conducted only on data presented in the published literature. Findings will be published and directly infused into our multidisciplinary team of academic researchers, youth partners, health professionals and knowledge users (healthcare and non-governmental organisation decision makers) to co-design and pilot test a digital psychoeducational health intervention to engage, educate and empower youth to be informed stewards of their mental health.

Quantifying cross-sectional and longitudinal associations in mental health symptoms within families: network models applied to UK cohort data

Por: Bai · Y. · Rayner · A. · Abel · K. M. · Cartwright-Hatton · S. · Wan · M. W. · Pierce · M.
Objectives

Families offer promising targets for mental health interventions. Existing evidence investigates parent-child dyads or partners; we use an innovative approach to look at triads of parents and their children. This gives us more detail on mental health dimensions and individuals central to mental health transmission in families.

Design

Both cross-sectional and longitudinal network models

Setting

We identified triads of children (under age 16), mothers and fathers from the UK Household Longitudinal Study, between 2009 and 2022.

Participants and methods

Cross-sectional networks captured independent associations between family members’ mental health (n=8795 families). Longitudinal networks examined directional temporal associations among family members’ emotional symptoms (n=3757 families).

Primary outcome measures

Children’s and parents’ mental health dimensions were assessed using the Strengths and Difficulties Questionnaire and the General Health Questionnaire, respectively.

Results

Mothers’ mental health, particularly emotional symptoms, was linked to children’s mental health, while fathers’ symptoms showed no independent association. In the longitudinal network, maternal feelings of being overwhelmed were associated with children’s future worry, affecting symptoms of nervousness and unhappiness, which then fed back into worsening maternal emotional symptoms.

Conclusions

Investigating family mental health using network models highlights mothers’ central role. The longitudinal relationship between maternal feelings of being overwhelmed and children’s anxiety, and the subsequent feedback into maternal anxiety, indicates a promising target for intervention.

Stunting incidence and reversal as metrics of postnatal linear growth faltering in low- and middle-income countries: a critical appraisal and simulation study

Por: Roth · D. E. · Watson · K. M. · Bassani · D. G.
Objectives

Length-for-age z-scores (LAZ) and stunting prevalence (%LAZ

Methods

We simulated a synthetic cohort with a harmonically downward-shifting LAZ trajectory from birth to 24 months of age, with mean LAZs similar to the HBGDki pooled South Asian cohorts, and without any input parameters intended to differentially affect individuals’ growth across the height distribution or at different ages. We compared HBGDki empirical estimates of age interval-specific frequencies of incident stunting onset and stunting reversal with those from the synthetic cohort. Using synthetic cohorts, we examined how estimates of incident onset and reversal were affected by missing data, magnitude of the whole-population shift in the LAZ distribution and strength of the between-time-point correlation. We also compared the 3–24 month pattern of linear growth faltering expressed as age-related trajectories of average growth delay (chronological age minus height–age), mean LAZ or stunting prevalence.

Results

Empirical estimates of age interval-specific incident stunting onset and stunting reversal in the HBGDki cohorts were similar to those observed in a synthetic cohort. Variability in LAZ threshold-crossing event rates is explained by starting LAZ, between-time-point correlation and the magnitude of the whole-population shift in the LAZ distribution. Incident stunting onset is also affected by missing data in preceding intervals. Stunting reversal occurs due to within-child variability (ie, imperfect between-time-point correlation) in the absence of any other phenomena that cause stunted children to become non-stunted at a later age. The linear growth faltering pattern based on growth delay differed from corresponding age-related trajectories of mean LAZ or stunting prevalence.

Conclusions

In longitudinal studies of linear growth faltering in LMICs, LAZ threshold-crossing indicators are byproducts of whole-population shifts in LAZ and within-child variability and should be interpreted accordingly. Reporting incident stunting onset and reversal rates, or analyses in which children are grouped by the timing of LAZ threshold-crossing events, may detract from efforts to understand when and why nearly all children in LMICs grow more slowly than expected for their age. Since mean LAZ and stunting prevalence are unsuitable for quantifying the rate and timing of population-average postnatal linear growth faltering, growth delay is recommended for consideration as a preferred metric.

Cohort profile: trajectory of knee health in runners with and without heightened osteoarthritis risk (TRAIL) in Australia--prospective cohort study

Por: De Oliveira Silva · D. · Mentiplay · B. F. · Girdwood · M. · Haberfield · M. J. · Bruder · A. M. · Culvenor · A. G. · West · T. J. · Hill · J. P. · Carey · D. L. · Johnston · R. T. R. · Crossley · K. M.
Purpose

The TRAjectory of knee heaLth in runners (TRAIL) study is a prospective cohort study investigating the long-term knee health trajectories of runners with and without a heightened osteoarthritis risk. This study aims to describe the recruitment results and baseline characteristics of the TRAIL cohort.

Participants

Runners aged 18–50 years and running ≥3 times and ≥10 km per week on average in the past 6 months were eligible. Participants were recruited via running podcasts, running clubs and social media between July 2020 and August 2023. Data were collected at study enrolment and at a face-to-face baseline testing session, which occurred a median of 33 weeks (IQR 18 to 86 weeks) after enrolment. Follow-up data collection is ongoing.

Findings to date

Out of 462 runners who completed an online registration form, 268 runners enrolled, of which 135 had a history of knee surgery (46% females) and 133 were non-surgical controls (50% females). 60% of the surgery group had undergone anterior cruciate ligament reconstruction, 33% meniscus and/or cartilage surgery, and 7% other knee surgery. 54 participants previously enrolled were unable to continue in the study before attending baseline data collection. Of the 214 runners who remained in the study and attended baseline data collection, 108 had a history of knee surgery (49% females) and 106 did not have a history of knee surgery (51% females).

Future plans

Participants will be followed for 10 years through ongoing patient-reported outcomes and continuous monitoring of training loads using wearable devices. At baseline, 4- and 10-year follow-up, knee MRI and knee-health patient-reported outcomes will be collected to evaluate structural and symptomatic knee osteoarthritis progression. Data will inform guidelines for safe running practices and rehabilitation post-knee surgery.

Trajectories of Recovery after Intravenous propofol versus inhaled VolatilE anaesthesia (THRIVE) randomised controlled trial in the USA: A protocol

Por: Tellor Pennington · B. R. · Janda · A. M. · Colquhoun · D. A. · Neuman · M. D. · Kidwell · K. M. · Spino · C. · Thelen-Perry · S. · Krambrink · A. · Huang · S. · Ignacio · R. · Wu · Z. · Swisher · L. · Cloyd · C. · Vaughn · M. T. · Pescatore · N. A. · Bollini · M. L. · Mashour · G. A.
Introduction

Millions of patients receive general anaesthesia every year with either propofol total intravenous anaesthesia (TIVA) or inhaled volatile anaesthesia (INVA). It is currently unknown which of these techniques is superior in relation to patient experience, safety and clinical outcomes. The primary aims of this trial are to determine (1) whether patients undergoing (a) major inpatient surgery, (b) minor inpatient surgery or (c) outpatient surgery have a superior quality of recovery after INVA or TIVA and (2) whether TIVA confers no more than a small (0.2%) increased risk of definite intraoperative awareness than INVA.

Methods and analysis

This protocol was co-created by a diverse team, including patient partners with personal experience of TIVA or INVA. The design is a 13 000-patient, multicentre, patient-blinded, randomised, comparative effectiveness trial. Patients 18 years of age or older, undergoing elective non-cardiac surgery requiring general anaesthesia with a tracheal tube or laryngeal mask airway will be eligible. Patients will be randomised 1:1 to one of two anaesthetic approaches, TIVA or INVA, using minimisation. The primary effectiveness endpoints are Quality of Recovery-15 (QOR-15) score on postoperative day (POD) 1 in patients undergoing (1) major inpatient surgery, (2) minor inpatient surgery or (3) outpatient surgery, and the primary safety endpoint is the incidence of unintended definite intraoperative awareness with recall in all patients, assessed on POD1 or POD30. Secondary endpoints include QOR-15 score on POD0, POD2 and POD7; incidence of delirium on POD0 and POD1; functional status on POD30 and POD90; health-related quality of life on POD30, POD90, POD180 and POD365; days alive and at home at POD30; patient satisfaction with anaesthesia at POD2; respiratory failure on POD0; kidney injury on POD7; all-cause mortality at POD30 and POD90; intraoperative hypotension; moderate-to-severe intraoperative movement; unplanned hospital admission after outpatient surgery in a free-standing ambulatory surgery centre setting; propofol-related infusion syndrome and malignant hyperthermia.

Ethics and dissemination

This study is approved by the ethics board at Washington University, serving as the single Institutional Review Board for all participating sites. Recruitment began in September 2023. Dissemination plans include presentations at scientific conferences, scientific publications, internet-based educational materials and mass media.

Trial registration number

NCT05991453.

Blue Light as an Anti-inflammatory and Analgesic Strategy in Thoracic Trauma (BLAASTT): protocol for a randomised controlled trial in adult trauma inpatients with painful rib fractures

Por: Kotcher · R. E. · Rosengart · M. R. · La Colla · L. · Lin · H.-H. S. · Vogt · K. M. · Xu · Y. · Neal · M. D.
Introduction

Blue light (peak wavelength 442 nm) has been shown to modulate the immune response in preclinical models of intra-abdominal sepsis and pneumonia. In vivo pathways involve optic nerve stimulation with transmission to the central nervous system, activation of parasympathetic pathways terminating at the spleen, and downstream immune effects including decreased inflammatory tissue damage and improved pathogen clearance. Related effects on pain mediators including proinflammatory cytokines (interleukin 6, TNF- α) and autonomic tone (increased parasympathetic outflow) suggest possible analgesic properties that would be highly relevant to a trauma population.

Methods and analysis

This is a randomised controlled trial in which adult trauma inpatients (18 years) with painful rib fractures will be allocated 1:1:1 to three arms: bright blue light intervention (peak 442 nm, ~1400 lux), bright full-spectrum light comparison (~1400 lux) and usual ambient light control. Bright light exposures will be administered for 4 consecutive hours daily for up to 3 days. The primary outcome will be any measurable changes in chest wall pain intensity during deep breathing, quantified using an 11-point Numerical Rating Scale. Secondary outcomes will assess chest wall pain intensity at rest, opioid requirements, delirium incidence, pulmonary complication incidence, hospital-free and intensive care unit-free days, and physiological markers of autonomic nervous system, circadian, and immune activation. Sample size analysis yields a total of 75 participants needed to detect a 2-point difference in pain scores with >80% power and assuming a 20% non-completion rate.

Ethics and dissemination

Full ethical approval for this trial has been granted by the University of Pittsburgh Institutional Review Board. On study completion, results will be published in the peer-reviewed literature and at ClinicalTrials.gov.

Trial registration number

NCT06626334.

Understanding the game experiences and mental health of youth: protocol for the Game-in-Action Quebec cohort study

Por: Paquin · V. · Raugh · I. · Davies · M. · Lepage · M. · Lavigne · K. M. · Dion · J. · Abdel-Baki · A. · Shah · J. L. · Iyer · S. N. · Ferrari · M.
Introduction

Video games have been linked to a range of positive and negative effects on the mental health of adolescents and young adults. However, to better understand how games affect the mental health of young people, their use and experiences must be situated in the sociocultural and personal life contexts of individuals. Drawing from a cultural-ecosocial approach, this study combines cross-sectional and digital phenotyping measures to examine the effects of video games on the mental health of youth.

Methods and analysis

Participants will be young people aged 16–25 years from the community and living in the province of Quebec, Canada. An initial sample of 1000 youth will complete a cross-sectional survey online, including measures of socio-demographic context, gaming practices and experiences, streaming practices and experiences, as well as personality and well-being. Qualitative questions will explore personal views on games and mental health. A subsample of 100 participants will be selected for digital phenotyping, including daily surveys of well-being, gaming, streaming and social experiences, combined with passive mobile sensing (eg, geolocation). Analyses will include regression and mixed models for quantitative data, reflexive thematic analysis for qualitative data, and an integration of quantitative and qualitative results using participatory methods.

Ethics and dissemination

The study received ethical approval from the Institutional Review Board of McGill University (24-02-015). The dissemination of results will be conducted in partnership with a multi-stakeholder advisory committee, including youth who play video games, and will involve peer-reviewed publications, presentations to policymakers in Quebec, and workshops for clinicians and researchers.

Feasibility and acceptability of contingency management and problem-solving therapy intervention for enhancing alcohol abstinence: a single-arm, mixed methods pilot clinical trial

Por: Hallihan · H. · Lee · S. · Rospenda · K. M. · Wu · Y. · Adomah · R. · Knepper · A. · Ma · J.
Objective

To assess the feasibility and acceptability of a new integrated behaviour therapy of contingency management and problem-solving therapy (CM-PST) in a fully remote format for young adults with alcohol use disorder (AUD).

Design

A single-arm clinical trial using mixed methods.

Setting

Both online and in-person recruitment in Chicagoland, USA.

Participants

20 young adults aged 18–24 with mild, moderate or severe AUD participated in the study.

Intervention

The CM-PST intervention included 8 sessions over 12 weeks, focusing on problem-solving skills, goal setting, stress management and behaviour change to support alcohol abstinence. Participants used digital materials, tracked weekly goals, submitted two times per day breathalyser tests for incentives and completed homework assignments.

Primary and secondary outcome measures

In this study, participants were assessed before and after the intervention using mixed methods to evaluate feasibility based on recruitment rates, retention rates of 85% and high adherence to the PST sessions defined as attendance and remaining for the full duration of each session, and acceptability based on participant feedback of ≥3 on Client Counselling Satisfaction Scale.

Results

A total of 20 participants completed the study. The mean age of the study participants was 21.35 (SD=2.18), ranging from 18 to 24 and 55% of participants were women. Adherence to the PST sessions, which include attending all eight PST sessions and remaining for the full duration of each session, was 100.0%, indicating strong engagement. Participant feedback highlighted the influence of CM on behaviour and decision-making and the effectiveness of PST in addressing life challenges.

Conclusion

This study’s results indicate that the CM-PST intervention is feasible and acceptable among participants, although the benchmark of 85% expected retention rate was unmet. Future studies could explore strategies to improve retention rates.

Trial registration number

NCT05778734.

Role of gut microbiome in colorectal cancer: a comprehensive umbrella review protocol

Por: Seneviwickrama · M. · Gunasekera · K. M. · Gamage · K. · Gonapaladeniya · M. · Ranasinghe · S.
Introduction

Colorectal cancer (CRC) is the third most common cancer and the second leading cause of cancer-related death globally. Growing evidence links gut microbiota dysbiosis to CRC, with several reviews reporting consistent microbial alterations in CRC patients that may serve as non-invasive biomarkers. However, findings vary across studies, and consensus on key microbial taxa is lacking. This umbrella review aims to clarify: (1) the association between gut microbiome composition and CRC development/progression, (2) specific microbial taxa linked to CRC risk, (3) the role of microbiome diversity in CRC outcomes and (4) potential microbial biomarkers for diagnosis, prognosis and treatment response.

Methods and analysis

This umbrella review will follow the Joanna Briggs Institute (JBI) Umbrella Review Guidelines and adhere to the Preferred Reporting Items for Overviews of Reviews. A comprehensive search will be conducted across MEDLINE (PubMed), Embase, CINAHL and key systematic review databases, including the Cochrane Database, JBI Evidence Synthesis and Database of Abstracts of Reviews of Effects, without language restrictions. The search strategy will use a combination of Medical Subject Headings terms and free-text keywords with Boolean operators. The review questions were developed using the Population, Concept and Context framework. Only high-quality (as determined by the JBI Critical Appraisal Checklist for Systematic Reviews and Research Syntheses), peer-reviewed quantitative systematic reviews with or without meta-analyses will be included. Overall effect estimates extracted from systematic reviews, with the number of studies that inform the outcome, will be presented.

Ethics and dissemination

No ethical approval is required since the work is carried out on published documents. Findings of this review will be disseminated among relevant stakeholders through multiple scientific avenues, including presentations at both national and international forums and manuscript publication in an open-access journal.

PROSPERO registration number

PROSPERO 2025 CRD420251035257. Available from:

https://www.crd.york.ac.uk/PROSPERO/view/CRD420251035257.

Intensive care clinicians experiences of palliative withdrawal of mechanical ventilation: a qualitative study

Por: Efstathiou · N. · Diridis · F. K. M. · Orr · M. · Baernholdt · M. · Vanderspank-Wright · B.
Objectives

To explore intensive care unit (ICU) clinicians’ experiences of withdrawing mechanical ventilation during end-of-life care.

Design

An exploratory qualitative design was used, with data collected via semistructured, face-to-face online interviews and analysed using reflexive thematic analysis.

Participants

We recruited ICU clinicians from two hospitals within the West Midlands region of the UK.

Data collection

Semistructured, face-to-face online interviews were used to explore experiences with limitation of life-sustaining treatments in ICU, decision-making and practices for withdrawing mechanical ventilation.

Findings

22 ICU clinicians were interviewed (Physiotherapist=1, Advanced Critical Care Practitioners=4, Physicians=9 and Nurses=8), of which 13 were women (59%). Four themes were developed. (1) Multilayered communication: effective communication was key in planning withdrawal and informing family members, with conflicts arising from cultural differences. (2) Considerations regarding the mode of withdrawing invasive mechanical ventilation: clinicians expressed differing preferences for the method of mechanical ventilation withdrawal. (3) Multiprofessional teamwork: collaborative teamwork was vital, with palliative care practitioners consulted during conflicts or challenging symptoms. (4) Clinicians’ feelings and impact: clinicians empathised with families and experienced psychological burden.

Conclusions

Physician preferences influence the withdrawal process, which is communicated within the multidisciplinary team. Clear protocols can help reduce ambiguity and support less experienced clinicians. Reflection on these practices may help mitigate burnout and compassion fatigue. Further research should examine the effects of physician demographics and patient cultural diversity on the withdrawal process.

Geographical patterns of tuberculosis notification rates and their association with socioeconomic factors in Nepal: a spatial cross-sectional study (2020-2023)

Por: Mahato · R. K. · Htike · K. M. · Koro · A. B. · Sornlorm · K. · Yadav · R. K. · Kafle · A. · Sharma · V. · Singh · D. B. · Laohasiriwong · W.
Objectives

To identify the patterns of tuberculosis (TB) notification rates and examine their relationship with social and economic determinants in Nepal between 2020 and 2023.

Design

Cross-sectional study.

Setting

Nepal.

Participants

All TB cases across all ages.

Primary outcome

Prevalence of TB cases.

Methods

This cross-sectional spatial analysis used the data set of the National Tuberculosis Control Centre, Nepal, covering the Fiscal Year (FY) 2020–2021 to 2022–2023. Moran’s I and Local Indicators of Spatial Association were employed to detect the spatial autocorrelation between the prevalence of TB and associated social and demographic factors.

Results

The overall prevalence rate for TB in FY 2020–2021 was 98.08 per 100 000 population. This increased to 129.82 per 100 000 population in FY 2021–2022, followed by a slight decrease to 128.39 per 100 000 population in FY 2022–2023. The highest TB prevalence was observed in Kathmandu, with 146 cases per 100 000 population in 2020–2021, and in Dang district, the rate decreased from 215–191 per 100 000 population. We investigated the spatial patterns of TB prevalence and highlighted the geographic areas in each district in Nepal from 2021 to 2023 with Moran’s I of 0.558, 0.614 and 0.596, respectively. The consistent identification of High-High clusters in specific districts like Banke, Kapilbastu and Parsa across all 3 years periods highlighted persistent high-risk areas for TB transmission in Nepal.

Conclusions

This study emphasised the strong spatial associations and the complex, diverse aspects of TB transmission shaped by demographic and socioeconomic factors. Our results highlighted the need for tailored public health approaches that account for specific social determinants to address TB effectively.

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