FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
AnteayerInterdisciplinares

Does a protocolised oxygenation target impact clinical outcomes in mechanically ventilated patients in the intensive care unit across the 10 academic and community hospitals in the UCHealth system? Protocol and statistical analysis plan for an EHR-embedde

Por: Sottile · P. D. · Mikkelsen · M. E. · Peterson · R. A. · Mcgrath · M. · Carlson · N. · Higgins · C. · Clinton · M. I. · Barbour · A. · Kautz · S. V. · Kwan · B. M. · West · S. · Ginde · A. A. · Aggarwal · N.
Introduction

We designed the Optimising Care in Critically Ill at the UCHealth by Liberalising the Target O2 in Mechanically ventilated intensive care unit (ICU) Patients to determine the effectiveness of a multimodal educational and electronic health record order panel intervention in limiting occult hypoxaemia and hyperoxaemia in patients receiving invasive mechanical ventilation by targeting a prespecified oxygen saturation (SpO2 90%–96%) range.

Methods and analysis

This trial is a pragmatic electronic health record-embedded, multisite, cluster-randomised, stepped-wedge implementation of a multimodal educational and electronic health record order panel intervention aimed at achieving a standardised intermediate target range of SpO2 (90%–96%) or partial pressure of oxygen (PaO2 60–100 mm Hg) in mechanically ventilated adult patients admitted to the ICU across a 10 hospital health system that includes a large academic centre and smaller community hospitals.

The primary endpoint is ventilator-free days to day 30, defined as the number of days alive and not receiving support through invasive mechanical ventilation following the first initiation of invasive mechanical ventilation in a participating ICU during the hospitalisation. Secondary outcomes include a variety of clinical endpoints: hospital-free days to day 30, all-cause mortality to day 90, need for supplemental oxygen at discharge and incidence of occult hypoxaemia and hypoxaemia. We will analyse primary and secondary endpoints using a mixed effects modelling framework, with specific distributions chosen depending on the type of outcome (eg, binary, count, ordinal, time-to-event).

Ethics and dissemination

Research is performed under a waiver of informed consent for minimal-risk research, as approved by Colorado Multiple Institutional Review Board (24-0065). Results will be disseminated in peer-reviewed publications and at national and international conferences.

Trial registration number

NCT06501118.

Breathing control training as a treatment for functional seizures (BREATHS trial): a multicentre, assessor-blinded, randomised controlled efficacy and acceptability trial study protocol

Por: Kanaan · R. · Duncan · R. · Mihalopoulos · C. · Braat · S. · OBrien · T. J. · Velakoulis · D. · Kwan · P. · Mulder · R. T. · Cook · M. · Mullen · S. · Mayne · D. · Oliver · G. · Eleftheriadis · D. · Ameen · O. · Chatterton · M. L. · DSouza · W. · Nicolo · J.-P. · Perucca · P. · Winton-Brow
Introduction

Functional seizures (FS) are events that resemble epileptic seizures, but are not attributed to brain pathology and are instead thought to be due to psychological factors. A small, multisite, open-label, single-arm, pilot trial of a breathing intervention known as breathing control training (BCT) found it to be safe and effective in reducing seizure frequency in FS. We propose a protocol for a study to confirm these results.

Methods and analysis

A 24-week, multicentre, individually-randomised, assessor-blinded, two-arm, parallel-group efficacy and acceptability trial of BCT versus control (Befriending) in 220 participants ≥16 years of age with FS. Eligible participants will be randomly allocated to receive two sessions of either BCT or Befriending over a 4-week period. Sessions will be delivered by a respiratory physiotherapist at a clinical care site or via telehealth. They will complete assessments prior to commencing treatment and at 4, 12 and 24 weeks after their initial session of BCT/Befriending. The trial will be conducted alongside treatment as usual. An economic evaluation including cost-utility and cost-effectiveness analyses will be carried out from health sector and societal perspectives.

Ethics and dissemination

The study has been approved by The Austin Health Human Research Ethics Committee (HREC/84335/Austin-2022) and the New Zealand Central Health and Disability Ethics Committee (2022 FULL 12324). Findings will be reported to trial participants and consumers; presented at local, national and international conferences; and disseminated by a peer-reviewed scientific journal.

Prognosis of patients hospitalised with primary or secondary pericardial disease: an Australian population-based retrospective cohort study

Por: Kwan · T. N. · Ravindran · J. · Kwan · G. · Brieger · D. · Chow · V. · Kritharides · L. · Ng · A. C. C.
Objectives

To describe the outcomes and associations of pericardial disease, with a particular focus on the outcomes of patients admitted with primary or secondary pericardial disease.

Design

Retrospective observational study.

Setting

All public and private hospitals in New South Wales, Australia.

Participants

Hospitalised patients with pericardial disease admitted from 2004 to 2021 that was (a) a primary diagnosis or (b) a secondary diagnosis.

Measures

Mortality both in-hospital and during several years of available follow-up.

Results

Out of 45 446 patients diagnosed with pericardial disease, under half (46.8%) had pericardial disease as the primary reason for hospitalisation. Patients in whom pericardial disease was the primary compared with the secondary diagnosis were more commonly male (68.2% vs 59.1%), younger (median 51.2 years vs 66.0 years) and less comorbid (age-adjusted median Charlson Comorbidity Index 1 vs 4). In patients with pericardial disease, adjusted in-hospital mortality was fivefold lower if this was the primary diagnosis (OR 0.21, p

Conclusions

Patients with pericardial disease have a low in-hospital mortality of about 1% if this was the primary diagnosis. However, patients in whom it was a secondary diagnosis, especially in the presence of comorbidities such as malignancy, had a much worse prognosis.

Safety profile of metformin in adolescents with type 2 diabetes: A pharmacovigilance analysis of the FDA Adverse Event Reporting System

by Mengsi Peng, Peng Shen, Kyung-In Joung, Kwang Joon Kim

Background

Although metformin is the first-line medicine for type 2 diabetes (T2D), its safety profile in adolescents remains poorly understood. This study seeks to investigate the adverse events linked to metformin use in adolescents diagnosed with T2D.

Methods

Data from the Food and Drug Administration Adverse Event Reporting System (FAERS), spanning Q1 2004 to Q2 2024, were retrospectively analyzed in this study. Adverse reactions were standardized using the Medical Dictionary for Regulatory Activities, then significant adverse drug reaction signals were identified through disproportionality analysis employing reporting odds ratio (ROR) and information component (IC) methods.

Results

Of 17,956,653 FAERS reports, 80,187 involved metformin, including 973 in adolescents (10–19 years), with 174 cases were identified with a T2D indication. Analysis at the system organ class level revealed that congenital, familial, and genetic disorders [ROR: 8.8 (4.0, 19.3); IC: 2.2 (1.1, 2.9)] and pregnancy conditions [ROR: 4.9 (2.5, 9.5); IC: 1.8 (0.8, 2.5)] showed the most significant signals. At the preferred term (PT) level, three signals were identified across all sexes and subgroups: treatment noncompliance [ROR: overall 4.14 (2.44, 7.02), male 4.27 (2.00, 9.12), and female 4.65 (2.22, 9.74); IC: overall 1.67 (0.88, 2.22), male 1.60 (0.46, 2.36), and female 1.74 (0.60, 2.50)], lactic acidosis [IC: overall 2.99 (1.91, 3.72), male 2.53 (0.76, 3.61), and female 2.76 (1.34, 3.67)], and gastrointestinal disorder [ROR: overall 13.09 (4.73, 36.23), male 54.33 (6.05, 487.96), female 5.34 (1.10, 25.84)]. Neurological disorders were observed only in males, while pregnancy-related adverse effects and renal disorders occurred exclusively in females. Additionally, the study identified potential new signals not documented in metformin labeling, including areflexia, muscle weakness, ataxia, decreased vibratory sense, rhabdomyolysis, substance use, and axillary pain.

Conclusion

The study reveals a complex safety profile of metformin in adolescents with T2D, warranting further research to confirm risks.

Effect of fascial closure using barbed sutures on incisional hernias in midline laparotomy for gynecological diseases: A multicenter randomized controlled trial (KGOG 4001)

by Yong Jae Lee, Nam Kyeong Kim, Kidong Kim, Chel Hun Choi, Keun Ho Lee, Jong-Min Lee, Kwang Beom Lee, Dong Hoon Suh, Sunghoon Kim, Min Kyu Kim, Seok Ju Seong, Myong Cheol Lim

Objective

To identify the effect of fascial closure using barbed sutures on the incidence of incisional hernia in patients undergoing elective midline laparotomy for gynecological diseases.

Methods

In this multicenter, non-blind randomized controlled trial conducted from February to December 2021, patients with a BMI 2 and aged >18 years, scheduled for midline laparotomy, were randomly assigned to receive either barbed (experimental) or non-barbed sutures (control) for fascial closure. The primary outcome was the cumulative incidence rate of incisional hernia up to 1-year post-surgery. Secondary outcomes included incisional hernia up to 2-years post-surgery, wound complications, and postoperative pain assessed by Brief Pain Inventory-Korean scores, and Numeric Rating Scale.

Results

Out of 174 patients (experimental, 86; control, 88), 36 were excluded due to dropout or loss to follow-up, leaving 138 patients (experimental, 67; control, 71) included in the analysis. The groups were balanced in terms of cancer surgeries, mean wound length, and mean surgery time. The cumulative incidence rates of incisional hernia up to 1-year (0.0% vs. 1.4%; p > 0.999) and 2-years (0.0% vs. 3.4%, p = 0.496) post-surgery did not differ significantly between the experimental and control groups. Additionally, no significant differences were observed in the incidence of wound dehiscence 4 weeks post-surgery, cumulative incidences of wound dehiscence and wound infection up to 4 weeks post-surgery, or postoperative pain scores between the groups.

Conclusions

Fascial closure using barbed sutures resulted in no cases of incisional hernia up to 2-years post-surgery, but did not demonstrate a significant reduction in incisional hernia rates compared with the non-barbed suture.

Trial registration

ClinicalTrials.gov NCT04643197

Three infections, one fight: an implementation study to map needle prevalence and evaluate HIV, syphilis and hepatitis C prevention interventions in Regina, Saskatchewan - a protocol

Por: Eaton · A. D. · Rowe · M. W. · Varghese · S. M. · House · H. · Pang · N. · Kwan · S. · Ford · P. · Reddy · V. D. · Acoose · T. · Littleford · J. · Lang · K. · Foreman · E. S. · Sasakamoose · J. · Pandey · M. · Medeiros · P. · Loutfy · M. R. · Grace · D. · Brennan · D. J. · Zhao · K. · Shuper
Introduction

Saskatchewan is facing a public health crisis driven by high rates of HIV, syphilis and hepatitis C virus (HCV) infections, particularly among people who use drugs. Injection drug use is a major contributor to these syndemic infections, exacerbated by structural barriers such as stigma, poverty and limited culturally safe healthcare. Innovative, community-informed approaches are urgently needed to improve prevention, testing and linkage to care.

Methods and analysis

This study will implement a rapid assessment and response system in Regina, Saskatchewan, Canada, integrating geospatial mapping of community needle prevalence with pop-up interventions. Needle hotspot maps will be used to guide the deployment of community-based pop-up events offering point-of-care testing for HIV, syphilis and HCV, alongside education on pre-exposure prophylaxis (PrEP) and postexposure prophylaxis (PEP). A convergent participatory mixed-methods design will be used to evaluate feasibility, acceptability and effectiveness, guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. Quantitative data will assess changes in knowledge of PrEP and PEP, satisfaction with the intervention and report new diagnoses and participant demographics descriptively. A qualitative substudy will include 30 participants and will explore experiences with the intervention, barriers to care and perceptions of service delivery.

Ethics and dissemination

Ethical approval has been obtained from the research ethics board of the Saskatchewan Health Authority (#24–91). Findings will be disseminated through peer-reviewed publications, conference presentations and community reporting. This study may provide a model of community-based geospatial testing and education that could be scaled up and adapted elsewhere.

Registration

Open Science Framework https://doi.org/10.17605/OSF.IO/HVK3B

❌