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Inter- and intra-rater reproducibility of quantitative T1 measurement using semiautomatic region of interest placement in myometrium

by Sadahiro Nakagawa, Takahiro Uno, Shunta Ishitoya, Eriko Takabayashi, Akiko Oya, Wakako Kubota, Atsutaka Okizaki

Purpose

This study aimed to investigate the inter- and intraobserver reproducibility of quantitative T1 (qT1) measurements using manual and semiautomatic region of interest (ROI) placements. We hypothesized the usefulness of the semiautomatic method, which utilizes a three-dimensional (3D) anatomical relationship between the myometrium and other tissues, for minimizing ROI placement variation, thereby improving qT1 reproducibility compared to the manual approach. The semiautomatic approach, which considered anatomical relationships, was expected to enhance reproducibility by reducing ROI placement variabilities.

Materials and methods

This study recruited 23 healthy female volunteers. Data with variable flip angle (VFA) and inversion recovery were acquired using 3D-spoiled gradient echo and spin echo sequences, respectively. T1 maps were generated with VFA. Manual and semiautomatic ROI placements were independently conducted. Mean qT1 values were calculated from the T1 maps using the corresponding pixel values of the myometrial ROI. Inter- and intraobserver reproducibility of qT1 values was investigated. The inter- and intraobserver reproducibility of qT1 values was evaluated by calculating the coefficient of variation (CoV). Further, reproducibility was evaluated with inter- and intraobserver errors and intraclass correlation coefficients (ICCs). Bland–Altman analysis was utilized to compare the results, estimate bias, and determine the limits of agreement.

Results

The mean inter- and intraobserver CoV of the qT1 values for semiautomatic ROI placement was significantly lower than those for manual ROI placement (p p p p Conclusion

Semiautomatic ROI placement demonstrated high reproducibility of qT1 measurements compared with manual methods. Semiautomatic ROI placement may be useful for evaluating uterine qT1 with high reproducibility.

Effect of vitamin D on clinical outcomes in patients with thermal injury

Abstract

Evaluating complications and mortality risks in burn patients is crucial for effective treatment planning and improving survival rates. This study investigated the relationship between the serum vitamin D level and the clinical outcomes of adult burns patients. This was a prospective cohort of adult patients hospitalized due to thermal burns at a burn centre in the north of Iran. Based on the level of 25 hydroxyvitamin D measured upon admission, patients were divided into two groups of patients with sufficient 25 hydroxyvitamin D level and insufficient 25 hydroxyvitamin D level. Descriptive statistics were used for baseline demographics. Univariate analysis was conducted using Mann–Whitney U, Chi-square, independent samples, and Fisher's exact tests. A multivariate logistic regression was performed to adjust for the effects of confounding variables. Statistical analyses were conducted using SPSS 28.0 software. A total of 220 patients were included in the study. The average total body surface area burned was 30.52 ± 9.34. Patients with insufficient vitamin D levels had longer hospital stays (12.53 vs. 11.45) and longer stays in the intensive care unit (ICU) (3.32 vs. 2.40) than those with appropriate vitamin D levels. Participants with insufficient vitamin D levels exhibited a numerically higher incidence of infections than those with adequate levels (p < 0.05). The multivariate regression found that vitamin D deficiency levels were associated with increased infection rates and prolonged hospital stay. This study suggests that vitamin D deficiency is a significant risk factor for adverse clinical outcomes in burn patients. Further research is needed to confirm these associations and to explore potential interventions to optimize vitamin D status in this patient population.

ATME--Needs, requirements and cross-sectoral patient journeys of patients with out-of-hospital mechanical ventilation and intensive care in outpatient settings: study protocol for an observational study

Por: Knizia · N.-A. · Hirschler · J. · Stegbauer · C. · Schwinger · A. · Büscher · A. · Englert · N. · Peters · L. · Bayarassou · H. A. · Mallmann · L. · Willms · G.
Introduction

An increasing number of tracheotomised and/or ventilated patients with high-cost out-of-hospital intensive care needs and, at the same time, a decreasing number of healthcare professionals inevitably lead to challenges in the care of this patient population. In addition, little is known about this population, their health restrictions, needs, patient journeys, care structures and processes. The project ‘Needs, requirements and cross-sectoral care pathways of out-of-hospital ventilated intensive care patients’ (ATME) aims to analyse these aspects and explore current care structures to inform further development of care in line with patients’ needs and requirements.

Methods and analysis

Qualitative and quantitative methods will be used. In preparation of a semistandardised survey, exploratory interviews will be conducted with tracheotomised and/or ventilated patients with out-of-hospital intensive care needs (TVPOI) (n=15), nursing care providers (n=30), outpatient medical centres, as well as outpatient medical, medical technology and therapeutic care providers (n=35). Three semistandardised survey questionnaires for TVPOI (n=2,000) will be developed and conducted with nursing care facilities (n=250) and outpatient medical centres for mechanical ventilation (n=25). Content analyses will be conducted for qualitative data; survey data will be analysed descriptively. In addition, healthcare claims data will be analysed descriptively to provide information on patient journeys. Three result workshops and one consensus conference will be carried out with representatives of the relevant target groups to analyse the suitability of care structures and to develop recommendations for action to improve TVPOI.

Ethics and dissemination

The ATME study received a positive vote from the Ethics Committee of the Osnabrück University of Applied Sciences and is registered in ‘Deutsches Register Klinischer Studien (DRKS)’ (registration number: DRKS00030891). The study results will be presented at national conferences and in relevant peer-reviewed journals. Additionally, study results will be published by the funding institution (the Innovation Committee of the Federal Joint Committee) on their website.

Engaging people with lived experiences on community advisory boards in community-based participatory research: a scoping review protocol

Por: Nelson · G. · Kettaneh · H. · Knox · B. · Purkey · E. · Chan-Nguyen · S. · Jenkins · M. · Bayoumi · I.
Introduction

Community-based participatory research (CBPR) is a collaborative research approach that equally engages researchers and community stakeholders throughout all steps of the research process to facilitate social change and increase research relevance. Community advisory boards (CABs) are a CBPR tool in which individuals with lived experience and community organisations are integrated into the research process and ensure the work aligns with community priorities. We seek to (1) explore the best practices for the recruitment and engagement of people with lived experiences on CABs and (2) identify the scope of literature on minimising power dynamics between organisations and community members with lived experience who work on CABs together.

Methods and analysis

This scoping review will follow the Arksey and O’Malley methodological framework, informed by Levac et al, and will be reported using a PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) diagram. Detailed and robust search strategies have been developed for Embase, Medline and PsychINFO. Grey literature references and reference lists of included articles published between 1 January 1990 and 30 March 2023 will be considered. Two reviewers will independently screen references in two successive stages of title/abstract and full-text screening. Conflicts will be decided by consensus or a third reviewer. Thematic analysis will be applied in three phases: open coding, axial coding and abstraction. Extracted data will be recorded and presented in a tabular format and/or graphical summaries, with a descriptive overview discussing how the research findings relate to the research questions. At this time, a preliminary search of peer-reviewed and grey literature has been conducted. Search results for peer-reviewed literature have been uploaded to Covidence for review and appraisal for relevance.

Ethics and dissemination

Formal ethics approval is not required for this review. Review findings will inform ongoing and future CBPR community advisory board dynamics.

Registration

The protocol has been registered prospectively on the Open Science Framework (https://doi.org/10.17605/OSF.IO/QF5D3)

Predictive value of serum albumin and calcium levels in burn patients with Pseudomonas aeruginosa infection: A comprehensive analysis of clinical outcomes

Abstract

In the ongoing challenge to reduce burn-associated mortality rates, this study explores the predictive capacity of clinical factors in burn patients, focusing on vitamin D, calcium, and serum albumin levels during hospitalisation in cases with Pseudomonas aeruginosa infection. Our research involves a comprehensive analysis of 100 burn patients, encompassing crucial clinical parameters such as the burn severity index, serum albumin, vitamin D, and calcium levels at admission. Data were meticulously entered into IBM Statistics SPSS software version 28 and subjected to statistical analysis. The study reveals an average patient age of 39.75 years and a notable 34% mortality rate. Additionally, the average lengths of hospital and intensive care unit (ICU) stays are determined to be 11.33 and 7.79 days, respectively. Significantly, a correlation between calcium and albumin variables and treatment outcomes is established, showcasing their potential to predict variable changes in patient mortality rates. Furthermore, a noteworthy association is observed between serum calcium levels and the duration of ICU hospitalisation. In conclusion, albumin and calcium variables emerge as sensitive and specific indicators for predicting outcomes in burn patients. Importantly, the independence of these factors from the physician's experience and diagnosis reduces human error and thus increases the accuracy of mortality prediction in this patient population.

Beyond the burn: An observational study of cardiovascular risk in burn survivors in the north of Iran

Abstract

Burn survivors experience profound physiological changes following injury, which may have lasting implications for cardiovascular health. This study aims to investigate the cardiovascular risk profile among burn survivors treated at a burn center in northern Iran. This observational study was conducted from 2022 to 2023 at the burn centre affiliated with Guilan University of Medical Sciences, Rasht, Iran. This study assessed a cohort study of 210 burn survivors, focusing on individuals with ≥20% TBSA burn injuries who had recovered and returned to their daily lives. This study assessed patients' lipid profiles, Framingham General Cardiovascular Risk Score (FGCRS) and risk factors, including demographics, clinical variables and physical activity. Statistical analysis employed descriptive and inferential statistics. The mean age was 49.23 years, and the mean TBSA burned was 37.06%. The risk of cardiovascular disease in 66% of the study population was less than 10%, and in 13%, it was more than 20%. Significant associations were identified between CVD risk and sex, diabetes, hypertension, BMI, TBSA burned, years after burn, physical activity level and LDL. Of the lipid profile measures, LDL, triglycerides and TC/HDL exceeded the desirable levels. This research highlights the heightened cardiovascular risk in burn survivors, emphasizing the necessity for targeted interventions and regular monitoring. Identifying modifiable risk factors enables healthcare practitioners to develop tailored strategies, enhancing cardiovascular health in this vulnerable population and improving overall outcomes and quality of life.

Qualitative study of challenges with recruitment of hospitals into a cluster controlled trial of clinical decision support in Australia

Por: Baysari · M. T. · Van Dort · B. A. · Stanceski · K. · Hargreaves · A. · Zheng · W. Y. · Moran · M. · Day · R. O. · Li · L. · Westbrook · J. · Hilmer · S. N.
Objective

To identify barriers to hospital participation in controlled cluster trials of clinical decision support (CDS) and potential strategies for addressing barriers.

Design

Qualitative descriptive design comprising semistructured interviews.

Setting

Five hospitals in New South Wales and one hospital in Queensland, Australia.

Participants

Senior hospital staff, including department directors, chief information officers and those working in health informatics teams.

Results

20 senior hospital staff took part. Barriers to hospital-level recruitment primarily related to perceptions of risk associated with not implementing CDS as a control site. Perceived risks included reductions in patient safety, reputational risk and increased likelihood that benefits would not be achieved following electronic medical record (EMR) implementation without CDS alerts in place. Senior staff recommended clear communication of trial information to all relevant stakeholders as a key strategy for boosting hospital-level participation in trials.

Conclusion

Hospital participation in controlled cluster trials of CDS is hindered by perceptions that adopting an EMR without CDS is risky for both patients and organisations. The improvements in safety expected to follow CDS implementation makes it challenging and counterintuitive for hospitals to implement EMR without incorporating CDS alerts for the purposes of a research trial. To counteract these barriers, clear communication regarding the evidence base and rationale for a controlled trial is needed.

Rituximab-combined anthracycline-free chemotherapy in newly diagnosed paediatric and adolescent patients with non-high-risk aggressive mature B cell lymphoma: protocol for a single-arm, open-label, multicentre, phase II study (the Japan Childrens Cancer G

Por: Sekimizu · M. · Fukano · R. · Koga · Y. · Mitsui · T. · Fujita · N. · Mori · T. · Hori · D. · Tanaka · M. · Ohki · K. · Iwafuchi · H. · Nakazawa · A. · Mori · T. · Kobayashi · R. · Hashimoto · H. · M. Saito · A. · Kamei · M. · on behalf of Lymphoma Committee of Japan Childrens Cancer G
Introduction

Children and adolescents with mature B cell non-Hodgkin lymphoma (B-NHL) are treated with short-intensive chemotherapy. The burden of short-term and long-term toxicity is highly relative to its high cure rate in good-risk patients. Although the addition of rituximab to standard lymphome Malin B (LMB) chemotherapy markedly prolongs event-free survival and overall survival in high-risk patients, the benefit of rituximab in good-risk patients remains to be elucidated. This clinical trial will examine whether the addition of rituximab eliminates anthracyclines in good-risk patients without compromising treatment outcomes.

Methods and analysis

We will perform a single-arm, open-label, multicentre phase II study. Low-risk (stage I – completely resected, stage II abdominal) and intermediate-risk (stages I and II – incompletely resected; stage II – resected, other than abdominal; stage III with LDH x upper limit of normal) patients with newly diagnosed B-NHL are eligible. Low-risk patients receive two courses of R-COM1P (rituximab, cyclophosphamide, vincristine, methotrexate, prednisolone and intrathecal methotrexate with hydrocortisone), and intermediate-risk patients receive COP (cyclophosphamide, vincristine, prednisolone and intrathecal methotrexate with hydrocortisone) followed by two courses each of R-COM3P and R-CYM (rituximab, cytarabine, methotrexate and intrathecal methotrexate with hydrocortisone). The primary endpoint is a 3-year event-free survival rate in paediatric patients (

Ethics and dissemination

This research was approved by the Certified Review Board at NHO Nagoya Medical Center (Nagoya, Japan) on 21 September 2021. Written informed consent is obtained from all patients and/or their guardians. The results of this study will be disseminated through peer-reviewed publications and conference presentations.

Study registration

Japan Registry of Clinical Trials, jRCTs041210104.

Measurement properties of the Mental Health Literacy Scale (MHLS) validation studies: a systematic review protocol

Por: ElKhalil · R. · AlMekkawi · M. · O'Connor · M. · Sherif · M. · Masuadi · E. · Ahmed · L. A. · Al-Rifai · R. H. · Belfakir · M. · Bayoumi · R. · Elbarazi · I.
Introduction

Mental Health Literacy (MHL) is important for improving mental health and reducing inequities in treatment. The Mental Health Literacy Scale (MHLS) is a valid and reliable assessment tool for MHL. This systematic review will examine and compare the measurement properties of the MHLS in different languages, enabling academics, clinicians and policymakers to make informed judgements regarding its use in assessments.

Methods and analysis

The review will adhere to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology for systematic reviews of patient-reported outcome measures and the Joanna Briggs Institute (JBI) Manual for Evidence Synthesis and will be presented following the Preferred Reporting Items for Systematic reviews and Meta-Analysis 2020 checklist. The review will be conducted in four stages, including an initial search confined to PubMed, a search of electronic scientific databases PsycINFO, CINAHL, Scopus, MEDLINE, Embase (Elsevier), PubMed (NLM) and ERIC, an examination of the reference lists of all papers to locate relevant publications and finally contacting the MHLS original author to identify validation studies that the searches will not retrieve. These phases will assist us in locating studies that evaluate the measurement properties of MHLS across various populations, demographics and contexts. The search will focus on articles published in English between May 2015 and December 2023. The methodological quality of the studies will be evaluated using the COSMIN Risk of Bias checklist, and a comprehensive qualitative and quantitative data synthesis will be performed.

Ethics and dissemination

Ethics approval is not required. The publication will be in peer-reviewed journals and presented at national and international conferences.

PROSPERO registration number

CRD42023430924.

Effectiveness and cost-effectiveness of community-based directly observed treatment (DOT) versus health facility-based DOT of tuberculosis in Africa: protocol for a systematic review and meta-analysis

Por: Baye · T. · Kassaw · A. T. · Gebrie · D. · Girmaw · F. · Ashagrie · G.
Background

Tuberculosis (TB) remains a significant global health challenge, especially prevalent in the WHO African region. The WHO’s End TB Strategy emphasises effective treatment approaches such as directly observed therapy (DOT), yet the optimal implementation of DOT, whether through health facility-based (HF DOT) or community-based (CB DOT) approaches, remains uncertain.

Objective

To conduct a systematic comparison of the effectiveness and cost-effectiveness of Community-Based Directly Observed Treatment (CB DOT) versus Health Facility-Based Directly Observed Treatment (HF DOT) for tuberculosis (TB) treatment in African settings.

Methods

We will conduct a systematic review and meta-analysis following Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. We will search PubMed, Embase, Web of Science, Scopus and the Cochrane Library for articles published up to 30 March 2023, without date restrictions. Eligible studies must be full economic evaluations conducted in African countries, comparing CB DOT to HF DOT regarding treatment outcomes and costs. Exclusion criteria include non-English, non-peer-reviewed or studies lacking caregiver involvement in CB DOT, health facility-based DOT comparison, direct comparability between CB DOT and HF DOT, significant selection bias or non-economic evaluations. Data extraction will be performed independently by reviewers, and meta-analyses will use STATA software. To pool the data, a random-effect model will be applied, and quality assessment of the studies will be conducted.

Ethics and dissemination

Ethical approval is not required as the study will use previously published articles available publicly. Findings will be presented at international and national conferences and published in open-access, peer-reviewed journals.

PROSPERO registration number

CRD42023443260.

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