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Efficacy and safety of autologous haematopoietic stem cell transplantation versus alemtuzumab, ocrelizumab, ofatumumab or cladribine in relapsing remitting multiple sclerosis (StarMS): protocol for a randomised controlled trial

Por: Brittain · G. · Petrie · J. · Duffy · K. E. M. · Glover · R. · Hullock · K. · Papaioannou · D. · Roldan · E. · Beecher · C. · Bursnall · M. · Ciccarelli · O. · Coles · A. J. · Cooper · C. · Giovannoni · G. · Gabriel · I. · Kazmi · M. · Kyriakou · C. · Nicholas · R. · Paling · D. · Peniket
Introduction

Autologous haematopoietic stem cell transplantation (aHSCT) is increasingly used as treatment for patients with active multiple sclerosis (MS), typically after failure of disease-modifying therapies (DMTs). A recent phase III trial, ‘Multiple Sclerosis International Stem Cell Transplant, MIST’, showed that aHSCT resulted in prolonged time to disability progression compared with DMTs in patients with relapsing remitting MS (RRMS). However, the MIST trial did not include many of the current high-efficacy DMTs (alemtuzumab, ocrelizumab, ofatumumab or cladribine) in use in the UK within the control arm, which are now offered to patients with rapidly evolving severe MS (RES-MS) who are treatment naïve. There remain, therefore, unanswered questions about the relative efficacy and safety of aHSCT over these high-efficacy DMTs in these patient groups. The StarMS trial (Autologous Stem Cell Transplantation versus Alemtuzumab, Ocrelizumab, Ofatumumab or Cladribine in Relapsing Remitting Multiple Sclerosis) will assess the efficacy, safety and long-term impact of aHSCT compared with high-efficacy DMTs in patients with highly active RRMS despite the use of standard DMTs or in patients with treatment naïve RES-MS.

Methods and analysis

StarMS is a multicentre parallel-group rater-blinded randomised controlled trial with two arms. A total of 198 participants will be recruited from 19 regional neurology secondary care centres in the UK. Participants will be randomly allocated to the aHSCT arm or DMT arm in a 1:1 ratio. Participants will remain in the study for 2 years with follow-up visits at 3, 6, 9, 12, 18 and 24 months postrandomisation. The primary outcome is the proportion of patients who achieve ‘no evidence of disease activity’ during the 2-year postrandomisation follow-up period in an intention to treat analysis. Secondary outcomes include efficacy, safety, cost-effectiveness and immune reconstitution of aHSCT and the four high-efficacy DMTs.

Ethics and dissemination

The study was approved by the Yorkshire and Humber—Leeds West Research Ethics Committee (20/YH/0061). Participants will provide written informed consent prior to any study specific procedures. The study results will be submitted to a peer-reviewed journal and abstracts will be submitted to relevant national and international conferences.

Trial registration number

ISRCTN88667898.

Pilot study of paediatric regional lung function assessment via X-ray velocimetry (XV) imaging in children with normal lungs and in children with cystic fibrosis

Por: Bruorton · M. · Donnelley · M. · Goddard · T. · OConnor · A. · Parsons · D. · Phillips · J. · Carson-Chahhoud · K. · Tai · A.
Introduction

Cystic fibrosis (CF) is a life-limiting autosomal recessive genetic condition. It is caused by mutations in the gene that encodes for a chloride and bicarbonate conducting transmembrane channel. X-ray velocimetry (XV) is a novel form of X-ray imaging that can generate lung ventilation data through the breathing cycle. XV technology has been validated in multiple animal models, including the β-ENaC mouse model of CF lung disease. It has since been assessed in early-phase clinical trials in adult human subjects; however, there is a paucity of data in the paediatric cohort, including in CF. The aim of this pilot study was to investigate the feasibility of performing a single-centre cohort study in paediatric patients with CF and in those with normal lungs to demonstrate the appropriateness of proceeding with further studies of XV in these cohorts.

Methods and analysis

This is a cross-sectional, single-centre, pilot study. It will recruit children aged 3–18 years to have XV lung imaging performed, as well as paired pulmonary function testing. The study will aim to recruit 20 children without CF with normal lungs and 20 children with CF. The primary outcome will be the feasibility of recruiting children and performing XV testing. Secondary outcomes will include comparisons between XV and current assessments of pulmonary function and structure.

Ethics and dissemination

This project has ethical approval granted by The Women’s and Children’s Hospital Human Research Ethics Committee (HREC ID 2021/HRE00396). Findings will be disseminated through peer-reviewed publication and conferences.

Trial registration number

ACTRN12623000109606.

Metabolomic signature between diabetic and non-diabetic obese patients: A protocol for systematic review

by Yuxing Tai, Xiaoqian Yang, Xiaochao Gang, Zhengri Cong, Sixian Wang, Peizhe Li, Mingjun Liu

Background

Type 2 diabetes mellitus (T2DM) is a chronic and progressive condition defined by hyperglycemia caused by abnormalities in insulin production, insulin receptor sensitivity, or both. Several studies have revealed that higher body mass index (BMI) is associated with increasing risk of developing diabetes. In this study, we perform a protocol for systematic review to explore metabolite biomarkers that could be used to identify T2DM in obese subjects.

Methods

The protocol of this review was registered in PROSPERO (CRD42023405518). Three databases, EMBASE, PubMed, and Web of Science were selected to collect potential literature from their inceptions to July December 2023. Data for collection will include title, authors, study subjects, publication date, sample size, detection and analytical platforms, participant characteristics, biological samples, confounding factors, methods of statistical analysis, the frequency and directions of changes in potential metabolic biomarkers, and major findings. Pathway analysis of differential metabolites will be performed with MetaboAnalyst 5.0 based on the Kyoto Encyclopedia of Genes and Genomes (KEGG) and the Human Metabolome Database.

Results

The results of this systematic review will be published in a peer-reviewed journal.

Conclusion

This systematic review will summarize the potential biomarkers and metabolic pathways to provide a new reference for the prevention and treatment of T2DM in obese subjects.

Application of in-silico drug discovery techniques to discover a novel hit for target-specific inhibition of SARS-CoV-2 Mpro’s revealed allosteric binding with MAO-B receptor: A theoretical study to find a cure for post-covid neurological disorder

by Magdi E. A. Zaki, Sami A. AL-Hussain, Aamal A. Al-Mutairi, Abdul Samad, Vijay H. Masand, Rahul G. Ingle, Vivek Digamber Rathod, Nikita Maruti Gaikwad, Summya Rashid, Pravin N. Khatale, Pramod V. Burakale, Rahul D. Jawarkar

Several studies have revealed that SARS-CoV-2 damages brain function and produces significant neurological disability. The SARS-CoV-2 coronavirus, which causes COVID-19, may infect the heart, kidneys, and brain. Recent research suggests that monoamine oxidase B (MAO-B) may be involved in metabolomics variations in delirium-prone individuals and severe SARS-CoV-2 infection. In light of this situation, we have employed a variety of computational to develop suitable QSAR model using PyDescriptor and genetic algorithm-multilinear regression (GA-MLR) models (R2 = 0.800–793, Q2LOO = 0.734–0.727, and so on) on the data set of 106 molecules whose anti-SARS-CoV-2 activity was empirically determined. QSAR models generated follow OECD standards and are predictive. QSAR model descriptors were also observed in x-ray-resolved structures. After developing a QSAR model, we did a QSAR-based virtual screening on an in-house database of 200 compounds and found a potential hit molecule. The new hit’s docking score (-8.208 kcal/mol) and PIC50 (7.85 M) demonstrated a significant affinity for SARS-CoV-2’s main protease. Based on post-covid neurodegenerative episodes in Alzheimer’s and Parkinson’s-like disorders and MAO-B’s role in neurodegeneration, the initially disclosed hit for the SARS-CoV-2 main protease was repurposed against the MAO-B receptor using receptor-based molecular docking, which yielded a docking score of -12.0 kcal/mol. This shows that the compound that inhibits SARS-CoV-2’s primary protease may bind allosterically to the MAO-B receptor. We then did molecular dynamic simulations and MMGBSA tests to confirm molecular docking analyses and quantify binding free energy. The drug-receptor complex was stable during the 150-ns MD simulation. The first computational effort to show in-silico inhibition of SARS-CoV-2 Mpro and allosteric interaction of novel inhibitors with MAO-B in post-covid neurodegenerative symptoms and other disorders. The current study seeks a novel compound that inhibits SAR’s COV-2 Mpro and perhaps binds MAO-B allosterically. Thus, this study will enable scientists design a new SARS-CoV-2 Mpro that inhibits the MAO-B receptor to treat post-covid neurological illness.

Intraorbital pressure–volume characteristics in a piglet model: In vivo pilot study

by Yasin Hamarat, Laimonas Bartusis, Vilma Putnynaite, Rolandas Zakelis, Mantas Deimantavicius, Vilma Zigmantaite, Ramunė Grigaleviciute, Audrius Kucinskas, Evaldas Kalvaitis, Arminas Ragauskas

Intracranial pressure measurement is frequently used for diagnosis in neurocritical care but cannot always accurately predict neurological deterioration. Intracranial compliance plays a significant role in maintaining cerebral blood flow, cerebral perfusion pressure, and intracranial pressure. This study’s objective was to investigate the feasibility of transferring external pressure into the eye orbit in a large-animal model while maintaining a clinically acceptable pressure gradient between intraorbital and external pressures. The experimental system comprised a specifically designed pressure applicator that can be placed and tightly fastened onto the eye. A pressure chamber made from thin, elastic, non-allergenic film was attached to the lower part of the applicator and placed in contact with the eyelid and surrounding tissues of piglets’ eyeballs. External pressure was increased from 0 to 20 mmHg with steps of 1 mmHg, from 20 to 30 mmHg with steps of 2 mmHg, and from 30 to 50 mmHg with steps of 5 mmHg. An invasive pressure sensor was used to measure intraorbital pressure directly. An equation was derived from measured intraorbital and external pressures (intraorbital pressure = 0.82 × external pressure + 3.12) and demonstrated that external pressure can be linearly transferred to orbit tissues with a bias (systematic error) of 3.12 mmHg. This is close to the initial intraorbital pressure within the range of pressures tested. We determined the relationship between intraorbital compliance and externally applied pressure. Our findings indicate that intraorbital compliance can be controlled across a wide range of 1.55 to 0.15 ml/mmHg. We observed that external pressure transfer into the orbit can be achieved while maintaining a clinically acceptable pressure gradient between intraorbital and external pressures.

Antimicrobial resistance, virulence profile, and genetic analysis of ESBL-producing <i>Escherichia coli</i> isolated from Nile tilapia in fresh markets and supermarkets in Thailand

by Woranich Hinthong, Varangkana Thaotumpitak, Jarukorn Sripradite, Nitaya Indrawattana, Thassanee Srisook, Thida Kongngoen, Edward R. Atwill, Saharuetai Jeamsripong

This study investigated the prevalence and antimicrobial resistance (AMR) of Escherichia coli (E. coli) in Nile tilapia from fresh markets and supermarkets. A total of samples (n = 828) were collected from Nile tilapia including fish flesh (n = 276), liver and kidney (n = 276), and intestine (n = 276). Overall prevalence of fecal coliforms (61.6%) and E. coli (53.0%) were observed. High prevalence of E. coli was found in the intestine (71.4%), followed by the liver and kidney (45.7%). The highest prevalence of resistance was commonly found against tetracycline (78.5%), ampicillin (72.8%), and sulfamethoxazole (45.6%) with resistance to only tetracycline (15.2%) as the most common antibiogram. The prevalence of multidrug resistance (MDR) (54.4%) and Extended-spectrum beta-lactamases (ESBLs) (5.7%) were examined. The predominant virulence genes (n = 158) were st (14.6%), followed by eaeA (0.6%). The blaTEM (73.4%), tetA (65.2%), and qnrS (57.6%). There is statistical significance between Nile tilapia from fresh markets and supermarkets. Based on logistic regression analysis, ampicillin-resistant E. coli was statistically associated with the phenotypic resistance to tetracycline and trimethoprim, and the presence of blaTEM and tetA (p

Dietary quality and cardiometabolic indicators in the USA: A comparison of the Planetary Health Diet Index, Healthy Eating Index-2015, and Dietary Approaches to Stop Hypertension

by Sarah M. Frank, Lindsay M. Jaacks, Christy L. Avery, Linda S. Adair, Katie Meyer, Donald Rose, Lindsey Smith Taillie

Background

The Planetary Health Diet Index (PHDI) measures adherence to the sustainable dietary guidance proposed by the EAT-Lancet Commission on Food, Planet, Health. To justify incorporating sustainable dietary guidance such as the PHDI in the US, the index needs to be compared to health-focused dietary recommendations already in use. The objectives of this study were to compare the how the Planetary Health Diet Index (PHDI), the Healthy Eating Index-2015 (HEI-2015) and Dietary Approaches to Stop Hypertension (DASH) relate to cardiometabolic risk factors.

Methods and findings

Participants from the National Health and Nutrition Examination Survey (2015–2018) were assigned a score for each dietary index. We examined disparities in dietary quality for each index. We used linear and logistic regression to assess the association of standardized dietary index values with waist circumference, blood pressure, HDL-C, fasting plasma glucose (FPG) and triglycerides (TG). We also dichotomized the cardiometabolic indicators using the cutoffs for the Metabolic Syndrome and used logistic regression to assess the relationship of the standardized dietary index values with binary cardiometabolic risk factors. We observed diet quality disparities for populations that were Black, Hispanic, low-income, and low-education. Higher diet quality was associated with improved continuous and binary cardiometabolic risk factors, although higher PHDI was not associated with high FPG and was the only index associated with lower TG. These patterns remained consistent in sensitivity analyses.

Conclusions

Sustainability-focused dietary recommendations such as the PHDI have similar cross-sectional associations with cardiometabolic risk as HEI-2015 or DASH. Health-focused dietary guidelines such as the forthcoming 2025–2030 Dietary Guidelines for Americans can consider the environmental impact of diet and still promote cardiometabolic health.

Concordance of shoulder symptoms and imaging findings: a protocol for the Finnish Imaging of Shoulder (FIMAGE) study

Por: Ibounig · T. · Buchbinder · R. · Sillanpää · N. · Rämö · L. · Toivonen · P. · Raatikainen · S. · Koskinen · S. · Härkänen · T. · Rissanen · H. · Czuba · T. · Paavola · M. · Jarvinen · T. · Taimela · S. · for the FIMAGE investigators · Björkenheim · Heliövaara · Kalsk
Introduction

Shoulder pain is a substantial medical and socioeconomic problem in most societies, affecting the ability to work or carry out leisure time activities as well as subsequently influencing physical and psychological well-being. According to a nationwide survey in Finland, 27% of the population reported shoulder pain within the last 30 days. In clinical practice, imaging findings of structural abnormalities are typically thought to explain symptoms, even though such findings are also prevalent in asymptomatic individuals, particularly with increasing age. Overall, there is a paucity of high-quality evidence on the prevalence, clinical relevance and prognosis of ‘abnormal’ imaging findings of the shoulder.

The aim of the Finnish Imaging of Shoulder (FIMAGE) study is fourfold: to assess (1) the prevalence of shoulder symptoms and the most common anatomical variants and imaging abnormalities of the shoulder; (2) the concordance between shoulder symptoms, function and imaging abnormalities; (3) the most important determinants of symptoms, function and imaging abnormalities; and (4) the course of shoulder complaints over 5 years.

Methods

The FIMAGE target population of 600 participants, aged 40–75 years, will be randomly selected from a nationally representative general population sample of 9922 individuals originally recruited for the Finnish Health 2000 Survey. On giving informed consent, the participants will be invited to a clinical visit that includes assessment of general health, shoulder symptoms, bilateral shoulder examination and imaging of both shoulders with plain radiography and MRI.

Ethics and dissemination

The study has been approved by the Institutional Review Board of the Helsinki and Uusimaa Hospital District. The findings will be published according to the Strengthening the Reporting of Observational Studies in Epidemiology criteria.

Trial registration number

NCT05641415.

Implementation of the advanced HIV disease care package with point-of-care CD4 testing during tuberculosis case finding: A mixed-methods evaluation

by Tinne Gils, Mashaete Kamele, Thandanani Madonsela, Shannon Bosman, Thulani Ngubane, Philip Joseph, Klaus Reither, Moniek Bresser, Erika Vlieghe, Tom Decroo, Irene Ayakaka, Lutgarde Lynen, Alastair Van Heerden

During TB-case finding, we assessed the feasibility of implementing the advanced HIV disease (AHD) care package, including VISITECT CD4 Advanced Disease (VISITECT), a semiquantitative test to identify a CD4≤200cells/μl. Adult participants with tuberculosis symptoms, recruited near-facility in Lesotho and South-Africa between 2021–2022, were offered HIV testing (capillary blood), Xpert MTB/RIF and Ultra, and MGIT culture (sputum). People living with HIV (PLHIV) were offered VISITECT (venous blood) and Alere tuberculosis-lipoarabinomannan (AlereLAM, urine) testing. AHD was defined as a CD4≤200cells/μl on VISITECT or a positive tuberculosis test. A CD4≤200cells/μl on VISITECT triggered Immy cryptococcal antigen (Immy CrAg, plasma) testing. Participants were referred with test results. To evaluate feasibility, we assessed i) acceptability and ii) intervention delivery of point-of-care diagnostics among study staff using questionnaires and group discussions, iii) process compliance, and iv) early effectiveness (12-week survival and treatment status) in PLHIV. Predictors for 12-week survival were assessed with logistic regression. Thematic content analysis and triangulation were performed. Among PLHIV (N = 676, 48.6% of 1392 participants), 7.8% were newly diagnosed, 81.8% on ART, and 10.4% knew their HIV status but were not on ART. Among 676 PLHIV, 41.7% had AHD, 29.9% a CD4≤200cells/μl and 20.6% a tuberculosis diagnosis. Among 200 PLHIV tested with Immy CrAg, 4.0% were positive. The procedures were acceptable for study staff, despite intervention delivery challenges related to supply and the long procedural duration (median: 73 minutes). At 12 weeks, among 276 PLHIV with AHD and 328 without, 3.3% and 0.9% had died, 84.8% and 92.1% were alive and 12.0% and 7.0% had an unknown status, respectively. Neither AHD nor tuberculosis status were associated with survival. Implementing AHD care package diagnostics was feasible during tuberculosis-case finding. AHD was prevalent, and not associated with survival, which is likely explained by the low specificity of VISITECT. Challenges with CD4 testing and preventive treatment uptake require addressing.

The relationship between sleep, gut microbiota, and metabolome in patients with depression and anxiety: A secondary analysis of the observational study

by Arisa Tanaka, Kenji Sanada, Katsuma Miyaho, Tomoyuki Tachibana, Shunya Kurokawa, Chiharu Ishii, Yoshihiro Noda, Shinichiro Nakajima, Shinji Fukuda, Masaru Mimura, Taishiro Kishimoto, Akira Iwanami

Background

Growing attention is paid to the association between alterations in the gut microbiota and their metabolites in patients with psychiatric disorders. Our study aimed to determine how gut microbiota and metabolomes are related to the sleep quality among patients with depression and anxiety disorders by analyzing the datasets of our previous study.

Methods

Samples were collected from 40 patients (depression: 32 patients [80.0%]); anxiety disorders: 8 patients [20.0%]) in this study. Gut microbiomes were analyzed using 16S rRNA gene sequencing and gut metabolomes were analyzed by a mass spectrometry approach. Based on the Pittsburgh Sleep Quality Index (PSQI), patients were categorized into two groups: the insomnia group (PSQI score ≥ 9, n = 20) and the non-insomnia group (PSQI score Results

The insomnia group showed a lower alpha diversity in the Chao1 and Shannon indices than the non-insomnia group after the false discovery rate (FDR) correction. The relative abundance of genus Bacteroides showed a positive correlation with PSQI scores in the non-insomnia group. The concentrations of glucosamine and N-methylglutamate were significantly higher in the insomnia group than in the non-insomnia group.

Conclusions

Our findings suggest that specific taxa could affect the sleep quality among patients with depression and anxiety disorders. Further studies are needed to elucidate the impact of sleep on specific gut microbiota and metabolomes in depression and anxiety disorders.

Untangling the effects of multiple exposures with a common reference group in an epidemiologic study: A practical revisit

by Robert E. Fontaine, Yulei He, Bao-Ping Zhu

When assessing multiple exposures in epidemiologic studies, epidemiologists often use multivariable regression models with main effects only to control for confounding. This method can mask the true effects of individual exposures, potentially leading to wrong conclusions. We revisited a simple, practical, and often overlooked approach to untangle effects of the exposures of interest, in which the combinations of all levels of the exposures of interest are recoded into a single, multicategory variable. One category, usually the absence of all exposures of interest, is selected as the common reference group (CRG). All other categories representing individual and joint exposures are then compared to the CRG using indicator variables in a regression model or in a 2×2 contingency table analysis. Using real data examples, we showed that using the CRG analysis results in estimates of individual and joint effects that are mutually comparable and free of each other’s confounding effects, yielding a clear, accurate, intuitive, and simple summarization of epidemiologic study findings involving multiple exposures of interest.

Study protocol for a single-blind, parallel-group, randomised, controlled non-inferiority trial of 4-day intensive versus standard cognitive behavioural therapy for adults with obsessive-compulsive disorder

Por: Ivanova · E. · Fondberg · R. · Flygare · O. · Sannemalm · M. · Asplund · S. · Dahlen · S. · Sampaio · F. · Andersson · E. · Mataix-Cols · D. · Ivanov · V. Z. · Rück · C.
Introduction

Individual cognitive behavioural therapy (CBT) with exposure and response prevention is an effective treatment for obsessive–compulsive disorder (OCD). However, individual CBT is costly and time-consuming, requiring weekly therapy sessions for 3–4 months. A 4-day intensive version of CBT for OCD delivered in group format has been recently developed in Norway (Bergen 4-day treatment, B4DT). B4DT has shown promising results in several uncontrolled and one small, randomised trial, but its non-inferiority to the gold standard treatment has not been established.

Methods and analysis

This single-blind, randomised controlled trial including 120 patients (60 per arm) will compare B4DT to individual CBT. The primary outcome is the blind assessor-rated Yale-Brown Obsessive Compulsive Scale (Y-BOCS). We hypothesise that B4DT will be non-inferior to gold standard CBT 15 weeks after treatment start. The non-inferiority margin is set at four points on the Y-BOCS. Secondary outcomes include time to treatment response, cost-effectiveness, response and remission rates, drop-out rates and adverse events.

Ethics and dissemination

This study has been approved by the Swedish Ethical Review Authority. Hypotheses were specified and analysis code published before data collection started. Results from all analyses will be reported in accordance with the Consolidated Standards of Reporting Trials statement for non-pharmacological trials and Consolidated Health Economic Evaluation Reporting Standards irrespective of outcome.

Trial registration number

NCT05608278.

A meta‐analysis evaluating wound infections and other complications following distal versus complete gastrectomy for gastric cancer

Abstract

A meta-analysis investigation was carried out to measure the wound infections (WIs) and other postoperative problems (PPs) of distal gastrectomy (DG) compared with total gastrectomy (TG) for gastric cancer (GC). A comprehensive literature investigation till February 2023 was used and 1247 interrelated investigations were reviewed. The 12 chosen investigations enclosed 2896 individuals with GC in the chosen investigations' starting point, 1375 of them were TG, and 1521 were DG. Odds ratio (OR) in addition to 95% confidence intervals (CIs) were utilized to compute the value of the WIs and other PPs of DG compared with TG for GC by the dichotomous approaches and a fixed or random model. TG had significantly higher overall PP (OR, 1.58; 95% CI, 1.15–2.18, p = 0.005), WIs (OR, 1.69; 95% CI, 1.07–2.67, p = 0.02), peritoneal abscess (PA) (OR, 2.99; 95% CI, 1.67–5.36, p < 0.001), anastomotic leakage (AL) (OR, 1.90; 95% CI, 1.21–2.97, p = 0.005) and death (OR, 2.26; 95% CI, 1.17–4.37, p = 0.02) compared to those with DG in individuals with GC. TG had significantly higher overall PP, WIs, PA, AL and death compared to those with DG in individuals with GC. However, care must be exercised when dealing with its values because of the low sample size of some of the nominated investigations for the meta-analysis.

Vulnerabilidad en mujeres víctimas de trata desde un enfoque sociocrítico enfermero: Salud, Derechos Humanos y Objetivos de Desarrollo Sostenible.

La trata de mujeres supone una grave violación de los derechos humanos. Está relacionada con la vulnerabilidad, la pobreza, la desigualdad de género, la desescolarización y con los procesos migratorios. En este problema global destaca además el incumplimiento de los Objetivos de Desarrollo Sostenible. Esta realidad acarrea graves problemas de salud a sus víctimas, punto de interés para la actuación de enfermería. Así, este trabajo realizado mediante el método de aprendizaje colaborativo Jigsaw, en el contexto de una asignatura optativa de cuarto curso del Grado en Enfermería, tiene como objetivo el análisis desde el paradigma socio crítico de las consecuencias que la trata supone para la salud de las mujeres, relacionándolo con la vulneración de sus derechos humanos y la incompatibilidad de esta práctica internacional con la consecución de los Objetivos de Desarrollo Sostenible, para concluir con recomendaciones que puedan orientar a la enfermería a proporcionar cuidados más adecuados desde su competencia como activista en salud. Se han identificado múltiples acciones dirigidas a la prevención, protección y atención de las mujeres víctima de trata, el conflicto se genera a la hora de ejecutarlas, ya que se ha constatado la desatención de estas mujeres desde múltiples enfoques.

Interventions to support nurses as second victims of patient safety incidents: A qualitative study of nurse managers' perceptions

Abstract

Aims

To describe nurse managers' perceptions of interventions to support nurses as second victims of patient safety incidents and to describe the management of interventions and ways to improve them.

Design

A qualitative study using interviews.

Methods

A purposive sample of nurse managers (n = 16) recruited from three hospital districts in Finland was interviewed in 2021. The data were analysed using elements of inductive and deductive content analysis.

Results

The study identified three main categories: (1) Management of second victim support, which contained three sub-categories related to the nurse manager's role, support received by the nurse manager and challenges of support management; (2) interventions to support second victims included existing interventions and operating models; and (3) improving second victim support, based on the sub-categories developing practices and developing an open and non-blaming patient safety culture.

Conclusion

Nurse managers play a crucial role in supporting nurses as second victims of patient safety incidents and coordinating additional support. Operating models for managing interventions could facilitate nurse managers' work and ensure adequate support for second victims. The support could be improved by increasing the awareness of the second victim phenomenon.

Implications for the Profession and Patient Care

Mitigating the harmful effects of patient safety incidents can improve nurses' well-being, reduce burden and attrition risks and positively impact patient safety.

Impact

Increasing awareness of the second victim phenomenon and coherent operation models would provide equal support for the nurses and facilitate nurse managers' work.

Reporting Method

COREQ checklist was used.

What does this paper contribute to the wider global clinical community? Nurse managers' role is significant in supporting the second victims and coordinating additional support. Awareness of the second victim phenomenon and coherent operating models can secure adequate support for the nurses and facilitate nurse managers' work.

Reframing care while enduring the traumatic nature of witnessing disrupted family‐patient‐nurses' relationships during COVID‐19

Abstract

Aim

To describe the lived experiences of nurses caring for patients and families in the context of COVID-19 in Brazil and United States.

Design

A phenomenological philosophical approach following the van Manen analysis method.

Methods

Participants were recruited in Brazil and the United States, including nurses working in health care settings caring for COVID-19 patients. Recruitment used purposive and snowball sampling. Participants completed a demographic survey and semi-structured interviews that were audio-recorded and transcribed for analysis. A cross-cultural examination occurred among researchers from each country.

Results

The result was described (n = 35) by the themes, representing the essences of each lifeworld (relationship, time, space and body). The nurses' lived experience was one of reframing care while enduring repeated trauma of witnessing disrupted patient-family-nurse relationships. Themes were as follows: (a) Living a silent and lonely experience; (b) Providing connectedness for disrupted patient and family relationships; (c) Feeling the burden of the demands; (d) Being a helping connector; (e) Reshaping spaces amidst evolving interventions and policies; (f) Creating safe spaces, surrounded by turmoil, threat, and distress within an unsafe environment; (g) Reorganizing care and reframing time; (h) Reconciling losses, regrets, victories and lessons.

Conclusion

The nurses' lived experience of caring for patients and families during the COVID-19 pandemic prompted the need to respond to repeated traumas and distress posed by interrupted patient-family and nurse-own family relationships, vulnerable bodies, threatened space and dynamic and volatile time.

Impact

Cultural nuances were discovered depending on the practice setting, political discourse and the autonomy of the nurse. Innovative models of care that create structures and processes to support nurses in caring for patients in threatening environments and the commitment to connecting family members have potential to contribute to the ongoing health of the nursing profession.

“Like fighting a fire with a water pistol”: A qualitative study of the work experiences of critical care nurses during the COVID‐19 pandemic

Abstract

Aim

To understand the experience of critical care nurses during the COVID-19 pandemic, through the application of the Job-Demand-Resource model of occupational stress.

Design

Qualitative interview study.

Methods

Twenty-eight critical care nurses (CCN) working in ICU in the UK NHS during the COVID-19 pandemic took part in semi-structured interviews between May 2021 and May 2022. Interviews were guided by the constructs of the Job-Demand Resource model. Data were analysed using framework analysis.

Results

The most difficult job demands were the pace and amount, complexity, physical and emotional effort of their work. Prolonged high demands led to CCN experiencing emotional and physical exhaustion, burnout, post-traumatic stress symptoms and impaired sleep. Support from colleagues and supervisors was a core job resource. Sustained demands and impaired physical and psychological well-being had negative organizational consequences with CCN expressing increased intention to leave their role.

Conclusions

The combination of high demands and reduced resources had negative impacts on the psychological well-being of nurses which is translating into increased consideration of leaving their profession.

Implications for the Profession and/or Patient Care

The full impacts of the pandemic on the mental health of CCN are unlikely to resolve without appropriate interventions.

Impact

Managers of healthcare systems should use these findings to inform: (i) the structure and organization of critical care workplaces so that they support staff to be well, and (ii) supportive interventions for staff who are carrying significant psychological distress as a result of working during and after the pandemic. These changes are required to improve staff recruitment and retention.

Reporting Method

We used the COREQ guidelines for reporting qualitative studies.

Patient and Public Contribution

Six CCN provided input to survey content and interview schedule. Two authors and members of the study team (T.S. and S.C.) worked in critical care during the pandemic.

Role delineation of advanced practice nursing: A cross‐sectional study

Abstract

Aims

To identify the roles and activities of nurses, including advanced practice nursing (APN), and to determine nursing practice patterns across health facilities in Saudi Arabia.

Methods

A descriptive cross-sectional design was used to collect data from 207 nurses working in the Saudi health sector between November 2021 and March 2022 through an online questionnaire. The Advanced Practice Role Delineation tool was used to measure and delineate nursing practice patterns and activities. Data were analysed using descriptive statistics and analysis of variance. The study followed the Strengthening the Reporting of Observational Studies in Epidemiology reporting guidelines.

Results

Findings showed that participants, regardless of their current role, reported high scores across all domains of practice. The highest average score was obtained for the Clinical Care domain. Except for the leadership domain, findings showed that those reported working as advanced practice nurses had higher average scores across all domains than those working as staff nurses or being in managerial/administrative positions. There were significant differences in the average Clinical Care scores between advanced practice nurses and staff nurses.

Conclusion

Advanced practice nursing roles and activities are being practised in Saudi Arabia; however, there is no clear delineation of these roles and activities according to a unified and national-level APN scope of practice.

Impacts

Advanced practice nursing roles are evolving in Saudi Arabia; however, no study has examined the existing patterns of APN activities in Saudi Arabia. This study highlights the practice patterns of advanced practice nurses and adds to the international evidence base on the need for delineating APN activities under a unified scope of practice. The findings of this study are beneficial to practitioners, researchers, and stakeholders as well as the legislative and regulatory bodies.

Patient or public contribution

No patient or public contribution.

Efficacy of splinting the wrist and metacarpophalangeal joints for the treatment of Carpal tunnel syndrome: an assessor-blinded randomised controlled trial

Por: Nadar · M. S. · Alotaibi · N. · Manee · F.
Objectives

To compare the efficacy of a traditional cock-up splint, which supports the wrist only, with a modified splint that supports the wrist and the metacarpophalangeal (MCP) joints of the medial four digits in the treatment of carpal tunnel syndrome (CTS).

Design

An assessor-blind randomised controlled trial.

Setting

Hospital-based hand therapy clinics.

Participants

Fifty-nine adults with mild-to-moderate CTS were randomly assigned to wear a wrist splint (control group) or an MCP splint (intervention group) for 6 weeks.

Outcome measures

The standardised outcome measures used included grip and pinch strength, the static two-point discrimination test, Phalen’s manoeuvre test, Tinel’s sign and the Boston CTS Questionnaire.

Results

Both groups improved significantly from splint use in some clinical features. The wrist splint and the MCP splint groups had significant improvements in lateral pinch strength (p=0.032 and p=0.002, respectively), two-point discrimination of the thumb (p=0.003 and p=0.041, respectively), two-point discrimination of the index (p=0.035 and p=0.023, respectively) and the Phalen’s manoeuvre symptoms (p=0.025 and p=0.002, respectively). The MCP splint group had additional improvements over the wrist splint group in tip pinch (p=0.012) and Palmar pinch (p=0.011) strength.

Conclusion

Splinting is a practical and effective intervention option for improving the symptoms of CTS. A wrist splint that incorporates the MCP joints is more effective than the traditional wrist-only splint, with long-lasting improvements that remained consistent after 6 months of the splint intervention. Using the more effective MCP splint may consequently reduce disability, facilitate return to work and lower the associated costs.

Trial registration number

ISRCTN13189602.

Effect of hydrocolloid dressings in the management of different grades of pressure wound ulcers in critically ill adult subjects: A meta‐analysis

Abstract

A meta-analysis was implemented to appraise the effect of hydrocolloid dressings (HCDs) in the management of different grades of pressure wound ulcers (PWUs) in critically ill adult subjects (CIUSs). Inclusive literature research until April 2023 was done, and 969 interconnected researches were revised. The 8 picked researches, enclosed 679 critically ill adult persons at the utilized researchers' starting point; 355 of them were utilizing HCDs, and 324 were controls. Odds ratio (OR) and 95% confidence intervals (CIs) were utilized to appraise the consequences of HCDs in treating CIUSs by the dichotomous approach and a fixed or random model. HCDs had significantly higher PWU complete healing (OR, 2.15; 95% CI, 1.54–3.02, p < 0.001), PWU stage II ulcers complete healing (OR, 2.82; 95% CI, 1.40–5.69, p = 0.004), and PWU stage III ulcers complete healing (OR, 3.73; 95% CI, 1.23–11.35, p = 0.02) compared to control in critically ill adult persons. HCDs had significantly higher PWU complete healing, PWU stage II ulcers complete healing, and PWU stage III ulcers complete healing compared with control in critically ill adult persons. However, caution needs to be taken when interacting with its values since there was a low sample size of most of the chosen research found for the comparisons in the meta-analysis.

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