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Multicentre randomised trial of screening with sFlt1/PlGF and planned delivery to prevent pre-eclampsia at term: protocol of the PE37 study

Por: Llurba · E. · Crispi · F. · Crovetto · F. · Youssef · L. · Delgado · J. L. · Puig · I. · Mora · J. · Krofta · L. · Mackova · K. · Martinez-Varea · A. · Tubau · A. · Ruiz · A. · Paya · A. · Prat · M. · Chantraine · F. · Comas · C. · Kajdy · A. · Lopez-Tinajero · M. F. · Figueras · F. · Gratac
Introduction

Pre-eclampsia affects ~5%–7% of pregnancies. Although improved obstetric care has significantly diminished its associated maternal mortality, it remains a leading cause of maternal morbidity and mortality in the world. Term pre-eclampsia accounts for 70% of all cases and a large proportion of maternal–fetal morbidity related to this condition. Unlike in preterm pre-eclampsia, the prediction and prevention of term pre-eclampsia remain unsolved. Previously proposed approaches are based on combined third-trimester screening and/or prophylactic drugs, but these policies are unlikely to be widely implementable in many world settings. Recent evidence shows that the soluble fms-like tyrosine kinase-1 (s-Flt-1) to placental growth factor (PlGF) ratio measured at 35–37 weeks’ gestation predicts term pre-eclampsia with an 80% detection rate. Likewise, recent studies demonstrate that induction of labour beyond 37 weeks is safe and well accepted by women. We hypothesise that a single-step universal screening for term pre-eclampsia based on sFlt1/PlGF ratio at 35–37 weeks followed by planned delivery beyond 37 weeks reduces the prevalence of term pre-eclampsia without increasing the caesarean section rates or worsening the neonatal outcomes.

Methods and analysis

We propose an open-label randomised clinical trial to evaluate the impact of a screening of term pre-eclampsia with the sFlt-1/PlGF ratio followed by planned delivery in asymptomatic nulliparous women at 35–37 weeks. Women will be assigned 1:1 to revealed (sFlt-1/PlGF known to clinicians) versus concealed (unknown) arms. A cut-off of >90th centile is used to define the high risk of subsequent pre-eclampsia and offer planned delivery from 37 weeks. The efficacy variables will be analysed and compared between groups primarily following an intention-to-treat approach, by ORs and their 95% CI. This value will be computed using a Generalised Linear Mixed Model for binary response (study group as fixed effect and the centre as intercept random effect).

Ethics and dissemination

The study is conducted under the principles of Good Clinical Practice. This study was accepted by the Clinical Research Ethics Committee of Hospital Clinic Barcelona on 20 November 2020. Subsequent approval by individual ethical committees and competent authorities was granted. The study results will be published in peer-reviewed journals and disseminated at international conferences.

Trial registration number

NCT04766866.

Ameliorating impact of coenzyme Q10 on the profile of adipokines, cardiomyopathy, and hematological markers correlated with the glucotoxicity sequelae in diabetic rats

by Yousif Jameel Jbrael, Badraldin Kareem Hamad

Background

In diabetes, high blood glucose induces glucotoxicity, resulting in the further damage of pancreatic beta-cells and then precipitating diabetic complications. This study was aimed to investigate the relationship between glucotoxicity with the level of adipokines, diabetic cardiomyopathy, and hematological markers. Moreover, the study examined the potential modulatory effect of coenzyme Q10 (CoQ10) on the aforementioned markers associated with the sequelae of diabetes mellitus.

Material and methods

Twenty-four male rats were randomly assigned to receive an injection of STZ to induce diabetes (n = 16) or to remain uninduced (n = 8). The hyperglycemic status was induced in fasting rats by single intraperitoneal injection of STZ (45 mg /kg b.w.) dissolved in citrate buffer (pH 4.5). Three days after STZ injection, rats were divided into three groups; Normal control group (A), Diabetic control group (B), and CoQ10- treated diabetic group (C). The group (C) was fed with the basal diet supplemented with 5 g of CoQ10 per kilogram of diet for three weeks after the diabetes induction. After 21 days, the blood and serum samples were taken to conduct biochemical analyses. Blood glucose was determined by Blood Glucose Monitoring System. Adipokines or cytokines were evaluated by ELISA from a serum sample. Cardiac myopathy biomarkers were estimated by UP-Converting Phosphor Immunoassay Analyzer, and hematological parameters were measured by automatic hematology analyzer.

Results

In hyperglycemic rats, the level of fasting blood glucose, and serum level of resistin, omentin, TNF-α, and cardiomyopathy biomarkers significantly increased (P Conclusion

Diabetic rats had higher serum levels of adipokines and cardiomyopathy markers. Among the hematological markers, GRA% and MID% increased while LYM% decreased. The profile of adipokines and cardiomyopathy markers improved when CoQ10 was supplemented. The study suggests that CoQ10 may have a beneficial effect on improving diabetic complications.

Morphological and ultrastructural investigation of the posterior atlanto-occipital membrane: Comparing children with Chiari malformation type I and controls

by Vijay M. Ravindra, Lorraina Robinson, Hailey Jensen, Elena Kurudza, Evan Joyce, Allison Ludwick, Russell Telford, Osama Youssef, Justin Ryan, Robert J. Bollo, Rajiv R. Iyer, John R. W. Kestle, Samuel H. Cheshier, Daniel S. Ikeda, Qinwen Mao, Douglas L. Brockmeyer

Introduction

The fibrous posterior atlanto-occipital membrane (PAOM) at the craniocervical junction is typically removed during decompression surgery for Chiari malformation type I (CM-I); however, its importance and ultrastructural architecture have not been investigated in children. We hypothesized that there are structural differences in the PAOM of patients with CM-I and those without.

Methods

In this prospective study, blinded pathological analysis was performed on PAOM specimens from children who had surgery for CM-I and children who had surgery for posterior fossa tumors (controls). Clinical and radiographic data were collected. Statistical analysis included comparisons between the CM-I and control cohorts and correlations with imaging measures.

Results

A total of 35 children (mean age at surgery 10.7 years; 94.3% white) with viable specimens for evaluation were enrolled: 24 with CM-I and 11 controls. There were no statistical demographic differences between the two cohorts. Four children had a family history of CM-I and five had a syndromic condition. The cohorts had similar measurements of tonsillar descent, syringomyelia, basion to C2, and condylar-to-C2 vertical axis (all p>0.05). The clival-axial angle was lower in patients with CM-I (138.1 vs. 149.3 degrees, p = 0.016). Morphologically, the PAOM demonstrated statistically higher proportions of disorganized architecture in patients with CM-I (75.0% vs. 36.4%, p = 0.012). There were no differences in PAOM fat, elastin, or collagen percentages overall and no differences in imaging or ultrastructural findings between male and female patients. Posterior fossa volume was lower in children with CM-I (163,234 mm3 vs. 218,305 mm3, p Conclusions

In patients with CM-I, the PAOM demonstrates disorganized architecture compared with that of control patients. This likely represents an anatomic adaptation in the presence of CM-I rather than a pathologic contribution.

Does offering small financial incentives to smokers at the time of being wait-listed for surgery increase smoking cessation by the day of surgery? A randomised feasibility trial

Por: Webb · A. · Coward · L. · Yousef · M. · Karamesinis · A. · Leong · S.
Objective

This study aims to assess whether offering small financial incentives to smokers on elective surgery wait-lists is feasible and increases quitting before surgery.

Design

Randomised controlled trial, prospective, double-blinded.

Setting

Single-centre, Australian metropolitan public hospital.

Participants

620 adult smokers (≥10 cigarettes per day) were randomised on being wait-listed for elective surgery and 404 underwent operations (28 January 2021–31 July 2022) at the hospital (65.2%) by trial’s end.

Intervention

Intervention participants were offered at wait-listing an $A70 supermarket voucher for verified abstinence on the day of surgery, provided they registered an intention to quit before surgery. Registrants intending to quit were also referred to Quitline. Neither intervention was offered to control participants (usual care). Smokers wait-listed from 17 May 2021 were offered an increased incentive of $A140.

Main outcome measures

Primary outcome, quitting at least 24 hours before surgery, verified by exhaled carbon monoxide testing. Feasibility outcomes were the proportion taking up offers, ease of patient contact and disputes about quit status.

Results

Of 620 randomised participants (control 312, intervention 308), 404 had surgery at the hospital during the trial (control 214, intervention 190), which was lower than expected (for COVID-19 reasons). Offering $A70 resulted in 21.9% registering to quit, increasing to 32.6% with $A140. Telephone calls were the most effective means to gain registrations. The proportion of intervention group patients verified quit at least 24 hours before surgery was similar to controls (9.5% vs 8.9%, OR 1.1, 95% CI 0.5 to 2.2). Quitline contact was higher in the intervention group (13.2% vs 2.3%, OR 6.3, 95% CI 2.3 to 21.6). Disputes over test results did not occur, but 17.4% of intervention participants claiming quit failed verification.

Conclusion

A single offer of financial rewards for perioperative cessation was feasible, without achieving clinically important quit differences.

Trial registration number

ACTRN12620000130965.

Simulation of gravity- and pump-driven perfusion techniques for measuring outflow facility of ex vivo and in vivo eyes

by Youssef Mohamed, Christopher L. Passaglia

Aqueous humor dynamics are commonly assessed by infusing fluid into the eye and measuring intraocular pressure (IOP). From the pressure-flow relationship, conventional outflow facility is estimated to study glaucomatous processes that lower facility or identify therapeutics that enhance facility in hopes of restoring healthy IOP levels. The relative merits and limitations of constant flow (CF), gravity-driven constant pressure (CPg), and pump-driven constant pressure (CPp) infusion techniques were explored via simulations of a lumped parameter viscoelastic model of the eye. Model parameter values were based on published perfusion system properties and outflow facility data from rodents. Step increases in pressure or flow were simulated without and with IOP noise recorded from enucleated eyes, anesthetized animals, and conscious animals. Steady-state response levels were determined using published window and ratio criteria. Model simulations show that all perfusion techniques estimate facility accurately and that ocular fluid dynamics set a hard limit on how fast measurements can be taken. This limit can be approached with CPg and CPp systems by increasing their gain but not with CF systems, which invariably take longest to settle. Facility experiment duration is further lengthened by inclusion of IOP noise, and data filtering is needed for steady-state detection with in vivo noise. The ratio criterion was particularly affected because noise in the flow data is amplified by the higher gain of CPg and CPp systems. A recursive regression method is introduced, which can ignore large transient IOP fluctuations that interfere with steady-state detection by fitting incoming data to the viscoelastic eye model. The fitting method greatly speeds up data collection without loss of accuracy, which could enable outflow facility measurements in conscious animals. The model may be generalized to study response dynamics to fluid infusion in other viscoelastic compartments of the body and model insights extended to optimize experiment design.

Prevalence of surgical site wound infection after spine surgery in nasal colonization of methicillin‐resistant Staphylococcus aureus: A meta‐analysis

Abstract

The purpose of the meta-analysis was to evaluate and compare the prevalence of surgical site infection (SSI) after spine surgery (SS) in nasal colonization of methicillin-resistant Staphylococcus aureus (MRSA). The results of this meta-analysis were analysed, and the odds ratio (OR) and mean difference (MD) with 95% confidence intervals (CIs) were calculated using dichotomous or contentious random- or fixed-effect models. For the current meta-analysis, 14 examinations spanning from 2014 to 2022 were included, encompassing 18 410 people who were tested for nasal colonization after SS. MRSA-positive had a significantly higher SSI (OR, 3.65; 95% CI, 2.48–5.37, p < 0.001) compared with MRSA-negative in SS subjects. However, no significant difference was found between methicillin-susceptible Staphylococcus aureus and Staphylococcus aureus negative (OR, 0.94; 95% CI, 0.32–2.79, p = 0.91), and Staphylococcus aureus positive and negative (OR, 2.13; 95% CI, 0.26–17.41, p = 0.48) in SS subjects. The examined data revealed that MRSA colonization had a significant effect on SSI; however, methicillin-susceptible Staphylococcus aureus and Staphylococcus aureus had no significant effect on SSI in SS subjects. However, given that some comparisons included a small number of chosen studies, attention should be given to their values.

Effects of burnout and work engagement in the relationship between self‐efficacy and safety behaviours—A chained mediation modelling analysis

Abstract

Aims

To explore the current situation, influencing factors and pathways of safety behaviour of nurses in tumour specialized hospitals, in order to provide a theoretical basis for managers to manage and train nurses, improve their safety behaviour level and ensure medical safety.

Design

An anonymous cross-sectional survey.

Method

A total of 2147 nurses from Grade A cancer hospitals in 15 provinces of China were selected by a convenient sampling method. Questionnaires were collected through the Questionnaire Star platform. Nurses' safety behaviour was measured using the nurse Safety Behaviour Scale, Self-efficacy by the General Self-efficacy Scale, and nurses' occupational burnout was measured by the occupational Burnout Scale, and work engagement through the the Work Engagement Scale. Structural equation modelling was used to test the relationship among nurses' safety behaviour, general self-efficacy, occupational burnout and work engagement. SPSS25.0 software was used to test the relationship among the safety behaviour of nurses, general self-efficacy, occupational burnout and work engagement.

Results

The total score of safety behaviour of nurses was 55.45 ± 6.879, the total score of general self-efficacy was 31.39 ± 5.729, the total score of occupational burnout was 44.99 ± 26.587, and the total score of work engagement was 38.48 ± 13.433; the scores of the Nurse Safety Behaviour Scale, Self-Efficacy Scale, and Work Engagement Scale were positively correlated (all p < .001); the occupational burnout scale was negatively correlated with the scores of self-efficacy scale, work engagement scale and nurse safety behaviour scale (all p < .001); Structural equation model analysis shows that self-efficacy and work engagement have a direct positive impact on nurse safety behaviour(β = .103, β = .096, all p < .001); Occupational burnout has a direct negative impact on self-efficacy, work engagement and nurse safety behaviour(β = −.371, β = −.413, β = −.328 all p < .001). Bootstrap analysis showed that occupational burnout and job involvement had a significant chain mediating effect between self-efficacy and the safety behaviour of nurses (95% CI: 0.148–0.21). The total effect of self-efficacy on the safety behaviour of nurses was 0.283 (p < .001, 95% CI: 0.225–0.301), the direct effect was 0.096 (p < .001, 95% CI: 0.042–0.15), and the indirect effect was 0.179 (p < .001, 95% CI: 0.085–0.215), The mediating effect accounted for 63.3% of the total effect size.

Conclusion

Occupational burnout and work engagement play a partial mediating role between self-efficacy and nurse safety behaviour. It is necessary to strengthen training on nurse safety culture awareness, improve the nurse self-efficacy and work engagement, reduce nurse occupational burnout, and thereby improve the level of nurses' safety behaviour.

Insight into the experiences of caregivers of older adults in long‐term care homes: A photovoice study

Abstract

Aims

To explore the lived experiences of caregivers of people living in long-term care (LTC) homes during the initial phases of the COVID-19 pandemic and potential supports and resources needed to improve caregivers' quality of life.

Background

Carers (or care partners) of adults in LTC contribute substantially to the health and well-being of their loved ones by providing physical care, emotional support and companionship. Despite their critical role, little is known about how caregivers have been impacted by the pandemic.

Design

An interpretive descriptive approach that incorporated the photovoice method was used.

Methods

Using a purposive sampling strategy, six family carers in Ontario, Canada were recruited between September and December 2021. Over a 4-week period, caregivers took pictures depicting their experience of the pandemic that were shared in a virtual focus group. Visual and text data were analysed using thematic analysis with an inductive approach.

Findings

Caregivers expressed feelings of frustration, confusion and joy. Emerging themes included: (i) feeling like a ‘criminal’ amidst visitor restrictions and rules; (ii) experiencing uncertainty and disappointment in the quality of care of long-term care homes; (iii) going through burnout; and (iv) focusing on small joys and cherished memories.

Conclusions

The combination of visual and textual methods provided unique insight into the mental distress, isolation and intense emotional burdens experienced by caregivers during the pandemic.

Impact

Our findings underscore the need for LTC organizations to work in unison with caregivers to optimize the care of residents and support the mental health of caregivers.

Reporting Method

This work adhered to the consolidated criteria for reporting qualitative research (COREQ) checklist.

Public Contributions

The caregivers included in the study were involved in the co-creative process as active contributors informing the design and validation of the codes and themes.

Patient safety culture predictors and outcomes for sustainable oncology nursing practice: A cross‐sectional correlational study

Abstract

Aims and Objectives

To examine the predictors and outcomes of patient safety culture (PSC) among oncology nurses working in public Saudi hospitals according to participant characteristics and evaluate the relationship between PSC domains.

Background

PSC is crucial in healthcare systems, particularly in oncology and chemotherapy units, and its assessment can enhance the standard service provided and cancer care quality. There is currently limited research on the status, predictors and outcomes of PSC in cancer care settings in developing countries, including Saudi Arabia.

Design

A cross-sectional correlational study.

Methods

A convenience sample of 101 oncology nurses working in two large Saudi tertiary care hospitals participated in this study. The Hospital Survey on Patient Safety Culture validated instrument and demographic and work surveys were completed by the participants. The study methods were compliant with the STROBE checklist. Descriptive statistics and multiple linear regressions were used to analyse the data.

Results

The areas of PSC strength were related to organizational learning–constant improvement, feedback and communication about errors, and transitions and handoffs. Manager/supervisor actions and expectations, hospital management support, communication openness, experience in the current unit and oncology unit/area were the predictors of PSC. In terms of PSC outcomes, the oncology nurses reported either no or one to two adverse events and a substantially good patient safety rating.

Conclusion

The level of PSC was lower than expected. Communication openness, experience in the current unit and oncology unit/area were the strongest predictors of PSC. Investing in oncology nursing practice that addresses these concerns and prioritizes patient safety is critical in Saudi cancer care settings to increase patient safety.

Relevance to clinical practice

The findings contribute to a better understanding of the predictors and outcomes of PSC, which should be considered when establishing effective nursing interventions or strategies for PSC in cancer care settings.

Patient or Public Contribution

No patient or public contribution.

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