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☐ ☆ ✇ BMJ Open

Restrictive use of Restraints and Delirium Duration in the Intensive Care Unit (R2D2-ICU): protocol for a French multicentre parallel-group open-label randomised controlled trial

Por: Sonneville · R. · Couffignal · C. · Sigaud · F. · Godard · V. · Audibert · J. · Contou · D. · Celier · A. · Djibre · M. · Schmidt · J. · Jaquet · P. · Mekontso Dessap · A. · Bourel · C. · Bellot · R. · Roy · C. · Lamara · F. · Essardy · F. · Timsit · J.-F. · Cornic · R. · Bouadma · L. · On b — Abril 17th 2024 at 17:18
Introduction

Physical restraint (PR) is prescribed in patients receiving invasive mechanical ventilation in the intensive care unit (ICU) to avoid unplanned removal of medical devices. However, it is associated with an increased risk of delirium. We hypothesise that a restrictive use of PR, as compared with a systematic use, could reduce the duration of delirium in ICU patients receiving invasive mechanical ventilation.

Methods and analysis

The Restrictive use of Restraints and Delirium Duration in ICU (R2D2-ICU) study is a national multicentric, parallel-group, randomised (1:1) open-label, controlled, superiority trial, which will be conducted in 10 ICUs. A total of 422 adult patients requiring invasive mechanical ventilation for an expected duration of at least 48 hours and eligible for prescription of PR will be randomly allocated within 6 hours from intubation to either the restrictive PR use group or the systematic PR use group, until day 14, ICU discharge or death, whichever comes first. In both groups, PR will consist of the use of wrist straps. The primary endpoint will be delirium or coma-free days, defined as the number of days spent alive in the ICU without coma or delirium within the first 14 days after randomisation. Delirium will be assessed using the Confusion Assessment Method-ICU twice daily. Key secondary endpoints will encompass agitation episodes, opioid, propofol, benzodiazepine and antipsychotic drug exposure during the 14-day intervention period, along with a core outcome set of measures evaluated 90 days postrandomisation.

Ethics and dissemination

The R2D2-ICU study has been approved by the Comité de Protection des Personnes (CPP) ILE DE FRANCE III—PARIS (CPP19.09.06.37521) on June 10th, 2019). Participant recruitment started on 25 January 2021. Results will be published in international peer-reviewed medical journals and presented at conferences.

Trial registration number

NCT04273360.

☐ ☆ ✇ BMJ Open

Global trends in chronic kidney disease-related mortality: a systematic review protocol

Por: Tungsanga · S. · Ghimire · A. · Hariramani · V. K. · Abdulrahman · A. · Khan · A. S. · Ye · F. · Kung · J. Y. · Klarenbach · S. · Thompson · S. · Collister · D. · Srisawat · N. · Okpechi · I. G. · Bello · A. K. — Abril 3rd 2024 at 18:19
Introduction

In recent decades, all-cause mortality has increased among individuals with chronic kidney disease (CKD), influenced by factors such as aetiology, standards of care and access to kidney replacement therapies (dialysis and transplantation). The recent COVID-19 pandemic also affected mortality over the past few years. Here, we outline the protocol for a systematic review to investigate global temporal trends in all-cause mortality among patients with CKD at any stage from 1990 to current. We also aim to assess temporal trends in the mortality rate associated with the COVID-19 pandemic.

Methods and analysis

We will conduct a systematic review of studies reporting mortality for patients with CKD following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We will search electronic databases, national and multiregional kidney registries and grey literature to identify observational studies that reported on mortality associated with any cause for patients with CKD of all ages with any stage of the disease. We will collect data between April and August 2023 to include all studies published from 1990 to August 2023. There will be no language restriction, and clinical trials will be excluded. Primary outcome will be temporal trends in CKD-related mortality. Secondary outcomes include assessing mortality differences before and during the COVID-19 pandemic, exploring causes of death and examining trends across CKD stages, country classifications, income levels and demographics.

Ethics and dissemination

A systematic review will analyse existing data from previously published studies and have no direct involvement with patient data. Thus, ethical approval is not required. Our findings will be published in an open-access peer-reviewed journal and presented at scientific conferences.

PROSPERO registration number

CRD42023416084.

☐ ☆ ✇ PLOS ONE Medicine&Health

Platelet versus fresh frozen plasma transfusion for coagulopathy in cardiac surgery patients

by Jake V. Hinton, Calvin M. Fletcher, Luke A. Perry, Noah Greifer, Jessica N. Hinton, Jenni Williams-Spence, Reny Segal, Julian A. Smith, Christopher M. Reid, Laurence Weinberg, Rinaldo Bellomo

Background

Platelets (PLTS) and fresh frozen plasma (FFP) are often transfused in cardiac surgery patients for perioperative bleeding. Their relative effectiveness is unknown.

Methods

We conducted an entropy-weighted retrospective cohort study using the Australian and New Zealand Society of Cardiac and Thoracic Surgeons National Cardiac Surgery Database. All adults undergoing cardiac surgery between 2005–2021 across 58 sites were included. The primary outcome was operative mortality.

Results

Of 174,796 eligible patients, 15,360 (8.79%) received PLTS in the absence of FFP and 6,189 (3.54%) patients received FFP in the absence of PLTS. The median cumulative dose was 1 unit of pooled platelets (IQR 1 to 3) and 2 units of FFP (IQR 0 to 4) respectively. After entropy weighting to achieve balanced cohorts, FFP was associated with increased perioperative (Risk Ratio [RR], 1.63; 95% Confidence Interval [CI], 1.40 to 1.91; P Conclusion

In perioperative bleeding in cardiac surgery patient, platelets are associated with a relative mortality benefit over FFP. This information can be used by clinicians in their choice of procoagulant therapy in this setting.

☐ ☆ ✇ BMJ Open

Acceptance of COVID-19 vaccine and associated factors among healthcare workers in Katsina state: a cross-sectional study in Northwest Nigeria

Por: Abubakar · A. T. · Suleiman · K. · Ahmad · S. I. · Yahaya · S. S. · Bello · U. I. · Suleiman · B. A. · Haladu · S. A. · Al-Mustapha · A. I. · Abubakar · M. I. — Diciembre 22nd 2023 at 17:32
Objectives

Healthcare workers were prioritised to receive the COVID-19 vaccine in Nigeria. Administration of COVID-19 vaccination in Nigeria was challenging because of a lack of trust in vaccine safety and vaccine effectiveness among healthcare workers, who are expected to provide reliable information about vaccines and vaccine-preventable diseases in the communities. Hence, their acceptance and attitudes towards COVID-19 preventive practices could influence the acceptance of the vaccine by the local population. This cross-sectional study assessed the acceptance of the COVID-19 vaccine among healthcare workers in Katsina State. We predicted the variables that increased the vaccine acceptance using logistic regression analysis.

Setting

This hospital-based study was conducted at primary, secondary and tertiary healthcare facilities in Nigeria.

Participants

A total of 793 healthcare workers were included in this study. Of these, 65.4% (n=519) were male.

Outcome measures

To assess acceptance of COVID-19 vaccine measures, and factors increasing acceptance among healthcare workers.

Results

Of the healthcare workers, 80% (638) were tested for the SARS-CoV-2, of whom 10.8% (n=65) tested positive. Approximately 97% (n=765) of them believed that the COVID-19 vaccine was safe, and 90% (n=714) received the first dose of the vaccine. Healthcare workers between 30 and 39 years were more likely to accept the vaccine (aOR: 7.06; 95% CI 2.36 to 21.07; p

Conclusions

Our findings showed that the age and prior COVID-19 testing were the main factors influencing the acceptance of the COVID-19 vaccine. There was high acceptance of the COVID-19 vaccine among healthcare workers in Katsina State, Nigeria. Future studies should focus on the completion of doses and serological testing for immunity.

☐ ☆ ✇ PLOS ONE Medicine&Health

A mixed methods PAR study investigating social capital as a resource for Black and other racially minoritised communities in the UK: A study protocol

by Georgina Gnan, Zara Asif, Sanchika Campbell, Jacqui Dyer, Anna Ehsan, Katrin Hoffmann, Hanna Kienzler, Shabbir Mellick, Nathaniel Martin, Cheryl Osei, Abreen Rebello, Imade Remouche, Rebecca Rhead, Denise Richards, Ibrahim Sabra, Sara Sabra, Pippa Sterk, Charlotte Woodhead, Stephani Hatch

Understanding how different Black and other racially minoritised communities thrive is an emerging priority area in mental health promotion. Literature demonstrates health benefits of social capital (social resources embedded within social networks). However, its effects are not always positive, particularly for certain subpopulations who are already disadvantaged.The CONtributions of social NEtworks to Community Thriving (CONNECT) study will use Participatory Action Research (PAR) to investigate social capital as a resource that benefits (or hinders) racially minoritised communities and their mental health. The CONNECT study was designed within a partnership with community organisations and responds to local policy in two South-East London Boroughs, thereby providing potential channels for the action component of PAR. Taking an anti-racism lens, we acknowledge the underpinning role of racism in creating health inequities. We apply an intersectional framework to be considerate of overlapping forms of oppression such as age, gender, socioeconomic status, and sexual orientation as an essential part of developing effective strategies to tackle health inequities. Key components of this mixed methods PAR study include (1) involving racialised minority community members as peer researchers in the team (2) collecting and analysing primary qualitative data via interviews, photovoice, and community mapping workshops, (3) developing relevant research questions guided by peer researchers and collaborating organisations and analysing secondary quantitative data accordingly, (4) integrating qualitative and quantitative phases, and (5) working closely with community and policy partners to act on our findings and use our research for social change.The PAR approach will allow us to engage community (voluntary sector and government) and academic partners in decision making and help address imbalances in power and resource allocation. Knowledge generated through this collaborative approach will contribute to existing community initiatives, policies, and council strategies. This will ensure the views and experiences of racially minoritised communities drive the changes we are collaboratively committed to achieving.
☐ ☆ ✇ BMJ Open

Effectiveness, safety and costs of the FreeStyle Libre glucose monitoring system for children and adolescents with type 1 diabetes in Spain: a prospective, uncontrolled, pre-post study

Por: Gonzalez-Pacheco · H. · Rivero-Santana · A. · Ramallo-Farina · Y. · Valcarcel-Nazco · C. · Alvarez-Perez · Y. · Garcia-Perez · L. · Garcia-Bello · M. A. · Perestelo-Perez · L. · Serrano-Aguilar · P. · The Health Professional Group · Vergaz · Prado Carro · Ortego · Martorell — Diciembre 14th 2023 at 04:03
Objectives

This study aimed to evaluate the effectiveness, safety and costs of FreeStyle Libre (FSL) glucose monitoring system for children and adolescents with type 1 diabetes mellitus (T1DM) in Spain.

Design

Prospective, multicentre pre-post study.

Setting

Thirteen Spanish public hospitals recruited patients from January 2019 to March 2020, with a 12-month follow-up.

Participants

156 patients were included.

Primary and secondary outcome measures

Primary: glycated haemoglobin (HbA1c) change. Secondary: severe hypoglycaemic events (self-reported and clinical records), quality of life, diabetes treatment knowledge, treatment satisfaction, adverse events, adherence, sensor usage time and scans. Healthcare resource utilisation was assessed for cost analysis from the National Health System perspective, incorporating direct healthcare costs. Data analysis used mixed regression models with repeated measures. The intervention’s total cost was estimated by multiplying health resource usage with unit costs.

Results

In the whole sample, HbA1c increased significantly (0.32%; 95% CI 0.10% to 0.55%). In the subgroup with baseline HbA1c≥7.5% (n=88), there was a significant reduction at 3 months (–0.46%; 95% CI –0.69% to –0.23%), 6 months (–0.49%; 95% CI –0.73% to –0.25%) and 12 months (–0.43%; 95% CI –0.68% to –0.19%). Well-controlled patients had a significant 12-month worsening (0.32%; 95% CI 0.18% to 0.47%). Self-reported severe hypoglycaemia significantly decreased compared with the previous year for the whole sample (–0.37; 95% CI –0.62 to –0.11). Quality of life and diabetes treatment knowledge showed no significant differences, but satisfaction increased. Adolescents had lower sensor usage time and scans than children. Reduction in HbA1c was significantly associated with device adherence. No serious adverse effects were observed. Data suggest that use of FSL could reduce healthcare resource use (strips and lancets) and costs related to productivity loss.

Conclusions

The use of FSL in young patients with T1DM was associated with a significant reduction in severe hypoglycaemia, and improved HbA1c levels were seen in patients with poor baseline control. Findings suggest cost savings and productivity gains for caregivers. Causal evidence is limited due to the study design. Further research is needed to confirm results and assess risks, especially for patients with lower baseline HbA1c.

☐ ☆ ✇ PLOS ONE Medicine&Health

Assessment of psychological terror and its impact on mental health and quality of life in medical residents at a reference medical center in Mexico: A cross-sectional study

by Víctor Manuel Enriquez Estrada, Neftali Eduardo Antonio-Villa, Omar Yaxhemen Bello-Chavolla, Carlos Fredy Cuevas-García, Pedro Luis Vargas Gutiérrez, Irma Sau-Yen Corlay Noriega, Luis Rey García-Cortés

Background

Mobbing, particularly in medical residencies, can lead to psychological terror with lasting mental and physical health consequences. Its impact on Mexican residents, however, remains underexplored.

Aim

This study aimed to investigate the prevalence and associated factors of psychological terror among medical residents at a medical center in Mexico City.

Methods

In a cross-sectional study, medical residents from various specialties were assessed for mobbing domains, quality of life, and anxiety/depression using the Leymann Inventory of Psychological Terror (LIPT), 36-Item Short Form Health Survey, Beck Depression Inventory-II, and Beck Anxiety Inventory, respectively. Psychological terror was defined as a LIPT score ≥ p80. Linear and binomial logistic regression models were used to explore independent predictors of mobbing and psychological terror.

Results

Of the 349 participants included (median age: 28; IQR: 27–30 years), 19.5% (95% CI: 15.5%-24.0%) were identified with psychological terror. Furthermore, 39% reported higher-degree trainees as mobbing perpetrators. Women in surgical residencies in their second or fifth year were found to experience higher levels of mobbing. Manifested bullying, workplace stigma, and inappropriate tasks were the most impacted mobbing domains. Anxiety, diminished mental health quality of life, and higher degree of medical specialization were independent predictors of mobbing. Meanwhile, increased anxiety, affiliation to surgical specialties, and being in the second or fifth year of training were identified as predictors of psychological terror.

Conclusions

Mobbing and psychological terror are prevalent conditions among medical residents in Mexico. Identification of occupational conditions and adverse psychological stressors can help to improve quality of life and training of medical residents.

☐ ☆ ✇ PLOS ONE Medicine&Health

Prime editing-mediated correction of the <i>CFTR</i> W1282X mutation in iPSCs and derived airway epithelial cells

by Chao Li, Zhong Liu, Justin Anderson, Zhongyu Liu, Liping Tang, Yao Li, Ning Peng, Jianguo Chen, Xueming Liu, Lianwu Fu, Tim M. Townes, Steven M. Rowe, David M. Bedwell, Jennifer Guimbellot, Rui Zhao

A major unmet need in the cystic fibrosis (CF) therapeutic landscape is the lack of effective treatments for nonsense CFTR mutations, which affect approximately 10% of CF patients. Correction of nonsense CFTR mutations via genomic editing represents a promising therapeutic approach. In this study, we tested whether prime editing, a novel CRISPR-based genomic editing method, can be a potential therapeutic modality to correct nonsense CFTR mutations. We generated iPSCs from a CF patient homozygous for the CFTR W1282X mutation. We demonstrated that prime editing corrected one mutant allele in iPSCs, which effectively restored CFTR function in iPSC-derived airway epithelial cells and organoids. We further demonstrated that prime editing may directly repair mutations in iPSC-derived airway epithelial cells when the prime editing machinery is efficiently delivered by helper-dependent adenovirus (HDAd). Together, our data demonstrated that prime editing may potentially be applied to correct CFTR mutations such as W1282X.
☐ ☆ ✇ BMJ Open

Prehospital acute life-threatening cardiovascular disease in elderly: an observational, prospective, multicentre, ambulance-based cohort study

Por: del Pozo Vegas · C. · Zalama-Sanchez · D. · Sanz-Garcia · A. · Lopez-Izquierdo · R. · Saez-Belloso · S. · Mazas Perez Oleaga · C. · Dominguez Azpiroz · I. · Elio Pascual · I. · Martin-Rodriguez · F. — Noviembre 23rd 2023 at 17:23
Objective

The aim was to explore the association of demographic and prehospital parameters with short-term and long-term mortality in acute life-threatening cardiovascular disease by using a hazard model, focusing on elderly individuals, by comparing patients under 75 years versus patients over 75 years of age.

Design

Prospective, multicentre, observational study.

Setting

Emergency medical services (EMS) delivery study gathering data from two back-to-back studies between 1 October 2019 and 30 November 2021. Six advanced life support (ALS), 43 basic life support and five hospitals in Spain were considered.

Participants

Adult patients suffering from acute life-threatening cardiovascular disease attended by the EMS.

Primary and secondary outcome measures

The primary outcome was in-hospital mortality from any cause within the first to the 365 days following EMS attendance. The main measures included prehospital demographics, biochemical variables, prehospital ALS techniques used and syndromic suspected conditions.

Results

A total of 1744 patients fulfilled the inclusion criteria. The 365-day cumulative mortality in the elderly amounted to 26.1% (229 cases) versus 11.6% (11.6%) in patients under 75 years old. Elderly patients (≥75 years) presented a twofold risk of mortality compared with patients ≤74 years. Life-threatening interventions (mechanical ventilation, cardioversion and defibrillation) were also related to a twofold increased risk of mortality. Importantly, patients suffering from acute heart failure presented a more than twofold increased risk of mortality.

Conclusions

This study revealed the prehospital variables associated with the long-term mortality of patients suffering from acute cardiovascular disease. Our results provide important insights for the development of specific codes or scores for cardiovascular diseases to facilitate the risk of mortality characterisation.

☐ ☆ ✇ Journal of Advanced Nursing

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.

☐ ☆ ✇ Evidentia

Efecto de la dieta libre de gluten en adolescentes y adultos jóvenes con enfermedad celíaca: una revisión sistemática

Objetivo principal: analizar de manera sistemática la evidencia disponible sobre el efecto de la dieta libre de gluten en adolescentes y adultos jóvenes con enfermedad celíaca. Metodología: Para la elaboración de esta revisión sistemática se siguió con la formulación de una pregunta, establecimiento de criterios de inclusión y exclusión, desarrollo de estrategias de búsqueda, la selección de artículos para ser incluidos en la revisión, extracción de datos y síntesis de los datos. Resultados principales: Se observó en todos los estudios incluidos que los síntomas, así como la presencia de anticuerpos específicos, disminuyeron en las personas con Enfermedad Celiaca que se adhirieron a la dieta libre de gluten. Conclusión principal: Respecto al efecto de la dieta libre de gluten en la enfermedad celíaca, se puede decir que los pacientes celíacos tienden a mejorar en los síntomas de esta patología. Sin embargo, algunos pacientes pueden no mostrar una mejoría significativa.

☐ ☆ ✇ Journal of Nursing Scholarship

General self‐efficacy as a mediator of the association between adverse childhood experiences and psychological distress in gender‐minority individuals

Por: Joseph A. Belloir · Fredric Fabiano · Kasey B. Jackman · Walter O. Bockting — Marzo 20th 2023 at 05:03

Abstract

Purpose

To investigate the mediating role of general self-efficacy (i.e., belief in one's competence to cope with a broad range of stressful or challenging demands) in the relationship between adverse childhood experiences (ACEs) and psychological distress (i.e., symptoms of stress, anxiety and depression) in gender minority individuals, which include people with a gender identity that is not aligned with their sex assigned at birth.

Design and methods

The study sample included gender minority participants who participated in Waves 4 and 5 of Project AFFIRM, a multi-site longitudinal study of gender minority health. ACEs, general self-efficacy, and psychological distress were measured using the Behavior Risk Factor Surveillance System ACE Module at Wave 4, the PROMIS General self-efficacy measure at Wave 4, and the Brief Symptoms Inventory Global Severity Index (GSI) at Wave 5, respectively. After adjustment for covariates, including age, race, sex assigned at birth, and income, multivariable linear regression analyses were conducted to assess each component of the proposed mediation model. Next, mediation analyses were used to determine whether general self-efficacy mediated the association between ACEs and psychological distress.

Findings

The sample for this study consisted of 166 gender minority adults with a mean age of 38.6 ± 12.2 years. Most were non-Hispanic White (46.4%) and female assigned at birth (59.6%). Mean ACEs score was 3.2 ± 2.1 (range 0–8), mean general self-efficacy score was 13.9 ± 3.6 (range 4–20), and mean raw-score GSI was 17.3 ± 13.7 (range 0–64). Participants who reported experiencing more ACEs had greater psychological distress (B 1.60; 95% CI = 0.66, 2.54) and lower general self-efficacy (B −0.41; 95% CI = −0.67, −0.15). In addition, lower general self-efficacy was associated with higher psychological distress (B −1.06; 95% CI = −1.61, −0.51). Bootstrap estimation of the indirect effect was significant (95% CI = 0.14, 0.90) and explained 27.1% (95% CI = 7.76, 69.76) of the total effect of ACEs on psychological distress in gender minority adults.

Conclusions

Our findings suggest that general self-efficacy partially mediated the positive association between ACEs and psychological distress in gender minority adults. Interventions that aim to improve general self-efficacy may be beneficial in alleviating psychological distress in gender minority adults.

Clinical relevance

Nurses can play an important role in reducing the health risks associated with ACEs by screening gender minority individuals using a trauma-informed approach to care and offering resources and referrals, as appropriate.

☐ ☆ ✇ Evidentia

Cuáles son los efectos de la relajación sobre los niveles de depresión en mujeres con embarazos de alto riesgo

Por: e12131 / · Ladini Sunanda Hernández Bello · Danny Rafael Ramírez Parra — Febrero 8th 2019 at 01:00

Se llevó a cabo la revisión crítica a través de CASPe1 como lista de comprobación para ensayo clínico aleatorizado, el estudio presenta un aporte relevante puesto que permite apropiarse de una técnica de relajación para disminuir el riesgo de depresión en mujeres embarazadas de alto riesgo obstétrico [Fragmento de texto].

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