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Hoy — Abril 19th 2024Tus fuentes RSS

Cost of SARS-CoV-2 self-test distribution programmes by different modalities: a micro-costing study in five countries (Brazil, Georgia, Malaysia, Ethiopia and the Philippines)

Por: Hansen · M. A. · Lekodeba · N. A. · Chevalier · J. M. · Ockhuisen · T. · del Rey-Puech · P. · Marban-Castro · E. · Martinez-Perez · G. Z. · Shilton · S. · Radzi Abu Hassan · M. · Getia · V. · Weinert-Mizuschima · C. · Tenorio Bezerra · M. I. · Chala · L. · Leong · R. · Peregino · R.
Objective

Diagnostic testing is an important tool to combat the COVID-19 pandemic, yet access to and uptake of testing vary widely 3 years into the pandemic. The WHO recommends the use of COVID-19 self-testing as an option to help expand testing access. We aimed to calculate the cost of providing COVID-19 self-testing across countries and distribution modalities.

Design

We estimated economic costs from the provider perspective to calculate the total cost and the cost per self-test kit distributed for three scenarios that differed by costing period (pilot, annual), the number of tests distributed (actual, planned, scaled assuming an epidemic peak) and self-test kit costs (pilot purchase price, 50% reduction).

Setting

We used data collected between August and December 2022 in Brazil, Georgia, Malaysia, Ethiopia and the Philippines from pilot implementation studies designed to provide COVID-19 self-tests in a variety of settings—namely, workplace and healthcare facilities.

Results

Across all five countries, 173 000 kits were distributed during pilot implementation with the cost/test distributed ranging from $2.44 to $12.78. The cost/self-test kit distributed was lowest in the scenario that assumed implementation over a longer period (year), with higher test demand (peak) and a test kit price reduction of 50% ($1.04–3.07). Across all countries and scenarios, test procurement occupied the greatest proportion of costs: 58–87% for countries with off-site self-testing (outside the workplace, for example, home) and 15–50% for countries with on-site self-testing (at the workplace). Staffing was the next key cost driver, particularly for distribution modalities that had on-site self-testing (29–35%) versus off-site self-testing (7–27%).

Conclusions

Our results indicate that it is likely to cost between $2.44 and $12.78 per test to distribute COVID-19 self-tests across common settings in five heterogeneous countries. Cost-effectiveness analyses using these results will allow policymakers to make informed decisions on optimally scaling up COVID-19 self-test distribution programmes across diverse settings and evolving needs.

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Specific nanoprobe design for MRI: Targeting laminin in the blood-brain barrier to follow alteration due to neuroinflammation

by Juan F. Zapata-Acevedo, Mónica Losada-Barragán, Johann F. Osma, Juan C. Cruz, Andreas Reiber, Klaus G. Petry, Amael Caillard, Audrey Sauldubois, Daniel Llamosa Pérez, Aníbal José Morillo Zárate, Sonia Bermúdez Muñoz, Agustín Daza Moreno, Rafaela V. Silva, Carmen Infante-Duarte, William Chamorro-Coral, Rodrigo E. González-Reyes, Karina Vargas-Sánchez

Chronic neuroinflammation is characterized by increased blood-brain barrier (BBB) permeability, leading to molecular changes in the central nervous system that can be explored with biomarkers of active neuroinflammatory processes. Magnetic resonance imaging (MRI) has contributed to detecting lesions and permeability of the BBB. Ultra-small superparamagnetic particles of iron oxide (USPIO) are used as contrast agents to improve MRI observations. Therefore, we validate the interaction of peptide-88 with laminin, vectorized on USPIO, to explore BBB molecular alterations occurring during neuroinflammation as a potential tool for use in MRI. The specific labeling of NPS-P88 was verified in endothelial cells (hCMEC/D3) and astrocytes (T98G) under inflammation induced by interleukin 1β (IL-1β) for 3 and 24 hours. IL-1β for 3 hours in hCMEC/D3 cells increased their co-localization with NPS-P88, compared with controls. At 24 hours, no significant differences were observed between groups. In T98G cells, NPS-P88 showed similar nonspecific labeling among treatments. These results indicate that NPS-P88 has a higher affinity towards brain endothelial cells than astrocytes under inflammation. This affinity decreases over time with reduced laminin expression. In vivo results suggest that following a 30-minute post-injection, there is an increased presence of NPS-P88 in the blood and brain, diminishing over time. Lastly, EAE animals displayed a significant accumulation of NPS-P88 in MRI, primarily in the cortex, attributed to inflammation and disruption of the BBB. Altogether, these results revealed NPS-P88 as a biomarker to evaluate changes in the BBB due to neuroinflammation by MRI in biological models targeting laminin.

Cambio cultural en cuidadores indígenas. Bases etnográficas para la enfermería transcultural

Este estudio tiene como objetivo comprender las prácticas de los cuidadores indígenas en contexto de cambio cultural. Parte de la idea de la necesidad de construir bases etnográficas que sirvan de insumos para la implementación de los enfoques de salud intercultural y enfermería transcultural, así como parte de la evidencia que facilite las prácticas de salud, a partir de descripciones competentes que ayuden a comprender la diversidad cultural de las poblaciones humanas. El abordaje metodológico se realizó desde la investigación cualitativa, con enfoque etnográfico, combinando revisión documental y entrevistas semiestructuradas a 44 personas. Se identificaron códigos, agrupados en subcategorías y categorías. Se encontraron varios tipos de cuidadores, de los cuales, se consideraron relevantes el médico tradicional y la partera. Sus prácticas se basan en saberes de la dimensión material y espiritual, entre las que se destaca el uso de plantas medicinales, rezo, interpretación de los sueños y ceremonias colectivas. Además, su labor depende del reconocimiento social, estatus del cuidador y rol en la organización social. Los modelos interculturales deben tener en cuenta a los cuidadores, en el marco de estrategias basadas en el diálogo de saberes y la participación.

Dementia friendly in the context of hospitalization: A concept analysis using the Walker & Avant Method

Abstract

Aim(s)

To evaluate the literature to inform and propose a conceptual definition for dementia friendly in the context of hospitalization.

Methods

The Walker & Avant method for concept analysis was utilized for this review.

Data Sources (Include Search Dates)

Initial search conducted June 2022. Repeated search conducted in February 2023. Databases for the literature search include Scopus, PubMed, CINAHL, PsycINFO, and AGELINE.

Results

Five attributes of the concept of dementia friendly in the context of hospitalization were identified including: staff knowledge/education, environmental modification, person-centred care, nursing care delivery and inclusion of family caregivers. Based on these attributes a conceptual definition is proposed.

Conclusion

A clarified definition for dementia friendly in the context of hospitalization will aid in understanding the concept, provide guidance for hospitals seeking to implement dementia-friendly interventions and benefit researchers aiming to study the impact of such programs.

Reporting Method

n/a.

Patient or Public Contribution

No Patient or Public Contribution.

Multicomponent (bio)markers for obesity risk prediction: a scoping review protocol

Por: Vahid · F. · Dessenne · C. · Tur · J. A. · Bouzas · C. · Devaux · Y. · Malisoux · L. · Monserrat-Mesquida · M. · Sureda · A. · Desai · M. S. · Turner · J. D. · Lamy · E. · Perez-Jimenez · M. · Ravn-Haren · G. · Andersen · R. · Forberger · S. · Nagrani · R. · Ouzzahra · Y. · Fontefrancesc
Introduction

Despite international efforts, the number of individuals struggling with obesity is still increasing. An important aspect of obesity prevention relates to identifying individuals at risk at early stage, allowing for timely risk stratification and initiation of countermeasures. However, obesity is complex and multifactorial by nature, and one isolated (bio)marker is unlikely to enable an optimal risk stratification and prognosis for the individual; rather, a combined set is required. Such a multicomponent interpretation would integrate biomarkers from various domains, such as classical markers (eg, anthropometrics, blood lipids), multiomics (eg, genetics, proteomics, metabolomics), lifestyle and behavioural attributes (eg, diet, physical activity, sleep patterns), psychological traits (mental health status such as depression) and additional host factors (eg, gut microbiota diversity), also by means of advanced interpretation tools such as machine learning. In this paper, we will present a protocol that will be employed for a scoping review that attempts to summarise and map the state-of-the-art in the area of multicomponent (bio)markers related to obesity, focusing on the usability and effectiveness of such biomarkers.

Methods and analysis

PubMed, Scopus, CINAHL and Embase databases will be searched using predefined key terms to identify peer-reviewed articles published in English until January 2024. Once downloaded into EndNote for deduplication, CADIMA will be employed to review and select abstracts and full-text articles in a two-step procedure, by two independent reviewers. Data extraction will then be carried out by several independent reviewers. Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews and Peer Review of Electronic Search Strategies guidelines will be followed. Combinations employing at least two biomarkers from different domains will be mapped and discussed.

Ethics and dissemination

Ethical approval is not required; data will rely on published articles. Findings will be published open access in an international peer-reviewed journal. This review will allow guiding future directions for research and public health strategies on obesity prevention, paving the way towards multicomponent interventions.

Fibre-rich Foods to Treat Obesity and Prevent Colon Cancer trial study protocol: a randomised clinical trial of fibre-rich legumes targeting the gut microbiome, metabolome and gut transit time of overweight and obese patients with a history of noncancerou

Por: Hartman · T. J. · Christie · J. · Wilson · A. · Ziegler · T. R. · Methe · B. · Flanders · W. D. · Rolls · B. J. · Loye Eberhart · B. · Li · J. V. · Huneault · H. · Cousineau · B. · Perez · M. R. · O'Keefe · S. J. D.
Introduction

Recently published studies support the beneficial effects of consuming fibre-rich legumes, such as cooked dry beans, to improve metabolic health and reduce cancer risk. In participants with overweight/obesity and a history of colorectal polyps, the Fibre-rich Foods to Treat Obesity and Prevent Colon Cancer randomised clinical trial will test whether a high-fibre diet featuring legumes will simultaneously facilitate weight reduction and suppress colonic mucosal biomarkers of colorectal cancer (CRC).

Methods/design

This study is designed to characterise changes in (1) body weight; (2) biomarkers of insulin resistance and systemic inflammation; (3) compositional and functional profiles of the faecal microbiome and metabolome; (4) mucosal biomarkers of CRC risk and (5) gut transit. Approximately 60 overweight or obese adults with a history of noncancerous adenomatous polyps within the previous 3 years will be recruited and randomised to one of two weight-loss diets. Following a 1-week run-in, participants in the intervention arm will receive preportioned high-fibre legume-rich entrées for two meals/day in months 1–3 and one meal/day in months 4–6. In the control arm, entrées will replace legumes with lean protein sources (eg, chicken). Both groups will receive in-person and written guidance to include nutritionally balanced sides with energy intake to lose 1–2 pounds per week.

Ethics and dissemination

The National Institutes of Health fund this ongoing 5-year study through a National Cancer Institute grant (5R01CA245063) awarded to Emory University with a subaward to the University of Pittsburgh. The study protocol was approved by the Emory Institutional Review Board (IRB approval number: 00000563).

Trial registration number

NCT04780477.

Nurses' views on the presence of family members during invasive procedures in hospitalised children: A questionnaire survey

Abstract

Aims and Objectives

(I) To identify the opinion and practices of nursing professionals regarding the presence of family members during invasive procedures in hospitalised children; (II) to determine the knowledge of nursing professionals about the patient-and family-centred care model.

Background

Family presence in invasive procedures benefits the patient and their relatives, but varied attitudes exist among healthcare personnel, with some being favourable and others unfavourable toward family presence.

Design

Observational, descriptive, cross-sectional study.

Methods

Study population: Nurses from paediatric critical care services, emergency services, hospital wards, day hospitals and outpatient clinics at a Catalan tertiary hospital who participated voluntarily between September 2021 and July 2022. Data collection instrument: A questionnaire prepared by the researchers, based on the literature and reviewed by experts. REDCap link with access to the questionnaire was sent out to potential respondents through the institutional email. Bivariate analysis was performed with the R 4.2 program. The study was approved by the hospital's Clinical Research Committee and participants gave informed consent before responding to the questionnaire.

Results

A total of 172 nurses participated, and 155 valid responses were obtained. All respondents consider the family as a key element in paediatric care and report inviting family members to participate in the care given to their child. However, 12.0% of nurses do not invite the family to be present in invasive procedures. Almost all respondents note the need for training to acquire communication skills and improve the management of emotions.

Conclusions

The results show a favourable opinion towards the presence of family members and highlight the need to train nurses to develop communication skills.

Relevance to clinical practice

The data provided can favour the design of measures to improve and promote the presence of parents during invasive procedures, reinforcing the patient-and family-centred care model and improving the quality of care provided. One example is the creation of family care protocols where the inclusion of parents and the roles of each individual involved in the care process appears.

Pharmacogenomics of poor drug metabolism in greyhounds: Canine P450 oxidoreductase genetic variation, breed heterogeneity, and functional characterization

by Stephanie E. Martinez, Amit V. Pandey, Tania E. Perez Jimenez, Zhaohui Zhu, Michael H. Court

Greyhounds metabolize cytochrome P450 (CYP) 2B11 substrates more slowly than other dog breeds. However, CYP2B11 gene variants associated with decreased CYP2B11 expression do not fully explain reduced CYP2B11 activity in this breed. P450 oxidoreductase (POR) is an essential redox partner for all CYPs. POR protein variants can enhance or repress CYP enzyme function in a CYP isoform and substrate dependent manner. The study objectives were to identify POR protein variants in greyhounds and determine their effect on coexpressed CYP2B11 and CYP2D15 enzyme function. Gene sequencing identified two missense variants (Glu315Gln and Asp570Glu) forming four alleles, POR-H1 (reference), POR-H2 (570Glu), POR-H3 (315Gln, 570Glu) and POR-H4 (315Gln). Out of 68 dog breeds surveyed, POR-H2 was widely distributed across multiple breeds, while POR-H3 was largely restricted to greyhounds and Scottish deerhounds (35% allele frequencies), and POR-H4 was rare. Three-dimensional protein structure modelling indicated significant effects of Glu315Gln (but not Asp570Glu) on protein flexibility through loss of a salt bridge between Glu315 and Arg519. Recombinant POR-H1 (reference) and each POR variant (H2-H4) were expressed alone or with CYP2B11 or CYP2D15 in insect cells. No substantial effects on POR protein expression or enzyme activity (cytochrome c reduction) were observed for any POR variant (versus POR-H1) when expressed alone or with CYP2B11 or CYP2D15. Furthermore, there were no effects on CYP2B11 or CYP2D15 protein expression, or on CYP2D15 enzyme kinetics by any POR variant (versus POR-H1). However, Vmax values for 7-benzyloxyresorufin, propofol and bupropion oxidation by CYP2B11 were significantly reduced by coexpression with POR-H3 (by 34–37%) and POR-H4 (by 65–72%) compared with POR-H1. Km values were unaffected. Our results indicate that the Glu315Gln mutation (common to POR-H3 and POR-H4) reduces CYP2B11 enzyme function without affecting at least one other major canine hepatic P450 (CYP2D15). Additional in vivo studies are warranted to confirm these findings.

Factores asociados con éxito al parto vaginal en mujeres con cesárea prevía

Carta al editor

Factores asociados con éxito al parto vaginal en mujeres con cesárea previa, Estudio transversal descriptivo publicado el 01/08/2017.

Resulta claro que tener un parto vaginal, después de una cesárea anterior, (PVDC) es un tema muy polémico, no obstante los riesgos que se presentan de manera directa aumentan el riesgo de tener una ruptura uterina, hemorragia obstétrica, choque hipovolémico, una dehiscencia de herida quirúrgica, sepsis puerperal o llevar a un trágico evento de muerte perinatal como alto riesgo, incrementando la tasa de mortalidad materno fetal.

Efectividad del cianocrilato en la reparación de heridas en cuero cabelludo, región ciliar y zona mentoniana en pediatría

Resumen:

Introducción. El uso en pediatría de adhesivos tisulares como el cianocrilato para el cierre de heridas ofrece ventajas significativas. Es un procedimiento sencillo rápido e indoloro, conformándose como una alternativa en la población pediátrica debido a las características específicas de estos pacientes. Objetivo. Evaluar la efectividad del adhesivo tisular con cianocrilato en el cierre de heridas en zonas pilosas y mentón. Metodología. Se diseñó un estudio observacional prospectivo conformado por pacientes pediátricos que acudieron a urgencias con heridas que requerían sutura en zona mentoniana, ceja y cuero cabelludo. Se valoraron variables demográficas y clínicas, así como la colaboración del menor y grado de satisfacción de padres y profesionales tras la aplicación de cianocrilato. A los 3 meses se valoró la cicatrización. Los datos se analizaron mediante el programa estadístico SSPS. Resultados. Las heridas en zonas pilosas presentaron una correcta epitelización con un índice ≤ 2 según escala de Vancouver. Se establecieron diferencias estadísticamente significativas entre la localización de la herida y su cicatrización (p<0.05). Se objetivó un grado de concordancia moderado entre la satisfacción de los padres y los profesionales con un p-valor < 0.001. Discusión. Los adhesivos tisulares con base de cianocrilato parecen una alternativa válida y segura para la reparación de heridas en zonas con folículo piloso. Cuenta con la aprobación de pacientes, familiares y profesionales que realizaron el procedimiento. Los resultados respecto a la cicatrización evaluados a los 3 meses son más satisfactorios en áreas pilosas.

ABSTRACT

Introduction. The use of tissue adhesives like cyanoacrylate for wound closure in pediatrics offers significant advantages. It is a simple, fast, and painless procedure, making it an alternative in the pediatric population due to the specific characteristics of these patients. Objective. To evaluate the effectiveness of tissue adhesive with cyanoacrylate in closing wounds on the scalp or hairy areas and the chin region. Methodology. A prospective observational study was designed, consisting of pediatric patients who presented to the emergency department with wounds requiring sutures in the chin, eyebrow, and scalp areas. Demographic and clinical variables were assessed, as well as the cooperation of the child and the satisfaction level of parents and healthcare professionals after the application of cyanoacrylate. Scar healing was assessed at 3 months. Data were analyzed using the statistical software SPSS. Results. Wounds in hairy areas showed proper epithelialization with an index ≤2 according to the Vancouver scale. Statistically significant differences were found in the relationship between wound location and its healing (p<0.05). Additionally, a moderate level of agreement was observed between parent and professional satisfaction, with a p-value <0.001. Discusión. Cyanoacrylate-based tissue adhesives appear to be a valid and safe alternative for wound repair in areas with hair follicles. They are well-received by patients, their families, and the professionals who performed the procedure. The results regarding scar healing evaluated at 3 months are more satisfactory on the scalp and eyebrow compared to the chin region.

Factors associated with non‐urgent presentations in the paediatric emergency department using Andersen's behavioural model: A cross‐sectional descriptive study

Abstract

Objectives

To explore the rate of NUPs and associated factors in the PED of the ‘Hospital Universitario y Politécnico La Fe’ in Valencia (Spain) using Andersen's Behavioural Model.

Methods

We conducted a descriptive cross-sectional study using Andersen's Behavioural Model in parents visiting the PED with their children at the ‘Hospital Universitario y Politécnico La Fe’ in Valencia (Spain).

Results

The study involved a total of 530 participants, of whom 419 (79%) had made an NUP. The predisposing factors identified were: (I) paediatric patients brought in by their fathers (OR = 0.460; p = 0.005), (II) lower educational attainment (OR = 3.841; p = 0.000), (III) first-time parenthood (OR = 2.335; p = 0.000) and (IV) higher parental stress (OR = 1.974; p = 0.023). The enabling factors included: (I) responsibility for a significant part of the childcare shared with others (OR = 0.348; p = 0.041) and (II) the perception that PEDs provide better care than primary care (PC) services (OR = 1.628; p = 0.005). The need factors were: (I) existing chronic illness in the child seeking care (OR = 0.343; p = 0.000) and (II) the perceived severity of the urgency (OR = 0.440; p = 0.031).

Conclusions

The NUP rates found in this study are similar to those found internationally. In accordance with Andersen's Behavioural Model, we identify predisposing, enabling and need factors to explain the multifactorial nature of NUPs in PEDs.

Implications for Practice

Identifying the factors associated with NUPs enables interventions to be targeted at those groups most likely to engage in NUPs, thereby optimising the functioning of the PED and improving the well-being of children and families. These interventions should focus on improving parental health literacy, providing education on making appropriate decisions about accessing health services and recognising severe symptoms in children, as well as improving access to high-quality PC services. Providing support to parents during the transition to parenthood would also be beneficial.

Reporting Method

This paper adheres to the STROBE initiative guidelines.

Contribution from patients or members of the public

Participants, who voluntarily agreed to take part, contributed to the study by completing a paper-based questionnaire containing all the study variables as prepared by the research team.

Exploring older people's experiences of the interpersonal care relationship between nurses and patients during hospitalization in the pandemic period: A qualitative study

Abstract

Aim

This article presents the findings of a qualitative study focusing on the experiences of people aged over 70 years in the interpersonal nurse–patient care relationship in hospital settings during and after the COVID-19 pandemic. The aim was to analyse different aspects of this relationship, including nurses' behaviour and caring attitudes, the person-centred model of care, patients' involvement in their own care and communication in the hospital context.

Design

An exploratory qualitative study was conducted on the basis of an interpretative framework.

Methods

Six focus groups were conducted. A total of 34 participants were purposively recruited from three nursing homes in Spain, Italy and Portugal. Specific inclusion criteria were used to select participants.

Results

Five main categories were identified. Analysis revealed the importance of empathy and sensitivity in caring relationships, as well as the need for personalized and patient-centred care. The importance of effective communication and recognition of ageist behaviour by professionals was highlighted. In addition, independent of the pandemic, situational factors in the hospital environment were identified that influence the interpersonal care relationship.

Conclusions

The study highlights the need to promote a person-centred model of care that takes into account the specific preferences and needs of older people. This is achieved by identifying elements of the interpersonal nurse–patient relationship. In addition to highlighting the disparity of opinion regarding an active or passive role in self-care and decision making, the importance of addressing ageism and improving communication is emphasized.

What problem did the study address?

The importance of the patient–nurse relationship in hospital care has been highlighted in previous studies. Critical elements of the patient care experience have been identified as empathy and effective communication. Ageism in healthcare has been recognized as a potential barrier to patient-centred care.

What were the key findings?

The main findings highlight the importance of empathy and personalized care, emphasize the importance of effective communication and address ageist behaviours in the nurse–patient relationship.

Where and who will the research impact?

By highlighting the need for person-centred care and improved communication strategies, particularly in the context of caring for older patients during and after the COVID-19 pandemic, this research will have an impact on healthcare professionals, policy makers and carers.

Reporting Method

The COREQ guideline was used.

Patient or public contribution

This study adopted a collaborative approach to ensure that patient perspectives were integrated into the research process. We organized regular focus groups. Patients were actively involved in shaping the research questions, refining the study design and interpreting the emerging findings. Their valuable input helped us to understand the nuances of their experience and to prioritize the aspects that were critical to their well-being. In addition, their insights guided the development of practical recommendations aimed at improving the interpersonal care relationship between nurses and patients in hospital settings, ensuring that their voices were heard and reflected in the proposed interventions. This patient-centred approach fostered a sense of empowerment among the participants. It reinforced the notion that their experiences and opinions are integral to shaping healthcare practice.

Professional quality of life and fear of COVID‐19 among Spanish nurses: A longitudinal repeated cross‐sectional study

Abstract

Aim and Objectives

To evaluate changes in compassion fatigue (CF), burnout (BO), compassion satisfaction (CS) and fear of COVID-19 among Spanish nurses by comparing two assessment points: before and after the COVID-19 vaccination campaign.

Background

The COVID-19 pandemic has produced a great impact in healthcare worker's professional quality of life, especially among nurses. CF, BO and fear of COVID-19 decisively affect the care provided by nurses and put them at risk for mental health problems, so longitudinal studies are essential.

Design

A repeated cross-sectional design was carried out with a time-lapse of 12 months.

Methods

A total of 439 registered nurses in December 2020 and 410 in December 2021 participated in this study through an online survey. Data were collected using the Professional Quality of Life Questionnaire and the Fear of COVID-19 Scale. Occupational and sociodemographic variables were also analysed. This article adheres to the STROBE guidelines for the reporting of observational studies.

Results

The fear of COVID-19 has not been reduced among nurses. The levels of BO remain stable and continue to be high in half of the professionals. CF has been reduced with a small effect size (d = 0.30), while CS has also decreased (d = 0.30). Positive correlations were found in both assessment points between fear of COVID-19 and BO (r = .44, p ≤ .001; r = .41, p ≤ .001) and also between fear of COVID and CF (r = .57, p ≤ .001; r = .50, p ≤ .001). Negative correlations between fear and CS were also found (r = − .16, p = .001; r = − .22, p ≤ .001).

Relevance to Clinical Practice

Programmes to reduce fear of COVID-19, BO and CF are needed to improve mental health and to prevent psychological distress among nurses, as well as to increase CS and preserve the productivity and quality of nursing care.

Patient or Public Contribution

The nurses collaborated by participating in the present study anonymously and disinterestedly.

Amantadine and/or transcranial magnetic stimulation for fatigue associated with multiple sclerosis (FETEM): study protocol for a phase 3 randomised, double-blind, cross-over, controlled clinical trial

Por: Matias-Guiu · J. A. · Gonzalez-Rosa · J. · Hernandez · M. A. · Martinez-Gines · M. L. · Portoles · A. · Perez-Macias · N. · Benito-Leon · J. · Padron · I. · Prieto · J. · Matias-Guiu · J.
Introduction

Fatigue is one of the most disabling symptoms of multiple sclerosis (MS), and effective treatments are lacking. Amantadine is one of the most used treatments, although its efficacy is under debate. Transcranial magnetic stimulation (TMS) is a promising intervention that has shown positive effects in some preliminary investigations. We aim to investigate the effect of 6 weeks of amantadine and/or TMS in fatigue due to MS.

Methods and analysis

The study is a national, multicentre, phase 3, randomised, double-blind, cross-over, placebo-controlled and sham-controlled clinical trial. Adult patients with relapsing-remitting MS, Expanded Disability Status Scale score of 1.5–4.5 and Fatigue Severity Score>4 are eligible for the trial. Participants will be randomised to one of the sequences of the study. Each sequence consists of four periods of 6 weeks of treatment and three washout periods of 12–18 weeks. All patients will receive all the combinations of therapies. The primary outcome is the Modified Fatigue Impact Scale. The secondary outcomes are the Symbol Digit Modalities Test (cognition), Beck Depression Inventory-II (depressive symptoms) and Short-Survey 12 (quality of life). Safety and cost-effectiveness will also be evaluated. An exploratory substudy including MRI and blood biomarkers will be conducted.

Ethics and dissemination

The study is approved by the Ethics Committee of the Hospital Clinico San Carlos and the Spanish Agency of Medications and Medical Devices. All study findings will be published in scientific peer-reviewed journals and presented at relevant scientific conferences.

Trial registration number

EudraCT 2021-004868-95; NCT05809414.

Dimensions of suffering and the need for palliative care: experiences and expectations of patients living with cancer and diabetes and their caregivers in Mexico - a qualitative study

Por: Doubova · S. V. · Bhadelia · A. · Perez-Moran · D. · Martinez-Vega · I. P. · Garcia-Cervantes · N. · Knaul · F.
Objectives

Over 40 million people in low-income and middle-income countries (LMICs) experience serious health-related suffering (SHS) annually and require palliative care. Patient and caregiver experiences of SHS in LMICs are understudied despite their importance in guiding palliative care provision. Diabetes and cancer are the second-leading and third-leading causes of death in Mexico, causing a significant SHS burden on patients, families and health systems. This study examines SHS and palliative care from the point of view of patients with cancer and diabetes and their caregivers.

Design

A qualitative descriptive study based on in-depth telephone interviews was conducted between August 2021 and February 2022. Data were analysed through inductive thematic analysis.

Participants

Overall, 20 patients with end-stage cancer, 13 patients with diabetes and 35 family caregivers were interviewed individually.

Setting

Participants were recruited from two family medicine clinics and a pain clinic in Mexico City.

Results

Seven themes emerged: (1) suffering as a multifaceted phenomenon, (2) diversity in perceptions of suffering, (3) different coping strategies, (4) need and perceived importance of relief from suffering, (5) barriers to accessing services to relieve suffering, (6) demand for the health sector’s active and humane role in addressing suffering and (7) preferences and need for comprehensive care for relief from suffering. The primary coping strategies included family companionship, protective buffering and faith-based support. Participants lacked knowledge of palliative care. They expressed the importance of relief from suffering, viewing it as the health sector’s responsibility and requesting more humane, personalised care and access to medicines and pain clinics.

Conclusions

The multifaceted nature of SHS highlights the health system’s responsibility to provide high-quality palliative care. Policies to enhance access to palliative care should integrate it into primary care, redesigning services towards patient and caregiver biopsychosocial and spiritual needs and ensuring access to medicines and competent health personnel.

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

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.

Metformin in the prevention of type 2 diabetes after gestational diabetes in postnatal women (OMAhA): a UK multicentre randomised, placebo-controlled, double-blind feasibility trial with nested qualitative study

Por: Bolou · A. · Drymoussi · Z. · Lanz · D. · Amaefule · C. E. · Gonzalez Carreras · F. J. · Pardo Llorente · M. d. C. · Dodds · J. · Pizzo · E. · Thomas · A. · Heighway · J. · Harden · A. · Sanghi · A. · Hitman · G. · Zamora · J. · Perez · T. · Huda · M. S. B. · Thangaratinam · S.
Objective

To determine the feasibility of a definitive trial of metformin to prevent type 2 diabetes in the postnatal period in women with gestational diabetes.

Design

A multicentre, placebo-controlled, double-blind randomised feasibility trial with qualitative evaluation.

Setting

Three inner-city UK National Health Service hospitals in London.

Participants

Pregnant women with gestational diabetes treated with medication.

Interventions

2 g of metformin (intervention) or placebo (control) from delivery until 1 year postnatally.

Primary outcome measures

Rates of recruitment, randomisation, follow-up, attrition and adherence to the intervention.

Secondary outcome measures

Preliminary estimates of glycaemic effects, qualitative exploration, acceptability of the intervention and costs.

Results

Out of 302 eligible women, 57.9% (175/302) were recruited. We randomised 82.3% (144/175) of those recruited, with 71 women in the metformin group and 73 women in the placebo group. Of the participants remaining in the study and providing any adherence information, 54.1% (59/109) took at least 75% of the target intervention dose; the overall mean adherence was 64% (SD 33.6). Study procedures were found to be acceptable to women and healthcare professionals. An increased perceived risk of developing type 2 diabetes, or a positive experience of taking metformin during pregnancy, encouraged participation and adherence to the intervention. Barriers to adherence included disruption to the medication schedule caused by the washout periods ahead of each study visit or having insufficient daily reminders.

Conclusions

It is feasible to run a full-scale definitive trial on the effectiveness of metformin to prevent type 2 diabetes in women with gestational diabetes, during the early postnatal period. Adherence and engagement with the study could be improved with more regular reminders and potentially the addition of ongoing educational or peer support to reinforce messages around type 2 diabetes prevention.

Trial registration number

ISRCTN20930880.

Post Intensive Care Syndrome in Swiss Paediatric survivors and their Families (PICSS-PF): a national, multicentre, longitudinal study protocol

Por: Rahmaty · Z. · Manning · J. C. · Perez · M.-H. · Ramelet · A.-S.
Introduction

Paediatric intensive care units (PICUs) survivors and their families often experience widespread morbidity and psychosocial consequences after discharge, known as post-intensive care syndrome in paediatrics (PICS-p). In Switzerland, more than 5000 children are admitted to PICUs each year, and despite the high survival rate, there are no data on post-PICU recovery. This study aims to investigate PICS in children and families and identify its associated factors.

Methods and analysis

This is a national, multicentre, longitudinal, observational study that includes PICU survivors, main family caregivers and siblings (n=1300) recruited from the eight Swiss accredited PICUs with follow-up at discharge, 1, 3 and 6 months after discharge from the PICU. Data will be collected on the domains of physical, emotional, social and cognitive health, as well as factors affecting the outcome related to demographics, clinical specification, PICU and family environment, as well as community and social resources. Structural equation models and growth mixture models will analyse the outcomes, and the heterogeneity of recovery that shed light on the diverse recovery experiences of children and their families. The study identifies risk and protective factors with a focus on the influence of social and familial resources. It will also explore the mutual impact of the child’s recovery and parent/sibling psychosocial health.

Ethics and dissemination

The protocol is approved by the CER-VD ethics committee. Participants will be provided with verbal and written explanations of the study, and their privacy and anonymity will be protected throughout the process. The results will be presented at local and international conferences.

Approval number

Swiss ethics committees ID: 2022-02128, representing the eight cantons for both French and German-speaking parts of Switzerland.

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

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.

Socioeconomic disparities in attention deficit hyperactivity disorder (ADHD) in Sweden: An intersectional ecological niches analysis of individual heterogeneity and discriminatory accuracy (IEN-AIHDA)

by Christoffer Hornborg, Rebecca Axrud, Raquel Pérez Vicente, Juan Merlo

We aimed (i) to gain a better understanding of the demographic and socioeconomical distribution of ADHD risk in Sweden; and (ii) to contribute to the critical discussion on medicalization, i.e., the tendency to define and treat behavioural and social problems as medical entities. For this purpose, we analysed the risk of suffering from ADHD in the whole Swedish population aged between 5 and 60 years, across 96 different strata defined by combining categories of gender, age, income, and country of birth. The stratified analysis evidenced considerable risk heterogeneity, with prevalence values ranging from 0.03% in high income immigrant women aged 50–59, to 6.18% in middle income immigrant boys aged 10–14. Our study questions the established idea that behavioural difficulties conceptualized as ADHD should be primarily perceived as a neurological abnormality. Rather, our findings suggest that there is a strong sociological component behind how some individuals become impaired and subject to medicalization.
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