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Feasibility study of a multimodal prehabilitation programme in women receiving neoadjuvant therapy for breast cancer in a major cancer hospital: a protocol

Por: Grant · S. J. · Kay · S. · Lacey · J. · Kumar · S. · Kerin-Ayres · K. · Stehn · J. · Gonzalez · M. · Templeton · S. · Heller · G. · Cockburn · J. · Wahlroos · S. · Malalasekera · A. · Mak · C. · Graham · S.
Introduction

Neoadjuvant therapy has become a standard treatment for patients with stage II/III HER2 positive and triple negative breast cancer, and in well-selected patients with locally advanced and borderline resectable high risk, luminal B breast cancer. Side effects of neoadjuvant therapy, such as fatigue, cardiotoxicity, neurotoxicity, anxiety, insomnia, vasomotor symptoms, gastrointestinal disturbance as well as a raft of immune-related adverse events, may impact treatment tolerance, long-term outcomes, and quality of life. Providing early supportive care prior to surgery (typically termed ‘prehabilitation’) may mitigate these side effects and improve quality of life.

During our codesign of the intervention, consumers and healthcare professionals expressed desire for a programme that ‘packaged’ care, was easy to access, and was embedded in their care pathway. We hypothesise that a multimodal supportive care programme including exercise and complementary therapies, underpinned by behavioural change theory will improve self-efficacy, quality of life, readiness for surgery and any additional treatment for women with breast cancer. We seek to explore cardiometabolic, residual cancer burden and surgical outcomes, along with chemotherapy completion (relative dose intensity). This article describes the protocol for a feasibility study of a multimodal prehabilitation programme.

Methods and analysis

This is a prospective, mixed-method, feasibility study of a multi-modal programme in a hospital setting for 20–30 women with breast cancer receiving neoadjuvant therapy. Primary outcomes are recruitment rate, retention rate, adherence and acceptability. Secondary outcomes include patient reported outcome measures (PROMs), surgical outcomes, length of stay, satisfaction with surgery, chemotherapy completion rates, changes in metabolic markers and adverse events. Interviews and focus groups to understand the experience with prehabilitation and different factors that may affect feasibility of the intervention . The output of this study will be a codesigned, evidence-informed intervention assessed for feasibility and acceptability by women with breast cancer and the healthcare professionals that care for them.

Ethics and dissemination

The study received ethics approval from the St Vincents Hospital HREC (HREC/2021/ETH12198). Trial results will be communicated to participants, healthcare professionals, and the public via publication and conferences.

Trial registration number

ACTRN12622000584730.

Diabetes care in the pandemic era in the Midwestern USA: a semi-structured interview study of the patient perspective

Por: Gonzalez Bravo · C. · Sabree · S. A. · Dukes · K. · Adeagbo · M. J. · Edwards · S. · Wainwright · K. · Schaeffer · S. E. · Villa · A. · Wilks · A. D. · Carvour · M. L.
Objectives

To understand patients’ experiences with diabetes care during the COVID-19 pandemic, with an emphasis on rural, medically underserved, and/or minoritised racial and ethnic groups in the Midwestern USA.

Design

Community-engaged, semi-structured interviews were conducted by medical student researchers trained in qualitative interviewing. Transcripts were prepared and coded in the language in which the interview was conducted (English or Spanish). Thematic analysis was conducted, and data saturation was achieved.

Setting

The study was conducted in communities in Eastern and Western Iowa.

Participants

Adults with diabetes (n=20) who were fluent in conversational English or Spanish were interviewed. One-third of participants were residents of areas designated as federal primary healthcare professional shortage areas and/or medically underserved areas, and more than half were recruited from medical clinics that offer care at no cost.

Results

Themes across both English and Spanish transcripts included: (1) perspectives of diabetes, care providers and care management; (2) challenges and barriers affecting diabetes care; and (3) participant feedback and recommendations. Participants reported major constraints related to provider availability, costs of care, access to nutrition counselling and mental health concerns associated with diabetes care during the pandemic. Participants also reported a lack of shared decision-making regarding some aspects of care, including amputation. Finally, participants recognised systems-level challenges that affected both patients and providers and expressed a preference for proactive collaboration with healthcare teams.

Conclusions

These findings support enhanced engagement of rural, medically underserved and minoritised groups as stakeholders in diabetes care, diabetes research and diabetes provider education.

Inflammatory markers in world trade center workers with asthma: Associations with post traumatic stress disorder

by Juan P. Wisnivesky, Nikita Agrawal, Jyoti Ankam, Adam Gonzalez, Alex Federman, Steven B. Markowitz, Janette M. Birmingham, Paula J. Busse

Background

Post-traumatic stress disorders (PTSD) is associated with worse asthma outcomes in individuals exposed to the World Trade Center (WTC) site.

Research question

Do WTC workers with coexisting PTSD and asthma have a specific inflammatory pattern that underlies the relationship with increased asthma morbidity?

Study design and methods

We collected data on a cohort of WTC workers with asthma recruited from the WTC Health Program. Diagnosis of PTSD was ascertained with a Structured Clinical Interview for DSM-5 (Diagnostic and Statistical Manuel of Mental Disorders) and the severity of PTSD symptoms was assessed with the PTSD Checklist 5. We obtained blood and sputum samples to measure cytokines levels in study participants.

Results

Of the 232 WTC workers with diagnosis of asthma in the study, 75 (32%) had PTSD. PTSD was significantly associated with worse asthma control (p = 0.002) and increased resource utilization (p = 0.0002). There was no significant association (p>0.05) between most blood or sputum cytokines with PTSD diagnosis or PCL-5 scores both in unadjusted and adjusted analyses.

Interpretation

Our results suggest that PTSD is not associated with blood and sputum inflammatory markers in WTC workers with asthma. These findings suggest that other mechanisms likely explain the association between PTSD and asthma control in WTC exposed individuals.

Mental health and risk of death and hospitalization in COVID–19 patients. Results from a large-scale population-based study in Spain

by Aida Moreno-Juste, Beatriz Poblador-Plou, Cristina Ortega-Larrodé, Clara Laguna-Berna, Francisca González-Rubio, Mercedes Aza-Pascual-Salcedo, Kevin Bliek-Bueno, María Padilla, Concepción de-la-Cámara, Alexandra Prados-Torres, Luis A. Gimeno-Feliú, Antonio Gimeno-Miguel

The COVID–19 pandemic has created unprecedented challenges for health care systems globally. This study aimed to explore the presence of mental illness in a Spanish cohort of COVID-19-infected population and to evaluate the association between the presence of specific mental health conditions and the risk of death and hospitalization. This is a retrospective cohort study including all individuals with confirmed infection by SARS-CoV-2 from the PRECOVID (Prediction in COVID–19) Study (Aragon, Spain). Mental health illness was defined as the presence of schizophrenia and other psychotic disorders, anxiety, cognitive disorders, depression and mood disorders, substance abuse, and personality and eating disorders. Multivariable logistic regression models were used to examine the likelihood of 30-day all-cause mortality and COVID–19 related hospitalization based on baseline demographic and clinical variables, including the presence of specific mental conditions, by gender. We included 144,957 individuals with confirmed COVID–19 from the PRECOVID Study (Aragon, Spain). The most frequent diagnosis in this cohort was anxiety. However, some differences were observed by sex: substance abuse, personality disorders and schizophrenia were more frequently diagnosed in men, while eating disorders, depression and mood, anxiety and cognitive disorders were more common among women. The presence of mental illness, specifically schizophrenia spectrum and cognitive disorders in men, and depression and mood disorders, substance abuse, anxiety and cognitive and personality disorders in women, increased the risk of mortality or hospitalization after COVID–19, in addition to other well-known risk factors such as age, morbidity and treatment burden. Identifying vulnerable patient profiles at risk of serious outcomes after COVID–19 based on their mental health status will be crucial to improve their access to the healthcare system and the establishment of public health prevention measures for future outbreaks.

Clinical and cost-effectiveness of DREAMS START (Dementia RElAted Manual for Sleep; STrAtegies for RelaTives) for people living with dementia and their carers: a study protocol for a parallel multicentre randomised controlled trial

Por: Rapaport · P. · Amador · S. · Adeleke · M. · Banerjee · S. · Barber · J. · Charlesworth · G. · Clarke · C. · Connell · C. · Espie · C. · Gonzalez · L. · Horsley · R. · Hunter · R. · Kyle · S. D. · Manela · M. · Morris · S. · Pikett · L. · Raczek · M. · Thornton · E. · Walker · Z. · Webster
Introduction

Many people living with dementia experience sleep disturbance and there are no known effective treatments. Non-pharmacological treatment options should be the first-line sleep management. For family carers, relatives’ sleep disturbance leads to interruption of their sleep, low mood and breakdown of care. Our team developed and delivered DREAMS START (Dementia RElAted Manual for Sleep; STrAtegies for RelaTives), a multimodal non-pharmacological intervention, showing it to be feasible and acceptable. The aim of this randomised controlled trial is to establish whether DREAMS START is clinically cost-effective in reducing sleep disturbances in people living with dementia living at home compared with usual care.

Methods and analysis

We will recruit 370 participant dyads (people living with dementia and family carers) from memory services, community mental health teams and the Join Dementia Research Website in England. Those meeting inclusion criteria will be randomised (1:1) either to DREAMS START or to usual treatment. DREAMS START is a six-session (1 hour/session), manualised intervention delivered every 1–2 weeks by supervised, non-clinically trained graduates. Outcomes will be collected at baseline, 4 months and 8 months with the primary outcome being the Sleep Disorders Inventory score at 8 months. Secondary outcomes for the person with dementia (all proxy) include quality of life, daytime sleepiness, neuropsychiatric symptoms and cost-effectiveness. Secondary outcomes for the family carer include quality of life, sleep disturbance, mood, burden and service use and caring/work activity. Analyses will be intention-to-treat and we will conduct a process evaluation.

Ethics and dissemination

London—Camden & Kings Cross Ethics Committee (20/LO/0894) approved the study. We will disseminate our findings in high-impact peer-reviewed journals and at national and international conferences. This research has the potential to improve sleep and quality of life for people living with dementia and their carers, in a feasible and scalable intervention.

Trial registration number

ISRCTN13072268.

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.

Fibroids and unexplained infertility treatment with epigallocatechin gallate: a natural compound in green tea (FRIEND) - protocol for a randomised placebo-controlled US multicentre clinical trial of EGCG to improve fertility in women with uterine fibroids

Por: Al-Hendy · A. · Segars · J. H. · Taylor · H. S. · Gonzalez · F. · Siblini · H. · Zamah · M. · Alkelani · H. · Singh · B. · Flores · V. A. · Christman · G. M. · Johnson · J. J. · Huang · H. · Zhang · H.
Introduction

Uterine fibroids affect 30%–77% of reproductive-age women and are a significant cause of infertility. Surgical myomectomies can restore fertility, but they often have limited and temporary benefits, with postoperative complications such as adhesions negatively impacting fertility. Existing medical therapies, such as oral contraceptives, gonadotropin hormone-releasing hormone (GnRH) analogues and GnRH antagonists, can manage fibroid symptoms but are not fertility friendly. This study addresses the pressing need for non-hormonal, non-surgical treatment options for women with fibroids desiring pregnancy. Previous preclinical and clinical studies have shown that epigallocatechin gallate (EGCG) effectively reduces uterine fibroid size. We hypothesise that EGCG from green tea extract will shrink fibroids, enhance endometrial quality and increase pregnancy likelihood. To investigate this hypothesis, we initiated a National Institute of Child Health and Human Development Confirm-funded trial to assess EGCG’s efficacy in treating women with fibroids and unexplained infertility.

Methods and analysis

This multicentre, prospective, interventional, randomised, double-blinded clinical trial aims to enrol 200 participants with fibroids and unexplained infertility undergoing intrauterine insemination (IUI). Participants will be randomly assigned in a 3:1 ratio to two groups: green tea extract (1650 mg daily) or a matched placebo, combined with clomiphene citrate-induced ovarian stimulation and timed IUI for up to four cycles. EGCG constitutes approximately 45% of the green tea extract. The primary outcome is the cumulative live birth rate, with secondary outcomes including conception rate, time to conception, miscarriage rate, change in fibroid volume and symptom severity scores and health-related quality of life questionnaire scores.

Ethics and dissemination

The FRIEND trial received approval from the Food and Drug adminstration (FDA) (investigational new drug number 150951), the central Institutional Review Board (IRB) at Johns Hopkins University and FRIEND-collaborative site local IRBs. The data will be disseminated at major conferences, published in peer-reviewed journals and support a large-scale clinical trial.

Trial registration number

NCT05364008.

Caregiving in the COVID‐19 pandemic: Family adaptations following an intensive care unit hospitalisation

Abstract

Aim and Objective

To identify how family caregivers adapt to the caregiving role following a relative's COVID-19-related intensive care unit (ICU) hospitalisation.

Background

Family caregiving is often associated with poor health amongst caregivers which may limit their capacity to effectively support patients. Though severe COVID-19 infection has necessitated increasing numbers of persons who require caregiver support, little is known about these caregivers, the persons they are caring for, or the strategies used to effectively adjust to the caregiving role.

Design

A qualitative descriptive study design was adopted, and findings are reported using COREQ.

Methods

A secondary analysis of transcripts from semi-structured interviews conducted with recently discharged ICU patients who had COVID-19 (n = 16) and their family caregivers (n = 16) was completed using thematic analysis. MAXQDA 2020 and Miro were used to organise data and complete coding. Analysis involved a structured process of open and closed coding to identify and confirm themes that elucidated adaptation to family caregiving.

Results

Six themes highlight how family caregivers adapt to the caregiving role following an ICU COVID-19-related hospitalisation including (1) engaging the support of family and friends, (2) increased responsibilities to accommodate caregiving, (3) managing emotions, (4) managing infection control, (5) addressing patient independence and (6) engaging support services. These themes were found to be congruent with the Roy adaptation model.

Conclusions

Family caregiving is a stressful transition following a patient's acute hospitalisation. Effective adaptation requires flexibility and sufficient support, beginning with the care team who can adequately prepare the family for the anticipated challenges of recovery.

Relevance to Clinical Practice

Clinical teams may improve post-hospitalisation care outcomes of patients by preparing families to effectively adjust to the caregiver role—particularly in identifying sufficient support resources.

Patient or Public Contribution

Participation of patients/caregivers in this study was limited to the data provided through participant interviews.

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.

Quantitative changes in the corneal endothelium and central corneal thickness during anterior chamber inflammation: A systematic review and meta-analysis

by Germán Mejía-Salgado, Paula Tatiana Muñoz-Vargas, Carlos Cifuentes-González, Gabriela Flórez-Esparza, Rebeca Paquentín-Jiménez, Miguel Ángel Castro-Monreal, Naomi Medina-Galindo, Gilma Norella Hernández-Herrera, Luz Elena Concha-del-Río, Alejandra de-la-Torre

Purpose

To establish the effects of anterior chamber inflammation (ACI) on the corneal endothelium parameters and central corneal thickness (CCT).

Methods

We conducted a comprehensive literature review using medical databases (PubMed, EMBASE, VHL, and medRxiv) on March 8, 2023, for studies that included patients with ACI who had undergone specular microscopy or pachymetry. Case series with >10 patients, cross-sectional, case-control, and cohort studies were included. The risk of bias was assessed using CLARITY tools and validated scales such as those by Hassan Murad et al. and Hoy et al. A narrative synthesis and a quantitative standardized mean difference meta-analysis, I2 heterogeneity assessment, and publication bias tests were conducted. The study was registered in PROSPERO (CRD42023420148) and approved by the Universidad del Rosario ethical committee (DVO005 2277- CV1712).

Results

Thirty-four studies, encompassing 1,388 eyes with ACI, were included. Compared with healthy controls, overall, ACI eyes show significant mean differences in endothelial parameters (endothelial cell density (ECD), coefficient of variation (CV), and hexagonality (HEX)) (P Conclusion

ACI leads to significant alterations in endothelial parameters and CCT. The primary contributors to these changes are increased IOP, uveitis duration, and intraocular surgeries. Further studies are needed to explore the impact of ACI etiology on the endothelium, potential biases in IOP measurements during acute ACI episodes, and the potential necessity for monitoring the endothelial parameters and CCT in patients with chronic ACI.

Molecular effects of polystyrene nanoplastics on human neural stem cells

by Raquel Martin-Folgar, Mª Carmen González-Caballero, Mónica Torres-Ruiz, Ana I. Cañas-Portilla, Mercedes de Alba González, Isabel Liste, Mónica Morales

Nanoplastics (NPs) have been found in many ecological environments (aquatic, terrestrial, air). Currently, there is great concern about the exposition and impact on animal health, including humans, because of the effects of ingestion and accumulation of these nanomaterials (NMs) in aquatic organisms and their incorporation into the food chain. NPs´ mechanisms of action on humans are currently unknown. In this study, we evaluated the altered molecular mechanisms on human neural stem cell line (hNS1) after 4 days of exposure to 30 nm polystyrene (PS) NPs (0.5, 2.5 and 10 μg/mL). Our results showed that NPs can induce oxidative stress, cellular stress, DNA damage, alterations in inflammatory response, and apoptosis, which could lead to tissue damage and neurodevelopmental diseases.

Impact of virtual reality‐based therapy on post‐stroke depression: A systematic review and meta‐analysis of randomized controlled trials

Abstract

Background

Post-stroke depression is the most common neuropsychiatric consequence and reduces rehabilitation effectiveness. However, the efficacy of virtual reality (VR) on mental health treatment for patients after a stroke is uncertain.

Aims

The aim of this study was to evaluate the efficacy of VR as a co-adjuvant form of treatment to reduce depression in stroke patients admitted to neurorehabilitation units.

Methods

We systematically searched medical databases including PubMed, CINAHL, PsycINFO, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov from inception to November 16, 2023. Clinical trials comparing the use of VR as an adjuvant form of treatment in stroke patients' rehabilitation with the usual treatment were included. Pooled standardized mean differences were calculated using a random-effects model. Subgroup analyses were performed according to type of stroke, VR characteristics, and the scale used to measure depression. Meta-regression analysis was performed for intervention duration and to determine the mean age of the participants.

Results

Eight studies and 388 stroke patients were included. The VR interventions were associated with a lower risk of depression in patients (ES = −0.69; 95% CI [−1.05, −0.33]; I 2 = 57.6%; p ≤ .02). The estimates were not affected by the type of stroke, the type of VR used, the blinding process, the type of scale used to detect depression, the duration of the intervention (weeks and minutes), and the total number of sessions. Meta-regression shows that younger samples (p = .00; 95% CI [0.01, 0.08) and longer interventions (p = < .05; 95% CI [−0.00, −0.00) lead to a greater reduction in depression.

Linking Evidence to Action

This review provides an important basis for treating depression in patients after a stroke. Professionals working in stroke neurorehabilitation units should consider VR as a form of co-adjuvant treatment for depression in patients.

Systematic Review Registration

CRD42022303968.

Proposal for a physiotherapy assessment form for the evaluation of women patients with uro-gynecological disorders: A Delphi study

by Ana González-Castro, Raquel Leirós-Rodríguez, Óscar Rodríguez-Nogueira, Mª José Álvarez-Álvarez, Arrate Pinto-Carral, Elena Andrade-Gómez

Background

The correct selection of treatment techniques and methods in physiotherapy depends directly on a well-structured anamnesis, examination and assessment. Within urogynecological and obstetric physiotherapy there is no standardized and protocolized assessment that allows to follow established steps. For all this, the main objective of this study was to identify the assessment items that should be included in the a physiotherapeutic uro-gynecological assessment.

Methods

Delphi study through a group of experts. Prior to this, a systematic search was carried out, accompanied by a review of grey literature, to obtain the possible items to be included in the forms. Subsequently, a Delphi study with two consecutive rounds of questionnaires was developed. A total of 6 expert physiotherapists participated in the study.

Results

The initial questionnaire had 97 items and after two rounds one item was eliminated to obtain a total of 96 items in the final questionnaire.

Conclusions

The experts agreed on most of the choices and finally obtained a standardized and protocolized assessment in uro-gynecological physiotherapy. Furthermore, this proposal should be considered by other professionals involved in the process of evaluation and treatment of pelvi-perineal alterations.

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.

Definition and clinical management of haemodialysis central venous catheter local infections (exit site and tunnel infection): An international consensus assessment

Abstract

Aim

To evaluate the relevance of signs and symptoms for the clinical identification of ESI and TI in HD-CVC, by means of international expert consensus, and to reach a consensus on a definition and clinical management (CM) for these infections.

Background

A recent systematic review showed a high heterogeneity in the signs/symptoms used for determining exit site infection (ESI) and tunnel infection (TI) of haemodialysis central venous catheter (HD-CVC).

Design

A modified Delphi ranking process was carried out between November 2020 and March 2021, consisting of four rounds using an online questionnaire with a panel of 26 experts from 12 countries.

Methods

Experts responded on the level of relevance for the identification of ESI and TI, based on a list of 22 signs/symptoms obtained from a previous systematic review, using a 4-point Likert-type scale. After reaching consensus on the signs/symptoms, they followed the same method to reach consensus on the CM. The STROBE Checklist was used to report this study.

Results

A high degree of consensus was reached to identify the presence of ESI based on nine signs/symptoms: presence of pain at the exit site (ES) during interdialysis period, with fever ≥38°C do not suspect other cause, local signs at the ES (inflammation, induration, swelling, hyperemia/erythema ≥2 cm from ES) and obvious abscess or purulent exudate at ES; and of TI. Likewise, 5 cm were agreed upon.

Conclusion

This Delphi study provides international expert consensus definitions of ESI and TI in HD-CVC, laying the groundwork for the validation of an HD-CVC ES clinical assessment scale for early identification of ESI.

Relevance to Clinical Practice

In addition, this study provides a series of attitudes to consensual clinics regarding signs/symptoms of local infections in HD-CVC, which may be useful as expert opinion in clinical practice guidelines, when there is insufficient scientific evidence.

Albológica sine die: De vivencias que habitan memorias donde subsiste la figura y la obra de Francisco Herrera-Rodríguez (1957-2023)

El objetivo de este artículo consiste en evocar de forma nítida las vivencias compartidas con el profesor e investigador Francisco Herrera-Rodríguez y explicitar los aspectos más significativos de su aportación a la historia de la medicina y la enfermería basadas tanto en la investigación histórica como en la narrativa resaltando su gran compromiso y dedicación con las fuentes literarias. La metodología empleada se ha centrado en la autobiografía rememorando momentos compartidos en contextos académicos, artísticos, literarios y de puro ocio; es decir en la elaboración de relatos de vida autobiográficos enfocados a los tiempos en los que se han producido interacciones de diversa índole entre  Francisco Herrera-Rodríguez y el autor. Los resultados muestran la importancia de las aportaciones de Francisco Herrera-Rodríguez a la historia de la medicina y la historia de la enfermería. Asimismo, queda demostrada la gran calidad humanística del mencionado investigador. Conclusiones: Francisco Herrera-Rodríguez, mediante el  cultivo de sus predilectas pasiones: la investigación histórica, la literatura, el dibujo,  la pintura y el arte en general; se erigió en un humanista de gran calado que incidió positivamente en la formación de historiadores de la medicina y la enfermería.

Una Historia Social de la corporeidad: del cuerpo físico al cuerpo vivido

En este trabajo se realiza una revisión de las distintas percepciones del cuerpo que han tenido diferentes sociedades a lo largo de la historia. Se verá cómo, en algunos momentos, predominaron en la representación social del cuerpo significados de tipo positivo, mientras que en otros momentos se percibió el cuerpo desde un punto de vista negativo.

Para la realización de este artículo se llevó a cabo una investigación cualitativa basada en la revisión de documentos de la historia del pensamiento y de la teoría social sobre la construcción de las representaciones sociales del cuerpo. Para ello se ha utilizado el marco teórico del constructivismo de carácter sistémico -en concreto, la teoría de los imaginarios sociales de Juan Luis Pintos- y la noción de ruptura epistemológica de Gaston Bachelard. Se presta, además, una especial atención a la perspectiva de género a la hora de la realización del estudio.

Se puede concluir que las representaciones sociales del cuerpo se han visto afectadas por un proceso de secularización y medicalización; afectando de modos distintos a la percepción del cuerpo femenino, que a la del masculino. Construyéndose a lo largo del tiempo una representación del cuerpo como algo cambiante y que asume un papel identitario para las personas.

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

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

Influence of physical fitness components on personality factors and risk perception of children and adolescents: a cross-sectional study

Objectives

To examine the associations of cardiorespiratory fitness (VO2 max) and muscular strength with indicators related to the risk scale, such as perceived competence, sensation seeking, competitiveness, risk taking and risk perception in sports.

Design

Cross-sectional study.

Setting

High schools from the Region of Murcia (Spain).

Participants

Three-hundred-and-seventeen adolescents participated (mean age: 13.69±1.2 years old).

Primary and secondary outcome measures

Body mass, body height, Course-Navette test, upper limb strength and psychoeducational factors that determine the propensity towards sports accidents in school children, the Sports Accident Propensity Scale were evaluated. It was performance t-test for independent samples, stepwise multiple linear regression models and a multiple mediation analysis.

Results

The analysis showed significant differences with respect to sex in height, VO2 max, handgrip strength and in all factors of the questionnaire (p=0.02-2 max, strength in the handgrip test and age showed a higher score in factors 1 and 3. Higher scores in factor 2 were associated with better VO2 max and strength in handgrip test. Youngers and better values of strength in the handgrip showed higher score in factors 4 and 5. The mediation analysis with two mediating variables (handgrip strength and VO2 max) showed a significant indirect effect. When handgrip strength and VO2 max were included in the equations, the association between sex and each factor ceased to be significant.

Conclusion

This study highlights the potential benefits of muscular strength (handgrip) and VO2 max in the perceived risk scale, and the variable of age on this.

Trial registration number

Clinical trial: NCT05544370 (pre-results).

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