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Efficacy and safety of deferoxamine, deferasirox and deferiprone triple iron chelator combination therapy for transfusion-dependent {beta}-thalassaemia with very high iron overload: a protocol for randomised controlled clinical trial

Introduction

Despite the improvement in medical management, many patients with transfusion-dependent β-thalassaemia die prematurely due to transfusion-related iron overload. As per the current guidelines, the optimal chelation of iron cannot be achieved in many patients, even with two iron chelators at their maximum therapeutic doses. Here, we evaluate the efficacy and safety of triple combination treatment with deferoxamine, deferasirox and deferiprone over dual combination of deferoxamine and deferasirox on iron chelation in patients with transfusion-dependent β-thalassaemia with very high iron overload.

Methods and analysis

This is a single-centre, open-label, randomised, controlled clinical trial conducted at the Adult and Adolescent Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into intervention or control groups. The intervention arm will receive a combination of oral deferasirox, oral deferiprone and subcutaneous deferoxamine for 6 months. The control arm will receive the combination of oral deferasirox and subcutaneous deferoxamine for 6 months. Reduction in iron overload, as measured by a reduction in the serum ferritin after completion of the treatment, will be the primary outcome measure. Reduction in liver and cardiac iron content as measured by T2* MRI and the side effect profile of trial medications are the secondary outcome measures.

Ethics and dissemination

Ethical approval for the study has been obtained from the Ethics Committee of the Faculty of Medicine, University of Kelaniya (Ref. P/06/02/2023). The trial results will be disseminated in scientific publications in reputed journals.

Trial registration number

The trial is registered in the Sri Lanka Clinical Trials Registry (Ref: SLCTR/2023/010).

Mental health nurses' empathy towards consumers with dual diagnosis: A descriptive study

Abstract

Aim

This study aimed to assess mental health nurses' empathy towards consumers with dual diagnosis in Australian mental health settings. The research question was What is mental health nurses' empathy towards consumers with co-existing mental health and drug and alcohol problems?

Design and Methods

A cross-sectional survey was carried out to understand mental health nurses' empathy. The convenience sample included 96 mental health nurses from various mental health settings with experience working with consumers with dual diagnosis. We assessed empathy using the Toronto Empathy Questionnaire. We utilised SPSS™ software to analyse both the descriptive data and multiple-regression.

Results

The mean empathy score was 47.71 (SD 8.28). The analysis of the association between demographic variables and individual subscales showed an association between the clinical setting and empathy (p = .031) and sympathetic physiological arousal (p = .049). The work sector was associated with sympathetic physiological arousal (p = .045) and conspecific altruism (p = .008). Emotional contagion (β = .98, p < .001), emotional comprehension (β = 1.02, p < .001), sympathetic physiological arousal (β = 1.01, p < .001) and conspecific altruism (β = 10.23, p < .001) predicted mental health nurses' empathy.

Conclusions

This study found that most mental health nurses showed empathy towards consumers with dual diagnosis. Mental health nurses who are more empathetic towards their consumers experience emotional contagion. They understand emotions better, show sympathetic physiological responses and exhibit kind behaviour towards consumers.

Implications for the Profession and Patient Care

Further research is required to understand how mental health nurses adapt to consumers' emotional states in different mental health settings. This information can help clinicians make better decisions about care quality for consumers with dual diagnosis.

Impact

This study addressed mental health nurses' empathy towards consumers with dual diagnosis. Mental health nurses showed increased empathy towards consumers with dual diagnosis. The empathy levels vary based on age, clinical setting, work sector and work experience. Mental health nurses' empathy levels were predicted by emotional contagion, emotion comprehension, sympathetic physiological arousal and conspecific altruism. Empathy enhancement among mental health nurses, particularly towards consumers with dual diagnosis, is crucial and should be regarded as a top priority by healthcare leaders and educators.

Reporting Method

Outlined by the Consensus-Based Checklist for Reporting of Survey Studies (CROSS).

Patient or Public Contribution

No Patient or Public Contribution.

Clinical evaluation of a fully electronic microfluidic white blood cell analyzer

by Jianye Sui, Zhongtian Lin, Shahriar Azizpour, Fei Chen, Sunanda Gaur, Kelly Keene, Farzad Soleimani, Tanaya Bhowmick, Zubaid Rafique, Mehdi Javanmard

The White Blood Cell (WBC) count is one of the key parameters signaling the health of the immune system. Abnormal WBC counts often signal a systemic insult to the body such as an underlying infection or an adverse side effect to medication. Typically, the blood collected is sent to a central lab for testing, and results come back within hours, which is often inconvenient and may delay time-sensitive diagnosis or treatment. Here, we present the CytoTracker, a fully electronic, microfluidic based instant WBC analyzer with the potential to be used at point-of-care. The CytoTracker is a lightweight, portable, affordable platform capable of quantifying WBCs within minutes using only 50 μl of blood (approximately one drop of blood). In this study, we clinically evaluated the accuracy and performance of CytoTracker in measuring WBC and granulocyte counts. A total of 210 adult patients were recruited in the study. We validated the CytoTracker against a standard benchtop analyzer (Horiba Point of Care Hematology Analyzer, ABX Micros 60). Linear dynamic ranges of 2.5 k/μl– 35 k/μl and 0.6 k/μl– 26 k/μl were achieved for total WBC count and granulocyte count with correlation coefficients of 0.97 and 0.98. In addition, we verified CytoTracker’s capability of identifying abnormal blood counts with above 90% sensitivity and specificity. The promising results of this clinical validation study demonstrate the potential for the use of the CytoTracker as a reliable and accurate point-of-care WBC analyzer.

Organisation and delivery of a dedicated multidisciplinary prone ventilation team in the intensive care unit: Strategies and lessons from COVID-19

by Luke Bracegirdle, Matthew Stubbs, Rezaur Rahman, Alexander I. R. Jackson, Helmi C. Burton-Papp, Robert Chambers, Sanjay Gupta, Michael P. W. Grocott, Ahilanandan Dushianthan

Background

COVID-19 placed immense strain on healthcare systems, necessitating innovative responses to the surge of critically ill patients, particularly those requiring mechanical ventilation. In this report, we detail the establishment of a dedicated critical care prone positioning team at University Hospital Southampton in response to escalating demand for prone positioning during the initial wave of the pandemic.

Methods

The formation of a prone positioning team involved meticulous planning and collaboration across disciplines to ensure safe and efficient manoeuvrers. A comprehensive training strategy, aligned with national guidelines, was implemented for approximately 550 staff members from a diverse background. We surveyed team members to gain insight to the lived experience.

Results

A total of 78 full-time team members were recruited and successfully executed over 1200 manoeuvres over an eight-week period. Our survey suggests the majority felt valued and expressed pride and willingness to participate again should the need arise.

Conclusion

The rapid establishment and deployment of a dedicated prone positioning team may have contributed to both patient care and staff well-being. We provide insight and lessons that may be of value for future respiratory pandemics. Future work should explore objective clinical outcomes and long-term sustainability of such services.

Analysis of maternal and child health spillover effects in PEPFAR countries

Por: Gaumer · G. · Crown · W. H. · Kates · J. · Luan · Y. · Hariharan · D. · Jordan · M. · Hurley · C. L. · Nandakumar · A.
Objectives

This study examined whether the US President’s Emergency Plan for AIDS Relief (PEPFAR) funding had effects beyond HIV, specifically on several measures of maternal and child health in low-income and middle-income countries (LMICs). The results of previous research on the question of PEPFAR health spillovers have been inconsistent. This study, using a large, multicountry panel data set of 157 LMICs including 90 recipient countries, adds to the literature.

Design

Seven indicators including child and maternal mortality, several child vaccination rates and anaemia among childbearing-age women are important population health indicators. Panel data and difference-in-differences estimators (DID) were used to estimate the impact of the PEPFAR programme from inception in 2004 to 2018 using a comparison group of 67 LMICs. Several different models of baseline (2004) covariates were used to help balance the comparison and treatment groups. Staggered DID was used to estimate impacts since all countries did not start receiving aid at PEPFAR’s inception.

Setting

All 157 LMICs from 1990 to 2018.

Participants

90 LMICs receiving PEPFAR aid and cohorts of those countries, including those required to submit annual country operational plans (COP), other recipient countries (non-COP), and three groupings of countries based on cumulative amount of per capita aid received (high, medium, low).

Interventions

PEPFAR aid to combat the HIV epidemic.

Primary outcome measures

Maternal mortality and child mortality rates, vaccination rates to protect children for diphtheria, whooping cough and tetanus, measles, HepB3, and tetanus, and prevalence of anaemia in women of childbearing age.

Results

Across PEPFAR recipient countries, large, favourable PEPFAR health effects were found for rates of childhood immunisation, child mortality and maternal mortality. These beneficial health effects were large and significant in all segments of PEPFAR recipient countries studied. We also found significant and favourable programme effects on the prevalence of anaemia in women of childbearing age in PEPFAR recipient countries receiving the most intensive financial support from the PEPFAR programme. Other recipient countries did not demonstrate significant effects on anaemia.

Conclusions

This study demonstrated that important health indicators, beyond HIV, have been consistently and favourably influenced by PEPFAR presence. Child and maternal mortality have been substantially reduced, and childhood immunisation rates increased. We also found no evidence of ‘crowding out’ or negative spillovers in these resource-poor countries. These findings add to the body of evidence that PEPFAR has had favourable health effects beyond HIV. The implications of these findings are that foreign aid for health in one area may have favourable health effects in other areas in recipient countries. More research is needed on the influence of the mechanisms at work that create these spillover health effects of PEPFAR.

Dietary magnesium, C-reactive protein and interleukin-6: The Strong Heart Family Study

by Nandana D. Rao, Rozenn N. Lemaitre, Colleen M. Sitlani, Jason G. Umans, Karin Haack, Veronica Handeland, Ana Navas-Acien, Shelley A. Cole, Lyle G. Best, Amanda M. Fretts

Objectives

To examine the associations of dietary Mg intake with inflammatory biomarkers (C-reactive protein (CRP) and interleukin 6 (IL-6)), and the interaction of dietary Mg intake with single nucleotide polymorphism (SNP) rs3740393, a SNP related to Mg metabolism and transport, on CRP and IL-6 among American Indians (AIs).

Methods

This cross-sectional study included AI participants (n = 1,924) from the Strong Heart Family Study (SHFS). Mg intake from foods and dietary supplements was ascertained using a 119-item Block food frequency questionnaire, CRP and IL-6 were measured from blood, and SNP rs3740393 was genotyped using MetaboChip. Generalized estimating equations were used to examine associations of Mg intake, and the interaction between rs3740393 and dietary Mg, with CRP and IL-6.

Results

Reported Mg intake was not associated with CRP or IL-6, irrespective of genotype. A significant interaction (p-interaction = 0.018) was observed between Mg intake and rs3740393 on IL-6. Among participants with the C/C genotype, for every 1 SD higher in log-Mg, log-IL-6 was 0.04 (95% CI: -0.10 to 0.17) pg/mL higher. Among participants with the C/G genotype, for every 1 SD higher in log-Mg, log-IL-6 was 0.08 (95% CI: -0.21 to 0.05) pg/mL lower, and among participants with the G/G genotype, for every 1 SD higher in log-Mg, log-IL-6 was 0.19 (95% CI: -0.38 to -0.01) pg/mL lower.

Conclusions

Mg intake may be associated with lower IL-6 with increasing dosage of the G allele at rs3740393. Future research is necessary to replicate this finding and examine other Mg-related genes that influence associations of Mg intake with inflammation.

Inhaled beclomethasone in the treatment of early COVID-19: a double-blind, placebo-controlled, randomised, hospital-based trial in Sri Lanka

Por: Mettananda · C. · Peiris · C. · Abeyrathna · D. · Gunasekara · A. · Egodage · T. · Dantanarayana · C. · Pathmeswaran · A. · Ranasinha · C.
Objectives

To study if early initiation of inhaled beclomethasone 1200 mcg in patients with asymptomatic, mild or moderate COVID-19 reduces disease progression to severe COVID-19.

Design

Double-blinded, parallel-groups, randomised, placebo-controlled trial.

Setting

A hospital-based study in Sri Lanka.

Participants

Adults with asymptomatic, mild or moderate COVID-19, presenting within the first 7 days of symptom onset or laboratory diagnosis of COVID-19, admitted to a COVID-19 intermediate treatment centre in Sri Lanka between July and November 2021.

Interventions

All participants received inhaled beclomethasone 600 mcg or placebo two times per day, for 10 days from onset of symptoms/COVID-19 test becoming positive if asymptomatic or until reaching primary endpoint, whichever is earlier.

Primary outcome measure

Progression of asymptomatic, mild or moderate COVID-19 to severe COVID-19.

Secondary outcome measures

The number of days with a temperature of 38°C or more and the time to self-reported clinical recovery.

Results

A total of 385 participants were randomised to receive beclomethasone(n=193) or placebo(n=192) stratified by age (≤60 or >60 years) and sex. One participant from each arm withdrew from the study. All participants were included in final analysis. Primary outcome occurred in 24 participants in the beclomethasone group and 26 participants in the placebo group (RR 0.90 ; p=0.763). The median time for self-reported clinical recovery in all participants was 5 days (95% CI 3 to 7) in the beclomethasone group and 5 days (95% CI 3 to 8) in the placebo group (p=0.5). The median time for self-reported clinical recovery in patients with moderate COVID-19 was 5 days (95% CI 3 to 7) in the beclomethasone group and 6 days (95% CI 4 to 9) in the placebo group (p=0.05). There were no adverse events.

Conclusions

Early initiation of inhaled beclomethasone in patients with asymptomatic, mild or moderate COVID-19 did not reduce disease progression to severe COVID-19.

Trial registration number

Sri Lanka Clinical Trials Registry; SLCTR/2021/017.

The meaning of preparedness for informal caregivers of older adults: A concept analysis

Abstract

Aim

To examine the concept of preparedness over time in research with informal caregivers of older adults.

Design

Concept analysis.

Methods

Rodgers' evolutionary method of concept analysis was used to guide this theoretical paper due to the dynamic nature of preparedness, which is influenced by both context and time. Using Rodgers' inductive approach, concept elements were derived from a content analysis of included studies. In the final step, to generate hypotheses and implications regarding the concept, the conceptual structure of preparedness of informal caregivers of older adults was connected to a theoretical problem in the nursing discipline using the Caregiving Stress Process Framework.

Data Sources

Four databases (EBSCO CINAHL, Ovid MEDLINE, Ovid PsycINFO and Scopus) were searched in November 2022 and updated in September 2023. No date limits were set for searching, as the intent was to analyse possible variations of the concept over time.

Results

The attributes of preparedness include self-confidence, having knowledge, skills and abilities to perform daily tasks, handling emotions and developed over time. These attributes can be compared with the stressors outlined in the Caregiving Stress Process Framework (i.e., the moment the caregiver identifies some ‘stressor’; something that prevents them from feeling confident in their preparedness).

Conclusion

The concept of preparedness of informal caregivers of older adults is defined as caregiver's self-confidence about their current competence related to the knowledge, skills and abilities to perform daily tasks, and to handle emotions over time. To link the concept to a theoretical perspective, we propose adaptations to a well-known theory, the Caregiving Stress Process Framework. Future research on caregiving preparedness needs to avoid circular definitions and work with the attributes of preparedness to support caregivers.

Implications for the Profession and/or Patient Care

This paper contributes to the development of interventions that focus on the health and preparedness of informal caregivers of older adults. Clarifying the concept of preparedness helps nurses to support caregivers since it is then known which aspects are included in the preparedness of caregivers (e.g., daily tasks and handling emotions). A more fulsome understanding of preparedness supports us to see beyond stressors of caregiving.

Impact

This study addresses informal caregivers of older adults' preparedness to provide care. We synthesized existing definitions that have been used in research with this population to propose a robust conceptualization of the concept of preparedness, which contributes to better understanding of how preparedness can be supported.

Reporting Method

We were unable to locate a reporting method related to this kind of work (concept analysis).

Patient or Public Contribution

Not applicable as no new data generated.

Optimization of solid oral dosage form administration to patients with swallowing difficulties: An integrative review

Abstract

Aim

To appraise and synthesize research investigating optimizing the administration of solid oral dosage forms (SODFs) to adults with swallowing difficulties.

Design

An integrative review.

Methods

An electronic search was conducted on Medical Literature Analysis and Retrieval System Online (Public Medline interface), Elsevier SciVerse Scopus and Scientific Electronic Library Online (updated February 2023). Restriction regarding the publication date was not considered for the inclusion of records. Studies addressing risks, general aspects, recommendations about patient postural adjustments, swallowing techniques, swallowing aids and aspects of concealment of SODFs were included.

Results

Fifty-three records published between 2002 and 2021 were included. The main administration risks were aspiration, asphyxia and solid oral dosage form-induced oral/oesophageal mucosal lesions. The most frequent general aspect reported was administering one oral dosage form at a time. The sitting position was the most patient postural adjustment mentioned. The most frequently reported solid oral dosage form swallowing technique was the lean-forward method for capsules. Solid oral dosage form swallowing aids cited: tongue and throat lubricant and solid oral dosage form coating device, swallowing cup and swallowing straw.

Conclusion

The literature data on administering SODFs for adults with swallowing difficulties were appraised and synthesized. Some aspects, for example, not administering SODFs simultaneously, can make swallowing safer. Postural adjustments and solid oral dosage form swallowing aids are important to avoid administration risks. Swallowing SODFs can be easier if learned by techniques. Liquid and food are helpful as vehicles, and several of these have been listed.

Implications for the Profession and/or Patient Care

By optimizing the contributing factors of administering oral pharmacotherapy, the nurse can use appropriate practices to improve patient safety. Additionally, knowing and establishing the administration aspects are reasonable steps for standardizing care for patients with swallowing oral dosage form difficulties.

Impact

This study addressed administering SODFs to adult patients with swallowing difficulties. The administration of SODFs to adult patients with swallowing difficulties can be optimized if only one oral dosage form at a time is administrated and if patient postural adjustments, swallowing techniques and swallowing aids are used. This investigation will impact the care of patients with swallowing difficulties.

Reporting Method

The authors declare they adhered to the relevant EQUATOR guidelines and report following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 Statement.

Patient or Public Contribution

No patient or public contribution.

Cultura alimentaria, tejidos que fortalecen el cuidado colectivo en una comunidad indígena

Objetivo: Explorar los factores de la estructura social y de cultura alimentaria de una comunidad indígena que fortalecen el cuidado colectivo. Materiales y métodos: Estudio cualitativo, método etnográfico; a través de muestreo propositivo: se realizaron 10 entrevistas semiestructuradas y observación participante; el análisis de contenido se apoyó en la herramienta Atlas ti 7.0. Resultados: Factores de tipo económico-político, educativo, social-cultural y espiritual aportaron evidencias de ejercicios y prácticas alimentarias que desde la cosmovisión indígena de equilibrio y conciencia con la “madre tierra” y de su ordenamiento territorial aportan a las prácticas colectivas e identitarias de la comunidad. Conclusiones: Alrededor de la alimentación, se tejen muchas prácticas que fortalecen el cuidado en la comunidad; de la shagra, se cosecha el alimento físico y espiritual, como también se constituye como un espacio de afirmación de identidad y pervivencia de saberes ancestrales que deben ser conservados.

Ansiedad, depresión y soledad en cuidadores de personas con enfermedad crónica

Objetivo principal: Determinar la relación entre ansiedad, depresión y soledad en cuidadores familiares de adultos mayores con enfermedades crónicas. Metodología: Diseño descriptivo correlacional. Se utilizó la Escala hospitalaria de ansiedad y depresión (α=.83) y la escala de Soledad (α=.95). Se hizo un cálculo de tamaño de muestra con programa G-Power 3.1.9.7 y se aplicó un muestreo a conveniencia. Se analizó con estadística descriptiva e inferencial, como Pearson y chi2. Resultados principales: Participaron 178 cuidadores familiares con una m de 45 años. Se encontró relación de la edad con la percepción de soledad (r=-.200) y el tiempo del cuidado con la puntuación de depresión (r=-.199) y ansiedad (r=-.179). Conclusión principal: Se encontró que, a mayor edad del cuidador, mayor es la percepción de soledad, y a mayor tiempo de cuidado, menor es la depresión y ansiedad, permitiendo implementar futuros programas de atención para mejorar la calidad de vida de los cuidadores.

Atención brindada por enfermeras a pacientes adultos en cuidados paliativos: una revisión sistemática

Objetivo: Identificar los cuidados que brindan las enfermeras a los pacientes adultos en cuidados paliativos. Método: Se trata de una revisión integradora, realizada en octubre de 2020. Resultados: se incluyeron 14 artículos. En cuanto a las dimensiones del cuidado, el 33,2% de los estudios abordaron solo una dimensión del cuidado: el 13,3% la dimensión física; El 13,3% aporta la dimensión espiritual y el 6,6% la dimensión emocional. Asociando dos dimensiones, apareció el 33,2%: el 13,3% trajo las dimensiones física y emocional; 6,6% las dimensiones emocional y social; 6,6% dimensiones físicas y sociales; y el 6,6% las dimensiones emocionales y espirituales del cuidado. Asociando tres dimensiones, el 20% aporta las dimensiones física, emocional y social del cuidado y, finalmente, solo el 6,6% aporta la asociación de las cuatro dimensiones. Conclusión: El estudio muestra el predominio de los cuidados brindados por enfermeras a los pacientes en cuidados paliativos en las dimensiones física y emocional.

Prevalencia de los cambios dermatológicos en personas diabéticas con ulceración del pie

Objetivo principal: Estimar la prevalencia de alteraciones dermatológicas en personas diabéticas con ulceración del pie atendidas en un centro de referencia en diabetes en Bahía. Metodología: Estudio transversal y retrospectivo. La población del estudio consistió en 133 pacientes tratados en 2017 y la recopilación de datos tuvo lugar entre agosto y octubre de 2018. Para el análisis de datos se utilizaron estadísticas descriptivas realizadas utilizando el software estadístico Statistical Package for the Social Sciences (SPSS 16.0). Resultados principales: El cambio más frecuente fue la callosidad (48,1%) seguido de xeroderma (47,4%), micosis interdigital (18%), onicomicosis (13,5%), fisuras (6,8%). Entre el momento del diagnóstico de diabetes y fisuras se encontraron asociaciones entre el momento del diagnóstico de diabetes y fisuras (p= 0,019), úlcera neuropática y xeroderma (p=0,015), úlcera infectada y callos o callos (p=0,010). La onicomicosis y el xeroderma eran más frecuentes en los hombres, mientras que los callos en las mujeres. Conclusión principal: En esta investigación se encontraron nuevas asociaciones. Se observó que la salud de los pies es una brecha en la literatura y este estudio tiene como objetivo ampliar el conocimiento sobre este tema, sirviendo para guiar los comportamientos de atención al paciente en los servicios y calificar la atención médica de las personas diabéticas.

Evaluación y cuidado de la piel al final de la vida

Este artículo contempla una actualización con base a los diez puntos establecidos por el consenso Skin Changes at the Life's End [Cambios en la Piel en el Final de la Vida] (Scale, por su sigla en inglés) y tiene por objetivo discutir la evaluación de las condiciones y el cuidado de la piel en el final de la vida. Acerca de los pacientes y familiares, se propone la construcción de un plan de cuidados basándose en sus deseos que deben ser debidamente registrados. Para los profesionales de salud, las recomendaciones buscan la educación para la evaluación de los signos clínicos de falla e insuficiencia de la piel. Así pues, la prioridad es la comodidad del paciente. Se concluye que la utilización del consenso Scale va al encuentro de la filosofía de los cuidados paliativos y puede así mejorar los aspectos multidimensionales involucrados en la calidad del proceso de morir.

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

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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