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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.

Feasibility, enablers and challenges of using timeliness metrics for household contact tracing and TB preventive therapy in Pakistan

by Bushra Jamil, Divya Nair, Pruthu Thekkur, Neelofar Laeeq, Anum Adil, Mohammed Khogali, Rony Zachariah, Selma Dar Berger, Srinath Satyanarayana, Ajay M. V. Kumar, Aaron Bochner, Amanda McClelland, Razia Fatima, Anthony D. Harries

Introduction

Screening household contacts of TB patients and providing TB preventive therapy (TPT) is a key intervention to end the TB epidemic. Global and timely implementation of TPT in household contacts, however, is dismal. We adapted the 7-1-7 timeliness metric designed to evaluate and respond to infectious disease outbreaks or pandemics, and assessed the feasibility, enablers and challenges of implementing this metric for screening and management of household contacts of index patients with bacteriologically-confirmed pulmonary TB in Karachi city, Pakistan.

Methods

We conducted an explanatory mixed methods study with a quantitative component (cohort design) followed by a qualitative component (descriptive design with focus group discussions).

Results

From January-June 2023, 92% of 450 index patients had their household contacts line-listed within seven days of initiating anti-TB treatment (“first 7”). In 84% of 1342 household contacts, screening outcomes were ascertained within one day of line-listing (“next 1”). In 35% of 256 household contacts eligible for further evaluation by a medical officer (aged ≤5 years or with chest symptoms), anti-tuberculosis treatment, TPT or a decision for no drugs was made within seven days of symptom screening (“second 7”). The principal reason for not starting anti-tuberculosis treatment or TPT was failure to consult a medical officer: only 129(50%) of 256 contacts consulted a medical officer. Reasons for poor performance in the “second 7” component included travel costs to see a medical officer, loss of daily earnings and fear of a TB diagnosis. Field staff reported that timeliness metrics motivated them to take prompt action in household contact screening and TPT provision and they suggested these be included in national guidelines.

Conclusions

Field staff found “7-1-7” timeliness metrics to be feasible and useful. Integration of these metrics into national guidelines could improve timeliness of diagnosis, treatment and prevention of TB within households of index patients.

The burden of non-disabled frailty and its associated factors among older adults in Bangladesh

by Sabuj Kanti Mistry, A. R. M. Mehrab Ali, Uday Narayan Yadav, Saruna Ghimire, Afsana Anwar, Md. Nazmul Huda, Fouzia Khanam, Rashidul Alam Mahumud, Ateeb Ahmad Parray, Shovon Bhattacharjee, David Lim, Mark Fort Harris

Objective

The present study aims to measure the prevalence of non-disabled frailty and its associated factors among Bangladeshi older adults.

Methods

This cross-sectional study was conducted during September and October 2021 among 1,045 Bangladeshi older adults (≥60 years). Telephone interviews, using a semi-structured questionnaire, were undertaken to collect data on participants’ characteristics and level of frailty. The non-disabled frailty was measured using the ‘Frail Non-Disabled (FiND)’ questionnaire. A multinomial logistic regression model assessed the factors associated with frailty among the participants.

Results

Around a quarter of the participants (24.8%) were frail. The multinomial regression analysis showed that older participants aged ≥80 years (RRR = 3.23, 95% CI: 1.41–7.37) were more likely to be frail compared to participants aged 60–69 years. Likewise, the participants living in a large family with ≥4 members (RRR = 1.39, 95% CI: 1.01–1.92) were more likely to be frail compared to those living in smaller families. Also, participants having memory or concentration problems (RRR = 1.56, 95% CI: 1.12–2.17) were more likely to be frail compared to those who were not suffering from these problems. Moreover, participants whose family members were non-responsive to their day-to-day assistance (RRR = 1.47, 95% CI: 1.06–2.03) were more likely to be frail compared to those whose family members were responsive. Furthermore, participants who were feeling lonely (RRR = 1.45, 95% CI: 1.07–1.98) were more likely to be frail than their counterparts who were not feeling lonely.

Conclusions

The findings of the present study suggest developing tailored interventions to address the burden of frailty among the older populations in Bangladesh. In particular, providing long-term care and health promotion activities can be of value in preventing frailty and reducing adverse health outcomes among this vulnerable population group.

Cost-effectiveness analysis of the Geriatric Fracture Center (GFC) concept: a prospective multicentre cohort study

Por: Joeris · A. · Sprague · S. · Blauth · M. · Gosch · M. · Wattanapanom · P. · Jarayabhand · R. · Poeze · M. · Wong · M. K. · Kwek · E. B. K. · Hegeman · J. H. · Perez-Uribarri · C. · Guerado · E. · Revak · T. J. · Zohner · S. · Joseph · D. · Phillips · M. R.
Introduction

Geriatric Fracture Centers (GFCs) are dedicated treatment units where care is tailored towards elderly patients who have suffered fragility fractures. The primary objective of this economic analysis was to determine the cost-utility of GFCs compared with usual care centres.

Methods

The primary analysis was a cost-utility analysis that measured the cost per incremental quality-adjusted life-year gained from treatment of hip fracture in GFCs compared with treatment in usual care centres from the societal perspective over a 1-year time horizon. The secondary analysis was a cost-utility analysis from a societal perspective over a lifetime time horizon. We evaluated these outcomes using a cost-utility analysis using data from a large multicentre prospective cohort study comparing GFCs versus usual care centres that took place in Austria, Spain, the USA, the Netherlands, Thailand and Singapore.

Results

GFCs may be cost-effective in the long term, while providing a more comprehensive care plan. Patients in usual care centre group were slightly older and had fewer comorbidities. For the 1-year analysis, the costs per patient were slightly lower in the GFC group (–$646.42), while the quality-adjusted life-years were higher in the usual care centre group (+0.034). The incremental cost-effectiveness ratio was $18 863.34 (US$/quality-adjusted life-year). The lifetime horizon analysis found that the costs per patient were lower in the GFC group (–$7210.35), while the quality-adjusted life-years were higher in the usual care centre group (+0.02). The incremental cost-effectiveness ratio was $320 678.77 (US$/quality-adjusted life-year).

Conclusions

This analysis found that GFCs were associated with lower costs compared with usual care centres. The cost-savings were greater when the lifetime time horizon was considered. This comprehensive cost-effectiveness analysis, using data from an international prospective cohort study, found that GFC may be cost-effective in the long term, while providing a more comprehensive care plan. A greater number of major adverse events were reported at GFC, nevertheless a lower mortality rate associated with these adverse events at GFC. Due to the minor utility benefits, which may be a result of greater adverse event detection within the GFC group and much greater costs of usual care centres, the GFC may be cost-effective due to the large cost-savings it demonstrated over the lifetime time horizon, while potentially identifying and treating adverse events more effectively. These findings suggest that the GFC may be a cost-effective option over the lifetime of a geriatric patient with hip fracture, although future research is needed to further validate these findings.

Level of evidence

Economic, level 2.

Trial registration number

NCT02297581.

Satisfacción con la simulación clínica de alta fidelidad previo y posterior a prácticas clínicas en estudiantes de enfermería

Objetivo principal: Analizar la satisfacción con la simulación clínica de alta fidelidad (SCAF) previo a prácticas clínicas versus posterior a prácticas clínicas en estudiantes de enfermería de una universidad pública de Chile. Metodología: Se realizó un estudio observacional analítico de cohorte transversal. La muestra fue de 178 estudiantes regulares de tercer y cuarto año de enfermería de una Universidad Pública de Chile. Para la recolección de datos se utilizó cuestionario de antecedentes sociodemográficos y académicos. El nivel de satisfacción de los estudiantes de enfermería con la SCAF se determinó mediante la aplicación del instrumento “Encuesta de calidad y satisfacción de simulación clínica”. Este instrumento se aplicó en dos oportunidades a los mismos estudiantes: previo a la práctica clínica (evaluación -EVI) y posterior a la realización de práctica clínica (evaluación II-EVII).  Resultados principales: La evaluación de la SCAF por los estudiantes obtuvo un puntaje total y el de todas las dimensiones clasificados como satisfechos en ambas evaluaciones. Al momento de comparar los puntajes totales y el de todas dimensiones se observó que estos disminuyeron significativamente en la EVII. Conclusión principal: Los estudiantes de enfermería demostraron niveles de satisfacción altos con la SCAF en ambas evaluaciones. No obstante, se observó una disminución significativa en los puntajes totales y en todas las dimensiones en la segunda evaluación, tras la experiencia clínica. Esto nos lleva a reflexionar sobre nuevos desafíos, tales como: aumentar el realismo de las SCAF, ofrecer más oportunidades de participación a los estudiantes y clarificar los objetivos de aprendizaje.

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