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Ayer — Mayo 14th 2024Tus fuentes RSS

Cost-effectiveness of a complex continuum of care intervention targeting women and children: protocol for an economic evaluation of the Bukhali trial in South Africa

Por: Palmer · T. · Leiva Granados · R. · Draper · C. · Norris · S. A. · Batura · N.
Introduction

As nearly two-thirds of women presenting at their first antenatal visit are either overweight or obese in urban South Africa, the preconception period is an opportunity to optimise health and offset transgenerational risk of both obesity and non-communicable diseases. This protocol describes the planned economic evaluation of an individually randomised controlled trial of a complex continuum of care intervention targeting women and children in Soweto, South Africa (Bukhali trial).

Methods and analysis

The economic evaluation of the Bukhali trial will be conducted as a within-trial analysis from both provider and societal perspectives. Incremental costs and health outcomes of the continuum of care intervention will be compared with standard care. The economic impact on implementing agencies (programme costs), healthcare providers, participants and their households will be estimated. Incremental cost-effectiveness ratios (ICERs) will be calculated in terms of cost per case of child adiposity at age years averted. Additionally, ICERs will also be reported in terms of cost per quality-adjusted life year gained. If Bukhali demonstrates effectiveness, we will employ a decision analytical model to examine the cost-effectiveness of the intervention over a child’s lifetime. A Markov model will be used to estimate long-term health benefits, healthcare costs and cost-effectiveness. Probabilistic sensitivity analyses will be conducted to explore uncertainty and ensure robust results. An analysis will be conducted to assess the equity impact of the intervention, by comparing intervention impact within quintiles of socioeconomic status.

Ethics and dissemination

The Bukhali trial economic evaluation has ethical approval from the Human Ethics Research Committee of the University of the Witwatersrand, Johannesburg, South Africa (M240162). The results of the economic evaluation will be disseminated in a peer-reviewed journal and presented at a relevant international conference.

Trial registration number

Pan African Clinical Trials Registry (PACTR201903750173871; https://pactr.samrc.ac.za).

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Multifaceted pharmacist-led interventions in secondary care settings between countries of various income levels: a scoping review protocol

Por: Tharmalinga Sharma · J. J. · McMillan · S. S. · Samaranayake · N. R. · Waas · D. A. · Coombes · I. D. · Wheeler · A. J.
Introduction

Clinical pharmacy services often involve multifaceted pharmacist-led interventions. However, current pharmacy practice models vary across different countries. Despite the documented benefits of clinical pharmacy services, the characteristics of pharmacist-led interventions in different countries have not yet been adequately explored and described. Therefore, this protocol outlines the methodology for a proposed scoping review aiming to investigate various types of multifaceted pharmacist-led interventions and the outcomes used to evaluate their effectiveness within secondary care settings. Additionally, the scoping review will map the current evidence surrounding the characteristics of interventions and outcomes reported across various countries of socioeconomic status.

Methods and analysis

The scoping review will be conducted according to the JBI Methodology for Scoping Reviews and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) Extension for Scoping Reviews. We will systematically search the following electronic databases: MEDLINE (Ovid), CINAHL (EbscoHost), Embase (embase.com), Scopus (scopus.com), Cochrane Library (cochranelibrary.com) and APA PsycInfo (Ovid). Additionally, the reference lists of identified reviews and included full texts will be searched for relevant papers. Grey literature sources, such as International Pharmaceutical Abstracts and the International Pharmaceutical Federation (FIP) website, will be searched. We will include primary studies published in the English language from January 2013 to December 2023, involving secondary care multifaceted pharmacist-led interventions. Two independent reviewers will screen studies against eligibility criteria and use a piloted data extraction form to extract relevant information. We will extract relevant data, complete a tabular summary from each included publication and analyse it.

Ethics and dissemination

Ethical approval is not required as we will be using data from publicly available literature sources. Findings will be disseminated in publications and presentations with relevant stakeholders. We aim to map available evidence across the breadth of studies that have reported multifaceted pharmacist-led interventions and their outcomes.

Estado actual de la Enfermería en los Centros de Día Gerontológicos de Huelva

Introducción: El envejecimiento poblacional ha desplegado un nuevo y amplio campo de estudio para la ciencia sanitaria en el que la enfermería debe investigar para garantizar la autonomía en salud de las personas mayores. Objetivo: Visibilizar los Centros de Día Gerontológicos (CDG) y las actividades de los profesionales de enfermería en dichos centros en Huelva. Metodología: Se ha realizado una investigación cualitativa a partir de cuestionarios y entrevistas dirigidas al personal de dirección y enfermería de varios Centros de Día de Huelva y provincia. Resultados: Los CDG son un recurso intermedio con múltiples objetivos y funciones, que ofrecen calidad de vida tanto para los mayores como para sus familiares. Se componen de un equipo básico de profesionales que trabaja de forma no permanente. La figura de la enfermería es esencial, pero cuenta con una situación laboral muy deficiente. Conclusión: Estos centros proporcionan cuidados profesionales y permiten la permanencia en los domicilios habituales favoreciendo la calidad de vida y autonomía de esta población mayor. La bibliografía sobre este tema es escasa, por lo que se considera necesario profundizar en su investigación junto con la puesta en marcha de programas y propuestas de mejora que den a conocer estos centros sociosanitarios.

Inter-facility transfers for emergency obstetrical and neonatal care in rural Madagascar: a cost-effectiveness analysis

Por: Franke · M. A. · Nordmann · K. · Frühauf · A. · Ranaivoson · R. M. · Rebaliha · M. · Rapanjato · Z. · Bärnighausen · T. · Muller · N. · Knauss · S. · Emmrich · J. V.
Context

There is a substantial lack of inter-facility referral systems for emergency obstetrical and neonatal care in rural areas of sub-Saharan Africa. Data on the costs and cost-effectiveness of such systems that reduce preventable maternal and neonatal deaths are scarce.

Setting

We aimed to determine the cost-effectiveness of a non-governmental organisation (NGO)-run inter-facility referral system for emergency obstetrical and neonatal care in rural Southern Madagascar by analysing the characteristics of cases referred through the intervention as well as its costs.

Design

We used secondary NGO data, drawn from an NGO’s monitoring and financial administration database, including medical and financial records.

Outcome measures

We performed a descriptive and a cost-effectiveness analysis, including a one-way deterministic sensitivity analysis.

Results

1172 cases were referred over a period of 4 years. The most common referral reasons were obstructed labour, ineffective labour and eclampsia. In total, 48 neonates were referred through the referral system over the study period. Estimated cost per referral was US$336 and the incremental cost-effectiveness ratio (ICER) was US$70 per additional life-year saved (undiscounted, discounted US$137). The sensitivity analysis showed that the intervention was cost-effective for all scenarios with the lowest ICER at US$99 and the highest ICER at US$205 per additional life-year saved. When extrapolated to the population living in the study area, the investment costs of the programme were US$0.13 per person and annual running costs US$0.06 per person.

Conclusions

In our study, the inter-facility referral system was a very cost-effective intervention. Our findings may inform policies, decision-making and implementation strategies for emergency obstetrical and neonatal care referral systems in similar resource-constrained settings.

Prevalence and determinants of antibiotics self-medication among indigenous people of Bangladesh: a cross-sectional study

Por: Mannan · A. · Chakma · K. · Dewan · G. · Saha · A. · Chy · N. U. H. A. · Mehedi · H. M. H. · Hossain · A. · Wnaiza · J. · Ahsan · M. T. · Rana · M. M. · Alam · N.
Objectives

Self-medication with antibiotics (SMA) contributes significantly to the emergence of antimicrobial resistance (AMR), especially in low-income countries including Bangladesh. This study aimed to generate evidence on the self-reported prevalence of antibiotic self-medication and its determinants among indigenous people residing in Bangladesh’s Chittagong Hill Tracts (CHT) districts.

Design

This study used a cross-sectional design with data collected through a survey using a semi-structured questionnaire.

Setting

This study was conducted from late January to early July 2021; among different indigenous group populations aged 18 years or more olders residing in the three districts of CHT.

Participants

A total of 1336 indigenous people residing in Bangladesh’s CHT districts were included.

Primary outcome and explanatory variables

The primary outcome measure was SMA while explanatory variables were socio-demographic characteristics, health status of participants, and knowledge of antibiotics usage and its side effects.

Results

Among the study participants, more males (60.54%) than females (51.57%) reported using antibiotics. The SMA rate was high among individuals with education levels below secondary (over 50%) and those in the low-income group (55.19%). The most common diseases reported were cough, cold and fever, with azithromycin being the most frequently used antibiotic. Levels of education, family income, having a chronic illness and place of residence were found to be the significant predictors of having good knowledge of antibiotic use as found in the ordered logit model. Findings from a logistic regression model revealed that men had 1.6 times higher odds (adjusted OR (AOR) 1.57; 95% CI 1.12 to 2.19) of SMA than women. Participants with ≥US$893 per month family income had lowest odds (AOR 0.14; 95% CI 0.03 to 0.64) of SMA than those who earned

Conclusion

Male gender, family income, place of residence and knowledge of antibiotics were the significant predictors of antibiotic self-medication. Hence, it is important to streamline awareness-raising campaigns at the community level to mitigate the practice of SMA in indigenous people and ultimately address the devastating effects of Antimicrobial resistance (AMR) in Bangladesh.

The effect of hyaluronic acid and iodine complex gel compared to Vaseline on deep second‐degree burn wound in rats

Abstract

The combination of hyaluronic acid and iodine (Hyodine) has sparked interest in wound care and could have valuable applications in treating burn injuries. We aimed to provide valuable insight into the potential advantages, limitations, and implications of using Hyodine in burn wound management. We studied 25 male rats to assess the clinical outcomes and wound-healing effects of Hyodine. Each rat received a deep second-degree burn wound on their back using metal stamps. Subsequently, the rats were then randomly split into two groups. The first group was treated with a layer of Hyodine gel, while the second group received Vaseline. The burn sites were photographed on days 1, 7, 14, and 21 using a digital camera. After excision of the burn wounds, histopathology slides were stained and evaluated in terms of the degree of epithelialization, angiogenesis, inflammatory cells' infiltration, and collagen amount and arrangement. Despite a non-significant difference regarding the extent of burn wound area between intervention and control groups in the first day of experiment, the rats that were treated with Vaseline showed a significant decrease compared to those who received Hyodine in the second and third weeks (p = 0.02). On the other hand, epithelialization, pathology score, and collagen synthesis were significantly different between days 7, 14, and 21 of each group. However, collagen arrangement and neovascularization were only significantly different between days 7, 14, and 21 in Hyodine group (p = 0.02 and p = 0.03, respectively). The Hyodine gel may offer beneficial outcomes in patients with a burn wound. Based on our findings, despite a non-significant difference in the extent of burn wound area, using Hyodine revealed a significant improvement in different histopathological variables including neovascularization, and collagen arrangement.

Online platform for cardiopulmonary resuscitation and automated external defibrillator training in a rural area: a community clinical trial protocol

Por: Taverna-Llaurado · E. · Martinez-Torres · S. · Granado-Font · E. · Palleja-Millan · M. · del Pozo · A. · Roca-Biosca · A. · Martin-Lujan · F. · Rey-Renones · C.
Introduction

Sudden death resulting from cardiorespiratory arrest carries a high mortality rate and frequently occurs out of hospital. Immediate initiation of cardiopulmonary resuscitation (CPR) by witnesses, combined with automated external defibrillator (AED) use, has proven to double survival rates. Recognising the challenges of timely emergency services in rural areas, the implementation of basic CPR training programmes can improve survival outcomes. This study aims to evaluate the effectiveness of online CPR-AED training among residents in a rural area of Tarragona, Spain.

Methods

Quasi-experimental design, comprising two phases. Phase 1 involves assessing the effectiveness of online CPR-AED training in terms of knowledge acquisition. Phase 2 focuses on evaluating participant proficiency in CPR-AED simulation manoeuvres at 1 and 6 months post training. The main variables include the score difference between pre-training and post-training test (phase 1) and the outcomes of the simulated test (pass/fail; phase 2). Continuous variables will be compared using Student’s t-test or Mann-Whitney U test, depending on normality. Pearson’s 2 test will be applied for categorical variables. A multivariate analysis will be conducted to identify independent factors influencing the main variable.

Ethics and dissemination

This study adheres to the tenets outlined in the Declaration of Helsinki and of Good Clinical Practice. It operated within the Smartwatch project, approved by the Clinical Research Ethics Committee of the Primary Care Research Institute IDIAP Jordi Gol i Gurina Foundation, code 23/081-P. Data confidentiality aligns with Spanish and European Commission laws for the protection of personal data. The study’s findings will be published in peer-reviewed journals and presented at scientific meetings.

Trial registration number

NCT05747495.

Priority populations experiences of isolation, quarantine and distancing for COVID-19: protocol for a longitudinal cohort study (Optimise Study)

Por: Pedrana · A. · Bowring · A. · Heath · K. · Thomas · A. J. · Wilkinson · A. · Fletcher-Lartey · S. · Saich · F. · Munari · S. · Oliver · J. · Merner · B. · Altermatt · A. · Nguyen · T. · Nguyen · L. · Young · K. · Kerr · P. · Osborne · D. · Kwong · E. J. L. · Corona · M. V. · Ke · T. · Zhang
Introduction

Longitudinal studies can provide timely and accurate information to evaluate and inform COVID-19 control and mitigation strategies and future pandemic preparedness. The Optimise Study is a multidisciplinary research platform established in the Australian state of Victoria in September 2020 to collect epidemiological, social, psychological and behavioural data from priority populations. It aims to understand changing public attitudes, behaviours and experiences of COVID-19 and inform epidemic modelling and support responsive government policy.

Methods and analysis

This protocol paper describes the data collection procedures for the Optimise Study, an ongoing longitudinal cohort of ~1000 Victorian adults and their social networks. Participants are recruited using snowball sampling with a set of seeds and two waves of snowball recruitment. Seeds are purposively selected from priority groups, including recent COVID-19 cases and close contacts and people at heightened risk of infection and/or adverse outcomes of COVID-19 infection and/or public health measures. Participants complete a schedule of monthly quantitative surveys and daily diaries for up to 24 months, plus additional surveys annually for up to 48 months. Cohort participants are recruited for qualitative interviews at key time points to enable in-depth exploration of people’s lived experiences. Separately, community representatives are invited to participate in community engagement groups, which review and interpret research findings to inform policy and practice recommendations.

Ethics and dissemination

The Optimise longitudinal cohort and qualitative interviews are approved by the Alfred Hospital Human Research Ethics Committee (# 333/20). The Optimise Study CEG is approved by the La Trobe University Human Ethics Committee (# HEC20532). All participants provide informed verbal consent to enter the cohort, with additional consent provided prior to any of the sub studies. Study findings will be disseminated through public website (https://optimisecovid.com.au/study-findings/) and through peer-reviewed publications.

Trial registration number

NCT05323799.

The other COVID‐19 survivors: Timing, duration, and health impact of post‐acute sequelae of SARS‐CoV‐2 infection

Abstract

Aims and Objectives

To determine the frequency, timing, and duration of post-acute sequelae of SARS-CoV-2 infection (PASC) and their impact on health and function.

Background

Post-acute sequelae of SARS-CoV-2 infection is an emerging major public health problem that is poorly understood and has no current treatment or cure. PASC is a new syndrome that has yet to be fully clinically characterised.

Design

Descriptive cross-sectional survey (n = 5163) was conducted from online COVID-19 survivor support groups who reported symptoms for more than 21 days following SARS-CoV-2 infection.

Methods

Participants reported background demographics and the date and method of their covid diagnosis, as well as all symptoms experienced since onset of covid in terms of the symptom start date, duration, and Likert scales measuring three symptom-specific health impacts: pain and discomfort, work impairment, and social impairment. Descriptive statistics and measures of central tendencies were computed for participant demographics and symptom data.

Results

Participants reported experiencing a mean of 21 symptoms (range 1–93); fatigue (79.0%), headache (55.3%), shortness of breath (55.3%) and difficulty concentrating (53.6%) were the most common. Symptoms often remitted and relapsed for extended periods of time (duration M = 112 days), longest lasting symptoms included the inability to exercise (M = 106.5 days), fatigue (M = 101.7 days) and difficulty concentrating, associated with memory impairment (M = 101.1 days). Participants reported extreme pressure at the base of the head, syncope, sharp or sudden chest pain, and “brain pressure” among the most distressing and impacting daily life.

Conclusions

Post-acute sequelae of SARS-CoV-2 infection can be characterised by a wide range of symptoms, many of which cause moderate-to-severe distress and can hinder survivors' overall well-being.

Relevance to Clinical Practice

This study advances our understanding of the symptoms of PASC and their health impacts.

Remote area nurses' experiences of workplace safety in very remote primary health clinics: A qualitative study

Abstract

Aim

To explore Remote Area Nurses' experiences of the implementation of workplace health and safety policies and risk mitigation strategies in Australian very remote primary health clinics.

Design

This qualitative study used online semi-structured interviews, with participants purposively sampled to maximize variation in work location and service type. Data were analysed using a reflexive thematic analysis approach. Coding was carried out inductively, with NVivo 12 aiding data management.

Setting

The interviews were conducted from 24 Februrary 2021 to 06 March 2021 with Remote Area Nurses from very remote primary health clinics in Australia.

Participants

Fifteen Remote Area Nurses participated in the study.

Results

Thematic analysis revealed varied approaches to workplace safety among the different health services and regions. While the spread of ‘never alone’ policies in many clinics addressed one of the significant risks faced by Remote Area Nurses, gaps remained even for hazards specifically highlighted in existing work health and safety legislation. Meaningful collaboration with staff and the community, local orientation, preparation for the role and providing quality care were protective factors for staff safety. Understaffing, unsafe infrastructure and inadequate equipment were common concerns among Remote Area Nurses.

Conclusion

Health services need to prioritize workplace safety and take a continuous quality improvement approach to its implementation. This will include ensuring safety strategies are appropriate for the local context, improving infrastructure maintenance, and establishing sustainable second responder systems such as a pool of drivers with local knowledge.

Implications for the Profession

Poor personal safety contributes to burnout and high turnover of staff. Nurses' insights into the barriers and enablers of current workplace safety strategies will aid policymakers and employers in future improvements.

Reporting Method

COREQ reporting guidelines were followed.

PIPE Statement

A panel of six Remote Area Nurses collaborated in the development of this project.

Gait analysis: An effective tool to mechanically monitor the bone regeneration of critical-sized defects in tissue engineering applications

by Pablo Blázquez-Carmona, Juan Mora-Macías, Juan Morgaz, María del Mar Granados, Jaime Domínguez, Esther Reina-Romo

Introduction

Tissue engineering has emerged as an innovative approach to treat critical-size bone defects using biocompatible scaffolds, thus avoiding complex distraction surgeries or limited stock grafts. Continuous regeneration monitoring is essential in critical-size cases due to the frequent appearance of non-unions. This work evaluates the potential clinical use of gait analysis for the mechanical assessment of a tissue engineering regeneration as an alternative to the traditional and hardly conclusive manual or radiological follow-up.

Materials and methods

The 15-mm metatarsal fragment of eight female merino sheep was surgically replaced by a bioceramic scaffold stabilized with an external fixator. Gait tests were performed weekly by making the sheep walk on an instrumented gangway. The evolution of different kinematic and dynamic parameters was analyzed for all the animal’s limbs, as well as asymmetries between limbs. Finally, potential correlation in the recovery of the gait parameters was evaluated through the linear regression models.

Results

After surgery, the operated limb has an altered way of carrying body weight while walking. Its loading capacity was significantly reduced as the stance phases were shorter and less impulsive. The non-operated limbs compensated for this mobility deficit. All parameters were normalizing during the consolidation phase while the bone callus was simultaneously mineralizing. The results also showed high levels of asymmetry between the operated limb and its contralateral, which exceeded 150% when analyzing the impulse after surgery. Gait recovery significantly correlated between symmetrical limbs.

Conclusions

Gait analysis was presented as an effective, low-cost tool capable of mechanically predicting the regeneration of critical-size defects treated by tissue engineering, as comparing regeneration processes or novel scaffolds. Despite the progressive normalization as the callus mineralized, the bearing capacity reduction and the asymmetry of the operated limb were more significant than in other orthopedic alternatives.

Association of fetal ultrasound anthropometric parameters with neurodevelopmental outcomes at 24 months of age

by Sowmya C. Karantha, Ravi P. Upadhyay, Abhinav Jain, Nita Bhandari, Neeta Dhabhai, Savita Sapra, Sitanshi Sharma, Ranadip Chowdhury, Sunita Taneja

Background

There is a paucity of studies which have examined associations between ultrasound based fetal anthropometric parameters and neurodevelopment in all infants. We examined the association between ultrasound based fetal anthropometric parameters and neurodevelopment in all infants through a secondary analysis of data collected in a large community based randomized controlled trial.

Methods

A total of 1465 mother-child dyads were included. Ultrasound based fetal anthropometric parameters which included the head circumference (HC), abdominal circumference (AC), femur length (FL), biparietal diameter (BPD) and transcerebellar diameter (TCD) were collected at 26–28 weeks of gestation and their association with neurodevelopment at 24 months of age was examined.

Results

Only the transcerebellar diameter z score was positively associated +0.54 units (95% CI: 0.15, 0.93) with motor composite score. When the neurodevelopment outcomes were analyzed as categorical, none of the fetal variables were associated with risk of moderate to severe neurodevelopment impairment.

Conclusion

The findings suggest that transcerebellar diameter could be useful for early prediction of neurodevelopmental outcomes in childhood.

Clinical trial registration

Clinical trial registration of Women and Infants Integrated Interventions for Growth Study Clinical Trial Registry–India, #CTRI/2017/06/008908; Registered on: 23/06/2017, (http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19339&EncHid=&userName=society%20for%20applied%20studies).

Reliability and validity assessment of a survey: Measuring satisfaction with cochlear implant rehabilitation services for children in Jordan

by Rana Alkhamra, Hala M. Al-Omari, Hanady A. Bani Hani

Background

Assessing parental satisfaction with healthcare services is crucial, particularly for parents and their children, who are the primary recipients of these services. In the context of Arabic-speaking parents, there is a notable absence of survey instruments tailored to measure their satisfaction. This study seeks to address this gap by validating a survey designed to evaluate parental satisfaction with rehabilitation services (RSs) provided to Jordanian children who have received cochlear implants (CIs).

Methods

The study included 92 participants and followed a four-step methodology: 1) a literature review and expert input; 2) cognitive interviews, pilot testing, and test-retest reliability testing; 3) data collection; 4) validity and reliability assessments.

Results

The survey’s validity was confirmed. Expert input and cognitive interviews improved content validity, and factor analysis established construct validity by revealing six factors explaining 82.33% of the variance in the survey scale. Convergent and discriminant validity were confirmed (composite reliability >0.7 and average variance extracted value >0.5). Cronbach’s α exceeded 0.8 for each factor and reached 0.855 for the total scale. Survey results showed reliance on speech therapy and audiology, varied rehabilitation durations, and progress. Parents expressed overall satisfaction, particularly influenced by technical quality and efficacy/outcome dimensions. Parents’ recommendations to enhance satisfaction with RSs included financial support, improved service accessibility, enhanced service delivery, specialized education, and increased public awareness.

Conclusion

This study validates an Arabic satisfaction survey, emphasizing the significance of multidisciplinary, extended rehabilitation programs, skilled professionals, and positive outcomes. It emphasizes the necessity for improved access to specialized care and collaboration among healthcare, government, and media to shape parental perceptions of RSs. While the findings indicate overall satisfaction, they also reveal challenges faced by parents, highlighting the need for comprehensive support systems. These insights assist healthcare providers and policymakers in enhancing care quality and meeting the needs of CI children’s families, thereby improving the RSs experience in Jordan.

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.

Protocol for the development of a core outcome set for neonatal sepsis (NESCOS)

by Petek Eylul Taneri, Jamie J. Kirkham, Eleanor J. Molloy, Linda Biesty, Richard A. Polin, James L. Wynn, Barbara J. Stoll, Niranjan Kissoon, Kondwani Kawaza, Mandy Daly, Aoife Branagan, Lívia Nagy Bonnard, Eric Giannoni, Tobias Strunk, Magdalena Ohaja, Kenneth Mugabe, Denise Suguitani, Fiona Quirke, Declan Devane

Neonatal sepsis is a serious public health problem; however, there is substantial heterogeneity in the outcomes measured and reported in research evaluating the effectiveness of the treatments. Therefore, we aim to develop a Core Outcome Set (COS) for studies evaluating the effectiveness of treatments for neonatal sepsis. Since a systematic review of key outcomes from randomised trials of therapeutic interventions in neonatal sepsis was published recently, we will complement this with a qualitative systematic review of the key outcomes of neonatal sepsis identified by parents, other family members, parent representatives, healthcare providers, policymakers, and researchers. We will interpret the outcomes of both studies using a previously established framework. Stakeholders across three different groups i.e., (1) researchers, (2) healthcare providers, and (3) patients’ parents/family members and parent representatives will rate the importance of the outcomes in an online Real-Time Delphi Survey. Afterwards, consensus meetings will be held to agree on the final COS through online discussions with key stakeholders. This COS is expected to minimize outcome heterogeneity in measurements and publications, improve comparability and synthesis, and decrease research waste.

Are pharmacists on the front lines of the opioid epidemic? A cross-sectional study of the practices and competencies of community and hospital pharmacists in Punjab, Pakistan

Por: Mubarak · N. · Zahid · T. · Rana · F. R. · Ijaz · U.-E.-B. · Shabbir · A. · Manzoor · M. · Khan · N. · Arif · M. · Naeem · M. M. · Kanwal · S. · Saif-ur-Rehman · N. · Zin · C. S. · Mahmood · K. · Asgher · J. · Elnaem · M. H.
Introduction

Countries are grappling with a rapidly worsening upsurge in the opioid-related overdose deaths, misuse and abuse. There is a dearth of data in Pakistan regarding the practices and competencies of pharmacists in handling opioid-related issues.

Study design

A cross-sectional study, conducted across Punjab, Pakistan.

Method

The study deployed a validated survey to evaluate the competencies and practices of the community and hospital pharmacists.

Results

504 community pharmacists and 279 hospital pharmacists participated in the survey with an overall response rate of 85.5%. Almost half of the respondents ‘never’ or ‘sometimes’ made clinical notes in a journal or dispensing software to monitor ongoing opioid use. Generally, pharmacists were reluctant to collaborate with physicians or notify police regarding the abuse/misuse of opioids. Hospital pharmacists achieved significantly higher mean competency scores than chain and independent community pharmacists (p

Conclusion

Both community and hospital pharmacists hold significant positions and potential to contribute meaningfully to the mitigation of harms and risks associated with opioids. Nevertheless, this study underscores notable deficiencies in the competence of pharmacists, whether in hospital or community settings in Punjab, concerning various aspects related to the dispensing and utilisation of opioids. It also highlights the pressing need for the development of strategies aimed at improving several practice areas including the documentation, the quality of patient counselling, the effectiveness of reporting mechanisms for opioid abuse and the stringent enforcement of regulatory policies to curtail opioid misuse. Thus, to mitigate the opioid epidemic in Pakistan, it is imperative to institute opioid stewardship initiatives aimed at rectifying the competency and procedural deficiencies within the pharmacist workforce.

Cut‐off scores of the Depression Anxiety Stress Scale‐8: Implications for improving the management of chronic pain

Abstract

Aim

Mental distress, non-specific symptoms of depression and anxiety, is common in chronic pelvic pain (CPP). It contributes to poor recovery. Women's health nurses operate in multidisciplinary teams to facilitate the assessment and treatment of CPP. However, valid cut-off points for identifying highly distressed patients are lacking, entailing a gap in CPP management.

Design

This instrumental cross-sectional study identified a statistically derived cut-off score for the Depression Anxiety Stress Scale-8 (DASS-8) among 214 Australian women with CPP (mean age = 33.3, SD = 12.4, range = 13–71 years).

Methods

Receiver operator characteristic curve, decision trees and K-means clustering techniques were used to examine the predictive capacity of the DASS-8 for psychiatric comorbidity, pain severity, any medication intake, analgesic intake and sexual abuse. The study is prepared according to the STROBE checklist.

Results

Cut-off points resulting from the analysis were ordered ascendingly. The median (13.0) was chosen as an optimal cut-off score for predicting key outcomes. Women with DASS-8 scores below 15.5 had higher analgesic intake.

Conclusion

CPP women with a DASS-8 score above 13.0 express greater pain severity, psychiatric comorbidity and polypharmacy. Thus, they may be a specific target for nursing interventions dedicated to alleviating pain through the management of associated co-morbidities.

Implications for patient care

At a cut-off point of 13.0, the DASS-8 may be a practical instrument for recommending a thorough clinician-based examination for psychiatric comorbidity to facilitate adequate CPP management. It may be useful for evaluating patients' response to nursing pain management efforts. Replications of the study in different populations/countries are warranted.

¿Existen cuestionarios de enfermería para predecir el deterioro neurológico en la Esclerosis Lateral Amiotrófica?

Objetivo principal: identificar la existencia de escalas de medición validadas que nos ayuden a predecir la existencia de deterioro neurológico del origen respiratorio y digestivo. Metodología: se realizó una revisión bibliográfica en diciembre de 2019 en las principales bases de datos. Resultados principales: se incluyeron artículos que describen instrumentos para la detección precoz del deterioro neurológico y la calidad de vida en pacientes con Esclerosis Lateral Amiotrófica. Se incluyeron 15 artículos que nos brindaron información sobre los ocho cuestionarios más importantes disponibles y validados para evaluar la progresión de la esclerosis lateral amiotrófica (EuroQoL, SF-12, SPB, ALSFR, ALSFRS-R, NPS, DMN, ALSAQ40). Conclusión principal: a pesar del trabajo constante para mejorar la calidad de vida y la dignidad de los pacientes y sus familias, actualmente no existe un cuestionario validado que prediga la existencia de deterioro neurológico respiratorio y digestivo.

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