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What impact has the Centre of Research Excellence in Digestive Health made in the field of gastrointestinal health in Australia and internationally? Study protocol for impact evaluation using the FAIT framework

Por: Koloski · N. · Duncanson · K. · Ramanathan · S. A. · Rao · M. · Holtmann · G. · Talley · N. J.
Introduction

The need for public research funding to be more accountable and demonstrate impact beyond typical academic outputs is increasing. This is particularly challenging and the science behind this form of research is in its infancy when applied to collaborative research funding such as that provided by the Australian National Health and Medical Research Council to the Centre for Research Excellence in Digestive Health (CRE-DH).

Methods and analysis

In this paper, we describe the protocol for applying the Framework to Assess the Impact from Translational health research to the CRE-DH. The study design involves a five-stage sequential mixed-method approach. In phase I, we developed an impact programme logic model to map the pathway to impact and establish key domains of benefit such as knowledge advancement, capacity building, clinical implementation, policy and legislation, community and economic impacts. In phase 2, we have identified and selected appropriate, measurable and timely impact indicators for each of these domains and established a data plan to capture the necessary data. Phase 3 will develop a model for cost–consequence analysis and identification of relevant data for microcosting and valuation of consequences. In phase 4, we will determine selected case studies to include in the narrative whereas phase 5 involves collation, data analysis and completion of the reporting of impact.

We expect this impact evaluation to comprehensively describe the contribution of the CRE-DH for intentional activity over the CRE-DH lifespan and beyond to improve outcomes for people suffering with chronic and debilitating digestive disorders.

Ethics and dissemination

This impact evaluation study has been registered with the Hunter New England Human Research Ethics Committee as project 2024/PID00336 and ethics application 2024/ETH00290. Results of this study will be disseminated via medical conferences, peer-reviewed publications, policy submissions, direct communication with relevant stakeholders, media and social media channels such as X (formely Twitter).

REKOVER study protocol: a pRospective patient treatment rEgistry of tramadol and dexKetoprofen trometamol oral fixed-dose combination (SKUDEXA) in mOderate to seVere acutE pain in Real-world setting in Asia

Por: Ho · K. Y. · Gyanwali · B. · Dimayuga · C. · Eufemio · E. M. · Bernardo · E. · Raju · G. · Chong · K. W. · Waithayayothin · K. · Ona · L. · Castro · M. A. L. · Sawaddiruk · P. · Salvador · R. C. · Roohi · S. A. · Tangwiwat · S. · Wilairatana · V. · Oon · Z. H. · Gupta · A. · Nagrale · D.
Introduction

Satisfactory management of acute pain remains a major medical challenge despite the availability of multiple therapeutic options including the fixed-dose combination (FDC) drugs. Tramadol and dexketoprofen trometamol (TRAM/DKP) 75/25 mg FDC was launched in 2018 in Asia and is widely used in the management of moderate to severe acute pain. There are limited data on its effectiveness and safety in Asian patients, and therefore, a need to better understand its usage patterns in clinical practice. We aim to understand the usage pattern of TRAM/DKP FDC, its effectiveness and tolerability in patients with moderate to severe acute pain in Asia.

Methods and analysis

REKOVER is a phase-IV, multicountry, multicentre, prospective, real-world observational study. A total of 750 postsurgical and non-surgical patients (male and female, aged 18–80 years) will be recruited from 13 tertiary-care hospitals (15 sites) in Singapore, Thailand, the Philippines and Malaysia. All patients prescribed with TRAM/DKP FDC and willing to participate in the study will be enrolled. The recruitment duration for each site will be 6 months. The severity of pain will be collected using Numeric Pain Rating Scale through the treatment period from day 1 to day 5, while satisfaction with the treatment will be evaluated using Patient Global Evaluation Scale at the end of treatment. Any adverse event reported during the study duration will be recorded for safety analysis (up to day 6). The study data will be entered into the ClaimIt portal and mobile application (app) (ObvioHealth, USA). All the inpatient data will be entered into the portal by the study site and for outpatient it will be done by patients through an app.

Ethics and dissemination

The study has been approved by the local ethics committee from each study sites in Singapore, Thailand, the Philippines and Malaysia. Findings will be disseminated through local and global conference presentations, publications in peer-reviewed scientific journals and continuing medical education.

Multicentre, randomised, double-blind, placebo-controlled, proof of concept study of LSALT peptide as prevention of acute respiratory distress syndrome and acute kidney injury in patients infected with SARS-CoV-2 (COVID-19)

Por: Somayaji · R. · Luke · D. R. · Lau · A. · Guner · R. · Tabak · O. F. · Hepokoski · M. · Gardetto · N. · Conrad · S. A. · Kumar · S. D. · Ghosh · K. · Robbins · S. M. · Senger · D. L. · Sun · D. · Lim · R. K. S. · Liu · J. · Eser · F. · Karaali · R. · Tremblay · A. · Muruve · D.
Objective

Dipeptidase-1 (DPEP-1) is a recently discovered leucocyte adhesion receptor for neutrophils and monocytes in the lungs and kidneys and serves as a potential therapeutic target to attenuate inflammation in moderate-to-severe COVID-19. We aimed to evaluate the safety and efficacy of the DPEP-1 inhibitor, LSALT peptide, to prevent specific organ dysfunction in patients hospitalised with COVID-19.

Design

Phase 2a randomised, placebo-controlled, double-blinded, trial.

Setting

Hospitals in Canada, Turkey and the USA.

Participants

A total of 61 subjects with moderate-to-severe COVID-19.

Interventions

Randomisation to LSALT peptide 5 mg intravenously daily or placebo for up to 14 days.

Primary and secondary outcome measures

The primary endpoint was the proportion of subjects alive and free of respiratory failure and/or the need for renal replacement therapy (RRT). Numerous secondary and exploratory endpoints were assessed including ventilation-free days, and changes in kidney function or serum biomarkers.

Results

At 28 days, 27 (90.3%) and 28 (93.3%) of subjects in the placebo and LSALT groups were free of respiratory failure and the need for RRT (p=0.86). On days 14 and 28, the number of patients still requiring more intensive respiratory support (O2 ≥6 L/minute, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation) was 6 (19.4%) and 3 (9.7%) in the placebo group versus 2 (6.7%) and 2 (6.7%) in the LSALT group, respectively (p=0.14; p=0.67). Unadjusted analysis of ventilation-free days demonstrated 22.8 days for the LSALT group compared with 20.9 in the placebo group (p=0.4). LSALT-treated subjects had a significant reduction in the fold expression from baseline to end of treatment of serum CXCL10 compared with placebo (p=0.02). Treatment-emergent adverse events were similar between groups.

Conclusion

In a Phase 2 study, LSALT peptide was demonstrated to be safe and tolerated in patients hospitalised with moderate-to-severe COVID-19.

Trial registration number

NCT04402957.

Heart failure clinic inclusion and exclusion criteria: cross-sectional study of clinics and referring providers perspectives

Por: Mamataz · T. · Virani · S. A. · McDonald · M. · Edgell · H. · Grace · S. L.
Objectives

There are substantial variations in entry criteria for heart failure (HF) clinics, leading to variations in whom providers refer for these life-saving services. This study investigated actual versus ideal HF clinic inclusion or exclusion criteria and how that related to referring providers' perspectives of ideal criteria.

Design, setting and participants

Two cross-sectional surveys were administered via research electronic data capture to clinic providers and referrers (eg, cardiologists, family physicians and nurse practitioners) across Canada.

Measures

Twenty-seven criteria selected based on the literature and HF guidelines were tested. Respondents were asked to list any additional criteria. The degree of agreement was assessed (eg, Kappa).

Results

Responses were received from providers at 48 clinics (37.5% response rate). The most common actual inclusion criteria were newly diagnosed HF with reduced or preserved ejection fraction, New York Heart Association class IIIB/IV and recent hospitalisation (each endorsed by >74% of respondents). Exclusion criteria included congenital aetiology, intravenous inotropes, a lack of specialists, some non-cardiac comorbidities and logistical factors (eg, rurality and technology access). There was the greatest discordance between actual and ideal criteria for the following: inpatient at the same institution (=0.14), congenital heart disease, pulmonary hypertension or genetic cardiomyopathies (all =0.36). One-third (n=16) of clinics had changed criteria, often for non-clinical reasons. Seventy-three referring providers completed the survey. Criteria endorsed more by referrers than clinics included low blood pressure with a high heart rate, recurrent defibrillator shocks and intravenous inotropes—criteria also consistent with guidelines.

Conclusions

There is considerable agreement on the main clinic entry criteria, but given some discordance, two levels of clinics may be warranted. Publicising evidence-based criteria and applying them systematically at referral sources could support improved HF patient care journeys and outcomes.

Landscape of Metis health and wellness: protocol for a scoping review

Por: Boutros · H. M. · Koprich · S. · Simms · A. J. · Tsui · N. · Boyle · R.-A. · Harrison · J. · Riddell · M. · Sanftenberg · S. · Cripps · S. · Edwards · S. A. · Metis Nation of Ontario (MNO)
Introduction

In Canada, Métis people are one of three distinct Indigenous peoples whose rights are recognised and affirmed in Section 35 of the federal Constitution Act, 1982. In line with Métis people having a unique culture, history, language and way of life, a distinctions-based approach is critical to understand the current landscape of Métis-specific health. In this paper, we present a scoping review protocol to describe this research landscape in Canada led by the Métis Nation of Ontario (MNO).

Methods and analysis

This scoping review protocol is reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews reporting guidelines and follows Arksey and O’Malley’s scoping review methodology. We will search electronic databases (Scopus, MEDLINE, Embase, Web of Science, CINAHL, APA PsycINFO, Anthropology Plus, Bibliography of Indigenous Peoples of North America, Canadian Business and Current Affairs, Indigenous Studies Portal, Informit Indigenous Collection, Collaborative Indigenous Garden, PubMed, ProQuest), grey literature sources and reference lists from selected papers. Two reviewers (HMB and SK) will double-blind screen all titles/abstracts and full-text studies for inclusion. Any health-related study or health report that includes a Métis-specific health, well-being or Métis social determinant of health outcome will be included. Relevant variables will be extracted following an iterative process whereby the data charting will be reviewed and updated.

Ethics and dissemination

Findings from this scoping review will be shared back through the MNO’s existing community-based communication channels. Traditional academic dissemination will also be pursued. Research ethics board approval is not required, since data are from peer-reviewed publications or publicly shared health reports and knowledge translation products.

Do they stay, or do they go? Children presenting to five emergency departments across New South Wales, Australia with acute burn injuries: a retrospective review

Por: Phillips · W. · Southern · E. · Cattell · C. · Owens · P. · Jaques · M. · Melbourne · G. · Kezhekkekara · S. · Frost · S. A.
Objective

The overall objective of the study was to describe the disposition status of children presenting with a burn injury to five emergency departments (ED) across New South Wales (NSW), Australia.

Design

A retrospective study design was used to review routinely collected ED data.

Setting

Study sites included five acute hospitals across NSW, Australia.

Participants

During the 5-year study period between 1 January 2015 to 31 December 2020, there were 5213 paediatric burn injury presentations.

Results

The mean age of burn injury presentations was 24 months (Inter-Quartile-Range (IQR) 12–84), of which 57% (2951/5213) were males. The most common presentation time was between 16:00 and 23:59 hours (63%, 3297/5213), and the median time spent in the ED was 3 hours (IQR 1–4). The majority (80%, 4196/5213) of the burn injuries presentations did not require hospital admission. The most common principal diagnoses were ‘Burn body region unspecified’ (n=1916) and ‘Burn of wrist and hand’ (n=1060).

Conclusion

Most children who presented to the hospital with a burn injury were not admitted. Often the details of these burns were poorly recorded and a complete picture of the true burden of burn injury in children, especially the ongoing care given outside the acute hospital setting, is missing. This information is crucial, as it would inform future models of care as the paradigm shifts rapidly towards primary, ambulatory and outpatient models of care.

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.

Exploring associations between pregnancy cravings and sociodemographic, lifestyle and health factors: insights from a cross-sectional population study in Jordan

Por: Kloub · S. M. · Banihani · S. A.
Objective

To explore the potential associations between pregnancy cravings and various sociodemographic, lifestyle and health factors.

Design

Cross-sectional study.

Setting

Population-based study in Jordan.

Participants

A total of 500 women who had children and experienced pregnancy cravings were included.

Primary and secondary outcome measures

Pregnancy cravings are prevalent among Jordanian women and associated with some sociodemographic, lifestyle and health factors.

Results

The results showed that 75.40% (377/500) of women experienced food cravings, with 40.6% and 29.1% of them having iron deficiency and vitamin D deficiency, respectively. The most commonly craved food items were sweets (17.2%, 86/500) and salts (22.2%, 115/500), while less than 1.0% of women craved non-food items. No significant correlation (p>0.05) was found between food cravings and the gender of the babies. Significant associations were found between food cravings and the mother’s educational level (p=0.023), weight loss (p

Conclusion

Pregnancy cravings, particularly for food items, with sweets and salts being the most commonly craved, are prevalent among Jordanian women and are associated with the mother’s educational level, changes in weight and the presence of anaemia. Additionally, the study found that iron and vitamin D deficiencies are prevalent health issues among women experiencing these cravings in Jordan. This research has important implications, emphasising the pressing need for targeted nutritional interventions and healthcare strategies to address identified deficiencies and improve maternal health outcomes in the region.

Self-management needs, strategies and support for sickle cell disease in developing countries: a scoping review protocol

Por: Druye · A. A. · Boso · C. M. · Amoadu · M. · Obeng · P. · Nabe · B. · Kagbo · J. E. · Doe · P. F. · Okantey · C. · Ofori · G. O. · Opoku-Danso · R. · Agyare · D. F. · Osei Berchie · G. · Owusu · G. · Nsatimba · F. · Abraham · S. A.
Introduction

Sickle cell disease (SCD) poses a significant global health burden, particularly affecting individuals in developing countries with constrained healthcare resources. While research on self-management in the context of SCD is emerging, it has predominantly focused on primary studies, and there is a notable dearth of evidence synthesis on SCD self-management in developing countries. This scoping review aims to identify and map self-management needs of individuals living with SCD, the strategies they employed to meet those needs, and the support systems available to them.

Methods and analysis

The review will be conducted following the Arksey and O’Malley’s (2005) 29 framework to comprehensively examine the landscape of SCD self-management research. Searches will be performed in PubMed, Scopus, Embase and Dimensions AI, with additional searches in other databases and grey literature. Indexed literature published in English from inception to January 2024 will be included. Reference list from included studies will also be searched manually. Two teams will be constituted to independently screen titles, abstracts and full text against the eligible criteria. Data will be extracted from included studies onto a customised data extraction form.

Ethics and dissemination

Ethical approval is not required for this review due to the fact that it synthesises information from available publications. The findings will be disseminated through publication in a peer-reviewed journal. Also, the findings will possibly be presented at relevant international and national conferences. This protocol has already been registered with the Open Science Framework. The study characteristics such as design and setting will be descriptively analysed and presented as graphs, tables and figures. Thematic analysis will also be conducted based on the study objectives and presented as a narrative summary.

Non-pharmacological therapies for pain management in paediatric intensive care units: a protocol for a scoping review

Introduction

In critically ill children, pain management is complex owing to cognitive development and the nature of hospitalisation in paediatric intensive therapy units. Although there are many protocols and guidelines for pain control via pharmacological interventions, non-pharmacological practices should also be explored and disseminated for their potential benefit.

Methods and analysis

A systematic literature search will be performed using the following databases: Academic Search Premier, Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Excerpta Medica Database, Virtual Health Library, Medical Literature Analysis and Retrieval System Online, ScienceDirect, Scopus, Web of Science Core Collection, Theses from Coordenacão de Aperfeicoamento de Pessoal de Nível Superior, Dart Europe, Open Access Theses and Dissertations and grey literature from Google Scholar. The research will consider quantitative and qualitative studies, mixed-method studies, systematic reviews, text articles, opinion articles, letters to editors and editorials in any language and from any database. The following will be eligible for inclusion: (1) newborns, infants, children and adolescents; and (2) non-pharmacological therapies used for pain in paediatric intensive care.

Ethics and dissemination

This study does not require ethical approval. The results of this research will be disseminated through social media channels and podcasts about pain in children.

Trial registration number

This protocol has been registered with the Open Science Framework (DOI 10.17605/OSF.IO/DZHKT).

Determining the feasibility of a codesigned and personalised intervention (Veg4Me) to improve vegetable intake in young adults living in rural Australian communities: protocol for a randomised controlled trial

Por: Livingstone · K. M. · Rawstorn · J. C. · Partridge · S. R. · Zhang · Y. · O · E. · Godrich · S. L. · McNaughton · S. A. · Hendrie · G. A. · Dullaghan · K. · Abbott · G. · Blekkenhorst · L. C. · Maddison · R. · Barnett · S. · Mathers · J. C. · Alston · L.
Introduction

Diets low in vegetables are a main contributor to the health burden experienced by young adults in rural communities. Digital health interventions provide an accessible delivery model that can be personalised to meet the diverse preferences of young adults. A personalisable digital vegetable intake intervention (Veg4Me) was codesigned to meet the needs of young adults living in rural communities. This study will determine the feasibility of delivering a personalised Veg4Me programme and compare preliminary effects with a non-personalised Veg4Me (control).

Methods and analysis

A 12-week assessor-blinded, two-arm, parallel randomised controlled trial will be undertaken from August 2023 until April 2024. A total of 150 eligible and consenting young adults (18–35 years; eat

Ethics and dissemination

All procedures involving human subjects were approved by Deakin University’s Human Ethics Advisory Group—Health (HEAG-H 06_2023) on 6 March 2023. Dissemination events will be held in the City of Greater Bendigo and the Colac Otway Shire. Summaries of the results will be disseminated to participants via email. Results will be disseminated to the scientific community through peer-reviewed publications and conference presentations.

Trial registration number

Australia New Zealand Clinical Trials Registry, ACTRN12623000179639p, prospectively registered on 21 February 2023, according to the World Health Organizational Trial Registration Data Set. Universal Trial Number U1111-1284-9027.

Integrated health system intervention aimed at reducing type 2 diabetes risk in women after gestational diabetes in South Africa (IINDIAGO): a randomised controlled trial protocol

Por: Norris · S. A. · Zarowsky · C. · Murphy · K. · Ware · L. J. · Lombard · C. · Matjila · M. · Chivese · T. · Muhwava · L. S. · Mutabazi · J. C. · Harbron · J. · Fairall · L. R. · Lambert · E. · Levitt · N.
Introduction

South Africa has a high prevalence of gestational diabetes mellitus (GDM; 15%) and many of these women (48%) progress to type 2 diabetes mellitus (T2DM) within 5 years post partum. A significant proportion (47%) of the women are not aware of their diabetes status after the index pregnancy, which may be in part to low postnatal diabetes screening rates. Therefore, we aim to evaluate a intervention that reduces the subsequent risk of developing T2DM among women with recent GDM. Our objectives are fourfold: (1) compare the completion of the nationally recommended 6-week postpartum oral glucose tolerance test (OGTT) between intervention and control groups; (2) compare the diabetes risk reduction between control and intervention groups at 12 months’ post partum; (3) assess the process of implementation; and (4) assess the cost-effectiveness of the proposed intervention package.

Methods and analyses

Convergent parallel mixed-methods study with the main component being a pragmatic, 2-arm individually randomised controlled trial, which will be carried out at five major referral centres and up to 26 well-baby clinics in the Western Cape and Gauteng provinces of South Africa. Participants (n=370) with GDM (with no prior history of either type 1 or type 2 diabetes) will be recruited into the study at 24–36 weeks’ gestational age, at which stage first data collection will take place. Subsequent data collection will take place at 6–8 weeks after delivery and again at 12 months. The primary outcome for the trial is twofold: first, the completion of the recommended 2-hour OGTT at the well-baby clinics 6–8 weeks post partum, and second, a composite diabetes risk reduction indicator at 12 months. Process evaluation will assess fidelity, acceptability, and dose of the intervention.

Ethics and dissemination

Ethics approval has been granted from University of Cape Town (829/2016), University of the Witwatersrand, Johannesburg (M170228), University of Stellenbosch (N17/04/032) and the University of Montreal (2019-794). The results of the trial will be disseminated through publication in peer-reviewed journals and presentations to key South African Government stakeholders and health service providers.

Protocol version

1 December 2022 (version #2). Any protocol amendments will be communicated to investigators, Human Ethics Research Committees, trial participants, and trial registries.

Trial registration number

PAN African Clinical Trials Registry (https://pactr.samrc.ac.za) on 11 June 2018 (identifier PACTR201805003336174).

Trends in inequalities in avoidable hospitalisations across the COVID-19 pandemic: a cohort study of 23.5 million people in England

Objective

To determine whether periods of disruption were associated with increased ‘avoidable’ hospital admissions and wider social inequalities in England.

Design

Observational repeated cross-sectional study.

Setting

England (January 2019 to March 2022).

Participants

With the approval of NHS England we used individual-level electronic health records from OpenSAFELY, which covered ~40% of general practices in England (mean monthly population size 23.5 million people).

Primary and secondary outcome measures

We estimated crude and directly age-standardised rates for potentially preventable unplanned hospital admissions: ambulatory care sensitive conditions and urgent emergency sensitive conditions. We considered how trends in these outcomes varied by three measures of social and spatial inequality: neighbourhood socioeconomic deprivation, ethnicity and geographical region.

Results

There were large declines in avoidable hospitalisations during the first national lockdown (March to May 2020). Trends increased post-lockdown but never reached 2019 levels. The exception to these trends was for vaccine-preventable ambulatory care sensitive admissions which remained low throughout 2020–2021. While trends were consistent by each measure of inequality, absolute levels of inequalities narrowed across levels of neighbourhood socioeconomic deprivation, Asian ethnicity (compared with white ethnicity) and geographical region (especially in northern regions).

Conclusions

We found no evidence that periods of healthcare disruption from the COVID-19 pandemic resulted in more avoidable hospitalisations. Falling avoidable hospital admissions has coincided with declining inequalities most strongly by level of deprivation, but also for Asian ethnic groups and northern regions of England.

Risk factors for SARS-CoV-2 infection: a test-negative case-control study with additional population controls in Norway

Por: Sarjomaa · M. · Zhang · C. · Tveten · Y. · Kersten · H. · Reiso · H. · Eikeland · R. · Kongerud · J. · Berg · K. K. · Thilesen · C. · Nordbo · S. A. · Aaberge · I. S. · Vandenbroucke · J. · Pearce · N. · Fell · A. K. M.
Objectives

This study aims to assess risk factors for SARS-CoV-2 infection by combined design; first comparing positive cases to negative controls as determined by PCR testing and then comparing these two groups to an additional prepandemic population control group.

Design and setting

Test-negative design (TND), multicentre case–control study with additional population controls in South-Eastern Norway.

Participants

Adults who underwent SARS-CoV-2 PCR testing between February and December 2020. PCR-positive cases, PCR-negative controls and additional age-matched population controls.

Primary outcome measures

The associations between various risk factors based on self- reported questionnaire and SARS-CoV-2 infection comparing PCR-positive cases and PCR-negative controls. Using subgroup analysis, the risk factors for both PCR-positive and PCR-negative participants were compared with a population control group.

Results

In total, 400 PCR-positive cases, 719 PCR-negative controls and 14 509 population controls were included. Male sex was associated with the risk of SARS-CoV-2 infection only in the TND study (OR 1.9, 95% CI 1.4 to 2.6), but not when PCR-positive cases were compared with population controls (OR 1.2, 95% CI 0.9. to 1.5). Some factors were positively (asthma, wood heating) or negatively (hypertension) associated with SARS-CoV-2 infection when PCR-positive cases were compared with population controls, but lacked convincing association in the TND study. Smoking was negatively associated with the risk of SARS-CoV-2 infection in both analyses (OR 0.5, 95% CI 0.3 to 0.8 and OR 0.6, 95% CI 0.4 to 0.8).

Conclusions

Male sex was a possible risk factor for SARS-CoV-2 infection only in the TND study, whereas smoking was negatively associated with SARS-CoV-2 infection in both the TND study and when using population controls. Several factors were associated with SARS-CoV-2 infection when PCR-positive cases were compared with population controls, but not in the TND study, highlighting the strength of combining case–control study designs during the pandemic.

Infection prevention and control compliance of healthcare workers towards COVID-19 in conflict-affected public hospitals of Ethiopia

Por: Daba · C. · Atamo · A. · Gebretsadik Weldehanna · D. · Oli · A. · Debela · S. A. · Luke · A. O. · Gebrehiwot · M.
Objective

Non-compliance with COVID-19 infection prevention and control (IPC) is one of the global public health problems particularly among those frontline healthcare workers. However, there are no detailed investigations on COVID-19 IPC compliance among healthcare workers in conflict-affected settings. The objective of this research was to assess compliance with COVID-19 IPC measures and determine the factors associated with it among healthcare providers in Ethiopian governmental hospitals affected by conflict.

Design

A cross-sectional study was carried out within institutional settings.

Study setting and period

The study was conducted in three public hospitals located in northeastern Ethiopia during the period of March to April 2022.

Participants

Simple random sampling technique was used to select 325 healthcare workers after proportional allocation was made to each public hospital.

Primary outcome measures

The primary outcome was non-compliance with COVID-19 IPC. A multivariable logistic regression analysis was employed to identify factors associated with the lack of adherence to the COVID-19 IPC protocol.

Results

Nearly half (150, 46.2%) of the healthcare workers had non-compliance with COVID-19 IPC protocol. Absence of hand washing soap (adjusted OR (AOR)=2.99; 95% CI 2.46 to 5.76), workload (AOR=2.25; 95% CI 1.33 to 3.84), disruption in the supply of piped water (AOR=1.82; 95% CI 1.11 to 2.99), did not undergo training in COVID-19 IPC (AOR=2.85; 95% CI 1.85 to 4.84), absence of COVID-19 IPC guidelines (AOR=2.14; 95% CI 1.11 to 4.13) and chewing khat (AOR=2.3; 95% CI 1.32 to 3.72) were determinant factors for non-compliance.

Conclusions

The magnitude of non-compliance with COVID-19 IPC was high. Hospital managers and federal ministry of health should provide regular training on COVID-19 IPC, continuous piped water and personal protective facilities for healthcare workers. Ultimately, improving the security situation in the area would help improve COVID-19 IPC compliance among healthcare workers in these and other similar conflict-affected settings.

Antibiotic use among hospitalised patients in Sierra Leone: a national point prevalence survey using the WHO survey methodology

Por: Kamara · I. F. · Kanu · J. · Maruta · A. · Fofanah · B. D. · Kamara · K. N. · Sheriff · B. · Katawera · V. · D'Almeida · S. A. · Musoke · R. · Nuwagira · I. · Lakoh · S. · Kamara · R. Z. · Tengbe · S. M. · Mansaray · A. R. · Koroma · Z. · Thomas · F. · Abiri · O. T. · Koroma · A. T. · Russ
Objective

Inappropriate use of antibiotics is a major driver of antibiotic resistance. A few studies conducted in Africa have documented that about half of hospitalised patients who receive antibiotics should not have received them. A few hospital-based studies that have been conducted in Sierra Leone have documented a high usage of antibiotics in hospitals. Therefore, we conducted a nationwide point prevalence survey on antibiotic use among hospitalised patients in Sierra Leone.

Design

We conducted a hospital-based, cross-sectional survey on the use of antibiotics using the WHO point prevalence survey methodology.

Setting

The study was conducted in 26 public and private hospitals that are providing inpatient healthcare services.

Participants

All patients admitted to paediatric and adult inpatient wards before or at 08:00 on the survey date were enrolled.

Outcome measures

Prevalence of antibiotic use, antibiotics Access, Watch and Reserve (AWaRe) categorisation, indication for antibiotic use prevalence and proportion of bacteria culture done.

Results

Of the 1198 patient records reviewed, 883 (73.7%, 95% CI 71.1% to 76.2%) were on antibiotics. Antibiotic use was highest in the paediatric wards (306, 85.7%), followed by medical wards (158, 71.2%), surgical wards (146, 69.5%), mixed wards (97, 68.8%) and lowest in the obstetrics and gynaecology wards (176, 65.7%). The most widely prescribed antibiotics were metronidazole (404, 22.2%), ceftriaxone (373, 20.5%), ampicillin (337, 18.5%), gentamicin (221, 12.1%) and amoxicillin (90, 5.0%). Blood culture was only done for one patient and antibiotic treatments were given empirically. The most common indication for antibiotic use was community-acquired infection (484, 51.9%) followed by surgical prophylaxis (222, 23.8%).

Conclusion

There was high usage of antibiotics in hospitals in Sierra Leone as the majority of patients admitted received an antibiotic. This has the potential to increase the burden of antibiotic resistance in the country. We, therefore, recommend the establishment of hospital antimicrobial stewardship programmes according to the WHO core components.

REMAP Periop: a randomised, embedded, multifactorial adaptive platform trial protocol for perioperative medicine to determine the optimal enhanced recovery pathway components in complex abdominal surgery patients within a US healthcare system

Por: Holder-Murray · J. · Esper · S. A. · Althans · A. R. · Knight · J. · Subramaniam · K. · Derenzo · J. · Ball · R. · Beaman · S. · Luke · C. · La Colla · L. · Schott · N. · Williams · B. · Lorenzi · E. · Berry · L. R. · Viele · K. · Berry · S. · Masters · M. · Meister · K. A. · Wilkinson · T.
Introduction

Implementation of enhanced recovery pathways (ERPs) has resulted in improved patient-centred outcomes and decreased costs. However, there is a lack of high-level evidence for many ERP elements. We have designed a randomised, embedded, multifactorial, adaptive platform perioperative medicine (REMAP Periop) trial to evaluate the effectiveness of several perioperative therapies for patients undergoing complex abdominal surgery as part of an ERP. This trial will begin with two domains: postoperative nausea/vomiting (PONV) prophylaxis and regional/neuraxial analgesia. Patients enrolled in the trial will be randomised to arms within both domains, with the possibility of adding additional domains in the future.

Methods and analysis

In the PONV domain, patients are randomised to optimal versus supraoptimal prophylactic regimens. In the regional/neuraxial domain, patients are randomised to one of five different single-injection techniques/combination of techniques. The primary study endpoint is hospital-free days at 30 days, with additional domain-specific secondary endpoints of PONV incidence and postoperative opioid consumption. The efficacy of an intervention arm within a given domain will be evaluated at regular interim analyses using Bayesian statistical analysis. At the beginning of the trial, participants will have an equal probability of being allocated to any given intervention within a domain (ie, simple 1:1 randomisation), with response adaptive randomisation guiding changes to allocation ratios after interim analyses when applicable based on prespecified statistical triggers. Triggers met at interim analysis may also result in intervention dropping.

Ethics and dissemination

The core protocol and domain-specific appendices were approved by the University of Pittsburgh Institutional Review Board. A waiver of informed consent was obtained for this trial. Trial results will be announced to the public and healthcare providers once prespecified statistical triggers of interest are reached as described in the core protocol, and the most favourable interventions will then be implemented as a standardised institutional protocol.

Trial registration number

NCT04606264.

Acceptance of COVID-19 vaccine and associated factors among healthcare workers in Katsina state: a cross-sectional study in Northwest Nigeria

Por: Abubakar · A. T. · Suleiman · K. · Ahmad · S. I. · Yahaya · S. S. · Bello · U. I. · Suleiman · B. A. · Haladu · S. A. · Al-Mustapha · A. I. · Abubakar · M. I.
Objectives

Healthcare workers were prioritised to receive the COVID-19 vaccine in Nigeria. Administration of COVID-19 vaccination in Nigeria was challenging because of a lack of trust in vaccine safety and vaccine effectiveness among healthcare workers, who are expected to provide reliable information about vaccines and vaccine-preventable diseases in the communities. Hence, their acceptance and attitudes towards COVID-19 preventive practices could influence the acceptance of the vaccine by the local population. This cross-sectional study assessed the acceptance of the COVID-19 vaccine among healthcare workers in Katsina State. We predicted the variables that increased the vaccine acceptance using logistic regression analysis.

Setting

This hospital-based study was conducted at primary, secondary and tertiary healthcare facilities in Nigeria.

Participants

A total of 793 healthcare workers were included in this study. Of these, 65.4% (n=519) were male.

Outcome measures

To assess acceptance of COVID-19 vaccine measures, and factors increasing acceptance among healthcare workers.

Results

Of the healthcare workers, 80% (638) were tested for the SARS-CoV-2, of whom 10.8% (n=65) tested positive. Approximately 97% (n=765) of them believed that the COVID-19 vaccine was safe, and 90% (n=714) received the first dose of the vaccine. Healthcare workers between 30 and 39 years were more likely to accept the vaccine (aOR: 7.06; 95% CI 2.36 to 21.07; p

Conclusions

Our findings showed that the age and prior COVID-19 testing were the main factors influencing the acceptance of the COVID-19 vaccine. There was high acceptance of the COVID-19 vaccine among healthcare workers in Katsina State, Nigeria. Future studies should focus on the completion of doses and serological testing for immunity.

Quality and safety issue: language barriers in healthcare, a qualitative study of non-Arab healthcare practitioners caring for Arabic patients in the UAE

Por: Al-Yateem · N. · Hijazi · H. · Saifan · A. R. · Ahmad · A. · Masa'Deh · R. · Alrimawi · I. · Rahman · S. A. · Subu · M. A. · Ahmed · F. R.
Objectives

To identify language-related communication barriers that expatriate (non-Arabic) healthcare practitioners in the UAE encounter in their daily practice.

Design

Qualitative study utilising semi-structured in-depth interviews. The interviews were conducted in English language.

Setting

Different healthcare facilities across the UAE. These facilities were accessed for data collection over a period of 3 months from January 2023 to March 2023.

Participants

14 purposively selected healthcare practitioners.

Intervention

No specific intervention was implemented; this study primarily aimed at gaining insights through interviews.

Primary and secondary outcomes

To understand the implications of language barriers on service quality, patient safety, and healthcare providers’ well-being.

Results

Three main themes emerged from our analysis of participants’ narratives: Feeling left alone, Trying to come closer to their patients and Feeling guilty, scared and dissatisfied.

Conclusions

Based on the perspectives and experiences of participating healthcare professionals, language barriers have notably influenced the delivery of healthcare services, patient safety and the well-being of both patients and practitioners in the UAE. There is a pressing need, as highlighted by these professionals, for the inclusion of professional interpreters and the provision of training to healthcare providers to enhance effective collaboration with these interpreters.

Health service factors affecting the COVID-19 vaccination campaign in a Ghanaian metropolis: A qualitative exploratory study

Por: Abraham · S. A. A. · Amoah · J. O. · Agyare · D. F. · Sekimpi · D. K. · Bosomtwe-Duker · D. · Druye · A. A. · Osei Berchie · G. · Obiri-Yeboah · D.
Objective

The study sought to explore the perspectives of vaccinators on the health system factors that impacted the COVID-19 vaccination campaign.

Design

The study employed an exploratory-descriptive qualitative design. Key-informants’ interviews were conducted using semi-structured guide to gather the data. Thematic analysis following the steps of Braun and Clark was conducted using ATLAS.ti software.

Setting

The study setting was the Cape Coast Metropolis where the Central Regional Health Directorate is located. The Directorate initiates and implements policy decisions across the region. It is also the only metropolis in the region that recorded about 5970 of the total COVID-19 cases recorded in Ghana.

Participants

Eleven vaccinators who had been trained for the COVID-19 vaccination and had participated in the campaign for at least 6 months were purposively sampled through the Regional Public Health Unit.

Results

Four themes were derived from the data after analysis; ‘vaccine-related issues’; ‘staffing issues’; ‘organising and planning the campaign’ and ‘surveillance and response systems’. Subthemes were generated under each major theme. Our results revealed the health service promoted the COVID-19 vaccination campaign through public education and ensured access to COVID-19 vaccines through the use of community outreaches. Also, the health service ensured adequate logistics supply for carrying out the campaign as well as ensured vaccinators were adequately equipped for adverse incidence reporting and management. Dissatisfaction among COVID-19 vaccinators attributed to low remuneration and delays in receiving allowances as well as shortfalls in efforts at securing transportation and a conducive venue for the vaccination exercise also emerged. Other challenges in the vaccination campaign were attributed to poor data entry platforms and limited access to internet facilities.

Conclusion

This study highlights the health system’s strategies and challenges during the COVID-19 vaccination campaign, emphasising the need for critical interventions to prevent low vaccination rates.

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