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CMRSegTools: An open-source software enabling reproducible research in segmentation of acute myocardial infarct in CMR images

by William A. Romero R., Magalie Viallon, Joël Spaltenstein, Lorena Petrusca, Olivier Bernard, Loïc Belle, Patrick Clarysse, Pierre Croisille

In the last decade, a large number of clinical trials have been deployed using Cardiac Magnetic Resonance (CMR) to evaluate cardioprotective strategies aiming at reducing the irreversible myocardial damage at the time of reperfusion. In these studies, segmentation and quantification of myocardial infarct lesion are often performed with a commercial software or an in-house closed-source code development thus creating a barrier for reproducible research. This paper introduces CMRSegTools: an open-source application software designed for the segmentation and quantification of myocardial infarct lesion enabling full access to state-of-the-art segmentation methods and parameters, easy integration of new algorithms and standardised results sharing. This post-processing tool has been implemented as a plug-in for the OsiriX/Horos DICOM viewer leveraging its database management functionalities and user interaction features to provide a bespoke tool for the analysis of cardiac MR images on large clinical cohorts. CMRSegTools includes, among others, user-assisted segmentation of the left-ventricle, semi- and automatic lesion segmentation methods, advanced statistical analysis and visualisation based on the American Heart Association 17-segment model. New segmentation methods can be integrated into the plug-in by developing components based on image processing and visualisation libraries such as ITK and VTK in C++ programming language. CMRSegTools allows the creation of training and testing data sets (labeled features such as lesion, microvascular obstruction and remote ROI) for supervised Machine Learning methods, and enables the comparative assessment of lesion segmentation methods via a single and integrated platform. The plug-in has been successfully used by several CMR imaging studies.

Environmental risk factors associated with the presence of <i>Mycobacterium ulcerans</i> in Victoria, Australia

by Kim R. Blasdell, Bridgette McNamara, Daniel P. O’Brien, Mary Tachedjian, Victoria Boyd, Michael Dunn, Peter T. Mee, Simone Clayton, Julie Gaburro, Ina Smith, Katherine B. Gibney, Ee Laine Tay, Emma C. Hobbs, Nilakshi Waidyatillake, Stacey E. Lynch, Timothy P. Stinear, Eugene Athan

In recent years reported cases of Buruli ulcer, caused by Mycobacterium ulcerans, have increased substantially in Victoria, Australia, with the epidemic also expanding geographically. To develop an understanding of how M. ulcerans circulates in the environment and transmits to humans we analyzed environmental samples collected from 115 properties of recent Buruli ulcer cases and from 115 postcode-matched control properties, for the presence of M. ulcerans. Environmental factors associated with increased odds of M. ulcerans presence at a property included certain native plant species and native vegetation in general, more alkaline soil, lower altitude, the presence of common ringtail possums (Pseudocheirus peregrinus) and overhead powerlines. However, only overhead powerlines and the absence of the native plant Melaleuca lanceolata were associated with Buruli ulcer case properties. Samples positive for M. ulcerans were more likely to be found at case properties and were associated with detections of M. ulcerans in ringtail possum feces, supporting the hypothesis that M. ulcerans is zoonotic, with ringtail possums the strongest reservoir host candidate. However, the disparity in environmental risk factors associated with M. ulcerans positive properties versus case properties indicates the involvement of human behavior or the influence of other environmental factors in disease acquisition that requires further study.

Minimum inhibitory concentrations of rifampin and isoniazid among multidrug and isoniazid resistant <i>Mycobacterium tuberculosis</i> in Ethiopia

by Muluwork Getahun, Henry M. Blumberg, Gobena Ameni, Dereje Beyene, Russell R. Kempker

Introduction

Traditionally, single critical concentrations of drugs are utilized for Mycobacterium tuberculosis (Mtb) drug susceptibility testing (DST); however, the level of drug resistance can impact treatment choices and outcomes. Mutations at the katG gene are the major genetic mutations in multidrug resistant (MDR) Mtb and usually associated with high level resistance. We assessed the minimum inhibitory concentrations (MICs) of MDR or rifampin resistant (RR) and isoniazid (INH) resistant Mtb isolates to determine the quantification of drug resistance among key anti-tuberculosis drugs.

Methods

The study was conducted on stored Mtb isolates collected as part of a national drug resistance survey in Ethiopia. MIC values were determined using Sensititre MYCOTB plates. A line probe assay (MTBDRplus) was also performed to identify genetic determinants of resistance for all isolates.

Results

MIC testing was performed on 74 Mtb isolates including 46 MDR, 2 RR and 26 INH phenotypically resistant isolates as determined by the Löwenstein Jensen (LJ) method. Four (15%) INH resistant Mtb isolates were detected as borderline rifampin resistance (MIC = 1 μg/ml) using MYCOTB MIC plates and no rifampin resistance mutations were detected by LPA. Among the 48 MDR/RR TB cases, 9 (19%) were rifabutin susceptible (MIC was between ≤0.25 and 0.5μg/ml). Additionally, the MIC for isoniazid was between 2–4 μg/ml (moderate resistance) for 58% of MDR TB isolates and 95.6% (n = 25) of the isolates had mutations at the katG gene.

Conclusion

Our findings suggest a role for rifabutin treatment in a subset of RR TB patients, thus potentially preserving an important drug class. The high proportion of moderate level INH resistant among MDR Mtb isolates indicates the potential benefit of high dose isoniazid treatment in a high proportion of katG gene harboring MDR Mtb isolates.

Mortality burden due to liver cirrhosis and hepatocellular carcinoma in Ghana; prevalence of risk factors and predictors of poor in-hospital survival

by Yvonne A. Nartey, Samuel O. Antwi, Ansumana S. Bockarie, Lindsey Hiebert, Henry Njuguna, John W. Ward, Yaw A. Awuku, Amelie Plymoth, Lewis R. Roberts

Liver-related diseases, including liver cirrhosis and hepatocellular carcinoma (HCC), are significant causes of mortality globally. Specific causes and predictors of liver-related mortality in low resource settings require assessment to help inform clinical decision making and develop strategies for improved survival. The objectives of this study were to determine the proportion of liver-related deaths associated with liver cirrhosis, HCC, and their known risk factors, and secondly to determine predictors of in-hospital mortality among cirrhosis and HCC patients in Ghana. We first performed a cross-sectional review of death register entries from 11 referral hospitals in Ghana to determine the proportion of liver-related deaths and the proportion of risk factors associated with these deaths. Secondly, we conducted a retrospective cohort review of 172 in-patient liver cirrhosis and HCC cases admitted to a tertiary referral centre and determined predictors of in-hospital mortality using binary logistic regression and Kaplan-Meier survival analysis. In total, 8.8% of deaths in Ghanaian adults were due to liver-related causes. The proportion of liver-related deaths attributed to HBV infection was 48.8% (95% CI: 45.95–51.76), HCV infection was 7.0% (95% CI: 5.58–8.45), HBV-HCV co-infection 0.5% (95% CI: 0.1–0.9) and alcohol was 10.0% (95% CI: 8.30–11.67). Of 172 cases of HCC and liver cirrhosis, the in-patient mortality rate was 54.1%. Predictors of in-patient mortality in cirrhotic patients were increasing WBC (OR = 1.14 95% CI: 1.00–1.30) and the revised model for end-stage liver disease with sodium (MELD-Na) score (OR = 1.24 95% CI: 1.01–1.54). For HCC patients, female sex (OR = 3.74 95% CI: 1.09–12.81) and hepatic encephalopathy (grade 1) were associated with higher mortality (OR = 5.66 95% CI: 1.10–29.2). In conclusion, HBV is linked to a high proportion of HCC-related deaths in Ghana, with high in-hospital mortality rates that require targeted policies to improve survival.

Liquid ozone therapies for the treatment of epithelial wounds: A systematic review and meta‐analysis

Abstract

Ozonated water and ozonated oils are emerging as potential therapies for wound care, but their efficacy has not been appropriately evaluated. The aim of this systematic review and meta-analysis was to evaluate the therapeutic potential of topical ozone in the treatment of mammalian wounds. A structured search of five scientific databases returned a total of 390 unique studies. Of these, 22 studies were included in this review. Four studies provided enough data to be included in a meta-analysis evaluating the time to complete wound healing. All studies were randomised controlled trials of humans or other mammalian animals that reported clinical signs of wound healing. Each study was critically analysed by a six-point assessment of the risk of bias. Wounds treated with topical ozone had a greater reduction in wound size than similar wounds treated with controls or standard of care in all studies. Those treated with ozonated liquids also had a shorter time to wound healing by approximately one week. In conclusion, topical ozone contributed to enhanced wound healing in all studies. While additional human experiments would be helpful to quantify ozone's specific effects on wound healing compared to standard treatment, topical ozone should be considered as part of an overall wound management strategy.

Patients self-reported medical care for low back pain: a nationwide population-based study

Por: Gomes · L. A. · Cruz · E. B. · Henriques · A. R. · Branco · J. C. · Canhao · H. · Rodrigues · A. M.
Objectives

To estimate the prevalence of medical care-seeking among adults with low back pain (LBP) and to characterise and compare use of diagnostic procedures and medical management between primary and secondary care.

Design

Cross-sectional study.

Setting

Data from the EpiReumaPt, a nationwide population-based study conducted in Portugal including a representative sample of non-institutionalised adults (n=10 661) stratified by administrative territorial units was analysed.

Participants

Individuals who self-reported history of LBP within the previous 12 months (n=6434) and sought medical care for this problem in the same period (n=2618).

Outcome measures

Patients’ self-reported diagnostic workup and management procedures performed by medical care for LBP collected through a structured questionnaire. Medical care procedures were stratified by level of care.

Results

The prevalence of medical care-seeking for LBP was 38.0% (95% CI 35.9% to 40.1%). Primary care in isolation (45.3%) was the most sought level of care. Emergency departments (25.9%) and orthopaedics (19.4%) were the most sought secondary medical specialties. Several pathoanatomical diagnoses were used, supported by laboratory or imaging tests (91.1%). Disc herniation (20.4%) and osteoarthritis (19.7%) were the most frequent diagnoses, and X-ray (63.7%) was the most frequent diagnostic procedure self-reported by individuals. Most (75.1%) reported being treated for LBP: 80.4% with oral medication and 49.9% with injectables. The mean duration of pharmacological treatment was 104.24 (SD, 266.80) days. The use of pathoanatomical diagnoses, laboratory or imaging tests, and pharmacological treatments were generally more frequent for secondary care (p

Conclusions

Medical care for LBP is frequent and associated with high levels of pathoanatomical diagnoses, imaging and laboratory tests and pharmacological therapy in both primary and secondary care settings. Funding and delivery actions should be prioritised to assure appropriate care for LBP.

Towards definitions of critical illness and critical care using concept analysis

Por: Kayambankadzanja · R. K. · Schell · C. O. · Gerdin Wärnberg · M. · Tamras · T. · Mollazadegan · H. · Holmberg · M. · Alvesson · H. M. · Baker · T.
Objective

As ‘critical illness’ and ‘critical care’ lack consensus definitions, this study aimed to explore how the concepts’ are used, describe their defining attributes, and propose potential definitions.

Design and methods

We used the Walker and Avant approach to concept analysis. The uses and definitions of the concepts were identified through a scoping review of the literature and an online survey of 114 global clinical experts. We used the Arksey and O’Malley framework for scoping reviews and searched in PubMed and Web of Science with a strategy including terms around critical illness/care and definitions/etymologies limited to publications in English between 1 January 2008 and 1 January 2020. The experts were selected through purposive sampling and snowballing, with 36.8% in Africa, 25.4% in Europe, 22.8% in North America, 10.5% in Asia, 2.6% in South America and 1.8% in Australia. They worked with anaesthesia or intensive care 59.1%, emergency care 15.8%, medicine 9.5%, paediatrics 5.5%, surgery 4.7%, obstetrics and gynaecology 1.6% and other specialties 3.9%. Through content analysis of the data, we extracted codes, categories and themes to determine the concepts’ defining attributes and we proposed potential definitions. To assist understanding, we developed model, related and contrary cases concerning the concepts, we identified antecedents and consequences to the concepts, and defined empirical referents.

Results

Nine and 13 articles were included in the scoping reviews of critical illness and critical care, respectively. A total of 48 codes, 14 categories and 4 themes were identified in the uses and definitions of critical illness and 60 codes, 13 categories and 5 themes for critical care. The defining attributes of critical illness were a high risk of imminent death; vital organ dysfunction; requirement for care to avoid death; and potential reversibility. The defining attributes of critical care were the identification, monitoring and treatment of critical illness; vital organ support; initial and sustained care; any care of critical illness; and specialised human and physical resources. The defining attributes led to our proposed definitions of critical illness as, ‘a state of ill health with vital organ dysfunction, a high risk of imminent death if care is not provided and the potential for reversibility’, and of critical care as, ‘the identification, monitoring and treatment of patients with critical illness through the initial and sustained support of vital organ functions.’

Conclusion

The concepts critical illness and critical care lack consensus definitions and have varied uses. Through concept analysis of uses and definitions in the literature and among experts, we have identified the defining attributes of the concepts and proposed definitions that could aid clinical practice, research and policy-making.

Accounts of preventative coping: an interview study of stroke survivors on general practice registers

Por: Scott Reid · P. · Neville · E. · Cater · F. · Mullis · R. · Mant · J. · Duschinsky · R.
Objectives

Preventative coping is an underexplored aspect of coping behaviour. Specifically, coping is a key concern in stroke survivor accounts, but this has yet to be investigated with reference to secondary prevention.

Design

Secondary analysis of a qualitative data set comprising semistructured interviews of 22 stroke survivors recruited from five general practices in the East of England. The topic guide included exploration of advice and support given by their doctor on medication and lifestyle. The interviews were coded using thematic analysis.

Results

The accounts emphasised individual responsibility. Two key themes were identified, which foregrounded the role of self-concept for coping: (a) striving to be ‘good’, (b) appeal to ideas of ‘personality’. In the former, preventative behaviour was depicted in moralistic terms, with the doctor as an adjudicator. In the latter, participants attributed their coping behaviour to their personality, which might help or hinder these efforts.

Conclusions

We highlight that coping was characterised by survivors as something enacted by the individual self, and consider how constructions of self may impact preventative coping efforts.

Prevalence and predictors of mother and newborn skin-to-skin contact at birth in Papua New Guinea

Por: Aboagye · R. G. · Okyere · J. · Dowou · R. K. · Adzigbli · L. A. · Tackie · V. · Ahinkorah · B. O. · Seidu · A.-A.
Objective

This study examined the prevalence and predictors of maternal and newborn skin-to-skin contact at birth in Papua New Guinea.

Design

Data for the study was extracted from the 2016–18 Papua New Guinea Demographic and Health Survey. We included 6,044 women with birth history before the survey in the analysis. Percentages were used to summarise the prevalence of maternal and newborn skin-to-skin contact. A multivariable multilevel binary logistic regression was adopted to examine the predictors of maternal and newborn skin-to-skin contact. The results were presented using adjusted ORs (aORs), with their respective 95% confidence intervals (CIs). Statistical significance was set at p

Setting

The study was conducted in Papua New Guinea.

Participant

Mothers with children under 5 years.

Outcome measures

Mother and newborn skin-to-skin contact.

Results

The prevalence of mother and newborn skin-to-skin contact was 45.2% (95% CI=42.4 to 48.0). The odds of mother and newborn skin-to-skin contact was higher among women with primary education (aOR=1.38; 95% CI=1.03 to 1.83), women with four or more antenatal care attendance (aOR=1.27; 95% CI=1.01 to 1.61), those who delivered at the health facility (aOR=1.27; 95% CI=1.01 to 1.61), and women from communities with high socioeconomic status (aOR=1.45; 95% CI=1.11 to 1.90).

Conclusion

The study has demonstrated that the prevalence of mother and newborn skin-to-skin contact in Papua New Guinea is low. Factors shown to be associated with mother and newborn skin-to-skin contact were maternal level of education, antenatal care attendance, health facility delivery, and community socioeconomic status. A concerted effort should be placed in improving maternal health service utilisation such as antenatal care attendance and skilled birth delivery, which subsequently lead to the practice of skin-to-skin contact. Also, women should be empowered through education as it has positive impact on their socioeconomic status and health service utilisation.

Multicountry study protocol of COCOON: COntinuing Care in COVID-19 Outbreak global survey of New, expectant, and bereaved parent experiences

Por: Loughnan · S. A. · Gautam · R. · Silverio · S. A. · Boyle · F. M. · Cassidy · J. · Ellwood · D. · Homer · C. · Horey · D. · Leisher · S. H. · de Montigny · F. · Murphy · M. · O'Donoghue · K. · Quigley · P. · Ravaldi · C. · Sandall · J. · Storey · C. · Vannacci · A. · Wilson · A. N. · Flena
Introduction

Globally, the COVID-19 pandemic has significantly disrupted the provision of healthcare and efficiency of healthcare systems and is likely to have profound implications for pregnant and postpartum women and their families including those who experience the tragedy of stillbirth or neonatal death. This study aims to understand the psychosocial impact of COVID-19 and the experiences of parents who have accessed maternity, neonatal and bereavement care services during this time.

Methods and analysis

An international, cross-sectional, online and/or telephone-based/face-to-face survey is being administered across 15 countries and available in 11 languages. New, expectant and bereaved parents during the COVID-19 pandemic will be recruited. Validated psychometric scales will be used to measure psychosocial well-being. Data will be analysed descriptively and by assessing multivariable associations of the outcomes with explanatory factors. In seven of these countries, bereaved parents will be recruited to a nested, qualitative interview study. The data will be analysed using a grounded theory analysis (for each country) and thematic framework analysis (for intercountry comparison) to gain further insights into their experiences.

Ethics and dissemination

Ethics approval for the multicountry online survey, COCOON, has been granted by the Mater Misericordiae Human Research Ethics Committee in Australia (reference number: AM/MML/63526). Ethics approval for the nested qualitative interview study, PUDDLES, has been granted by the King’s College London Biomedical & Health Sciences, Dentistry, Medicine and Natural & Mathematical Sciences Research Ethics Subcommittee (reference number: HR-19/20-19455) in the UK. Local ethics committee approvals were granted in participating countries where required. Results of the study will be published in international peer-reviewed journals and through parent support organisations. Findings will contribute to our understanding of delivering maternity care services, particularly bereavement care, in high-income, lower middle-income and low-income countries during this or future health crises.

Quality of reporting of randomised controlled trials of artificial intelligence in healthcare: a systematic review

Por: Shahzad · R. · Ayub · B. · Siddiqui · M. A. R.
Objectives

The aim of this study was to evaluate the quality of reporting of randomised controlled trials (RCTs) of artificial intelligence (AI) in healthcare against Consolidated Standards of Reporting Trials—AI (CONSORT-AI) guidelines.

Design

Systematic review.

Data sources

We searched PubMed and EMBASE databases for studies reported from January 2015 to December 2021.

Eligibility criteria

We included RCTs reported in English that used AI as the intervention. Protocols, conference abstracts, studies on robotics and studies related to medical education were excluded.

Data extraction

The included studies were graded using the CONSORT-AI checklist, comprising 43 items, by two independent graders. The results were tabulated and descriptive statistics were reported.

Results

We screened 1501 potential abstracts, of which 112 full-text articles were reviewed for eligibility. A total of 42 studies were included. The number of participants ranged from 22 to 2352. Only two items of the CONSORT-AI items were fully reported in all studies. Five items were not applicable in more than 85% of the studies. Nineteen per cent (8/42) of the studies did not report more than 50% (21/43) of the CONSORT-AI checklist items.

Conclusions

The quality of reporting of RCTs in AI is suboptimal. As reporting is variable in existing RCTs, caution should be exercised in interpreting the findings of some studies.

What are common barriers and helpful solutions to colorectal cancer screening? A cross-sectional survey to develop intervention content for a planning support tool

Por: Kotzur · M. · Macdonald · S. · O'Carroll · R. E. · O'Connor · R. C. · Irvine · A. · Steele · R. J. C. · Robb · K. A.
Objective

Colorectal screening using faecal immunochemical tests (FITs) can save lives if the people invited participate. In Scotland, most people intend to complete a FIT but this is not reflected in uptake rates. Planning interventions can bridge this intention-behaviour gap. To develop a tool supporting people willing to do colorectal screening with planning to complete a FIT, this study aimed to identify frequently experienced barriers and solutions to these barriers.

Design

This is a cross-sectional study.

Setting

Participants were recruited through the Scottish Bowel Screening Programme to complete a mailed questionnaire.

Participants

The study included 2387 participants who had completed a FIT (mean age 65 years, 40% female) and 359 participants who had not completed a FIT but were inclined to do so (mean age 63 years, 39% female).

Outcome measures

The questionnaire assessed frequency of endorsement of colorectal screening barriers and solutions.

Results

Participants who had not completed a FIT endorsed significantly more barriers than those who had completed a FIT, when demographic, health and behavioural covariates were held constant (F(1,2053)=13.40, p2=0.01). Participants who completed a FIT endorsed significantly more solutions than those who did not (U=301 585.50, z=–3.21, p

Conclusion

This survey identified six barriers and seven solutions as key content to include in the development of a planning tool for colorectal screening using the FIT. Participatory research is required to codesign an engaging and accessible planning tool.

Development and validation of a dynamic 48-hour in-hospital mortality risk stratification for COVID-19 in a UK teaching hospital: a retrospective cohort study

Por: Wiegand · M. · Cowan · S. L. · Waddington · C. S. · Halsall · D. J. · Keevil · V. L. · Tom · B. D. M. · Taylor · V. · Gkrania-Klotsas · E. · Preller · J. · Goudie · R. J. B.
Objectives

To develop a disease stratification model for COVID-19 that updates according to changes in a patient’s condition while in hospital to facilitate patient management and resource allocation.

Design

In this retrospective cohort study, we adopted a landmarking approach to dynamic prediction of all-cause in-hospital mortality over the next 48 hours. We accounted for informative predictor missingness and selected predictors using penalised regression.

Setting

All data used in this study were obtained from a single UK teaching hospital.

Participants

We developed the model using 473 consecutive patients with COVID-19 presenting to a UK hospital between 1 March 2020 and 12 September 2020; and temporally validated using data on 1119 patients presenting between 13 September 2020 and 17 March 2021.

Primary and secondary outcome measures

The primary outcome is all-cause in-hospital mortality within 48 hours of the prediction time. We accounted for the competing risks of discharge from hospital alive and transfer to a tertiary intensive care unit for extracorporeal membrane oxygenation.

Results

Our final model includes age, Clinical Frailty Scale score, heart rate, respiratory rate, oxygen saturation/fractional inspired oxygen ratio, white cell count, presence of acidosis (pH

Conclusions

Our model incorporates both static risk factors (eg, age) and evolving clinical and laboratory data, to provide a dynamic risk prediction model that adapts to both sudden and gradual changes in an individual patient’s clinical condition. On successful external validation, the model has the potential to be a powerful clinical risk assessment tool.

Trial registration

The study is registered as ‘researchregistry5464’ on the Research Registry (www.researchregistry.com).

Automated digital counselling with social network support as a novel intervention for patients with heart failure: protocol for randomised controlled trial

Por: Peiris · R. G. · Ross · H. · Chan · C. T. · Poon · S. · Auguste · B. L. · Rac · V. E. · Farkouh · M. · McDonald · M. · Kaczorowski · J. · Code · J. · Duero Posada · J. · Ong · S. · Kobulnik · J. · Tomlinson · G. · Huszti · E. · Arcand · J. · Thomas · S. G. · Akbari · A. · Maunder · R. · Grov
Introduction

Heart failure (HF) symptoms improve through self-care, for which adherence remains low among patients despite the provision of education for these behaviours by clinical teams. Open Access Digital Community Promoting Self-Care, Peer Support and Health Literacy (ODYSSEE–vCHAT) combines automated digital counselling with social network support to improve mortality and morbidity, engagement with self–care materials, and health-related quality of life.

Methods and analysis

Use of ODYSSEE-vCHAT via Internet-connected personal computer by 162 HF patients will be compared with a control condition over 22 months. The primary outcome is a composite index score of all-cause mortality, all-cause emergency department visits, and HF-related hospitalisation at trial completion. Secondary outcomes include individual components of the composite index, engagement with self-care materials, and patient-reported measures of physical and psychosocial well-being, disease management, health literacy, and substance use. Patients are recruited from tertiary care hospitals in Toronto, Canada and randomised on a 1:1 ratio to both arms of the trial. Online assessments occur at baseline (t=0), months 4, 8 and 12, and trial completion. Ordinal logistic regression analyses and generalised linear models will evaluate primary and secondary outcomes.

Ethics and dissemination

The trial has been approved by the research ethics boards at the University Health Network (20-5960), Sunnybrook Hospital (5117), and Mount Sinai Hospital (21-022-E). Informed consent of eligible patients occurs in person or online. Findings will be shared with key stakeholders and the public. Results will allow for the preparation of a Canada-wide phase III trial to evaluate the efficacy of ODYSSEE-vCHAT in improving clinical outcomes and raising the standard of outpatient care.

Trial registration number

NCT04966104

Developing digital contact tracing tailored to haulage in East Africa to support COVID-19 surveillance: a protocol

Por: Muwonge · A. · Mpyangu · C. M. · Nsangi · A. · Mugerwa · I. · Bronsvoort · B. M. d. · Porphyre · T. · Ssebaggala · E. R. · Kiayias · A. · Mwaka · E. S. · Joloba · M.
Introduction

At the peak of Uganda’s first wave of SARS-CoV-2 in May 2020, one in three COVID-19 cases was linked to the haulage sector. This triggered a mandatory requirement for a negative PCR test result at all ports of entry and exit, resulting in significant delays as haulage drivers had to wait for 24–48 hours for results, which severely crippled the regional supply chain.

To support public health and economic recovery, we aim to develop and test a mobile phone-based digital contact tracing (DCT) tool that both augments conventional contact tracing and also increases its speed and efficiency.

Methods and analysis

To test the DCT tool, we will use a stratified sample of haulage driver journeys, stratified by route type (regional and local journeys).

We will include at least 65% of the haulage driver journeys ~83 200 on the network through Uganda. This allows us to capture variations in user demographics and socioeconomic characteristics that could influence the use and adoption of the DCT tool. The developed DCT tool will include a mobile application and web interface to collate and intelligently process data, whose output will support decision-making, resource allocation and feed mathematical models that predict epidemic waves.

The main expected result will be an open source-tested DCT tool tailored to haulage use in developing countries.

This study will inform the safe deployment of DCT technologies needed for combatting pandemics in low-income countries.

Ethics and dissemination

This work has received ethics approval from the School of Public Health Higher Degrees, Research and Ethics Committee at Makerere University and The Uganda National Council for Science and Technology. This work will be disseminated through peer-reviewed publications, our websites https://project-thea.org/ and Github for the open source code https://github.com/project-thea/.

Systematic scoping review on moral distress among physicians

Por: Quek · C. W. N. · Ong · R. R. S. · Wong · R. S. M. · Chan · S. W. K. · Chok · A. K.-L. · Shen · G. S. · Teo · A. Y. T. · Panda · A. · Burla · N. · Wong · Y. A. · Chee · R. C. H. · Loh · C. Y. L. · Lee · K. W. · Tan · G. H. N. · Leong · R. E. J. · Koh · N. S. Y. · Ong · Y. T. · Chin · A. M
Background

Concepts of moral distress (MD) among physicians have evolved and extend beyond the notion of psychological distress caused by being in a situation in which one is constrained from acting on what one knows to be right. With many accounts involving complex personal, professional, legal, ethical and moral issues, we propose a review of current understanding of MD among physicians.

Methods

A systematic evidence-based approach guided systematic scoping review is proposed to map the current concepts of MD among physicians published in PubMed, Embase, PsycINFO, Web of Science, SCOPUS, ERIC and Google Scholar databases. Concurrent and independent thematic and direct content analysis (split approach) was conducted on included articles to enhance the reliability and transparency of the process. The themes and categories identified were combined using the jigsaw perspective to create domains that form the framework of the discussion that follows.

Results

A total of 30 156 abstracts were identified, 2473 full-text articles were reviewed and 128 articles were included. The five domains identified were as follows: (1) current concepts, (2) risk factors, (3) impact, (4) tools and (5) interventions.

Conclusions

Initial reviews suggest that MD involves conflicts within a physician’s personal beliefs, values and principles (personal constructs) caused by personal, ethical, moral, contextual, professional and sociocultural factors. How these experiences are processed and reflected on and then integrated into the physician’s personal constructs impacts their self-concepts of personhood and identity and can result in MD. The ring theory of personhood facilitates an appreciation of how new experiences create dissonance and resonance within personal constructs. These insights allow the forwarding of a new broader concept of MD and a personalised approach to assessing and treating MD. While further studies are required to test these findings, they offer a personalised means of supporting a physician’s MD and preventing burn-out.

Developing an Australian Melanoma Clinical Outcomes Registry (MelCOR): a protocol paper

Por: Jobson · D. · Roffey · B. · Best · R. · Button-Sloan · A. · Cossio · D. · Evans · S. · Shang · C. · Moore · J. · Arnold · C. · Mann · G. · Shackleton · M. · Soyer · H. P. · Morton · R. L. · Zalcberg · J. · Mar · V.
Introduction

Australia has the highest incidence of melanoma in the world with variable care provided by a diverse range of clinicians. Clinical quality registries aim to identify these variations in care and provide anonymised, benchmarked feedback to clinicians and institutions to improve patient outcomes. The Australian Melanoma Clinical Outcomes Registry (MelCOR) aims to collect population-wide, clinical-level data for the early management of cutaneous melanoma and provide anonymised feedback to healthcare providers.

Methods and analysis

A modified Delphi process will be undertaken to identify key clinical quality indicators for inclusion in the MelCOR pilot. MelCOR will prospectively collect data relevant to these quality indicators, initially for all people over the age of 18 years living in Victoria and Queensland with a melanoma diagnosis confirmed by histopathology, via a two-stage recruitment and consent process. In stage 1, existing State-based cancer registries contact the treating clinician and provide an opportunity for them to opt themselves or their patients out of direct contact with MelCOR. After stage 1, re-identifiable clinical data are provided to the MelCOR under a waiver of consent. In stage 2, the State-based cancer registry will approach the patient directly and invite them to opt in to MelCOR and share identifiable data. If a patient elects to opt in, MelCOR will be able to contact patients directly to collect patient-reported outcome measures. Aggregated data will be used to provide benchmarked, comparative feedback to participating institutions/clinicians.

Ethics and dissemination

Following the successful collection of pilot data, the feasibility of an Australia-wide roll out will be evaluated. Key quality indicator data will be the core of the MelCOR dataset, with additional data points added later. Annual reports will be issued, first to the relevant stakeholders followed by the public. MelCOR is approved by the Alfred Ethics Committee (58280/127/20).

Running on empty: a longitudinal global study of psychological well-being among runners during the COVID-19 pandemic

Por: Vistisen · H. T. · Sonderskov · K. M. · Dinesen · P. T. · Brund · R. B. K. · Nielsen · R. O. · Ostergaard · S. D.
Objectives

There are indications that the COVID-19 pandemic has had a profound negative effect on psychological well-being. Here, we investigated this hypothesis using longitudinal data from a large global cohort of runners, providing unprecedented leverage for understanding how the temporal development in the pandemic pressure relates to well-being across countries.

Design

Prospective cohort study.

Setting

Global.

Participants

We used data from the worldwide Garmin-RUNSAFE cohort that recruited runners with a Garmin Connect account, which is used for storing running activities tracked by a Garmin device. A total of 7808 Garmin Connect users from 86 countries participated.

Primary and secondary outcome measures

From 1 August 2019 (prepandemic) to 31 December 2020, participants completed surveys every second week that included the five-item WHO Well-Being Index (WHO-5). Pandemic pressure was proxied by the number of COVID-19-related deaths per country, retrieved from the Coronavirus Resource Centre at Johns Hopkins University. Panel data regression including individual- and time-fixed effects was used to study the association between country-level COVID-19-related deaths over the past 14 days and individual-level self-reported well-being over the past 14 days.

Results

The 7808 participants completed a total of 125 409 WHO-5 records over the study period. We found a statistically significant inverse relationship between the number of COVID-19-related deaths and the level of psychological well-being—independent of running activity and running injuries (a reduction of 1.42 WHO-5 points per COVID-19-related death per 10 000 individuals, p

Conclusions

This study suggests that the COVID-19 pandemic has had a negative effect on the psychological well-being of the affected populations, which is concerning from a global mental health perspective.

Haemodynamic effects of a 10-min treatment with a high inspired oxygen concentration in the emergency department: a prospective observational study

Por: Stolmeijer · R. · van Ieperen · E. · Lameijer · H. · van Beest · P. · ter Maaten · J. C. · ter Avest · E.

Previous studies show that prolonged exposure to a high inspired oxygen concentration (FiO2) is associated with unfavourable haemodynamic effects. Until now, it is unknown if similar effects also occur after oxygen therapy of limited duration in the emergency department (ED).

Objectives

To investigate the haemodynamic effects of a high FiO2 administered for a limited duration of time in patients who receive preoxygenation for procedural sedation and analgesia (PSA) in the ED.

Design, settings and participants

In a prospective cohort study, cardiac output (CO), stroke volume (SV) and systemic vascular resistance (SVR) were measured using the Clearsight non-invasive CO monitoring system in patients who received preoxygenation for PSA in the ED. Measurements were performed at baseline, after 5 min of preoxygenation via a non-rebreathing mask at 15 /L min and after 5 min of flush rate oxygen administration.

Outcomes measures

The primary outcome was defined as the change in CO (L/min) from baseline after subsequent preoxygenation with 15 L/min and flush rate.

Results

Sixty patients were included. Mean CO at baseline was 6.5 (6.0–6.9) L/min and decreased to 6.3 (5.8–6.8) L/min after 5 min of oxygen administration at a rate of 15 L/min, and to 6.2 (5.7–6.70) L/min after another 5 min at flush rate (p=0.037). Mean SV remained relatively constant during this period, whereas mean SVR increased markedly (from 781 (649–1067), to 1244 (936–1695) to 1337 (988–1738) dyn/s/cm–5, p10% decrease in CO.

Conclusion

Exposure of patients to a high FiO2 for 5–10 min results in a significant drop in CO in one out of four patients. Therefore, even in the ED and in prehospital care, where oxygen is administered for a limited amount of time, FiO2 should be titrated based on deficit whenever this is feasible and high flow oxygen should not be given as a routine treatment.

Economic impact of the first pass effect in mechanical thrombectomy for acute ischaemic stroke treatment in Spain: a cost-effectiveness analysis from the national health system perspective

Objective

The mechanical thrombectomy (MT) benefit is related to the degree of reperfusion achieved. First pass effect (FPE) is defined as complete/near revascularisation of the large-vessel occlusion (modified Thrombolysis in Cerebral Infarction (mTICI) 2c-3) after a single device pass. This study assessed the health benefit and economic impact of achieving FPE for acute ischaemic stroke (AIS) patients from the Spanish National Health System (NHS) perspective.

Design

A lifetime Markov model was used to estimate incremental costs and health outcomes (measured in quality-adjusted life-years (QALYs)) of patients that achieve FPE. A subanalysis of the Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischaemic Stroke (STRATIS) registry was performed to obtain clinical outcomes. The base case included all patients that achieved at least a final mTICI ≥2 b, while the alternative scenario included all patients regardless of their final mTICI (0–3). Treatment costs were updated to reflect current practice based on expert panel consensus, while other acute and long-term costs were obtained from a previous cost-effectiveness analysis of MT performed in Spain. Sensitivity analyses were performed to assess the model’s robustness.

Setting

Spanish healthcare perspective.

Participants

AIS patients in Spain.

Interventions

FPE following MT.

Outcome measures

The model estimated QALYs, lifetime costs and net monetary benefit for the FPE and non-FPE group, depending on the inclusion of reperfusion groups and formal care costs.

Results

STRATIS subanalysis estimated significantly better clinical outcomes at 90 days for the FPE group in all scenarios. In the base case, the model estimated lifetime cost saving per patient of 16 583 and an incremental QALY gain of 1.2 years of perfect health for the FPE group. Cost savings and QALY gains were greater in the alternative scenario (-44 289; 1.75). In all scenarios, cost savings were driven by the long-term cost reduction.

Conclusion

Achieving FPE after MT can lead to better health outcomes per AIS patient and important cost savings for the Spanish NHS.

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