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 AthanIn 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.
by Anika Kästner, Petra Lücker, Martina Sombetzki, Manja Ehmke, Nicole Koslowski, Swantje Mittmann, Arne Hannich, Antje Schwarz, Kristian Meinck, Lena Schmeyers, Katrin Schmidt, Emil C. Reisinger, Wolfgang HoffmannBackground
Since the onset of the COVID-19 pandemic, children have been mentally and physically burdened, particularly due to school closures, with an associated loss of learning. Therefore, efficient testing strategies with high sensitivity are necessary to keep schools open. Apart from individual rapid antigen testing, various methods have been investigated, such as PCR-based pool-testing of nasopharyngeal swabs, gargle, or saliva samples. To date, previous validation studies have found the PCR-based saliva swab pool testing method to be an effective screening method, however, the acceptability and feasibility of a widespread implementation in the school-setting among stakeholders has not been comprehensively evaluated.Methods
In this pilot study, SARS-CoV-2 saliva swab pool testing of up to 15 swabs per pool was conducted in ten primary and special schools in Mecklenburg-Western Pomerania, Germany, over a period of one month. Thereafter, parents, teachers and school principals of the participating schools as well as the participating laboratories were surveyed about the feasibility and acceptability of this method, its large-scale implementation and challenges. Data were analyzed quantitatively and qualitatively.Results
During the study period, 1,630 saliva swab pools were analyzed, of which 22 tested SARS-CoV-2 positive (1.3%). A total of N = 315 participants took part in the survey. Across all groups, the saliva swab pool testing method was perceived as more child-friendly (>87%), convenient (>82%), and easier (>81%) compared to rapid antigen testing by an anterior nasal swab. Over 80% of all participants favored widespread, regular use of the saliva swab method.Conclusion
In school settings in particular, a high acceptability of the test method is crucial for a successful SARS-CoV-2 surveillance strategy. All respondents clearly preferred the saliva swab method, which can be used safely without complications in children six years of age and older. Hurdles and suggestions for improvement of an area-wide implementation were outlined.
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.
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.
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).
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.
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
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.
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.
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.
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.’
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.
Radiation emergencies are rare but can have minor confined effects to catastrophic consequences across the large geographical territories. Geographical disparities in the preparedness for radiation emergencies can negatively impact public-safety and delay protective actions. We examined such disparities using the global and regional radiation preparedness data from the revised annual International Health Regulations (IHR) data sets.
We used IHR State Party Annual Reporting (SPAR) tool and its associated health indicators developed to mitigate public health risk from radiation emergencies. Using the most recent (2019) SPAR database developed for radiation emergencies, along with 12 other cross-sector indicators, we examined the disparities among WHO state and region-wide capacity scores for operational preparedness.
Based on the analysis of the 2019 annual reporting data sets from 171 countries, radiation emergency was one of the top three global challenges with an average global preparedness capacity of 55%. Radiation emergency preparedness capacity scores showed highest dispersion score among all 13 capacities suggesting higher disparities for preparedness across the globe. Only 38% of the countries had advanced functional capacity with ≥80% operational readiness, with 28% countries having low to very low operational readiness. No geographical regions had ≥80% operational readiness for radiation emergencies, with 4/6 geographical regions showing limited capacity or effectiveness. Global data from 171 countries showed that the capacity to respond to radiation emergencies correlated with the capacity for chemical events with a correlation coefficient () of 0.70 (CI 0.61 to 0.77).
We found major global disparities for the operational preparedness against radiation emergencies. Collaborative approaches involving the public health officials and policymakers at the regional and state levels are needed to develop additional guidance to adapt emergency preparedness plans for radiation incidents.
The present study aimed to understand what factors can lead to late HIV diagnosis of illegal gold miners at French Guiana’s border with Brazil.
An exploratory qualitative study with in-depth interviews and observations was conducted between November 2019 and February 2020.
The study was conducted in the main medical healthcare service and two non-governmental organisation premises in the Oyapock border region, which is a supply area for illegal gold mining sites.
Fifteen people living with HIV diagnosed with CD4 count 6/L were interviewed. Seven women and eight men participated; they were between 31 and 79 years old, and the median time since HIV diagnosis was 6 years. Eight had links to illegal gold mining.
Three key themes for late HIV diagnosis emerged: (1) the presence of economic and political structural factors which constitute risks for this illegal activity, specifically the repression of gold mining sites by French Armed Forces and the distance from healthcare facilities; (2) representations of the body and health, related to the living conditions of this population; prioritisation of health emergencies and long-term self-medication; and (3) gender roles shaping masculinity and heterosexuality contributing to a perception of not being at risk of HIV and delaying testing.
This study highlights structural, group-based and individual factors that reduce access to HIV testing and healthcare in general for a population of migrant workers in an illegal gold mining area. Faced with harsh living conditions and state repression, these workers develop a vision of health which prioritises the functionality of the body. Associated with gender roles which are partly shaped both by the mining activity and its geographical location, this vision can lead to late HIV diagnosis.
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.
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 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.
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.
This is a cross-sectional study.
Participants were recruited through the Scottish Bowel Screening Programme to complete a mailed questionnaire.
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).
The questionnaire assessed frequency of endorsement of colorectal screening barriers and solutions.
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
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.
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.
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.
All data used in this study were obtained from a single UK teaching hospital.
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.
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.
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
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.
The study is registered as ‘researchregistry5464’ on the Research Registry (www.researchregistry.com).
This survey study is designed to understand the impact of the COVID-19 pandemic on stress among specific subpopulations of college students.
An online questionnaire was sent to the students from University of Nevada, Las Vegas, between October 2020 and December to assess the psychological impact of COVID-19. A total of 2091 respondents signed the consent form online and their responses were collected.
Measures of psychological stress, as prescribed by the Perceived Stress Scale (PSS-10). An explanatory factor analysis was carried out on the PSS-10 results. We subsequently analysed each factor using stepwise linear regression that focused on various sociodemographic groups.
A two-factor model was obtained using the explanatory factor analysis. After comparing with the past studies that investigated the factor structure of the PSS-10 scale, we identified these two factors as ‘anxiety’ and ‘irritability’. The subsequent stepwise linear regression analysis suggested that gender and age (p
To our knowledge, this is the first study that assessed the perceived stress of university students in the USA during the COVID-19 pandemic. Through exploratory factor analysis, we showed that the PSS-10 scale could be summarised as a two-factor structure. A stepwise regression approach was used, and we found both of the factors are significantly associated with the gender of the participants. However, we found no significant association between both factors and ethnicity. Our findings will help identify students with a higher risk for stress and mental health issues in pandemics and future crises.
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.
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.
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.
The purpose of this paper is to present two divergent mental models of integrated advanced liver disease (AdvLD) care among 26 providers who treat patients with AdvLD.
3 geographically dispersed United States Veterans Health Administration health systems.
26 professionals (20 women and 6 men) participated, including 9 (34.6%) gastroenterology, hepatology, and transplant physicians, 2 (7.7%) physician assistants, 7 (27%) nurses and nurse practitioners, 3 (11.5%) social workers and psychologists, 4 (15.4%) palliative care providers and 1 (3.8%) pharmacist.
We conducted qualitative in-depth interviews of providers caring for patients with AdvLD. We used framework analysis to identify two divergent mental models of integrated AdvLD care. These models vary in timing of initiating various constituents of care, philosophy of integration, and supports and resources needed to achieve each model.
Clinicians described integrated care as an approach that incorporates elements of curative care, symptom and supportive care, advance care planning and end-of-life services from a multidisciplinary team. Analysis revealed two mental models that varied in how and when these constituents are delivered. One mental model involves sequential transitions between constituents of care, and the second mental model involves synchronous application of the various constituents. Participants described elements of teamwork and coordination supports necessary to achieve integrated AdvLD care. Many discussed the importance of having a multidisciplinary team integrating supportive care, symptom management and palliative care with liver disease care.
Health professionals agree on the constituents of integrated AdvLD care but describe two competing mental models of how these constituents are integrated. Health systems can promote integrated care by assembling multidisciplinary teams, and providing teamwork and coordination supports, and training that facilitates patient-centred AdvLD care.
To summarise peer-reviewed evidence on the effect of a cancer diagnosis on the different sources of income of individuals diagnosed with cancer during adulthood (age ≥18 years).
A scoping review following the Joanna Briggs Institute’s methodological framework for conducting scoping reviews and reporting results following the Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for Scoping Reviews checklist.
Ovid MEDLINE, PsycINFO, CINAHL, EMBASE, Econ-Lit and Evidence-based Medicine Reviews, and reference lists of evidence syntheses. Published literature of any study type in English was searched from January 2000 to December 2020.
Study participants were individuals diagnosed with cancer during adulthood (age ≥18 years). Studies from any country and/or healthcare system were included. Primary outcomes were employment income (eg, individual or household); investment income (eg, stocks/bonds, properties, savings); government transfer payments (eg, disability income/pension); debt and bankruptcy.
Findings are summarised descriptively and in tabular form.
From 6297 citations retrieved, 63 studies (67 articles) met our inclusion criteria. Most (51%) were published in 2016–2020; 65% were published in the USA or Scandinavia. Survivors incurred debt (24 studies), depleted savings (13 studies) and liquidated stocks/bonds (7 studies) in response to a cancer diagnosis. 41 studies reported changes to employment income; of these, 12 case–control studies reported varying results: 5 reported survivors earned less than controls, 4 reported no significant differences, 2 reported mixed results and 1 reported income increased. Initial declines in income tended to lessen over time.
Cancer’s impact on survivors’ income is complex and time-varying. Longitudinal studies are needed to document the trend of initial declines in income, with declines lessening over time, and its variations. Study designs using standardised income measures and capturing treatment type and follow-up time will improve our understanding of cancer’s impact on survivors’ income.
Severely calcified coronary stenoses are difficult to treat with percutaneous coronary interventions. The presence of severe calcifications complicates lesion preparation, advancement of stents and achievement of full stent expansion. Intervention in these lesions is associated with an increased risk of complications and procedural failure compared with treatment of less calcified lesions. Due to the high burden of comorbidity, patients with severely calcified lesions are often excluded from interventional trials, and there is little evidence on how to treat these patients.
We will conduct a systematic review of randomised trials enrolling patients with calcified coronary artery disease undergoing percutaneous coronary intervention. We will investigate any percutaneous treatment option including any lesion preparation, stenting or postdilatation technique. We will search The Cochrane Central Register of Controlled Trials, Medical Literature Analysis and Retrieval System Online, Latin American and Caribbean Health Sciences Literature, Science Citation Index Expanded, and Excerpta Medica database for studies from inception to 31 October 2022. The coprimary outcome is all-cause mortality and serious adverse events. If appropriate, we will conduct meta-analysis, trial sequential analysis and network meta-analysis.
No ethics approval is required for this study. The results will be published in a peer-reviewed journal in this field.
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.
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.
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
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.
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.
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.
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.
In 2017, in Germany, a structural reform of the outpatient psychotherapy guideline took place, aiming to reduce waiting times, to facilitate flexible low-threshold access (eg, general reachability by phone) and to lower access barriers for specific patient groups. The reform included new service elements, such as the implementation of additional psychotherapeutic consultations, acute short-term psychotherapeutic interventions and relapse prophylaxis as well as the promotion of group therapies, the facilitation of psychotherapists’ availability, and the installation of appointment service centres. The ES-RiP project aims to thoroughly evaluate the effects of the reform with a special focus on patients with a comorbidity of mental disorders and chronic physical conditions (cMPs) compared with patients with a mental disorder but no long-term physical condition (MnoP). The project aims to evaluate (a) the extent to which the reform goals were achieved in the large group of patients with cMPs compared with MnoP, (b) the barriers that might hinder the implementation of the new guideline and (c) the procedures required for further developing and improving outpatient psychotherapy.
A mixed-methods design (quantitative, qualitative) along with a multilevel approach (patients, service providers, payers) triangulating several data sources (primary and secondary data) will be applied to evaluate the reform from different perspectives.
Ethical approval was obtained from the coordinating committee as well as one local ethics committee, Justus Liebig University Giessen and Marburg – Faculty of Medicine (approval number: AZ 107/20) and Heidelberg (approval number: S-466/2020). The results of this study will be disseminated through expert panels, conference presentations and publications in peer-reviewed journals.
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.
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.
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).
A range of referral criteria and scores have been developed in recent years to help with screening for the need of specialist palliative care (SPC) in advanced, incurable cancer patients. However, referral criteria have not yet been widely implemented in oncology, as they usually need to be revised by physicians or nurses with limited time resources. To develop an easily applicable screening for the need for SPC in incurable cancer inpatients, we aim to (a) test inter-rater reliability of multiprofessional expert opinion as reference standard for SPC need (phase I) and (b) explore the diagnostic validity of selected patient-reported outcome measures (PROMs) and routine data for the need of SPC (phase II).
Inclusion criteria for patients are metastatic or locally advanced, incurable cancer, ≥18 years of age and informed consent by patient or proxy. (Exclusion criteria: malignant haematological disease as main diagnosis). In phase I, three palliative care consultation teams (PCTs) of three German university hospitals assess the SPC need of 20 patient cases. Fleiss’ Kappa will be calculated for inter-rater reliability. In phase II, 208 patients are consecutively recruited in four inpatient oncology wards of Freiburg University Hospital. The PCT will provide assessment of SPC need. As potential referral criteria, patients complete PROMs and a selection of routine data on person, disease and treatment is documented. Logistic regression models and ROC analyses are employed to test their utility in screening for SPC need.
Our findings will be published in peer-reviewed journals and presented at national and international scientific meetings and congresses. Ethical approval was granted by the Ethics Committee of Albert-Ludwigs—University Freiburg, Germany (approval no. 20-1103).
German Clinical Trials Register, DRKS00021686, registered on 17 December 2020.
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).
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.
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.
The primary outcome was defined as the change in CO (L/min) from baseline after subsequent preoxygenation with 15 L/min and flush rate.
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.
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.