An evidence-based framework for priority clinical research questions for COVID-19

Background On 31 December, 2019, the World Health Organization China Country Office was informed of cases of pneumonia of unknown aetiology. Since then, there have been over 75000 cases globally of the 2019 novel coronavirus (COVID-19), 2000 deaths, and over 14000 cases recovered. Outbreaks of novel agents represent opportunities for clinical research to inform real-time public health action. In 2018, we conducted a systematic review to identify priority research questions for Severe Acute Respiratory Syndrome-related coronavirus (SARS-CoV) and Middle East Respiratory Syndrome-related coronavirus (MERS-CoV). Here, we review information available on COVID-19 and provide an evidenced-based framework for priority clinical research in the current outbreak. Methods Three bibliographic databases were searched to identify clinical studies published on SARS-CoV and MERS-CoV in the outbreak setting. Studies were grouped thematically according to clinical research questions addressed. In February 2020, available information on COVID19 was reviewed and compared to the results of the SARS-CoV and MERS-CoV systematic review. Results From the research objectives for SARS-CoV and MERS-CoV, ten themes in the literature were identified: Clinical characterisation, prognosis, diagnosis, clinical management, viral pathogenesis, epidemiological characterisation, infection prevention and control/transmission, susceptibility, psychosocial, and aetiology. For COVID19, some information on clinical presentation, diagnostic testing, and aetiology is available but many clinical research gaps have yet to be filled. Conclusions Based on a systematic review of other severe coronaviruses, we summarise the state of clinical research for COVID-19, highlight the research gaps, and provide recommendations for the implementation of standardised protocols. Databased on internationally standardised protocols will inform clinical practice real-time

Comparison of Forward and Reverse Wingate Anaerobic Tests: A Brief Technical Note

BACKGROUND: The Wingate anaerobic test (WAT) is traditionally performed in the forward pedaling direction on a cycle ergometer. However, reverse (backward) pedaling during a WAT test may be a novel way to convey meaningful information related to performance and rehabilitation. This study compared peak power measurements between 30-second forward pedaling WAT (FWAT) with a 30-second reverse pedaling WAT (RWAT). METHODS: 10 male and 10 female participants (age 27.6 ± 7.31 yrs, mass 74.9 ± 21.3 kg and height 172.6 ± 10.9 cm) volunteered to participate. Participants performed one FWAT and one RWAT at 7.5% of body mass on a specially modified Monark cycle ergometer. Tests were separated 2 days of rest. Peak power output (PPO), mean power output (MPO), relative PPO (RPPO), relative MPO (RMPO), fatigue index (%FI), and rating of perceived exertion (RPE) were measured. RESULTS: The FWAT power measurements were all significantly greater (p \u3c 0.05) than RWAT power measurements except MPO (p \u3e 0.05); and that RPE was significantly greater (p \u3c 0.05) in FWAT than RWAT. Specifically, FWAT vs. RWAT (M ± SD) are as follows: PPO watts (w) = 731.7 ± 237.1 vs. 529.6 ± 192.2; RPPO w/kg = 10.2 ± 2.3 vs. 7.2 ± 1.6; MPO w = 510.2 ± 162.1 vs. 415.1 ± 146.2; RMPO w/kg = 7.3 ± 1.5 vs. 5.8 ± 1.3; %FI = 49.2 ± 8.7 vs. 37.4 ± 13.7; and RPE = 19.4 ± 1.1 vs. 15.8 ± 1.5. Gender did not impact the relative differences in these relationships. CONCLUSION: Practitioners and clinicians may use this information to begin to understand the power and perceived exertion relationships of forward versus reverse pedaling during a WAT; exercise prescription for rehabilitation and performance may benefit

Are we there yet? Closing the gap in indigenous health in Australia: Monitoring clinical performance in Aboriginal and Islander community control health services in Queensland

Abstract presented at the World Congress of Cardiology, Dubai, United Arab Emirates, 18-21 April 2012

A review of new challenges and solutions to the timely and effective implementation of clinical research responses to high priority diseases of epidemic and pandemic potential: a scoping review protocol

Background: Conducting and implementing clinical research response during pandemic and epidemic diseases outbreaks are often fraught with challenges due to their unprecedented nature. In previous research, challenges to the implementation of clinical research responses during pandemic and epidemic outbreaks were identified and solutions suggested. While the emergence of the Covid-19 pandemic has, on one hand, highlighted new and unresolved challenges, several novel solutions such as the Randomised Evaluation of Covid-19 Therapy (RECOVERY) trial were also implemented and reported in the literature. This scoping review, therefore, aims to synthesise and update solutions to the barriers affecting the implementation of clinical research responses during new, emerging or re-emerging diseases of pandemic and epidemic potential, to further inform strategies that would enhance pandemic and epidemic preparedness and response. Methods: This scoping review will be conducted using the Preferred Reporting Items for Systematic Reviews and Meta-analysis- Extension for Scoping Reviews (PRISMA-ScR). Search will be conducted in six scientific databases: Ovid MEDLINE, Ovid Global Health, OVID PsycINFO, Ovid Embase, Scopus Epistemonikos, and complemented by a grey literature search in Google Scholar. Terms related to clinical trial, high consequence infectious diseases and the PEARLES domains will be used in the search. Two reviewers will independently screen retrieved articles in Rayyan software. Descriptive data of studies will be extracted into a pre-developed Microsoft Excel template while qualitative data related to the PEARLES solutions or barriers will be coded in NVivo. Results will be synthesised thematically and presented in a narrative style. Conclusions: This scoping review will synthesise new and updated solutions to the PEARLES challenges encountered during the implementation of clinical research responses to high consequence epidemics and pandemics. Furthermore, it will examine how challenges and proposed solutions identified prior to the emergence of Covid-19 have been addressed and tested in real time

Research priorities for Long Covid: refined through an international multi-stakeholder forum.

No Abstract available

Addressing challenges for clinical research responses to emerging epidemics and pandemics: a scoping review.

BACKGROUND: Major infectious disease outbreaks are a constant threat to human health. Clinical research responses to outbreaks generate evidence to improve outcomes and outbreak control. Experiences from previous epidemics have identified multiple challenges to undertaking timely clinical research responses. This scoping review is a systematic appraisal of political, economic, administrative, regulatory, logistical, ethical and social (PEARLES) challenges to clinical research responses to emergency epidemics and solutions identified to address these. METHODS: A scoping review. We searched six databases (MEDLINE, Embase, Global Health, PsycINFO, Scopus and Epistemonikos) for articles published from 2008 to July 2018. We included publications reporting PEARLES challenges to clinical research responses to emerging epidemics and pandemics and solutions identified to address these. Two reviewers screened articles for inclusion, extracted and analysed the data. RESULTS: Of 2678 articles screened, 76 were included. Most presented data relating to the 2014-2016 Ebola virus outbreak or the H1N1 outbreak in 2009. The articles related to clinical research responses in Africa (n = 37), Europe (n = 8), North America (n = 5), Latin America and the Caribbean (n = 3) and Asia (n = 1) and/or globally (n = 22). A wide range of solutions to PEARLES challenges was presented, including a need to strengthen global collaborations and coordination at all levels and develop pre-approved protocols and equitable frameworks, protocols and standards for emergencies. Clinical trial networks and expedited funding and approvals were some solutions implemented. National ownership and community engagement from the outset were a key enabler for delivery. Despite the wide range of recommended solutions, none had been formally evaluated. CONCLUSIONS: To strengthen global preparedness and response to the COVID-19 pandemic and future epidemics, identified solutions for rapid clinical research deployment, delivery, and dissemination must be implemented. Improvements are urgently needed to strengthen collaborations, funding mechanisms, global and national research capacity and capability, targeting regions vulnerable to epidemics and pandemics. Solutions need to be flexible to allow timely adaptations to context, and research led by governments of affected regions. Research communities globally need to evaluate their activities and incorporate lessons learnt to refine and rehearse collaborative outbreak response plans in between epidemics

Isolation facilities for highly infectious diseases in Europe - A cross-sectional analysis in 16 countries

BACKGROUND: Highly Infectious Diseases (HIDs) are (i) easily transmissible form person to person; (ii) cause a life-threatening illness with no or few treatment options; and (iii) pose a threat for both personnel and the public. Hence, even suspected HID cases should be managed in specialised facilities minimizing infection risks but allowing state-of-the-art critical care. Consensus statements on the operational management of isolation facilities have been published recently. The study presented was set up to compare the operational management, resources, and technical equipment among European isolation facilities. Due to differences in geography, population density, and national response plans it was hypothesized that adherence to recommendations will vary. METHODS AND FINDINGS: Until mid of 2010 the European Network for Highly Infectious Diseases conducted a cross-sectional analysis of isolation facilities in Europe, recruiting 48 isolation facilities in 16 countries. Three checklists were disseminated, assessing 44 items and 148 specific questions. The median feedback rate for specific questions was 97.9% (n = 47/48) (range: n = 7/48 (14.6%) to n = 48/48 (100%). Although all facilities enrolled were nominated specialised facilities' serving countries or regions, their design, equipment and personnel management varied. Eighteen facilities fulfilled the definition of a High Level Isolation Unit'. In contrast, 24 facilities could not operate independently from their co-located hospital, and five could not ensure access to equipment essential for infection control. Data presented are not representative for the EU in general, as only 16/27 (59.3%) of all Member States agreed to participate. Another limitation of this study is the time elapsed between data collection and publication; e.g. in Germany one additional facility opened in the meantime. CONCLUSION: There are disparities both within and between European countries regarding the design and equipment of isolation facilities. With regard to the International Health Regulations, terminology, capacities and equipment should be standardised

Considering the role of cognitive control in expert performance

© 2014, Springer Science+Business Media Dordrecht. Dreyfus and Dreyfus’ (1986) influential phenomenological analysis of skill acquisition proposes that expert performance is guided by non-cognitive responses which are fast, effortless and apparently intuitive in nature. Although this model has been criticised (e.g., by Breivik Journal of Philosophy of Sport, 34, 116–134 2007, Journal of the Philosophy of Sport, 40, 85–106 2013; Eriksen 2010; Montero Inquiry:An interdisciplinary Journal of Philosophy, 53, 105–122 2010; Montero and Evans 2011) for over-emphasising the role that intuition plays in facilitating skilled performance, it does recognise that on occasions (e.g., when performance goes awry for some reason) a form of ‘detached deliberative rationality’ may be used by experts to improve their performance. However, Dreyfus and Dreyfus (1986) see no role for calculative problem solving or deliberation (i.e., drawing on rules or mental representations) when performance is going well. In the current paper, we draw on empirical evidence, insights from athletes, and phenomenological description to argue that ‘continuous improvement’ (i.e., the phenomenon whereby certain skilled performers appear to be capable of increasing their proficiency even though they are already experts; Toner and Moran 2014) among experts is mediated by cognitive (or executive) control in three distinct sporting situations (i.e., in training, during pre-performance routines, and while engaged in on-line skill execution). We conclude by arguing that Sutton et al. Journal of the British Society for Phenomenology, 42, 78–103 (2011) ‘applying intelligence to the reflexes’ (AIR) approach may help to elucidate the process by which expert performers achieve continuous improvement through analytical/mindful behaviour during training and competition