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Current Good Clinical Practice guidelines are bureaucratic and should align with less burdensome examples of international trial policy
Clinical trials must be conducted in ways that protect participants and produce reliable results. Both are central tenets of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guideline.1 The ICH GCP guideline was developed to harmonise the conduct of trials across world regions and, since the mid‐1990s, its core principles have provided the bedrock for trial conduct. However, the devil is in the detail and, in the case of the ICH GCP guideline, that detail (and the interpretation of each word) has far‐reaching consequences.
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Inappropriate behaviour harms health workers and patients, and evidence‐based solutions are needed
Health care is the largest employment sector in Australia, more than 1.7 million workers (14% of all employees).1 Incivility, bullying, aggression, and negative workplace cultures seem endemic and have repeatedly been associated with poor workforce and clinical outcomes, but high quality evaluation of interventions for eliminating these behaviours are rare.2,3,4
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Adequate capacity — beds, equipment, consumables, and, crucially, trained personnel — is needed to cope with a surge of critically ill patients
In this issue of the MJA, Burrell and his co‐authors report on the management and outcomes of patients with coronavirus disease 2019 (COVID‐19) admitted to Australian intensive care units (ICUs) during February–June 2020.1 The ICU mortality rate was impressively low (22% for patients requiring mechanical ventilation, 5% for those who did not). Given the excellent quality of care, it is worth exploring other reasons for this low mortality.
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I was involved with UCL, the UCL Hospitals NHS Foundation Trust, and Mercedes F1 in the development of a CPAP device (UCL Ventura) for use in patients with COVID‐19 on a not‐for profit, humanitarian basis.
As we all look forward to 2021 after a horror year, the MJA will continue to work to cement its status as a highly influential top‐tier journal
Welcome to the MJA in 2021. Many will be pleased 2020 is finally over and will be looking forward to a better year.1,2 There are hopeful signs. The public health response to the coronavirus disease 2019 (COVID‐19) pandemic across Australia has been exemplary to date,3,4 and while challenges remain, multiple vaccines have been successful in phase 3 trials and vaccination is anticipated to commence in Australia soon.5 The United States presidential election is over after a very prolonged dispute, and for many this is a relief. I leave it up to the historians to debate how a US administration could fail so spectacularly in the public health response to a pandemic, but wonder if the necessary lessons will be learned globally before the next major infectious diseases outbreak, the risk of which continues to increase with a warming planet.6 The dire impact of climate change on health, including mortality, appears to be being taken more seriously in the United Kingdom, Europe and, at last, the US, although Australia disappointingly remains a laggard for now.6,7
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A complete list of my conflict of interest disclosures is available at https://www.mja.com.au/journal/staff/editor‐chief‐professor‐nick‐talley.
Peer support initiatives can help health professionals experiencing mental health and wellbeing challenges during the COVID‐19 pandemic and beyond
The coronavirus disease 2019 (COVID‐19) pandemic has placed the health care workforce under an unprecedented level of stress. No area of the health workforce is immune to COVID‐19‐related changes to usual work practices. The impact of this acute stress has occurred in the context of a health care profession that was already struggling with major work‐related challenges including anxiety, depression, secondary trauma, compassion fatigue and burnout. Importantly, these issues may have been exacerbated by the COVID‐19 pandemic due to the direct consequences of health care workers being infected, and the indirect consequences of the economic impact on their families and friends, the rigours of lockdown and the adverse effects on health and wellbeing felt across all aspects of society.
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We thank the many health care professionals who have enthusiastically supported the Hand‐n‐Hand initiative from its humble beginnings, those who have volunteered to support their colleagues during these challenging times and those who have helped to promote the importance of peer support in the health care sector.
We are all founding members of the Hand‐n‐Hand peer support initiative. Kym Jenkins and Brett McDermott are also members of the #MindingCOVID writing group, which has provided resources for Hand‐n‐Hand.
Recommendations to guide residential aged care facilities in preparing for and managing infectious disease outbreaks
The coronavirus disease 2019 (COVID‐19) pandemic is devastating the residential aged care facility (RACF; eg, care homes, nursing homes, long term care) population. Globally, older people living in RACFs comprise almost half (47%) of all deaths from COVID‐19,1 which now exceeds 1.4 million deaths (at 27 November 2020).2
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This work was supported by the Ballarat Health Service and the Department of Forensic Medicine, Monash University. None of the funders influenced the design, methods, subject recruitment, data collection, analysis or preparation of the article. We thank all the medical practitioners and nurses who participated in this study at short notice, and Safer Care Victoria for hosting and Ballarat Health Service for supporting Joseph Ibrahim’s sabbatical leave.
No relevant disclosures.
At the end of 2019 and into 2020, catastrophic fires in Australia consumed homes, lives, wildlife and land. Just as the fires subsided, Australia, like the rest of the world, faced another emergency — the COVID‐19 pandemic.1 It is instructive to reflect on lessons from the health disasters of the past year.
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A complete list of Nick Talley’s disclosures is available at https://www.mja.com.au/journal/staff/editor-chief-professor-nick-talley.
These days of 2020
Have seen ravages aplenty
An “unprecedented” year born in ash and smoke and flame.
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Objectives: To evaluate the circulation lifespan of forks and teaspoons in an institutional tearoom.
Design: Longitudinal quality improvement study, based on prospective tracking of marked teaspoons and forks.
Setting: Staff tearoom in a public teaching and research hospital, Brisbane.
Participants: Tearoom patrons blinded to the purposes of the study.
Intervention: Stainless steel forks and teaspoons (18 each) were marked with red spots and introduced alongside existing cutlery (81 items) in the tearoom.
Main outcome measures: Twice weekly count of marked forks and teaspoons for seven weeks; baseline and end of study count of all utensils on day 45.
Results: The loss of marked teaspoons (six of 18) was greater than that of forks (one of 18) by the conclusion of the study period (P = 0.038). The overall rate of utensil loss was 2.2 per 100 days for teaspoons and spoons, and –2.2 per 100 days for forks and knives.
Conclusions: Teaspoon disappearance is a more substantial problem than fork migration in a multidisciplinary staff tearoom, and may reflect different kleptomaniacal or individual appropriation tendencies. If giving cutlery this Christmas, give teaspoons, not forks. The symbolism of fork rebirth or resurrection is appropriate for both Christmas and Easter, and forks are also mighty useful implements for eating cake!
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This study was undertaken with in kind support by the Royal Brisbane and Women’s Hospital Critical Care and Clinical Support Services Directorate; Cheryl Fourie contributed OPI Got the Blues for Red nail lacquer. We extend special thanks to Gordon McGurk, chair of the Royal Brisbane and Women’s Hospital Human Research Ethics Committee, whose insightful comments feature in our report.
No relevant disclosures.
Abstract
Objectives: To assess the risks associated with relaxing coronavirus disease 2019 (COVID‐19)‐related physical distancing restrictions and lockdown policies during a period of low viral transmission.
Design: Network‐based viral transmission risks in households, schools, workplaces, and a variety of community spaces and activities were simulated in an agent‐based model, Covasim.
Setting: The model was calibrated for a baseline scenario reflecting the epidemiological and policy environment in Victoria during March–May 2020, a period of low community viral transmission.
Intervention: Policy changes for easing COVID‐19‐related restrictions from May 2020 were simulated in the context of interventions that included testing, contact tracing (including with a smartphone app), and quarantine.
Main outcome measure: Increase in detected COVID‐19 cases following relaxation of restrictions.
Results: Policy changes that facilitate contact of individuals with large numbers of unknown people (eg, opening bars, increased public transport use) were associated with the greatest risk of COVID‐19 case numbers increasing; changes leading to smaller, structured gatherings with known contacts (eg, small social gatherings, opening schools) were associated with lower risks. In our model, the rise in case numbers following some policy changes was notable only two months after their implementation.
Conclusions: Removing several COVID‐19‐related restrictions within a short period of time should be undertaken with care, as the consequences may not be apparent for more than two months. Our findings support continuation of work from home policies (to reduce public transport use) and strategies that mitigate the risk associated with re‐opening of social venues.