Methods for living guidelines: early guidance based on practical experience. Paper 2: consumer engagement in living guidelines.

OBJECTIVES: To describe and reflect on the consumer engagement approaches used in five living guidelines from the perspectives of consumers (i.e., patients, carers, the public, and their representatives) and guideline developers. STUDY DESIGN AND SETTING: In a descriptive report, we used a template to capture engagement approaches and the experiences of consumers and guideline developers in living guidelines in Australia and the United Kingdom. Responses were summarized using descriptive synthesis. RESULTS: One guideline used a Consumer Panel, three included two to three consumers in the guideline development group, and one did both. Much of our experience was common to all guidelines (e.g., consumers felt welcomed but that their role initially lacked clarity). We identified six challenges and opportunities specific to living guidelines: managing the flow of work; managing engagement in online environments; managing membership of the panel; facilitating more flexibility, variety and depth in engagement; recruiting for specific skills-although these can be built over time; developing living processes to improve; and adapting consumer engagement together. CONCLUSION: Consumer engagement in living guidelines should follow established principles of consumer engagement in guidelines. Conceiving the engagement as living, underpinned by a living process evaluation, allows the approach to be developed with consumers over time.

Methods for living guidelines: early guidance based on practical experience. Paper 5: decisions on methods for evidence synthesis and recommendation development for living guidelines.

OBJECTIVES: Producing living guidelines requires making important decisions about methods for evidence identification, appraisal, and integration to allow the living mode to function. Clarifying what these decisions are and the trade-offs between options is necessary. This article provides living guideline developers with a framework to enable them to choose the most suitable model for their living guideline topic, question, or context. STUDY DESIGN AND SETTING: We developed this guidance through an iterative process informed by interviews, feedback, and a consensus process with an international group of living guideline developers. RESULTS: Several key decisions need to be made both before commencing and throughout the continual process of living guideline development and maintenance. These include deciding what approach is taken to the systematic review process; decisions about methods to be applied for the evidence appraisal process, including the use of unpublished data; and selection of "triggers" to incorporate new studies into living guideline recommendations. In each case, there are multiple options and trade-offs. CONCLUSION: We identify trade-offs and important decisions to be considered throughout the living guideline development process. The most appropriate, and most sustainable, mode of development and updating will be dependent on the choices made in each of these areas.

Daily oxygenation support for patients hospitalized with SARS-CoV-2 in an integrated health system.

Background: Many studies of novel coronavirus 2019 (COVID-19) are constructed to report hospitalization outcomes, with few large multi-center population-based reports on the time course of intra-hospitalization characteristics, including daily oxygenation support requirements. Comprehensive epidemiologic profiles of oxygenation methods used by day and by week during hospitalization across all severities are important to illustrate the clinical and economic burden of COVID-19 hospitalizations.Methods: This is a retrospective, multicenter observational cohort study of 15,361 consecutive hospitalizations of patients with COVID-19 at 25 adult acute care hospitals in Texas participating in the Society of Critical Care Medicine Discovery Viral Respiratory Illness Universal Study (VIRUS) COVID-19 registryResults: At initial hospitalization, the majority required nasal cannula (44.0%) with increasing proportion of invasive mechanical ventilation in the first week and particularly the weeks to follow. After four weeks of acute illness, 69.9% of adults hospitalized with COVID-19 required intermediate (e.g., high-flow nasal cannula, non-invasive ventilation) or advanced respiratory support (e.g., invasive mechanical ventilation), with similar proportions extending to hospitalizations lasting 6 weeks or longer.Conclusions: Data representation of intra-hospital processes of care drawn from hospitals with varied size, teaching and trauma designations is important to presenting a balanced perspective of care delivery mechanisms employed, such as daily oxygen method utilization.

Weekly updating of guideline recommendations was feasible: the Australian National COVID-19 clinical evidence Taskforce.

OBJECTIVES: To investigate how quickly evidence was incorporated into the Australian living guidelines for COVID-19 during the first 12 months of the pandemic. STUDY DESIGN AND SETTING: For each study concerning drug therapies included in the guideline from April 3, 2020 to April 1, 2021, we extracted the publication date of the study, and the guideline version the study was included in. We analyzed two subgroups of studies as follows: those published in high impact factor journals and those with 100 or more participants. RESULTS: In the first year, we published 37 major versions of the guidelines, incorporating 129 studies that investigated 48 drug therapies informing 115 recommendations. The median time from first publication of a study to incorporation in the guideline was 27 days (interquartile range [IQR], 16 to 44), ranging from 9 to 234 days. For the 53 studies in the highest impact factor journals, the median was 20 days (IQR 15 to 30), and for the 71 studies with 100 or more participants the median was 22 days (IQR 15 to 36). CONCLUSION: Developing and sustaining living guidelines where evidence is rapidly incorporated is a resource- and time-intensive undertaking; however, this study demonstrates that it is feasible, even over a long period.

Methods for living guidelines: early guidance based on practical experience. Paper 1: Introduction.

OBJECTIVES: To introduce methods for living guidelines based on practical experiences by the Australian Living Evidence Consortium (ALEC), the National Institute of Health and Care Excellence (NICE), and the Infectious Diseases Society of America (IDSA), with methodological support from the US Grading of Recommendations, Assessment, Development and Evaluations (GRADE) Network. STUDY DESIGN AND SETTING: Members of ALEC, NICE, and the US GRADE Network, convened a working group to share experiences of the methods used to develop living guidelines and outline the key differences between traditional and living guidelines methods. RESULTS: The guidance includes the following steps: 1) deciding if the guideline is a priority for a living approach, 2) preparing for living guideline development, 3) literature surveillance and frequency of searching, 4) assessment and synthesis of the evidence, 5) publication and dissemination, and 6) transitioning recommendations out of living mode. CONCLUSION: This paper introduces methods for living guidelines and provides examples of the similarities and differences in approach across multiple organizations conducting living guidelines. It also introduces a series of papers exploring methods for living guidelines based on our practical experiences, including consumer involvement, selecting and prioritizing questions, search decisions, and methods decisions.

Methods for living guidelines: early guidance based on practical experience. Paper 3: selecting and prioritizing questions for living guidelines.

OBJECTIVES: This article is part of a series on methods for living guidelines, consolidating practical experiences from developing living guidelines. It focuses on methods for identification, selection, and prioritization of clinical questions for a living approach to guideline development. STUDY DESIGN AND SETTING: Members of the Australian Living Evidence Consortium, the National Institute of Health and Care Excellence and the US Grading of Recommendations, Assessment, Development and Evaluations Network, convened a working group. All members have expertize and practical experience in the development of living guidelines. We collated methods, documents on prioritization from each organization's living guidelines, conducted interviews and held working group discussions. We consolidated these to form best practice principles which were then edited and agreed on by the working group members. RESULTS: We developed best practice principles for (1) identification, (2) selection, and (3) prioritization, of questions for a living approach to guideline development. Several different strategies for undertaking prioritizing questions are explored. CONCLUSION: The article provides guidance for prioritizing questions in living guidelines. Subsequent articles in this series explore consumer involvement, search decisions, and methods decisions that are appropriate for questions with different priority levels.

The National COVID-19 Clinical Evidence Taskforce: pregnancy and perinatal guidelines.

INTRODUCTION: Pregnant women are at higher risk of severe illness from coronavirus disease 2019 (COVID-19) than non-pregnant women of a similar age. Early in the COVID-19 pandemic, it was clear that evidenced-based guidance was needed, and that it would need to be updated rapidly. The National COVID-19 Clinical Evidence Taskforce provided a resource to guide care for people with COVID-19, including during pregnancy. Care for pregnant and breastfeeding women and their babies was included as a priority when the Taskforce was set up, with a Pregnancy and Perinatal Care Panel convened to guide clinical practice. MAIN RECOMMENDATIONS: As of May 2022, the Taskforce has made seven specific recommendations on care for pregnant women and those who have recently given birth. This includes supporting usual practices for the mode of birth, umbilical cord clamping, skin-to-skin contact, breastfeeding, rooming-in, and using antenatal corticosteroids and magnesium sulfate as clinically indicated. There are 11 recommendations for COVID-19-specific treatments, including conditional recommendations for using remdesivir, tocilizumab and sotrovimab. Finally, there are recommendations not to use several disease-modifying treatments for the treatment of COVID-19, including hydroxychloroquine and ivermectin. The recommendations are continually updated to reflect new evidence, and the most up-to-date guidance is available online (https://covid19evidence.net.au). CHANGES IN MANAGEMENT RESULTING FROM THE GUIDELINES: The National COVID-19 Clinical Evidence Taskforce has been a critical component of the infrastructure to support Australian maternity care providers during the COVID-19 pandemic. The Taskforce has shown that a rapid living guidelines approach is feasible and acceptable.

Care for adults with COVID-19: living guidelines from the National COVID-19 Clinical Evidence Taskforce.

INTRODUCTION: The Australian National COVID-19 Clinical Evidence Taskforce was established in March 2020 to maintain up-to-date recommendations for the treatment of people with coronavirus disease 2019 (COVID-19). The original guideline (April 2020) has been continuously updated and expanded from nine to 176 recommendations, facilitated by the rapid identification, appraisal, and analysis of clinical trial findings and subsequent review by expert panels. MAIN RECOMMENDATIONS: In this article, we describe the recommendations for treating non-pregnant adults with COVID-19, as current on 1 August 2022 (version 61.0). The Taskforce has made specific recommendations for adults with severe/critical or mild disease, including definitions of disease severity, recommendations for therapy, COVID-19 prophylaxis, respiratory support, and supportive care. CHANGES IN MANAGEMENT AS A RESULT OF THE GUIDELINE: The Taskforce currently recommends eight drug treatments for people with COVID-19 who do not require supplemental oxygen (inhaled corticosteroids, casirivimab/imdevimab, molnupiravir, nirmatrelvir/ritonavir, regdanvimab, remdesivir, sotrovimab, tixagevimab/cilgavimab) and six for those who require supplemental oxygen (systemic corticosteroids, remdesivir, tocilizumab, sarilumab, baricitinib, casirivimab/imdevimab). Based on evidence of their achieving no or only limited benefit, ten drug treatments or treatment combinations are not recommended; an additional 42 drug treatments should only be used in the context of randomised trials. Additional recommendations include support for the use of continuous positive airway pressure, prone positioning, and endotracheal intubation in patients whose condition is deteriorating, and prophylactic anticoagulation for preventing venous thromboembolism. The latest updates and full recommendations are available at www.covid19evidence.net.au.

Care of older people and people requiring palliative care with COVID-19: guidance from the Australian National COVID-19 Clinical Evidence Taskforce.

INTRODUCTION: Older people living with frailty and/or cognitive impairment who have coronavirus disease 2019 (COVID-19) experience higher rates of critical illness. There are also people who become critically ill with COVID-19 for whom a decision is made to take a palliative approach to their care. The need for clinical guidance in these two populations resulted in the formation of the Care of Older People and Palliative Care Panel of the National COVID-19 Clinical Evidence Taskforce in June 2020. This specialist panel consists of nursing, medical, pharmacy and allied health experts in geriatrics and palliative care from across Australia. MAIN RECOMMENDATIONS: The panel was tasked with developing two clinical flow charts for the management of people with COVID-19 who are i) older and living with frailty and/or cognitive impairment, and ii) receiving palliative care for COVID-19 or other underlying illnesses. The flow charts focus on goals of care, communication, medication management, escalation of care, active disease-directed care, and managing symptoms such as delirium, anxiety, agitation, breathlessness or cough. The Taskforce also developed living guideline recommendations for the care of adults with COVID-19, including a commentary to discuss special considerations when caring for older people and those requiring palliative care. CHANGES IN MANAGEMENT AS RESULT OF THE GUIDELINE: The practice points in the flow charts emphasise quality clinical care, with a focus on addressing the most important challenges when caring for older individuals and people with COVID-19 requiring palliative care. The adult recommendations contain additional considerations for the care of older people and those requiring palliative care.

Bowel perforation in morbid obesity secondary to COVID-19 infection.

The pathophysiology of SARS-CoV-2 is unique in the different pathways the virus utilizes to induce severe systemic inflammation, leading to a higher potential for critical care requirements and a poorer prognosis. Although there are several risk factors for the development of severe infection, one associated with poorer outcome is obesity. In this report, we present a case of bowel perforation in an obese patient with severe COVID-19 infection.

Clinical care of children and adolescents with COVID-19: recommendations from the National COVID-19 Clinical Evidence Taskforce.

INTRODUCTION: The epidemiology and clinical manifestations of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are different in children and adolescents compared with adults. Although coronavirus disease 2019 (COVID-19) appears to be less common in children, with milder disease overall, severe complications may occur, including paediatric inflammatory multisystem syndrome (PIMS-TS). Recognising the distinct needs of this population, the National COVID-19 Clinical Evidence Taskforce formed a Paediatric and Adolescent Care Panel to provide living guidelines for Australian clinicians to manage children and adolescents with COVID-19 and COVID-19 complications. Living guidelines mean that these evidence-based recommendations are updated in near real time to give reliable, contemporaneous advice to Australian clinicians providing paediatric care. MAIN RECOMMENDATIONS: To date, the Taskforce has made 20 specific recommendations for children and adolescents, including definitions of disease severity, recommendations for therapy, respiratory support, and venous thromboembolism prophylaxis for COVID-19 and for the management of PIMS-TS. CHANGES IN MANAGEMENT AS A RESULT OF THE GUIDELINES: The Taskforce currently recommends corticosteroids as first line treatment for acute COVID-19 in children and adolescents who require oxygen. Tocilizumab could be considered, and remdesivir should not be administered routinely in this population. Non-invasive ventilation or high flow nasal cannulae should be considered in children and adolescents with hypoxaemia or respiratory distress unresponsive to low flow oxygen if appropriate infection control measures can be used. Children and adolescents with PIMS-TS should be managed by a multidisciplinary team. Intravenous immunoglobulin and corticosteroids, with concomitant aspirin and thromboprophylaxis, should be considered for the treatment of PIMS-TS. The latest updates and full recommendations are available at www.covid19evidence.net.au.

Gender Differences in Critical Illness and Critical Care Research.

Gender is emerging as a factor that may impact the trajectory of critical illness; clinical trials in critical care have largely enrolled men with little attention to equal distribution of sexes. Distribution of admission to the intensive care unit and utilization of resources differs by gender. Sex hormones are thought to impact the course of critical illness. Management and outcomes in sepsis and acute respiratory distress syndrome have been demonstrated to differ by gender as well as in pregnancy. Outcomes of critically ill patients may be impacted by gender.

Clinical care of pregnant and postpartum women with COVID-19: Living recommendations from the National COVID-19 Clinical Evidence Taskforce.

To date, 18 living recommendations for the clinical care of pregnant and postpartum women with COVID-19 have been issued by the National COVID-19 Clinical Evidence Taskforce. This includes recommendations on mode of birth, delayed umbilical cord clamping, skin-to-skin contact, breastfeeding, rooming-in, antenatal corticosteroids, angiotensin-converting enzyme inhibitors, disease-modifying treatments (including dexamethasone, remdesivir and hydroxychloroquine), venous thromboembolism prophylaxis and advanced respiratory support interventions (prone positioning and extracorporeal membrane oxygenation). Through continuous evidence surveillance, these living recommendations are updated in near real-time to ensure clinicians in Australia have reliable, evidence-based guidelines for clinical decision-making. Please visit https://covid19evidence.net.au/ for the latest recommendation updates.

Weekly updates of national living evidence-based guidelines: methods for the Australian living guidelines for care of people with COVID-19.

BACKGROUND AND OBJECTIVES: The Australian National COVID-19 Clinical Evidence Taskforce is a consortium of 31 Australian health professional organisations developing living, evidence-based guidelines for care of people with COVID-19, which are updated weekly. This article describes the methods used to develop and maintain the guidelines. METHODS: The guidelines use the GRADE methods and are designed to meet Australian NHMRC standards. Each week, new evidence is reviewed, current recommendations are revised, and new recommendations made. These are published in MAGIC and disseminated through traditional and social media. Relevant new questions to be addressed are continually sought from stakeholders and practitioners. For prioritized questions, the evidence is actively monitored and updated. Evidence surveillance combines horizon scans and targeted searches. An evidence team appraises and synthesizes evidence and prepares evidence-to-decision frameworks to inform development of recommendations. A guidelines leadership group oversees the development of recommendations by multidisciplinary guidelines panels and is advised by a consumer panel. RESULTS: The Taskforce formed in March 2020, and the first recommendations were published 2 weeks later. The guidelines have been revised and republished on a weekly basis for 24 weeks, and as of October 2020, contain over 90 treatment recommendations, suggesting that living methods are feasible in this context. CONCLUSIONS: The Australian guidelines for care of people with COVID-19 provide an example of the feasibility of living guidelines and an opportunity to test and improve living evidence methods.