Testing guidelines during times of crisis: challenges and limitations of developing rapid and living guidelines.

BACKGROUND: The start of the COVID-19 pandemic presented a situation in which there was an urgent need for decision-making that relates to diagnosis, but the evidence was lacking, of low certainty or constantly changing. Rapid and living guideline development methods were needed and had to be applied to rigorous guideline approaches, such as the Grading of Recommendations Assessment, Development, and Evaluation approach. OBJECTIVES: To describe the process of developing rapid diagnosis guidelines when there is limited and imperfect available data at the time of crisis. SOURCES: Case example from four Infectious Disease Society of America COVID-19 diagnostic guidelines. CONTENT: As the world was experiencing panic with COVID-19, there were serious doubts about the feasibility of following a rigorous process for guideline development when timeliness was of extreme value. The Infectious Disease Society of America guideline panels supported by several methodologists strongly believed that at times of crisis, it is more important than ever to follow a rigorous process. The panel adopted a rapid and living systematic review methodology and applied the Grading of Recommendations Assessment, Development and Evaluation approach to four diagnosis guidelines despite the challenges of scarce and dynamic evidence. We describe the methodological details of the rapid and living approach (data extraction, meta-analysis, Evidence to Decision framework, and recommendation development), the challenge of resources, the challenge of scarce evidence, the challenge of rapidly changing evidence, as well as 'wins' from the Infectious Disease Society of America experience. IMPLICATIONS: Mitigation of pandemics relies on rapid and accurate diagnosis, which is challenged by many knowledge gaps. This necessitates emerging evidence is rapidly incorporated in a living fashion with several decisional and contextual factors to ensure the best public health strategies and care for patients. This process must be systematic and transparent for developing trustworthy guidelines and should be supported by all stakeholders, including researchers, editors, publishers, professional societies, and policymakers.

International alliance and AGREE-ment of 71 clinical practice guidelines on the management of critical care patients with COVID-19: a living systematic review.

OBJECTIVE: We aimed to systematically identify and critically assess the clinical practice guidelines (CPGs) for the management of critically ill patients with COVID-19 with the AGREE II instrument. STUDY DESIGN AND SETTING: We searched Medline, CINAHL, EMBASE, CNKI, CBM, WanFang, and grey literature from November 2019 - November 2020. We did not apply language restrictions. One reviewer independently screened the retrieved titles and abstracts, and a second reviewer confirmed the decisions. Full texts were assessed independently and in duplicate. Disagreements were resolved by consensus. We included any guideline that provided recommendations on the management of critically ill patients with COVID-19. Data extraction was performed independently and in duplicate by two reviewers. We descriptively summarized CPGs characteristics. We assessed the quality with the AGREE II instrument and we summarized relevant therapeutic interventions. RESULTS: We retrieved 3,907 records and 71 CPGs were included. Means (Standard Deviations) of the scores for the 6 domains of the AGREE II instrument were 65%(SD19.56%), 39%(SD19.64%), 27%(SD19.48%), 70%(SD15.74%), 26%(SD18.49%), 42%(SD34.91) for the scope and purpose, stakeholder involvement, rigor of development, clarity of presentation, applicability, editorial independence domains, respectively. Most of the CPGs showed a low overall quality (less than 40%). CONCLUSION: Future CPGs for COVID-19 need to rely, for their development, on standard evidence-based methods and tools.

Developing a Thai national critical care allocation guideline during the COVID-19 pandemic: a rapid review and stakeholder consultation.

BACKGROUND: At the height of the COVID-19 pandemic, Thailand had almost depleted its critical care resources, particularly intensive care unit (ICU) beds and ventilators. This prompted the necessity to develop a national guideline for resource allocation. This paper describes the development process of a national guideline for critical resource allocation in Thailand during the COVID-19 pandemic. METHODS: The guideline development process consisted of three steps: (1) rapid review of existing rationing guidelines and literature; (2) interviews of Thai clinicians experienced in caring for COVID-19 cases; and (3) multi-stakeholder consultations. At steps 1 and 2, data was synthesized and categorized using a thematic and content analysis approach, and this guided the formulation of the draft guideline. Within step 3, the draft Thai critical care allocation guideline was debated and finalized before entering the policy-decision stage. RESULTS: Three-order prioritization criteria consisting of (1) clinical prognosis using four tools (Charlson Comorbidity Index, Sequential Organ Failure Assessment, frailty assessment and cognitive impairment assessment), (2) number of life-years saved and (3) social usefulness were proposed by the research team based on literature reviews and interviews. At consultations, stakeholders rejected using life-years as a criterion due to potential age and gender discrimination, as well as social utility due to a concern it would foster public distrust, as this judgement can be arbitrary. It was agreed that the attending physician is required to be the decision-maker in the Thai medico-legal context, while a patient review committee would play an advisory role. Allocation decisions are to be documented for transparency, and no appealing mechanism is to be applied. This guideline will be triggered only when demand exceeds supply after the utmost efforts to mobilize surge capacity. Once implemented, it is applicable to all patients, COVID-19 and non-COVID-19, requiring critical care resources prior to ICU admission and during ICU stay. CONCLUSIONS: The guideline development process for the allocation of critical care resources in the context of the COVID-19 outbreak in Thailand was informed by scientific evidence, medico-legal context, existing norms and societal values to reduce risk of public distrust given the sensitive nature of the issue and ethical dilemmas of the guiding principle, though it was conducted at record speed. Our lessons can provide an insight for the development of similar prioritization guidelines, especially in other low- and middle-income countries.

Neuromuscular blockade in patients with ARDS: a rapid practice guideline.

The aim of this Intensive Care Medicine Rapid Practice Guideline (ICM-RPG) is to formulate an evidence-based guidance for the use of neuromuscular blocking agents (NMBA) in adults with acute respiratory distress syndrome (ARDS). The panel comprised 20 international clinical experts from 12 countries, and 2 patient representatives. We adhered to the methodology for trustworthy clinical practice guidelines and followed a strict conflict of interest policy. We convened panelists through teleconferences and web-based discussions. Guideline experts from the guidelines in intensive care, development, and evaluation Group provided methodological support. Two content experts provided input and shared their expertise with the panel but did not participate in drafting the final recommendations. We followed the Grading of Recommendations Assessment, Development, and Evaluation approach to assess the certainty of evidence and grade recommendations and suggestions. We used the evidence to decision framework to generate recommendations. The panel provided input on guideline implementation and monitoring, and suggested future research priorities. The overall certainty in the evidence was low. The ICM-RPG panel issued one recommendation and two suggestions regarding the use of NMBAs in adults with ARDS. Current evidence does not support the early routine use of an NMBA infusion in adults with ARDS of any severity. It favours avoiding a continuous infusion of NMBA for patients who are ventilated using a lighter sedation strategy. However, for patients who require deep sedation to facilitate lung protective ventilation or prone positioning, and require neuromuscular blockade, an infusion of an NMBA for 48 h is a reasonable option.

Development of rapid guidelines: 3. GIN-McMaster Guideline Development Checklist extension for rapid recommendations.

BACKGROUND: Practice guidelines require a substantial investment of resources and time, often taking between 1 and 3 years from conceptualisation to publication. However, urgent situations require the development of recommendations in a shorter timeframe. In this third and final article in the series exploring challenges and solutions in developing rapid guidelines (RGs), we propose guiding principles for the development of RGs. METHODS: We utilised the Guideline International Network-McMaster Guideline Development Checklist (GDC) as a starting point for elements to consider during RG development. We built on those elements using the findings from a systematic review of guideline manuals, a survey of international organisations conducting RGs, and interviews of guideline developers within WHO. We reviewed initial findings and developed an intermediate list of elements, as well as narrative guidance. We then invited experts to validate the intermediate list, reviewing for placement, brevity and redundancy. We used this iterative process and group consensus to determine the final elements for RG development guidance. RESULTS: Our work identified 21 principles within the topics of the Guideline International Network-McMaster GDC to guide the planning and development of RGs. Principles fell within 15 of the 18 checklist topics, highlighting strategies to streamline and expedite the guideline development process. CONCLUSIONS: We defined principles to guide the development of RGs, while maintaining a standardised, rigorous and transparent process. These principles will serve as guidance for guideline developers responding to urgent situations such as public health urgencies. Integration of these principles within currently disseminated guideline development standards will facilitate the use of those tools in situations necessitating RG recommendations.