Infectious Diseases Society of America Guidelines on the Treatment and Management of Patients with COVID-19.

BACKGROUND: There are many pharmacologic therapies that are being used or considered for treatment of coronavirus disease 2019 (COVID-19), with rapidly changing efficacy and safety evidence from trials. OBJECTIVE: Develop evidence-based, rapid, living guidelines intended to support patients, clinicians, and other healthcare professionals in their decisions about treatment and management of patients with COVID-19. METHODS: In March 2020, the Infectious Diseases Society of America (IDSA) formed a multidisciplinary guideline panel of infectious disease clinicians, pharmacists, and methodologists with varied areas of expertise to regularly review the evidence and make recommendations about the treatment and management of persons with COVID-19. The process used a living guideline approach and followed a rapid recommendation development checklist. The panel prioritized questions and outcomes. A systematic review of the peer-reviewed and grey literature was conducted at regular intervals. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess the certainty of evidence and make recommendations. RESULTS: Based on the most recent search conducted on May 31, 2022, the IDSA guideline panel has made 30 recommendations for the treatment and management of the following groups/populations: pre- and post-exposure prophylaxis, ambulatory with mild-to-moderate disease, hospitalized with mild-to-moderate, severe but not critical, and critical disease. As these are living guidelines, the most recent recommendations can be found online at: https://idsociety.org/COVID19guidelines. CONCLUSIONS: At the inception of its work, the panel has expressed the overarching goal that patients be recruited into ongoing trials. Since then, many trials were done which provided much needed evidence for COVID-19 therapies. There still remain many unanswered questions as the pandemic evolved which we hope future trials can answer.

Pharmacologic Treatment and Management of Coronavirus Disease 2019.

Over the last 2 years, there has been gradual and sustained progress toward our understanding of pharmacotherapy for coronavirus disease 2019 (COVID-19) as a result of large- and small-scale randomized controlled trials. Numerous new and repurposed treatments have been evaluated; some have demonstrated benefit in clinically important outcomes like mortality and hospitalization, and optimism for oral antiviral treatments is growing. Given the rapidly evolving landscape of COVID-19 treatments, frontline clinicians should use treatment and management guidelines to guide their approach to each patient, with the individual's severity and location of illness in mind to appreciate the nuances in clinical evidence.

Lessons Learned from Coronavirus Disease 2019 (COVID-19) Therapies: Critical Perspectives From the Infectious Diseases Society of America (IDSA) COVID-19 Treatment Guideline Panel.

Despite the challenges of the pandemic, there has been substantial progress with coronavirus disease 2019 (COVID-19) therapies. Pivotal COVID-19 trials like SOLIDARITY, RECOVERY, and ACCT-1 were rapidly conducted and data disseminated to support effective therapies. However, critical shortcomings remain on trial conduct, dissemination and interpretation of study results, and regulatory guidance in pandemic settings. The lessons that we learned have implications for both the current pandemic and future emerging infectious diseases. There is a need for establishing and standardizing clinical meaningful outcomes in therapeutic trials and for targeting defined populations and phenotypes that will most benefit from specific therapies. Standardized processes should be established for rapid and critical data review and dissemination to ensure scientific integrity. Clarity around the evidence standards needed for issuance of both emergency use authorization (EUA) and biologic license application (BLA) should be established and an infrastructure for executing rapid trials in epidemic settings maintained.

Therapeutic Emergency Use Authorizations (EUAs) During Pandemics: Double-edged Swords.

Given the urgent need for treatments during the coronavirus disease 2019 pandemic, the US Food and Drug Administration issued emergency use authorizations (EUAs) for multiple therapies. In several instances, however, these EUAs were issued before sufficient evidence of a given therapy's efficacy and safety were available, potentially promoting ineffective or even harmful therapies and undermining the generation of definitive evidence. We describe the strengths and weaknesses of the different therapeutic EUAs issued during this pandemic. We also contrast them to the vaccine EUAs and suggest a framework and criteria for an evidence-based, trustworthy, and publicly transparent therapeutic EUA process for future pandemics.

Infectious Diseases Society of America Guidelines on the Treatment and Management of Patients with COVID-19.

BACKGROUND: There are many pharmacologic therapies that are being used or considered for treatment of COVID-19. There is a need for frequently updated practice guidelines on their use, based on critical evaluation of rapidly emerging literature. OBJECTIVE: Develop evidence-based rapid guidelines intended to support patients, clinicians and other health-care professionals in their decisions about treatment and management of patients with COVID-19. METHODS: IDSA formed a multidisciplinary guideline panel of infectious disease clinicians, pharmacists, and methodologists with varied areas of expertise. Process followed a rapid recommendation checklist. The panel prioritized questions and outcomes. Then a systematic review of the peer-reviewed and grey literature was conducted. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess the certainty of evidence and make recommendations. RESULTS: The IDSA guideline panel agreed on 7 treatment recommendations and provided narrative summaries of other treatments undergoing evaluations. CONCLUSIONS: The panel expressed the overarching goal that patients be recruited into ongoing trials, which would provide much needed evidence on the efficacy and safety of various therapies for COVID-19, given that we could not make a determination whether the benefits outweigh harms for most treatments.

Infectious Diseases Society of America Guidelines on the Treatment and Management of Patients with COVID-19

Develop evidence-based rapid guidelines intended to support patients, clinicians and other health-care professionals in their decisions about treatment and management of patients with COVID-19.

Development and Implementation of Team-Based Panel Management Tools: Filling the Gap between Patient and Population Information Systems.

Effective team-based models of care, such as the Patient-Centered Medical Home, require electronic tools to support proactive population management strategies that emphasize care coordination and quality improvement. Despite the spread of electronic health records (EHRs) and vendors marketing population health tools, clinical practices still may lack the ability to have: (1) local control over types of data collected/reports generated, (2) timely data (eg, up-to-date data, not several months old), and accordingly (3) the ability to efficiently monitor and improve patient outcomes. This article describes a quality improvement project at the hospital system level to develop and implement a flexible panel management (PM) tool to improve care of subpopulations of patients (eg, panels of patients with diabetes) by clinical teams. An in-depth case analysis approach is used to explore barriers and facilitators in building a PM registry tool for team-based management needs using standard data elements (eg, laboratory values, pharmacy records) found in EHRs. Also described are factors that may contribute to sustainability; to date the tool has been adapted to 6 disease-focused subpopulations encompassing more than 200,000 patients. Two key lessons emerged from this initiative: (1) though challenging, team-based clinical end users and information technology needed to work together consistently to refine the product, and (2) locally developed population management tools can provide efficient data tracking for frontline clinical teams and leadership. The preliminary work identified critical gaps that were successfully addressed by building local PM registry tools from EHR-derived data and offers lessons learned for others engaged in similar work. (Population Health Management 2016;19:232-239).