Current opinion in critical care
-
Randomized clinical trials (RCTs) have come to be accepted as the gold standard for assessing the efficacy and effectiveness of therapeutics and interventions in medicine. In this paper, we aim to describe some evolving concepts associated with the design and conduct of RCTs and outline new approaches aiming to increase efficiency and reduce costs. ⋯ While conventional RCTs remain the gold standard for generating evidence, new trial designs may be considered to reduce sample size and costs while improving trial efficiency and power. However, they raise new challenges for testing feasibility, conduct, ethical oversight and statistical analysis.
-
Curr Opin Crit Care · Oct 2021
ReviewJanus Kinase inhibitors for the treatment of hospitalized patients with COVID-19.
Janus Kinase (JAK) inhibitors have been successfully utilized in the clinical treatment of several rheumatologic (e.g. rheumatoid arthritis) and inflammatory diseases (e.g. hemophagocytic lymphohistiocytosis). Based on the growing evidence that moderate and severe COVID-19 infections are associated with a dysregulated inflammatory state, this class of medications has been repurposed as a potential therapy for COVID-19, an infection caused by Severe Acute Respiratory Syndrome Coronavirus 2. ⋯ JAK inhibitors are novel treatment agents in the field of infectious diseases. One JAK inhibitor, baricitinib has demonstrated significant clinical and survival benefits in hospitalized patients with COVID-19 in phase III randomized placebo-controlled trials. Baricitinib is already recommended for clinical practice by multiple guidelines.
-
Curr Opin Crit Care · Oct 2021
ReviewWhat can a learning healthcare system teach us about improving outcomes?
This review describes the learning healthcare system paradigm, recent examples, and future directions. Patients, clinicians, and health systems frequently encounter decisions between available treatments, technologies, and healthcare delivery methods with little or no evidence about the comparative effectiveness and safety of the available options. Learning healthcare systems endeavor to recognize such knowledge gaps, integrate comparative effectiveness research - including clinical trials - into clinical care to address the knowledge gaps, and seamlessly implement the results into practice to improve care and patient outcomes. ⋯ Learning healthcare systems have the potential to answer questions of importance to patients, clinicians, and health system leaders, improve efficiency of healthcare delivery, and improve patient outcomes. Achieving this goal will require realignment of the culture around clinical care, institutional and federal investment, expanded stakeholder engagement, tailored ethical and regulatory guidance, and methodologic advances in information technology and biostatistics.
-
COVID-19 represents an unprecedented public health crisis caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The antiviral remdesivir is one component of treating COVID-19. Unfortunately, the trials evaluating remdesivir have reported mixed results, leading to uncertainty on when to use remdesivir. This review discusses the trials evaluating the efficacy of remdesivir for COVID-19 and other supporting data to help inform the role of remdesivir in patients with COVID-19. ⋯ The majority of trials evaluating remdesivir suggest that remdesivir is effective in the treatment of patients hospitalized with COVID-19. Although there may be a benefit in some subgroups more than others, there is insufficient data to make definitive statements about benefits or lack of benefits in particular groups. Remdesivir has demonstrated clinical benefits such as decreased time in the hospital, lower progression to mechanical ventilation, and decreased utilization of other hospital resources; it is unclear if it reduces mortality, but one randomized controlled trial suggested possible survival benefits. Based on the data available, remdesivir has been approved (or authorized for early use) in 48 countries.
-
Curr Opin Crit Care · Oct 2021
ReviewCoronavirus disease 2019 respiratory failure: what is the best supportive care for patients who require ICU admission?
Currently, there is no cure for SARS-CoV-2 infection, yet hospital mortality rates for COVID-19 have improved over the course of the pandemic and may be due in part to improved supportive care in the ICU. This review highlights the evidence for and against various ICU supportive therapies for the treatment of critically ill patients with COVID-19. ⋯ In general, the COVID-19 pandemic reaffirmed the benefits of standard supportive care for respiratory failure and in particular, recent advances in ARDS treatment. Prone ventilation of nonintubated patients, an approach that was adopted early in the pandemic, is associated with improvement in oxygenation, but its impact on clinical outcome remains unclear. Otherwise, prone mechanical ventilation and avoidance of excessive tidal volumes, conservative fluid management, antibiotic stewardship and early evaluation for extracorporeal membrane oxygenation (ECMO) -- basic tenants of severe respiratory infections and ARDS care -- remain at the core of management of patients with severe COVID-19.