AbstractImportanceThe COVID-19 pandemic has increased the need for high-quality evidence in critical care, while also increasing the barriers to conducting the research needed to produce such evidence.ObjectiveTo determine the effect of the first wave of the COVID-19 pandemic on critical care clinical research.DesignMonthly electronic survey (March - August 2020).SettingAdult or pediatric intensive care units (ICUs) from any country participating in at least one research study before the COVID-19 pandemic.ParticipantsWe recruited one researcher or research coordinator per center, identified via established research networks.Intervention(s)NoneMain Outcome(s) and Measure(s)Primary: Suspending recruitment in clinical research; Secondary: impact of specific factors on research conduct (5-point scales from no effect to very large effect). We assessed the association between research continuity and month, presence of hospitalized patients with COVID-19, and population (pediatric vs. adult ICU) using mixed-effects logistic regression.Results126 centers (56% pediatric) from 23 countries participated. 95 (75%) of centers suspended recruitment in at least some studies and 37 (29%) suspended recruitment in all studies on at least one month. The proportion of centers reporting recruitment in all studies increased over time (OR per month 1.3, 95% CI 1.1 to 1.5, p = 0.007), controlling for hospitalized patients with COVID-19 and type of ICU (pediatric vs. other). The five factors most frequently identified as having a large or very large effect on clinical research were: local prioritization of COVID-19 specific research (68, 54%), infection control policies limiting access to patients with COVID-19 (61, 49%), infection control policies limiting access to the ICU (52, 41.6%), increased workload of clinical staff (38, 30%), and safety concerns of research staff (36, 29%).Conclusions and RelevanceDecisions to pause or pursue clinical research varied across centers. Research activity increased over time, despite the presence of hospitalized patients with COVID-19. Guiding principles to safely sustain research during this and future pandemic waves are urgently needed.Key PointsQuestionWhat was the effect of the COVID-19 pandemic on research in 126 adult and pediatric intensive care units (ICUs) between March and August 2020?
Findings95 (75%) centers suspended recruitment in at least some studies. Decisions to continue recruitment increased over time (OR per month 1.3, 95% CI 1.1 to 1.5, p = 0.007), controlling for ICU type and the presence of patients with COVID-19.MeaningResearch activity varied across centers and increased over time, despite the presence of hospitalized patients with COVID-19. Guiding principles to safely sustain research during this and future pandemic waves are urgently needed.
The screen log: a tool for monitoring critical care clinical research activity