The effect of COVID-19 on critical care research during the first year of the pandemic: A prospective longitudinal multinational survey

Abstract

Importance: The 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. Objective: To determine the effect of the first wave of the COVID-19 pandemic on critical care clinical research. Design: Monthly electronic survey (March - August 2020). Setting: Adult or pediatric intensive care units (ICUs) from any country participating in at least one research study before the COVID-19 pandemic. Participants: We recruited one researcher or research coordinator per center, identified via established research networks. Intervention(s): None Main 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. Results: 126 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 Relevance: Decisions 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.

Research interrupted: applying the CONSERVE 2021 Statement to a randomized trial of rehabilitation during critical illness affected by the COVID-19 pandemic

“…In this report, we documented our approaches to address extenuating circumstances and patient retention for a complex At the start of the pandemic, researchers expressed many concerns about the conduct of non-COVID-19 clinical trials. Members of our group collaboratively developed guidelines for continuing or restarting nonpandemic focused research [6] as many clinical trials were interrupted or halted by the pandemic [7]. A myriad of challenges from these interruptions have included lost treatment opportunities for patients [8,9], threatened trial equipment supply chains [9], missed medication doses in vulnerable populations [10], uncertainties about re-starting trials [11], and challenges with data integrity and interpretability due to intercurrent complications (e.g., unavailable study drug, treatment discontinuation due to COVID-19 illness, and missing data) [12][13][14].…”

“…6 Department of Family Medicine and Emergency Medicine, Université Laval, Quebec, QC, Canada. 7 Department of Medicine and Department of Epidemiology and Biostatistics, Western University, London, ON, Canada. 8 Department of Physiotherapy, Austin Health, Heidelberg, VIC, Australia.…”

Critical Care Cycling to ImproveLowerExtremity Strength (CYCLE): protocol for an international, multicentre randomised clinical trial of early in-bed cycling for mechanically ventilated patients

“…Like many trials, the global COVID-19 pandemic imposed extenuating circumstances on CYCLE, and ICUs worldwide prioritised COVID-19-related research and clinical care for critically ill patients with COVID-19. 79 80 After 17 March 2020, we paused recruitment in all recruiting centres due to institutional directives prohibiting non-COVID clinical research. Our first site resumed recruitment in June 2020.…”

Implementing early rehabilitation and mobilisation for children in UK paediatric intensive care units: the PERMIT feasibility study

“…We had planned to speak to parents with direct experience of involvement in research studies, but the research suspension imposed in response to directives to prioritise COVID-related research made this challenging. 100 We spoke to parents of four children (aged 1 month to 16 years) who had experienced one or more PICU admission(s) at BCH and Kings College London. One parent had experience of their child being recruited to a number of non-PICU research studies.…”