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

  1. Mark Duffett
  2. Deborah J Cook
  3. Geoff Strong
  4. Jan Hau Lee
  5. Michelle E Kho

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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 2020 - February 2021).

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

127 centers (57% 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 1.2 to 1.4, p < 0.001), 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 with local adaptation to safely sustain research during this and future pandemics are urgently needed.

Key Points

Question

What was the effect of the COVID-19 pandemic on research in 127 adult and pediatric intensive care units (ICUs) between March 2020 and February 2021?

Findings

95 (75%) centers suspended recruitment into at least some studies. Active recruitment into studies increased over time (OR per month 1.3, 95% CI 1.2 to 1.4, p < 0.001), controlling for ICU type and the presence of patients with COVID-19.

Meaning

Research 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 pandemics are urgently needed.

Article activity feed

  1. Version published to 10.1101/2020.10.21.20216945v2 on medRxiv
  2. ScreenIT

    SciScore for 10.1101/2020.10.21.20216945: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementIRB: After, Research Ethics Board (REB) approval we sent monthly surveys to one investigator or research coordinator at each site with up to two reminders to non-respondents each month.
    Consent: Survey completion implied informed consent.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    No key resources detected.

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Limitations include the convenience sample of participating centers and limited representation from regions with the highest demand for critical care resources during the first wave of the pandemic.

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  3. Version published to 10.1101/2020.10.21.20216945v1 on medRxiv