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Outcomes Evaluated in Controlled Clinical Trials on the Management of COVID-19: A Methodological Systematic Review

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  • Alexander G Mathioudakis
  • Markus Fally
  • Rola Hashad
  • Ahmed Kouta
  • Ali Sina Hadi
  • Sean Blandin Knight
  • Nawar Diar Bakerly
  • Dave Singh
  • Paula R Williamson
  • Tim Felton
  • Jørgen Vestbo
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It is crucial that randomized controlled trials (RCTs) on the management of coronavirus disease 2019 (COVID-19) evaluate the outcomes that are critical to patients and clinicians, to facilitate relevance, interpretability, and comparability. This methodological systematic review describes the outcomes evaluated in 415 RCTs on the management of COVID-19, that were registered with ClinicalTrials.gov, by 5 May 2020, and the instruments used to measure these outcomes. Significant heterogeneity was observed in the selection of outcomes and instruments. Mortality, adverse events and treatment success or failure are only evaluated in 64.4%, 48.4% and 43% of the included studies, respectively, while other outcomes are selected less often. Studies focusing on more severe presentations (hospitalized patients or requiring intensive care) most frequently evaluate mortality (72.5%) and adverse events (55.6%), while hospital admission (50.8%) and viral detection/load (55.6%) are most frequently assessed in the community setting. Outcome measurement instruments are poorly reported and heterogeneous. Follow-up does not exceed one month in 64.3% of these earlier trials, and long-term COVID-19 burden is rarely assessed. The methodological issues identified could delay the introduction of potentially life-saving treatments in clinical practice. Our findings demonstrate the need for greater consistency, to enable decision makers to compare and contrast studies.

Original languageEnglish
Article number350
JournalLife (Basel, Switzerland)
Volume10
Issue number12
Pages (from-to)1-32
Number of pages32
ISSN2075-1729
DOIs
Publication statusPublished - 15 Dec 2020

    Research areas

  • Coronavirus disease 2019, COVID-19, Endpoints, Outcomes, Randomized controlled trials, Systematic reviews, Trial methods

ID: 61897022