TY - JOUR
T1 - Outcomes evaluated in controlled clinical trials on the management of COVID-19
T2 - A methodological systematic review
AU - Mathioudakis, Alexander G.
AU - Fally, Markus
AU - Hashad, Rola
AU - Kouta, Ahmed
AU - Hadi, Ali Sina
AU - Knight, Sean Blandin
AU - Bakerly, Nawar Diar
AU - Singh, Dave
AU - Williamson, Paula R.
AU - Felton, Tim
AU - Vestbo, Jørgen
N1 - Funding Information:
Funding: This study was supported by the NIHR Manchester Biomedical Research Centre (BRC).
Funding Information:
Conflicts of Interest: None of the authors report and CoIs related to this work. A.G.M. reports grants from Boehringer Ingelheim outside the submitted work. N.D.B. reports personal fees and non-financial support from GlaxoSmithKline, AstraZeneca, Boehringer Ingelheim, TEVA, Chiesi, and Novartis, outside the submitted work. D.S. reports grants and personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, Genentech, GlaxoSmithKline, Glenmark, Menarini, Mundipharma, Novartis, Peptinnovate, Pfizer, Pulmatrix, Therevance and
Publisher Copyright:
© 2020 by the authors. Licensee MDPI, Basel, Switzerland.
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/12/15
Y1 - 2020/12/15
N2 - 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 5/5/2020, 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.
AB - 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 5/5/2020, 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.
KW - Coronavirus disease 2019
KW - COVID-19
KW - Endpoints
KW - Outcomes
KW - Randomized controlled trials
KW - Systematic reviews
KW - Trial methods
UR - http://www.scopus.com/inward/record.url?scp=85097932736&partnerID=8YFLogxK
U2 - 10.3390/life10120350
DO - 10.3390/life10120350
M3 - Article
AN - SCOPUS:85097932736
SN - 2075-1729
VL - 10
SP - 1
EP - 32
JO - Life
JF - Life
IS - 12
M1 - 350
ER -