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

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Harvard

Mathioudakis, AG, Fally, M, Hashad, R, Kouta, A, Hadi, AS, Knight, SB, Bakerly, ND, Singh, D, Williamson, PR, Felton, T & Vestbo, J 2020, 'Outcomes Evaluated in Controlled Clinical Trials on the Management of COVID-19: A Methodological Systematic Review', Life (Basel, Switzerland), bind 10, nr. 12, 350, s. 1-32. https://doi.org/10.3390/life10120350

APA

Mathioudakis, A. G., Fally, M., Hashad, R., Kouta, A., Hadi, A. S., Knight, S. B., Bakerly, N. D., Singh, D., Williamson, P. R., Felton, T., & Vestbo, J. (2020). Outcomes Evaluated in Controlled Clinical Trials on the Management of COVID-19: A Methodological Systematic Review. Life (Basel, Switzerland), 10(12), 1-32. [350]. https://doi.org/10.3390/life10120350

CBE

MLA

Vancouver

Author

Mathioudakis, Alexander G ; Fally, Markus ; Hashad, Rola ; Kouta, Ahmed ; Hadi, Ali Sina ; Knight, Sean Blandin ; Bakerly, Nawar Diar ; Singh, Dave ; Williamson, Paula R ; Felton, Tim ; Vestbo, Jørgen. / Outcomes Evaluated in Controlled Clinical Trials on the Management of COVID-19 : A Methodological Systematic Review. I: Life (Basel, Switzerland). 2020 ; Bind 10, Nr. 12. s. 1-32.

Bibtex

@article{91a5b9f3fce94d0ea9fc396acb423256,
title = "Outcomes Evaluated in Controlled Clinical Trials on the Management of COVID-19: A Methodological Systematic Review",
abstract = "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.",
keywords = "Coronavirus disease 2019, COVID-19, Endpoints, Outcomes, Randomized controlled trials, Systematic reviews, Trial methods",
author = "Mathioudakis, {Alexander G} and Markus Fally and Rola Hashad and Ahmed Kouta and Hadi, {Ali Sina} and Knight, {Sean Blandin} and Bakerly, {Nawar Diar} and Dave Singh and Williamson, {Paula R} and Tim Felton and J{\o}rgen Vestbo",
year = "2020",
month = dec,
day = "15",
doi = "10.3390/life10120350",
language = "English",
volume = "10",
pages = "1--32",
journal = "Life",
issn = "2075-1729",
publisher = "MDPI Multidisciplinary Digital Publishing Institute",
number = "12",

}

RIS

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

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 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.

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 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.

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 - Journal article

C2 - 33333777

VL - 10

SP - 1

EP - 32

JO - Life

JF - Life

SN - 2075-1729

IS - 12

M1 - 350

ER -

ID: 61897022