Outcomes Evaluated in Controlled Clinical Trials on the Management of COVID-19: A Methodological Systematic Review
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 outcom...
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| Format: | Article |
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MDPI AG
2020-12-01
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| Online Access: | https://www.mdpi.com/2075-1729/10/12/350 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Alexander G. Mathioudakis |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-10T14:04:05Z |
| format | Article |
| id | doaj.art-9794f09279354fe797a3987d93de223c |
| institution | Directory Open Access Journal |
| issn | 2075-1729 |
| language | English |
| last_indexed | 2024-03-10T14:04:05Z |
| publishDate | 2020-12-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Life |
| spelling | doaj.art-9794f09279354fe797a3987d93de223c2023-11-21T00:50:31ZengMDPI AGLife2075-17292020-12-01101235010.3390/life10120350Outcomes Evaluated in Controlled Clinical Trials on the Management of COVID-19: A Methodological Systematic ReviewAlexander G. Mathioudakis0Markus Fally1Rola Hashad2Ahmed Kouta3Ali Sina Hadi4Sean Blandin Knight5Nawar Diar Bakerly6Dave Singh7Paula R. Williamson8Tim Felton9Jørgen Vestbo10Division of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, The University of Manchester, Manchester Academic Health Science Centre, Manchester M23 9LT, UKDepartment of Internal Medicine, Section for Pulmonary Diseases, Herlev Gentofte Hospital, 2900 Hellerup, DenmarkDivision of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, The University of Manchester, Manchester Academic Health Science Centre, Manchester M23 9LT, UKDivision of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, The University of Manchester, Manchester Academic Health Science Centre, Manchester M23 9LT, UKDepartment of Respiratory Medicine, Salford Royal Infirmary NHS Foundation Trust, Manchester M6 8HD, UKDivision of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, The University of Manchester, Manchester Academic Health Science Centre, Manchester M23 9LT, UKDepartment of Respiratory Medicine, Salford Royal Infirmary NHS Foundation Trust, Manchester M6 8HD, UKDivision of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, The University of Manchester, Manchester Academic Health Science Centre, Manchester M23 9LT, UKMRC/NIHR Trials Methodology Research Partnership, Department of Health Data Science, University of Liverpool, Liverpool L69 3BX, UKDivision of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, The University of Manchester, Manchester Academic Health Science Centre, Manchester M23 9LT, UKDivision of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, The University of Manchester, Manchester Academic Health Science Centre, Manchester M23 9LT, UKIt 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.https://www.mdpi.com/2075-1729/10/12/350coronavirus disease 2019COVID-19outcomesendpointsrandomized controlled trialssystematic reviews |
| spellingShingle | 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 Outcomes Evaluated in Controlled Clinical Trials on the Management of COVID-19: A Methodological Systematic Review Life coronavirus disease 2019 COVID-19 outcomes endpoints randomized controlled trials systematic reviews |
| title | Outcomes Evaluated in Controlled Clinical Trials on the Management of COVID-19: A Methodological Systematic Review |
| title_full | Outcomes Evaluated in Controlled Clinical Trials on the Management of COVID-19: A Methodological Systematic Review |
| title_fullStr | Outcomes Evaluated in Controlled Clinical Trials on the Management of COVID-19: A Methodological Systematic Review |
| title_full_unstemmed | Outcomes Evaluated in Controlled Clinical Trials on the Management of COVID-19: A Methodological Systematic Review |
| title_short | Outcomes Evaluated in Controlled Clinical Trials on the Management of COVID-19: A Methodological Systematic Review |
| title_sort | outcomes evaluated in controlled clinical trials on the management of covid 19 a methodological systematic review |
| topic | coronavirus disease 2019 COVID-19 outcomes endpoints randomized controlled trials systematic reviews |
| url | https://www.mdpi.com/2075-1729/10/12/350 |
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