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 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.
| Errataetall: |
CommentIn: Clin Microbiol Infect. 2022 Mar;28(3):456-457. - PMID 34823009 |
|---|---|
| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2020 |
|---|---|
| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:10 |
|---|---|
| Enthalten in: |
Life (Basel, Switzerland) - 10(2020), 12 vom: 15. Dez. |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Mathioudakis, Alexander G [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
COVID-19 |
|---|
| Anmerkungen: |
Date Revised 15.03.2022 published: Electronic CommentIn: Clin Microbiol Infect. 2022 Mar;28(3):456-457. - PMID 34823009 Citation Status PubMed-not-MEDLINE |
|---|
| doi: |
10.3390/life10120350 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM318987678 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM318987678 | ||
| 003 | DE-627 | ||
| 005 | 20231225170516.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231225s2020 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.3390/life10120350 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1063.xml |
| 035 | |a (DE-627)NLM318987678 | ||
| 035 | |a (NLM)33333777 | ||
| 035 | |a (PII)E350 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Mathioudakis, Alexander G |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Outcomes Evaluated in Controlled Clinical Trials on the Management of COVID-19 |b A Methodological Systematic Review |
| 264 | 1 | |c 2020 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Revised 15.03.2022 | ||
| 500 | |a published: Electronic | ||
| 500 | |a CommentIn: Clin Microbiol Infect. 2022 Mar;28(3):456-457. - PMID 34823009 | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a coronavirus disease 2019 | |
| 650 | 4 | |a endpoints | |
| 650 | 4 | |a outcomes | |
| 650 | 4 | |a randomized controlled trials | |
| 650 | 4 | |a systematic reviews | |
| 650 | 4 | |a trial methods | |
| 700 | 1 | |a Fally, Markus |e verfasserin |4 aut | |
| 700 | 1 | |a Hashad, Rola |e verfasserin |4 aut | |
| 700 | 1 | |a Kouta, Ahmed |e verfasserin |4 aut | |
| 700 | 1 | |a Hadi, Ali Sina |e verfasserin |4 aut | |
| 700 | 1 | |a Knight, Sean Blandin |e verfasserin |4 aut | |
| 700 | 1 | |a Bakerly, Nawar Diar |e verfasserin |4 aut | |
| 700 | 1 | |a Singh, Dave |e verfasserin |4 aut | |
| 700 | 1 | |a Williamson, Paula R |e verfasserin |4 aut | |
| 700 | 1 | |a Felton, Tim |e verfasserin |4 aut | |
| 700 | 1 | |a Vestbo, Jørgen |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Life (Basel, Switzerland) |d 2011 |g 10(2020), 12 vom: 15. Dez. |w (DE-627)NLM243284799 |x 2075-1729 |7 nnns |
| 773 | 1 | 8 | |g volume:10 |g year:2020 |g number:12 |g day:15 |g month:12 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.3390/life10120350 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 10 |j 2020 |e 12 |b 15 |c 12 | ||