Randomised controlled trials for COVID-19: evaluation of optimal randomisation methodologies-need for data validation of the completed trials and to improve ongoing and future randomised trial designs.
Identifieur interne : 000837 ( Main/Corpus ); précédent : 000836; suivant : 000838Randomised controlled trials for COVID-19: evaluation of optimal randomisation methodologies-need for data validation of the completed trials and to improve ongoing and future randomised trial designs.
Auteurs : Venkata R. Emani ; Sanjeev Goswami ; Dheeraj Nandanoor ; Shaila R. Emani ; Nidhi K. Reddy ; Raghunath ReddySource :
- International journal of antimicrobial agents [ 1872-7913 ] ; 2021.
English descriptors
- KwdEn :
- COVID-19 (drug therapy), COVID-19 (mortality), Critical Illness (MeSH), Hospitalization (MeSH), Humans (MeSH), Hydroxychloroquine (therapeutic use), Lopinavir (therapeutic use), Mortality (MeSH), Randomized Controlled Trials as Topic (methods), Randomized Controlled Trials as Topic (statistics & numerical data), Ritonavir (therapeutic use), Selection Bias (MeSH).
- MESH :
- chemical , therapeutic use : Hydroxychloroquine, Lopinavir, Ritonavir.
- drug therapy : COVID-19.
- methods : Randomized Controlled Trials as Topic.
- mortality : COVID-19.
- statistics & numerical data : Randomized Controlled Trials as Topic.
- Critical Illness, Hospitalization, Humans, Mortality, Selection Bias.
Abstract
During the emerging COVID-19 (coronavirus disease 2019) pandemic, initially there were no proven treatment options. With the release of randomised controlled trial (RCT) results, we are beginning to see possible treatment options for COVID-19. The RECOVERY trial showed an absolute risk reduction in mortality by 2.8% with dexamethasone, and the ACTT-1 trial showed that treatment with remdesivir reduced the time to recovery by 4 days. Treatment with hydroxychloroquine (HCQ) and lopinavir/ritonavir did not show any mortality benefit in either the RECOVERY or World Health Organization (WHO) Solidarity trials. The National Institutes of Health (NIH) and Brazilian HCQ trials did not show any benefit for HCQ based on the seven-point ordinal scale outcomes. The randomisation methodologies utilised in these controlled trials and the quality of published data were reviewed to examine their adaptability to treat patients. We found that the randomisation methodologies of these trials were suboptimal for matching the studied groups based on disease severity among critically-ill hospitalised COVID-19 patients with high mortality rates. The published literature is very limited regarding the disease severity metrics among the compared groups and failed to show that the data are without fatal sampling errors and sampling biases. We also found that there is a definite need for the validation of data in these trials along with additional important disease severity metrics to ensure that the trials' conclusions are accurate. We also propose proper randomisation methodologies for the design of RCTs for COVID-19 as well as guidance for the publication of COVID-19 trial results.
DOI: 10.1016/j.ijantimicag.2020.106222
PubMed: 33189891
PubMed Central: PMC7659806
Links to Exploration step
pubmed:33189891Le document en format XML
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Electronic address: vemani@yahoo.com.</nlm:affiliation></affiliation></author><author><name sortKey="Goswami, Sanjeev" sort="Goswami, Sanjeev" uniqKey="Goswami S" first="Sanjeev" last="Goswami">Sanjeev Goswami</name><affiliation><nlm:affiliation>San Joaquin Critical Care Medical Group, 1801 E March Ln c300, Stockton, CA 95210, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Nandanoor, Dheeraj" sort="Nandanoor, Dheeraj" uniqKey="Nandanoor D" first="Dheeraj" last="Nandanoor">Dheeraj Nandanoor</name><affiliation><nlm:affiliation>Synergy Med, 1801 E March Ln STE D460, Stockton, CA 95210, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Emani, Shaila R" sort="Emani, Shaila R" uniqKey="Emani S" first="Shaila R" last="Emani">Shaila R. Emani</name><affiliation><nlm:affiliation>Central Valley Cardiovascular Associates, Inc., 1148 Norman Drive, Suite #2, Manteca, CA 95336, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Reddy, Nidhi K" sort="Reddy, Nidhi K" uniqKey="Reddy N" first="Nidhi K" last="Reddy">Nidhi K. 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Emani</name><affiliation><nlm:affiliation>Central Valley Cardiovascular Associates, Inc., 1148 Norman Drive, Suite #2, Manteca, CA 95336, USA. Electronic address: vemani@yahoo.com.</nlm:affiliation></affiliation></author><author><name sortKey="Goswami, Sanjeev" sort="Goswami, Sanjeev" uniqKey="Goswami S" first="Sanjeev" last="Goswami">Sanjeev Goswami</name><affiliation><nlm:affiliation>San Joaquin Critical Care Medical Group, 1801 E March Ln c300, Stockton, CA 95210, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Nandanoor, Dheeraj" sort="Nandanoor, Dheeraj" uniqKey="Nandanoor D" first="Dheeraj" last="Nandanoor">Dheeraj Nandanoor</name><affiliation><nlm:affiliation>Synergy Med, 1801 E March Ln STE D460, Stockton, CA 95210, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Emani, Shaila R" sort="Emani, Shaila R" uniqKey="Emani S" first="Shaila R" last="Emani">Shaila R. Emani</name><affiliation><nlm:affiliation>Central Valley Cardiovascular Associates, Inc., 1148 Norman Drive, Suite #2, Manteca, CA 95336, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Reddy, Nidhi K" sort="Reddy, Nidhi K" uniqKey="Reddy N" first="Nidhi K" last="Reddy">Nidhi K. Reddy</name><affiliation><nlm:affiliation>Stockton Primary Care, 805 N California St #102, Stockton, CA 95204, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Reddy, Raghunath" sort="Reddy, Raghunath" uniqKey="Reddy R" first="Raghunath" last="Reddy">Raghunath Reddy</name><affiliation><nlm:affiliation>Stockton Primary Care, 805 N California St #102, Stockton, CA 95204, USA.</nlm:affiliation></affiliation></author></analytic><series><title level="j">International journal of antimicrobial agents</title><idno type="eISSN">1872-7913</idno><imprint><date when="2021" type="published">2021</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>COVID-19 (drug therapy)</term><term>COVID-19 (mortality)</term><term>Critical Illness (MeSH)</term><term>Hospitalization (MeSH)</term><term>Humans (MeSH)</term><term>Hydroxychloroquine (therapeutic use)</term><term>Lopinavir (therapeutic use)</term><term>Mortality (MeSH)</term><term>Randomized Controlled Trials as Topic (methods)</term><term>Randomized Controlled Trials as Topic (statistics & numerical data)</term><term>Ritonavir (therapeutic use)</term><term>Selection Bias (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Hydroxychloroquine</term><term>Lopinavir</term><term>Ritonavir</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>COVID-19</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Randomized Controlled Trials as Topic</term></keywords><keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>COVID-19</term></keywords><keywords scheme="MESH" qualifier="statistics & numerical data" xml:lang="en"><term>Randomized Controlled Trials as Topic</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Critical Illness</term><term>Hospitalization</term><term>Humans</term><term>Mortality</term><term>Selection Bias</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">During the emerging COVID-19 (coronavirus disease 2019) pandemic, initially there were no proven treatment options. With the release of randomised controlled trial (RCT) results, we are beginning to see possible treatment options for COVID-19. The RECOVERY trial showed an absolute risk reduction in mortality by 2.8% with dexamethasone, and the ACTT-1 trial showed that treatment with remdesivir reduced the time to recovery by 4 days. Treatment with hydroxychloroquine (HCQ) and lopinavir/ritonavir did not show any mortality benefit in either the RECOVERY or World Health Organization (WHO) Solidarity trials. The National Institutes of Health (NIH) and Brazilian HCQ trials did not show any benefit for HCQ based on the seven-point ordinal scale outcomes. The randomisation methodologies utilised in these controlled trials and the quality of published data were reviewed to examine their adaptability to treat patients. We found that the randomisation methodologies of these trials were suboptimal for matching the studied groups based on disease severity among critically-ill hospitalised COVID-19 patients with high mortality rates. The published literature is very limited regarding the disease severity metrics among the compared groups and failed to show that the data are without fatal sampling errors and sampling biases. We also found that there is a definite need for the validation of data in these trials along with additional important disease severity metrics to ensure that the trials' conclusions are accurate. We also propose proper randomisation methodologies for the design of RCTs for COVID-19 as well as guidance for the publication of COVID-19 trial results.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">33189891</PMID><DateCompleted><Year>2021</Year><Month>01</Month><Day>22</Day></DateCompleted><DateRevised><Year>2021</Year><Month>03</Month><Day>10</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1872-7913</ISSN><JournalIssue CitedMedium="Internet"><Volume>57</Volume><Issue>1</Issue><PubDate><Year>2021</Year><Month>Jan</Month></PubDate></JournalIssue><Title>International journal of antimicrobial agents</Title><ISOAbbreviation>Int J Antimicrob Agents</ISOAbbreviation></Journal><ArticleTitle>Randomised controlled trials for COVID-19: evaluation of optimal randomisation methodologies-need for data validation of the completed trials and to improve ongoing and future randomised trial designs.</ArticleTitle><Pagination><MedlinePgn>106222</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S0924-8579(20)30433-7</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.ijantimicag.2020.106222</ELocationID><Abstract><AbstractText>During the emerging COVID-19 (coronavirus disease 2019) pandemic, initially there were no proven treatment options. With the release of randomised controlled trial (RCT) results, we are beginning to see possible treatment options for COVID-19. The RECOVERY trial showed an absolute risk reduction in mortality by 2.8% with dexamethasone, and the ACTT-1 trial showed that treatment with remdesivir reduced the time to recovery by 4 days. Treatment with hydroxychloroquine (HCQ) and lopinavir/ritonavir did not show any mortality benefit in either the RECOVERY or World Health Organization (WHO) Solidarity trials. The National Institutes of Health (NIH) and Brazilian HCQ trials did not show any benefit for HCQ based on the seven-point ordinal scale outcomes. The randomisation methodologies utilised in these controlled trials and the quality of published data were reviewed to examine their adaptability to treat patients. We found that the randomisation methodologies of these trials were suboptimal for matching the studied groups based on disease severity among critically-ill hospitalised COVID-19 patients with high mortality rates. The published literature is very limited regarding the disease severity metrics among the compared groups and failed to show that the data are without fatal sampling errors and sampling biases. We also found that there is a definite need for the validation of data in these trials along with additional important disease severity metrics to ensure that the trials' conclusions are accurate. We also propose proper randomisation methodologies for the design of RCTs for COVID-19 as well as guidance for the publication of COVID-19 trial results.</AbstractText><CopyrightInformation>Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Emani</LastName><ForeName>Venkata R</ForeName><Initials>VR</Initials><AffiliationInfo><Affiliation>Central Valley Cardiovascular Associates, Inc., 1148 Norman Drive, Suite #2, Manteca, CA 95336, USA. Electronic address: vemani@yahoo.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Goswami</LastName><ForeName>Sanjeev</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>San Joaquin Critical Care Medical Group, 1801 E March Ln c300, Stockton, CA 95210, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Nandanoor</LastName><ForeName>Dheeraj</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Synergy Med, 1801 E March Ln STE D460, Stockton, CA 95210, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Emani</LastName><ForeName>Shaila R</ForeName><Initials>SR</Initials><AffiliationInfo><Affiliation>Central Valley Cardiovascular Associates, Inc., 1148 Norman Drive, Suite #2, Manteca, CA 95336, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Reddy</LastName><ForeName>Nidhi K</ForeName><Initials>NK</Initials><AffiliationInfo><Affiliation>Stockton Primary Care, 805 N California St #102, Stockton, CA 95204, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Reddy</LastName><ForeName>Raghunath</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Stockton Primary Care, 805 N California St #102, Stockton, CA 95204, USA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016454">Review</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>11</Month><Day>12</Day></ArticleDate></Article><MedlineJournalInfo><Country>Netherlands</Country><MedlineTA>Int J Antimicrob Agents</MedlineTA><NlmUniqueID>9111860</NlmUniqueID><ISSNLinking>0924-8579</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>2494G1JF75</RegistryNumber><NameOfSubstance 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|area= CovidChloroV1
|flux= Main
|étape= Corpus
|type= RBID
|clé= pubmed:33189891
|texte= Randomised controlled trials for COVID-19: evaluation of optimal randomisation methodologies-need for data validation of the completed trials and to improve ongoing and future randomised trial designs.
}}
Pour générer des pages wiki
HfdIndexSelect -h $EXPLOR_AREA/Data/Main/Corpus/RBID.i -Sk "pubmed:33189891" \
| HfdSelect -Kh $EXPLOR_AREA/Data/Main/Corpus/biblio.hfd \
| NlmPubMed2Wicri -a CovidChloroV1
| This area was generated with Dilib version V0.6.38. |  |