COVID-19 coronavirus research has overall low methodological quality thus far: case in point for chloroquine/hydroxychloroquine.
Identifieur interne : 001888 ( Main/Corpus ); précédent : 001887; suivant : 001889COVID-19 coronavirus research has overall low methodological quality thus far: case in point for chloroquine/hydroxychloroquine.
Auteurs : Paul Elias Alexander ; Victoria Borg Debono ; Manoj J. Mammen ; Alfonso Iorio ; Komal Aryal ; Dianna Deng ; Eva Brocard ; Waleed AlhazzaniSource :
- Journal of clinical epidemiology [ 1878-5921 ] ; 2020.
English descriptors
- KwdEn :
- Biomedical Research (methods), COVID-19 (MeSH), Chloroquine (therapeutic use), Coronavirus Infections (drug therapy), Coronavirus Infections (epidemiology), Humans (MeSH), Hydroxychloroquine (therapeutic use), Observational Studies as Topic (MeSH), Pandemics (MeSH), Pneumonia, Viral (drug therapy), Pneumonia, Viral (epidemiology), Randomized Controlled Trials as Topic (MeSH), Research Design (standards).
- MESH :
- chemical , therapeutic use : Chloroquine, Hydroxychloroquine.
- drug therapy : Coronavirus Infections, Pneumonia, Viral.
- epidemiology : Coronavirus Infections, Pneumonia, Viral.
- methods : Biomedical Research.
- standards : Research Design.
- COVID-19, Humans, Observational Studies as Topic, Pandemics, Randomized Controlled Trials as Topic.
Abstract
OBJECTIVES/BACKGROUND AND OBJECTIVES
Prior epidemics of high-mortality human coronaviruses, such as the acute respiratory syndrome coronavirus (SARS-CoV or SARS-1) in 2003, have driven the characterization of compounds that could be possibly active against the currently emerging novel coronavirus SARS-CoV-2 (COVID-19). Presently, no approved treatment or prophylaxis is available for COVID-19. We comment on the existing COVID-19 research methodologies in general and the published reporting. Given the media attention and claims of effectiveness, we chose chloroquine and hydroxychloroquine, in combination with azithromycin, as an area of COVID-19 research to examine.
METHODS/STUDY DESIGN AND SETTING
MEDLINE and EMBASE electronic databases were searched from 2019 to present (April 3rd, 2020) using a mix of keywords such as COVID-19 and chloroquine and hydroxychloroquine. We also searched the largest clinical medicine preprint repository, medRxiv.org.
RESULTS
We found 6 studies, 3 randomized control trials and 3 observational studies, focusing on chloroquine and hydroxychloroquine (with azithromycin). We critically appraised the evidence.
CONCLUSION
We found that the COVID-19 research methodology is very poor in the area of chloroquine/hydroxychloroquine research. In screening the literature, we observed the same across COVID-19 research in relation to potential treatments. The reporting is very poor and sparse, and patient-important outcomes needed to discern decision-making priorities are not reported. We do understand the barriers to perform rigorous research in health care settings overwhelmed by a novel deadly disease. However, this emergency pandemic situation does not transform flawed methods and data into credible results. The adequately powered, comparative, and robust clinical research that is needed for optimal evidence-informed decision-making remains absent in COVID-19.
DOI: 10.1016/j.jclinepi.2020.04.016
PubMed: 32330521
PubMed Central: PMC7194626
Links to Exploration step
pubmed:32330521Le document en format XML
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Electronic address: alexap@mcmaster.ca.</nlm:affiliation></affiliation></author><author><name sortKey="Debono, Victoria Borg" sort="Debono, Victoria Borg" uniqKey="Debono V" first="Victoria Borg" last="Debono">Victoria Borg Debono</name><affiliation><nlm:affiliation>Health Research Methods, Evidence and Impact (HEI), Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada; Department of Anesthesia, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Mammen, Manoj J" sort="Mammen, Manoj J" uniqKey="Mammen M" first="Manoj J" last="Mammen">Manoj J. Mammen</name><affiliation><nlm:affiliation>Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Iorio, Alfonso" sort="Iorio, Alfonso" uniqKey="Iorio A" first="Alfonso" last="Iorio">Alfonso Iorio</name><affiliation><nlm:affiliation>Health Research Methods, Evidence and Impact (HEI), Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada; Department of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Aryal, Komal" sort="Aryal, Komal" uniqKey="Aryal K" first="Komal" last="Aryal">Komal Aryal</name><affiliation><nlm:affiliation>Health Research Methods, Evidence and Impact (HEI), Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Deng, Dianna" sort="Deng, Dianna" uniqKey="Deng D" first="Dianna" last="Deng">Dianna Deng</name><affiliation><nlm:affiliation>Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Brocard, Eva" sort="Brocard, Eva" uniqKey="Brocard E" first="Eva" last="Brocard">Eva Brocard</name><affiliation><nlm:affiliation>Graduate Student (International Intern), France.</nlm:affiliation></affiliation></author><author><name sortKey="Alhazzani, Waleed" sort="Alhazzani, Waleed" uniqKey="Alhazzani W" first="Waleed" last="Alhazzani">Waleed Alhazzani</name><affiliation><nlm:affiliation>Health Research Methods, Evidence and Impact (HEI), Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada; GUIDE Research Methods Group, McMaster University, Hamilton, Ontario, Canada; Department of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2020">2020</date><idno type="RBID">pubmed:32330521</idno><idno type="pmid">32330521</idno><idno type="doi">10.1016/j.jclinepi.2020.04.016</idno><idno type="pmc">PMC7194626</idno><idno type="wicri:Area/Main/Corpus">001888</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">001888</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">COVID-19 coronavirus research has overall low methodological quality thus far: case in point for chloroquine/hydroxychloroquine.</title><author><name sortKey="Alexander, Paul Elias" sort="Alexander, Paul Elias" uniqKey="Alexander P" first="Paul Elias" last="Alexander">Paul Elias Alexander</name><affiliation><nlm:affiliation>Health Research Methods, Evidence and Impact (HEI), Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada; GUIDE Research Methods Group, McMaster University, Hamilton, Ontario, Canada. Electronic address: alexap@mcmaster.ca.</nlm:affiliation></affiliation></author><author><name sortKey="Debono, Victoria Borg" sort="Debono, Victoria Borg" uniqKey="Debono V" first="Victoria Borg" last="Debono">Victoria Borg Debono</name><affiliation><nlm:affiliation>Health Research Methods, Evidence and Impact (HEI), Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada; Department of Anesthesia, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Mammen, Manoj J" sort="Mammen, Manoj J" uniqKey="Mammen M" first="Manoj J" last="Mammen">Manoj J. Mammen</name><affiliation><nlm:affiliation>Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Iorio, Alfonso" sort="Iorio, Alfonso" uniqKey="Iorio A" first="Alfonso" last="Iorio">Alfonso Iorio</name><affiliation><nlm:affiliation>Health Research Methods, Evidence and Impact (HEI), Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada; Department of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Aryal, Komal" sort="Aryal, Komal" uniqKey="Aryal K" first="Komal" last="Aryal">Komal Aryal</name><affiliation><nlm:affiliation>Health Research Methods, Evidence and Impact (HEI), Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Deng, Dianna" sort="Deng, Dianna" uniqKey="Deng D" first="Dianna" last="Deng">Dianna Deng</name><affiliation><nlm:affiliation>Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Brocard, Eva" sort="Brocard, Eva" uniqKey="Brocard E" first="Eva" last="Brocard">Eva Brocard</name><affiliation><nlm:affiliation>Graduate Student (International Intern), France.</nlm:affiliation></affiliation></author><author><name sortKey="Alhazzani, Waleed" sort="Alhazzani, Waleed" uniqKey="Alhazzani W" first="Waleed" last="Alhazzani">Waleed Alhazzani</name><affiliation><nlm:affiliation>Health Research Methods, Evidence and Impact (HEI), Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada; GUIDE Research Methods Group, McMaster University, Hamilton, Ontario, Canada; Department of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Journal of clinical epidemiology</title><idno type="eISSN">1878-5921</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Biomedical Research (methods)</term><term>COVID-19 (MeSH)</term><term>Chloroquine (therapeutic use)</term><term>Coronavirus Infections (drug therapy)</term><term>Coronavirus Infections (epidemiology)</term><term>Humans (MeSH)</term><term>Hydroxychloroquine (therapeutic use)</term><term>Observational Studies as Topic (MeSH)</term><term>Pandemics (MeSH)</term><term>Pneumonia, Viral (drug therapy)</term><term>Pneumonia, Viral (epidemiology)</term><term>Randomized Controlled Trials as Topic (MeSH)</term><term>Research Design (standards)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Chloroquine</term><term>Hydroxychloroquine</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Coronavirus Infections</term><term>Pneumonia, Viral</term></keywords><keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Coronavirus Infections</term><term>Pneumonia, Viral</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Biomedical Research</term></keywords><keywords scheme="MESH" qualifier="standards" xml:lang="en"><term>Research Design</term></keywords><keywords scheme="MESH" xml:lang="en"><term>COVID-19</term><term>Humans</term><term>Observational Studies as Topic</term><term>Pandemics</term><term>Randomized Controlled Trials as Topic</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>OBJECTIVES/BACKGROUND AND OBJECTIVES</b></p><p>Prior epidemics of high-mortality human coronaviruses, such as the acute respiratory syndrome coronavirus (SARS-CoV or SARS-1) in 2003, have driven the characterization of compounds that could be possibly active against the currently emerging novel coronavirus SARS-CoV-2 (COVID-19). Presently, no approved treatment or prophylaxis is available for COVID-19. We comment on the existing COVID-19 research methodologies in general and the published reporting. Given the media attention and claims of effectiveness, we chose chloroquine and hydroxychloroquine, in combination with azithromycin, as an area of COVID-19 research to examine.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS/STUDY DESIGN AND SETTING</b></p><p>MEDLINE and EMBASE electronic databases were searched from 2019 to present (April 3rd, 2020) using a mix of keywords such as COVID-19 and chloroquine and hydroxychloroquine. We also searched the largest clinical medicine preprint repository, medRxiv.org.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>We found 6 studies, 3 randomized control trials and 3 observational studies, focusing on chloroquine and hydroxychloroquine (with azithromycin). We critically appraised the evidence.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSION</b></p><p>We found that the COVID-19 research methodology is very poor in the area of chloroquine/hydroxychloroquine research. In screening the literature, we observed the same across COVID-19 research in relation to potential treatments. The reporting is very poor and sparse, and patient-important outcomes needed to discern decision-making priorities are not reported. We do understand the barriers to perform rigorous research in health care settings overwhelmed by a novel deadly disease. However, this emergency pandemic situation does not transform flawed methods and data into credible results. The adequately powered, comparative, and robust clinical research that is needed for optimal evidence-informed decision-making remains absent in COVID-19.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">32330521</PMID><DateCompleted><Year>2020</Year><Month>06</Month><Day>18</Day></DateCompleted><DateRevised><Year>2020</Year><Month>12</Month><Day>18</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1878-5921</ISSN><JournalIssue CitedMedium="Internet"><Volume>123</Volume><PubDate><Year>2020</Year><Month>07</Month></PubDate></JournalIssue><Title>Journal of clinical epidemiology</Title><ISOAbbreviation>J Clin Epidemiol</ISOAbbreviation></Journal><ArticleTitle>COVID-19 coronavirus research has overall low methodological quality thus far: case in point for chloroquine/hydroxychloroquine.</ArticleTitle><Pagination><MedlinePgn>120-126</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S0895-4356(20)30371-1</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.jclinepi.2020.04.016</ELocationID><Abstract><AbstractText Label="OBJECTIVES/BACKGROUND AND OBJECTIVES">Prior epidemics of high-mortality human coronaviruses, such as the acute respiratory syndrome coronavirus (SARS-CoV or SARS-1) in 2003, have driven the characterization of compounds that could be possibly active against the currently emerging novel coronavirus SARS-CoV-2 (COVID-19). Presently, no approved treatment or prophylaxis is available for COVID-19. We comment on the existing COVID-19 research methodologies in general and the published reporting. Given the media attention and claims of effectiveness, we chose chloroquine and hydroxychloroquine, in combination with azithromycin, as an area of COVID-19 research to examine.</AbstractText><AbstractText Label="METHODS/STUDY DESIGN AND SETTING">MEDLINE and EMBASE electronic databases were searched from 2019 to present (April 3rd, 2020) using a mix of keywords such as COVID-19 and chloroquine and hydroxychloroquine. We also searched the largest clinical medicine preprint repository, medRxiv.org.</AbstractText><AbstractText Label="RESULTS">We found 6 studies, 3 randomized control trials and 3 observational studies, focusing on chloroquine and hydroxychloroquine (with azithromycin). We critically appraised the evidence.</AbstractText><AbstractText Label="CONCLUSION">We found that the COVID-19 research methodology is very poor in the area of chloroquine/hydroxychloroquine research. In screening the literature, we observed the same across COVID-19 research in relation to potential treatments. The reporting is very poor and sparse, and patient-important outcomes needed to discern decision-making priorities are not reported. We do understand the barriers to perform rigorous research in health care settings overwhelmed by a novel deadly disease. However, this emergency pandemic situation does not transform flawed methods and data into credible results. The adequately powered, comparative, and robust clinical research that is needed for optimal evidence-informed decision-making remains absent in COVID-19.</AbstractText><CopyrightInformation>Copyright © 2020 Elsevier Inc. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Alexander</LastName><ForeName>Paul Elias</ForeName><Initials>PE</Initials><AffiliationInfo><Affiliation>Health Research Methods, Evidence and Impact (HEI), Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada; GUIDE Research Methods Group, McMaster University, Hamilton, Ontario, Canada. Electronic address: alexap@mcmaster.ca.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Debono</LastName><ForeName>Victoria Borg</ForeName><Initials>VB</Initials><AffiliationInfo><Affiliation>Health Research Methods, Evidence and Impact (HEI), Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada; Department of Anesthesia, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mammen</LastName><ForeName>Manoj J</ForeName><Initials>MJ</Initials><AffiliationInfo><Affiliation>Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Iorio</LastName><ForeName>Alfonso</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Health Research Methods, Evidence and Impact (HEI), Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada; Department of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Aryal</LastName><ForeName>Komal</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Health Research Methods, Evidence and Impact (HEI), Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Deng</LastName><ForeName>Dianna</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Brocard</LastName><ForeName>Eva</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Graduate Student (International Intern), France.</Affiliation></AffiliationInfo></Author><Author 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