Bringing New Meaning to the Term "Adaptive Trial": Challenges of Conducting Clinical Research During the Coronavirus Disease 2019 Pandemic and Implications for Implementation Science.
Identifieur interne : 000226 ( Main/Exploration ); précédent : 000225; suivant : 000227Bringing New Meaning to the Term "Adaptive Trial": Challenges of Conducting Clinical Research During the Coronavirus Disease 2019 Pandemic and Implications for Implementation Science.
Auteurs : Westyn Branch-Elliman [États-Unis] ; A Rani Elwy [États-Unis] ; Paul Monach [États-Unis]Source :
- Open forum infectious diseases [ 2328-8957 ] ; 2020.
Abstract
Although implementation of evidence-based practices takes an average of 17 years, in the context of the global pandemic, coronavirus disease 2019 (COVID-19) interventions were adopted in a greatly compressed time frame. This rapid uptake creates major challenges for conducting COVID-19 clinical research studies, because quickly evolving standards make it difficult to adapt in real time. The rapid dissemination and implementation of COVID-19 interventions is the realization of goals long pursued by the implementation science community. However, the downside of the rapid implementation is that low-quality evidence with little to no scientific vetting may be quickly integrated into clinical care, resulting in lost opportunities to advance our scientific understanding about how to manage infected patients. In the future, novel adaptive designs embedded into electronic health records (Embedded Quantified, Integrated-into-Practice Trial [EQuIPT] designs) that allow for easier and better access to clinical trials may simultaneously improve care and advance healthcare innovations.
DOI: 10.1093/ofid/ofaa490
PubMed: 33204763
PubMed Central: PMC7654375
Affiliations:
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This rapid uptake creates major challenges for conducting COVID-19 clinical research studies, because quickly evolving standards make it difficult to adapt in real time. The rapid dissemination and implementation of COVID-19 interventions is the realization of goals long pursued by the implementation science community. However, the downside of the rapid implementation is that low-quality evidence with little to no scientific vetting may be quickly integrated into clinical care, resulting in lost opportunities to advance our scientific understanding about how to manage infected patients. In the future, novel adaptive designs embedded into electronic health records (Embedded Quantified, Integrated-into-Practice Trial [EQuIPT] designs) that allow for easier and better access to clinical trials may simultaneously improve care and advance healthcare innovations.</div></front></TEI><pubmed><MedlineCitation Status="PubMed-not-MEDLINE" Owner="NLM"><PMID Version="1">33204763</PMID><DateRevised><Year>2020</Year><Month>11</Month><Day>18</Day></DateRevised><Article PubModel="Electronic-eCollection"><Journal><ISSN IssnType="Print">2328-8957</ISSN><JournalIssue CitedMedium="Print"><Volume>7</Volume><Issue>11</Issue><PubDate><Year>2020</Year><Month>Nov</Month></PubDate></JournalIssue><Title>Open forum infectious diseases</Title><ISOAbbreviation>Open Forum Infect Dis</ISOAbbreviation></Journal><ArticleTitle>Bringing New Meaning to the Term "Adaptive Trial": Challenges of Conducting Clinical Research During the Coronavirus Disease 2019 Pandemic and Implications for Implementation Science.</ArticleTitle><Pagination><MedlinePgn>ofaa490</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1093/ofid/ofaa490</ELocationID><Abstract><AbstractText>Although implementation of evidence-based practices takes an average of 17 years, in the context of the global pandemic, coronavirus disease 2019 (COVID-19) interventions were adopted in a greatly compressed time frame. This rapid uptake creates major challenges for conducting COVID-19 clinical research studies, because quickly evolving standards make it difficult to adapt in real time. The rapid dissemination and implementation of COVID-19 interventions is the realization of goals long pursued by the implementation science community. However, the downside of the rapid implementation is that low-quality evidence with little to no scientific vetting may be quickly integrated into clinical care, resulting in lost opportunities to advance our scientific understanding about how to manage infected patients. In the future, novel adaptive designs embedded into electronic health records (Embedded Quantified, Integrated-into-Practice Trial [EQuIPT] designs) that allow for easier and better access to clinical trials may simultaneously improve care and advance healthcare innovations.</AbstractText><CopyrightInformation>Published by Oxford University Press on behalf of Infectious Diseases Society of America 2020.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Branch-Elliman</LastName><ForeName>Westyn</ForeName><Initials>W</Initials><Identifier Source="ORCID">0000-0002-9658-5124</Identifier><AffiliationInfo><Affiliation>VA Boston Healthcare System, Department of Medicine, Boston, Massachussetts, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Harvard Medical School, Boston, Massachussetts, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>VA Boston Center for Healthcare Organization and Implementation Research (CHOIR), Boston, Massachussetts, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Elwy</LastName><ForeName>A Rani</ForeName><Initials>AR</Initials><AffiliationInfo><Affiliation>VA Boston Center for Healthcare Organization and Implementation Research (CHOIR), Boston, Massachussetts, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Alpert Medical School of Brown University, Department of Psychiatry and Human Behavior, Providence, Rhode Island, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Monach</LastName><ForeName>Paul</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>VA Boston Healthcare System, Department of Medicine, Boston, Massachussetts, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Harvard Medical School, Boston, Massachussetts, USA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016421">Editorial</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>10</Month><Day>19</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Open Forum Infect Dis</MedlineTA><NlmUniqueID>101637045</NlmUniqueID><ISSNLinking>2328-8957</ISSNLinking></MedlineJournalInfo><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">COVID-19</Keyword><Keyword MajorTopicYN="N">adaptive clinical trials</Keyword><Keyword MajorTopicYN="N">diffusion of innovations</Keyword><Keyword MajorTopicYN="N">implementation science</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>09</Month><Day>21</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2020</Year><Month>10</Month><Day>15</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>11</Month><Day>18</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>11</Month><Day>19</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2020</Year><Month>11</Month><Day>19</Day><Hour>6</Hour><Minute>1</Minute></PubMedPubDate></History><PublicationStatus>epublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">33204763</ArticleId><ArticleId IdType="doi">10.1093/ofid/ofaa490</ArticleId><ArticleId IdType="pii">ofaa490</ArticleId><ArticleId IdType="pmc">PMC7654375</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>États-Unis</li></country><region><li>Rhode Island</li></region></list><tree><country name="États-Unis"><noRegion><name sortKey="Branch Elliman, Westyn" sort="Branch Elliman, Westyn" uniqKey="Branch Elliman W" first="Westyn" last="Branch-Elliman">Westyn Branch-Elliman</name></noRegion><name sortKey="Branch Elliman, Westyn" sort="Branch Elliman, Westyn" uniqKey="Branch Elliman W" first="Westyn" last="Branch-Elliman">Westyn Branch-Elliman</name><name sortKey="Branch Elliman, Westyn" sort="Branch Elliman, Westyn" uniqKey="Branch Elliman W" first="Westyn" last="Branch-Elliman">Westyn Branch-Elliman</name><name sortKey="Elwy, A Rani" sort="Elwy, A Rani" uniqKey="Elwy A" first="A Rani" last="Elwy">A Rani Elwy</name><name sortKey="Elwy, A Rani" sort="Elwy, A Rani" uniqKey="Elwy A" first="A Rani" last="Elwy">A Rani Elwy</name><name sortKey="Monach, Paul" sort="Monach, Paul" uniqKey="Monach P" first="Paul" last="Monach">Paul Monach</name><name sortKey="Monach, Paul" sort="Monach, Paul" uniqKey="Monach P" first="Paul" last="Monach">Paul Monach</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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