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Implementing an outpatient clinical trial on COVID-19 treatment in an emergency epidemic context: a mixed methods study among operational and research stakeholders within the Coverage trial, Bordeaux (France)

dc.rights.licenseopenen_US
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorGRENIER, Carine
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorLONIEWSKI, Macha
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorPLAZY, Melanie
dc.contributor.authorONAISI, Racha
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorDOUCET, Marie-Helene
dc.contributor.authorJOSEPH, Jean-Philippe
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorDUVIGNAUD, Alexandre
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorMALVY, Denis
ORCID: 0000-0003-1948-9355
IDREF: 148480993
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorANGLARET, Xavier
hal.structure.identifierBordeaux population health [BPH]
hal.structure.identifierGlobal Health in the Global South [GHiGS]
dc.contributor.authorORNE-GLIEMANN, Joanna
dc.date.accessioned2023-02-15T10:59:21Z
dc.date.available2023-02-15T10:59:21Z
dc.date.issued2022-12-03
dc.identifier.issn0778-7367en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/171960
dc.description.abstractEnBACKGROUND: The emergency set-up and implementation of outpatient clinical trials on epidemic emerging infectious diseases such as COVID-19 raise many issues in terms of research structuration, regulations, and health systems organization. We aimed to describe the experience and points of view of different stakeholders involved in a French home-based outpatient trial on COVID-19 and to identify the early barriers and facilitators to the trial implementation. METHODS: We conducted a mixed-methods study in July 2020. A self-administered questionnaire was emailed to 213 clinical, operational and research stakeholders involved in the Coverage trial; individual semi-directed interviews were conducted among 14 stakeholders. Questionnaire data and written interview notes are presented together by key theme. RESULTS: One hundred fifty six stakeholders responded to the questionnaire. 53.4% did not have prior experience in clinical research. The motivation of most stakeholders to participate in the Coverage trial was to feel useful during the pandemic. 87.9% agreed that the trial had an unusual set-up timeframe, and many regretted a certain lack of regulatory flexibility. Mobile medical teams and specific professional skills were perceived as instrumental for outpatient research. CONCLUSIONS: The implementation of a home-based outpatient clinical trial on COVID-19 was perceived as relevant and innovative although requiring important adaptations of usual professional responsibilities and standard research procedures. Lessons learned from the Coverage trial underline the need for improved networks between hospital and community medicine, and call for a dedicated and reactive outpatient research platform on emerging or threatening infectious diseases.
dc.description.sponsorshipTraitement à domicile des personnes infectées par le SRAS-CoV-2 sans signe de gravité mais à risque de complications: un essai randomisé à plusieurs bras et en plusieurs étapes (MAMS) pour évaluer l'efficacité de plusieurs antiviraux - ANR-20-COVI-0040en_US
dc.language.isoENen_US
dc.rightsAttribution 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/us/*
dc.subject.enCovid
dc.subject.enTreatment
dc.subject.enAmbulatory
dc.subject.enPerceptions
dc.subject.enImplementation
dc.title.enImplementing an outpatient clinical trial on COVID-19 treatment in an emergency epidemic context: a mixed methods study among operational and research stakeholders within the Coverage trial, Bordeaux (France)
dc.title.alternativeArch Public Healthen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1186/s13690-022-00999-9en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed36463300en_US
bordeaux.journalArchives of Public Healthen_US
bordeaux.volume80en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue1en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamGHIGS_BPHen_US
bordeaux.teamPHARES_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
bordeaux.identifier.funderIDAgence Nationale de la Rechercheen_US
hal.exportfalse
dc.rights.ccPas de Licence CCen_US
bordeaux.COinSctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=Archives%20of%20Public%20Health&rft.date=2022-12-03&rft.volume=80&rft.issue=1&rft.eissn=0778-7367&rft.issn=0778-7367&rft.au=GRENIER,%20Carine&LONIEWSKI,%20Macha&PLAZY,%20Melanie&ONAISI,%20Racha&DOUCET,%20Marie-Helene&rft.genre=article


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