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.license | open | en_US |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| dc.contributor.author | GRENIER, Carine | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| dc.contributor.author | LONIEWSKI, Macha | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| hal.structure.identifier | Global Health in the Global South [GHiGS] | |
| dc.contributor.author | PLAZY, Melanie | |
| dc.contributor.author | ONAISI, Racha | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| hal.structure.identifier | Global Health in the Global South [GHiGS] | |
| dc.contributor.author | DOUCET, Marie-Helene | |
| dc.contributor.author | JOSEPH, Jean-Philippe | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| hal.structure.identifier | Global Health in the Global South [GHiGS] | |
| dc.contributor.author | DUVIGNAUD, Alexandre | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| hal.structure.identifier | Global Health in the Global South [GHiGS] | |
| dc.contributor.author | MALVY, Denis | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| hal.structure.identifier | Global Health in the Global South [GHiGS] | |
| dc.contributor.author | ANGLARET, Xavier | |
| hal.structure.identifier | Bordeaux population health [BPH] | |
| hal.structure.identifier | Global Health in the Global South [GHiGS] | |
| dc.contributor.author | ORNE-GLIEMANN, Joanna | |
| dc.date.accessioned | 2023-02-15T10:59:21Z | |
| dc.date.available | 2023-02-15T10:59:21Z | |
| dc.date.issued | 2022-12-03 | |
| dc.identifier.issn | 0778-7367 | en_US |
| dc.identifier.uri | https://oskar-bordeaux.fr/handle/20.500.12278/171960 | |
| dc.description.abstractEn | BACKGROUND: 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.sponsorship | Traitement 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 | en_US |
| dc.language.iso | EN | en_US |
| dc.rights | Attribution 3.0 United States | * |
| dc.rights.uri | http://creativecommons.org/licenses/by/3.0/us/ | * |
| dc.subject.en | Covid | |
| dc.subject.en | Treatment | |
| dc.subject.en | Ambulatory | |
| dc.subject.en | Perceptions | |
| dc.subject.en | Implementation | |
| dc.title.en | 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.title.alternative | Arch Public Health | en_US |
| dc.type | Article de revue | en_US |
| dc.identifier.doi | 10.1186/s13690-022-00999-9 | en_US |
| dc.subject.hal | Sciences du Vivant [q-bio]/Santé publique et épidémiologie | en_US |
| dc.identifier.pubmed | 36463300 | en_US |
| bordeaux.journal | Archives of Public Health | en_US |
| bordeaux.volume | 80 | en_US |
| bordeaux.hal.laboratories | Bordeaux Population Health Research Center (BPH) - UMR 1219 | en_US |
| bordeaux.issue | 1 | en_US |
| bordeaux.institution | Université de Bordeaux | en_US |
| bordeaux.institution | INSERM | en_US |
| bordeaux.team | GHIGS_BPH | en_US |
| bordeaux.team | PHARES_BPH | en_US |
| bordeaux.peerReviewed | oui | en_US |
| bordeaux.inpress | non | en_US |
| bordeaux.identifier.funderID | Agence Nationale de la Recherche | en_US |
| hal.export | false | |
| dc.rights.cc | Pas de Licence CC | en_US |
| bordeaux.COinS | ctx_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 |
