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)
Abstract 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 vi...
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| Format: | Article |
| Language: | English |
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BMC
2022-12-01
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| Series: | Archives of Public Health |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13690-022-00999-9 |
| _version_ | 1797985537180565504 |
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| author | Carine Grenier Macha Loniewski Mélanie Plazy Racha Onaisi Marie-Hélène Doucet Jean-Philippe Joseph Alexandre Duvignaud Denis Malvy Xavier Anglaret Joanna Orne-Gliemann the Coverage study group |
| author_facet | Carine Grenier Macha Loniewski Mélanie Plazy Racha Onaisi Marie-Hélène Doucet Jean-Philippe Joseph Alexandre Duvignaud Denis Malvy Xavier Anglaret Joanna Orne-Gliemann the Coverage study group |
| author_sort | Carine Grenier |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-04-11T07:19:46Z |
| format | Article |
| id | doaj.art-450c10513c634982800b538120e215d5 |
| institution | Directory Open Access Journal |
| issn | 2049-3258 |
| language | English |
| last_indexed | 2024-04-11T07:19:46Z |
| publishDate | 2022-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Archives of Public Health |
| spelling | doaj.art-450c10513c634982800b538120e215d52022-12-22T04:37:48ZengBMCArchives of Public Health2049-32582022-12-0180111010.1186/s13690-022-00999-9Implementing 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)Carine Grenier0Macha Loniewski1Mélanie Plazy2Racha Onaisi3Marie-Hélène Doucet4Jean-Philippe Joseph5Alexandre Duvignaud6Denis Malvy7Xavier Anglaret8Joanna Orne-Gliemann9the Coverage study groupUniversity of BordeauxUniversity of BordeauxUniversity of BordeauxDepartment of General Practice, University of BordeauxUniversity of BordeauxDepartment of General Practice, University of BordeauxUniversity of BordeauxUniversity of BordeauxUniversity of BordeauxUniversity of BordeauxAbstract 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.https://doi.org/10.1186/s13690-022-00999-9CovidTreatmentAmbulatoryPerceptionsImplementation |
| spellingShingle | Carine Grenier Macha Loniewski Mélanie Plazy Racha Onaisi Marie-Hélène Doucet Jean-Philippe Joseph Alexandre Duvignaud Denis Malvy Xavier Anglaret Joanna Orne-Gliemann the Coverage study group 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) Archives of Public Health Covid Treatment Ambulatory Perceptions Implementation |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| topic | Covid Treatment Ambulatory Perceptions Implementation |
| url | https://doi.org/10.1186/s13690-022-00999-9 |
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