Publications et travaux de recherche
2023
Prevost, Virginie; Tran, Titi; Clarisse, Bénédicte; Leconte, Alexandra; Duchange, Nathalie; Moutel, Grégoire; Gouriot, Mylène
Shared Meditation Involving Cancer Patients, Health Professionals and Third Persons: Perceptions of Participants Through a Focus Group Study Article de journal
Dans: Integrative Cancer Therapies, vol. 22, p. 1-9, 2023.
Résumé | Liens | BibTeX | Étiquettes: Recherche
@article{Prevost2023,
title = {Shared Meditation Involving Cancer Patients, Health Professionals and Third Persons: Perceptions of Participants Through a Focus Group Study},
author = {Virginie Prevost and Titi Tran and Bénédicte Clarisse
and Alexandra Leconte and Nathalie Duchange and Grégoire Moutel and Mylène Gouriot},
doi = {10.1177/15347354231186995},
year = {2023},
date = {2023-06-23},
urldate = {2023-06-23},
journal = {Integrative Cancer Therapies},
volume = {22},
pages = {1-9},
abstract = {People with cancer often experience psychological distress and in addition, the practice of oncology is one of the most
stressful areas of medicine for health professionals. Mindfulness meditation has been used to alleviate stress-related
symptoms. We therefore ran a pilot study to assess the feasibility of a mindfulness intervention involving cancer patients,
health professionals, and third persons together, as part of a comprehensive project aiming to evaluate the added value
of ‘meditating together’. Following on from our quantitative analyses of the project, we investigated its qualitative aspects
through focus groups to explore the perceptions of participants regarding their experience. Focus groups conducted in 7
patients, 7 health professionals, and 8 third persons after the intervention showed that ‘meditating together’ was generally
appreciated, particularly by patients, who found it motivating and a way to relieve their feelings of loneliness in the face
of illness. All participants reported better stress management. They also shared benefits and difficulties concerning the
practice of meditation and the programme’s modalities. In addition, they all stated that the programme should be lasting.
The opinion of the patients (our target population) will be decisive in building an optimized programme that will suit them
the best. In conclusion, the protocol and the qualitative findings of the present study validate the rationale for conducting
a fully powered randomized trial to demonstrate the potential added value of shared meditation and how it improves wellbeing by promoting bridge-building between cancer patients, health professionals and others.},
keywords = {Recherche},
pubstate = {published},
tppubtype = {article}
}
People with cancer often experience psychological distress and in addition, the practice of oncology is one of the most
stressful areas of medicine for health professionals. Mindfulness meditation has been used to alleviate stress-related
symptoms. We therefore ran a pilot study to assess the feasibility of a mindfulness intervention involving cancer patients,
health professionals, and third persons together, as part of a comprehensive project aiming to evaluate the added value
of ‘meditating together’. Following on from our quantitative analyses of the project, we investigated its qualitative aspects
through focus groups to explore the perceptions of participants regarding their experience. Focus groups conducted in 7
patients, 7 health professionals, and 8 third persons after the intervention showed that ‘meditating together’ was generally
appreciated, particularly by patients, who found it motivating and a way to relieve their feelings of loneliness in the face
of illness. All participants reported better stress management. They also shared benefits and difficulties concerning the
practice of meditation and the programme’s modalities. In addition, they all stated that the programme should be lasting.
The opinion of the patients (our target population) will be decisive in building an optimized programme that will suit them
the best. In conclusion, the protocol and the qualitative findings of the present study validate the rationale for conducting
a fully powered randomized trial to demonstrate the potential added value of shared meditation and how it improves wellbeing by promoting bridge-building between cancer patients, health professionals and others.
stressful areas of medicine for health professionals. Mindfulness meditation has been used to alleviate stress-related
symptoms. We therefore ran a pilot study to assess the feasibility of a mindfulness intervention involving cancer patients,
health professionals, and third persons together, as part of a comprehensive project aiming to evaluate the added value
of ‘meditating together’. Following on from our quantitative analyses of the project, we investigated its qualitative aspects
through focus groups to explore the perceptions of participants regarding their experience. Focus groups conducted in 7
patients, 7 health professionals, and 8 third persons after the intervention showed that ‘meditating together’ was generally
appreciated, particularly by patients, who found it motivating and a way to relieve their feelings of loneliness in the face
of illness. All participants reported better stress management. They also shared benefits and difficulties concerning the
practice of meditation and the programme’s modalities. In addition, they all stated that the programme should be lasting.
The opinion of the patients (our target population) will be decisive in building an optimized programme that will suit them
the best. In conclusion, the protocol and the qualitative findings of the present study validate the rationale for conducting
a fully powered randomized trial to demonstrate the potential added value of shared meditation and how it improves wellbeing by promoting bridge-building between cancer patients, health professionals and others.
Peyro-Saint-Paul, Laure; Gaillard, Cathy; Paris, Adeline; Gourio, Charlotte; Zerger, Céleste; Ficheux, Maxence; Grandazzi, Guillaume; Parienti, Jean-Jacques; Morello, Rémy
Compensating patients in trials: Perspectives from an ethical committee versus sponsor Article de journal
Dans: European Journal of Clinical Investigation, 2023.
Résumé | Liens | BibTeX | Étiquettes: Recherche
@article{Peyro-Saint-Paul2023,
title = {Compensating patients in trials: Perspectives from an ethical committee versus sponsor},
author = {Laure Peyro-Saint-Paul and Cathy Gaillard and Adeline Paris and Charlotte Gourio and Céleste Zerger and Maxence Ficheux and Guillaume Grandazzi and Jean-Jacques Parienti and Rémy Morello},
url = {https://onlinelibrary.wiley.com/doi/full/10.1111/eci.14044},
doi = {10.1111/eci.14044},
year = {2023},
date = {2023-06-21},
journal = {European Journal of Clinical Investigation},
abstract = {Background: According to European clinical research legislation, no undue influence,
including financial incentives, should be used to encourage participation
in clinical trials. Financial compensation should be based on the inconvenience
experienced by patients and is determined by the sponsor.
Objectives: The objective of this study was to assess the adequacy of patients'
financial compensation by obtaining an external ethical opinion compared to the
actual compensation provided.
Methods: We randomly selected and reviewed 50 clinical drug trials, including
25 academic and 25 industry-sponsored
studies. An external ethics group consisting
of three members from French ethics committees, blinded to the actual
compensation and the sponsor, retrospectively reviewed the study characteristics
and assessed whether financial compensation was appropriate. Cohen's Kappa
test measured agreement between actual compensation and the ethics group's
opinion, and the McNemar test measured discrepancies.
Results: There was no agreement between the actual financial compensation
and the ethics group's opinion (K = −.07; 95% CI = [−.16–.
02]). More discrepancies
were found in favour of financial compensation according to the ethics group
than provided by sponsors (12 vs. 2, p = .016). The ethics group recommended
financial compensation in 12 out of 50 studies (24%), which were studies with a
higher number of additional visits (p = .004) and were more frequently sponsored
by industry (p = .008). Sponsors only provided financial compensation in 2 out of
50 studies (4%).
Conclusion: Patients are rarely compensated despite the perceived inconvenience.
Both sponsors and ethics members struggle to determine the need for financial
compensation, indicating a need for more precise recommendations for
both parties.},
keywords = {Recherche},
pubstate = {published},
tppubtype = {article}
}
Background: According to European clinical research legislation, no undue influence,
including financial incentives, should be used to encourage participation
in clinical trials. Financial compensation should be based on the inconvenience
experienced by patients and is determined by the sponsor.
Objectives: The objective of this study was to assess the adequacy of patients'
financial compensation by obtaining an external ethical opinion compared to the
actual compensation provided.
Methods: We randomly selected and reviewed 50 clinical drug trials, including
25 academic and 25 industry-sponsored
studies. An external ethics group consisting
of three members from French ethics committees, blinded to the actual
compensation and the sponsor, retrospectively reviewed the study characteristics
and assessed whether financial compensation was appropriate. Cohen's Kappa
test measured agreement between actual compensation and the ethics group's
opinion, and the McNemar test measured discrepancies.
Results: There was no agreement between the actual financial compensation
and the ethics group's opinion (K = −.07; 95% CI = [−.16–.
02]). More discrepancies
were found in favour of financial compensation according to the ethics group
than provided by sponsors (12 vs. 2, p = .016). The ethics group recommended
financial compensation in 12 out of 50 studies (24%), which were studies with a
higher number of additional visits (p = .004) and were more frequently sponsored
by industry (p = .008). Sponsors only provided financial compensation in 2 out of
50 studies (4%).
Conclusion: Patients are rarely compensated despite the perceived inconvenience.
Both sponsors and ethics members struggle to determine the need for financial
compensation, indicating a need for more precise recommendations for
both parties.
including financial incentives, should be used to encourage participation
in clinical trials. Financial compensation should be based on the inconvenience
experienced by patients and is determined by the sponsor.
Objectives: The objective of this study was to assess the adequacy of patients'
financial compensation by obtaining an external ethical opinion compared to the
actual compensation provided.
Methods: We randomly selected and reviewed 50 clinical drug trials, including
25 academic and 25 industry-sponsored
studies. An external ethics group consisting
of three members from French ethics committees, blinded to the actual
compensation and the sponsor, retrospectively reviewed the study characteristics
and assessed whether financial compensation was appropriate. Cohen's Kappa
test measured agreement between actual compensation and the ethics group's
opinion, and the McNemar test measured discrepancies.
Results: There was no agreement between the actual financial compensation
and the ethics group's opinion (K = −.07; 95% CI = [−.16–.
02]). More discrepancies
were found in favour of financial compensation according to the ethics group
than provided by sponsors (12 vs. 2, p = .016). The ethics group recommended
financial compensation in 12 out of 50 studies (24%), which were studies with a
higher number of additional visits (p = .004) and were more frequently sponsored
by industry (p = .008). Sponsors only provided financial compensation in 2 out of
50 studies (4%).
Conclusion: Patients are rarely compensated despite the perceived inconvenience.
Both sponsors and ethics members struggle to determine the need for financial
compensation, indicating a need for more precise recommendations for
both parties.
Moutel, Grégoire; Gouriot, Mylène; Suzat, Bertille; Batteur, Annick; Ploteau, Stéphane; Destrieux, Christophe; Grandazzi, Guillaume
Don du corps à la science : un nouveau cadre de régulation qui répond à certaines questions mais en soulève bien d’autres ! Article de journal
Dans: Médecine/Sciences, vol. 39, no. 2, p. 164-169, 2023.
Résumé | Liens | BibTeX | Étiquettes: Don du corps, Recherche
@article{Moutel2023,
title = {Don du corps à la science : un nouveau cadre de régulation qui répond à certaines questions mais en soulève bien d’autres ! },
author = {Grégoire Moutel and Mylène Gouriot and Bertille Suzat and Annick Batteur and Stéphane Ploteau and Christophe Destrieux and Guillaume Grandazzi},
doi = {10.1051/medsci/2023011},
year = {2023},
date = {2023-02-01},
urldate = {2023-02-01},
journal = {Médecine/Sciences},
volume = {39},
number = {2},
pages = {164-169},
abstract = {En France, entre 2 500 et 3 000 personnes donnent leur corps à la science chaque année après leur mort ; elles contribuent ainsi à l’enseignement
de l’anatomie, à la recherche et à l’apprentissage et l’amélioration des pratiques chirurgicales. La décision doit être prise de son vivant et le consentement exprimé par écrit auprès d’un des vingt-sept centres de don du corps répartis sur le territoire national. Suite au scandale du centre parisien des Saints-Pères, le décret du 27 avril 2022 relatif au don de corps à des fins d’enseignement et de recherche, qui s’inscrit dans le cadre des nouvelles lois de bioéthique, était très attendu pour clarifier certaines pratiques. Mais ce décret soulève de nouvelles questions car nombreuses sont les règles qu’il propose qui ne nous apparaissent pas pertinentes au regard des valeurs du don et du fonctionnement
des centres de don. Les nouveaux modes de régulation proposés génèrent des questions chez les donneurs et les professionnels de terrain avec
un risque de mauvaise régulation. Nous pensons que si la puissance publique ne s’engage pas dans une régulation plus adaptée au terrain, si
les enjeux éthiques ne sont pas mieux clarifiés et si les universités n’ont pas les moyens pour mettre en œuvre ces nouvelles organisations, la
pérennisation du don du corps et des centres de don pourrait devenir difficile.},
keywords = {Don du corps, Recherche},
pubstate = {published},
tppubtype = {article}
}
En France, entre 2 500 et 3 000 personnes donnent leur corps à la science chaque année après leur mort ; elles contribuent ainsi à l’enseignement
de l’anatomie, à la recherche et à l’apprentissage et l’amélioration des pratiques chirurgicales. La décision doit être prise de son vivant et le consentement exprimé par écrit auprès d’un des vingt-sept centres de don du corps répartis sur le territoire national. Suite au scandale du centre parisien des Saints-Pères, le décret du 27 avril 2022 relatif au don de corps à des fins d’enseignement et de recherche, qui s’inscrit dans le cadre des nouvelles lois de bioéthique, était très attendu pour clarifier certaines pratiques. Mais ce décret soulève de nouvelles questions car nombreuses sont les règles qu’il propose qui ne nous apparaissent pas pertinentes au regard des valeurs du don et du fonctionnement
des centres de don. Les nouveaux modes de régulation proposés génèrent des questions chez les donneurs et les professionnels de terrain avec
un risque de mauvaise régulation. Nous pensons que si la puissance publique ne s’engage pas dans une régulation plus adaptée au terrain, si
les enjeux éthiques ne sont pas mieux clarifiés et si les universités n’ont pas les moyens pour mettre en œuvre ces nouvelles organisations, la
pérennisation du don du corps et des centres de don pourrait devenir difficile.
de l’anatomie, à la recherche et à l’apprentissage et l’amélioration des pratiques chirurgicales. La décision doit être prise de son vivant et le consentement exprimé par écrit auprès d’un des vingt-sept centres de don du corps répartis sur le territoire national. Suite au scandale du centre parisien des Saints-Pères, le décret du 27 avril 2022 relatif au don de corps à des fins d’enseignement et de recherche, qui s’inscrit dans le cadre des nouvelles lois de bioéthique, était très attendu pour clarifier certaines pratiques. Mais ce décret soulève de nouvelles questions car nombreuses sont les règles qu’il propose qui ne nous apparaissent pas pertinentes au regard des valeurs du don et du fonctionnement
des centres de don. Les nouveaux modes de régulation proposés génèrent des questions chez les donneurs et les professionnels de terrain avec
un risque de mauvaise régulation. Nous pensons que si la puissance publique ne s’engage pas dans une régulation plus adaptée au terrain, si
les enjeux éthiques ne sont pas mieux clarifiés et si les universités n’ont pas les moyens pour mettre en œuvre ces nouvelles organisations, la
pérennisation du don du corps et des centres de don pourrait devenir difficile.
2022
Moutel, Grégoire; Destrieux, Christophe; Suzat, Bertille; Charvin, Maud; Baqué, Patrick; Ploteau, Stéphane; Gouriot, Mylène; Grandazzi, Guillaume
Don du corps à la science et usages des corps à finalités pédagogiques et scientifiques : enjeux éthiques et perspectives pour demain Article de journal
Dans: Bulletin de l'Académie Nationale de Médecine, vol. 206, no. 8, p. 1043-1050, 2022.
Résumé | Liens | BibTeX | Étiquettes: Don du corps, Recherche
@article{Moutel2022cb,
title = {Don du corps à la science et usages des corps à finalités pédagogiques et scientifiques : enjeux éthiques et perspectives pour demain},
author = {Grégoire Moutel and Christophe Destrieux and Bertille Suzat and Maud Charvin and Patrick Baqué and Stéphane Ploteau and Mylène Gouriot and Guillaume Grandazzi},
doi = {https://doi.org/10.1016/j.banm.2022.02.019},
year = {2022},
date = {2022-09-05},
urldate = {2022-09-05},
journal = {Bulletin de l'Académie Nationale de Médecine},
volume = {206},
number = {8},
pages = {1043-1050},
abstract = {Le don du corps à la science est essentiel et indispensable pour l’enseignement de l’anatomie, l’apprentissage et l’amélioration des pratiques chirurgicales ; il l’est également pour la recherche dans de nombreuses spécialités médicales. Il s’agit d’un don volontaire, fait du vivant du patient, par écrit, auprès des centres de don dans de nombreuses facultés de médecine en France. Il s’impose aux proches mais peut heurter des consciences. Malgré la grande qualité et la grande rigueur de travail de la majorité des centres du don en France, un certain nombre de problèmes et de questions nouvelles ont émergé ces dernières années. Ces questions concernent les modalités d’information du donateur sur les usages possibles des corps, l’information des proches sur cette démarche, les frais de transports des corps, les modalités de traçabilité de la volonté des défunts, le devenir des cendres après utilisation des corps quant aux conditions de retour ou non aux familles, mais aussi les moyens et la logistique des centres. Du fait de toutes ces questions et de la problématique d’un centre parisien de don où la dignité des corps a été mise à mal, le législateur a souhaité s’emparer du sujet à travers les nouvelles lois de bioéthique de 2021. Les pratiques et règles éthiques autour de la pratique du don du corps à la science vont donc évoluer dans les années à venir. Cet article fait le point sur les évolutions à anticiper et sur les questions éthiques qu’elles soulèvent en regard de la symbolique du corps mort et du respect de la dignité des défunts.},
keywords = {Don du corps, Recherche},
pubstate = {published},
tppubtype = {article}
}
Le don du corps à la science est essentiel et indispensable pour l’enseignement de l’anatomie, l’apprentissage et l’amélioration des pratiques chirurgicales ; il l’est également pour la recherche dans de nombreuses spécialités médicales. Il s’agit d’un don volontaire, fait du vivant du patient, par écrit, auprès des centres de don dans de nombreuses facultés de médecine en France. Il s’impose aux proches mais peut heurter des consciences. Malgré la grande qualité et la grande rigueur de travail de la majorité des centres du don en France, un certain nombre de problèmes et de questions nouvelles ont émergé ces dernières années. Ces questions concernent les modalités d’information du donateur sur les usages possibles des corps, l’information des proches sur cette démarche, les frais de transports des corps, les modalités de traçabilité de la volonté des défunts, le devenir des cendres après utilisation des corps quant aux conditions de retour ou non aux familles, mais aussi les moyens et la logistique des centres. Du fait de toutes ces questions et de la problématique d’un centre parisien de don où la dignité des corps a été mise à mal, le législateur a souhaité s’emparer du sujet à travers les nouvelles lois de bioéthique de 2021. Les pratiques et règles éthiques autour de la pratique du don du corps à la science vont donc évoluer dans les années à venir. Cet article fait le point sur les évolutions à anticiper et sur les questions éthiques qu’elles soulèvent en regard de la symbolique du corps mort et du respect de la dignité des défunts.
Papet, Eloise; Moutel, Grégoire; Pinson, Jean; Monge, Matthieu; Roussel, Edouard; Teniere, Tom; Tuech, Jean-Jacques; Bridoux, Valérie
Methodological and ethical quality of surgical trials from 2016 to 2020 Article de journal
Dans: Langenbeck's Archives of Surgery, no. 407, p. 3793-3802, 2022.
Résumé | Liens | BibTeX | Étiquettes: Recherche
@article{Papet2022,
title = {Methodological and ethical quality of surgical trials from 2016 to 2020},
author = {Eloise Papet and Grégoire Moutel and Jean Pinson and Matthieu Monge and Edouard Roussel and Tom Teniere and Jean-Jacques Tuech and Valérie Bridoux },
doi = {10.1007/s00423-022-02649-8},
year = {2022},
date = {2022-08-27},
urldate = {2022-08-27},
journal = {Langenbeck's Archives of Surgery},
number = {407},
pages = {3793-3802},
abstract = {Purpose: Randomized controlled trials (RCTs) are the gold standard tool used to evaluate therapeutic interventions. The published results showed that progress still needs to be made not only from a methodological point of view but also from an ethical point of view. The aim of this study was to evaluate the methodological and ethical qualities of randomized clinical trials in surgery over the last few years.
Methods: All of the articles chosen for review reported on randomized controlled surgical trials and were published in 10 international journals between 2016 and 2020. Eligible studies were identified, selected, and then evaluated based on a broad set of predetermined criteria. Methodological quality was evaluated using the Jadad scale, and ethical quality was evaluated using the Berdeu score.
Results: The methodological quality score (Jadad scale) ranged from 5 to 13, with a mean of 10.0 ± 1.54. The methodological quality was insufficient (score ≤ 9) for 162 trials (31.2%). The ethical quality score ranged from 0.25 to 1, with a mean of 0.8 ± 0.11. Fifty-two articles (10%) did not state that informed consent was requested from the participants, and 21 articles (4%) did not report either research ethics committee or institutional committee protocol approval.
Conclusion: The randomized clinical surgical trials analyzed showed that they had satisfactory methods in only 70% of the cases and that they had respected the fundamental ethical principles in 90% of the cases. However, less than 8% of the studies reported planned interim analysis, prospectively defined stopping rules, and independent monitoring committee.},
keywords = {Recherche},
pubstate = {published},
tppubtype = {article}
}
Purpose: Randomized controlled trials (RCTs) are the gold standard tool used to evaluate therapeutic interventions. The published results showed that progress still needs to be made not only from a methodological point of view but also from an ethical point of view. The aim of this study was to evaluate the methodological and ethical qualities of randomized clinical trials in surgery over the last few years.
Methods: All of the articles chosen for review reported on randomized controlled surgical trials and were published in 10 international journals between 2016 and 2020. Eligible studies were identified, selected, and then evaluated based on a broad set of predetermined criteria. Methodological quality was evaluated using the Jadad scale, and ethical quality was evaluated using the Berdeu score.
Results: The methodological quality score (Jadad scale) ranged from 5 to 13, with a mean of 10.0 ± 1.54. The methodological quality was insufficient (score ≤ 9) for 162 trials (31.2%). The ethical quality score ranged from 0.25 to 1, with a mean of 0.8 ± 0.11. Fifty-two articles (10%) did not state that informed consent was requested from the participants, and 21 articles (4%) did not report either research ethics committee or institutional committee protocol approval.
Conclusion: The randomized clinical surgical trials analyzed showed that they had satisfactory methods in only 70% of the cases and that they had respected the fundamental ethical principles in 90% of the cases. However, less than 8% of the studies reported planned interim analysis, prospectively defined stopping rules, and independent monitoring committee.
Methods: All of the articles chosen for review reported on randomized controlled surgical trials and were published in 10 international journals between 2016 and 2020. Eligible studies were identified, selected, and then evaluated based on a broad set of predetermined criteria. Methodological quality was evaluated using the Jadad scale, and ethical quality was evaluated using the Berdeu score.
Results: The methodological quality score (Jadad scale) ranged from 5 to 13, with a mean of 10.0 ± 1.54. The methodological quality was insufficient (score ≤ 9) for 162 trials (31.2%). The ethical quality score ranged from 0.25 to 1, with a mean of 0.8 ± 0.11. Fifty-two articles (10%) did not state that informed consent was requested from the participants, and 21 articles (4%) did not report either research ethics committee or institutional committee protocol approval.
Conclusion: The randomized clinical surgical trials analyzed showed that they had satisfactory methods in only 70% of the cases and that they had respected the fundamental ethical principles in 90% of the cases. However, less than 8% of the studies reported planned interim analysis, prospectively defined stopping rules, and independent monitoring committee.
Declercq, Pierre-Louis; Fournel, Isabelle; Demeyere, Matthieu; Ksiazek, Eléa; Meunier-Beillard, Nicolas; Rivière, Antoine; Clarot, Caroline; Maizel, Julien; Schnell, David; Plantefeve, Gaetan; Ampere, Alexandre; Daubin, Cédric; Sauneuf, Bertrand; Kalfon, Pierre; Federici, Laura; Redureau, Élise; Bousta, Mehdi; Lagache, Laurie; Vanderlinden, Thierry; Nseir, Saad; Combe, Béatrice La; Bourdin, Gaël; Monchi, Mehran; Nyunga, Martine; Ramakers, Michel; Oulehri, Walid; Georges, Hugues; Gandonniere, Charlotte Salmon; Badie, Julio; Delbove, Agathe; Monnet, Xavier; Beduneau, Gaetan; Artaud-Macari, Élise; Abraham, Paul; Delberghe, Nicolas; Bouar, Gurvan Le; Miailhe, Arnaud-Felix; Hraiech, Sami; Bironneau, Vanessa; Sedillot, Nicholas; Hoppe, Marie-Anne; Barbar, Saber Davide; Calcaianu, George-Daniel; Dellamonica, Jean; Terzi, Nicolas; Delpierre, Cyrille; Gélinotte, Stéphanie; Rigaud, Jean-Philippe; Labruyère, Marie; Georges, Marjolaine; Binquet, Christine; Quenot, Jean-Pierre; RECOVIDS, Trial Investigators
Influence of socioeconomic status on functional recovery after ARDS caused by SARS-CoV-2: a multicentre, observational study Article de journal
Dans: BMJ Open, vol. 12, no. 4, p. e057368, 2022.
Résumé | Liens | BibTeX | Étiquettes: Recherche
@article{Declercq2022,
title = {Influence of socioeconomic status on functional recovery after ARDS caused by SARS-CoV-2: a multicentre, observational study},
author = {Pierre-Louis Declercq and Isabelle Fournel and Matthieu Demeyere and Eléa Ksiazek and Nicolas Meunier-Beillard and Antoine Rivière and Caroline Clarot and Julien Maizel and David Schnell and Gaetan Plantefeve and Alexandre Ampere and Cédric Daubin and Bertrand Sauneuf and Pierre Kalfon and Laura Federici and Élise Redureau and Mehdi Bousta and Laurie Lagache and Thierry Vanderlinden and Saad Nseir and Béatrice La Combe and Gaël Bourdin and Mehran Monchi and Martine Nyunga and Michel Ramakers and Walid Oulehri and Hugues Georges and Charlotte Salmon Gandonniere and Julio Badie and Agathe Delbove and Xavier Monnet and Gaetan Beduneau and Élise Artaud-Macari and Paul Abraham and Nicolas Delberghe and Gurvan Le Bouar and Arnaud-Felix Miailhe and Sami Hraiech and Vanessa Bironneau and Nicholas Sedillot and Marie-Anne Hoppe and Saber Davide Barbar and George-Daniel Calcaianu and Jean Dellamonica and Nicolas Terzi and Cyrille Delpierre and Stéphanie Gélinotte and Jean-Philippe Rigaud and Marie Labruyère and Marjolaine Georges and Christine Binquet and Jean-Pierre Quenot and Trial Investigators RECOVIDS},
url = {https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9035836/},
doi = {10.1136/bmjopen-2021-057368},
year = {2022},
date = {2022-04-22},
journal = {BMJ Open},
volume = {12},
number = {4},
pages = {e057368},
abstract = {Introduction: Prognosis of patients with COVID-19 depends on the severity of the pulmonary affection. The most severe cases may progress to acute respiratory distress syndrome (ARDS), which is associated with a risk of long-term repercussions on respiratory function and neuromuscular outcomes. The functional repercussions of severe forms of COVID-19 may have a major impact on quality of life, and impair the ability to return to work or exercise. Social inequalities in healthcare may influence prognosis, with socially vulnerable individuals more likely to develop severe forms of disease. We describe here the protocol for a prospective, multicentre study that aims to investigate the influence of social vulnerability on functional recovery in patients who were hospitalised in intensive care for ARDS caused by COVID-19. This study will also include an embedded qualitative study that aims to describe facilitators and barriers to compliance with rehabilitation, describe patients' health practices and identify social representations of health, disease and care.
Methods and analysis: The "Functional Recovery From Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19: Influence of Socio-Economic Status" (RECOVIDS) study is a mixed-methods, observational, multicentre cohort study performed during the routine follow-up of post-intensive care unit (ICU) functional recovery after ARDS. All patients admitted to a participating ICU for PCR-proven SARS-CoV-2 infection and who underwent chest CT scan at the initial phase AND who received respiratory support (mechanical or not) or high-flow nasal oxygen, AND had ARDS diagnosed by the Berlin criteria will be eligible. The primary outcome is the presence of lung sequelae at 6 months after ICU discharge, defined either by alterations on pulmonary function tests, oxygen desaturation during a standardised 6 min walk test or fibrosis-like pulmonary findings on chest CT. Patients will be considered to be socially disadvantaged if they have an "Evaluation de la Précarité et des Inégalités de santé dans les Centres d'Examen de Santé" (EPICES) score ≥30.17 at inclusion.},
keywords = {Recherche},
pubstate = {published},
tppubtype = {article}
}
Introduction: Prognosis of patients with COVID-19 depends on the severity of the pulmonary affection. The most severe cases may progress to acute respiratory distress syndrome (ARDS), which is associated with a risk of long-term repercussions on respiratory function and neuromuscular outcomes. The functional repercussions of severe forms of COVID-19 may have a major impact on quality of life, and impair the ability to return to work or exercise. Social inequalities in healthcare may influence prognosis, with socially vulnerable individuals more likely to develop severe forms of disease. We describe here the protocol for a prospective, multicentre study that aims to investigate the influence of social vulnerability on functional recovery in patients who were hospitalised in intensive care for ARDS caused by COVID-19. This study will also include an embedded qualitative study that aims to describe facilitators and barriers to compliance with rehabilitation, describe patients' health practices and identify social representations of health, disease and care.
Methods and analysis: The "Functional Recovery From Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19: Influence of Socio-Economic Status" (RECOVIDS) study is a mixed-methods, observational, multicentre cohort study performed during the routine follow-up of post-intensive care unit (ICU) functional recovery after ARDS. All patients admitted to a participating ICU for PCR-proven SARS-CoV-2 infection and who underwent chest CT scan at the initial phase AND who received respiratory support (mechanical or not) or high-flow nasal oxygen, AND had ARDS diagnosed by the Berlin criteria will be eligible. The primary outcome is the presence of lung sequelae at 6 months after ICU discharge, defined either by alterations on pulmonary function tests, oxygen desaturation during a standardised 6 min walk test or fibrosis-like pulmonary findings on chest CT. Patients will be considered to be socially disadvantaged if they have an "Evaluation de la Précarité et des Inégalités de santé dans les Centres d'Examen de Santé" (EPICES) score ≥30.17 at inclusion.
Methods and analysis: The "Functional Recovery From Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19: Influence of Socio-Economic Status" (RECOVIDS) study is a mixed-methods, observational, multicentre cohort study performed during the routine follow-up of post-intensive care unit (ICU) functional recovery after ARDS. All patients admitted to a participating ICU for PCR-proven SARS-CoV-2 infection and who underwent chest CT scan at the initial phase AND who received respiratory support (mechanical or not) or high-flow nasal oxygen, AND had ARDS diagnosed by the Berlin criteria will be eligible. The primary outcome is the presence of lung sequelae at 6 months after ICU discharge, defined either by alterations on pulmonary function tests, oxygen desaturation during a standardised 6 min walk test or fibrosis-like pulmonary findings on chest CT. Patients will be considered to be socially disadvantaged if they have an "Evaluation de la Précarité et des Inégalités de santé dans les Centres d'Examen de Santé" (EPICES) score ≥30.17 at inclusion.
Labruyère, Marie; Meunier-Beillard, Nicolas; FionaEcarnot,; Large, Audrey; Aptel, François; Roudaut, Jean-Baptiste; Andreu, Pascal; Dargent, Auguste; Rigaud, Jean-Philippe; Quenot, Jean-Pierre
Family perceptions of clinical research and the informed consent process in the ICU Article de journal
Dans: Journal of Critical Care, vol. 68, p. 141-143, 2022.
Résumé | Liens | BibTeX | Étiquettes: Recherche
@article{Labruyère2020,
title = {Family perceptions of clinical research and the informed consent process in the ICU},
author = {Marie Labruyère and Nicolas Meunier-Beillard and FionaEcarnot and Audrey Large and François Aptel and Jean-Baptiste Roudaut and Pascal Andreu and Auguste Dargent and Jean-Philippe Rigaud and Jean-Pierre Quenot},
doi = {https://doi.org/10.1016/j.jcrc.2020.09.032},
year = {2022},
date = {2022-04-01},
urldate = {2022-04-01},
journal = {Journal of Critical Care},
volume = {68},
pages = {141-143},
abstract = {Purpose
We investigated experiences of families who provide consent for research on behalf of a loved-one hospitalized in intensive care (ICU).
Methods
Multicentre, qualitative, descriptive study using semi-directive interviews in 3 ICUs. Eligible relatives were aged >18 years, and had provided informed consent for a clinical trial on behalf of a patient hospitalized in ICU. Interviews were conducted from 06/2018 to 06/2019 by a qualified sociologist, recorded and transcribed.
Results
Fifteen relatives were interviewed; average age 50.3 ± 15 years. All emphasized their interest in clinical research, seeing it as a duty. Involving their loved-one in research allowed them to find meaning in the events. Participants underlined that trust in caregivers and communication are determinant. The strict regulation of research was perceived as a guarantee of safety. Participants felt they lacked the intellectual capacity and knowledge to question explanations. The greatest fear was not that they might incur a risk for the patient, but rather, that they might deprive the patient of a chance at a cure.
Conclusion
Acceptance of research opportunities by relatives on behalf of decisionally-incapacitated patients is underpinned by trust in the physicians and the legislative framework. Communication and the quality of information provided by the caregivers are key.},
keywords = {Recherche},
pubstate = {published},
tppubtype = {article}
}
Purpose
We investigated experiences of families who provide consent for research on behalf of a loved-one hospitalized in intensive care (ICU).
Methods
Multicentre, qualitative, descriptive study using semi-directive interviews in 3 ICUs. Eligible relatives were aged >18 years, and had provided informed consent for a clinical trial on behalf of a patient hospitalized in ICU. Interviews were conducted from 06/2018 to 06/2019 by a qualified sociologist, recorded and transcribed.
Results
Fifteen relatives were interviewed; average age 50.3 ± 15 years. All emphasized their interest in clinical research, seeing it as a duty. Involving their loved-one in research allowed them to find meaning in the events. Participants underlined that trust in caregivers and communication are determinant. The strict regulation of research was perceived as a guarantee of safety. Participants felt they lacked the intellectual capacity and knowledge to question explanations. The greatest fear was not that they might incur a risk for the patient, but rather, that they might deprive the patient of a chance at a cure.
Conclusion
Acceptance of research opportunities by relatives on behalf of decisionally-incapacitated patients is underpinned by trust in the physicians and the legislative framework. Communication and the quality of information provided by the caregivers are key.
We investigated experiences of families who provide consent for research on behalf of a loved-one hospitalized in intensive care (ICU).
Methods
Multicentre, qualitative, descriptive study using semi-directive interviews in 3 ICUs. Eligible relatives were aged >18 years, and had provided informed consent for a clinical trial on behalf of a patient hospitalized in ICU. Interviews were conducted from 06/2018 to 06/2019 by a qualified sociologist, recorded and transcribed.
Results
Fifteen relatives were interviewed; average age 50.3 ± 15 years. All emphasized their interest in clinical research, seeing it as a duty. Involving their loved-one in research allowed them to find meaning in the events. Participants underlined that trust in caregivers and communication are determinant. The strict regulation of research was perceived as a guarantee of safety. Participants felt they lacked the intellectual capacity and knowledge to question explanations. The greatest fear was not that they might incur a risk for the patient, but rather, that they might deprive the patient of a chance at a cure.
Conclusion
Acceptance of research opportunities by relatives on behalf of decisionally-incapacitated patients is underpinned by trust in the physicians and the legislative framework. Communication and the quality of information provided by the caregivers are key.
2021
de La Blanchardière, Arnaud; Barde, François; Peiffer-Smajda, Nathan; Maisonneuve, Hervé
Revues prédatrices : une vraie menace pour la recherche médicale. 2 Evaluer leurs conséquences et engager une riposte Article de journal
Dans: La Revue de médecine interne, no. 42, p. 427-433, 2021.
Résumé | Liens | BibTeX | Étiquettes: Recherche
@article{nokey,
title = {Revues prédatrices : une vraie menace pour la recherche médicale. 2 Evaluer leurs conséquences et engager une riposte},
author = {Arnaud de La Blanchardière and François Barde and Nathan Peiffer-Smajda and Hervé Maisonneuve},
doi = {10.1016/j.revmed.2021.03.327},
year = {2021},
date = {2021-03-01},
urldate = {2021-03-01},
journal = {La Revue de médecine interne},
number = {42},
pages = {427-433},
abstract = {Les conséquences délétères des revues « prédatrices » sont nombreuses, que le chercheur leur ait soumis son travail naïvement ou en connaissance de cause : travaux peu/pas lus par la communauté internationale en l’absence d’indexation et disparition de toute trace numérique en l’absence d’archivage. La réputation des chercheurs mais aussi des universités et des organismes de recherche, comme le crédit de la science auprès des citoyens, peuvent être durablement dégradés. Ces revues, en libre accès sur le modèle auteur-payeur, représentent autant de ressources indisponibles pour les revues légitimes. Une mobilisation conjointe de tous les acteurs concernés est nécessaire : chercheurs, universités et facultés de médecine, sections du conseil national des universités, éditeurs de revues légitimes, organismes de recherche, sociétés savantes, comités d’éthiques, financeurs, médias et décideurs politiques. Publier dans une revue prédatrice est désormais une méconduite scientifique.},
keywords = {Recherche},
pubstate = {published},
tppubtype = {article}
}
Les conséquences délétères des revues « prédatrices » sont nombreuses, que le chercheur leur ait soumis son travail naïvement ou en connaissance de cause : travaux peu/pas lus par la communauté internationale en l’absence d’indexation et disparition de toute trace numérique en l’absence d’archivage. La réputation des chercheurs mais aussi des universités et des organismes de recherche, comme le crédit de la science auprès des citoyens, peuvent être durablement dégradés. Ces revues, en libre accès sur le modèle auteur-payeur, représentent autant de ressources indisponibles pour les revues légitimes. Une mobilisation conjointe de tous les acteurs concernés est nécessaire : chercheurs, universités et facultés de médecine, sections du conseil national des universités, éditeurs de revues légitimes, organismes de recherche, sociétés savantes, comités d’éthiques, financeurs, médias et décideurs politiques. Publier dans une revue prédatrice est désormais une méconduite scientifique.
de La Blanchardière, Arnaud; Barde, François; Peiffer-Smajda, Nathan; Maisonneuve, Hervé
Revues prédatrices : une vraie menace pour la recherche médicale. 1. Identifier ces revues et comprendre leur fonctionnement Article de journal
Dans: La Revue de médecine interne, no. 42, p. 421-426, 2021.
Résumé | Liens | BibTeX | Étiquettes: Recherche
@article{deBlanchardière2021,
title = {Revues prédatrices : une vraie menace pour la recherche médicale. 1. Identifier ces revues et comprendre leur fonctionnement},
author = {Arnaud de La Blanchardière and François Barde and Nathan Peiffer-Smajda and Hervé Maisonneuve},
doi = {10.1016/j.revmed.2021.03.329},
year = {2021},
date = {2021-03-01},
urldate = {2021-03-01},
journal = {La Revue de médecine interne},
number = {42},
pages = {421-426},
abstract = {Le modèle de publication en accès ouvert « auteur-payeur », apparu en 2002, attribue à l’auteur ou son institution les frais de traitements des articles dus à la revue après acceptation, pour un montant de quelques centaines à plusieurs milliers d’euros. De nouveaux éditeurs, aux objectifs purement commerciaux, ont surgi vers la fin des années 2000, qui proposent à des auteurs naïfs et/ou désireux d’étoffer rapidement leurs curriculum vitae par des publications dans des « revues prédatrices ». Elles sont caractérisées par des sollicitations agressives par courriels, un manque d’éthique, l’absence de précisions sur l’éditeur et le comité éditorial, la pauvreté de l’examen critique par les pairs, des auteurs venant préférentiellement de certains pays, des frais de traitement des articles non spécifiés et plus faibles, une absence d’indexation et la promesse d’une publication rapide.},
keywords = {Recherche},
pubstate = {published},
tppubtype = {article}
}
Le modèle de publication en accès ouvert « auteur-payeur », apparu en 2002, attribue à l’auteur ou son institution les frais de traitements des articles dus à la revue après acceptation, pour un montant de quelques centaines à plusieurs milliers d’euros. De nouveaux éditeurs, aux objectifs purement commerciaux, ont surgi vers la fin des années 2000, qui proposent à des auteurs naïfs et/ou désireux d’étoffer rapidement leurs curriculum vitae par des publications dans des « revues prédatrices ». Elles sont caractérisées par des sollicitations agressives par courriels, un manque d’éthique, l’absence de précisions sur l’éditeur et le comité éditorial, la pauvreté de l’examen critique par les pairs, des auteurs venant préférentiellement de certains pays, des frais de traitement des articles non spécifiés et plus faibles, une absence d’indexation et la promesse d’une publication rapide.
2020
Barde, François; Peiffer-Smadja, Nathan; de La Blanchardière, Arnaud
Fraude scientifique : une menace majeure pour la recherche médicale Article de journal
Dans: La Revue de Médecine Interne, vol. 41, no. 5, p. 330-334, 2020.
Résumé | Liens | BibTeX | Étiquettes: Recherche
@article{Barde2020,
title = {Fraude scientifique : une menace majeure pour la recherche médicale},
author = {François Barde and Nathan Peiffer-Smadja and Arnaud de La Blanchardière},
doi = {10.1016/j.revmed.2020.02.004},
year = {2020},
date = {2020-02-25},
urldate = {2020-02-25},
journal = {La Revue de Médecine Interne},
volume = {41},
number = {5},
pages = {330-334},
abstract = {Les fraudes scientifiques, proprement dites (falsification et fabrication de données, plagiat) et apparentées (manipulation de données, références et auteurs de complaisance), sont avouées respectivement par 2 % et 33 % des chercheurs. Les conséquences de telles fraudes sont désastreuses, tant pour les médecins – les plus touchés des scientifiques au vu du nombre d’articles rétractés – que pour les patients qui font les frais d’informations erronées pouvant avoir des conséquences sanitaires. Afin de lutter contre les causes (promotion des médecins et attribution de ressources sur des critères de recherche purement quantitatifs, absence de formation médicale à l’intégrité scientifique, difficulté des processus de mise en évidence de fraude scientifique, impunité juridique), il existe des solutions législatives, universitaires, numériques et éditoriales, mais l’essentiel relève de changements culturels radicaux et urgents.},
keywords = {Recherche},
pubstate = {published},
tppubtype = {article}
}
Les fraudes scientifiques, proprement dites (falsification et fabrication de données, plagiat) et apparentées (manipulation de données, références et auteurs de complaisance), sont avouées respectivement par 2 % et 33 % des chercheurs. Les conséquences de telles fraudes sont désastreuses, tant pour les médecins – les plus touchés des scientifiques au vu du nombre d’articles rétractés – que pour les patients qui font les frais d’informations erronées pouvant avoir des conséquences sanitaires. Afin de lutter contre les causes (promotion des médecins et attribution de ressources sur des critères de recherche purement quantitatifs, absence de formation médicale à l’intégrité scientifique, difficulté des processus de mise en évidence de fraude scientifique, impunité juridique), il existe des solutions législatives, universitaires, numériques et éditoriales, mais l’essentiel relève de changements culturels radicaux et urgents.
