Publications et travaux de recherche
2026
Prevost, Virginie; Tran, Titi; Clarisse, Bénédicte; Leconte, Alexandra; Fernette, Marie; Grandazzi, Guillaume; Gouriot, Mylène
The experience of shared meditation involving people with cancer, health professionals and third persons: a qualitative focus-group study Article de journal
Dans: Integrative Cancer Therapies, vol. 25, p. 1-13, 2026.
Résumé | Liens | BibTeX | Étiquettes: Recherche
@article{Prevost2026,
title = {The experience of shared meditation involving people with cancer, health professionals and third persons: a qualitative focus-group study},
author = {Virginie Prevost and Titi Tran and Bénédicte Clarisse and Alexandra Leconte and Marie Fernette and Guillaume Grandazzi and Mylène Gouriot},
doi = {10.1177/15347354261439128},
year = {2026},
date = {2026-03-20},
urldate = {2026-03-20},
journal = {Integrative Cancer Therapies},
volume = {25},
pages = {1-13},
abstract = {In recent years, mindfulness-based interventions have gained in popularity as a non-pharmacological intervention for improving
well-being in oncology. Our project aims to address the benefit of shared meditation involving patients, medical staff ant
third parties (neither patients, nor carers). The intervention programme was based on 12 weekly 2h sessions (including
2 half-day retreats), followed by 3 monthly follow-up sessions in remote format. Focus groups were conducted at the end
of our programme for each category of the 42 participants who experienced shared meditation based on 5 preselected
open-ended questions. Responses were transcribed and analysed using NVivo software. Four salient themes were identified
attesting that shared meditation: (1) was a positive experience, with physical and psychological benefits, even though requiring
much commitment, (2) provided an experience enabling them to see themselves as people rather than just patients, (3)
allowed them to rethink their lives by reconsidering their relationship with themselves and their disease, and (4) improved
their relationships, not only with carers in the therapeutic setting but also outside it, with third parties. Their feelings of
stigmatisation linked to the disease were attenuated. Improvement of psychosocial skills was reported as a major benefit of
shared meditation. Beyond the positive effects on well-being, shared meditation could enable patients and others to develop
a sense of social connectedness and to nurture a sense of common humanity. Our qualitative data provide valuable insights
into how shared meditation can be implemented, not only within the care setting but also within the community at large.},
keywords = {Recherche},
pubstate = {published},
tppubtype = {article}
}
well-being in oncology. Our project aims to address the benefit of shared meditation involving patients, medical staff ant
third parties (neither patients, nor carers). The intervention programme was based on 12 weekly 2h sessions (including
2 half-day retreats), followed by 3 monthly follow-up sessions in remote format. Focus groups were conducted at the end
of our programme for each category of the 42 participants who experienced shared meditation based on 5 preselected
open-ended questions. Responses were transcribed and analysed using NVivo software. Four salient themes were identified
attesting that shared meditation: (1) was a positive experience, with physical and psychological benefits, even though requiring
much commitment, (2) provided an experience enabling them to see themselves as people rather than just patients, (3)
allowed them to rethink their lives by reconsidering their relationship with themselves and their disease, and (4) improved
their relationships, not only with carers in the therapeutic setting but also outside it, with third parties. Their feelings of
stigmatisation linked to the disease were attenuated. Improvement of psychosocial skills was reported as a major benefit of
shared meditation. Beyond the positive effects on well-being, shared meditation could enable patients and others to develop
a sense of social connectedness and to nurture a sense of common humanity. Our qualitative data provide valuable insights
into how shared meditation can be implemented, not only within the care setting but also within the community at large.
Papet, Eloise; Moutel, Grégoire; Pinson, Jean; Roussel, Edouard; Bridoux, Valérie; Tuech, Jean-Jacques
A scoping review focused on cooperative group involvement in surgical randomized controlled trials Article de journal
Dans: Journal of Surgical Research, vol. 318, iss. February 2026, p. 120-125, 2026.
Résumé | Liens | BibTeX | Étiquettes: Recherche
@article{Papet2026,
title = {A scoping review focused on cooperative group involvement in surgical randomized controlled trials},
author = {Eloise Papet and Grégoire Moutel and Jean Pinson and Edouard Roussel and Valérie Bridoux and Jean-Jacques Tuech},
doi = {10.1016/j.jss.2025.12.008},
year = {2026},
date = {2026-02-01},
journal = {Journal of Surgical Research},
volume = {318},
issue = {February 2026},
pages = {120-125},
abstract = {Introduction: Surgical randomized controlled trials (RCTs) are increasingly conducted in complex, multicenter contexts. Despite growing emphasis on research transparency and rigor, concerns remain regarding the methodological and ethical standards of such trials. Cooperative groups (CGs), well-established in oncology research, may play a role in improving trial quality in surgery―a domain where their influence remains underexplored. This scoping review aims to map the methodological and ethical quality of phase III surgical RCTs published between 2016 and 2020 in international surgical journals, with a focus on the potential impact of CG involvement.
Material and methods: We systematically searched ten major surgical journals for RCTs published between January 2016 and December 2020. Eligible trials were assessed using the Jadad scale (methodological quality) and the Berdeu score (ethical quality). We recorded study characteristics including sample size, funding source, multicenter design, and presence of a CG.
Results: A total of 520 surgical RCTs were included. The mean Jadad score was 10.0 (±1.54) and the mean Berdeu score was 0.8 (±0.11). Only 50 trials (10%) involved a CG. These trials showed a trend toward higher methodological quality (mean Jadad 10.4 versus 9.97; P = 0.0593) and more frequent inclusion of quality-of-life assessments (28% versus 13%; P = 0.0056). Public funding was significantly more common in CG-led trials (56% versus 33%; P < 0.001).
Conclusions: This scoping review highlights that CG involvement in surgical RCTs is still limited but may be associated with improved methodological practices and broader outcome measures, such as quality of life. These findings suggest that greater involvement of CGs could strengthen research infrastructure and make surgical trials more patient-centered.},
keywords = {Recherche},
pubstate = {published},
tppubtype = {article}
}
Material and methods: We systematically searched ten major surgical journals for RCTs published between January 2016 and December 2020. Eligible trials were assessed using the Jadad scale (methodological quality) and the Berdeu score (ethical quality). We recorded study characteristics including sample size, funding source, multicenter design, and presence of a CG.
Results: A total of 520 surgical RCTs were included. The mean Jadad score was 10.0 (±1.54) and the mean Berdeu score was 0.8 (±0.11). Only 50 trials (10%) involved a CG. These trials showed a trend toward higher methodological quality (mean Jadad 10.4 versus 9.97; P = 0.0593) and more frequent inclusion of quality-of-life assessments (28% versus 13%; P = 0.0056). Public funding was significantly more common in CG-led trials (56% versus 33%; P < 0.001).
Conclusions: This scoping review highlights that CG involvement in surgical RCTs is still limited but may be associated with improved methodological practices and broader outcome measures, such as quality of life. These findings suggest that greater involvement of CGs could strengthen research infrastructure and make surgical trials more patient-centered.
2024
Prevost, Virginie; Tran, Titi; Leconte, Alexandra; Lequesne, Justine; Fernette, Marie; Segura, Carine; Chevigné, Sylvie; Gouriot, Mylène; Clarisse, Bénédicte
Dans: BMC Cancer, vol. 24, iss. 1, p. 1097, 2024.
Résumé | Liens | BibTeX | Étiquettes: Recherche
@article{Prevost2024,
title = {A randomised study to evaluate the potential added value of shared meditation involving people with cancer, health professionals and third persons compared to meditation conducted with patients only: design of the Implic-2 protocol},
author = {Virginie Prevost and Titi Tran and Alexandra Leconte and Justine Lequesne and Marie Fernette and Carine Segura and Sylvie Chevigné and Mylène Gouriot and Bénédicte Clarisse},
url = {https://pubmed.ncbi.nlm.nih.gov/39232668/},
doi = {10.1186/s12885-024-12521-1},
year = {2024},
date = {2024-09-04},
journal = {BMC Cancer},
volume = {24},
issue = {1},
pages = {1097},
abstract = {Background
In oncology, the suffering of patients and the burnout of health professionals are key issues. Mindfulness meditation is a holistic approach that can help to improve well-being. While numerous studies have shown the benefits of meditation for both patients and health professionals, the added value of offering shared meditation to groups of patients, health professionals and third persons has not been assessed. Beyond strengthening the relationship between carers and patients, opening up meditation sessions to third parties (neither carers nor patients) enables patients to escape the stigma of their illness. We previously conducted a pilot study that validated the feasibility and the relevance of shared meditation with a specifically designed programme.
Methods/Design
IMPLIC-2 is a two-arm randomised study designed to assess the added value of this meditation programme (optimised following the pilot study), particularly for cancer patients (our target population). People motivated to follow the programme, without previous regular practice of meditation and able to participate in the sessions are eligible. The study will include 96 participants: 16 health professionals, 16 third persons and 64 patients. The latter will be randomized in two arms: the experimental arm (“Shared” meditation) consisting of 4 mixed groups of 8 patients, 4 health professionals and 4 third parties, and the control arm (“Patient” meditation) consisting of 2 groups of 16 patients. Validated questionnaires will be used to measure the effects of the programme, notably in terms of quality of life, perceived stress, feelings of self-efficacy, qualities of mindfulness and self-compassion, and carers’ burn-out. Participants’ perception of a change in their quality of life and satisfaction will be measured at the end of the programme. A complementary qualitative focus-group approach will be used to optimise implementation of the programme beyond the study.
Discussion
The well-being of oncology patients would be improved. Dealing with overworked carers would have a beneficial impact on the way they interact with patients. In addition, encounters between the three types of population will allow otherness to be viewed differently and alleviate suffering by promoting collective humanity.},
keywords = {Recherche},
pubstate = {published},
tppubtype = {article}
}
In oncology, the suffering of patients and the burnout of health professionals are key issues. Mindfulness meditation is a holistic approach that can help to improve well-being. While numerous studies have shown the benefits of meditation for both patients and health professionals, the added value of offering shared meditation to groups of patients, health professionals and third persons has not been assessed. Beyond strengthening the relationship between carers and patients, opening up meditation sessions to third parties (neither carers nor patients) enables patients to escape the stigma of their illness. We previously conducted a pilot study that validated the feasibility and the relevance of shared meditation with a specifically designed programme.
Methods/Design
IMPLIC-2 is a two-arm randomised study designed to assess the added value of this meditation programme (optimised following the pilot study), particularly for cancer patients (our target population). People motivated to follow the programme, without previous regular practice of meditation and able to participate in the sessions are eligible. The study will include 96 participants: 16 health professionals, 16 third persons and 64 patients. The latter will be randomized in two arms: the experimental arm (“Shared” meditation) consisting of 4 mixed groups of 8 patients, 4 health professionals and 4 third parties, and the control arm (“Patient” meditation) consisting of 2 groups of 16 patients. Validated questionnaires will be used to measure the effects of the programme, notably in terms of quality of life, perceived stress, feelings of self-efficacy, qualities of mindfulness and self-compassion, and carers’ burn-out. Participants’ perception of a change in their quality of life and satisfaction will be measured at the end of the programme. A complementary qualitative focus-group approach will be used to optimise implementation of the programme beyond the study.
Discussion
The well-being of oncology patients would be improved. Dealing with overworked carers would have a beneficial impact on the way they interact with patients. In addition, encounters between the three types of population will allow otherness to be viewed differently and alleviate suffering by promoting collective humanity.
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}
}
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}
}
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}
}
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}
}
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}
}
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.
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}
}
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}
}
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}
}
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}
}