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7. Information Sheets and Informed Consent Forms for Clinical Study Participants: Towards Standardised Recommendations?

Author

Alberola, Bernard, Bergmann, Jean-François, Bernard-Harlaut, Micheline, Cailliot, Christian, Chappuy, Hélène, Chassany, Olivier, Coron, Xavier, Cracowski, Jean-Luc, Decousus, Hervé, Demonfaucon, Christophe, Fagard, Catherine, Fischer, Hugues, Gelpi, Odile, Golinelli, Danielle, Gourlay, Marie-Laurence, Guy, Gilles, Juillets, Yves, Le Coent, Rémi, Legrand, Christian, Malchiodi, Monique, Morin, Anne-Laure, Nalet, Véronique, Olympie, Alain, Rivaille, François, Sibenaler, Claire, Thizon de Gaulle, Isabelle, and Billon, Nathalie

Published
2009
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8. Note d’information et consentement des patients participant à des essais cliniques : vers des recommandations standardisées ?

Author

Alberola, Bernard, Bergmann, Jean-François, Bernard-Harlaut, Micheline, Cailliot, Christian, Chappuy, Hélène, Chassany, Olivier, Coron, Xavier, Cracowski, Jean-Luc, Decousus, Hervé, Demonfaucon, Christophe, Fagard, Catherine, Fischer, Hugues, Gelpi, Odile, Golinelli, Danielle, Gourlay, Marie-Laurence, Guy, Gilles, Juillets, Yves, Le Coent, Rémi, Legrand, Christian, Malchiodi, Monique, Morin, Anne-Laure, Nalet, Véronique, Olympie, Alain, Rivaille, François, Sibenaler, Claire, de Gaulle, Isabelle Thizon, and Billon, Nathalie

Published
2009
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12. Biosimilaires, y a-t-il un problème ? Le point de vue des associations de patients.

Author

Olympie, Alain

Abstract

The arrival of biotherapies has been an important advance in the treatment of chronic inflammatory bowel diseases, chronic inflammatory rheumatism or psoriasis. While other innovative treatments are expected, why such a debate on the biosimilars of anti-TNF? The confusion in the evolution of official speech and the lack of interest of physicians before the arrival of biosimilars led patient associations to mobilize to clarify positions that were sometimes contradictory. Were the savings placed first before the safety of patients? The complexity of the subject and these "big" molecules would not it reproduce the difficulties encountered for the generics in the past? What security for patients between the "scientific extrapolation/immunogenicity" vs. "real life with the original drug"? The information (meant as adherence) of the patients, the traceability and the biosimilar manufacture were the main issues brought by the associations. The arrival of the biosimilar for infliximab, a hospital prescription product that has been available since march 2015, made it possible to prepare that of adalimumab delivered in the community pharmacies in 2018. The prescription by the physician and possible the substitution by the pharmacist must go through the information of the patient, the only informed decision-maker. It is the condition for a necessary confidence in the long-term management of their chronic diseases. [ABSTRACT FROM AUTHOR]

Published
2018
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19. Note d’information et consentement des patients participant à des essais cliniques : vers des recommandations standardisées ?

Author

Chassany, Olivier, primary, Bernard-Harlaut, Micheline, additional, Guy, Gilles, additional, Billon, Nathalie, additional, Alberola, Bernard, additional, Bergmann, Jean-François, additional, Cailliot, Christian, additional, Chappuy, Hélène, additional, Chassany, Olivier, additional, Coron, Xavier, additional, Cracowski, Jean-Luc, additional, Decousus, Hervé, additional, Demonfaucon, Christophe, additional, Fagard, Catherine, additional, Fischer, Hugues, additional, Gelpi, Odile, additional, Golinelli, Danielle, additional, Gourlay, Marie-Laurence, additional, Juillets, Yves, additional, Le Coent, Rémi, additional, Legrand, Christian, additional, Malchiodi, Monique, additional, Morin, Anne-Laure, additional, Nalet, Véronique, additional, Olympie, Alain, additional, Rivaille, François, additional, Sibenaler, Claire, additional, and de Gaulle, Isabelle Thizon, additional

Published
2009
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20. Information Sheets and Informed Consent Forms for Clinical Study Participants: Towards Standardised Recommendations?

Author

Chassany, Olivier, primary, Bernard-Harlaut, Micheline, additional, Guy, Gilles, additional, Billon, Nathalie, additional, Alberola, Bernard, additional, Bergmann, Jean-François, additional, Cailliot, Christian, additional, Chappuy, Hélène, additional, Chassany, Olivier, additional, Coron, Xavier, additional, Cracowski, Jean-Luc, additional, Decousus, Hervé, additional, Demonfaucon, Christophe, additional, Fagard, Catherine, additional, Fischer, Hugues, additional, Gelpi, Odile, additional, Golinelli, Danielle, additional, Gourlay, Marie-Laurence, additional, Juillets, Yves, additional, Le Coent, Rémi, additional, Legrand, Christian, additional, Malchiodi, Monique, additional, Morin, Anne-Laure, additional, Nalet, Véronique, additional, Olympie, Alain, additional, Rivaille, François, additional, Sibenaler, Claire, additional, and Thizon de Gaulle, Isabelle, additional

Published
2009
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21. Impact of Inflammatory Bowel Disease on Patients' Caregivers: Results From a French Survey.

Author

El Hajj W, Buisson A, Olympie A, Ravel MH, Devos C, Trang-Poisson C, Macaigne G, and Nahon S

Subjects
Humans, Female, Middle Aged, Male, Caregivers psychology, Quality of Life, Surveys and Questionnaires, Inflammatory Bowel Diseases psychology, Crohn Disease psychology, Colitis, Ulcerative psychology
Abstract

Background: The impact of inflammatory bowel disease (IBD) on caregivers has rarely been investigated. Our work aims to explore the burden of IBD on the different aspects of caregivers' lives., Methods: We conducted an online survey via the social network of the French IBD patient organization addressed to patients' caregivers who were asked to fill in a questionnaire covering the impact of the disease on different aspects of their lives. Impacts were measured by a visual analog scale (VAS). A VAS score ≥5 of 10 was considered significantly high. We then performed uni- and multivariate analyses of predictors of higher impact on parents and partners, separately., Results: A total of 853 caregivers participated, predominantly women (77%). The mean age was 48.5 years. Their relationship with the patient was mainly parents in 57.1% and partners in 30.6%. The type of IBD was Crohn's disease in 63% and ulcerative colitis in 35%. The psychological burden was the highest among parents and was mainly correlated with a lack of knowledge about IBD and professional compromise (P < .05). The impact on leisure was the highest among partners and was affected by psychological, sexual, and professional burdens (P < .05). About 50% of partners experienced an absent sexual relationship for weeks/months and decreased libido regardless of IBD type. Professional impact was greater in parents compared with partners, and 36% of caregivers needed work arrangements., Conclusions: IBD has a high impact on different aspects of life of patients' caregivers. Therefore, interventions to reduce the disease burden in this population are needed., (© The Author(s) 2023. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Published
2024
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22. Living with inflammatory bowel

Author

Olympie A

Abstract

Competing Interests: A. Olympie déclare des interventions ponctuelles (activités de conseil et conférences, colloques, actions de formation) pour AbbVie, Ferring, Hospira, Lilly, MSD, Norgine, Otsuka, Pfizer, Sanofi et Takeda ; et avoir été pris en charge à l’occasion de déplacements pour congrès par Roche.

Published
2015

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