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3. Association between culture and the preference for, and perceptions of, 11 routes of medicine administration: A survey in 21 countries and regions

Author

Murdan, Sudaxshina, Wei, Li, van Riet-Nales, Diana A., Gurmu, Abyot Endale, Usifoh, Stella Folajole, Tăerel, Adriana-Elena, Yıldız-Peköz, Ayca, Krajnović, Dušanka, Azzopardi, Lilian M., Brock, Tina, Fernandes, Ana I., dos Santos, André Luis Souza, Anto, Berko Panyin, Vallet, Thibault, Lee, Eunkyung Euni, Jeong, Kyeong Hye, Akel, Marwan, Tam, Eliza, Volmer, Daisy, Douss, Tawfik, Shukla, Sharvari, Yamamura, Shigeo, Lou, Xiaoe, van Riet, Bauke H.G., Usifoh, Cyril O., Duwiejua, Mahama, Ruiz, Fabrice, and Furnham, Adrian

Published
2023
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7. Contributors

Author

Atanasova, Boriana, primary, Bacle, Irène, additional, Bassereau, J.F., additional, Charles, Mathilde, additional, Csoltova, Erika, additional, Dacleu Ndengue, Jessica, additional, Dairou, Victoire, additional, De Viti, Chloé, additional, Delarue, Julien, additional, Dreyfuss, Lise, additional, Dumaine, Marion, additional, Duthoit-Saint Georges, Valérie, additional, Lageat, Thierry, additional, Larose-Forges, Claire, additional, Le Goff, Gaëlle, additional, Leitner, Erich, additional, Lemercier-Talbot, Anaïs, additional, Maignant, Allan, additional, Marque, Céline, additional, Mehinagic, Emira, additional, Mérat, Emmanuelle, additional, Pello, Régine Charvet, additional, Pensé-Lhéritier, Anne-Marie, additional, Petiot, Jean-François, additional, Petot, Hélène, additional, Rogues, Julien, additional, Roso, Alicia, additional, Ruiz, Fabrice, additional, Segond, Nais, additional, Seince, Nicolas, additional, Sheehan, Liz, additional, Shine, Margaret, additional, Siegmund, Barbara, additional, Sigurani, Séverine, additional, Symoneaux, Ronan, additional, Vallet, Thibault, additional, and Wrana, Elisabeth, additional

Published
2022
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12. 2748. Ceftolozane/tazobactam For the Treatment of Cystic Fibrosis Patients: Results from a French Prospective Cohort Study

Author

Bourge, Xavier, primary, Akrich, Brune, additional, Boutoille, David, additional, Brassac, Isabelle, additional, Mackosso, Carole, additional, Tavares, Linsay Monteiro, additional, Mootien, Joy, additional, Ruiz, Fabrice, additional, Timsit, Jean-François, additional, Castan, Bernard, additional, and Burgel, Pierre-Regis, additional

Published
2023
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13. How the new European data protection regulation affects clinical research and recommendations?

Author

Bertoye, Pierre-Henri, Boidin, Romain, Bureau, Serge, Chrétien, Jean-Marie, Delval, Cécile, Deplanque, Dominique, Dubray, Claude, Duchossoy, Luc, Edel, Valérie, Fouret, Cécile, Galaup, Ariane, Lesaulnier, Frédérique, Matei, Mihaela, Naudet, Florian, Plattner, Valérie, Rubio, Michel, Ruiz, Fabrice, Sénéchal-Cohen, Sophie, Simon, Tabassome, Vidal, Anne, Viola, Anne, Violleau, Mireille, Demotes-Mainard, Jacques, Cornu, Catherine, and Guérin, Aurélie

Published
2019
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14. Quel impact du nouveau règlement européen sur la protection des données sur la recherche clinique et recommandations

Author

Bertoye, Pierre-Henri, Boidin, Romain, Bureau, Serge, Chrétien, Jean-Marie, Delval, Cécile, Deplanque, Dominique, Dubray, Claude, Duchossoy, Luc, Edel, Valérie, Fouret, Cécile, Galaup, Ariane, Lesaulnier, Frédérique, Matei, Mihaela, Naudet, Florian, Plattner, Valérie, Rubio, Michel, Ruiz, Fabrice, Sénéchal-Cohen, Sophie, Simon, Tabassome, Vidal, Anne, Viola, Anne, Violleau, Mireille, Demotes-Mainard, Jacques, Cornu, Catherine, and Guérin, Aurélie

Published
2019
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15. Ceftolozane/Tazobactam for the Treatment of Complicated Infections in Hospital Settings—A French Real-world Study.

Author

Timsit, Jean-François, Mootien, Joy, Akrich, Brune, Bourge, Xavier, Brassac, Isabelle, Castan, Bernard, Mackosso, Carole, Tavares, Linsay Monteiro, Ruiz, Fabrice, Boutoille, David, and Ruimy, Raymond

Subjects
URINARY tract infections, KLEBSIELLA pneumoniae, INTRA-abdominal infections, TAZOBACTAM, PSEUDOMONADACEAE, PSEUDOMONAS aeruginosa, TREATMENT failure
Abstract

Background This study describes the conditions of use of ceftolozane/tazobactam (C/T) and associated outcomes in French hospital settings. Methods This was a prospective, multicenter, French observational study. Patients who received at least 1 dose of C/T were included and followed up as per routine clinical practice, until stop of C/T. Results A total of 260 patients were enrolled between October 2018 and December 2019 in 30 centers across France. Of these, 177 (68.0%) received C/T as per indication of usage following the results of the antibiogram (documented cases). Among documented patients, the mean age was 61.8 years, 73.4% were males, and 93.8% presented with multidrug-resistant (MDR) bacteria at inclusion. C/T was most frequently prescribed for pneumonia (48.6%), bacteremia (14.7%), complicated intra-abdominal infections (13.0%), or complicated urinary tract infections (9.6%). Pseudomonas aeruginosa was the species most frequently isolated with 212 strains from 155 patients, and 96.2% of these strains were susceptible to C/T. The median duration of C/T treatment was 16.1 days (1–115, n = 176). Complete or partial cure was achieved in 71.7% of patients, C/T was discontinued upon adaptation to microbiology results in 11.3% of patients for the following reasons: treatment failure in 2.8%, death in 4.0%, adverse events in 1.7%, and other in 8.5%. Conclusions This is the first prospective observational study of C/T utilization in a health care setting enrolling many patients in France. C/T demonstrated a high rate of clinical effectiveness in MDR infections, confirming it as an effective treatment option for complicated infections in a high-risk population. [ABSTRACT FROM AUTHOR]

Published
2024
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18. Rational and practical considerations to guide a target product profile for patient-centric drug product development with measurable patient outcomes – A proposed roadmap

Author

Stegemann, Sven, primary, Sheehan, Liz, additional, Rossi, Alessandra, additional, Barrett, Andrew, additional, Paudel, Amrit, additional, Crean, Abina, additional, Ruiz, Fabrice, additional, Bresciani, Massimo, additional, Liu, Fang, additional, Shariff, Zakia, additional, Shine, Margarete, additional, Schmelzer, Christel, additional, and Pense-Lheritier, Anne-Marie, additional

Published
2022
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20. A Decision Support Tool Facilitating Medicine Design for Optimal Acceptability in The Older Population

Author

Vallet, Thibault, Belissa, Emilie, Laribe-Caget, Sandra, Chevallier, Alain, Chedhomme, François-Xavier, Leglise, Patrick, Piccoli, Matthieu, Michelon, Hugues, Bloch, Vanessa, Meaume, Sylvie, Grancher, Anne-Sophie, Bachalat, Nathalie, Boulaich, Imad, Abdallah, Fattima, Rabus, Maite, Rwabihama, Jean-Paul, Ribemont, Annie-Claude, Lachuer, Celia, Perquy, Ines, Lechowski, Laurent, Delahaye, Anne, Depoisson, Mathieu, Orven, Yann, Guinot, Caroline, Gibaud, Stephane, Michel, Corinne, Mahiou, Abdel, Belbachir, Sid-Ahmed, Trouvin, Jean-Hugues, Dufaÿ-Wojcicki, Amelie, Boudy, Vincent, and Ruiz, Fabrice

Published
2018
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26. Exploring Acceptability Drivers of Oral Antibiotics in Children: Findings from an International Observational Study

Author

Vallet, Thibault, primary, Bensouda, Yahya, additional, Saito, Jumpei, additional, Mathiesen, Liv, additional, Pokharkar, Varsha, additional, Klingmann, Viviane, additional, Peak, Matthew, additional, Elhamdaoui, Omar, additional, Yamatani, Akimasa, additional, Ivanovic, Ivana, additional, Sajith, Manjusha, additional, Münch, Juliane, additional, Bracken, Louise, additional, Duncan, Jennifer Claire, additional, Salunke, Smita, additional, Wang, Siri, additional, and Ruiz, Fabrice, additional

Published
2021
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27. Health technology assessment of paediatric medicines: European landscape, challenges and opportunities inside the conect4children project.

Author

Moretti, Francesco, Ruiz, Fabrice, Bonifazi, Fedele, Pizzo, Elena, and Kindblom, Jenny M.

Subjects
*TECHNOLOGY assessment, *MEDICAL technology, *TECHNOLOGICAL innovations, *CHILD patients, *PEDIATRICS, *HEALTH services accessibility
Abstract

The medicine development process is complex and requires time and effort to ensure safety, efficacy and quality. In paediatrics, this process is even more challenging, as it involves a subgroup of the population that already faces a considerable gap in the clinical evaluation of medicines and devices compared to the adult population. Moreover, access to therapies is heavily influenced by national health technology assessment (HTA) recommendations, which often form the basis for pricing and reimbursement decisions that affect the availability of effective treatments within the national health systems. Yet performing an HTA to assess the relative effectiveness and cost‐effectiveness of a new children's treatment has several non‐trivial implications, creating a critical issue for the paediatric population. In addition, the advent of innovative health technologies for children emphasises the need to empower the role of HTAs in paediatrics. This article aims at describing the most relevant elements of the drug development process in the paediatric field by focusing on the HTA. Particular attention will be paid to the factors that influence market access for new paediatric medicines and patients' access to treatment. The article will also highlight some central methodological challenges in conducting HTA in the paediatric field. Finally, the article will provide insight into how initiatives, such as conect4children, may subsequently reinforce HTA awareness in the paediatric community and strengthen collaborations through network mechanisms. [ABSTRACT FROM AUTHOR]

Published
2022
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28. Proposed Tool to Compare and Assess the Applicability of Taste Assessment Techniques for Pharmaceuticals

Author

Clapham, David, primary, Bennett, Joanne, additional, Cram, Anne, additional, Discihnger, Angela, additional, Inghelbrecht, Sabine, additional, Pense-Lheriter, Anne-Marie, additional, Ruiz, Fabrice, additional, Salunke, Smita, additional, Schiele, Julia, additional, Soto, Jessica, additional, Walsh, Jennifer, additional, and Tuleu, Catherine, additional

Published
2021
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29. Acceptability of different oral dosage forms in paediatric patients in hospital setting.

Author

Pokharkar, Varsha, Sajith, Manjusha, Vallet, Thibault, Akshantal, Shruti, Shah, Rathin, Ruiz, Fabrice, and Salunke, Smita

Subjects
HOSPITALS, DRUG tablets, ORAL drug administration, CROSS-sectional method, DRUGS, GENETIC techniques, DOSAGE forms of drugs
Abstract

Objective: The understanding of acceptability of existing dosage forms is limited in most of the world and hinders the development of acceptable, age-appropriate medicines. The attributes of paediatric medicine acceptability may differ from country to country based on culture, healthcare infrastructure and health policies. This study was designed to map the acceptability of oral medicines in paediatric patients treated in hospital in India.Methods: An observational, cross-sectional study was conducted in patients aged below 18 years and taking any form of oral medication. Acceptability scores were obtained using CAST-ClinSearch Acceptability Score Test tool.Findings: 490 patients were recruited and 193 evaluations of different pharmaceutical products available in 20 dosage forms and 7 routes of administration were studied. Oral liquids (50%) and tablets (35%) were the most commonly prescribed and administered forms. Regardless of the therapeutic class and age, the oral liquids were 'positively accepted' in infants and toddlers. Acceptability of tablets improved with age and appeared to be generally good from the age of 6.Conclusion: This study indicates the limited progress towards adoption of age-appropriate dosage forms in India and thus impact on the acceptability of existing oral dosage forms. The key challenges posed by the adoption of age-appropriate formulations in India are (1) awareness of importance of appropriate administration and acceptability of medicines to children in India, (2) availability of age-appropriate dosage forms and (3) lack of child-appropriate medicine policies. [ABSTRACT FROM AUTHOR]

Published
2022
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32. The CONSTANCES Cohort Biobank: An Open Tool for Research in Epidemiology and Prevention of Diseases

Author

Henny, Joseph, Nadif, Rachel, Le Got, Stéphane, Lemonnier, Sylvie, Ozguler, Anna, Ruiz, Fabrice, Beaumont, Katy, Brault, Dominique, Sandt, Estelle, Goldberg, Marcel, Zins, Marie, Cohortes épidémiologiques en population (CONSTANCES), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay-Université de Paris (UP), Centre de recherche en épidémiologie et santé des populations (CESP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Sud - Paris 11 (UP11)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), ClinSearch [Malakoff, France], Luxembourg Institute of Health (LIH), Integrated BioBank of Luxembourg (IBBL), Université de Paris - UFR Médecine Paris Centre [Santé] (UP Médecine Paris Centre), Université de Paris (UP), Infrastructures en Biologie Santé et Agronomie, IBiSA: ANR-11-INBS-0002 H. Lundbeck A/S AstraZeneca France MSD France, The Constances Cohort Study was supported and funded by the Caisse nationale d’assurance maladie (CNAM). The Constances Cohort Study is an Infrastructure nationale en Biologie et Santé and benefits from a grant from ANR (ANR-11-INBS-0002) and from the Ministry of Research. Constances is also partly funded by MSD, AstraZeneca and Lundbeck., ANR-11-INBS-0002,CONSTANCES,La cohorte CONSTANCES - Infrastructure épidémiologique ouverte pour la recherche et la surveillance(2011), HAL UVSQ, Équipe, Infrastructures - La cohorte CONSTANCES - Infrastructure épidémiologique ouverte pour la recherche et la surveillance - - CONSTANCES2011 - ANR-11-INBS-0002 - INBS - VALID, Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay-Université Paris Cité (UPCité), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Paris Cité - UFR Médecine [Santé] (UPCité UFR Médecine), and Université Paris Cité (UPCité)

Subjects
biobanking methodology, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, urine samples, blood samples, longitudinal studies, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, DNA, population-based cohort, biorepository, observational studies
Abstract

International audience; “General-purpose cohorts” in epidemiology and public health are designed to cover a broad scope of determinants and outcomes, in order to answer several research questions, including those not defined at study inception. In this context, the general objective of the CONSTANCES project is to set up a large population-based cohort that will contribute to the development of epidemiological research by hosting ancillary projects on a wide range of scientific domains, and to provide public health information. CONSTANCES was designed as a randomly selected sample of French adults aged 18–69 years at study inception; 202,045 subjects were included over an 8-year period. At inclusion, the selected participants are invited to attend one of the 24 participating Health Prevention Centers (HPCs) for a comprehensive health examination. The follow-up includes a yearly self-administered questionnaire, and a periodic visit to an HPC. Procedures have been developed to use the national healthcare databases to allow identification and validation of diseases over the follow-up. The biological collection (serum, lithium heparinized plasma, EDTA plasma, urine and buffy coat) began gradually in June 2018. At the end of the inclusions, specimens from 83,000 donors will have been collected. Specimens are collected according to a standardized protocol, identical in all recruitment centers. All operations relating to bio-banking have been entrusted by Inserm to the Integrated Biobank of Luxembourg (IBBL). A quality management system has been put in place. Particular attention has been paid to the traceability of all operations. The nature of the biological samples stored has been deliberately limited due to the economic and organizational constraints of the inclusion centers. Some research works may require specific collection conditions, and can be developed on request for a limited number of subjects and in specially trained centers. The biological specimens that are collected will allow for a large spectrum of biomarkers studies and genetic and epigenetic markers through candidate or agnostic approaches. By linking the extensive data on personal, lifestyle, environmental, occupational and social factors with the biomarker data, the CONSTANCES cohort offers the opportunity to study the interplays between these factors using an integrative approach and state-of-the-art methods.

Published
2020

34. Medicine acceptability for older people in hospital and care home: the influence of setting.

Author

Jani, Yogini H, Liu, Fang, Orlu, Mine, Desai, Neel, Chayla, Florence du, Ruiz, Fabrice, and Vallet, Thibault

Abstract

Objective Medicines acceptability is likely to have a significant impact on older people's adherence and, consequently, treatment effectiveness. The objective was to explore the influence of setting on medicines acceptability in older people. Methods A multi-centre, prospective, cross-sectional, observational study was conducted in one care home and one elderly care hospital ward in London, UK, involving individuals on ≥1 medicine(s) and aged ≥65 years. Data-driven approach was applied using multiple observer-reported outcomes analysis tool to distinguish between positively and negatively accepted medicines. Key findings 263 observer reports from the care home (n = 97) and hospital ward (n = 166) involving 155 distinct medicinal products were assessed. Collectively, medicines appeared better accepted by patients at the hospital. Differences appeared to be driven by variations in solid oral dosage form (SODF) acceptability. Patients with dysphagia poorly accepted medicines in both settings, as expected. SODFs were unexpectedly better accepted in the hospital than in the care home in patients without dysphagia. Conclusions Medicines acceptability was affected by patient's characteristics, dosage form type and setting. Changes in care practices between care home and hospital may affect medicine administration and lead to variations in the ability and willingness of patients and carers to use the product as intended. [ABSTRACT FROM AUTHOR]

Published
2022
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39. Acceptability of oral liquid pharmaceutical products in older adults: palatability and swallowability issues

Author

Belissa, Emilie, primary, Vallet, Thibault, additional, Laribe-Caget, Sandra, additional, Chevallier, Alain, additional, Chedhomme, François-Xavier, additional, Abdallah, Fattima, additional, Bachalat, Nathalie, additional, Belbachir, Sid-Ahmed, additional, Boulaich, Imad, additional, Bloch, Vanessa, additional, Delahaye, Anne, additional, Depoisson, Mathieu, additional, Wojcicki, Amélie Dufaÿ, additional, Gibaud, Stéphane, additional, Grancher, Anne-Sophie, additional, Guinot, Caroline, additional, Lachuer, Celia, additional, Lechowski, Laurent, additional, Leglise, Patrick, additional, Mahiou, Abdel, additional, Meaume, Sylvie, additional, Michel, Corinne, additional, Michelon, Hugues, additional, Orven, Yann, additional, Perquy, Ines, additional, Piccoli, Matthieu, additional, Rabus, Maïté, additional, Ribemont, Annie-Claude, additional, Rwabihama, Jean-Paul, additional, Trouvin, Jean-Hugues, additional, Ruiz, Fabrice, additional, and Boudy, Vincent, additional

Published
2019
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40. What impact of the new European Data Protection Regulation on clinical research and recommendations

Author

Demotes-Mainard, Jacques, Cornu, Catherine, Guerin, Aurelie, Bertoye, Pierre-Henri, Boidin, Romain, Bureau, Serge, Chretien, Jean-Marie, Delval, Cecile, Deplanque, Dominique, Dubray, Claude, Duchossoy, Luc, Edel, Valerie, Fouret, Cecile, Galaup, Ariane, Lesaulnier, Frederique, Matei, Mihaela, Naudet, Florian, Plattner, Valerie, Rubio, Michel, Ruiz, Fabrice, Senechal-Cohen, Sophie, Simon, Tabassome, Vidal, Anne, Viola, Anne, Violleau, Mireille, European Clinical Research Infrastructures Network [Dusseldorf] (ECRIN), CIC CHU Lyon (inserm), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM), Pfizer, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Centre d'Investigation Clinique - Innovation Technologique de Lille - CIC 1403 - CIC 9301 (CIC Lille), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), CHU Clermont-Ferrand, Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Hospices Civils de Lyon (HCL), Université de Rennes 1 (UR1), and Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
Recherche clinique, Big data, [SHS.DROIT]Humanities and Social Sciences/Law, CNIL, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Textes réglementaires, Protection des données, [SDV.ETH]Life Sciences [q-bio]/Ethics
Abstract

International audience; La recherche clinique, menée sur des sujets humains ou à partir de leurs données, se trouve confrontée à des exigences contradictoires, avec, d’une part, le principe de science ouverte (transparence et partage des données), les possibilités offertes par les « big data » et la réutilisation des données issues de la recherche ou du soin et, d’autre part, l’encadrement réglementaire et législatif qui évolue, avec notamment le règlement général sur la protection des données ou RGPD. Une table ronde était organisée à Giens en octobre 2018, afin d’identifier les zones de tension, les besoins de clarification et de fluidification, et de faire des recommandations visant à promouvoir la recherche clinique tout en assurant un haut niveau de protection des patients. Après une mise au point effectuée en commun sur ces évolutions, les participants à la table ronde ont pu proposer des recommandations, dont les principales sont (1) de clarifier : ce qui est considéré comme données anonymisées et ce que représente « l’intérêt public » au sens du RGPD ; (2) de poursuivre le développement des méthodologies de référence par la CNIL ; (3) de promouvoir l’utilisation secondaire des données, en facilitant une information et un consentement élargi des patients, en clarifiant les circonstances d’application de leurs droits de retrait, d’opposition, de façon à limiter le risque de biais ; (4) faciliter l’accès aux entrepôts de données par la mise à disposition de supports technologiques et méthodologiques. Enfin, développer les échanges au niveau européen entre autorités sur les sujets de recherche, promouvoir la participation des autorités françaises à l’élaboration des codes de conduite, et la mise en place d’une procédure d’harmonisation volontaire pour coordonner les avis des autorités de protection des données, tout en s’assurant que les principaux documents soient disponibles en langue anglaise.

Published
2019

42. Sex Differences in Medicine Acceptability: A New Factor to Be Considered in Medicine Formulation

Author

Ruiz, Fabrice, primary, Keeley, Alexander, additional, Léglise, Patrick, additional, Tuleu, Catherine, additional, Lachuer, Célia, additional, Rwabihama, Jean-Paul, additional, Bachalat, Nathalie, additional, Boulaich, Imad, additional, Abdallah, Fattima, additional, Rabus, Maité, additional, Ribemont, Annie-Claude, additional, Michelon, Hugues, additional, Wojcicki, Amélie Dufaÿ, additional, Orlu, Mine, additional, Vallet, Thibault, additional, and Boudy, Vincent, additional

Published
2019
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43. Quel impact du nouveau règlement européen sur la protection des données sur la recherche clinique et recommandations

Author

Demotes-Mainard, Jacques, primary, Cornu, Catherine, additional, Guérin, Aurélie, additional, Bertoye, Pierre-Henri, additional, Boidin, Romain, additional, Bureau, Serge, additional, Chrétien, Jean-Marie, additional, Delval, Cécile, additional, Deplanque, Dominique, additional, Dubray, Claude, additional, Duchossoy, Luc, additional, Edel, Valérie, additional, Fouret, Cécile, additional, Galaup, Ariane, additional, Lesaulnier, Frédérique, additional, Matei, Mihaela, additional, Naudet, Florian, additional, Plattner, Valérie, additional, Rubio, Michel, additional, Ruiz, Fabrice, additional, Sénéchal-Cohen, Sophie, additional, Simon, Tabassome, additional, Vidal, Anne, additional, Viola, Anne, additional, and Violleau, Mireille, additional

Published
2019
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44. How the new European data protection regulation affects clinical research and recommendations?

Author

Demotes-Mainard, Jacques, primary, Cornu, Catherine, additional, Guérin, Aurélie, additional, Bertoye, Pierre-Henri, additional, Boidin, Romain, additional, Bureau, Serge, additional, Chrétien, Jean-Marie, additional, Delval, Cécile, additional, Deplanque, Dominique, additional, Dubray, Claude, additional, Duchossoy, Luc, additional, Edel, Valérie, additional, Fouret, Cécile, additional, Galaup, Ariane, additional, Lesaulnier, Frédérique, additional, Matei, Mihaela, additional, Naudet, Florian, additional, Plattner, Valérie, additional, Rubio, Michel, additional, Ruiz, Fabrice, additional, Sénéchal-Cohen, Sophie, additional, Simon, Tabassome, additional, Vidal, Anne, additional, Viola, Anne, additional, and Violleau, Mireille, additional

Published
2019
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45. Quality of spirometry testing in the Constances Cohort and prevalence of airway obstruction

Author

Fuhrman, Claire, Cyr, Diane, Giraud, Violaine, Ruiz, Fabrice, Perez, Thierry, Iwatsubo, Yuriko, Leynaert, Bénédicte, Delmas, Marie-Christine, Roche, Nicolas, Santé publique France - French National Public Health Agency [Saint-Maurice, France], Cohortes épidémiologiques en population (CONSTANCES), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay-Université Paris Cité (UPCité), Hôpital Ambroise Paré [AP-HP], ClinSearch [Malakoff, France], Hôpital Albert Calmette, Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Physiopathologie et Epidémiologie des Maladies Respiratoires (PHERE (UMR_S_1152 / U1152)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), and Demarquay, Sandrine

Subjects
[SDV] Life Sciences [q-bio], Trouble ventilatoire obstructif, Spirométrie, [SDV]Life Sciences [q-bio], Prevalence, Cohort, Airway obstruction, Spirometry test, Cohorte, Prévalence
Abstract

INTRODUCTION – The aim of this study was to describe the quality of spirometry tests and to provide a preliminary estimation of airway obstruction (AO) prevalence among the first participants to the CONSTANCES cohort. METHODS – CONSTANCES is an epidemiological population-based cohort composed of a representative sample of voluntary participants selected randomly and aged 18-69 years. Spirometry tests (pre-bronchodilator flow-volume curves) were performed according to standard operating procedures. A sample of spirometry tests, rated as valid by the operator, was checked by two chest physicians. The prevalence of AO (defined by a FEV1/FVC, Introduction-Cet article présente une évaluation de la qualité des spirométries et une première estimation de la prévalence du trouble ventilatoire obstructif (TVO) chez les premiers participants à Constances. Méthodes-Constances est une cohorte épidémiologique constituée de volontaires tirés au sort et âgés de 18 à 69 ans à l'inclusion. Les spirométries (courbes débit-volume sans test de bronchodilatation) ont été réalisées selon une procédure standardisée. Leur qualité a été évaluée par deux pneumologues sur un échantillon de courbes jugées exploitables par l'opérateur. La prévalence du TVO a été estimée chez les adultes de 30 à 69 ans recrutés au 31 janvier 2014 et ayant une spirométrie exploitable. Le TVO a été défini par un rapport VEMS/CVF

Published
2016

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