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6 results on '"MESH: Patient Reported Outcome Measures"'

1. Health-related quality of life and utility outcomes with selinexor in relapsed/refractory diffuse large B-cell lymphoma

Author

Agnes Nagy, Rene-Olivier Casasnovas, Sameer Bakhshi, Sharon Shacham, Juan-Manuel Sancho, Ronit Gurion, Josée M. Zijlstra, Jatin P. Shah, Miklos Egyed, Brian T. Hill, Krzysztof Warzocha, Gabriel Tremblay, Michael W. Schuster, Fritz Offner, Reda Bouabdallah, Dimitrios Tomaras, Paolo Caimi, Andre Goy, Priyanka Samal, Catherine Thieblemont, Joost S.P. Vermaat, Matthew Ku, Ulrich Jäger, John Kuruvilla, Nagesh Kalakonda, George A Follows, Eric Van Den Neste, Miguel Ángel Canales Albendea, Michael Kauffman, Nada Hamad, Fatima De la Cruz, Patrick Daniele, Marie Maerevoet, Theodoros Vasilakopoulos, Federica Cavallo, Sylvain Choquet, Karyopharm Therapeutics Inc., Newton, MA, U918, Service d'Hématologie Clinique (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Institut Jules Bordet [Bruxelles], Faculté de Médecine [Bruxelles] (ULB), Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB), Amsterdam UMC, Addenbrooke's Hospital, Cambridge University NHS Trust, Leiden University Medical Center (LUMC), Institute of Translational Medicine, University of Liverpool, Hackensack University Medical Center [Hackensack], Service d'Hématologie clinique [CHU Pitié-Salpêtrière], CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Catholique de Louvain = Catholic University of Louvain (UCL), Cleveland Clinic, Service d'Hémato-oncologie [CHU Saint-Louis], Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), University of Turin, Hospital Universitario Virgen del Rocío [Sevilla], University Health Network, St Vincent's Hospital Melbourne [Australia], Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Medizinische Universität Wien = Medical University of Vienna, University Hospitals Case Medical Center, Tel Aviv University [Tel Aviv], Institute of Hematology and Transfusion Medicine[Warsaw, Poland] (IHTM), Germans Trias i Pujol Hospital, Barcelona Autonomous University, Stony Brook University [SUNY] (SBU), State University of New York (SUNY), Ghent University Hospital, National and Kapodistrian University of Athens (NKUA), Semmelweis University [Budapest], Hospital Universitario La Paz, UCL - SSS/DDUV - Institut de Duve, UCL - SSS/DDUV/BCHM - Biochimie-Recherche métabolique, and UCL - (SLuc) Service d'hématologie

Subjects
Male, Oncology, Cancer Research, Health utility, FACT-Lym, patient reported outcomes, MESH: Patient Reported Outcome Measures, MESH: Aged, 80 and over, 0302 clinical medicine, Quality of life, Recurrence, Medicine and Health Sciences, Aged, 80 and over, MESH: Aged, MESH: Middle Aged, health, [SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology, General Medicine, Middle Aged, MESH: Drug Resistance, Neoplasm, 3. Good health, health-related quality of life, Hydrazines, EQ-5D-5L, patient-reported outcomes, 030220 oncology & carcinogenesis, Female, health utility, Lymphoma, Large B-Cell, Diffuse, MESH: Hydrazines, Adult, disutility of adverse events, medicine.medical_specialty, diffuse large B-cell lymphoma, [SDV.CAN]Life Sciences [q-bio]/Cancer, 03 medical and health sciences, Refractory, Internal medicine, medicine, Humans, health state utility, selinexor, Patient Reported Outcome Measures, Aged, Health related quality of life, MESH: Humans, business.industry, MESH: Quality of Life, MESH: Adult, Triazoles, medicine.disease, MESH: Male, MESH: Recurrence, Lymphoma, MESH: Triazoles, utility, Drug Resistance, Neoplasm, Relapsed refractory, Quality of Life, MESH: Lymphoma, Large B-Cell, Diffuse, business, MESH: Female, Diffuse large B-cell lymphoma, Progressive disease, 030215 immunology
Abstract

Aim: Evaluate health-related quality of life (HRQoL) and health utility impact of single-agent selinexor in heavily pretreated patients with relapsed/refractory diffuse large B-cell lymphoma. Patients & methods: Functional Assessment of Cancer Therapy (FACT) - Lymphoma and EuroQoL five-dimensions five-levels data collected in the single-arm Phase IIb trial SADAL (NCT02227251) were analyzed with mixed-effects models. Results: Treatment responders maintained higher FACT - Lymphoma (p = 3 adverse events and serious adverse events were not associated with clinically meaningful negative QoL impacts.

Published
2021
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2. Implementation of an electronic patient-reported measure of barriers to antiretroviral therapy adherence with the Opal patient portal: Protocol for a mixed method type 3 hybrid pilot study at a large Montreal HIV clinic

Author

Kim Engler, Serge Vicente, Yuanchao Ma, Tarek Hijal, Joseph Cox, Sara Ahmed, Marina Klein, Sofiane Achiche, Nitika Pant Pai, Alexandra de Pokomandy, Karine Lacombe, Bertrand Lebouché, McGill University = Université McGill [Montréal, Canada], Université du Québec à Montréal = University of Québec in Montréal (UQAM), École Polytechnique de Montréal (EPM), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), and HAL-SU, Gestionnaire

Subjects
RNA viruses, Health Care Providers, Pilot Projects, MESH: Patient Reported Outcome Measures, Pathology and Laboratory Medicine, Immunodeficiency Viruses, Medicine and Health Sciences, Electronic Health Records, Public and Occupational Health, Medical Personnel, MESH: Electronic Health Records, Data Management, Multidisciplinary, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, MESH: Health Services, HIV diagnosis and management, Viral Load, Health Services, Vaccination and Immunization, Professions, Anti-Retroviral Agents, Medical Microbiology, Research Design, Viral Pathogens, Viruses, Medicine, Pathogens, Computer and Information Sciences, Canada, Patients, Science, Immunology, Antiretroviral Therapy, Research and Analysis Methods, MESH: Anti-Retroviral Agents, Microbiology, Medication Adherence, Antiviral Therapy, Patient Portals, MESH: Canada, Registered Report Protocol, Physicians, Virology, Retroviruses, Humans, Patient Reported Outcome Measures, Microbial Pathogens, MESH: Humans, Lentivirus, Organisms, Biology and Life Sciences, HIV, Pilot Studies, MESH: Medication Adherence, MESH: Pilot Projects, Diagnostic medicine, Health Care, MESH: Patient Portals, People and Places, Population Groupings, Preventive Medicine, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Viral Transmission and Infection
Abstract

Background Adherence to antiretroviral therapy (ART) remains problematic. Regular monitoring of its barriers is clinically recommended, however, patient-provider communication around adherence is often inadequate. Our team thus decided to develop a new electronically administered patient-reported outcome measure (PROM) of barriers to ART adherence (the I-Score) to systematically capture this data for physician consideration in routine HIV care. To prepare for a controlled definitive trial to test the I-Score intervention, a pilot study was designed. Its primary objectives are to evaluate patient and physician perceptions of the I-Score intervention and its implementation strategy. Methods This one-arm, 6-month study will adopt a mixed method type 3 implementation-effectiveness hybrid design and be conducted at the Chronic Viral Illness Service of the McGill University Health Centre (Montreal, Canada). Four HIV physicians and 32 of their HIV patients with known or suspected adherence problems will participate. The intervention will involve having patients complete the I-Score through a smartphone application (Opal), before meeting with their physician. Both patients and physicians will have access to the I-Score results, for consideration during the clinic visits at Times 1, 2 (3 months), and 3 (6 months). The implementation strategy will focus on stakeholder involvement, education, and training; promoting the intervention’s adaptability; and hiring an Application Manager to facilitate implementation. Implementation, patient, and service outcomes will be collected (Times 1-2-3). The primary outcome is the intervention’s acceptability to patients and physicians. Qualitative data obtained, in part, through physician focus groups (Times 2–3) and patient interviews (Times 2–3) will help evaluate the implementation strategy and inform any methodological adaptations. Discussion This study will help plan a definitive trial to test the efficacy of the I-Score intervention. It will generate needed data on electronic PROM interventions in routine HIV care that will help improve understanding of conditions for their successful implementation. Clinical trial registration ClinicalTrials.gov identifier: NCT04702412; https://clinicaltrials.gov/.

Published
2021
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3. Patient-reported symptoms during direct-acting antiviral treatment: A real-life study in HIV-HCV coinfected patients (ANRS CO13 HEPAVIH)

Author

Fabienne Marcellin, Vincent Di Beo, Hugues Aumaitre, Marion Mora, Linda Wittkop, Claudine Duvivier, Camelia Protopopescu, Karine Lacombe, Laure Esterle, Cyril Berenger, Camille Gilbert, Olivier Bouchaud, Isabelle Poizot-Martin, Philippe Sogni, Dominique Salmon-Ceron, Patrizia Carrieri, D. Salmon, L. Wittkop, P. Sogni, L. Esterle, P. Trimoulet, J. Izopet, L. Serfaty, V. Paradis, B. Spire, P. Carrieri, M.A. Valantin, G. Pialoux, J. Chas, I. Poizot-Martin, K. Barange, A. Naqvi, E. Rosenthal, A. Bicart-See, O. Bouchaud, A. Gervais, C. Lascoux-Combe, C. Goujard, K. Lacombe, C. Duvivier, D. Neau, P. Morlat, F. Bani-Sadr, L. Meyer, F. Boufassa, B. Autran, A.M. Roque, C. Solas, H. Fontaine, D. Costagliola, L. Piroth, A. Simon, D. Zucman, F. Boué, P. Miailhes, E. Billaud, H. Aumaître, D. Rey, G. Peytavin, V. Petrov-Sanchez, D. Lebrasseur-Longuet, R. Usubillaga, B. Terris, P. Tremeaux, C. Katlama, H. Stitou, P. Cacoub, S. Nafissa, Y. Benhamou, F. Charlotte, S. Fourati, O. Zaegel, H. Laroche, C. Tamalet, P. Callard, F. Bendjaballah, C. Amiel, C. Le Pendeven, B. Marchou, L. Alric, S. Metivier, J. Selves, F. Larroquette, V. Rio, J. Haudebourg, M.C. Saint-Paul, A. De Monte, V. Giordanengo, C. Partouche, A. Martin, M. Ziol, Y. Baazia, V. Iwaka-Bande, A. Gerber, M. Uzan, D. Garipuy, M.J. Ferro-Collados, F. Nicot, Y. Yazdanpanah, H. Adle-Biassette, G. Alexandre, J.M. Molina, P. Bertheau, M.L. Chaix, C. Delaugerre, S. Maylin, J. Bottero, J. Krause, P.M. Girard, D. Wendum, P. Cervera, J. Adam, C. Viala, D. Vittecocq, Y. Quertainmont, E. Teicher, C. Pallier, O. Lortholary, C. Rouzaud, J. Lourenco, F. Touam, C. Louisin, V. Avettand-Fenoel, E. Gardiennet, A. Mélard, A. Ochoa, E. Blanchard, S. Castet-Lafarie, C. Cazanave, D. Malvy, M. Dupon, H. Dutronc, F. Dauchy, L. Lacaze-Buzy, A. Desclaux, P. Bioulac-Sage, S. Reigadas, D. Lacoste, F. Bonnet, N. Bernard, M. Hessamfar, J, F. Paccalin, C. Martell, M.C. Pertusa, M. Vandenhende, P. Mercié, T. Pistone, M.C. Receveur, M. Méchain, P. Duau, C. Rivoisy, I. Faure, S. Caldato, P. Bellecave, C. Tumiotto, J.L. Pellegrin, J.F. Viallard, E. Lazzaro, C. Greib, C. Majerholc, M. Brollo, E. Farfour, J. Polo Devoto, I. Kansau, V. Chambrin, C. Pignon, L. Berroukeche, R. Fior, V. Martinez, S. Abgrall, M. Favier, C. Deback, Y. Lévy, S. Dominguez, J.D. Lelièvre, A.S. Lascaux, G. Melica, F. Raffi, C. Allavena, V. Reliquet, D. Boutoille, C. Biron, M. Lefebvre, N. Hall, S. Bouchez, A. Rodallec, L. Le Guen, C. Hemon, D. Peyramond, C. Chidiac, F. Ader, F. Biron, A. Boibieux, L. Cotte, T. Ferry, T. Perpoint, J. Koffi, F. Zoulim, F. Bailly, P. Lack, M. Maynard, S. Radenne, M. Amiri, F. Valour, C. Augustin-Normand, C. Scholtes, T.T. Le-Thi, P. Chavanet, M. Duong Van Huyen, M. Buisson, A. Waldner-Combernoux, S. Mahy, R. Binois, A.L. Simonet-Lann, D. Croisier-Bertin, A. Salmon Rousseau, C. Martins, S. Galim, D. Lambert, Y. Nguyen, J.L. Berger, M. Hentzien, V. Brodard, M. Partisani, M.L. Batard, C. Cheneau, M. Priester, C. Bernard-Henry, E. de Mautort, P. Gantner et S Fafi-Kremer, F. Roustant, P. Platterier, I. Kmiec, L. Traore, S. Lepuil, S. Parlier, V. Sicart-Payssan, E. Bedel, S. Anriamiandrisoa, C. Pomes, M. Mole, C. Bolliot, P. Catalan, M. Mebarki, A. Adda-Lievin, P. Thilbaut, Y. Ousidhoum, F.Z. Makhoukhi, O. Braik, R. Bayoud, C. Gatey, M.P. Pietri, V. Le Baut, R. Ben Rayana, D. Bornarel, C. Chesnel, D. Beniken, M. Pauchard, S. Akel, C. Lions, A. Ivanova, A.-S. Ritleg, C. Debreux, L. Chalal, J. Zelie, H. Hue, A. Soria, M. Cavellec, S. Breau, A. Joulie, P. Fisher, S. Gohier, S. Ogoudjobi, C. Brochier, V. Thoirain-Galvan, M. Le Cam, M. Chalouni, V. Conte, L. Dequae-Merchadou, M. Desvallees, C. Gilbert, S. Gillet, R. Knight, T. Lemboub, F. Marcellin, L. Michel, M. Mora, C. Protopopescu, P. Roux, S. Tezkratt, T. Barré, M. Baudoin, M. Santos, V. Di Beo, M. Nishimwe, Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale (SESSTIM - U1252 INSERM - Aix Marseille Univ - UMR 259 IRD), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Observatoire régional de la santé Provence-Alpes-Côte d'Azur [Marseille] (ORS PACA), Centre Hospitalier Saint Jean de Perpignan, Institut de Santé Publique, d'Epidémiologie et de Développement (ISPED), Université Bordeaux Segalen - Bordeaux 2, Team MORPH3EUS (INSERM U1219 - UB - ISPED), Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Pôle de Santé publique [Bordeaux], CHU Bordeaux [Bordeaux], Service des Maladies infectieuses et tropicales [CHU Necker], CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institut Cochin (IC UM3 (UMR 8104 / U1016)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), CIC Bordeaux, Université Bordeaux Segalen - Bordeaux 2-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de maladies infectieuses et tropicales [CHU Avicenne], Hôpital Avicenne [AP-HP], Université Paris 13 (UP13), Hôpital Sainte-Marguerite [CHU - APHM] (Hôpitaux Sud ), Département d'hépatologie [CHU Cochin], Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM), Immunobiologie des Cellules dendritiques, Institut Pasteur [Paris] (IP)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service Maladies infectieuses et tropicales [AP-HP Hôpital Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), This study was sponsored and funded by the French National Agency for Research on Aids and Viral Hepatitis (ANRS)., ANRS CO13 HEPAVIH Study Group : : D Salmon, L Wittkop, P Sogni, L Esterle, P Trimoulet, J Izopet, L Serfaty, V Paradis, B Spire, P Carrieri, M A Valantin, G Pialoux, J Chas, I Poizot-Martin, K Barange, A Naqvi, E Rosenthal, A Bicart-See, O Bouchaud, A Gervais, C Lascoux-Combe, C Goujard, K Lacombe, C Duvivier, D Neau, P Morlat, F Bani-Sadr, L Meyer, F Boufassa, B Autran, A M Roque, C Solas, H Fontaine, D Costagliola, L Piroth, A Simon, D Zucman, F Boué, P Miailhes, E Billaud, H Aumaître, D Rey, G Peytavin, V Petrov-Sanchez, D Lebrasseur-Longuet, D Salmon, R Usubillaga, P Sogni, B Terris, P Tremeaux, C Katlama, M A Valantin, H Stitou, A Simon, P Cacoub, S Nafissa, Y Benhamou, F Charlotte, S Fourati, I Poizot-Martin, O Zaegel, H Laroche, C Tamalet, G Pialoux, J Chas, P Callard, F Bendjaballah, C Amiel, C Le Pendeven, B Marchou, L Alric, K Barange, S Metivier, J Selves, F Larroquette, E Rosenthal, A Naqvi, V Rio, J Haudebourg, M C Saint-Paul, A De Monte, V Giordanengo, C Partouche, O Bouchaud, A Martin, M Ziol, Y Baazia, V Iwaka-Bande, A Gerber, M Uzan, A Bicart-See, D Garipuy, M J Ferro-Collados, J Selves, F Nicot, A Gervais, Y Yazdanpanah, H Adle-Biassette, G Alexandre, G Peytavin, C Lascoux-Combe, J M Molina, P Bertheau, M L Chaix, C Delaugerre, S Maylin, K Lacombe, J Bottero, J Krause, P M Girard, D Wendum, P Cervera, J Adam, C Viala, D Vittecocq, C Goujard, Y Quertainmont, E Teicher, C Pallier, O Lortholary, C Duvivier, C Rouzaud, J Lourenco, F Touam, C Louisin, V Avettand-Fenoel, E Gardiennet, A Mélard, D Neau, A Ochoa, E Blanchard, S Castet-Lafarie, C Cazanave, D Malvy, M Dupon, H Dutronc, F Dauchy, L Lacaze-Buzy, A Desclaux, P Bioulac-Sage, P Trimoulet, S Reigadas, P Morlat, D Lacoste, F Bonnet, N Bernard, M Hessamfar J, F Paccalin, C Martell, M C Pertusa, M Vandenhende, P Mercié, D Malvy, T Pistone, M C Receveur, M Méchain, P Duau, C Rivoisy, I Faure, S Caldato, P Bioulac-Sage, P Trimoulet, S Reigadas, P Bellecave, C Tumiotto, J L Pellegrin, J F Viallard, E Lazzaro, C Greib, P Bioulac-Sage, P Trimoulet, S Reigadas, D Zucman, C Majerholc, M Brollo, E Farfour, F Boué, J Polo Devoto, I Kansau, V Chambrin, C Pignon, L Berroukeche, R Fior, V Martinez, S Abgrall, M Favier, C Deback, Y Lévy, S Dominguez, J D Lelièvre, A S Lascaux, G Melica, E Billaud, F Raffi, C Allavena, V Reliquet, D Boutoille, C Biron, M Lefebvre, N Hall, S Bouchez, A Rodallec, L Le Guen, C Hemon, P Miailhes, D Peyramond, C Chidiac, F Ader, F Biron, A Boibieux, L Cotte, T Ferry, T Perpoint, J Koffi, F Zoulim, F Bailly, P Lack, M Maynard, S Radenne, M Amiri, F Valour, J Koffi, F Zoulim, F Bailly, P Lack, M Maynard, S Radenne, C Augustin-Normand, C Scholtes, T T Le-Thi, L Piroth, P Chavanet, M Duong Van Huyen, M Buisson, A Waldner-Combernoux, S Mahy, R Binois, A L Simonet-Lann, D Croisier-Bertin, A Salmon Rousseau, C Martins, H Aumaître, S Galim, F Bani-Sadr, D Lambert, Y Nguyen, J L Berger, M Hentzien, V Brodard, D Rey, M Partisani, M L Batard, C Cheneau, M Priester, C Bernard-Henry, E de Mautort, P Gantner Et S Fafi-Kremer, F Roustant, P Platterier, I Kmiec, L Traore, S Lepuil, S Parlier, V Sicart-Payssan, E Bedel, S Anriamiandrisoa, C Pomes, F Touam, C Louisin, M Mole, C Bolliot, P Catalan, M Mebarki, A Adda-Lievin, P Thilbaut, Y Ousidhoum, F Z Makhoukhi, O Braik, R Bayoud, C Gatey, M P Pietri, V Le Baut, R Ben Rayana, D Bornarel, C Chesnel, D Beniken, M Pauchard, S Akel, S Caldato, C Lions, A Ivanova, A-S Ritleg, C Debreux, L Chalal, J Zelie, H Hue, A Soria, M Cavellec, S Breau, A Joulie, P Fisher, S Gohier, D Croisier-Bertin, S Ogoudjobi, C Brochier, V Thoirain-Galvan, M Le Cam, P Carrieri, M Chalouni, V Conte, L Dequae-Merchadou, M Desvallees, L Esterle, C Gilbert, S Gillet, R Knight, T Lemboub, F Marcellin, L Michel, M Mora, C Protopopescu, P Roux, B Spire, S Tezkratt, T Barré, M Baudoin, M Santos, V Di Beo, M Nishimwe, L Wittkop., Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Paris (UP), Services des Maladies Infectieuses et Tropicales [CHU Saint-Antoine], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital Cochin [AP-HP], Institut Pasteur [Paris]-Institut National de la Santé et de la Recherche Médicale (INSERM), and Dupuis, Christine

Subjects
MESH: Antiviral Agents, medicine.medical_specialty, simeprevir + ribavirin (1). CI, [SDV]Life Sciences [q-bio], MEDLINE, sofosbuvir + simeprevir (3), HIV Infections, MESH: Patient Reported Outcome Measures, Antiviral Agents, sofosbuvir + ribavirin (4), 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, MORPH3Eus, Humans, Patient Reported Outcome Measures, 030212 general & internal medicine, Antiviral treatment, ComputingMilieux_MISCELLANEOUS, MESH: Hepatitis C, MESH: Humans, Hepatology, Coinfection, business.industry, ledipasvir/sofosbuvir (49), ledipasvir/sofosbuvir + ribavirin (10), Hepatitis C, MESH: HIV Infections, Hepatitis C, Chronic, medicine.disease, 3. Good health, MESH: Coinfection, MESH: Hepatitis C, Chronic, [SDV] Life Sciences [q-bio], confidence interval, daclatasvir + sofosbuvir + ribavirin (5), 030211 gastroenterology & hepatology, Life study, business, ombitasvir/ paritaprevir/ritonavir + ribavirin (1), Direct acting, daclatasvir + sofosbuvir (32)
Abstract

International audience; No abstract available

Published
2020
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4. Decision of adjuvant chemotherapy in intermediate risk luminal breast cancer patients: A prospective multicenter trial assessing the clinical and psychological impact of EndoPredict® (EpClin) use (UCBG 2–14)

Author

N Quenel-Tueux, Séverine Guiu, Fabrice Kwiatkowski, Cyril Foa, Jean-Philippe Jacquin, Veronique Girre, Olfa Derbel, Suzette Delaloge, Alain Lortholary, Marianne Leheurteur, Annick Le Rol, Antoine Arnaud, Emmanuel Guardiola, Christelle Jouannaud, Christelle Levy, Alexander Valent, Frédérique Penault-Llorca, Lionel Uwer, Diane Boinon, Jérôme Lemonnier, Stéphanie Catala, Imagerie Moléculaire et Stratégies Théranostiques (IMoST), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), and UNICANCER

Subjects
MESH: Genes, erbB-2, medicine.medical_treatment, MESH: Mastectomy, [SDV]Life Sciences [q-bio], Anxiety, MESH: Genetic Markers, MESH: Patient Reported Outcome Measures, Psychological Distress, MESH: Risk Assessment, 0302 clinical medicine, Breast cancer, MESH: Aged, 80 and over, Clinical endpoint, Genomic test, Prospective Studies, 030212 general & internal medicine, Stage (cooking), Prospective cohort study, Patient reported outcomes, Mastectomy, Aged, 80 and over, MESH: Aged, MESH: Middle Aged, MESH: Genetic Testing, MESH: Genomics, MESH: Clinical Decision-Making, Uncertainty, Genomics, General Medicine, Middle Aged, respiratory system, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, 3. Good health, Distress, Receptors, Estrogen, Chemotherapy, Adjuvant, MESH: Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, MESH: Receptors, Estrogen, Female, Original Article, medicine.symptom, MESH: Uncertainty, Adult, Genetic Markers, medicine.medical_specialty, Clinical Decision-Making, Antineoplastic Agents, Breast Neoplasms, MESH: Psychological Distress, Risk Assessment, lcsh:RC254-282, MESH: Clinical Decision Rules, 03 medical and health sciences, Clinical Decision Rules, Internal medicine, Multicenter trial, medicine, Humans, Chemotherapy, Genetic Testing, Patient Reported Outcome Measures, Aged, MESH: Humans, MESH: Anxiety, business.industry, MESH: Adult, Genes, erbB-2, medicine.disease, MESH: Prospective Studies, EndoPredict®, MESH: Antineoplastic Agents, Surgery, business, MESH: Female, MESH: Breast Neoplasms
Abstract

Purpose Genomic tests can identify ER-positive HER2-negative localized breast cancer patients who may not benefit from adjuvant chemotherapy. Such tests seem especially interesting in “intermediate” clinico-pathological risk categories. The psychological impact of the decision uncertainty in these women remains largely unexplored. We assessed the clinical and psychological impact of EndoPredict® (EpClin), a clinico-genomic test, in these patients. Methods This multicenter, single arm prospective study (NCT02773004) enrolled patients for which adjuvant chemotherapy was uncertain, based on predefined criteria. The primary endpoint was the proportion of change between initial adjuvant decision and final administration of chemotherapy. Secondary endpoints included post-test (Day 17) and 1-year patient reported outcomes. Results One third of 200 evaluable patients had a high EpClin score (≥3.32867; 10 years cumulative risk of distance failure ≥10%). The overall change rate of chemotherapy decision was 72/200 (35.8%, 95% CI 29.2–42.4). Chemotherapy was withdrawn in 57 cases (28.4% [22.2–34.8]) and added in 15 (7.5% [3.8–11.2]. 6 changes (8%) were based on patients’ decisions. Anxiety and distress levels increased at Day 17 when adding chemotherapy after the test result (p, Highlights • EndoPredict ® (EpClin) allowed a chemotherapy decision modification in 35% of the patients included in the Adendom trial. • Patient-physician concertation is important: 8% of treatment changes are based on patients’ will. • A single-step decision including the test appears preferable to limit anxiety and distress.

Published
2020
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5. Distribution- and anchor-based methods to determine the minimally important difference on patient-reported outcome questionnaires in oncology: a structured review

Author

Nina Deliu, Amélie Anota, Ahmad Ousmen, Franck Bonnetain, Anne Brédart, Fabio Efficace, Francesco Cottone, Caroline Mollevi, C. Touraine, Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC (UMR INSERM 1098) (RIGHT), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS [Bourgogne-Franche-Comté]), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), CRLCC Val d'Aurelle - Paul Lamarque, Italian Group for Adult Hematologic Diseases (GIMEMA), Laboratoire de Psychopathologie et Processus de Santé (LPPS - EA 4057), Université Paris Descartes - Paris 5 (UPD5), Institut Curie [Paris], Institut de Recherche en Cancérologie de Montpellier (IRCM - U1194 Inserm - UM), CRLCC Val d'Aurelle - Paul Lamarque-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Herrada, Anthony, Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS [Bourgogne-Franche-Comté])-Université de Franche-Comté (UFC), and Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)

Subjects
Oncology, medicine.medical_specialty, Psychometrics, Distribution-based approach, Psychological intervention, Minimally important difference, [SDV.CAN]Life Sciences [q-bio]/Cancer, Review, MESH: Patient Reported Outcome Measures, lcsh:Computer applications to medicine. Medical informatics, Medical Oncology, Standard deviation, 03 medical and health sciences, 0302 clinical medicine, [SDV.CAN] Life Sciences [q-bio]/Cancer, MESH: Psychometrics, Neoplasms, Internal medicine, Statistical significance, Health care, medicine, Anchor-based approach, Humans, Clinical significance, MESH: Neoplasms, Patient Reported Outcome Measures, 030212 general & internal medicine, MESH: Medical Oncology, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, Data collection, Patient-reported outcomes, MESH: Humans, business.industry, Public Health, Environmental and Occupational Health, MESH: Quality of Life, General Medicine, 3. Good health, Sample size determination, 030220 oncology & carcinogenesis, Quality of Life, lcsh:R858-859.7, Patient-reported outcome, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

Background Interpretation of differences or changes in patient-reported outcome scores should not only consider statistical significance, but also clinical relevance. Accordingly, accurate determination of the minimally important difference (MID) is crucial to assess the effectiveness of health care interventions, as well as for sample size calculation. Several methods have been proposed to determine the MID. Our aim was to review the statistical methods used to determine MID in patient-reported outcome (PRO) questionnaires in cancer patients, focusing on the distribution- and anchor-based approaches and to present the variability of criteria used as well as possible limitations. Methods We performed a systematic search using PubMed. We searched for all cancer studies related to MID determination on a PRO questionnaire. Two reviewers independently screened titles and abstracts to identify relevant articles. Data were extracted from eligible articles using a predefined data collection form. Discrepancies were resolved by discussion and the involvement of a third reviewer. Results Sixty-three articles were identified, of which 46 were retained for final analysis. Both distribution- and anchor-based approaches were used to assess the MID in 37 studies (80.4%). Different time points were used to apply the distribution-based method and the most frequently reported distribution was the 0.5 standard deviation at baseline. A change in a PRO external scale (N = 13, 30.2%) and performance status (N = 15, 34.9%) were the most frequently used anchors. The stability of the MID over time was rarely investigated and only 28.2% of studies used at least 3 assessment timepoints. The robustness of anchor-based MID was questionable in 37.2% of the studies where the minimal number of patients by anchor category was less than 20. Conclusion Efforts are needed to improve the quality of the methodology used for MID determination in PRO questionnaires used in oncology. In particular, increased attention to the sample size should be paid to guarantee reliable results. This could increase the use of these specific thresholds in future studies. Electronic supplementary material The online version of this article (10.1186/s12955-018-1055-z) contains supplementary material, which is available to authorized users.

Published
2018
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6. Evaluation of extreme patient-reported outcome in early spondyloarthritis and its impact on the effect of TNF-α blockers treatment

Author

Meghnathi, Bhowmik, Claudepierre, Pascal, Dougados, Maxime, Moltó, Anna, Université Paris Descartes - Paris 5 (UPD5), Université Paris Descartes - Faculté de Médecine (UPD5 Médecine), Service de rhumatologie [CHU Cochin], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Sorbonne Paris Cité (USPC), Service de rhumatologie [CHU Henri Mondor], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor, and Université Autonome de Barcelone

Subjects
Adult, Male, MESH: Antirheumatic Agents, MESH: Socioeconomic Factors, Time Factors, MESH: Biological Products, MESH: Spondylarthritis, MESH: Patient Reported Outcome Measures, MESH: Phenotype, MESH: Risk Factors, Risk Factors, Spondylarthritis, Humans, Patient Reported Outcome Measures, MESH: Treatment Outcome, Biological Products, MESH: Humans, MESH: Middle Aged, Tumor Necrosis Factor-alpha, MESH: Time Factors, MESH: Adult, Middle Aged, MESH: Male, MESH: Sickness Impact Profile, Phenotype, Treatment Outcome, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, MESH: Tumor Necrosis Factor-alpha, Antirheumatic Agents, MESH: Sexual Health, Female, MESH: Female
Abstract

To describe the prevalence of extreme patient-reported outcomes (PRO) in an early axial spondyloarthritis setting, to compare the phenotype of patients with/without extreme PRO and to evaluate the impact of extreme PRO on the effectiveness of TNF-α blockers (TNFb).This analysis was performed in the DESIR cohort. Extreme PRO were measured at baseline and were defined as a score ≥8 on at least three of first five BASDAI items. Phenotype of patient's with/without extreme PRO was compared. Impact of extreme PRO on TNFb effectiveness was evaluated by comparing the retention rate of the first TNFb in both groups by survival curves analysis (log-rank and Cox analysis).Extreme PRO were present in 95 out of the 708 patients (13.4%). Patients with extreme PRO were older (mean (SD) age of 35.4(8.6) years vs. 33.5(8.7) years), more frequently females (65.3% vs. 51.9%), had higher BASDAI (7.1 vs. 4.1), reported more frequently history of depression (25.3% vs. 10.2%) and use of anti-depressive drugs (19.0% vs. 7.2%). TNFb treatment was more frequently initiated in the extreme PRO group (48.4% vs. 25.5%), while the proportion of patients still on TNFb at 2 years was significantly lower in the extreme PRO group 18.6% (n=8) vs. 39.5% (n=60). Presence of extreme PRO was independently associated with first TNFb discontinuation (HR 1.8, [95% CI 1.2;2.9], p=0.01)).Although presence of extreme PRO in this early axSpA setting was not very frequent, patients with extreme PRO were more likely to receive a TNFb and less likely to maintain the treatment at 2 years. Further studies evaluating the specific impact of extreme PRO on TNFb treatment in axSpA are warranted.

Published
2017
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