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1. Age, successive waves, immunization, and mortality in elderly COVID-19 hematological patients: EPICOVIDEHA findings

Author

Giuseppe Rossi, Jon Salmanton-García, Chiara Cattaneo, Francesco Marchesi, Julio Dávila-Valls, Sonia Martín-Pérez, Federico Itri, Alberto López-García, Andreas Glenthøj, Maria Gomes da Silva, Caroline Besson, Monia Marchetti, Barbora Weinbergerová, Ozren Jaksic, Moraima Jiménez, Yavuz M. Bilgin, Jaap Van Doesum, Francesca Farina, Pavel Žák, Luisa Verga, Graham P. Collins, Valentina Bonuomo, Jens Van Praet, Marcio Nucci, Stef Meers, Ildefonso Espigado, Nicola S. Fracchiolla, Toni Valković, Christian Bjørn Poulsen, Natasha Čolović, Giulia Dragonetti, Marie-Pierre Ledoux, Carlo Tascini, Caterina Buquicchio, Ola Blennow, Francesco Passamonti, Marina Machado, Jorge Labrador, Rafael F. Duarte, Martin Schönlein, Lucia Prezioso, Iker Falces-Romero, Austin Kulasekararaj, Carolina Garcia-Vidal, Noemí Fernández, Ghaith Abu-Zeinah, Irati Ormazabal-Vélez, Tatjana Adžić-Vukičević, Klára Piukovics, Igor Stoma, Annarosa Cuccaro, Gabriele Magliano, Tomáš Szotkowski, Tomás-José González-López, Shaimaa El-Ashwah, Rui Bergantim, Uluhan Sili, Johan Maertens, Fatih Demirkan, Cristina De Ramón, Verena Petzer, Maria Ilaria Del Principe, Milan Navrátil, Michelina Dargenio, Guldane Cengiz Seval, Michail Samarkos, Zdeněk Ráčil, László Imre Pinczés, Tobias Lahmer, Alessandro Busca, Gustavo-Adolfo Méndez, Antonio Vena, Monika M. Biernat, Maria Merelli, Maria Calbacho, Aleksandra Barać, Martina Bavastro, Alessandro Limongelli, Osman Ilhan, Dominik Wolf, Gökçe Melis Çolak, Ramón García-Sanz, Ziad Emarah, Bojana Mišković, Stefanie K. Gräfe, Miloš Mladenović, Tommaso Francesco Aiello, Lucía Núñez-Martín-Buitrago, Anna Nordlander, Elena Arellano, Giovanni Paolo Maria Zambrotta, Emanuele Ammatuna, Alba Cabirta, Maria Vittoria Sacchi, Raquel Nunes Rodrigues, Ditte Stampe Hersby, Michaela Hanakova, Laman Rahimli, Raul Cordoba, Oliver A. Cornely, Livio Pagano, Joyce MARQUES DE ALMEIDA, José-Ángel HERNÁNDEZ-RIVAS, Anna GUIDETTI, Olimpia FINIZIO, Zlate STOJANOSKI, Milche CVETANOSKI, Joseph MELETIADIS, Nick DE JONGE, Darko ANTIĆ, Natasha ALI, Maria Chiara TISI, Laura SERRANO, Gaëtan PLANTEFEVE, Nina KHANNA, Martin HOENIGL, Martin ČERŇAN, Carolina MIRANDA-CASTILLO, María FERNÁNDEZ-GALÁN, Alexandra SERRIS, Nurettin ERBEN, Rémy DULÉRY, Avinash AUJAYEB, Mario Virgilio PAPA, Jan NOVÁK, Mario DELIA, Giuseppe SAPIENZA, Florian REIZINE, Ali S. OMRANI, Roberta DI BLASI, Sylvain LAMURE, Ľuboš DRGOŇA, Nicola COPPOLA, Josip BATINIĆ, Murtadha AL-KHABORI, José-María RIBERA-SANTA SUSANA, Monica PIEDIMONTE, Jorge LOUREIRO-AMIGO, Guillemette FOUQUET, Rita FAZZI, François DANION, Jörg SCHUBERT, Baerbel HOELL-NEUGEBAUER, Nathan C. BAHR, Ayel Omar YAHIA, Ana TORRES-ATIENZA, Ikhwan RINALDI, Marina POPOVA, Hans-Beier OMMEN, Maria Enza MITRA, Malgorzata MIKULSKA, Ira LACEJ, Sofya KHOSTELIDI, Sein WIN, Donald VINH, Modar SALEH, Juergen PRATTES, Pavel JINDRA, Fabio GUOLO, Roberta DELLA PEPA, Ekaterina CHELYSHEVA, Przemyslaw ZDZIARSKI, Vivien WAI-MAN, Andrés SOTO-SILVA, Hans Martin ORTH, Sandra MALAK, Lisset LORENZO DE LA PEÑA, Martin KOLDITZ, Chi Shan KHO, Christopher H. HEATH, Ana GROH, Eleni GAVRIILAKI, Monica FUNG, Matthias EGGER, Elizabeth DE KORT, Erik DE CABO, Tania CUSHION, Fazle Rabbi CHOWDHURY, M. Mansour CEESAY, Mathias BREHON, Gina VARRICCHIO, Agostino TAFURI, María-Josefa JIMÉNEZ-LORENZO, Nikolai KLIMKO, Panagiotis TSIRIGOTIS, Anastasia ANTONIADOU, and Maria VEHRESCHILD

Subjects
Elderly, SARS-CoV-2, Hematological malignancy, High-risk patient, COVID-19, Infectious and parasitic diseases, RC109-216
Abstract

Objectives: Elderly patients with hematologic malignancies face the highest risk of severe COVID-19 outcomes. The infection's impact on different age groups remains unstudied in detail. Methods: We analyzed elderly patients (age groups: 65-70, 71-75, 76-80, and >80 years old) with hematologic malignancies included in the EPICOVIDEHA registry between January 2020 and July 2022. Univariable and multivariable Cox regression models were conducted to identify factors influencing death in COVID-19 patients with hematological malignancy. Results: The study included data from 3,603 elderly patients (aged 65 or older) with hematological malignancy, with a majority being male (58.1%) and a significant proportion having comorbidities. The patients were divided into four age groups, and the analysis assessed COVID-19 outcomes, vaccination status, and other variables in relation to age and pandemic waves. The 90-day survival rate for patients with COVID-19 was 71.2%, with significant differences between groups. The pandemic waves had varying impacts, with the first wave affecting patients over 80 years old, the second being more severe in 65-70, and the third being the least severe in all age groups. Factors contributing to 90-day mortality included age, comorbidities, lymphopenia, active malignancy, acute leukemia, less than three vaccine doses, severe COVID-19, and using only corticosteroids as treatment. Conclusion: These data underscore the heterogeneity of elderly hematological patients, highlight the different impacts of COVID-19 waves and the pivotal importance of vaccination, and may help in planning future healthcare efforts.

Published
2023
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2. Decoding the historical tale: COVID-19 impact on haematological malignancy patients—EPICOVIDEHA insights from 2020 to 2022Research in context

Author

Jon Salmanton-García, Francesco Marchesi, Francesca Farina, Barbora Weinbergerová, Federico Itri, Julio Dávila-Valls, Sonia Martín-Pérez, Andreas Glenthøj, Ditte Stampe Hersby, Maria Gomes da Silva, Raquel Nunes Rodrigues, Alberto López-García, Raúl Córdoba, Yavuz M. Bilgin, Iker Falces-Romero, Shaimaa El-Ashwah, Ziad Emarah, Caroline Besson, Milena Kohn, Jaap Van Doesum, Emanuele Ammatuna, Monia Marchetti, Jorge Labrador, Giovanni Paolo Maria Zambrotta, Luisa Verga, Ozren Jaksic, Marcio Nucci, Klára Piukovics, Alba Cabirta-Touzón, Moraima Jiménez, Elena Arellano, Ildefonso Espigado, Ola Blennow, Anna Nordlander, Stef Meers, Jens van Praet, Tommaso Francesco Aiello, Carolina Garcia-Vidal, Nicola Fracchiolla, Mariarita Sciumè, Guldane Cengiz Seval, Pavel Žák, Caterina Buquicchio, Carlo Tascini, Stefanie K. Gräfe, Martin Schönlein, Tatjana Adžić-Vukičević, Valentina Bonuomo, Chiara Cattaneo, Summiya Nizamuddin, Martin Čerňan, Gaëtan Plantefeve, Romane Prin, Tomas Szotkovski, Graham P. Collins, Michelina Dargenio, Verena Petzer, Dominik Wolf, Natasha Čolović, Lucia Prezioso, Toni Valković, Francesco Passamonti, Gustavo-Adolfo Méndez, Uluhan Sili, Antonio Vena, Martina Bavastro, Alessandro Limongelli, Rafael F. Duarte, Marie-Pierre Ledoux, Milche Cvetanoski, Zlate Stojanoski, Marina Machado, Josip Batinić, Gabriele Magliano, Monika M. Biernat, Nikola Pantić, Christian Bjørn Poulsen, Annarosa Cuccaro, Maria Ilaria Del Principe, Austin Kulasekararaj, Irati Ormazabal-Vélez, Alessandro Busca, Fatih Demirkan, Marriyam Ijaz, Nikolai Klimko, Igor Stoma, Sofya Khostelidi, Noemí Fernández, Ali S. Omrani, Rui Bergantim, Nick De Jonge, Guillemette Fouquet, Milan Navrátil, Ghaith Abu-Zeinah, Michail Samarkos, Johan Maertens, Cristina De Ramón, Anna Guidetti, Ferenc Magyari, Tomás José González-López, Tobias Lahmer, Olimpia Finizio, Natasha Ali, László Imre Pinczés, Esperanza Lavilla-Rubira, Alessandra Romano, Maria Merelli, Mario Delia, Maria Calbacho, Joseph Meletiadis, Darko Antić, José-Ángel Hernández-Rivas, Joyce Marques de Almeida, Murtadha Al-Khabori, Martin Hoenigl, Maria Chiara Tisi, Nina Khanna, Aleksandra Barać, Noha Eisa, Roberta Di Blasi, Raphaël Liévin, Carolina Miranda-Castillo, Nathan C. Bahr, Sylvain Lamure, Mario Virgilio Papa, Ayel Yahya, Avinash Aujayeb, Jan Novák, Nurettin Erben, María Fernández-Galán, José-María Ribera-Santa Susana, Ikhwan Rinaldi, Rita Fazzi, Monica Piedimonte, Rémy Duléry, Yung Gonzaga, Andrés Soto-Silva, Giuseppe Sapienza, Alexandra Serris, Ľuboš Drgoňa, Ana Groh, Laura Serrano, Eleni Gavriilaki, Athanasios Tragiannidis, Juergen Prattes, Nicola Coppola, Vladimir Otašević, Miloš Mladenović, Mirjana Mitrović, Bojana Mišković, Pavel Jindra, Sofia Zompi, Maria Vittoria Sacchi, Carolin Krekeler, Maria Stefania Infante, Daniel García-Bordallo, Gökçe Melis Çolak, Jiří Mayer, Marietta Nygaard, Michaela Hanáková, Zdeněk Ráčil, Matteo Bonanni, Philipp Koehler, Laman Rahimli, Oliver A. Cornely, Livio Pagano, Francisco Javier Martín-Vallejo, Przemyslaw Zdziarski, Hossein Zarrinfer, Jana Wittig, Sein Win, Vivien Wai-Man, Benjamín Víšek, Donald C. Vinh, Maria Vehreschild, Gina Varricchio, Panagiotis Tsirigotis, Ana Torres-Tienza, Alina Daniela Tanase, Agostino Tafuri, Maria Stamouli, Jiří Sramek, Carole Soussain, Ayten Shirinova, Jörg Schubert, Enrico Schalk, Mohammad Reza Salehi, Modar Saleh, Giorgio Rosati, Elisa Roldán, Florian Reizine, Mayara Rêgo, Isabel Regalado-Artamendi, Marina Popova, Fernando Pinto, Laure Philippe, Hans Martin Orth, Hans-Beier Ommen, Aleš Obr, Lucía Núñez-Martín-Buitrago, Nicolas Noël, Julia Neuhann, Gianpaolo Nadali, Julia A. Nacov, Ana M. Munhoz Alburquerque, Maria Enza Mitra, Malgorzata Mikulska, Sibylle Mellinghoff, Ben Mechtel, Juan-Alberto Martín-González, Sandra Malak, Jorge Loureiro-Amigo, Lisset Lorenzo De La Peña, Giulia Liberti, Marianne Landau, Ira Lacej, Martin Kolditz, Chi Shan Kho, Reham Abdelaziz Khedr, Meinolf Karthaus, Linda Katharina Karlsson, María-Josefa Jiménez-Lorenzo, Macarena Izuzquiza, Baerbel Hoell-Neugebauer, Raoul Herbrecht, Christopher H. Heath, Fabio Guolo, Jan Grothe, Antonio Giordano, Sergey Gerasymchuk, Ramón García-Sanz, Nicole García-Poutón, Vaneuza Araújo Moreira Funke, Monica Fung, Charlotte Flasshove, Luana Fianchi, Jenna Essame, Matthias Egger, Bernard Drenou, Giulia Dragonetti, Maximilian Desole, Roberta Della Pepa, Bénédicte Deau Fischer, Elizabeth De Kort, Erik De Cabo, François Danion, Etienne Daguindau, Tania Cushion, Louise Cremer, Marianna Criscuolo, Gregorio Cordini, Antonella Cingolani, Fabio Ciceri, Fazle Rabbi Chowdhury, Ekaterina Chelysheva, Adrien Chauchet, Louis Yi Ann Chai, M. Mansour Ceesay, Elena Busch, Mathias Brehon, Davimar M.M. Borducchi, Stephen Booth, Serge Bologna, Caroline Berg Venemyr, Rebeca Bailén-Almorox, Anastasia Antoniadou, Amalia N. Anastasopoulou, and Fevzi Altuntaş

Subjects
Vaccination, ICU, COVID-19, Haematological malignancy, Immunosuppression, Medicine (General), R5-920
Abstract

Summary: Background: The COVID-19 pandemic heightened risks for individuals with hematological malignancies due to compromised immune systems, leading to more severe outcomes and increased mortality. While interventions like vaccines, targeted antivirals, and monoclonal antibodies have been effective for the general population, their benefits for these patients may not be as pronounced. Methods: The EPICOVIDEHA registry (National Clinical Trials Identifier, NCT04733729) gathers COVID-19 data from hematological malignancy patients since the pandemic's start worldwide. It spans various global locations, allowing comprehensive analysis over the first three years (2020–2022). Findings: The EPICOVIDEHA registry collected data from January 2020 to December 2022, involving 8767 COVID-19 cases in hematological malignancy patients from 152 centers across 41 countries, with 42% being female. Over this period, there was a significant reduction in critical infections and an overall decrease in mortality from 29% to 4%. However, hospitalization, particularly in the ICU, remained associated with higher mortality rates. Factors contributing to increased mortality included age, multiple comorbidities, active malignancy at COVID-19 onset, pulmonary symptoms, and hospitalization. On the positive side, vaccination with one to two doses or three or more doses, as well as encountering COVID-19 in 2022, were associated with improved survival. Interpretation: Patients with hematological malignancies still face elevated risks, despite reductions in critical infections and overall mortality rates over time. Hospitalization, especially in ICUs, remains a significant concern. The study underscores the importance of vaccination and the timing of COVID-19 exposure in 2022 for enhanced survival in this patient group. Ongoing monitoring and targeted interventions are essential to support this vulnerable population, emphasizing the critical role of timely diagnosis and prompt treatment in preventing severe COVID-19 cases. Funding: Not applicable.

Published
2024
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3. COVID-19 infection in adult patients with hematological malignancies: a European Hematology Association Survey (EPICOVIDEHA)

Author

Livio Pagano, Jon Salmanton-García, Francesco Marchesi, Alessandro Busca, Paolo Corradini, Martin Hoenigl, Nikolai Klimko, Philipp Koehler, Antonio Pagliuca, Francesco Passamonti, Luisa Verga, Benjamin Víšek, Osman Ilhan, Gianpaolo Nadali, Barbora Weinbergerová, Raúl Córdoba-Mascuñano, Monia Marchetti, Graham P. Collins, Francesca Farina, Chiara Cattaneo, Alba Cabirta, Maria Gomes-Silva, Federico Itri, Jaap van Doesum, Marie-Pierre Ledoux, Martin Čerňan, Ozren Jakšić, Rafael F. Duarte, Gabriele Magliano, Ali S. Omrani, Nicola S. Fracchiolla, Austin Kulasekararaj, Toni Valković, Christian Bjørn Poulsen, Marina Machado, Andreas Glenthøj, Igor Stoma, Zdeněk Ráčil, Klára Piukovics, Milan Navrátil, Ziad Emarah, Uluhan Sili, Johan Maertens, Ola Blennow, Rui Bergantim, Carolina García-Vidal, Lucia Prezioso, Anna Guidetti, Maria Ilaria del Principe, Marina Popova, Nick de Jonge, Irati Ormazabal-Vélez, Noemí Fernández, Iker Falces-Romero, Annarosa Cuccaro, Stef Meers, Caterina Buquicchio, Darko Antić, Murtadha Al-Khabori, Ramón García-Sanz, Monika M. Biernat, Maria Chiara Tisi, Ertan Sal, Laman Rahimli, Natasa Čolović, Martin Schönlein, Maria Calbacho, Carlo Tascini, Carolina Miranda-Castillo, Nina Khanna, Gustavo-Adolfo Méndez, Verena Petzer, Jan Novák, Caroline Besson, Rémy Duléry, Sylvain Lamure, Marcio Nucci, Giovanni Zambrotta, Pavel Žák, Guldane Cengiz Seval, Valentina Bonuomo, Jiří Mayer, Alberto López-García, Maria Vittoria Sacchi, Stephen Booth, Fabio Ciceri, Margherita Oberti, Marco Salvini, Macarena Izuzquiza, Raquel Nunes-Rodrigues, Emanuele Ammatuna, Aleš Obr, Raoul Herbrecht, Lucía Núñez-Martín-Buitrago, Valentina Mancini, Hawraa Shwaylia, Mariarita Sciumè, Jenna Essame, Marietta Nygaard, Josip Batinić, Yung Gonzaga, Isabel Regalado-Artamendi, Linda Katharina Karlsson, Maryia Shapetska, Michaela Hanakova, Shaimaa El-Ashwah, Zita Borbényi, Gökçe Melis Çolak, Anna Nordlander, Giulia Dragonetti, Alessio Maria Edoardo Maraglino, Amelia Rinaldi, Cristina De Ramón-Sánchez, Oliver A. Cornely, and EPICOVIDEHA working group

Subjects
COVID-19, Pandemic, Hematological malignancies, Epidemiology, EHA, Diseases of the blood and blood-forming organs, RC633-647.5, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Background Patients with hematological malignancies (HM) are at high risk of mortality from SARS-CoV-2 disease 2019 (COVID-19). A better understanding of risk factors for adverse outcomes may improve clinical management in these patients. We therefore studied baseline characteristics of HM patients developing COVID-19 and analyzed predictors of mortality. Methods The survey was supported by the Scientific Working Group Infection in Hematology of the European Hematology Association (EHA). Eligible for the analysis were adult patients with HM and laboratory-confirmed COVID-19 observed between March and December 2020. Results The study sample includes 3801 cases, represented by lymphoproliferative (mainly non-Hodgkin lymphoma n = 1084, myeloma n = 684 and chronic lymphoid leukemia n = 474) and myeloproliferative malignancies (mainly acute myeloid leukemia n = 497 and myelodysplastic syndromes n = 279). Severe/critical COVID-19 was observed in 63.8% of patients (n = 2425). Overall, 2778 (73.1%) of the patients were hospitalized, 689 (18.1%) of whom were admitted to intensive care units (ICUs). Overall, 1185 patients (31.2%) died. The primary cause of death was COVID-19 in 688 patients (58.1%), HM in 173 patients (14.6%), and a combination of both COVID-19 and progressing HM in 155 patients (13.1%). Highest mortality was observed in acute myeloid leukemia (199/497, 40%) and myelodysplastic syndromes (118/279, 42.3%). The mortality rate significantly decreased between the first COVID-19 wave (March–May 2020) and the second wave (October–December 2020) (581/1427, 40.7% vs. 439/1773, 24.8%, p value

Published
2021
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5. Correlation between systemic iron parameters and substantia nigra iron stores in restless legs syndrome

Author

Laura Botta, Celia Garcia-Malo, Carolina Miranda Castillo, Sara Boi, Irene Cano-Pumarega, Diego Garcia-Borreguero, Andrea Castro-Villacañas Farzamnia, Verónica Martínez Vidal, Samantha Anguizola, Sabela Novo-Ponte, and Sofia Romero Peralta

Subjects
medicine.medical_specialty, Ultrasonography, Doppler, Transcranial, Iron, Substantia nigra, Gastroenterology, Correlation, Internal medicine, Restless Legs Syndrome, mental disorders, Medicine, Humans, Restless legs syndrome, chemistry.chemical_classification, medicine.diagnostic_test, Transferrin saturation, business.industry, Echogenicity, General Medicine, medicine.disease, Substantia Nigra, Cross-Sectional Studies, chemistry, Transferrin, Serum iron, Hemoglobin, business
Abstract

Objective To evaluate the relation between systemic iron parameters (SIP) and substantia nigra (SN) iron deposits, as assessed by transcranial sonography (TCS) in restless legs syndrome (RLS). Methods We conducted a cross-sectional study in RLS patients, from whom blood samples with SIP were obtained, consisting of total iron-binding capacity (TIBC), serum ferritin, hemoglobin, transferrin saturation (TSAT), serum iron, and serum transferrin. TCS was performed over the SN, and the substantia nigra echogenicity index (SNEI) was determined according to established methods. Symptom severity was evaluated using the international restless legs scale (IRLS). A Spearman correlation was performed. Results A total of 167 patients were studied. Correlations between SNEI and SIP were as follows: serum ferritin (R = 0.0422; n.s.), TSAT (R = 0.0883; n.s.), TIBC (R = −0.1091; n.s.), serum transferrin (R = −0.0420; n.s.), hemoglobin (R = 0.0185; n.s.), serum iron (R = 0.0389; n.s.). No correlation was found with age and IRLS (R = 0.1375; n.s. and R = 0.0880, n.s., respectively). Conclusions SIP are not correlated with SN iron content in RLS, quantified by means of TCS. TCS of the SN might be a more valid estimate and could be useful in the evaluation of RLS patients.

Published
2021

6. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in adults with haematological malignancies: a phase 3, randomised, clinical trial and post-hoc efficacy analysis

Author

David Pohlreich, Lidia Oostvogels, Mohamed El Idrissi, Alemnew F Dagnew, Jaime Pérez de Oteyza, Maria Belen Navarro Matilla, Dong-Gun Lee, Lars Rombo, Osman Ilhan, Shelly A. McNeil, Aránzazu Alonso Alonso, Po Nan Wang, Anna Johnston, Marta López-Fauqued, Jae Yong Kwak, Raquel Oña Navarrete, Gianluca Gaidano, Javier de la Serna, Ariah Schattner, Philippe Rodon, Ahmed Masood, Teresa del Campo, Bruno Salaun, Terrance Comeau, Andrew Peniket, John Murphy, Boris Afanasyev, Hyeon Seok Eom, Pere Barba Suñol, Sam Milliken, Alessandro Lucchesi, Pierre Zachee, Aleksey Kuvshinov, Seok Jin Kim, Anna Carolina Miranda Castillo, Stella Bowcock, Tzeon Jye Chiou, Stephane Lepretre, Richard Eek, Veli-Jukka Anttila, Faisal Sultan, Sebastian Grosicki, Anne Schuind, Patricia Disperati, Jo Anne H. Young, William Hwang, Thierry Guillaume, Emmanuel Di Paolo, Philippe Quittet, Paul Turner, Dariusz Woszczyk, Dimas Quiel, Norbert Blesing, Naheed Mir, Lucrecia Yáñez San Segundo, Ching Yuan Kuo, Humphrey Pullon, Koen Theunissen, Jae Hoon Lee, Karlis Pauksens, Thomas C. Heineman, Wojciech Homenda, Nikolay Ilyin, Johan Sanmartin Berglund, Dominik Selleslag, Marjatta Sinisalo, Kathleen M. Mullane, Sang Kyun Sohn, Kadir Acar, Albert Kwok Wai Lie, Mickael Aoun, Won Sik Lee, Francesco Zaja, Alexandr Myasnikov, Gabriela Rodriguez Macías, Laura Campora, Je Jung Lee, Olga Samoylova, Peter Van den Steen, Dagnew, A. F., Ilhan, O., Lee, W. -S., Woszczyk, D., Kwak, J. -Y., Bowcock, S., Sohn, S. K., Rodriguez Macias, G., Chiou, T. -J., Quiel, D., Aoun, M., Navarro Matilla, M. B., de la Serna, J., Milliken, S., Murphy, J., Mcneil, S. A., Salaun, B., Di Paolo, E., Campora, L., Lopez-Fauqued, M., El Idrissi, M., Schuind, A., Heineman, T. C., Van den Steen, P., Oostvogels, L., Acar, K., Afanasyev, B., Alonso Alonso, A., Anttila, V. -J., Barba Sunol, P., Blesing, N., Comeau, T., del Campo, T., Disperati, P., Eek, R., Eom, H., Gaidano, G., Grosicki, S., Guillaume, T., Homenda, W., Hwang, W., Ilyin, N., Johnston, A., Kim, S. J., Kuo, C. -Y., Kuvshinov, A., Lee, D. -G., Lee, J. H., Lee, J. -J., Lepretre, S., Lie, A. K. -W., Lucchesi, A., Masood, A., Mir, N., Miranda Castillo, A. C., Mullane, K., Myasnikov, A., Ona Navarrete, R., Pauksens, K., Peniket, A., Perez de Oteyza, J., Pohlreich, D., Pullon, H., Quittet, P., Rodon, P., Rombo, L., Samoylova, O., Sanmartin Berglund, J., Schattner, A., Selleslag, D., Sinisalo, M., Sultan, F., Theunissen, K., Turner, P., Wang, P. -N., Yanez San Segundo, L., Young, J. -A., Zachee, P., and Zaja, F.

Subjects
Adult, Male, Herpesvirus 3, Human, medicine.medical_specialty, Adolescent, Population, Antineoplastic Agents, Antibodies, Viral, Placebo, Hematological malignancies, Immunocompromised Host, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Viral Envelope Proteins, Internal medicine, medicine, Herpes Zoster Vaccine, Humans, Single-Blind Method, 030212 general & internal medicine, education, Adverse effect, Fatigue, Immunity, Cellular, Vaccines, Synthetic, education.field_of_study, Vaccines, Reactogenicity, H. Zoster, business.industry, Immunogenicity, Middle Aged, CD4 Lymphocyte Count, Injection Site Reaction, Vaccination, Clinical trial, Infectious Diseases, Hematologic Neoplasms, 030220 oncology & carcinogenesis, Female, Zoster vaccine, business, Vaccine, medicine.drug
Abstract

BACKGROUND: The adjuvanted recombinant zoster vaccine (Shingrix) can prevent herpes zoster in older adults and autologous haemopoietic stem cell transplant recipients. We evaluated the safety and immunogenicity of this vaccine in adults with haematological malignancies receiving immunosuppressive cancer treatments. METHODS: In this phase 3, randomised, observer-blind, placebo-controlled study, done at 77 centres worldwide, we randomly assigned (1:1) patients with haematological malignancies aged 18 years and older to receive two doses of the adjuvanted recombinant zoster vaccine or placebo 1-2 months apart during or after immunosuppressive cancer treatments, and stratified participants according to their underlying diseases. The co-primary objectives of the study were the evaluation of safety and reactogenicity of the adjuvanted recombinant zoster vaccine compared with placebo from the first vaccination up to 30 days after last vaccination in all participants; evaluation of the proportion of participants with a vaccine response in terms of anti-glycoprotein E humoral immune response to the adjuvanted recombinant zoster vaccine at month 2 in all participants, excluding those with non-Hodgkin B-cell lymphoma and chronic lymphocytic leukaemia; and evaluation of the anti-glycoprotein E humoral immune responses to the vaccine compared with placebo at month 2 in all participants, excluding those with non-Hodgkin B-cell lymphoma and chronic lymphocytic leukaemia. We assessed immunogenicity in the per-protocol cohort for immunogenicity and safety in the total vaccinated cohort. The study is registered with ClinicalTrials.gov, number NCT01767467, and with the EU Clinical Trials Register, number 2012-003438-18. FINDINGS: Between March 1, 2013, and Sept 10, 2015, we randomly assigned 286 participants to adjuvanted recombinant zoster vaccine and 283 to placebo. 283 in the vaccine group and 279 in the placebo group were vaccinated. At month 2, 119 (80·4%, 95% CI 73·1-86·5) of 148 participants had a humoral vaccine response to adjuvanted recombinant zoster vaccine, compared with one (0·8%, 0·0-4·2) of 130 participants in the placebo group, and the adjusted geometric mean anti-glycoprotein E antibody concentration was 23 132·9 mIU/mL (95% CI 16 642·8-32 153·9) in the vaccine group and 777·6 mIU/mL (702·8-860·3) in the placebo group (adjusted geometric mean ratio 29·75, 21·09-41·96; p

Published
2019

7. Closing the value-based circle in shared decision-making: a digital framework for informing the shared decision-making process through patient reported outcome and experience measures

Author

Marta del Olmo Rodríguez, Rafael Martos Martinez, Adriana Pascual Martínez, Carolina Miranda Castillo, Jorge Short Apellaniz, Bernadette Pfang, Enrique Baca-García, and Raúl Córdoba Mascuñano

Subjects
value-based healthcare, patient-reported outcomes, PROMS, digital patient decision aid, PREMs, shared decision-making, Public aspects of medicine, RA1-1270
Abstract

BackgroundThe spreading adoption of value-based models of healthcare delivery has incentivized the use of patient-reported outcomes and experience measures (PROMs and PREMs) in clinical practice, with the potential to enrich the decision-making process with patient-reported data.MethodsThis perspective article explores PROs and the shared decision-making (SDM) process as components of value-based healthcare. We describe the potential of PROMs and PREMs within the decision-making process and present a digital framework for informing the shared decision-making process using aggregated data from a healthcare system PROMs and PREMs program, including early results from implementation in hospital network in Madrid, Spain.ResultsThe proposed digital framework incorporates aggregated data from a hospital network PROMs and PREMs program as part of a digital patient decision aid (PDA) for patients with lymphoma. After the first hematologist appointment, participating patients access the PDA to review relevant information about clinical and patient-reported outcomes for each of the possible options, assign a personal order of priority to different outcomes, and then select their preferred course of action. Patients’ answers are automatically uploaded to the EHR and discussed with hematologists at the next appointment. After beginning treatment, patients are invited to participate in the network PROMs program; participants’ PROMs data are fed back into the PDA, thus “closing the circle” between the decision-making process and patient-reported data collection.During the first 14 months after launching the decision aid in October 2022, of 25 patients diagnosed with follicular lymphoma at the four participating hospitals, 13 patients decided to participate. No significant differences in age or sex were observed between groups. Average SDM Q-9 score for patients filling in the questionnaire (n = 6) was 36.15 of 45 points.ConclusionVarious obstacles toward widespread implementation of SDM exist such as time constraints, lack of motivation, and resistance to change. Support and active engagement from policy makers and healthcare managers is key to overcome hurdles for capturing patient-reported data and carrying out shared decision-making at healthcare system level. Early results of a digital framework for PRO-enriched SDM seem to be beneficial to the decision-making process.

Published
2024
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8. P1689: REAL-WORLD EVIDENCE OF USING TELEMEDICINE TO CAPTURE ELECTRONIC PROM IMPROVES QUALITY OF LIFE ASSESSMENT, HEALTHCARE RESOURCES MANAGEMENT AND OVERALL SURVIVAL IN PATIENTS WITH LYMPHOMA

Author

Sergio Ramos, Natalia Barreras, Gabriela Salvatierra, Anna Carolina Miranda Castillo, Laura Bermejo, Pilar Beltran, Daniel Naya, Elena Gonzalez, Maria Yuste, Adriana Pascual, Eva Castillo, Miriam Riesco, Celia Urrutia, Antonio Herrero, Alberto Lopez-Garcia, Maria Angeles Perez Saenz, Daniel Morillo, Pilar Llamas, Javier Becares, Carla Barriocanal, Marta DEL Olmo, Jorge Short, Javier Arcos, and Raul Cordoba

Subjects
Diseases of the blood and blood-forming organs, RC633-647.5
Published
2023
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