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1. The Key Role of Patient Involvement in the Development of Core Outcome Sets in Prostate Cancer

Author

Smith, Emma Jane, N'Dow, James, Plass, Karin, Ribal, Maria, Mottet, Nicolas, Shepherd, Robert, Moris, Lisa, Lardas, Michael, Van den Broeck, Thomas, Willemse, Peter-Paul, Campi, Riccardo, Gacci, Mauro, Bjartell, Anders, Evans-Axelsson, LU Susan, Briganti, Alberto, Gandaglia, Giorgio, Crosti, Daniele, Meoni, Massimiliano, Garzonio, Roberto, Bangma, Chris, Roobol, Monique, Remmers, Sebastiaan, Tilki, Derya, Auvinen, Anssi, Murtola, Teemu, Visakorpi, Tapio, Talala, Kirsi, Tammela, Teuvo, Siltari, Aino, Van Hemelrijck, Mieke, Beyer, Katharina, Lejeune, Stephane, van Diggelen, Femke, Byrne, Sophie, Fialho, Luz, Cardone, Antonella, Gono, Paulina, De Meulder, Bertrand, Auffray, Charles, Balaur, Irina-Afrodita, Taibi, Nesrine, Power, Shaun, Kermani, Nazanin Zounemat, van Bochove, Kees, Cirillo, Elisa, Moinat, Maxim, Voss, Emma, Horgan, Denis, Fullwood, Louise, Holtorf, Marc, Lancet, Doron, Bernstein, Gabi, Omar, Imran, MacLennan, Sara, MacLennan, Steven, Tripathee, Sheela, Huber, Johannes, Wirth, Manfred, Froehner, Michael, Brenner, Beate, Borkowetz, Angelika, Thomas, Christian, Horn, Friedemann, Reiche, Kristin, Kreuz, Markus, Josefsson, Andreas, Tandefelt, Delila Gasi, Hugosson, Jonas, Schalken, Jack, Huisman, Henkjan, Hofmarcher, Thomas, Lindgren, Peter, Andersson, Emelie, Fridhammar, Adam, Asiimwe, Alex, Verholen, Frank, Zong, Jihong, Butler-Ransohoff, John-Edward, Williamson, Todd, Chandrawansa, Kumari, Waldeck, Reg, Molnar, Megan, Bruno, Amanda, Herrera, Ronald, Nevedomskaya, Ekaterina, Fatoba, Samuel, Constantinovici, Niculae, Mohamed, Ateesha, Steinbeißer, Carl, Kedhagae, Siddhanth, Maass, Monika, Torremante, Patrizia, Voss, Marc Dietrich, Devecseri, Zsuzsanna, Abbott, Tom, Kiran, Amit, Dau, Chad, Papineni, Kishore, Wang-silvanto, Jing, Hass, Steve, Snijder, Robert, Doyé, Verena, Wang, Xuewei, Garnham, Andy, Lambrecht, Mark, Wolfinger, Russ, Rogiers, Stijn, Servan, Angela, Casariego, Joaquin, Samir, Mohamed, Pascoe, Katie, Robinson, Paul, Reich, Christian, Ratwani, Shilpa, Longden-Chapman, Elaine, Burke, Danny, Agapow, Paul, Derkits, Sahra, Licour, Muriel, Ang, Michelle, Payne, Sarah, Yong, Alan, Thompson, Lucy, Le Mare, Sophia, Bussmann, Michael, Köhler, Inken, Juckeland, Guido, Kotik, Daniel, MacLennan, Sara J., Mastris, Ken, Hooker, Gary, Greene, Robert, Briers, Erik, Omar, Muhammad Imran, Healey, Jemma, Venderbos, Lionne D.F., Smith, Emma J., Bjorkqvist, Josefine, Roobol, Monique J., and N’Dow, James

Published
2021
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5. Neurocognitive Screening in Allogeneic Hematopoietic Cell Transplant

Author

Abdelwahab, Sarah, primary, Desamito, John, additional, Guzik, Alison, additional, McGinty, Erin, additional, Giannetti, Kayla, additional, Basurto, Sarah, additional, Kosar, Jennifer, additional, Willett, Karen, additional, Molnar, Megan, additional, Floden, Darlene, additional, Busch, Robyn, additional, Hamilton, Betty K., additional, and Ferraro, Christina S, additional

Published
2023
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6. Generalizability of randomized controlled trials in heart failure with reduced ejection fraction

Author

Cardiovasculaire Epi Team 7B, Cardiovasculaire Epi Team 5, Circulatory Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Biostatistiek Onderzoek, Child Health, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, JC onderzoeksprogramma Methodologie, Onderzoek Precision medicine, Directie Raad van Bestuur, Team Medisch, Global Health, Regenerative Medicine and Stem Cells, Lim, Yvonne Mei Fong, Molnar, Megan, Vaartjes, Ilonca, Savarese, Gianluigi, Eijkemans, Marinus J C, Uijl, Alicia, Vradi, Eleni, Suzart-Woischnik, Kiliana, Brugts, Jasper J, Brunner-La Rocca, Hans-Peter, Blanc-Guillemaud, Vanessa, Couvelard, Fabrice, Baudier, Claire, Dyszynski, Tomasz, Waechter, Sandra, Lund, Lars H, Hoes, Arno W, Tyl, Benoit, Asselbergs, Folkert W, Gerlinger, Christoph, Grobbee, Diederick E, Cronin, Maureen, Koudstaal, Stefan, Cardiovasculaire Epi Team 7B, Cardiovasculaire Epi Team 5, Circulatory Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Biostatistiek Onderzoek, Child Health, Infection & Immunity, JC onderzoeksprogramma Infectieziekten, JC onderzoeksprogramma Methodologie, Onderzoek Precision medicine, Directie Raad van Bestuur, Team Medisch, Global Health, Regenerative Medicine and Stem Cells, Lim, Yvonne Mei Fong, Molnar, Megan, Vaartjes, Ilonca, Savarese, Gianluigi, Eijkemans, Marinus J C, Uijl, Alicia, Vradi, Eleni, Suzart-Woischnik, Kiliana, Brugts, Jasper J, Brunner-La Rocca, Hans-Peter, Blanc-Guillemaud, Vanessa, Couvelard, Fabrice, Baudier, Claire, Dyszynski, Tomasz, Waechter, Sandra, Lund, Lars H, Hoes, Arno W, Tyl, Benoit, Asselbergs, Folkert W, Gerlinger, Christoph, Grobbee, Diederick E, Cronin, Maureen, and Koudstaal, Stefan

Published
2022

7. Generalizability of randomized controlled trials in heart failure with reduced ejection fraction

Author

Lim, Yvonne Mei Fong, Molnar, Megan, Vaartjes, Ilonca, Savarese, Gianluigi, Eijkemans, Marinus J.C., Uijl, Alicia, Vradi, Eleni, Suzart-Woischnik, Kiliana, Brugts, Jasper J., Brunner-La Rocca, Hans Peter, Blanc-Guillemaud, Vanessa, Couvelard, Fabrice, Baudier, Claire, Dyszynski, Tomasz, Waechter, Sandra, Lund, Lars H., Hoes, Arno W., Tyl, Benoit, Asselbergs, Folkert W., Gerlinger, Christoph, Grobbee, Diederick E., Cronin, Maureen, Koudstaal, Stefan, Lim, Yvonne Mei Fong, Molnar, Megan, Vaartjes, Ilonca, Savarese, Gianluigi, Eijkemans, Marinus J.C., Uijl, Alicia, Vradi, Eleni, Suzart-Woischnik, Kiliana, Brugts, Jasper J., Brunner-La Rocca, Hans Peter, Blanc-Guillemaud, Vanessa, Couvelard, Fabrice, Baudier, Claire, Dyszynski, Tomasz, Waechter, Sandra, Lund, Lars H., Hoes, Arno W., Tyl, Benoit, Asselbergs, Folkert W., Gerlinger, Christoph, Grobbee, Diederick E., Cronin, Maureen, and Koudstaal, Stefan

Abstract

BACKGROUND: Heart failure (HF) trials have stringent inclusion and exclusion criteria, but limited data exist regarding generalizability of trials. We compared patient characteristics and outcomes between patients with HF and reduced ejection fraction (HFrEF) in trials and observational registries. METHODS AND RESULTS: Individual patient data for 16 922 patients from five randomized clinical trials and 46 914 patients from two HF registries were included. The registry patients were categorized into trial-eligible and non-eligible groups using the most commonly used inclusion and exclusion criteria. A total of 26 104 (56%) registry patients fulfilled the eligibility criteria. Unadjusted all-cause mortality rates at 1 year were lowest in the trial population (7%), followed by trial-eligible patients (12%) and trial-non-eligible registry patients (26%). After adjustment for age and sex, all-cause mortality rates were similar between trial participants and trial-eligible registry patients [standardized mortality ratio (SMR) 0.97; 95% confidence interval (CI) 0.92-1.03] but cardiovascular mortality was higher in trial participants (SMR 1.19; 1.12-1.27). After full case-mix adjustment, the SMR for cardiovascular mortality remained higher in the trials at 1.28 (1.20-1.37) compared to RCT-eligible registry patients. CONCLUSION: In contemporary HF registries, over half of HFrEF patients would have been eligible for trial enrolment. Crude clinical event rates were lower in the trials, but, after adjustment for case-mix, trial participants had similar rates of survival as registries. Despite this, they had about 30% higher cardiovascular mortality rates. Age and sex were the main drivers of differences in clinical outcomes between HF trials and observational HF registries.

Published
2022

9. Diagnostic and prognostic factors in patients with prostate cancer: a systematic review

Author

Beyer, Katharina, primary, Moris, Lisa, additional, Lardas, Michael, additional, Haire, Anna, additional, Barletta, Francesco, additional, Scuderi, Simone, additional, Molnar, Megan, additional, Herrera, Ronald, additional, Rauf, Abdul, additional, Campi, Riccardo, additional, Greco, Isabella, additional, Shiranov, Kirill, additional, Dabestani, Saeed, additional, van den Broeck, Thomas, additional, Arun, Sujenthiran, additional, Gacci, Mauro, additional, Gandaglia, Giorgio, additional, Omar, Muhammad Imran, additional, MacLennan, Steven, additional, Roobol, Monique J, additional, Farahmand, Bahman, additional, Vradi, Eleni, additional, Devecseri, Zsuzsanna, additional, Asiimwe, Alex, additional, Zong, Jihong, additional, Maclennan, Sara J, additional, Collette, Laurence, additional, NDow, James, additional, Briganti, Alberto, additional, Bjartell, Anders, additional, and Van Hemelrijck, Mieke, additional

Published
2022
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10. Generalizability of randomized controlled trials in heart failure with reduced ejection fraction

Author

Lim, Yvonne Mei Fong, primary, Molnar, Megan, additional, Vaartjes, Ilonca, additional, Savarese, Gianluigi, additional, Eijkemans, Marinus J C, additional, Uijl, Alicia, additional, Vradi, Eleni, additional, Suzart-Woischnik, Kiliana, additional, Brugts, Jasper J, additional, Brunner-La Rocca, Hans-Peter, additional, Blanc-Guillemaud, Vanessa, additional, Couvelard, Fabrice, additional, Baudier, Claire, additional, Dyszynski, Tomasz, additional, Waechter, Sandra, additional, Lund, Lars H, additional, Hoes, Arno W, additional, Tyl, Benoit, additional, Asselbergs, Folkert W, additional, Gerlinger, Christoph, additional, Grobbee, Diederick E, additional, Cronin, Maureen, additional, and Koudstaal, Stefan, additional

Published
2021
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11. The Key Role of Patient Involvement in the Development of Core Outcome Sets in Prostate Cancer

Author

Beyer, Katharina, primary, MacLennan, Sara J., additional, Moris, Lisa, additional, Lardas, Michael, additional, Mastris, Ken, additional, Hooker, Gary, additional, Greene, Robert, additional, Briers, Erik, additional, Omar, Muhammad Imran, additional, Healey, Jemma, additional, Tripathee, Sheela, additional, Gandaglia, Giorgio, additional, Venderbos, Lionne D.F., additional, Smith, Emma J., additional, Bjorkqvist, Josefine, additional, Asiimwe, Alex, additional, Huber, Johannes, additional, Roobol, Monique J., additional, Zong, Jihong, additional, Bjartell, Anders, additional, N’Dow, James, additional, Briganti, Alberto, additional, MacLennan, Steven, additional, Van Hemelrijck, Mieke, additional, Smith, Emma Jane, additional, N'Dow, James, additional, Plass, Karin, additional, Ribal, Maria, additional, Mottet, Nicolas, additional, Shepherd, Robert, additional, Van den Broeck, Thomas, additional, Willemse, Peter-Paul, additional, Campi, Riccardo, additional, Gacci, Mauro, additional, Evans-Axelsson, LU Susan, additional, Crosti, Daniele, additional, Meoni, Massimiliano, additional, Garzonio, Roberto, additional, Bangma, Chris, additional, Roobol, Monique, additional, Remmers, Sebastiaan, additional, Tilki, Derya, additional, Auvinen, Anssi, additional, Murtola, Teemu, additional, Visakorpi, Tapio, additional, Talala, Kirsi, additional, Tammela, Teuvo, additional, Siltari, Aino, additional, Beyer, Katharina, additional, Lejeune, Stephane, additional, van Diggelen, Femke, additional, Byrne, Sophie, additional, Fialho, Luz, additional, Cardone, Antonella, additional, Gono, Paulina, additional, De Meulder, Bertrand, additional, Auffray, Charles, additional, Balaur, Irina-Afrodita, additional, Taibi, Nesrine, additional, Power, Shaun, additional, Kermani, Nazanin Zounemat, additional, van Bochove, Kees, additional, Cirillo, Elisa, additional, Moinat, Maxim, additional, Voss, Emma, additional, Horgan, Denis, additional, Fullwood, Louise, additional, Holtorf, Marc, additional, Lancet, Doron, additional, Bernstein, Gabi, additional, Omar, Imran, additional, MacLennan, Sara, additional, Wirth, Manfred, additional, Froehner, Michael, additional, Brenner, Beate, additional, Borkowetz, Angelika, additional, Thomas, Christian, additional, Horn, Friedemann, additional, Reiche, Kristin, additional, Kreuz, Markus, additional, Josefsson, Andreas, additional, Tandefelt, Delila Gasi, additional, Hugosson, Jonas, additional, Schalken, Jack, additional, Huisman, Henkjan, additional, Hofmarcher, Thomas, additional, Lindgren, Peter, additional, Andersson, Emelie, additional, Fridhammar, Adam, additional, Verholen, Frank, additional, Butler-Ransohoff, John-Edward, additional, Williamson, Todd, additional, Chandrawansa, Kumari, additional, Waldeck, Reg, additional, Molnar, Megan, additional, Bruno, Amanda, additional, Herrera, Ronald, additional, Nevedomskaya, Ekaterina, additional, Fatoba, Samuel, additional, Constantinovici, Niculae, additional, Mohamed, Ateesha, additional, Steinbeißer, Carl, additional, Kedhagae, Siddhanth, additional, Maass, Monika, additional, Torremante, Patrizia, additional, Voss, Marc Dietrich, additional, Devecseri, Zsuzsanna, additional, Abbott, Tom, additional, Kiran, Amit, additional, Dau, Chad, additional, Papineni, Kishore, additional, Wang-silvanto, Jing, additional, Hass, Steve, additional, Snijder, Robert, additional, Doyé, Verena, additional, Wang, Xuewei, additional, Garnham, Andy, additional, Lambrecht, Mark, additional, Wolfinger, Russ, additional, Rogiers, Stijn, additional, Servan, Angela, additional, Casariego, Joaquin, additional, Samir, Mohamed, additional, Pascoe, Katie, additional, Robinson, Paul, additional, Reich, Christian, additional, Ratwani, Shilpa, additional, Longden-Chapman, Elaine, additional, Burke, Danny, additional, Agapow, Paul, additional, Derkits, Sahra, additional, Licour, Muriel, additional, Ang, Michelle, additional, Payne, Sarah, additional, Yong, Alan, additional, Thompson, Lucy, additional, Le Mare, Sophia, additional, Bussmann, Michael, additional, Köhler, Inken, additional, Juckeland, Guido, additional, and Kotik, Daniel, additional

Published
2021
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14. Elucidating the genetic risk of obesity through the human blood plasma proteome

Author

Zaghlool, Shaza B., primary, Sharma, Sapna, additional, Molnar, Megan, additional, Matías‐García, Pamela R., additional, Elhadad, Mohamed A., additional, Waldenberger, Melanie, additional, Peters, Annette, additional, Rathmann, Wolfgang, additional, Graumann, Johannes, additional, Gieger, Christian, additional, Grallert, Harald, additional, and Suhre, Karsten, additional

Published
2020
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15. Generalizability of randomized controlled trials in heart failure with reduced ejection fraction.

Author

Lim YMF, Molnar M, Vaartjes I, Savarese G, Eijkemans MJC, Uijl A, Vradi E, Suzart-Woischnik K, Brugts JJ, Brunner-La Rocca HP, Blanc-Guillemaud V, Couvelard F, Baudier C, Dyszynski T, Waechter S, Lund LH, Hoes AW, Tyl B, Asselbergs FW, Gerlinger C, Grobbee DE, Cronin M, and Koudstaal S

Subjects
Humans, Stroke Volume, Randomized Controlled Trials as Topic, Registries, Heart Failure
Abstract

Background: Heart failure (HF) trials have stringent inclusion and exclusion criteria, but limited data exist regarding generalizability of trials. We compared patient characteristics and outcomes between patients with HF and reduced ejection fraction (HFrEF) in trials and observational registries., Methods and Results: Individual patient data for 16 922 patients from five randomized clinical trials and 46 914 patients from two HF registries were included. The registry patients were categorized into trial-eligible and non-eligible groups using the most commonly used inclusion and exclusion criteria. A total of 26 104 (56%) registry patients fulfilled the eligibility criteria. Unadjusted all-cause mortality rates at 1 year were lowest in the trial population (7%), followed by trial-eligible patients (12%) and trial-non-eligible registry patients (26%). After adjustment for age and sex, all-cause mortality rates were similar between trial participants and trial-eligible registry patients [standardized mortality ratio (SMR) 0.97; 95% confidence interval (CI) 0.92-1.03] but cardiovascular mortality was higher in trial participants (SMR 1.19; 1.12-1.27). After full case-mix adjustment, the SMR for cardiovascular mortality remained higher in the trials at 1.28 (1.20-1.37) compared to RCT-eligible registry patients., Conclusion: In contemporary HF registries, over half of HFrEF patients would have been eligible for trial enrolment. Crude clinical event rates were lower in the trials, but, after adjustment for case-mix, trial participants had similar rates of survival as registries. Despite this, they had about 30% higher cardiovascular mortality rates. Age and sex were the main drivers of differences in clinical outcomes between HF trials and observational HF registries., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Published
2022
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