Principles and recommendations for incorporating estimands into clinical study protocol templates

Autor: Helle Lynggaard, James Bell, Christian Lösch, Amel Besseghir, Khadija Rantell, Volker Schoder, Vivian Lanius

Publikováno v: Trials, Vol 23, Iss 1, Pp 1-15 (2022)

Abstract Clinical study protocols are the foundation of good clinical studies. Prospective and multidisciplinary collaboration that pays attention to the design of all components of the study protocol can ensure that a clinical study will answer the

Externí odkaz: https://doaj.org/article/5bcd4a8937fe437cb3502ec61c52e7a2

Patterns of missing data in the use of the endometriosis symptom diary

Autor: Christoph Gerlinger, Christian Seitz, Vivian Lanius, Claudia Haberland, Susanne Lippert, Hans-Rudolf Tinneberg, Frank Oehmke

Publikováno v: BMC Women's Health, Vol 18, Iss 1, Pp 1-6 (2018)

Background Endometriosis is a common, chronic condition in women of reproductive age that is characterized by the presence of functional endometriotic lesions outside the uterus. The Endometriosis Symptom Diary (ESD) is an electronic patient-reported

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::566257dec12409a6eb34a3774795135a
http://link.springer.com/article/10.1186/s12905-018-0578-0

Rationale, Design and Baseline Characteristics of Participants in the C ardiovascular O utco m es for P eople Using A nticoagulation S trategie s (COMPASS) Trial

Autor: Jae Hyung Kim, Matyas Keltai, Ajay K. Kakkar, Masatsugu Hori, Fernando Lanas, Nana Pogosova, Gilles R. Dagenais, Salim Yusuf, Camilo Felix, Patrick J. Commerford, Christian Torp-Pedersen, Antonio L. Dans, Dragos Vinereanu, Katalin Keltai, Georg Ertl, Jong-Won Ha, Aldo P. Maggioni, Peter Verhamme, Khalid Yusoff, Frank Misselwitz, Nancy Cook Bruns, Eva Lonn, Vivian Lanius, Philippe Gabriel Steg, Jackie Bosch, Rafael Diaz, Deepak L. Bhatt, John Varigos, Lisheng Liu, Keith A.A. Fox, Jun Zhu, Petr Widimsky, Kaj Metsärinne, Patricio Lopez-Jaramillo, Stuart J. Connolly, Victor Aboyans, Edmond Chen, Lars Rydén, Paul Moayyedi, John W. Eikelboom, Marco Alings, Tomasz J. Guzik, Leopoldo S. Piegas, Stefan Störk, Alvaro Avezum, Alexander Parkhomenko, Kelley R. Branch, Andre Lamy, Fei Yuan, Yan Liang, Jeffrey L. Probstfield, Andrew Tonkin, Sonia S. Anand, Darryl P. Leong, Basil S. Lewis, Robert G. Hart, Mukul Sharma, Martin O'Donnell

Publikováno v: Bosch, J, Eikelboom, J W, Connolly, S J, Bruns, N C, Lanius, V, Yuan, F, Misselwitz, F, Chen, E, Diaz, R, Alings, M, Lonn, E M, Widimsky, P, Hori, M, Avezum, A, Piegas, L S, Bhatt, D L, Branch, K R H, Probstfield, J L, Liang, Y, Liu, L, Zhu, J, Maggioni, A P, Lopez-Jaramillo, P, O'Donnell, M, Fox, K A A, Kakkar, A, Parkhomenko, A N, Ertl, G, Störk, S, Keltai, K, Keltai, M, Ryden, L, Dagenais, G R, Pogosova, N, Dans, A L, Lanas, F, Commerford, P J, Torp-Pedersen, C, Guzik, T J, Verhamme, P B, Vinereanu, D, Kim, J-H, Ha, J-W, Tonkin, A M, Varigos, J D, Lewis, B S, Felix, C, Yusoff, K, Steg, P G, Aboyans, V, Metsarinne, K P, Anand, S S, Hart, R G, Lamy, A, Moayyedi, P, Leong, D P, Sharma, M & Yusuf, S 2017, ' Rationale, Design and Baseline Characteristics of Participants in the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) Trial ', Canadian journal of cardiology, vol. 33, no. 8, pp. 1027-1035 . https://doi.org/10.1016/j.cjca.2017.06.001
Bosch, J, Eikelboom, J W, Connolly, S J, Bruns, N C, Lanius, V, Yuan, F, Misselwitz, F, Chen, E, Diaz, R, Alings, M, Lonn, E M, Widimsky, P, Hori, M, Avezum, A, Piegas, L S, Bhatt, D L, Branch, K R H, Probstfield, J L, Liang, Y, Liu, L, Zhu, J, Maggioni, A P, Lopez-Jaramillo, P, O'Donnell, M, Fox, K A A, Kakkar, A, Parkhomenko, A N, Ertl, G, Störk, S, Keltai, K, Keltai, M, Ryden, L, Dagenais, G R, Pogosova, N, Dans, A L, Lanas, F, Commerford, P J, Torp-Pedersen, C, Guzik, T J, Verhamme, P B, Vinereanu, D, Kim, J H, Ha, J W, Tonkin, A M, Varigos, J D, Lewis, B S, Felix, C, Yusoff, K, Steg, P G, Aboyans, V, Metsarinne, K P, Anand, S S, Hart, R G, Lamy, A, Moayyedi, P, Leong, D P, Sharma, M & Yusuf, S 2017, ' Rationale, design and baseline characteristics of participants in the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial ', Canadian Journal of Cardiology, vol. 33, no. 8, pp. 1027-1035 . https://doi.org/10.1016/j.cjca.2017.06.001

BACKGROUND: Long-term aspirin prevents vascular events but is only modestly effective. Rivaroxaban alone or in combination with aspirin might be more effective than aspirin alone for vascular prevention in patients with stable coronary artery disease

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0f4fe1a87d9e362169a4473659669402
https://doi.org/10.1016/j.cjca.2017.06.001

Major Adverse Limb Events and Mortality in Patients With Peripheral Artery Disease: The COMPASS Trial

Autor: Sonia S, Anand, Francois, Caron, John W, Eikelboom, Jackie, Bosch, Leanne, Dyal, Victor, Aboyans, Maria Teresa, Abola, Kelley R H, Branch, Katalin, Keltai, Deepak L, Bhatt, Peter, Verhamme, Keith A A, Fox, Nancy, Cook-Bruns, Vivian, Lanius, Stuart J, Connolly, Salim, Yusuf

Publikováno v: Journal of the American College of Cardiology. 71(20)

Patients with lower extremity peripheral artery disease (PAD) are at increased risk of major adverse cardiovascular events (MACE) and major adverse limb events (MALE). There is limited information on the prognosis of patients who experience MALE.Amon

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::5c6faa8795e7727b6c6088d7a0321895
https://pubmed.ncbi.nlm.nih.gov/31241606

Effects of interferon beta-1b on cognitive performance in patients with a first event suggestive of multiple sclerosis

Autor: Iris-Katharina Penner, Brigitte Stemper, Pasquale Calabrese, Ludwig Kappos, Xavier Montalban, Gilles Edan, Chris H. Polman, Hans-Peter Hartung, Christoph Pohl, Frederik Barkhof, Rupert Sandbrink, Dirk Pleimes, Vivian Lanius, Mark S. Freedman, David Miller

Publikováno v: Penner, I K, Stemper, B, Calabrese, P, Freedman, M S, Polman, C H, Edan, G, Hartung, H P, Miller, D H, Montalban, X, Barkhof, F, Pleimes, D, Lanius, V, Pohl, C, Kappos, L & Sandbrink, R 2012, ' Effects of interferon beta-1b on cognitive performance in patients with a first event suggestive of multiple sclerosis ', Multiple Sclerosis, vol. 18, no. 10, pp. 1466-1471 . https://doi.org/10.1177/1352458512442438
Multiple Sclerosis (Houndmills, Basingstoke, England)
Multiple Sclerosis, 18(10), 1466-1471. SAGE Publications Ltd

Background: Cognitive dysfunction occurs at the earliest stages of multiple sclerosis (MS), including the stage of clinically isolated syndrome (CIS). Methods: We evaluated the impact of interferon beta-1b (IFNβ-1b) 250 µg on cognitive performance

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::68d3588b1a2bedba16976b0a382ded93
https://opus4.kobv.de/opus4-fau/files/3960/penner_effects.pdf