Single-arm studies involving patient-reported outcome data in oncology: a literature review on current practice.
(odnośnik otworzy się w nowym oknie)
Autorzy:
Liu L, Choi J, Musoro JZ, Sauerbrei W, Amdal CD, Alanya A, Barbachano Y, Cappelleri JC, Falk RS, Fiero MH, Regnault A, Reijneveld JC, Sandin R, Thomassen D, Roychoudhury S, Goetghebeur E, le Cessie S; SISAQOL-IMI Work Package 3
Opublikowane w:
Lancet Oncology, 2023, ISSN 1470-2045
Wydawca:
The Lancet Publishing Group
DOI:
10.1016/s1470-2045(23)00110-9
Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI): stakeholder views, objectives, and procedures.
(odnośnik otworzy się w nowym oknie)
Autorzy:
Pe M, Alanya A, Falk RS, Amdal CD, Bjordal K, Chang J, Cislo P, Coens C, Dirven L, Speck RM, Fitzgerald K, Galinsky J, Giesinger JM, Holzner B, Le Cessie S, O'Connor D, Oliver K, Pawar V, Quinten C, Schlichting M, Ren J, Roychoudhury S, Taphoorn MJB, Velikova G, Wintner LM, Griebsch I, Bottomley A; SISAQOL-IMI Consortium.
Opublikowane w:
Lancet Oncology, 2023, ISSN 1470-2045
Wydawca:
The Lancet Publishing Group
DOI:
10.1016/s1470-2045(23)00157-2
SISAQOL-IMI consensus-based guidelines to design, analyse, interpret, and present patient-reported outcomes in cancer clinical trials
(odnośnik otworzy się w nowym oknie)
Autorzy:
Cecilie D Amdal, Ragnhild S Falk, Ahu Alanya, Michael Schlichting, Satrajit Roychoudhury, Vishal Bhatnagar, Lisa M Wintner, Antoine Regnault, Anders Ingelgård, Corneel Coens, Saskia le Cessie, Bernhard Holzner, Jane Chang, Martin Taphoorn, Paul Cislo, Johannes M Giesinger, Joseph C Cappelleri, Vivek Pawar, Silene ten Seldam, Elektra J Papadopoulos, Melanie J Calvert, Kenth L Joseph, Andrew Bottom
Opublikowane w:
The Lancet Oncology, Numer 26, 2025, Strona(/y) e683-e693, ISSN 1470-2045
Wydawca:
The Lancet Publishing Group
DOI:
10.1016/s1470-2045(25)00520-0
The role of the estimand framework in the analysis of patient-reported outcomes in single-arm trials: a case study in oncology
(odnośnik otworzy się w nowym oknie)
Autorzy:
Doranne Thomassen, Satrajit Roychoudhury, Cecilie Delphin Amdal, Dries Reynders, Jammbe Z. Musoro, Willi Sauerbrei, Els Goetghebeur, Saskia le Cessie, null null, Rajesh Kamalakar, Kavita Sail, Ethan Basch, Jaap Reijneveld, Karen Keating, Yun Su, Ahu Alanya, Gerhard Rumpold, Maxime Sasseville, Jennifer Black, Geert Molenberghs, Khadija Rantell, Michael Schlichting, Antoine Regnault, David Ness, Sil
Opublikowane w:
BMC Medical Research Methodology, Numer 24, 2024, ISSN 1471-2288
Wydawca:
BioMed Central
DOI:
10.1186/s12874-024-02408-x
Handling missing values in patient-reported outcome data in the presence of intercurrent events
(odnośnik otworzy się w nowym oknie)
Autorzy:
Doranne Thomassen, Satrajit Roychoudhury, Cecilie Delphin Amdal, Dries Reynders, Jammbe Z. Musoro, Willi Sauerbrei, Els Goetghebeur, Saskia le Cessie, null null, Rajesh Kamalakar, Kavita Sail, Ethan Basch, Jaap Reijneveld, Christoph Gerlinger, Ahu Alanya, Gerhard Rumpold, Maxime Sasseville, Jennifer Black, Geert Molenberghs, Khadija Rantell, Michael Schlichting, Antoine Regnault, David Ness, Silen
Opublikowane w:
BMC Medical Research Methodology, Numer 25, 2025, ISSN 1471-2288
Wydawca:
BioMed Central
DOI:
10.1186/s12874-025-02510-8