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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.
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. Pe M, et al. Among authors: griebsch i. Lancet Oncol. 2023 Jun;24(6):e270-e283. doi: 10.1016/S1470-2045(23)00157-2. Lancet Oncol. 2023. PMID: 37269858 Free article. Review.
SPIRIT-PRO Extension explanation and elaboration: guidelines for inclusion of patient-reported outcomes in protocols of clinical trials.
Calvert M, King M, Mercieca-Bebber R, Aiyegbusi O, Kyte D, Slade A, Chan AW, Basch E, Bell J, Bennett A, Bhatnagar V, Blazeby J, Bottomley A, Brown J, Brundage M, Campbell L, Cappelleri JC, Draper H, Dueck AC, Ells C, Frank L, Golub RM, Griebsch I, Haywood K, Hunn A, King-Kallimanis B, Martin L, Mitchell S, Morel T, Nelson L, Norquist J, O'Connor D, Palmer M, Patrick D, Price G, Regnault A, Retzer A, Revicki D, Scott J, Stephens R, Turner G, Valakas A, Velikova G, von Hildebrand M, Walker A, Wenzel L. Calvert M, et al. Among authors: griebsch i. BMJ Open. 2021 Jun 30;11(6):e045105. doi: 10.1136/bmjopen-2020-045105. BMJ Open. 2021. PMID: 34193486 Free PMC article. Review.
International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: recommendations of the SISAQOL Consortium.
Coens C, Pe M, Dueck AC, Sloan J, Basch E, Calvert M, Campbell A, Cleeland C, Cocks K, Collette L, Devlin N, Dorme L, Flechtner HH, Gotay C, Griebsch I, Groenvold M, King M, Kluetz PG, Koller M, Malone DC, Martinelli F, Mitchell SA, Musoro JZ, O'Connor D, Oliver K, Piault-Louis E, Piccart M, Quinten C, Reijneveld JC, Schürmann C, Smith AW, Soltys KM, Taphoorn MJB, Velikova G, Bottomley A; Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium. Coens C, et al. Among authors: griebsch i. Lancet Oncol. 2020 Feb;21(2):e83-e96. doi: 10.1016/S1470-2045(19)30790-9. Lancet Oncol. 2020. PMID: 32007209 Free article. Review.
43 results