TY - JOUR

T1 - Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials

T2 - a start in setting international standards

AU - Bottomley, Andrew

AU - Pe, Madeline

AU - Sloan, Jeff

AU - Basch, Ethan

AU - Bonnetain, Franck

AU - Calvert, Melanie

AU - Campbell, Alicyn

AU - Cleeland, Charles

AU - Cocks, Kim

AU - Collette, Laurence

AU - Dueck, Amylou C

AU - Devlin, Nancy

AU - Flechtner, Hans-Henning

AU - Gotay, Carolyn

AU - Greimel, Eva

AU - Griebsch, Ingolf

AU - Groenvold, Mogens

AU - Hamel, Jean-Francois

AU - King, Madeleine

AU - Kluetz, Paul G

AU - Koller, Michael

AU - Malone, Daniel C

AU - Martinelli, Francesca

AU - Mitchell, Sandra A

AU - Moinpour, Carol M

AU - Musoro, Jammbe

AU - O'Connor, Daniel

AU - Oliver, Kathy

AU - Piault-Louis, Elisabeth

AU - Piccart, Martine

AU - Pimentel, Francisco L

AU - Quinten, Chantal

AU - Reijneveld, Jaap C

AU - Schürmann, Christoph

AU - Smith, Ashley Wilder

AU - Soltys, Katherine M

AU - Taphoorn, Martin J B

AU - Velikova, Galina

AU - Coens, Corneel

AU - Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) consortium

N1 - Copyright © 2016 Elsevier Ltd. All rights reserved.

PY - 2016/11

Y1 - 2016/11

N2 - Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures are analysed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. To address these problems, the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative has been established. This consortium, directed by the European Organisation for Research and Treatment of Cancer (EORTC), was convened to provide recommendations on how to standardise the analysis of HRQOL and other patient-reported outcomes data in cancer randomised trials. This Personal View discusses the reasons why this project was initiated, the rationale for the planned work, and the expected benefits to cancer research, patient and provider decision making, care delivery, and policy making.

AB - Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures are analysed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. To address these problems, the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative has been established. This consortium, directed by the European Organisation for Research and Treatment of Cancer (EORTC), was convened to provide recommendations on how to standardise the analysis of HRQOL and other patient-reported outcomes data in cancer randomised trials. This Personal View discusses the reasons why this project was initiated, the rationale for the planned work, and the expected benefits to cancer research, patient and provider decision making, care delivery, and policy making.

U2 - 10.1016/S1470-2045(16)30510-1

DO - 10.1016/S1470-2045(16)30510-1

M3 - Comment/debate

C2 - 27769798

VL - 17

SP - e510-e514

JO - The Lancet Oncology

JF - The Lancet Oncology

SN - 1470-2045

IS - 11

ER -