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 - Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) consortium
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
N1 - Funding Information:
EORTC received an unrestricted education grant from Boehringer Ingelheim GmbH to initiate this work and additional financial support was provided by the EORTC Cancer Research Fund and Fonds Cancer (FOCA) from Belgium. Andrew Bottomley confirms final responsibility for the decision to submit for publication. This publication reflects the views of the individual authors and should not be construed to represent official views or policies of the US Food and Drug Administration, US National Cancer Institute, Medicines and Healthcare products Regulatory Agency, or Health Canada.
Funding Information:
AB reports grants from Boehringer Ingelheim, grants from EORTC cancer research fund during the conduct of the study; grants from Merck outside the submitted work; and is a member of the EORTC Quality of Life Group executive committee. FB reports grants, personal fees, and non-financial support from Ipsen, Amgen, Janssen, Novartis and Roche, personal fees from Amgen, Merck Serono, Ipsen, Bayer, BMS, Nestle, Integragen, Chugai, and Janssen outside the submitted work. MC reports other conflicts from International Society for Quality of Research, personal fees from Astellas Pharma, and Ferring Pharma outside the submitted work; and MC is Director of the Centre for Patient Reported Outcomes Research at the University of Birmingham and is involved in a number of local and international initiatives to promote best practice for patient-reported outcomes in trials including the development of a SPIRIT-PRO Extension and CONSORT-PRO. AC reports that she is an employee of Genentech. KC reports a grant from EORTC Quality of Life Group and personal fees from Amgen, Endomag, AstraZeneca, and Bristol-Myers Squibb outside the submitted work. ND reports that the Office of Health Economics receives funding from the Association of the British Pharmaceutical Industry. ND is a member of the EuroQoL Group, the European-based international group that developed the EQ-5D. ND is also a member of the Board of Directors of ISPOR. IG is an employee of Boehringer Ingelheim, Germany. Boehringer Ingelheim provided an unrestricted educational fund to initiate this work. MG reports that he is past chair of the EORTC Quality of Life Group, has received grants from this group, and is Board member of EORTC and International Society of Quality of Life Research. MK reports grants from EORTC Quality of Life Group and personal fees from Mundipharma outside the submitted work. KO reports grants for the International Brain Tumour Alliance from Roche, GSK, Lilly, Novocure, Novartis, Celldex, MagForce, Accuray, Photonamic, Medac, to-BBB, Apogenix, Pfizer, AbbVie, Northwest Biotherapeutics, VBL Therapeutics, The Sontag Foundation, The Brain Tumour Network, and the Ivy Foundation, all of which are outside the submitted work. KO has a consultancy company that reports honoraria and personal fees from GSK, Lilly, Novartis, Bayer, Bristol-Myers Squibb, and Sarcoma Patients EuroNet Association, all of which are outside the submitted work. MJBT reports personal fees from Hoffman-La Roche outside the submitted work. GV reports that she is the past chair of the EORTC Quality of Life group and past president of the International Society for Quality of Research. All other authors declare no competing interests.
Publisher Copyright:
© 2016 Elsevier Ltd
PY - 2016/11/1
Y1 - 2016/11/1
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.
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U2 - 10.1016/S1470-2045(16)30510-1
DO - 10.1016/S1470-2045(16)30510-1
M3 - Review article
C2 - 27769798
AN - SCOPUS:84995577351
VL - 17
SP - e510-e514
JO - The Lancet Oncology
JF - The Lancet Oncology
SN - 1470-2045
IS - 11
ER -