Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards

Andrew Bottomley; Madeline Pe; Jeff Sloan; Ethan Basch; Franck Bonnetain; Alicyn Campbell; Charles Cleeland; Kim Cocks; Laurence Collette; Amylou C Dueck; Nancy Devlin; Hans-Henning Flechtner; Carolyn Gotay; Eva Greimel; Ingolf Griebsch; Mogens Groenvold; Jean-Francois Hamel; Madeleine King; Paul G Kluetz; Michael Koller; Daniel C Malone; Francesca Martinelli; Sandra A Mitchell; Carol M Moinpour; Jammbe Musoro; Daniel O'Connor; Kathy Oliver; Elisabeth Piault-Louis; Martine Piccart; Francisco L Pimentel; Chantal Quinten; Jaap C Reijneveld; Christoph Schürmann; Ashley Wilder Smith; Katherine M Soltys; Martin J B Taphoorn; Galina Velikova; Corneel Coens; Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) consortium; Melanie Calvert

doi:10.1016/S1470-2045(16)30510-1

Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards

Andrew Bottomley, Madeline Pe, Jeff Sloan, Ethan Basch, Franck Bonnetain, Alicyn Campbell, Charles Cleeland, Kim Cocks, Laurence Collette, Amylou C Dueck, Nancy Devlin, Hans-Henning Flechtner, Carolyn Gotay, Eva Greimel, Ingolf Griebsch, Mogens Groenvold, Jean-Francois Hamel, Madeleine King, Paul G Kluetz, Michael KollerDaniel C Malone, Francesca Martinelli, Sandra A Mitchell, Carol M Moinpour, Jammbe Musoro, Daniel O'Connor, Kathy Oliver, Elisabeth Piault-Louis, Martine Piccart, Francisco L Pimentel, Chantal Quinten, Jaap C Reijneveld, Christoph Schürmann, Ashley Wilder Smith, Katherine M Soltys, Martin J B Taphoorn, Galina Velikova, Corneel Coens, Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) consortium, Melanie Calvert

Applied Health Research

Research output: Contribution to journal › Article › peer-review

100 Citations (Scopus)

Abstract

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.

Original language	English
Pages (from-to)	e510-e514
Journal	The Lancet Oncology
Volume	17
Issue number	11
Early online date	18 Oct 2016
DOIs	https://doi.org/10.1016/S1470-2045(16)30510-1
Publication status	Published - Nov 2016

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1016/S1470-2045(16)30510-1Licence: None: All rights reserved

Cite this

Bottomley, A., Pe, M., Sloan, J., Basch, E., Bonnetain, F., Campbell, A., Cleeland, C., Cocks, K., Collette, L., Dueck, A. C., Devlin, N., Flechtner, H-H., Gotay, C., Greimel, E., Griebsch, I., Groenvold, M., Hamel, J-F., King, M., Kluetz, P. G., ... Calvert, M. (2016). Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards. The Lancet Oncology, 17(11), e510-e514. https://doi.org/10.1016/S1470-2045(16)30510-1

@article{419d4b4b04484ff48d9ea5d257deb17a,

title = "Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards",

abstract = "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.",

author = "Andrew Bottomley and Madeline Pe and Jeff Sloan and Ethan Basch and Franck Bonnetain and Alicyn Campbell and Charles Cleeland and Kim Cocks and Laurence Collette and Dueck, {Amylou C} and Nancy Devlin and Hans-Henning Flechtner and Carolyn Gotay and Eva Greimel and Ingolf Griebsch and Mogens Groenvold and Jean-Francois Hamel and Madeleine King and Kluetz, {Paul G} and Michael Koller and Malone, {Daniel C} and Francesca Martinelli and Mitchell, {Sandra A} and Moinpour, {Carol M} and Jammbe Musoro and Daniel O'Connor and Kathy Oliver and Elisabeth Piault-Louis and Martine Piccart and Pimentel, {Francisco L} and Chantal Quinten and Reijneveld, {Jaap C} and Christoph Sch{\"u}rmann and Smith, {Ashley Wilder} and Soltys, {Katherine M} and Taphoorn, {Martin J B} and Galina Velikova and Corneel Coens and consortium, {Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL)} and Melanie Calvert",

year = "2016",

month = nov,

doi = "10.1016/S1470-2045(16)30510-1",

language = "English",

volume = "17",

pages = "e510--e514",

journal = "The Lancet Oncology",

issn = "1470-2045",

publisher = "Elsevier",

number = "11",

}

Bottomley, A, Pe, M, Sloan, J, Basch, E, Bonnetain, F, Campbell, A, Cleeland, C, Cocks, K, Collette, L, Dueck, AC, Devlin, N, Flechtner, H-H, Gotay, C, Greimel, E, Griebsch, I, Groenvold, M, Hamel, J-F, King, M, Kluetz, PG, Koller, M, Malone, DC, Martinelli, F, Mitchell, SA, Moinpour, CM, Musoro, J, O'Connor, D, Oliver, K, Piault-Louis, E, Piccart, M, Pimentel, FL, Quinten, C, Reijneveld, JC, Schürmann, C, Smith, AW, Soltys, KM, Taphoorn, MJB, Velikova, G, Coens, C, consortium, SISIAP-ROAQOLED & Calvert, M 2016, 'Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards', The Lancet Oncology, vol. 17, no. 11, pp. e510-e514. https://doi.org/10.1016/S1470-2045(16)30510-1

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

AU - Calvert, Melanie

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 - Article

C2 - 27769798

SN - 1470-2045

VL - 17

SP - e510-e514

JO - The Lancet Oncology

JF - The Lancet Oncology

IS - 11

ER -

Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards

Abstract

UN SDGs

Access to Document

Fingerprint

Cite this