TY - JOUR
T1 - International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials
T2 - recommendations of the SISAQOL Consortium
AU - Coens, Corneel
AU - Pe, Madeline
AU - Dueck, Amylou C
AU - Sloan, J
AU - Basch, Ethan
AU - Calvert, Melanie
AU - Campbell , A
AU - Cleeland, Charles
AU - Cocks, K
AU - Collette , L
AU - Devlin, N
AU - Dorme, Lien
AU - Flechtner, Hans-Henning
AU - Gotay , C
AU - Griebsch, I
AU - Groenvold , M
AU - King, M
AU - Kluetz, Paul G
AU - Koller , M
AU - Malone, Daniel C
AU - Martinelli, Francesca
AU - Mitchell, Sandra A
AU - Musoro, Jammbe
AU - O'Connor, D
AU - Oliver , K
AU - Piault-Louis, Elisabeth
AU - Piccart, Martine
AU - Quinten, C
AU - Reijneveld, Jaap C
AU - Schurmann, C
AU - Smith , AW
AU - Soltys, Katherine M
AU - Taphoorn , M
AU - Velikova, Galina
AU - Bottomley , A
PY - 2020/2/1
Y1 - 2020/2/1
N2 - Patient-reported outcomes (PROs), such as symptoms, function, and other health-related quality-of-life aspects, are increasingly evaluated in cancer randomised controlled trials (RCTs) to provide information about treatment risks, benefits, and tolerability. However, expert opinion and critical review of the literature showed no consensus on optimal methods of PRO analysis in cancer RCTs, hindering interpretation of results. The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium was formed to establish PRO analysis recommendations. Four issues were prioritised: developing a taxonomy of research objectives that can be matched with appropriate statistical methods, identifying appropriate statistical methods for PRO analysis, standardising statistical terminology related to missing data, and determining appropriate ways to manage missing data. This Policy Review presents recommendations for PRO analysis developed through critical literature reviews and a structured collaborative process with diverse international stakeholders, which provides a foundation for endorsement; ongoing developments of these recommendations are also discussed.
AB - Patient-reported outcomes (PROs), such as symptoms, function, and other health-related quality-of-life aspects, are increasingly evaluated in cancer randomised controlled trials (RCTs) to provide information about treatment risks, benefits, and tolerability. However, expert opinion and critical review of the literature showed no consensus on optimal methods of PRO analysis in cancer RCTs, hindering interpretation of results. The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium was formed to establish PRO analysis recommendations. Four issues were prioritised: developing a taxonomy of research objectives that can be matched with appropriate statistical methods, identifying appropriate statistical methods for PRO analysis, standardising statistical terminology related to missing data, and determining appropriate ways to manage missing data. This Policy Review presents recommendations for PRO analysis developed through critical literature reviews and a structured collaborative process with diverse international stakeholders, which provides a foundation for endorsement; ongoing developments of these recommendations are also discussed.
UR - http://www.scopus.com/inward/record.url?scp=85078657870&partnerID=8YFLogxK
U2 - 10.1016/S1470-2045(19)30790-9
DO - 10.1016/S1470-2045(19)30790-9
M3 - Article
SN - 1470-2045
VL - 21
SP - e83-e96
JO - The Lancet Oncology
JF - The Lancet Oncology
IS - 2
ER -
