TY - JOUR
T1 - Assessing meaningful change in quality of life over time
T2 - A users’ guide for clinicians
AU - Sprangers, Mirjam A.G.
AU - Moinpour, Carol M.
AU - Moynihan, Timothy J.
AU - Patrick, Donald L.
AU - Revicki, Dennis A.
AU - Aarinson, Neil
AU - Barofsky, Ivan
AU - Berzon, Rick
AU - Bonomi, Amy
AU - Bullinger, Monika
AU - Cappelleri, Joseph C.
AU - Cella, David
AU - Fairclough, Dianne L.
AU - Ferrans, Carol Estwing
AU - Frost, Marlene H.
AU - Guyatt, Gordon H.
AU - Hays, Ron D.
AU - Marquis, Patrick
AU - Norman, Geoff
AU - Osoba, David
AU - Rummans, Teresa
AU - Scott, Charles
AU - Sloan, Jeff A.
AU - Symonds, Tara
AU - Varricchio, Claudette
AU - Wong, Gilbert
AU - Wu, Albert
AU - Wyrwich, Kathleen
N1 - Funding Information:
This project was supported in part by Public Health Service grants CA25224, CA37404, CA15083, CA35269, CA35113, CA35272, CA52352, CA35103, CA37417, CA63849, CA35448, CA35101, CA35195, CA35415, and CA35103. The entire Symposium on the Clinical Significance of Quality-of-Life Measures in Cancer Patients will be available for purchase as a bound booklet from the Proceedings Editorial Office at a later date.
Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 2002
Y1 - 2002
N2 - The objective of this article is to help clinicians interpret trial-based quality of life (QOL) changes over time. We address a series of questions and provide guidelines that are fundamental to assessing and interpreting change. The issues addressed are as follows: (1) What are the characteristics of the population for whom changes in QOL are reported? (2) Is the QOL questionnaire reliable, valid, and responsive to change? (3) Are the timing and frequency of assessments adequate? (4) Is the study adequately powered? (5) How are multiple QOL outcomes addressed in analyses? (6) How are multiple time points handled? (7) Can alternative explanations account for the observed change or lack of observed change (eg, handling of missing data, survival differences, and changes in patient's QOL perspective over time)? and (8) How is statistical significance translated into meaningful change? These guidelines will support clinicians in reviewing the clinical trial literature, which in turn can help them use the data in the treatment decision process.
AB - The objective of this article is to help clinicians interpret trial-based quality of life (QOL) changes over time. We address a series of questions and provide guidelines that are fundamental to assessing and interpreting change. The issues addressed are as follows: (1) What are the characteristics of the population for whom changes in QOL are reported? (2) Is the QOL questionnaire reliable, valid, and responsive to change? (3) Are the timing and frequency of assessments adequate? (4) Is the study adequately powered? (5) How are multiple QOL outcomes addressed in analyses? (6) How are multiple time points handled? (7) Can alternative explanations account for the observed change or lack of observed change (eg, handling of missing data, survival differences, and changes in patient's QOL perspective over time)? and (8) How is statistical significance translated into meaningful change? These guidelines will support clinicians in reviewing the clinical trial literature, which in turn can help them use the data in the treatment decision process.
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U2 - 10.4065/77.6.561
DO - 10.4065/77.6.561
M3 - Article
C2 - 12059127
AN - SCOPUS:0036266786
SN - 0025-6196
VL - 77
SP - 561
EP - 571
JO - Mayo Clinic proceedings
JF - Mayo Clinic proceedings
IS - 6
M1 - 62000
ER -