Assessing meaningful change in quality of life over time: A users’ guide for clinicians

Mirjam A.G. Sprangers; Carol M. Moinpour; Timothy J. Moynihan; Donald L. Patrick; Dennis A. Revicki; Neil Aarinson; Ivan Barofsky; Rick Berzon; Amy Bonomi; Monika Bullinger; Joseph C. Cappelleri; David Cella; Dianne L. Fairclough; Carol Estwing Ferrans; Marlene H. Frost; Gordon H. Guyatt; Ron D. Hays; Patrick Marquis; Geoff Norman; David Osoba; Teresa Rummans; Charles Scott; Jeff A. Sloan; Tara Symonds; Claudette Varricchio; Gilbert Wong; Albert Wu; Kathleen Wyrwich

doi:10.4065/77.6.561

Assessing meaningful change in quality of life over time: A users’ guide for clinicians

Mirjam A.G. Sprangers^*, Carol M. Moinpour, Timothy J. Moynihan, Donald L. Patrick, Dennis A. Revicki, Neil Aarinson, Ivan Barofsky, Rick Berzon, Amy Bonomi, Monika Bullinger, Joseph C. Cappelleri, David Cella, Dianne L. Fairclough, Carol Estwing Ferrans, Marlene H. Frost, Gordon H. Guyatt, Ron D. Hays, Patrick Marquis, Geoff Norman, David OsobaTeresa Rummans, Charles Scott, Jeff A. Sloan, Tara Symonds, Claudette Varricchio, Gilbert Wong, Albert Wu, Kathleen Wyrwich

^*Corresponding author for this work

Medical Social Sciences

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

145 Scopus citations

Abstract

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.

Original language	English (US)
Article number	62000
Pages (from-to)	561-571
Number of pages	11
Journal	Mayo Clinic Proceedings
Volume	77
Issue number	6
DOIs	https://doi.org/10.4065/77.6.561
State	Published - 2002

ASJC Scopus subject areas

Medicine(all)

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Sprangers, M. A. G., Moinpour, C. M., Moynihan, T. J., Patrick, D. L., Revicki, D. A., Aarinson, N., Barofsky, I., Berzon, R., Bonomi, A., Bullinger, M., Cappelleri, J. C., Cella, D., Fairclough, D. L., Ferrans, C. E., Frost, M. H., Guyatt, G. H., Hays, R. D., Marquis, P., Norman, G., ... Wyrwich, K. (2002). Assessing meaningful change in quality of life over time: A users’ guide for clinicians. Mayo Clinic Proceedings, 77(6), 561-571. [62000]. https://doi.org/10.4065/77.6.561

@article{3bb4f8574ef240538324c223dac8f955,

title = "Assessing meaningful change in quality of life over time: A users{\textquoteright} guide for clinicians",

abstract = "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.",

author = "Sprangers, {Mirjam A.G.} and Moinpour, {Carol M.} and Moynihan, {Timothy J.} and Patrick, {Donald L.} and Revicki, {Dennis A.} and Neil Aarinson and Ivan Barofsky and Rick Berzon and Amy Bonomi and Monika Bullinger and Cappelleri, {Joseph C.} and David Cella and Fairclough, {Dianne L.} and Ferrans, {Carol Estwing} and Frost, {Marlene H.} and Guyatt, {Gordon H.} and Hays, {Ron D.} and Patrick Marquis and Geoff Norman and David Osoba and Teresa Rummans and Charles Scott and Sloan, {Jeff A.} and Tara Symonds and Claudette Varricchio and Gilbert Wong and Albert Wu and Kathleen Wyrwich",

year = "2002",

doi = "10.4065/77.6.561",

language = "English (US)",

volume = "77",

pages = "561--571",

journal = "Mayo Clinic Proceedings",

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Sprangers, MAG, Moinpour, CM, Moynihan, TJ, Patrick, DL, Revicki, DA, Aarinson, N, Barofsky, I, Berzon, R, Bonomi, A, Bullinger, M, Cappelleri, JC, Cella, D, Fairclough, DL, Ferrans, CE, Frost, MH, Guyatt, GH, Hays, RD, Marquis, P, Norman, G, Osoba, D, Rummans, T, Scott, C, Sloan, JA, Symonds, T, Varricchio, C, Wong, G, Wu, A & Wyrwich, K 2002, 'Assessing meaningful change in quality of life over time: A users’ guide for clinicians', Mayo Clinic Proceedings, vol. 77, no. 6, 62000, pp. 561-571. https://doi.org/10.4065/77.6.561

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

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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JO - Mayo Clinic Proceedings

JF - Mayo Clinic Proceedings

IS - 6

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Assessing meaningful change in quality of life over time: A users’ guide for clinicians

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