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

Research output: Contribution to journalArticlepeer-review

139 Scopus citations


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 languageEnglish (US)
Article number62000
Pages (from-to)561-571
Number of pages11
JournalMayo Clinic proceedings
Issue number6
StatePublished - 2002

ASJC Scopus subject areas

  • Medicine(all)


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