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Article first published online: 1 JUN 2007
Copyright © 2007 American Cancer Society
Volume 110, Issue 1, pages 196–202, 1 July 2007
How to Cite
Ringash, J., O'Sullivan, B., Bezjak, A. and Redelmeier, D. A. (2007), Interpreting clinically significant changes in patient-reported outcomes . Cancer, 110: 196–202. doi: 10.1002/cncr.22799
Presented in part at the American Society of Clinical Oncology 36th Annual Meeting, May 21–23, 2000, New Orleans, Louisiana.
This research was carried out as part of a master of science dissertation at The University of Toronto. Baseline data on this group of patients have been previously published. An analysis limited to the Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) scale data has been published elsewhere.
- Issue published online: 15 JUN 2007
- Article first published online: 1 JUN 2007
- Manuscript Revised: 14 MAR 2007
- Manuscript Accepted: 14 MAR 2007
- Manuscript Received: 3 JAN 2007
- quality of life;
- health utility;
- outcomes. patient reported outcomes;
- minimal important difference;
- meaningful change;
- laryngeal neoplasms;
- head and neck neoplasms
The goal of this study was to determine what magnitude of change in a patient-reported outcome score is clinically meaningful, so a clinicians' guide may be provided for estimating the minimal important difference (MID) when empiric estimates are not available.
Consecutive laryngeal cancer patients (n = 98) rated their quality of life (QOL) relative to other patients. These comparisons were contrasted with arithmetic differences in scores on the Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) scale, Functional Assessment of Cancer Therapy-General (FACT-G) scale, 2 utility measures (the time tradeoff [TTO] and Daily Active Time Exchange [DATE]), and performance status (Karnofsky) scores.
The FACT-H&N score needed to differ by 4% for average patients to rate themselves as “a little bit better” relative to other patients (95% CI, 1%–8%) and by 9% to rate themselves as “a little bit worse” relative to others (95% CI, 4%–13%). The corresponding values for other measures were FACT-G 4% (1%–7%) and 8% (95% CI, 5%–11%); TTO 5% (95% CI, 0%–11%) and 6% (95% CI, 0%–10%); DATE 5% (95%CI, 2%–9%) and 14% (95% CI, 0%–5%); Karnofsky 4% (95% CI, 1%–6%) and 10% (95% CI, 7%–13%). In each case, the minimal important difference (MID) was about 5% to 10% of the instrument range.
One rule of thumb for interpreting a difference in QOL scores is a benchmark of about 10% of the instrument range. Patients appear to be more sensitive to favorable differences, so an improvement of 5% may be meaningful. This simple benchmark may be useful as a rough guide to meaningful change. Cancer 2007. © 2007 American Cancer Society.