A combination of distribution- and anchor-based approaches determined minimally important differences (MIDs) for four endpoints in a breast cancer scale

David T. Eton, David Cella, Kathleen J. Yost, Susan E. Yount, Amy H. Peterman, Donna S. Neuberg, George W. Sledge, William C. Wood

Research output: Contribution to journalArticle

225 Scopus citations

Abstract

To determine distribution- and anchor-based minimal important difference (MID) estimates for four scores from the Functional Assessment of Cancer Therapy-Breast (FACT-B): the breast cancer subscale (BCS), Trial Outcome Index (TOI), FACT-G (the general version), and FACT-B. We used data from a Phase III clinical trial in metastatic breast cancer (ECOG study 1193; n = 739) and a prospective observational study of pain in metastatic breast cancer (n = 129). One third and one half of the standard deviation and 1 standard error of measurement were used as distribution-based criteria. Clinical indicators used to determine anchor-based differences included ECOG performance status, current pain, and response to treatment. FACT-B scores were responsive to performance status and pain anchors, but not to treatment response. By combining the results of distribution- and anchor-based methods, MID estimates were obtained: BCS = 2-3 points, TOI = 5-6 points, FACT-G = 5-6 points, and FACT-B = 7-8 points. Distribution- and anchor-based estimates of the MID do show convergence. These estimates can be used in combination with other measures of efficacy to determine meaningful benefit and provide a basis for sample size estimation in clinical trials.

Original languageEnglish (US)
Pages (from-to)898-910
Number of pages13
JournalJournal of Clinical Epidemiology
Volume57
Issue number9
DOIs
StatePublished - Sep 1 2004

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Keywords

  • Breast cancer
  • Clinical significance
  • Functional Assessment of Cancer Therapy-Breast questionnaire
  • Minimal important difference
  • Quality of life
  • health-related

ASJC Scopus subject areas

  • Epidemiology

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