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

211 Citations (Scopus)

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 2004
Externally publishedYes

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Breast Neoplasms
Pain
Therapeutics
Phase III Clinical Trials
Sample Size
Observational Studies
Clinical Trials
Prospective Studies

Keywords

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

ASJC Scopus subject areas

  • Medicine(all)
  • Public Health, Environmental and Occupational Health
  • Epidemiology

Cite this

A combination of distribution- and anchor-based approaches determined minimally important differences (MIDs) for four endpoints in a breast cancer scale. / Eton, David T; Cella, David; Yost, Kathleen J; Yount, Susan E.; Peterman, Amy H.; Neuberg, Donna S.; Sledge, George W.; Wood, William C.

In: Journal of Clinical Epidemiology, Vol. 57, No. 9, 09.2004, p. 898-910.

Research output: Contribution to journalArticle

Eton, David T ; Cella, David ; Yost, Kathleen J ; Yount, Susan E. ; Peterman, Amy H. ; Neuberg, Donna S. ; Sledge, George W. ; Wood, William C. / A combination of distribution- and anchor-based approaches determined minimally important differences (MIDs) for four endpoints in a breast cancer scale. In: Journal of Clinical Epidemiology. 2004 ; Vol. 57, No. 9. pp. 898-910.
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