Combining anchor and distribution-based methods to derive minimal clinically important differences on the Functional Assessment of Cancer Therapy (FACT) anemia and fatigue scales

David Cella, David T. Eton, Jin Shei Lai, Amy H. Peterman, Douglas E. Merkel

Research output: Contribution to journalArticle

487 Scopus citations

Abstract

Magnitude differences in scores on a measure of quality of life that correspond to differences in function or clinical course are called clinically important differences (CIDs). Anchor-based and distribution-based methods were used to provide ranges of CIDs for five targeted scale scores of the Functional Assessment of Cancer Therapy - Anemia (FACT-An) questionnaire. Three samples of cancer patients were used: Sample 1 included 50 patients participating in a validation study of the FACT-An; Sample 2 included 131 patients participating in a longitudinal study of chemotherapy-induced fatigue; sample 3 included 2,402 patients enrolled in a community-based clinical trial evaluating the effectiveness and safety of a treatment for anemia. Three clinical indicators (hemoglobin level; performance status; response to treatment) were used to determine anchor-based differences. One-half of the standard deviation and 1 standard error of measurement were used as distribution-based criteria. Analyses supported the following whole number estimates of a minimal CID for these five targeted scores: Fatigue Scale = 3.0; FACT-G total score = 4.0; FACT-An total score = 7.0; Trial Outcome Index - Fatigue = 5.0; and Trial Outcome Index - Anemia = 6.0. These estimates provide a basis for sample size estimation when planning for a clinical trial or other longitudinal study, when the purpose is to ensure detection of meaningful change over time. They can also be used in conjunction with more traditional clinical markers to assist investigators in determining treatment efficacy.

Original languageEnglish (US)
Pages (from-to)547-561
Number of pages15
JournalJournal of pain and symptom management
Volume24
Issue number6
DOIs
StatePublished - Dec 1 2002

Keywords

  • Anemia
  • Clinical significance
  • Fatigue
  • Quality of life

ASJC Scopus subject areas

  • Nursing(all)
  • Clinical Neurology
  • Anesthesiology and Pain Medicine

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