Psychometric evaluation of the FACT Colorectal Cancer Symptom Index (FCSI-9) : reliability, validity, responsiveness, and clinical meaningfulness

Colwell, Hilary H.; Mathias, Susan D.; Turner, Michelle P.; Lu, John; Wright, Nicola; Peeters, Marc; Cella, David; Devercelli, Giovanna

doi:10.1634/THEONCOLOGIST.2009-0034

Title

Psychometric evaluation of the FACT Colorectal Cancer Symptom Index (FCSI-9) : reliability, validity, responsiveness, and clinical meaningfulness

Author

Colwell, Hilary H.

Mathias, Susan D.

Turner, Michelle P.

Lu, John

Wright, Nicola

Peeters, Marc

Cella, David

Devercelli, Giovanna

Abstract

Background. Patient-reported outcomes (PROs) are essential for evaluating treatment effects on health-related quality of life and symptoms from the patient's perspective. This study sought to evaluate the psychometric properties of the nine-item Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network Colorectal Cancer Symptom Index (FCSI-9) in a metastatic colorectal cancer (mCRC) population. Methods. The FCSI-9 and EQ-5D were administered every 24 weeks to mCRC subjects in a phase III clinical trial. Three hundred ninety-one mCRC subjects completed the questionnaires at baseline and at least one follow-up assessment. Internal consistency reliability, testretest reliability, construct validity, known groups validity, responsiveness, and the minimum important difference (MID) of the FCSI-9 were evaluated. Results. The internal consistency and testretest reliability of the FCSI-9 were acceptable (0.81 and 0.76, respectively). Construct validity was supported based on moderate correlations with the EQ-5D. Known groups validity was evaluated by examining the FCSI-9 scores of subjects categorized by their Eastern Cooperative Oncology Group performance status (PS) score. Subjects with better PS scores reported significantly higher FCSI-9 scores than those with lower PS scores at both baseline and week 8. Responsiveness, as measured by Guyatt's statistic, was 0.77 from baseline to week 8 and 0.60 from week 4 to week 12. Considering all data together, the MID of the FCSI-9 is estimated to be in the range of 1.53.0 points. Conclusion. Results provide preliminary evidence of the reliability, validity, and responsiveness of the FCSI-9.

Language

English

Source (journal)

The oncologist. - Place of publication unknown

Publication

Place of publication unknown : 2010

ISSN

1083-7159 [print]

1549-490X [online]

DOI

10.1634/THEONCOLOGIST.2009-0034

Volume/pages