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Psychometric evaluation of the FACT colorectal cancer symptom index (FCSI-9): reliability, validity, responsiveness, and clinical meaningfulness

(2010) ONCOLOGIST. 15(3). p.308-316
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Organization
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 2-4 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, test-retest reliability, construct validity, known groups validity, responsiveness, and the minimum important difference (MID) of the FCSI-9 were evaluated. Results. The internal consistency and test-retest 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 1.5-3.0 points. Conclusion. Results provide preliminary evidence of the reliability, validity, and responsiveness of the FCSI-9. The Oncologist 2010; 15: 308-316
Keywords
INSTRUMENTS, CRITERIA, Patient outcomes, Colorectal cancer, FUNCTIONAL ASSESSMENT, HEALTH-STATUS, Quality of life, Reliability and validity, Questionnaire

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MLA
Colwell, Hilary H, Susan D Mathias, Michelle P Turner, et al. “Psychometric Evaluation of the FACT Colorectal Cancer Symptom Index (FCSI-9): Reliability, Validity, Responsiveness, and Clinical Meaningfulness.” ONCOLOGIST 15.3 (2010): 308–316. Print.
APA
Colwell, H. H., Mathias, S. D., Turner, M. P., Lu, J., Wright, N., Peeters, M., Cella, D., et al. (2010). Psychometric evaluation of the FACT colorectal cancer symptom index (FCSI-9): reliability, validity, responsiveness, and clinical meaningfulness. ONCOLOGIST, 15(3), 308–316.
Chicago author-date
Colwell, Hilary H, Susan D Mathias, Michelle P Turner, John Lu, Nicola Wright, Marc Peeters, David Cella, and Giovanna Devercelli. 2010. “Psychometric Evaluation of the FACT Colorectal Cancer Symptom Index (FCSI-9): Reliability, Validity, Responsiveness, and Clinical Meaningfulness.” Oncologist 15 (3): 308–316.
Chicago author-date (all authors)
Colwell, Hilary H, Susan D Mathias, Michelle P Turner, John Lu, Nicola Wright, Marc Peeters, David Cella, and Giovanna Devercelli. 2010. “Psychometric Evaluation of the FACT Colorectal Cancer Symptom Index (FCSI-9): Reliability, Validity, Responsiveness, and Clinical Meaningfulness.” Oncologist 15 (3): 308–316.
Vancouver
1.
Colwell HH, Mathias SD, Turner MP, Lu J, Wright N, Peeters M, et al. Psychometric evaluation of the FACT colorectal cancer symptom index (FCSI-9): reliability, validity, responsiveness, and clinical meaningfulness. ONCOLOGIST. 2010;15(3):308–16.
IEEE
[1]
H. H. Colwell et al., “Psychometric evaluation of the FACT colorectal cancer symptom index (FCSI-9): reliability, validity, responsiveness, and clinical meaningfulness,” ONCOLOGIST, vol. 15, no. 3, pp. 308–316, 2010.
@article{1193793,
  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 2-4 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, test-retest reliability, construct validity, known groups validity, responsiveness, and the minimum important difference (MID) of the FCSI-9 were evaluated.
Results. The internal consistency and test-retest 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 1.5-3.0 points.
Conclusion. Results provide preliminary evidence of the reliability, validity, and responsiveness of the FCSI-9. The Oncologist 2010; 15: 308-316},
  author       = {Colwell, Hilary H and Mathias, Susan D and Turner, Michelle P and Lu, John and Wright, Nicola and Peeters, Marc and Cella, David and Devercelli, Giovanna},
  issn         = {1083-7159},
  journal      = {ONCOLOGIST},
  keywords     = {INSTRUMENTS,CRITERIA,Patient outcomes,Colorectal cancer,FUNCTIONAL ASSESSMENT,HEALTH-STATUS,Quality of life,Reliability and validity,Questionnaire},
  language     = {eng},
  number       = {3},
  pages        = {308--316},
  title        = {Psychometric evaluation of the FACT colorectal cancer symptom index (FCSI-9): reliability, validity, responsiveness, and clinical meaningfulness},
  url          = {http://dx.doi.org/10.1634/theoncologist.2009-0034},
  volume       = {15},
  year         = {2010},
}

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