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Trial registration numbers: EXTEND NCT00351468, RAISE NCT00370331.
To assess the validity and reliability of the fatigue subscale of the Functional Assessment of Chronic Illness Therapy (FACIT-F), a 6-item subset from the thrombocytopenia subscale of the Functional Assessment of Cancer Therapy (FACT-Th6) and the Short Form-36 Version 2 (SF-36v2) in 2 clinical trials of the thrombopoietin receptor agonist eltrombopag in chronic immune thrombocytopenia (ITP) patients.
In the 6-month, RAndomized placebo-controlled ITP Study with Eltrombopag (RAISE; n = 197), the FACIT-F, FACT-Th6, and SF-36v2 were administered at baseline, day 43, weeks 14 and 26, or early withdrawal. In the ongoing open-label extension study, Eltrombopag EXTENDed Dosing Study (EXTEND; n = 154), measures were administered at baseline, at the beginning of each stage, and at permanent discontinuation of study medication.
FACIT-F, FACT-Th6, and SF-36v2 demonstrated acceptable internal consistency reliability (i.e., all Cronbach’s alphas >0.70) and test–retest reliability (all intraclass correlation coefficients >0.70). Construct validity was supported by moderate (0.35 < r < 0.50) to strong (r > 0.50) inter-measure correlations for baseline and change scores. A small to medium magnitude of effect was captured by the FACIT-F and FACT-Th6 among patients who experienced sustained platelet responses.
Results provide support for the validity, reliability, and responsiveness of the FACIT-F, FACT-Th6, and SF-36v2 in chronic ITP patients.
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Ballem, P. J., Segal, G. M., Stratton, J. R., Gernsheimer, T., Adamson, J. W., & Slichter, S. J. (1987). Mechanisms of thrombocytopenia in chronic autoimmune thrombocytopenic purpura. Evidence of both impaired platelet production and increased platelet clearance. The Journal of Clinical Investigation, 80, 33–40. PubMedCrossRef
Feudjo-Tepie, M. A., Robinson, N. J., & Bennett, D. (2008). Prevalence of diagnosed chronic immune thrombocytopenic purpura in the us: Analysis of a large us claim database: A rebuttal. Journal of Thrombosis Haemostasis, 6, 711–712, author reply 713.
Mathias, S. D., Bussel, J. B., George, J. N., McMillan, R., Okano, G. J., & Nichol, J. L. (2007). A disease-specific measure of health-related quality of life for use in adults with immune thrombocytopenic purpura: Its development and validation. Health and Quality of Life Outcomes, 5, 11. PubMedCrossRef
Mathias, S. D., Gao, S. K., Miller, K. L., Cella, D., Snyder, C., Turner, R., et al. (2008). Impact of chronic immune thrombocytopenic purpura (ITP) on health-related quality of life: A conceptual model starting with the patient perspective. Health and Quality of Life Outcomes, 6, 13. Available at http://www.hqlo.com/content/16/11/13.
Cella, D., Eton, D. T., Lai, J. S., Peterman, A. H., & Merkel, D. E. (2002). Combining anchor and distribution-based methods to derive minimal clinically important differences on the functional assessment of cancer therapy (FACT) anemia and fatigue scales. Journal of Pain and Symptom Management, 24, 547–561. PubMedCrossRef
Ware, J. E., Kosinski, M., Bjorner, J. B., Turner-Bowker, D. M., Gandek, B., & Mariush, M. E. (2007). User’s manual for the sf- 36v2 health survey (2nd ed.). Lincoln, RI: Quality Metric Incorporated.
Cheng, G., Saleh, M. N., Marcher, C., Vasey, S., Mayer, B., Aivado, M., et al. (2010). Eltrombopag for the long-term management of chronic idiopathic thrombocytopenic purpura: A 6-month, randomized, phase iii study (RAISE). Lancet. Epub ahead of print.
Saleh, M. N., Bussel, J. B., Cheng, G., Meddeb, B., Mayer, B., Bailey, C., et al. (2009). Long-term treatment of chronic immune thrombocytopenic purpura with oral eltrombopag: Results from the extend study. Blood, 114, Abstract 682.
Marra, C. A., Woolcott, J. C., Kopec, J. A., Shojania, K., Offer, R., Brazier, J. E., et al. (2005). A comparison of generic, indirect utility measures (the hui2, hui3, sf-6d, and the eq-5d) and disease-specific instruments (the raqol and the haq) in rheumatoid arthritis. Social Science and Medicine, 60, 1571–1582. PubMedCrossRef
Guttman, L. (1954). Some necessary conditions for common-factor analysis. Psychometrika, 19, 149–161. CrossRef
Kaiser, H. F. (1960). The application of electronic computers to factor analysis. Educational and Psychological Measurement, 20, 141–151. CrossRef
Kaiser, H. F. (1961). A note on Guttman’s lower bound for the number of common factors. British Journal of Mathematical and Statistical Psychology, 14, 1.
Kline, P. (1993). Handbook of psychological testing. London: Routledge.
Cohen, J. (1977). Statistical power analysis for the behavioral science (revised ed.) New York: Academic Press.
Liang, K.-Y., & Seger, S. L. (1986). Longitudinal data analysis using generalized linear models. Biometrika, 73, 13–22. CrossRef
Guyatt, G. H., King, D. R., Feeny, D. H., Stubbing, D., & Goldstein, R. S. (1999). Generic and specific measurement of health-related quality of life in a clinical trial of respiratory rehabilitation. Journal of Clinical Epidemiology, 52(3), 187–92. PubMed PMID: 10210235.
McGraw, K. O., & Wong, S. P. (1996). Forming inferences about some intraclass correlation coefficients. Psychological Methods, 1, 30–46. CrossRef
- Validation of the FACIT-fatigue subscale, selected items from FACT-thrombocytopenia, and the SF-36v2 in patients with chronic immune thrombocytopenia
Kelly M. Grotzinger
- Springer Netherlands