Reliability, validity, and minimally important differences of the SF-6D in systemic sclerosis

Quality of Life Research

Volumn 16, Issue 6, 2007, Pages 1083-1092

  Khanna, Dinesh ^a,b   Furst, Daniel E ^d   Wong, Weng Kee ^d   Tsevat, Joel ^a,b,c   Clements, Philip J ^d   Park, Grace S ^d   Postlethwaite, Arnold E ^e   Ahmed, Mansoor ^a,c   Ginsburg, Shaari ^a,c   Hays, Ron D ^d,f  

^a UNIVERSITY OF CINCINNATI MEDICAL CENTER   (United States)

^b UNIVERSITY OF CINCINNATI   (United States)

^c VETERANS AFFAIRS MEDICAL CENTER   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

^e UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER   (United States)

^f RAND CORPORATION   (United States)

Author keywords

Minimally important difference; Preference based measures; Scleroderma; SF 6D; Systemic sclerosis; Utility measures

Indexed keywords

COLLAGEN; PLACEBO;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORRELATION ANALYSIS; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; OBSERVATIONAL STUDY; PATIENT ASSESSMENT; PRIORITY JOURNAL; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; RELIABILITY; SYSTEMIC SCLEROSIS; TEST RETEST RELIABILITY; VALIDITY;

ADULT; AGED; COLLAGEN; CROSS-SECTIONAL STUDIES; FEMALE; HUMANS; MALE; MIDDLE AGED; OUTCOME ASSESSMENT (HEALTH CARE); PATIENT SATISFACTION; PLACEBOS; PSYCHOMETRICS; QUALITY OF LIFE; SCLERODERMA, SYSTEMIC; SICKNESS IMPACT PROFILE; SKINFOLD THICKNESS; UNITED STATES;

EID: 34547408278     PISSN: 09629343     EISSN: None     Source Type: Journal    
DOI: 10.1007/s11136-007-9207-3     Document Type: Article

References (53)

1. Mayes, M. D., Lacey, J. V., Jr., Beebe-Dimmer, J., Gillespie, B. W., Cooper, B., & Laing, T. J., et al. (2003). Prevalence, incidence, survival, and disease characteristics of systemic sclerosis in a large US population. Arthritis and Rheumatism, 48(8), 2246-2255.
2. Clements, P. J. (2000). Systemic sclerosis (scleroderma) and related disorders: Clinical aspects. Baillieres Best Practice & Research Clinical Rheumatology, 14(1), 1-16.
3. Charles, C., Clements, P., & Furst, D. E. (2006). Systemic sclerosis: hypothesis-driven treatment strategies. Lancet, 367(9523), 1683-1691.
4. Altman, R. D., Medsger, T. A., Jr., Bloch, D. A., & Michel, B. A. (1991). Predictors of survival in systemic sclerosis (scleroderma). Arthritis and Rheumatism, 34(4), 403-413.
5. Malcarne, V. L. (2004). Psychological adjustment in systemic sclerosis. In P. J. Clements & D. E. Furst (Eds.), Systemic sclerosis (pp. 331-350). Philadelphia: Lippincott Williams and Wilkins.
6. Khanna, D. (2006). Health-related quality of life: A primer with focus on scleroderma. Scleroderma Care and Research, 3(2), 3-13 (Accessed at http://www.sctconline.org/pdfs/SCARV3N2.pdf on March 2nd, 2007).
7. Ware, J., Kosinski, M., & Dewey, J. (2000). How to score version two of the SF-36 health survey. Lincoln, RI: Quality Metric Incorporated.
8. Fries, J. F., Spitz, P., Kraines, R. G., & Holman, H. R. (1980). Measurement of patient outcome in arthritis. Arthritis and Rheumatism, 23(2), 137-145.
9. Torrance, G. (1986). Measurement of health state utilities for economic appraisal. Journal of Health Economics, 5, 1-30.
10. Von Neumann, J., & Morgenstern, O. (1953). Theory of games and economic behavior. New York: Wiley.
11. Froberg, D. G., & Kane, R. L. (1989). Methodology for measuring health-state preferences-II: Scaling methods. Journal of Clinical Epidemiology, 42(5), 459-471.
12. Brazier, J., Roberts, J., & Deverill, M. (2002). The estimation of a preference-based measure of health from the SF-36. Journal of Health Economics, 21(2), 271-292.
13. Khanna, D., Ahmed, M., Furst, D. E., Ginsburg, S. S., Park, G. S., & Hornung, R., et al. (2007). Health values of patients with systemic sclerosis. Arthritis and Rheumatism, 57(1), 86-93.
14. Jaeschke, R., Singer, J., & Guyatt, G. H. (1989). Measurement of health status. Ascertaining the minimal clinically important difference. Controlled Clinical Trials, 10(4), 407-415.
15. van Walraven, C., Mahon, J. L., Moher, D., Bohm, C., & Laupacis, A. (1999). Surveying physicians to determine the minimal important difference: Implications for sample-size calculation. Journal of Clinical Epidemiology, 52(8), 717-723.
16. Hays, R. D., Farivar, S., & Liu, H. (2005). Approaches and recommendations for estimating minimally important differences for health-related quality of life measures. COPD: Journal of Chronic Obstructive Pulmonary Disease, 2, 63-67.
17. Preliminary criteria for the classification of systemic sclerosis (scleroderma). (1980). Subcommittee for scleroderma criteria of the American Rheumatism Association Diagnostic and Therapeutic Criteria Committee. Arthritis and Rheumatism, 23(5), 581-590.
18. Postlethwaite, A., Furst, D., Wong, W. K., & Clements, P. (2005). Oral tolerance (OT). Induction to type I collagen (CI) significantly reduces the skin score in patients with diffuse systemic sclerosis (SSc) with late-phase disease. Results of a NIAMS/NIAID multicenter phase II placebo-controlled double blind clinical trial. Arthritistis and Rheumatism [Abstract].
19. Clements, P., Lachenbruch, P., Siebold, J., White, B., Weiner, S., & Martin, R., et al. (1995). Inter and intraobserver variability of total skin thickness score (modified Rodnan TSS) in systemic sclerosis. The Journal of Rheumatology, 22(7), 1281-1285.
20. Crapo, R. O., Morris, A. H., & Gardner, R. M. (1981). Reference spirometric values using techniques and equipment that meet ATS recommendations. The American Review of Respiratory Disease, 123(6), 659-664.
21. Khanna, D., Furst, D. E., Clements, P. J., Park, G. S., Hays, R. D., & Yoon, J., et al. (2005). Responsiveness of the SF-36 and the Health Assessment Questionnaire Disability Index in a systemic sclerosis clinical trial. Journal of Rheumatology, 32(5), 832-840.
22. Steen, V. D., & Medsger, T. A., Jr. (1997). The value of the Health Assessment Questionnaire and special patient-generated scales to demonstrate change in systemic sclerosis patients over time. Arthritis and Rheumatism, 40(11), 1984-1991.
23. UMaker User's Manual. (1999). UMDNJ Technical Report.
24. Arias, E. (2004). United States life tables, 2002. National Vital Statistics Reports, 53(6), 1-38.
25. Nunnally, J. (1978). Psychometric theory. New York: McGraw-Hill.
26. Franzblau, A. (1958). A primer of statistics for non-statisticians. New York: Brace & World.
27. Khanna, D., Clements, P. J., Furst, D. E., Chon, Y., Elashoff, R., & Roth, M. D., et al. (2005). Correlation of the degree of dyspnea with health-related quality of life, functional abilities, and diffusing capacity for carbon monoxide in patients with systemic sclerosis and active alveolitis: Results from the Scleroderma Lung Study. Arthritis and Rheumatism, 52(2), 592-600.
28. Clements, P. J., Wong, W. K., Hurwitz, E. L., Furst, D. E., Mayes, M., & White, B., et al. (2001). The Disability Index of the Health Assessment Questionnaire is a predictor and correlate of outcome in the high-dose versus low-dose penicillamine in systemic sclerosis trial. Arthritis and Rheumatism, 44(3), 653-661.
29. Osoba, D., Bezjak, A., Brundage, M., Zee, B., Tu, D., & Pater, J. (2005). Analysis and interpretation of health-related quality-of-life data from clinical trials: Basic approach of The National Cancer Institute of Canada Clinical Trials Group. European Journal of Cancer, 41(2), 280-287.
30. Cole, J. C., Khanna, D., Clements, P. J., Seibold, J. R., Tashkin, D. P., & Paulus, H. E., et al. (2006). Single-factor scoring validation for the Health Assessment Questionnaire-Disability Index (HAQ-DI) in patients with systemic sclerosis and comparison with early rheumatoid arthritis patients. Quality of Life Research, 15(8), 1383-1394.
31. Wells, G. A., Tugwell, P., Kraag, G. R., Baker, P. R., Groh, J., & Redelmeier, D. A. (1993). Minimum important difference between patients with rheumatoid arthritis: The patient's perspective. Journal of Rheumatology, 20(3), 557-560.
32. Khanna, D., Furst, D. E., Hays, R. D., Park, G. S., Wong, W. K., & Seibold, J. R., et al. (2006, October). Minimally important difference in diffuse systemic sclerosis - results from the d-penicillamine study. Annals of the Rheumatic Diseases, 65(10), 1325-1329.
33. Becker, L. A. (2000). Effect size. Accessed on October 12, 2006 from http://web.uccs.edu/lbecker/Psy590/es.htm.
34. Cohen, J. (1992). A power primer. Psychological Bulletin, 112, 155-159.
35. Kopec, J. A., & Willison, K. D. (2003). A comparative review of four preference-weighted measures of health-related quality of life. Journal of Clinical Epidemiology, 56(4), 317-325.
36. Marra, C. A., Esdaile, J. M., Guh, D., Kopec, J. A., Brazier, J. E., & Koehler, B. E., et al. (2004). A comparison of four indirect methods of assessing utility values in rheumatoid arthritis. Medical Care, 42(11), 1125-1131.
37. Brazier, J., Roberts, J., Tsuchiya, A., & Busschbach, J. (2004). A comparison of the EQ-5D and SF-6D across seven patient groups. Health Economics, 13(9), 873-884.
38. Hays, R. D. (2005). Reliability and validity (including responsiveness). In P. Fayers & R. D. Hays (Eds.), Assessing quality of life in clinical trials (pp. 25-39). New York: Oxford.
39. Feeny, D., Wu, L., & Eng, K. (2004). Comparing short form 6D, standard gamble, and Health Utilities Index Mark 2 and Mark 3 utility scores: Results from total hip arthroplasty patients. Quality of Life Research, 13(10), 1659-1670.
40. Ariza-Ariza, R., Hernandez-Cruz, B., Carmona, L., Dolores Ruiz-Montesinos, M., Ballina, J., & Navarro-Sarabia, F. (2006). Assessing utility values in rheumatoid arthritis: A comparison between time trade-off and the EuroQol. Arthritis and Rheumatism, 55(5), 751-756.
41. Khanna, D., Yan, X., Tashkin, D. P., Furst, D. E., Elashoff, D., Roth, M., et al. (2007). Impact of oral cyclophosphamide on health-related quality of life in patients with active scleroderma lung disease-results from the scleroderma lung study. Arthritis and Rheumatism (in press).
42. Walters, S. J., & Brazier, J. E. (2005). Comparison of the minimally important difference for two health state utility measures: EQ-5D and SF-6D. Quality of Life Research, 14(6), 1523-1532.
43. Guyatt, G. H., Feeny, D. H., & Patrick, D. L. (1993). Measuring health-related quality of life. Annals of Internal Medicine, 118(8), 622-629.
44. Guyatt, G. H., Norman, G. R., Juniper, E. F., & Griffith, L. E. (2002). A critical look at transition ratings. Journal of Clinical Epidemiology, 55(9), 900-908.
45. Guyatt, G. H., Osoba, D., Wu, A. W., Wyrwich, K. W., & Norman, G. R. (2002). Methods to explain the clinical significance of health status measures. Mayo Clinic Proceedings, 77(4), 371-383.
46. Yost, K. J., Sorensen, M. V., Hahn, E. A., Glendenning, G. A., Gnanasakthy, A., & Cella, D. (2005). Using multiple anchor- and distribution-based estimates to evaluate clinically meaningful change on the Functional Assessment of Cancer Therapy-Biologic Response Modifiers (FACT-BRM) instrument. Value Health, 8(2), 117-127.
47. Tsevat, J., Weeks, J. C., Guadagnoli, E., Tosteson, A. N., Mangione, C. M., & Pliskin, J. S., et al. (1994). Using health-related quality-of-life information: Clinical encounters, clinical trials, and health policy. Journal of General Internal Medicine, 9(10), 576-582.
48. Patrick, D. L., & Erickson, P. (1993). Health status and health policy : Quality of life in health care evaluation and resource allocation. New York: Oxford University Press.
49. Drummond, M. (2001). Introducing economic and quality of life measurements into clinical studies. Annals of Medicine, 33(5), 344-349.
50. Hays, R. D., & Woolley, J. M. (2000). The concept of clinically meaningful difference in health-related quality-of-life research. How meaningful is it? Pharmacoeconomics, 18(5), 419-423.
51. Torrance, G. W. (1997). Preferences for health outcomes and cost-utility analysis. The American Journal of Managed Care, 3(Suppl.), S8-S20.
52. Revicki, D., & Fairclough, D. L. (2005). Preventing missing data. In P. Fayers & R. D. Hays (Eds.), Assessing quality of life in clinical trials (pp. 167-178). New York: Oxford University Press.
53. Crosby, R. D., Kolotkin, R. L., & Williams, G. R. (2003). Defining clinically meaningful change in health-related quality of life. Journal of Clinical Epidemiology, 56(5), 395-407.