Psychometric characteristics of the short form 36 health survey and functional assessment of chronic illness Therapy-Fatigue subscale for patients with ankylosing spondylitis

Health and Quality of Life Outcomes

Robert L Wong¹  Michelle P Luo²  Anne M Rentz³  Dennis A Revicki³ 

[1] Abbott Laboratories, Abbott Immunology, Parsippany, NJ, USA;Formerly Abbott Laboratories, Global Health Economics & Outcomes Research, Abbott Park, IL, USA;Outcomes Research, United BioSource Corporation, Bethesda, MD, USA

关键词: Validity;    Reliability;    Physical and mental health;    Health-related quality of life;    Ankylosing spondylitis;   

Others  :  826692
DOI  :  10.1186/1477-7525-9-36

 received in 2011-02-02, accepted in 2011-05-22,  发布年份 2011

【 摘 要 】

Background

We evaluated the psychometric characteristics of the Short Form 36 (SF-36) Health Survey and the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue subscale in patients with ankylosing spondylitis (AS).

Methods

We analyzed clinical and patient-reported outcome (PRO) data collected during 12-week, double-blind, placebo-controlled periods of two randomized controlled trials comparing adalimumab and placebo for the treatment of active AS. The Bath Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Functional Index, and other clinical measures were collected during the clinical trial. We evaluated internal consistency/reliability, construct validity, and responsiveness to change for the SF-36 and FACIT-Fatigue.

Results

The SF-36 (Cronbach alpha, 0.74-0.92) and FACIT-Fatigue (Cronbach alpha, 0.82-0.86) both had good internal consistency/reliability. At baseline, SF-36 and FACIT-Fatigue scores correlated significantly with Ankylosing Spondylitis Quality of Life scores (r = -0.36 to -0.66 and r = -0.70, respectively; all p < 0.0001). SF-36 scores varied by indicators of clinical severity, with greater impairment observed for more severe degrees of clinical activity (all p < 0.0001). FACIT-Fatigue scores correlated significantly with SF-36 scores (r = 0.42 to 0.74; all p < 0.0001) and varied by clinical severity (p < 0.05 to p < 0.0001).

Conclusions

The SF-36 is a reliable, valid, and responsive measure of health-related quality of life and the FACIT-Fatigue is a brief and psychometrically sound measure of the effects of fatigue on patients with AS. These PROs may be useful in evaluating effectiveness of new treatments for AS.

Trial Registration

ClinicalTrials.gov: NCT00085644 and NCT00195819

【 授权许可】

   
2011 Revicki et al; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

【 参考文献 】

• [1]Russell AS: Ankylosing spondylitis: history. In Rheumatology. Edited by Klippel JK, Dieppe PA. London: Mosby; 1998:1-2.
• [2]Sieper J, Braun J, Rudwaleit M, Boonen A, Zink A: Ankylosing spondylitis: an overview. Ann Rheum Dis 2001, 60(Suppl 3):3-18.
• [3]Bostan EE, Borman P, Bodur H, Barca N: Functional disability and quality of life in patients with ankylosing spondylitis. Rheumatol Int 2003, 23(3):121-126.
• [4]Dagfinrud H, Mengshoel AM, Hagen KB, Loge JH, Kvien TK: Health status of patients with ankylosing spondylitis: a comparison with the general population. Ann Rheum Dis 2004, 63(12):1605-1610.
• [5]Haywood KL, Garratt AM, Dziedzic K, Dawes PT: Patient centered assessment of ankylosing spondylitis-specific health related quality of life: evaluation of the Patient Generated Index. J Rheumatol 2003, 30(4):764-773.
• [6]Ward MM: Quality of life in patients with ankylosing spondylitis. Rheum Dis Clin North Am 1998, 24(4):815-827. x
• [7]Zink A, Braun J, Listing J, Wollenhaupt J: Disability and handicap in rheumatoid arthritis and ankylosing spondylitis--results from the German rheumatological database. German Collaborative Arthritis Centers. J Rheumatol 2000, 27(3):613-622.
• [8]Haywood KL, A MG, Jordan K, Dziedzic K, Dawes PT: Disease-specific, patient-assessed measures of health outcome in ankylosing spondylitis: reliability, validity and responsiveness. Rheumatology (Oxford) 2002, 41(11):1295-1302.
• [9]Da Costa D, Dritsa M, Ring A, Fitzcharles MA: Mental health status and leisure-time physical activity contribute to fatigue intensity in patients with spondylarthropathy. Arthritis Rheum 2004, 51(6):1004-1008.
• [10]Jones SD, Steiner A, Garrett SL, Calin A: The Bath Ankylosing Spondylitis Patient Global Score (BAS-G). Br J Rheumatol 1996, 35(1):66-71.
• [11]Wanders AJ, Gorman JD, Davis JC, Landewe RB, van der Heijde DM: Responsiveness and discriminative capacity of the assessments in ankylosing spondylitis disease-controlling antirheumatic therapy core set and other outcome measures in a trial of etanercept in ankylosing spondylitis. Arthritis Rheum 2004, 51(1):1-8.
• [12]Ruta DA, Hurst NP, Kind P, Hunter M, Stubbings A: Measuring health status in British patients with rheumatoid arthritis: reliability, validity and responsiveness of the short form 36-item health survey (SF-36). Br J Rheumatol 1998, 37(4):425-436.
• [13]Ware JE Jr, Snow KK, Kosinski M, Gandek B: SF-36 Health Survey: Manual and Interpretation Guide. Boston: The Health Institute, New England Medical Center; 1993.
• [14]Doward LC, McKenna SP, Meads DM, Twiss J, Revicki D, Wong RL, Luo MP: Translation and validation of non-English versions of the Ankylosing Spondylitis Quality of Life (ASQOL) questionnaire. Health Qual Life Outcomes 2007, 5:7. BioMed Central Full Text
• [15]Doward LC, Spoorenberg A, Cook SA, Whalley D, Helliwell PS, Kay LJ, McKenna SP, Tennant A, van der Heijde D, Chamberlain MA: Development of the ASQoL: a quality of life instrument specific to ankylosing spondylitis. Ann Rheum Dis 2003, 62(1):20-26.
• [16]Abbott CA, Helliwell PS, Chamberlain MA: Functional assessment in ankylosing spondylitis: evaluation of a new self-administered questionnaire and correlation with anthropometric variables. Br J Rheumatol 1994, 33(11):1060-1066.
• [17]Hays R, Revicki DA: Reliability and validity (including responsiveness). In Assessing Quality of Life in Clinical Trials. 2nd edition. Edited by Fayers P, Hays R. New York: Oxford University Press; 2005:25-39.
• [18]Revicki DA, Osoba D, Fairclough D, Barofsky I, Berzon R, Leidy NK, Rothman M: Recommendations on health-related quality of life research to support labeling and promotional claims in the United States. Qual Life Res 2000, 9(8):887-900.
• [19]Braun J, Brandt J, Listing J, Zink A, Alten R, Burmester G, Gromnica-Ihle E, Kellner H, Schneider M, Sorensen H, Zeidler H, Sieper J: Two year maintenance of efficacy and safety of infliximab in the treatment of ankylosing spondylitis. Ann Rheum Dis 2005, 64(2):229-234.
• [20]Braun J, McHugh N, Singh A, Wajdula JS, Sato R: Improvement in patient-reported outcomes for patients with ankylosing spondylitis treated with etanercept 50 mg once-weekly and 25 mg twice-weekly. Rheumatology (Oxford) 2007, 46(6):999-1004.
• [21]van der Heijde D, Dijkmans B, Geusens P, Sieper J, DeWoody K, Williamson P, Braun J: Efficacy and safety of infliximab in patients with ankylosing spondylitis: results of a randomized, placebo-controlled trial (ASSERT). Arthritis Rheum 2005, 52(2):582-591.
• [22]van Tubergen A, Coenen J, Landewe R, Spoorenberg A, Chorus A, Boonen A, van der Linden S, van der Heijde D: Assessment of fatigue in patients with ankylosing spondylitis: a psychometric analysis. Arthritis Rheum 2002, 47(1):8-16.
• [23]Davis JC, Revicki D, van der Heijde DM, Rentz AM, Wong RL, Kupper H, Luo MP: Health-related quality of life outcomes in patients with active ankylosing spondylitis treated with adalimumab: results from a randomized controlled study. Arthritis Rheum 2007, 57(6):1050-1057.
• [24]van der Heijde D, Kivitz A, Schiff MH, Sieper J, Dijkmans BA, Braun J, Dougados M, Reveille JD, Wong RL, Kupper H, Davis JC Jr: Efficacy and safety of adalimumab in patients with ankylosing spondylitis: results of a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2006, 54(7):2136-2146.
• [25]van der Heijde D, Schiff MH, Sieper J, Kivitz AJ, Wong RL, Kupper H, Dijkmans BA, Mease PJ, Davis JC Jr: Adalimumab effectiveness for the treatment of ankylosing spondylitis is maintained for up to 2 years: long-term results from the ATLAS trial. Ann Rheum Dis 2009, 68(6):922-929.
• [26]Lambert RG, Salonen D, Rahman P, Inman RD, Wong RL, Einstein SG, Thomson GT, Beaulieu A, Choquette D, Maksymowych WP: Adalimumab significantly reduces both spinal and sacroiliac joint inflammation in patients with ankylosing spondylitis: a multicenter, randomized, double-blind, placebo-controlled study. Arthritis Rheum 2007, 56(12):4005-4014.
• [27]van der Linden S, Valkenburg HA, Cats A: Evaluation of diagnostic criteria for ankylosing spondylitis. A proposal for modification of the New York criteria. Arthritis Rheum 1984, 27(4):361-368.
• [28]Cella D, Yount S, Sorensen M, Chartash E, Sengupta N, Grober J: Validation of the Functional Assessment of Chronic Illness Therapy Fatigue Scale relative to other instrumentation in patients with rheumatoid arthritis. J Rheumatol 2005, 32(5):811-819.
• [29]Cella D, Lai JS, Chang CH, Peterman A, Slavin M: Fatigue in cancer patients compared with fatigue in the general United States population. Cancer 2002, 94(2):528-538.
• [30]Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E: Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage 1997, 13(2):63-74.
• [31]Ware JE Jr, Kosinski M, Keller S: SF-36 Physical and Mental Health Summary Scores: A User's Manual. Boston: The Health Institute, New England Medical Center; 1994.
• [32]Chorus AM, Miedema HS, Boonen A, Van Der Linden S: Quality of life and work in patients with rheumatoid arthritis and ankylosing spondylitis of working age. Ann Rheum Dis 2003, 62(12):1178-1184.
• [33]Haibel H, Rudwaleit M, Braun J, Sieper J: Six months open label trial of leflunomide in active ankylosing spondylitis. Ann Rheum Dis 2005, 64(1):124-126.
• [34]Garrett S, Jenkinson T, Kennedy LG, Whitelock H, Gaisford P, Calin A: A new approach to defining disease status in ankylosing spondylitis: the Bath Ankylosing Spondylitis Disease Activity Index. J Rheumatol 1994, 21(12):2286-2291.
• [35]Calin A, Garrett S, Whitelock H, Kennedy LG, O'Hea J, Mallorie P, Jenkinson T: A new approach to defining functional ability in ankylosing spondylitis: the development of the Bath Ankylosing Spondylitis Functional Index. J Rheumatol 1994, 21(12):2281-2285.
• [36]Anderson JJ, Baron G, van der Heijde D, Felson DT, Dougados M: Ankylosing spondylitis assessment group preliminary definition of short-term improvement in ankylosing spondylitis. Arthritis Rheum 2001, 44(8):1876-1886.
• [37]Nunnally JC, Bernstein IH: Psychometric Theory. 3rd edition. New York: McGraw-Hill; 1994.
• [38]Cronbach LJ: Coefficient alpha and the internal structure of tests. Psychometrika 1951, 16(3):297-334.
• [39]Braun J, Brandt J, Listing J, Zink A, Alten R, Golder W, Gromnica-Ihle E, Kellner H, Krause A, Schneider M, Sorensen H, Zeidler H, Thriene W, Sieper J: Treatment of active ankylosing spondylitis with infliximab: a randomised controlled multicentre trial. Lancet 2002, 359(9313):1187-1193.
• [40]Davis JC, Van Der Heijde D, Braun J, Dougados M, Cush J, Clegg DO, Kivitz A, Fleischmann R, Inman R, Tsuji W: Recombinant human tumor necrosis factor receptor (etanercept) for treating ankylosing spondylitis: a randomized, controlled trial. Arthritis Rheum 2003, 48(11):3230-3236.
• [41]Gorman JD, Sack KE, Davis JC Jr: Treatment of ankylosing spondylitis by inhibition of tumor necrosis factor alpha. N Engl J Med 2002, 346(18):1349-1356.
• [42]Van den Bosch F, Kruithof E, Baeten D, De Keyser F, Mielants H, Veys EM: Effects of a loading dose regimen of three infusions of chimeric monoclonal antibody to tumour necrosis factor alpha (infliximab) in spondyloarthropathy: an open pilot study. Ann Rheum Dis 2000, 59(6):428-433.
• [43]Haywood KL, Garratt AM, Dawes PT: Patient-assessed health in ankylosing spondylitis: a structured review. Rheumatology (Oxford) 2005, 44(5):577-586.
• [44]Cella D, Eton DT, Lai JS, Peterman AH, Merkel DE: Combining anchor and distribution-based methods to derive minimal clinically important differences on the Functional Assessment of Cancer Therapy (FACT) anemia and fatigue scales. J Pain Symptom Manage 2002, 24(6):547-561.
• [45]Yount S, Sorensen MV, Cella D, Sengupta N, Grober J, Chartash EK: Adalimumab plus methotrexate or standard therapy is more effective than methotrexate or standard therapies alone in the treatment of fatigue in patients with active, inadequately treated rheumatoid arthritis. Clin Exp Rheumatol 2007, 25(6):838-846.