Approaches for estimating minimal clinically important differences in systemic lupus erythematosus

Arthritis Research and Therapy

Volumn 17, Issue 1, 2015, Pages

  Rai, Sharan K ^a,b   Yazdany, Jinoos ^c   Fortin, Paul R ^d   Aviña Zubieta, J Antonio ^a,b  

^a ARTHRITIS RESEARCH CENTRE OF CANADA   (Canada)

^b UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d LAVAL UNIVERSITY   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTICAL ERROR; ARTICLE; CLINICAL RESEARCH; CONCEPT ANALYSIS; CONCEPTUAL FRAMEWORK; DELPHI STUDY; EFFECT SIZE; MEASUREMENT; MINIMAL CLINICALLY IMPORTANT DIFFERENCE; OUTCOME ASSESSMENT; PATIENT ATTITUDE; PATIENT CARE; PRACTICE GUIDELINE; QUALITY OF LIFE; RELIABILITY; SCORING SYSTEM; STANDARDIZATION; STATISTICAL ANALYSIS; STATISTICAL SIGNIFICANCE; SYSTEMIC LUPUS ERYTHEMATOSUS; TREATMENT RESPONSE; DISABILITY; FEMALE; HUMAN; LUPUS ERYTHEMATOSUS, SYSTEMIC; MALE; SEVERITY OF ILLNESS INDEX;

DISABILITY EVALUATION; FEMALE; HUMANS; LUPUS ERYTHEMATOSUS, SYSTEMIC; MALE; SEVERITY OF ILLNESS INDEX;

EID: 84930632543     PISSN: 14786354     EISSN: 14786362     Source Type: Journal    
DOI: 10.1186/s13075-015-0658-6     Document Type: Article

References (56)

1. Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989;10:407-15.
2. Colangelo KJ, Pope JE, Peschken C. The minimally important difference for patient reported outcomes in systemic lupus erythematosus including the HAQ-DI, pain, fatigue, and SF-36. J Rheumatol. 2009;36:2231-7.
3. Yazdany J. Health-related quality of life measurement in adult systemic lupus erythematosus: Lupus Quality of Life (LupusQoL), Systemic Lupus Erythematosus-Specific Quality of Life Questionnaire (SLEQOL), and Systemic Lupus Erythematosus Quality of Life Questionnaire (L-QoL). Arthritis Care Res (Hoboken). 2011;63:S413-9.
4. Strand V, Crawford B. Improvement in health-related quality of life in patients with SLE following sustained reductions in anti-dsDNA antibodies. Expert Rev Pharmacoecon Outcomes Res. 2005;5:317-26.
5. Thumboo J, Strand V. Health-related quality of life in patients with systemic lupus erythematosus: an update. Ann Acad Med Singapore. 2007;36:115-22.
6. Leong KP, Kong KO, Thong BY, Koh ET, Lian TY, Teh CL, et al. Development and preliminary validation of a systemic lupus erythematosus-specific quality-of-life instrument (SLEQOL). Rheumatology (Oxford). 2005;44:1267-76.
7. Kuriya B, Gladman DD, Ibañez D, Urowitz MB. Quality of life over time in patients with systemic lupus erythematosus. Arthritis Rheum. 2008;59:181-5.
8. American College of Rheumatology Ad Hoc Committee on Systemic Lupus Erythematosus Response Criteria. The American College of Rheumatology response criteria for systemic lupus erythematosus clinical trials: measures of overall disease activity. Arthritis Rheum. 2004;50:3418-26.
9. Navarra SV, Guzmán RM, Gallacher AE, Hall S, Levy RA, Jimenez RE, et al. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet. 2011;377:721-31.
10. Furie R, Petri M, Zamani O, Cervera R, Wallace DJ, Tegzová D, et al. A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. Arthritis Rheum. 2011;63:3918-30.
11. Luijten KM, Tekstra J, Bijlsma JW, Bijl M. The Systemic Lupus Erythematosus Responder Index (SRI); a new SLE disease activity assessment. Autoimmun Rev. 2012;11:326-9.
12. Furie RA, Petri MA, Wallace DJ, Ginzler EM, Merrill JT, Stohl W, et al. Novel evidence-based systemic lupus erythematosus responder index. Arthritis Rheum. 2009;61:1143-51.
13. Merrill JT, Neuwelt CM, Wallace DJ, Shanahan JC, Latinis KM, Oates JC, et al. Efficacy and safety of rituximab in moderately-to-severely active systemic lupus erythematosus: the randomized, double-blind, phase II/III systemic lupus erythematosus evaluation of rituximab trial. Arthritis Rheum. 2010;62:222-33.
14. Rovin BH, Furie R, Latinis K, Looney RJ, Fervenza FC, Sanchez-Guerrero J, et al. Efficacy and safety of rituximab in patients with active proliferative lupus nephritis: the Lupus Nephritis Assessment with Rituximab study. Arthritis Rheum. 2012;64:1215-26.
15. Merrill JT, Burgos-Vargas R, Westhovens R, Chalmers A, D'Cruz D, Wallace DJ, et al. The efficacy and safety of abatacept in patients with non-life-threatening manifestations of systemic lupus erythematosus: results of a twelve-month, multicenter, exploratory, phase IIb, randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010;62:3077-87.
16. Lu TY, Jónsdóttir T, van Vollenhoven RF, Isenberg DA. Prolonged B-cell depletion following rituximab therapy in systemic lupus erythematosus: a report of two cases. Ann Rheum Dis. 2008;67:1493-4.
17. Reynolds JA, Toescu V, Yee CS, Prabu A, Situnayake D, Gordon C. Effects of rituximab on resistant SLE disease including lung involvement. Lupus. 2009;18:67-73.
18. Leandro MJ, Cambridge G, Edwards JC, Ehrenstein MR, Isenberg DA. B-cell depletion in the treatment of patients with systemic lupus erythematosus: a longitudinal analysis of 24 patients. Rheumatology (Oxford). 2005;44:1542-5.
19. van Vollenhoven RF, Gunnarsson I, Welin-Henriksson E, Sundelin B, Osterborg A, Jacobson SH, et al. Biopsy-verified response of severe lupus nephritis to treatment with rituximab (anti-CD20 monoclonal antibody) plus cyclophosphamide after biopsy-documented failure to respond to cyclophosphamide alone. Scand J Rheumatol. 2004;33:423-7.
20. Wofsy D, Hillson JL, Diamond B. Abatacept for lupus nephritis: alternative definitions of complete response support conflicting conclusions. Arthritis Rheum. 2012;64:3660-5.
21. Liang MH. Longitudinal construct validity: establishment of clinical meaning in patient evaluative instruments. Med Care. 2000;38:II84-90.
22. Beaton DE, Boers M, Wells GA. Many faces of the minimal clinically important difference (MCID): a literature review and directions for future research. Curr Opin Rheumatol. 2002;14:109-14.
23. Crosby RD, Kolotkin RL, Williams GR. Defining clinically meaningful change in health-related quality of life. J Clin Epidemiol. 2003;56:395-407.
24. Beaton DE, Bombardier C, Katz JN, Wright JG, Wells G, Boers M, et al. Looking for important change/differences in studies of responsiveness. OMERACT MCID Working Group. Outcome Measures in Rheumatology. Minimal Clinically Important Difference. J Rheumatol. 2001;28:400-5.
25. Strand V, Gladman D, Isenberg D, Petri M, Smolen J, Tugwell P. Endpoints: consensus recommendations from OMERACT IV, Outcome Measures in Rheumatology. Lupus. 2000;9:322-7.
26. Smolen JS, Strand V, Cardiel M, Edworthy S, Furst D, Gladman D, et al. Randomized clinical trials and longitudinal observational studies in systemic lupus erythematosus: consensus on a preliminary core set of outcome domains. J Rheumatol. 1999;26:504-7.
27. Wells G, Beaton D, Shea B, Boers M, Simon L, Strand V, et al. Minimal clinically important differences: review of methods. J Rheumatol. 2001;28:406-12.
28. Lassere MN, van der Heijde D, Johnson KR. Foundations of the minimal clinically important difference for imaging. J Rheumatol. 2001;28:890-1.
29. Lydick E, Epstein RS. Interpretation of quality of life changes. Qual Life Res. 1993;2:221-6.
30. Wyrwich KW, Bullinger M, Aaronson N, Hays RD, Patrick DL, Symonds T, et al. Estimating clinically significant differences in quality of life outcomes. Qual Life Res. 2005;14:285-95.
31. Hays RD, Woolley JM. The concept of clinically meaningful difference in health-related quality-of-life research. How meaningful is it? Pharmacoeconomics. 2000;18:419-23.
32. Copay AG, Subach BR, Glassman SD, Polly Jr DW, Schuler TC. Understanding the minimum clinically important difference: a review of concepts and methods. Spine J. 2007;7:541-6.
33. Gatchel RJ, Lurie JD, Mayer TG. Minimal clinically important difference. Spine. 2010;35:1739-43.
34. Yazdany J, Yelin EH, Panopalis P, Trupin L, Julian L, Katz PP. Validation of the systemic lupus erythematosus activity questionnaire in a large observational cohort. Arthritis Rheum. 2008;59:136-43.
35. Hudgens SA, Yost K, Cella D, Hahn EA, Peterman A. Comparing retrospective and prospective anchors for identifying minimally important differences [abstract]. Qual Life Res. 2002;11:629.
36. Wyrwich KW, Tierney WM, Wolinsky FD. Further evidence supporting an SEM-based criterion for identifying meaningful intra-individual changes in health-related quality of life. J Clin Epidemiol. 1999;52:861-73.
37. Wolinsky FD, Wan GJ, Tierney WM. Changes in the SF-36 in 12 months in a clinical sample of disadvantaged older adults. Med Care. 1998;36:1589-98.
38. McHorney CA, Tarlov AR. Individual-patient monitoring in clinical practice: are available health status surveys adequate? Qual Life Res. 1995;4:293-307.
39. Brunner HI, Higgins GC, Klein-Gitelman MS, Lapidus SK, Olson JC, Onel K, et al. Minimal clinically important differences of disease activity indices in childhood-onset systemic lupus erythematosus. Arthritis Care Res (Hoboken). 2010;62:950-9.
40. Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life: the remarkable universality of half a standard deviation. Med Care. 2003;41:582-92.
41. Katz P, Morris A, Trupin L, Yazdany J, Yelin E. Disability in valued life activities among individuals with systemic lupus erythematosus. Arthritis Rheum. 2008;59:465-73.
42. Cohen J. Statistical power analysis for the behavioural sciences. New York: Academic Press; 1988.
43. Taylor SJ, Taylor AE, Foy MA, Fogg AJ. Responsiveness of common outcome measures for patients with low back pain. Spine. 1999;24:1805-12.
44. Fortin PR, Abrahamowicz M, Clarke AE, Neville C, Du Berger R, Fraenkel L, et al. Do lupus disease activity measures detect clinically important change? J Rheumatol. 2000;27:1421-8.
45. Angst F, Aeschlimann A, Stucki G. Smallest detectable and minimal clinically important differences of rehabilitation intervention with their implications for required sample sizes using WOMAC and SF-36 quality of life measurement instruments in patients with osteoarthritis of the lower extremities. Arthritis Care Res. 2001;45:384-91.
46. Ferguson RJ, Robinson AB, Splaine M. Use of the reliable change index to evaluate clinical significance in SF-36 outcomes. Qual Life Res. 2002;11:509-16.
47. Liang MH, Fossel AH, Larson MG. Comparisons of five health status instruments for orthopedic evaluation. Med Care. 1990;28:632-42.
48. Beaton DE, Hogg-Johnson S, Bombardier C. Evaluating changes in health status: reliability and responsiveness of five generic health status measures in workers with musculoskeletal disorders. J Clin Epidemiol. 1997;50:79-93.
49. Garratt AM, Ruta DA, Abdalla MI, Russell IT. SF 36 health survey questionnaire: II. Responsiveness to changes in health status in four common clinical conditions. Qual Health Care. 1994;3:186-92.
50. Chang E, Abrahamowicz M, Ferland D, Fortin PR, the CANIOS Investigators. Comparison of the responsiveness of lupus disease activity measures to changes in systemic lupus erythematosus activity relevant to patients and physicians. J Clin Epidemiol. 2002;55:488-97.
51. Black N, Murphy M, Lamping D, McKee M, Sanderson C, Askham J, et al. Consensus development methods: a review of best practice in creating clinical guidelines. J Health Serv Res Policy. 1999;4:236-48.
52. McKenna HP. The Delphi technique: a worthwhile research approach for nursing? J Adv Nurs. 1994;19:1221-5.
53. Brunner HI, Klein-Gitelman MS, Higgins GC, Lapidus SK, Levy DM, Eberhard A, et al. Toward the development of criteria for global flares in juvenile systemic lupus erythematosus. Arthritis Care Res (Hoboken). 2010;62:811-20.
54. Wells G, Li T, Maxwell L, MacLean R, Tugwell P. Determining the minimal clinically important differences in activity, fatigue, and sleep quality in patients with rheumatoid arthritis. J Rheumatol. 2007;34:280-9.
55. Cella D, Yount S, Rothrock N, Gershon R, Cook K, Reeve B, et al. The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care. 2007;45:S3-S11.
56. Cella D, Hahn EA, Dineen K. Meaningful change in cancer-specific quality of life scores: differences between improvement and worsening. Qual Life Res. 2002;11:207-21.