Minimal clinically important difference as applied in rheumatology: An OMERACT Rasch working group systematic review and critique

Journal of Rheumatology

Volumn 43, Issue 1, 2016, Pages 194-202

  Erdogan, Beyza Doganay ^a   Leung, Ying Ying ^b   Pohl, Christoph ^c   Tennant, Alan ^d   Conaghan, Philip G ^e  

^a ANKARA UNIVERSITY   (Turkey)

^b DUKE NUS MEDICAL SCHOOL   (Singapore)

^c CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^d SWISS PARAPLEGIC RESEARCH   (Switzerland)

^e UNIVERSITY OF LEEDS   (United Kingdom)

Author keywords

Anchor based approaches; Distribution based approaches; Minimal clinically important difference; Osteoarthritis; Patient reported outcome measures; Rheumatoid arthritis

Indexed keywords

HEALTH ASSESSMENT QUESTIONNAIRE; HUMAN; INTERMETHOD COMPARISON; MATHEMATICAL COMPUTING; MINIMAL CLINICALLY IMPORTANT DIFFERENCE; OSTEOARTHRITIS; PATIENT-REPORTED OUTCOME; REVIEW; RHEUMATOID ARTHRITIS; RHEUMATOLOGY; SHORT FORM 36; SIMPLIFIED DISEASE ACTIVITY INDEX; SYSTEMATIC REVIEW; VISUAL ANALOG SCALE; WESTERN ONTARIO AND MCMASTER UNIVERSITIES OSTEOARTHRITIS INDEX; ARTHRITIS, RHEUMATOID; COMPARATIVE STUDY; CONSENSUS DEVELOPMENT; DISABILITY; DISEASE COURSE; FEMALE; JOINT CHARACTERISTICS AND FUNCTIONS; MALE; PAIN MEASUREMENT; PATIENT SATISFACTION; PHYSIOLOGY; PRACTICE GUIDELINE; QUALITY OF LIFE; RISK ASSESSMENT; SENSITIVITY AND SPECIFICITY; SEVERITY OF ILLNESS INDEX; STANDARDS; STATISTICS AND NUMERICAL DATA;

ARTHRITIS, RHEUMATOID; CONSENSUS DEVELOPMENT CONFERENCES AS TOPIC; DISABILITY EVALUATION; DISEASE PROGRESSION; FEMALE; HUMANS; MALE; OSTEOARTHRITIS; PAIN MEASUREMENT; PATIENT SATISFACTION; PRACTICE GUIDELINES AS TOPIC; QUALITY OF LIFE; RANGE OF MOTION, ARTICULAR; RHEUMATOLOGY; RISK ASSESSMENT; SENSITIVITY AND SPECIFICITY; SEVERITY OF ILLNESS INDEX;

EID: 85011805790     PISSN: 0315162X     EISSN: 14992752     Source Type: Journal    
DOI: 10.3899/jrheum.141150     Document Type: Review

References (53)

1. 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.
2. Copay AG, Subach BR, Glassman SD, Polly DW Jr, Schuler TC. Understanding the minimum clinically important difference: a review of concepts and methods. Spine J 2007;75:541-6.
3. Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials 1989;10:407-15.
4. King MT. A point of minimal important difference (MID): a critique of terminology and methods. Expert Rev Pharmacoecon Outcomes Res 2011;11:171-84.
5. Wells G, Anderson J, Beaton D, Bellamy N, Boers M, Bombardier C, et al. Minimal clinically important difference module: summary, recommendations, and research agenda. J Rheumatol 2001;28:452-4.
6. Crosby RD, Kolotkin RL, Williams GR. Defining clinically meaningful change in health-related quality of life. J Clin Epidemiol 2003;56:395-407.
7. Tubach F, Ravaud P, Beaton D, Boers M, Bombardier C, Felson DT, et al. Minimal clinically important improvement and patient acceptable symptom state for subjective outcome measures in rheumatic disorders. J Rheumatol 2007;34:1188-93.
8. U.S. Department of Health and Human Services Food and Drug Administration, Center of Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH). Clinical/Medical. Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. [Internet. Accessed April 14, 2015.] Available from: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf
9. Merbitz C, Morris J, Grip JC. Ordinal scales and foundations of misinference. Arch Phys Med Rehabil 1989;70:308-12.
10. Marra CA, Woolcott JC, Kopec JA, Shonjania K, Offer R, Brazier JE, et al. 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. Soc Sci Med 2005;60:1571-82.
11. Batcho CS, Durez P, Thonnard JL. Responsiveness of the ABILHAND questionnaire in measuring changes in rheumatoid arthritis patients. Arthritis Care Res 2011;63:135-41.
12. Kersten P, White PJ, Tennant A. The visual analogue WOMAC 3.0 scale - internal validity and responsiveness of the VAS version. BMC Muskulsokelet Disord 2010;11:80.
13. Wells GA, Tugwell P, Kraag GR, Baker PR, Groh J, Redelmeier DA. Minimum important difference between patients with rheumatoid arthritis: the patient's perspective. J Rheumatol 1993;20:557-60.
14. Kosinski M, Zhao SZ, Dedhiya S, Osterhaus JT, Ware JE Jr. Determining minimally important changes in generic and disease-specific health-related quality of life questionnaires in clinical trials of rheumatoid arthritis. Arthritis Rheum 2000;43:1478-87.
15. 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 Rheum 2001;45:384-91.
16. de Boer YA, Hazes JM, Winia PC, Brand R, Rozing PM. Comparative responsiveness of four elbow scoring instruments in patients with rheumatoid arthritis. J Rheumatol 2001;28:2616-23.
17. Angst F, Aeschlimann A, Michel BA, Stucki G. Minimal clinically important rehabilitation effects in patients with osteoarthritis of the lower extremities. J Rheumatol 2002;29:131-8.
18. Walters SJ, Brazier JE. What is the relationship between the minimally important difference and health state utility values? The case of the SF-6D. Health Qual Life Outcomes 2003;1:4.
19. 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;32:811-9.
20. Quintana JM, Escobar A, Bilbao A, Arostegui I, Lafuente I, Vidaurreta I. Responsiveness and clinically important differences for the WOMAC and SF-36 after hip joint replacement. Osteoarthritis Cartilage 2005;13:1076-83.
21. Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, et al. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis 2005;64:29-33.
22. Chiou CF, Sherbourne CD, Cornelio I, Lubeck DP, Paulus HE, Dylan M, et al. Development and validation of the revised Cedars-Sinai health-related quality of life for rheumatoid arthritis instrument. Arthritis Rheum 2006;55:856-63.
23. Tubach F, Dougados M, Falissard B, Baron G, Logeart I, Ravaud P. Feeling good rather than feeling better matters more to patients. Arthritis Rheum 2006;55:526-30.
24. Dawson J, Doll H, Coffey J, Jenkinson C. Oxford and Birmingham Foot and Ankle Clinical Research Group. Responsiveness and minimally important change for the Manchester-Oxford foot questionnaire (MOXFQ) compared with AOFAS and SF-36 assessments following surgery for hallux valgus. Osteoarthritis Cartilage 2007;15:918-31.
25. Escobar A, Quintana JM, Bilbao A, Aróstegui I, Lafuente I, Vidaurreta I. Responsiveness and clinically important differences for the WOMAC and SF-36 after total knee replacement. Osteoarthritis Cartilage 2007;15:273-80.
26. 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.
27. Pouchot J, Kherani RB, Brant R, Lacaille D, Lehman AJ, Ensworth S, et al. Determination of the minimal clinically important difference for seven fatigue measures in rheumatoid arthritis. J Clin Epidemiol 2008;61:705-13.
28. Pope JE, Khanna D, Norrie D, Ouimet JM. The minimally important difference for the health assessment questionnaire in rheumatoid arthritis clinical practice is smaller than in randomized controlled trials. J Rheumatol 2009;36:254-9.
29. Shauver MJ, Chung KC. The minimal clinically important difference of the Michigan hand outcomes questionnaire. J Hand Surg Am 2009;34:509-14.
30. Greco NJ, Anderson AF, Mann BJ, Cole BJ, Farr J, Nissen CW, et al. Responsiveness of the International Knee Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster Universities Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with focal articular cartilage defects. Am J Sports Med 2010;38:891-902.
31. Kvamme MK, Kristiansen IS, Lie E, Kvien TK. Identification of cutpoints for acceptable health status and important improvement in patient-reported outcomes, in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. J Rheumatol 2010;37:26-31.
32. Akinpelu AO, Odole AC, Raheem S. Minimal clinically important difference of Ibadan knee hip osteoarthritis outcome measure (IKHOAM) a cross-sectional study. J Phys Ther 2011;3:52-60.
33. Ornetti P, Dougados M, Paternotte S, Logeart I, Gossec L. Validation of a numerical rating scale to assess functional impairment in hip and knee osteoarthritis: comparison with the WOMAC function scale. Ann Rheum Dis 2011;70:740-6.
34. Quintana JM, Aguirre U, Barrio I, Orive M, Garcia S, Escobar A. Outcomes after total hip replacement based on patients' baseline status: what results can be expected? Arthritis Care Res 2012;64:563-72.
35. Williams VJ, Piva SR, Irrgang JJ, Crossley C, Fitzgerald GK. Comparison of reliability and responsiveness of patient-reported clinical outcome measures in knee osteoarthritis rehabilitation. J Orthop Sports Phys Ther 2012;42:716-23.
36. Clement ND, Macdonald D, Simpson AH. The minimal clinically important difference in the Oxford knee score and Short Form 12 score after total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc 2013;22:1933-9.
37. Dures EK, Hewlett SE, Cramp FA, Greenwood R, Nicklin JK, Urban M, et al. Reliability and sensitivity to change of the Bristol Rheumatoid Arthritis Fatigue scales. Rheumatology 2013;52:1832-9.
38. Ebert JR, Smith A, Wood DJ, Ackland TR. A comparison of the responsiveness of 4 commonly used patient-reported outcome instruments at 5 years after matrix-induced autologous chondrocyte implantation. Am J Sports Med 2013;41:2791-9.
39. Escobar A, García Pérez L, Herrera-Espiñeira C, Aizpuru F, Sarasqueta C, Gonzalez Sáenz de Tejada M, et al. Total knee replacement; minimal clinically important differences and responders. Osteoarthritis Cartilage 2013;21:2006-12.
40. Harris KK, Dawson J, Jones LD, Beard DJ, Price AJ. Extending the use of PROMs in the NHS - using the Oxford Knee Score in patients undergoing non-operative management for knee osteoarthritis: A validation study. BMJ Open 2013;3:e003365.
41. Hays RD, Spritzer KL, Fries JF, Krishnan E. Responsiveness and minimally important difference for the Patient-Reported Outcomes Measurement Information System (PROMIS) 20-item physical functioning short form in a prospective observational study of rheumatoid arthritis. Ann Rheum Dis 2015;74:104-7.
42. Sorensen AA, Howard D, Tan WH, Ketchersid J, Calfee RP. Minimal clinically important differences of 3 patient-rated outcomes instruments. J Hand Surg Am 2013;38:641-9.
43. Paulsen A, Roos EM, Pedersen AB, Overgaard S. Minimal clinically important improvement (MCII) and patient-acceptable symptom state (PASS) in total hip arthroplasty (THA) patients 1 year postoperatively. Acta Orthop 2014;85:39-48.
44. Singh JA, Luo R, Landon GC, Suarez-Almazor M. Reliability and clinically important improvement thresholds for osteoarthritis pain and function scales: a multicenter study. J Rheumatol 2014;41:509-15.
45. Strand V, Kosinski M, Gnanasakthy A, Mallya U, Mpofu S. Secukinumab treatment in rheumatoid arthritis is associated with incremental benefit in the clinical outcomes and HRQoL improvements that exceed minimally important thresholds. Health Qual Life Outcomes 2014;12:31.
46. Ward MM, Guthrie LC, Alba MI. Clinically important changes in individual and composite measures of rheumatoid arthritis activity: thresholds applicable in clinical trials. Ann Rheum Dis 2014 May 1 (E-pub ahead of print).
47. Leung YY, Png ME, Conaghan P, Tennant A. A systemic literature review on the application of Rasch analysis in musculoskeletal disease - a special interest group report of OMERACT 11. J Rheumatol 2014;41:159-64.
48. Wright BD, Linacre JM. Observations are always ordinal; measurements, however, must be interval. Arch Phys Med Rehabil 1989;70:857-60.
49. Boers M, Kirwan JR, Wells G, Beaton D, Gossec L, d'Agostino MA, et al. Developing core outcome measurement sets for clinical trials: OMERACT Filter 2.0. J Clin Epidemiol 2014;67:745-53.
50. Mills RJ, Calabresi M, Tennant A, Young CA. Perceived changes and minimum clinically important difference of the Neurological Fatigue Index for multiple sclerosis (NFI-MS). Mult Scler 2013;19:502-5.
51. Gatchel RJ, Mayer TG. Testing minimal clinically important difference: consensus or conundrum? Spine J 2010;10:321-7.
52. 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.
53. Rouquette A, Blanchin M, Sébille V, Guillemin F, Côté SM, Falissard B, et al. The minimal clinically important difference determined using item response theory models: an attempt to solve the issue of the association with baseline score. J Clin Epidemiol 2014;67:433-40.