Systematic review of patient-reported outcome measures (PROMs) for assessing disease activity in rheumatoid arthritis

RMD Open

Volumn 2, Issue 2, 2016, Pages

  Hendrikx, Jos ^a   De Jonge, Marieke J ^a   Fransen, Jaap ^a   Kievit, Wietske ^a   Van Riel, Piet L C M ^a  

^a RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84987934259     PISSN: None     EISSN: 20565933     Source Type: Journal    
DOI: 10.1136/rmdopen-2015-000202     Document Type: Review

References (65)

1. Aletaha D, Landewe R, Karonitsch T, et al. Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations. Arthritis Rheum 2008;59:1371-7.
2. Anderson J, Caplan L, Yazdany J, et al. Rheumatoid arthritis disease activity measures: American College of Rheumatology recommendations for use in clinical practice. Arthritis Care Res (Hoboken) 2012;64:640-7.
3. Stoffer MA, Schoels MM, Smolen JS, et al. Evidence for treating rheumatoid arthritis to target: results of a systematic literature search update. Ann Rheum Dis 2016;75:16-22.
4. Katz PP. Introduction to special issue: patient outcomes in rheumatology, 2011. Arthritis Care Res (Hoboken) 2011;63(Suppl 11):S1-3.
5. Maska L, Anderson J, Michaud K. Measures of functional status and quality of life in rheumatoid arthritis: Health Assessment Questionnaire Disability Index (HAQ), Modified Health Assessment Questionnaire (MHAQ), Multidimensional Health Assessment Questionnaire (MDHAQ), Health Assessment Questionnaire II (HAQ-II), Improved Health Assessment Questionnaire (Improved HAQ), and Rheumatoid Arthritis Quality of Life (RAQoL). Arthritis Care Res (Hoboken) 2011;63(Suppl 11):S4-13.
6. Anderson JK, Zimmerman L, Caplan L, et al. Measures of rheumatoid arthritis disease activity: Patient (PtGA) and Provider (PrGA) Global Assessment of Disease Activity, Disease Activity Score (DAS) and Disease Activity Score with 28-Joint Counts (DAS28), Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), Patient Activity Score (PAS) and Patient Activity Score-II (PASII), Routine Assessment of Patient Index Data (RAPID), Rheumatoid Arthritis Disease Activity Index (RADAI) and Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5), Chronic Arthritis Systemic Index (CASI), Patient-Based Disease Activity Score With ESR (PDAS1) and Patient-Based Disease Activity Score without ESR (PDAS2), and Mean Overall Index for Rheumatoid Arthritis (MOI-RA). Arthritis Care Res (Hoboken) 2011;63(Suppl 11):S14-36.
7. Hawker GA, Mian S, Kendzerska T, et al. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken) 2011;63(Suppl 11):S240-52.
8. Hewlett S, Dures E, Almeida C. Measures of fatigue: Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire (BRAF MDQ), Bristol Rheumatoid Arthritis Fatigue Numerical Rating Scales (BRAF NRS) for severity, effect, and coping, Chalder Fatigue Questionnaire (CFQ), Checklist Individual Strength (CIS20R and CIS8R), Fatigue Severity Scale (FSS), Functional Assessment Chronic Illness Therapy (Fatigue) (FACIT-F), Multi-Dimensional Assessment of Fatigue (MAF), Multi-Dimensional Fatigue Inventory (MFI), Pediatric Quality Of Life (PedsQL) Multi-Dimensional Fatigue Scale, Profile of Fatigue (ProF), Short Form 36 Vitality Subscale (SF-36 VT), and Visual Analog Scales (VAS). Arthritis Care Res (Hoboken) 2011;63(Suppl 11):S263-286.
9. Choy EH, Khoshaba B, Cooper D, et al. Development and validation of a patient-based disease activity score in rheumatoid arthritis that can be used in clinical trials and routine practice. Arthritis Rheum 2008;59:192-9.
10. Houssien DA, Stucki G, Scott DL. A patient-derived disease activity score can substitute for a physician-derived disease activity score in clinical research. Rheumatology (Oxford) 1999;38:48-52.
11. Janta I, Naredo E, Martinez-Estupinan L, et al. Patient self-assessment and physician's assessment of rheumatoid arthritis activity: which is more realistic in remission status? A comparison with ultrasonography. Rheumatology (Oxford) 2013;52:2243-50.
12. Kavanaugh A, Lee SJ, Weng HH, et al. Patient-derived joint counts are a potential alternative for determining Disease Activity Score. J Rheumatol 2010;37:1035-41.
13. Riazzoli J, Nilsson JÅ, Teleman A, et al. Patient-reported 28 swollen and tender joint counts accurately represent RA disease activity and can be used to assess therapy responses at the group level. Rheumatology (Oxford) 2010;49:2098-103.
14. Mokkink LB, Terwee CB, Gibbons E, et al. Inter-rater agreement and reliability of the COSMIN (COnsensus-based Standards for the selection of health status Measurement Instruments) checklist. BMC Med Res Methodol 2010;10:82.
15. Mokkink LB, Terwee CB, Knol DL, et al. The COSMIN checklist for evaluating the methodological quality of studies on measurement properties: a clarification of its content. BMC Med Res Methodol 2010;10:22.
16. Mokkink LB, Terwee CB, Patrick DL, et al. The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes. J Clin Epidemiol 2010;63:737-45.
17. Mokkink LB, Terwee CB, Patrick DL, et al. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res 2010;19:539-49.
18. Terwee CB, Mokkink LB, Knol DL, et al. Rating the methodological quality in systematic reviews of studies on measurement properties: a scoring system for the COSMIN checklist. Qual Life Res 2012;21:651-7.
19. Terwee CB, Jansma EP, Riphagen II, et al. Development of a methodological PubMed search filter for finding studies on measurement properties of measurement instruments. Qual Life Res 2009;18:1115-23.
20. Fransen J, Langenegger T, Michel BA, et al. Feasibility and validity of the RADAI, a self-administered rheumatoid arthritis disease activity index. Rheumatology (Oxford) 2000;39:321-7.
21. Leeb BF, Haindl PM, Maktari A, et al. Patient-centered rheumatoid arthritis disease activity assessment by a modified RADAI. J Rheumatol 2008;35:1294-9.
22. Leeb BF, Sautner J, Mai HT, et al. A comparison of patient questionnaires and composite indexes in routine care of rheumatoid arthritis patients. Joint Bone Spine 2009;76:658-64.
23. Pincus T, Bergman MJ, Yazici Y, et al. An index of only patient-reported outcome measures, routine assessment of patient index data 3 (RAPID3), in two abatacept clinical trials: similar results to disease activity score (DAS28) and other RAPID indices that include physician-reported measures. Rheumatology (Oxford) 2008;47:345-9.
24. Rintelen B, Haindl PM, Sautner J, et al. The rheumatoid arthritis disease activity index-5 in daily use. Proposal for disease activity categories. J Rheumatol 2009;36:918-24.
25. Veehof MM, ten Klooster PM, Taal E, et al. Psychometric properties of the Rheumatoid Arthritis Disease Activity Index (RADAI) in a cohort of consecutive Dutch patients with RA starting anti-tumour necrosis factor treatment. Ann Rheum Dis 2008;67:789-93.
26. Wolfe F, Michaud K, Pincus T. A composite disease activity scale for clinical practice, observational studies, and clinical trials: the patient activity scale (PAS/PAS-II). J Rheumatol 2005;32:2410-15.
27. van Tulder M, Furlan A, Bombardier C, et al. Editorial Board of the Cochrane Collaboration Back Review G. Updated method guidelines for systematic reviews in the Cochrane collaboration back review group. Spine (Phila Pa 1976) 2003;28:1290-9.
28. Schellingerhout JM, Heymans MW, Verhagen AP, et al. Measurement properties of translated versions of neck-specific questionnaires: a systematic review. BMC Med Res Methodol 2011;11:87.
29. Furlan AD, Pennick V, Bombardier C, et al. 2009 updated method guidelines for systematic reviews in the Cochrane Back Review Group. Spine (Phila Pa 1976) 2009;34:1929-41.
30. Schellingerhout JM, Verhagen AP, Heymans MW, et al. Measurement properties of disease-specific questionnaires in patients with neck pain: a systematic review. Qual Life Res 2012;21:659-70.
31. Nunnally J, Bernstein I. Psychometric theory. 3rd edn. New York: MCGraw-Hill, 1994.
32. Hinkle DE, Wiersma W, Jurs SG. Applied statistics for the behavioral sciences. Boston, MA: Houghton Mifflin, 2003.
33. Streiner DL, Norman GR. Health measurement scales: a practical guide to their development and use. 4th edn. Oxford, UK: Oxford University Press, 2008.
34. Cicchetti DV, Sparrow SA. Developing criteria for establishing interrater reliability of specific items: applications to assessment of adaptive behavior. Am J Ment Defic 1981;86:127-37.
35. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics 1977;33:159-74.
36. Fleiss JL. Statistical methods for rates and proportions. 2nd edn. New York: John Wiley & Sons, 1981.
37. Swets JA. Measuring the accuracy of diagnostic systems. Science 1988;240:1285-93.
38. Blanchais A, Berthelot JM, Fontenoy AM, et al. Weekly home self-assessment of RAPID-4/3 scores in rheumatoid arthritis: a 6-month study in 26 patients. Joint Bone Spine 2010;77:582-7.
39. Bossert M, Prati C, Vidal C, et al. Evaluation of self-report questionnaires for assessing rheumatoid arthritis activity: a cross-sectional study of RAPID3 and RADAI5 and flare detection in 200 patients. Joint Bone Spine 2012;79:57-62.
40. Castrejón I, Bergman MJ, Pincus T. MDHAQ/RAPID3 to recognize improvement over 2 months in usual care of patients with osteoarthritis, systemic lupus erythematosus, spondyloarthropathy, and gout, as well as rheumatoid arthritis. J Clin Rheumatol 2013;19:169-74.
41. Castrejón I, Dougados M, Combe B, et al. Can remission in rheumatoid arthritis be assessed without laboratory tests or a formal joint count? Possible remission criteria based on a self-report RAPID3 score and careful joint examination in the ESPOIR cohort. J Rheumatol 2013;40:386-93.
42. Fransen J, Häuselmann H, Michel BA, et al. Responsiveness of the self-assessed rheumatoid arthritis disease activity index to a flare of disease activity. Arthritis Rheum 2001;44:53-60.
43. Fujiwara M, Kita Y. Reexamination of the assessment criteria for rheumatoid arthritis disease activity based on comparison of the Disease Activity Score 28 with other simpler assessment methods. Mod Rheumatol 2013;23:260-8.
44. Harrington JT. The uses of disease activity scoring and the physician global assessment of disease activity for managing rheumatoid arthritis in rheumatology practice. J Rheumatol 2009;36:925-9.
45. Heegaard C, Dreyer L, Egsmose C, et al. Test-retest reliability of the disease activity score 28 CRP (DAS28-CRP), the simplified disease activity index (SDAI) and the clinical disease activity index (CDAI) in rheumatoid arthritis when based on patient self-assessment of tender and swollen joints. Clin Rheumatol 2013;32:1493-500.
46. Pincus T. RAPID3, an index of only 3 patient self-report core data set measures, but not ESR, recognizes incomplete responses to methotrexate in usual care of patients with rheumatoid arthritis. Bull Hosp Jt Dis (2013) 2013;71:117-20.
47. Pincus T, Chung C, Segurado OG, et al. An index of patient reported outcomes (PRO-Index) discriminates effectively between active and control treatment in 4 clinical trials of adalimumab in rheumatoid arthritis. J Rheumatol 2006;33:2146-52.
48. Pincus T, Furer V, Keystone E, et al. RAPID3 (Routine Assessment of Patient Index Data 3) severity categories and response criteria: similar results to DAS28 (Disease Activity Score) and CDAI (Clinical Disease Activity Index) in the RAPID 1 (Rheumatoid Arthritis Prevention of Structural Damage) clinical trial of certolizumab pegol. Arthritis Care Res (Hoboken) 2011;63:1142-9.
49. Pincus T, Hines P, Bergman MJ, et al. Proposed severity and response criteria for Routine Assessment of Patient Index Data (RAPID3): results for categories of disease activity and response criteria in abatacept clinical trials. J Rheumatol 2011;38:2565-71.
50. Pincus T, Strand V, Koch G, et al. An index of the three core data set patient questionnaire measures distinguishes efficacy of active treatment from that of placebo as effectively as the American College of Rheumatology 20% response criteria (ACR20) or the Disease Activity Score (DAS) in a rheumatoid arthritis clinical trial. Arthritis Rheum 2003;48:625-30.
51. Pincus T, Swearingen CJ, Bergman M, et al. RAPID3 (Routine Assessment of Patient Index Data 3), a rheumatoid arthritis index without formal joint counts for routine care: proposed severity categories compared to disease activity score and clinical disease activity index categories. J Rheumatol 2008;35:2136-47.
52. Pincus T, Swearingen CJ, Bergman MJ, et al. RAPID3 (Routine Assessment of Patient Index Data) on an MDHAQ (Multidimensional Health Assessment Questionnaire): agreement with DAS28 (Disease Activity Score) and CDAI (Clinical Disease Activity Index) activity categories, scored in five versus more than ninety seconds. Arthritis Care Res (Hoboken) 2010;62:181-9.
53. Rintelen B, Sautner J, Haindl P, et al. Remission in rheumatoid arthritis: a comparison of the 2 newly proposed ACR/EULAR remission criteria with the rheumatoid arthritis disease activity index-5, a patient self-report disease activity index. J Rheumatol 2013;40:394-400.
54. Salaffi F, Ciapetti A, Gasparini S, et al. The comparative responsiveness of the patient self-report questionnaires and composite disease indices for assessing rheumatoid arthritis activity in routine care. Clin Exp Rheumatol 2012;30:912-21.
55. Salaffi F, Migliore A, Scarpellini M, et al. Psychometric properties of an index of three patient reported outcome (PRO) measures, termed the CLinical ARthritis Activity (PRO-CLARA) in patients with rheumatoid arthritis. The NEW INDICES study. Clin Exp Rheumatol 2010;28:186-200.
56. Singh H, Gupta V, Ray S, et al. Evaluation of disease activity in rheumatoid arthritis by Routine Assessment of Patient Index Data 3 (RAPID3) and its correlation to Disease Activity Score 28 (DAS28) and Clinical Disease Activity Index (CDAI): an Indian experience. Clin Rheumatol 2012;31:1663-9.
57. Stucki G, Liang MH, Stucki S, et al. A self-administered rheumatoid arthritis disease activity index (RADAI) for epidemiologic research. Psychometric properties and correlation with parameters of disease activity. Arthritis Rheum 1995;38:795-8.
58. Sullivan MB, Iannaccone C, Cui J, et al. Evaluation of selected rheumatoid arthritis activity scores for office-based assessment. J Rheumatol 2010;37:2466-8.
59. Uhlig T, Kvien TK, Pincus T. Test-retest reliability of disease activity core set measures and indices in rheumatoid arthritis. Ann Rheum Dis 2009;68:972-5.
60. Mokkink LB, Terwee CB, Stratford PW, et al. Evaluation of the methodological quality of systematic reviews of health status measurement instruments. Qual Life Res 2009;18:313-33.
61. Castrejón I, Gossec L, Carmona L. The EULAR Outcome Measures Library: an evolutional database of validated patient-reported instruments. Ann Rheum Dis 2015;74:475-6.
62. Gossec L, Dougados M, Rincheval N, et al. Elaboration of the preliminary Rheumatoid Arthritis Impact of Disease (RAID) score: a EULAR initiative. Ann Rheum Dis 2009;68:1680-5.
63. Gossec L, Paternotte S, Aanerud GJ, et al. Finalisation and validation of the rheumatoid arthritis impact of disease score, a patient-derived composite measure of impact of rheumatoid arthritis: a EULAR initiative. Ann Rheum Dis 2011;70:935-42.
64. Lydersen S. Statistical review: frequently given comments. Ann Rheum Dis 2015;74:323-5.
65. Mokkink LB, Terwee CB, Patrick DL, et al. Cosmin Manual. [pdf] 2012 [cited 2015 10-07-2015]; 2012:[COnsensus-based Standards for the selection of health Measurement INstruments checklist manual]. http://www.cosmin.nl/images/upload/files/COSMIN%20checklist%20manual%20v9.pdf