Updating the OMERACT filter: Implications for imaging and soluble biomarkers

Journal of Rheumatology

Volumn 41, Issue 5, 2014, Pages 1016-1024

  D'Agostino, Maria Antonietta ^a   Boers, Maarten ^b   Kirwan, John ^c   Van Der Heijde, Désirée ^d   Østergaard, Mikkel ^e   Schett, Georg ^f   Landewé, Robert B ^g   Maksymowych, Walter P ^h   Naredo, Esperanza ⁱ   Dougados, Maxime ^j   Iagnocco, Annamaria ^k   Bingham, Clifton O ^l   Brooks, Peter M ^m   Beaton, Dorcas E ⁿ   Gandjbakhch, Frederique ^o   Gossec, Laure ^o   Guillemin, Francis ^p   Hewlett, Sarah E ^q   Kloppenburg, Margreet ^d   March, Lyn ^d   Mease, Philip J ^r   Moller, Ingrid ^s   Simon, Lee S ^t   Singh, Jasvinder A ^u   Strand, Vibeke ^v   Wakefield, Richard J ^w   Wells, George A ^x   Tugwell, Peter ^v   Conaghan, Philip G ^y   more..

^a LABORATOIRE DES SCIENCES DU CLIMAT ET DE L ENVIRONNEMENT   (France)

^b VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^c UNIVERSITY OF BRISTOL   (United Kingdom)

^d LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^e GLOSTRUP UNIVERSITY HOSPITAL   (Denmark)

^f UNIVERSITY OF ERLANGEN NUREMBERG   (Germany)

^g UNIVERSITY OF AMSTERDAM   (Netherlands)

^h UNIVERSITY OF ALBERTA   (Canada)

ⁱ HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑÓN   (Spain)

^j UNIVERSITÉ PARIS DESCARTES   (France)

^k SAPIENZA UNIVERSITY OF ROME   (Italy)

^l JOHNS HOPKINS UNIVERSITY   (United States)

^m UNIVERSITY OF MELBOURNE   (Australia)

ⁿ UNIVERSITY OF TORONTO   (Canada)

^o Oncogenetic and Molecular Angiogenetic Laboratory   (France)

^p UNIVERSITÉ DE LORRAINE   (France)

^q UNIVERSITY OF THE WEST OF ENGLAND   (United Kingdom)

^r Swedish Medical Center and University of Washington   (United States)

^s Instituto Poal   (Spain)

^t UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^u STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^v UNIVERSITY OF LEEDS   (United Kingdom)

^w Epidemiology and Community Medicine   (United Kingdom)

^x UNIVERSITY OF OTTAWA   (Canada)

^y SDG LLC   (United States)

more..

Author keywords

Biomarkers; Imaging; Omeract filter; Outcome and process assessment; Validation framework

Indexed keywords

BIOLOGICAL MARKER;

ARTICLE; BIOCHEMISTRY; CLINICAL RESEARCH; CONCEPTUAL FRAMEWORK; DISEASE ACTIVITY; DISEASE SEVERITY; KNEE OSTEOARTHRITIS; NUCLEAR MAGNETIC RESONANCE IMAGING; OUTCOME ASSESSMENT; PRACTICE GUIDELINE; PRIORITY JOURNAL; RHEUMATOID ARTHRITIS; RHEUMATOLOGY; SPONDYLARTHRITIS; VALIDATION PROCESS; VALIDATION STUDY; CLINICAL TRIAL (TOPIC); CONSENSUS DEVELOPMENT; HUMAN; METABOLISM; REPRODUCIBILITY; RHEUMATIC DISEASES; STANDARDS; TREATMENT OUTCOME; TRENDS;

BIOLOGICAL MARKERS; CLINICAL TRIALS AS TOPIC; HUMANS; OUTCOME AND PROCESS ASSESSMENT (HEALTH CARE); REPRODUCIBILITY OF RESULTS; RHEUMATIC DISEASES; RHEUMATOLOGY;

EID: 84899705989     PISSN: 0315162X     EISSN: 14992752     Source Type: Journal    
DOI: 10.3899/jrheum.131313     Document Type: Article

References (79)

1. Thornbury JR. Eugene W. Caldwell Lecture. Clinical efficacy of diagnostic imaging: love it or leave it. AJR Am J Roentgenol 1994;162:1-8
2. Lassere MN. Imaging: the need for standardization. Best Pract Res Clin Rheumatol 2008;22:1001-18
3. Fineberg HV, Bauman R, Sosman M. Computerized cranial tomography. Effect on diagnostic and therapeutic plans. JAMA 1977;238:224-7
4. Boers M, Brooks P, Strand V, Tugwell P. The OMERACT Filter for outcome measures in rheumatology. J Rheumatol 1998;25:198-9
5. Boers M, Kirwan JR, Wells G, et al. Developing core outcome measurement sets for clinical trials: OMERACT Filter 2.0. J Clin Epidemiol 2014 (in press)
6. Boers M, Idzerda L, Kirwan JR, Beaton D, Escorpizo R, Boonen A, et al. Toward a generalized framework of core measurement areas in clinical trials: A position paper for OMERACT 11. J Rheumatol 2014;41:978-85
7. Kirwan JR, Bartlett SJ, Beaton D, Boers M, Bosworth A, Brooks PM, et al. Updating the OMERACT Filter: Implications for patient reported outcomes. J Rheumatol 2014;41:1011-15
8. van der Heijde D. Quantification of radiological damage in inflammatory arthritis: rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Best Pract Res Clin Rheumatol 2004;18:847-60
9. Bruynesteyn K, van der Heijde D, Boers M, van der Linden S, Lassere M, van der Vleuten C. The Sharp/van der Heijde method out-performed the Larsen/Scott method on the individual patient level in assessing radiographs in early rheumatoid arthritis. J Clin Epidemiol 2004;57:502-12
10. Bruynesteyn K, Landewé R, van der Linden S, van der Heijde D. Radiography as primary outcome in rheumatoid arthritis: acceptable sample sizes for trials with 3 months' follow-up. Ann Rheum Dis 2004;63:1413-8
11. Bruynesteyn K, van der Heijde D, Boers M, Saudan A, Peloso P, Paulus H, Houben H, et al. Detecting radiological changes in rheumatoid arthritis that are considered important by clinical experts: Influence of reading with or without known sequence. J Rheumatol 2002;29:2306-12
12. Østergaard M, Peterfy C, Conaghan P, McQueen F, Bird P, Ejbjerg B, et al. OMERACT rheumatoid arthritis magnetic resonance imaging studies. Core set of MRI acquisitions, joint pathology definitions, and the OMERACT RA-MRI scoring system. J Rheumatol 2003;30:1385-6.
13. Haavardsholm EA, Østergaard M, Ejbjerg BJ, Kvan NP, Uhlig TA, Lilleas FG, et al. Reliability and sensitivity to change of the OMERACT rheumatoid arthritis magnetic resonance imaging score in a multireader, longitudinal setting. Arthritis Rheum 2005;52:3860-7
14. Hetland ML, Ejbjerg B, Horslev-Petersen K, Jacobsen S, Vestergaard A, Jurik AG, et al. MRI bone oedema is the strongest predictor of subsequent radiographic progression in early rheumatoid arthritis. Results from a 2-year randomised controlled trial (CIMESTRA). Ann Rheum Dis 2009;68:384-90
15. Jimenez-Boj E, Nobauer-Huhmann I, Hanslik-Schnabel B, Dorotka R, Wanivenhaus AH, Kainberger F, et al. Bone erosions and bone marrow edema as defined by magnetic resonance imaging reflect true bone marrow inflammation in rheumatoid arthritis. Arthritis Rheum 2007;56:1118-24
16. McQueen FM, Gao A, Østergaard M, King A, Shalley G, Robinson E, et al. High-grade MRI bone oedema is common within the surgical field in rheumatoid arthritis patients undergoing joint replacement and is associated with osteitis in subchondral bone. Ann Rheum Dis 2007;66:1581-7
17. Døhn UM, Ejbjerg BJ, Court-Payen, Hasselquist M, Narvestad E, Szkudlarek M, et al. Are bone erosions detected by magnetic resonance imaging and ultrasonography true erosions? A comparison with computed tomography in rheumatoid arthritis metacarpophalangeal joints. Arthritis Res Ther 2006;8:R110
18. Haavardsholm EA, Østergaard M, Hammer HB, Boyesen P, Boonen A, van der Heijde D, et al. Monitoring anti-TNFalpha treatment in rheumatoid arthritis: responsiveness of magnetic resonance imaging and ultrasonography of the dominant wrist joint compared with conventional measures of disease activity and structural damage. Ann Rheum Dis 2009;68:1572-9
19. Conaghan PG, Emery P, Østergaard M, Keystone EC, Genovese MC, Hsia EC, et al. Assessment by MRI of inflammation and damage in rheumatoid arthritis patients with methotrexate inadequate response receiving golimumab: results of the GO-FORWARD trial. Ann Rheum Dis 2011;70:1968-74
20. Østergaard M, Emery P, Conaghan PG, Fleischmann R, Hsia EC, Xu W, et al. Significant improvement in synovitis, osteitis, and bone erosion following golimumab and methotrexate combination therapy as compared with methotrexate alone: A magnetic resonance imaging study of 318 methotrexate-naive rheumatoid arthritis patients. Arthritis Rheum 2011;63:3712-22.
21. Conaghan PG, Durez P, Alten RE, Burmester GR, Tak PP, Klareskog L, et al. Impact of intravenous abatacept on synovitis, osteitis and structural damage in patients with rheumatoid arthritis and an inadequate response to methotrexate: the ASSET randomised controlled trial. Ann Rheum Dis 2013;72:1287-94
22. Peterfy C, Emery P, Tak PP, Østergaard M, DiCarlo J, Otsa K, et al. Rituximab (RTX) plus methotrexate (MTX) prevents bone erosion and joint-space narrowing (JSN) and reduces synovitis, osteitis as shown on MRI: results from a randomized placebo controlled trial in patients with rheumatoid arthritis (RA-SCORE) [abstract]. Ann Rheum Dis 2011;70 Suppl 3:152
23. Emerging Risk Factors Collaboration, Kaptoge S, Di Angelantonio E, Lowe G, Pepys MB, Thompson SG, et al. C-reactive protein concentration and risk of coronary heart disease, stroke, and mortality: an individual participant meta-analysis. Lancet 2010;375:132-40
24. Möttönen T, Paimela L, Leirisalo-Repo M, Kautiainen H, Ilonen J, Hannonen P. Only high disease activity and positive rheumatoid factor indicate poor prognosis in patients with early rheumatoid arthritis treated with "sawtooth" strategy. Ann Rheum Dis 1998;57:533-9
25. Plant MJ, Williams AL, O'Sullivan MM, Lewis PA, Coles EC, Jessop JD. Relationship between time-integrated C-reactive protein levels and radiologic progression in patients with rheumatoid arthritis. Arthritis Rheum 2000;43:1473-7
26. van Leeuwen MA, van Rijswijk MH, van der Heijde DM, Te Meerman GJ, van Riel PL, Houtman PM, et al. The acute-phase response in relation to radiographic progression in early rheumatoid arthritis: a prospective study during the first three years of the disease. Br J Rheumatol 1993;32 Suppl 3:9-13
27. van Leeuwen MA, van Rijswijk MH, Sluiter WJ, van Riel PL, Kuper IH, van de Putte LB, et al. Individual relationship between progression of radiological damage and the acute phase response in early rheumatoid arthritis. Towards development of a decision support system. J Rheumatol 1997;24:20-7
28. Visser K, Goekoop-Ruiterman YP, de Vries-Bouwstra JK, Ronday HK, Seys PE, Kerstens PJ, et al. A matrix risk model for the prediction of rapid radiographic progression in patients with rheumatoid arthritis receiving different dynamic treatment strategies: post hoc analyses from the BeSt study. Ann Rheum Dis 2010;69:1333-7
29. Machold KP, Stamm TA, Nell VP, Pflugbeil S, Aletaha D, Steiner G, et al. Very recent onset rheumatoid arthritis: clinical and serological patient characteristics associated with radiographic progression over the first years of disease. Rheumatology 2007;46:342-9
30. Buyse M, Sargent DJ, Grothey A, Matheson A, de Gramont A. Biomarkers and surrogate end points - the challenge of statistical validation. Nat Rev Clin Oncol 2010;7:309-17
31. Rönnelid J, Wick MC, Lampa J, Lindblad S, Nordmark B, Klareskog L, et al. Longitudinal analysis of citrullinated protein/peptide antibodies (anti-CP) during 5 year follow up in early rheumatoid arthritis: anti-CP status predicts worse disease activity and greater radiological progression. Ann Rheum Dis 2005;64:1744-9
32. Kastbom A, Strandberg G, Lindroos A, Skogh T. Anti-CCP antibody test predicts the disease course during 3 years in early rheumatoid arthritis (the Swedish TIRA project). Ann Rheum Dis 2004;63:1085-9
33. Forslind K, Ahlmén M, Eberhardt K, Hafström I, Svensson B; BARFOT Study Group. Prediction of radiological outcome in early rheumatoid arthritis in clinical practice: role of antibodies to citrullinated peptides (anti-CCP). Ann Rheum Dis 2004;63:1090-5
34. Hammer HB, Ødegård S, Syversen SW, Landewé R, van der Heijde D, Uhlig T, et al. Calprotectin (a major S100 leucocyte protein) predicts 10-year radiographic progression in patients with rheumatoid arthritis. Ann Rheum Dis 2010;69:150-4
35. Posthumus MD, Limburg PC, Westra J, van Leeuwen MA, van Rijswijk MH. Serum matrix metalloproteinase 3 in early rheumatoid arthritis is correlated with disease activity and radiological progression. J Rheumatol 2000;27:2761-8
36. Garnero P, Landewé R, Boers M, Verhoeven A, Van Der Linden S, Christgau S, et al. Association of baseline levels of markers of bone and cartilage degradation with long-term progression of joint damage in patients with early rheumatoid arthritis: the COBRA study. Arthritis Rheum 2002;46:2847-56
37. Landewé R, Geusens P, Boers M, van der Heijde D, Lems W, te Koppele J, et al. Markers for type II collagen breakdown predict the effect of disease-modifying treatment on long-term radiographic progression in patients with rheumatoid arthritis. Arthritis Rheum 2004;50:1390-9
38. Geusens PP, Landewé RB, Garnero P, Chen D, Dunstan CR, Lems WF, et al. The ratio of circulating osteoprotegerin to RANKL in early rheumatoid arthritis predicts later joint destruction. Arthritis Rheum 2006;54:1772-7
39. Charni N, Juillet F, Garnero P. Urinary type II collagen helical peptide (HELIX-II) as a new biochemical marker of cartilage degradation in patients with osteoarthritis and rheumatoid arthritis. Arthritis Rheum 2005;52:1081-90
40. Sharif M, Salisbury C, Taylor D, Kirwan JR. Changes in biochemical markers of joint tissue metabolism in a randomised controlled trial of glucocorticoids in early rheumatoid arthritis. Arthritis Rheum 1998;41:1203-9
41. Maksymowych WP. MRI and X-ray in axial spondyloarthritis: the relationship between inflammatory and structural changes. Arthritis Res Ther 2012;14:207
42. Wanders AJ, Landewé RB, Spoorenberg A, Dougados M, van der Linden S, Mielants H, et al. What is the most appropriate radiologic scoring method for ankylosing spondylitis? A comparison of the available methods based on the Outcome Measures in Rheumatology Clinical Trials filter. Arthritis Rheum 2004; 50:2622-32
43. Gong Y, Zheng N, Chen SB, Xiao ZY, Wu MY, Liu Y, et al. Ten years experience on needle biopsy in the early diagnosis of sacroiliitis. Arthritis Rheum 2012;64:1399-406
44. Maksymowych WP, Inman RD, Salonen D, Dhillon SS, Williams M, Stone M, et al. Spondyloarthritis Research Consortium of Canada magnetic resonance imaging index for assessment of sacroiliac joint inflammation in ankylosing spondylitis. Arthritis Rheum 2005;53:703-9
45. Landewe RB, Hermann KG, van der Heijde DM, Baraliakos X, Jurik AG, Lambert RG, et al. Scoring sacroiliac joints by magnetic resonance imaging: a multiple-reader reliability experiment. J Rheumatol 2005;32:2050-5
46. Maksymowych WP, Dhillon SS, Park R, Salonen D, Inman RD, Lambert RG, et al. Validation of the Spondyloarthritis Research Consortium of Canada (SPARCC) MRI spinal inflammation index: is it necessary to score the entire spine? Arthritis Rheum 2007;57:501-7
47. Lukas C, Braun J, van der Heijde D, Hermann KG, Rudwaleit M, Østergaard M, et al. Scoring inflammatory activity of the spine by magnetic resonance imaging in ankylosing spondylitis: a multireader experiment. J Rheumatol 2007;34:862-70
48. van der Heijde D, Landewé R, Hermann KG, Rudwaleit M, Østergaard M, Oostveen A, et al. Is there a preferred method for scoring activity of the spine by magnetic resonance imaging in ankylosing spondylitis? J Rheumatol 2007;34:871-3
49. Braun J, Baraliakos X, Golder W, Brandt J, Rudwaleit M, Listing J, et al. Magnetic resonance imaging examinations of the spine in patients with ankylosing spondylitis, before and after successful therapy with infliximab: evaluation of a new scoring system. Arthritis Rheum 2003;48:1126-36
50. Lambert RG, Salonen D, Rahman P, Inman RD, Wong RL, Einstein SG, et al. 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;56:4005-14
51. Braun J, Baraliakos X, Hermann KG, van der Heijde D, Inman RD, Deodhar AA, et al. Golimumab reduces spinal inflammation in ankylosing spondylitis: MRI results of the randomised, placebo-controlled GO-RAISE study. Ann Rheum Dis 2012;71:878-84
52. Visvanathan S, Wagner C, Marini JC, Baker D, Gathany T, Han J, et al. Inflammatory biomarkers, disease activity and spinal disease measures in patients with ankylosing spondylitis after treatment with infliximab. Ann Rheum Dis 2008;67:511-7
53. Maksymowych WP. Biomarkers in spondyloarthritis: from pathophysiology to disease assessment. Joint Bone Spine 2012;79:4-6
54. Maksymowych WP, Landewé R, Conner-Spady B, Dougados M, Mielants H, van der Tempel, et al. Serum matrix metalloproteinase 3 is an independent predictor of structural damage progression in patients with ankylosing spondylitis. Arthritis Rheum 2007;56:1846-53
55. Appel H, Ruiz-Heiland G, Listing J, Zwerina J, Herrmann M, Mueller R, et al. Altered skeletal expression of sclerostin and its link to radiographic progression in ankylosing spondylitis. Arthritis Rheum 2009;60:3257-62
56. Heiland GR, Appel H, Poddubnyy D, Zwerina J, Hueber A, Haibel H, et al. High level of functional dickkopf-1, predicts protection from syndesmophyte formation in patients with ankylosing spondylitis. Ann Rheum Dis 2012;71:572-4
57. Park MC, Park YB, Lee SK. Relationship of bone morphogenetic proteins to disease activity and radiographic damage in patients with ankylosing spondylitis. Scand J Rheumatol 2008;37:200-4
58. Sieper J, Appel H, Rudwaleit M, Haibel H, Poddubnyy D, Baraliakos X, et al. Inverse correlation between serum levels of dickkopf 1 (DKK1) and new bone formation in ankylosing spondylitis patients [abstract]. Ann Rheum Dis 2010;69 Suppl 3:442
59. Gandjbakhch F, Terslev L, Joshua F, Wakefield RJ, Naredo E, D'Agostino MA; OMERACT Ultrasound Task Force. Ultrasound in the evaluation of enthesitis: status and perspectives. Arthritis Res Ther 2011;13:R188
60. Naredo E, Wakefield RJ, Iagnocco A, Terslev L, Filippucci E, Gandjbakhch F, et al. The OMERACT ultrasound task force- status and perspectives. J Rheumatol 2011;38:2063-7
61. Naredo E, Batlle-Gualda E, García-Vivar ML, García-Aparicio AM, Fernández-Sueiro JL, Fernández-Prada M, et al. Power Doppler ultrasonography assessment of entheses in spondyloarthropathies: response to therapy of entheseal abnormalities. J Rheumatol 2010;37:2110-7
62. D'Agostino MA, Conaghan PG, Naredo E, Aegerter P, Iagnocco A, Freeston JE, et al. The OMERACT ultrasound task force- Advances and priorities. J Rheumatol 2009;36:1829-32. Erratum in: J Rheumatol 2009;36:2625.
63. D'Agostino MA, Aegerter P, Jousse-Joulin S, Chary-Valckenaere I, Lecoq B, Gaudin P, et al. How to evaluate and improve the reliability of power Doppler ultrasonography for assessing enthesitis in spondylarthritis. Arthritis Rheum 2009;61:61-9
64. Reichmann WM, Maillefert JF, Hunter DJ, Katz JN, Conaghan PG, Losina E. Responsiveness to change and reliability of measurement of radiographic joint space width in osteoarthritis of the knee: a systematic review. Osteoarthritis Cartilage 2011;19:550-6
65. Conaghan PG, Hunter DJ, Maillefert JF, Reichmann WM, Losina E. Summary and recommendations of the OARSI FDA Osteoarthritis Assessment of Structural Change Working Group. Osteoarthritis Cartilage 2011;19:606-10
66. Bellamy N, Kirwan J, Boers M, Brooks P, Strand V, Tugwell P, et al. Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis. Consensus development at OMERACT III. J Rheumatol 1997;24:799-802
67. Manno RL, Bingham CO 3rd, Paternotte S, Gossec L, Halhol H, Giacovelli G, et al. OARSI-OMERACT initiative: defining thresholds for symptomatic severity and structural changes in disease modifying osteoarthritis drug (DMOAD) clinical trials. Osteoarthritis Cartilage 2012;20:93-101
68. Gossec L, Paternotte S, Bingham CO, Clegg DO, Coste P, Conaghan PG, Davis AM, et al. OARSI/OMERACT initiative to define states of severity and indication for joint replacement in hip and knee osteoarthritis. An OMERACT 10 Special Interest Group. J Rheumatol 2011;38:1765-9
69. Iagnocco A, Perricone C, Scirocco C, Ceccarelli F, Modesti M, Gattamelata A, et al. The interobserver reliability of ultrasound in knee osteoarthritis. Rheumatology 2012;51:2013-9
70. Keen HI, Mease PJ, Bingham CO, Giles JT, Kaeley G, Conaghan PG. Systematic review of MRI, ultrasound, and scintigraphy as outcome measures for structural pathology in interventional therapeutic studies of knee arthritis: focus on responsiveness. J Rheumatol 2011;38:142-54
71. Conaghan PG, D'Agostino MA, Le Bars M, Baron G, Schmidely N, Wakefield R, et al. Clinical and ultrasonographic predictors of joint replacement for knee osteoarthritis: results from a large, 3-year, prospective EULAR study. Ann Rheum Dis 2010;69:644-7
72. D'Agostino MA, Conaghan P, Le Bars M, Baron G, Grassi W, Martin-Mola E, et al. EULAR report on the use of ultrasonography in painful knee osteoarthritis. Part 1: prevalence of inflammation in osteoarthritis. Ann Rheum Dis 2005;64:1703-9
73. Conaghan P, D'Agostino MA, Ravaud P, Baron G, Le Bars M, Grassi W, et al. EULAR report on the use of ultrasonography in painful knee osteoarthritis. Part 2: exploring decision rules for clinical utility. Ann Rheum Dis 2005;64:1710-4
74. Hunter DJ, Zhang W, Conaghan PG, Hirko K, Menashe L, Li L, et al. Systematic review of the concurrent and predictive validity of MRI biomarkers in OA. Osteoarthritis Cartilage 2011;19:557-88
75. Hunter DJ, Zhang W, Conaghan PG, Hirko K, Menashe L, Reichmann WM, et al. Responsiveness and reliability of MRI in knee osteoarthritis: a meta-analysis of published evidence. Osteoarthritis Cartilage 2011;19:589-605
76. Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol 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
77. Lassere MN, Johnson KR, Boers M, Tugwell P, Brooks P, Simon L, et al. Definitions and validation criteria for biomarkers and surrogate endpoints: development and testing of a quantitative hierarchical levels of evidence schema. J Rheumatol 2007; 34:670-15
78. Maksymowych WP, Landewe R, Tak PP, Ritchlin CJ, Ostergaard M, Mease PJ, et al. Reappraisal of OMERACT 8 draft validation criteria for a soluble biomarker reflecting structural damage endpoints in rheumatoid arthritis, psoriatic arthritis, and spondyloarthritis: The OMERACT 9 v2 criteria. J Rheumatol 2009;36:1785-91
79. Maksymowych WP, Fitzgerald O, Wells GA, Gladman DD, Landewe R, Ostergaard M, et al. Proposal for levels of evidence schema for validation of a soluble biomarker reflecting damage endpoints in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, and recommendations for study design. J Rheumatol 2009;36:1792-9.