Updating the OMERACT Filter: Implications for Imaging and Soluble Biomarkers

被引：13

作者：

D'Agostino, Maria-Antonietta ^{[1
,2
]}

Boers, Maarten ^{[3
,4
]}

Kirwan, John ^{[5
]}

van der Heijde, Desiree ^{[6
]}

Ostergaard, Mikkel ^{[7
]}

Schett, Georg ^{[8
,9
]}

Landewe, Robert B. ^{[10
,11
]}

Maksymowych, Walter P. ^{[12
]}

Naredo, Esperanza ^{[13
]}

Dougados, Maxime ^{[14
]}

Iagnocco, Annamaria ^{[15
]}

Bingham, Clifton O., III ^{[16
]}

Brooks, Peter M. ^{[17
,18
]}

Beaton, Dorcas E.

Gandjbakhch, Frederique

Gossec, Laure ^{[19
]}

Guillemin, Francis ^{[20
,21
]}

Hewlett, Sarah E. ^{[22
]}

Kloppenburg, Margreet ^{[6
]}

March, Lyn

Mease, Philip J. ^{[23
,24
]}

Moller, Ingrid ^{[25
]}

Simon, Lee S. ^{[26
]}

Singh, Jasvinder A. ^{[27
,28
]}

Strand, Vibeke ^{[29
]}

Wakefield, Richard J. ^{[30
]}

Wells, George A.

Tugwell, Peter ^{[31
]}

Conaghan, Philip G. ^{[30
]}

机构：

[1] Hop Ambroise Pare, AP HP, Dept Rheumatol, 9 Ave Charles de Gaulle, F-92100 Boulogne, France

[2] Versailles St Quentin Yvelines Univ, Dept Rheumatol, Ambroise Pare Hosp, AP HP, Boulogne, France

[3] Vrije Univ Amsterdam Med Ctr, Dept Epidemiol & Biostat, Amsterdam, Netherlands

[4] Vrije Univ Amsterdam Med Ctr, Dept Rheumatol, Amsterdam, Netherlands

[5] Univ Bristol, Acad Rheumatol Unit, Bristol Royal Infirm, Bristol, Avon, England

[6] Leiden Univ Med Ctr, Dept Rheumatol, Leiden, Netherlands

[7] Copenhagen Univ Hosp Glostrup, Copenhagen Ctr Arthrit Res, Ctr Rheumatol & Spine Dis, Copenhagen, Denmark

[8] Univ Erlangen Nurnberg, Dept Internal Med 3, D-91054 Erlangen, Germany

[9] Univ Erlangen Nurnberg, Inst Clin Immunol, D-91054 Erlangen, Germany

[10] Univ Amsterdam, Acad Med Ctr, Dept Clin Immunol & Rheumatol, NL-1105 AZ Amsterdam, Netherlands

[11] Atrium Med Ctr, Amsterdam, Netherlands

[12] Univ Alberta, Dept Med, Edmonton, AB, Canada

[13] Hosp Gen Gregorio Maranon, Dept Rheumatol, Madrid, Spain

[14] Paris Descartes Univ, Fac Med, Cochin Hosp, AP HP,Rheumatol B, Paris, France

[15] Univ Roma La Sapienza, Rheumatol Unit, I-00185 Rome, Italy

[16] Johns Hopkins Univ, Div Rheumatol, Baltimore, MD USA

[17] Univ Melbourne, Melbourne, Vic, Australia

[18] St Michaels Hosp, Mobil Program Clin Res Unit, Toronto, ON M5B1W8, Canada

[19] Univ Paris 06, Pitie Salpetriere Hosp, AP HP, Dept Rheumatol,GRC UPMC EEMOIS 08, Paris, France

[20] Univ Lorraine, Univ Paris 05, EA APEMAC 4360, Nancy, France

[21] CHU Nancy, Inserm CIC EC, Nancy, France

[22] Univ W England, Dept Nursing, Bristol BS161QY, Avon, England

[23] Swedish Med Ctr, Seattle, WA USA

[24] Univ Washington, Seattle, WA 98195 USA

[25] Inst Poal, Barcelona, Spain

[26] SDG LLC, Cambridge, MA USA

[27] Birmingham Vet Affairs Med Ctr, Birmingham, AL USA

[28] Univ Alabama Birmingham, Birmingham, AL USA

[29] Stanford Univ, Sch Med, Div Immunol Rheumatol, Palo Alto, CA 94304 USA

[30] Univ Leeds, Leeds Inst Rheumat & Musculoskeletal Med, Leeds, W Yorkshire, England

[31] Univ Ottawa, Dept Med, Ottawa, ON, Canada

来源：

JOURNAL OF RHEUMATOLOGY | 2014年 / 41卷 / 05期

关键词：

BIOMARKERS; IMAGING; OUTCOME AND PROCESS ASSESSMENT; OMERACT FILTER; VALIDATION FRAMEWORK; EARLY RHEUMATOID-ARTHRITIS; SPONDYLOARTHRITIS RESEARCH CONSORTIUM; SACROILIAC JOINT INFLAMMATION; POWER DOPPLER ULTRASONOGRAPHY; PAINFUL KNEE OSTEOARTHRITIS; ULTRASOUND TASK-FORCE; ACUTE-PHASE RESPONSE; DAMAGE END-POINTS; DISEASE-ACTIVITY; RADIOGRAPHIC PROGRESSION;

D O I：

10.3899/jrheum.131313

中图分类号：

R5 [内科学];

学科分类号：

100201 [内科学];

摘要：

Objective. The Outcome Measures in Rheumatology (OMERACT) Filter provides a framework for the validation of outcome measures for use in rheumatology clinical research. However, imaging and biochemical measures may face additional validation challenges because of their technical nature. The Imaging and Soluble Biomarker Session at OMERACT 11 aimed to provide a guide for the iterative development of an imaging or biochemical measurement instrument so it can be used in therapeutic assessment. Methods. A hierarchical structure was proposed, reflecting 3 dimensions needed for validating an imaging or biochemical measurement instrument: outcome domain(s), study setting, and performance of the instrument. Movement along the axes in any dimension reflects increasing validation. For a given test instrument, the 3-axis structure assesses the extent to which the instrument is a validated measure for the chosen domain, whether it assesses a patient-centered or disease-centered variable, and whether its technical performance is adequate in the context of its application. Some currently used imaging and soluble biomarkers for rheumatoid arthritis, spondy-loarthritis, and knee osteoarthritis were then evaluated using the original OMERACT Filter and the newly proposed structure. Breakout groups critically reviewed the extent to which the candidate biomarkers complied with the proposed stepwise approach, as a way of examining the utility of the proposed 3-dimensional structure. Results. Although there was a broad acceptance of the value of the proposed structure in general, some areas for improvement were suggested including clarification of criteria for achieving a certain level of validation and how to deal with extension of the structure to areas beyond clinical trials. Conclusion. General support was obtained for a proposed tri-axis structure to assess validation of imaging and soluble biomarkers; nevertheless, additional work is required to better evaluate its place within the OMERACT Filter 2.0.

引用

页码：1016 / 1024

页数：9

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