TY - JOUR
T1 - Evaluation of minimally invasive, ultrasound-guided synovial biopsy techniques by the OMERACT filter - Determining validation requirements
AU - Humby, Frances
AU - Kelly, Stephen
AU - Bugatti, Serena
AU - Manzo, Antonio
AU - Filer, Andrew
AU - Mahto, Arti
AU - Fonseca, Joao Eurico
AU - Lauwerys, Bernard
AU - D'Agostino, Maria-Antonietta
AU - D'Agostino, Maria Antonietta
AU - Naredo, Esperanza
AU - Lories, Rik
AU - Montecucco, Carlomaurizio
AU - Tak, Paul Peter
AU - Fitzgerald, Oliver
AU - Smith, Malcolm D.
AU - Veale, Douglas J.
AU - Choy, Ernest H.
AU - Strand, Vibeke
AU - Pitzalis, Costantino
PY - 2016
Y1 - 2016
N2 - Objective: Because limited data currently support the clinical utility of peripherally expressed biomarkers in guiding treatment decisions for patients with rheumatoid arthritis, the search has turned to the disease tissue. The strategic aim of the Outcome Measures in Rheumatology (OMERACT) synovitis working group over the years has been to develop novel diagnostic and prognostic synovial biomarkers. A critical step in this process is to refine and validate minimally invasive, technically simple, robust techniques to sample synovial tissue, for use both in clinical trials and routine clinical practice. The objective of the synovitis working group (SWG) at OMERACT 12 (2014) was to examine whether recently developed ultrasound (US)-guided synovial biopsy techniques could be validated according to the OMERACT filter for future clinical use recommendation. Methods: The SWG examined whether current data reporting US-guided synovial biopsy of both large and small joints addressed the OMERACT filters of truth, discrimination, and feasibility. Results: There are currently limited data examining the performance of US-guided synovial biopsy, mainly from observational studies. Thus, it remains critical to evaluate its performance, within the clinical trials context, against the current gold standard of arthroscopic biopsy, with particular reference to: (1) synovial tissue yield, (2) capacity to determine treatment response as measured by a validated synovial biomarker, and (3) tolerability of the procedure. Conclusion: We summarize the discrete work packages agreed to as requirements to validate US-guided synovial biopsy and therefore lead to a global consensus on the use of synovial biopsy for research and clinical practice.
AB - Objective: Because limited data currently support the clinical utility of peripherally expressed biomarkers in guiding treatment decisions for patients with rheumatoid arthritis, the search has turned to the disease tissue. The strategic aim of the Outcome Measures in Rheumatology (OMERACT) synovitis working group over the years has been to develop novel diagnostic and prognostic synovial biomarkers. A critical step in this process is to refine and validate minimally invasive, technically simple, robust techniques to sample synovial tissue, for use both in clinical trials and routine clinical practice. The objective of the synovitis working group (SWG) at OMERACT 12 (2014) was to examine whether recently developed ultrasound (US)-guided synovial biopsy techniques could be validated according to the OMERACT filter for future clinical use recommendation. Methods: The SWG examined whether current data reporting US-guided synovial biopsy of both large and small joints addressed the OMERACT filters of truth, discrimination, and feasibility. Results: There are currently limited data examining the performance of US-guided synovial biopsy, mainly from observational studies. Thus, it remains critical to evaluate its performance, within the clinical trials context, against the current gold standard of arthroscopic biopsy, with particular reference to: (1) synovial tissue yield, (2) capacity to determine treatment response as measured by a validated synovial biomarker, and (3) tolerability of the procedure. Conclusion: We summarize the discrete work packages agreed to as requirements to validate US-guided synovial biopsy and therefore lead to a global consensus on the use of synovial biopsy for research and clinical practice.
KW - Antirheumatic Agents
KW - Arthritis, Rheumatoid
KW - Female
KW - Humans
KW - Image-Guided Biopsy
KW - Male
KW - Minimally Invasive Surgical Procedures
KW - Patient Safety
KW - Practice Guidelines as Topic
KW - Rheumatoid arthritis ultrasound
KW - Severity of Illness Index
KW - Synovial Membrane
KW - Synovitis
KW - Synovitis biopsy
KW - Treatment Outcome
KW - Ultrasonography, Doppler
KW - Antirheumatic Agents
KW - Arthritis, Rheumatoid
KW - Female
KW - Humans
KW - Image-Guided Biopsy
KW - Male
KW - Minimally Invasive Surgical Procedures
KW - Patient Safety
KW - Practice Guidelines as Topic
KW - Rheumatoid arthritis ultrasound
KW - Severity of Illness Index
KW - Synovial Membrane
KW - Synovitis
KW - Synovitis biopsy
KW - Treatment Outcome
KW - Ultrasonography, Doppler
UR - http://hdl.handle.net/10807/169079
U2 - 10.3899/jrheum.141199
DO - 10.3899/jrheum.141199
M3 - Article
SN - 0315-162X
VL - 43
SP - 208
EP - 213
JO - THE JOURNAL OF RHEUMATOLOGY
JF - THE JOURNAL OF RHEUMATOLOGY
ER -