Evaluation of minimally invasive, ultrasound-guided synovial biopsy techniques by the OMERACT filter - Determining validation requirements

Frances Humby, Stephen Kelly, Serena Bugatti, Antonio Manzo, Andrew Filer, Arti Mahto, Joao Eurico Fonseca, Bernard Lauwerys, Maria Antonietta D'Agostino, Esperanza Naredo, Rik Lories, Carlomaurizio Montecucco, Paul Peter Tak, Oliver Fitzgerald, Malcolm D. Smith, Douglas J. Veale, Ernest H. Choy, Vibeke Strand, Costantino Pitzalis

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)208-213
Number of pages6
JournalJournal of Rheumatology
Volume43
Issue number1
DOIs
Publication statusPublished - Jan 1 2016

Fingerprint

Biopsy
Synovitis
Biomarkers
Clinical Trials
Rheumatology
Observational Studies
Rheumatoid Arthritis
Research Design
Joints
Outcome Assessment (Health Care)
Therapeutics
Research

Keywords

  • Rheumatoid arthritis ultrasound
  • Synovitis biopsy

ASJC Scopus subject areas

  • Immunology and Allergy
  • Rheumatology
  • Immunology
  • Medicine(all)

Cite this

Evaluation of minimally invasive, ultrasound-guided synovial biopsy techniques by the OMERACT filter - Determining validation requirements. / Humby, Frances; Kelly, Stephen; Bugatti, Serena; Manzo, Antonio; Filer, Andrew; Mahto, Arti; Fonseca, Joao Eurico; Lauwerys, Bernard; D'Agostino, Maria Antonietta; Naredo, Esperanza; Lories, Rik; Montecucco, Carlomaurizio; Tak, Paul Peter; Fitzgerald, Oliver; Smith, Malcolm D.; Veale, Douglas J.; Choy, Ernest H.; Strand, Vibeke; Pitzalis, Costantino.

In: Journal of Rheumatology, Vol. 43, No. 1, 01.01.2016, p. 208-213.

Research output: Contribution to journalArticle

Humby, F, Kelly, S, Bugatti, S, Manzo, A, Filer, A, Mahto, A, Fonseca, JE, Lauwerys, B, D'Agostino, MA, Naredo, E, Lories, R, Montecucco, C, Tak, PP, Fitzgerald, O, Smith, MD, Veale, DJ, Choy, EH, Strand, V & Pitzalis, C 2016, 'Evaluation of minimally invasive, ultrasound-guided synovial biopsy techniques by the OMERACT filter - Determining validation requirements', Journal of Rheumatology, vol. 43, no. 1, pp. 208-213. https://doi.org/10.3899/jrheum.141199
Humby, Frances ; Kelly, Stephen ; Bugatti, Serena ; Manzo, Antonio ; Filer, Andrew ; Mahto, Arti ; Fonseca, Joao Eurico ; Lauwerys, Bernard ; D'Agostino, Maria Antonietta ; Naredo, Esperanza ; Lories, Rik ; Montecucco, Carlomaurizio ; Tak, Paul Peter ; Fitzgerald, Oliver ; Smith, Malcolm D. ; Veale, Douglas J. ; Choy, Ernest H. ; Strand, Vibeke ; Pitzalis, Costantino. / Evaluation of minimally invasive, ultrasound-guided synovial biopsy techniques by the OMERACT filter - Determining validation requirements. In: Journal of Rheumatology. 2016 ; Vol. 43, No. 1. pp. 208-213.
@article{257f961b5fe245ed97e9ddf8aebb4217,
title = "Evaluation of minimally invasive, ultrasound-guided synovial biopsy techniques by the OMERACT filter - Determining validation requirements",
abstract = "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.",
keywords = "Rheumatoid arthritis ultrasound, Synovitis biopsy",
author = "Frances Humby and Stephen Kelly and Serena Bugatti and Antonio Manzo and Andrew Filer and Arti Mahto and Fonseca, {Joao Eurico} and Bernard Lauwerys and D'Agostino, {Maria Antonietta} and Esperanza Naredo and Rik Lories and Carlomaurizio Montecucco and Tak, {Paul Peter} and Oliver Fitzgerald and Smith, {Malcolm D.} and Veale, {Douglas J.} and Choy, {Ernest H.} and Vibeke Strand and Costantino Pitzalis",
year = "2016",
month = "1",
day = "1",
doi = "10.3899/jrheum.141199",
language = "English",
volume = "43",
pages = "208--213",
journal = "Journal of Rheumatology",
issn = "0315-162X",
publisher = "Journal of Rheumatology",
number = "1",

}

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 - 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 - 2016/1/1

Y1 - 2016/1/1

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 - Rheumatoid arthritis ultrasound

KW - Synovitis biopsy

UR - http://www.scopus.com/inward/record.url?scp=84983514615&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84983514615&partnerID=8YFLogxK

U2 - 10.3899/jrheum.141199

DO - 10.3899/jrheum.141199

M3 - Article

AN - SCOPUS:84983514615

VL - 43

SP - 208

EP - 213

JO - Journal of Rheumatology

JF - Journal of Rheumatology

SN - 0315-162X

IS - 1

ER -