The Use of the OMERACT Ultrasound Tenosynovitis Scoring System in Multicenter Clinical Trials

Mads Ammitzbøll-Danielsen; Mikkel Østergaard; Esperanza Naredo; Annamaria Iagnocco; Ingrid Möller; Maria-Antonietta D'Agostino; Frédérique Gandjbakhch; Lene Terslev

doi:10.3899/jrheum.170501

The Use of the OMERACT Ultrasound Tenosynovitis Scoring System in Multicenter Clinical Trials

J Rheumatol. 2018 Feb;45(2):165-169. doi: 10.3899/jrheum.170501. Epub 2017 Dec 15.

Authors

Mads Ammitzbøll-Danielsen^{1

2}, Mikkel Østergaard^{3

4}, Esperanza Naredo^{3

4}, Annamaria Iagnocco^{3

4}, Ingrid Möller^{3

4}, Maria-Antonietta D'Agostino^{3

4}, Frédérique Gandjbakhch^{3

4}, Lene Terslev^{3

4}

Affiliations

¹ From the Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark; Department of Rheumatology, Hospital General Universitario Gregorio Marañón and Universidad Complutense, Madrid; Department of Rheumatology, Joint and Bone Research Unit, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain; Dipartimento Scienze Cliniche e Biologiche, Università degli Studi di Torino, Turin, Italy; Servicio de Reumatología, Instituto Poal de Reumatologia Barcelona, Barcelona, Spain; Department of Rheumatology, AP-HP Ambroise Paré Hospital, Boulogne-Billancourt, Université Versailles Saint Quentin en Yvelines; Department of Rheumatology, Pitie Salpetriere Hospital, AP-HP, Université Paris 6-UPMC, Paris, France. ammitz7@gmail.com.
² M. Ammitzbøll-Danielsen, MD, PhD, COPECARE, Center for Rheumatology and Spine Diseases, Rigshospitalet, and Department of Clinical Medicine, University of Copenhagen; M. Østergaard, MD, PhD, DMSc, Professor, COPECARE, Center for Rheumatology and Spine Diseases, Rigshospitalet, and Department of Clinical Medicine, University of Copenhagen; E. Naredo, MD, Department of Rheumatology, Hospital General Universitario Gregorio Marañón and Universidad Complutense, and Department of Rheumatology, Joint and Bone Research Unit, Hospital Universitario Fundación Jiménez Díaz; A. Iagnocco, MD, Professor, Dipartimento Scienze Cliniche e Biologiche, Università degli Studi di Torino; I. Möller, MD, Servicio de Reumatología, Instituto Poal de Reumatologia; M.A. D'Agostino, MD, PhD, Professor, Department of Rheumatology, AP-HP Ambroise Paré Hospital; F. Gandjbakhch, MD, Department of Rheumatology, Pitie Salpetriere Hospital, AP-HP; L. Terslev, MD, PhD, COPECARE, Center for Rheumatology and Spine Diseases, Rigshospitalet. ammitz7@gmail.com.
³ From the Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark; Department of Rheumatology, Hospital General Universitario Gregorio Marañón and Universidad Complutense, Madrid; Department of Rheumatology, Joint and Bone Research Unit, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain; Dipartimento Scienze Cliniche e Biologiche, Università degli Studi di Torino, Turin, Italy; Servicio de Reumatología, Instituto Poal de Reumatologia Barcelona, Barcelona, Spain; Department of Rheumatology, AP-HP Ambroise Paré Hospital, Boulogne-Billancourt, Université Versailles Saint Quentin en Yvelines; Department of Rheumatology, Pitie Salpetriere Hospital, AP-HP, Université Paris 6-UPMC, Paris, France.
⁴ M. Ammitzbøll-Danielsen, MD, PhD, COPECARE, Center for Rheumatology and Spine Diseases, Rigshospitalet, and Department of Clinical Medicine, University of Copenhagen; M. Østergaard, MD, PhD, DMSc, Professor, COPECARE, Center for Rheumatology and Spine Diseases, Rigshospitalet, and Department of Clinical Medicine, University of Copenhagen; E. Naredo, MD, Department of Rheumatology, Hospital General Universitario Gregorio Marañón and Universidad Complutense, and Department of Rheumatology, Joint and Bone Research Unit, Hospital Universitario Fundación Jiménez Díaz; A. Iagnocco, MD, Professor, Dipartimento Scienze Cliniche e Biologiche, Università degli Studi di Torino; I. Möller, MD, Servicio de Reumatología, Instituto Poal de Reumatologia; M.A. D'Agostino, MD, PhD, Professor, Department of Rheumatology, AP-HP Ambroise Paré Hospital; F. Gandjbakhch, MD, Department of Rheumatology, Pitie Salpetriere Hospital, AP-HP; L. Terslev, MD, PhD, COPECARE, Center for Rheumatology and Spine Diseases, Rigshospitalet.

PMID: 29247153
DOI: 10.3899/jrheum.170501

Abstract

Objective: To test the sensitivity to change of the Outcome Measures in Rheumatology Clinical Trials (OMERACT) ultrasound (US) scoring system for tenosynovitis when applied in a multicenter design.

Methods: RA patients with US-verified tenosynovitis were recruited when scheduled for treatment intensification. Tenosynovitis was assessed at baseline, and 3 and 6 months followup, using the semiquantitative OMERACT scoring system.

Results: Expressed in median (25th; 75th percentiles), the overall greyscale and Doppler score decreased significantly from baseline at 4 (2; 7) and 3 (2; 6), to 6 months at 2 (0; 3) and 0 (0; 1, p < 0.01), respectively, and showed high responsiveness (standardized response mean ≥ 0.8).

Conclusion: The OMERACT US scoring system for tenosynovitis showed high responsiveness, supporting its use for diagnosing and monitoring tenosynovitis in multicenter trials.

Keywords: OMERACT; RHEUMATOID ARTHRITIS; TENOSYNOVITIS; ULTRASONOGRAPHY.

Publication types

Clinical Trial
Multicenter Study

MeSH terms

Adult
Aged
Arthritis, Rheumatoid / diagnostic imaging*
C-Reactive Protein / analysis
Female
Follow-Up Studies
Health Surveys
Humans
Male
Middle Aged
Outpatients
Pain Measurement / methods
Research Design*
Statistics, Nonparametric
Synovitis / diagnostic imaging
Tenosynovitis / diagnostic imaging*
Ultrasonography, Doppler

Substances

C-Reactive Protein