Lene Terslev1,2, Esperanza Naredo1,2, Helen I Keen1,2, George A W Bruyn1,2, Annamaria Iagnocco1,2, Richard J Wakefield1,2, Philip G Conaghan1,2, Lara J Maxwell1,2, Dorcas E Beaton1,2, Maarten Boers1,2, Maria-Antonietta D'Agostino3,4. 1. From the Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen, Denmark; Department of Rheumatology, Bone and Joint Research Unit, Hospital Universitario Fundación Jiménez Díaz, IIS Fundación Jiménez Díaz; Universidad Autónoma de Madrid, Madrid, Spain; Department of Rheumatology, University of Perth, Perth, Australia; Department of Rheumatology, MC Groep Hospitals, Lelystad; Department of Epidemiology and Biostatistics, and Amsterdam Rheumatology and Immunology Center, Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands; Dipartimento di Scienze Cliniche e Biologiche (DSCB) Università degli Studi di Torino, Medicina Fisica Riabilitativa Universitaria (MFRU) Città della Salute e della Scienza, Turin, Italy; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; NIHR Leeds Biomedical Research Centre, Leeds, UK; University of Ottawa and Centre for Practice-Changing Research, Ottawa Hospital Research Institute, Ottawa; Institute for Work and Health and Institute for Health Policy Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Rheumatology Department, AP-HP, Hôpital Ambroise Paré, Boulogne-Billancourt; INSERM U1173, Labex Inflamex, Université Versailles St-Quentin en Yvelines, Montigny Les Bretonneux, France. 2. L. Terslev, MD, PhD, Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet; E. Naredo, MD, Department of Rheumatology, Bone and Joint Research Unit, Hospital Universitario Fundación Jiménez Díaz, IIS Fundación Jiménez Díaz, and Universidad Autónoma de Madrid; H.I. Keen, MD, PhD, Department of Rheumatology, University of Perth; G.A. Bruyn, MD, PhD, Department of Rheumatology, MC Groep Hospitals; A. Iagnocco, MD, DSCB Università degli Studi di Torino, MFRU Città della Salute e della Scienza; R.J. Wakefield, MD, PhD, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre; P.G. Conaghan, MD, PhD, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre; L.J. Maxwell, PhD, University of Ottawa and Centre for Practice-Changing Research, Ottawa Hospital Research Institute; D.E. Beaton, PhD, Institute for Work and Health and Institute for Health Policy Management and Evaluation, University of Toronto; M. Boers, MD, PhD, Department of Epidemiology and Biostatistics, and Amsterdam Rheumatology and Immunology Center, Amsterdam UMC, Vrije Universiteit; M.A. D'Agostino, MD, PhD, Rheumatology Department, AP-HP, Hôpital Ambroise Paré, and INSERM U1173, Labex Inflamex, Université Versailles St-Quentin en Yvelines. 3. From the Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen, Denmark; Department of Rheumatology, Bone and Joint Research Unit, Hospital Universitario Fundación Jiménez Díaz, IIS Fundación Jiménez Díaz; Universidad Autónoma de Madrid, Madrid, Spain; Department of Rheumatology, University of Perth, Perth, Australia; Department of Rheumatology, MC Groep Hospitals, Lelystad; Department of Epidemiology and Biostatistics, and Amsterdam Rheumatology and Immunology Center, Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands; Dipartimento di Scienze Cliniche e Biologiche (DSCB) Università degli Studi di Torino, Medicina Fisica Riabilitativa Universitaria (MFRU) Città della Salute e della Scienza, Turin, Italy; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; NIHR Leeds Biomedical Research Centre, Leeds, UK; University of Ottawa and Centre for Practice-Changing Research, Ottawa Hospital Research Institute, Ottawa; Institute for Work and Health and Institute for Health Policy Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Rheumatology Department, AP-HP, Hôpital Ambroise Paré, Boulogne-Billancourt; INSERM U1173, Labex Inflamex, Université Versailles St-Quentin en Yvelines, Montigny Les Bretonneux, France. maria-antonietta.dagostino@apr.aphp.fr. 4. L. Terslev, MD, PhD, Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet; E. Naredo, MD, Department of Rheumatology, Bone and Joint Research Unit, Hospital Universitario Fundación Jiménez Díaz, IIS Fundación Jiménez Díaz, and Universidad Autónoma de Madrid; H.I. Keen, MD, PhD, Department of Rheumatology, University of Perth; G.A. Bruyn, MD, PhD, Department of Rheumatology, MC Groep Hospitals; A. Iagnocco, MD, DSCB Università degli Studi di Torino, MFRU Città della Salute e della Scienza; R.J. Wakefield, MD, PhD, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre; P.G. Conaghan, MD, PhD, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre; L.J. Maxwell, PhD, University of Ottawa and Centre for Practice-Changing Research, Ottawa Hospital Research Institute; D.E. Beaton, PhD, Institute for Work and Health and Institute for Health Policy Management and Evaluation, University of Toronto; M. Boers, MD, PhD, Department of Epidemiology and Biostatistics, and Amsterdam Rheumatology and Immunology Center, Amsterdam UMC, Vrije Universiteit; M.A. D'Agostino, MD, PhD, Rheumatology Department, AP-HP, Hôpital Ambroise Paré, and INSERM U1173, Labex Inflamex, Université Versailles St-Quentin en Yvelines. maria-antonietta.dagostino@apr.aphp.fr.
Abstract
OBJECTIVE: To describe the Outcome Measures in Rheumatology (OMERACT) stepwise approach to select and develop an imaging instrument with musculoskeletal ultrasound (US) as an example. METHODS: The OMERACT US Working Group (WG) developed a 4-step process to select instruments based on imaging. Step 1 applies the OMERACT Framework Instrument Selection Algorithm (OFISA) to existing US outcome measurement instruments for a specific indication. This step requires a literature review focused on the truth, discrimination, and feasibility aspects of the instrument for the target pathology. When the evidence is completely unsatisfactory, Step 2 is a consensus process to define the US characteristics of the target pathology including one or more so-called "elementary lesions". Step 3 applies the agreed definitions to the image, evaluates their reliability, develops a severity grading of the lesion(s) at a given anatomical site, and evaluates the effect of the acquisition technique on feasibility and lesion(s) detection. Step 4 applies and assesses the definition(s) and scoring system(s) in cross-sectional studies and multicenter trials. The imaging instrument is now ready to pass a final OFISA check. RESULTS: With this process in place, the US WG now has 18 subgroups developing US instruments in 10 different diseases. Half of them have passed Step 3, and the groups for enthesitis (spondyloarthritis, psoriatic arthritis), synovitis, and tenosynovitis (rheumatoid arthritis) have finished Step 4. CONCLUSION: The US WG approach to select and develop outcome measurement instruments based on imaging has been repeatedly and successfully applied in US, but is generic for imaging and fits with OMERACT Filter 2.1.
OBJECTIVE: To describe the Outcome Measures in Rheumatology (OMERACT) stepwise approach to select and develop an imaging instrument with musculoskeletal ultrasound (US) as an example. METHODS: The OMERACT US Working Group (WG) developed a 4-step process to select instruments based on imaging. Step 1 applies the OMERACT Framework Instrument Selection Algorithm (OFISA) to existing US outcome measurement instruments for a specific indication. This step requires a literature review focused on the truth, discrimination, and feasibility aspects of the instrument for the target pathology. When the evidence is completely unsatisfactory, Step 2 is a consensus process to define the US characteristics of the target pathology including one or more so-called "elementary lesions". Step 3 applies the agreed definitions to the image, evaluates their reliability, develops a severity grading of the lesion(s) at a given anatomical site, and evaluates the effect of the acquisition technique on feasibility and lesion(s) detection. Step 4 applies and assesses the definition(s) and scoring system(s) in cross-sectional studies and multicenter trials. The imaging instrument is now ready to pass a final OFISA check. RESULTS: With this process in place, the US WG now has 18 subgroups developing US instruments in 10 different diseases. Half of them have passed Step 3, and the groups for enthesitis (spondyloarthritis, psoriatic arthritis), synovitis, and tenosynovitis (rheumatoid arthritis) have finished Step 4. CONCLUSION: The US WG approach to select and develop outcome measurement instruments based on imaging has been repeatedly and successfully applied in US, but is generic for imaging and fits with OMERACT Filter 2.1.
Authors: Alen Zabotti; Sara Zandonella Callegher; Annarita Tullio; Arso Vukicevic; Alojzija Hocevar; Vera Milic; Giacomo Cafaro; Marina Carotti; Konstantina Delli; Orazio De Lucia; Diana Ernst; Francesco Ferro; Angelica Gattamelata; Giuseppe Germanò; Ivan Giovannini; Daniel Hammenfors; Malin V Jonsson; Sandrine Jousse-Joulin; Pierluigi Macchioni; Simone Parisi; Carlo Perricone; Martin Helmut Stradner; Nenad Filipovic; Athanasios G Tzioufas; Francesca Valent; Salvatore De Vita Journal: Front Med (Lausanne) Date: 2020-11-23
Authors: Patricia Vega-Fernandez; Tracy V Ting; Edward J Oberle; Courtney McCracken; Janet Figueroa; Mekibib Altaye; Amy Cassedy; Gurjit S Kaeley; Johannes Roth Journal: Arthritis Care Res (Hoboken) Date: 2021-07-30 Impact factor: 5.178