Improving domain definition and outcome instrument selection: Lessons learned for OMERACT from imaging.

Autor: D'Agostino MA; Università Cattolica del Sacro Cuore; Rheumatology UOC, Fondazione Policlinico Universitario Agostino Gemelli, IRCSS, Rome, Italy; UVSQ, Inserm U1173, Infection et inflammation, Laboratory of Excellence INFLAMEX, Université Paris-Saclay, Montigny-le-Bretonneux, France. Electronic address: mariaantonietta.dagostino@unicatt.it., Beaton DE; Institute for Work & Health and Institute for Health Policy Management and Evaluation, University of Toronto, Toronto., Maxwell LJ; Faculty of Medicine, University of Ottawa, Ottawa, Canada., Cembalo SM; OMERACT Patient Research Partner., Hoens AM; OMERACT Patient Research Partner; University of British Columbia Faculty of Medicine Department of Physical Therapy, Canada; Patient Partner, Arthritis Research Canada., Hofstetter C; OMERACT Patient Research Partner., Zabalan C; OMERACT Patient Research Partner; Romanian League against Rheumatism., Bird P; University of New South Wales, Sydney, Australia., Christensen R; Section for Biostatistics and Evidence-Based Research, the Parker Institute, Bispebjerg, Frederiksberg Hospital, Copenhagen, Denmark; Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Denmark., de Wit M; OMERACT Patient Research Partner., Doria AS; The Hospital for Sick Children, Medical Imaging Department, University of Toronto, Toronto, Canada., Maksymowych WP; Department of Medicine, University of Alberta, Canada., Oo WM; Rheumatology Department, Institute of Bone and Joint Disease, Kolling Institute, Sydney University, Sydney, Australia; Department of Physical Medicine and Rehabilitation, University of Medicine, Mandalay, Mandalay, Myanmar., Østergaard M; Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark., Serban T; La Colletta Hospital, Rheumatology Department, ASL3 Genovese, Genoa, Italy., Sloan VS; Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ, USA; The Peace Corps, USA., Terslev L; Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark., van Rossum MA; Amsterdam Rheumatology and Immunology Center | Reade and Emma Children's Hospital Amsterdam University Medical Centers, Amsterdam, The Netherlands., Conaghan PG; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and NIHR Leeds Biomedical Research Centre, UK., Boers M; Department of Epidemiology and Data Science, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands; Amsterdam Rheumatology and Immunology Center, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Jazyk: angličtina
Zdroj: Seminars in arthritis and rheumatism [Semin Arthritis Rheum] 2021 Oct; Vol. 51 (5), pp. 1125-1133. Date of Electronic Publication: 2021 Aug 20.
DOI: 10.1016/j.semarthrit.2021.08.004
Abstrakt: Objectives: Imaging is one of the most rapidly evolving fields in medicine. Unfortunately, many imaging technologies have been applied as measurement instruments without rigorous evaluation of the evidence supporting their truth, discriminatory capability and feasibility for that context of use. The Outcome Measures in Rheumatology (OMERACT) Filter 2.1 Instrument Selection Algorithm (OFISA) is used to evaluate such evidence for use of an instrument in a research setting. The objectives of this work are to: [1] define and describe the key conceptual aspects that are essential for the evaluation of imaging as an outcome measurement instrument and [2] describe how these aspects can be assessed through OFISA.
Methods: Experts in imaging and/or methodology met to formalize concepts and define key steps. These concepts were discussed with a team of patient research partners with interest in imaging to refine technical and methodological aspects into comprehensible information. A workshop was held at OMERACT2020 and feedback was incorporated into existing OMERACT process for domain and instrument selection.
Results: Three key lessons were identified: (1) a clear definition of the domain we want to measure is a necessary prerequisite to the selection of a good instrument, (2) the sources of variability that can directly influence the instrument should be clearly identified, (3) incorporating these first two lessons into OFISA improves the quality of every instrument selection process.
Conclusions: The incorporation of these lessons in the updated OMERACT Filter (now 2.2) will improve the quality of the selection process for all types of outcome measurement instruments.
Competing Interests: Declaration of Competing Interest Dorcas Beaton, Paul Bird, Maarten Boers, Sam Michel Cembalo, Philip Conaghan, Maria Antonietta D'Agostino, Maarten de Wit, Alison Hoens, Catherine Hofstetter, Lara Maxwell, Win Min Oo, Marion van Rossum, Teodora Serban, Lene Terslev, Codruta Zabalan report they have nothing to disclose. Andrea Doria reports: Advisory Board(s) International Prophylaxis Study Group (not for profit), OMERACT SIG in MRI in JIA (not for profit), Research Support Baxalta-Shire (Research Grant), Novo Nordisk (Research Grant), Terry Fox Foundation (Research Grant), PSI Foundation (Research Grant), Society of Pediatric Radiology (Research Grant), Garron Family Cancer Centre (Research Grant). Robin Christensen reports: The Parker Institute is grateful for the financial support received from public and private foundations, companies and private individuals over the years. The Parker Institute is supported by a core grant from the Oak Foundation; The Oak Foundation is a group of philanthropic organizations that, since its establishment in 1983, has given grants to not-for-profit organizations around the world. Prof. Christensen is a founding member of the Technical Advisory Group of OMERACT, an organization that develops outcome measures in rheumatology and receives arms-length funding from 12 companies. Walter P. Maksymowych is Chief Medical Officer of CARE Arthritis, a company that develops and validates imaging-based scoring systems for application in clinical trials and basic and clinical research of arthritis disorders. Victor Sloan reports stock for service as member of Board of Directors of Oncopath Genomics LLC outside the submitted work and as CEO of Sheng Consulting LLC I provided clinical research consulting services to several pharmaceutical companies involved in developing new therapies for autoimmune disease. Mikkel Østergaard reports grants, personal fees and non-financial support from AbbVie, grants, personal fees and non-financial support from BMS, personal fees from Boehringer-Ingelheim, personal fees from Eli Lilly, personal fees and non-financial support from Janssen, grants, personal fees and non-financial support from Merck, personal fees and non-financial support from Pfizer, personal fees and non-financial support from Roche, grants, personal fees and non-financial support from UCB, grants and personal fees from Celgene, personal fees from Sanofi, personal fees from Regeneron, grants, personal fees and non-financial support from Novartis, personal fees from Gilead, outside the submitted work.
(Copyright © 2021. Published by Elsevier Inc.)
Databáze: MEDLINE
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