Core Domain Set Selection According to OMERACT Filter 2.1: The OMERACT Methodology

Lara J Maxwell; Dorcas E Beaton; Beverley J Shea; George A Wells; Maarten Boers; Shawna Grosskleg; Clifton O Bingham 3rd; Philip G Conaghan; Maria Antonietta D'Agostino; Maarten de Wit; Laure Gossec; Lyn March; Lee S Simon; Jasvinder A Singh; Vibeke Strand; Peter Tugwell

doi:10.3899/jrheum.181097

Core Domain Set Selection According to OMERACT Filter 2.1: The OMERACT Methodology

J Rheumatol. 2019 Aug;46(8):1014-1020. doi: 10.3899/jrheum.181097. Epub 2019 Feb 15.

Authors

Lara J Maxwell^{1

2}, Dorcas E Beaton^{3

4}, Beverley J Shea^{3

4}, George A Wells^{3

4}, Maarten Boers^{3

4}, Shawna Grosskleg^{3

4}, Clifton O Bingham 3rd^{3

4}, Philip G Conaghan^{3

4}, Maria Antonietta D'Agostino^{3

4}, Maarten de Wit^{3

4}, Laure Gossec^{3

4}, Lyn March^{3

4}, Lee S Simon^{3

4}, Jasvinder A Singh^{3

4}, Vibeke Strand^{3

4}, Peter Tugwell^{3

4}

Affiliations

¹ From the Centre for Practice-Changing Research, Ottawa Hospital Research Institute; Ottawa Hospital Research Institute, Clinical Epidemiology Program; School of Epidemiology, Public Health and Preventive Medicine, Faculty of Medicine, University of Ottawa; Cardiovascular Research Methods Centre, University of Ottawa Heart Institute; Department of Epidemiology and Community Medicine, University of Ottawa; Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa; Institute for Work & Health; Institute Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Clinical Epidemiology, Amsterdam UMC, Vrije Universiteit Amsterdam; Amsterdam University Medical Centre, Department of Medical Humanities, Amsterdam Public Health, Amsterdam, the Netherlands; Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland; Medicine and Epidemiology, Department of Medicine at the School of Medicine, University of Alabama, Birmingham, Alabama; SDG LLC, Cambridge, Massachusetts; Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, California, USA; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; UK National Institute for Health Research (NIHR) Leeds Biomedical Research Centre, Leeds, UK; Hôpital Ambroise Paré, Rheumatology Department, Boulogne-Billancourt; INSERM U1173, Laboratoire d'Excellence INFLAMEX, UFR Simone Veil, Versailles-Saint-Quentin University, Saint-Quentin en Yvelines; Sorbonne Universités, UPMC Univ Paris 06; AP-HP, Pitié Salpêtrière Hospital, Department of Rheumatology, Paris, France; Rheumatology and Musculoskeletal Epidemiology, Sydney Medical School, Institute of Bone and Joint Research; Department of Rheumatology, Royal North Shore Hospital, St Leonards, Australia. lmaxwell@uottawa.ca.
² L.J. Maxwell, PhD, University of Ottawa and Centre for Practice-Changing Research, Ottawa Hospital Research Institute; B.J. Shea, PhD, Clinical Investigator, Ottawa Hospital Research Institute, Clinical Epidemiology Program, and School of Epidemiology, Public Health and Preventive Medicine, Faculty of Medicine, University of Ottawa; D.E. Beaton, PhD, Senior Scientist, Institute for Work & Health, and Associate Professor, Institute Health Policy, Management and Evaluation, University of Toronto; G.A. Wells, MSc, PhD, Director, Cardiovascular Research Methods Centre, University of Ottawa Heart Institute, and Professor, Department of Epidemiology and Community Medicine, University of Ottawa; M. Boers, MD, PhD, Professor of Clinical Epidemiology, Amsterdam UMC, Vrije Universiteit Amsterdam; S. Grosskleg, OMERACT Secretariat, University of Ottawa; C.O. Bingham III, MD, Division of Rheumatology, Department of Medicine, Johns Hopkins University; P.G. Conaghan, MD, PhD, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Biomedical Research Centre; M.A. D'Agostino, MD, PhD, AP-HP, Professor of Rheumatology, Hôpital Ambroise Paré, Rheumatology Department, and INSERM U1173, Laboratoire d'Excellence INFLAMEX, UFR Simone Veil, Versailles-Saint-Quentin University; M. de Wit, PhD, OMERACT Patient Research Partner, and Amsterdam University Medical Centre, Department of Medical Humanities, Amsterdam Public Health; L. Gossec, MD, PhD, Professor of Rheumatology, Sorbonne Universités, UPMC Univ Paris 06, and AP-HP, Pitié Salpêtrière Hospital, Department of Rheumatology; L. March, MBBS, PhD, Liggins Professor of Rheumatology and Musculoskeletal Epidemiology, Sydney Medical School, Institute of Bone and Joint Research and Department of Rheumatology, Royal North Shore Hospital; J.A. Singh, MBBS, MPH, Professor of Medicine and Epidemiology, Department of Medicine at the School of Medicine, University of Alabama; L.S. Simon, MD, Co-Managing Director of SDG LLC; V. Strand, Biopharmaceutical Consultant, Portola Valley, California, USA; P. Tugwell, MD, MSc, Professor, Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, and Clinical Epidemiology Program, Ottawa Hospital Research Institute. lmaxwell@uottawa.ca.
³ From the Centre for Practice-Changing Research, Ottawa Hospital Research Institute; Ottawa Hospital Research Institute, Clinical Epidemiology Program; School of Epidemiology, Public Health and Preventive Medicine, Faculty of Medicine, University of Ottawa; Cardiovascular Research Methods Centre, University of Ottawa Heart Institute; Department of Epidemiology and Community Medicine, University of Ottawa; Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa; Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa; Institute for Work & Health; Institute Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada; Clinical Epidemiology, Amsterdam UMC, Vrije Universiteit Amsterdam; Amsterdam University Medical Centre, Department of Medical Humanities, Amsterdam Public Health, Amsterdam, the Netherlands; Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland; Medicine and Epidemiology, Department of Medicine at the School of Medicine, University of Alabama, Birmingham, Alabama; SDG LLC, Cambridge, Massachusetts; Division of Immunology/Rheumatology, Stanford University School of Medicine, Palo Alto, California, USA; Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds; UK National Institute for Health Research (NIHR) Leeds Biomedical Research Centre, Leeds, UK; Hôpital Ambroise Paré, Rheumatology Department, Boulogne-Billancourt; INSERM U1173, Laboratoire d'Excellence INFLAMEX, UFR Simone Veil, Versailles-Saint-Quentin University, Saint-Quentin en Yvelines; Sorbonne Universités, UPMC Univ Paris 06; AP-HP, Pitié Salpêtrière Hospital, Department of Rheumatology, Paris, France; Rheumatology and Musculoskeletal Epidemiology, Sydney Medical School, Institute of Bone and Joint Research; Department of Rheumatology, Royal North Shore Hospital, St Leonards, Australia.
⁴ L.J. Maxwell, PhD, University of Ottawa and Centre for Practice-Changing Research, Ottawa Hospital Research Institute; B.J. Shea, PhD, Clinical Investigator, Ottawa Hospital Research Institute, Clinical Epidemiology Program, and School of Epidemiology, Public Health and Preventive Medicine, Faculty of Medicine, University of Ottawa; D.E. Beaton, PhD, Senior Scientist, Institute for Work & Health, and Associate Professor, Institute Health Policy, Management and Evaluation, University of Toronto; G.A. Wells, MSc, PhD, Director, Cardiovascular Research Methods Centre, University of Ottawa Heart Institute, and Professor, Department of Epidemiology and Community Medicine, University of Ottawa; M. Boers, MD, PhD, Professor of Clinical Epidemiology, Amsterdam UMC, Vrije Universiteit Amsterdam; S. Grosskleg, OMERACT Secretariat, University of Ottawa; C.O. Bingham III, MD, Division of Rheumatology, Department of Medicine, Johns Hopkins University; P.G. Conaghan, MD, PhD, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Biomedical Research Centre; M.A. D'Agostino, MD, PhD, AP-HP, Professor of Rheumatology, Hôpital Ambroise Paré, Rheumatology Department, and INSERM U1173, Laboratoire d'Excellence INFLAMEX, UFR Simone Veil, Versailles-Saint-Quentin University; M. de Wit, PhD, OMERACT Patient Research Partner, and Amsterdam University Medical Centre, Department of Medical Humanities, Amsterdam Public Health; L. Gossec, MD, PhD, Professor of Rheumatology, Sorbonne Universités, UPMC Univ Paris 06, and AP-HP, Pitié Salpêtrière Hospital, Department of Rheumatology; L. March, MBBS, PhD, Liggins Professor of Rheumatology and Musculoskeletal Epidemiology, Sydney Medical School, Institute of Bone and Joint Research and Department of Rheumatology, Royal North Shore Hospital; J.A. Singh, MBBS, MPH, Professor of Medicine and Epidemiology, Department of Medicine at the School of Medicine, University of Alabama; L.S. Simon, MD, Co-Managing Director of SDG LLC; V. Strand, Biopharmaceutical Consultant, Portola Valley, California, USA; P. Tugwell, MD, MSc, Professor, Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, and Clinical Epidemiology Program, Ottawa Hospital Research Institute.

PMID: 30770502
DOI: 10.3899/jrheum.181097

Abstract

Objective: To describe the Outcome Measures in Rheumatology (OMERACT) Filter 2.1 methodology for core domain set selection.

Methods: The "OMERACT Way for Core Domain Set selection" framework consists of 3 stages: first, generating candidate domains through literature reviews and qualitative work, then a process of consensus to obtain agreement from those involved, and finally formal voting on the OMERACT Onion. The OMERACT Onion describes the placement of domains in layers/circles: mandatory in all trials/mandatory in specific circumstances (inner circle); important but optional (middle circle); or research agenda (outer circle). Five OMERACT working groups presented their core domain sets for endorsement by the OMERACT community. Tools including a workbook and whiteboard video were created to assist the process. The methods workshop at OMERACT 2018 introduced participants to this framework.

Results: The 5 OMERACT working groups achieved consensus on their proposed core domain sets. After the Methodology Workshop training exercise at OMERACT 2018, over 90% of participants voted that they were confident that they understood the process of core domain set selection.

Conclusion: The methods described in this paper were successfully used by the 5 working groups voting on domains at the OMERACT 2018 meeting, demonstrating the feasibility of the process. In addition, participants at OMERACT 2018 expressed increased confidence and understanding of the core domain set selection process after the training exercise. This methodology will continue to evolve, and we will use innovative technology such as whiteboard videos as a key part of our dissemination and implementation strategy for new methods.

Keywords: OMERACT; OUTCOMES ASSESSMENT HEALTH CARE; OUTCOMES RESEARCH; RHEUMATOLOGY.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Clinical Trials as Topic*
Consensus
Humans
Outcome Assessment, Health Care*
Rheumatology*