Instrument Selection Using the OMERACT Filter 2.1: The OMERACT Methodology

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

doi:10.3899/jrheum.181218

Instrument Selection Using the OMERACT Filter 2.1: The OMERACT Methodology

J Rheumatol. 2019 Aug;46(8):1028-1035. doi: 10.3899/jrheum.181218. Epub 2019 Feb 1.

Authors

Dorcas E Beaton^{1

2}, Lara J Maxwell^{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 P de Wit^{3

4}, Laure Gossec^{3

4}, Lyn M 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 Institute for Work & Health and Institute for Health Policy Management and Evaluation, University of Toronto, Toronto; Clinical Epidemiology Program, and Centre for Practice-Changing Research, Ottawa Hospital Research Institute; Cardiovascular Research Methods Centre, University of Ottawa Heart Institute; Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ontario, Canada; Department of Epidemiology and Biostatistics, and Department of Medical Humanities, Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands; Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland; Medicine Service, VA Medical Center; Department of Medicine, School of Medicine, University of Alabama; Division of Epidemiology, School of Public Health, University of Alabama, Birmingham, Alabama; SDG LLC, Cambridge, Massachusetts, 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 Université; Pitié Salpêtrière hospital, AP-HP, Rheumatology Department, Paris, France; Sydney Medical School, Institute of Bone and Joint Research and Department of Rheumatology, Royal North Shore Hospital, St. Leonards, Australia. dbeaton@iwh.on.ca.
² D.E. Beaton, PhD, Senior Scientist, Institute for Work & Health, Department of Occupational Science and Occupational Therapy, Rehabilitation Sciences Institute, and Associate Professor, Institute Health Policy, Management and Evaluation, University of Toronto; B.J. Shea, PhD, Senior Scientist, Ottawa Hospital Research Institute, Clinical Epidemiology Program, and School of Epidemiology, Public Health and Preventive Medicine, Faculty of Medicine, University of Ottawa; L.J. Maxwell, PhD, Methodological Advisory to the Technical Advisory Group, OMERACT, University of Ottawa, and Centre for Practice-Changing Research, Ottawa Hospital Research Institute; 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, BS, Secretariat, OMERACT, and University of Ottawa; C.O. Bingham III, MD, Professor of Medicine, Division of Rheumatology, Johns Hopkins University; P.G. Conaghan, MD, PhD, Director, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and Deputy Director, NIHR Leeds Biomedical Research Centre; M.A. D'Agostino, MD, PhD, AP-HP, Hôpital Ambroise Paré, Rheumatology Department, and INSERM U1173, Laboratoire d'Excellence INFLAMEX, UFR Simone Veil, Versailles-Saint-Quentin University; M.P. de Wit, PhD, OMERACT Patient Research Partner, and Amsterdam University Medical Centre, Department Medical Humanities, Amsterdam Public Health; L. Gossec, MD, PhD, Sorbonne Université, and AP-HP, Pitié Salpêtrière Hospital, Department of Rheumatology; L.M. March, MBBS, PhD, Liggins Professor of Rheumatology and Musculoskeletal Epidemiology, Sydney Medical School, Institute of Bone and Joint Research, and Head of 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 at Birmingham; L.S. Simon, MD, Co-managing director of SDG LLC; V. Strand, MD, MACR, FACP, Biopharmaceutical Consultant; 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. dbeaton@iwh.on.ca.
³ From the Institute for Work & Health and Institute for Health Policy Management and Evaluation, University of Toronto, Toronto; Clinical Epidemiology Program, and Centre for Practice-Changing Research, Ottawa Hospital Research Institute; Cardiovascular Research Methods Centre, University of Ottawa Heart Institute; Division of Rheumatology, Department of Medicine, and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ontario, Canada; Department of Epidemiology and Biostatistics, and Department of Medical Humanities, Amsterdam UMC, Vrije Universiteit, Amsterdam, the Netherlands; Division of Rheumatology, Department of Medicine, Johns Hopkins University, Baltimore, Maryland; Medicine Service, VA Medical Center; Department of Medicine, School of Medicine, University of Alabama; Division of Epidemiology, School of Public Health, University of Alabama, Birmingham, Alabama; SDG LLC, Cambridge, Massachusetts, 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 Université; Pitié Salpêtrière hospital, AP-HP, Rheumatology Department, Paris, France; Sydney Medical School, Institute of Bone and Joint Research and Department of Rheumatology, Royal North Shore Hospital, St. Leonards, Australia.
⁴ D.E. Beaton, PhD, Senior Scientist, Institute for Work & Health, Department of Occupational Science and Occupational Therapy, Rehabilitation Sciences Institute, and Associate Professor, Institute Health Policy, Management and Evaluation, University of Toronto; B.J. Shea, PhD, Senior Scientist, Ottawa Hospital Research Institute, Clinical Epidemiology Program, and School of Epidemiology, Public Health and Preventive Medicine, Faculty of Medicine, University of Ottawa; L.J. Maxwell, PhD, Methodological Advisory to the Technical Advisory Group, OMERACT, University of Ottawa, and Centre for Practice-Changing Research, Ottawa Hospital Research Institute; 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, BS, Secretariat, OMERACT, and University of Ottawa; C.O. Bingham III, MD, Professor of Medicine, Division of Rheumatology, Johns Hopkins University; P.G. Conaghan, MD, PhD, Director, Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, and Deputy Director, NIHR Leeds Biomedical Research Centre; M.A. D'Agostino, MD, PhD, AP-HP, Hôpital Ambroise Paré, Rheumatology Department, and INSERM U1173, Laboratoire d'Excellence INFLAMEX, UFR Simone Veil, Versailles-Saint-Quentin University; M.P. de Wit, PhD, OMERACT Patient Research Partner, and Amsterdam University Medical Centre, Department Medical Humanities, Amsterdam Public Health; L. Gossec, MD, PhD, Sorbonne Université, and AP-HP, Pitié Salpêtrière Hospital, Department of Rheumatology; L.M. March, MBBS, PhD, Liggins Professor of Rheumatology and Musculoskeletal Epidemiology, Sydney Medical School, Institute of Bone and Joint Research, and Head of 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 at Birmingham; L.S. Simon, MD, Co-managing director of SDG LLC; V. Strand, MD, MACR, FACP, Biopharmaceutical Consultant; 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: 30709952
DOI: 10.3899/jrheum.181218

Abstract

Objective: Outcome Measures in Rheumatology (OMERACT) Filter 2.1 revised the process used for core outcome measurement set selection to add rigor and transparency in decision making. This paper describes OMERACT's methodology for instrument selection.

Methods: We presented instrument selection processes, tools, and reporting templates at OMERACT 2018, introducing the concept of "3 pillars, 4 questions, 7 measurement properties, 1 answer." Truth, discrimination, and feasibility are the 3 original OMERACT pillars. Based on these, we developed 4 signaling questions. We introduced the Summary of Measurement Properties table that summarizes the 7 measurement properties: truth (domain match, construct validity), discrimination [test-retest reliability, longitudinal construct validity (responsiveness), clinical trial discrimination, thresholds of meaning], and feasibility. These properties address a set of standards which, when met, answer the one question: Is there enough evidence to support the use of this instrument in clinical research of the benefits and harms of treatments in the population and study setting described? The OMERACT Filter 2.1 was piloted on 2 instruments by the Psoriatic Arthritis Working Group.

Results: The methodology was reviewed in a full plenary session and facilitated breakout groups. Tools to facilitate retention of the process (i.e., "The OMERACT Way") were provided. The 2 instruments were presented, and the recommendation of the working group was endorsed in the first OMERACT Filter 2.1 Instrument Selection votes.

Conclusion: Instrument selection using OMERACT Filter 2.1 is feasible and is now being implemented.

Keywords: HEALTH STATUS INDICATOR; OMERACT; OUTCOME ASSESSMENT; OUTCOME MEASURES; RELIABILITY AND VALIDITY; REPRODUCIBILITY OF RESULTS.

Publication types

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

MeSH terms

Antirheumatic Agents / therapeutic use*
Arthritis, Psoriatic / drug therapy*
Clinical Trials as Topic*
Humans
Outcome Assessment, Health Care*
Reproducibility of Results
Rheumatology / standards*

Substances

Antirheumatic Agents