Research ArticleArticle
Toward a Generalized Framework of Core Measurement Areas in Clinical Trials: A Position Paper for OMERACT 11
Maarten Boers, Leanne Idzerda, John R. Kirwan, Dorcas Beaton, Reuben Escorpizo, Annelies Boonen, Susan Magasi, Ian Sinha, Gerold Stucki and Peter Tugwell
The Journal of Rheumatology March 2014, jrheum.131307; DOI: https://doi.org/10.3899/jrheum.131307
Maarten Boers
From the Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands; Centre for Global Health Research, Institute of Population Health, University of Ottawa, Ottawa; University of Bristol, Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, UK; Mobility Program Clinical Research Unit, Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Toronto, Canada; International Classification of Functioning, Disability, and Health (ICF) Research Branch in cooperation with the World Health Organization (WHO) Collaborating Centre for the Family of International Classifications in Germany; Swiss Paraplegic Research (SPF), Nottwil; Department of Health Sciences and Health Policy, University of Lucerne, Lucerne; and at SPF, Nottwil, Switzerland; Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center and Caphri Research Institute, Maastricht, The Netherlands; Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA; Respiratory Unit, Alder Hey Children’s Hospital, Liverpool, UK; Department of Medicine, University of Ottawa, Ottawa, Canada. M. Boers, MD, PhD, Department of Epidemiology and Biostatistics, VU University Medical Center; L. Idzerda, MSc, Centre for Global Health Research, Institute of Population Health, University of Ottawa; J.R. Kirwan, MD, FRCP, Professor of Rheumatic Diseases, University of Bristol, Academic Rheumatology Unit, Bristol Royal Infirmary; D. Beaton, BScOT, PhD, Scientist and Director, Mobility Program Clinical Research Unit, Li Ka Shing Knowledge Institute of St. Michael’s Hospital; R. Escorpizo, PT, DPT, MSc, Research Scientist; G. Stucki, MD, MS, Director and Chair, ICF Research Branch in cooperation with the WHO Collaborating Centre for the Family of International Classifications in Germany, SPF, and Department of Health Sciences and Health Policy, University of Lucerne; A. Boonen, MD, PhD, Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center and Caphri Research Institute; S. Magasi, PhD, Assistant Professor, Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University; I. Sinha, PhD, Specialist Registrar in Paediatric Respiratory Medicine, Respiratory Unit, Alder Hey Children’s Hospital; P. Tugwell, MD, MSC, FRCPC, Professor, Department of Medicine, University of Ottawa, and Canada Research Chair. Address correspondence to Dr. Boers, Department of Epidemiology and Biostatistics, VU University Medical Center, PK 6Z 185, PO Box 7057, 1007 MB Amsterdam, The Netherlands. E-mail: eb{at}vumc.nl
Leanne Idzerda
From the Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands; Centre for Global Health Research, Institute of Population Health, University of Ottawa, Ottawa; University of Bristol, Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, UK; Mobility Program Clinical Research Unit, Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Toronto, Canada; International Classification of Functioning, Disability, and Health (ICF) Research Branch in cooperation with the World Health Organization (WHO) Collaborating Centre for the Family of International Classifications in Germany; Swiss Paraplegic Research (SPF), Nottwil; Department of Health Sciences and Health Policy, University of Lucerne, Lucerne; and at SPF, Nottwil, Switzerland; Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center and Caphri Research Institute, Maastricht, The Netherlands; Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA; Respiratory Unit, Alder Hey Children’s Hospital, Liverpool, UK; Department of Medicine, University of Ottawa, Ottawa, Canada. M. Boers, MD, PhD, Department of Epidemiology and Biostatistics, VU University Medical Center; L. Idzerda, MSc, Centre for Global Health Research, Institute of Population Health, University of Ottawa; J.R. Kirwan, MD, FRCP, Professor of Rheumatic Diseases, University of Bristol, Academic Rheumatology Unit, Bristol Royal Infirmary; D. Beaton, BScOT, PhD, Scientist and Director, Mobility Program Clinical Research Unit, Li Ka Shing Knowledge Institute of St. Michael’s Hospital; R. Escorpizo, PT, DPT, MSc, Research Scientist; G. Stucki, MD, MS, Director and Chair, ICF Research Branch in cooperation with the WHO Collaborating Centre for the Family of International Classifications in Germany, SPF, and Department of Health Sciences and Health Policy, University of Lucerne; A. Boonen, MD, PhD, Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center and Caphri Research Institute; S. Magasi, PhD, Assistant Professor, Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University; I. Sinha, PhD, Specialist Registrar in Paediatric Respiratory Medicine, Respiratory Unit, Alder Hey Children’s Hospital; P. Tugwell, MD, MSC, FRCPC, Professor, Department of Medicine, University of Ottawa, and Canada Research Chair. Address correspondence to Dr. Boers, Department of Epidemiology and Biostatistics, VU University Medical Center, PK 6Z 185, PO Box 7057, 1007 MB Amsterdam, The Netherlands. E-mail: eb{at}vumc.nl
John R. Kirwan
From the Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands; Centre for Global Health Research, Institute of Population Health, University of Ottawa, Ottawa; University of Bristol, Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, UK; Mobility Program Clinical Research Unit, Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Toronto, Canada; International Classification of Functioning, Disability, and Health (ICF) Research Branch in cooperation with the World Health Organization (WHO) Collaborating Centre for the Family of International Classifications in Germany; Swiss Paraplegic Research (SPF), Nottwil; Department of Health Sciences and Health Policy, University of Lucerne, Lucerne; and at SPF, Nottwil, Switzerland; Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center and Caphri Research Institute, Maastricht, The Netherlands; Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA; Respiratory Unit, Alder Hey Children’s Hospital, Liverpool, UK; Department of Medicine, University of Ottawa, Ottawa, Canada. M. Boers, MD, PhD, Department of Epidemiology and Biostatistics, VU University Medical Center; L. Idzerda, MSc, Centre for Global Health Research, Institute of Population Health, University of Ottawa; J.R. Kirwan, MD, FRCP, Professor of Rheumatic Diseases, University of Bristol, Academic Rheumatology Unit, Bristol Royal Infirmary; D. Beaton, BScOT, PhD, Scientist and Director, Mobility Program Clinical Research Unit, Li Ka Shing Knowledge Institute of St. Michael’s Hospital; R. Escorpizo, PT, DPT, MSc, Research Scientist; G. Stucki, MD, MS, Director and Chair, ICF Research Branch in cooperation with the WHO Collaborating Centre for the Family of International Classifications in Germany, SPF, and Department of Health Sciences and Health Policy, University of Lucerne; A. Boonen, MD, PhD, Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center and Caphri Research Institute; S. Magasi, PhD, Assistant Professor, Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University; I. Sinha, PhD, Specialist Registrar in Paediatric Respiratory Medicine, Respiratory Unit, Alder Hey Children’s Hospital; P. Tugwell, MD, MSC, FRCPC, Professor, Department of Medicine, University of Ottawa, and Canada Research Chair. Address correspondence to Dr. Boers, Department of Epidemiology and Biostatistics, VU University Medical Center, PK 6Z 185, PO Box 7057, 1007 MB Amsterdam, The Netherlands. E-mail: eb{at}vumc.nl
Dorcas Beaton
From the Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands; Centre for Global Health Research, Institute of Population Health, University of Ottawa, Ottawa; University of Bristol, Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, UK; Mobility Program Clinical Research Unit, Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Toronto, Canada; International Classification of Functioning, Disability, and Health (ICF) Research Branch in cooperation with the World Health Organization (WHO) Collaborating Centre for the Family of International Classifications in Germany; Swiss Paraplegic Research (SPF), Nottwil; Department of Health Sciences and Health Policy, University of Lucerne, Lucerne; and at SPF, Nottwil, Switzerland; Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center and Caphri Research Institute, Maastricht, The Netherlands; Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA; Respiratory Unit, Alder Hey Children’s Hospital, Liverpool, UK; Department of Medicine, University of Ottawa, Ottawa, Canada. M. Boers, MD, PhD, Department of Epidemiology and Biostatistics, VU University Medical Center; L. Idzerda, MSc, Centre for Global Health Research, Institute of Population Health, University of Ottawa; J.R. Kirwan, MD, FRCP, Professor of Rheumatic Diseases, University of Bristol, Academic Rheumatology Unit, Bristol Royal Infirmary; D. Beaton, BScOT, PhD, Scientist and Director, Mobility Program Clinical Research Unit, Li Ka Shing Knowledge Institute of St. Michael’s Hospital; R. Escorpizo, PT, DPT, MSc, Research Scientist; G. Stucki, MD, MS, Director and Chair, ICF Research Branch in cooperation with the WHO Collaborating Centre for the Family of International Classifications in Germany, SPF, and Department of Health Sciences and Health Policy, University of Lucerne; A. Boonen, MD, PhD, Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center and Caphri Research Institute; S. Magasi, PhD, Assistant Professor, Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University; I. Sinha, PhD, Specialist Registrar in Paediatric Respiratory Medicine, Respiratory Unit, Alder Hey Children’s Hospital; P. Tugwell, MD, MSC, FRCPC, Professor, Department of Medicine, University of Ottawa, and Canada Research Chair. Address correspondence to Dr. Boers, Department of Epidemiology and Biostatistics, VU University Medical Center, PK 6Z 185, PO Box 7057, 1007 MB Amsterdam, The Netherlands. E-mail: eb{at}vumc.nl
Reuben Escorpizo
From the Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands; Centre for Global Health Research, Institute of Population Health, University of Ottawa, Ottawa; University of Bristol, Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, UK; Mobility Program Clinical Research Unit, Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Toronto, Canada; International Classification of Functioning, Disability, and Health (ICF) Research Branch in cooperation with the World Health Organization (WHO) Collaborating Centre for the Family of International Classifications in Germany; Swiss Paraplegic Research (SPF), Nottwil; Department of Health Sciences and Health Policy, University of Lucerne, Lucerne; and at SPF, Nottwil, Switzerland; Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center and Caphri Research Institute, Maastricht, The Netherlands; Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA; Respiratory Unit, Alder Hey Children’s Hospital, Liverpool, UK; Department of Medicine, University of Ottawa, Ottawa, Canada. M. Boers, MD, PhD, Department of Epidemiology and Biostatistics, VU University Medical Center; L. Idzerda, MSc, Centre for Global Health Research, Institute of Population Health, University of Ottawa; J.R. Kirwan, MD, FRCP, Professor of Rheumatic Diseases, University of Bristol, Academic Rheumatology Unit, Bristol Royal Infirmary; D. Beaton, BScOT, PhD, Scientist and Director, Mobility Program Clinical Research Unit, Li Ka Shing Knowledge Institute of St. Michael’s Hospital; R. Escorpizo, PT, DPT, MSc, Research Scientist; G. Stucki, MD, MS, Director and Chair, ICF Research Branch in cooperation with the WHO Collaborating Centre for the Family of International Classifications in Germany, SPF, and Department of Health Sciences and Health Policy, University of Lucerne; A. Boonen, MD, PhD, Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center and Caphri Research Institute; S. Magasi, PhD, Assistant Professor, Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University; I. Sinha, PhD, Specialist Registrar in Paediatric Respiratory Medicine, Respiratory Unit, Alder Hey Children’s Hospital; P. Tugwell, MD, MSC, FRCPC, Professor, Department of Medicine, University of Ottawa, and Canada Research Chair. Address correspondence to Dr. Boers, Department of Epidemiology and Biostatistics, VU University Medical Center, PK 6Z 185, PO Box 7057, 1007 MB Amsterdam, The Netherlands. E-mail: eb{at}vumc.nl
Annelies Boonen
From the Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands; Centre for Global Health Research, Institute of Population Health, University of Ottawa, Ottawa; University of Bristol, Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, UK; Mobility Program Clinical Research Unit, Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Toronto, Canada; International Classification of Functioning, Disability, and Health (ICF) Research Branch in cooperation with the World Health Organization (WHO) Collaborating Centre for the Family of International Classifications in Germany; Swiss Paraplegic Research (SPF), Nottwil; Department of Health Sciences and Health Policy, University of Lucerne, Lucerne; and at SPF, Nottwil, Switzerland; Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center and Caphri Research Institute, Maastricht, The Netherlands; Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA; Respiratory Unit, Alder Hey Children’s Hospital, Liverpool, UK; Department of Medicine, University of Ottawa, Ottawa, Canada. M. Boers, MD, PhD, Department of Epidemiology and Biostatistics, VU University Medical Center; L. Idzerda, MSc, Centre for Global Health Research, Institute of Population Health, University of Ottawa; J.R. Kirwan, MD, FRCP, Professor of Rheumatic Diseases, University of Bristol, Academic Rheumatology Unit, Bristol Royal Infirmary; D. Beaton, BScOT, PhD, Scientist and Director, Mobility Program Clinical Research Unit, Li Ka Shing Knowledge Institute of St. Michael’s Hospital; R. Escorpizo, PT, DPT, MSc, Research Scientist; G. Stucki, MD, MS, Director and Chair, ICF Research Branch in cooperation with the WHO Collaborating Centre for the Family of International Classifications in Germany, SPF, and Department of Health Sciences and Health Policy, University of Lucerne; A. Boonen, MD, PhD, Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center and Caphri Research Institute; S. Magasi, PhD, Assistant Professor, Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University; I. Sinha, PhD, Specialist Registrar in Paediatric Respiratory Medicine, Respiratory Unit, Alder Hey Children’s Hospital; P. Tugwell, MD, MSC, FRCPC, Professor, Department of Medicine, University of Ottawa, and Canada Research Chair. Address correspondence to Dr. Boers, Department of Epidemiology and Biostatistics, VU University Medical Center, PK 6Z 185, PO Box 7057, 1007 MB Amsterdam, The Netherlands. E-mail: eb{at}vumc.nl
Susan Magasi
From the Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands; Centre for Global Health Research, Institute of Population Health, University of Ottawa, Ottawa; University of Bristol, Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, UK; Mobility Program Clinical Research Unit, Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Toronto, Canada; International Classification of Functioning, Disability, and Health (ICF) Research Branch in cooperation with the World Health Organization (WHO) Collaborating Centre for the Family of International Classifications in Germany; Swiss Paraplegic Research (SPF), Nottwil; Department of Health Sciences and Health Policy, University of Lucerne, Lucerne; and at SPF, Nottwil, Switzerland; Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center and Caphri Research Institute, Maastricht, The Netherlands; Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA; Respiratory Unit, Alder Hey Children’s Hospital, Liverpool, UK; Department of Medicine, University of Ottawa, Ottawa, Canada. M. Boers, MD, PhD, Department of Epidemiology and Biostatistics, VU University Medical Center; L. Idzerda, MSc, Centre for Global Health Research, Institute of Population Health, University of Ottawa; J.R. Kirwan, MD, FRCP, Professor of Rheumatic Diseases, University of Bristol, Academic Rheumatology Unit, Bristol Royal Infirmary; D. Beaton, BScOT, PhD, Scientist and Director, Mobility Program Clinical Research Unit, Li Ka Shing Knowledge Institute of St. Michael’s Hospital; R. Escorpizo, PT, DPT, MSc, Research Scientist; G. Stucki, MD, MS, Director and Chair, ICF Research Branch in cooperation with the WHO Collaborating Centre for the Family of International Classifications in Germany, SPF, and Department of Health Sciences and Health Policy, University of Lucerne; A. Boonen, MD, PhD, Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center and Caphri Research Institute; S. Magasi, PhD, Assistant Professor, Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University; I. Sinha, PhD, Specialist Registrar in Paediatric Respiratory Medicine, Respiratory Unit, Alder Hey Children’s Hospital; P. Tugwell, MD, MSC, FRCPC, Professor, Department of Medicine, University of Ottawa, and Canada Research Chair. Address correspondence to Dr. Boers, Department of Epidemiology and Biostatistics, VU University Medical Center, PK 6Z 185, PO Box 7057, 1007 MB Amsterdam, The Netherlands. E-mail: eb{at}vumc.nl
Ian Sinha
From the Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands; Centre for Global Health Research, Institute of Population Health, University of Ottawa, Ottawa; University of Bristol, Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, UK; Mobility Program Clinical Research Unit, Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Toronto, Canada; International Classification of Functioning, Disability, and Health (ICF) Research Branch in cooperation with the World Health Organization (WHO) Collaborating Centre for the Family of International Classifications in Germany; Swiss Paraplegic Research (SPF), Nottwil; Department of Health Sciences and Health Policy, University of Lucerne, Lucerne; and at SPF, Nottwil, Switzerland; Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center and Caphri Research Institute, Maastricht, The Netherlands; Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA; Respiratory Unit, Alder Hey Children’s Hospital, Liverpool, UK; Department of Medicine, University of Ottawa, Ottawa, Canada. M. Boers, MD, PhD, Department of Epidemiology and Biostatistics, VU University Medical Center; L. Idzerda, MSc, Centre for Global Health Research, Institute of Population Health, University of Ottawa; J.R. Kirwan, MD, FRCP, Professor of Rheumatic Diseases, University of Bristol, Academic Rheumatology Unit, Bristol Royal Infirmary; D. Beaton, BScOT, PhD, Scientist and Director, Mobility Program Clinical Research Unit, Li Ka Shing Knowledge Institute of St. Michael’s Hospital; R. Escorpizo, PT, DPT, MSc, Research Scientist; G. Stucki, MD, MS, Director and Chair, ICF Research Branch in cooperation with the WHO Collaborating Centre for the Family of International Classifications in Germany, SPF, and Department of Health Sciences and Health Policy, University of Lucerne; A. Boonen, MD, PhD, Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center and Caphri Research Institute; S. Magasi, PhD, Assistant Professor, Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University; I. Sinha, PhD, Specialist Registrar in Paediatric Respiratory Medicine, Respiratory Unit, Alder Hey Children’s Hospital; P. Tugwell, MD, MSC, FRCPC, Professor, Department of Medicine, University of Ottawa, and Canada Research Chair. Address correspondence to Dr. Boers, Department of Epidemiology and Biostatistics, VU University Medical Center, PK 6Z 185, PO Box 7057, 1007 MB Amsterdam, The Netherlands. E-mail: eb{at}vumc.nl
Gerold Stucki
From the Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands; Centre for Global Health Research, Institute of Population Health, University of Ottawa, Ottawa; University of Bristol, Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, UK; Mobility Program Clinical Research Unit, Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Toronto, Canada; International Classification of Functioning, Disability, and Health (ICF) Research Branch in cooperation with the World Health Organization (WHO) Collaborating Centre for the Family of International Classifications in Germany; Swiss Paraplegic Research (SPF), Nottwil; Department of Health Sciences and Health Policy, University of Lucerne, Lucerne; and at SPF, Nottwil, Switzerland; Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center and Caphri Research Institute, Maastricht, The Netherlands; Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA; Respiratory Unit, Alder Hey Children’s Hospital, Liverpool, UK; Department of Medicine, University of Ottawa, Ottawa, Canada. M. Boers, MD, PhD, Department of Epidemiology and Biostatistics, VU University Medical Center; L. Idzerda, MSc, Centre for Global Health Research, Institute of Population Health, University of Ottawa; J.R. Kirwan, MD, FRCP, Professor of Rheumatic Diseases, University of Bristol, Academic Rheumatology Unit, Bristol Royal Infirmary; D. Beaton, BScOT, PhD, Scientist and Director, Mobility Program Clinical Research Unit, Li Ka Shing Knowledge Institute of St. Michael’s Hospital; R. Escorpizo, PT, DPT, MSc, Research Scientist; G. Stucki, MD, MS, Director and Chair, ICF Research Branch in cooperation with the WHO Collaborating Centre for the Family of International Classifications in Germany, SPF, and Department of Health Sciences and Health Policy, University of Lucerne; A. Boonen, MD, PhD, Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center and Caphri Research Institute; S. Magasi, PhD, Assistant Professor, Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University; I. Sinha, PhD, Specialist Registrar in Paediatric Respiratory Medicine, Respiratory Unit, Alder Hey Children’s Hospital; P. Tugwell, MD, MSC, FRCPC, Professor, Department of Medicine, University of Ottawa, and Canada Research Chair. Address correspondence to Dr. Boers, Department of Epidemiology and Biostatistics, VU University Medical Center, PK 6Z 185, PO Box 7057, 1007 MB Amsterdam, The Netherlands. E-mail: eb{at}vumc.nl
Peter Tugwell
From the Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands; Centre for Global Health Research, Institute of Population Health, University of Ottawa, Ottawa; University of Bristol, Academic Rheumatology Unit, Bristol Royal Infirmary, Bristol, UK; Mobility Program Clinical Research Unit, Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Toronto, Canada; International Classification of Functioning, Disability, and Health (ICF) Research Branch in cooperation with the World Health Organization (WHO) Collaborating Centre for the Family of International Classifications in Germany; Swiss Paraplegic Research (SPF), Nottwil; Department of Health Sciences and Health Policy, University of Lucerne, Lucerne; and at SPF, Nottwil, Switzerland; Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center and Caphri Research Institute, Maastricht, The Netherlands; Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA; Respiratory Unit, Alder Hey Children’s Hospital, Liverpool, UK; Department of Medicine, University of Ottawa, Ottawa, Canada. M. Boers, MD, PhD, Department of Epidemiology and Biostatistics, VU University Medical Center; L. Idzerda, MSc, Centre for Global Health Research, Institute of Population Health, University of Ottawa; J.R. Kirwan, MD, FRCP, Professor of Rheumatic Diseases, University of Bristol, Academic Rheumatology Unit, Bristol Royal Infirmary; D. Beaton, BScOT, PhD, Scientist and Director, Mobility Program Clinical Research Unit, Li Ka Shing Knowledge Institute of St. Michael’s Hospital; R. Escorpizo, PT, DPT, MSc, Research Scientist; G. Stucki, MD, MS, Director and Chair, ICF Research Branch in cooperation with the WHO Collaborating Centre for the Family of International Classifications in Germany, SPF, and Department of Health Sciences and Health Policy, University of Lucerne; A. Boonen, MD, PhD, Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Center and Caphri Research Institute; S. Magasi, PhD, Assistant Professor, Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University; I. Sinha, PhD, Specialist Registrar in Paediatric Respiratory Medicine, Respiratory Unit, Alder Hey Children’s Hospital; P. Tugwell, MD, MSC, FRCPC, Professor, Department of Medicine, University of Ottawa, and Canada Research Chair. Address correspondence to Dr. Boers, Department of Epidemiology and Biostatistics, VU University Medical Center, PK 6Z 185, PO Box 7057, 1007 MB Amsterdam, The Netherlands. E-mail: eb{at}vumc.nl
Abstract
Objective The Outcome Measures in Rheumatology (OMERACT) international consensus initiative has successfully developed core sets of outcome measures for trials of many rheumatologic conditions, but its expanding scope called for clarification and updating of its underlying conceptual framework and working process. To develop a core set of what we propose to call outcome measurement instruments, consensus must be reached both on what to measure and how to measure. This article deals with the first part: a framework necessary to ensure comprehensiveness of the domains chosen for measurement. We formulated a conceptual framework of core measurement areas in clinical trials, for discussion at the OMERACT 11 conference.
Methods We formulated a framework and definitions of key concepts adapted from the literature, and followed an iterative consensus process (small group processes and an Internet-based survey) of those involved including patients, health professionals, and methodologists within and outside rheumatology.
Results The draft framework comprises 4 core “areas”: death, life impact (all aspects of how a patient feels or functions), resource use (monetary and other costs of the health condition and interventions), and pathophysiologic manifestations (disease-specific clinical and psychological signs, biomarkers, and potential surrogate outcome measures necessary to assess specific effects). The survey responses (262 of 2293, response rate 11%) indicated broad agreement with the draft framework and the proposed definitions of key concepts, including understandability and feasibility. A total of 283 comments were processed.
Conclusion In an iterative process, we have developed a generic framework for outcome measurement and working definitions of key concepts ready for discussion at the OMERACT 11 conference.
In this issue
The Journal of Rheumatology
Vol. 53, Issue 2
1 Feb 2026
Toward a Generalized Framework of Core Measurement Areas in Clinical Trials: A Position Paper for OMERACT 11
Maarten Boers, Leanne Idzerda, John R. Kirwan, Dorcas Beaton, Reuben Escorpizo, Annelies Boonen, Susan Magasi, Ian Sinha, Gerold Stucki, Peter Tugwell
The Journal of Rheumatology Mar 2014, jrheum.131307; DOI: 10.3899/jrheum.131307
Toward a Generalized Framework of Core Measurement Areas in Clinical Trials: A Position Paper for OMERACT 11
Maarten Boers, Leanne Idzerda, John R. Kirwan, Dorcas Beaton, Reuben Escorpizo, Annelies Boonen, Susan Magasi, Ian Sinha, Gerold Stucki, Peter Tugwell
The Journal of Rheumatology Mar 2014, jrheum.131307; DOI: 10.3899/jrheum.131307
