Monika E Finger1,2, Annelies Boonen1,2, Thasia G Woodworth1,2, Reuben Escorpizo1,2, Robin Christensen1,2, Sabrina M Nielsen1,2, Amye L Leong1,2, Marieke Scholte Voshaar1,2, Caroline A Flurey1,2, Nataliya Milman1,2, Suzanne M Verstappen1,2, Rieke Alten1,2, Francis Guillemin1,2, Margreet Kloppenburg1,2, Dorcas E Beaton1,2, Peter S Tugwell1,2, Lyn M March1,2, Daniel E Furst1,2, Christoph Pohl3,4. 1. From the Empowerment, Participation and Social Integration Unit, Swiss Paraplegic Research, Nottwil, Switzerland; Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Centre; CAPHRI Research Institute, Maastricht University, Maastricht; Department of Psychology, Health and Technology, University of Twente, Enschede; Department of Rheumatology, and Department of Clinical Epidemiology, Leiden University Medical Centre, Leiden, the Netherlands; Division of Rheumatology, David Geffen School of Medicine, University of California, Los Angeles; Bone and Joint Decade, the Global Alliance for Musculoskeletal Health, and Healthy Motivation, Santa Barbara, California; Department of Rehabilitation and Movement Science, The University of Vermont, Burlington, Vermont, USA; Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Faculty of Health and Applied Sciences, University of the West of England, Bristol; Arthritis Research UK Epidemiology Unit, University of Manchester, Manchester, UK; Division of Rheumatology, Department of Medicine, University of Ottawa and Ottawa Hospital; Centre for Global Health, Institute of Population Health, University of Ottawa and Ottawa Hospital; Department of Clinical Epidemiology, Ottawa Hospital Research Institute; Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa; Musculoskeletal Health and Outcomes Research, Li Ka Shing Knowledge Institute, St. Michael's Hospital; Institute for Work and Health, and Institute of Health Policy, Management and Evaluation, Rehabilitation Sciences Institute, and Departments of Occupational Science and Occupational Therapy, University of Toronto, Toronto, Ontario, Canada; Schlosspark-Klinik, University Medicine Berlin, Berlin, Germany; University of Lorraine, EA 4360 APEMAC, Nancy, France; Institute of Bone and Joint Research, University of Sydney; Rheumatology and Musculoskeletal Epidemiology, Sydney Medical School, Sydney; Department of Rheumatology, Royal North Shore Hospital, St Leonards, Australia. 2. M.E. Finger, PT, PhD, MPTSc, Empowerment, Participation and Social Integration Unit, Swiss Paraplegic Research; A. Boonen, MD, PhD, Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Centre, and CAPHRI Research Institute, Maastricht University; T.G. Woodworth, MD, Consultant, Division of Rheumatology, David Geffen School of Medicine, University of California; R. Escorpizo, PT, DPT, MSc, Empowerment, Participation and Social Integration Unit, Swiss Paraplegic Research, and Department of Rehabilitation and Movement Science, The University of Vermont; R. Christensen, PhD, MSc, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital; S.M. Nielsen, MSc, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital; A.L. Leong, MBA, Bone and Joint Decade, the Global Alliance for Musculoskeletal Health, and Healthy Motivation; M. Scholte Voshaar, MSc, Department of Psychology, Health and Technology, University of Twente; C.A. Flurey, PhD CPsychol, Faculty of Health and Applied Sciences, University of the West of England; N. Milman, PhD, Division of Rheumatology, Department of Medicine, University of Ottawa and the Ottawa Hospital, and Department of Clinical Epidemiology, Ottawa Hospital Research Institute; S.M. Verstappen, PhD, Arthritis Research UK Epidemiology Unit, University of Manchester; R. Alten, MD, PhD, Schlosspark-Klinik, University Medicine Berlin; F. Guillemin, MD, PhD, University of Lorraine, EA 4360 APEMAC; M. Kloppenburg, MD, PhD, Professor, Department of Rheumatology, and Department of Clinical Epidemiology, Leiden University Medical Centre; D.E. Beaton, PhD, Musculoskeletal Health and Outcomes Research, Li Ka Shing Knowledge Institute, St. Michael's Hospital, and Institute for Work and Health, and Institute of Health Policy, Management and Evaluation, Rehabilitation Sciences Institute, and Department of Occupational Science and Occupational Therapy, University of Toronto, and Department of Epidemiology and Community Medicine, University of Ottawa, and Centre for Global Health, Institute of Population Health, University of Ottawa, and Ottawa Hospital; P.S. Tugwell, MD, Department of Epidemiology and Community Medicine, University of Ottawa, and Centre for Global Health, Institute of Population Health, University of Ottawa, and Ottawa Hospital; L.M. March, MBBS, PhD, Liggins Professor of Rheumatology and Musculoskeletal Epidemiology, Sydney Medical School, and Institute of Bone and Joint Research, University of Sydney, and Department of Rheumatology, Royal North Shore Hospital; D.E. Furst, MD, Division of Rheumatology, David Geffen School of Medicine, University of California; C. Pohl, MD, Schlosspark-Klinik, University Medicine Berlin. 3. From the Empowerment, Participation and Social Integration Unit, Swiss Paraplegic Research, Nottwil, Switzerland; Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Centre; CAPHRI Research Institute, Maastricht University, Maastricht; Department of Psychology, Health and Technology, University of Twente, Enschede; Department of Rheumatology, and Department of Clinical Epidemiology, Leiden University Medical Centre, Leiden, the Netherlands; Division of Rheumatology, David Geffen School of Medicine, University of California, Los Angeles; Bone and Joint Decade, the Global Alliance for Musculoskeletal Health, and Healthy Motivation, Santa Barbara, California; Department of Rehabilitation and Movement Science, The University of Vermont, Burlington, Vermont, USA; Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Faculty of Health and Applied Sciences, University of the West of England, Bristol; Arthritis Research UK Epidemiology Unit, University of Manchester, Manchester, UK; Division of Rheumatology, Department of Medicine, University of Ottawa and Ottawa Hospital; Centre for Global Health, Institute of Population Health, University of Ottawa and Ottawa Hospital; Department of Clinical Epidemiology, Ottawa Hospital Research Institute; Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa; Musculoskeletal Health and Outcomes Research, Li Ka Shing Knowledge Institute, St. Michael's Hospital; Institute for Work and Health, and Institute of Health Policy, Management and Evaluation, Rehabilitation Sciences Institute, and Departments of Occupational Science and Occupational Therapy, University of Toronto, Toronto, Ontario, Canada; Schlosspark-Klinik, University Medicine Berlin, Berlin, Germany; University of Lorraine, EA 4360 APEMAC, Nancy, France; Institute of Bone and Joint Research, University of Sydney; Rheumatology and Musculoskeletal Epidemiology, Sydney Medical School, Sydney; Department of Rheumatology, Royal North Shore Hospital, St Leonards, Australia. christoph.pohl222@googlemail.com. 4. M.E. Finger, PT, PhD, MPTSc, Empowerment, Participation and Social Integration Unit, Swiss Paraplegic Research; A. Boonen, MD, PhD, Department of Internal Medicine, Division of Rheumatology, Maastricht University Medical Centre, and CAPHRI Research Institute, Maastricht University; T.G. Woodworth, MD, Consultant, Division of Rheumatology, David Geffen School of Medicine, University of California; R. Escorpizo, PT, DPT, MSc, Empowerment, Participation and Social Integration Unit, Swiss Paraplegic Research, and Department of Rehabilitation and Movement Science, The University of Vermont; R. Christensen, PhD, MSc, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital; S.M. Nielsen, MSc, Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital; A.L. Leong, MBA, Bone and Joint Decade, the Global Alliance for Musculoskeletal Health, and Healthy Motivation; M. Scholte Voshaar, MSc, Department of Psychology, Health and Technology, University of Twente; C.A. Flurey, PhD CPsychol, Faculty of Health and Applied Sciences, University of the West of England; N. Milman, PhD, Division of Rheumatology, Department of Medicine, University of Ottawa and the Ottawa Hospital, and Department of Clinical Epidemiology, Ottawa Hospital Research Institute; S.M. Verstappen, PhD, Arthritis Research UK Epidemiology Unit, University of Manchester; R. Alten, MD, PhD, Schlosspark-Klinik, University Medicine Berlin; F. Guillemin, MD, PhD, University of Lorraine, EA 4360 APEMAC; M. Kloppenburg, MD, PhD, Professor, Department of Rheumatology, and Department of Clinical Epidemiology, Leiden University Medical Centre; D.E. Beaton, PhD, Musculoskeletal Health and Outcomes Research, Li Ka Shing Knowledge Institute, St. Michael's Hospital, and Institute for Work and Health, and Institute of Health Policy, Management and Evaluation, Rehabilitation Sciences Institute, and Department of Occupational Science and Occupational Therapy, University of Toronto, and Department of Epidemiology and Community Medicine, University of Ottawa, and Centre for Global Health, Institute of Population Health, University of Ottawa, and Ottawa Hospital; P.S. Tugwell, MD, Department of Epidemiology and Community Medicine, University of Ottawa, and Centre for Global Health, Institute of Population Health, University of Ottawa, and Ottawa Hospital; L.M. March, MBBS, PhD, Liggins Professor of Rheumatology and Musculoskeletal Epidemiology, Sydney Medical School, and Institute of Bone and Joint Research, University of Sydney, and Department of Rheumatology, Royal North Shore Hospital; D.E. Furst, MD, Division of Rheumatology, David Geffen School of Medicine, University of California; C. Pohl, MD, Schlosspark-Klinik, University Medicine Berlin. christoph.pohl222@googlemail.com.
Abstract
OBJECTIVE: The importance of contextual factors (CF) for appropriate patient-specific care is widely acknowledged. However, evidence in clinical trials on how CF influence outcomes remains sparse. The 2014 Outcome Measures in Rheumatology (OMERACT) Handbook introduced the role of CF in outcome assessment and defined them as "potential confounders and/or effect modifiers of outcomes in randomized controlled trials." Subsequently, the CF Methods Group (CFMG) was formed to develop guidance on how to address CF in clinical trials. METHODS: First, the CFMG conducted an e-mail survey of OMERACT working groups (WG) to analyze how they had addressed CF in outcome measurement so far. The results facilitated an informed discussion at the OMERACT 2016 CFMG Special Interest Group (SIG) session, with the aim of gaining preliminary consensus regarding an operational definition of CF and to make a first selection of potentially relevant CF. RESULTS: The survey revealed that the WG had mostly used the OMERACT Handbook and/or the International Classification of Functioning, Disability and Health (ICF) definition. However, significant heterogeneity was found in the methods used to identify, refine, and categorize CF candidates. The SIG participants agreed on using the ICF as a framework along with the OMERACT Handbook definition. A list with 28 variables was collected including person-related factors and physical and social environments. Recommendations from the SIG guided the CFMG to formulate 3 preliminary projects on how to identify and analyze CF. CONCLUSION: New methods are urgently needed to assist researchers to identify and characterize CF that significantly influence the interpretation of results in clinical trials. The CFMG defined first steps to develop further guidance.
OBJECTIVE: The importance of contextual factors (CF) for appropriate patient-specific care is widely acknowledged. However, evidence in clinical trials on how CF influence outcomes remains sparse. The 2014 Outcome Measures in Rheumatology (OMERACT) Handbook introduced the role of CF in outcome assessment and defined them as "potential confounders and/or effect modifiers of outcomes in randomized controlled trials." Subsequently, the CF Methods Group (CFMG) was formed to develop guidance on how to address CF in clinical trials. METHODS: First, the CFMG conducted an e-mail survey of OMERACT working groups (WG) to analyze how they had addressed CF in outcome measurement so far. The results facilitated an informed discussion at the OMERACT 2016 CFMG Special Interest Group (SIG) session, with the aim of gaining preliminary consensus regarding an operational definition of CF and to make a first selection of potentially relevant CF. RESULTS: The survey revealed that the WG had mostly used the OMERACT Handbook and/or the International Classification of Functioning, Disability and Health (ICF) definition. However, significant heterogeneity was found in the methods used to identify, refine, and categorize CF candidates. The SIG participants agreed on using the ICF as a framework along with the OMERACT Handbook definition. A list with 28 variables was collected including person-related factors and physical and social environments. Recommendations from the SIG guided the CFMG to formulate 3 preliminary projects on how to identify and analyze CF. CONCLUSION: New methods are urgently needed to assist researchers to identify and characterize CF that significantly influence the interpretation of results in clinical trials. The CFMG defined first steps to develop further guidance.
Authors: Nataliya Milman; Eilish McConville; Joanna C Robson; Annelies Boonen; Peter Tugwell; George A Wells; Dipayan Chaudhuri; Jill Dawson; Gunnar Tomasson; Susan Ashdown; Don Gebhart; Georgia Lanier; Jacqueline Peck; Carol A McAlear; Katherine S Kellom; Peter F Cronholm; Peter A Merkel Journal: J Rheumatol Date: 2019-02-01 Impact factor: 4.666