Rachelle Buchbinder1,2, Matthew J Page3,4, Hsiaomin Huang3,4, Arianne P Verhagen3,4, Dorcas Beaton3,4, Christian Kopkow3,4, Mario Lenza3,4, Nitin B Jain3,4, Bethan Richards3,4, Pamela Richards3,4, Marieke Voshaar3,4, Danielle van der Windt3,4, Joel J Gagnier3,4. 1. Monash Department of Clinical Epidemiology, Cabrini Institute and Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University; School of Public Health and Preventive Medicine, Monash University, Melbourne; Department of Rheumatology, Royal Prince Alfred Hospital; Sydney Medical School, University of Sydney, Sydney, Australia; School of Social and Community Medicine, University of Bristol, Bristol; Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Staffordshire, UK; Department of Orthopedic Surgery, and Department of Epidemiology, School of Public Health, University of Michigan, Ann Arbor, Michigan; Department of Physical Medicine and Rehabilitation, Vanderbilt University Medical Center, Nashville, Tennessee, USA; Department of General Practice, Erasmus Medical Centre University, Rotterdam; Department of Psychology, Health and Technology, University of Twente, Enschede, the Netherlands; St. Michael's Hospital, Musculoskeletal Health and Outcomes Research, The Li Ka Shing Knowledge Institute, composed of the Keenan Research Center and the Li Ka Shing International Healthcare Education Center of St. Michael's Hospital; Institute for Work and Health, Toronto, Ontario, Canada; University Hospital Carl Gustav Carus Dresden, Center for Evidence-Based Healthcare, Dresden, Germany; Hospital Israelita Albert Einstein, Sao Paulo, Brazil. rachelle.buchbinder@monash.edu. 2. R. Buchbinder, PhD, Director, Monash Department of Clinical Epidemiology, Cabrini Institute, and Professor, Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University; M.J. Page, PhD, Research Fellow, School of Public Health and Preventive Medicine, Monash University, and School of Social and Community Medicine, University of Bristol; H. Huang, MPH, Research Associate, Department of Orthopedic Surgery, University of Michigan; A.P. Verhagen, PhD, Associate Professor, Department of General Practice, Erasmus Medical Centre University; D. Beaton, PhD, Musculoskeletal Health and Outcomes Research, Li Ka Shing Knowledge Institute, St. Michael's Hospital, and Institute for Work and Health, and Occupational Science and Occupational Therapy, Rehabilitation Sciences Institute, Institute of Health Policy Management and Evaluation, University of Toronto; C. Kopkow, MPH, Research Fellow, University Hospital Carl Gustav Carus Dresden, Center for Evidence-Based Healthcare; M. Lenza, PhD, Coordinator of Orthopaedics of Hospital Israelita Albert Einstein; N.B. Jain, MD, Associate Professor, Department of Physical Medicine and Rehabilitation, Vanderbilt University Medical Center; B. Richards, MMed (Clin Epi), Director Department of Rheumatology, Royal Prince Alfred Hospital, and Senior Lecturer, Sydney Medical School, University of Sydney; P. Richards, Patient Research Partner, University of Bristol, M. Voshaar, MSc, Research Fellow, Department of Psychology, Health and Technology, University of Twente; D. van der Windt, PhD, Professor of Primary Care Epidemiology, Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University; J.J. Gagnier, PhD, Assistant Professor, Departments of Orthopedic Surgery and Epidemiology, and Director, Clinical Epidemiology and Research in Orthopedic Surgery, University of Michigan. rachelle.buchbinder@monash.edu. 3. Monash Department of Clinical Epidemiology, Cabrini Institute and Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University; School of Public Health and Preventive Medicine, Monash University, Melbourne; Department of Rheumatology, Royal Prince Alfred Hospital; Sydney Medical School, University of Sydney, Sydney, Australia; School of Social and Community Medicine, University of Bristol, Bristol; Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Staffordshire, UK; Department of Orthopedic Surgery, and Department of Epidemiology, School of Public Health, University of Michigan, Ann Arbor, Michigan; Department of Physical Medicine and Rehabilitation, Vanderbilt University Medical Center, Nashville, Tennessee, USA; Department of General Practice, Erasmus Medical Centre University, Rotterdam; Department of Psychology, Health and Technology, University of Twente, Enschede, the Netherlands; St. Michael's Hospital, Musculoskeletal Health and Outcomes Research, The Li Ka Shing Knowledge Institute, composed of the Keenan Research Center and the Li Ka Shing International Healthcare Education Center of St. Michael's Hospital; Institute for Work and Health, Toronto, Ontario, Canada; University Hospital Carl Gustav Carus Dresden, Center for Evidence-Based Healthcare, Dresden, Germany; Hospital Israelita Albert Einstein, Sao Paulo, Brazil. 4. R. Buchbinder, PhD, Director, Monash Department of Clinical Epidemiology, Cabrini Institute, and Professor, Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University; M.J. Page, PhD, Research Fellow, School of Public Health and Preventive Medicine, Monash University, and School of Social and Community Medicine, University of Bristol; H. Huang, MPH, Research Associate, Department of Orthopedic Surgery, University of Michigan; A.P. Verhagen, PhD, Associate Professor, Department of General Practice, Erasmus Medical Centre University; D. Beaton, PhD, Musculoskeletal Health and Outcomes Research, Li Ka Shing Knowledge Institute, St. Michael's Hospital, and Institute for Work and Health, and Occupational Science and Occupational Therapy, Rehabilitation Sciences Institute, Institute of Health Policy Management and Evaluation, University of Toronto; C. Kopkow, MPH, Research Fellow, University Hospital Carl Gustav Carus Dresden, Center for Evidence-Based Healthcare; M. Lenza, PhD, Coordinator of Orthopaedics of Hospital Israelita Albert Einstein; N.B. Jain, MD, Associate Professor, Department of Physical Medicine and Rehabilitation, Vanderbilt University Medical Center; B. Richards, MMed (Clin Epi), Director Department of Rheumatology, Royal Prince Alfred Hospital, and Senior Lecturer, Sydney Medical School, University of Sydney; P. Richards, Patient Research Partner, University of Bristol, M. Voshaar, MSc, Research Fellow, Department of Psychology, Health and Technology, University of Twente; D. van der Windt, PhD, Professor of Primary Care Epidemiology, Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University; J.J. Gagnier, PhD, Assistant Professor, Departments of Orthopedic Surgery and Epidemiology, and Director, Clinical Epidemiology and Research in Orthopedic Surgery, University of Michigan.
Abstract
OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) Shoulder Core Outcome Set Special Interest Group (SIG) was established to develop a core outcome set (COS) for clinical trials of shoulder disorders. METHODS: In preparation for OMERACT 2016, we systematically examined all outcome domains and measurement instruments reported in 409 randomized trials of interventions for shoulder disorders published between 1954 and 2015. Informed by these data, we conducted an international Delphi consensus study including shoulder trial experts, clinicians, and patients to identify key domains that should be included in a shoulder disorder COS. Findings were discussed at a stakeholder premeeting of OMERACT. At OMERACT 2016, we sought consensus on a preliminary core domain set and input into next steps. RESULTS: There were 13 and 15 participants at the premeeting and the OMERACT 2016 SIG meeting, respectively (9 attended both meetings). Consensus was reached on a preliminary core domain set consisting of an inner core of 4 domains: pain, physical function/activity, global perceived effect, and adverse events including death. A middle core consisted of 3 domains: emotional well-being, sleep, and participation (recreation and work). An outer core of research required to inform the final COS was also formulated. CONCLUSION: Our next steps are to (1) analyze whether participation (recreation and work) should be in the inner core, (2) conduct a third Delphi round to finalize definitions and wording of domains and reach final endorsement for the domains, and (3) determine which instruments fulfill the OMERACT criteria for measuring each domain.
OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) Shoulder Core Outcome Set Special Interest Group (SIG) was established to develop a core outcome set (COS) for clinical trials of shoulder disorders. METHODS: In preparation for OMERACT 2016, we systematically examined all outcome domains and measurement instruments reported in 409 randomized trials of interventions for shoulder disorders published between 1954 and 2015. Informed by these data, we conducted an international Delphi consensus study including shoulder trial experts, clinicians, and patients to identify key domains that should be included in a shoulder disorder COS. Findings were discussed at a stakeholder premeeting of OMERACT. At OMERACT 2016, we sought consensus on a preliminary core domain set and input into next steps. RESULTS: There were 13 and 15 participants at the premeeting and the OMERACT 2016 SIG meeting, respectively (9 attended both meetings). Consensus was reached on a preliminary core domain set consisting of an inner core of 4 domains: pain, physical function/activity, global perceived effect, and adverse events including death. A middle core consisted of 3 domains: emotional well-being, sleep, and participation (recreation and work). An outer core of research required to inform the final COS was also formulated. CONCLUSION: Our next steps are to (1) analyze whether participation (recreation and work) should be in the inner core, (2) conduct a third Delphi round to finalize definitions and wording of domains and reach final endorsement for the domains, and (3) determine which instruments fulfill the OMERACT criteria for measuring each domain.
Authors: Christina Jerosch-Herold; Rachel Chester; Lee Shepstone; Joshua I Vincent; Joy C MacDermid Journal: Qual Life Res Date: 2017-11-29 Impact factor: 4.147
Authors: Teemu V Karjalainen; Nitin B Jain; Juuso Heikkinen; Renea V Johnston; Cristina M Page; Rachelle Buchbinder Journal: Cochrane Database Syst Rev Date: 2019-12-09
Authors: Matthew Thomas Sims; Byron Nice Detweiler; Jared Thomas Scott; Benjamin McKinnley Howard; Grant Richard Detten; Matt Vassar Journal: PLoS One Date: 2017-11-10 Impact factor: 3.240
Authors: Qiukui Hao; Tahira Devji; Dena Zeraatkar; Yuting Wang; Anila Qasim; Reed A C Siemieniuk; Per Olav Vandvik; Tuomas Lähdeoja; Alonso Carrasco-Labra; Thomas Agoritsas; Gordon Guyatt Journal: BMJ Open Date: 2019-02-20 Impact factor: 2.692
Authors: Pieter Coenen; Gerben Hulsegge; Joost G Daams; Rutger C van Geenen; Gino M Kerkhoffs; Maurits W van Tulder; Judith A Huirne; Johannes R Anema; P Paul Kuijer Journal: BMJ Open Sport Exerc Med Date: 2020-03-26
Authors: Teemu V Karjalainen; Nitin B Jain; Cristina M Page; Tuomas A Lähdeoja; Renea V Johnston; Paul Salamh; Lauri Kavaja; Clare L Ardern; Arnav Agarwal; Per O Vandvik; Rachelle Buchbinder Journal: Cochrane Database Syst Rev Date: 2019-01-17