title: Outcome Domains and Measures in Total Joint Replacement Clinical Trials: Can We Harmonize Them? An OMERACT Collaborative Initiative.
abstract: OBJECTIVE
  To develop a plan for harmonizing outcomes for people undergoing total joint replacement (TJR), to achieve consensus regarding TJR outcome research.
  
  
  METHODS
  The TJR working group met during the 2014 Outcome Measures in Rheumatology (OMERACT) 12 meeting in Budapest, Hungary. Multiple conference calls preceded the face-to-face meeting. Brief presentations were made during a 1.5-h meeting, which included an overview of published systematic reviews of TJR trials and the results of a recent systematic review of TJR clinical trial outcome domains and measures. This was followed by discussion of potential core set areas/domains for TJR clinical trials (as per OMERACT Filter 2.0) as well as the challenges associated with the measurement of these domains.
  
  
  RESULTS
  Working group participants discussed which TJR clinical trial outcome domains/areas map to the inner versus outer core for core domain set. Several challenges were identified with TJR outcomes including how to best measure function after TJR, elucidating the source of the pre- and post-TJR joint pain being measured, joint-specific versus generic quality of life instruments and the importance of patient satisfaction and revision surgery as outcomes. A preliminary core domain set for TJR clinical trials was proposed and included pain, function, patient satisfaction, revision, adverse events, and death. This core domain set will be further vetted with a broader audience.
  
  
  CONCLUSIONS
  An international effort with active collaboration with the orthopedic community to standardize key outcome domains and measures is under way with the TJR working group. This effort will be further developed with new collaborations.
authors.affiliation: From the Birmingham Veterans Affairs Medical Center and University of Alabama at Birmingham, Birmingham, Alabama; University of Arizona, Tucson, Arizona, USA; Warwick Clinical Trials Unit, University of Warwick, Coventry, UK; Institute of Rheumatology and Orthopedics, Royal Prince Alfred Hospital; Sydney Medical School, University of Sydney, Sydney, Australia; Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique; AP-HP, Pitié Salpêtrière Hospital, Department of Rheumatology, Paris, France; Department of Medicine and Women's College Hospital, University of Toronto, Toronto, Ontario, Canada; Virginia Commonwealth University, Richmond, Virginia, USA; Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne; Monash Department of Clinical Epidemiology, Cabrini Hospital, Melbourne, Victoria, Australia.J.A. Singh, MD, MPH, Professor of Medicine and Epidemiology, Birmingham VA Medical Center and University of Alabama at Birmingham; M. Dohm, MD, Assistant Professor of Medicine and Orthopedics, University of Arizona; A.P. Sprowson, MD, FRCS, Associate Professor of Trauma and Orthopaedics, Warwick Clinical trials Unit, University of Warwick; P.D. Wall, MBChB (Hons), MRCS (Edin), PhD, Orthopaedic Speciality Registrar, Warwick Clinical Trials Unit, University of Warwick; B.L. Richards, MBBS (Hons), MMed (Clin Epi), MSports Med, Senior Clinical Lecturer, Institute of Rheumatology and Orthopaedics, Royal Prince Alfred Hospital and Sydney Medical School, University of Sydney; L. Gossec, MD, PhD, Professor of Rheumatology, Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Department of Rheumatology; G.A. Hawker, MD, MSc, Professor of Medicine, Department of Medicine and Women's College Hospital, University of Toronto; D.L. Riddle, PhD, Professor of Medicine, Virginia Commonwealth University; R. Bu
authors.forename: Jasvinder A
authors.initials: JA
authors.lastname: Singh
authors.affiliation: From the Birmingham Veterans Affairs Medical Center and University of Alabama at Birmingham, Birmingham, Alabama; University of Arizona, Tucson, Arizona, USA; Warwick Clinical Trials Unit, University of Warwick, Coventry, UK; Institute of Rheumatology and Orthopedics, Royal Prince Alfred Hospital; Sydney Medical School, University of Sydney, Sydney, Australia; Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique; AP-HP, Pitié Salpêtrière Hospital, Department of Rheumatology, Paris, France; Department of Medicine and Women's College Hospital, University of Toronto, Toronto, Ontario, Canada; Virginia Commonwealth University, Richmond, Virginia, USA; Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne; Monash Department of Clinical Epidemiology, Cabrini Hospital, Melbourne, Victoria, Australia.J.A. Singh, MD, MPH, Professor of Medicine and Epidemiology, Birmingham VA Medical Center and University of Alabama at Birmingham; M. Dohm, MD, Assistant Professor of Medicine and Orthopedics, University of Arizona; A.P. Sprowson, MD, FRCS, Associate Professor of Trauma and Orthopaedics, Warwick Clinical trials Unit, University of Warwick; P.D. Wall, MBChB (Hons), MRCS (Edin), PhD, Orthopaedic Speciality Registrar, Warwick Clinical Trials Unit, University of Warwick; B.L. Richards, MBBS (Hons), MMed (Clin Epi), MSports Med, Senior Clinical Lecturer, Institute of Rheumatology and Orthopaedics, Royal Prince Alfred Hospital and Sydney Medical School, University of Sydney; L. Gossec, MD, PhD, Professor of Rheumatology, Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Department of Rheumatology; G.A. Hawker, MD, MSc, Professor of Medicine, Department of Medicine and Women's College Hospital, University of Toronto; D.L. Riddle, PhD, Professor of Medicine, Virginia Commonwealth University; R. Bu
authors.forename: Michael
authors.initials: M
authors.lastname: Dohm
authors.affiliation: From the Birmingham Veterans Affairs Medical Center and University of Alabama at Birmingham, Birmingham, Alabama; University of Arizona, Tucson, Arizona, USA; Warwick Clinical Trials Unit, University of Warwick, Coventry, UK; Institute of Rheumatology and Orthopedics, Royal Prince Alfred Hospital; Sydney Medical School, University of Sydney, Sydney, Australia; Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique; AP-HP, Pitié Salpêtrière Hospital, Department of Rheumatology, Paris, France; Department of Medicine and Women's College Hospital, University of Toronto, Toronto, Ontario, Canada; Virginia Commonwealth University, Richmond, Virginia, USA; Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne; Monash Department of Clinical Epidemiology, Cabrini Hospital, Melbourne, Victoria, Australia.J.A. Singh, MD, MPH, Professor of Medicine and Epidemiology, Birmingham VA Medical Center and University of Alabama at Birmingham; M. Dohm, MD, Assistant Professor of Medicine and Orthopedics, University of Arizona; A.P. Sprowson, MD, FRCS, Associate Professor of Trauma and Orthopaedics, Warwick Clinical trials Unit, University of Warwick; P.D. Wall, MBChB (Hons), MRCS (Edin), PhD, Orthopaedic Speciality Registrar, Warwick Clinical Trials Unit, University of Warwick; B.L. Richards, MBBS (Hons), MMed (Clin Epi), MSports Med, Senior Clinical Lecturer, Institute of Rheumatology and Orthopaedics, Royal Prince Alfred Hospital and Sydney Medical School, University of Sydney; L. Gossec, MD, PhD, Professor of Rheumatology, Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Department of Rheumatology; G.A. Hawker, MD, MSc, Professor of Medicine, Department of Medicine and Women's College Hospital, University of Toronto; D.L. Riddle, PhD, Professor of Medicine, Virginia Commonwealth University; R. Bu
authors.forename: Andrew P
authors.initials: AP
authors.lastname: Sprowson
authors.affiliation: From the Birmingham Veterans Affairs Medical Center and University of Alabama at Birmingham, Birmingham, Alabama; University of Arizona, Tucson, Arizona, USA; Warwick Clinical Trials Unit, University of Warwick, Coventry, UK; Institute of Rheumatology and Orthopedics, Royal Prince Alfred Hospital; Sydney Medical School, University of Sydney, Sydney, Australia; Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique; AP-HP, Pitié Salpêtrière Hospital, Department of Rheumatology, Paris, France; Department of Medicine and Women's College Hospital, University of Toronto, Toronto, Ontario, Canada; Virginia Commonwealth University, Richmond, Virginia, USA; Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne; Monash Department of Clinical Epidemiology, Cabrini Hospital, Melbourne, Victoria, Australia.J.A. Singh, MD, MPH, Professor of Medicine and Epidemiology, Birmingham VA Medical Center and University of Alabama at Birmingham; M. Dohm, MD, Assistant Professor of Medicine and Orthopedics, University of Arizona; A.P. Sprowson, MD, FRCS, Associate Professor of Trauma and Orthopaedics, Warwick Clinical trials Unit, University of Warwick; P.D. Wall, MBChB (Hons), MRCS (Edin), PhD, Orthopaedic Speciality Registrar, Warwick Clinical Trials Unit, University of Warwick; B.L. Richards, MBBS (Hons), MMed (Clin Epi), MSports Med, Senior Clinical Lecturer, Institute of Rheumatology and Orthopaedics, Royal Prince Alfred Hospital and Sydney Medical School, University of Sydney; L. Gossec, MD, PhD, Professor of Rheumatology, Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Department of Rheumatology; G.A. Hawker, MD, MSc, Professor of Medicine, Department of Medicine and Women's College Hospital, University of Toronto; D.L. Riddle, PhD, Professor of Medicine, Virginia Commonwealth University; R. Bu
authors.forename: Peter D
authors.initials: PD
authors.lastname: Wall
authors.affiliation: From the Birmingham Veterans Affairs Medical Center and University of Alabama at Birmingham, Birmingham, Alabama; University of Arizona, Tucson, Arizona, USA; Warwick Clinical Trials Unit, University of Warwick, Coventry, UK; Institute of Rheumatology and Orthopedics, Royal Prince Alfred Hospital; Sydney Medical School, University of Sydney, Sydney, Australia; Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique; AP-HP, Pitié Salpêtrière Hospital, Department of Rheumatology, Paris, France; Department of Medicine and Women's College Hospital, University of Toronto, Toronto, Ontario, Canada; Virginia Commonwealth University, Richmond, Virginia, USA; Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne; Monash Department of Clinical Epidemiology, Cabrini Hospital, Melbourne, Victoria, Australia.J.A. Singh, MD, MPH, Professor of Medicine and Epidemiology, Birmingham VA Medical Center and University of Alabama at Birmingham; M. Dohm, MD, Assistant Professor of Medicine and Orthopedics, University of Arizona; A.P. Sprowson, MD, FRCS, Associate Professor of Trauma and Orthopaedics, Warwick Clinical trials Unit, University of Warwick; P.D. Wall, MBChB (Hons), MRCS (Edin), PhD, Orthopaedic Speciality Registrar, Warwick Clinical Trials Unit, University of Warwick; B.L. Richards, MBBS (Hons), MMed (Clin Epi), MSports Med, Senior Clinical Lecturer, Institute of Rheumatology and Orthopaedics, Royal Prince Alfred Hospital and Sydney Medical School, University of Sydney; L. Gossec, MD, PhD, Professor of Rheumatology, Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Department of Rheumatology; G.A. Hawker, MD, MSc, Professor of Medicine, Department of Medicine and Women's College Hospital, University of Toronto; D.L. Riddle, PhD, Professor of Medicine, Virginia Commonwealth University; R. Bu
authors.forename: Bethan L
authors.initials: BL
authors.lastname: Richards
authors.affiliation: From the Birmingham Veterans Affairs Medical Center and University of Alabama at Birmingham, Birmingham, Alabama; University of Arizona, Tucson, Arizona, USA; Warwick Clinical Trials Unit, University of Warwick, Coventry, UK; Institute of Rheumatology and Orthopedics, Royal Prince Alfred Hospital; Sydney Medical School, University of Sydney, Sydney, Australia; Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique; AP-HP, Pitié Salpêtrière Hospital, Department of Rheumatology, Paris, France; Department of Medicine and Women's College Hospital, University of Toronto, Toronto, Ontario, Canada; Virginia Commonwealth University, Richmond, Virginia, USA; Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne; Monash Department of Clinical Epidemiology, Cabrini Hospital, Melbourne, Victoria, Australia.J.A. Singh, MD, MPH, Professor of Medicine and Epidemiology, Birmingham VA Medical Center and University of Alabama at Birmingham; M. Dohm, MD, Assistant Professor of Medicine and Orthopedics, University of Arizona; A.P. Sprowson, MD, FRCS, Associate Professor of Trauma and Orthopaedics, Warwick Clinical trials Unit, University of Warwick; P.D. Wall, MBChB (Hons), MRCS (Edin), PhD, Orthopaedic Speciality Registrar, Warwick Clinical Trials Unit, University of Warwick; B.L. Richards, MBBS (Hons), MMed (Clin Epi), MSports Med, Senior Clinical Lecturer, Institute of Rheumatology and Orthopaedics, Royal Prince Alfred Hospital and Sydney Medical School, University of Sydney; L. Gossec, MD, PhD, Professor of Rheumatology, Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Department of Rheumatology; G.A. Hawker, MD, MSc, Professor of Medicine, Department of Medicine and Women's College Hospital, University of Toronto; D.L. Riddle, PhD, Professor of Medicine, Virginia Commonwealth University; R. Bu
authors.forename: Laure
authors.initials: L
authors.lastname: Gossec
authors.affiliation: From the Birmingham Veterans Affairs Medical Center and University of Alabama at Birmingham, Birmingham, Alabama; University of Arizona, Tucson, Arizona, USA; Warwick Clinical Trials Unit, University of Warwick, Coventry, UK; Institute of Rheumatology and Orthopedics, Royal Prince Alfred Hospital; Sydney Medical School, University of Sydney, Sydney, Australia; Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique; AP-HP, Pitié Salpêtrière Hospital, Department of Rheumatology, Paris, France; Department of Medicine and Women's College Hospital, University of Toronto, Toronto, Ontario, Canada; Virginia Commonwealth University, Richmond, Virginia, USA; Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne; Monash Department of Clinical Epidemiology, Cabrini Hospital, Melbourne, Victoria, Australia.J.A. Singh, MD, MPH, Professor of Medicine and Epidemiology, Birmingham VA Medical Center and University of Alabama at Birmingham; M. Dohm, MD, Assistant Professor of Medicine and Orthopedics, University of Arizona; A.P. Sprowson, MD, FRCS, Associate Professor of Trauma and Orthopaedics, Warwick Clinical trials Unit, University of Warwick; P.D. Wall, MBChB (Hons), MRCS (Edin), PhD, Orthopaedic Speciality Registrar, Warwick Clinical Trials Unit, University of Warwick; B.L. Richards, MBBS (Hons), MMed (Clin Epi), MSports Med, Senior Clinical Lecturer, Institute of Rheumatology and Orthopaedics, Royal Prince Alfred Hospital and Sydney Medical School, University of Sydney; L. Gossec, MD, PhD, Professor of Rheumatology, Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Department of Rheumatology; G.A. Hawker, MD, MSc, Professor of Medicine, Department of Medicine and Women's College Hospital, University of Toronto; D.L. Riddle, PhD, Professor of Medicine, Virginia Commonwealth University; R. Bu
authors.forename: Gillian A
authors.initials: GA
authors.lastname: Hawker
authors.affiliation: From the Birmingham Veterans Affairs Medical Center and University of Alabama at Birmingham, Birmingham, Alabama; University of Arizona, Tucson, Arizona, USA; Warwick Clinical Trials Unit, University of Warwick, Coventry, UK; Institute of Rheumatology and Orthopedics, Royal Prince Alfred Hospital; Sydney Medical School, University of Sydney, Sydney, Australia; Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique; AP-HP, Pitié Salpêtrière Hospital, Department of Rheumatology, Paris, France; Department of Medicine and Women's College Hospital, University of Toronto, Toronto, Ontario, Canada; Virginia Commonwealth University, Richmond, Virginia, USA; Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne; Monash Department of Clinical Epidemiology, Cabrini Hospital, Melbourne, Victoria, Australia.J.A. Singh, MD, MPH, Professor of Medicine and Epidemiology, Birmingham VA Medical Center and University of Alabama at Birmingham; M. Dohm, MD, Assistant Professor of Medicine and Orthopedics, University of Arizona; A.P. Sprowson, MD, FRCS, Associate Professor of Trauma and Orthopaedics, Warwick Clinical trials Unit, University of Warwick; P.D. Wall, MBChB (Hons), MRCS (Edin), PhD, Orthopaedic Speciality Registrar, Warwick Clinical Trials Unit, University of Warwick; B.L. Richards, MBBS (Hons), MMed (Clin Epi), MSports Med, Senior Clinical Lecturer, Institute of Rheumatology and Orthopaedics, Royal Prince Alfred Hospital and Sydney Medical School, University of Sydney; L. Gossec, MD, PhD, Professor of Rheumatology, Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Department of Rheumatology; G.A. Hawker, MD, MSc, Professor of Medicine, Department of Medicine and Women's College Hospital, University of Toronto; D.L. Riddle, PhD, Professor of Medicine, Virginia Commonwealth University; R. Bu
authors.forename: Daniel L
authors.initials: DL
authors.lastname: Riddle
authors.affiliation: From the Birmingham Veterans Affairs Medical Center and University of Alabama at Birmingham, Birmingham, Alabama; University of Arizona, Tucson, Arizona, USA; Warwick Clinical Trials Unit, University of Warwick, Coventry, UK; Institute of Rheumatology and Orthopedics, Royal Prince Alfred Hospital; Sydney Medical School, University of Sydney, Sydney, Australia; Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique; AP-HP, Pitié Salpêtrière Hospital, Department of Rheumatology, Paris, France; Department of Medicine and Women's College Hospital, University of Toronto, Toronto, Ontario, Canada; Virginia Commonwealth University, Richmond, Virginia, USA; Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne; Monash Department of Clinical Epidemiology, Cabrini Hospital, Melbourne, Victoria, Australia.J.A. Singh, MD, MPH, Professor of Medicine and Epidemiology, Birmingham VA Medical Center and University of Alabama at Birmingham; M. Dohm, MD, Assistant Professor of Medicine and Orthopedics, University of Arizona; A.P. Sprowson, MD, FRCS, Associate Professor of Trauma and Orthopaedics, Warwick Clinical trials Unit, University of Warwick; P.D. Wall, MBChB (Hons), MRCS (Edin), PhD, Orthopaedic Speciality Registrar, Warwick Clinical Trials Unit, University of Warwick; B.L. Richards, MBBS (Hons), MMed (Clin Epi), MSports Med, Senior Clinical Lecturer, Institute of Rheumatology and Orthopaedics, Royal Prince Alfred Hospital and Sydney Medical School, University of Sydney; L. Gossec, MD, PhD, Professor of Rheumatology, Sorbonne Universités, UPMC Univ Paris 06, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Department of Rheumatology; G.A. Hawker, MD, MSc, Professor of Medicine, Department of Medicine and Women's College Hospital, University of Toronto; D.L. Riddle, PhD, Professor of Medicine, Virginia Commonwealth University; R. Bu
authors.forename: Rachelle
authors.initials: R
authors.lastname: Buchbinder
mesh_terms: D000328:Adult; D000368:Aged; D019644:Arthroplasty, Replacement, Hip / Q000379:methods* / Q000592:standards; D002986:Clinical Trials as Topic / Q000592:standards*; D003245:Consensus Statements as Topic; D003299:Cooperative Behavior; D003697:Delphi Technique; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009936:Organizational Innovation; D010003:Osteoarthritis / Q000175:diagnosis / Q000601:surgery*; D017063:Outcome Assessment, Health Care; D017410:Practice Guidelines as Topic; D036301:Qualitative Research
keywords: ARTHROPLASTY; CONSENSUS; DOMAINS; HARMONIZATION; OUTCOME MEASURES; TOTAL JOINT REPLACEMENT