title: Identifying a core set of outcome domains to measure in clinical trials for shoulder disorders: a modified Delphi study.
abstract: OBJECTIVE
  To achieve consensus on the most important outcome domains to measure across all clinical trials for shoulder disorders.
  
  
  METHODS
  We performed an online modified Delphi study with an international, multidisciplinary and multistakeholder panel. A literature review and the OMERACT Filter 2.0 framework was used to generate a list of potential core domains, which were presented to patients, clinicians and researchers in two Delphi rounds. Participants were asked to judge the importance of each potential core domain and provide a rationale for their response. A core domain was defined a priori as a domain that at least 67% of participants considered core.
  
  
  RESULTS
  In both rounds, 335 individuals were invited to participate (268 clinicians/researchers and 67 patients); response rates were 27% (n=91) and 29% (n=96), respectively. From a list of 41 potential core domains, four domains met our criteria for inclusion: 'pain', 'physical functioning', 'global assessment of treatment success' and 'health-related quality of life'. Two additional domains, 'sleep functioning' and 'psychological functioning', met the criteria for inclusion by some, but not all stakeholder groups. There was consensus that 'number of deaths' was not a core domain, but insufficient agreement on whether or not several other domains, including 'range of motion' and 'muscle strength', were core domains.
  
  
  CONCLUSIONS
  Based on international consensus from patients, clinicians and researchers, 'pain', 'physical functioning', 'global assessment of treatment success' and 'health-related quality of life' were considered core outcome domains for shoulder disorder trials. The value of several other domains needs further consideration.
authors.affiliation: School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia; School of Social and Community Medicine, University of Bristol, Bristol, UK.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Page
authors.affiliation: Department of Orthopaedic Surgery , University of Michigan , Ann Arbor, Michigan , USA.
authors.forename: Hsiaomin
authors.initials: H
authors.lastname: Huang
authors.affiliation: Department of General Practice , Erasmus MC, University Medical Center Rotterdam , Rotterdam , The Netherlands.
authors.forename: Arianne P
authors.initials: AP
authors.lastname: Verhagen
authors.affiliation: Monash Department of Clinical Epidemiology, Cabrini Institute and Monash University, Melbourne, Victoria, Australia; Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.
authors.forename: Rachelle
authors.initials: R
authors.lastname: Buchbinder
authors.affiliation: Department of Orthopaedic Surgery, University of Michigan, Ann Arbor, Michigan, USA; Department of Epidemiology, School of Public Health, University of Michigan, Ann Arbor,  Michigan, USA.
authors.forename: Joel J
authors.initials: JJ
authors.lastname: Gagnier
keywords: Outcomes research; Patient perspective; Qualitative research