title: Core domain and outcome measurement sets for shoulder pain trials are needed: systematic review of physical therapy trials.
abstract: OBJECTIVE
  To explore the outcome domains and measurement instruments reported in published randomized controlled trials of physical therapy interventions for shoulder pain (rotator cuff disease, adhesive capsulitis, or nonspecific shoulder pain).
  
  
  METHODS
  We included trials comparing physical therapy to any other intervention for shoulder pain, indexed up to March 2015 in CENTRAL, MEDLINE, EMBASE, or CINAHL Plus. Two authors independently selected trials for inclusion and extracted information on the domains and measurement instruments reported.
  
  
  RESULTS
  We included 171 trials. Most trials measured pain (87%), function (72%), and range of movement (67%), whereas adverse events, global assessment of treatment success, strength, and health-related quality of life were measured in 18-27% of trials, and work disability and referral for surgery were measured in less than 5% of trials. Thirty-five different measurement instruments for pain and 29 for function were noted. Measurement of function increased markedly from 1973 to 2014. In rotator cuff disease trials, there was a more frequent measurement of pain and strength and a less frequent measurement of range of movement compared with adhesive capsulitis trials.
  
  
  CONCLUSIONS
  There was wide diversity in the domains and measurement instruments reported. Our results provide the foundation for the development of a core domain and outcome measurement set for use in future shoulder pain trials.
authors.affiliation: School of Public Health and Preventive Medicine, Monash University, Level 1, 549 St Kilda Road, Melbourne, Victoria, 3004, Australia; School of Social and Community Medicine, University of Bristol, 39 Whatley Road, Bristol, BS8 2PS, UK.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Page
authors.affiliation: School of Public Health and Preventive Medicine, Monash University, Level 1, 549 St Kilda Road, Melbourne, Victoria, 3004, Australia.
authors.forename: Joanne E
authors.initials: JE
authors.lastname: McKenzie
authors.affiliation: School of Public Health and Preventive Medicine, Monash University, Level 1, 549 St Kilda Road, Melbourne, Victoria, 3004, Australia.
authors.forename: Sally E
authors.initials: SE
authors.lastname: Green
authors.affiliation: Department of Occupational Science and Occupational Therapy, University of Toronto, 160-500 University Avenue, Toronto, Ontario, M5G 1V7, Canada.
authors.forename: Dorcas E
authors.initials: DE
authors.lastname: Beaton
authors.affiliation: Department of Physical Medicine and Rehabilitation, Vanderbilt University School of Medicine, 2201 Children's Way, Suite 1318, Nashville, TN, 37212, USA; Department of Orthopaedics, Vanderbilt University School of Medicine, 215 Light Hall, Nashville, TN, 37232, USA.
authors.forename: Nitin B
authors.initials: NB
authors.lastname: Jain
authors.affiliation: Hospital Israelita Albert Einstein, Avenida Albert Einstein, 627/701 - Morumbi, São Paulo, 05652-900, Brazil.
authors.forename: Mario
authors.initials: M
authors.lastname: Lenza
authors.affiliation: Department of General Practice, Erasmus MC, University Medical Center Rotterdam, PO Box 2040, Rotterdam, 3000 CA, The Netherlands.
authors.forename: Arianne P
authors.initials: AP
authors.lastname: Verhagen
authors.affiliation: Monash Department of Clinical Epidemiology, Cabrini Institute, Monash University, 183 Wattletree Road, Malvern, Victoria, 3144, Australia; Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Level 6, 99 Commercial Road, Melbourne, Victoria, 3004, Australia.
authors.forename: Stephen
authors.initials: S
authors.lastname: Surace
authors.affiliation: Monash Department of Clinical Epidemiology, Cabrini Institute, Monash University, 183 Wattletree Road, Malvern, Victoria, 3144, Australia; Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Level 6, 99 Commercial Road, Melbourne, Victoria, 3004, Australia.
authors.forename: Jessica
authors.initials: J
authors.lastname: Deitch
authors.affiliation: Monash Department of Clinical Epidemiology, Cabrini Institute, Monash University, 183 Wattletree Road, Malvern, Victoria, 3144, Australia; Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Level 6, 99 Commercial Road, Melbourne, Victoria, 3004, Australia. Electronic address: rachelle.buchbinder@monash.edu.
authors.forename: Rachelle
authors.initials: R
authors.lastname: Buchbinder
mesh_terms: D006801:Humans; D063868:Patient Outcome Assessment; D026741:Physical Therapy Modalities; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data*; D020069:Shoulder Pain / Q000628:therapy*
keywords: Clinical trial; Outcome assessment (health care); Physical therapy modalities; Research methodology; Shoulder pain; Systematic review