title: Defining the fracture population in a pragmatic multicentre randomised controlled trial: PROFHER and the Neer classification of proximal humeral fractures.
abstract: OBJECTIVE
  Accurate characterisation of fractures is essential in fracture management trials. However, this is often hampered by poor inter-observer agreement. This article describes the practicalities of defining the fracture population, based on the Neer classification, within a pragmatic multicentre randomised controlled trial in which surgical treatment was compared with non-surgical treatment in adults with displaced fractures of the proximal humerus involving the surgical neck.
  
  
  METHODS
  The trial manual illustrated the Neer classification of proximal humeral fractures. However, in addition to surgical neck displacement, surgeons assessing patient eligibility reported on whether either or both of the tuberosities were involved. Anonymised electronic versions of baseline radiographs were sought for all 250 trial participants. A protocol, data collection tool and training presentation were developed and tested in a pilot study. These were then used in a formal assessment and classification of the trial fractures by two independent senior orthopaedic shoulder trauma surgeons.
  
  
  RESULTS
  Two or more baseline radiographic views were obtained for each participant. The independent raters confirmed that all fractures would have been considered for surgery in contemporaneous practice. A full description of the fracture population based on the Neer classification was obtained. The agreement between the categorisation at baseline (tuberosity involvement) and Neer classification as assessed by the two raters was only fair (kappa 0.29). However, this disparity did not appear to affect trial findings, specifically in terms of influencing the effect of treatment on the primary outcome of the trial.
  
  
  CONCLUSIONS
  A key reporting requirement, namely the description of the fracture population, was achieved within the context of a pragmatic multicentre randomised clinical trial. This article provides important guidance for researchers designing similar trials on fracture management.Cite this article: H. H. G. Handoll, S. D. Brealey, L. Jefferson, A. Keding, A. J. Brooksbank, A. J. Johnstone, J. J. Candal-Couto, A. Rangan. Defining the fracture population in a pragmatic multicentre randomised controlled trial: PROFHER and the Neer classification of proximal humeral fractures.Bone Joint Res 2016;5:481-489. DOI: 10.1302/2046-3758.510.BJR-2016-0132.R1.
authors.affiliation: Health and Social Care Institute, School of Health and Social Care, Teesside University, Middlesbrough, Tees Valley, TS1 3BA, UK.
authors.forename: H H G
authors.initials: HH
authors.lastname: Handoll
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, Heslington, York, YO10 5DD, UK.
authors.forename: S D
authors.initials: SD
authors.lastname: Brealey
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, Heslington, York, YO10 5DD, UK.
authors.forename: L
authors.initials: L
authors.lastname: Jefferson
authors.affiliation: York Trials Unit, Department of Health Sciences, University of York, Heslington, York, YO10 5DD, UK.
authors.forename: A
authors.initials: A
authors.lastname: Keding
authors.affiliation: Department of Orthopaedics and Trauma, Glasgow Royal Infirmary, 84 Castle Street, Glasgow, G4 0SF, UK.
authors.forename: A J
authors.initials: AJ
authors.lastname: Brooksbank
authors.affiliation: Orthopaedic Trauma Unit, Aberdeen Royal Infirmary, Foresterhill, Aberdeen, AB25 2ZN, UK.
authors.forename: A J
authors.initials: AJ
authors.lastname: Johnstone
authors.affiliation: Northumbria Healthcare NHS Trust, Wansbeck General Hospital, Woodhorn Lane, Ashington, Northumberland, NE63 9JJ, UK.
authors.forename: J J
authors.initials: JJ
authors.lastname: Candal-Couto
authors.affiliation: Department of Trauma and Orthopaedics, James Cook University Hospital, South Tees Hospitals NHS Trust, Marton Road, Middlesbrough, TS4 3BW, UK amar.rangan@york.ac.uk.
authors.forename: A
authors.initials: A
authors.lastname: Rangan
keywords: Fracture classification; Pragmatic randomised controlled trials; Proximal humeral fractures