title: A randomised controlled trial to compare the clinical and cost-effectiveness of prism glasses, visual search training and standard care in patients with hemianopia following stroke: a protocol.
abstract: BACKGROUND
  Homonymous hemianopia is a common and disabling visual problem after stroke. Currently, prism glasses and visual scanning training are proposed to improve it. The aim of this trial is to determine the effectiveness of these interventions compared to standard care.
  
  
  METHODS
  The trial will be a multicentre three arm individually randomised controlled trial with independent assessment at 6 week, 12 week and 26 week post-randomisation. Recruitment will occur in hospital, outpatient and primary care settings in UK hospital trusts. A total of 105 patients with homonymous hemianopia and without ocular motility impairment, visual inattention or pre-existent visual field impairment will be randomised to one of three balanced groups. Randomisation lists will be stratified by site and hemianopia level (partial or complete) and created using simple block randomisation by an independent statistician. Allocations will be disclosed to patients by the treating clinician, maintaining blinding for outcome assessment. The primary outcome will be change in visual field assessment from baseline to 26 weeks. Secondary measures will include the Rivermead Mobility Index, Visual Function Questionnaire 25/10, Nottingham Extended Activities of Daily Living, Euro Qual-5D and Short Form-12 questionnaires. Analysis will be by intention to treat.
  
  
  BACKGROUND
  This study has been developed and supported by the UK Stroke Research Network Clinical Studies Group working with service users. Multicentre ethical approval was obtained through the North West 6 Research ethics committee (Reference 10/H1003/119). The trial is funded by the UK Stroke Association. Trial Registration: Current Controlled Trials ISRCTN05956042. Dissemination will consider usual scholarly options of conference presentation and journal publication in addition to patient and public dissemination with lay summaries and articles.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN05956042.
authors.affiliation: Department of Health Services Research, University of Liverpool, Liverpool, UK.
authors.forename: F J
authors.initials: FJ
authors.lastname: Rowe
authors.affiliation: Department of Elderly Care, Warrington and Halton Hospitals NHS Foundation Trust, Warrington, UK.
authors.forename: P G
authors.initials: PG
authors.lastname: Barton
authors.affiliation: Clinical Trials Research Unit, University of Liverpool, Liverpool, UK.
authors.forename: E
authors.initials: E
authors.lastname: Bedson
authors.affiliation: Clinical Trials Research Unit, University of Liverpool, Liverpool, UK.
authors.forename: R
authors.initials: R
authors.lastname: Breen
authors.affiliation: Department of Biostatistics, University of Liverpool, Liverpool, UK.
authors.forename: E J
authors.initials: EJ
authors.lastname: Conroy
authors.affiliation: Clinical Trials Research Unit, University of Liverpool, Liverpool, UK.
authors.forename: E
authors.initials: E
authors.lastname: Cwiklinski
authors.affiliation: Department of Orthoptics, Oxford University Hospitals NHS Trust, Oxford, UK.
authors.forename: C
authors.initials: C
authors.lastname: Dodridge
authors.affiliation: School of Health Sciences, University of Nottingham, Nottingham, UK.
authors.forename: A
authors.initials: A
authors.lastname: Drummond
authors.affiliation: Department of Biostatistics, University of Liverpool, Liverpool, UK.
authors.forename: M
authors.initials: M
authors.lastname: Garcia-Finana
authors.affiliation: Department of Orthoptics, Salford Royal NHS Foundation Trust, Manchester, UK.
authors.forename: C
authors.initials: C
authors.lastname: Howard
authors.affiliation: Eye Clinic Impact Team, Royal National Institute for the Blind, Birmingham, UK.
authors.forename: S
authors.initials: S
authors.lastname: Johnson
authors.affiliation: Department of Orthoptics, Oxford University Hospitals NHS Trust, Oxford, UK.
authors.forename: C
authors.initials: C
authors.lastname: MacIntosh
authors.affiliation: Department of Ophthalmology, Aintree University Hospital NHS Foundation Trust, Liverpool, UK.
authors.forename: C P
authors.initials: CP
authors.lastname: Noonan
authors.affiliation: Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK.
authors.forename: A
authors.initials: A
authors.lastname: Pollock
authors.affiliation: Speakability North West, London, UK.
authors.forename: J
authors.initials: J
authors.lastname: Rockliffe
authors.affiliation: Faculty of Medicine and Health, University of East Anglia, Norwich, UK.
authors.forename: C
authors.initials: C
authors.lastname: Sackley
authors.affiliation: Department of Orthoptics, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
authors.forename: T
authors.initials: T
authors.lastname: Shipman
mesh_terms: D003362:Cost-Benefit Analysis; D004867:Equipment Design; D005139:Eyeglasses; D006423:Hemianopsia / Q000191:economics* / Q000209:etiology / Q000628:therapy*; D006801:Humans; D012107:Research Design; D016037:Single-Blind Method; D020521:Stroke / Q000150:complications; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
keywords: REHABILITATION MEDICINE; STROKE MEDICINE