title: Head Position in Stroke Trial (HeadPoST)--sitting-up vs lying-flat positioning of patients with acute stroke: study protocol for a cluster randomised controlled trial.
abstract: BACKGROUND
  Positioning a patient lying-flat in the acute phase of ischaemic stroke may improve recovery and reduce disability, but such a possibility has not been formally tested in a randomised trial. We therefore initiated the Head Position in Stroke Trial (HeadPoST) to determine the effects of lying-flat (0°) compared with sitting-up (≥ 30°) head positioning in the first 24 hours of hospital admission for patients with acute stroke.
  
  
  METHODS
  We plan to conduct an international, cluster randomised, crossover, open, blinded outcome-assessed clinical trial involving 140 study hospitals (clusters) with established acute stroke care programs. Each hospital will be randomly assigned to sequential policies of lying-flat (0°) or sitting-up (≥ 30°) head position as a 'business as usual' stroke care policy during the first 24 hours of admittance. Each hospital is required to recruit 60 consecutive patients with acute ischaemic stroke (AIS), and all patients with acute intracerebral haemorrhage (ICH) (an estimated average of 10), in the first randomised head position policy before crossing over to the second head position policy with a similar recruitment target. After collection of in-hospital clinical and management data and 7-day outcomes, central trained blinded assessors will conduct a telephone disability assessment with the modified Rankin Scale at 90 days. The primary outcome for analysis is a shift (defined as improvement) in death or disability on this scale. For a cluster size of 60 patients with AIS per intervention and with various assumptions including an intracluster correlation coefficient of 0.03, a sample size of 16,800 patients at 140 centres will provide 90 % power (α 0.05) to detect at least a 16 % relative improvement (shift) in an ordinal logistic regression analysis of the primary outcome. The treatment effect will also be assessed in all patients with ICH who are recruited during each treatment study period.
  
  
  CONCLUSIONS
  HeadPoST is a large international clinical trial in which we will rigorously evaluate the effects of different head positioning in patients with acute stroke.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT02162017 (date of registration: 27 April 2014); ANZCTR identifier: ACTRN12614000483651 (date of registration: 9 May 2014). Protocol version and date: version 2.2, 19 June 2014.
authors.affiliation: The George Institute for Global Health, University of Sydney and Royal Prince Alfred Hospital, Sydney, Australia. pventurelli@georgeinstitute.org.au.|Vascular Neurology Program, Neurology Service, Department of Medicine, Clínica Alemana de Santiago, Universidad del Desarrollo, Santiago, Chile. pventurelli@georgeinstitute.org.au.
authors.forename: Paula
authors.initials: P
authors.lastname: Muñoz-Venturelli
authors.affiliation: The George Institute for Global Health, University of Sydney and Royal Prince Alfred Hospital, Sydney, Australia. harima@georgeinstitute.org.au.
authors.forename: Hisatomi
authors.initials: H
authors.lastname: Arima
authors.affiliation: Vascular Neurology Program, Neurology Service, Department of Medicine, Clínica Alemana de Santiago, Universidad del Desarrollo, Santiago, Chile. plavados@alemana.cl.|Department of Neurological Sciences, Faculty of Medicine, University of Chile, Santiago, Chile. plavados@alemana.cl.
authors.forename: Pablo
authors.initials: P
authors.lastname: Lavados
authors.affiliation: Vascular Neurology Program, Neurology Service, Department of Medicine, Clínica Alemana de Santiago, Universidad del Desarrollo, Santiago, Chile. abrunser@alemana.cl.
authors.forename: Alejandro
authors.initials: A
authors.lastname: Brunser
authors.affiliation: Department of Neurology, Peking Union Medical College Hospital, Beijing, China. pengbin3@hotmail.com.
authors.forename: Bin
authors.initials: B
authors.lastname: Peng
authors.affiliation: Department of Neurology, Peking Union Medical College Hospital, Beijing, China. pumchcuily@sina.com.
authors.forename: Liying
authors.initials: L
authors.lastname: Cui
authors.affiliation: Department of Neurology, Shanghai 85th Hospital of PLA, Shanghai, China. lsong8185@163.com.
authors.forename: Lily
authors.initials: L
authors.lastname: Song
authors.affiliation: The George Institute for Global Health, University of Sydney and Royal Prince Alfred Hospital, Sydney, Australia. lbillot@georgeinstitute.org.au.
authors.forename: Laurent
authors.initials: L
authors.lastname: Billot
authors.affiliation: School of Health, University of Central Lancashire, Preston, UK. lizboaden@btinternet.com.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Boaden
authors.affiliation: The George Institute for Global Health, University of Sydney and Royal Prince Alfred Hospital, Sydney, Australia. mhackett@georgeinstitute.org.au.|School of Health, University of Central Lancashire, Preston, UK. mhackett@georgeinstitute.org.au.
authors.forename: Maree L
authors.initials: ML
authors.lastname: Hackett
authors.affiliation: The George Institute for Global Health, University of Sydney and Royal Prince Alfred Hospital, Sydney, Australia. stephane.heritier@monash.edu.
authors.forename: Stephane
authors.initials: S
authors.lastname: Heritier
authors.affiliation: The George Institute for Global Health, University of Sydney and Royal Prince Alfred Hospital, Sydney, Australia. sjan@georgeinstitute.org.au.
authors.forename: Stephen
authors.initials: S
authors.lastname: Jan
authors.affiliation: Nursing Research Institute, St Vincent's Health Australia (Sydney) and Australian Catholic University, Sydney, Australia. Sandy.Middleton@acu.edu.au.
authors.forename: Sandy
authors.initials: S
authors.lastname: Middleton
authors.affiliation: Vascular Neurology Program, Neurology Service, Department of Medicine, Clínica Alemana de Santiago, Universidad del Desarrollo, Santiago, Chile. volavarria@alemana.cl.
authors.forename: Verónica V
authors.initials: VV
authors.lastname: Olavarría
authors.affiliation: The George Institute for Global Health, University of Sydney and Royal Prince Alfred Hospital, Sydney, Australia. jlim@georgeinstitute.org.au.
authors.forename: Joyce Y
authors.initials: JY
authors.lastname: Lim
authors.affiliation: The George Institute for Global Health, University of Sydney and Royal Prince Alfred Hospital, Sydney, Australia. rlindley@georgeinstitute.org.au.
authors.forename: Richard I
authors.initials: RI
authors.lastname: Lindley
authors.affiliation: The George Institute for Global Health, University of Sydney and Royal Prince Alfred Hospital, Sydney, Australia. eheeley@georgeinstitute.org.au.
authors.forename: Emma
authors.initials: E
authors.lastname: Heeley
authors.affiliation: Department of Cardiovascular Sciences and Leicester Cardiovascular Biomedical Research Unit, University of Leicester, Leicester, UK. tgr2@leicester.ac.uk.
authors.forename: Thompson
authors.initials: T
authors.lastname: Robinson
authors.affiliation: Vascular and Neurology Emergency Service, Faculty of Medicine, Clinical Hospital of Ribeirão Preto, University of Sao Paulo, Ribeirão Preto, Brazil. opontesneto@fmrp.usp.br.
authors.forename: Octavio
authors.initials: O
authors.lastname: Pontes-Neto
authors.affiliation: Stroke Unit, State Third Hospital, Ulanbaatar, Mongolia. lkhamtsoo@yahoo.com.
authors.forename: Lkhamtsoo
authors.initials: L
authors.lastname: Natsagdorj
authors.affiliation: Stroke Centre, Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan. tay@kmu.edu.tw.
authors.forename: Ruey-Tay
authors.initials: RT
authors.lastname: Lin
authors.affiliation: School of Health, University of Central Lancashire, Preston, UK. CLWatkins@uclan.ac.uk.|Nursing Research Institute, St Vincent's Health Australia (Sydney) and Australian Catholic University, Sydney, Australia. CLWatkins@uclan.ac.uk.
authors.forename: Caroline
authors.initials: C
authors.lastname: Watkins
authors.affiliation: The George Institute for Global Health, University of Sydney and Royal Prince Alfred Hospital, Sydney, Australia. canderson@georgeinstitute.org.au.
authors.forename: Craig S
authors.initials: CS
authors.lastname: Anderson
mesh_terms: D001208:Asia; D001315:Australia; D001938:Brazil; D002543:Cerebral Hemorrhage / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D002560:Cerebrovascular Circulation; D002677:Chile; D002985:Clinical Protocols; D018592:Cross-Over Studies; D004185:Disability Evaluation; D006257:Head / Q000098:blood supply*; D006801:Humans; D016015:Logistic Models; D056888:Patient Positioning / Q000009:adverse effects / Q000379:methods*; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012307:Risk Factors; D018401:Sample Size; D020521:Stroke / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D016683:Supine Position; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom