title: Views of paramedics on their role in an out-of-hospital ambulance-based trial in ultra-acute stroke: qualitative data from the Rapid Intervention With Glyceryl Trinitrate in Hypertensive Stroke Trial (RIGHT).
abstract: OBJECTIVE
  Optimal practices for recruiting, consenting, and randomizing patients, and delivering treatment in out-of-hospital ultra-acute stroke trials, remain unclear. We aim to identify key barriers and facilitators relevant to the design and conduct of ambulance-based stroke trials and to formulate preliminary recommendations for the design of future trials.
  
  
  METHODS
  Using semistructured interviews, we investigated the experiences and challenges faced by paramedics who took part in a randomized controlled trial in suspected ultra-acute stroke, the Rapid Intervention With Glyceryl Trinitrate in Hypertensive Stroke Trial (RIGHT), in which recruitment, consent, randomization, assessment, and treatment were delivered by paramedics before hospitalization.
  
  
  RESULTS
  We purposively selected a diversity sample of 14 of the 78 paramedics who participated in RIGHT. We identified 13 themes (7 facilitators and 6 barriers to out-of-hospital stroke research). A simple stroke diagnostic tool, use of proxy consent on behalf of patients, and straightforward trial processes were identified as the main facilitators. Recruitment became easier with each new randomization attempt. Key barriers reported were informed consent in the emergency setting, lack of institutional support for research, learning curve and rarity (each paramedic treats only a few eligible patients), and difficulty in attending training sessions. Interviewed paramedics were motivated to participate in research.
  
  
  CONCLUSIONS
  Ultra-acute stroke research in the out-of-hospital environment is feasible, but important barriers need to be addressed. Proxy consent by paramedics addresses some of the difficulties with the consent process in the out-of-hospital setting.
authors.affiliation: Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK; Stroke Service, Nottingham University Hospitals National Health Service Trust, Nottingham, UK.
authors.forename: Sandeep
authors.initials: S
authors.lastname: Ankolekar
authors.affiliation: School of Health Sciences, University of Nottingham, Nottingham, UK.
authors.forename: Ruth
authors.initials: R
authors.lastname: Parry
authors.affiliation: Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK; Stroke Service, Nottingham University Hospitals National Health Service Trust, Nottingham, UK.
authors.forename: Nikola
authors.initials: N
authors.lastname: Sprigg
authors.affiliation: School of Health and Social Care, University of Lincoln, UK.
authors.forename: A Niroshan
authors.initials: AN
authors.lastname: Siriwardena
authors.affiliation: Stroke Trials Unit, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK; Stroke Service, Nottingham University Hospitals National Health Service Trust, Nottingham, UK. Electronic address: philip.bath@nottingham.ac.uk.
authors.forename: Philip M W
authors.initials: PM
authors.lastname: Bath
mesh_terms: D001291:Attitude of Health Personnel; D035843:Biomedical Research; D004632:Emergency Medical Services; D004634:Emergency Medical Technicians; D006801:Humans; D006973:Hypertension / Q000150:complications; D007407:Interviews as Topic; D024382:Professional Role; D036301:Qualitative Research; D020521:Stroke / Q000188:drug therapy* / Q000209:etiology; D020458:Third-Party Consent