title: Human factors in prehospital research: lessons from the PARAMEDIC trial.
abstract: BACKGROUND
  There is an urgent need to develop prehospital research capability in order to improve the care of patients presenting to emergency medical services (EMS). The Prehospital Randomised Assessment of a Mechanical compression Device In Cardiac arrest trial, a pragmatic cluster randomised trial evaluating the LUCAS-2 device, represents the largest randomised controlled trial conducted by UK ambulance services to date. The aim of this study was to identify and analyse factors that may influence paramedic attitudes to, and participation in, clinical trials.
  
  
  METHODS
  Personal and organisational experience from this trial was assessed by feedback from a workshop attended by collaborators from participating EMS and a survey of EMS personnel participating in the trial. A work systems model was used to explain the impact of five interwoven themes-person, organisation, tasks, tools & technology and environment-on trial conduct including gathering of high-quality data.
  
  
  RESULTS
  The challenge of training a geographically diverse EMS workforce required development of multiple educational solutions. In order to operationalise the trial protocol, internal organisational relationships were perceived as essential. Staff perceptions of the normalisation of participation and ownership of the trial influenced protocol compliance rates. Undertaking research was considered less burdensome when additional tasks were minimised and more difficult when equipment was unavailable. The prehospital environment presents practical challenges for undertaking clinical trials, but our experience suggests these are not insurmountable and should not preclude conducting high-quality research in this setting.
  
  
  CONCLUSIONS
  Application of a human factors model to the implementation of a clinical trial protocol has improved understanding of the work system, which can inform the future conduct of clinical trials and foster a research culture within UK ambulance services.
  
  
  BACKGROUND
  ISRCTN08233942.
authors.affiliation: South Central Ambulance Service NHS Foundation Trust, Otterbourne, UK.
authors.forename: Helen
authors.initials: H
authors.lastname: Pocock
authors.affiliation: South Central Ambulance Service NHS Foundation Trust, Otterbourne, UK NIHR Southampton Respiratory Biomedical Research Unit, University Hospital Southampton NHS Foundation Trust, Southampton, Hampshire, UK.
authors.forename: Charles D
authors.initials: CD
authors.lastname: Deakin
authors.affiliation: Faculty of Health, Social Care and Education, Kingston University and St George's, University of London, London, UK.
authors.forename: Tom
authors.initials: T
authors.lastname: Quinn
authors.affiliation: Warwick Clinical Trials Unit, University of Warwick, Coventry, UK Heart of England NHS Foundation Trust, Birmingham, UK.
authors.forename: Gavin D
authors.initials: GD
authors.lastname: Perkins
authors.affiliation: Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.
authors.forename: Jessica
authors.initials: J
authors.lastname: Horton
authors.affiliation: Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.
authors.forename: Simon
authors.initials: S
authors.lastname: Gates
mesh_terms: D000488:Allied Health Personnel / Q000193:education*; D001291:Attitude of Health Personnel; D035843:Biomedical Research; D004632:Emergency Medical Services / Q000592:standards*; D004739:England; D006336:Heart Massage / Q000592:standards*; D006801:Humans; D058687:Out-of-Hospital Cardiac Arrest / Q000628:therapy*; D011795:Surveys and Questionnaires; D013647:Task Performance and Analysis
keywords: cardiac arrest; pre-hospital; research, clinical; research, operational; resuscitation