title: Barriers to recruitment for surgical trials in head and neck oncology: a survey of trial investigators.
abstract: OBJECTIVE
  Many randomised trials in surgery suffer from recruitment rates that lag behind projected targets. We aim to identify perceived barriers to recruitment among these pioneering trials in the field of head and neck cancer surgery.
  
  
  METHODS
  Recruiting centres to all three trials (Selective Elective Neck Dissection (SEND), Positron Emission Tomography (PET)-Neck and Hyperbaric Oxygen in the Prevention of Osteoradionecrosis (HOPON)) were contacted by email by the chief investigators. Responders were asked to complete a web-based survey in order to identify the barriers to recruitment in their centre and grade each by severity.
  
  
  METHODS
  Secondary care: 44 head and neck oncology regional referral centres.
  
  
  METHODS
  Analysis was based on 85 responses evenly distributed between the three trials.
  
  
  RESULTS
  The most commonly identified perceived barriers to recruitment (more than 50% of responders identified the item as a barrier in all the three trials) in the order of frequency were: patients consent refusal because of expressed treatment preference, patients consent refusal owing to aversion to randomisation, excess complexity/amount of information provided to patients and lack of time in clinic to accommodate research. The most severely rated of these problems was consent refusal because of the expressed treatment preference and lack of time in the clinic.
  
  
  CONCLUSIONS
  Our findings confirm others' work in surgery that the most significant barrier to trial recruitment in head and neck cancer surgery is the patient's preference for one arm of the trial. It may be that additional training for those taking consent may be helpful in this regard. It is also important to adequately resource busy surgical clinics to support clinical trial recruitment.
authors.affiliation: Department of Biostatistics, University of Liverpool, Liverpool, UK.
authors.forename: Geetinder
authors.initials: G
authors.lastname: Kaur
authors.forename: Iain
authors.initials: I
authors.lastname: Hutchison
authors.forename: Hisham
authors.initials: H
authors.lastname: Mehanna
authors.forename: Paula
authors.initials: P
authors.lastname: Williamson
authors.forename: Richard
authors.initials: R
authors.lastname: Shaw
authors.forename: Catrin
authors.initials: C
authors.lastname: Tudur Smith