title: Novel consent process for research in dying patients unable to give consent.
abstract: OBJECTIVE
  To develop a process of advance consent to enable research to be undertaken in patients in the terminal phase.
  
  
  METHODS
  Feasibility study of an advance consent process to support a randomised controlled trial of two antimuscarinic drugs (hyoscine hydrobromide and glycopyrronium bromide) in the management of noisy respirations associated with retained secretions ("death rattle").
  
  
  METHODS
  Palliative care wards in a major cancer centre.
  
  
  METHODS
  Patients admitted to a palliative care ward who may develop "death rattle" and thus be eligible for randomisation.
  
  
  METHODS
  Patient accrual; acceptability of the consent process.
  
  
  RESULTS
  Of the 107 patients approached, 58 patients gave advance consent to participate in the study. Of these, 15 patients developed death rattle and were randomised to receive either hyoscine or glycopyrronium; 16 patients died elsewhere; 15 patients died on the palliative care wards but were not randomised; 12 patients are still alive.
  
  
  CONCLUSIONS
  Initial assessment suggests that this is a workable consent process allowing research to be undertaken in patients who are unable to give consent at the time of randomisation. Patient accrual rates to date are lower than needed to recruit adequate numbers in the time allotted to answer the research question.
authors.affiliation: Department of Palliative Medicine, Royal Marsden Hospital, Sutton, Surrey SM2 5PT.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Rees
authors.forename: Janet
authors.initials: J
authors.lastname: Hardy
mesh_terms: D016223:Advance Directives; D005240:Feasibility Studies; D006024:Glycopyrrolate / Q000627:therapeutic use*; D006801:Humans; D007258:Informed Consent; D018727:Muscarinic Antagonists / Q000627:therapeutic use*; D012135:Respiratory Sounds; D012601:Scopolamine / Q000627:therapeutic use*; D013727:Terminal Care; D019452:Terminally Ill
chemical_list: D018727:Muscarinic Antagonists; D012601:Scopolamine; D006024:Glycopyrrolate