title: Informed consent in trials for neurological emergencies: the example of subarachnoid haemorrhage.
abstract: BACKGROUND
  In patients with acute life threatening diseases, and in their relatives, the ability to make a balanced decision on participation in a clinical trial may be impaired.
  
  
  OBJECTIVE
  To assess what relevant information could be recalled by patients who were living independently after a subarachnoid haemorrhage, and by their relatives; and to determine how these patients and relatives had reacted to the informed consent encounter.
  
  
  METHODS
  Twenty months (range 7 to 31) after treatment for subarachnoid haemorrhage, 49 patients and 47 relatives who had participated in one of two randomised trials on medical management were interviewed. The interview consisted of items on: spontaneous recall and knowledge of trial design; understanding of the trial design and the informed consent procedure; the amount and clarity of the information given; and reasons for participating. Finally patients and relatives were asked whether they would participate again in similar circumstances.
  
  
  RESULTS
  One third of the patients recalled having participated in a clinical trial. Thirteen per cent of the patients and 20% of the relatives felt that the information supplied had not been sufficient. Nine per cent of the patients and half the relatives had read the written information. None of the patients and one relative thought that participation had been obligatory. Twenty eight per cent of the patients and 94% of the relatives felt in retrospect that they had been capable of making an adequate decision. Virtually all patients and relatives would participate again in similar circumstances.
  
  
  CONCLUSIONS
  Many patients and their relatives have little recall of the informed consent procedure and the essentials of acute subarachnoid haemorrhage trials. However, most were satisfied with the overall procedure and would participate again.
authors.affiliation: Department of Neurology University Medical Centre Utrecht, Utrecht, Netherlands.
authors.forename: R
authors.initials: R
authors.lastname: Schats
authors.forename: E H
authors.initials: EH
authors.lastname: Brilstra
authors.forename: G J E
authors.initials: GJ
authors.lastname: Rinkel
authors.forename: A
authors.initials: A
authors.lastname: Algra
authors.forename: J
authors.initials: J
authors.lastname: Van Gijn
mesh_terms: D003657:Decision Making; D004632:Emergency Medical Services; D005192:Family Health; D006801:Humans; D007255:Information Services; D007258:Informed Consent; D011939:Mental Recall; D010358:Patient Participation; D010817:Physician-Patient Relations; D016032:Randomized Controlled Trials as Topic; D013345:Subarachnoid Hemorrhage / Q000628:therapy*; D014342:Truth Disclosure