title: Variability in the Perception of Informed Consent for IV-tPA during Telestroke Consultation.
abstract: OBJECTIVE
  To study the perception of informed consent among various raters for thrombolysis in acute ischemic stroke patients receiving intravenous tissue plasminogen activator (IV-tPA).
  
  
  METHODS
  Twenty randomly selected videotaped telestroke consultations of acute stroke patients administered IV-tPA were retrospectively reviewed. Adequacy of informed consent was reviewed by five raters: a neurologist and emergency physician who routinely treat stroke, a medical risk management paralegal, a bioethicist, and a lay person. Raters assessed the quality of the informed consent presentation by the treating physician and the degree of understanding demonstrated by the patient/family authorizing consent. Factors associated with adequacy of consent were analyzed.
  
  
  RESULTS
  Consent was rated as adequately understood by the patient-family in 78.6% cases. Agreement between all five raters with regard to the patient-family understanding of consent was poor and also between the subgroups of non-physician and physician (all k < 0.20). Similarly, the quality of the physician consent process was poor for agreement between all five raters (k = 0.07) or between the subgroup of the three non-physician raters (k = -0.06) and fair between the two physician raters (k = 0.24). The legal reviewer and the bioethicist rated the physician consent process as being of lower quality than did the two physicians and the layperson.
  
  
  CONCLUSIONS
  Despite high variability in the perception of informed consent among raters in this time-sensitive clinical situation, almost 80% of patients were rated by all reviewers as having adequate understanding of risks and benefits of tPA. This suggests the need for a standardized but brief tPA consent process that includes patient/family demonstration of understanding.
authors.affiliation: Department of Emergency Medicine, Mount Auburn Hospital Cambridge, MA, USA.
authors.forename: Lisa
authors.initials: L
authors.lastname: Thomas
authors.forename: Anand
authors.initials: A
authors.lastname: Viswanathan
authors.forename: Thomas I
authors.initials: TI
authors.lastname: Cochrane
authors.forename: John
authors.initials: J
authors.lastname: Johnson
authors.forename: Janice
authors.initials: J
authors.lastname: O'Brien
authors.forename: Marilyn
authors.initials: M
authors.lastname: McMahon
authors.forename: Janine Marie
authors.initials: JM
authors.lastname: Santimauro
authors.forename: Lee H
authors.initials: LH
authors.lastname: Schwamm