title: Informed Consent for Intravenous Tissue Plasminogen Activator in New York State Designated Stroke Centers.
abstract: OBJECTIVE
  Our objective was to assess informed consent procedures for intravenous tissue plasminogen activator in acute stroke among New York State (NYS) Department of Health (DOH) designated stroke centers.
  
  
  METHODS
  A 13-question survey stratified by 0- to 3-hour and 3.0- to 4.5-hour treatment windows was used to determine the type of consent or if no consent was required.
  
  
  RESULTS
  Of the 117 hospitals, 111 responded (95%). All 111 hospitals provided treatment within the 3-hour window, whereas 97 (87%) provided treatment beyond the 3-hour window (P < .001). For hospitals that did provide treatment, there was a difference between the percentages of hospitals requiring consent (verbal or written) within 3 hours (82%) and beyond 3 hours (92%) (P = .04). Of the hospitals requiring consent, there was a difference in the type of consent: 31 of 91 (34%) required written consent within the 3-hour window, whereas 57 of 89 (64%) required written consent beyond the 3-hour window (P < .001). Within both treatment windows, 98% accepted a health-care proxy or surrogate in lieu of the patient. Of the hospitals with less than 500 beds, 11 of 81 (14%) did not require consent within the 3-hour treatment window, compared to hospitals with 500 or more beds where 9 of 30 (30%) did not require consent within the 3-hour treatment window (P < .05). Beyond the 3-hour treatment window, hospitals with more than 500 beds required written consent-2-fold increase "compared to less than 3 hour window" (P < .05). Fifty-five percent of the hospitals were academic, whereas 45% were nonacademic. Academic status was not related to the type of consent in either window.
  
  
  CONCLUSIONS
  Significant variability exists in the types of informed consent based on hospital bed size and treatment windows across NYS DOH designated stroke centers.
authors.affiliation: Department of Neurology, New York Medical College, Valhalla, New York. Electronic address: miwneuro@gmail.com.
authors.forename: Michael I
authors.initials: MI
authors.lastname: Weintraub
authors.affiliation: Stroke and Cardiac Services, New York State Department of Health, Albany, New York.
authors.forename: Anna D
authors.initials: AD
authors.lastname: Colello
authors.affiliation: Quality and Systems Improvement, American Heart Association/American Stroke Association, Robbinsville, New Jersey.
authors.forename: Samantha A
authors.initials: SA
authors.lastname: Johnson
authors.affiliation: Performance Improvement and Patient Safety, University North Carolina Hospitals, Chapel Hill, North Carolina.
authors.forename: Fabienne
authors.initials: F
authors.lastname: McClellan
authors.affiliation: Research Design Associates, Yorktown Heights, New York.
authors.forename: Steven P
authors.initials: SP
authors.lastname: Cole
authors.affiliation: Department of Neurology, University Rochester School of Medicine, Rochester, New York.
authors.forename: Curtis
authors.initials: C
authors.lastname: Benesch
authors.affiliation: Department of Neurology, Maimonides Medical Center, Brooklyn, New York.
authors.forename: Steven H
authors.initials: SH
authors.lastname: Rudolph
authors.affiliation: Department of Neurology, SUNY Downstate Medical Center and Kings County Medical Center, Brooklyn, New York.
authors.forename: Steven R
authors.initials: SR
authors.lastname: Levine
mesh_terms: D032962:Consent Forms / Q000941:ethics; D005343:Fibrinolytic Agents / Q000008:administration & dosage*; D019538:Health Care Surveys; D054625:Healthcare Disparities / Q000941:ethics; D006742:Hospital Bed Capacity; D006761:Hospitals / Q000941:ethics*; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D007262:Infusions, Intravenous; D009518:New York; D010818:Practice Patterns, Physicians' / Q000941:ethics; D017064:Process Assessment, Health Care / Q000941:ethics*; D020521:Stroke / Q000175:diagnosis / Q000188:drug therapy*; D015912:Thrombolytic Therapy / Q000941:ethics*; D013997:Time Factors; D061665:Time-to-Treatment; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator
keywords: Tissue plasminogen activator; acute ischemic stroke; informed consent; stroke centers; thrombolysis