Informed consent for thrombolytic therapy for patients with acute ischemic stroke treated in routine clinical practice.
OBJECTIVE
Little is known about informed consent for tissue plasminogen activator (tPA). Our objectives were to determine how frequently informed consent is obtained when tPA is given to stroke patients in clinical practice and whether the person providing consent (patient or surrogate) was the appropriate decision-maker.


METHODS
This retrospective cohort included acute stroke patients given tPA in 10 Connecticut hospitals (1996-1998). Consent was defined as any documentation of discussion about risks and benefits of tPA. Patients had adequate decision-making capacity if they were alert, oriented, and without aphasia or neglect (patient was appropriate decision-maker). Patients with any of these deficits were considered to have diminished capacity (surrogate was appropriate decision-maker).


RESULTS
Among 63 patients who received tPA, 53 (84%) had informed consent documented; 16/53 (30%) gave their own consent. Among patients with adequate decision-making capacity, 5/8 (63%) had consent by surrogate. Among patients with diminished capacity, 7/38 (18%) provided their own consent.


CONCLUSIONS
A substantial percentage of patients who received tPA for stroke had no consent documented. Surrogates often provided consent when the patients had capacity; conversely, patients with diminished capacity sometimes provided their own consent. Given the urgency and weight of the decision regarding tPA, more explicit informed consent and capacity assessment should be considered for treatment protocols.
Rosenbaum
Julie R
JR
Department of Internal Medicine, Yale University School of Medicine, West Haven, Conn, USA. julie.rosenbaum@yale.edu
Bravata
Dawn M
DM
Concato
John
J
Brass
Lawrence M
LM
Kim
Nancy
N
Fried
Terri R
TR
D000208:Acute Disease; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002545:Brain Ischemia / Q000188:drug therapy* / Q000523:psychology; D015331:Cohort Studies; D003237:Connecticut; D004282:Documentation; D004630:Emergencies; D005260:Female; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D006801:Humans; D007258:Informed Consent / Q000706:statistics & numerical data*; D008297:Male; D016743:Mental Competency; D008875:Middle Aged; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data; D012189:Retrospective Studies; D012720:Severity of Illness Index; D020458:Third-Party Consent / Q000706:statistics & numerical data; D015912:Thrombolytic Therapy / Q000523:psychology / Q000706:statistics & numerical data; D010959:Tissue Plasminogen Activator / Q000627:therapeutic use*
D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator