Published Online
on July 8, 2004

A more recent version of this article appeared on September 1, 2004

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Submitted on May 7, 2004
Revised on May 26, 2004
Accepted on June 3, 2004

Informed Consent for Thrombolytic Therapy for Patients With Acute Ischemic Stroke Treated in Routine Clinical Practice

Julie R. Rosenbaum MD^*; Dawn M. Bravata MD; John Concato MD, MPH; Lawrence M. Brass MD; Nancy Kim MD; and Terri R. Fried MD

From the Robert Wood Johnson Clinical Scholars Program (D.M.B., J.C., N.K.), the Department of Internal Medicine (J.R.R., D.M.B., J.C., N.K., T.R.F.), and the Department of Neurology (L.M.B.), Yale University School of Medicine; and the Clinical Epidemiology Research Center (D.M.B., J.C., T.R.F.), the Medical Service (D.M.B., J.C., T.R.F.), and the Neurology Service (L.M.B.), VA Connecticut Healthcare System, West Haven, Conn.

^* To whom correspondence should be addressed. E-mail: julie.rosenbaum{at}yale.edu.

Background and Purpose--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.

Key words: cerebral ischemia • informed consent • mental competency • thrombolytic therapy

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