Informed Consent for Thrombolytic Therapy in Acute Ischemic Stroke
To the Editor:
We read with interest the article by Rosenbaum et al1 evaluating how frequently informed consent is documented when thrombolysis for acute ischemic stroke is administered in clinical practice. Through a retrospective analysis of patients who received tissue plasminogen activator (tPA), they found that informed consent was documented in 84% of the charts. As the authors acknowledge, their study is based on current practice immediately after the approval of intravenous tPA for acute ischemic stroke. The authors do not state whether all patients in their study were treated according National Institute of Neurological Disorders and Stroke criteria.2
The documentation of consent for standard of care surgical procedures may differ from medical interventions. Few physicians will obtain a specific consent for administering intravenous antibiotics for pneumonia. In contrast, all surgeons will obtain a signed informed consent document before operating on a routine herniated lumbar disc. Emergency treatments in which patient incompetence caused by the acute illness or time pressure usually requires a 2-physician consent process. Medical treatments tend to be covered by a general written consent for hospital treatments signed at admission. Moreover, presentation at an emergency ward may itself imply some degree of consent for evaluation and treatment. Differences may also exist by jurisdiction according to local medico-legal practices.3 Importantly, a clear distinction must be made between consent for research4 and consent for the standard care. Standards for the former tend to be governed by national or international policy (ie, Declaration of Helsinki), whereas the latter are governed by local jurisprudence.
Thrombolytic treatment of stroke, although a medical therapy, is much more akin to an acute neurosurgical intervention and the low risk of symptomatic intracranial hemorrhage would seem to warrant a documented consent process. Very few patients, in our experience, are competent in the acute phase to make their own decisions about tPA therapy. Although intravenous tPA is considered standard of care for acute ischemic stroke with onset of symptoms within 3 hours,5 the widening confidence and familiarity with thrombolytic treatment has led to an increasing number of patients being treated outside published guidelines; the same authors showed in a previous article that up to 97% of patients are treated with major or minor protocol deviations (67% are treated in the presence of a major protocol deviation).6 Off-protocol treatments present the most risk to the patient and medico-legally to the physician
How many patients in this series were treated outside protocol and how many of them had documentation of informed consent in the chart?
Rosenbaum JR, Bravata DM, Concato J, Brass LM, Kim N, Fried TR. Informed consent for thrombolytic therapy for patients with acute ischemic stroke treated in routine clinical practice. Stroke. 2004; 35: e353–e355.
Brian T Bateman, Philip M Meyers, H Christian Schumacher, Sundeep Mangla, John Pile-Spellman. Conducting stroke research with an exception from the requirement for informed consent. Stroke. 2003;34:1317.
Adams HP Jr., Adams RJ, Brott T, del Zoppo GJ, Furlan A, Goldstein LB, Grubb RL, Higashida R, Kidwell C, Kwiatkowski TG, Marler JR, Hademenos GJ, Stroke Council of the American Stroke Association. Guidelines for the early management of patients with ischemic stroke: a scientific statement from the Stroke Council of the American Stroke Association. Stroke. 2003; 34: 1056–1083.
We thank Sivakumar et al for their interest in our article.1 The data reported in this article come from a medical record review of patients with acute ischemic stroke who were treated with thrombolysis during the period 1996 to 1998. Among the 63 patients in this study, 42 (67%) had at least 1 major protocol deviation from the National Institute of Neurological Disorders and Stroke criteria for appropriate use of thrombolytic therapy. Patients who received thrombolysis despite a major protocol deviation were less likely to have evidence of informed consent (33/42, 79%) than patients treated without a major protocol deviation (20/21, 95%; P=0.14). Among patients who received thrombolysis with consent documentation in the chart, patients treated despite major protocol deviations were more likely to have had consent provided by a proxy (28/33, 85%) than patients without major protocol deviations (9/20, 45%; P=0.0022).
Sivakumar et al state that “medical treatments tend to be covered by a general written consent for hospital treatments signed at admission.” We found no such consent forms in the 63 charts included in this study.
We agree with the careful distinctions made by Sivakumar et al regarding situations in which the need to obtain written consent is more urgent, such as when participating in research. However, we believe that although the “documentation of consent for standard of care surgical procedures may differ from medical interventions,” a more meaningful threshold for obtaining written consent might focus instead on relative risks and benefits of the intervention proposed, as opposed to what kind of an intervention it is, whether medical or surgical.