Thrombolysis for Acute Ischemic Stroke: The Patient’s Point of View

Abstract

Background: The use of thrombolytic therapy for acute ischemic stroke is still controversial. A major problem is balancing the improvement in functional ability against the risk of early death from cerebral hemorrhage. Our aim was to assess whether patients who have had a stroke, and their proxies, would give consent to thrombolysis if this therapy were introduced into clinical practice for acute ischemic stroke in Italy. Methods: A 10-item questionnaire was administered by personnel not directly involved in the care of patients in 12 Italian hospitals. Interviews were carried out with at least 10 consecutive stroke inpatients per center in the postacute phase and to their proxies. Results: There were 685 responders (377 female), median age 58 years (range 18–98); 332 were patients and 353 proxies. Responders were representative of the Italian population as a whole as regards mean age and sex, education and marital status; 59% of responders (95% confidence interval 55–62%) would agree to thrombolysis in the case of stroke. There was more uncertainty among proxies than patients, especially when the decision had to be taken for a relative (41 vs. 17% could not decide, p < 0.001). The preference for thrombolysis was higher among more educated people (p = 0.001) and was not influenced by sex, age and marital status. Overall, 81% of responders would prefer to risk dying rather than remain severely disabled. Conclusion: Thrombolytic therapy is feasible in Italy as there is ample willingness to trade off a better functional outcome with a higher risk of death. Education is the main sociodemographic determinant of independent decision-making, as only those with an adequate cultural level are able to discriminate between one treatment option and another. The proxy’s uncertainty about how to interpret a patient’s preference regarding consent to thrombolytic therapy should be tackled, since proxies play a key role in making patients’ preferences known in case of incompetence after an acute stroke.

Ethical Issues of Informed Consent in Acute Stroke

“…Making decisions for an urgent stroke clinical trial testing potentially risky drugs is obviously psychologically stressful for relatives. The difficulties of getting consent from a relative in the setting of thrombolysis for acute ischemic stroke has recently been shown by Ciccone et al [5]. In their study, 41% of relatives could not decide on the patient’s enrollment versus 17% of patients (p = 0.001).…”

“…In the USA, consent can be obtained from the legally authorized representative [2]. In Italy, the waiver of consent is legally accepted in clinical research in case of life-threatening situations in which the patient is not able to give consent [5]. …”

Gender issues in acute stroke thrombolysis

“…31 In contrast, gender did not influence thrombolysis treatment preference in another study in which acute stroke patients and their proxies were hypothetically asked about intravenous thrombolysis, prior to initiation of a thrombolysis programme in Italy. 32 …”

Prediction of Functional Outcome in Patients With Primary Intracerebral Hemorrhage

“…However, there are important limitations to their application because they may be (1) significantly confounded by the self-fulfilling prophecy of withdrawal of care that is the most potent predictor of death in ICH, 5,6,20 because all scores were tested and validated in cohorts in which withdrawal of care was common; and (2) uninformative to families who are most often preoccupied with their loved one's chance of functional recovery, should the patient survive, rather than simply the likelihood of survival. 21,22 Currently available tools that are specifically designed to predict functional recovery in ICH 14,[23][24][25][26] have limited usefulness because they either were developed in highly selected groups of patients or excluded clinical predictors known to influence ICH outcomes.…”