Legal medicine implications in fibrinolytic therapy of acute ischemic stroke.

BACKGROUND: Before the advent of fibrinolytic therapy as a gold standard method of care for cases of acute ischemic stroke in Romania, issues regarding legal medicine aspects involved in this area of medical expertise were already presented and, in the majority of cases, the doctors seem to be unprepared for these situations. MAIN TEXT: The present research illustrates some of the cases in which these aspects were involved, that adressed a clinical center having 6 years of professional experience in the application of fibrinolytic treatment for stroke. The following cases report either situations in which the afore mentioned therapy was not rightfully administrated or legal aspects regarding the obtainment of informed consent. CONCLUSION: Obtaining informed consent is a mandatory procedure, which takes time, to the detriment of application of fibrinolytic treatment.

Ethical Issues in Vascular Neurology.

There are ethical aspects to each of the three phases of cerebrovascular disease: hyperacute management, acute prognostication and management of early complications, and long-term recovery and reintegration with the community. This article addresses ethical concerns pertinent to each phase. First, we discuss ethical issues regarding consent for thrombolysis and endovascular treatment for acute ischemic stroke, including a review of considerations regarding the provision of acute stroke treatment advice over the telephone. Next, we discuss capacity for consent and prognostication after ischemic stroke and intracranial hemorrhage, with a focus on the problems of the self-fulfilling prophecy. Finally, we discuss residual disability and patients' return to driving. Consideration of these ethical dimensions of cerebrovascular disease will assist neurologists in caring for patients and families suffering from this complex condition.

Informed Consent for Intravenous Tissue Plasminogen Activator in New York State Designated Stroke Centers.

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.

Controversy and consent: achieving patient autonomy in thrombolysis for acute submassive pulmonary embolism.

Acute pulmonary embolism (PE) is associated with a wide variation in patient outcome ranging from completely asymptomatic to cardiac failure and death. This presents a challenge to clinicians in ensuring the correct treatment for individual patients is given and that adverse events secondary to treatment complications are minimised. The evidence for those with massive PEs and non-massive PEs is clear for and against the use of thrombolysis, respectively. However, in those with 'sub-massive' PE there is no clear consensus on whether there is a treatment benefit. We present the case of a patient who presented with a non-haemodynamically significant PE but with evidence of right ventricular dilatation, and discuss the difficulties in treatment decisions in such cases, including the ethical and legal principles of consent, and how clinicians might best allow their patients to make informed decisions when in clinical equipoise.

Inability to consent does not diminish the desirability of stroke thrombolysis.

OBJECTIVE: Some have argued that physicians should not presume to make thrombolysis decisions for incapacitated patients with acute ischemic stroke because the risks and benefits of thrombolysis involve deeply personal values. We evaluated the influence of the inability to consent and of personal health-related values on older adults' emergency treatment preferences for both ischemic stroke and cardiac arrest. METHODS: A total of 2,154 US adults age ≥50 years read vignettes in which they had either suffered an acute ischemic stroke and could be treated with thrombolysis, or had suffered a sudden cardiac arrest and could be treated with cardiopulmonary resuscitation. Participants were then asked (1) whether they would want the intervention, or (2) whether they would want to be given the intervention even if their informed consent could not be obtained. We elicited health-related values as predictors of these judgments. RESULTS: Older adults were as likely to want stroke thrombolysis when unable to consent (78.1%) as when asked directly (76.2%), whereas older adults were more likely to want cardiopulmonary resuscitation when unable to consent (83.6% compared to 75.9%). Greater confidence in the medical system and reliance on statistical information in decision making were both associated with desiring thrombolysis. INTERPRETATION: Older adults regard thrombolysis no less favorably when considering a situation in which they are unable to consent. These findings provide empirical support for recent professional society recommendations to treat ischemic stroke with thrombolysis in appropriate emergency circumstances under a presumption of consent.

Telephone consultations for tissue plasminogen activator administration in acute stroke.

Effective treatment for acute ischemic stroke has been available for 17 years, but wide geographic variability remains in timely access to neurologic expertise and other components of stroke systems of care. Telemedical technology can be used to improve such access, but it is debatable whether neurologists have an ethical obligation to provide consultation regarding tissue plasminogen activator use via the telephone. This article examines whether neurologists are ethically obligated to provide telephone-mediated acute stroke consultation.

Behavioral equipoise: a way to resolve ethical stalemates in clinical research.

Randomized trials depend on clinicians feeling that they are morally justified in allowing their patients to be randomized across treatment arms. Typically such justification rides on what has been called "clinical equipoise"--when there is disagreement of opinion among the community of experts about whether one treatment is better than another, then physicians can ethically enter their patients into a clinical trial, even if individual physicians are not at equipoise. Recent debates over prominent studies, however, illustrate that controversy can be easily created rather than dispelled by trials, with many clinicians choosing not to use the proven therapy until they receive more convincing evidence of its superiority. In such situations, we propose that a new standard of equipoise be used to guide decisions about the ethical justifications for research trials--a standard of behavioral equipoise. Under behavioral equipoise, a trial is potentially justifiable if it addresses behavioral resistance to prior scientific evidence.

Ethic issue in ischemic stroke patients wit thrombolytic therapy.

OBJECTIVE: To discuss the ethical challenge in thrombolytic therapy. BACKGROUND: Thrombolytic therapy with recombinant tissue-type plasminogen activator (rt-Pa) has been found to be beneficial to the outcome of patients who had a stroke. However, the ethic issue that is related to intravenous rt-Pa infusion has not been discussed. PATIENTS: Four patients with a middle cerebral artery (MCA) infarct arrived at the emergency department (ER) of our hospital within 3 hours of stroke onset. All of them violated the guidelines of thrombolytic therapy for patients. The families of three patients insisted on the thrombolytic therapy. Two patients received rt-Pa infusion and two did not. RESULTS: Two patients who received rt-Pa infusion experienced hemorrhagic transformation. One died on the fifth day after stroke, and the other one had a poor outcome with a modified ranking scale (mRS) of 5. One of the two patients who did not receive rt-Pa infusion suffered from hemorrhagic transformation and died on the third day after stroke, and the other one had a poor outcome with mRS of 5. CONCLUSIONS: These 4 cases highlight the complexity of thrombolytic therapy in patients who violate the guidelines because the families insisted on thrombolytic therapy. No one is sure that the family's decision was the patient's wish. When a stroke patient violates the guidelines of thrombolytic therapy and the family of the patient insists on the thrombolytic therapy, a conversation between patients, patients' families and clinicians is necessary. Physician should tell patient and their families about the high risk of hemorrhagic transformation and mortality. If the family wants to make a decision, physician should request patient or patient's families to sign an against medical advice form and follow the patient's or their family's decision for the outcome.

An exploration of the ethical dimensions pertinent to gaining consent for thrombolysis.

--This paper explores some of the pertinent ethical principles involved in gaining consent in thrombolysis, relevant to both nurses and paramedics. --It describes ethical concerns regarding this practice. --Two key themes that have been explored are around the issue of autonomy and paternalism. --With nurse-initiated thrombolysis gaining momentum, an awareness of key ethical dimensions is fundamental.