Thomas I. Cochrane

Risk of Guillain-Barré syndrome after meningococcal conjugate vaccination.

A new meningococcal conjugate vaccine (MCV4) was introduced in 2005. Shortly after, case reports of Guillain–Barré syndrome (GBS), a serious demyelinating disease, began to be reported to the Vaccine Adverse Event Reporting System. In 2006, the Centers for Disease Control and Prevention and the Food and Drug Administration requested the evaluation of GBS risk after MCV4 vaccination. We conducted a study to assess the risk of GBS after MCV4 vaccination using health plan administrative and claims data together with the review of primary medical records of potential cases.

Unnecessary Time Pressure in Refusal of Life-Sustaining Therapies: Fear of Missing the Opportunity to Die

During an illness requiring brief use of life-sustaining therapy (LST), patients and surrogates sometimes feel that LST must be withdrawn before it becomes unnecessary to avoid later being stuck living in a debilitated condition that the patient considers worse than death. This fear depends on the belief that the patient can legitimately refuse only artificial LST, so that if such therapies are no longer required, he or she will have missed the ‘opportunity to die.’ This fear of being stuck with life can lead to premature decisions to terminate LST and is unfounded because adequate ethical and moral justification exists for refusal of not just artificial LST, but also for refusal of natural LST, including oral hydration and nutrition.

The Effects of Closed-Loop Medical Devices on the Autonomy and Accountability of Persons and Systems.

Closed-loop medical devices such as brain-computer interfaces are an emerging and rapidly advancing neurotechnology. The target patients for brain-computer interfaces (BCIs) are often severely paralyzed, and thus particularly vulnerable in terms of personal autonomy, decisionmaking capacity, and agency. Here we analyze the effects of closed-loop medical devices on the autonomy and accountability of both persons (as patients or research participants) and neurotechnological closed-loop medical systems. We show that although BCIs can strengthen patient autonomy by preserving or restoring communicative abilities and/or motor control, closed-loop devices may also create challenges for moral and legal accountability. We advocate the development of a comprehensive ethical and legal framework to address the challenges of emerging closed-loop neurotechnologies like BCIs and stress the centrality of informed consent and refusal as a means to foster accountability. We propose the creation of an international neuroethics task force with members from medical neuroscience, neuroengineering, computer science, medical law, and medical ethics, as well as representatives of patient advocacy groups and the public.

The controversy over artificial hydration and nutrition

With regard to the controversy over artificial hydration and nutrition, Bernat and Beresford concisely and correctly characterized the current state of affairs.1 In doing so they had to include the longstanding debate over whether hydration and nutrition provided by feeding tube is “artificial” or “natural.” We recently argued that the artificial vs natural distinction is irrelevant.2 Despite several decades of debate, there is still no consensus over whether tube feedings are artificial or natural—and we should not expect agreement on this in the future. More importantly, the right to refuse life-sustaining therapies derives straightforwardly from a right to self-determination and bodily integrity. From a moral standpoint, we argue that this right includes refusal of any unwanted therapies whatsoever, including oral hydration and nutrition when it is feasible—as, for example, in some patients with advanced dementia who could be fed by hand but are not for the sake of convenience and economy.3,4 Disclosure: The authors report no …

Variability in the Perception of Informed Consent for IV-tPA during Telestroke Consultation.

Objective: To study the perception of informed consent among various raters for thrombolysis in acute ischemic stroke patients receiving intravenous tissue plasminogen activator (IV-tPA). Methods: Twenty randomly selected videotaped telestroke consultations of acute stroke patients administered IV-tPA were retrospectively reviewed. Adequacy of informed consent was reviewed by five raters: a neurologist and emergency physician who routinely treat stroke, a medical risk management paralegal, a bioethicist, and a lay person. Raters assessed the quality of the informed consent presentation by the treating physician and the degree of understanding demonstrated by the patient/family authorizing consent. Factors associated with adequacy of consent were analyzed. Results: Consent was rated as adequately understood by the patient-family in 78.6% cases. Agreement between all five raters with regard to the patient-family understanding of consent was poor and also between the subgroups of non-physician and physician (all k < 0.20). Similarly, the quality of the physician consent process was poor for agreement between all five raters (k = 0.07) or between the subgroup of the three non-physician raters (k = −0.06) and fair between the two physician raters (k = 0.24). The legal reviewer and the bioethicist rated the physician consent process as being of lower quality than did the two physicians and the layperson. Conclusion: Despite high variability in the perception of informed consent among raters in this time-sensitive clinical situation, almost 80% of patients were rated by all reviewers as having adequate understanding of risks and benefits of tPA. This suggests the need for a standardized but brief tPA consent process that includes patient/family demonstration of understanding.

Withdrawing and withholding life-sustaining treatment.

The ethics of decisions to withhold or withdraw life-sustaining therapies are reviewed. Special attention is paid to the ethical and moral distinctions - or lack thereof - between withholding and withdrawing. The ethical principles informing decisions to forgo life-sustaining therapy are covered, along with the difficulty of making such decisions in the face of prognostic uncertainty. Specific advice is provided regarding the decision-making process, and recent literature regarding decision-making in the neurologic intensive care unit is reviewed.

Swiss cheese brain.

A 66-year-old woman with hypertension and hypercholesterolemia presented with 2 days of cough, low-grade fever, and severe encephalopathy. Nasal influenza A antigen was detected. As her fever resolved, her mental status returned to normal. Brain MRI revealed extensive non-enhancing T2 hyperintensities (figure 1). Figure 1. Axial T2 …

Guidelines for ethical behavior relating to clinical practice issues in neuromuscular and electrodiagnostic medicine

The American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) developed guidelines to formalize the ethical standards that neuromuscular and electrodiagnostic (EDx) physicians should observe in their clinical and scientific activities. Neuromuscular and EDx medicine is a subspecialty of medicine that focuses on evaluation, diagnosis, and comprehensive medical management, including rehabilitation of individuals with neuromuscular disorders. Physicians working in this subspecialty focus on disorders of the motor unit, including muscle, neuromuscular junction, axon, plexus, nerve root, anterior horn cell, and the peripheral nerves (motor and sensory). The neuromuscular and EDx physicians goal is to diagnose and treat these conditions to mitigate their impact and improve the patients quality of life. The guidelines are consistent with the Principles of Medical Ethics adopted by the American Medical Association and represent a revision of previous AANEM guidelines.

Clinical improvement of monomelic amyotrophy after avoidance of sustained neck flexion.

To the Editor: Management of monomelic amyotrophy (Hirayama disease) is controversial and includes clinical observation, use of a cervical collar, and cervical decompression and fusion.1 Cessation of symptom progression with persistent arm weakness is the most common outcome.1,2 Some have documented regression of symptoms with cervical collar use or after cervical spine surgery.2 We describe clinical improvement in a young man with monomelic amyo-trophy who was asked to avoid prolonged neck flexion without using a cervical collar. A 19-year old man presented with 8 months of progressive asymmetric arm weakness and atrophy. There was no preceding trauma. He denied pain or sensory loss. When flexing his cervical spine, he described a “pulling” sensation originating in his lower cervical/upper thoracic region and radiating into his right fifth digit. He was starting college and when studying in bed with his head propped in flexion the hypothenar eminence and fifth digit would twitch or cramp. His medical history was unremarkable. His examination revealed atrophy in the right thenar and hypothenar eminences, fasciculations in the right first dorsal interosseous (FDI), and asymmetric weakness in muscles of the C7/C8/T1 myotomes [right elbow extensors, wrist extensors, finger flexors, finger abductors, and thumb abductors all medical research council (MRC) grade 4] but was particularly prominent in the right finger extensors, most dramatically in digits 3 and 4 (MRC grade 0 in digits 3 and 4; grade 3 in digit 5; and grade 4 in digit 2). The rest of the neurologic examination was normal. Nerve conduction studies were unremarkable. Electromyography demonstrated abnormalities in muscles innervated by C7/C8/T1 anterior horn cells, worse on the right. Fibrillation potentials and positive sharp waves were seen in the right FDI, extensor digitorum communis (EDC), and flexor carpi radialis. In these muscles, there were either no voluntary motor unit potentials (EDC) or reduced recruitment of chronically remodeled units (FDI, flexor carpi radialis). Similar changes were also seen in the right abductor pollicis brevis and triceps, and in the left FDI, abductor pollicis brevis and EDC. Needle examination of the legs and thoracic paraspinals was normal. Cervical spine magnetic resonance imaging revealed the loss of normal cervical lordosis but no disc herniation or cord signal change. Computed tomography myelogram demonstrated indentation on the right anterior cervical cord at the C5-6 vertebral level in flexion views (Fig. 1). The patient was advised to avoid all activities involving substantial neck flexion and to sleep with his neck in a neutral position. A year later, the patient reported improved strength in the right finger extensors, finger flexors, and wrist extensors (MRC grades 4, 5, and 5, respectively). These changes in strength resulted in significant improvement of his ability to type and perform manual tasks. After 3 years of follow-up, he has remained stable and continues to avoid neck flexion. FIGURE 1 Computed tomography myelogram. A, Axial image at C5-6 with neck neutrally aligned. B, Axial image at C5-6 with neck in flexion. Note the flattening and indentation (arrow) on the right anterior cervical cord. The radiographic findings and clinical course argue in favor of a compressive etiology of monomelic amyotrophy in this patient. Conservative management was a moderately successful strategy even with radiologic signs of cervical cord compression.

Is the Use of Modafinil, a Pharmacological Cognitive Enhancer, Cheating?.

Abstract Drugs used to provide improvement of cognitive functioning have been shown to be effective in healthy individuals. It is sometimes assumed that the use of these drugs constitutes cheating in an academic context. We examine whether this assumption is ethically sound. Beyond providing the most up-to-date discussion of modafinil use in an academic context, this contribution includes an overview of the safety of modafinil use in greater depth than previous studies addressing the issue of cheating. Secondly, we emphasize two crucial, but hitherto nearly overlooked, nuances to the issues: (a) the potential for modafinil to decrease inequality and disadvantage in academic settings, and (b) the fact that how modafinil is used dramatically impacts its effects on health, coercion, fairness, authenticity and effort. Finally, we explicitly defend the position that there are no qualitatively morally relevant differences between modafinil use and other enhancement modalities; any such differences are in degree, not kind.