Review of the legal obligations of the doctor to discuss Sudden Unexplained Death in Epilepsy (SUDEP) – A cohort controlled comparative cross-matched study in an outpatient epilepsy clinic

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Beran RG, Weber S, Sungaran R, Venn N, and Hung A (2004) Review of the legal obligations of the doctor to discuss Sudden Unexplained Death in Epilepsy (SUDEP) – A cohort controlled comparative cross-matched study in an outpatient epilepsy clinic. Seizure 13:7 523–8.

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Abstract: INTRODUCTION:Acknowledging informed consent and warning of material risk, the present study examined the current debate regarding early discussion of Sudden Unexplained Death in Epilepsy (SUDEP). It sought to confirm the profile of those prone to SUDEP and to determine the basis for disclosure to patients. METHODS: Patients with SUDEP attending an Australian outpatient epilepsy clinic between 1985 and 2000 were compared to an age, gender and epilepsy type cross-matched control group to ascertain risk factors for SUDEP and similarities to published parameters. These were evaluated as the basis for actions in negligence for either disclosure or failure to disclose. RESULTS: Twenty-one SUDEP patients were identified: aged 18-70 years; the majority had localisation-related epilepsy (13:8, 62%); male to female ratio was 3:1; and 15/21 used polypharmacy, compared with 8/21 controls (P = 0.02951). Handedness, alcohol use or deterioration of epilepsy were unrelated. DISCUSSION: This population mirrored the literature and confirmed an absence of risk factors amenable to modification. As discussion of SUDEP with males with localisation-related epilepsy on polypharmacy could not alter outcome it is unlikely that failure to disclose could be causal and hence successful in an action for negligence. Conversely, disclosure, in the absence of the patient seeking the information, may causally adversely affect quality of life hence providing successful action in negligence. Duty of care dictates open and frank discussion with those seeking the information. Thus, each case must be managed individually and doctors are advised to document the decision-making process.

Keywords: Sudden unexplained death, Epilepsy, Risk factors, Informed consent, Material risk, Therapeutic privilege

Context

  • Case-control study examining data from 15 years of patient management in an Australian clinic. 21 cases of SUDEP were identified in the clinic records, yet there was no clear evidence of modifiable risk factors. The authors concluded that without evidence of an influence of patient behavior on likelihood of SUDEP there is no reason to inform patients of the possibility of SUDEP, and that informing patients could lead to increased distress and thus subject the physician to the assessment of negligence.

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