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27-08-2012 | Legal medicine | Article

Informed consent process lacks information about adverse events, treatment alternatives


Free abstract

medwireNews: There is a lack of information about adverse events and treatment options during the informed consent process, show the results of a video simulation-based study of patients with schizophrenia, family members of patients with schizophrenia, and healthcare providers.

Furthermore, after watching the simulated scenario involving a patient with new-onset psychosis and her physician discussing consent to initiate antipsychotic medication, information retention differed between patients, family members, and the healthcare providers.

"Interestingly, patients and family members 'remembered' symptoms that were not stated to be treated by the medication, or even mentioned in the video," observe the researchers.

"This emphasizes the need for providers to be very specific and determine the nature of their patients' understanding," write John Fromson, from Massachusetts General Hospital in Boston, USA, and colleagues in the Journal of Medical Ethics.

To determine whether standards of informed consent are meeting the needs of this group of interested parties, Fromson and team constructed a web-accessed patient-physician scenario, viewed by 107 participants (2.8% patients, 46.7% family members, 50.5% providers) who completed a follow-up survey.

Overall, 67.3% of patients and family members and 59.6% of healthcare providers listed the correct time and dose for taking the recommended treatment, with 28.4% and 48.0% of the former group remembering the reasons for taking the medication and the adverse events associated with it.

Interestingly, note Fromson et al, the most common reason (78.8%) for taking the recommended treatment listed by patients and family was "to decrease or stop the voices." However, the doctor in the simulation did not mention that the medication treated these symptoms, indicating that respondents had projected their own experiences onto the situation or extrapolated from the symptoms discussed.

Further discussion appeared most frequently (65%) among suggestions for additional elements of the informed consent process, with risk (37%) and information about treatment (38%) also high on the list.

"For alternative treatments, describing another pharmacological treatment option was insufficient, and discussion of alternative psychosocial and pharmacological treatments is advised," suggest the researchers.

Patients, family members, and providers concurred on some elements of the simulation, with significant positive correlation between ratings of the simulation physician's performance on four of the established elements of informed consent (including reviewing the patient's symptoms and assessing her treatment preferences), and how comfortable the respondent would feel if they were the patient.

The researchers conclude that "it is only by offering an informed consent process that considers patient preference that patients may make those decisions while preserving their autonomy."

medwireNews ( is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2012

By Sarah Guy, medwireNews Reporter

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