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

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

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Title: Variability in the Perception of Informed Consent for IV-tPA during Telestroke Consultation
Author: Johnson, John; O’Brien, Janice; McMahon, Marilyn; Santimauro, Janine Marie; Thomas, Lisa E.; Viswanathan, Anand; Cochrane, Thomas I.; Schwamm, Lee H.

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Citation: Thomas, Lisa, Anand Viswanathan, Thomas I. Cochrane, John Johnson, Janice O’Brien, Marilyn McMahon, Janine Marie Santimauro, and Lee H. Schwamm. 2012. Variability in the perception of informed consent for IV-tPA during telestroke consultation. Frontiers in Neurology 3:128.
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Abstract: 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.
Published Version: doi:10.3389/fneur.2012.00128
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