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Patient Understanding of Potential Risk and Benefit With Informed Consent in a Left Ventricular Assist Device Population

A Pilot Study

Edlund, John E. PhD; Edlund, Adrianne E. RN, MS; Carey, Mary G. PhD, RN

doi: 10.1097/JCN.0000000000000188

Background: Consent issues have not been thoroughly explored in a left ventricular assist device (LVAD) population.

Objective: The purpose of this pilot study was to explore patients’ knowledge of their LVAD, including the accuracy of patients’ understanding of the LVAD, potential complications, and lifestyle changes necessary after implantation.

Methods: Hospitalized patients with LVAD were recruited to complete a questionnaire.

Results: Among 16 patients, 13 (mean [SD] age, 60.2 [11.16] years) completed the protocol.

Conclusions: Some of the items had a high level of accuracy, whereas other items suffered from poor performance (including complications from implantation and long-term survival rates). In addition, verbal aptitude was associated with overall scores on the questionnaire, such that patients with a higher verbal aptitude scored better on the questionnaire.

Clinical Implications: The results of this pilot study suggest that patients would benefit from an improved consent process to increase their knowledge of the device.

John E. Edlund, PhD Assistant Professor of Psychology, Department of Psychology, Rochester Institute of Technology, New York.

Adrianne E. Edlund, RN, MS Nurse Leader, Nursing Practice, University of Rochester Medical Center, New York.

Mary G. Carey, PhD, RN Associate Professor and Director of Clinical Nursing Research, University of Rochester Medical Center, New York.

The authors have no funding or conflicts of interest to disclose.

Correspondence John E. Edlund, PhD, Department of Psychology, Rochester Institute of Technology, 18 Lomb Memorial Dr, Rochester, NY 14623 (

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