Patient decision-making tools for LVADs found to be inadequate

Left ventricular assist device (LVAD) decision-making tools for heart failure patients are inadequate, according to research published online Oct. 14 in Circulation: Cardiovascular Quality and Outcomes. Few reviewed materials mentioned risks, although all discussed benefits.

Out of 149 videos, brochures and websites, 77 met first-level inclusion criteria. All 77 mentioned benefits to the patient but only 43 included risks.

Of those 77, 14 met enough criteria to make them decision aids and presented LVAD as a choice. However, none of those 14 could be considered a true decision aid and only one supported not undergoing the procedure.

Lead author Matthew Iacovetto, BS, of the University of Colorado School of Medicine in Aurora, and colleagues explored information available to patients on LVAD surgery. The research team reviewed materials obtained from top LVAD hospitals, device manufacturers and web searches to determine the scope and quality of educational materials provided to patients.

They collected internet-based materials between July 1, 2013 and July 15, 2013, obtained through Google searches supplemented by searches of websites from top heart transplant hospitals, cardiovascular associations, manufacturers, patient advocacy organizations and patient aid warehouse organizations. Hospital-based materials were requested from clinicians at the 25 heart transplant hospitals previously noted following a survey.

Researchers reviewed materials for quality and accuracy of content, bias, readability and length. Bias was scored by a survey of volunteers. Decision-making capacity was analyzed through use of International Patient Decision Aid Standards criteria for content, development and effectiveness.

Half of the available materials used outdated statistics. The materials tended to be above the reading level of average Americans (approximately grade 11 as opposed to eighth grade), with only two scoring below.

Most were biased toward undergoing LVAD, without full discussion of risks or distinctions between LVAD types: bridge-to-transplant vs. destination therapy. Few addressed caregiver issues.

Most of the materials met fewer than 50 percent of the 16 International Patient Decision Aid Standards Criteria. None had 75 percent or more of the criteria covered.

Among the frequently used materials, a pamphlet and video from Thoratec, one was the only to use “decision” or “option” in the title, and the other was scored most biased out of all materials rated.

“LVADs provide a stark example of how an invasive therapy with complex tradeoffs has prompted the rapid creation of patient-oriented educational information,” Iacovetto et al wrote. They noted further that as much of the available information lacks full disclosure of risks vs benefit, was biased toward undergoing the procedure and was written at a reading level too high for most patients, patients were undergoing procedures without full knowledge of lifestyle impacts, despite signing informed consent.

Iacovetto et al recommended that a system of standards for evaluating materials be established to help grade and improve quality of content available. They hoped that their findings would motivate the development of unbiased, comprehensive and easy-to-understand materials for patients to help clarify the LVAD decision-making process.