麻豆传媒

Patient information on left ventricular assist devices (LVAD) is biased in favor of the device, and is suboptimal for helping people determine their pros and cons, according to researchers.

Multiple print, online, and multimedia sources (77) addressed the potential benefits of LVAD, but only 43 of the 77 included a discussion of risks, while significantly less than half addressed lifestyle considerations (29) and surgical details (26). Less than a dozen included information for caregivers, or on hospice or palliative care, wrote , of the University of Colorado in Aurora, and colleagues.

Only 14 of the 77 items contained content suitable for helping patients actually make decisions, the authors wrote online in , and even then, they fell short, displaying a bias toward LVAD, the use of outdated statistics, and a reading level above that of the average American.

"The vast majority of Americans would not be able to comprehend the material because of the high literacy levels," the authors said. "Low health literacy has been associated with poor health outcomes, providing further evidence to its significance."

The authors were prompted to conduct the study when they noticed that the patient materials on LVAD that they used appeared "flimsy," Allen told 麻豆传媒.

"Artificial heart technology has improved over time, and so programs like ours are implanting more LVADs," he said. "However, we noticed that most of what we had to offer patients was essentially marketing information produced by the manufacturers of devices. Advertisements are what they are."

Serious Considerations

LVAD is offered to patients who are in severe heart failure when medication is no longer working. LVAD is recommended for certain carefully selected patients and does offer survival benefits.

But the risks of the LVAD and the necessary lifestyle changes make the decision to undergo implantation "a scary and emotional" one Allen told 麻豆传媒. Approximately half of all LVAD patients are readmitted to the hospital within the first year. Bleeding, stroke, and device-related infection can occur, and nearly one in 10 people need to have surgery to replace their LVAD pump within the first year.

Patients who undergo the procedure will have open heart surgery and stay in the hospital for weeks. After they return home, they must have their pump plugged into a power source and carry equipment, such as a battery pack and controller, with them at all times. They must also avoid immersion in water and manage an electrical cord that penetrates the skin.

Most hospital programs that offer LVAD also require patients to have a caregiver who will help maintain the pump and care for the patient.

The rapid rise in use of the procedure has led to "the rapid creation of patient-oriented educational information," the authors said. Patients need high quality educational materials when they are in the process of making important decisions related to their care, Allen's group wrote.

"This is a time when patients are acutely ill, processing large amounts of new information and making decisions that often have major long-term implications for the patient and their loved ones," they explained.

What's more, while healthcare professionals do communicate with their patients about these procedures and the risks and benefits, opinions about them can vary. Because discussions in clinical settings are often limited by time constraints, patients are often referred to educational materials to supplement their information regarding LVAD implantation. The scope and quality of this information has not been formally evaluated until now, the authors said.

"With a significant portion of materials being distributed by manufacturers to hospital programs, conflict of interest and a distinction between marketing versus education should be a serious consideration when recommending educational supplements to patients," the authors said.

Study Details

To identify patient education material about LVADs, the researchers conducted targeted Internet searches between July 1, 2013 and July 15, 2013. This effort was supplemented with searches of the websites of medical organizations, mechanical circulatory support device manufacturers, patient advocacy organizations, and hospitals noted for heart transplant volume and excellence.

The researchers also contacted clinicians at 25 of the medical centers to ask them about the materials they used to educate patients about LVAD at their facilities. These clinicians were invited to share the materials they gave to patients as part of the LVAD education process.

Materials identified for the study were assessed for the extent and quality of content, as well as the reading level. The 14 items that appeared to be geared toward decision-making were also presented to a group of 10 volunteers, who were asked to rate each one for balance of the information and how clear it was. They were given a six-question multiple choice questionnaire using a.

None of these 14 items met 75% or more of the modified(IPDAS) criteria developed by the . The modified IPDAS checklist contains 16 questions related to the quality of the content and the effectiveness of the material.

Within this 14-item subset, the most commonly used items were the most biased, the authors said. Fifty percent of hospital programs surveyed for the study said they gave patients an educational video entitled "A Treatment Choice for Heart Failure," created by Thoratec, a company that makes VAD devices.

The 10 volunteers who assessed the 14 items scored this video as among the most biased, the authors said. The authors wrote that "although this video includes the subtitle 'shared decision making,' it highlights provocative quotes such as 'either you want to live or you want to give up'."

Problem is Fixable

Earlier studies of other procedures, such cardiac-defibrillator implantation (ICD), have demonstrated shortcomings in educational material that are similar to what researchers found in this study, the authors said.

"Importantly," the authors said, "the weaknesses found in current materials can be remedied in future publications."

To that end, the authors have created decision aids "that are truly patient centered" and follow the IPDAS criteria in order to provide information to patients in an optimal way, Allen said.

Their LVAD decision aids, as well as ICD decision aids, can be accessed

The authors acknowledged some study limitations. Many of the material included in the study were not meant to be "stand-alone" resources, and thus comprehensively judging the material in this fashion may be overly critical.

Also, many mechanical circulatory support centers probably provide counseling in addition to the supplemental published resources. The extent to which patients and clinicians rely on materials such as those included in this study in making their decisions is unknown.

Other limitations include the fact that there is no standardized way to assess the quality of education materials, and that cultural sensitivity, which can have a considerable impact on the effectiveness of an educational resources, was not assessed.

Agreeing to an LVAD is a major decision for patients and their families, Allen pointed out, so information and educational materials are important. Ideally, this complex medical decision should be aided by nuanced and balanced information, he added.

From the American Heart Association:

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