Feature: Doc, patient perceptions differ on PCI, consent needs overhaul

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Discrepancies exist between how patients and cardiologists perceive the benefits of PCI,and while many cardiologists understand the procedural benefits, many patients misjudge them and believe the procedure is used to prevent death or MI, according to a study published in the Sept. 6 edition of the Annals of Internal Medicine. The informed consent process at hospitals is laced with flaws, and should be revised, Alicia Fernandez, MD, of the University of California, San Francisco, told Cardiovascular Business News.

For the study, Michael B. Rothberg, MD, from Baystate Medical Center in Springfield, Mass., and Tufts University School of Medicine in Boston, and colleagues analyzed questionnaires collected from 153 patients receiving elective coronary catheterization and possible PCI between Dec. 1, 2007, and Aug. 31, 2008. Additionally, 10 interventional cardiologists and 17 referring cardiologists responded.

“Despite the lack of randomized trial evidence, some cardiologists believe that PCI can reduce major cardiac events and mortality for patients with chronic stable angina, but other issues, such as medicolegal liability, may also play a role,” the authors wrote. “Patients may also overestimate the benefits of PCI. Their beliefs about the necessity of the procedure and its efficacy are likely to be shaped by their interaction with their physicians.”

To study these perceptions, Rothberg et al distributed a questionnaire that asked patients 24 questions pertaining to patient characteristics, presence/absence of angina, whether PCI procedure was explained, who explained it, expectations of PCI and whether the patient thought he/she knew enough about the procedure.

Of the 153 patients, 68 percent had angina, 42 percent had activity-limiting angina, 77 percent had a positive stress test and 29 percent had previous MI. A total of 53 patients underwent PCI.

The 53 patients undergoing PCI were more likely to have had positive stress test results. Of those who did not undergo stress testing, 13 patients were indicated for PCI for angina, five for dyspnea, two for atrial fibrillation and left ventricular dysfunction and one for previous MI.

“What Rothberg and colleagues found was that the majority of patients felt that they knew why they were having the procedure done,” said Fernandez. “The majority of patients felt that they knew enough about the procedure, but at the same time they felt that the reason for performing the PCI was to reduce mortality and to prevent a heart attack as well as to reduce angina.”

According to the results, 96 percent of patients felt that they understood why then would undergo PCI, while over half of the respondents said that they were “actively” involved in the decision-making process.

Additionally, 88 percent of the patients thought that undergoing PCI would reduce the risk of future MI, while 82 percent thought the intervention would reduce the risk for a future fatal MI. On the contrary, cardiologists felt that PCI would prevent MI in only nine patient cases (17 percent), while PCI would prevent fatal MI in eight patient cases (15 percent).

The informed consent process was created to weigh the pros and cons of certain patient procedures, Fernandez said. “Informed consent is supposed to tell patients about the anticipated risk of a procedure, but it’s also supposed to outline the anticipated benefits so patients can really understand what the possible risk-benefit ratio is and also what alternatives there are to undergoing that procedure.

“During the study, there was a real discrepancy between what the patients thought the procedure was supposed to do and what the cardiologist thought the procedure was supposed to do," offered Fernandez. "This represents a failure of the informed consent process."

The results also showed that 77 percent of patients reported pre-PCI angina compared with 98 percent of cardiologists. Additionally, compared with cardiologists, patients were least likely to report that they participated in the decision-making process to undergo PCI, 78 versus 94 percent. The authors reported that most cardiologists believed that the benefits of PCI “were largely limited to symptom relief.”

Fernandez said that the results were not all that surprising. “We know that patients often fail to understand the anticipated benefit of treatment and I think that that is partly because it is difficult to perform informed consent well.”

She noted that the system is flawed because physicians are not well trained in the informed consent process and may also be confined by time.

“It’s important to incorporate decision aids or educational material so that patients at least get a brochure outlining the risks, the expected benefits and others that are not expected benefits,” she said. Fernandez noted that particularly in the case of PCI, patients are often not told about the alternative, which is medical therapy.

While Fernandez offered that adjusting the structure of informed consent materials may be easiest to improving the process, she said this also may not be the most beneficial. Incorporating a physician/patient decision-making process that includes the administration of educational materials and informative videos, particularly at high-volume centers, may help improve informed consent and patient awareness.

Most challenging, Fernandez said, would be “changing the context in which we make decision.” This would entail changing the reimbursement system. “Currently, any decision process is going to favor doing the procedure and I think this is where we need to have a better alignment between reimbursement and high-quality care.”

Rothberg and colleagues noted that currently physicians have "little incentive to discourage patients from undergoing PCI," and this thought process may lead to the high prevalence of intervention in patients whose symptoms may not be all that limiting.

Fernandez offered that there should be renovations in the process in which physicians and patients make decisions and make them together, rather than separately. “We need to create a research infrastructure to understand why procedure A is better than B, or how procedure A compares to procedure B,” she said.

Fernandez said that if patients’ understanding of the risks and benefits of PCI were better known, rates for PCI procedures, which are performed in an estimated 1.2 million patients, would fall.

“What we take from this study is that patients routinely overestimate the benefits of a procedure just as they may sometimes overestimate the risks. This is why this is an important study, particularly for PCI. It is as we call ‘preference sensitive’ because it is a valid alternative but so is medical therapy. In the future, a patient’s wishes should guide our decision making,” she concluded.