Few therapeutic recommendations for heart disease are based on a rigorous study

Less than 10% of the treatment recommendations that US doctors rely on to manage the care of heart patients rely on evidence from several large randomized clinical trials – the gold standard for obtaining scientific data .

In fact, the proportion of well-founded recommendations for cardiac care has actually declined from 10 years ago, when an earlier analysis revealed a similar shortage of rigorous studies supporting treatment guidelines. The latest study, led by the Duke Clinical Research Institute, is online March 15 JAMA.

"In 2009, the clinical research firm had called for improvement after this previous study highlighted several deficiencies," said lead author Renato Lopes, MD, Ph.D., a cardiologist and Professor of Medicine at Duke.

"But in reality, despite some initiatives and greater focus on conducting randomized controlled trials, the gap between the evidence and the need for evidence has not improved," Lopes said.

"In fact, the proportion of US recommendations from cardiovascular recommendations, backed by high quality evidence, has actually declined from 11% to 9% over the past decade," said Lopes. "To deliver the health care our patients deserve, clinical research must be transformed."

Lopes and his colleagues, including former FDA Commissioner Robert M. Califf, reviewed evidence supporting more than 6,300 treatment recommendations published by the American College of Cardiology and the American Heart Association (ACC / AHA), as well as by the European Society of Cardiology (ESC). ).

These treatment standards are used to define and manage basic cardiovascular conditions such as high blood pressure and high cholesterol, and therapeutic compliance is widely considered to improve patient outcomes.

The quality of the data that underpins the recommendations is important to minimize study-related biases and confounders inherent in the study, which could then affect real patients in real-world conditions.

Guidelines writing committees rank recommendations based on the level of evidence supporting them: The As level is based on evidence from several randomized controlled trials; Bs levels are supported by a single randomized controlled trial or by non-randomized studies such as observational analyzes; and C levels are determined by experts. The researchers recorded the level of evidence attributed by the guidelines writing committees in the current reference documents.

According to their study, the team led by Duke revealed that only 8.5% of CAC / AHA recommendations were based on Level A evidence, while 50% of studies had Level B and 41 data, 5% had a level of risk C.

"Patients should be able to expect that the medical care they receive will be supported by sound science and will lead to better results," said lead author Alexander Fanaroff, MD. Reduced cardiovascular mortality has slowed in recent years, thus improving the evidence base for treatment guidelines could help prevent this trend. "

Califf noted that technology had evolved considerably over the past decade and that more needed to be done to incorporate the growing capacity for data entry and improvement of clinical research.

"Computer changes and the widespread use of electronic medical records have removed the technical limitations of a much more efficient and scalable clinical research system," Califf said. "We need to change the way the system works so that patients and clinicians can be confident that their decisions are based on high quality evidence."

---

---

Provided by
Duke University Medical Center