"We hope that these data definitions can advance research and clinical care, to increase the adoption of both proven old therapies and new innovations in cardiology," Dr. Christopher Cannon, a cardiologist at Brigham and Women's Hospital in Boston and chairman of the data standards writing committee, said in a news release.
The work product of this effort is described as “a relatively dry document” but with an important aim for its use by researchers and clinicians “as a way to improve care, ultimately, by all speaking the same language,” said Cannon in a video about the release on the ACC website. “But this process is one which is becoming more and more important in several different ways.
“First off,” Cannon said, “this is something we have done in conjunction with the Food and Drug Administration to have the standardized outcomes like MI or cardiovascular death to have the same definitions. So, if trials adopt this, it would allow a better cross comparison between trials of different interventions.”
Cannon said the new standards guidelines “also can facilitate the development of registries, which are used for quality improvement initiatives, performance improvement programs, so that everyone can work with a standard vocabulary, and again facilitate comparison between different registries.”
Also, as medicine moves toward electronic health records, standardized definitions within clinical care in the health records “could then facilitate the use of electronic health-record information to look at outcomes and potentially even do randomized clinical trials within the use of electronic health-record information,” he said.
Similar documents have also dealt with electrophysiology, cardiac imaging and heart failure.
An ACCF/AHA taskforce worked with 13 other organizations to develop standards for seven categories: Demographics and admission; history and risk factors, clinical presentation (such as date and time of symptom onset or blood pressure on first medical contact); diagnostic procedure (such as electrocardiography findings); invasive therapeutic intervention (such as type of pacemaker implanted); medication; and outcomes (including death during hospitalization).
“It is hoped that standardized definitions will facilitate better cross-comparison of results and clinical outcomes between different clinical trials and registries,” the report said. “Finally, considering the application of these data elements to use in the real-world setting, the writing committee paid close attention to the level of detail required to fully describe certain variables, such as timing of prior cardiovascular events, timing of procedures, specific drug names versus classes of drugs, and types of insurance.”
