"It is hoped by all involved that these data definitions can advance research and clinical care, thereby increasing the adoption of both proven old therapies and new innovations in cardiology," said Christopher Cannon, MD, FACC, chair of the writing committee and cardiologist at Brigham and Women's Hospital in Boston. "This advancement can support our ultimate goal – to improve outcomes for patients with cardiovascular disease."
The new data elements and definitions include seven categories:
- Demographic and admission — including patient's sex, date of birth, race, source of admission, and payment type.
- History and risk factors — including history of prior angina, previous history of heart failure, and date of prior coronary artery bypass grafting.
- Clinical presentation — including the date and time of symptom onset, heart rate, systolic blood pressure on first medical contact, height and weight.
- Diagnostic procedure — including rhythm determined by electrocardiography (ECG), site where first ECG was obtained, LDL value, HDL value, and glucose.
- Invasive therapeutic intervention — including type of pacemaker implanted, the date of noninvasive stress testing, the culprit artery responsible for the ACS, and the percent of stenosis in the left main coronary artery.
- Medication — including the dose of anticoagulant administered, the administration of a beta-blocker in the first 24 hours, and the prescription of aspirin at hospital discharge.
- Outcomes — including death during hospitalization, occurrence of reinfarction, surgical intervention required for bleeding, and the requirement of transfusion.
To develop the data standards, the writing committee reviewed case report forms, data elements and data definitions from national and international ACS registries and previous or ongoing clinical trials to develop an initial set of data elements. They note that data elements and definitions were linked whenever possible to evidence-based national guidelines. In addition, the Task Force coordinated efforts with the U.S. Food and Drug Administration, which has also developed standardized definitions of major outcomes for clinical trials.
The writing committee members note that there were several goals of the development of clinical data standards, including better cross-comparison of results and clinical outcomes between different clinical trials and registries; development and implementation of future registries at both individual hospital and national levels; facilitation of quality improvement by collecting data as part of a quality improvement program at a hospital, state or national level and thereby improve the process of care and clinical outcomes.
They add that data elements and definitions can be used in the development of performance measures by identifying underutilization of therapies; can become the basis for developing a standardized charting process for use within EHRs; will allow adjustment for comorbidities and other variables that may affect outcomes and quality metrics between different providers, hospitals and geographical networks and ensure scientific comparison.
Finally, the writing committee members note that in considering the use of these data elements in the real-world, "for any of the data elements the user can decide to collect more or less information, depending on the circumstance." Furthermore, "the goal was to be as concise as possible to facilitate the use of these variables in real-world registry or trial settings," they add.
The data standards were also developed in collaboration with the American College of Emergency Physicians, Emergency Nurses Association, National Association of Emergency Medical Technicians, National Association of EMS Physicians, Preventative Cardiovascular Nurses Association, Society for Angiography and Interventions, Society of Cardiovascular Patient Care, and Society of Thoracic Surgeons.