S 4.1 STANDARDS FOR CARDIOVASCULAR DATA: A Concept Paper

Karl Hammermeister, MD, FACC

Staff Cardiologist, Denver VA Medical Center
Professor of Medicine, University of Colorado Health Sciences Center

E-mail: khammer@sembilan.uchsc.edu

Attribution: This paper represents a synthesis of concepts developed by the author in the course of his work with the Department of Veterans Affairs and the American College of Cardiology Database Committee. However, the concepts presented here do not necessarily represent official statements or policy of either the Department of Veterans Affairs or the American College of Cardiology.

Much of the most critical information for clinical decision making is still recorded as free-form, hand-written notes. In no other large-scale enterprise are such archaic methods used for managing THE information fundamental to its success, as in medicine. Major efforts are currently underway to expand the use of electronic information management hardware and software in cardiovascular care. However, this effort is being significantly impeded by the lack of clinical information standards. The American College of Cardiology is convening an international conference to initiate the process for the standardization of language used by care providers to make the clinical decisions required for patient care. This paper discusses the conceptual issues that must be considered in the planning of this standardization process and proposes a plan for achieving international standardization of cardiovascular clinical data. If successful, standardization will accrue major benefits to patient care, clinical research, and industry. It is proposed that this standardization effort be an international, collaborative effort between cardiovascular clinicians, their professional societies, and industry concerned with cardiovascular information technology.

Clinical information standardization should address minimum information content, as well as data elements and definitions. Minimum information content may be defined as that required to make the major clinical decisions for a defined episode of care. Clinical practice guidelines can serve as a logical basis for defining minimum information content. The clinical criteria in the guideline for recommending a process of care (e.g., coronary arteriography) represent the minimum information content for that decision node, and can be easily converted to data elements. The use of electronic data entry leads to an expanded concept of the data element, the data object. A data object could include the data element, specifications of responses, definitions, an audit trail, built-in data quality checks and data completion requirements, distinction between unknown and missing values, and a data object identifier.

We propose a six-step standardization process: 1) the creation of pathways of care linking major clinical decision nodes, 2) the determination of minimum information content as the clinical decision node criteria derived from clinical practice guidelines, 3) the creation of a database of currently used data element wordings and definitions, 4) a consensus process by working groups to standardize all components of the data object, 5) publication of the results, and 6) continuous up-dating and revision.

An international cardiovascular data standards conference to be held June 27 - 28, 1996, at Heart House, the American College of Cardiology Headquarters, Bethesda, Maryland, to initiate the development of standards for cardiovascular information. The goals of this conference are four-fold: 1) to achieve agreement upon which standards are necessary, 2) to define the processes for achieving these standards, 3) to complete a pilot standardization project of limited data sets for prediction of short-term outcomes following percutaneous transluminal coronary angioplasty (PTCA) and coronary artery bypass graft (CABG) surgery, and 4) to initiate planning for a more permanent structure that will be required for up-dating and revision, and to address other cardiovascular topic areas.