B. Quality of Care and HTA

HTA is an important source of information for quality of care. Although a thorough discussion of this relationship is not within the scope of this document, the following are some definitions and fundamental relationships concerning these concepts.

Quality of care is a measure or indicator of the degree to which health care is expected to increase the likelihood of desired health outcomes and is consistent with prevailing standards of health care. HTA and quality assurance are distinct yet interdependent processes that contribute to quality of care.

HTA generates findings that add knowledge about the relationship between health care interventions and outcomes. This knowledge can be used to develop and update a range of standards and guidelines for improving health care quality, including clinical practice guidelines, manufacturing standards, clinical laboratory standards, adverse event reporting, architecture and facility design standards, and other criteria, practices, and policies regarding the performance of health care. Participation of clinicians, and particularly opinion leaders, in HTA and in developing evidence-based clinical practice guidelines can improve the acceptance and adoption of those guidelines and, thereby, quality of care.

The purpose of quality assurance activities is to ensure that the best available knowledge concerning the use of health care to improve health outcomes is properly used. It involves the implementation of health care standards, including activities to correct, reduce variations in, or otherwise improve health care practices relative to these standards. Continuous quality improvement (CQI) and total quality management (TQM) (Gann 1994; Wakefield 1993) are among the systematic approaches to implementing quality assurance that have been adapted for hospitals and other health care institutions. Such approaches include, for example, the identification of “best practices” and the use of benchmarking to develop improved clinical pathways or disease management for medical and surgical procedures, administrative operations, etc. (Kim 2003; Kwan 2003; Pilnick 2001). For example, CQI has been evaluated in a multicenter RCT as a means improve the adoption of two process-of-care measures for coronary artery bypass graft surgery (CABG): preoperative β–blockade therapy and internal mammary artery grafting (Ferguson 2003). Notably, in this RCT, the intervention being tested was not those two health care interventions, but CQI.

Quality assurance involves a measurement and monitoring function, i.e., quality assessment. Quality assessment is, primarily, a means for determining how well health care is delivered in comparison with applicable standards or acceptable bounds of care. These standards or bounds may be grouped according to the structure of care (e.g., institutional, professional, and physical characteristics), the process of care (content or nature of the health care delivered) and the outcomes of care (health status and well-being of patients) (Donabedian 1988). Increasingly, quality assurance involves studies of effectiveness data, including health outcomes and the determinants of those outcomes from the perspectives of clinicians, patients, administrators, and policymakers (McDonald 2000). In detecting these differences between how well health care is delivered and applicable standards, quality assessment can also call attention to the need for further HTA or other investigations.

In summary, HTA is among the sources of knowledge used to set standards for health care, and quality assurance is used to determine the extent to which health care providers adhere to these standards (Lohr 1990; Lohr and Rettig 1988). Major reorganization of health care systems may be required to ensure that stronger evidence is generated systematically for setting standards of care, and that standards of care are broadly implemented (Institute of Medicine, Committee on Quality of Health Care in America 2001).