An epidemiologic approach to quality improvement, quality assurance, and clinical research.

ASSESSMENT AND ASSURANCE OF PATIENT-CARE QUALITY AT THE CLINICAL CENTER: HISTORICAL PERSPECTIVES The Clinical Center of the National Institutes of Health is a 450-bed tertiary referral research hospital. The mission of the Clinical Center is to conduct "cutting-edge" clinical research. All patients have been referred by their own physicians to the Clinical Center to participate in research protocols. Thus, most clinical care in our hospital is delivered within the context of one of the many active scientific protocols. Before any patients are admitted to these protocols, the protocols receive exhaustive critique-including expert review of the science, analysis of the study's experimental design and statistical approach, evaluation for the protection of human subjects from research risks, and assessment of the study from a bioethical perspective. Thus, substantial clinical "quality assurance" occurs before any patients are entered into these protocols. Many, if not most, protocols are innovative; most differ substantially from the accepted "standard of care." Because our patients volunteer as "subjects" in clinical research, they are not charged for care at the Clinical Center. For these reasons, several traditional quality assurance/utilization review tenets have limited relevance. For example, if quarterly magnetic resonance imaging scans are ordered for all patients in a given protocol, determining the appropriateness of an individual scan becomes moot. Further, if half of the patients in a double-blinded efficacy study receive placebo, comparisons of patient outcomes are not appropriate. Determining appropriate "length-of-stay" criteria for patients receiving novel therapies, especially because toxicities and adverse events arising from these therapies cannot realistically be anticipated, is equally as problematic. From an organizational perspective, most of our investigators work for one of 13 categorical institutes of the National Institutes of Health. Nursing and the traditional medical departmental staffs work for the Clinical Center. Thus, the overwhelming majority of the physician staff have primary allegiance to one of 13 institutes-each of which is distinct from the Clinical Center. Each institute has its own financial management structure, and each has its own line of authority. Thus, the organizational intricacies that can complicate quality assessment activities in academic medical centers are richly represented at the Clinical Center. A separate but related issue is that many of our senior investigators are recognized as national or international authorities or "standard-setters" in their respective fields. Historically, because of their knowledge, skills, and expertise, our investigators have envisioned institutional quality assurance efforts as essentially equivalent to invasions of privacy. Although these views may be somewhat typical of the feelings of all institutionbased physicians, the problem is magnified when the investigator whose care is being assessed has been responsible for describing the medical syndrome being studied or for developing a novel, effective therapy. For these (and several other) reasons, traditional quality assurance activities met with extremely lim-