Research Versus Quality Improvement: Distinct or a Distinction Without a Difference? A Case Study Comparison of Two Studies

摘要

Our case study comparison suggests that the research designation for Study 1 and the QI project designation for Study 2 were based on factors including motivation, the objective and the context of knowledge production, study selection and design, sources of funding, and sources of internal validity. However, we also found 45 CFR 46 regulatory criteria and other criteria used by IRBs that would support the research designation in the later phase of Study 2, such as coproduction of knowledge through operational and research collaboration, a rigorous evaluation phase after the intervention that had similar philosophical underpinnings of research, IRB review for social accountability, and ultimate publication into scientific journals at the dissemination phase. Indeed, the IRB switched the designation from QI to research as the dividing lines blurred. As demonstrated by the literature and by Study 2, the differentiation between research and QI is contentious and perhaps, as in many other cases, even unattainable. The criteria of general-izability and rigor, with their inherent value, are applicable, we believe, to QI as well as research. Other criteria, such as randomization at the individual patient level, would readily identify a subset of research. If we are to develop a "learning health care system" that constantly seeks to improve itself and share what it has learned with others in an expeditious manner, we need better ways to address the regulatory issues while protecting everyone's safety; that is, minimizing risk and protecting patients' confidentiality. The improvement of the health care system depends on it.