Hospitalists are often asked to participate in or lead quality improvement (QI) and research initiatives, locally and nationally. Because data collection and feedback are part of any QI effort, and because the results of these efforts are often published, the hospitalists who lead these efforts often ask (or are asked by others) the question: “Is this research?” The short answer is that QI research is different from standard QI efforts in many respects. In this chapter, we will address the differences between standard QI efforts and research, some reasons to do QI research, the appropriate time to do QI research (for you and for the scientific question at hand), how “rigorously” to conduct QI research, getting started with the process, the ingredients for a successful project, and issues related to study design and methods that are either unique to or are particularly relevant to QI research.
This chapter will address both “quality improvement” and “patient safety” research. The two terms are often used interchangeably, and often the line between them is gray. For example, is an effort to increase β-blocker use to prevent a second myocardial infarction an issue of QI or safety? That said, “safety” is often used in the context of rare incidents where there is a strong link between an error and its associated outcome (eg, wrong-site surgery). The issues regarding both types of research are often the same. This chapter will review additional issues unique to patient safety research that take account of the rarity of many safety events.
Collecting, analyzing, and reporting data does not turn a QI project into research. The important characteristic of QI research, as opposed to standard QI efforts, is that the question to be answered is not “can we improve care here?” but “does this intervention work in general?” If the goal is to design and test a novel intervention to improve care (or to test an established intervention in a novel setting), to establish whether a particular intervention works in a wide variety of settings such that it might become a new standard of care, and/or to learn generalizable lessons about how to successfully implement such an intervention, then it is research.
QI research is not just writing up the results of a QI project. In fact, writing up the results should be part of almost all QI efforts so that other institutions may learn from your experience and you may earn “academic credit” for having done the work. The SQUIRE Guidelines (http://www.squire-statement.org/) provide detailed advice on how to write up such results. Content unique to these reports (as opposed to conventional research manuscripts) include:
Introduction: description of the local problem and the intended improvement
Methods: discussion of any ethical issues, planning the intervention, and planning the study of ...