Quality improvement (QI) involves systematic evaluation to identify, correct or prevent problems with the purpose of providing continually improved patient care with activities designed to enhance the well-being of patients. QI is often considered to be a separate entity from research because the benefits of the QI intervention are believed to outweigh any potential harms. QI is not governed by human subjects regulations, and informed consent is typically not obtained. However, there are examples of QI interventions that were ultimately demonstrated to be ineffective or even harmful (such as tight glycemic control for critically ill patients).
Not only is it necessary to “do no harm”, but it is also important for QI interventions to have demonstrated benefit. QI initiatives, even when low risk, have an associated opportunity cost. Thus, time and effort spent on an ineffective therapy detracts from the ability to tackle other efforts. Additionally, given that lessons learned from QI efforts can be informative and generalizable, reports of successful (and unsuccessful) QI initiatives are worth disseminating. The SQUIRE 2.0 guidelines were developed as guidance for publishing on QI. The guidelines require reports to include a description of how the impact of the intervention was assessed and the methods by which the results were attributed to the intervention. Thus, although QI is often believed not to include the rigor of research, it would be incorrect to assume that no rigor is required.
Thus, we would argue that QI, research and clinical practice are overlapping entities with the common goal of obtaining knowledge to improve health care. That being said, not all of research is QI and not all QI is research. The line can seem blurry, and controversies have erupted around this distinction.
- How should QI and research be differentiated from each other?
- Should QI and research be subject to the same human subjects regulations? If not, how should they differ?
- When the boundary between QI and research is blurred, should there be human subjects regulations in place?
- Would more regulations result in worsened or improved patient quality and safety?
- What is the best way to get involved with QI and QI research?
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