Improving practices within an institution is generally regarded as good management. The use of continuous quality improvement techniques (CQI), however, begins to make innovation look like research, and therein lies a problem.
The primary purpose of ethical review is to assure that a research design uses ethical methods and otherwise conforms to ethical standards. External oversight is provided by committees (often called IRBs, or institutional review boards) that are usually comprised of peers from the scientific, professional, and medical communities and laypeople representing community perspectives.
Research and quality improvement share many characteristics. In CQI endeavors, patients are subject to the efforts to correct, enhance, or otherwise change those practices. This process may involve changes a patient will not notice, such as a new flowchart on which to record vital signs. Or the process may involve noticeable changes that are not burdensome or that a patient might welcome, such as a new practice of having attending physicians' names and phone numbers at the bedside. However, the process may entail changes that result in practices contrary to a patient's expectations - for instance, visits from additional staff members or participation in advance care planning discussions.
Patients whose lives are touched by CQI endeavors are not usually regarded as research subjects. Improvement teams may not have any obligation to obtain the informed consent of their subjects, or even to notify their subjects of the changes being implemented and evaluated, even when some risk to patients is possible. External review is not usually sought. However, to assure that the "good intentions" being examined are not merely the whim of the improvement team, the endeavor should be grounded in the values shared across a community of peers.
|Table 2.2 Characteristics Typical of CQI and Research|
|Immediate practice change||X|
|Enrich knowledge base||X|
|Immediate behavior change||X|
|Applies to larger group||X|
|Careful, systematic study||X|
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This online version of the book Improving Care for the End of Life: A Sourcebook for Health Care Managers and Clinicians is provided with permission of Americans for Better Care of the Dying [ www.abcd-caring.org ] and Oxford University Press. All rights reserved.
For further information on quality improvement in end-of-life care visit The Palliative Care Policy Center [ www.medicaring.org ].