Understanding the Patient Perspective in the Ethical Gray Space between Research and Quality Improvement

Quality improvement (QI) projects and clinical research projects both contribute to the body of evidence that furthers clinical practice. With a recent shift in making research more pragmatic, the lines between QI and research can be blurred. The purpose of this study was to develop a survey aimed at understanding the patient's perspective on being part of QI and research projects in a hospital or health care system (HCS). The goal is to identify if a common ethical framework exists for the implementation of minimal risk projects. Additionally, we wanted to understand the drivers of patient's decisions pertaining to projects aimed at improving patient care. In order to assess this, we developed constructs, or subjects of measurement, of sequential examples that assess these concepts. Patients were asked to select a response ranging from definitely yes to definitely not (Likert scale) on a number of questions related to their comfort level of providing their permission for hospitals to implement these projects. The surveys will allow us to better understand the patient perspective when it comes to improving patient care in a minimal risk setting. Their responses will enable us to establish when permission would be needed to carry out certain activities intended to improve patient care. Additionally, the surveys may allow us to assess potential linkages between attitudes and actions and the strength of that association across various scenarios. Further data collection is needed to obtain a more concrete understanding of patient's comfort level in participating in patient care improvement projects