Overzealous oversight of healthcare quality improvement projects

Abstract

Purpose -This paper seeks to describe a recent impasse resulting from failure of a federal oversight agency to distinguish between observational studies documenting the impact of quality improvement activities versus experimental clinical trials research. Design/methodology/approach -This paper provides a review of popular press accounts, regulations, and relevant correspondence; and interviews with project leaders. Findings -A controversial federal decision in the USA quickly galvanized unusually harsh criticism from a very wide range of professional associations, healthcare researchers, and patient safety advocacy groups. Originality/value -This incident, at a time when application of quality improvement methods and public reporting networks are becoming more widespread in healthcare, illustrates the urgent need for better distinction between clinical trials research versus quality improvement research projects. Institutional review boards are ill-advised to apply familiar ethical safeguard reviews appropriate to the former to the latter.

Evaluating factors affecting patient satisfaction using the Kano model

“…In recent years, the application of quality methodologies and tools to improve healthcare processes began expanding at an exponential rate. Prior research suggests that healthcare providers could greatly benefit from quality improvement activities focused on patient satisfaction as they reduce waste as well as costs while enhancing patient safety and healthcare quality 137 Evaluating factors affecting patient satisfaction (Mazur, 2003;Birnbaum and Ratcliffe, 2008;Gremyr and Raharjo, 2013;Padma et al, 2014;.…”