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Comment & Response
May 2018

Rigor in Quality Improvement Studies and the Role of Time-Series Methodologies

Author Affiliations
  • 1Duke Cancer Institute, Duke University, Durham, North Carolina
  • 2National Quality Forum, Washington, DC
JAMA Intern Med. 2018;178(5):725. doi:10.1001/jamainternmed.2018.0866

To the Editor In response to the editorial by Grady et al1 published in a recent issue of JAMA Internal Medicine, most quality improvement activities in medicine are not research, which is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”2(p94) Because of expectations for generalizability, study designs that test hypotheses, maximize external validity, and test multiple contexts, are expected. Conversely, most quality improvement, though such activities may be systematic and data driven, is not designed to be generalizable, prompting recommendations exempting quality improvement from usual human subjects research review.2

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