June 17, 2016: Oversight on the Borderline

June 17, 2016: Oversight on the Borderline


Oversight on the Borderline: Quality Improvement and Pragmatic Research


Jonathan Finkelstein, MD, MPH, Boston Children’s Hospital and Harvard Medical School


Research oversight; Human subjects protection; Quality improvement; QI research; Pragmatic research

Key Points

  • Pragmatic research involves the creation of generalizable knowledge about the relative effectiveness of alternative treatments or strategies, conducted in “real world” healthcare settings and designed to be maximally applicable under routine conditions.
  • Quality improvement (QI) involves “systemic, data-guided activities designed to bring about immediate improvements in health care delivery in particular settings” (The Hastings Center). QI research involves the creation of generalizable knowledge about methods for measuring and improving healthcare quality, or that utilize quality improvement tools and strategies in study design or intervention.
  • Healthcare organizations should have systematic, transparent processes for designating activities as QI or research and determining what independent evaluation each will receive.
  • Healthcare organizations should have formal and explicit oversight of non-routine QI activities.
  • QI-related research should be reviewed by an IRB; for such a review to be effective, IRBs should develop particular expertise in assessing QI studies.
  • Stakeholder engagement should be included in the review of QI and QI-related research proposals and implementation.

Discussion Themes

When does “learning from data” become “seeking generalizable knowledge”? When does “measurement” become “systematic collection”?

How do we think about routine operations in a learning healthcare system with best practices seamlessly embedded in the delivery process and new knowledge captured as an integral by-product of the delivery experience?

What QI activities should have explicit ethical oversight in order to help ensure adherence to fundamental ethical principles of health care?

Are there special considerations in the oversight of pragmatic QI research activities that optimally protect patients and other participants yet allow for rapid system learning?

For More Information

Read more about the intersection of QI and pragmatic research in Finkelstein et al. (2015) in Clinical Trials: http://1.usa.gov/28KzAew.

For more information on The Hastings Center reports and publications: http://www.thehastingscenter.org/publications-resources/.

#QualityImprovement; #pctGR
@PCTGrandRounds, @Collaboratory1, @PCORnetwork

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