Brian P. Jacob, David C. Chen, Bruce Ramshaw, Shirin Towfigh (eds.) - The SAGES Manual of Groin Pain-Springer International Publishing (2016)

45. Value-Based Clinical Quality Improvement for Chronic Groin…
513
The need for human subjects research protections and the use of IRB
processes have been challenged; when true CQI efforts are implemented,
there is a clear distinction when compared to human subjects research
that does require an IRB process. True CQI is focused on local process
improvement and utilizes evidence- based medicine interpreted by the
clinical team, ideally including the patient and family in a shared decision
process. CQI is not appropriate for pre-market studies, for interventions
that could clearly increase risks for patients, or for efforts that
intend to produce generalizable knowledge as a priority, rather than local
process improvement as a priority. The intent to publish is not sufficient
to classify the effort as human subjects research. This information about
the distinction between human subjects research and CQI is clearly presented
in the FAQ format on the US Health and Human Services website
[ 13 ]. It should be noted that the results of a CQI project in one local
environment do not necessarily apply to another, different local environment.
Local environmental variation can produce different patient results
from the same process improvement intervention.
Summary
The use of CQI applied to the entire cycle of care for improving
value-based outcomes is a complex systems solution for healthcare. The
implementation of CQI is facilitated by implementing a multidisciplinary
hernia team, by learning how to design dynamic clinical processes, by
learning how to interpret data and data analyses, by learning how to generate
and implement ideas for process improvement, and finally, by
developing a patient and family committee to assist with the hernia team
process improvement ideas. Future plans include adding a process activity-based
cost model so that true value for the entire cycle of care can be
measured and adding additional collaborative hernia teams in other locations
so that knowledge can be shared and data can be pooled to define
patterns and subpopulations from larger data sets, termed big data.
To our knowledge, this is the first publication demonstrating the use
of CQI for patients with chronic pain after hernia repair. Additional
prospective randomized controlled studies are not adequate or appropriate
for this type of real-world attempt to improve patient value, because
they are designed for hypothesis testing and generalizable knowledge,
rather than for attempting to improve patient value in a local clinical
environment. Continuing to refine processes, define value-based outcomes,
and apply complex system data analytics has the potential to