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FOTO Rehab Outcomes Blog

New Approach: Real World Clinical Research

Don't let the title of the abstract divert your attention. 

Value based purchasing will require some of the exact components mentioned in the abstract:

  1.  A Data Registry: this allows for national benchmarks. Registry means that organization that holds and maintains the registry has met certain requirements to be qualified as a registry. 
  2. Integration with EMR: this allows for immediate knowledge of cost of services if the EMR has a built in reporting system to capture cost of episodes of care.
  3. Integration with EMR: this could allow for immediate knowledge of generalized services provided if EMR has built-in reporting features to indicate CPT codes performed. In the rehabilitation world, this may not prove to be really helpful because the codes used in rehabilitation are quite generic. "Therapeutic exercise" has no meaning when trying to learn what kind of exercise provided the outcome. Was the exercise isometric... was it isotonic... was it eccentric... was it endurance type exercise. What could happen though, there could be a generic comparison of clinicians in their outcomes and what their episodes of care looked like via generic services billed. There may be differences noted which may help in discussions or in clinical education.
  4. A Data Registry: thinking forward with Merit-Based Incentive Payment System (MIPS), a registry will be extremely helpful for reporting quality measures and outcomes. 

It seems for future success you'll need both an EMR and a data registry. FOTO is a qualified data registry for MIPS and for the Canadian Physiotherapy Association

Below you will find a quick view of the abstract. 


A New Approach to Clinical Research: Integrating Clinical Care, Quality Reporting, and Research Using a Wound Care Network-Based Learning Healthcare System.



The disparity between ideal evidence from randomized controlled trials and real-world evidence in medical research has prompted the United States Food and Drug Administration to consider the use of real-world data to better understand safety and effectiveness of new devices for a broader patient population and to prioritize real-world data in regulatory decision making. As the healthcare system transitions from volume- to value-based care, there is a growing need to harness the power of real-world data to change the paradigm for wound care clinical research and enable more generalizable clinical trials. This paper describes the implementation of a network-based learning healthcare system by a for-profit consortium of wound care clinics that integrates wound care management, quality improvement, and comparative effectiveness research, by harnessing structured real-world data within a purpose-built electronic health record at the point of care. Centers participating in the consortium submit their clinical data and quality measures to a qualified clinical data registry for wound care, enabling benchmarking of their data across this national network. The common definitional framework of the purpose-built electronic health record and the 21 wound-specific quality measures help to standardize the potential sources of bias in real-world data, making the consortium data useful for comparative effectiveness research. This consortium can transform wound care clinical research and raise the standards of care, while helping physicians achieve success with the Merit-Based Incentive Payment System.

2017 Apr 17. doi: 10.1111/wrr.12538. [Epub ahead of print]