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Recent years have seen a deeper appreciation of which healthcare data have value, and which are nothing more than “digital snake oil”. (See this interview with the C.E.O. of the American Medical Association.) The U.S. F.D.A. and the European Medicines Agency have stressed the importance of “real world evidence”, in sharp contrast to the majority of tightly constrained clinical trials undertaken by industry. This latter type of data aggregation — while expensive, lengthy and usually based on well-designed protocols — are typically dedicated to obtaining regulatory approval for a single product and indication. The conclusions drawn from these data thus have little value to broader healthcare objectives of clinicians, their patients or payers.

Meanwhile, value-based medicine, personalized medicine, narrow networks and other powerful trends in healthcare delivery all have a common denominator – the demand for real world evidence derived from broad patient populations and supporting superior, long-term outcomes. This real-world evidence can only be achieved by filtering — through the prism of independent medical science — longitudinal, integrated and verifiable “real world” data. “Real world” means not in the laboratory, but in the clinic or other relevant setting.

One sees daily where failure by industry or clinicians to support claims with real world evidence invites scrutiny from regulators, patients, the media, fellow clinicians and competitors. Fortunately, modern tools and processes allow for the efficient development of objective and indication/procedure-specific in-clinic observational protocols, as well as the ability to derived real world evidence from the resulting aggregated large “n” real world data. To find out more, contact us at info@rgnmed.com.

Multiple studies presented this year have revealed positive results for PRP treatments in Hip OA when compared to hyaluronic acid and other conventional treatments. Most notably, one trial showed only 11% of patients who got PRP shots in their hips went on to get a hip replacement compared to 50% in the hyaluronic acid group over the course of 6 months. Other important results for PRP include:

1.    Better HOOS scores and other PROMs
2.    Increased ROM in patients
3.    Higher patient satisfaction

These sorts of studies are easy to recreate and validate, as long as you have the tools to e-monitor patient HOOS scores, reward PROM completion with engaging progress reports, and correlate those outcomes to pre-clinical factors, such as the characterization of your PRP product.

The inCytes™ app offers all of these features and more, allowing you to design the surveys, reports, and evidence for any pathology or product.

Government regulators, providers, payers and patients increasingly recognize the potential benefits of human cell and tissue products (“HCT/P”). At the same time, they are differentiating between “good actors” and “bad actors” in the clinical delivery of those HCT/P’s. The recent U.S. federal court injunction against US Stem Cell Centers confirms the FDA’s commitment to enforcing its HCT/P regulations against clinicians it places in the latter category. That case makes clear, for example, that enzymatic digestion of adipose – commonly used to produce stromal vascular fraction – is considered more than minimal manipulation and thus subject to regulation as a drug.
 
The FDA HCT/P regulations in this broad field involve three foundational concepts: autologous source, minimal manipulation and homologous use. To help clinicians understand and document compliance with them, inCytes™ now includes a short survey/report addressing key elements surrounding harvest, processing and delivery of a large number of applicable cell/tissue types. The survey and report – easily modifiable for specific practice considerations – will inform regulatorily-compliant clinical protocols, support patient engagement, establish correlations with outcomes, and document protocol and regulatory compliance.
 
Surveys and reports, all easily customized, are available on inCytes™ for many indications, procedures and patient cohorts. New ones are created regularly, often for the specific needs of Users.  Sign up for a free, custom trial today of the platform designed by clinicians for clinicians to capture and exploit true clinical evidence.



Ever-more powerful algorithms are “crawling” through the petabytes of insurance claims, PROM’s [3], pharmacy, genome and other healthcare databases in an attempt to drive more efficient therapies and medications and to help control spiraling medical costs.  However, the results have lagged the promise.  See here and here for two examples (from the American Medical Association, and Harvard Medical School.)

A major reason for disappointment with “big data” is the absence of data which are reliable (collected real-time), longitudinal (integrated across the patient’s entire treatment path) and clinically-relevant (represents the scientific and clinical criteria associated in the respected medical literature with better outcomes.)

Such useful data are notoriously difficult to obtain. By definition, they should be collected before, at and after the point of care by treating physicians or their assistants. However, those healthcare professionals are already overburdened by their clinical responsibilities, as well as other data-entry requirements increasingly demanded by government and insurers. Practicing physicians are often uncertain as to which clinical/scientific data should be collected.  Pre-treatment and post-discharge outcomes data are, at best, episodic and poorly correlated with clinical data.   Moreover, they are often not standardized and are difficult to obtain.

inCytes™ was developed by leading product-independent clinicians and medical scientists.  It is now being used to address the foregoing obstacles.  It is an important tool. efficient and low-cost for any group – hospitals, ACO’s, payors, regulators, clinicians and researchers — seeking to develop evidence-based, superior, predictable and lower-cost outcomes over the long term for broad patient groups.