Registries have traditionally been viewed as static repositories of data to be reviewed in a summary fashion after a predetermined time period.  The expanding need for drilled down relevant data has led to the development of creative sophisticated data analytics technologies.  We have witnessed the transformation of registry data collection which now includes curation of relevant raw data ranging from medical images and pathology slides to genomics.  Clinical or other predetermined data relevant to a given patient can be collected real-time from anywhere the patient is seen, regardless of the data’s EHR vendor of origin. In addition, the way in which the data is viewed real-time can be customized according to the viewer’s profile.  These developments have evolved the registry into a living digital narrative. I will discuss below some of the most useful applications of such exemplary registries.

1. Provide real-world data for regulators. The Physician Quality Reporting System (PQRS) has been used since 2015 as a metric to determine negative Medicare payment adjustments to providers who do not meet quality standards. Without getting into unnecessary detail, one of the options of providing these metrics is reporting from clinical registries.  These registries are chosen from an approved list of registries.  The FDA has chimed in with a Guidance on the Use of Real-World Data to Support Regulatory Decision-Making for Medical Devices. The FDA recognizes that real-world data “…may be of sufficient quality to help inform or augment FDA’s understanding of the benefit-risk profile of devices at various points in their life cycle…”  Registries therefore have found their strength in reflecting the real world experiences of patients and physicians.  Clinical trials by design are rigorous and closely monitored. Adverse events and effectiveness of therapy many times require longer follow-up with more real world experience (without the restrictions placed by trials) to become known.
2. Improve patient safety. A corollary to adverse events and efficacy is patient safety. The safety of a medication or device may reflect predictable or unpredictable serious adverse events. It might be a universal issue which is discovered only after a prolonged period of exposure. Examples are found in  the implantable pacemaker and defibrillator and orthopedic device industries or long-term risk of certain medications (ex. anti-inflammatory drugs and risk of heart attack). Registries can collect post-marketing real world data and lead to discovery of patient safety issues significantly in advance of word of mouth communications which have a bias of the threshold of information transmission.
3. Supplant claims data with more accurate and relevant data. The inferiority of administrative claims data versus clinical registry data has been known for years. Some believe that the use of the more granular ICD-10 diagnostic claims codes will close the accuracy gap between claims and clinical data. I personally do not believe claims data will ever supplant patient reported outcomes (PRO) data because PRO data reflects not only outcomes but the outcome relevant to that patient.  I have previously discussed the importance of PROs. In addition, the aggregation of raw data can even potentially affect disease treatment strategies.  Consider the hypothetical situation in which a cancer registry pairs pathology slide data with imaging, chemistry, genetic, treatment and clinical data from physical examination.  Subgroups of patients might be identified from various combinations of data which benefit from different treatments they received (or didn’t).
4. Provide a vehicle for PRO standardization. Patient reported outcomes are the key to determining quality. The importance of PROs and their standardization are eloquently discussed in an editorial in the New England Journal of Medicine: “…Experience in other fields suggests that systematic outcomes measurement is the sine qua non of value improvement. It is also essential to all true value-based reimbursement models being discussed or implemented in health care. The lack of outcomes measurement has slowed down reimbursement reform and led to hesitancy among health care providers to embrace accountability for results…”  Data sets derived from registries or any patient portal can be used in the development of PRO standards.  In addition, the data can be compared real-time to existing international standards thereby facilitating changes in treatment strategy earlier than would otherwise be guided by government reported analytics via feedback many months later. One might hypothesize that the visualization of data relevant to them compared to others who achieved best outcomes standards by patients via self-management platform portals might affect changes.
5. Real-world patient reported data for price support of effective new drugs.  Many specialty medications notably biologics are very expensive. They obtain FDA approval and are priced out of reach for most patients.  They are denied reimbursement by many insurance carriers either outright or via impossible barriers to overcome.  A prime example is reimbursement for new injectable cholesterol medications for refractory familial hypercholesterolemia (which is not rare with an estimated prevalence of 1:200 Americans and as high as 1:60 persons in central Pennsylvania).  Some carriers require genetic testing to document a diagnosis (though the diagnosis can be made via significantly high blood levels alone), but won’t pay for the genetic testing which costs $2-3K dollars. Would payers rather pay for heart bypass surgery? Post-marketing patient registries which provide patient reported outcomes could significantly lower drug costs by providing data showing better efficacy than the approval studies.  This might tip the benefit-cost ratio for payers to support a drug or other treatment’s cost.

As one can see, registries performed with quality technologies can have profound effects on healthcare from many standpoints. Investment in digital tools which make Big Data come alive and transform it into relevant data can be helpful to all healthcare stakeholders. One must see this as an ROI for cost savings at its finest.