Opportunity Alert – AC-150513-054 – Longitudinal Biometric Registries
Date Sourced: March 31, 2016
Category: Funding Opportunity
Status: Qualifying
Potential (High-Moderate-Low): High
Add to SFA (Y/N): TBD
Client Action Required (Y/N): No
Opportunity:
There is a growing interest among in using patient registries to monitor
safety and track outcomes. Research funding continues to grow for creating,
maintaining, and extending the value of patient registries. The purpose of
every registry varies, however, most are intended to support data
collection needed to: conduct clinical assessment, gauge treatment
effectiveness, track disease progression, payment certification, public
health surveillance, quality improvement, or cohort marketing.
Summary of Activities/Tasks:
1. March 31, 2016 – Reached out to, and spoke with approximately 8 patient
registry organizations and NIH NIGMS. Strategies for aggregating new
registries are generally driven by either physicians, patients or HIEs. If
supported by a consortium, it is common for each participating group to
receive its own data and with performance benchmarks against a universal
data set. I believe the registry that best support our aims, is one driven
by the collection of real-time remote patient biometric data. A typical
patient-centered registry pools detailed information on individual patients
including demographic traits, health-related characteristics, and
patient-reported outcomes. These registries are usually defined as focused
on: (a) rare disease; (b) chronic disease; or (c) under-served or
under-represented populations.
2. April 1, 2016 – Evolving CMS reimbursement, as well as the shifting
emphasis to improved health outcomes supported by clinical evidence, is
creating demand for new registry applications. These include use as:
decision-making aids, risk-adjustment tools, and alternatives to public
reporting requirements. The primary benefit to participation for patients
is the ability to share relevant data; support research on how biometric
variables, reported symptoms and other patient reported data may affect
disease progression; and potentially connect with care providers for timely
treatment and care intervention. A new registry could rely on: (1)
individuals opting into the registry; (2) consenting to the third-party use
of their data; (3) receiving a RPM kit; (4) generating longitudinal data
for each individual over a period of 12 months or more.
3. April 6, 2016 – To date, the University of Virginia Health System,
University of Maryland, and the University of Washington have indicated an
interest in discussing a patient-centric registry that is largely aimed at
collecting biometric data using remote patient monitoring kits. Children’s
Hospital Colorado may also be worth approaching. Initiating discussions
with other institutions is also possible.
Forward Statements and Guidance:
I am currently outlining the following for presentation/discussion with
interested registry collaborators: (a) General aspects of the registry
(i.e., population, comparators, desired outcomes, etc.); (b) Research
questions/aims; (c) Approaches to data collection; (d) Research/study
design and methods; (e) Statistical and epidemiological analysis plan; (f)
Quality control and quality assurance; and (g) Reporting. To be completed
by 4/30/2016.
End.
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