The FPIES Global Registry Getting to Know the Patient Registry
Part 2 of 3 in Registry Series
What is a Patient Registry?
Also referred to as a
“disease registry” or “clinical registry,” a Patient Registry is
a program that collects and stores data related to health information for a
specific purpose and in an organized and uniform manner.
In our case, this purpose is
to use collected information to further clarify facets of FPIES presentation,
diagnosis, treatment and management, and its impact on the whole individual, by
means of:
·
Further defining
symptom presentation
·
Examining
potential risk factors
·
Reviewing quality
of life and psychosocial issues,
·
Investigating
co-occurrence of other conditions,
·
Exploring
treatment and management approaches currently in use
A patient registry must
carefully observe confidentiality. In The FPIES
Global Patient Registry , patient confidentiality is of utmost
importance. The platform for the registry is the CONNECT program from Patient
Crossroads, a platform designed for use by rare disease organizations to create
patient registries in order to facilitate awareness to the various facets involved
in each diagnosis. Key points:
·
Data submitted to
the registry becomes de-identified – any and all identifying characteristics
(name, email, etc) are unable to be associated with data by registry and portal
participants
·
You can choose
the level of contact you have with CONNECT and registry partners, including the
decision to opt out of any contact, without your decision impacting
participation in surveys
·
Data is so secure
that the NIH actually houses its own GRDR through Patient Crossroads.
For more, read here:
https://www.patientcrossroads.com/security-privacy.html
What can my family gain from joining the patient
registry?
◦
Participation in
surveys that will serve to bolster information in the registry
and may be used for research
◦
A broader
understanding about the rare
disease community to which you belong by viewing the information compiled from
the surveys offered--- information is able to be viewed as soon as each
completed survey is submitted!
◦
The ability to
review the collective registry's information with the patient's medical team in
order to potentially enhance the quality of care
◦
To
impact the patient-family-physician relationship through the
sharing of information for individualized care of the child
◦
Free
access to surveys in
a secured patient database registry program.
What does my child's medical team gain by registering
for the portal?
◦
A potentially
better understanding of the current trends in the affected patient
community
◦
Knowledge of current
clinical studies for FPIES that researchers may post in the data portal
◦
Ability to impact
management strategies and diagnostic considerations, in terms of
individualized care and the identification and consideration for co-occurrence
of related disorders.
◦
Ability to impact
the patient-family-physician relationship through the sharing of
information
◦
Free access to view de-identified patient data from the Connect
program, including the FPIES Global Patient Registry which houses data from over
300 participants at this time
What information can be found in the registry?
Surveys will contain a
variety of FPIES-specific and general patient history questions. General
questions will mainly originate from the question library of Patient
Crossroads, a compilation of registry questions already vetted and approved for
use in any of the various registries in the Patient Crossroads database, and
also through the NIH's GRDR, for the rare diseases' collective voice. General
questions will focus on a variety of patient history topics, including birth
history, quality of life, and others, providing a foundation for more specific
FPIES information in later surveys.
FPIES-specific
questions will be engineered by
the FPIES Foundation's Medical Advisory Board with support from our Executive
Board. These will investigate aspects related to presentation and diagnosis,
daily and emergency management strategies, and clues for potential treatment
options possessing more universal effectiveness.
These questions will then be submitted
for review by an IRB (institutional review board), examining ethical
considerations, evidence of informed consent, and so on, ensuring that the
rights of participants are considered and upheld. Once approved by the IRB, the
questions will receive final approval from Patient Crossroads and be entered into
their question library. The FPIES-specific survey will at that time be posted
to the registry for participants to complete as they are able.
There is no limit to
the amount of general surveys and FPIES-specific surveys that can be posted for participant completion and we
intend to post multiple surveys over time, keeping with trends in the existing
research and those as observed in the patient community.
Both medical professionals
and registered participants can view de-identified medical data
from the completed CONNECT FPIES registry surveys, compiled in easy-to-read
charts and graphs.
Why do some surveys seem to feature content not
necessarily specific to FPIES?
The FPIES Global Patient Registry is set up
as an on-going program, and will be collecting information over time.
Much like the food journal
that many families use to monitor how their children are tolerating a new food
during food trials, the registry will also track a variety of topics in order
to determine any existing patterns among the general patient population diagnosed with FPIES. By including a combination of
general and specific surveys, a “wide net” is cast, allowing for a broader view
of each participant's experience and background, potentially revealing
previously unseen significance in certain factors or patterns.
What is the cost?
◦
Registry
participants do not pay anything
for their participation or in order to view the data or information posted by
researchers and industry professionals
◦
Medical
professionals and researchers can
register to access the data portal at no cost
◦
Specialized
FPIES-specific surveys, upon
approval by The FPIES Foundation's esteemed Medical Advisory Board, will be
submitted to an IRB for review prior to being posted on the registry for
participants to complete. There is a cost for IRB review and those costs will
be absorbed by The FPIES Foundation as part of our research initiatives.
How can I register today?
1.
Go to the FPIES
Foundation's home page (www.fpiesfoundation.org) and click on the blue “Connect” logo on the left
side of the page
2.
You will arrive
at the home page for The FPIES Foundation Global Registry. Click the blue box
that says “Click to Register Now!”
3.
Complete the
“Consent and Registration” section. Click “Register” and you are ready to go!
4.
On your dashboard
page, you will be able to select surveys to complete at your convenience. View
the results as you complete each one and learn more about the FPIES community
as you CONNECT!! Be sure to register each member of your family diagnosed with
FPIES
5.
For PORTAL
Registration, simply go to the
patient crossroads homepage at www.patientcrossroads.com and click on the button that says “log in/sign up” and
follow the prompts!
For
additional support, contact us at contact@thefpiesfoundation.org
The FPIES Global Patient Registry
- This registry is operated on the Patient Crossroads CONNECT platform and adheres to the Patient Crossroadsprivacy policy and terms of use.
- For questions regarding the registry’s privacy policy, terms of use, and/or any other questions regarding the FPIES Global Patient Registry, please email us: contact@thefpiesfoundation.org.
This post was written by the Executive Board of The FPIES Foundation
