Monday, July 21, 2014

The FPIES Global Registry: Getting to Know the Patient Registry

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
The term “patient registry” also refers to the records that are then created as a result of the processes used to collect and store data. (for more, see: http://www.ncbi.nlm.nih.gov/books/NBK49448/)

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

Tuesday, July 8, 2014

The FPIES Global Patient Registry: An Introduction and Overview

The FPIES Global Patient Registry An Introduction and Overview

Part 1 of 3 in a Registry Series

In November 2013, we at The FPIES Foundation presented the first-of-its-kind FPIES Global Patient Registry, via the Patient Crossroads CONNECT program.

Some Key Terms:


·         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.
·         De-identified Data: Information that is stripped of any and all identifying characteristics (name, email, etc) so that those viewing the data cannot see any connection to the participant from whom it came
·         Institutional Review Board (IRB): this may also be referred to as an ethics review board. It is put into place in order to approve, monitor and review research that involves people-- it exists in order to protect research participants (http://www.medterms.com/script/main/art.asp?articlekey=22413)

There are two essential parts to the registry:


·         The patient registry, which houses surveys (general questions and FPIES-specific questions) for registered participants to complete.

General Surveys will mainly utilize questions from the Patient Crossroads question library, a library of previously IRB-approved questions for use by any of the participating registry programs utilizing the CONNECT platform
     FPIES-Specific Surveys will utilize questions engineered by The FPIES Foundation's medical advisory board, with support from the Executive Board. Those questions, once internally approved, will then be sent for approval by an IRB (Institutional Review Board) before being submitted to the Patient Crossroads CONNECT program for final approval and  survey publication on the FPIES Global Patient Registry.

·         The data portal, a newly released component of the CONNECT program, is for use by medical professionals, researchers, and other industry professionals (such as pharmaceutical companies). The portal is free for these professionals to register and allows them to view the de-identified, anonymous information entered into the patient registry by registry participants

How does the FPIES Global Patient Registry work?


The FPIES Global Patient Registry is set up through Patient Crossroads' Connect program-- a program offering platforms for rare disease organizations to create registries for their individual patient populations and data portals to display de-identified information from these registries. Registered participants, as well as registered medical, research and pharmaceutical professionals, can then view the information in a secured location. The registry is intended to present a “big picture” of FPIES and all of the issues that may or may not affect each individual patient. It aims to further research endeavors, examine improved treatments and achieve a better understanding of this diagnosis.

An important privacy feature of a research registry is the collection of data with de-identified information

De-identified information means that when you submit information into any of the surveys or the registration process of the Connect database, the information will not be able to be attached to you or your child's identifying characteristics. The information will be stored by means of a code, accessible only to Patient Crossroads staff. Even if you select the option to allow researchers to contact you, the contacting is done through Patient Crossroads. The researcher contacting you still does not have any identifying information about you, your child or even your contact information. All of those are protected, making this database secure and confidential. In fact, its privacy standards are so high, the Patient Crossroads registry system is utilized by NIH (the National Institute of  Health) to power its Global Rare Diseases Patient Registry and Data Repository (GRDR)!





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!
6.      For additional support, contact us at contact@thefpiesfoundation.org





Patient Registry

Data Portal
What information can be viewed?
De-identified data from the FPIES Global Patient Registry
De-identified data from the FPIES Global Patient Registry 

Who can register?
Individuals diagnosed with FPIES can be registered by their guardians to be survey participants
Medical professionals, researchers, industry professionals





How is my information protected?

All information submitted by participants is de-identified-- this means that all identifying characteristics (name, contact info, etc) are removed from the information in the registry.

In fact, the privacy standards are so high, the Patient Crossroads registry system is utilized by NIH (the National Institute of  Health) to power its Global Rare Diseases Patient Registry and Data Repository (GRDR)!
·         All information submitted by participants is de-identified
·         If data portal participants wish to contact registry participants, Patient Crossroads does not disclose any information to these portal participants, but directs the communication to the registry participant without revealing any identifying info in the process.
·         Once contacted, it is the choice of the participant whether or not to reveal any information to the individual contacting them.


Why would someone contact me?
If you select the option to be contacted (this is part of the registration page-- you may opt in or opt out without your decision impacting your ability to participate in the registry)you may be contacted in regards to participation in clinical trials


For more information and FAQ about the Patient Crossroads CONNECT program, go to: https://connect.patientcrossroads.org/en/home/frequently-asked-questions.html

Thursday, July 3, 2014

Standing up for FPIES – Nicole’s story

Standing up for FPIES – Nicole’s story

Nichole with her mom
My daughter Nicole was diagnosed with FPIES when she was 4 years old.  She had struggled with chronic issues since 18mths of age and we were more than thankful to have a diagnosis.  Nicole has several safe foods, including Chicken, Eggs, EleCare Jr Vanilla, Apples, celery, zucchini, carrots and peas.  Nicole is currently a 4th grader in the Chicago area and loves going to school.  She often struggles due to the strain FPIES puts on her body and the missed days, but has always loved learning and her teacher is amazing. 
A few months ago, Nicole told me about how the kids made up a game to not play with her because she eats chicken every day for lunch.  The kids would tease her and say they couldn't touch her because she smelled like chicken.  We have taught Nicole that she needs to stand up for herself and that she should just ignore the teasing.  She had friends and seemed to be handling the situation.  We try to not make a big deal out of it simply because this is her life and it’s not going to change. We want her to be thankful for what she can do, not what she can’t!


A few weeks ago, Nicole came home and said she wrote a letter to her class telling them that they had hurt her feelings and would they please stop.  Below is the letter (Rewritten by me but in Nicole’s words)

“Dear. Mrs. Class
I really hope you’ll read this because I don’t like the way you treat me because one day you made up this game don’t touch Nicole it real hurt my feeling and you alway whisper about it really really hurt my feeling and the game don’t touch Nicole just because I eat chicken I lost my friend because of that. So please read and listen. Sincerely, Nicole.”

I reached out to her teacher to find out if she had prompted the letter and her response is below:

“Good morning Mr. and Mrs. Pelters,

I am proud to say that your daughter wrote that letter without any prompting. I simply opened my mailbox Wednesday to find it sitting there. I read it, and nearly cried. I asked Nicole to meet me in the hall, and that is where I asked her if I could read it to the class. She said, "Yes." Then I asked when she would like me to read it. At first she said Friday, and then I asked, "Are you sure you want to wait until then?" She then changed her mind and told me to read it at the end of the day.

At the end of the day, I made sure we had enough time, and I had everyone ready to go and sitting on the rug. I have to say I had a hard time reading the letter, but when I was finished it was silent. We had a quick discussion about what they thought, and I can say that was one of my proudest moments of my class. They came to the conclusion that they were acting like bullies, and that no one should ever feel that way. We also talked a little about how limiting her diet is, and one student even said that it wasn't her fault that she has this condition.

Thank you for teaching your child the importance of voicing her thoughts and feelings. She has made our class open their eyes.”

I was blown away that my child had the forethought to write the letter all on her own.  Each of her classmates wrote her an apology letter and I have attached a few here as well.

I asked Nicole to tell me why she wrote the letter she said, “Because I wanted to speak up to them and told them how I felt”

I then asked her how she felt: “I felt like I was stuck in a cage and I couldn't get out for a long time.”
Finally I asked her what happened after she wrote the letter-- “I felt like I could stand up for anything.”
As a mom, I could not be more proud of my girl.  She stood up for herself and spoke up for what she felt.  I hope that by sharing her story others can know that they can also stand up for themselves!

Letter’s from her friends:

The first is one that I thought really summed up the idea:
“Dear Nicole,
You are so welcome! I hope that you feel better. Do you want to read to someone partners together if we are both at read to someone? If so then thank you if we are not together at the same center then maybe next time we can be together.  You are the best girl I have ever met! If you have food allergies who cares you are no different than anyone else! You are the best!”

This is one that Nicole loved:
“Dear Nicole
I’m really sorry that about that horrible game people played behind your back. I hope that I wasn’t one of those people that did that to you  and if I was I’m super duper sorry and the only reason I would of done that is to be like everybody else.  I also know that its not your fault that you can only eat certain stuff and by the way I almost cried when (teacher) read what you wrote in the letter I felt so so so bad I can’t even imagine how hard some days can be for you. From your friend”

Nichole with her family 


*     *     *     *     *

Written and shared by Katrina Pelters, mother to Nichole.  To follow Nicole's story, you can read more here:  http://nicolestrials.wordpress.com/ This site is not owned and operated by The FPIES Foundation-- this link is being provided for supportive and awareness purposes. Please read our link policy here: http://fpiesfoundation.org/about-us-link-policy/