Frequently Asked Questions

Why does our community need a patient registry?

The underlying biological mechanism linking infection and neuropsychiatric symptoms is hypothesized to be a pseudo-autoimmune/auto-inflammatory reaction, in which an abnormal immune response causes damage to the child’s brain tissue due to cross-reactive antibodies and/or abnormal activation of the immune system. Current research is focused on identifying effective interventions for individuals with PANS. However, to date there are no comprehensive studies that aim to understand the epidemiology of PANS.

While interviewing dozens of researchers, we were told that the barriers to study the condition were too great. Not only was there not extensive funding, but with no large scale data, it was too expensive to study.  Those same researchers said they would be enthusiastic about investigating PANS if they had data to help lessen the learning curve and microgrants to offset the cost of post-doc time in the lab.

With a lack of comprehensive studies, PANS remains a gray area among the medical community today. We believe an International PANS registry will encourage new scientists to study the condition and the patient-reported data will provide unique insights into the true nature of the disorder.

What is the specific aim of the registry project?

The aims of this project are to (1) establish a registry with a minimum of 1,000 PANS cases and 1,000 unaffected siblings (for those who do not have unaffected siblings they would simply enroll all children as CASES) (2) collect epidemiological survey data and medical/health history information (3) provide a means to link registry data to future biobanked biological specimens for enrolled cases and controls, and (4) to summarize the survey results and publish them in peer-reviewed journals. It is our hope that by doing so, we will be able to unlock some of the mysteries around PANS by having a broad view from pregnancy to present time on environmental and genetic factors that may lead to a PANS diagnosis.

It is our hope that this data will allow us to identify sub-groups within the larger umbrella of PANS to try and gain insights into why current treatments are effective for some patients and fail to work for others.

WHY SHOULD I PARTICIPATE?

By adding your data to IPR you are helping to advance life-changing initiatives in research, education, and advocacy. Large scale data from thousands of patients living with PANS will allow researchers to analyze disease patterns and help answer questions most important to patients.

WHAT TYPE OF RESEARCH QUESTIONS WILL IPR HELP ANSWER?

WHY ARE WE ENROLLING SIBLINGS?

WHO CREATED IPR?
Launched as a charitable program of Pediatric Research & Advocacy Iniative (PRAI), a 501(c)(3) organization aimed at accelerating patient-centered research initiatives, IPR was developed in collaboration with the parent community,  Erin E. Masterson, PhD, MPH, and several members of the PANS scientific and medical community. 

After reviewing the submissions, they were sorted into:

• Questions that could be answered using data from the IPR.
• Questions that couldn’t be answered using Registry data, but that could shed light on other research areas.

A half a dozen practicing physicians were then asked what type of data would be useful to them.  In addition, a dozen researchers not yet studying PANS were asked what type of data might encourage them to add PANS to their investigations. A team of people within our community went through the questions that could be answered with registry data and Erin Masterson, MPH, PhD organized them into topic areas and restructured them to reduce bias. More than 2,000 community members voted on the questions that were most important to their daily lives.

You can learn more about the history of IPR by reading our story.

IS THIS REGISTRY APPROVED BY AN INSTITUTIONAL REVIEW BOARD (IRB)? 
The Registry sponsor applied for approval from the University of Washington, (UW). The IPR was granted an approved exempt determination under federal IRB rules.  This determination included a review of the Registry surveys and overall study to ensure appropriate provisions are in place to protect the privacy and safety of participating subjects and their data in the United States and Canada.  

How will you ensure the safety of participant data collected in this study?

We take your privacy very seriously.  Exported datasets containing subject identifiers will be managed according to the Registry’s approved IRB protocol and will be saved on a secure, HIPAA-compliant, password- protected Cloud server in an electronic data file that only the project Primary Investigator (PI) and lead epidemiologist have access to. Both individuals have met the National Institute of Health’s (NIH) Protecting Research Human Participants Requirements.  

To minimize the risk of harm and protect registry participants’ rights and welfare, the IPR project team will only use coded/de-identified data for analyses. Identifying information, including contact information, will be kept securely and separately from the analytic data. Children and adolescents will not be put at risk because their caregiver will act on their behalf.  De-identified information is never attached to the health information that we share with researchers and paper copies will never be used.  

We realize security and privacy are of the utmost importance, if you have any questions we can help answer related to the protection of your health data and we have not covered those questions here, email our registry team: info@pansregistry.org

Who can register?

Due to a lack of funding the IPR at the University of Washington is not currently accepting new enrollments.  Peer-review publications are in process.  Please refer to our latest manuscript with additional details. 

Do adults over the age of 18 qualify?

Yes.  Adults with a previous or current diagnosis of PANS qualify for IPR and may enroll themselves. We also ask that they ask their unaffected adult (or parents of their less than 18 year old) siblings to register. 

CAN INDIVIDUALS WITH CO-MORBID CONDITIONS LIKE AUTISM, MAST CELL DISEASE OR DOWN SYNDROME PARTICIPATE?

Yes.  Having more than one diagnosis does not disqualify anyone from participating in the IPR registry as we hope that researchers will find value in studying different subgroups within the PANS community.  IPR enrollment only requires that an individual has or is suspected of having PANS (or PANDAS).  We will be actively encouraging research into these areas.

What if my child is in remission, or was later diagnosed with something else, are you still interested in our participation?

Absolutely!  Having children and adults who are now actively in remission would be incredibly valuable for our research efforts.  While you are no longer in the trenches, you can help shape the future for families with PANS by participating in IPR.  Similarly, if you ever received a diagnosis of PANS and went on to be diagnosed with another condition, sharing that information can potentially help other misdiagnoses from happening.  We encourage all families with a previous or current diagnosis of PANS, regardless of current health situation to participate in IPR.

What type of information should I have on hand prior to enrollment?

Before getting started, it may help to gather any of the following documentation that you might have on hand. If you don’t have these, and can’t recall specifics, just tell us you don’t remember in your responses! We want the most accurate information possible, so we would rather know you are unsure than have you guess.  

• Medical Records
• Bloodwork and other labs
• Cunningham Panel
• Vaccine history
• Birth/Pregnancy History
• Treatments tried
• Prescription history
• Diagnosis dates
• Clinical history

WHAT AM I COMMITTING TO BY AGREEING TO PARTICIPATE IN IPR?

WHEN WILL THE PARENT COMMUNITY GET ACCESS TO REGISTRY FINDINGS?

As soon as we get reportable results, we will share it with the community. We firmly believe that patients and their families who share their data deserve to be among the first group to learn any new findings.  It is our intention to report results by email to those who have registered once we have a large enough data set to analyze.

Will this data be published?  

In order to engage more scientists so that they may want to investigate PANS, our preliminary analysis will include stratified descriptions, simple correlations and associations using multivariate regression techniques to assess relationships between PANS and potentially-related factors. The emphasis of these analyses will be on (a) characterizing symptoms and trajectories according to health, environmental and demographic information, (b) identifying potential causes and associated factors related to specific neuropsychiatric symptoms (by comparing to siblings), and (c) summarizing treatment outcomes for individuals with PANS. Results will be summarized in manuscripts that will be submitted to journals for peer-review.  In addition, Erin Masterson, PhD, University of Washington Seattle, and co-creator of IPR, will present data at multiple conferences to raise awareness and generate interest among the scientific community

HOW IS IPR FUNDED?
The initial funding for IPR was provided by PRAI, an independent, non-profit, nongovernmental organization led by families of patients with the disorder.  All financial support has been the result of parent-led fundraising efforts. 
As of September 2024, IPR is maintained probono at the University of Washington.  IPR is no longer accepting individual donations from it’s website due to a lack of broad funding to continue this project.  If anyone is interested in keeping the database actively utilized, please contact help@pansregistry.org for additional information.   Individual donations obtained from the parent community fully funded the database, hosting, and HIPAA-compliant cloud storage for  3 years.  If there is broad interest in keeping this project active, donations will support database management and the creation of research manuscripts and future publications.