Frequently Asked Questions
We know how critical it is that you are fully informed when sharing medical information about yourself or your children. Our FAQ’s seek to provide a clear overview of what you can expect if you participate in the IPR.
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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-inflamm
While interviewing dozens of researchers studying neuroimmunology, microbiology, toxicology and infectious disease, we were told that the barriers to study the condition were too great. Not only was there not funding 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.
After a year of generating hypotheses from families who are in the trenches, we have incorporated questions into the study design that caregivers want answers to. We believe parents know their children best and the unique survey design based on their instincts will aid scientific discovery like never before.
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.
We will be looking to evaluate potential environmental influences during pregnancy and early life that may make a child more susceptible to having PANS. In addition, we hope that IPR will help us understand comorbid conditions and symptoms that are not currently acknowledged within the PANS community to get a broader view of the systemic implications of having the disorder. Your data can shape the types of research studies to be conducted that are most beneficial to you – the patient. IPR is a unique initiative as it allows us to have a large-scale approach to researching complex disease patterns with insights from patients, families, clinicians and scientists.
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?
There are a number of questions that may be answered using the data gathered through IPR. Including, but not limited to:
- What causes PANS?
- How do cases with a PANS diagnosis differ from those without one?
- Are there subgroups of PANS patients that can be clearly defined other than PANDAS?
- What signs or symptoms (if any) may exist prior to a “lightening like onset”? Similarly, do patients who fail to experience sudden and dramatic onset required by the criteria share commonalities with those who do?
- How can we develop better treatments for PANS?
- Are there children with PANS who develop the condition as a result of maternal immune activation or environmental toxicants?
- How effective are current treatments?
- What are the barriers to diagnosis?
- Does early treatment result in better outcomes for patients suffering? And which treatments offer the most impressive results?
- Do children with PANS have unusual characteristics or illness patterns? If so, what are they?
WHY WERE SIBLINGS CHOSEN AS CONTROLS?
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, epidemiologist, 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 would be valuable that 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.
SAFETY & SECURITY
IS THIS REGISTRY APPROVED BY AN INSTITUTIONAL REVIEW BOARD (IRB)?
The Registry sponsor applied for approval from IntegReview, a woman-owned, independent IRB with over 20 years of experience reviewing research initiatives. 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. To learn more about IntegReview visit: www.integreview.com
HOW DO I KNOW THE DATABASE ITSELF CAN BE TRUSTED?
The Registry sponsor interviewed over 20 software platforms before settling on Dacima, a Canadian owned technology company who is trusted worldwide for hundreds of Clinical Trials and other research studies. The founders are experienced epidemiologists and researchers themselves, who intimately understand the importance of ensuring safety and privacy of patient data.
The software is designed as a secure Electronic Data Capture (EDC) software application and database to ensure that access to any data stored in the database is protected from unauthorized access. The transfer of data from your browser to the server is encrypted using SSL/TLS encryption and the database is encrypted.
How will you ensure the safety of participant data collected in this study?
We take your privacy very seriously. Patient information will be entered on Dacima’s HIPAA protected web server. 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. If additional collaborators are ever added to the IRB study team, an email will go out to all participants informing them of the new addition and giving them the opportunity to remove their data if they so wish. 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: firstname.lastname@example.org
ARE THERE BEST PRACTICES TO HELP NAVIGATE THE SOFTWARE?
Yes. Please refer to our BEST PRACTICES and TIPS page for important information to help navigate the registry software and make your experience as seamless as possible.
Who can register?
The target population for this registry are children, adolescents, and adults with a clinical diagnosis of PANS, as well as children with a diagnosis of PANS who later qualify for an Autoimmune Encephalitis diagnosis based on strict AE criteria. This includes adopted and biological children. Adopted children will be able to share that they “Do not know information on pregnancy” if they do not have that information available to them. Children who do NOT have a control sibling are welcome to register. Controls are not specific to each child. They are only compared to the larger CASE cohort as a whole. Please note, as PANDAS is a subset of PANS, it is included in the overarching umbrella every time we refer to PANS in our communications.
We are also collecting data on those who believe they have PANS and have been unable to receive a diagnosis, as well as those who received a PANS diagnosis and later learned that it was a misdiagnosis. Siblings who do not have PANS also will be asked to enroll. Caregivers will be asked to respond for children and adolescents. ***Important information! All children, both cases and controls must be entered at the time of eligibility, otherwise, they will not be able to participate in IPR. Please enroll all children (both those with and those without PANS) at the start of the survey.***
Is this available in all countries?
The International PANS Registry will first launch in the United States and Canada as part of our expedited IRB approval process with additional countries planned for phase 2 roll out.
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
AFTER ENROLLING IN IPR
WHAT AM I COMMITTING TO BY AGREEING TO PARTICIPATE IN IPR?
By enrolling in IPR, you are agreeing to share accurate and honest health information to the best of your knowledge, regarding yourself, your children with PANS and their healthy siblings.
HOW LONG DOES THE SURVEY TO TAKE TO FILL OUT?
IPR has a number of surveys important to researchers. Each survey may be completed in 20 minutes or less. You may complete as many surveys (or as few) as you would like, and log back in at a later time to complete the rest. If you want to answer them all at once, you should expect to spend at least one and a half to two hours per child due to the vast and diverse information we are trying to obtain. ****Important information! You must add all children both CASE and CONTROL at the initial start of the registry. You can be sure to do this by reporting your total number of children when asked in the initial series of questions. You can NOT add children later/after registering. Failure to do so will result in no additional family members being able to participate in IPR. PLEASE add all children whether they have PANS or not at the START of the registry process. Thank you!****
This registry is long because it’s comprehensive. If you fall into the category of people who might not think your time is worth it, we beg you to reconsider. We wanted to know anything and everything about your child’s environment, maternal and patient health history, demographics, treatments trialed, etc. because after years of talking to families just like you, we believe there’s a ton of information about the nature of PANS that is not showing up in the current research because no one has asked the questions that the community value.
We want to open up new areas to investigate in PANS to find out why treatments work for one child and not another and hopefully be able to one day prevent PANS altogether. We know your time is sacred, however, we believe in this registry and it’s ability to find answers for our children so we don’t have to spend countless hours searching online, attending new doctor appointments, and trialing treatments hoping something, anything, works. We promise that if you sacrifice your precious time, we will do everything in our power to make every second worth it.
CAN I TAKE IPR FROM MY CELL PHONE?
While we have done our absolute best to make the survey mobile friendly, phones are notorious for having issues with complex tables. While it can be done, we highly recommend using a desktop, ipad or laptop computer due to the complex and robust survey questions and tables included. We know for sure that the tables associated with pregnancy and treatment, if taken on mobile, the phone MUST be turned sideways in order to see the table correctly. We highly suggest at a minimum, that you take the pregnancy and treatment sections on desktop. If you must do it on mobile, please turn it sideways. And if you have technical difficulties, do not skip the questions, but reach out to us at email@example.com so we can help you work through them.
WHAT IF I LOSE MY USER NAME AND PASSWORD?
If you lose your user name and password simply click “Recover User Name and Password” below where you would normally enter that information.
HOW WILL YOU COMMUNICATE RESEARCH FINDINGS AND OTHER INFORMATION WITH FAMILIES?
You will receive updates from us periodically, for example, when there is a new survey, important news, and/or research findings. You will also receive any opportunities to participate in clinical trials and focus groups as a result of your participation. We believe patients and their families should hear the results of research before anyone else. All IPR funded research or research receiving microgrants from the registry sponsor will be shared first with families who participated.
HOW CAN MY HEALTHCARE PROVIDER PARTICIPATE IN IPR?
Your provider can order educational IPR brochures to display in his/her office at no cost by simply sending an email to firstname.lastname@example.org with the subject line BROCHURES.
CAN I REMOVE MY DATA AT A LATER DATE?
You may choose to remove your data from IPR by written request whenever you wish. However, data already being aggragated for research purposes’ including the study participant de-identified patient information, will not be able to remove study participants once the work has begun. The data can and will be removed from the database and not used for future research purposes by written request.
WHAT IF MY CHILD’S HEALTH HISTORY CHANGES? WILL WE BE ABLE TO UPDATE THAT?
After the initial roll-out, IPR will add a “flare diary” so you can prospectively report symptoms, suspected triggers and treatment success (or not) as your child experiences them. You will also eventually be able to log back into the Registry to update us if your CONTROL child develops PANS symptoms (becomes a CASE). Stay tuned to learn more about the release of these new features!
WHAT IF I DON’T UNDERSTAND A QUESTION OR MY ANSWER DOESN’T FIT IN ANY CATEGORY GIVEN?
To keep the information unbiased and the data as clean and accurate as possible, please understand the registry sponsor CANNOT advise families on how to answer questions. We have added “I do not know” or “other,” option (with the option to write in a custom response) to most questions. We do however feel that while maybe not a perfect fit, most questions have a broader category that most symptoms, treatments, and clinical history fall under. So please do your best to answer as honesty and as accurately as you can to choose the best option.
I NEED TO CHANGE AN ANSWER IN A PREVIOUS SURVEY. HOW DO I GO ABOUT THAT?
You can go back and change your answers by clicking on topic buttons and using the navigation bar at the bottom of the screen to scroll and move to “next” and “previous” pages. When you have to go back to make a change, it is important to click “next” on the bottom navigation bar until you get to the last page of the topic and are sent back to the dashboard. If you instead click “Save and return to menu,” the page completion count on the topic button will turn red, indicating the topic is not complete.
IF YOU DON’T NEED TO HAVE A DIAGNOSIS OF PANS FOR ELIGIBILITY, HOW WILL YOU ENSURE THE DATA ISN’T SKEWED?
Since there’s no official test for PANS, a diagnosis is subjective whether a provider has given the label or not. We know many children with an original diagnosis of OCD, Tourette’s ODD, ASD, etc. later come to find out they have PANS. Because of the strict criteria around PANDAS and the lack of knowledge and acceptance amongst pracititoners, we’ve included patients with a diagnosis, as well as those who were unable to receive one but believe their psychiatric symptoms are immune-mediated. What is great about this survey is that if a researcher only wants to see officially diagnosed patients, they can obtain that specific information. However, if they want to study a broader population to see what commonalities exist among that population, they can query that data as well. This way, no child is left behind.
WHAT IF MY CHILD’S UNAFFECTED SIBLING HAS SOME SIGNS OF PANS BUT WE ARE UNSURE WHETHER THEY SHOULD BE A CASE OR CONTROL?
If one of your children has “soft signs” of PANS but you are unsure whether or not they should register as a CASE, please enroll the sibling as a CASE so that you may be able to report symptoms appropriately.
CAN WE SUBMIT ANONYMOUSLY?
The registry data is only as good as the information that it receives. In order for your data to be included, we must have a valid contact email for registration and follow up. However, if you are worried about privacy issues, we do encourage you to consider using a child’s nickname. This would not prohibit you from entering the registry. However, it is VERY important that you remember which nickname is attached to each child so that you are reporting on the appropriate child. Failure to do so could greatly skew data. If your child does not have a nickname, we suggest using a shorter version of their first name. It is our sincere hope that all information be filled out in the survey so that no children are left out of analyses. The larger the cohort, the better story we will be able to tell. As a reminder, all information is de-identified when used for research purposes. So your private details will always remain private.
WHAT IF I HAVE A TECHNICAL PROBLEM PROHIBITING ME FROM CONTINUING?
The IPR database just moved to a new version, so unfortunately, there may be some hiccups as bugs are being worked out. If you have any technical difficulties, please do the following to help us fix it quickly:
1. Tell us what question you’re on and under what topic area.
2. Screen shot the message or error you see.
3. Send that screen shot by email to email@example.com and someone will get back to you within 24 hours.
While we hope these errors are far and few between. We have already successfully piloted 100 families to work out any bugs. So we feel confident this should be an easy process. However, there are always unknowns. Following the above three steps will ensure that we escalate any technical issues quickly and streamline the process for other participants. Thank you for your patience and understanding.
HOW WILL I KNOW WHEN I’VE COMPLETED THE REGISTRY?
Upon completion of IPR you should receive a confirmation email as well as a final page letting you know you’ve completed the entire survey. At any time during the survey, you can view the dashboard which include “count indicators”to track your progress. These indicators are RED with corresponding completed/total survey’s (eg. 4/6) when surveys still need your attention , and GREEN (eg. 6/6) when the all survey in that topic are complete.
If you did not receive a confirmation email or confirmation page, and believe you’ve completed all the surveys, please email firstname.lastname@example.org and let us know so that we can make sure that it has been completed in its entirety.
I RECEIVED AN EMAIL SAYING I WASN’T ELIGIBLE TO ENROLL BUT I THINK I MEET THE CRITERIA. WHAT DO I DO?
WHAT IF I HAVE SUGGESTIONS OR FEEDBACK ABOUT THE REGISTRY?
We want to make the registry the best it can be, which is why we’ve involved the parent community and clinical and scientific community every step of the way. If you have any suggestions or feedback, please feel free to email us at email@example.com and let us know what we can do to make IPR even more useful.
WILL I KNOW HOW MY DATA IS BEING USED?
Your child’s anonymized information will be pooled with data from thousands of other children with PANS. The pooled information is used by researchers to identify patterns that would not otherwise be visible, and to gain insights into the causes, mechanisms, and management of the disease.
IPR will provide updates about the research studies to registered participants as soon as details are given. What is unique about IPR is we are giving each patient control over how their data is used for research.During intake, you will be asked how you would like to share your information, so please choose what’s most comfortable for you and your family. If you do not want anonymized data to be available for public policy, we simply will not include your child when presenting that information when we receive public health data requests. If your family is unwilling to share de-identified data with pharmaceutical companies, that is your decision as well. If you want to engage citizen scientists in the scientific process, you can opt to share your de-identified data with them. Your data will never be sold or shared without your written consent and absolutely no one other than the trained registry staff associated with the IRB will have access to your de-identified data. We highly encourage patients to allow a diverse range of people to have access to their child’s de-identified information as the more minds on the case and the more people working on PANS, the better. Remember, this data is DE-IDENTIFIED and the IPR Data Use Committee is comprised of families with the same fears and concerns over our children’s health history and privacy as you are. We hope that participants will share their de-identified data and trust the registry committee to ensure all researchers obtaining the data will conduct research that will be of great benefit to the PANS community. We believe the power to choose who has access to your data, de-identified or otherwise, solely belongs to you.
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
WILL I EVER BE CONTACTED TO PARTICIPATE IN RESEARCH TRIALS?
Researchers will never contact you directly because all health information is de-identified and your contact information will never be shared. The Pediatric Research & Advocacy Initiative (registry sponsor) will inform you of any opportunities to participate in clinical trials or research studies, and you will be able to follow-up with the researcher or biopharmaceutical company directly.
WHAT HAPPENS NEXT AFTER IPR HAS A ROBUST DATA SET?
Once we recieve a large enough data set, the registry sponsor will start reaching out to dozens of labs across the country to garner interest in the data to be used for scientific purposes. We will be asking that graduate students consider making PANS a subject of their theses and dissertations. We will fundraise for microgrants to encentivize postdocs and junior investigators to analyze and write publications on the data. And mine data to see if there’s any reason to believe that there may be a reason to believe that the environment might play a role in PANS.
HOW DO PEOPLE ACCESS THE DATA?
Our IPR website will soon have a 1-2 page Data Use Agreement (DUA) for researchers to request what variables they’d like to query with a short written explanation of what data will be used for. A small committee of community members and researchers will review their request and, once approved, a data manager will pull de-identified data to share using HIPAA compliant policies and procedures.
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 is a result of parent-led fundraising efforts.
Currently, IPR is maintained through individual donations obtained from the parent community and is fully funded for the database, hosting, and HIPAA-compliant cloud storage for a minimum of 3 years. Ongoing donations will go to support microgrants for researchers, database management, and the creation of research manuscripts and future publications.
IF I DONATE TO IPR WHAT IS MY MONEY GOING TO SUPPORT?
Thanks to the incredible work of the parent community, IPR is fully funded for 36 months for the administrative aspects of the registry including hosting, HIPAA-compliant CLOUD storage, the creation of one manuscript laying out how IPR was created a basic overview of data findings, marketing and analysis. Additional funds will be needed. The registry sponsor (PRAI) has made IPR it’s sole charitable program, therefore, 100% of funds donated to the registry go directly to support the success of the registry and entice researchers to investigate PANS with microgrants. Our most immediate funding need is a data analyst to be the gatekeeper for the data and the conduit between researchers and patient data. This person will be responsible for reading through requests for data and communicating it to the IPR Data Use Committee and pulling the queries for researcher. This resource needs to be proficient in SAS statistical software and have a basic understanding of database analysis.
Help Sustain our Registry
100% of donations go towards research projects
I went to a psychiatrist once who had a cup on her desk that read “Don’t confuse your Google Degree with my Medical Degree.” To those of us in the trenches, online support groups are invaluable resources. When a group of people with shared experiences spend countless hours going over intimate details of their child’s symptoms and clinical history, of course that pooled knowledge would be worth its weight in gold. I can’t imagine what we could accomplish if parents, clinicians, and researchers aligned with one another to find answers for our kids. Plus, no one is more determined than a parent when it comes to helping their child.