Frequently Asked Questions

 

What is the purpose of this registry?
The goals of the registry is to rapidly define the impact of COVID-19 on patients with IBD and how factors such as age, comorbidities, and IBD treatments impact COVID outcomes.

 

How is the data from this registry going to be shared/disbursed?
The data will be shared 1) directly on the website http://www.covidibd.org , 2) through listservs and social media, and 3) via scholarly publications. We plan to update the website three times weekly, with reports including number of cases (and COVID outcomes) by country, number of cases by treatment, etc.

 

What steps have been taken to ensure the security of the data?
We have created a registry that contains only de-identified data, in accordance with HIPAA Safe Harbor De-Identification standards. The UNC-Chapel Hill Office for Human Research Ethics has determined that storage and analysis of de-identified data does not constitute human subjects research as defined under federal regulations [45 CFR 46.102 and 21 CFR 56.102] and does not require IRB approval.

Our database system (REDCap) provides for secure web-based data entry with the data stored on secure servers at the University of North Carolina at Chapel Hill.  All data is encrypted during transmission. The web and database servers are monitored by the IT staff, patched frequently, and scanned by a third party vendor to ensure that they are protected against known vulnerabilities.  Access is by individual user id, and is restricted to the forms and/or functions that the user needs to have.

 

When should I fill out a Case Report Form?
If you have a patient with inflammatory bowel disease (IBD) and confirmed SARS-CoV-2/COVID-19 testing than please complete the form after the patient has had COIVD-19 for a long enough duration to experience partial or complete recovery, hospitalization, or death. If the patient’s clinical status changes after a form has been completed, please refer to question #5.

 

Once a survey has been submitted, can it be re-accessed or edited at a later time? What if I have updated information about a case after submission?
Once a survey has been submitted it can not be re-accessed or edited at a later time. However, if you have updated information or any changes since you have reported a case, please re-report the case and email COVID.IBD@unc.edu to ask our team to remove the duplicate entry.

 

Who should fill out the Case Report Form?
Health care providers taking care of patients with IBD and documented COVID-19.

 

Can patients fill out the Case Report Form?
No, the Case Report Form is designed to be filled out by a health care provider. Patients with IBD and documented COVID 19 should encourage their health care provider to complete a Case Report Form on their behalf.

 

I am a patient. How can I help?
Thank you for your interest in helping with this international effort! Please consider asking your health care provider to report on our website (www.covidibd.org) if you or any of their IBD patients contract COVID-19.  We encourage you to check our website frequently, as we will be posting data and updates at least weekly.

 

I have a personal medical question about myself or my friend/family member. Can your team answer it for me?
We are unable to answer personal medical questions. Currently, we do not have the data to determine how or if IBD medications or disease type change the risk associated with COVID 19. We recommend checking with your health care provider regarding any personal medical questions and utilizing the IBD Patient Guidance from the Crohn’s and Colitis Foundation (https://www.crohnscolitisfoundation.org/coronavirus-update/adults). In addition, we recommend following the CDC recommendations regarding COVID-19, which can be found here: https://www.cdc.gov/coronavirus/2019-ncov/index.html.

 

How long will it take to complete the survey?
It will take approximately five minutes to complete the survey.

 

Can your team accept biological specimens (including blood samples) from patients?
We do not have the infrastructure to accept patient samples at this time. However, we may consider conducting studies with biological samples in the future, so please stay tuned for updates.

 

Can health care providers anywhere in the world report a case to this registry?
Yes. This is an international effort, and we encourage health care providers around the world to report to this registry.

 

Will this registry lead to care recommendations or guideline development?
Yes, we hope that this will produce sufficient data to inform care of IBD patients.

 

Have you considered allowing reported of suspected cases in addition to confirmed cases?
After much deliberation, we have decided to accept only confirmed cases at this time. The main reason for this decision is that suspected cases may include cases of non-COVID-19 illness, including other viral illnesses or allergy. We have made this decision to ensure that the data collected is reflective only of true COVID-19 cases. We recognize there are limitations to this approach, including the scarcity of testing at many locations.

 

Is there a collaborative goal with the users of the database?
This is a collaborative, world-wide effort. With users reporting cases in real time, we hope to rapidly determine the impact of COVID-19 on patients with IBD and ascertain how medications, comorbidities, and demographic factors modulate their risk. As above, these data will be made available on our project website and frequently updated.

 

What cases have been reported so far?
Please see the Current Data tab on our website (www.covidibd.org) for updated reports, including number of cases (and COVID outcomes) by country, number of cases by treatment, etc.

 

How often will you update the website with the most recent data?
We plan to update the website three times weekly, with reports including number of cases (and COVID outcomes) by country, number of cases by treatment, etc.

 

Who is organizing this project?
This project is being led by Drs. Michael Kappelman (Pediatric Gastroenterologist) and Erica Brenner (Pediatric Gastroenterology fellow) at the University of North Carolina at Chapel Hill and Drs. Ryan Ungaro (Gastroenterologist) and Jean-Frederic Colombel (Gastroenterologist) at the Icahn School of Medicine at Mount Sinai, New York.

 

Are there any partnering organizations/societies?
Official partners include the Crohn’s & Colitis Foundation, the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN), the International Organization for the Study of IBD (IOIBD), the European Crohn’s and Colitis Organisation (ECCO), and the Asian Organization for Crohn’s & Colitis.

 

If I have additional questions, whom should I contact?
Please direct questions to COVID.IBD@unc.edu.