What is the purpose of this registry?
The goal of the registry is to report on outcomes of cases of COVID-19 in this population of patients.
How will the data from this registry be shared?
The data will be shared directly on the website covidsicklecell.org, through social media (follow us on @SickleCellWI) and via scholarly publications. The website will be updated at least weekly and include the number of cases and COVID outcomes, demographics, medical history, COVID disease severity and symptoms and locations.
What steps have been taken to ensure the security of the data?
The registry contains only de-identified data, in accordance with HIPAA Safe Harbor De-Identification standards. The Medical College of Wisconsin Human Research Protection Program 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 does not require IRB approval.
The REDCap database provides for secure web-based data entry with the data stored on secure servers at The Medical College of Wisconsin. 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 and is restricted to the forms and/or functions that the user needs to have.
When should a case be reported?
If you have a patient with sickle cell disease (SCD) 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 I have already reported a case, how can I update it with additional information?
Once a survey has been submitted it cannot 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 firstname.lastname@example.org to ask our team to remove the duplicate entry.
Who should fill out the case report form?
Health care providers or reporters on behalf of the providers taking care of patients with SCD and documented COVID-19.
Can a patient fill out the case report form?
No, the Case Report Form is designed to be filled out by a health care provider or reporters on behalf of the providers. Patients with SCD 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 (covidsicklecell.org) if you or any of their SCD 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 any medical questions or provide any medical advice. We recommend checking with your health care provider regarding any personal medical questions.
Is the registry collecting information on COVID-19 cases in those with sickle cell trait?
We are not collecting information on COVID-19 cases for those with sickle cell trait.
How long will it take to complete the survey?
It will take approximately ten minutes to complete the survey.
Can your team accept biological specimens (including blood samples) from patients?
We currently do not have the infrastructure to accept patient samples. However, we may consider collaborating with others 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?
We hope these data are informative and increase our understanding of the care of SCD patients with COVID-19.
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 and the possibility of a false negative COVID-19 test.
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 quickly identify the impact of COVID-19 on patients with sickle cell disease and understand the impact of risk factors such as genotype, prior sickle cell disease complications, or sickle cell disease related medications, on health outcomes.
What cases have been reported so far?
Please see the Updates & Data tab on our website (covidsicklecell.org) for updated reports, including on the number of cases, outcomes, patient history and treatment, etc.
How often will the website be updated with the most recent data?
We plan to update the website weekly with reports on the number of cases, outcomes, patient history and treatment, etc.
Who is organizing this project?
This project is being led by Drs. Julie Panepinto and Amanda Brandow (Pediatric Hematologists), Dr. Ashima Singh (Epidemiologist) and Dr. Lana Mucalo (Postdoctoral Fellow) at The Medical College of Wisconsin.
If I have additional questions, whom should I contact?
Please direct questions to email@example.com.