This site was created to publish open source data in real time about the current safety and feasibility of sinus procedures. Our purpose was to create transparent data reporting for the ENT and PATIENT community in order to take a more scientific, data driven approach to delivering sinus care in these uncertain times. We believe this data is critical for policy decisions now and in the future should there be a spike in COVID-19 disease in any region of the country.
Our Goal:
Collect data on the safety of performing nasal/sinus procedures in the office and OR during the COVID-19 pandemic.
Eligibility:
All cases performed after April 1, 2020 are eligible nationwide.
Data Collection Method:
- Surgeons will be asked to register (name, email) at which time you will receive a unique surgeon identifier code.
- After 30 days post-procedure we ask that you input data regarding the case on a simple form that can be accessed via a URL. You can click here to see a sample of the form. Please do not submit data before receiving a surgeon identifier code.
- No identifiable patient information will be collected. All surgeon data will be masked. No IRB approval or patient consent is needed to submit the data. See this link for more information to the HHS position statement on Surgical Registry Data.
Endpoints:
- Did the patient or medical staff develop COVID-19 in the 30 day period after the procedure?
- Was there presumed disease transmission to the patient from the procedure?
- Was there presumed disease transmission to the doctor or staff from the procedure?
Reporting:
- Due to the fluidity of the Covid-19 pandemic, data will be published in real-time on this site.
- NO SURGEON SPECIFIC DATA WILL BE PUBLISHED OR SOLD. We use a surgeon identifier code to prevent corrupt data submission to the registry. All data is stored on HIPAA compliant servers.
- Device-specific data will be limited as much as possible (the type of balloon, shaver used, etc.). This site is not funded or tied to the medical device industry.
- The primary use of surgical registry data will be for publishing results on this site in as close to real time as possible.
- Future publication in peer reviewed journals is not a goal at this time but if this becomes necessary to bring a scientific discussion to national, state or local policy decisions we may pursue this. By submitting your case data to the registry you consent to the ethical use of the data in whole or part now and for future uses without further consent.
- Initially when the amount of data is limited the results will be presented for the entire country. As more data comes in the state by state data may be published.
Thank you for participating!
Jim Atkins MD
Brad Bichey MD MPH
This Registry is independently hosted, managed, and funded by Brad Bichey MD and James Atkins MD