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FAQs

Is this form of data collection approved?

Yes.

The project does not collect individually identifiable data and has been cleared by the University of Oxford Clinical Trials & Research Governance unit as not requiring formal ethical approval but instead representing a largescale audit outcomes project. As such, it is therefore registered as an approved audit with Oxford University Hospitals (ref: 5955)

Why are there two registries (COVID-Hep.net and SECURE-Cirrhosis)?

When we launched, we launched simultaneously with the team running SECURE-Cirrhosis from the University of North Carolina in the United States. Both projects had and have similar aims.

The two projects started with separate research board approvals, separate links with major societies and individuals, and separate data collection tools collecting different data points.

In recognition that both datasets would be more powerful if they could be easily combined, we have subsequently collaborated and made the data gathered by our two data collection tools equivalent.

As such, two complimentary and mutually supportive collaborative projects have developed. We have agreed to ask that submitting centres decide which portal to send their case reports of COVID-19 in liver disease to based on their geography: see the map below. Ultimately, we will work together to build the most comprehensive dataset possible.

COVID-Hep SECURE-Cirrhosis map
Where should I submit my case?

As described above, we are working collaboratively with SECURE-Cirrhosis in the United States. We are asking submitters to direct their case reports based on geography.

Please see the map above: blue for COVID-Hep.net and red for SECURE-Cirrhosis. Broadly, for The Americas and China, Japan, Koreas, and Mongolia, use SECURE-Cirrhosis; for the rest of the world, use COVID-Hep.net.

Do email us if required.

What is the purpose of the COVID-Hep project?

This collaborative registry project aims to the impact of COVID-19 (caused by the novel virus SARS-CoV-2) on patients with chronic liver disease and who have received liver transplants. It intends to record how pre-existing liver disease or liver transplantation affects the course of COVID-19. It will also record how patient factors such as age, sex, comobidity, and medication may influence disease course and outcomes.

When should I submit a Case Report Form to the COVID-Hep registry?

The registry aims to collect data for any patient with chronic liver disease or a previous liver transplant who is receives a laboratory confirmed diagnosis of COVID19 (caused by SARS-CoV-2 infection) regardless of the severity of disease.

Please submit a Case Report after the patient's disease trajectory has become clear i.e. after they have been discharged from your care, recovered from the illness or died.

Can I submit from outside Europe?

Yes, please do. Although we are based in Europe, we encourage submissions worldwide. However, if you are submitting from the Americas, China, Japan, Koreas, and Mongolia, we encourage you to use the service at SECURE-Cirrhosis which is based in the USA and with whom we are collaborating.

Who should complete Case Reports?

Case Reports should be completed by those providing healthcare to the patients whose details are recorded. Patients wishing to record their experience should please encourage their healthcare providers to do so.

The COVID-Hep project is particulary interested in differences between presentations between geographies and we welcome submissions worldwide (but for submissions from the Americas, China, Japan, Koreas, and Mongolia, please see above).

Why should I submit a Case Report Form to the COVID-Hep registry?

The intention is that the registry will provide valuable insights to those caring for patients with chronic liver disease or liver transplants.

In addition to the above, we will credit all contributors in any publications resulting from this work and we intend to invite major contributors to be included in our authorship.

How long does submitting a Case Report take?

About 5 minutes. The Case Report form is a balance between recording sufficient information to build an informative registry and the valuable time of our contributors

How many cases have been reported to date?

Please look at our Updates page.

What are the characteristics of the cases reported to date?

Please look at our Updates page. We will include summary data initially. As the data set becomes large enough, we intend to publish more granular assessment of cases reported.

Can I pause and return to the submission process?

Sadly, no. Please complete the form in one session. If you need to change something, please contact us.

Do I have to answer every question in the form?

No. However, the more questions that you can answer, the more useful the dataset that will result.

Something else?

Please email us.