No. Where possible we are issuing only ONE SINGLE REDCap login per site.
The login details can be shared with all members of your team who will be responsible for uploading patient data. We encourage teamwork to identify patients and upload data, to increase data accuracy.
If you believe your hospital would benefit from having more than one account (e.g. large hospital with multiple teams collecting data separately), please email us ([email protected]) and we issue more than one login if appropriate.
Yes – to help sub-teams within hospitals to navigate faster to only relevant records we have created a speciality-specific dashboard on REDCap. Here you can select the sub-study in which you are participating and see only those patient records.
A short tutorial video on how to navigate the dashboard can be found at:
You should include patients diagnosed with SARS-CoV-2 infection within 7 days before or 30 days after surgery (via lab test, computed tomography scan or clinical diagnosis in the absence of the previous). Patients being diagnosed outside of this time-window should be excluded from CovidSurg cohort study.
The index operation should be taken as the first operation they had after SARS-CoV-2 diagnosis (this operation should be within 7 days of SARS-CoV-2 diagnosis in order for the patient to be eligible for inclusion).
Yes – you can retrospectively collect data about patients who previously underwent surgery and were diagnosed with SARS-CoV-2 infection within 7 days before or 30 days after surgery (via lab test, computed tomography scan or clinical diagnosis in the absence of the previous).
Primary endpoint is 30-day mortality, including in-hospital or out of hospital follow-up. However, we don’t expect any additional follow-up. So, data can be completed using the information available at the hospital at 30 days (accepting that this may miss some morbidity /mortality in the community).
Investigators can enrol patients with confirmed diagnoses of Colorectal, Oesophagogastric, Head & Neck, Lung, Hepatopancreatobiliary, Urological, Neurological, Gynaecological, Breast cancers and soft-tissue or Bone Sarcoma.
Yes – please do! We want to capture data for all patients who would have been planned for
an operation with curative intent in the pre-COVID era, whether or not they ultimately have
an operation/ it is delayed / they have alternate treatment.
You should state that a patient has COVID-19 if the diagnosis was made up to 7 days before or 30 days after surgery. Patients being diagnosed outside this time-window should be stated as COVID-19 negative.
You must follow all applicable ethical requirements at your hospital.
Example: in the United Kingdom, CovidSurg is being registered as audit or service evaluation, this means that patient consent is not required. However, in some countries patient consent (written or verbal) may be required, please liaise with local approval committees for more information.
It might we worth noting to your ethical committee that only routinely collected and fully anonymised data is uploaded. Not even specific operation dates are uploaded.
There is no expectation for patients to undergo any extra tests. Please just complete all
datapoints that are routinely available. Our data management team will ask you to confirm
this before the dataset is locked for analysis.
This study has an adaptive protocol and the data points we are collecting have been chosen
for their generalisability across regions and the conclusions that can be drawn. If you think
there is an important missing datapoint, please contact [email protected] and a decision will be made by our Data Monitoring Committee.
Ideally, we want to capture all eligible patients across all specialties to minimise bias.
However, if you decide to exclude particular specialties then that is fine, as long as you are capturing data on all the cancer patients with a decision for surgery within the respective specialties (CovidSurg Cohort, Cancer or both).
Each site can access and download their own data from REDCap.
We are designing a process to apply to access data in case specific groups wish to perform wider analysis, using data from several centres (e.g. country specific or specialty specific analysis). Further details will be available soon.
Yes – the nature of these studies means, teams will evolve throughout the data collection
period. The Principal Investigators in each hospital will have the responsibility to fill a form for each collaborator with their details and role. For each paper, we will include the members of the team who contributed to data collection for the patients included in that particular paper.
There is no strict limit to the number of authors, as long as it is reasonable given the number os patients included. We will analyse outliers on a case-by-case basis.
YES, a resident/trainee/registrar can assume the role of the PI.
The PI is required to take responsibility for study conduct and Clinical Governance departments. A consultant might be required or best placed to do this but we allow trainees/residents to take this role when locally appropriate.
Yes – other professionals contributing to the study at your site can be registered and recognised. All the collaborators can register their details at https://is.gd/covidsurgsetup to receive study updates!
We recommend that consultant/attending physicians or trainees act as local Principal Investigators. Medical students are very welcome to help collect data where appropriate but are not best placed to lead a local team. If further questions please contact us through [email protected].
Please check that all data was entered before the deadline of the study in which the publication resulted from. If you missed the deadline, any subsequent data entered and associated contributor acknowledgment will appear in relevant future publications.
Currently we have a template DSA, which has been approved by the legal services
department at the University of Birmingham. Please email [email protected] if
you require a DSA and we would be happy to share this with you to cover the key areas of
concern. However, due to the COVID-19 situation, our university’s legal services are closed until June 2020, so we are unable to consider requests for significant amendments to the document as these will require legal review but we can consider minor modifications.
If you wish to disseminate information about the studies in your country and help further sites to enrol, please contacts us through [email protected]. We acknowledge this is a demanding task and we will recognise active country contacts as co-authors in our corporative co-authorship.