CovidSurg FAQs Contents

  1. Registration and REDCap

  2. Inclusion criteria for COVIDSURG COHORT study

  3. Inclusion criteria for COVIDSURG CANCER study

  4. Data: consent, collection, access, and analysis

  5. Collaborators and authorship

  6. Documents and information for approvals

  7. Country contacts

  8. Other

Registration and Redcap

  • Registration for CovidSurg and CovidSurg-Cancer has now closed. Future studies are currently being designed and details on how you can register for these will be made available in due course.

  • Please follow the steps on this form to register and / or gain REDCap access.

  • Please allow 24-48 hours to receive your login and remember to check your junk/spam folder.

  • 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.

  • We can consider requests from sites requiring additional logins (e.g. for very large teams, or for teams working across different sites).

  • To request this, please contact [email protected].

  • 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:

    https://drive.google.com/file/d/1snLPi14_4Jac_4jhEe0bwMisCGQC8t0X/view.

  • Collaborators can be added via the authorship project on REDCap.

  • You can contact [email protected].com. Our team will be able to confirm your username and arrange a password re-set for you.

Inclusion criteria for COVIDSURG COHORT study

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.

No – it is based on the diagnosis made by a senior doctor according to clinical judgement. This will be accepted as COVID-19 diagnosis only when lab tests or CT scans are not available/performed.

No – only confirmed SARS-CoV-2 positive patients should be included. When the test is negative, the patient should be excluded.

Yes – if a post-operative COVID-19 diagnosis was made up to 30 days after surgery. Please
collect details about COVID-19 diagnosis (lab test, CT scan or clinical diagnosis if no testing
performed).

Patients with a negative test should be excluded from CovidSurg Cohort Study. Even if they have clinical symptoms which could be COVID, the test (swab or CT) is the inclusion criteria.

Patients undergoing a procedure performed by a surgeon in an operating theatre should be included.

  • Percutaneous procedures (e.g. insertion of central venous catheters, interventional radiology procedures).

  • Bedside procedures (e.g. in the intensive care unit, unless due to the pandemic operations are routinely being performed in the intensive care unit that would normally be performed in theatre).

No – percutaneous procedures are excluded.

The index operation should be taken as the first operation that took place in the 30 days preceding their diagnosis.

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).

Inclusion criteria for COVIDSURG CANCER study

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.

Please contact the specialty leads for CovidSurg Cancer through the contact form on the bottom of this webpage:
https://globalsurg.org/cancercovidsurg/
If your specialty is not listed, please contact us on  [email protected] for more details.

  • Patients planned for curative cancer surgery that have surgery completed during the COVID-19 pandemic.

  • Patients that would have been planned for curative surgery in the pre-COVID-era that have surgery delayed or cancelled during the COVID-19 pandemic.

  • Please view the flow diagram at the bottom of this webpage https://globalsurg.org/covidsurg/

No – only resection procedures should be included.

No – you should only include malignant tumours.

No – only malignant tumours should be included. This will provide clarity to the study denominator.

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.

Yes – this is a specialty specific inclusion criterion. In addition to surgery with curative
intent, patients with life-prolonging intent may be included.

Please view the flow diagram in our main page https://globalsurg.org/covidsurg/,  join the relevant subspecialty WhatsApp group for discussion or
contact us at [email protected].

Specialty specific WhatsApp groups:

Oesophagogastric: https://chat.whatsapp.com/FpgYwgoPY9r3QfV2hVoU7Q

Colorectal: https://chat.whatsapp.com/JBueqyJLKNVE5YVwwxwCq6

Lung: https://chat.whatsapp.com/DoGh6ZteS4AHDlVnVYAB8o

HPB: https://chat.whatsapp.com/LCIDs5YU68p0loEB5YkOgr

Sarcoma: https://chat.whatsapp.com/DfJybL7AUAcHyZ1qm2W2YS

Head and Neck: https://chat.whatsapp.com/EZQOKXkYJXuI4RActVeNZc

Gynae: https://chat.whatsapp.com/DZN0TiDT4Qy9ZvkqhWszqF

Breast: https://chat.whatsapp.com/GDp4r7rBKUcJa5ATEMpLbJ

Neuro: https://chat.whatsapp.com/D2ieh34P7Mo5RcAHCtxhZa

Urology: https://chat.whatsapp.com/HY9pS9kq5R1Hl9K6fw0Du4

Paediatrics: https://chat.whatsapp.com/J8CVb6lANPd7ymYhO1uOm7

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.

Data: consent, collection, access and analysis

  • 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.

Yes – you can find template Patient Information Sheets and Informed Consents forms in
multiple languages on our study webpages:

CovidSurg Cohort Study: https://globalsurg.org/covidsurgcohortstudy/

CovidSurg Cancer Study: https://globalsurg.org/cancercovidsurg/

From the date of the first COVID-19 positive case at your hospital. If you work in a COVIDfree hospital, your reference should be the start of the outbreak in your city/region.

For CovidSurg Cohort study: at present, data collection is due to end on 30th September 2020.

For CovidSurg Cancer study: new patients should be entered during 3 months since the starting date of the study at your hospital (beginning of COVID in your hospital/city).

30-day follow-up data should be collected from the date of the index operation.

Yes – you can retrospectively collect data about eligible patients from the date when your
hospital started being affected by COVID-19.

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.

  • The last date for which data for new patients can be entered is July 31st. For information on other upcoming deadlines, please visit https://globalsurg.org/covidsurg/

Collaborators and authorship

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.

  • There are no formal authorship limits, as long as the number of collaborators is reasonable given the number of patients included. Please see the question above for further details.

  • All collaborators from sites who contribute at least one patient will be recognised on any resulting publications as PubMed-citable co-authors.

  • A corporate authorship model will be used under CovidSurg Collaborative group, for example: https://pubmed.ncbi.nlm.nih.gov/29452941.

  • 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.

Documents and information for approvals

  • Mr Aneel Bhangu

  • Senior Clinical Lecturer in Global Surgery | NIHR Unit on Global Surgery

  • Institute of Translational Medicine, University of Birmingham, Edgbaston, Birmingham, UK, B15 2TH
    Tel: +44 (0) 121 3718121

  • Carolyn Pike OBE, Director of Legal Services

  • University of Birmingham, Edgbaston, Birmingham B15 2TT
    Tel: 0121 414 3916
    Email: [email protected]

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.

YES – we have provided a support letter from our CovidSurg Lead Mr. Aneel Bhangu as well as the Royal College of Surgeons and other supporting societies. These can be found at:

YES – we have provided several ethics/ IRB on our homepage. These can be found at:

• https://globalsurg.org/covidsurgcohortstudy/ (for CovidSurg) AND

• https://globalsurg.org/cancercovidsurg/ (for CovidSurg-Cancer)

Country Contacts

  • Yes – we have a Disseminations Committee, where several enthusiastic colleagues agreed to act as country contacts for CovidSurg. They can support you through the setup process at your hospital.

  • Please visit https://globalsurg.org/covidsurg-network/ to contact your country lead, if required.

  • You can contact the CovidSurg steering committee through [email protected].

  • 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.

Other

  • The patient resource booklet is available in a variety of formats and languages at bit.ly/surgerycovid.

  • If you require the booklet in a language not listed, you can get in contact with the Dissemination Committee link who may be able to accommodate your request.

  • Unfortunately, names provided in the survey are only populated in the html emailed certificate. Due to the number of attendees, manual PDF population is not possible.

  • Please e-mail [email protected].com, adding the webinar name and date so that our team can retrieve your certificate.