CovidSurg-Cancer HEAD & NECK Follow-Up Study

The primary intention of the COVIDSurg-Cancer study was to evaluate the 30-day SARS-CoV-2 infection rates in elective cancer surgery. The end points for that project were restricted to evaluation at a timepoint only four months following the first enrolled case (June 2020) however significant clinically relevant questions that cannot be addressed within the intended study window remain, particularly for Head & Neck Cancer patients.

Of paramount importance for this patient group, is assessment of whether the changes in care, deemed necessary at the time, have had a long-term impact on patient outcomes.

To that end, we will extend follow up analysis for Head & Neck cancer patients through inclusion of mature (12 & 24 month) outcome data and of additional data fields of specific head & neck importance, including aspects such as the influence of modified surgical practices on functional outcomes and disease-free intervals. These data points and assessment timepoints were beyond the remit of the original CovidSurg-Cancer study.

This follow-up study seeks to address the hypothesis that the COVID-19 pandemic, and unintended consequences of alteration in clinical management, have negatively impacted upon outcomes (survival or otherwise).

To evaluate the impact of treatment delay and/or case management alteration of patients treated during the COVID-19 pandemic (March-June 2020) in terms of survival and function.

COVIDSurg-Cancer HEAD & NECK Follow-Up Study is an international, multi-centre, audit of current practice.

All sites who enrolled patients with a diagnosis of Head & Neck malignancy into the COVIDSurg-Cancer study are invited to continue to follow-up their patients.

Sites will not be required to identify any new patients. Patients enrolled during the 3-month study period of the COVIDSurg-Cancer (early 2020) will be followed up at the 12 and 24 months time points.

There is no change to the patient treatment, the CovidSurg-Cancer HEAD &NECK Follow-Up Study is an audit of practice.

All patients who were included in COVIDSurg-Cancer with diagnosis of Head & Neck malignancy are eligible for long-term follow-up at 12 and 24 months post study entry date (June 2021 & June 2022).

Table of key dates and milestones in the CovidSurg Cancer Head and Neck Follow-up Study

• Prospective data collection at 12 and 24 time points (data collection during June 2021 and June 2022)
• Only routinely collected data will be used
• No patient identifiable information will be uploaded to the central study database
• Data will not be published at identifiable hospital level

For all collaborators from sites, the corporate authorship model will be followed, as was the case in the parent COVIDSurg and COVIDSurg Cancer Studies (see publication). Those collaborators who contribute follow-up data on at least one patient will be recognised on any resulting publications as PubMed-citable co-authors. Flexible to service demands and given the longer-term nature of data capture, no authorship limits will be imposed at a centre level; as many collaborating investigators are required, and work to support the project will be recognised on all future outputs.

• Prospective data collection at 12 and 24 time points (data collection during June 2021 and June 2022)
• Data will be collected using the secure web application REDCap
• Complete one CRF per patient at each time point

If your hospital captured patient information for COVIDSurg-Cancer during the 3-month identification window (typically March-May 2020):

1. Confirm your continued intention to follow-up these patients longer term here: https://redcap.link/covidsurgfu. The information you provide in the survey will help us keep in touch with you during the study and to create logins for you to access the study database.
2. Please ensure that you maintain your local records linking Medical Record Numbers with REDCap IDs (the COVIDSurg Link Sheet)
3. Review the local approval (ethical, audit or institutional review board) that was required for the initial COVIDSurg-Cancer study and resubmit as necessary for the CovidSurg-Cancer HEAD & NECK Follow-Up Study to ensure that approval remains in place for the extended follow-up.

More details on the CovidSurg-Cancer HEAD & NECK Follow-Up Study can be found in the following documents:

• COVIDSurg Invitation Letter
• HRA Decision Tool
• COVIDSurg-Cancer H&N Follow-up study Protocol
• COVIDSurg-Cancer H&N 12-month Follow-up 
• COVIDSurg-Cancer H&N Follow-up Data Completion Guide
• COVIDSurg-Cancer H&N Follow-up Study REDCap User Guide

In order to carry out the COVIDSurg-Cancer HEAD & NECK Follow-Up Study, we will need to collect information about you, and some of this information will be your personal data. Under data protection law, we have to provide you with very specific information about what we do with your data and about your rights. We have set out below the key information you need to know about how we will use your personal data.

The University of Birmingham’s web page ‘Data Protection - How the University Uses Your Data’ sets out much of this information, including how to ask any questions you may have about how your personal data is used, exercise any of your rights or complain about the way your data is being handled. The rest of the key information you need to know about how we used your personal data is set out below.

The University of Birmingham, Edgbaston, Birmingham B15 2TT and the University Hospitals Birmingham NHS Foundation Trust are the data controllers for the personal data that we process in relation to you.

We will collect and process your personal data so that we can enable you to log in and access the study database so you can participate in the project, and to contact you for additional information to support our research.

The legal justification we have under data protection law for processing your personal data is that it is necessary to do so for our research, which is a task we carry out in the public interest. 

For the purposes of the research project, we will share your personal data with the BiCOPS team at the University of Birmingham (Birmingham Centre for Observational and Prospective Studies) and the COVIDSurg-Cancer HEAD & NECK Follow-Up study management group, and other collaborators of the COVIDSurg-Cancer HEAD & NECK Follow-Up study. The administrators of the Global Surgery REDCap instance will also have access to your personal data, some may not be employed by the University. In addition, your REDCap user name will be visible to other users allocated to the same project as you.

Your login information will be removed from the database when the project you are allocated to is deleted. Information collected as part of a survey will be kept for as long as it is useful for that project.

This privacy notice is effective from 11-March-2021 and is reviewed when necessary. Any changes will be published here.