What is the rationale for undertaking this audit?

The COVID-19 pandemic has led to worldwide repercussions in healthcare delivery, including that of cancer care. Management of patients confirmed to have breast cancer may involve an ‘altered’ treatment pathway. It is clear that there is much to learn from this, particularly with the anticipated de-escalation of adjuvant treatment and potential delay in surgery.

What is the principle aim of the audit?

To document and describe breast cancer management (surgery, neoadjuvant / adjuvant chemotherapy and radiotherapy) during the COVID-19 pandemic and compare this to current accepted (pre-COVID-19) practice.

What are the standards being measured by this clinical audit?

The aim of this audit is to document and describe the management of breast cancer that is ‘altered’ in view of the COVID-19 pandemic. This will be compared against standard accepted and published breast cancer management pathways and outcomes.

What is the source of standards?

Standard accepted and evidence-based breast cancer management pathways, as recommended by NICE, The Association of Breast Surgeons, and the published literature. 

How do you intend to collect data?

Identification of patients with ‘altered’ management (in view of COVID-19) will occur at the MDT meeting. Further non-identifiable data will be collected from the patient records. Data collection will occur in accordance with Caldicott II principles. Study data will be collected and managed using REDCap electronic data capture tools hosted at University of Manchester. Data for each patient will be pseudo-anonymised using a unique alphanumeric study identification number. A local secure record of the NHS number corresponding to the study identification number will be kept, but not uploaded – NO patient identifiable data will be uploaded for the purpose of the audit 

What do you expect the sample size to be?

The number of patients expected to be treated for cancer over a 3-month period.

Data ownership

Each breast unit will have the ownership of their local data. Each breast unit will be able to use their data for internal audit meetings and presentations, as well as for capacity planning in the post-COVID phase.

In participating in this audit, you give permission for the data to be used for combined (regional) output.

How will this data be analysed and disseminated?

All data analysis will occur centrally and will be led by the steering group.

The REDCap platform will allow each breast unit to see/download their own data at any given time. There will be a built-in functionality that gives each site an output for Section 2 in real-time, allowing each site to see a graph and list of patients in each ‘COVID-altered’ category.