UK Foot & Ankle COVID-19 National Audit (UK-FALCON)

 

About

The UK-FALCON Audit is being run by the BOFAS Outcomes and Scientific Committees.

As the UK comes out of the first wave of COVID-19, it is imperative we retrospectively review the relationship of COVID-19 with foot and ankle surgery. There is an urgent need to understand the incidence of perioperative symptomatic COVID-19 in patients who have undergone foot and ankle surgery to estimate the possible risk going forward and to plan interventions to limit this risk. Although most surgical interventions have been limited to trauma cases, a look at the UK wide experience will possibly provide us with a demographic similar to our usual patient group. This data will look to inform management and allow more realistic consenting in this turbulent time.

 

Primary Objective

To determine the percentage of patients receiving foot and ankle surgery in the UK, during the audit period, who were positive for COVID-19, and to audit their 30-day mortality rate.

 

Inclusion Criteria

All patients undergoing ANY foot and ankle surgery in an operating theatre (whether COVID-19 positive or not)

 

Study Period

Retrospective Portion (Initial Phase):

The retrospective portion will include patients operated between 13th January 2020 and 31st July 2020. Data entry for the retrospective portion of the study closes on 31st July 2020, but as patients need to be followed up for 30 days for COVID-19, data capture will be completed by 30th August 2020.

Prospective Portion (Second Phase):

The prospective portion will include patients operated between 1st September 2020 and 30th November 2020. This date may be altered if there is a second wave. This phase will capture data as units resume elective activity.

 

Registration

Registration for the Audit has now closed

 

Key Documents

UK-FALCON - Protocol

UK-FALCON - Data Entry Helpsheet

UK-FALCON - Data Entry Video Walkthrough

 

*Please make sure you are using version 2 of the data entry spreadsheet*

 

FAQ

1. What is the purpose of the ‘sub-processor’ specified in the data protection agreement?

This clause has been put in to allow completely anonymised data to be sent securely for statistical analysis to a team member outside Leicester Hospitals

 

2. If a patient is admitted twice (for separate procedures) how should they be treated? What about patients with multiple procedures?

In this case please include them as separate patients – i.e. with a different anonymised patient number. The anonymised number you submit to us must all be unique as they will be entered into a RedCAP database with that number as the unique identifier. All episodes will be analysed as separate patients as everything is anonymised.

We recognise some patients will have multiple procedures for different conditions. Any non-foot-and-ankle cases should not be included. If patients had surgery on multiple areas of the foot and ankle at the same sitting, then include these as one patient and record as one of the operation codes (for e.g. if they had metatarsal and calcaneal fractures, you may choose to record as calcaneal fracture as that is the more significant injury). If they had trips to theatre for multiple procedures treated at different times, then please record as separate patients and procedures. We anticipate that this will be only a minority of patients. Multiple returns to theatre for the same procedure (e.g. wound debridement) can be recorded as complications and in the comments section. 

 

3. We are a split site with some patients being carried out on a blue pathway and some in green pathways in a private hospital – should they all be included, and how?

In this case you can include all patients, classify yourself as a split site and mark each patient as being operated on in the relevant pathway. Please do not create separate spreadsheets as this will make data migration problematic. 

 

4. Is the deadline an absolute?

As we are looking at COVID rates up to to 30 days post op and the last date of inclusion is 31st July, you will not be able to give us a completed data set before the 1st September. We are hoping to get and collate data from 70 units and will need to process the data quite soon after this to have the data available for presentation in our 4th BOFAS COVID Webinar. This only works if we have a tight deadline window and can get all the units' data in within that time frame as we cannot analyse data over and over. We would be looking to close the data collection by the end of that week - hopefully most trusts can collect most of the data by the 30th august and use the last couple of days to chase up data on the last few patients. 

 

5. How can I find out which of my patients had COVID or symptoms of COVID?

Each trust should have recorded the COVID status for patients in relation to their hospital episode in this time. The business intelligence department or equivalent in your hospital keep log of activity and have Covid status as well. The other way to cross check would be to cross match patients unique identifier to the lab data. 

Unfortunately at this stage, we don’t have access to national data on COVID and are largely relying on local data from each trust. The aspect around 'patients with symptoms of COVID' was included to mirror the methodology of other studies. However, this will be of little relevance as all UK patients with symptoms of COVID should have been tested.

 

6. The datasheet is locked down, can we have an unlocked copy?

The datasheet has been specifically locked down to only allow entry of data in a consistent format accepted by RedCAP. If this was not done inevitably we would get data from some units which would break from the format and be unusable. We are hoping to get data from 40+ units and will not be able to validate data from each unit individually if the format is different. Ideally an audit of this scope would be run via a form by form entry - however we felt that an excel sheet was a more familiar format and easier to visualise during data entry. If you feel that you would like to add / hide columns etc as part of your workflow, we would suggest you create a separate document which you can work on and then convert the data to the format we require using the "Key" sheet and then copy it to our spreadsheet.

 

7. If some data is not available (e.g. operation time) can we leave it blank?

Whilst we would stress that all data should be completed where possible, we appreciate that some data may not be available in all cases. Providing the critical data is available (dates, demographics, COVID status, pathway, operation type, etc), data such as operation duration may be left blank if not available. 

 

Contacts

For any general queries please contact (please read FAQ above first):

Jo Millard  |  administrator@bofas.org.uk

 

To submit your completed datasheet please email:

uk.falcon@nhs.net

 

Joint Project Leads

Mr Jitendra Mangwani
University Hospitals of Leicester NHS Trust
BOFAS Scientific Committee & Outcomes Committee
 
Prof Lyndon Mason
Liverpool University Hospitals NHS Foundation Trust, University of Liverpool
BOFAS Outcomes Committee
 
Mr Karan Malhotra
Royal National Orthopaedic Hospital NHS Trust
BOFAS Outcomes Committee & IT Committee

 

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