Dear BOTA member,
The British Orthopaedic Trainees Association would like to invite you to participate in the BOTA National Summer Audit Project 2017, the WAX study.
Building on the success of the Lost Tribe Audit and the POTS Study, we wish to create a model which is used to help answer clinically important questions that will directly link with future funded research.
This study aims to address a “Recommendation for Research” from NICE. It will evaluate the variation in weight bearing practice in acute adult malleolar ankle fractures and establish a precedent for a multi-centre randomised control trial in the near future, which we hope you will also be involved in. We’ve signed up 53 collaborators so far, and we are interested in involving you as a collaborator. We encourage a Medstudent, FY1, FY2, CT1 or CT2 – to work with an SpR/ staff grade to collect the data.
You may be aware that the project “Enhanced Recovery After Lower Limb Arthroplasty (ERALLA)” has been accepted for publication in the Annals of Surgery RCSEng with all authors listed under a collaboration – we will be aiming to do the same with WAX.
In addition, the WAX study will form part of an NIHR grant application for an RCT in 2018 led by the University of Oxford. If successful, the team at Oxford hopes to recruit BOTA Trainees to be “secondary investigators” in a new model for running multicentre RCT’s.
The audit will be a snapshot of all acute malleolar ankle fractures first presenting to orthopaedic services between 8am Monday 3rd July to 8am Monday 17th July 2017.
This study will audit weight bearing advice against the BOAST 12 guidelines.
All Skeletally mature acute malleolar ankle fractures between these dates will be included. Information on the patient’s age, gender, injury, operation, date/time of injury and surgery, weight bearing status and form of immobilisation will be recorded.
We are trying to get collaborators in as many hospitals across the UK as possible, there is no limit as to the number of collaborators in each hospital. All collaborators that sign up will receive a ‘toolkit’ via email which explains the process of the study in more detail. As a collaborator for your hospital you are expected to register the audit with you local audit department and record details for all acute adult malleolar ankle fractures presenting to your department within the study period. All collaborators who have submitted data will receive joint first authorship on any subsequent presentations and publications.
We hope you will join us in making this collaborative research project a great success. To register as a collaborator via the 1 minute signup form click here: https://goo.gl/forms/T04JVhmydkyM4mtV2
The BOTA Committee
The Rules of Engagement
- Each collaborator who submits data will be named as co-first author on any publications produced from the data collected.
- More than one collaborator from a given hospital can submit data. It is preferable to work together with a colleague who is also signed up from your trust to avoid duplication.
- Collaborators who fail to submit data by 20.08.17 will not be deemed as having successfully participated in the project and will not be included as an author. In essence, if you submit a completed data collection spreadsheet (sent to [email protected]), then you are recognised as a collaborator. If there are any problems with your data collection of any kind, please email [email protected] so that we can help you resolve any problems. The intention is to have everyone included in this wide reaching trainee-organised national audit.
- All collaborators are asked to register the WAX study with their local audit department after completing local audit registration forms and identifying a consultant to supervise the project.
- All collaborators will be sent detailed information from the analysis of the data collected (locally, regionally, and nationally) so that they may be able to present it to their local trust if they wish (this is encouraged).
- To establish current practice for weight-bearing in acute adult malleolar ankle fractures treated surgically in the UK.
- To establish current practice for weight-bearing in acute stable adult malleolar ankle fractures treated non-surgically in the UK.
Standards: BOAST guidelines set a standard for audit of weight bearing in ankle fractures.
Collaborators in each participating trust will collect data prospectively using a locked, coded Excel spreadsheet. No patient identifiable data will be gathered. The recruitment data collection period is between 08.00am Monday 3rd July to 08.00am Monday 17th July. All Skeletally mature acute malleolar ankle fractures between these dates will be included. Information on the patient’s age, gender, injury, operation, date/time of injury and surgery, weight bearing status and form of immobilisation will be recorded.
For aim 1: % compliance with point 13 will be calculated for each hospital and hospital-by-hospital variation will be calculated for fracture classification and method of fixation, type of immobilisation and duration restricted-weight bearing. Subgroup analysis for open fractures, severe soft tissue compromise and severely comminuted or osteoporotic fractures. Fractures requiring syndesmotic screws will be excluded. No statistical analysis is planned.
For aim 2, % compliance to the points 8 and 9 will be calculated for each hospital. Hospital-by-hospital variation will be calculated for fracture classification, type of immobilisation and duration restricted-weight bearing. Where stability is uncertain at initial presentation, variations for determining stability will be calculated, including if weight bearing XR’s are used and if this is in or out of plaster. All collaborators will be expected to ensure the trust data is presented at a local departmental audit meeting.
Step by Step method for collaborators:
- Register for the Audit by signing up via this Google link https://goo.gl/forms/T04JVhmydkyM4mtV2
or registering interest on the BONE Website
- Provide details to the following questions if known:
-Send any guidelines/ protocols for management of ankle fractures
-Send any rehab protocols/ leaflets
- Identify local consultant lead and register the audit with local audit department – example form attached.
- For a 2-week period from July 3rd – July 17th identify all malleolar ankle fractures presenting to your trust orthopaedic services. Recommendations for this include:
- Fracture clinic (or virtual fracture clinic) – asking clinicians at end of each clinic. Screening all XR’s from fracture clinic list to identify ankle fractures
- On-call patient admissions list
- Theatre lists
- Plaster Room
- Prospectively Collect data using spreadsheet provided, recommended sources of information:
- A) Electronic Clinic letters
- PACS/ Radiology systems
- Operation notes
- Discussion with treating clinician
- Data collection ends once unrestricted weight bearing (with or without a splint) is permitted by the treating clinician (or a date is indicated in advance).
- Data spreadsheet to be emailed to [email protected] by 20th August 2017. This allows time for follow-up patients where stability was uncertain at initial presentation (anticipated that stability should be confirmed with repeat XR within 2 weeks)
Method of Fracture Classification.: AO Classification
This allows classification by XR findings alone
We would like you to include all fractures, but we do not need you to follow up unstable ankle fractures (AO A2,A3, B2, B3 or C) that were treated conservatively.
Data collection points:
1) Date of 1st clinic/ Presentation to orthopaedics
This means when they appear on an orthopaedic admissions list, fracture clinic or theatre list and indicates assessment by an orthopaedic surgeon. We are not assessing the weight-bearing practise of A&E. However, if your hospital has a documented ortho-A&E protocol which bypasses stable ankle fractures from fracture clinic – discuss this with us [email protected] and we’ll advise.
2) Documented comorbidities
Answer yes if documented, you do not need to chase these. If the surgeon is unaware of the comorbidity, it is unlikely to influence their weight-bearing decision.
3) Documented Mobility Concerns
These might include if they were not independently mobile pre-fracture or they have other/ concomitant injuries that the treating clinician indicated might prevent them being able to mobilise non-weight bearing etc.
Independently mobile = “Were able to walk independently out of doors with no more than the use of a stick”
4) Date of Definitive fixation
If a temporising Ex-fix is used, do not use this. Use the date of definitive fixation.
5) Type of Definitive fixation
Any fixation including syndesmosis screws – we do not need you to follow these patients up – just fill in the spreadsheet based on the op note. These will likely be excluded from analysis.
Exfix – only if used for definitive fixation
Standard ORIF – any combination of plates, screws, tension band wires not included in the other options.
6) Date of Unrestricted weight-bearing
The term “unrestricted” helps to reduce ambiguity and create binary categories.
As a guide: “restricted” weight-bearing = Non-weight-bearing, partial weight-bearing, toe-touch weight bearing (with or without a splint/ boot/ plaster)
“unrestricted” = Full weight-bearing, weight-bear as tolerated, weight bearing as required to survive (WARTS) (with or without a splint/ boot/ plaster)
7) Op note
Only answer yes if stability/ comminution or soft tissue concerns are specifically documented.
For Conservatively managed fractures – points as above plus:
8) Xr within 2 weeks?
Did they come back to clinic within 2 weeks for another XR? Was this a weight-bearing XR and were they in a cast/ boot or not?
9) Required Surgery later?
This is only if they changed to the operative pathway after the <2 week clinic review. If so highlight this when filling the operative spreadsheet so we don’t overestimate the total number of ankle fractures.
10) Please do not try to alter the fixed data entry categories – any different options or slight difference in spelling or spacing will render the data useless/ prevent analysis. Select the best-fit option possible – add short notes in the comments cell if required.
Who can be involved?
Anyone (including non-BOTA members and medical students) can be the named collaborator for a hospital and submit the data for that unit.
Why Should I do this Audit?
Because you get to be an equal first author of a large multicentre trainee led audit addressing a “Recommendation for Research” from NICE. It is also an easy way to tick off a requirement for ARCP. This data will be used to highlight current practice and directly inform a randomised control trial. You will be invited to participate in the randomised control trial if BONE lead the delivery.
How do I become a named collaborator for my hospital?
By registering your interest on https://goo.gl/forms/T04JVhmydkyM4mtV2
You will receive an email with the toolkit, download the spreadsheet and collect data within the study time period (08:00 03/7/2016 – 08:00 17/07/2016), and submit data spreadsheet by 20th August 2017 23:59.
How many people can be involved from one hospital?
There is no limit on how many people can be involved from each hospital. It is recommended that collaborators from the same trust work together to avoid unnecessary duplication of work.
Do I need permission from my hospital?
Yes, you will need to register the audit with your hospital’s audit department and ask one of your consultants to be the supervising consultant for the project. It is advisable to download your local trust audit registration form and populate it using information available in the toolkit.
When is data collection happening?
Data collection will happen for patients presenting to fracture clinic or admitted to hospital between 08:00 Monday 3rd July – 08:00 Monday 17th July. Most Data will be collected during this period. Where patients are asked to come back for further review to determine stability, data may need to be collected after this period (likely maximum 2 weeks after 17th of July).
What are we collecting data on?
We are collecting data on all adult acute malleolar ankle fractures presenting to orthopaedics services between 08:00 3rd July and 08:00 17th July in the NHS. Patients under 16 years of age or who are skeletally immature are excluded. Further information is available in the toolkit.
What happens if your hospital is purely for Paediatric or elective Orthopaedics?
If your hospital does not treat acute adult ankle fractures, then you can still sign up and try to liaise with a colleague/ friend to collect data at a neighbouring hospital.
How Do I collect Data?
The data collection spreadsheet is very simple to complete. Start by completing your details including which hospital you are collecting data for, and who are your co-collaborators (inc their email addresses). Do not record ANY patient identifiable data into the spreadsheet. Please complete each column for each patient and avoid leaving gaps in the data. Some cells are coded and will only allow you to submit data in a particular format (e.g. Date as DD/MM/YYYY). Most of the data can be collected from the operation notes and from PACS but please make sure that you have not missed any acute malleolar ankle fractures. Data should be collected prospectively and spreadsheets should be emailed to [email protected] AFTER the data collection period has finished (08:00 on 17th July 2016) but before 20th August 2016 at 23:59.
Can I use Operation notes and/ or electronic clinic letters?
Absolutely. This audit is designed to avoid having to chase patient notes. It is best to collect the data each day as you go along. Most of the information can be collected from the operation notes and from PACS. Any missing data may need to be collected from the electronic patient record/patient case notes.
What if my trust has more than one site?
Complete a data collection spreadsheet for each hospital site and email them to [email protected]. Make sure you put your FirstNameSurnameHospital.xls in the filename.
How do I record data?
Data should be recorded on the WAX Audit spreadsheet (found in the toolkit). This should be submitted by emailing the completed spreadsheet to [email protected] no later than 20th August 2017 23:59
What Classification system will be used?
This allows classification by XR findings alone. We would like you to include all fractures, but we do not need you to follow up unstable ankle fractures (AO A2,A3, B2, B3 or C) that were treated conservatively.
I’m a student/ FY/ CT1-2 and don’t feel confident interpreting Ankle XR’s – can I still participate? Absolutely – We really want enthusiastic juniors involved so you will be able to participate in future research/ recruit for the RCT on behalf of BONE later in your training. If you can’t find a senior to help you, email us [email protected] and we will either help you find a collaborator locally or remotely help you with Interpretation.
Do you really want all malleolar fractures? What about Osteoporotic patients and Open fractures? What about Syndesmotic screws and unstable fractures treated conservatively?
Yes we want data on all malleolar fractures in skeletally mature patients. We will do subgroup analysis on atypical/ open fractures/ osteoporotic patients. We will likely exclude syndesmotic screws and unstable fractures treated conservatively but will want to report this in the paper. We will not want the same amount of data for these patients, this will be explained in the toolkit.
What if I am missing some data or patients have no electronic letters available before 20.08.17?
Please aim to obtain the missing data from the individuals before submitting the data for the whole department. If there is a delay in typing the letter, it may be easier to track down the one or two sets of notes that are missing or speak directly to the treating clinician for clarification rather than waiting for the letters to be typed. If the treating clinician has requested a review of >4 weeks to determine stability or decide on weight bearing, please contact us @ [email protected].
What happens if I sign up but don’t submit data?
You will not be recognised as an author or WAX collaborator. If there are any difficulties hindering your ability to submit data, please contact [email protected] and we will help you.
What if I sign up to the Audit and check the fracture clinic and admissions list but there are no ankle fractures in the 2-week period?
We stress that you should enter data for all adult malleolar ankle fractures, even if they fit the exclusion criteria above. If there are still no fractures, we will include you as a collaborator but will ask you to send us acknowledgement of your audit registration form and may ask you to send a report from clinical coding for the time period involved to ensure none have been missed.
How do I get involved in the write-up?
We will advertise for collaborators to get involved in the write-up phase of the project after all the data has been collected and analysed. We welcome anyone who is interested to be involved in all aspects of this project. The idea is that it is equally owned by all collaborators. Everyone involved will have the data and slides sent to them so that they can present it locally after completion of the audit.
How does authorship work?
All publications from this work will name collaborators as equal first authors under the title “BONE collaborators” regardless of any individual’s extra input designing or write up the project.
What if I move hospital before the data collection is complete
We realize this could happen if there is >2 weeks delay until the final decision for weight-bearing is made. There were many factors and compromises that led to this date range being selected. Hopefully one of your team will still be around to collect the data, if not we encourage you to liaise with an incoming junior doctor. If you are struggling to identify someone, let us know and we’ll see if we can help from our database of other collaborators.
All resources to help you do this audit are found below. The registration form is pre-filled with all the salient information and the only edits you’ll need to make are those specifically relating to yourself and your hospital.
Collaborators will be personally emailed a spreadsheet in which to collect data with instructions on how to submit prior to the data collection window.
A map of all collaborating hospitals can be found below.