1. National Diabetes Foot Care Audit (NDFA) 2015 – what we know so far
NDFA is part of the National Diabetes Audit programme family
William Jeffcoate
National Clinical Lead of the National Diabetes Foot Care Audit

2. National Diabetes Foot Care Audit (NDFA) 2015 – what we know so far
NDFA is part of the National Diabetes Audit programme family
William Jeffcoate
National Clinical Lead of the National Diabetes Foot Care Audit
with hundreds of other people

3. Contributors NDFA Advisory Group
William Jeffcoate Consultant Diabetologist, Nottingham University Hospitals NHS Trust
Bob Young Consultant Diabetologist and Specialist Clinical Lead, NDA
Roger Gadsby GP Clinical Lead, NDA
Emma Barron Head of Health Intelligence, National Cardiovascular Intelligence Network (NCVIN), PHE
Sue Brown Patient representative
Sophie Colling NDA Project Support Officer, Diabetes UK
Anna Duggan Audit Coordinator, Health and Social Care Information Centre (HSCIC)
Laura Fargher NDA Engagement Manager, Diabetes UK
Catherine Gooday Podiatrist, FDUK
Michelle Goodeve Diabetes Lead Podiatrist, Broomfield Hospital, Chelmsford
Alex Harrington Podiatrist, Gloucester Care Services NHS Trust
Naomi Holman Head of Health Intelligence, National Cardiovascular Intelligence Network (NCVIN), PHE
Roy Johnson Patient representative
Tom Latham NDFA Clinical Audit Manager, Health and Social Care Information Centre (HSCIC)
Ian Loftus Consultant Vascular Surgeon, St George’s/Chair National Vascular Registry
Claire Meace, Higher Information Analyst, Health and Social Care Information Centre
Gerry Rayman Consultant Diabetologist, Ipswich Hospital NHS Trust
David Roberts, Patient Representative
Hana Rous Patient Representative
Rhys Thomas Consultant Orthopaedic Surgeon, University Hospital Llandough
Arthur Yelland Senior Information Analyst, Health and Social Care Information Centre (HSCIC)

4. Aims of the NDFA
Ongoing audit of people with DFUs in England and Wales (estimated total 60,000 pa)
To document variation in case-mix adjusted outcomes between commissioners (CCGs/LHBs); service providers (Trusts/LHBs); foot care services
To find links between variation in outcome and variation in practice
To provide evidence to justify existing guidance which is currently based largely on expert opinion
Ultimately, to improve clinical outcome

5. Aims of the NDFA
Ongoing audit of people with DFUs in England and Wales (estimated total 60,000 pa)
To document variation in case-mix adjusted outcomes between commissioners (CCGs/LHBs); service providers (Trusts/LHBs); foot care services
To find links between variation in outcome and variation in practice
To provide evidence to justify existing guidance which is currently based largely on expert opinion
Ultimately, to improve clinical outcome

6. Aims of the NDFA
Ongoing audit of people with DFUs in England and Wales (estimated total 60,000 pa)
To document variation in case-mix adjusted outcomes between commissioners (CCGs/LHBs); service providers (Trusts/LHBs); foot care services
To find links between variation in outcome and variation in practice
To provide evidence to justify existing guidance which is currently based largely on expert opinion
Ultimately, to improve clinical outcome

7. Aims of the NDFA
Ongoing audit of people with DFUs in England and Wales (estimated total 60,000 pa)
To document variation in case-mix adjusted outcomes between commissioners (CCGs/LHBs); service providers (Trusts/LHBs); foot care services
To find links between variation in outcome and variation in practice
To provide evidence to justify existing guidance which is currently based largely on expert opinion
Ultimately, to improve clinical outcome

8. Aims of the NDFA
Ongoing audit of people with DFUs in England and Wales (estimated total 60,000 pa)
To document variation in case-mix adjusted outcomes between commissioners (CCGs/LHBs); service providers (Trusts/LHBs); foot care services
To find links between variation in outcome and variation in practice
To provide evidence to justify existing guidance which is currently based largely on expert opinion
Ultimately, to improve clinical outcome

9. STRUCTURE
Questionnaire sent annually to commissioners and service providers
Is there a training programme to ensure all HCPs are competent to undertake annual foot checks ?
Is there a pathway for referral of all people at increased risk to a designated FPS ?
Is there a pathway for all new/deteriorating foot disease to allow referral for expert assessment within 24 hours, if needed ?

10. Data from newly presenting cases (1)
Case details: i. NHS number (to link to NDA, HES and ONS) ii. Ulcer description

11. SINBAD Ulcer features and severity score at presentation
Site - ulcer penetration of the hind-foot 0/1
Ischaemia - impaired circulation 0/1
Neuropathy - loss of protective sensation 0/1
Bacterial infection - clinical signs of infection 0/1
Area – ulcer area greater than 1cm 2 0/1
Depth - ulcer reaches tendon or bone 0/1
Total score: 0-6
Score of 3 or more significantly associated with prolonged time to healing (Ince P et al Diabetes Care 2008)

12. Data from newly presenting cases (2)
Case details:
i. NHS number (to link to NDA, HES and ONS)
ii. Ulcer description (SINBAD features and score)
Process:
Time elapsed from first presentation to a HCP to first expert assessment: 2 days, 2 weeks, 2 months....
Outcomes:
Alive and ulcer-free at 12 weeks
(Alive and ulcer-free at 24 weeks)
(Survival, hospital bed days, major/minor amputations)

13. Results (provisional)

14. Structure of footcare services
Response to NDFA Structures Audit questionnaire
received from only 60 per cent of commissioners
(CCGs in England and LHBs in Wales)
Only 62% of those responding were able to give a
definitive answer to all three questions
Foot care service
Yes No
Don't know
Conflicting response
Not recorded
Training for routine diabetic foot examinations
57%
19%
20% 4% 0%
Foot protection service
77%
10% 6% 3%
Pathway for assessment within 24 hrs
54%
25% 9% 2%
11%

15. Newly presenting cases – people (1)
5,215 episodes in 5,015 people in 9 months
3% associated with active or possibly active Charcot
90% of people linked to NDA database

16. Newly presenting cases – people (1)
5,215 episodes in 5,015 people in 9 months
3% associated with active or possibly active Charcot
90% of people linked to NDA database
NDFA patient profile similar to NDA except:
Gender (male: 70% vs 56%)
Age (67 years vs 64)
Ethnicity in Type 2 diabetes:
White ethnic group: 69% NDFA vs 61% NDA;
Asian ethnic group: 3% NDFA vs 10% NDA

17. Participation by networks
Country / Network^
Trusts/
LHBs
Services
Ulcers
Cheshire and Merseyside 3
169
East Midlands 8
562
East of England 11 15
486
Greater Manchester, Lancashire and South Cumbria 9
573
London 10 12
439
Northern England
464
South East Coast
317
South West
700
Thames Valley 2 77
Wessex
118
West Midlands 7
342
Yorkshire and the Humber 14
638
England 90
112
4,885
Wales 17
330
England and Wales 97
129
5,215
^ Service providers and associated foot-care services in England are mapped to Strategic Clinical Networks (SCNs) using the service provider’s postcode.

18. Newly presenting cases – ulcers (1)
Time elapsed from first presentation to first expert assessment

19. Newly presenting cases – ulcers (2)
Distribution of SINBAD scores

20. Outcome – ulcers (3) Being alive and ulcer-free at 12 weeks
12 week outcome
All diabetes (N=5,215)
No foot ulcer
2,302
49%
Foot ulcer present
2,373
51%
Deceased
119
Unknown outcome
421

21. Analysis of aggregated ulcer data
Descriptive
ii. Associations between structures of care and
(a) ulcer type/severity and (b) clinical outcome
No statistically significant associations yet identified.
(missing data;
returns made by FPS/MDFS members
ie a source of a possibly selected population)

22. Analysis of aggregated ulcer data
Descriptive
ii. Associations between structures of care and
(a) ulcer type/severity and (b) clinical outcome
Associations between time to first assessment and

23. Analysis of aggregated ulcer data
Time to presentation and ulcer severity^
^ Less severe ulcers have a SINBAD score <3. Severe ulcers have a SINBAD score >=3.

24. Analysis of aggregated ulcer data
Ulcer severity and being alive and ulcer-free at 12 weeks^
^ Severe ulcers have a SINBAD score >=3.

25. Analysis of aggregated ulcer data
Time to presentation and being alive and ulcer-free at 12 weeks^
^ Where the percentages to the right of the bar are red-bolded, the difference between the interval group and the comparison group (<= 2 days) is statistically significant (p <0.05).

26. Analysis of adjusted aggregated outcomes
Need for case-mix adjustment
Logistic regression used to investigate associations between the audit variables and 12 week healing outcomes.
Provisional results suggest that sex, smoking status, Charcot foot disease, the SINBAD components and time to assessment have a significant association with 12 week healing outcomes.
However the quality of the model was insufficient to apply to the data submitted for the first NDFA publication (c-statistic of 0.69).

27. Analysis of aggregated ulcer data (5)
Apparent geographical variation in outcome
By network/country – less severe ulcers^
^ Less severe ulcers have a SINBAD score <3

28. Analysis of aggregated ulcer data (6)
By network/country – severe ulcers^
^ Severe ulcers have a SINBAD score >=3

29. Potential limitations
Outcome data incomplete
Reliability of data not yet assessed
Inherent weakness of audit in relation to assumptions of causation
Selection of centres (including by administrative barriers: approval, consent)
Selection of cases (including software problems e.g. repeat registrations, 24 week follow-ups)
Missing data: selected population

30. The next stage Year 1 Individual centre feedback Full outcome measures
Continue
Procedures for consent?
Forum for (clinical) user feedback
Revision of questions asked

31. Summary
Unique spectrum of clinical outcome of diabetic foot ulcers in England and Wales
5,215 episodes in 5,015 people in 9 months
Incomplete adoption of guidance: valuable for assessing the guidance itself
Ulcer onset linked to age, gender and ethnic group
Outcome at 12 weeks: approximately 50% ulcer free
Significant associations between
time to assessment and ulcer severity
ulcer severity and 12 week outcome (being ulcer-free)
time to assessment and 12 week outcome
Apparent geographical variation remains to be confirmed

32. National Diabetes Foot Care Audit (NDFA) 2015 – what we know so far
NDFA is part of the National Diabetes Audit programme family
William Jeffcoate
National Clinical Lead of the National Diabetes Foot Care Audit
A fantastic shared achievement