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

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

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)

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

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

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

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

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

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 ?

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

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)

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)

Results (provisional)

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%

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

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

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.

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

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

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

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)

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

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.

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

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).

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).

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

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

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

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

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

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