National Diabetes Foot Care Audit (NDFA) of England and Wales: 2014-

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National Diabetes Foot Care Audit (NDFA) of England and Wales: 2014- NDFA is part of the National Diabetes Audit programme family William Jeffcoate Clinical Lead of the National Diabetes Foot Care Audit on behalf of many other people 1

Aims of National Diabetes Footcare Audit Ongoing audit of (all) DFUs in England and Wales To monitor geographical variation in outcomes To find links between variation in outcome and variation in practice across the whole care pathway To provide evidence to justify existing guidance (which is currently based largely on expert opinion) Ultimately, to reduce geographical variation and improve clinical outcome

Parent National Diabetes Audit 2004- Monthly download from databases of participating GPs of all people with diabetes in E&W ~ 80% Demographics, diabetes type, management, complications Burden of baseline NDFA data collection reduced linkage to core data through unique NHS number NHS number also used to link to Hospital Episode Statistics and Office of National Statistics

Parent National Diabetes Audit 2004- Monthly download from databases of participating GPs of all people with diabetes in E&W ~ 80% Demographics, diabetes type, management, complications Burden of baseline NDFA data collection reduced linkage to core data through unique NHS number NHS number also used to link to Hospital Episode Statistics and Office of National Statistics The National Diabetes Footcare Audit includes only a very small number of questions.

NATIONAL DIABETES FOOTCARE AUDIT Structure of care services Process of care: data from specialist carers on individual cases of newly presenting ulcers Outcome of care (i) (ii) clinical: healing/being healed hospital activity: admissions, amputations

STRUCTURE AUDIT Questionnaire sent annually to commissioners and service administrators i. Is there a training programme to ensure all HCPs are competent to undertake annual foot checks? ii. iii. 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?

NEW ULCERS: BASELINE All new referrals to specialist (those assuming care) teams: i. Consent ii. NHS number

NEW ULCERS: BASELINE All new referrals to specialist (those assuming care) teams: i. Consent ii. NHS number iii. Ulcer status: SINBAD description and score (a single index ulcer is selected for each episode)

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)

NEW ULCERS: PROCESS All new referral to specialist (those assuming care) teams i ii. Process: NHS number Ulcer description (SINBAD features and score) iii. Time elapsed from first presentation to a HCP to first expert assessment: 2 days 2 days to 2 weeks 2 weeks to 2 months > 2 months

NEW ULCERS: OUTCOMES All new referral to specialist (those assuming care) teams i ii. Process: NHS number Ulcer description (SINBAD features and score) iii. Time elapsed from first presentation to a HCP to first expert assessment: 2 days, 2 weeks, 2 months... Outcomes: i. Alive and ulcer-free at 12 weeks Yes/No ii. (Alive and ulcer-free at 24 weeks) Yes/No iii. (Survival, hospital bed days, major/minor amputations)

Results (provisional)

Newly presenting cases - people 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 Expected demographics: older more males lower prevalence of ethnic minorities

% of patients Newly presenting cases ulcers Distribution of SINBAD scores 30.0 25.0 20.0 15.0 10.0 5.0 0.0 0 1 2 3 4 5 6 n 236 1139 1429 1210 817 326 58 (%) 4.5 21.8 27.4 23.2 15.7 6.3 1.1

Process time to presentation Time elapsed from first presentation to a HCP to first expert assessment Self presenting 29.1 <= 2 days 14.4 3-13 days 28.7 14 days - 2 months 20.1 > 2 months 7.7 0 5 10 15 20 25 30 35 Percentage of ulcers

Time to presentation and severity ii. Time to presentation and ulcer severity^ Self presenting 66.1 33.9 <= 2 days 50.7 49.3 3-13 days 14 days - 2 months > 2 months 40.3 51.0 47.3 59.7 49.0 52.7 0 20 40 60 80 100 SINBAD < 3 SINBAD >= 3 SINBAD Score prevalence of patients within interval group (%) ^ Less severe ulcers have a SINBAD score <3. Severe ulcers have a SINBAD score >=3.

Outcome being alive and ulcer-free Ulcer severity and being alive and ulcer-free at 12 weeks^ % ulcer free at 12 weeks 0.0 20.0 40.0 60.0 80.0 Severe ulcer? 36.0 60.3 No Yes ^ Severe ulcers have a SINBAD score >=3.

Outcome being alive and ulcer-free Time to presentation and being alive and ulcerfree at 12 weeks^ Ulcer free cases at 12 weeks (%) 0.0 10.0 20.0 30.0 40.0 50.0 60.0 Self presenting 56.3 <= 2 days 3-13 days 49.3 50.0 14 days - 2 months 43.2 > 2 months 34.3 ^ 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).

Cheshire and Merseyside East Midlands Wessex Thames Valley London Wales East of England South East Coast Northern England Greater Manchester, Lancs and S. Cumbria Yorkshire and the Humber West Midlands South West % ulcer free at 12 weeks 2 8 2 2 9 7 11 11 8 9 9 7 9 Apparent regional variation (2) By network/country severe ulcers^ 70.0 60.0 England and Wales 50.0 40.0 30.0 20.0 10.0 0.0 ^ Severe ulcers have a SINBAD score >=3

Summary of initial findings Unique insight into clinical outcome of diabetic foot ulcers in NHS care in England and Wales 5,215 episodes in 5,015 people in 9 months 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 Accepted Limitations but undeniable Possibilities

Aims of National Diabetes Footcare Audit Ongoing audit will reduce geographical variation and improve outcome overall

Limitations Complete outcome data awaitedselection of centres (interest, managerial encouragement versus administrative barriers approval, consent, time) Selection of cases (pressure of time, capacity, language) Current very limited of involvement of some services: orthopaedic, vascular Inherent weakness of audit in differentiating between association and causation Lack of case-mix adjustment: crude data reflect the whole pathway; case-mix adjusted reflect specialist care.

Possibilities An ever-increasing dataset from a UK population Comparison of amputation data (HES) between registered and non-registered cases Definition of details of the structure and process of care significantly linked to outcome Use of case-mix adjusted data to compare performance of specialist teams Evidence-based refinement of clinical guidance Ultimately, elimination of variation and improvement in overall outcome in UK Potential for extrapolation to other populations

National Diabetes Foot Care Audit (NDFA) of England and Wales: 2014- NDFA is part of the National Diabetes Audit programme family William Jeffcoate National Clinical Lead of the National Diabetes Foot Care Audit 24