West of Ireland Diabetes Foot Study: Epidemiology, Cost, Feasibility and Implications for Clinical Practice and Policy

1. West of Ireland Diabetes Foot Study:Epidemiology, Cost, Feasibility and Implications for Clinical Practice and Policy Dr Sean Dinneen, Principal Investigator Laura Kelly, Research Podiatrist Lorna Hurley, Project Manager

2. Introduction • 15% of people with diabetes develop foot ulceration • Risk factors: • diabetic neuropathy • structural foot deformity • peripheral arterial disease • Complications: infection, osteomyelitis, gangrene • 5% to 15% with diabetic foot ulcers require amputation • Lack of research on the diabetes foot in Ireland • In-patient expenditure for diabetic foot ulceration = €23,500 per patient (Smith et al, 2005)

3. Multidisciplinary Team Management of Diabetes Foot Ulcers General Practitioner & Practice Nurse Diabetes Specialist Team (Medical & Nursing) Public Health Nurses Foot Ulcer Management Hospital Podiatrist Orthopaedic Specialists Community Podiatrists Vascular Specialists Plaster technicians Physiotherapists Orthotists

4. Many foot related complications can be prevented International Guidelines recommend annual screening for diabetes foot complications 1998 study in WHB: great variation in the frequency of foot checks by GP’s HSE: greater emphasis on Primary Care Management of chronic diseases Need for clear guidance and training for health professionals involved in diabetes care

5. Background: Pilot Study • Pilot Study carried out in 2006 • Patients recruited from one city-practice • 30 patients attended for screening (44%) • Neurological Assessment • NDS (Vibration, Temperature, Blunt/sharp sensation, Ankle Jerk) • 10g monofilament • Vascular Assessment • Palpation of Pedal Pulses • ABPI

6. Results of Pilot Study

7. (Edmonds & Foster 2006)4 Figure 1: Monofilament testing Figure 2: ABPI testing

8. Pilot Study Conclusions • A significant number of patients have abnormalities detectable on a simple panel of foot screening tests • These tests are relatively easy to perform • A standardised panel of Foot Screening Tests could easily incorporated into the patients annual review visit in General Practice • A larger study is required to establish the true prevalence of diabetes foot complications

9. Diabetes Foot Study Research Team • Dr Sean Dinneen, Principal Investigator • Laura Kelly, Research Podiatrist • Lorna Hurley, Project Manager • Dr Liam Glynn, GP • Dr Caroline McIntosh, Head of Podiatry, NUIG • Paddy Gillespie, Health Economist, NUIG • Trish Godwin, Chiropody Manager, Galway PCCC • John Newell, Statistician, NUIG • Dr Adam Garrow, University of Salford

10. The West of Ireland Diabetes Foot Study: Epidemiology, Cost, Feasibility and Implications for Clinical Practice and Policy

11. Aims To establish a set of easy to use measures for screening for diabetes foot complications To apply these measures to a large sample of patients attending local general practices To recruit medical and nursing staff from these practices to become skilled in performing diabetes foot examinations To establish the prevalence of diabetes foot complications in this population To determine the incidence and predictors of new diabetic foot events at 18 months  

12. Aims (continued) • To determine the impact of foot complications on Health Status, Quality of Life, Anxiety & Depression • In all patients developing new foot ulcers: • Establish the degree to which these patients used the health service for the duration of their foot care episode • Establish the cost of each foot care episode to the patient and to the health service

13. Study Design • Design: • Longitudinal observational study • Main Study: Foot Screening Study (est. n=560) • baseline screening visit • 18 month follow-up • Sub-study: Foot Ulcer Cost Analysis • Prospective gathering of cost data

15. Recruitment Practice Recruitment • Recruitment of General Practices (Nov‘08–Apr ‘09) • Letters of ‘Invitation to participate’ sent • Practice meetings & presentations • Training of Practice Nurses Patient Recruitment • Joint review of diabetes register and inclusion/exclusion criteria • Invitation letters to patients • Practice-based clinics performed by the Practice Nurse and Research Podiatrist

16. Overview of Screening Study Baseline Visit • Consent • Questionnaires • Foot Screening • Vascular Assessment • Neurological Assessment • Plantar Pressure Assessment • Foot Wound Alert Card 6 month & 12 months • Wound Alert reminder letters Follow-up visit (18 months) • Questionnaires • Foot Screening Tests (as above)

17. Screening Study: Issues Arising • Choice of Questionnaires • Generic (SF-12 v EUroQoL) • Disease Specific (ADDQoL v WB-Q28) • Choice of Vascular Assessment • Pulse palpation ± Doppler Waveform ± ABPI / Toe Pressure • Training / skill issue • Assessing Deformity • Observational tests - too subjective

18. Plantar Pressure Assessment PressureStat®

19. Overview of Cost Analysis Sub-Study • Podiatric review of all foot wounds (& photo) • Foot Ulcer Grading (Texas Classification System) • NeuroQol questionnaire • Support from Health Economists • Patient Resource Items • Health Economic Questionnaire • Healthcare Resource Items: • Hand-held log of all health service contact • Review of all medical notes

20. Cost Analysis: Issues Arising • Small numbers: estimated 2% incidence • Potential for missing some ulcers due to: • Failure of patients to report • Failure of health professionals to report • Uncertainty as to the diagnosis of an ulcer e.g. “ when does a wound become an ulcer?” • Potential for missing some health service contact when calculating the Health Service Resource Cost • Unit-Cost Data is not readily available for some outpatient visits

21. Progress to date • REC Approval from ICGP and GUH • Awaiting approval of some amendments • 8 practices recruited so far • Training day held in September for PN’s • Approximately 5 clinics booked (Nov-Dec)

22. Thank You! Questions?