Can the introduction of a 12-lead ECG help reduce mortality in those presenting with foot ulceration to multidisciplinary diabetic foot clinics? An observational evaluation of a real-world implementation pilot in England
Authors' conclusion
The evaluation confirms the high mortality seen in those presenting with diabetic foot ulceration. Overall mortality at the participating units was not significantly reduced at 2 or 5 years, with confidence intervals just crossing parity. Implementation of the 12-lead ECG into the routine care pathway proved challenging for clinical teams-overall a third of attendees had one, although some units delivered the intervention to over 60% of attendees-and the evaluation was therefore underpowered. Nonetheless, the signals of potential mortality benefit among those who had an ECG suggest that units in a position to operationalise implementation may wish to consider this.
Study context
- Population
- New attendees with diabetic foot ulceration recorded in the National Diabetes Footcare Audit (NDFA), England, July 2014–December 2017
- Exposure
- Care in pilot units introducing 12-lead ECG vs care in any other unit in England
- Pilot unitsn = 3,110
- ECGn = 1,015
- Other unitsn = 25,195reference
- Outcome
- Mortality RR following first assessment
- Follow-up
- 2 and 5 years
Methodological detailsmulticentre, Poisson regression adjusted for age, sex, ethnicity, deprivation, type and duration of DM, ulcer severity and prior-year morbidity, 33% of pilot-unit attendees received an ECG; some units >60%; evaluation underpowered
- Multicentre
- Poisson regression adjusted for age, sex, ethnicity, deprivation, type and duration of DM, ulcer severity and prior-year morbidity
- 33% of pilot-unit attendees received an ECG; some units >60%; evaluation underpowered
Main finding
As reported in the abstract
Observational data: associations, not effects.
Further findings
| Outcome | RR (95% CI) | |
|---|---|---|
| Mortality, ECGvs no ECG at pilot units · 2 and 5 yearsAt 5 years; lower | 0.86 (0.76–0.97) | |
| Mortality, ECGvs no ECG at pilot units · 2 and 5 yearsAt 2 years; not lower | 0.87 (0.72–1.04) | |
| Mortality, ECGvs attendees at all other centres · 2 and 5 yearsAt 5 years; lower | 0.87 (0.78–0.96) | |
| Mortality, ECGvs attendees at all other centres · 2 and 5 yearsAt 2 years; not lower | 0.86 (0.74–1.01) | |
| 0.512Relative risk (log scale) |
| Outcome | ECG | No ECG | Other units |
|---|---|---|---|
| Unadjusted mortality at 2 years | 16.3% | 20.5% | 20.1% |
| Unadjusted mortality at 5 years | 37.4% | 45.2% | 42.6% |
Original publication
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