Aims/hypothesis

The risk of dying within 2 years of presentation with diabetic foot ulceration is over six times the risk of amputation, with CVD the major contributor. Using an observational evaluation of a real-world implementation pilot, we aimed to assess whether for those presenting with diabetic foot ulceration in England, introducing a 12-lead ECG into routine care followed by appropriate clinical action was associated with reduced mortality.

Methods

Between July 2014 and December 2017, ten multidisciplinary diabetic foot services in England participated in a pilot project introducing 12-lead ECGs for new attendees with foot ulceration. Inception coincided with launch of the National Diabetes Footcare Audit (NDFA), whereby all diabetic footcare services in England were invited to enter data on new attendees with foot ulceration. Poisson regression models assessed the mortality RR at 2 and 5 years following first assessment of those receiving care in a participating pilot unit vs those receiving care in any other unit in England, adjusting for age, sex, ethnicity, deprivation, type and duration of diabetes, ulcer severity, and morbidity in the year prior to first assessment.

Results

Of the 3110 people recorded in the NDFA at a participating unit during the pilot, 33% (1015) were recorded as having received an ECG. A further 25,195 people recorded in the NDFA had attended another English footcare service. Unadjusted mortality in the pilot units was 16.3% (165) at 2 years and 37.4% (380) at 5 years for those who received an ECG, and 20.5% (430) and 45.2% (950), respectively, for those who did not receive an ECG. For people included in the NDFA at other units, unadjusted mortality was 20.1% (5075) and 42.6% (10,745), respectively. In the fully adjusted model, mortality was not significantly lower for those attending participating units at 2 (RR 0.93 [95% CI 0.85, 1.01]) or 5 years (RR 0.95 [95% CI 0.90, 1.01]). At participating units, mortality in those who received an ECG vs those who did not was lower at 5 years (RR 0.86 [95% CI 0.76, 0.97]), but not at 2 years (RR 0.87 [95% CI 0.72, 1.04]). Comparing just those that received an ECG with attendees at all other centres in England, mortality was lower at 5 years (RR 0.87 [95% CI 0.78, 0.96]), but not at 2 years (RR 0.86 [95% CI 0.74, 1.01]).

Conclusions/interpretation

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.

Data availability

Data from the National Diabetes Audit can be requested through the National Health Service Digital Data Access Request Service process at: https://digital.nhs.uk/services/data-access-request-service-dars/dars-products-and-services/data-set-catalogue/national-diabetes-audit-nda

Graphical Abstract

中文翻译：

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引入 12 导联心电图是否有助于降低在多学科糖尿病足诊所就诊的足部溃疡患者的死亡率？对英国现实世界实施试点的观察评估

目标/假设

糖尿病足溃疡出现后 2 年内死亡的风险是截肢风险的六倍多，其中 CVD 是主要原因。通过对现实世界实施试点的观察性评估，我们旨在评估对于英国患有糖尿病足溃疡的患者，将 12 导联心电图引入常规护理并随后采取适当的临床行动是否与降低死亡率相关。

方法

2014 年 7 月至 2017 年 12 月期间，英格兰的 10 个多学科糖尿病足部服务机构参与了一个试点项目，为患有足部溃疡的新参与者引入 12 导联心电图。该项目的成立恰逢国家糖尿病足部护理审计 (NDFA) 的启动，英格兰所有糖尿病足部护理服务机构都被邀请输入患有足部溃疡的新参加者的数据。泊松回归模型评估了在参与试点单位接受护理的患者与在英格兰任何其他单位接受护理的患者进行首次评估后 2 年和 5 年的死亡率 RR，并根据年龄、性别、种族、贫困、糖尿病类型和持续时间进行调整、溃疡严重程度和首次评估前一年的发病率。

结果

试点期间参与单位的 NDFA 记录了 3110 人，其中 33% (1015) 被记录为接受了心电图检查。 NDFA 记录的另外 25,195 人曾参加过另一项英国足部护理服务。在试点单位中，接受心电图检查的患者 2 年未调整死亡率为 16.3%（165 人），5 年未调整死亡率为 37.4%（380 人），而接受心电图检查的患者则分别为 20.5%（430 人）和 45.2%（950 人）。未收到心电图。对于其他单位纳入 NDFA 的人员，未经调整的死亡率分别为 20.1% (5075) 和 42.6% (10,745)。在完全调整的模型中，参加参与单位的患者在 2 年（RR 0.93 [95% CI 0.85，1.01]）或 5 年（RR 0.95 [95% CI 0.90，1.01]）时的死亡率并未显着降低。在参与单位，接受心电图检查的患者与未接受心电图检查的患者相比，5 年时的死亡率较低 (RR 0.86 [95% CI 0.76, 0.97])，但 2 年时死亡率较低 (RR 0.87 [95% CI 0.72, 1.04]) ）。仅将接受心电图检查的患者与英格兰所有其他中心的参加者进行比较，5 年死亡率较低 (RR 0.87 [95% CI 0.78, 0.96])，但 2 年死亡率较低 (RR 0.86 [95% CI 0.74, 1.01] ]）。

结论/解释

该评估证实了糖尿病足溃疡患者的高死亡率。参与单位的总体死亡率在 2 或 5 年内并未显着降低，置信区间刚刚跨越奇偶校验。事实证明，将 12 导联心电图纳入常规护理途径对临床团队来说具有挑战性——尽管有些单位向超过 60% 的参与者提供了干预措施，但总体而言，三分之一的参与者拥有 12 导联心电图——因此评估力度不足。尽管如此，接受心电图检查的患者潜在死亡率获益的信号表明，有能力实施实施的单位不妨考虑这一点。

数据可用性

可以通过国家卫生服务数字数据访问请求服务流程请求国家糖尿病审计的数据：https://digital.nhs.uk/services/data-access-request-service-dars/dars-products-and-服务/数据集目录/国家糖尿病审计-NDA

图形概要