NHS Fife, R&D Department, Queen Margaret Hospital, Dunfermline, UK.
The Sir James Mackenzie Institute for Early Diagnosis, The School of Medicine, University of St Andrews, St Andrews, UK.
Health Technol Assess. 2020 Nov;24(62):1-198. doi: 10.3310/hta24620.
Diabetes-related foot ulcers give rise to considerable morbidity, generate a high monetary cost for health and social care services and precede the majority of diabetes-related lower extremity amputations. There are many clinical prediction rules in existence to assess risk of foot ulceration but few have been subject to validation.
Our objectives were to produce an evidence-based clinical pathway for risk assessment and management of the foot in people with diabetes mellitus to estimate cost-effective monitoring intervals and to perform cost-effectiveness analyses and a value-of-information analysis.
We developed and validated a prognostic model using predictive modelling, calibration and discrimination techniques. An overview of systematic reviews already completed was followed by a review of randomised controlled trials of interventions to prevent foot ulceration in diabetes mellitus. A review of the health economic literature was followed by the construction of an economic model, an analysis of the transitional probability of moving from one foot risk state to another, an assessment of cost-effectiveness and a value-of-information analysis.
The effects of simple and complex interventions and different monitoring intervals for the clinical prediction rules were evaluated.
The main outcome was the incidence of foot ulceration. We compared the new clinical prediction rules in conjunction with the most effective preventative interventions at different monitoring intervals with a 'treat-all' strategy.
Data from an electronic health record for 26,154 people with diabetes mellitus in one Scottish health board were used to estimate the monitoring interval. The Prediction Of Diabetic foot UlcerationS (PODUS) data set was used to develop and validate the clinical prediction rule.
We searched for eligible randomised controlled trials of interventions using search strategies created for Ovid (Wolters Kluwer, Alphen aan den Rijn, the Netherlands), MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials. Randomised controlled trials in progress were identified via the International Standard Randomised Controlled Trial Number Registry and systematic reviews were identified via PROSPERO. Databases were searched from inception to February 2019.
The clinical prediction rule was found to accurately assess the risk of foot ulceration. Digital infrared thermometry, complex interventions and therapeutic footwear with offloading devices were found to be effective in preventing foot ulcers. The risk of developing a foot ulcer did not change over time for most people. We found that interventions to prevent foot ulceration may be cost-effective but there is uncertainty about this. Digital infrared thermometry and therapeutic footwear with offloading devices may be cost-effective when used to treat all people with diabetes mellitus regardless of their ulcer risk.
The threats to the validity of the results in some randomised controlled trials in the review and the large number of missing data in the electronic health record mean that there is uncertainty in our estimates.
There is evidence that interventions to prevent foot ulceration are effective but it is not clear who would benefit most from receiving the interventions. The ulceration risk does not change over an 8-year period for most people with diabetes mellitus. A change in the monitoring interval from annually to every 2 years for those at low risk would be acceptable.
Improving the completeness of electronic health records and sharing data would help improve our knowledge about the most clinically effective and cost-effective approaches to prevent foot ulceration in diabetes mellitus.
This study is registered as PROSPERO CRD42016052324.
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 24, No. 62. See the NIHR Journals Library website for further project information.
与糖尿病相关的足部溃疡会导致相当高的发病率，给卫生和社会保健服务带来高昂的费用，并导致大多数糖尿病相关的下肢截肢。目前有许多临床预测规则来评估足部溃疡的风险，但很少有经过验证的。
我们的目标是制定一个基于证据的临床途径，用于评估糖尿病患者的足部风险和管理，以估计成本效益的监测间隔，并进行成本效益分析和价值信息分析。
我们使用预测建模、校准和区分技术开发和验证了一个预测模型。首先概述了已经完成的系统评价，然后对预防糖尿病足溃疡的干预措施的随机对照试验进行了评价。在对卫生经济学文献进行综述后，构建了一个经济模型，分析了从一种足部风险状态向另一种状态过渡的转移概率，评估了成本效益，并进行了价值信息分析。
评估了简单和复杂干预措施以及不同监测间隔对临床预测规则的影响。
主要结果是足部溃疡的发生率。我们比较了新的临床预测规则与不同监测间隔下最有效的预防干预措施与“治疗所有”策略的效果。
使用苏格兰一个卫生委员会的 26154 名糖尿病患者的电子健康记录数据来估计监测间隔。使用 Prediction Of Diabetic foot UlcerationS (PODUS) 数据集来开发和验证临床预测规则。
我们使用为 Ovid（Wolters Kluwer，Alphen aan den Rijn，荷兰）、MEDLINE、EMBASE 和 Cochrane 对照试验中心注册库创建的搜索策略，搜索了干预措施的合格随机对照试验。通过国际标准随机对照试验编号注册处确定正在进行的随机对照试验，并通过 PROSPERO 确定系统评价。从成立到 2019 年 2 月，对数据库进行了搜索。
发现该临床预测规则能够准确评估足部溃疡的风险。数字红外线测温仪、复杂干预措施和具有减压装置的治疗性鞋具被发现能有效预防足部溃疡。大多数人足部溃疡的风险不会随时间而改变。我们发现，预防足部溃疡的干预措施可能具有成本效益，但对此存在不确定性。数字红外线测温仪和具有减压装置的治疗性鞋具在治疗所有糖尿病患者时可能具有成本效益，无论其溃疡风险如何。
综述中的一些随机对照试验的结果存在有效性威胁，电子健康记录中大量数据缺失，这意味着我们的估计存在不确定性。
有证据表明预防足部溃疡的干预措施是有效的，但尚不清楚谁最受益于接受这些干预措施。对于大多数糖尿病患者来说，溃疡风险在 8 年内不会改变。对于低风险人群，将监测间隔从每年改为每两年一次是可以接受的。
提高电子健康记录的完整性并共享数据将有助于提高我们对预防糖尿病足溃疡最具临床效果和成本效益的方法的认识。
本研究已在 PROSPERO CRD42016052324 中注册。
本项目由英国国家健康研究所（NIHR）健康技术评估计划资助，将在；第 24 卷，第 62 期。请访问 NIHR 期刊库网站以获取更多项目信息。
