Cost-Effectiveness of Lower Extremity Nerve Decompression Surgery in the Prevention of Ulcers and Amputations: A Markov Analysis.

BACKGROUND: The costs and health effects associated with lower extremity complications in diabetes mellitus are an increasing burden to society. In selected patients, lower extremity nerve decompression is able to reduce symptoms of neuropathy and the concomitant risks of diabetic foot ulcers and amputations. To estimate the health and economic effects of this type of surgery, the cost-effectiveness of this intervention compared to current nonsurgical care was studied. METHODS: To estimate the incremental cost-effectiveness of lower extremity nerve decompression over a 10-year period, a Markov model was developed to simulate the onset and progression of diabetic foot disease in patients with diabetes and neuropathy who underwent lower extremity nerve decompression surgery, compared to a group undergoing current nonsurgical care. Mean survival time, health-related quality of life, presence or risk of lower extremity complications, and in-hospital costs were the outcome measures assessed. Data from the Rotterdam Diabetic Foot Study were used as current care, complemented with information from international studies on the epidemiology of diabetic foot disease, resource use, and costs, to feed the model. RESULTS: Lower extremity nerve decompression surgery resulted in improved life expectancy (88,369.5 life-years versus 86,513.6 life-years), gain of quality-adjusted life-years (67,652.5 versus 64,082.3), and reduced incidence of foot complications compared to current care (490 versus 1087). The incremental cost-effectiveness analysis was -€59,279.6 per quality-adjusted life-year gained, which is below the Dutch critical threshold of less than €80,000 per quality-adjusted life-year. CONCLUSIONS: Decompression surgery of lower extremity nerves improves survival, reduces diabetic foot complications, and is cost saving and cost-effective compared with current care, suggesting considerable socioeconomic benefit for society.

(Cost-)effectiveness of lower extremity nerve decompression surgery in subjects with diabetes: the DeCompression (DECO) trial-study protocol for a randomised controlled trial.

INTRODUCTION: The peripheral nerves of patients with diabetes are often pathologically swollen, which results in entrapment at places of anatomical narrowing. This results in nerve dysfunction. Surgical treatment of compression neuropathies in the lower extremities (lower extremity nerve decompression (LEND)) results in relief of symptoms and gain in peripheral nerve function, which may lead to less sensory loss (short term) and less associated detrimental effects including foot ulceration and amputations, and lower costs (long term). The aim of the DeCompression trial is to evaluate the effectiveness and (cost-)effectiveness of surgical decompression of compressed lower extremity nerves (LEND surgery) compared with patients treated with conventional (non-surgical) care. METHODS AND ANALYSIS: A stratified randomised (1 to 1) controlled trial comparing LEND surgery (intervention) with conventional non-surgical care (control strategy) in subjects with diabetes with problems of neuropathy due to compression neuropathies in the lower extremity. Randomisation is stratified for participating hospital (n=11) and gender. Patients and controls have the same follow-up at 1.5, 3, 6, 9, 12, 18, 24 and 48 months. Participants (n=344) will be recruited in 12 months and enrolled in all affiliated hospitals in which they receive both the intervention or conventional non-surgical care and follow-up. Outcome assessors are blinded to group assignment. PRIMARY OUTCOME: disease-specific quality of life (Norfolk Quality of Life Questionnaire-Diabetic Neuropathy). SECONDARY OUTCOMES: health-related quality of life (EuroQoL 5-dimension 5-level (EQ-5D5L), 36-item Short Form (SF-36)), plantar sensation (Rotterdam Diabetic Foot Test Battery), incidence of ulcerations/amputations, resource use and productivity loss (Medical Cost Questionnaire, Productivity Cost Questionnaire) during follow-up. The incremental cost-effectiveness ratio will be estimated on the basis of the collected empirical data and a cost-utility model. ETHICS AND DISSEMINATION: Ethics approval has been granted by the Medical Research Ethics Committee of Utrecht University Medical Center (reference: NL68312.041.19v5, protocol number: 19-335/M). Dissemination of results will be via journal articles and presentations at national and international conferences. TRIAL REGISTRATION NUMBER: NetherlandsTrial Registry NL7664.

Balance, risk of falls, risk factors and fall-related costs in individuals with diabetes.

AIMS: Sensory loss and impaired balance are considered risk factors of incident falls. The aim of this study was to assess the relationship between degree of foot sensation and balance, risk of falls, incidence of fall-related injuries and costs in a cohort of patients with diabetes. METHODS: (Non)-neuropathic subjects participating in the Rotterdam Diabetic Foot Study were followed prospectively. Subjects underwent sensory testing of the feet (39 item Rotterdam Diabetic Foot Study Test Battery (RDF-39)); balance was assessed at the second follow-up (Brief-BESTest) as were data on incident falls. Medical records and financial data were abstracted to estimate fall-related morbidity and in-hospital costs. RESULTS: A higher RDF-39 score, cerebral artery disease, type 2 diabetes, height and age were predictors of the Brief-BESTest total score. 41/296 patients (13.9%) reported two or more falls during follow-up. Predictors for recurrent falls were a higher RDF-39 score (aOR: 1.124, p < 0.0005), male gender (aOR: 0.319, p = 0.016), age (aOR: 0.938, p = 0.003) and type 2 diabetes (aOR: 3.157, p = 0.100). Thirty-one patients used medical resources (median US$ 440.45 (IQR: 179-1162). CONCLUSIONS: Degree of sensory loss correlates significantly with an increased imbalance and risk of falls. The RDF-39 may be used as stratification tool in medical decision-making and patient information.

In-hospital costs of diabetic foot disease treated by a multidisciplinary foot team.

BACKGROUND: The diabetic foot imposes significant burden on healthcare systems. Obtaining knowledge on the extent of the costs of diabetic foot ulcers (DFUs) is of value to health care researchers investigating cost-effectiveness of interventions that prevent these costly complications. OBJECTIVES: To estimate the in-hospital costs associated with the treatment of DFUs by a multidisciplinary diabetic foot team. METHODS: Persons with DFUs presenting to our team in 2013 and 2014 were followed and use of care was estimated. Exclusion criteria were a single visit only and ulcers above the ankle. Demographic data and per-person incremental clinical outcomes (e.g., healing with or without amputation and rehabilitation) were assessed. Resource use was identified, measured and multiplied by unit costs. RESULTS: Eighty-nine persons were identified with 56 persons meeting the inclusion criteria (with 69 DFU episodes). The median in-hospital care was 17weeks (inter quartile range: 7-34). Average in-hospital costs were US$ 10,827 (range: 702-82,880) per DFU episode. Primary healed DFUs costs on average US$ 4830, single minor amputations on average US$ 13,580, multiple minor amputations on average US$ 31,835 and major amputations on average US$ 73,813 per episode. Costs differed significantly between groups (p<0.001). CONCLUSION: DFUs are associated with substantial immediate and long-term in-hospital costs. Our study provides estimates of these costs, aiding researchers and health policy analysis.