A randomised controlled trial and cost-consequence analysis of traditional and digital foot orthoses supply chains in a National Health Service setting: application to feet at risk of diabetic plantar ulceration

Autor: A Martinez-Santos, Christopher J. Nester, Nathan Bray, Daniel Parker, G. H. Nuttall, Rhiannon Tudor Edwards, T. Hugill
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Zdroj: Journal of Foot and Ankle Research, Vol 12, Iss 1, Pp 1-13 (2019)
Journal of Foot and Ankle Research
ISSN: 1757-1146
DOI: 10.1186/s13047-018-0311-0
Popis: Background: Diabetic foot ulceration is a considerable cost to the NHS and foot orthotic\ud provision is a core strategy for the management of the people with diabetes and a moderate\ud to high risk of foot ulceration. The traditional process to produce a custom-made foot orthotic\ud device is to use manual casting of foot shape and physical moulding of orthoses materials.\ud Parts of this process can be undertaken using digital tools rather than manual processes with\ud potential advantages. The aim of this trial was to provide the first comparison of a traditional\ud orthoses supply chain to a digital supply chain over a 6 month period. The trial used plantar\ud pressure, health status, and health service time and cost data to compare the two supply\ud chains.\ud \ud Methods: 57 participants with diabetes were randomly allocated to each supply chain. Plantar\ud pressure data and health status (EQ5D, ICECAP) was assessed at point of supply and at sixmonths.\ud The costs for orthoses and clinical services accessed by participants were assessed\ud over the 6 months of the trial. Primary outcomes were: reduction in peak plantar pressure at\ud the site of highest pressure, assessed for non-inferiority to current care. Secondary outcomes\ud were: reduction in plantar pressure at foot regions identified as at risk (>200kPa), costconsequence\ud analysis (supply chain, clinician time, service use) and health status.\ud \ud Results: At point of supply pressure reduction for the digital supply chain was non-inferior to\ud a predefined margin and superior (p\ud \ud Conclusions: Custom made foot orthoses reduce pressure as expected. Given some\ud assumptions about the cost models we used, the supply chain process adopted to produce\ud the orthoses seems to have marginal impact on overall costs and health status.\ud \ud Trial Registration: retrospectively registered on ISRCTN registry (ISRCTN10978940,\ud 04/11/2015).\ud Key Words: Foot Orthotic, Biomechanics, Diabetes, Plantar Pressure, Cost, Health\ud Economics, Supply Chain
Databáze: OpenAIRE
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