Emanuele Cereda1, Catherine Klersy2, Manuela Andreola3, Roberto Pisati4, Jos M G A Schols5, Riccardo Caccialanza6, Federico D'Andrea7. 1. Servizio di Dietetica e Nutrizione Clinica, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. Electronic address: e.cereda@smatteo.pv.it. 2. Servizio di Biometria e Statistica, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. 3. SS di Prevenzione e Cura Lesioni Vascolari, ASL NO, Novara, Italy. 4. Medical Department, Nutricia Italia, Milano, Italy. 5. Faculty of Health, Medicine and Life Sciences, School for Public Health and Primary Care (Caphri), Maastricht University, Maastricht, The Netherlands; Dept. HSR, School for Public Health and Primary Care (Caphri), Maastricht University, Maastricht, The Netherlands; Dept. Family Medicine, School for Public Health and Primary Care (Caphri), Maastricht University, Maastricht, The Netherlands. 6. Servizio di Dietetica e Nutrizione Clinica, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy. 7. SCDO Dietetica e Nutrizione Clinica, Azienda Ospedaliera Universitaria "Maggiore della Carità", Novara, Italy.
Abstract
BACKGROUND & AIMS: The Oligo Element Sore Trial has shown that supplementation with a disease-specific nutritional formula enriched with arginine, zinc, and antioxidants improves pressure ulcer (PU) healing in malnourished patients compared to an isocaloric-isonitrogenous support. However, the use of such a nutritional formula needs to be supported also by a cost-effectiveness evaluation. METHODS: This economic evaluation - from a local healthcare system perspective - was conducted alongside a multicenter, randomized, controlled trial following a piggy-back approach. The primary efficacy endpoint was the percentage of change in PU area at 8 weeks. The cost analysis focused on: the difference in direct medical costs of local PU care between groups and incremental cost-effectiveness ratio (ICER) of nutritional therapy related to significant study endpoints (percentage of change in PU area and ≥40% reduction in PU area at 8 weeks). RESULTS: Although the experimental formula was more expensive (mean difference: 39.4 Euros; P < 0.001), its use resulted in money saving with respect to both non-nutritional PU care activities (difference, -113.7 Euros; P = 0.001) and costs of local PU care (difference, -74.3 Euros; P = 0.013). Therefore, given its efficacy it proved to be a cost-effective intervention. The robustness of these results was confirmed by the sensitivity analyses. CONCLUSION: The use of a disease-specific oral nutritional formula not only results in better healing of PUs, but also reduces the costs of local PU care from a local healthcare system perspective.
RCT Entities:
BACKGROUND & AIMS: The Oligo Element Sore Trial has shown that supplementation with a disease-specific nutritional formula enriched with arginine, zinc, and antioxidants improves pressure ulcer (PU) healing in malnourished patients compared to an isocaloric-isonitrogenous support. However, the use of such a nutritional formula needs to be supported also by a cost-effectiveness evaluation. METHODS: This economic evaluation - from a local healthcare system perspective - was conducted alongside a multicenter, randomized, controlled trial following a piggy-back approach. The primary efficacy endpoint was the percentage of change in PU area at 8 weeks. The cost analysis focused on: the difference in direct medical costs of local PU care between groups and incremental cost-effectiveness ratio (ICER) of nutritional therapy related to significant study endpoints (percentage of change in PU area and ≥40% reduction in PU area at 8 weeks). RESULTS: Although the experimental formula was more expensive (mean difference: 39.4 Euros; P < 0.001), its use resulted in money saving with respect to both non-nutritional PU care activities (difference, -113.7 Euros; P = 0.001) and costs of local PU care (difference, -74.3 Euros; P = 0.013). Therefore, given its efficacy it proved to be a cost-effective intervention. The robustness of these results was confirmed by the sensitivity analyses. CONCLUSION: The use of a disease-specific oral nutritional formula not only results in better healing of PUs, but also reduces the costs of local PU care from a local healthcare system perspective.
Authors: M Arora; L A Harvey; J V Glinsky; H S Chhabra; M S Hossain; N Arumugam; P K Bedi; I D Cameron; A J Hayes Journal: Spinal Cord Date: 2017-08-15 Impact factor: 2.772