ObjectivesDiabetic foot ulcer (DFU) is a common complication of diabetes and not only an important factor of mortality among patients with diabetes but also decreases the quality of life. The short form of Diabetic Foot Ulcer Scale (DFS-SF) provides comprehensive measurement of the impact of diabetic foot ulcers on patients’ health related quality of life (HRQoL). The purpose of this study was to translate DFS-SF into Polish and evaluate its psychometric performance in patients with diabetic foot ulcers.MethodsThe DFS-SF translation process was performed in line with Principles of Good Practice for the Translation and Cultural Adaptation Process for patient reported outcome measures (PROMs) developed by ISPOR TCA group. Assessment of the reliability and validity of Polish DFS-SF was performed in native Polish patients with current DFU.ResultsThe DFS-SF validation study involved 212 patients diagnosed with DFU, with 4.4 years of DFU duration on average. The average ulcer size was 5.5 sq. cm, and generally only one limb was affected. Men (72%) and type 2 diabetes patients (86%) prevailed, with 17.8 years representing the mean time since diagnosis. The mean population age was 62.5 years. The internal consistency of all scales of the Polish DFS-SF was high (Cronbach’s alpha ranged from 0.82 to 0.93). Item convergent and discriminant validity was satisfactory (median corrected item-scale correlation ranged from 0.61 to 0.81). The Polish DFS-SF demonstrated good construct validity when correlated with the SF-36v2 and showed better psychometric performance than SF-36v2.ConclusionsThe newly translated Polish DFS-SF may be used to assess the impact of DFU on HRQoL in Polish patients.Electronic supplementary materialThe online version of this article (doi:10.1186/s12955-017-0587-y) contains supplementary material, which is available to authorized users.
trality and percentages determined. RESULTS: The data reveal a 100% written diagnosis for all prescriptions encountered. There were more females than males (70% vs 30%). The average number of drugs per prescription was 6.0. About 61% of the diabetic patients were also diagnosed with hypertension. Biguanides (95%) were the commonest oral hypoglycaemic agent prescribed while calcium channel antagonist (60%) was the commonest antihypertensive prescribed. The average cost of medication per prescription was GHC 40.0 (Ghana cedi)-approx $20.5 (USD), were as the average total cost of drugs per patient for the entire year was GHC 235.2 (Ghana cedi)-approx $120 (USD) CONCLUSIONS: The study demonstrates that most patients attending the diabetic clinic in Ho Municipal Hospital are females. The cost of diabetic medications to patient per prescription was expectedly high, particularly due to the high number of drugs prescribed. Most diabetic patients have hypertension. The prescription of ACE-I therefore need to be improved to reduce the rate of cardiovascular complication in diabetes.
on health related quality of life. Attention is needed to highlight determinants of health related quality of life and to implement policies for better management of Type 2 Diabetes Mellitus, particularly in early treatment phases where improving Health Related Quality of Life is still possible.
Objectives: To assess the cost-effectiveness of the SGLT2is empagliflozin 10mg and 25mg compared to other SGLT2is (canagliflozin 100mg and canagliflozin 300mg) when administered as an add-on to MET+SU in patients with T2DM in the UK. MethOds: Long-term diabetes-related complications, QALYs, and costs were estimated for T2DM patients failing MET+SU. A micro-simulation model was developed based on the United Kingdom Prospective Diabetes Study (UKPDS68) and the Januvia Diabetes Economic (JADE) model. A network meta-analysis comparing efficacy and safety across SGLT2is was used to populate the model. Data gaps were completed with information derived from published sources, including previous cost-effectiveness models. Costs and QALYs were estimated over a patients' lifetime from the UK National Health Service perspective. Results: Empagliflozin 10mg attained the highest QALYs (6.991, compared to 6.98 for canagliflozin 100mg, 6.978 for empagliflozin 25mg and 6.976 for canagliflozin 300mg) due to slightly better HbA1c, SBP and weight control, and a small number of non-severe hypoglycaemias, compared to higher doses. Canagliflozin 300mg was the most costly strategy (£32,087, vs. £31,217 for canagliflozin 100mg, £31,409 for empagliflozin 10mg and £31,557 for empagliflozin 25mg). Therefore, empagliflozin 10mg dominated both canagliflozin 300mg and empagliflozin 25mg, and resulted in an incremental costeffectiveness ratio of £17,445 per QALY gained vs. canagliflozin 100mg. However, incremental QALY and cost differences were not significant based on 95% percentile confidence intervals. These results remained robust when sensitivity analyses were conducted, including utilities, adverse events, discontinuation, modelling of weight, impact of BMI, duration of effect, time horizon and discount rates. cOnclusiOns: Differences in QALYs and costs between SGLT2is as add-ons to MET+SU were minor. On average, empagliflozin 10mg resulted to be the most cost-effective option for T2DM patients failing MET+SU when commonly accepted thresholds in the UK were considered, with an incremental cost per QALY of £17,445 compared to canagliflozin 100mg.
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