Analytical approach:
An economic evaluation, based on a multicentre observational trial, was undertaken. The impact of the advanced dressing was assessed over 30 days. The authors stated that the perspective was that of the public home care provider.
Effectiveness data:
The effectiveness data were from a multicentre observational trial that was conducted in 23 health care centres in Italy. This included 362 patients, with the inclusion criteria set independently by each centre. Each centre continued to use their usual type of dressing, with 201 patients receiving advanced dressings, and 150 receiving simple dressings; 11 patients dropped out of the trial. Observational data were collected by case report forms and using questionnaires. The main clinical effectiveness of the dressings was measured by a reduction in the lesion size. The intervention was also assessed for three dimensions: its accessibility for the family and caregivers, pain, and severe adverse events. The data were collected by semi-structured interviews and a questionnaire with yes or no responses.
Monetary benefit and utility valuations:
Not applicable.
Measure of benefit:
The benefit was measured by the reduction in ulcer lesion size.
Cost data:
Three cost components were included: medication and devices, personnel, and health care worker transport. Medication and device costs were from provider supplier records. Personnel costs were calculated for the type of professional health care worker who visited the patient. Transport costs were measured using the distance from the health care centre to the patient's home, the type of motor vehicle, and fuel consumption. The impact of the new treatment on the organisation was measured, for various resource parameters, by questionnaire. These included the number of visits and their durations, the possibility that health workers could perform other activities, the personnel required for each visit, and their training. The costs were measured in 2008 and inflated to 2010 prices, using Italian inflation rates. They were reported in Euros (EUR).
Analysis of uncertainty:
A deterministic sensitivity analysis, in which the key cost parameters were altered, was undertaken. A bootstrapping analysis, using 100 random samples, estimated the variance in the cost per visit and cost over 30 days. A Monte Carlo simulation, of 100 different scenarios, over five years, with yearly variations for the costs of personnel, medications and devices, and transport, assessed the impact of their uncertainty on the total cost for each patient.