hta_ knee intro.qxp - Ministero della Salute

5. Context-specific analysis
Context specific analysis was important to determine the utilisation and costs of knee prostheses
among the centres of the Italian National Health Service (INHS). The aim of this chapter was
to offer an impact scenario of utilisation of knee prostheses, in terms of diffusion and purchasing
costs. We carried out a survey to collect data on the prostheses used in Italy, prices and volume
of activity. The cost-effectiveness analysis are presented in Chapter 8. We also contacted the association
of producers and distributors of medical devices (ASSOBIOMEDICA) and the Istituto
Superiore di Sanità (ISS, the Italian equivalent to the NIH) for collaboration and technical support.
5.1 Methods for contextual analysis: national survey
As there is no central register of TKR prostheses currently on the Italian market, we carried
out a survey to gather data on prostheses currently used in Italy, their purchasing prices and activities
volume by means of a structured questionnaire (Appendix 2) sent to public hospital services
and private accredited providers of the INHS.
Information on the price of the devices, purchasing procedures and volume of activity of the
responding centres was collected on several types of devices used in different centres of the INHS,
both for primary total knee replacement and revision knee replacement for 2006 and 2007.
The survey was carried out on a sample of healthcare centres (observational sample) providing
primary TKR and revision. From the information contained in the hospital discharge records (SDO)
we identified centres that had undertaken at least one total knee replacement or revision procedure
(ICD-9-CM 81.54 and 81.55). From this list a proportional stratified sample was extracted by
Region and volume of activity. The selection of the centres included in the observation sample was
random. We requested information on the models of prosthesis purchased and their product code,
name of manufacturers and quantity purchased by single centre; we also asked for information
about unit price for single system of prosthesis or unit price for single component of a system and
also information on purchase conditions (Directly by Local Unit/Hospitals; Centralised purchase by
Regions or other type of organisational level). This was because different purchasing procedures
that could influence the purchase price of the device. To complete our data-set, we acquired the
volume of activity for the year 2007. We gathered and compared all data.
5.2 Results
5.2.1 Description of sample
Using hospital discharge records we identified 721 centres which had undertaken at least one
replacement or revision of the knee in 2006. All the 721 centres were public health centres or private
INHS-accredited providers as the hospital discharge records include only public or private
accredited centres. We managed data using SAS (The SAS System for Windows – version 8).
Random sampling was carried out using the method in Appendix 3. A total of 152 centres were
randomly selected and received a structured questionnaire by post and e-mail. Five centres were
excluded as they answered that in 2007 they were not accredited by the INHS. The final sample
was based on 147 centres. Table 5.1 shows the territorial distribution of the random sample.
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