hta_ knee intro.qxp - Ministero della Salute

6. Assessing the evidence from clinical studies:
systematic review
6.1 Methods
6.1.1 Evidence searches
We conducted a systematic review of the scientific literature in English by consulting the following
databases:
• PubMed
• EMBASE
• The Cochrane Library
from 1 st January 1998 to 28 th February 2009. We used Procite software – ISI ResearchSoft
(version 5 Windows 2000/98/95/NT) to manage the bibliography. Details of search strategy and
search terms are reported in Appendix 6.
6.1.2 Inclusion criteria
Type of study
We included systematic reviews, randomised controlled trials and observational studies. We
also considered HTA reports and guidelines produced in other countries.
Population
We included studies on people older than 50 with OA that received primary total knee replacement
(ICD-9-CM 81.54) (assessment of the revision procedure was not a report objective). We
also included aggregate data for patients between the ages of 45-49 as long as the observed cases
did not exceed 25% of the total.
Type of prostheses
We included studies on prostheses for primary TKR used in Italy by public and private accredited
providers as identified by our survey (see chapter 5).
Outcome
The outcome considered was the effectiveness of the devices in terms of implant survival rate.
Follow up
The minimum follow up considered was 5 years.
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