The evaluation of diagnostic tests: evidence on technical and diagnostic accuracy, impact on patient outcome and cost-effectiveness is needed
Accepted 13 March 2007. published online 30 August 2007.
Abstract
Objective
Before introducing a test in clinical practice, its characteristics and added value should be assessed. Diagnostic accuracy studies only are not sufficient; the test's impact on patient outcome ought to be assessed as well. To do this, we propose a stepwise evaluation of diagnostic tests.
Study Design and Setting
Theoretical–conceptual approach.
Results
First, the test's technical accuracy refers to the ability to produce usable information under standardized conditions. In a second step, the place of the new test in the clinical pathway is determined. Thirdly, the test's diagnostic accuracy is assessed, depending on its intended goal. The fourth step assesses the test's impact on the patient outcome. Depending on the place of the test in the clinical pathway, existing evidence can be used, or new evidence will be needed. At the final step, a cost-effectiveness analysis assesses the test's financial and societal consequences.
Conclusion
Diagnostic tests evaluation should consider the technical accuracy, the test's place in the clinical pathway, its diagnostic accuracy, and its impact on patient outcome.
aDepartment of General Practice, Katholieke Universiteit Leuven, Belgium
bBelgian Health Care Knowledge Centre, Brussels, Belgium
cDepartment of General Practice, Universiteit Maastricht, the Netherlands
dCEBAM, Belgian Centre for Evidence Based Medicine, Leuven, Belgium
Corresponding author. Ann Van den Bruel, Academic Centre of General Practice, Katholieke Universiteit Leuven, Kapucijnenvoer 33 blok J, 3000 Leuven, Belgium. Tel.: +32-16-33-74-90; fax: +32-16-33-74-80.
ABSTRACT