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BMJ 2005;330 (26 March), doi:10.1136/bmj.330.7493.0-e
Harms and benefits of new diagnostic tests should be fully evaluated and understood before they become available for use in clinical practice, argue Gluud and Gluud (p 724). They propose a four phase process of assessment, mirroring that used for new drugs. Using brain natriuretic peptide for diagnosing heart failure as an illustrative example, they describe the four phases in diagnostic research. They claim the process is applicable to a wide range of tests including laboratory techniques, diagnostic imaging, pathology, evaluation of disability, electrodiagnostic tests, and endoscopy.
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