Evidence based diagnostics

doi:10.1136/bmj.330.7493.724

BMJ 2005;330:724-726 (26 March), doi:10.1136/bmj.330.7493.724

Education and debate

Evidence based diagnostics

Christian Gluud, head of department¹, Lise Lotte Gluud, specialist registrar¹

¹ Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, H:S Rigshospitalet, Copenhagen University Hospital, DK-2100 Copenhagen, Denmark

Correspondence to: C Gluud cgluud@ctu.rh.dk

Diagnostic tests are often much less rigorously evaluated thannew drugs. It is time to ensure that the harms and benefitsof new tests are fully understood

The first 150 words of the full text of this article appear below.

Introduction

No international consensus exists on the methods for assessingdiagnostic tests. Previous recommendations stress that studiesof diagnostic tests should match the type of diagnostic question.^1
2Once the specificity and sensitivity of a test have been established,the final question is whether tested patients fare better thansimilar untested patients. This usually requires a randomisedtrial. Few tests are currently evaluated in this way. In thispaper, we propose an architecture for research into diagnostictests that parallels the established phases in drug research.

Stages of research

We have divided studies of diagnostic tests into four phases(box). We use research on brain natriuretic peptide for diagnosingheart failure as an illustrative example.² However, the architectureis applicable to a wide range of tests including laboratorytechniques, diagnostic imaging, pathology, evaluation of disability,electrodiagnostic tests, and endoscopy.

Establishing the normal range

In drug research, phase I studies deal with pharmacokinetics,pharmacodynamics, and safe doses.³ Phase I diagnostic . . . [Full text of this article]

Diagnostic accuracy

Clinical effects

Long term consequences

Conclusion

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