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 than new drugs. It is time to ensure that the harms and benefits of 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 assessing diagnostic tests. Previous recommendations stress that studies of diagnostic tests should match the type of diagnostic question.1 2 Once the specificity and sensitivity of a test have been established, the final question is whether tested patients fare better than similar untested patients. This usually requires a randomised trial. Few tests are currently evaluated in this way. In this paper, we propose an architecture for research into diagnostic tests 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 diagnosing heart failure as an illustrative example.2 However, the architecture is applicable to a wide range of tests including laboratory techniques, 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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Rapid Responses:

Read all Rapid Responses

Analytical problems (not only) with BNP determining
Rudolf Gasko
bmj.com, 26 Mar 2005 [Full text]
Licensing diagnostic tests may benefit everyone
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Sten Öhman
bmj.com, 29 Mar 2005 [Full text]
Multivariable approaches should not be left out in evidence based diagnostics
Gerben ter Riet, et al.
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Evidence based diagnostics and genetic testing
Simon P Sanderson, et al.
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Authors' reply
Christian Gluud, et al.
bmj.com, 24 May 2005 [Full text]
Cost-effectiveness should be included in diagnostic research
Joanna D Schaafsma, et al.
bmj.com, 3 Jun 2005 [Full text]



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