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IJE Advance Access published online on May 23, 2005
International Journal of Epidemiology, doi:10.1093/ije/dyi105
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Published by Oxford University Press on behalf of the International Epidemiological Association © The Author 2005; all rights reserved.
Accepted April 20, 2005

Original paper

Consequences of different diagnostic ‘gold standards’ in test accuracy research: Carpal Tunnel Syndrome as an example

Lucas M. Bachmann 1, Peter Jüni 2*, Stephan Reichenbach 2, Hans-Rudolf Ziswiler 3, Alfons G. Kessels 4, and Esther Vögelin 5

1 Department of Social and Preventive Medicine, University of Berne, Switzerland; Horten Centre, University of Zurich, Switzerland
2 Department of Social and Preventive Medicine, University of Berne, Switzerland; Department of Rheumatology and Clinical Immunology, Inselspital University of Berne, Switzerland; MRC Health Services Research Collaboration, Department of Social Medicine, University of Bristol, UK
3 Department of Rheumatology and Clinical Immunology, Inselspital University of Berne, Switzerland
4 Horten Centre, University of Zurich, Switzerland; Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Hospital, Maastricht, The Netherlands
5 Department of Hand Surgery, Inselspital, University of Berne, Switzerland

* To whom correspondence should be addressed.
Peter Jüni, E-mail: juni{at}ispm.unibe.ch


  Abstract

Test accuracy studies assume the existence of a well-defined illness definition and clear-cut diagnostic gold standards or reference standards. However, in clinical reality illness definitions may be vague or a mere description of a set of manifestations, mostly clinical signs and symptoms. This can lead to disagreements among experts about the correct classification of an illness and the adequate reference standard. Using data from a diagnostic accuracy study in carpal tunnel syndrome, we explored the impact of different definitions on the estimated test accuracy and found that estimated test performance characteristics varied considerably depending on the chosen reference standard. In situations without a clear-cut illness definition, randomized controlled trials may be preferable to test accuracy studies for the evaluation of a novel test. These studies do not determine the diagnostic accuracy, but the clinical impact of a novel test on patient management and outcome.

Keywords: Sensitivity and specificity; ROC curve; reference standards; carpal tunnel syndrome; ultrasonography.
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