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BMJ 2003;327:162 (19 July), doi:10.1136/bmj.327.7407.162-a
| The first 150 words of the full text of this article appear below. |
EDITORInd and Whitley, as well as other respondents to our paper on bmj.com, refer to the issue of our split sample design.1 Many such previous studies show that monolayers are superior to conventional smears (and were used to obtain approval from the Food and Drug Administration for ThinPreps). Now some who praised this design when it favoured monolayers are discovering that it is "flawed" or "faulty" when it gives the opposite results.
Our paper shows that the main issue for monolayer evaluation is not the
split sample bias (paucicellular monolayers were negligible, and the results
were similar for the subgroup of women with large amounts of material
remaining after monolayer preparation). It is instead the workup or
verification bias, present whenever the reference test is not systematically
used. This bias inflates sensitivity and favours the test with the higher rate
of false positive results: the monolayer technique.
Joël Coste, professor of medical statistics
Département de Biostatistique, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Faculté de Médecine Cochin-Port Royal, Université Paris V, Paris, France coste@cochin.univ-paris5.fr
Béatrix Cochand-Priollet, assistant-professor of pathology
Service d'Anatomie et Cytologie Pathologiques, Hôpital Lariboisière, Assistance Publique-Hôpitaux de Paris, Paris
Patricia de Cremoux, assistant-professor of pharmacology
Laboratoire de Physiopathologie, Département de Biologie des Tumeurs, Institut Curie, Paris