The Virtual Colonoscopy Study: A large multicenter clinical trial designed to compare two diagnostic screening procedures

Valerie L. Durkalski, Yuko Y. Palesch, Benoit C. Pineau, David Vining, Peter B. Cotton

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

This paper reviews the design of a large multicenter clinical trial currently being conducted to test the equivalence of two screening procedures for colorectal polyps. The primary outcome is the sensitivity and specificity of the new and standard procedures for detecting subjects with and without polyps of a size ≥6 mm, respectively. An important secondary outcome is the accuracy of these procedures in detecting individual polyps. A total of 619 participants underwent virtual colonoscopy, the new procedure, followed by conventional colonoscopy, the standard procedure. Strategies for the design and implementation of the study are shared as well as the challenges encountered.

Original languageEnglish (US)
Pages (from-to)570-583
Number of pages14
JournalControlled clinical trials
Volume23
Issue number5
DOIs
StatePublished - Jan 1 2002

Fingerprint

Computed Tomographic Colonography
Multicenter Studies
Clinical Trials
Polyps
Colonoscopy
Sensitivity and Specificity

Keywords

  • Colonoscopy
  • Diagnostic testing
  • Noninferiority
  • One-sided equivalence

ASJC Scopus subject areas

  • Pharmacology

Cite this

The Virtual Colonoscopy Study : A large multicenter clinical trial designed to compare two diagnostic screening procedures. / Durkalski, Valerie L.; Palesch, Yuko Y.; Pineau, Benoit C.; Vining, David; Cotton, Peter B.

In: Controlled clinical trials, Vol. 23, No. 5, 01.01.2002, p. 570-583.

Research output: Contribution to journalArticle

Durkalski, Valerie L. ; Palesch, Yuko Y. ; Pineau, Benoit C. ; Vining, David ; Cotton, Peter B. / The Virtual Colonoscopy Study : A large multicenter clinical trial designed to compare two diagnostic screening procedures. In: Controlled clinical trials. 2002 ; Vol. 23, No. 5. pp. 570-583.
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