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 J. Vining; Peter B. Cotton

doi:10.1016/S0197-2456(02)00232-5

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 J. Vining, Peter B. Cotton

Research output: Contribution to journal › Article › peer-review

16 Scopus citations

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 language	English (US)
Pages (from-to)	570-583
Number of pages	14
Journal	Controlled clinical trials
Volume	23
Issue number	5
DOIs	https://doi.org/10.1016/S0197-2456(02)00232-5
State	Published - Oct 2002
Externally published	Yes

Keywords

Colonoscopy
Diagnostic testing
Noninferiority
One-sided equivalence

ASJC Scopus subject areas

Pharmacology

Access to Document

10.1016/S0197-2456(02)00232-5

Cite this

@article{3b21e244297d4b50b8815c479db96f8c,

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

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.",

keywords = "Colonoscopy, Diagnostic testing, Noninferiority, One-sided equivalence",

author = "Durkalski, {Valerie L.} and Palesch, {Yuko Y.} and Pineau, {Benoit C.} and Vining, {David J.} and Cotton, {Peter B.}",

note = "Funding Information: This work was supported in part by the Office of Navy Research (ONR) Grant No. N00014-99-1-0784 from the Department of Defense. ",

year = "2002",

month = oct,

doi = "10.1016/S0197-2456(02)00232-5",

language = "English (US)",

volume = "23",

pages = "570--583",

journal = "Controlled clinical trials",

issn = "0197-2456",

publisher = "Elsevier BV",

number = "5",

}

TY - JOUR

T1 - The Virtual Colonoscopy Study

T2 - A large multicenter clinical trial designed to compare two diagnostic screening procedures

AU - Durkalski, Valerie L.

AU - Palesch, Yuko Y.

AU - Pineau, Benoit C.

AU - Vining, David J.

AU - Cotton, Peter B.

N1 - Funding Information: This work was supported in part by the Office of Navy Research (ONR) Grant No. N00014-99-1-0784 from the Department of Defense.

PY - 2002/10

Y1 - 2002/10

N2 - 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.

AB - 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.

KW - Colonoscopy

KW - Diagnostic testing

KW - Noninferiority

KW - One-sided equivalence

UR - http://www.scopus.com/inward/record.url?scp=0036774023&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0036774023&partnerID=8YFLogxK

U2 - 10.1016/S0197-2456(02)00232-5

DO - 10.1016/S0197-2456(02)00232-5

M3 - Article

C2 - 12392872

AN - SCOPUS:0036774023

SN - 0197-2456

VL - 23

SP - 570

EP - 583

JO - Controlled clinical trials

JF - Controlled clinical trials

IS - 5

ER -

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

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this