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

被引：12

作者：

Durkalski, VL

Palesch, YY

Pineau, BC

Vining, DJ

Cotton, PB

机构：

[1] Med Univ S Carolina, MUSC Fdn Res & Dev, TCIG STATS, Clin Innovat Grp, Charleston, SC 29425 USA

[2] Wake Forest Univ, Sch Med, Dept Gastroenterol, Winston Salem, NC 27109 USA

[3] Wake Forest Univ, Sch Med, Dept Radiol, Winston Salem, NC 27109 USA

[4] Med Univ S Carolina, Ctr Digest Dis, Charleston, SC 29425 USA

来源：

CONTROLLED CLINICAL TRIALS | 2002年 / 23卷 / 05期

关键词：

diagnostic testing; one-sided equivalence; noninferiority; colonoscopy;

D O I：

10.1016/S0197-2456(02)00232-5

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

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 greater than or equal to6 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. (C) 2002 Elsevier Science Inc. All rights reserved.

引用

页码：570 / 583

页数：14

共 37 条

[1] Ahlquist D A, 1997, Gastrointest Endosc Clin N Am, V7, P439
[2] ARMINSKI T. C., 1964, DIS COLON RECTUM, V7, P249, DOI 10.1007/BF02630528
[3] Bensen S, 1999, AM J GASTROENTEROL, V94, P194
[4] APPLICATION OF MATCHED PAIR PROCEDURES TO SITE-SPECIFIC DATA IN PERIODONTAL RESEARCH
DONNER, A
ELIASZIW, M
[J]. JOURNAL OF CLINICAL PERIODONTOLOGY, 1991, 18 (10) : 755 - 759
[5] DURKALSKI VL, 2002, IN PRESS STAT ME JUN
[6] Ebbutt AF, 1998, STAT MED, V17, P1691, DOI 10.1002/(SICI)1097-0258(19980815/30)17:15/16<1691::AID-SIM971>3.3.CO
[7] 2-A
[8] *FDA, 1992, POINTS CONS
[9] A comparison of virtual and conventional colonoscopy for the detection of colorectal polyps
Fenlon, HM
Nunes, DP
Schroy, PC
Barish, MA
Clarke, PD
Ferrucci, JT
[J]. NEW ENGLAND JOURNAL OF MEDICINE, 1999, 341 (20) : 1496 - 1503
[10] Design and interpretation of equivalence trials
Fleming, TR
[J]. AMERICAN HEART JOURNAL, 2000, 139 (04) : S171 - S176

← 1 2 3 4 →