188宝金博页面版

RESEARCH Open AccessVirtual colonoscopy, optical colonoscopy,or fecal occult blood testing for colorectalcancer screening: results of a pilotrandomized controlled trialJohn J. You 1,2* , Yudong Liu 3 , John Kirby 4 , Parag Vora 5 and Paul Moayyedi 1AbstractBackground: No head-to-head randomized controlled trials have demonstrated the superiority of one colorectalscreening modality over another in reducing colorectal cancer mortality. We conducted a pilot randomizedcontrolled trial of fecal occult blood testing (FOBT), optical colonoscopy (OC), and virtual colonoscopy (VC), toinform the planning of a larger evaluative trial.Methods: Eligible patients (aged 50 to 70) were recruited from five primary care practices in Hamilton, ON, Canada,between March 23, 2010 and August 11, 2010, and randomized 1:1:1 in a parallel design using an automated,centralized telephone service to either FOBT, OC, or VC. To reflect conventional practice, patients received noadditional reminders to complete their allocated screening test beyond those received in usual practice. Theprimary outcome was completion of the assigned screening procedure. Results of the index test and any follow-upinvestigations were ascertained at 6 months. Participants, caregivers, and outcome assessors were not blinded togroup assignment. The trial was stopped early due to lack of ongoing funding.Results: A total of 198 participants were enrolled, of whom 67 were allocated to FOBT, 66 to OC, and 65 to VC. Theallocated screening procedure was completed by 43 (64 %) subjects allocated to FOBT (95 % confidence interval [CI],52–75 %), 53 (80 %) subjects allocated to OC (95 % CI, 69–88 %), and 50 (77 %) subjects allocated to VC (95 % CI,65–85 %); because the trial stopped early, we had insufficient statistical power to detect clinically relevant differences incompletion rates. During 6 months follow-up, colorectal adenomas were detected in 0 (0 %) subjects allocated to FOBT,12 (18 %) subjects allocated to OC, and 2 (3 %) subjects allocated to VC. One subject in the OC arm had histologicalevidence of high-grade dysplasia. No subjects were diagnosed with colorectal cancer.Conclusions: In this pilot randomized controlled trial of colorectal cancer screening in a primary care setting,64–80 % of subjects completed their allocated screening test. These findings may be of value to investigators planningclinical trials to evaluate the effectiveness of colorectal cancer screening.Trial registration: ClinicalTrials.gov NCT00865527. https://clinicaltrials.gov/ct2/show/NCT00865527Keywords: Colonoscopy, Colorectal cancer, Computed tomography colonography, Fecal occult blood testing, pilotstudy, Prevention, Randomized controlled trial, Screening, Virtual colonoscopy* Correspondence: jyou@mcmaster.ca1 Department of Medicine, McMaster University, 1280 Main Street West, RoomHSC-2C8, Hamilton, Ontario L8S 4K1, Canada2 Department of Clinical Epidemiology & Biostatistics, McMaster University,1280 Main Street West, Room HSC-2C8, Hamilton, Ontario L8S 4K1, CanadaFull list of author information is available at the end of the articleTRIALS© 2015 You et al. This is an Open Access article distributed under the terms of the Creative Commons AttributionLicense (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproductionin any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.You et al. Trials (2015) 16:296 DOI 10.1186/s13063-015-0826-7