Dataset Information

Uptake and positive predictive value of fecal occult blood tests: A randomized controlled trial.

ABSTRACT:

Objective

The aim of this study is to compare the uptake of three mailed high-sensitivity fecal occult blood tests (FOBTs).

Methods

We conducted a parallel 3-arm randomized controlled trial in an integrated healthcare delivery system in Washington State. From January 2010 through February 2011, automated data were used to identify potentially eligible patients aged 50-74 due for colorectal cancer screening. Participants were mailed one of three FOBT kits (1-sample OC-Auto® fecal immunochemical test [FIT], 2-sample InSure® FIT, or 3-sample guaiac Hemoccult SENSA®), instructions, and a postage-paid return envelope. We performed a modified intent-to-treat analysis with return of any FOBT within 6 months of randomization as the primary outcome.

Results

Of the 9922 people invited, 2873 returned surveys, 2263 were randomized, and 2234 were analyzed. FOBTs were returned by 1431 participants. At 6 months post-randomization, the proportions screened by any FOBT were 0.69 (95% confidence interval [CI] 0.66-0.72) for the OC-Auto arm, 0.64 (95% CI: 0.61-0.68) for the InSure arm, and 0.61 (95% CI: 0.58-0.65) for the Hemoccult SENSA arm (P<0.001 for any difference). Pairwise comparisons showed significant differences between the OC-Auto group and each of the other groups after correction for multiple comparisons.

Conclusion

Uptake of mailed FOBT kits varies by kit type.

SUBMITTER: Chubak J

PROVIDER: S-EPMC3856243 | biostudies-literature | 2013 Nov

REPOSITORIES: biostudies-literature

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Publications

Uptake and positive predictive value of fecal occult blood tests: A randomized controlled trial.

Chubak Jessica J Bogart Andy A Fuller Sharon S Laing Sharon S SS Green Beverly B BB

Preventive medicine 20130909 5

<h4>Objective</h4>The aim of this study is to compare the uptake of three mailed high-sensitivity fecal occult blood tests (FOBTs).<h4>Methods</h4>We conducted a parallel 3-arm randomized controlled trial in an integrated healthcare delivery system in Washington State. From January 2010 through February 2011, automated data were used to identify potentially eligible patients aged 50-74 due for colorectal cancer screening. Participants were mailed one of three FOBT kits (1-sample OC-Auto® fecal i ...[more]

PMID: 24029556

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Project description:BACKGROUND:Fecal occult blood tests (FOBTs) are recommended by the US Preventive Services Task Force as a screening method for colorectal cancer (CRC), but they are only effective if positive results are followed by colonoscopy. Surprisingly, a large proportion of patients with a positive result do not follow this recommendation. OBJECTIVE:The objective of this study was to examine the effectiveness of text messaging (short message service, SMS) in increasing adherence to colonoscopy follow-up after a positive FOBT result. METHODS:This randomized controlled trial was conducted with patients who had positive CRC screening results. Randomization was stratified by residential district and socioeconomic status (SES). Subjects in the control group (n=238) received routine care that included an alert to the physician regarding the positive FOBT result. The intervention group (n=232) received routine care and 3 text messaging SMS reminders to visit their primary care physician. Adherence to colonoscopy was measured 120 days from the positive result. All patient information, including test results and colonoscopy completion, were obtained from their electronic medical records. Physicians of study patients completed an attitude survey regarding FOBT as a screening test for CRC. Intervention and control group variables (dependent and independent) were compared using chi-square test. Logistic regression was used to calculate odds ratios (ORs) and 95% CIs for performing colonoscopy within 120 days for the intervention group compared with the control group while adjusting for potential confounders including age, gender, SES, district, ethnicity, and physicians' attitude. RESULTS:Overall, 163 of the 232 patients in the intervention group and 112 of the 238 patients in the control group underwent colonoscopy within 120 days of the positive FOBT results (70.3% vs 47.1%; OR 2.17, 95% CI 1.49-3.17; P<.001); this association remained significant after adjusting for potential confounders (P=.001). CONCLUSIONS:A text message (SMS) reminder is an effective, simple, and inexpensive method for improving adherence among patients with positive colorectal screening results. This type of intervention could also be evaluated for other types of screening tests. TRIAL REGISTRATION:ClinicalTrials.gov NCT03642652; https://clinicaltrials.gov/ct2/show/NCT03642652 (Archived by WebCite at http://www.webcitation.org/74TlICijl).

Project description:BackgroundNo head-to-head randomized controlled trials have demonstrated the superiority of one colorectal screening modality over another in reducing colorectal cancer mortality. We conducted a pilot randomized controlled trial of fecal occult blood testing (FOBT), optical colonoscopy (OC), and virtual colonoscopy (VC), to inform the planning of a larger evaluative trial.MethodsEligible 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 no additional reminders to complete their allocated screening test beyond those received in usual practice. The primary outcome was completion of the assigned screening procedure. Results of the index test and any follow-up investigations were ascertained at 6 months. Participants, caregivers, and outcome assessors were not blinded to group assignment. The trial was stopped early due to lack of ongoing funding.ResultsA total of 198 participants were enrolled, of whom 67 were allocated to FOBT, 66 to OC, and 65 to VC. The allocated 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 in completion 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 histological evidence of high-grade dysplasia. No subjects were diagnosed with colorectal cancer.ConclusionsIn 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 planning clinical trials to evaluate the effectiveness of colorectal cancer screening.Trial registrationClinicalTrials.gov NCT00865527. https://clinicaltrials.gov/ct2/show/NCT00865527.

Dataset Information

Uptake and positive predictive value of fecal occult blood tests: A randomized controlled trial.

Objective

Methods

Results

Conclusion

Publications

Uptake and positive predictive value of fecal occult blood tests: A randomized controlled trial.

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