Dataset Information

Effect of Colonoscopy Outreach vs Fecal Immunochemical Test Outreach on Colorectal Cancer Screening Completion: A Randomized Clinical Trial.

ABSTRACT: Importance:Mailed fecal immunochemical test (FIT) outreach is more effective than colonoscopy outreach for increasing 1-time colorectal cancer (CRC) screening, but long-term effectiveness may need repeat testing and timely follow-up for abnormal results. Objective:Compare the effectiveness of FIT outreach and colonoscopy outreach to increase completion of the CRC screening process (screening initiation and follow-up) within 3 years. Design, Setting, and Participants:Pragmatic randomized clinical trial from March 2013 to July 2016 among 5999 participants aged 50 to 64 years who were receiving primary care in Parkland Health and Hospital System and were not up to date with CRC screenings. Interventions:Random assignment to mailed FIT outreach (n?=?2400), mailed colonoscopy outreach (n?=?2400), or usual care with clinic-based screening (n?=?1199). Outreach included processes to promote repeat annual testing for individuals in the FIT outreach group with normal results and completion of diagnostic and screening colonoscopy for those with an abnormal FIT result or assigned to colonoscopy outreach. Main Outcomes and Measures:Primary outcome was screening process completion, defined as adherence to colonoscopy completion, annual testing for a normal FIT result, diagnostic colonoscopy for an abnormal FIT result, or treatment evaluation if CRC was detected. Secondary outcomes included detection of any adenoma or advanced neoplasia (including CRC) and screening-related harms (including bleeding or perforation). Results:All 5999 participants (median age, 56 years; women, 61.9%) were included in the intention-to-screen analyses. Screening process completion was 38.4% in the colonoscopy outreach group, 28.0% in the FIT outreach group, and 10.7% in the usual care group. Compared with the usual care group, between-group differences for completion were higher for both outreach groups (27.7% [95% CI, 25.1% to 30.4%] for the colonoscopy outreach group; 17.3% [95% CI, 14.8% to 19.8%] for FIT outreach group), and highest in the colonoscopy outreach group (10.4% [95% CI, 7.8% to 13.1%] for the colonoscopy outreach group vs FIT outreach group; P?

SUBMITTER: Singal AG

PROVIDER: S-EPMC5648645 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Effect of Colonoscopy Outreach vs Fecal Immunochemical Test Outreach on Colorectal Cancer Screening Completion: A Randomized Clinical Trial.

Singal Amit G AG Gupta Samir S Skinner Celette Sugg CS Ahn Chul C Santini Noel O NO Agrawal Deepak D Mayorga Christian A CA Murphy Caitlin C Tiro Jasmin A JA McCallister Katharine K Sanders Joanne M JM Bishop Wendy Pechero WP Loewen Adam C AC Halm Ethan A EA

JAMA 20170901 9

<h4>Importance</h4>Mailed fecal immunochemical test (FIT) outreach is more effective than colonoscopy outreach for increasing 1-time colorectal cancer (CRC) screening, but long-term effectiveness may need repeat testing and timely follow-up for abnormal results.<h4>Objective</h4>Compare the effectiveness of FIT outreach and colonoscopy outreach to increase completion of the CRC screening process (screening initiation and follow-up) within 3 years.<h4>Design, setting, and participants</h4>Pragmat ...[more]

PMID: 28873161

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Project description:IMPORTANCE:Colorectal cancer (CRC) screening saves lives, but participation rates are low among underserved populations. Knowledge on effective approaches for screening the underserved, including best test type to offer, is limited. OBJECTIVE:To determine (1) if organized mailed outreach boosts CRC screening compared with usual care and (2) if FIT is superior to colonoscopy outreach for CRC screening participation in an underserved population. DESIGN, SETTING, AND PARTICIPANTS:We identified uninsured patients, not up to date with CRC screening, age 54 to 64 years, served by the John Peter Smith Health Network, Fort Worth and Tarrant County, Texas, a safety net health system. INTERVENTIONS:Patients were assigned randomly to 1 of 3 groups. One group was assigned to fecal immunochemical test (FIT) outreach, consisting of mailed invitation to use and return an enclosed no-cost FIT (n?=?1593). A second was assigned to colonoscopy outreach, consisting of mailed invitation to schedule a no-cost colonoscopy (n?=?479). The third group was assigned to usual care, consisting of opportunistic primary care visit–based screening (n?=?3898). In addition, FIT and colonoscopy outreach groups received telephone follow-up to promote test completion. MAIN OUTCOME MEASURES:Screening participation in any CRC test within 1 year after randomization. RESULTS:Mean patient age was 59 years; 64% of patients were women. The sample was 41% white, 24% black, 29% Hispanic, and 7% other race/ethnicity. Screening participation was significantly higher for both FIT (40.7%) and colonoscopy outreach (24.6%) than for usual care (12.1%) (P?<?.001 for both comparisons with usual care). Screening was significantly higher for FIT than for colonoscopy outreach (P?<?.001). In stratified analyses, screening was higher for FIT and colonoscopy outreach than for usual care, and higher for FIT than for colonoscopy outreach among whites, blacks, and Hispanics (P?<?.005 for all comparisons). Rates of CRC identification and advanced adenoma detection were 0.4% and 0.8% for FIT outreach, 0.4% and 1.3% for colonoscopy outreach, and 0.2% and 0.4% for usual care, respectively (P?<?.05 for colonoscopy vs usual care advanced adenoma comparison; P?>?.05 for all other comparisons). Eleven of 60 patients with abnormal FIT results did not complete colonoscopy. CONCLUSIONS AND REVELANCE: Among underserved patients whose CRC screening was not up to date, mailed outreach invitations resulted in markedly higher CRC screening compared with usual care. Outreach was more effective with FIT than with colonoscopy invitation. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT01191411.

Project description:BACKGROUND & AIMS:Biomarker assays could increase the accuracy of noninvasive detection of colorectal cancer (CRC); fecal immunochemical tests (FITs) are estimated to miss 27%-47% of CRCs and 70%-80% of advanced adenomas per round of screening. We investigated the conditions under which biomarker screens would be cost-effective compared with FIT screens of average-risk individuals. METHODS:We used the MISCAN-Colon microsimulation model to estimate the effects of various CRC screening test characteristics on life-years gained (LYG) and; age-specific all-cause mortality was based on the 2010 Dutch life tables. Simulated CRC incidence rate and CRC stage distribution were calibrated to observed data in The Netherlands from 1999 through 2003 (before opportunities for screening). Survival rates after diagnosis of CRC at an age younger than 75 years were based on CRC relative survival data from 1985 through 2004; survival for individuals diagnosed at an age of 75 years or older was adjusted to fit the observed age-increasing mortality/incidence ratio. We modeled FIT along with hypothetical biomarker tests with different test performance levels. For each biomarker test we calculated the maximum unit cost for the test to be cost-effective compared with FIT, assuming a willingness-to-pay threshold of €50,000 ($56,000) per LYG. RESULTS:Biennial FIT screening of subjects 55-75 years old provided 84.9 LYG at a cost of €122,000 ($137,000) per 1000 participants. Considering a unit cost of €7 ($8) for FIT (including kit and analysis only, excluding organizational costs), a biomarker test that detects CRC with higher levels of specificity and sensitivity (100%) and advanced adenomas at a proportionally higher level of sensitivity (53%) should never exceed a cost of €51 ($57). The threshold cost could increase to more than €200 ($224) for high-performing biomarker tests in cases of limited colonoscopy capacity or higher uptake of this test. CONCLUSIONS:By using the MISCAN-Colon microsimulation model to estimate effects of CRC screening tests, we found that for a biomarker test with increased overall performance to be cost-effective, it should not exceed 7-fold the unit cost of FIT. This maximum would increase substantially if colonoscopy becomes more expensive or scarce, or if the new test has higher screening uptake. These values could be used to estimate the added value of new biomarkers compared with current FIT screening.

Project description:ImportanceThe effectiveness of stool-based colorectal cancer (CRC) screening, including fecal immunochemical tests (FITs), relies on colonoscopy completion among patients with abnormal results, but in safety net systems and federally qualified health centers, in which FIT is frequently used, colonoscopy completion within 1 year of an abnormal result rarely exceeds 50%. Clinician-identified factors in follow-up of abnormal FIT results are understudied and could lead to more effective interventions to address this issue.ObjectiveTo describe clinician-identified barriers and facilitators to colonoscopy completion among patients with abnormal FIT results in a safety net health care system.Design, setting, and participantsThis qualitative study was conducted using semistructured key informant interviews with primary care physicians (PCPs) and staff members in a large safety net health care system in Washington state. Eligible clinicians were recruited through all-staff meetings and clinic medical directors. Interviews were conducted from February to December 2020 through face-to-face interactions or digital meeting platforms. Interview transcripts were analyzed deductively and inductively using a content analysis approach. Data were analyzed from September through December 2020.Main outcomes and measuresBarriers and facilitators to colonoscopy completion after an abnormal FIT result were identified by PCPs and staff members.ResultsAmong 21 participants, there were 10 PCPs and 11 staff members; 20 participants provided demographic information. The median (interquartile range) age was 38.5 (33.0-51.5) years, 17 (85.0%) were women, and 9 participants (45.0%) spent more than 75% of their working time engaging in patient care. All participants identified social determinants of health, organizational factors, and patient cognitive factors as barriers to colonoscopy completion. Participants suggested that existing resources that addressed these factors facilitated colonoscopy completion but were insufficient to meet national follow-up colonoscopy goals.Conclusions and relevanceIn this qualitative study, responses of interviewed PCPs and staff members suggested that the barriers to colonoscopy completion in a safety net health system may be modifiable. These findings suggest that interventions to improve follow-up of abnormal FIT results should be informed by clinician-identified factors to address multilevel challenges to colonoscopy completion.

Dataset Information

Effect of Colonoscopy Outreach vs Fecal Immunochemical Test Outreach on Colorectal Cancer Screening Completion: A Randomized Clinical Trial.

Publications

Effect of Colonoscopy Outreach vs Fecal Immunochemical Test Outreach on Colorectal Cancer Screening Completion: A Randomized Clinical Trial.

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