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Patient-Reported Barriers to Completing a Diagnostic Colonoscopy Following Abnormal Fecal Immunochemical Test Among Uninsured Patients.

ABSTRACT: BACKGROUND:For colorectal cancer (CRC) screening to improve survival, patients with an abnormal fecal immunochemical test (FIT) must follow-up with a diagnostic colonoscopy. Adherence to follow-up is low and patient-level barriers for suboptimal adherence have yet to be explored. OBJECTIVE:To characterize barriers for non-completion of diagnostic colonoscopy after an abnormal FIT reported by under- and uninsured patients receiving care in a safety-net health system. DESIGN:A longitudinal, cohort study of CRC screening outreach to 8565 patients using mailed FIT kits. Patients with abnormal FIT results received telephonic navigation to arrange for a no-cost diagnostic colonoscopy. PATIENTS:Adults aged 50-64 years receiving care at a North Texas safety-net health system. APPROACH:Descriptive analyses characterized the patient sample and reasons for lack of follow-up after abnormal FIT over the 3-year outreach program. Thematic qualitative analyses characterized reasons for lack of follow-up with a colonoscopy after the abnormal FIT. KEY RESULTS:Of 689 patients with an abnormal FIT, 45% (n?=?314) did not complete a follow-up colonoscopy. Among the 314 non-completers, 184 patients reported reasons for not completing a follow-up colonoscopy included health insurance-related challenges (38%), comorbid conditions (37%), social barriers such as transportation difficulties and lack of social support (29%), concerns about FIT/colonoscopy process (12%), competing life priorities (12%), adverse effects of bowel preparation (3%), and poor health literacy (3%). Among the 314 non-completers, 131 patients did not report a barrier, as 51% reported that that had completed a previous colonoscopy in the past 10 years, 10% refused with no reason, and 10% were never reached by phone. CONCLUSIONS:Future studies aimed at improving FIT screening and subsequent colonoscopy rates need to address the unique needs of patients for effective and sustainable screening programs. TRIAL REGISTRATION:NCT01946282.

SUBMITTER: Jetelina KK

PROVIDER: S-EPMC6712145 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Patient-Reported Barriers to Completing a Diagnostic Colonoscopy Following Abnormal Fecal Immunochemical Test Among Uninsured Patients.

Jetelina Katelyn K KK Yudkin Joshua S JS Miller Stacie S Berry Emily E Lieberman Alicea A Gupta Samir S Balasubramanian Bijal A BA

Journal of general internal medicine 20190621 9

<h4>Background</h4>For colorectal cancer (CRC) screening to improve survival, patients with an abnormal fecal immunochemical test (FIT) must follow-up with a diagnostic colonoscopy. Adherence to follow-up is low and patient-level barriers for suboptimal adherence have yet to be explored.<h4>Objective</h4>To characterize barriers for non-completion of diagnostic colonoscopy after an abnormal FIT reported by under- and uninsured patients receiving care in a safety-net health system.<h4>Design</h4> ...[more]

PMID: 31228053

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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.

Project description: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?<?.001 for all comparisons). Compared with usual care, the between-group differences in adenoma and advanced neoplasia detection rates were higher for both outreach groups (colonoscopy outreach group: 10.3% [95% CI, 9.5% to 12.1%] for adenoma and 3.1% [95% CI, 2.0% to 4.1%] for advanced neoplasia, P?<?.001 for both comparisons; FIT outreach group: 1.3% [95% CI, -0.1% to 2.8%] for adenoma and 0.7% [95% CI, -0.2% to 1.6%] for advanced neoplasia, P?<?.08 and P?<?.13, respectively), and highest in the colonoscopy outreach group (colonoscopy outreach group vs FIT outreach group: 9.0% [95% CI, 7.3% to 10.7%] for adenoma and 2.4% [95% CI, 1.3% to 3.3%] for advanced neoplasia, P?<?.001 for both comparisons). There were no screening-related harms in any groups. Conclusions and Relevance:Among persons aged 50 to 64 years receiving primary care at a safety-net institution, mailed outreach invitations offering FIT or colonoscopy compared with usual care increased the proportion completing CRC screening process within 3 years. The rate of screening process completion was higher with colonoscopy than FIT outreach. Trial Registration:clinicaltrials.gov Identifier: NCT01710215.

Project description:Background & aimsNoninvasive tests used in colorectal cancer screening, such as the fecal immunochemical test (FIT), are more acceptable but detect neoplasias with lower levels of sensitivity than colonoscopy. We investigated whether lowering the cut-off concentration of hemoglobin for designation as an abnormal FIT result increased the detection of advanced neoplasia in a mailed outreach program.MethodsWe performed a prospective study of 17,017 uninsured patients, age 50 to 64 years, who were not current with screening and enrolled in a safety-net system in Texas. We reduced the cut-off value for an abnormal FIT result from 20 or more to 10 or more ?g hemoglobin/g feces a priori. All patients with abnormal FIT results were offered no-cost diagnostic colonoscopy. We compared proportions of patients with abnormal FIT results and neoplasia yield for standard vs lower cut-off values, as well as absolute hemoglobin concentration distribution among 5838 persons who completed the FIT. Our primary aim was to determine the effects of implementing a lower hemoglobin concentration cut-off value on colonoscopy demand and yield, specifically colorectal cancer (CRC) and advanced neoplasia detection, compared with the standard, higher, hemoglobin concentration cut-off value.ResultsThe proportions of patients with abnormal FIT results were 12.3% at the 10 or more ?g hemoglobin/g feces and 6.6% at the standard 20 or more ?g hemoglobin/g feces cut-off value (P = .0013). Detection rates for the lower vs the standard threshold were 10.2% vs 12.7% for advanced neoplasia (P = .12) and 0.9% vs 1.2% for CRC (P = .718). The positive predictive values were 18.9% for the lower threshold vs 24.4% for the standard threshold for advanced neoplasia (P = .053), and 1.7% vs 2.4% for CRC (P = .659). The number needed to screen to detect 1 case with advanced neoplasia was 45 at the lower threshold compared with 58 at the standard threshold; the number needed to scope to detect 1 case with advanced neoplasia increased from 4 to 5. Most patients with CRC (72.7%) or advanced adenoma (67.3%) had hemoglobin concentrations of 20 or more ?g/g feces. In the group with 10 to 19 ?g hemoglobin/g feces, there were 3 patients with CRC (3 of 11; 27.3%) and 36 with advanced adenoma (36 of 110; 32.7%) who would not have been detected at the standard positive threshold (advanced neoplasia Pcomparison < .001). The proportion of patients found to have no neoplasia after an abnormal FIT result (false positives) was not significantly higher with the lower cut-off value (44.4%) than the standard cut-off value (39.1%) (P = .1103).ConclusionsIn a prospective study of 17,017 uninsured patients, we found that reducing the abnormal FIT result cut-off value (to ?10 ?g hemoglobin/g feces) might increase detection of advanced neoplasia, but doubled the proportion of patients requiring a diagnostic colonoscopy. If colonoscopy capacity permits, health systems that use quantitative FITs should consider lowering the abnormal cut-off value to optimize CRC detection and prevention. (ClinicalTrials.gov no: NCT01946282.).

Project description:ImportanceThe potential role of the fecal immunochemical test (FIT) for screening patients at increased risk for colorectal cancer (CRC) has not yet been elucidated.ObjectiveTo assess the diagnostic accuracy of FIT for CRC or advanced neoplasia (AN) in asymptomatic patients at above-average risk.Data sourcesMEDLINE, EMBASE, Cochrane Library, and gray literature sources through August 2016.Study selectionDiagnostic studies evaluating the accuracy of FIT for CRC or AN in patients with a personal or familial history of CRC using colonoscopy as the reference standard.Data extraction and synthesisTwo authors (A.K. and P.P.) independently extracted data and evaluated study quality using the Quality Assessment of Diagnostic Accuracy Studies-2 tool, and evaluated the quality of the body of evidence by means of GRADE (Grading of Recommendations Assessment, Development, and Evaluation). Hierarchical models were used to synthesize available evidence.Main outcomes and measuresThe primary outcome was the diagnostic performance of FIT for detecting CRC or AN.ResultsWe included 12 studies (6204 participants). Seven studies were deemed at high or unclear risk of bias. The average sensitivity of FIT for CRC was 93% (95% CI, 53%-99%), and the average specificity was 91% (95% CI, 89%-92%), yielding a positive likelihood ratio (LR+) of 10.30 (CI 7.7-13.9) and a negative likelihood ratio (LR-) of 0.08 (95% CI, 0.01-0.75) (GRADE: very low). The average sensitivity of FIT for AN was 48% (95% CI, 39%-57%); and the average specificity was 93% (95% CI, 91%-94%), yielding an LR+ of 6.55 (95% CI, 5.0-8.5) and an LR- of 0.57 (95% CI, 0.48-0.67) (GRADE: very low). Subgroup analyses indicated that FIT cutoff values between 15- and 25-μg/g feces provided the best combination of sensitivity and specificity for the diagnosis of CRC (93% and 94%, respectively). Quantitative and 1-sample FIT showed adequate test performance, but data on other FIT brands and multiple samples were insufficient.Conclusions and relevanceThe FIT has high overall diagnostic accuracy for CRC but moderate accuracy for AN in patients at above-average personal or familial risk. Heterogeneity and wide confidence intervals limit the trustworthiness of our findings.

Dataset Information

Patient-Reported Barriers to Completing a Diagnostic Colonoscopy Following Abnormal Fecal Immunochemical Test Among Uninsured Patients.

Publications

Patient-Reported Barriers to Completing a Diagnostic Colonoscopy Following Abnormal Fecal Immunochemical Test Among Uninsured Patients.

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