Unsatisfactory Fecal Immunochemical Tests for Colorectal Cancer Screening: Prevalence, Reasons, and Subsequent Testing.

BACKGROUND: Fecal immunochemical test (FIT) is an effective colorectal cancer screening modality. Little is known about prevalence, reasons, and testing after unsatisfactory FIT, or a FIT that cannot be processed by the laboratory due to inadequate stool specimen or incomplete labeling. METHODS: Our retrospective cohort study examined unsatisfactory FIT among average-risk individuals aged 50-74 years in a large, integrated, safety-net health system who completed an index FIT from 2010 to 2019. We determined prevalence of unsatisfactory FIT and categorized reasons hierarchically. We used multivariable logistic regression models to identify factors associated with: (i) unsatisfactory FIT; and (ii) subsequent testing within 15 months of the unsatisfactory FIT. RESULTS: Of 56,980 individuals completing an index FIT, 10.2% had an unsatisfactory FIT. Reasons included inadequate specimen (51%), incomplete labeling (27%), old specimen (13%), and broken/leaking container (8%). Unsatisfactory FIT was associated with being male [OR, 1.10; confidence interval (CI), 1.03-1.16], Black (OR, 1.46; CI, 1.33-1.61), Spanish speaking (OR, 1.12; CI, 1.01-1.24), on Medicaid (OR, 1.42; CI, 1.28-1.58), and received FIT by mail (OR, 2.66; CI, 2.35-3.01). Among those with an unsatisfactory FIT, fewer than half (41%) completed a subsequent test within 15 months (median, 4.4 months). Adults aged 50-54 years (OR, 1.16; CI, 1.01-1.39) and those who received FIT by mail (OR, 1.92; CI, 1.49-2.09) were more likely to complete a subsequent test. CONCLUSIONS: One in ten returned a FIT that could not be processed, mostly due to patient-related reasons. Fewer than half completed a subsequent test after unsatisfactory FIT. IMPACT: Screening programs should address these breakdowns such as specimen collection and labeling to improve real-world effectiveness. See related In the Spotlight, p. 183.

Improving Colorectal Cancer Screening in a Regional Safety-Net Health System over a 10-Year Period: Lessons for Population Health.

BACKGROUND: Despite national policy efforts to increase colorectal cancer (CRC) screening, rates in vulnerable populations remain suboptimal. Many types of interventions have been employed, but their impact on improving population-level rates of CRC screening over time is uncertain. OBJECTIVE: Assess the impact of 10 years of different in-reach and outreach strategies to improve CRC screening and identify factors associated with being screen up-to-date (SUTD). DESIGN: Observational cohort study. PARTICIPANTS: Patients aged 50-74 years from 12 community-based primary care clinics in an integrated, regional safety-net health system. INTERVENTIONS: Multiple system-level interventions were implemented over time (visit-based electronic health record [EHR] reminders, quality measurement, annual preventive service letters, and mailed fecal immunohistochemical stool tests [FIT]). MAIN MEASURES: CRC SUTD rates by calendar year among those with a primary care (PC) visit in the prior 1 and 3 years and their multivariable correlates. KEY RESULTS: The sample included 31,786-40,405 patients/year. In 2011, mean age was 58.9, 63.9% were women, 37.0% were Hispanic, 39.3% Black, 16.8% White, and 6.6% Asian/Other, and 60.5% were uninsured/Medicaid. Three-quarters of patients had ≥ 1 PC visit in the prior year. Lower-intensity interventions (EHR reminders, quality measurement, annual prevention letters) had limited impact on SUTD rates (2-3% rise). Implementing system-wide mailed FIT increased rates from 51.2 to 61.9% among those with a PC visit in the past year (40.5 to 46.8% with a PC visit ≤ 3 years). Stopping mailed FIT due to COVID wiped out these gains. Higher screening rates were associated with the following: older age; female; more comorbidities, PC clinic visits, and prior FITs; and better insurance coverage. Hispanics had the highest SUTD rates followed by Asians, Blacks, and Whites (p < 0.05). CONCLUSIONS: Implementation of a system-wide mailed FIT program had the greatest impact on SUTD rates. Lower-intensity interventions (EHR reminders, quality measurement, and patient letters) had limited effects.

Prevalence and correlates of false-positive results after 3-D screening mammography among uninsured women in a community outreach program.

False-positive results have been rarely investigated among uninsured minority women who undergo 3-D screening mammography. Here, we analyzed data from 21,022 women participating in the Breast Screening and Patient Navigation (BSPAN) program of North Texas with an aim to report prevalence and correlates of false-positive results after 3-D screening mammography, stratified by age. False-positives were defined as a negative diagnostic mammogram or a negative biopsy within 1 year of a positive screen. We used multivariable logistic regression to assess associations of demographic and clinical covariates and false positive results for age groups 40-49 and 50-64 years. Prevalence of false-positive results was 11.8% and 9.6% in the 40-49 and 50-64 age groups, respectively. Multivariable logistic regression demonstrated that, in the 40-49 age group, women who were non-menopausal, did not use hormone replacement therapy (HRT), and had self-reported prior mammograms had higher odds of false-positive results than those who were menopausal, used HRT and had no self-reported prior mammograms, respectively. In the 50-64 age group, women with a prior self-reported diagnostic mammogram had higher odds of false-positive results than those without a prior self-reported diagnostic mammogram. This study establishes contemporary evidence regarding prevalence and correlates of false-positive results after 3-D mammography in the unique BSPAN population, and demonstrate that use of 3-D mammography is not enough to reduce false-positive rates among uninsured women served through community outreach programs. Further research is needed to explore improved techniques to reduce false-positive rates, and ensure optimal use of scarce resources in outreach programs.

Long-term Mammography Adherence among Uninsured Women Enrolled in the Breast Screening and Patient Navigation (BSPAN) Program.

BACKGROUND: The Breast Screening and Patient Navigation (BSPAN) Program provides access to no-cost breast cancer screening services to uninsured women in North Texas. Using data from the longitudinal BSPAN program (2012-2019), we assessed prevalence and correlates of (i) baseline adherence and (ii) longitudinal adherence to screening mammograms. METHODS: Outcomes were baseline adherence (adherent if women received second mammogram 9-30 months after the index mammogram) and longitudinal adherence (assessed among baseline adherent women and defined as being adherent 39 months from the index mammogram). We used multivariable logistic regression and multivariable Cox proportional hazards model to assess associations of sociodemographic and clinical characteristics with baseline and longitudinal adherence, respectively. RESULTS: Of 19,292 women, only 5,382 (27.9%) were baseline adherent. Baseline adherence was more likely among women who were partnered, preferred speaking Spanish, had poor reading ability, had prior Papanicolaou (PAP) testing, and prior screening mammograms, compared with women who were non-partnered, preferred speaking English, had good reading ability, had no prior PAP testing, and no prior screening mammograms, respectively. Of those who were baseline adherent, 4,364 (81.1%) women demonstrated longitudinal adherence. Correlates of longitudinal adherence were similar to those from baseline adherence. CONCLUSIONS: A large proportion of baseline adherent women (>80%) achieved longitudinal adherence, which highlights the importance of concentrating resources during the second mammogram in the progression toward continued adherence. IMPACT: Results from our unique dataset provide realistic mammography adherence rates and may be generalizable to other areas introducing no-cost screening to low-income women, independent of any regular patient-centered medical home.

Reimbursement Matters: Overcoming Barriers to Clinical Trial Accrual.

BACKGROUND: Accrual to cancer clinical trials is suboptimal. Few data exist regarding whether financial reimbursement might increase accruals. OBJECTIVE: The objective of this study was to assess perceptions about reimbursement to overcome barriers to trial accrual. RESEARCH DESIGN: This was a cross-sectional survey. SUBJECTS: Oncologists identified from the American Medical Association Physician Masterfile. MEASURES: We report descriptive statistics, associations of physician characteristics with perceptions of reimbursement, domains, and subthemes of free-text comments. RESULTS: Respondents (n=1030) were mostly medical oncologists (59.4%), ages 35-54 (67%), and male (75%). Overall, 30% reported discussing trials with >25% of patients. Barriers perceived were administrative/regulatory, physician/staff time, and eligibility criteria. National Cancer Institute cooperative group participants and practice owners were more likely to endorse higher reimbursement. Respondents indicated targeted reimbursement would help improve infrastructure, but also noted potential ethical problems with reimbursement for discussion (40.7%) and accrual (85.9%). Free-text comments addressed reimbursement sources, recipients, and concerns about the real and apparent conflict of interest. CONCLUSIONS: Though concerns about a potential conflict of interest remain paramount and must be addressed in any new system of reimbursement, oncologists believe reimbursement to enhance infrastructure could help overcome barriers to trial accrual.

Outcomes associated with use of the Cancer Risk Intake System among primary care safety-net patients identified as needing colorectal cancer screening.

Despite demonstrated primary and secondary prevention benefits, screening for colorectal cancer (CRC) is sub-optimal. We implemented the Cancer Risk Intake System (CRIS) among a convenience sample of patients presenting for primary care in Dallas County safety-net clinics. CRIS, which assesses individuals' CRC risks and generates guideline-based screening recommendations for them and their providers, had been found in a randomized trial to facilitate risk-based screening, compared to usual care. Here, of 924 patients ages ≥50 who used CRIS, 699 were identified as needing screening, with 39.2% needing colonoscopy rather than FIT. However, following use of CRIS and patients' and providers' receipt of guideline-concordant recommendations, 20.9% elevated-risk patients received no screening orders, only 44.1% received guideline-concordant colonoscopy orders, and less than half of these (48.4%) completed colonoscopy. Guideline-concordant screening orders were more common for average-risk patients (62.5% received orders for FIT and 26.6% for colonoscopy). However, like their elevated-risk counterparts who received screening orders, more than half of average-risk patients in each order group (52.3% for FIT and 52.8% for colonoscopy) did not complete screening. We found no correlates for receiving screening orders, but higher comorbidity scores were associated with less screening completion among the average-risk group. We had hoped CRIS would facilitate risk-based screening but, although orders for and receipt of colonoscopy were more common for elevated- than average-risk patients, they were still suboptimal in this clinical setting with a "FIT-first" strategy. A stronger intervention may be necessary to increase guideline-concordant recommendations and screening among patients 50 and older.

Patient and Physician Factors Associated with Undisclosed Prostate Cancer Screening in a Sample of Predominantly Immigrant Black Men.

Medical guidelines do not recommend prostate cancer screening, particularly without informed and shared decision making. This study investigates undisclosed opportunistic screening using prostate specific antigen (PSA) testing in black immigrant and African American men. Participants (N = 142) were insured urban men, 45- to 70-years old. Patients' reports of testing were compared with medical claims to assess undisclosed PSA testing. Most (94.4 %) men preferred to share in screening decisions, but few (46.5 %) were aware PSA testing was performed. Four factors predicted being unaware of testing: low formal education, low knowledge about prostate cancer, no intention to screen, and no physician recommendation (all p's < .05). Undisclosed PSA testing was common. Both patient and provider factors increased risk of being uninformed about prostate cancer screening. Interventions combining patient education and physician engagement in shared decision making may better align practice with current prostate cancer screening guidelines.