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.

Factors associated with shorter-interval cervical cancer screening for young women in three United States healthcare systems.

Frequently changing cervical cancer screening guidelines over the past two decades have been inconsistently adopted in the United States. Current guidelines set the recommended screening interval to three years for average-risk women aged 21-29 years. Few studies have evaluated how patient and provider factors are associated with implementation of cervical cancer screening intervals among younger women. This study evaluated multilevel factors associated with screening interval length among 69,939 women aged 21-29 years with an initial negative Pap screen between 2010 and 2015 across three large health systems in the U.S. Shorter-interval screening was defined as a second screening Pap within 2.5 years of an initial negative Pap. Mixed-effects logistic regression was performed for each site to identify provider and patient characteristics associated with shorter-interval screening. The odds of shorter-interval screening decreased over the study period across all sites, though the proportion of patients screened within 2.5 years remained between 7.5% and 20.7% across sites in 2014-2015. Patient factors including insurance, race/ethnicity, and pregnancy were associated with shorter-interval screening, though the patterns differed across sites. At one site, the variation in shorter-interval screening explained by the provider was 10.6%, whereas at the other two sites, the provider accounted for < 2% of the variation in shorter-interval screening. Our results highlight the heterogeneity in factors driving cervical cancer screening interval across health systems and point to the need for tailored approaches targeted to both providers and patients to improve guideline-concordant screening.

Cost-Effectiveness Analysis of CAR T-Cell Therapies vs Antibody Drug Conjugates for Patients with Advanced Multiple Myeloma.

OBJECTIVES: Among advanced multiple myeloma (MM) patients, B-cell maturation antigen (BCMA) specific targets like Belantamab Mafodotin (belamaf) and CAR T-cell therapies have been shown to improve clinical outcomes, but at significant costs. To compare the expected costs per quality-adjusted life years (QALYs) gained among a hypothetical cohort of triple refractory MM patients treated with one of three BCMA-directed therapies: (1) idecabtagene vicleucel (ide-cel), (2) ciltacabtagene autoleucel (cilta-cel), and (3) belamaf for up to 20 months. METHODS: In this cost-effectiveness analysis, we built a Monte Carlo Markov Chain microsimulation model using estimates and parameters from the evidence on MM treatment for 10 000 hypothetical patients between the ages for 40 and 80. We assigned expected years of life remaining and made varying assumptions about survival beyond 5 years. RESULTS: We predicted total cost of treatment for CAR-T therapy to be six times greater than for belamaf, but the QALYs gained from treatment are 6 to 8 times greater. Ide-cel was weakly dominated by cilta-cel and our base-case incremental cost effectiveness ratio (ICER) comparing cilta-cel with belamaf was $109,497 per QALY gained, averaging $123,618 in probabilistic sensitivity analyses. CONCLUSIONS: These findings hinge on the assumption of longer-term survival but suggest that the use of CAR-T therapy is approaching standard ICER thresholds.