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BACKGROUND: Blood-based biomarker tests can potentially change the landscape of colorectal cancer (CRC) screening. We characterize the conditions under which blood test screening would be as effective and cost-effective as annual fecal immunochemical testing (FIT) or decennial colonoscopy. METHODS: We used the three CISNET-Colon models to compare scenarios of no screening, annual FIT, decennial colonoscopy, and a blood test meeting CMS coverage criteria (74% CRC sensitivity and 90% specificity). We varied the sensitivity to detect CRC (74%-92%), advanced adenomas (AAs, 10%-50%), screening interval (1-3 years), and test cost ($25-$500). Primary outcomes included quality-adjusted life-years gained (QALYG) from screening and costs for an US average-risk 45-year-old cohort. RESULTS: Annual FIT yielded 125-163 QALYG per 1,000 at a cost of $3,811-5,384 per person, whereas colonoscopy yielded 132-177 QALYG at a cost of $5,375-7,031 per person. A blood test with 92% CRC sensitivity and 50% AA sensitivity yielded 117-162 QALYG if used every three years and 133-173 QALYG if used every year but would not be cost-effective if priced above $125 per test. If used every three years, a $500 blood test only meeting CMS coverage criteria yielded 83-116 QALYG, at a cost of $8,559-9,413 per person. CONCLUSION: Blood tests that only meet CMS coverage requirements should not be recommended to patients who would otherwise undergo screening by colonoscopy or FIT due to lower benefit. Blood tests need higher AA sensitivity (above 40%) and lower costs (below $125) to be cost-effective.
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BACKGROUND & AIMS: Barrett's esophagus (BE) is the precursor to esophageal adenocarcinoma (EAC). Endoscopic eradication therapy (EET) can be effective in eradicating BE and related neoplasia and has greater risk of harms and resource use than surveillance endoscopy. This clinical practice guideline aims to inform clinicians and patients by providing evidence-based practice recommendations for the use of EET in BE and related neoplasia. METHODS: The Grading of Recommendations Assessment, Development and Evaluation framework was used to assess evidence and make recommendations. The panel prioritized clinical questions and outcomes according to their importance for clinicians and patients, conducted an evidence review, and used the Evidence-to-Decision Framework to develop recommendations regarding the use of EET in patients with BE under the following scenarios: presence of (1) high-grade dysplasia, (2) low-grade dysplasia, (3) no dysplasia, and (4) choice of stepwise endoscopic mucosal resection (EMR) or focal EMR plus ablation, and (5) endoscopic submucosal dissection vs EMR. Clinical recommendations were based on the balance between desirable and undesirable effects, patient values, costs, and health equity considerations. RESULTS: The panel agreed on 5 recommendations for the use of EET in BE and related neoplasia. Based on the available evidence, the panel made a strong recommendation in favor of EET in patients with BE high-grade dysplasia and conditional recommendation against EET in BE without dysplasia. The panel made a conditional recommendation in favor of EET in BE low-grade dysplasia; patients with BE low-grade dysplasia who place a higher value on the potential harms and lower value on the benefits (which are uncertain) regarding reduction of esophageal cancer mortality could reasonably select surveillance endoscopy. In patients with visible lesions, a conditional recommendation was made in favor of focal EMR plus ablation over stepwise EMR. In patients with visible neoplastic lesions undergoing resection, the use of either endoscopic mucosal resection or endoscopic submucosal dissection was suggested based on lesion characteristics. CONCLUSIONS: This document provides a comprehensive outline of the indications for EET in the management of BE and related neoplasia. Guidance is also provided regarding the considerations surrounding implementation of EET. Providers should engage in shared decision making based on patient preferences. Limitations and gaps in the evidence are highlighted to guide future research opportunities.
Subject(s)
Adenocarcinoma , Barrett Esophagus , Endoscopic Mucosal Resection , Esophageal Neoplasms , Esophagoscopy , Barrett Esophagus/surgery , Barrett Esophagus/pathology , Humans , Esophageal Neoplasms/surgery , Esophageal Neoplasms/pathology , Endoscopic Mucosal Resection/adverse effects , Esophagoscopy/standards , Esophagoscopy/adverse effects , Adenocarcinoma/surgery , Adenocarcinoma/pathology , Gastroenterology/standards , Evidence-Based Medicine/standards , Treatment Outcome , Clinical Decision-Making , Ablation Techniques/adverse effects , Ablation Techniques/standardsABSTRACT
Background: Social determinants of health (SDoH) have been associated with disparate outcomes among those with metabolic dysfunction-associated steatotic liver disease (MASLD) and its risk factors. To address SDoH among this population, real-time SDoH screening in clinical settings is required, yet optimal screening methods are unclear. We performed a scoping review to describe the current literature on SDoH screening conducted in the clinical setting among individuals with MASLD and MASLD risk factors. Methods: Through a systematic literature search of MEDLINE, Embase, and CINAHL Complete databases through 7/2023, we identified studies with clinic-based SDoH screening among individuals with or at risk for MASLD that reported pertinent clinical outcomes including change in MASLD risk factors like diabetes and hypertension. Results: Ten studies (8 manuscripts, 2 abstracts) met inclusion criteria involving 148,151 patients: 89,408 with diabetes and 25,539 with hypertension. Screening was primarily completed in primary care clinics, and a variety of screening tools were used. The most commonly collected SDoH were financial stability, healthcare access, food insecurity and transportation. Associations between clinical outcomes and SDoH varied; overall, higher SDoH burden was associated with poorer outcomes including elevated blood pressure and hemoglobin A1c. Conclusion: Despite numerous epidemiologic studies showing associations between clinical outcomes and SDoH, and guidelines recommending SDoH screening, few studies describe in-clinic SDoH screening among individuals with MASLD risk factors and none among patients with MASLD. Future research should prioritize real-time, comprehensive assessments of SDoH, particularly among patients at risk for and with MASLD, to mitigate disease progression and reduce MASLD health disparities.
Subject(s)
Mass Screening , Social Determinants of Health , Humans , Hypertension , Non-alcoholic Fatty Liver Disease , Risk FactorsABSTRACT
BACKGROUND & AIMS: A blood-based colorectal cancer (CRC) screening test may increase screening participation. However, blood tests may be less effective than current guideline-endorsed options. The Centers for Medicare & Medicaid Services (CMS) covers blood tests with sensitivity of at least 74% for detection of CRC and specificity of at least 90%. In this study, we investigate whether a blood test that meets these criteria is cost-effective. METHODS: Three microsimulation models for CRC (MISCAN-Colon, CRC-SPIN, and SimCRC) were used to estimate the effectiveness and cost-effectiveness of triennial blood-based screening (from ages 45 to 75 years) compared to no screening, annual fecal immunochemical testing (FIT), triennial stool DNA testing combined with an FIT assay, and colonoscopy screening every 10 years. The CMS coverage criteria were used as performance characteristics of the hypothetical blood test. We varied screening ages, test performance characteristics, and screening uptake in a sensitivity analysis. RESULTS: Without screening, the models predicted 77-88 CRC cases and 32-36 CRC deaths per 1000 individuals, costing $5.3-$5.8 million. Compared to no screening, blood-based screening was cost-effective, with an additional cost of $25,600-$43,700 per quality-adjusted life-year gained (QALYG). However, compared to FIT, triennial stool DNA testing combined with FIT, and colonoscopy, blood-based screening was not cost-effective, with both a decrease in QALYG and an increase in costs. FIT remained more effective (+5-24 QALYG) and less costly (-$3.2 to -$3.5 million) than blood-based screening even when uptake of blood-based screening was 20 percentage points higher than uptake of FIT. CONCLUSION: Even with higher screening uptake, triennial blood-based screening, with the CMS-specified minimum performance sensitivity of 74% and specificity of 90%, was not projected to be cost-effective compared with established strategies for colorectal cancer screening.
Subject(s)
Colonoscopy , Colorectal Neoplasms , Cost-Benefit Analysis , Early Detection of Cancer , Occult Blood , Humans , Colorectal Neoplasms/diagnosis , Colorectal Neoplasms/economics , Middle Aged , Aged , United States , Early Detection of Cancer/economics , Early Detection of Cancer/methods , Female , Male , Colonoscopy/economics , Colonoscopy/statistics & numerical data , Centers for Medicare and Medicaid Services, U.S. , Quality-Adjusted Life Years , Sensitivity and Specificity , Predictive Value of Tests , Feces/chemistry , Computer Simulation , Models, EconomicABSTRACT
INTRODUCTION: Guidelines suggest 1-time screening with esophagogastroduodenoscopy (EGD) for Barrett's esophagus (BE) in individuals at an increased risk of esophageal adenocarcinoma (EAC). We aimed to estimate the yield of repeat EGD performed at prolonged intervals after a normal index EGD. METHODS: We conducted a national retrospective analysis within the U S Veterans Health Administration, identifying patients with a normal index EGD between 2003 and 2009 who subsequently had a repeat EGD. We tabulated the proportion with a new diagnosis of BE, EAC, or esophagogastric junction adenocarcinoma (EGJAC) and conducted manual chart review of a sample. We fitted logistic regression models for the odds of a new diagnosis of BE/EAC/EGJAC. RESULTS: We identified 71,216 individuals who had a repeat EGD between 1 and 16 years after an index EGD without billing or cancer registry codes for BE/EAC/EGJAC. Of them, 4,088 had a new billing or cancer registry code for BE/EAC/EGJAC after the repeat EGD. On manual review of a stratified sample, most did not truly have new BE/EAC/EGJAC. A longer duration between EGD was associated with greater odds of a new diagnosis (adjusted odds ratio [aOR] for each 5 years 1.31; 95% confidence interval [CI] 1.19-1.44), particularly among those who were younger during the index EGD (ages 19-29 years: aOR 3.92; 95% CI 1.24-12.4; ages 60-69 years: aOR 1.19; 95% CI 1.01-1.40). DISCUSSION: The yield of repeat EGD for BE/EAC/EGJAC seems to increase with time after a normal index EGD, particularly for younger individuals. Prospective studies are warranted to confirm these findings.
Subject(s)
Adenocarcinoma , Barrett Esophagus , Esophageal Neoplasms , Humans , Barrett Esophagus/diagnosis , Barrett Esophagus/pathology , Retrospective Studies , Esophageal Neoplasms/diagnosis , Esophageal Neoplasms/epidemiology , Esophageal Neoplasms/etiology , Adenocarcinoma/diagnosis , Adenocarcinoma/epidemiology , Adenocarcinoma/complications , Endoscopy, Gastrointestinal/adverse effectsABSTRACT
BACKGROUND: Cancer screening should be recommended only when the balance between benefits and harms is favorable. This review evaluated how U.S. cancer screening guidelines reported harms, within and across organ-specific processes to screen for cancer. OBJECTIVE: To describe current reporting practices and identify opportunities for improvement. DESIGN: Review of guidelines. SETTING: United States. PATIENTS: Patients eligible for screening for breast, cervical, colorectal, lung, or prostate cancer according to U.S. guidelines. MEASUREMENTS: Information was abstracted on reporting of patient-level harms associated with screening, diagnostic follow-up, and treatment. The authors classified harms reporting as not mentioned, conceptual, qualitative, or quantitative and noted whether literature was cited when harms were described. Frequency of harms reporting was summarized by organ type. RESULTS: Harms reporting was inconsistent across organ types and at each step of the cancer screening process. Guidelines did not report all harms for any specific organ type or for any category of harm across organ types. The most complete harms reporting was for prostate cancer screening guidelines and the least complete for colorectal cancer screening guidelines. Conceptualization of harms and use of quantitative evidence also differed by organ type. LIMITATIONS: This review considers only patient-level harms. The authors did not verify accuracy of harms information presented in the guidelines. CONCLUSION: The review identified opportunities for improving conceptualization, assessment, and reporting of screening process-related harms in guidelines. Future work should consider nuances associated with each organ-specific process to screen for cancer, including which harms are most salient and where evidence gaps exist, and explicitly explore how to optimally weigh available evidence in determining net screening benefit. Improved harms reporting could aid informed decision making, ultimately improving cancer screening delivery. PRIMARY FUNDING SOURCE: National Cancer Institute.
Subject(s)
Colorectal Neoplasms , Prostatic Neoplasms , Humans , Male , United States , Early Detection of Cancer/adverse effects , Prostate-Specific Antigen , Prostatic Neoplasms/diagnosis , Mass Screening/adverse effects , Colorectal Neoplasms/diagnosisABSTRACT
BACKGROUND: Colorectal cancer (CRC) screening is underutilized despite evidence that screening improves survival. Since healthcare provider recommendation is a strong predictor of CRC screening completion, providers are encouraged to engage eligible patients in collaborative decision-making that attends to patients' values, needs, and preferences for guideline-concordant screening modalities. METHODS: This three-arm randomized controlled trial is testing the effectiveness of an evidence-based video intervention informing patients of screening choices delivered in a clinic prior to a healthcare appointment. We hypothesize that participants randomized to watch a basic video describing CRC and screening in addition to an informed choice video showing the advantages and disadvantages of fecal immunochemical test (FIT), stool DNA FIT (s-DNA FIT), and colonoscopy (Arm 3) will exhibit a greater proportion of time adherent to CRC screening guidelines after 1, 3 and 6 years than those who only watch the basic video (Arm 2) or no video at all (Arm 1). Primary care and Obstetrician/Gynecology clinics across the United States are recruiting 5280 patients, half who have never been screened and half who previously screened but are currently not guideline adherent. Participants complete surveys prior to and following an index appointment to self-report personal, cognitive, and environmental factors potentially associated with screening. Proportion of time adherent to screening guidelines will be assessed using medical record data and supplemented with annual surveys self-reporting screening. CONCLUSION: Results will provide evidence on the effectiveness of informational and motivational videos to encourage CRC screening that can be easily integrated into clinical practice. CLINICALTRIALS: gov #NCT05246839.
Subject(s)
Colorectal Neoplasms , Early Detection of Cancer , Colonoscopy , Humans , Mass Screening , Occult Blood , Prospective Studies , United StatesABSTRACT
In safety-net healthcare systems, colonoscopy completion within 1-year of an abnormal fecal immunochemical test (FIT) result rarely exceeds 50%. Understanding how electronic health records (EHR) documented reasons for missed colonoscopy match or differ from patient-reported reasons, is critical to optimize effective interventions to address this challenge. We conducted a convergent mixed-methods study which included a retrospective analysis of EHR data and semi-structured interviews of adults 50-75 years old, with abnormal FIT results between 2014 and 2020 in a large safety-net healthcare system. Of the 299 patients identified, 59.2% (n = 177) did not complete a colonoscopy within one year of their abnormal result. EHR abstraction revealed a documented reason for lack of follow-up colonoscopy in 49.2% (n = 87/177); patient-level (e.g., declined colonoscopy; 51.5%) and multi-factorial reasons (e.g., lost to follow-up; 37.9%) were most common. In 18 patient interviews, patient (e.g., fear of colonoscopy), provider (e.g., lack of result awareness), and system-level reasons (e.g., scheduling challenges) were most common. Only three reasons for lack of colonoscopy overlapped between EHR data and patient interviews (competing health issues, lack of transportation, and abnormal FIT result attributed to another cause). In a cohort of safety-net patients with abnormal FIT results, the most common reasons for lack of follow-up were patient-related. Our analysis revealed a discordance between EHR documented and patient-reported reasons for lack of colonoscopy after an abnormal FIT result. Mixed-methods analyses, as in the present study, may give us the greatest insight into modifiable determinants to develop effective interventions beyond quantitative and qualitative data analysis alone.
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BACKGROUND & AIMS: Guidelines suggest endoscopic screening for esophageal adenocarcinoma (EAC) among individuals with symptoms of gastroesophageal reflux disease (GERD) and additional risk factors. We aimed to determine at what age to perform screening and whether sex and race should influence the decision. METHODS: We conducted comparative cost-effectiveness analyses using 3 independent simulation models. For each combination of sex and race (White/Black, 100,000 individuals each), we considered 41 screening strategies, including one-time or repeated screening. The optimal strategy was that with the highest effectiveness and an incremental cost-effectiveness ratio <$100,000 per quality-adjusted life-year gained. RESULTS: Among White men, 536 EAC deaths were projected without screening, and screening individuals with GERD twice at ages 45 and 60 years was optimal. Screening the entire White male population once at age 55 years was optimal in 26% of probabilistic sensitivity analysis runs. Black men had fewer EAC deaths without screening (n = 84), and screening those with GERD once at age 55 years was optimal. Although White women had slightly more EAC deaths (n = 103) than Black men, the optimal strategy was no screening, although screening those with GERD once at age 55 years was optimal in 29% of probabilistic sensitivity analysis runs. Black women had a very low burden of EAC deaths (n = 29), and no screening was optimal, as benefits were very small and some strategies caused net harm. CONCLUSIONS: The optimal strategy for screening differs by race and sex. White men with GERD symptoms can potentially be screened more intensely than is recommended currently. Screening women is not cost-effective and may cause net harm for Black women.
Subject(s)
Adenocarcinoma , Barrett Esophagus , Esophageal Neoplasms , Gastroesophageal Reflux , Adenocarcinoma/epidemiology , Barrett Esophagus/diagnosis , Cost-Benefit Analysis , Esophageal Neoplasms/epidemiology , Female , Gastroesophageal Reflux/complications , Humans , Male , Middle AgedSubject(s)
Racism , Systemic Racism , Black or African American , Humans , Racism/prevention & control , United StatesABSTRACT
Disparities in colorectal cancer (CRC) mortality among White, Black, and American Indian/Alaska Native (AIAN) men are attributable to differences in early detection screening. Determining how masculinity barriers influence CRC screening completion is critical for cancer prevention and control. To determine whether masculinity barriers to medical care are associated with lower rates of ever completing CRC screening, a survey-based study was employed from December 2020-January 2021 among 435 White, Black, and AIAN men (aged 45-75) who resided in the US. Logistic regression models were fit to four Masculinity Barriers to Medical Care subscales predicting ever completing CRC screening. For all men, being strong was associated with 54% decreased odds of CRC screening completion (OR 0.46, 95% CI 0.23 to 0.94); each unit increase in negative attitudes toward medical professionals and exams decreased the odds of ever completing CRC screening by 57% (OR 0.43, 95% CI 0.21 to 0.86). Black men who scored higher on negativity toward medical professionals and exams had decreased odds of ever screening. Consideration of masculinity in future population-based and intervention research is critical for increasing men's participation in CRC screening, with more salience for Black men.
Subject(s)
Colorectal Neoplasms , Colorectal Neoplasms/diagnosis , Early Detection of Cancer , Humans , Male , Masculinity , Mass Screening , MenABSTRACT
INTRODUCTION: Transportation is a common barrier to colonoscopy completion for colorectal cancer (CRC) screening. The study aims to identify the barriers, facilitators, and process recommendations to implement a rideshare non-emergency medical transportation (NEMT) intervention following colonoscopy completion within a safety-net healthcare setting. METHODS: We used informal stakeholder engagement, story boards - a novel user-centered design technique, listening sessions and the nominal group technique to identify the barriers, facilitators, and process to implementing a rideshare NEMT program following colonoscopy completion in a large safety-net healthcare system. RESULTS: Barriers to implementing a rideshare NEMT intervention for colonoscopy completion included: inability to expand an existing NEMT program beyond Medicaid patients and lack of patient chaperones with rideshare NEMT programs. Facilitators included: commercially available rideshare NEMT platforms that were lower cost and had shorter wait times than the alternative of taxis. Operationalizing and implementing a rideshare NEMT intervention in our healthcare system required the following steps: 1) identifying key stakeholders, 2) engaging stakeholder groups in discussion to identify barriers and solutions, 3) obtaining institutional sign-off, 4) developing a process for reviewing and selecting a rideshare NEMT program, 5) executing contracts, 6) developing a standard operating procedure and 7) training clinic staff to use the rideshare platform. DISCUSSION: Rideshare NEMT after procedural sedation is administered may improve colonoscopy completion rates and provide one solution to inadequate CRC screening. If successful, our rideshare model could be broadly applicable to other safety-net health systems, populations with high social needs, and settings where procedural sedation is administered.
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OBJECTIVE: Annual fecal immunochemical tests can reduce colorectal cancer incidence and mortality. However, screening is a multi-step process and most patients do not perfectly adhere to guideline-recommended screening schedules. Our objective was to compare the reduction in colorectal cancer incidence and life-years gained based on US guideline-concordant fecal immunochemical test screening to scenarios with a range of delays. METHOD: The Colorectal Cancer Simulated Population model for Incidence and Natural history (CRC-SPIN) microsimulation model was used to estimate the effect of systematic departures from fecal immunochemical test screening guidelines on lifetime screening benefit. RESULTS: The combined effect of consistent modest delays in screening initiation (1 year), repeated fecal immunochemical test screening (3 months), and receipt of follow-up or surveillance colonoscopy (3 months) resulted in up to 1.3 additional colorectal cancer cases per 10,000, 0.4 additional late-stage colorectal cancer cases per 10,000 and 154.7 fewer life-years gained per 10,000. A 5-year delay in screening initiation had a larger impact on screening effectiveness than consistent small delays in repeated fecal immunochemical test screening or receipt of follow-up colonoscopy after an abnormal fecal immunochemical test. The combined effect of consistent large delays in screening initiation (5 years), repeated fecal immunochemical test screening (6 months), and receipt of follow-up or surveillance colonoscopy (6 months) resulted in up to 3.7 additional colorectal cancer cases per 10,000, 1.5 additional late-stage colorectal cancer cases per 10,000 and 612.3 fewer life-years gained per 10,000. CONCLUSIONS: Systematic delays across the screening process can result in meaningful reductions in colorectal cancer screening effectiveness, especially for longer delays. Screening delays could drive differences in colorectal cancer incidence across patient groups with differential access to screening.
Subject(s)
Colorectal Neoplasms , Early Detection of Cancer , Colonoscopy/methods , Colorectal Neoplasms/diagnosis , Colorectal Neoplasms/epidemiology , Early Detection of Cancer/methods , Humans , Mass Screening/methods , Occult BloodABSTRACT
BACKGROUND & AIMS: Gastric cancer (GC) remains a leading cause of mortality among certain racial, ethnic, and immigrant groups in the United States (US). The majority of GCs are diagnosed at advanced stages, and overall survival remains poor. There exist no structured national strategies for GC prevention in the US. METHODS: On March 5-6, 2020 a summit of researchers, policy makers, public funders, and advocacy leaders was convened at Stanford University to address this critical healthcare disparity. After this summit, a writing group was formed to critically evaluate the effectiveness, potential benefits, and potential harms of methods of primary and secondary prevention through structured literature review. This article represents a consensus statement prepared by the writing group. RESULTS: The burden of GC is highly inequitably distributed in the US and disproportionately falls on Asian, African American, Hispanic, and American Indian/Alaskan Native populations. In randomized controlled trials, strategies of Helicobacter pylori testing and treatment have been demonstrated to reduce GC-specific mortality. In well-conducted observational and ecologic studies, strategies of endoscopic screening have been associated with reduced GC-specific mortality. Notably however, all randomized controlled trial data (for primary prevention) and the majority of observational data (for secondary prevention) are derived from non-US sources. CONCLUSIONS: There exist substantial, high-quality data supporting GC prevention derived from international studies. There is an urgent need for cancer prevention trials focused on high-risk immigrant and minority populations in the US. The authors offer recommendations on how strategies of primary and secondary prevention can be applied to the heterogeneous US population.
Subject(s)
Helicobacter Infections , Helicobacter pylori , Stomach Neoplasms , Ethnicity , Healthcare Disparities , Helicobacter Infections/epidemiology , Hispanic or Latino , Humans , Secondary Prevention , Stomach Neoplasms/epidemiology , Stomach Neoplasms/prevention & control , United States/epidemiologyABSTRACT
Mortality from colorectal cancer is reduced through screening and early detection; moreover, removal of neoplastic lesions can reduce cancer incidence. While understanding of the risk factors, pathogenesis, and precursor lesions of colorectal cancer has advanced, the cause of the recent increase in cancer among young adults is largely unknown. Multiple invasive, semi- and non-invasive screening modalities have emerged over the past decade. The current emphasis on quality of colonoscopy has improved the effectiveness of screening and prevention, and the role of new technologies in detection of neoplasia, such as artificial intelligence, is rapidly emerging. The overall screening rates in the US, however, are suboptimal, and few interventions have been shown to increase screening uptake. This review provides an overview of colorectal cancer, the current status of screening efforts, and the tools available to reduce mortality from colorectal cancer.