Comparative Effectiveness and Cost-Effectiveness of Colorectal Cancer Screening With Blood-Based Biomarkers (Liquid Biopsy) vs Fecal Tests or Colonoscopy.

BACKGROUND & AIMS: Colorectal cancer (CRC) screening is highly effective but underused. Blood-based biomarkers (liquid biopsy) could improve screening participation. METHODS: Using our established Markov model, screening every 3 years with a blood-based test that meets minimum Centers for Medicare & Medicaid Services' thresholds (CMSmin) (CRC sensitivity 74%, specificity 90%) was compared with established alternatives. Test attributes were varied in sensitivity analyses. RESULTS: CMSmin reduced CRC incidence by 40% and CRC mortality by 52% vs no screening. These reductions were less profound than the 68%-79% and 73%-81%, respectively, achieved with multi-target stool DNA (Cologuard; Exact Sciences) every 3 years, annual fecal immunochemical testing (FIT), or colonoscopy every 10 years. Assuming the same cost as multi-target stool DNA, CMSmin cost $28,500/quality-adjusted life-year gained vs no screening, but FIT, colonoscopy, and multi-target stool DNA were less costly and more effective. CMSmin would match FIT's clinical outcomes if it achieved 1.4- to 1.8-fold FIT's participation rate. Advanced precancerous lesion (APL) sensitivity was a key determinant of a test's effectiveness. A paradigm-changing blood-based test (sensitivity >90% for CRC and 80% for APL; 90% specificity; cost ≤$120-$140) would be cost-effective vs FIT at comparable participation. CONCLUSIONS: CMSmin could contribute to CRC control by achieving screening in those who will not use established methods. Substituting blood-based testing for established effective CRC screening methods will require higher CRC and APL sensitivities that deliver programmatic benefits matching those of FIT. High APL sensitivity, which can result in CRC prevention, should be a top priority for screening test developers. APL detection should not be penalized by a definition of test specificity that focuses on CRC only.

Timely Colonoscopy After Positive Fecal Immunochemical Tests in the Veterans Health Administration: A Qualitative Assessment of Current Practice and Perceived Barriers.

INTRODUCTION: The Veterans Health Administration introduced a clinical reminder system in 2018 to help address process gaps in colorectal cancer screening, including the diagnostic evaluation of positive fecal immunochemical test (FIT) results. We conducted a qualitative study to explore the differences between facilities who performed in the top vs bottom decile for follow-up colonoscopy. METHODS: Seventeen semistructured interviews with gastroenterology (GI) providers and staff were conducted at 9 high-performing and 8 low-performing sites. RESULTS: We identified 2 domains, current practices and perceived barriers, and most findings were described by both high- and low-performing sites. Findings exclusive to 1 group mainly pertained to current practices, especially arranging colonoscopy for FIT-positive patients. We observed only 1 difference in the perceived barriers domain, which pertained to primary care providers. DISCUSSION: These results suggest that what primarily distinguishes high- and low-performing sites is not a difference in barriers but rather in the GI clinical care process. Developing and disseminating patient education materials about the importance of diagnostic colonoscopy, eliminating in-person precolonoscopy visits when clinically appropriate, and involving GI in missed colonoscopy appointments and outside referrals should all be considered to increase follow-up colonoscopy rates. Our study illustrates the challenges of performing a timely colonoscopy after a positive FIT result and provides insights on improving the clinical care process for patients who are at substantially increased risk for colorectal cancer.

What Is Organized Screening and What Is Its Value?

Most screening in the United States occurs in an opportunistic fashion, although organized screening occurs in some integrated health care systems. Organized colorectal cancer (CRC) screening consists of an explicit screening policy, defined target population, implementation team, health care team for clinical care delivery, quality assurance infrastructure, and method for identifying cancer outcomes. Implementation of an organized screening program offers opportunities to systematically assess the success of the program and develop interventions to address identified gaps in an effort to optimize CRC outcomes. There is evidence of that organized screening is associated with improvements in screening participation and CRC mortality.

Strategies for Colorectal Cancer Screening.

The incidence of colorectal cancer (CRC) is increasing worldwide. CRC has high mortality when detected at advanced stages, yet it is also highly preventable. Given the difficulties in implementing major lifestyle changes or widespread primary prevention strategies to decrease CRC risk, screening is the most powerful public health tool to reduce mortality. Screening methods are effective but have limitations. Furthermore, many screen-eligible people remain unscreened. We discuss established and emerging screening methods, and potential strategies to address current limitations in CRC screening. A quantum step in CRC prevention might come with the development of new screening strategies, but great gains can be made by deploying the available CRC screening modalities in ways that optimize outcomes while making judicious use of resources.

A Nationwide Survey and Needs Assessment of Colonoscopy Quality Assurance Programs in the VA.

Variability exists in quality documentation, measurement, and reporting practices of colonoscopy screening in VA facilities, and most do not have formal performance improvement plans.

Predictors of Use of Monitored Anesthesia Care for Outpatient Gastrointestinal Endoscopy in a Capitated Payment System.

BACKGROUND & AIMS: Use of monitored anesthesia care (MAC) for gastrointestinal endoscopy has increased in the Veterans Health Administration (VHA) as in fee-for-service environments, despite the absence of financial incentives. We investigated factors associated with use of MAC in an integrated health care delivery system with a capitated payment model. METHODS: We performed a retrospective cohort study using multilevel logistic regression, with MAC use modeled as a function of procedure year, patient- and provider-level factors, and facility effects. We collected data from 2,091,590 veterans who underwent outpatient esophagogastroduodenoscopy and/or colonoscopy during fiscal years 2000-2013 at 133 facilities. RESULTS: The adjusted rate of MAC use in the VHA increased 17% per year (odds ratio for increase, 1.17; 95% confidence interval, 1.09-1.27) from fiscal year 2000 through 2013. The most rapid increase occurred starting in 2011. VHA use of MAC was associated with patient-level factors that included obesity, obstructive sleep apnea, higher comorbidity, and use of prescription opioids and/or benzodiazepines, although the magnitude of these effects was small. Provider-level and facility factors were also associated with use of MAC, although again the magnitude of these associations was small. Unmeasured facility-level effects had the greatest effect on the trend of MAC use. CONCLUSIONS: In a retrospective study of veterans who underwent outpatient esophagogastroduodenoscopy and/or colonoscopy from fiscal year 2000 through 2013, we found that even in a capitated system, patient factors are only weakly associated with use of MAC. Facility-level effects are the most prominent factor influencing increasing use of MAC. Future studies should focus on better defining the role of MAC and facility and organizational factors that affect choice of endoscopic sedation. It will also be important to align resources and incentives to promote appropriate allocation of MAC based on clinically meaningful patient factors.

Editorial: Financial Incentives to Improve Colorectal Cancer Screening: Does it Make Cents?

While colorectal cancer screening reduces colorectal cancer incidence and mortality, there is much room for improvement in screening adherence particularly among the uninsured and ethnic minorities. In this issue, Gupta et al. conducted a randomized controlled study to test the impact of a small financial incentive on screening adherence. Their negative study, taken in the context of prior studies and behavioral economics literature, leads us to conclude that it does not pay to add this small financial incentive to community outreach. Instead, we should invest in a systematic approach to screening, including patient navigation.

Impact and outcomes of research sponsored by the American Society for Gastrointestinal Endoscopy.

BACKGROUND AND AIMS: Since 1985, the American Society for Gastrointestinal Endoscopy (ASGE) has awarded grants for endoscopic-related research. The goals of this study were to examine trends in ASGE grant funding and to assess productivity of previous recipients of the ASGE grant awards. METHODS: This was a retrospective cohort analysis of all research grants awarded by the ASGE through 2009. Measures of academic productivity and self-assessment of the ASGE awards' impact on the recipients' careers were defined by using publicly available resources (eg, National Library of Medicine-PubMed) and administration of an electronic survey to award recipients. RESULTS: The ASGE awarded 304 grants totaling $12.5 million to 214 unique awardees. Funding increased 7.5-fold between 1985 and 1989 (mean $102,000/year) and between 2005 and 2009 (mean $771,000/year). The majority of awardees were men (83%), were at or below the level of assistant professor (82%), with a median of 3 years of postfellowship experience at the time of the award, and derived from a broad spectrum of institutions as measured by National Institutes of Health funding rank (median 26, interquartile range [IQR] 12-64). Nineteen percent had a master's degree in a research-related field. Awardees' median publications per year increased from 3.5 (IQR 1.2-9.0) before funding to 5.7 (IQR 1.8-9.5) since funding; P = .04, and median h-index scores increased from 3 (IQR 1-8) to 17 (IQR 8-26); P < .001. Multivariate analysis found that the presence of a second advanced degree (eg, masters or doctorate) was independently predictive of high productivity (odds ratio [OR] 2.92; 95% confidence interval [CI], 1.09-7.81). Among 212 unique grant recipients, 82 (40%) completed the online survey. Of the respondents, median peer-reviewed publications per year increased from 3.4 (IQR 1.9-5.5) to 4.5 (IQR 2.0-9.5); P = .17. Ninety-one percent reported that the ASGE grant had a positive or very positive impact on their careers, and 85% of respondents are currently practicing in an academic environment. Most of the grants resulted in at least 1 peer-reviewed publication (67% per Internet-based search and 81% per survey). CONCLUSIONS: The ASGE research program has grown considerably since 1985, with the majority of grants resulting in at least 1 grant-related publication. Overall academic productivity increased after the award, and the majority of awardees report a positive or very positive impact of the award on their careers. Medical professional societies are an important sponsor of clinical research.

Determination of colonoscopy indication from administrative claims data.

BACKGROUND: Colonoscopy outcomes, such as polyp detection or complication rates, may differ by procedure indication. OBJECTIVES: To develop methods to classify colonoscopy indications from administrative data, facilitating study of colonoscopy quality and outcomes. RESEARCH DESIGN: We linked 14,844 colonoscopy reports from the Clinical Outcomes Research Initiative, a national repository of endoscopic reports, to the corresponding Medicare Carrier and Outpatient File claims. Colonoscopy indication was determined from the procedure reports. We developed algorithms using classification and regression trees and linear discriminant analysis (LDA) to classify colonoscopy indication. Predictor variables included ICD-9CM and CPT/HCPCS codes present on the colonoscopy claim or in the 12 months prior, patient demographics, and site of colonoscopy service. Algorithms were developed on a training set of 7515 procedures, then validated using a test set of 7329 procedures. RESULTS: Sensitivity was lowest for identifying average-risk screening colonoscopies, varying between 55% and 86% for the different algorithms, but specificity for this indication was consistently over 95%. Sensitivity for diagnostic colonoscopy varied between 77% and 89%, with specificity between 55% and 87%. Algorithms with classification and regression trees with 7 variables or LDA with 10 variables had similar overall accuracy, and generally lower accuracy than the algorithm using LDA with 30 variables. CONCLUSIONS: Algorithms using Medicare claims data have moderate sensitivity and specificity for colonoscopy indication, and will be useful for studying colonoscopy quality in this population. Further validation may be needed before use in alternative populations.

Association between facility characteristics and the process of care delivered to patients with hepatitis C virus infection.

BACKGROUND: Available data suggest problems in the process of care provided to patients with chronic hepatitis C (HCV). However, the solutions to these problems are less obvious. Healthcare facility factors are potentially modifiable and may enhance process quality in HCV treatment. METHODS: We evaluated the relationship between the process of HCV care and facility factors including number of weekly half-day HCV clinics per 1,000 HCV patients, HCV-specific quality-improvement initiatives, and administrative service of the HCV clinic (gastroenterology, infectious disease, primary care) for a cohort of 34,258 patients who sought care in 126 Veterans Affairs facilities during 2003-2006. We measured HCV care on the basis of 23 HCV-specific process measures capturing pretreatment (seven measures), preventive and/or comorbid (seven measures), and treatment and treatment monitoring care (nine measures). RESULTS: Patients seen at a facility with >8 half-day clinics were 52 % more likely to receive overall indicated care (OR 1.52, 95 % CI 1.13-2.05). Patients seen at a facility with >3 HCV quality improvement initiatives were more likely to receive better preventive and/or comorbid care (OR 1.32, 95 % CI 1.00-1.74). Compared with patients in facilities with no dedicated HCV clinic, patients at facilities with gastroenterology-based clinics received better pretreatment care (OR 1.36, 95 % CI 1.01-1.85) and more antiviral treatment (OR 1.45, 95 % CI 1.06-1.97) whereas those at facilities with infectious disease-based or primary care-based clinics received better preventive and/or comorbid care (OR 1.59, 95 % CI 1.06-2.39 and 1.84, 95 % CI 1.21-2.79 respectively). CONCLUSION: Several facility factors affected the process of HCV care. These factors may serve as targets for quality-improvement efforts.

Regional variation in anesthesia assistance during outpatient colonoscopy is not associated with differences in polyp detection or complication rates.

BACKGROUND & AIMS: We investigated the rate and predictors of anesthesia assistance during outpatient colonoscopy and whether anesthesia assistance is associated with colonoscopy interventions and outcomes. METHODS: We performed a retrospective cohort study using a 20% sample of Medicare administrative claims submitted during the 2003 calendar year. We analyzed data from 328,177 adults, 66 years old or older, who underwent outpatient colonoscopy examinations. RESULTS: Overall, 8.7% of outpatient colonoscopies were performed with anesthesia assistance. In multivariate analysis, independent predictors of anesthesia assistance included black race, female sex, and a nonscreening indication; anesthesia assistance increased with median income and comorbidities. General and colorectal surgeons, fewer years in their practice, and nonhospital site of service were also significantly associated with anesthesia assistance. The strongest predictor of anesthesia assistance was the Medicare carrier, with odds ratios ranging from 0.22 (95% confidence interval: 0.12-0.43) for the Arkansas carrier (crude rate 0.9%) to 9.90 (95% confidence interval: 7.92-12.39) for the Empire carrier in New York area (crude rate 35.3%) compared with the Wisconsin carrier (crude rate 4.3%). There was also considerable variation among endoscopists; 75% of providers had no colonoscopies with anesthesia assistance recorded in their dataset, and 4.5% of providers had anesthesia assistance in at least three quarters of their examinations. Anesthesia assistance was not associated with the diagnosis of polyps, the performance of biopsy or polypectomy, or complications in multivariate analyses. CONCLUSIONS: There are significant variations among regions and sites of service in anesthesia assistance during outpatient colonoscopies of Medicare beneficiaries. Although this variation has considerable economic implications, it was not associated with measures of patient risk or outcomes, such as polyp detection or procedure-related complications.

Assessment and management of low bone density in inflammatory bowel disease and performance of professional society guidelines.

BACKGROUND: Inflammatory bowel disease (IBD) patients have increased prevalence of osteoporosis, leading to guideline recommendations for bone mineral density (BMD) testing. The study aim was to identify predictors of BMD testing and treatment and assess guideline effectiveness to identify IBD patients with osteoporosis. METHODS: Records of all IBD patients at seven medical facilities were reviewed for clinical data and BMD testing from January 1996 through October 2006. RESULTS: A total of 2035 patients had 317 bone density tests performed. Osteopenia was found in 48% of patients, osteoporosis in 26%. Among patients meeting guideline criteria for BMD testing and ≥1 year of follow-up, 23.3% underwent testing. The strongest predictors of testing were menopause (adjusted hazard ratio [AHR] 3.02) and receiving care at a tertiary center (AHR 2.56). Testing rates were low in patients with age ≥60 years, ulcerative colitis, and a history of inpatient IBD treatment. Osteoporotic patients received calcium/vitamin D and bisphosphonates in 59% and 75% of cases, respectively. Osteoporotic males had a 37% rate of hypogonadism. Guideline criteria do not distinguish patients with osteoporosis. The criteria had a sensitivity, specificity, positive predictive value, and negative predictive value of 84%, 23%, 27%, and 81% for osteoporosis in the tested population, respectively. CONCLUSIONS: Osteoporosis is highly prevalent in the IBD population, but BMD testing and osteoporosis treatments are underutilized. Male hypogonadism is common in osteoporotic IBD patients. Guidelines do not identify IBD patients with osteoporosis.

Accuracy of Medicare claims for identifying findings and procedures performed during colonoscopy.

BACKGROUND: Administrative claims data are frequently used for quality measurement. OBJECTIVE: To examine the accuracy of administrative claims for potential colonoscopy quality measures, including findings (polyp or tumor detection), procedures (biopsy or polypectomy), and incomplete colonoscopy. DESIGN: Cross-sectional study. PATIENTS: Patients age 65 and older undergoing colonoscopy in the Clinical Outcomes Research Initiative National Endoscopic Database in 2006. We linked colonoscopy records for these patients to Medicare colonoscopy claims by using patient age, sex, date of procedure, and performing provider's Unique Physician Identification Number. MAIN OUTCOME MEASUREMENTS: Sensitivity, specificity, positive and negative predictive values of the Medicare claims for potential quality measures, including colonoscopy findings and procedures. RESULTS: We linked Medicare colonoscopy claims to 15,168 of the 30,011 Clinical Outcomes Research Initiative colonoscopy records. Sensitivity of the claims for colon polyps was 93.4%, with a specificity of 97.8%. Sensitivity of claims for other diagnoses, including colorectal tumors was suboptimal, although specificity was high. In contrast, sensitivity of claims for procedures-biopsy (with or without cautery) or polypectomy-was high (87.2%-97.6%), with specificity >97%. Claims had poor sensitivity for identification of incomplete colonoscopy. LIMITATIONS: Potential for inaccurate matching of colonoscopy records and Medicare claims. CONCLUSIONS: Medicare claims have high sensitivity and specificity for polyp detection, biopsy, and polypectomy at colonoscopy, but sensitivity is low for other diagnoses such as tumor detection and for incomplete colonoscopy. Caution is needed when using Medicare claims data for certain important quality measures, in particular tumor detection and incomplete colonoscopy.

Utilization and predictors of early repeat colonoscopy in Medicare beneficiaries.

OBJECTIVES: Early repeat colonoscopy after an index examination may be justifiable, but may also reflect quality issues during the first examination. The aims of this study were to examine the use of second colonoscopy within 1 year of an index colonoscopy, and to examine patient and provider factors associated with use of early repeat colonoscopy. METHODS: We performed a retrospective cohort study using a 20% nationally representative sample of 2003 Medicare claims. Patients aged ≥ 66 years undergoing colonoscopy were included in this study. We identified the use of second colonoscopy and barium enema within 1 year of the index procedure. We used logistic regression analyses to examine the independent predictors of these procedures. RESULTS: We included 328,167 outpatient colonoscopies. In all, 5% had second colonoscopy and 2.2% had barium enema within 1 year of the index examination. Early repeat colonoscopy was more common if the index examination was performed by a family physician (odds ratio 1.39, 95% confidence interval 1.23-1.56), general surgeon (odds ratio 1.18, 95% confidence interval 1.10-1.27) or internist (odds ratio 1.12, 95% confidence interval 1.02-1.23) compared with a gastroenterologist, or after colonoscopies by an endoscopist in the lower quartiles of colonoscopy volume compared with endoscopists in the highest quartile. Increasing patient age and comorbidity, polyp detection, biopsy, polyp removal, incomplete index examination, and site of service were also significantly associated with early repeat colonoscopy. CONCLUSIONS: Early repeat colonoscopy is not unusual. The association of specialty and colonoscopy volume with early repeat colonoscopy suggests that there are modifiable processes of care or training that may prevent some of these repeat procedures.

Cost-effectiveness of hepatitis A vaccination for individuals with chronic hepatitis C.

The incidence of hepatitis A infection in the United States has decreased dramatically in recent years because of childhood immunization programs. A decision analysis of the cost-effectiveness of hepatitis A vaccination for adults with hepatitis C was conducted. No vaccination strategy is cost-effective for adults with hepatitis C using the recent lower anticipated hepatitis A incidence, private sector costs, and a cost-effectiveness criterion of $100,000/QALY. Vaccination is cost-effective only for individuals who have cleared the hepatitis C virus when Department of Veterans Affairs costs are used. The recommendation to vaccinate adults with hepatitis C against hepatitis A should be reconsidered.

New endoscopic and cytologic tools for cancer surveillance in the digestive tract.

Cancer surveillance is an increasing part of everyday practice in gastrointestinal Endoscopy due to the identification of high-risk groups from genetic and biomarker testing, genealogic and epidemiologic studies, and the increasing number of cancer survivors. An efficient surveillance program requires a cost-effective means for image-guided cancer detection and biopsy. A laser-based tethered-capsule endoscope with enhanced spectral imaging is introduced for unsedated surveillance of the lower esophagus. An ultrathin version of this same endoscope technology provides a 1.2-mm guidewire with imaging capability and cannula-style tools are proposed for image-guided biopsy. Advanced three-dimensional cell visualization techniques are described for increasing the sensitivity of early cancer diagnosis from hematoxylin-stained cells sampled from the pancreatic and biliary ducts.