An Observational Analysis of a Novel Digital Rectoscope.

BACKGROUND: This is an analysis of the first 50 in-human uses of a novel digital rigid sigmoidoscope. The technology provides digital image capture, telemedicine capabilities, improved ergonomics, and the ability to biopsy under pneumorectum while maintaining the low cost of conventional rigid sigmoidoscopy. The primary outcome was adverse events, and the secondary outcome was diagnostic view. PRELIMINARY RESULTS: Fifty patients underwent outpatient (n = 25) and surgical rectal assessment (n = 25), with a mean age of 60 years. This included 31 men and 19 women with 12 different clinical use indications. No adverse events were reported, and no defects were reported with the instrumentation. Satisfactory diagnoses were obtained in 48 (96%) of 50 uses, images were captured in 48 (96%) of 50 uses, and biopsies were successfully taken in 13 uses (26%). No adverse events were recorded. Independent reviewers of recorded videos agreed on the quality and diagnostic value of the images with a κ of 0.225 (95% CI, 0.144-0.305) when assessing whether the target pathology was adequately visualized. IMPACT OF INNOVATION: The improved views afforded by digital rectoscopy facilitated a satisfactory clinical diagnosis in 96% of uses. The device was successfully deployed in the operating room and outpatients irrespective of bowel preparation method, where it has the potential to replace flexible sigmoidoscopy for specific use cases. The technology provides a high-quality image and video that can be securely recorded for documentation and medicolegal purposes with agreement between blinded users despite a lack of standardized training and heterogenous pathology. We perceive significant impact of this technology for the assessment of colorectal anastomoses, the office management of colitis, "watch and wait," and for diagnostic support in rectal cancer diagnosis. The technology has significant potential to facilitate proctoring and training, and it now requires prospective trials to validate its diagnostic accuracy against more costly flexible sigmoidoscopy systems.

Enhancing bowel screening: Preventing colorectal cancer by flexible sigmoidoscopy in New Zealand.

OBJECTIVES: The prevention of colorectal cancer (CRC) attainable from introducing once-in-a-lifetime flexible sigmoidoscopy (FSIG) screening was assessed. STUDY DESIGN: This is a review of relevant available information for the assessment of the impact and resource demands of FSIG in New Zealand. METHODS: The reduction in bowel cancer incidence achievable by one-off FSIG screening from 50 to 59 years of age, an age group for which bowel screening is not currently offered, was reviewed. The prevention of CRC attainable from an offer of screening at 55 years of age in New Zealand was also estimated. The number and cost of the FSIG screening procedures required and referrals for colonoscopies and the savings in treatment were calculated. RESULTS: Annually, about 27,500 FSIG screening procedures would be required if 50% of those turning 55 years of age accepted an offer of once-in-a-lifetime FSIG screening. This would result in three-four-fold fewer people being referred for colonoscopy than in the national 2-yearly faecal immunochemical test (FIT) screening programme and subsequently reduce demand for colonoscopy from a false-positive FIT. The number of CRC cases prevented would increase over 17 years to more than 300 per year by 2033. After 10-15 years of screening, the annual savings in health service costs, primarily from CRC prevented, were sufficient to completely fund the FSIG screening. CONCLUSIONS: Inclusion of FSIG screening in the national bowel screening programme would significantly reduce both the incidence and mortality of CRC in New Zealand, reduce the colonoscopy demand of current bowel screening and reduce long-term health service costs.

Comparison of Program Resources Required for Colonoscopy and Fecal Screening: Findings From 5 Years of the Colorectal Cancer Control Program.

INTRODUCTION: Colonoscopy and guaiac fecal occult blood tests and fecal immunochemical tests (FOBT/FIT) are the most common colorectal cancer screening methods in the United States. However, information is limited on the program resources required over time to use these tests. METHODS: We collected cost data from 29 Centers for Disease Control and Prevention Colorectal Cancer Control Program (CRCCP) grantees by using a standardized data collection instrument for 5 program years (2009-2014). We created a panel data set with 124 records and assessed differences by screening test used. RESULTS: Forty-four percent of all programs (N = 124) offered colonoscopy (55 of 124), 32% (39 of 124) offered FOBT/FIT, and 24% (30 of 124) offered both. Overall, total cost per person was higher in program year 1 ($3,962), the beginning of CRCCP than in subsequent program years ($1,714). The cost per person was $3,153 for programs using colonoscopy and $1,291 for those using FOBT/FIT with diagnostic colonoscopy. The average clinical cost per person was $1,369 for colonoscopy and $280 for FOBT/FIT during the program (these do not reflect cost of repeated FOBT/FIT screens). Programs serving a large number of people had lower per-person costs than those serving a small volume, probably because of fixed costs related to nonclinical expenses. CONCLUSION: Colorectal cancer screening programs incur costs in addition to the clinical cost of the screening procedures to support planning and management, contracting with providers, and tracking patients. Because programs can achieve potential economies of scale, partnerships among smaller programs for screening delivery could decrease overall costs.

Economic evaluations of screening strategies for the early detection of colorectal cancer in the average-risk population: A systematic literature review.

BACKGROUND: Colorectal cancer (CRC) screening has proven effective in reducing CRC mortality. This study aimed to systematically review, and evaluate the reporting quality, of the economic evidence regarding CRC screening in average-risk individuals. METHODS: Databases searched included Medline, EMBASE, National Health Service Economic Evaluation, Database of Abstracts of Reviews of Effects, Cost-Effectiveness Analysis registry, EconLit, and Health Technology Assessment database. Eligible studies were cost-effectiveness and cost-utility analyses comparing CRC screening strategies in average-risk individuals, published in English or Spanish, between January 2012 and November 2018. Reporting quality was assessed using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist. RESULTS: Of 1,993 publications initially retrieved, 477 were excluded by duplicate review, 1,449 by title/abstract review, and 34 by full-text review. Finally, 33 publications were included in the qualitative synthesis. Most studies were conducted in Europe (36,4%), followed by United States (24,2%) and Asia (24,2%). The main screening modalities considered were fecal immunochemical tests (70%), colonoscopy (67%), guaiac fecal occult blood test (42%) and flexible sigmoidoscopy (30%). In most studies, CRC screening was deemed cost-effective compared to no screening. Sensitivity analyses indicated that cost of CRC screening tests, adherence to screening, screening test sensitivity, and cost of CRC treatment had the greatest impact on cost-effectiveness results across studies. The majority of studies (73%) adequately reported at least 50% of the items included in the CHEERS checklist. Least well reported items included setting, study perspective, discount rate, model choice, and methods to identify effectiveness data or to estimate resource use and costs. CONCLUSIONS: CRC screening is an efficient alternative to no screening. Nevertheless, it is not possible to conclude which strategy should be preferred for population-based screening programs. Although we observed an overall good adherence to CHEERS recommendations, there is still room for improvement in economic evaluations reporting in this field.

Cost-effectiveness of colorectal cancer screening programmes using sigmoidoscopy and immunochemical faecal occult blood test.

OBJECTIVE: Several European countries are implementing organized colorectal cancer (CRC) screening programmes using faecal immunochemical test (FIT) and/or flexible sigmoidoscopy (FS), but the cost-effectiveness of these programmes is not yet available. We aimed to assess cost-effectiveness, based on data from the established Piedmont screening programme. METHODS: Using the Piedmont programme data, a Markov model was constructed comparing three strategies in a simulated cohort of 100,000 subjects: single FS, biennial FIT, or sequential strategy (FS + FIT offered to FS non-responders). Estimates for CRC incidence and mortality prevention were derived from studies of organized screening. Cost analysis for FS and FIT was based on data from organized programmes. Incremental cost-effectiveness ratios (ICER) between the different strategies were calculated. Sensitivity and probabilistic analyses were performed. RESULTS: Direct costs for FS, and for FIT at first and subsequent rounds, were estimated as €160, €33, and €21, respectively. All the simulated strategies were effective (10-17% CRC incidence reduction) and cost-effective vs. no screening (ICER <€1000 per life-year saved). FS and FS + FIT were the only cost-saving strategies, with FS least expensive (€15 saving per person invited). FS + FIT and FS were the only non-dominated strategies. FS + FIT were more effective and cost-effective than FS (ICER €1217 per life-year saved). The residual marginal uncertainty was mainly related to parameters inherent to FIT effectiveness and adherence. CONCLUSIONS: Organized CRC screening programmes are highly cost-effective, irrespective of the test selected. A sequential approach with FS and FIT appears the most cost-effective option. A single FS is the least expensive, but convenient, approach.

Evaluation of the benefits, harms and cost-effectiveness of potential alternatives to iFOBT testing for colorectal cancer screening in Australia.

The Australian National Bowel Cancer Screening Program (NBCSP) will fully roll-out 2-yearly screening using the immunochemical Faecal Occult Blood Testing (iFOBT) in people aged 50 to 74 years by 2020. In this study, we aimed to estimate the comparative health benefits, harms, and cost-effectiveness of screening with iFOBT, versus other potential alternative or adjunctive technologies. A comprehensive validated microsimulation model, Policy1-Bowel, was used to simulate a total of 13 screening approaches involving use of iFOBT, colonoscopy, sigmoidoscopy, computed tomographic colonography (CTC), faecal DNA (fDNA) and plasma DNA (pDNA), in people aged 50 to 74 years. All strategies were evaluated in three scenarios: (i) perfect adherence, (ii) high (but imperfect) adherence, and (iii) low adherence. When assuming perfect adherence, the most effective strategies involved using iFOBT (annually, or biennially with/without adjunct sigmoidoscopy either at 50, or at 54, 64 and 74 years for individuals with negative iFOBT), or colonoscopy (10-yearly, or once-off at 50 years combined with biennial iFOBT). Colorectal cancer incidence (mortality) reductions for these strategies were 51-67(74-80)% in comparison with no screening; 2-yearly iFOBT screening (i.e. the NBCSP) would be associated with reductions of 51(74)%. Only 2-yearly iFOBT screening was found to be cost-effective in all scenarios in context of an indicative willingness-to-pay threshold of A$50,000/life-year saved (LYS); this strategy was associated with an incremental cost-effectiveness ratio of A$2,984/LYS-A$5,981/LYS (depending on adherence). The fully rolled-out NBCSP is highly cost-effective, and is also one of the most effective approaches for bowel cancer screening in Australia.

Comparative effectiveness of screening strategies for colorectal cancer.

BACKGROUND: Screening for colorectal cancer (CRC) has been successful in decreasing the incidence and mortality from CRC. Although new screening tests have become available, their relative impact on CRC outcomes remains unexplored. This study compares the outcomes of various screening strategies on CRC outcomes. METHODS: A Markov model representing the natural history of CRC was built and validated against empiric data from screening trials as well as the Microstimulation Screening Analysis (MISCAN) model. Thirteen screening strategies based on colonoscopy, sigmoidoscopy, computed tomographic colonography, as well as fecal immunochemical, occult blood, and stool DNA testing were compared with no screening. A simulated sample of the US general population ages 50 to 75 years with an average risk of CRC was followed for up to 35 years or until death. Effectiveness was measured by discounted life years gained and the number of CRCs prevented. Discounted costs and cost-effectiveness ratios were calculated. A discount rate of 3% was used in calculations. The study took a societal perspective. RESULTS: Colonoscopy emerged as the most effective screening strategy with the highest life years gained (0.022 life years) and CRCs prevented (n = 1068) and the lowest total costs ($2861). These values were 0.012 life years gained, 574 CRCs prevented, and a total cost of $3164, respectively, for FOBT; and 0.011 life years gained, 647 CRCs prevented, and a total cost of $4296, respectively, for DNA testing. Improved sensitivity or specificity of a screening test for CRC detection was not sufficient to close the outcomes gap compared with colonoscopy. CONCLUSIONS: Improvement in CRC-detection performance is not sufficient to improve screening outcomes. Special attention must be directed to detecting precancerous adenomas. Cancer 2017;123:1516-1527. © 2017 American Cancer Society.

Cost Effectiveness of Screening Colonoscopy Depends on Adequate Bowel Preparation Rates - A Modeling Study.

BACKGROUND: Inadequate bowel preparation during screening colonoscopy necessitates repeating colonoscopy. Studies suggest inadequate bowel preparation rates of 20-60%. This increases the cost of colonoscopy for our society. AIM: The aim of this study is to determine the impact of inadequate bowel preparation rate on the cost effectiveness of colonoscopy compared to other screening strategies for colorectal cancer (CRC). METHODS: A microsimulation model of CRC screening strategies for the general population at average risk for CRC. The strategies include fecal immunochemistry test (FIT) every year, colonoscopy every ten years, sigmoidoscopy every five years, or stool DNA test every 3 years. The screening could be performed at private practice offices, outpatient hospitals, and ambulatory surgical centers. RESULTS: At the current assumed inadequate bowel preparation rate of 25%, the cost of colonoscopy as a screening strategy is above society's willingness to pay (<$50,000/QALY). Threshold analysis demonstrated that an inadequate bowel preparation rate of 13% or less is necessary before colonoscopy is considered more cost effective than FIT. At inadequate bowel preparation rates of 25%, colonoscopy is still more cost effective compared to sigmoidoscopy and stool DNA test. Sensitivity analysis of all inputs adjusted by ±10% showed incremental cost effectiveness ratio values were influenced most by the specificity, adherence, and sensitivity of FIT and colonoscopy. CONCLUSIONS: Screening colonoscopy is not a cost effective strategy when compared with fecal immunochemical test, as long as the inadequate bowel preparation rate is greater than 13%.

Screening for colorectal cancer: spoiled for choice?

There are many different potential screening strategies for colorectal cancer (CRC) that vary both in the likely magnitude of their benefits on CRC mortality and their impact on health services. Many approaches to CRC screening are cost-effective, but there is substantial uncertainty about the optimal approach. Decision models using Markov or microsimulation modelling that compare the cost-effectiveness of different screening strategies are useful in this regard. We have reviewed recent decision models that compare the cost-effectiveness of one-off flexible sigmoidoscopy screening with immunochemical faecal occult blood (FIT) based screening. Models consistently show that any population-based screening is cost-effective compared with no screening, and that FIT-based screening is more effective than one-off sigmoidoscopy screening. The combination of one-off sigmoidoscopy with FIT is more effective in saving lives than either modality alone, but has the greatest impact on health service resources. The recent decision to proceed with biennial FIT-based screening is consistent with current evidence.

The cost-effectiveness of training US primary care physicians to conduct colorectal cancer screening in family medicine residency programs.

BACKGROUND: Demand for a wide array of colorectal cancer screening strategies continues to outpace supply. One strategy to reduce this deficit is to dramatically increase the number of primary care physicians who are trained and supportive of performing office-based colonoscopies or flexible sigmoidoscopies. This study evaluates the clinical and economic implications of training primary care physicians via family medicine residency programs to offer colorectal cancer screening services as an in-office procedure. METHODS: Using previously established clinical and economic assumptions from existing literature and budget data from a local grant (2013), incremental cost-effectiveness ratios are calculated that incorporate the costs of a proposed national training program and subsequent improvements in patient compliance. Sensitivity analyses are also conducted. RESULTS: Baseline assumptions suggest that the intervention would produce 2394 newly trained residents who could perform 71,820 additional colonoscopies or 119,700 additional flexible sigmoidoscopies after ten years. Despite high costs associated with the national training program, incremental cost-effectiveness ratios remain well below standard willingness-to-pay thresholds under base case assumptions. Interestingly, the status quo hierarchy of preferred screening strategies is disrupted by the proposed intervention. CONCLUSIONS: A national overhaul of family medicine residency programs offering training for colorectal cancer screening yields satisfactory incremental cost-effectiveness ratios. However, the model places high expectations on primary care physicians to improve current compliance levels in the US.

Cost Effectiveness of Colorectal Cancer Screening Strategies.

BACKGROUND: Several screening tests are available to detect colorectal cancer (CRC) and reduce the incidence and mortality of CRC. The purpose of this review was to determine how current CRC screening strategies for CRC compare with no screening and whether agreement exists with regard to the cost effectiveness of different strategies. METHODS: Databases were searched for cost-effectiveness analyses focused on CRC screening strategies in the United States and published between May 2007 and February 2014. We analyzed the uses of fecal occult blood, fecal immunochemistry, and stool DNA tests, as well as sigmoidoscopy, colonoscopy, and virtual colonoscopy. A paired comparison of each screening strategy with no screening across each of the studies reviewed was conducted. A series of paired comparisons of the results reported in each of the studies is also included. RESULTS: When compared with no screening, all CRC screening strategies evaluated in this review were cost effective. There was disagreement as to which screening strategy was the most cost effective. However, sigmoidoscopy combined with fecal blood testing always dominated either strategy alone. Studies comparing colonoscopy with fecal blood testing, sigmoidoscopy, or both had mixed results. CONCLUSIONS: Compared with no screening, all CRC screening strategies are more cost effective. Study results disagree as to which screening strategy should be the preferred method.

In-hospital weight loss, prescribed diet and food acceptance / Perda de peso hospitalar, dieta prescrita e aceitação de alimentos

BACKGROUND: Weight loss and malnutrition may be caused by many factors, including type of disease and treatment. AIM: The present study investigated the occurrence of in-hospital weight loss and related factors. METHOD: This cross-sectional study investigated the following variables of 456 hospitalized patients: gender, age, disease, weight variation during hospital stay, and type and acceptance of the prescribed diet. Repeated measures analysis of variance (ANOVA) was used for comparing patients' weight in the first three days in hospital stay and determining which factors affect weight. The generalized estimating equation was used for comparing the food acceptance rates. The significance level was set at 5%. RESULTS: The most prescribed diet was the regular (28.8%) and 45.5% of the patients lost weight during their stay. Acceptance of hospital food increased from the first to the third days of stay (p=0.0022) but weight loss was still significant (p<0.0001). Age and type of prescribed diet did not affect weight loss during the study period but type of disease and gender did. Patients with neoplasms (p=0.0052) and males (p=0.0002) lost more weight. CONCLUSION: Weight loss during hospital stay was associated only with gender and type of disease. .

RACIONAL: A perda de peso e a desnutrição podem ser desencadeadas por vários fatores, além de estar relacionada com o tipo de doença e com a terapia empregada. OBJETIVO: Investigar a ocorrência de perda de peso e fatores relacionados, durante a internação. MÉTODO: Estudo transversal com 456 pacientes hospitalizados, sendo estudadas as seguintes variáveis: sexo, idade, doença, evolução de peso, tipo e aceitação da dieta prescrita. Para comparar o peso entre os três primeiros dias de internação e para o estudo dos fatores que interferiram na alteração do peso, foi utilizada a Análise de Variância (ANOVA) para medidas repetidas. Para comparar a proporção de respostas na aceitação da dieta, foi utilizado o método das Equações de Estimação Generalizadas (EEG), com nível de significância de 5%. RESULTADOS: A dieta mais prescrita foi a geral (28.8%) e 45.5% dos pacientes perderam peso durante a internação. A aceitação da dieta hospitalar melhorou do 1º para o 3º dia de internação (p=0.0022), mas mesmo assim, a perda foi significativa (p<0.0001). Verificou-se que a idade e o tipo de dieta prescrita não influenciaram na perda de peso no período; mas, o tipo de doença e o sexo, apresentaram influência nos pacientes portadores de neoplasias (p=0.0052) e o sexo masculino (p=0.0002) apresentou mais perda de peso. CONCLUSÃO: A perda de peso no decorrer da internação foi relacionada apenas ao sexo e ao tipo de doença. .

Should colorectal cancer screening be considered in elderly persons without previous screening? A cost-effectiveness analysis.

BACKGROUND: The U.S. Preventive Services Task Force recommends against routine screening for colorectal cancer (CRC) in adequately screened persons older than 75 years but does not address the appropriateness of screening in elderly persons without previous screening. OBJECTIVE: To determine at what ages CRC screening should be considered in unscreened elderly persons and to determine which test is indicated at each age. DESIGN: Microsimulation modeling study. DATA SOURCES: Observational and experimental studies. TARGET POPULATION: Unscreened persons aged 76 to 90 years with no, moderate, and severe comorbid conditions. TIME HORIZON: Lifetime. PERSPECTIVE: Societal. INTERVENTION: One-time colonoscopy, sigmoidoscopy, or fecal immunochemical test (FIT) screening. OUTCOME MEASURES: Quality-adjusted life-years gained, costs, and costs per quality-adjusted life-year gained. RESULTS OF BASE-CASE ANALYSIS: In unscreened elderly persons with no comorbid conditions, CRC screening was cost-effective up to age 86 years. Screening with colonoscopy was indicated up to age 83 years, sigmoidoscopy was indicated at age 84 years, and FIT was indicated at ages 85 and 86 years. In unscreened persons with moderate comorbid conditions, screening was cost-effective up to age 83 years (colonoscopy indicated up to age 80 years, sigmoidoscopy at age 81 years, and FIT at ages 82 and 83 years). In unscreened persons with severe comorbid conditions, screening was cost-effective up to age 80 years (colonoscopy indicated up to age 77 years, sigmoidoscopy at age 78 years, and FIT at ages 79 and 80 years). RESULTS OF SENSITIVITY ANALYSES: Results were most sensitive to assuming a lower willingness to pay per quality-adjusted life-year gained. LIMITATION: Only persons at average risk for CRC were considered. CONCLUSION: In unscreened elderly persons CRC screening should be considered well beyond age 75 years. A colonoscopy is indicated at most ages. PRIMARY FUNDING SOURCE: National Cancer Institute.

Rate of detection of advanced neoplasms in proximal colon by simulated sigmoidoscopy vs fecal immunochemical tests.

BACKGROUND & AIMS: We compared the ability of biennial fecal immunochemical testing (FIT) and one-time sigmoidoscopy to detect colon side-specific advanced neoplasms in a population-based, multicenter, nationwide, randomized controlled trial. METHODS: We identified asymptomatic men and women, 50-69 years old, through community health registries and randomly assigned them to groups that received a single colonoscopy examination or biennial FIT. Sigmoidoscopy yield was simulated from results obtained from the colonoscopy group, according to the criteria proposed in the UK Flexible Sigmoidoscopy Trial for colonoscopy referral. Patients who underwent FIT and were found to have ≥75 ng hemoglobin/mL were referred for colonoscopy. Data were analyzed from 5059 subjects in the colonoscopy group and 10,507 in the FIT group. The main outcome was rate of detection of any advanced neoplasm proximal to the splenic flexure. RESULTS: Advanced neoplasms were detected in 317 subjects (6.3%) in the sigmoidoscopy simulation group compared with 288 (2.7%) in the FIT group (odds ratio for sigmoidoscopy, 2.29; 95% confidence interval, 1.93-2.70; P = .0001). Sigmoidoscopy also detected advanced distal neoplasia in a higher percentage of patients than FIT (odds ratio, 2.61; 95% confidence interval, 2.20-3.10; P = .0001). The methods did not differ significantly in identifying patients with advanced proximal neoplasms (odds ratio, 1.17; 95% confidence interval, 0.78-1.76; P = .44). This was probably due to the lower performance of both strategies in detecting patients with proximal lesions (sigmoidoscopy detected these in 19.1% of patients and FIT in 14.9% of patients) vs distal ones (sigmoidoscopy detected these in 86.8% of patients and FIT in 33.5% of patients). Sigmoidoscopy, but not FIT, detected proximal lesions in lower percentages of women (especially those 50-59 years old) than men. CONCLUSIONS: Sigmoidoscopy and FIT have similar limitations in detecting advanced proximal neoplasms, which depend on patients' characteristics; sigmoidoscopy underperforms for women 50-59 years old. Screening strategies should be designed on the basis of target population to increase effectiveness and cost-effectiveness. ClinicalTrials.gov number: NCT00906997.

Population screening for colorectal cancer by flexible sigmoidoscopy or CT colonography: study protocol for a multicenter randomized trial.

BACKGROUND: Colorectal cancer (CRC) is the second most prevalent type of cancer in Europe. A single flexible sigmoidoscopy (FS) screening at around the age of 60 years prevents about one-third of CRC cases. However, FS screens only the distal colon, and thus mortality from proximal CRC is unaffected. Computed tomography colonography (CTC) is a highly accurate examination that allows assessment of the entire colon. However, the benefit of CTC testing as a CRC screening test is uncertain. We designed a randomized trial to compare participation rate, detection rates, and costs between CTC (with computer-aided detection) and FS as primary tests for population-based screening. METHODS/DESIGN: An invitation letter to participate in a randomized screening trial comparing CTC versus FS will be mailed to a sample of 20,000 people aged 58 or 60 years, living in the Piedmont region and the Verona district of Italy. Individuals with a history of CRC, adenomas, inflammatory bowel disease, or recent colonoscopy, or with two first-degree relatives with CRC will be excluded from the study by their general practitioners. Individuals responding positively to the invitation letter will be then randomized to the intervention group (CTC) or control group (FS), and scheduled for the screening procedure. The primary outcome parameter of this part of the trial is the difference in advanced neoplasia detection between the two screening tests. Secondary outcomes are cost-effectiveness analysis, referral rates for colonoscopy induced by CTC versus FS, and the expected and perceived burden of the procedures. To compare participation rates for CTC versus FS, 2,000 additional eligible subjects will be randomly assigned to receive an invitation for screening with CTC or FS. In the CTC arm, non-responders will be offered fecal occult blood test (FOBT) as alternative screening test, while in the FS arm, non-responders will receive an invitation letter to undergo screening with either FOBT or CTC. Data on reasons for participation and non-participation will also be collected. DISCUSSION: This study will provide reliable information concerning benefits and risks of the adoption of CTC as a mass screening intervention in comparison with FS. The trial will also evaluate the role of computer-aided detection in a screening setting. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01739608.

Clinical use of CT colonography for colorectal cancer screening in military training facilities and potential impact on HEDIS measures.

PURPOSE: The National Committee for Quality Assurance developed the Healthcare Effectiveness Data and Information Set(®) (HEDIS(®)) to provide quality measures for the evaluation of standards of medical care across health plans. Screening for colorectal cancer (CRC) has been shown to increase the detection of early-stage disease and reduce mortality. Current HEDIS measures for CRC screening include fecal occult blood testing, flexible sigmoidoscopy, and colonoscopy. The aim of this analysis was to quantify the use of CT colonography (CTC) for CRC screening and demonstrate the potential impact of including CTC as a HEDIS-acceptable screening modality. METHODS: Demographic and health care utilization data from the Military Health System Population Health Portal for January 1, 2005, through December 31, 2010, for individuals aged 50 to 75, were analyzed to determine the degree of overall utilization of CTC. Screening compliance for CRC per HEDIS was also estimated, and the incremental impact of adding HEDIS-eligible patients who had undergone CTC as their only CRC screening test was then evaluated for two similarly sized, regional Navy medical centers. RESULTS: Across all sites (10 Army, 4 Navy, 3 Air Force), 17,187 CTC studies were performed, with increasing utilization during the 6-year study period. At the two Navy medical centers, screening compliance ranged from 33.8% to 67.9% without CTC and from 33.8% to 84.0% with CTC. CONCLUSIONS: CTC is actively being used for CRC screening across military treatment facilities. The inclusion of CTC as a HEDIS-compliant CRC screening test has the potential to significantly increase health care system compliance for National Committee for Quality Assurance CRC screening measures.

Comparative effectiveness and cost-effectiveness of screening colonoscopy vs. sigmoidoscopy and alternative strategies.

OBJECTIVES: Fecal occult blood testing (FOBT) and sigmoidoscopy are proven to decrease colorectal cancer (CRC) incidence and mortality. Sigmoidoscopy's benefit is limited to the distal colon. Observational data are conflicting regarding the degree to which colonoscopy affords protection against proximal CRC. Our aim was to explore the comparative effectiveness and cost-effectiveness of colonoscopy vs. sigmoidoscopy and alternative CRC screening strategies in light of the latest published data. METHODS: We performed a contemporary cost-utility analysis using a Markov model validated against data from randomized controlled trials of FOBT and sigmoidoscopy. Persons at average CRC risk within the general US population were modeled. Screening strategies included those recommended by the United States (US) Preventive Services Task Force, including colonoscopy every 10 years (COLO), flexible sigmoidoscopy every 5 years (FS), annual fecal occult blood testing, annual fecal immunochemical testing (FIT), and the combination FS/FIT. The main outcome measures were quality-adjusted life-years (QALYs) and costs. RESULTS: In the base case, FIT dominated other strategies. The advantage of FIT over FS and COLO was contingent on rates of uptake and adherence that are well above current US rates. Compared with FIT, FS and COLO both cost <$50,000/QALY gained when FIT per-cycle adherence was <50%. COLO cost $56,800/QALY gained vs. FS in the base case. COLO cost <$100,000/QALY gained vs. FS when COLO yielded a relative risk of proximal CRC of <0.5 vs. no screening. In probabilistic analyses, COLO was cost-effective vs. FS at a willingness-to-pay threshold of $100,000/QALY gained in 84% of iterations. CONCLUSIONS: Screening colonoscopy may be cost-effective compared with FIT and sigmoidoscopy, depending on the relative rates of screening uptake and adherence and the protective benefit of colonoscopy in the proximal colon. Colonoscopy's cost-effectiveness compared with sigmoidoscopy is contingent on the ability to deliver ~50% protection against CRC in the proximal colon.