Once-only Flexible Sigmoidoscopy Research Articles

Long-term effects of once-only flexible sigmoidoscopy screening on colorectal cancer incidence and mortality: 21-year follow-up of the UK Flexible Sigmoidoscopy Screening randomised controlled trial

Flexible sigmoidoscopy screening reduces colorectal cancer incidence and mortality; however, uncertainty exists about the duration of protection and differences by sex and age. We assessed effects of once-only flexible sigmoidoscopy screening after 21 years' follow-up. The UK Flexible Sigmoidoscopy Screening Trial is a multicentre randomised controlled trial that recruited men and women aged 55-64 years from general practices serving 14 hospitals. Among participants indicating that they would attend flexible sigmoidoscopy screening if invited, randomisation (2:1) to the control (no further contact) or intervention (invited to once-only flexible sigmoidoscopy screening) group was performed centrally in blocks of 12, stratified by centre, general practice, and household type. Masking of intervention was infeasible. Primary outcomes were colorectal cancer incidence and mortality. The Kaplan-Meier method estimated cumulative incidence. Primary analyses estimated intention-to-treat hazard ratios (HRs) and risk differences, overall and stratified by subsite, sex, and age. The trial is registered with ISRCTN, number 28352761. Among participants recruited between Nov 14, 1994, and March 30, 1999, 170 432 were eligible and 113 195 were randomly assigned to the control group and 57 237 were randomly assigned to the intervention group. 406 participants were excluded from analyses (268 in the control group and 138 in the intervention group), leaving 112 927 participants in the control group (55 336 [49%] men and 57 591 [51%] women) and 57 099 in the intervention group (27 966 [49%] men and 29 103 [51%] women). Of participants who were invited to be screened, 40 624 (71%) attended screening. Median follow-up was 21·3 years (IQR 18·0-22·2). In the invited-to-screening group, colorectal cancer incidence was reduced compared with the control group (1631 vs 4201 cases; cumulative incidence at 21 years was 3·18% [95% CI 3·03 to 3·34] vs 4·16% [4·04 to 4·29]; HR 0·76 [95% CI 0·72 to 0·81]) with 47 fewer cases per 100 000 person-years (95% CI -56 to -37). Colorectal cancer mortality was also reduced in the invited-to-screening group compared with the control group (502 vs 1329 deaths; cumulative incidence at 21 years was 0·97% [0·88 to 1·06] vs 1·33% [1·26 to 1·40]; HR 0·75 [0·67 to 0·83]) with 16 fewer deaths per 100 000 person-years (-21 to -11). Effects were particularly evident in the distal colorectum (726 incident cancer cases in the invited-to-screening group vs 2434 cases in the control group; HR 0·59 [0·54 to 0·64]; 47 fewer cases per 100 000 person-years [-54 to -41]; 196 cancer deaths in the invited-to-screening group vs 708 deaths in the control group; HR 0·55 [0·47 to 0·64]; 15 fewer deaths per 100 000 person-years [-19 to -12]) and not the proximal colon (871 incident cancer cases in the invited-to-screening group vs 1749 cases in the control group; HR 0·98 [0·91 to 1·07]; one fewer case per 100 000 person-years [-8 to 5]; 277 cancer deaths in the invited-to-screening group vs 547 deaths in the control group; HR 1·00 [0·86 to 1·15]; zero fewer deaths per 100 000 person-years [-4 to 4]). The HR for colorectal cancer incidence was lower in men (0·70 [0·65-0·76]) than women (0·86 [0·79 to 0·93]; pinteraction=0·0007) but there was no difference by age. We show that once-only flexible sigmoidoscopy screening reduces colorectal cancer incidence and mortality for two decades and provide important data to inform colorectal cancer screening guidelines. National Institute for Health and Care Research Health Technology Assessment Programme and the Medical Research Council.

Promoting healthy lifestyle habits among participants in cancer screening programs: Results of the randomized controlled Sti.Vi study.

Background:Unhealthy diets, physical inactivity, alcohol and tobacco consumption are among the leading risk factors for non-communicable diseases. It is estimated that around 40% of cancers could be prevented by adopting healthy lifestyles.Design and methods:The Stili di Vita (Sti.Vi) study was a randomized study for assessing the impact of healthy lifestyle interventions on anthropometric measures, metabolic parameters, and health outcomes among participants of cancer screening programs in Turin (Italy). Eligible women aged 50–54 years, invited to biennial mammography screening, and 58-years-old men and women, invited to a once-only sigmoidoscopy for colorectal cancer (CRC) screening were randomly allocated to Diet group (DG), Physical Activity group (PAG), Physical Activity plus Diet group (PADG), or control group (CG). Physical and eating habits, metabolic and anthropometric measurements, repeatedly collected, were the study outcomes. The active intervention, offered to participants assigned to the DG, PAG, and PADG arms, consisted of a basic module and an advanced module. The effect of the interventions was estimated through logistic regression or a difference in differences approach. A multiple imputation procedure was implemented to deal with missing values and q-values have been calculated in the presence of multiple hypothesis testing.Results:Out of the 8442 screened attendees, 1270 signed informed consent, while 1125 participants accomplished the baseline visit. Participants were equally distributed across the four treatments as following: 273 (24.3%) in DG, 288 (25.6%) in the PAG, 283 (25.1%) in PADG, and 281 (25%) in the CG. Participants assigned to DG or PADG increased their consumption of whole grains (OR = 1.77, 95% CI: 1.20–2.60 and OR = 1.55, 95% CI: 1.06–2.27, respectively) and legumes (OR = 1.77, 95% CI: 1.12–2.79 and OR = 2.24, 95% CI: 1.41–3.57, respectively), with respect to CG. The participants randomized to DG reduced processed meat and increased fruit consumption (OR = 2.57, 95% CI: 1.76–3.76 and OR = 2.38, 95% CI: 1.12–5.06, respectively). The effects were more evident in the CRC screening subgroup. No relevant difference was observed between PAG and CG. No impact was observed on physical activity habits.Conclusions:Our findings suggest that active interventions can increase awareness and induce diet changes. However, participation rate and compliance to the courses was quite low, innovative strategies to enhance participants’ retention are needed, with the ultimate goal of increasing awareness and inducing positive lifestyle changes.

Long-Term Follow-up of the Italian Flexible Sigmoidoscopy Screening Trial.

Recent reports showed that the protective effect of flexible sigmoidoscopy (FS) screening was maintained up to17 years, although differences were reported by sex. To assess long-term reduction of colorectal cancer (CRC) incidence and mortality after a single FS screening. Parallel randomized controlled trial. (ISRCTN registry number: 27814061). 6 centers in Italy. Persons aged 55 to 64 years expressing interest in having FS screening if invited, recruited from 1995 to 1999 and followed until 2012 (incidence) and 2014 to 2016 (mortality). Eligible persons were randomly assigned (1:1 ratio) to either the once-only FS screening group or control (usual care) group. Incidence and mortality rate ratios (RRs) and rate differences. A total of 34272 persons (17136 in each group) were included in the analysis; 9911 participants had screening in the intervention group. Median follow-up was 15.4 years for incidence and 18.8 years for mortality. Incidence of CRC was reduced by 19% (RR, 0.81 [95% CI, 0.71 to 0.93]) in the intention-to-treat (ITT) analysis, comparing the intervention with the control group, and by 33% (RR, 0.67 [CI, 0.56 to 0.81]) in the per protocol (PP) analysis, comparing participants screened in the intervention group with the control persons. Colorectal cancer mortality was reduced by 22% (RR, 0.78 [CI, 0.61 to 0.98]) in the ITT analysis and by 39% (RR, 0.61 [CI, 0.44 to 0.84]) in the PP analysis. Incidence of CRC was statistically significantly reduced among both men and women. Colorectal cancer mortality was statistically significantly reduced among men (ITT RR, 0.73 [CI, 0.54 to 0.97]) but not among women (ITT RR, 0.90 [CI, 0.59 to 1.37]). Self-selection of volunteers from the general population sample targeted for recruitment may limit generalizability. The strong protective effect of a single FS screening for CRC incidence and mortality was maintained up to 15 and 19 years, respectively. Italian Association for Cancer Research, Italian National Research Council, Istituto Oncologico Romagnolo, Fondo "E. Tempia," University of Milan, and Local Health Unit ASL-Torino.

The CRCbiome study: a large prospective cohort study examining the role of lifestyle and the gut microbiome in colorectal cancer screening participants

BackgroundColorectal cancer (CRC) screening reduces CRC incidence and mortality. However, current screening methods are either hampered by invasiveness or suboptimal performance, limiting their effectiveness as primary screening methods. To aid in the development of a non-invasive screening test with improved sensitivity and specificity, we have initiated a prospective biomarker study (CRCbiome), nested within a large randomized CRC screening trial in Norway. We aim to develop a microbiome-based classification algorithm to identify advanced colorectal lesions in screening participants testing positive for an immunochemical fecal occult blood test (FIT). We will also examine interactions with host factors, diet, lifestyle and prescription drugs. The prospective nature of the study also enables the analysis of changes in the gut microbiome following the removal of precancerous lesions.MethodsThe CRCbiome study recruits participants enrolled in the Bowel Cancer Screening in Norway (BCSN) study, a randomized trial initiated in 2012 comparing once-only sigmoidoscopy to repeated biennial FIT, where women and men aged 50–74 years at study entry are invited to participate. Since 2017, participants randomized to FIT screening with a positive test result have been invited to join the CRCbiome study. Self-reported diet, lifestyle and demographic data are collected prior to colonoscopy after the positive FIT-test (baseline). Screening data, including colonoscopy findings are obtained from the BCSN database. Fecal samples for gut microbiome analyses are collected both before and 2 and 12 months after colonoscopy. Samples are analyzed using metagenome sequencing, with taxonomy profiles, and gene and pathway content as primary measures. CRCbiome data will also be linked to national registries to obtain information on prescription histories and cancer relevant outcomes occurring during the 10 year follow-up period.DiscussionThe CRCbiome study will increase our understanding of how the gut microbiome, in combination with lifestyle and environmental factors, influences the early stages of colorectal carcinogenesis. This knowledge will be crucial to develop microbiome-based screening tools for CRC. By evaluating biomarker performance in a screening setting, using samples from the target population, the generalizability of the findings to future screening cohorts is likely to be high.Trial registrationClinicalTrials.gov Identifier: NCT01538550.

Estimation of overdiagnosis in colorectal cancer screening with sigmoidoscopy and faecal occult blood testing: comparison of simulation models

ObjectiveTo estimate overdiagnosis of colorectal cancer (CRC) for screening with sigmoidoscopy and faecal occult blood testing (FOBT).DesignSimulation study using data from randomised trials.SettingPrimary screening, UK, NorwayParticipants152 850 individuals from the...

Implementation of long-term non-participant reminders for flexible sigmoidoscopy screening.

The clinical effectiveness of screening is highly dependent on uptake. Previous randomised controlled trials suggest that non-participant reminders, which highlight the opportunity to re-book an appointment, can improve participation. The present analysis examines the impact of implementing these reminders within the English Flexible Sigmoidoscopy (FS) Screening Programme, which offers once-only FS screening to adults aged 55-59years. We assessed the screening status of 26,339 individuals invited for once-only FS screening in England. A total of 10,952 (41.6%) had attended screening, and were subsequently ineligible. The remaining 15,387 had not attended screening, and were selected to receive a reminder, 1-2years after their invitation. Descriptive statistics were used to assess the increase in uptake and the adenoma detection rate (ADR) of those who self-referred, six months after the delivery of the final reminder. Pearson's Chi-Square was used to compare the ADR between those who attended when invited and those who self-referred. Of the 15,387 adults eligible to receive a reminder, 13,626 (88.6%) were sent a reminder as intended (1,761 were not sent a reminder, due to endoscopy capacity). Of these, 8.0% (n=1,086) booked and attended an appointment, which equated to a 4.1% increase in uptake from 41.6% at baseline, to 45.7% at follow-up. The ADR was significantly higher for those who self-referred, compared with those who attended when invited (13.3% and 9.5%, respectively; X 2=16.138, p=0.000059). The implementation of non-participant reminders led to a moderate increase in uptake. Implementing non-participant reminders could help mitigate the negative effects of COVID-19 on uptake.

Modeling in Colorectal Cancer Screening: Assessing External and Predictive Validity of MISCAN-Colon Microsimulation Model Using NORCCAP Trial Results.

Microsimulation models are increasingly being used to inform colorectal cancer (CRC) screening recommendations. MISCAN-Colon is an example of such a model, used to inform the Dutch CRC screening program and US Preventive Services Task Force guidelines. Assessing the validity of these models is essential to provide transparency regarding their performance. In this study, we tested the external and predictive validity of MISCAN-Colon. We validated MISCAN-Colon using the Norwegian Colorectal Cancer Prevention (NORCCAP) trial, a randomized controlled trial that examined the effectiveness of once-only flexible sigmoidoscopy (FS) screening. We simulated the study population and design of the NORCCAP trial in MISCAN-Colon and compared 10- to 12-year model-predicted hazard ratios (HRs) for overall and distal CRC incidence and mortality to those observed. In addition, we compared the numbers of screen-detected neoplasia. Finally, we predicted the trial's future results to allow for the assessment of predictive validity. MISCAN-Colon predicted an HR for overall CRC incidence (0.85), distal CRC incidence (0.82), overall CRC mortality (0.68), and distal CRC mortality (0.62). These were within the limits of the 95% confidence intervals of the NORCCAP trial results. Similar results were observed for the number of screen-detected cancers. The model significantly underestimated the number of screen-detected adenomas. Model-predicted HRs for CRC incidence and mortality up to 15- to 17-year follow-up were 0.84 and 0.72, respectively. Although the underestimation of screen-detected adenomas requires further investigation, MISCAN-Colon is able to make a valid replication of the CRC incidence and mortality reduction of an FS screening trial, which suggests that it can be considered a useful tool to support decision making on CRC screening.

Effect of once-only flexible sigmoidoscopy screening on the outcomes of subsequent faecal occult blood test screening.

ObjectiveTo investigate the outcomes of biennial guaiac faecal occult blood test (gFOBT) screening after once-only flexible sigmoidoscopy (FS) screening.MethodsBetween 1994 and 1999, as part of the UK FS Screening Trial (UKFSST), adults aged 55–64 were randomly allocated to an intervention group (offered FS screening) or a control group (not contacted). From 2006, a subset of UKFSST participants (20,895/44,041 intervention group; 41,497/87,149 control group) were invited to biennial gFOBT screening by the English Bowel Cancer Screening Programme. We analysed gFOBT uptake, test positivity, yield of colorectal cancer (CRC), and positive predictive value (PPV) for CRC, advanced adenomas (AAs), and advanced colorectal neoplasia (ACN: AA/CRC).ResultsUptake of gFOBT at first invitation was 1.9% lower (65.7% vs. 67.6%, p < 0.01) among intervention versus control group participants. Positivity was 0.4% lower (2.0% vs. 2.4%, p < 0.01) and CRC yield was 0.08% lower (0.19% vs. 0.27%, p = 0.14). PPVs were also lower in the intervention versus control group, at 10.3% vs. 12.3% (p = 0.44) for CRC, 22.7% vs. 31.4% (p < 0.01) for AA, and 33.0% vs. 43.7% (p < 0.01) for ACN. Among those who refused FS (n = 5532), gFOBT uptake at first invitation was 47.7%, CRC yield was 0.25%, and PPV for ACN was 46.2%. Among FS attenders (n = 15,363), uptake was 72.2%, CRC yield was 0.18%, and PPV for ACN was 27.9%.ConclusionsUptake, positivity and PPV of gFOBT screening were reduced following prior offer of FS screening. However, a quarter of FS screened participants receiving a diagnostic examination after positive gFOBT were diagnosed with ACN.

Changes in health behavior 1 year after testing negative at a colorectal cancer screening: a randomized-controlled study.

When planning national screening programs, it is important to investigate potential changes in health behavior initiated by the screening. Knowledge of the consequences of different colorectal cancer (CRC) screening modalities for health behavior is limited. We aimed to investigate differences in 1-year health behavior changes after testing negative in CRC screening by one of two screening modalities. Participants of both sexes aged 50-74 years assigned randomly to five biennial rounds of fecal immunochemical test (FIT), one round of flexible sigmoidoscopy (FS), or no screening (control) were invited to complete a self-reported lifestyle questionnaire on smoking, body weight, physical activity, alcohol intake, and consumption of selected dietary items at baseline and at 1-year follow-up. In total, 1809 and 1327 individuals in the FIT and the FS arm, respectively, completed the lifestyle questionnaire, as did 1029 controls. We analyzed differences in 1-year health behavior changes between the arms at follow-up by analysis of covariance and logistic regression. Overall, 1-year changes in health behavior were moderate and probably of no clinical relevance. Participants with negative CRC screening test results in the first round of the FIT arm reduced their alcohol consumption significantly more than controls [-0.29 glass/week (95% confidence interval -0.54 to -0.04)]. Body weight decreased more in participants with negative screening test results in the FS than in the FIT arm [-0.31 kg (95% confidence interval -0.55 to -0.08)]. The present study did not suggest unfavorable short-term consequences in the health behavior of individuals who received a negative CRC screening test result from either a first round of FIT or a once-only FS screening.

Diagnostic performance of flexible sigmoidoscopy combined with fecal immunochemical test in colorectal cancer screening: meta-analysis and modeling.

Once-only flexible sigmoidoscopy (FS), which reliably detects neoplasms in the distal colon and rectum but not in the proximal colon, has been shown to reduce incidence and mortality of distal colorectal cancer (CRC). Fecal immunochemical tests (FITs) detect the majority of CRCs and some proportion of adenomas also in the proximal colon. We assessed the expected diagnostic performance of combined application of FS and FIT. We systematically reviewed screening studies conducted in an average risk population that reported specificities and site-specific sensitivities of FITs for detection of CRC or advanced adenoma (AA). Only studies that conducted colonoscopy in all subjects were included. PubMed and Web of Science were searched until May 13, 2016. Reference lists of eligible studies were also screened. Sensitivity of FS was derived from colonoscopy results, assuming the same sensitivity as colonoscopy for left-sided neoplasms and follow-up colonoscopy after detection of distal adenomas. Bivariate meta-analyses were used to derive summary estimates of overall sensitivity and specificity of individual and joint application of both tests. Ten eligible studies were identified. Summary estimates (95% confidence intervals) of overall sensitivity for detecting CRC and AA were 65% (56-74%) and 27% (23-31%) for FIT alone, 67% (58-75%) and 67% (59-75%) for FS alone, and 89% (83-92%) and 75% (68-80%), respectively, for the combination of both tests. The pooled specificity (95% CI) of FIT was 92% (90-95%). Adding a FIT to a once-only screening FS would substantially increase sensitivity of CRC screening at a modest loss in specificity.

Long term effects of once-only flexible sigmoidoscopy screening after 17 years of follow-up: the UK Flexible Sigmoidoscopy Screening randomised controlled trial

SummaryBackgroundColorectal cancer is the third most common cancer worldwide. Previous analyses have only reported follow-up after flexible sigmoidoscopy for a maximum of 12 years. We aimed to examine colorectal cancer incidence and mortality after a single flexible sigmoidoscopy screening and 17 years of follow-up.MethodsIn this multicentre randomised trial (UK Flexible Sigmoidoscopy Screening Trial), done between Nov 14, 1994, and March 30, 1999, 170 432 eligible men and women, who had indicated on a previous questionnaire that they would probably attend screening if invited, were randomly assigned (1:2) to an intervention group (offered flexible sigmoidoscopy screening) or a control group (not contacted). Randomisation was done centrally in blocks of 12, and stratified by trial centre, general practice, and household type. The nature of the intervention did not allow the staff to be masked to arm of the trial; however, randomisation was done in batches so that the control group and participants not yet randomised were unaware of their allocation status. The primary outcomes were incidence and mortality of colorectal cancer. Hazard ratios (HRs) and 95% CIs for colorectal cancer incidence and mortality were estimated for intention-to-treat and per-protocol analyses. The trial is registered with ISRCTN, number 28352761.FindingsOur cohort analysis included 170 034 people: 112 936 in the control group and 57 098 in the intervention group, 40 621 (71%) of whom were screened and 16 477 (29%) were not screened. During screening and a median of 17·1 years' follow-up, colorectal cancer was diagnosed in 1230 individuals in the intervention group and 3253 in the control group, and 353 individuals in the intervention group versus 996 individuals in the control group died from colorectal cancer. In intention-to-treat analyses, colorectal cancer incidence was reduced by 26% (HR 0·74 [95% CI 0·70–0·80]; p<0·0001) in the intervention group versus the control group and colorectal cancer mortality was reduced by 30% (0·70 [0·62–0·79]; p<0·0001) in the intervention group versus the control group. In per-protocol analyses, adjusted for non-compliance, colorectal cancer incidence and mortality were 35% (HR 0·65 [95% CI 0·59–0·71]) and 41% (0·59 [0·49–0·70]) lower in the screened group.InterpretationA single flexible sigmoidoscopy continues to provide substantial protection from colorectal cancer diagnosis and death, with protection lasting at least 17 years.FundingNational Institute for Health Research Efficacy and Mechanism Evaluation.

Likely effect of adding flexible sigmoidoscopy to the English NHS Bowel Cancer Screening Programme: impact on colorectal cancer cases and deaths

Background:From 2013, once-only flexible sigmoidoscopy (FS) at age 55 is being phased into the England National Health Service Bowel Cancer Screening Programme (NHSBCSP), augmenting biennial guaiac faecal occult blood testing (gFOBT) at ages 60–74. Here, we project the impact of this change on colorectal cancer (CRC) cases and deaths prevented in England by mid-2030.Methods:We simulated the life-course of English residents reaching age 55 from 2013 onwards. Model inputs included population numbers, invitation rates and CRC incidence and mortality rates. The impact of gFOBT and FS alone on CRC incidence and mortality were derived from published trials, assuming an uptake of 50% for FS and 57% for gFOBT. For FS plus gFOBT, we assumed the gFOBT effect to be 75% of the gFOBT alone impact.Results:By mid-2030, 8.5 million individuals will have been invited for once-only FS screening. Adding FS to gFOBT screening is estimated to prevent an extra 9627 (−10%) cases and 2207 (−12%) deaths by mid-2030. If FS uptake is 38% or 71%, respectively, an extra 7379 (−8%) or 13 689 (−15%) cases and 1691 (−9%) or 3154 (−17%) deaths will be prevented by mid-2030.Conclusions:Adding once-only FS at age 55 to the NHSBCSP will prevent ∼10 000 CRC cases and ∼2000 CRC deaths by mid-2030 if FS uptake is 50%. In 2030, one cancer was estimated to be prevented per 150 FS screening episodes, and one death prevented per 900 FS screening episodes. The actual reductions will depend on the FS invitation schedule and uptake rates.

Abstract 3242: Colorectal cancer screening pilot: Comparative effectiveness research using two screening modalities

Abstract Although several modalities are being used in colorectal cancer (CRC) screening, only fecal occult blood testing (FOBT) and flexible sigmoidoscopy (FS) have been subjected to randomized trials and long-term follow-up. Both have been found to reduce CRC mortality compared to no screening (18% and 28%, respectively), but a direct comparison between the two has never been done with end-point CRC incidence and mortality. Also, it is not clear which modality is the most cost-effective in any given population. In Norway, a country with high colorectal cancer incidence and little prior screening against the disease, the government decided to start a comparative effectiveness research pilot in 2012 with these two screening modalities. The pilot aims to randomize the entire population aged 50-74 in a defined geographical area in South-East Norway (approximately 140 000 individuals) to one of two screening modalities. Half will be randomized to biennial screening with immunochemical FOBT (OC-Sensor Diana, Eiken Ltd), and half to once only screening with FS. The enrollment will take four years and the pilot includes a number of sub-studies to determine how the screening is perceived in the target population. We report the results from the enrollment in the main trial after the first 18 months. A total of 35746 women and men have been invited so far, 21495 to iFOBT and 14251 to FS. Participation rates have been 49% in the FS arm, and 57% in the iFOBT arm, with slightly higher rates among women than men. Positive FS was defined as advanced neoplasia or three or more adenomas. A total of 10.6% of the FS patients have been referred to colonoscopy. The cut-off value for positive iFOBT was set to 75 ug/L, and 780 patients (6.4%) have so far tested positive and referred to colonoscopy. Forty-three cases of CRC have been detected in the FS group so far, at a rate of 6/1000 examined, somewhat higher in men (7.3/1000) than in women (5/1000). Thirty-nine cancers have been found in the FOBT group after first screening round (3.1/1000 examined), with 4.6/1000 in men and 1.9/1000 in women. Overall the adenoma detection rate at sigmoidoscopy is 14%. A total of 881 high-risk adenomas (adenomas &amp;gt;10 mm, or with high-grade dysplasia or villous features) have been detected. Adenoma detection rate at colonoscopy in the referred population is 60.5%. Complications at sigmoidoscopy have so far been 14/1000 exams, with the vast majority being vasovagal. At colonoscopy the complication rate is currently 5.8/1000, the main ones being reported are bleeding or vasovagal reactions. Conclusion: participation rates in both arms are slightly below the expected 50% for FS and 60% for FOBT. Cancer rates among those screened are higher in the once-only FS than after first round of biennial iFOBT screening, but rates are within the expected range. Citation Format: Giske Ursin, Anita Jørgensen, Ole Petter Børmer, Thomas de Lange, Per K. Sandvei, Christian Thorjussen, Geir Hoff. Colorectal cancer screening pilot: Comparative effectiveness research using two screening modalities. [abstract]. In: Proceedings of the 105th Annual Meeting of the American Association for Cancer Research; 2014 Apr 5-9; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2014;74(19 Suppl):Abstract nr 3242. doi:10.1158/1538-7445.AM2014-3242

Effect of flexible sigmoidoscopy screening on colorectal cancer incidence and mortality: a randomized clinical trial.

Colorectal cancer is a major health burden. Screening is recommended in many countries. To estimate the effectiveness of flexible sigmoidoscopy screening on colorectal cancer incidence and mortality in a population-based trial. Randomized clinical trial of 100,210 individuals aged 50 to 64 years, identified from the population of Oslo city and Telemark County, Norway. Screening was performed in 1999-2000 (55-64-year age group) and in 2001 (50-54-year age group), with follow-up ending December 31, 2011. Of those selected, 1415 were excluded due to prior colorectal cancer, emigration, or death, and 3 could not be traced in the population registry. Participants randomized to the screening group were invited to undergo screening. Within the screening group, participants were randomized 1:1 to receive once-only flexible sigmoidoscopy or combination of once-only flexible sigmoidoscopy and fecal occult blood testing (FOBT). Participants with positive screening test results (cancer, adenoma, polyp ≥10 mm, or positive FOBT) were offered colonoscopy. The control group received no intervention. Colorectal cancer incidence and mortality. A total of 98,792 participants were included in the intention-to-screen analyses, of whom 78,220 comprised the control group and 20,572 comprised the screening group (10,283 randomized to receive a flexible sigmoidoscopy and 10,289 to receive flexible sigmoidoscopy and FOBT). Adherence with screening was 63%. After a median of 10.9 years, 71 participants died of colorectal cancer in the screening group vs 330 in the control group (31.4 vs 43.1 deaths per 100,000 person-years; absolute rate difference, 11.7 [95% CI, 3.0-20.4]; hazard ratio [HR], 0.73 [95% CI, 0.56-0.94]). Colorectal cancer was diagnosed in 253 participants in the screening group vs 1086 in the control group (112.6 vs 141.0 cases per 100,000 person-years; absolute rate difference, 28.4 [95% CI, 12.1-44.7]; HR, 0.80 [95% CI, 0.70-0.92]). Colorectal cancer incidence was reduced in both the 50- to 54-year age group (HR, 0.68; 95% CI, 0.49-0.94) and the 55- to 64-year age group (HR, 0.83; 95% CI, 0.71-0.96). There was no difference between the flexible sigmoidoscopy only vs the flexible sigmoidoscopy and FOBT screening groups. In Norway, once-only flexible sigmoidoscopy screening or flexible sigmoidoscopy and FOBT reduced colorectal cancer incidence and mortality on a population level compared with no screening. Screening was effective both in the 50- to 54-year and the 55- to 64-year age groups. clinicaltrials.gov Identifier: NCT00119912.

PWE-051 Bowelscope: Early Results From The Pilot Sites

IntroductionUK population colorectal cancer (CRC) screening has been successfully implemented with Bowel Cancer Screening Programme (BCSP) faecal occult blood testing biannually from age 60–75.A large UK study of once-only flexible...

Offline: The error of our health technology assessment ways

As research budgets are squeezed, so scientists talk confidently of “impact”. Their goal is to prove that research is making a difference to someone, somewhere. Occasionally, these claims will be true. In 2010, we published a randomised trial of once-only flexible sigmoidoscopy in symptom-free men and women aged 55–64 years. If a polyp was discovered, it was quickly removed. The result was a 43% fall in mortality from colorectal cancer. By March this year, six pilot sites were testing the practicalities of a national screening programme based on these findings. That is impact! When evaluating health technologies, it seems reasonable to argue that impact should equate with effectiveness. Clinical effectiveness is what matters most to patients. And in the UK, our widely admired Health Technology Assessment (HTA) programme leads the field in testing clinical effectiveness. Last week, the HTA programme reached its 20th anniversary. It was, as Iain Chalmers pointed out at a symposium to reflect on its success, “a celebration really worth celebrating”. The self-congratulation was understandable. But was it justifiable? With the performance of the UK in terms of premature mortality (as the UK Global Burden of Disease Study concluded earlier this year) “persistently and significantly” below the European Union average, there can be no room for complacency about whether our research system is producing the right evidence to improve the health of the nation. Now is a moment to question the emphasis of the UK's HTA programme on clinical effectiveness alone.

Early colon cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

Early colon cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

Cost-effectiveness of population-based screening for colorectal cancer: a comparison of guaiac-based faecal occult blood testing, faecal immunochemical testing and flexible sigmoidoscopy.

Background:Several colorectal cancer-screening tests are available, but it is uncertain which provides the best balance of risks and benefits within a screening programme. We evaluated cost-effectiveness of a population-based screening programme in Ireland based on (i) biennial guaiac-based faecal occult blood testing (gFOBT) at ages 55–74, with reflex faecal immunochemical testing (FIT); (ii) biennial FIT at ages 55–74; and (iii) once-only flexible sigmoidoscopy (FSIG) at age 60.Methods:A state-transition model was used to estimate costs and outcomes for each screening scenario vs no screening. A third party payer perspective was adopted. Probabilistic sensitivity analyses were undertaken.Results:All scenarios would be considered highly cost-effective compared with no screening. The lowest incremental cost-effectiveness ratio (ICER vs no screening €589 per quality-adjusted life-year (QALY) gained) was found for FSIG, followed by FIT (€1696) and gFOBT (€4428); gFOBT was dominated. Compared with FSIG, FIT was associated with greater gains in QALYs and reductions in lifetime cancer incidence and mortality, but was more costly, required considerably more colonoscopies and resulted in more complications. Results were robust to variations in parameter estimates.Conclusion:Population-based screening based on FIT is expected to result in greater health gains than a policy of gFOBT (with reflex FIT) or once-only FSIG, but would require significantly more colonoscopy resources and result in more individuals experiencing adverse effects. Weighing these advantages and disadvantages presents a considerable challenge to policy makers.

Uptake of population-based flexible sigmoidoscopy screening for colorectal cancer: a nurse-led feasibility study

To assess uptake of once-only flexible sigmoidoscopy (FS) in a community sample to determine whether FS would be viable as a method of population-based screening for colorectal cancer. All adults aged 60-64 years registered at three General Practices in North West London, UK (510 men and women) were sent a letter of invitation to attend FS screening carried out by an experienced nurse, followed by a reminder if they did not make contact to confirm or decline the invitation. The primary outcome was attendance at the endoscopy unit for a FS test. Of the 510 people invited to attend, 280 (55%) underwent FS. Among non-attenders, 91 (18%) were ineligible for screening or did not receive the invitation, 19 (4%) accepted the offer of screening but were unable to attend during the study period, 52 (10%) declined the offer, 41 (8%) did not respond to the invitation, and 27 (5%) accepted the offer of screening but did not attend. Attendance among those eligible to be screened, who had received the invitation, was 67%. People from more socioeconomically deprived neighbourhoods were less likely to attend (odds ratio [OR] = 0.90; confidence interval [CI] = 0.84-0.96; P = 0.003). Women were more likely to attend than men (OR = 1.44; CI = 1.01-2.05; P = 0.041). Attendance rates in this pilot for nurse-led, population-based FS screening were higher than those reported in other FS studies, and comparable with adherence to fecal occult blood testing (FOBT) in the UK FOBT pilot. Having a female nurse endoscopist may have been responsible for increasing female uptake rates but this warrants confirmation in a larger study.

Comparing Attendance and Detection Rate of Colonoscopy With Sigmoidoscopy and FIT for Colorectal Cancer Screening

We conducted a study to estimate population coverage and detection rate (DR) achievable through different strategies of colorectal cancer (CRC) screening. A population-based multicenter randomized trial comparing 3 strategies was used: (1) biennial immunologic fecal occult blood test (FIT), (2) "once only" sigmoidoscopy (FS), and (3) "once only" colonoscopy (TC). A random sample of men and women, aged 55 to 64 years, was drawn from general practitioners' (GP) rosters. Eligible subjects, randomized within GP, were mailed a personal invitation. Nonresponders in groups 2 and 3 were invited again at 12 and 24 months. Screenees with "high-risk" distal polyps (villous component >20%, high-grade dysplasia, CRC, size >or=10 mm, >2 adenomas) at FS, or with positive FIT, were referred for TC. The attendance rate was 32.3% (1965/6075) for FIT, 32.3% (1944/6018) for FS, 26.5% (1597/6021) for TC. FIT detected 2 patients with CRC (0.1%) and 21 with an advanced adenoma (1.1%). The corresponding figures were as follows: 12 (0.6%) and 86 (4.5%) patients, respectively, for FS; 13 (0.8%) and 100 (6.3%) patients, respectively, for TC. To detect 1 advanced neoplasm, it would be necessary to invite 264 people with FIT, 60 with FS, 53 with TC. FS would have detected 27.3% of the proximal advanced neoplasms detected at TC. Assuming the same participation rate at TC as at FS, 48 TCs would be necessary to detect 1 additional advanced neoplasm missed by FS. When participants are offered 1 screening test, participation is lower in a TC than in an FS program. However, DR of advanced neoplasia is higher with TC.