BACKGROUND: New screening tests for colorectal cancer continue to emerge, but the evidence needed to justify their adoption in screening programs remains uncertain.
METHODS: A review of the literature and a consensus approach by experts was undertaken to provide practical guidance on how to compare new screening tests with proven screening tests.
RESULTS: Findings and recommendations from the review included the following: Adoption of a new screening test requires evidence of effectiveness relative to a proven comparator test. Clinical accuracy supported by programmatic population evaluation in the screening context on an intention-to-screen basis, including acceptability, is essential. Cancer-specific mortality is not essential as an endpoint provided that the mortality benefit of the comparator has been demonstrated and that the biologic basis of detection is similar. Effectiveness of the guaiac-based fecal occult blood test provides the minimum standard to be achieved by a new test. A 4-phase evaluation is recommended. An initial retrospective evaluation in cancer cases and controls (Phase 1) is followed by a prospective evaluation of performance across the continuum of neoplastic lesions (Phase 2). Phase 3 follows the demonstration of adequate accuracy in these 2 prescreening phases and addresses programmatic outcomes at 1 screening round on an intention-to-screen basis. Phase 4 involves more comprehensive evaluation of ongoing screening over multiple rounds. Key information is provided from the following parameters: the test positivity rate in a screening population, the true-positive and false-positive rates, and the number needed to colonoscope to detect a target lesion.
CONCLUSIONS: New screening tests can be evaluated efficiently by this stepwise comparative approach.

OBJECTIVES: Efficacy of two low volume bowel cleansing preparations, polyethylene glycol plus ascorbate (PEG + Asc) and sodium picosulfate/magnesium citrate (NaPic/MgCit), were compared for polyp and adenoma detection rate (PDR and ADR) and overall cleansing ability. Primary endpoint was PDR (the number of patients with ≥ 1 polypoid or flat lesion recorded by the colonoscopist).
METHODS: Diagnostic, surveillance or screening colonoscopy patients were enrolled into this investigator-blinded, multi-center Phase IV study and randomized 1:1 to receive PEG + Asc (administered the evening before and the morning of colonoscopy, per label) or NaPic/MgCit (administered in the morning and afternoon the day before colonoscopy, per label). The blinded colonoscopist documented any lesion and assessed cleansing quality (Harefield Cleansing Scale).
RESULTS: Of 394 patients who completed the study, 393 (PEG + Asc, N = 200; NaPic/MgCit, N = 193) had a colonoscopy. Overall PDR for PEG+Asc versus NaPic/MgCit was 51.5% versus 44.0%, p = 0.139. PDR and ADR on the right side of the bowel were significantly higher with PEG + Asc versus NaPic/MgCit (PDR: 56[28.0%] versus 32[16.6%], p = 0.007; ADR: 42[21.0%] versus 23[11.9%], p = 0.015), as was detection of flat lesions (43[21.5%] versus 25[13.0%], p = 0.025). Cleansing quality was better with PEG + Asc than NaPic/MgCit (98.5% versus 57.5% considered successful cleansing). Overall, there were 132 treatment-emergent adverse events (93 versus 39 for PEG+Asc and NaPic/MgCit, respectively). These were mainly mild abdominal symptoms, all of which were reported for higher proportions of patients in the PEG+Asc than NaPic/MgCit group. Twice as many patients in the NaPic/MgCit versus the PEG + Asc group reported tolerance of cleansing solution as 'very good'.
CONCLUSIONS: Compared with NaPic/MgCit, PEG + Asc may be more efficacious for overall cleansing ability, and subsequent detection of right-sided and flat lesions. This is likely attributable to the different administration schedules of the two bowel cleansing preparations, which may positively impact the detection and prevention of colorectal cancer, thereby improving mortality rates.
TRIAL REGISTRATION: ClinicalTrials.gov NCT01689792.

OBJECTIVES: To examine attitudes towards an annual faecal immunochemical test for haemoglobin (FIT) versus three-yearly colonoscopic surveillance of individuals at intermediate risk of colorectal cancer (CRC).
SETTING: A London hospital.
METHODS: Five semi-structured discussion groups were conducted with 28 adults (aged 60-74, 61% female) with different levels of CRC risk and experience of colonoscopy or colonoscopic surveillance. Information was presented sequentially using a step-by-step discussion guide. Results were analyzed using thematic analysis.
RESULTS: When evaluating FIT in the context of a surveillance programme, all respondents readily made comparisons with related tests that they had been exposed to previously. Those with no experience of surveillance were enthusiastic about an annual FIT to replace three-yearly colonoscopy, because they felt that the higher testing frequency could improve detection of advanced lesions. Those with experience of colonoscopic surveillance did not perceive FIT to be as accurate as colonoscopy, and therefore either preferred colonoscopy on its own or wanted an annual FIT in addition to three-yearly colonoscopy.
CONCLUSIONS: FIT may be well-received as an additional method of surveillance for new patients at intermediate risk of CRC. More research is required to better understand potential barriers associated with FIT surveillance for patients with experience of colonoscopic surveillance.

Multidisciplinary, evidence-based guidelines for quality assurance in colorectal cancer screening and diagnosis have been developed by experts in a project coordinated by the International Agency for Research on Cancer. The full guideline document covers the entire process of population-based screening. It consists of 10 chapters and over 250 recommendations, graded according to the strength of the recommendation and the supporting evidence. The 450-page guidelines and the extensive evidence base have been published by the European Commission. The chapter on quality assurance in endoscopy includes 50 graded recommendations. The content of the chapter is presented here to promote international discussion and collaboration by making the principles and standards recommended in the new EU Guidelines known to a wider professional and scientific community. Following these recommendations has the potential to enhance the control of colorectal cancer through improvement in the quality and effectiveness of endoscopy and other elements in the screening process, including multidisciplinary diagnosis and management of the disease.

Multidisciplinary, evidence-based guidelines for quality assurance in colorectal cancer screening and diagnosis have been developed by experts in a project coordinated by the International Agency for Research on Cancer. The full guideline document covers the entire process of population-based screening. It consists of 10 chapters and over 250 recommendations, graded according to the strength of the recommendation and the supporting evidence. The 450-page guidelines and the extensive evidence base have been published by the European Commission. The chapter on faecal occult blood testing includes 21 graded recommendations. The content of the chapter is presented here to promote international discussion and collaboration by making the principles and standards recommended in the new EU Guidelines known to a wider professional and scientific community. Following these recommendations has the potential to enhance the control of colorectal cancer through improvement in the quality and effectiveness of screening programmes and services.

Multidisciplinary, evidence-based guidelines for quality assurance in colorectal cancer screening and diagnosis have been developed by experts in a project coordinated by the International Agency for Research on Cancer. The full guideline document covers the entire process of population-based screening. It consists of 10 chapters and over 250 recommendations, graded according to the strength of the recommendation and the supporting evidence. The 450-page guidelines and the extensive evidence base have been published by the European Commission. The chapter on evaluation and interpretation of screening outcomes includes 20 graded recommendations. The content of the chapter is presented here to promote international discussion and collaboration by making the principles and standards recommended in the new EU Guidelines known to a wider professional and scientific community. Following these recommendations has the potential to enhance the control of colorectal cancer through improvement in the quality and effectiveness of the screening process, including multi-disciplinary diagnosis and management of the disease.

Multidisciplinary, evidence-based guidelines for quality assurance in colorectal cancer screening and diagnosis have been developed by experts in a project coordinated by the International Agency for Research on Cancer. The full guideline document covers the entire process of population-based screening. It consists of 10 chapters and over 250 recommendations, graded according to the strength of the recommendation and the supporting evidence. The 450-page guidelines and the extensive evidence base have been published by the European Commission. The chapter on communication includes 35 graded recommendations. The content of the chapter is presented here to promote international discussion and collaboration by making the principles and standards recommended in the new EU Guidelines known to a wider professional and scientific community. Following these recommendations has the potential to enhance the control of colorectal cancer through improvement in the quality and effectiveness of screening programmes and services.

Multidisciplinary, evidence-based guidelines for quality assurance in colorectal cancer screening and diagnosis have been developed by experts in a project coordinated by the International Agency for Research on Cancer. The full guideline document covers the entire process of population-based screening. It consists of 10 chapters and over 250 recommendations, graded according to the strength of the recommendation and the supporting evidence. The 450-page guidelines and the extensive evidence base have been published by the European Commission. The chapter on management of lesions detected in colorectal cancer screening includes 32 graded recommendations. The content of the chapter is presented here to promote international discussion and collaboration by making the principles and standards recommended in the new EU Guidelines known to a wider professional and scientific community. Following these recommendations has the potential to enhance the control of colorectal cancer through improvement in the quality and effectiveness of the screening process, including multi-disciplinary diagnosis and management of the disease.

Multidisciplinary, evidence-based guidelines for quality assurance in colorectal cancer screening and diagnosis have been developed by experts in a project coordinated by the International Agency for Research on Cancer. The full guideline document covers the entire process of population-based screening. It consists of 10 chapters and over 250 recommendations, graded according to the strength of the recommendation and the supporting evidence. The 450-page guidelines and the extensive evidence base have been published by the European Commission. The chapter on quality assurance in pathology in colorectal cancer screening and diagnosis includes 23 graded recommendations. The content of the chapter is presented here to promote international discussion and collaboration by making the principles and standards recommended in the new EU Guidelines known to a wider professional and scientific community. Following these recommendations has the potential to enhance the control of colorectal cancer through improvement in the quality and effectiveness of the screening process, including multi-disciplinary diagnosis and management of the disease.

Multidisciplinary, evidence-based guidelines for quality assurance in colorectal cancer screening and diagnosis have been developed by experts in a project coordinated by the International Agency for Research on Cancer. The full guideline document covers the entire process of population-based screening. It consists of 10 chapters and over 250 recommendations, graded according to the strength of the recommendation and the supporting evidence. The 450-page guidelines and the extensive evidence base have been published by the European Commission. The chapter on professional requirements and training includes 23 graded recommendations. The content of the chapter is presented here to promote international discussion and collaboration by making the principles and standards recommended in the new EU Guidelines known to a wider professional and scientific community. Following these recommendations has the potential to enhance the control of colorectal cancer through improvement in the quality and effectiveness of surveillance and other elements in the screening process, including multi-disciplinary diagnosis and management of the disease.

BACKGROUND: Little is known about the psychological predictors of colorectal screening uptake in England and mediators of associations between uptake and socioeconomic status (SES). This study tested the hypotheses that although higher threat and efficacy beliefs, lower cancer fatalism, lower depression, and better self-rated health would predict higher screening uptake, only efficacy beliefs, fatalism, depression, and self-rated health would mediate associations between uptake and SES.
METHODS: Data from 529 adults aged 60 to 69 who had completed a postal survey in 2005-2006 were linked with data on fecal occult blood test (FOBt) uptake recorded at the screening "hub" following its introduction in 2007, resulting in a prospective study.
RESULTS: Screening uptake was 56% and was higher among people with higher SES, better self-rated health, higher self-efficacy beliefs, and lower cancer fatalism in univariate analyses. Path analysis on participants with complete data (n = 515) showed that both better self-rated health and lower cancer fatalism were directly associated with higher uptake of FOBt screening and significantly mediated pathways from SES to uptake. Lower depression only had an indirect effect on uptake through better self-rated health. Efficacy beliefs did not mediate the relationship between SES and uptake.
CONCLUSION: SES differences in uptake of FOBt in England are partially explained by differences in cancer fatalism, self-rated health, and depression.
IMPACT: This is one of only a few studies to examine mediators of the relationship between SES and screening uptake, and future research could test the effectiveness of interventions to reduce fatalistic beliefs to increase equality of uptake.

OBJECTIVE: This study aimed to document the association between health literacy and willingness and ability to seek information about the new colorectal cancer (CRC) screening program in the UK.(1) We also assessed self-efficacy for screening to determine the impact of health literacy on perceived confidence to take part in screening.
METHODS: Ninety-six participants aged 50-69 years completed the British version of the Test of Functional Health Literacy in Adults (TOFHLA) (UK-TOFHLA) and used an interactive information menu to select information on why and how to participate in CRC screening. We derived a measure of reading effort by calculating the average amount of time spent reading individual information links. Each participant also completed a measure of comprehension, and self-efficacy for participating in screening.
RESULTS: A multivariate analysis supported the hypothesis that lower health literacy would be associated with less information-seeking (b=.079, 95% confidence interval, .001-.157) greater effort in reading (b=-.965, 95% CI, -1.457 to -.473) and less self-efficacy for CRC screening (b=.61, 95% CI, .009-.131).
CONCLUSION: Lower health literacy had a direct impact on information-seeking. It was also independently associated with perceived confidence to participate in screening.
PRACTICE IMPLICATIONS: Reliance on printed communication when inviting low literate adults for screening can be problematic. The independent association between health literacy and self-efficacy further adds to the challenge of developing accessible and effective health promotion materials in this area.

Although in its infancy, organized screening for colorectal cancer (CRC) in the general population is increasing at regional and national levels. Documenting and describing these initiatives is critical to identifying, sharing and promoting best practice in the delivery of CRC screening. Subsequently, the International Colorectal Cancer Screening Network (ICRCSN) was established in 2003 to promote best practice in the delivery of organized screening programs. The initial aim was to identify and document organized screening initiatives that commenced before May 2004. Each identified initiative was sent 1 questionnaire per screening modality: fecal occult blood test, flexible sigmoidoscopy or total colonoscopy. Information was collected on screening methodology, testing details and initiative status. In total, 35 organized initiatives were identified in 17 countries, including 10 routine population-based screening programs, 9 pilots and 16 research projects. Fecal occult blood tests were the most frequently used screening modality, and total colonoscopy was seldom used as a primary screening test. The eligible age for screening ranged from 40 years old to no upper limit; most initiatives included participants aged 50 to 64. Recruitment was usually done by a mailed invitation or during a visit to a family physician. In conclusion, this is the first investigation describing the delivery of CRC screening protocols to various populations. The work of the ICRCSN is enabling valuable information to be shared and a common nomenclature to be established.

BACKGROUND AND AIMS: Variation in the adenoma detection rate (ADR) at flexible sigmoidoscopy screening has been shown to be due to variation in endoscopist performance. There are no objective methods for scoring an endoscopist's performance reliably, and the aim of this study was to develop a valid and reliable objective scoring method using video footage of screening flexible sigmoidoscopies.
METHODS: In a series of five experiments, experienced endoscopists (the scorers) independently scored a sample (n = 43) of the 40 000 flexible sigmoidoscopy extubations recorded as part of the United Kingdom Flexible Sigmoidoscopy Screening Trial (UK FSST). The scoring system, the parameters scored, and their definitions evolved over the course of the five experiments. The initial visual analogue score (range 0-100) used in the first two experiments evolved into a five-point score that ranged from 1 (E, poor) to 5 (A, excellent) in the last three experiments. The final parameters scored were: time spent viewing the mucosa, re-examination of poorly viewed areas, suctioning of fluid pools, distension of the lumen, lower rectal examination, and overall quality of the examination. The first four experiments scored one individual case per endoscopist; in experiment 5, an overall score was awarded for five cases performed by each endoscopist being assessed.
RESULTS: Scoring five cases examined by an individual endoscopist using the A-E grading system was the most reliable method (interclass correlation coefficient 0.89). Cluster analysis demonstrated that the endoscopists in the high-scoring ADR group (ADR 14.7-15.9 %) could be differentiated from those in the intermediate- and low-scoring ADR groups (ADR 8.6-12.6 %).
CONCLUSIONS: An objective scoring system for assessing the accuracy of performance at screening flexible sigmoidoscopy, based on video footage, is described. Endoscopists who might benefit from further training can be identified using this method.

OBJECTIVES: Inflammatory bowel disease (IBD) is usually diagnosed as a result of symptoms but occasionally is found during investigation for other conditions. An earlier report from Nottingham had found a high prevalence of previously undetected "asymptomatic" IBD detected as a result of colorectal cancer screening, and the aim of this study was to reassess the prevalence, symptoms, and outcome in these patients.
METHODS: We investigated subjects found to be fecal occult blood (FOB) positive in a randomized trial of FOB screening for colorectal cancer. All FOB-positive subjects were investigated by colonoscopy or flexible sigmoidoscopy and barium enema. Subjects with IBD were referred back to their general practitioner for any further investigation and treatment.
RESULTS: Seventy-five thousand two hundred fifty-three subjects (aged 45-74) were sent FOB tests and 44,838 (60%) completed a series of tests on one or more occasions. Of 133,000 test series, 1.5% were positive. During investigation 53 cases of previously undetected IBD (52 of ulcerative colitis) were found; 52% (27/52) had proctosigmoiditis only, whereas 25% (13/52) had pancolitis. Only 17% (9/52) were completely asymptomatic, with a half or more reporting some rectal bleeding (54%) or diarrhea (50%). The overall prevalence of undetected ulcerative colitis was 69/10(5) (95% CI = 50-88/10(5)) in people offered screening and 116/10(5) (95% CI = 85-147/10(5)) in people accepting screening and was higher in men. Of 32 subjects followed up 2-12 yr after diagnosis, 91% (29) continued to have few or no symptoms, with only 12 currently receiving any treatment for their colitis.
CONCLUSIONS: In comparison with detected disease, undetected ulcerative colitis is relatively common but does usually cause some symptoms. It generally appears to follow a benign course, but a significant proportion have extensive colitis and may therefore be at an increased risk of colorectal cancer.

The effectiveness of cancer screening depends crucially on two elements: the sojourn time (that is, the duration of the preclinical screen-detectable period) and the sensitivity of the screening test. Previous literature on methods of estimating mean sojourn time and sensitivity has largely concentrated on breast cancer screening. Screening for colorectal cancer has been shown to be effective in randomized trials, but there is little literature on the estimation of sojourn time and sensitivity. It would be interesting to demonstrate whether methods commonly used in breast cancer screening could be used in colorectal cancer screening. In this paper, the authors consider various analytic strategies for fitting exponential models to data from a screening program for colorectal cancer conducted in Calvados, France, between 1991 and 1994. The models yielded estimates of mean sojourn time of approximately 2 years for 45- to 54-year-olds, 3 years for 55- to 64-year-olds, and 6 years for 65- to 74-year-olds. Estimates of sensitivity were approximately 75%, 50%, and 40% for persons aged 45-54, 55-64, and 65-74 years, respectively. There is room for improvement in all models in terms of goodness of fit, particularly for the first year after screening, but results from randomized trials indicate that the sensitivity estimates are roughly correct.

There is an increased risk of colorectal cancer in patients who have had an attack of chronic ulcerative colitis, and there is evidence to suggest that patients with Crohn's disease are also at risk. It is difficult to give a precise estimate of the increased danger that patients with inflammatory bowel disease have over the normal population because published results are inconsistent. Twenty years ago patients with long-standing extensive ulcerative colitis were often advised to undergo proctocolectomy to protect against the development of cancer, but since then most physicians have adopted a policy of regular colonoscopic surveillance in an attempt to detect early cancer or pre-cancer. When published studies of surveillance results are critically analyzed, it appears that relatively little benefit accrues from this approach. Better methods of surveillance are needed to determine which individuals with chronic ulcerative colitis are most likely to develop cancer.

The syndromes known as familial adenomatous polyposis (FAP) and hereditary nonpolyposis colorectal cancer (HNPCC) represent paradigms of the arguments for and against screening surveillance. This article details the protean manifestations of these conditions. It is not a how-to-do-it article with a suitably selected tranche of endoscopic pictures, but rather, it is an attempt to see what should be done.

It may be useful to draw an analogy between the proposed screening programme for colorectal cancer and the cervical cancer screening programme. Both tumours show a spectrum of histological abnormalities consistent with a premalignant phase. The natural history of these premalignant lesions is poorly understood and although some will progress, if untreated, to invasive disease, most will not. Light microscopy cannot confidently distinguish which cases will progress and which will regress, and clinicians are therefore obliged to treat all. This will result in the destruction of many lesions of uncertain malignant potential. The secondary prevention of cervical cancer, although therapeutically efficacious, is inefficient. A lack of understanding of the natural history of intraepithelial neoplasia has frustrated attempts to develop rational referral criteria, and it is only now that the appropriate trials are being undertaken. The development of outpatient investigative and therapeutic procedures has resulted in many more women being referred for investigation and treatment, with predictable pressure on other services offered by gynaecologists, but no demonstrable saving of life. Similar uncertainties surround a screening programme for colorectal cancer. The principal concerns are not about the efficacy of polypectomy in interrupting the polyp cancer sequence, although uncertainties about the frequency with which cancer arises de novo do require that the effectiveness of this intervention is formally tested. Our major concerns are with compliance, and the management of the individual who tests positive--that is, who is found to have a distal polyp. Technological advances and operator enthusiasm may, as has happened with the cervical screening programme, lead to a relaxation in the indications for further investigation and treatment. Such a development would affect resources substantially if a population screening programme were in place. Nevertheless, there are grounds for believing that a screening programme for colorectal cancer, using sigmoidoscopy, might be successful in certain age groups if compliance was satisfactory. The scale of benefits may be comparable with those achieved by the breast screening programme. Our limited cost analysis, which relates to only to specific items of clinical activity, suggest that the mean cost for each case of cancer prevented will be about 8000 pounds sterling. These conclusions suggest that screening by flexible sigmoidoscopy merits serious consideration. It is also imperative, however, that consideration should be given to resolving some of the uncertainties about the clinical management and surveillance of those found to have distal polyps.

STUDY OBJECTIVE: The aim was to estimate costs and yields of faecal occult blood screening and rescreening for colorectal cancer, for differing age cohorts.
DESIGN: Cost and clinical data were used as the basis for modelling the expected costs, and cost savings, resulting from the treatment of screen detected cancers, as compared with cancers detected by symptomatic presentation.
SETTING: Data were derived from the MRC screening trial currently in progress in Nottingham.
PARTICIPANTS: Approximately 140,000 subjects, age 50-79 years, were randomly allocated to a test (screened) and a control (unscreened) group.
MAIN RESULTS: The net costs of detecting and treating a cancer following colorectal screening fall as the age of the target population increases, owing principally to the increasing incidence of the disease with age. Generally, the marginal detection and treatment costs falls for all age groups with the first screening round, but rises considerably with the second. If allowance is made for cancers prevented as a result of early detection and excision of adenomas, the costs of screening are substantially reduced for all age groups.
CONCLUSIONS: Assuming a cost per QALY (quality adjusted life year gained) equivalent to that derived for the breast cancer screening programme, and a QALY gain from colorectal screening of one year, three screens, each separated by two years, appear economically justified for populations aged 60 years and above. Expected gains from cancer prevention make two screens justifiable for those between 45 and 59 years of age.

The widely-accepted hypothesis of a development sequence from colorectal adenoma to carcinoma is felt by clinicians to legitimate adenoma excision during routine colonoscopic investigation. Using published data on adenoma development, and adenoma prevalence data derived from the Nottingham colorectal cancer screening trial, the number of carcinomas prevented by early excision as a result of screening is predicted. The cost-effectiveness of early excision is then evaluated with reference to the expected treatment costs saved. These cost savings are found to represent a discount on the overall costs of mass population screening for colorectal cancer.

STUDY OBJECTIVE: The aim was to make projections of the likely costs and yield resulting from the implementation of a faecal occult blood screening programme for colorectal cancer.
DESIGN: Cost and clinical data were derived from the MRC colorectal screening trial currently in progress in Nottingham, UK.
SETTING: The above data were used as the basis for modelling the likely implications were the trial to be reproduced as a screening programme within a "typical" family practitioner committee area.
MAIN RESULTS: For an average family practitioner committee area with a target population of 75,000 subjects aged 50-74 years, the initial screening round might be expected to detect 85 cancers at a total cost of approximately 250,000 pounds. This represents a cost per cancer detected of 2700 pounds and a cost per person screened of approximately 5 pounds. For subsequent screening rounds, total costs might be expected to fall although average costs are likely to remain approximately constant.
CONCLUSIONS: The model is successful in generating "order of magnitude" estimates for the costs of implementation of a screening programme for colorectal cancer. As benefit estimates are not yet available, however, no cost-effectiveness analysis can be undertaken at this stage. In general, sensitivity analyses reveal that programme costs are more sensitive to changes in clinical variables, especially detection and compliance rates, than they are to variations in the costs of resource inputs. A screening programme with a more elaborate protocol than that currently employed in the Nottingham trial will entail considerable cost increases.