Stephen R. Cole

Comparison of a brush‐sampling fecal immunochemical test for hemoglobin with a sensitive guaiac‐based fecal occult blood test in detection of colorectal neoplasia

Fecal immunochemical tests (FIT) are an advanced fecal occult blood test (FOBT) technology that reduces barriers to population screening by simplifying the logistics of stool‐sampling. The current study was conducted to undertake a paired comparison of a sensitive guaiac FOBT (GFOBT; Hemoccult II Sensa, Beckman Coulter, Fullerton, CA) with a brush‐sampling FIT (InSure; Enterix, North Ryde, NSW, Australia), to determine whether this FIT improves detection of significant neoplasia.

A Randomised Trial of the Impact of New Faecal Haemoglobin Test Technologies on Population Participation in Screening for Colorectal Cancer

OBJECTIVES To investigate the effect on participation in colorectal cancer screening of testing for blood products in faeces using technologies that remove dietary restrictions (i.e. immunochemical tests) and simplify faecal sampling (i.e. tests that use brush sampling). METHODS SETTING Urban residents (n=1818) of Adelaide, Australia, aged between 50 and 69 years, randomly selected from the electoral roll. DESIGN Three randomised cohorts of 606 invitees were offered a screening test by mail in 2001. The Hemoccult SENSA and FlexSure OBT cohorts were instructed to sample three stools using a spatula while the InSureTM cohort sampled two stools using a brush. The Hemoccult SENSA cohort was asked to restrict certain (high-peroxidase) foods and drugs. MAIN OUTCOME MEASURES Participation (i.e. return of completed sample kits within 12 weeks) and generalised linear modelling (GLM) of relationships between participation, test technologies and demographic variables. RESULTS Participation was 23.4%, 30.5% and 39.6% for the Hemoccult, FlexSure and InSure cohorts, respectively (chi(2)=37.1, p<0.00001). GLM demonstrated that participation was increased by 28% by removal of restrictions (p=0.01) and by 30% by simplification of sampling (p=0.001); both together increased participation by 66% (p<0.001). The differences in participation between tests occurred in the first three weeks. Socio-economic status, gender or age did not significantly influence technology-based improvements in participation. CONCLUSIONS The brush-sampling faecal immunochemical test for haemoglobin (InSure) achieves the best participation rates by simplifying sampling and removing the need for restrictions of diet and drugs. Because participation in screening is vital to detection, this new technology should contribute to better detection of neoplasia at the population level.

Participation in screening for colorectal cancer based on a faecal occult blood test is improved by endorsement by the primary care practitioner

OBJECTIVES: To investigate the influence of general practitioner (GP) endorsement on participation in screening for colorectal cancer based on a faecal occult blood test (FOBT). SETTING: South Australian residents (n=2400), in 1999, aged >50 years. METHODS: Random selection of three groups (GP1, GP2, GP3) from two general practices and of one group (ER) from the federal electoral roll; n=600 per group. Without previous communication or publicity, subjects were posted an offer of screening by immunochemical FOBT. The GP1 and ER groups were invited without indication that their GP was involved; GP2 received an invitation indicating support from the practice; and GP3 received an invitation on practice letterhead and signed by a practice partner. A reminder was posted at 6 weeks. Participation was defined as return of correctly completed FOBT sample cards within 12 weeks. RESULTS: Participation rates were: GP1 192/600 (32.0%), GP2 228/600 (38.0%), and GP3 244/600 (40.7%); &khgr;2=10.2, p=0.006. Both GP2 and GP3 differed significantly from GP1 (odds ratio (OR) 0.77, 95% confidence interval (95% CI) 0.60 to 0.98 and relative risk (RR)=0.69, 95% CI 0.54 to 0.87 respectively). ER (193/600 (32.2%)) and GP1 were not significantly different. Age but not sex was significantly associated with participation. Overall test positivity rate was 4.6%; five malignancies were found in the 918 who performed FOBT. CONCLUSIONS: Association of a GP of recent contact with a screening offer in the form of a personalised letter of invitation achieves better participation than does the same letter from a centralised screening unit that does not mention the GP. Thus, GP enhanced participation is achievable without their actual involvement. Additional strategies are needed to further improve participation.

An advance notification letter increases participation in colorectal cancer screening.

Objectives: To determine the impact of novel invitation strategies on population participation in faecal immunochemical test (FIT)-based colorectal cancer (CRC) screening. Setting A community screening programme in Adelaide, South Australia. Methods: In total, 2400 people aged 50–74 years were randomly allocated to one of four CRC screening invitation strategies: (a) Control: standard invitation-to-screen letter explaining risk of CRC and the concept, value and method of screening; (b) Risk: invitation with additional messages related to CRC risk; (c) Advocacy: invitation with additional messages related to advocacy for screening from previous screening programme participants and (d) Advance Notification: first, a letter introducing Control letter messages followed by the standard invitation-to-screen. Invitations included an FIT kit. Programme participation rates were determined for each strategy relative to control. Associations between participation and sociodemographic variables were explored. Results: At 12 weeks after invitation, participation was: Control: 237/600 (39.5%); Risk: 242/600 (40.3%); Advocacy: 216/600 (36.0%) and Advance Notification: 290/600 (48.3%). Participation was significantly greater than Control only in the Advance Notification group (Relative risk [RR] 1.23, 95% confidence interval [CI] 1.06–1.43). This effect was apparent as early as two weeks from date of offer; Advance Notification: 151/600 (25.2%) versus Control: 109/600 (18.2%, RR 1.38, 95% CI 1.11–1.73). Conclusions: Advance notification significantly increased screening participation. The effect may be due to a population shift in readiness to undertake screening, and is consistent with the Transtheoretical Model of behaviour change. Risk or lay advocacy strategies did not improve screening participation. Organized screening programmes should consider using advance notification letters to improve programme participation.

Interval faecal occult blood testing in a colonoscopy based screening programme detects additional pathology

Background: Colonoscopic based surveillance is recommended for patients at increased risk of colorectal cancer. The appropriate interval between surveillance colonoscopies remains in debate, as is the “miss rate” for colorectal cancer within such screening programmes. Aims: The main aim of this study was to determine whether a one-off interval faecal occult blood test (FOBT) facilitates the detection of significant neoplasia within a colonoscopic based surveillance programme. Secondary aims were to determine if invitees were interested in participating in interval screening, and to determine whether interval lesions were missed or whether they developed rapidly since the previous colonoscopy Patients: Patients enrolled in a colonoscopic based screening programme due to a personal history of colorectal neoplasia or a significant family history. Methods: Patients within the screening programme were invited to perform an immunochemical FOBT (Inform). A positive result was followed by colonoscopy; significant neoplasia was defined as colorectal cancer, adenomas either ⩾10 mm or with a villous component, high grade dysplasia, or multiplicity (⩾3 adenomas). Participation rates were determined for age, sex, and socioeconomic subgroups. Colonoscopy recall databases were examined to determine the interval between previous colonoscopy and FOBT offer, and correlations between lesion characteristics and interval time were determined. Results: A total of 785 of 1641 patients invited (47.8%) completed an Inform kit. A positive result was recorded for 57 (7.3%). Fifty two of the 57 test positive patients completed colonoscopy; 14 (1.8% of those completing the FOBT) had a significant neoplastic lesion. These consisted of six colorectal cancers and eight significant adenomas. Conclusions: A one off immunochemical faecal occult blood test within a colonoscopy based surveillance programme had a participation rate of nearly 50% and appeared to detect additional pathology, especially in patients with a past history of colonic neoplasia.

Advances in Fecal Occult Blood Tests: The FIT Revolution

There is a wide choice of fecal occult blood tests (FOBTs) for colorectal cancer screening. Goal: To highlight the issues applicable when choosing a FOBT, in particular which FOBT is best suited to the range of screening scenarios. Four scenarios characterize the constraints and expectations of screening programs: (1) limited colonoscopy resource with a need to constrain test positivity rate; (2) a priority for maximum colorectal neoplasia detection with little need to constrain colonoscopy workload; (3) an “adequate” endoscopy resource that allows balancing the benefits of detection with the burden of service provision; and (4) a need to maximize participation in screening. Guaiac-based FOBTs (gFOBTs) have significant deficiencies, and fecal immunochemical tests (FITs) for hemoglobin have emerged as better tests. gFOBTs are not sensitive to small bleeds, specificity can be affected by diet or drugs, participant acceptance can be low, laboratory quality control opportunities are limited, and they have a fixed hemoglobin concentration cutoff determining positivity. FITs are analytically more specific, capable of quantitation and hence provide flexibility to adjust cutoff concentration for positivity and the balance between sensitivity and specificity. FITs are clinically more sensitive for cancers and advanced adenomas, and because they are easier to use, acceptance rates are high. Conclusions: FOBT must be chosen carefully to meet the needs of the applicable screening scenario. Quantitative FIT can be adjusted to suit Scenarios 1, 2 and 3, and for each, they are the test of choice. FITs are superior to gFOBT for Scenario 4 and gFOBT is only suitable for Scenario 1.

Interval Fecal Immunochemical Testing in a Colonoscopic Surveillance Program Speeds Detection of Colorectal Neoplasia

BACKGROUND & AIMS Rapidly progressing or missed lesions can reduce the effectiveness of colonoscopy-based colorectal cancer surveillance programs. We investigated whether giving fecal immunochemical tests (FITs) for hemoglobin between surveillance colonoscopies resulted in earlier detection of neoplasia. METHODS The study included 1736 patients with a family history or past neoplasia; they received at least 2 colonoscopy examinations and were followed for a total of 8863 years. Patients were excluded from the study if they had genetic syndromes, colorectal surgery, or inflammatory bowel disease. An FIT was offered yearly, in the interval between colonoscopies; if results were positive, the colonoscopy was performed earlier than scheduled. RESULTS Among the 1071 asymptomatic subjects (61%) who received at least 1 FIT, the test detected 12 of 14 cancers (86% sensitivity) and 60 of 96 (63%) advanced adenomas. In patients with positive results from the FIT, the diagnosis of cancer was made 25 months (median) earlier and diagnosis of advanced adenoma 24 months earlier. Patients who had repeated negative results from FIT had an almost 2-fold decrease in risk for cancer and advanced adenoma compared with patients who were not tested (5.5% vs 10.1%, respectively, P = .0004). The most advanced stages of neoplasia, observed across the continuum from nonadvanced adenoma to late-stage cancer, were associated with age (increased with age), sex (increased in males), and FIT result. The probability of most advanced neoplastic stage was lowest among those with a negative result from the FIT (odds ratio, 0.68; P < .001). CONCLUSIONS Interval examinations using the FIT detected neoplasias sooner than scheduled surveillances. Subjects with negative results from the FIT had the lowest risk for the most advanced stage of neoplasia. Interval FIT analyses can be used to detect missed or rapidly developing lesions in surveillance programs.

How equitable are colorectal cancer screening programs which include FOBTs? A review of qualitative and quantitative studies.

OBJECTIVE To review published literature on the equity of participation in colorectal cancer screening amongst different population subgroups, in addition to identifying factors identified as barriers and facilitators to equitable screening. Studies were included in the review if they included FOBT as at least one of the screening tests. METHOD Relevant published articles were identified through systematic electronic searches of selected databases and the examination of the bibliographies of retrieved articles. Studies of the association with colorectal cancer screening test participation, barriers to equitable participation in screening, and studies examining interventional actions to facilitate screening test participation were included. Data extraction and analysis was undertaken using an approach to the synthesis of qualitative and quantitative studies called Realist Review. RESULTS Sixty-three articles were identified that met the inclusion criteria. SES status, ethnicity, age and gender have been found as predictors of colorectal cancer screening test participation. This review also found that the potential for equitable cancer screening test participation may be hindered by access barriers which vary amongst population sub-groups. CONCLUSION This review provides evidence of horizontal inequity in colorectal cancer screening test participation, but limited understanding of the mechanism by which it is sustained, and few evidence-based solutions.

Shift to earlier stage at diagnosis as a consequence of the National Bowel Cancer Screening Program

Objective: To assess the impact of the National Bowel Cancer Screening Program (NBCSP) in South Australia.

Screening for colorectal cancer by faecal occult blood test: why people choose to refuse

To better understand the personal barriers that limit participation in faecal occult blood test (FOBT) screening for colorectal cancer, non‐participants from a recent screening initiative were sent detailed questionnaires, defining their reasons for not participating, as well as how to make screening more attractive. The important barrier was procrastination. The type of FOBT kit offered influenced the reasons for not participating. Convenient FOBT and greater general practitioner involvement may be important for optimizing community acceptance of FOBT‐based screening.