Colorectal cancer

Population screening: Evidence summary and recommendations (PSC1a-d)

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Clinical practice guidelines for the prevention, early detection and management of colorectal cancer > Population screening: Evidence summary and recommendations (PSC1a-d)



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Professor James St. John AO; MB,BS; MD; D Med Sc; FRCP; FRACP; AGAF, Dr Hooi Ee MB; BS; PhD; FRACP, Canfell,K, Chetcuti, A, Emery, J, Paul Grogan, Macrae, F, Professor Mark Jenkins PhD BSc, Lew, JB, Cancer Council Australia Colorectal Cancer Guidelines Working Party. Guidelines:Colorectal cancer/Population screening recommendations . In: Clinical practice guidelines for the prevention, early detection and management of colorectal cancer. Sydney: Cancer Council Australia. [Version URL: https://wiki.cancer.org.au/australiawiki/index.php?oldid=173044, cited 2023 Mar 31]. Available from: https://wiki.cancer.org.au/australia/Guidelines:Colorectal_cancer.


Last modified:
7 November 2017 23:31:11





Evidence summary table[edit source]

Evidence summary Level References
Screening benefit (PSC1a)
Several RCTs evaluating guaiac faecal occult blood test -based screening demonstrated a significant reduction in colorectal cancer-specific mortality, compared with no screening. I, II [1], [2], [3], [4], [5], [6], [7], [8], [9], [10], [11]
A large study evaluating the combination of once-only immunochemical faecal occult blood testing, with flexible sigmoidoscopy (but not colonoscopy) for those with a positive test, showed a 32% reduction in rectal cancer mortality, but no reduction in overall mortality or colon cancer-specific mortality, at 8-year follow-up. II [12]
A total of 4 Level II RCTs compared flexible sigmoidoscopy as a screening modality with no screening, and reported a combined 28% reduction in colorectal cancer-specific mortality in those randomised to screening after nearly 11 years of follow-up. This benefit in colorectal cancer-specific mortality was attributed only to a reduction in distal colorectal cancer-specific mortality and not proximal colorectal cancer-specific mortality. Most trials provided a once-only flexible sigmoidoscopy as the screening test. I, II [1], [2], [3], [4], [5], [6], [7]
No high-level RCTs were found that compared screening with colonoscopy, CT colonography, faecal DNA biomarkers, or blood or plasma cancer-specific biomarkers such as DNA, with no screening. N/A
Only one RCT (NORCCAP) reported the combination of two screening modalities, flexible sigmoidoscopy and immunochemical faecal occult blood testing (iFOBT). The overall reduction in colorectal cancer-specific mortality was only statistically significant for those who had flexible sigmoidoscopy and iFOBT (HR = 0.62, p = 0.01) and not for flexible sigmoidoscopy alone (HR = 0.84, p = 0.30). II [13]
Screening test accuracy (PSC1b)
iFOBT performed best at detection of colorectal cancer (when compared to a colonoscopy reference standard), and was also able to detect a proportion of advanced adenomas. II, III-1 [14], [15], [16], [17], [18], [19], [20], [21], [22], [23], [24], [25], [26], [27], [28], [29], [30], [31], [32], [33], [34], [35], [36], [37], [38]
There is insufficient evidence to fully assess the diagnostic performance (including longitudinal outcomes) of non-FOBT faecal or blood-based cancer-specific biomarker assays. II, III-1 [39], [40], [41], [19]
There is insufficient evidence to determine how the diagnostic performance of iFOBT or biomarker assays may alter with participant age, sex, or risk of colorectal cancer. II, III-1 [41], [19], [42], [20]
Screening cost effectiveness (PSC1c)
Assuming 100% adherence to screening recommendations, modelling predicted the most effective screening strategies would be:
  • iFOBT every year in people aged 50–74 years
  • once-only colonoscopy screening at age 50 years combined with iFOBT every 2 years in people aged 52–74
  • colonoscopy screening every 10 years at ages 55, 65 and 75 years
  • iFOBT screening every 2 years at age 50–74 years, with or without adjunct flexible sigmoidoscopy (either at age 50 years or at ages 54, 64 and 74 years) for individuals with negative iFOBT.

Analysis based on early data from cross-sectional studies also suggested that screening with a faecal DNA assay every 2 years may be effective if emerging evidence supports the assumed test characteristics.

N/A
The current National Bowel Cancer Screening Program (NBCSP) strategy (iFOBT every 2 years at age 50–74 years) is associated with predicted reductions of 52% in colorectal cancer incidence and 75% in colorectal cancer-specific mortality in perfectly adherent people. Overall, the most effective strategies (as noted above) were associated with a 52–67% reduction in colorectal cancer incidence and 75–82% reduction in colorectal cancer mortality, compared with no screening, given perfect adherence. N/A
The incremental cost-effectiveness (ICER) analysis identified five strategies that represented the best value for money of all the available strategies assessed (i.e. strategies found to cost the least among all strategies with similar or higher effectiveness), but only two of these would be cost-effective in Australia under all scenarios, given the indicative willingness-to-pay threshold of A$50,000 per life–year saved:
  • CT colonography every 10 years
  • iFOBT every 2 years at age 50–74 years (the current program).

However, analysis for CT colonography screening was based on more limited evidence for cross-sectional accuracy and there is a lack of evidence for longitudinal outcomes (long-term benefit). In the modelled analysis, the current NBCSP was the most effective of these two strategies.

iFOBT screening every year was not found to be cost-effective, with an ICER of > $100,000 per life–year saved.

N/A
The ICER for the current NBCSP (iFOBT screening every 2 years), compared with the next most effective strategy (CT colonography) on the cost-effectiveness frontier, was A$6,412-33,535 per life–year saved (depending on participation), taking into account all the other strategies included in the analysis.

This is not the same as the cost-effectiveness ratio (CER) of the current NBCSP compared with no screening (estimated at approximately $2,000–3,000 per life–year saved).

Each of these estimates provides a measure of the cost-effectiveness of the current NBCSP, but the ICER considers a range of other, theoretically possible, options. Whichever measure is used, the current NBCSP was found to be cost-effective.

N/A
The current NBCSP (iFOBT screening every 2 years) requires 56 colonoscopies to prevent one colorectal cancer death, assuming 100% adherence to screening recommendations. No other strategy was found to have both fewer colorectal cancer deaths and fewer colonoscopies than iFOBT every 2 years, implying that the current NBCSP has an optimal balance of benefits and harms. N/A
Screening age (PSC1d)
To date, no published RCTs have reported outcomes related to colorectal cancer screening-specific outcomes in those less than 50 years of age, or greater than 75 years of age. N/A
Screening with iFOBT once every two years between 50 and 74 years (the current NBCSP) was predicted to reduce colorectal cancer incidence by 52% and reduce colorectal cancer mortality by 74%, compared to no screening (assuming perfect adherence). N/A
Compared to the current NBCSP, lowering the screening start age to 40 or 45 years would result in additional reductions of 2–6 percentage points in colorectal cancer incidence and 2–9 percentage points in colorectal cancer-specific mortality, in all participation scenarios considered. N/A
Extending the age of ceasing screening to 79 or 84 years would result an additional reduction of 1–2 percentage points in colorectal cancer incidence and 2–5 percentage points in colorectal cancer mortality. N/A
When considering cost-effectiveness only for those strategies involving iFOBT every 2 years, but with different age ranges, four strategies were found to have the best value for money of all the available strategies assessed (i.e. strategies found to cost the least among all strategies with similar or higher effectiveness).

In context of an indicative willingness-to-pay threshold of A$50,000 per life–year saved in Australia, only two were found to be cost-effective in all participation scenarios: the current program (ICER $4,264–8,075 per life–year saved) and screening at 45–74 years (ICER $19,451–40,813 per life–year saved).

Extending the screening end age to 79 or 84 years was not found to be cost-effective in this analysis.

N/A
Although potentially cost-effective, lowering the screening start age to 45 years was predicted to be associated with a less favourable ratio of benefits to harms than the current program. The number-needed-to-colonoscope (NNC) for the current program for each death prevented is 39–56, whereas the NNC for each extra death prevented by starting at age 45 years is 67–375 (depending on participation).

At current levels of participation, starting from age 45 years would be associated with an additional 67 colonoscopies for each additional death prevented, compared with an NNC of 39 colonoscopies per death prevented for the existing program.

N/A
Starting at age 45 years would increase the demand for colonoscopy services by 7–14% (depending on participation). N/A
The effect of starting screening earlier is amplified in imperfect adherence scenarios because the increase in deaths prevented is primarily due to an overall increase in the number of those screened at least once in a lifetime at any age (i.e. being screened at least once is the major determinant of outcome).

Screening from age 50 to age 74 years is more cost effective than screening people in their forties.

N/A

N/A: not applicable
^NHMRC classification of levels of evidence does not currently encompass modelling studies.

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Recommendations[edit source]

Overall population screening strategy[edit source]

Evidence-based recommendationQuestion mark transparent.png Grade
Overall population screening strategy

The recommended strategy for population screening in Australia, directed at those at average risk of colorectal cancer and without relevant symptoms, is immunochemical faecal occult blood testing every 2 years, starting at age 50 years and continuing to age 74 years.

C

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Primary screening test[edit source]

Evidence-based recommendationQuestion mark transparent.png Grade
Primary screening test

An immunochemical faecal occult blood test is recommended as the screening modality for the detection of colorectal cancer in the average-risk population.

C


Evidence-based recommendationQuestion mark transparent.png Grade
Primary screening test

The emerging faecal, blood or serum tests for cancer-specific biomarkers such as DNA are not recommended as population screening modalities for colorectal cancer.

C


Evidence-based recommendationQuestion mark transparent.png Grade
Primary screening test

The use of flexible sigmoidoscopy as a primary screening test is not recommended for population screening in the average-risk population.

C

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Frequency of testing[edit source]

Evidence-based recommendationQuestion mark transparent.png Grade
Frequency of testing

Population screening for colorectal cancer using immunochemical faecal blood testing every 2 years is recommended. It is not recommended that the frequency of screening within the NBCSP be increased to yearly.

N/A

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Target age group[edit source]

Evidence-based recommendationQuestion mark transparent.png Grade
Target age group

It is recommended that the age range for organised population screening continues to be 50–74 years.

N/A


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Target age group

Starting at age 40 is not recommended for population screening as it is unlikely to be cost-effective.

N/A


Evidence-based recommendationQuestion mark transparent.png Grade
Target age group

Although modelling indicated that it may be cost-effective, starting screening at age 45 is not recommended for population screening because there is a much less favourable ratio of benefits to harms than for 50–74 years.

N/A


Evidence-based recommendationQuestion mark transparent.png Grade
Target age group

Extending the age range to 79 or 84 years is not recommended for population screening as it is unlikely to be cost-effective.

N/A

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Consensus-based recommendationQuestion mark transparent.png

Resources should be invested in increasing participation in the existing NBCSP target age group of 50–74, rather than by lowering the starting age of screening, to optimise the balance of effectiveness, cost-effectiveness and ratio of benefits to harms.


Consensus-based recommendationQuestion mark transparent.png

In people aged 45–49 years who request screening after being fully informed of the benefits and harms of testing, general practitioners (GPs) could offer an immunochemical faecal occult blood test every 2 years during the lead-up to the first routine invitation by the NBCSP at age 50 years.


Practice pointQuestion mark transparent.png

Encouragement by GPs and practice staff substantially boosts participation in colorectal cancer screening. Patient endorsement letters in advance of receiving a test kit, the use of GP reminder systems and practice audit are approaches likely to improve participation rates. Increased participation in the NBCSP will increase the program’s effectiveness and cost-effectiveness.


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GPs have a critically important role in managing the interface between population screening and personalised care. This role includes identifying and advising those who should opt off the NBCSP because of the presence of major comorbidities and limited life expectancy and those who should defer participation for several months because of recent surgery or major illness.


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Participation in a population screening program is not recommended for people with symptoms such as rectal bleeding or persistent change in bowel habit or with iron-deficiency anaemia, nor for those who should be having regular surveillance or screening based on colonoscopy, e.g. for past colorectal cancer or adenoma, chronic inflammatory bowel disease, a strong family history of colorectal cancer, or a high-risk genetic cancer syndrome (see Risk and screening based on family history of colorectal cancer).


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Individuals who have had a high-quality colonoscopy performed within the previous two years should allow another two years to elapse (i.e. skip a round) before participating in their next round of iFOBT screening. Colorectal cancer will rarely be present within that interval.

High-quality colonoscopy is defined in the Clinical Practice Guidelines for Surveillance Colonoscopy.


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GPs have a key role in advising patients who are at average or slightly above average risk that iFOBT is the preferred method of screening. They should discuss the relative harms and benefits of colonoscopy and discourage inappropriate use of colonoscopy as a screening method.


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Participants with positive iFOBT results should have follow-up investigation unless there was a clear breach in protocol when samples were collected (e.g. menstrual blood loss close to the time of sample collection). Repeating the iFOBT test after a positive result carries the risk of a falsely negative test result on the second occasion because of low levels of bleeding from a cancer or adenoma, intermittent bleeding, or uneven distribution of blood in the stools.


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Colonoscopy should be performed as promptly as possible after a positive iFOBT to minimise the risk of psychological harm, although there is no evidence that prognosis is worsened within 120 days if cancer is present.

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Considerations in making these recommendations[edit source]

The recommendation for iFOBT every 2 years, starting at age 50 years and continuing to age 74 years, is based on effectiveness, cost-effectiveness, the balance of benefits to harms and feasibility within the current Australian health care system. A previous analysis with ‘Policy1-Bowel’ model found that with current levels of participation, the NBCSP is expected to prevent 92,200 cancer cases and 59,000 deaths over the period 2015-2040; an additional 24,300 and 37,300 cases and 16,800 and 24,800 deaths would be prevented if participation was increased to 50% and 60%, respectively.[43] In 2020, an estimated 101,000 program-related colonoscopies will be performed, associated with approximately 270 adverse events; an additional 32,500 and 49,800 colonoscopies and 88 and 134 adverse events would occur if participation was increased to 50% and 60%, respectively. The overall number-needed-to-screen (NNS) is 647-788 per death prevented, with NNC of 52-59 colonoscopies per death prevented. The program is highly cost-effective due to the cancer treatment costs averted (cost-effectiveness ratio compared to no screening, A$2,000-3,000/life-year saved) and is expected to become cost saving by 2029, with A$1.7, A$2.0 and A$2.1 billion in savings accrued (2015 prices) between 2030–2040, at participation rates of 40%, 50% and 60%, respectively.

We used a comprehensive validated model to simulate the NBCSP. The analysis of 14 screening scenarios showed that only iFOBT every 2 years, and CT colonography every 10 years, were cost-effective at all three levels of participation and that iFOBT every 2 years (as used in the current NBCSP) had a cost-effectiveness ratio of $2,000–$3,000 per life–year saved as well as a favourable profile with respect to the NNC.

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Applicability to the Australian setting[edit source]

The ‘Policy1-Bowel’ model was used to simulate the NBCSP and alternative screening approaches. Calculated rates of colorectal cancer incidence and mortality, survival figures for colorectal cancer, the probability of dying from other causes and population size and projected size were all derived from Australian data. The costs of screening, investigation and stage-specific treatment all related to Australia. In addition, cost-effectiveness assessment related to the willingness-to-pay threshold of $AUD 50,000 per life–year saved used in Australia.

These findings relate to population screening in Australia. Their applicability to other countries will depend on similarities to Australia, including level of risk for colorectal cancer and the design and costs of their health services.

Balance of benefits and harms[edit source]

The risks of screening include potential psychological adverse effects, which range from the trauma of identifying disease in symptom-free, healthy individuals, to stress experienced by people in whom cancer is suspected although later discounted, to more subtle concerns of participants during the screening process.[44] Healthcare professionals must recognise the potential adverse psychological effects of screening, although several studies have shown no evidence of long-term harm after screening.[45][46][47] These potential adverse effects are balanced by avoiding the distress associated with diagnosis of an advanced cancer when there has been no opportunity for early detection by screening.

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Choice of target age range for population screening[edit source]

The age range for organised population screening continues to be 50–74 years, based on considerations of effectiveness, cost-effectiveness and the balance of benefits to harms.

When assessing changes to the screening age, reducing the starting age of 45 years was cost-effective, but with a much less favourable ratio of benefits to harms than for 50–74 years and required a substantially higher number of colonoscopies for each extra cancer death prevented.

Since screening from age 50–74 years was both more effective and cost-effective, resources would be better invested in increasing participation in the existing NBCSP target age group rather than in starting screening at the age of 45 years. Screening after 74 years of age was not found to be cost-effective and is not recommended.

Choice of testing interval for population screening[edit source]

The recommendation not to increase the current frequency of testing is based on the modelling study findings that annual testing with iFOBTs would not be a cost-effective screening strategy in the Australian setting.

Modelling indicated that testing with iFOBTs every 2 years is a very cost-effective screening strategy for colorectal cancer in the Australian setting.

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Choice of immunochemical occult blood test as preferred screening test for population screening[edit source]

Faecal occult blood tests versus flexible sigmoidoscopy or CT colonography[edit source]

Population-based screening using faecal occult blood tests or flexible sigmoidoscopy can reduce colorectal cancer-specific mortality. While both methods of screening are effective, there are major concerns about feasibility, acceptability, and cost-effectiveness with flexible sigmoidoscopy.

While the literature review demonstrated the effectiveness of flexible sigmoidoscopy for population screening, it has several disadvantages. Its acceptability to health professionals and the target population is unclear in Australia. Participants are likely to request sedation, which substantially increases costs. Requests for flexible sigmoidoscopy may result in complete colonoscopy instead. Population screening based on flexible sigmoidoscopy would not be feasible in Australia because of the lack of dedicated facilities and staff to support such a program, the high capital cost of developing those facilities, problems of access related to travel times for participants living in outer regional, rural and remote areas. Modelling indicated that screening based on flexible sigmoidoscopy would not be cost-effective.

The high level of cost effectiveness for CT colonography should be interpreted in the light of a limited evidence base for long-term outcomes after CT colonography screening. Furthermore, we were unable to fully take into account infrastructure investments and costs that would be required. CT colonography was not considered to be a feasible option for population screening, as a substantial increase in infrastructure, capacity and workforce would be necessary.

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Immunochemical versus guaiac occult blood tests[edit source]

There is supporting high-level evidence from one RCT of iFOBT,[12] three large RCTs evaluating screening with guaiac faecal occult blood test (gFOBT)[1][2][3] from the 1990s, as well as three case-control studies[48][49][50] on the effectiveness of FOBT as a population-based screening modality.

The success of iFOBT screening for colorectal cancer in the Australian population was reported in the 2012 Analysis of Bowel Cancer Outcomes for the National Bowel Cancer Screening Program.[51] In this report, colorectal cancer mortality was compared between people in the NBCSP invitee and the never-invited groups in an intention-to-screen colorectal cancer mortality analysis. Of the 10,080 never-invited people with a colorectal cancer diagnosis, 1,973 (19.6%) had died of colorectal cancer before 2012. Of the 2,609 people in the NBCSP invitee group with a colorectal cancer diagnosis, 298 (11.4%) had died of colorectal cancer by the same date: hazard ratio (HR) 1.77; 95% confidence interval (CI) 1.57 to 2.00. When corrected for potential lead-time bias in screen-detected cancers, the risk of death from colorectal cancer was still significantly higher in the never-invited group (hazard ratio 1.15, 95% CI: 1.01–1.31). The mean follow-up time to bowel cancer death for all diagnoses was 18.6 months (range 0–64.3 months, standard deviation 13.9 months).

To date, there has been only one high-level published RCT that compared iFOBT-based screening with no screening.[12] With the widespread availability of evidence-based colorectal cancer screening in many countries including Australia (National Bowel Cancer Screening Program [NBCSP]), it would be unethical to initiate new randomised controlled trials to compare screening by iFOBT with no screening.[52]

Whilst population-based trials of iFOBT have not been as comprehensive as for gFOBT, the European guidelines for quality assurance in colorectal cancer screening and diagnosis (2010)[53] recommend population screening with iFOBT over gFOBT on the basis of:

  • superior performance (e.g. sensitivity and specificity) in detecting cancers and adenomas
  • greater acceptability to participants
  • comparable complication rates and costs.[54]

iFOBTs used as a screening modality for colorectal cancer will also detect a significant proportion of advanced adenomas in the average-risk population. Removal of advanced adenomas at colonoscopy should reduce the future incidence of colorectal cancer.

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Health system implications of the recommendations[edit source]

Clinical practice[edit source]

Implementation of the recommendation to continue the current NBCSP strategy for screening in the average-risk population (iFOBT every 2 years, at age 50–74 years) will not result in any change in clinical practice.

GPs have a critically important role in managing the interface between population screening and personalised care, identifying and advising those who should opt off because of major co-morbidities and limited life expectancy, the presence of special risk factors, recent colonoscopy for whatever reason, and those who should defer the invitation until they recover from recent surgery or major illness.

GPs are able to promote and substantially boost participation in the NBCSP. Other key roles include explaining the significance of positive screening test results, arranging colonoscopy, discussing any further action that needs to be taken as well as interacting with the central register.

Colonoscopy services urgently need to introduce booking systems within a model of care that give priority to these and other high-risk groups to put this into effect.

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Resourcing[edit source]

Implementation of the screening recommendations will not result in any change from the resource requirements already predicted.

Resourcing considerations for implementation of the recommendations include:

  • continued expansion of the NBCSP to complete rollout of screening every two years by 2020
  • expansion of public awareness campaigns and promotion of the NBCSP to GPs to boost participation rates
  • exploration of alternative screening pathways to boost participation rates in the Indigenous population and other disadvantaged groups.

It would be highly desirable to establish centralised adenoma registers to evaluate the extent and significance of detection of adenomas in the NBCSP, to predict the likely contribution of adenoma resection to incidence and mortality reduction in colorectal cancer, and to support quality improvement in the high volume and costly area of colonoscopic post-polypectomy surveillance.

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Barriers to implementation[edit source]

No new barriers to the implementation of the screening recommendations are envisaged.

Existing barriers to participation in FOBT screening fall into several categories, including inconvenience of the testing process, aversion to manipulating faeces, lack of perceived benefit of screening, fear of a diagnosis of cancer, cost, views about personal invulnerability, and cultural beliefs and attitudes.[55][56] Recent studies have demonstrated that several of these barriers can be at least partially overcome so as to improve participation.[57][58][59]

The use of iFOBTs, which require no change in diet or medication, simplifying the method of stool sampling, and endorsement of screening by a person’s own GP all lead to a significant improvement in participation.[57][58][59]

Appropriate public education and promotion is usually necessary to enhance participation rates.

In Australia, weather conditions and geographic factors may affect performance of iFOBTs.[60][61] High temperatures and delays to sample analysis may each reduce test sensitivity for cancer and advanced adenomas. This is of special importance in remote regions where return of postal items may be slow and throughout Australia during hot summer months.

Next section: discussion

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References[edit source]

  1. ↑ 1.0 1.1 1.2 Mandel JS, Bond JH, Church TR, Snover DC, Bradley GM, Schuman LM, et al. Reducing mortality from colorectal cancer by screening for fecal occult blood. Minnesota Colon Cancer Control Study. N Engl J Med 1993 May 13;328(19):1365-71 Available from: http://www.ncbi.nlm.nih.gov/pubmed/8474513.
  2. ↑ 2.0 2.1 2.2 Hardcastle JD, Chamberlain JO, Robinson MH, Moss SM, Amar SS, Balfour TW, et al. Randomised controlled trial of faecal-occult-blood screening for colorectal cancer. Lancet 1996 Nov 30;348(9040):1472-7 Available from: http://www.ncbi.nlm.nih.gov/pubmed/8942775.
  3. ↑ 3.0 3.1 3.2 Kronborg O, Fenger C, Olsen J, Jørgensen OD, Søndergaard O. Randomised study of screening for colorectal cancer with faecal-occult-blood test. Lancet 1996 Nov 30;348(9040):1467-71 Available from: http://www.ncbi.nlm.nih.gov/pubmed/8942774.
  4. ↑ 4.0 4.1 Mandel JS, Church TR, Bond JH, Ederer F, Geisser MS, Mongin SJ, et al. The effect of fecal occult-blood screening on the incidence of colorectal cancer. N Engl J Med 2000 Nov 30;343(22):1603-7 Available from: http://www.ncbi.nlm.nih.gov/pubmed/11096167.
  5. ↑ 5.0 5.1 Mandel JS, Church TR, Ederer F, Bond JH. Colorectal cancer mortality: effectiveness of biennial screening for fecal occult blood. J Natl Cancer Inst 1999 Mar 3;91(5):434-7 Available from: http://www.ncbi.nlm.nih.gov/pubmed/10070942.
  6. ↑ 6.0 6.1 Jørgensen OD, Kronborg O, Fenger C. A randomised study of screening for colorectal cancer using faecal occult blood testing: results after 13 years and seven biennial screening rounds. Gut 2002 Jan;50(1):29-32 Available from: http://www.ncbi.nlm.nih.gov/pubmed/11772963.
  7. ↑ 7.0 7.1 Scholefield JH, Moss S, Sufi F, Mangham CM, Hardcastle JD. Effect of faecal occult blood screening on mortality from colorectal cancer: results from a randomised controlled trial. Gut 2002 Jun;50(6):840-4 Available from: http://www.ncbi.nlm.nih.gov/pubmed/12010887.
  8. ↑ Hewitson P, Glasziou P, Irwig L, Towler B, Watson E. Screening for colorectal cancer using the faecal occult blood test, Hemoccult. Cochrane Database Syst Rev 2007 Jan 24;(1):CD001216 Available from: http://www.ncbi.nlm.nih.gov/pubmed/17253456.
  9. ↑ Hewitson P, Glasziou P, Watson E, Towler B, Irwig L. Cochrane systematic review of colorectal cancer screening using the fecal occult blood test (hemoccult): an update. Am J Gastroenterol 2008 Jun;103(6):1541-9 Available from: http://www.ncbi.nlm.nih.gov/pubmed/18479499.
  10. ↑ Scholefield JH, Moss SM, Mangham CM, Whynes DK, Hardcastle JD. Nottingham trial of faecal occult blood testing for colorectal cancer: a 20-year follow-up. Gut 2012 Jul;61(7):1036-40 Available from: http://www.ncbi.nlm.nih.gov/pubmed/22052062.
  11. ↑ Towler B, Irwig L, Glasziou P, Kewenter J, Weller D, Silagy C. A systematic review of the effects of screening for colorectal cancer using the faecal occult blood test, hemoccult. BMJ (Clinical research ed) 1998;317:559-65 Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC28648/.
  12. ↑ 12.0 12.1 12.2 Zheng S, Chen K, Liu X, Ma X, Yu H, Chen K, et al. Cluster randomization trial of sequence mass screening for colorectal cancer. Dis Colon Rectum 2003 Jan;46(1):51-8 Available from: http://www.ncbi.nlm.nih.gov/pubmed/12544522.
  13. ↑ Holme Ø, Løberg M, Kalager M, Bretthauer M, Hernán MA, Aas E, et al. Effect of flexible sigmoidoscopy screening on colorectal cancer incidence and mortality: a randomized clinical trial. JAMA 2014 Aug 13;312(6):606-15 Available from: http://www.ncbi.nlm.nih.gov/pubmed/25117129.
  14. ↑ Park DI, Ryu S, Kim YH, Lee SH, Lee CK, Eun CS, et al. Comparison of guaiac-based and quantitative immunochemical fecal occult blood testing in a population at average risk undergoing colorectal cancer screening. Am J Gastroenterol 2010 Sep;105(9):2017-25 Available from: http://www.ncbi.nlm.nih.gov/pubmed/20502450.
  15. ↑ Castro I, Cubiella J, Rivera C, González-Mao C, Vega P, Soto S, et al. Fecal immunochemical test accuracy in familial risk colorectal cancer screening. Int J Cancer 2014 Jan 15;134(2):367-75 Available from: http://www.ncbi.nlm.nih.gov/pubmed/23818169.
  16. ↑ Gimeno-García AZ, Quintero E, Nicolás-Pérez D, Hernández-Guerra M, Parra-Blanco A, Jiménez-Sosa A. Screening for familial colorectal cancer with a sensitive immunochemical fecal occult blood test: a pilot study. Eur J Gastroenterol Hepatol 2009 Sep;21(9):1062-7 Available from: http://www.ncbi.nlm.nih.gov/pubmed/19307978.
  17. ↑ Ng SC, Ching JY, Chan V, Wong MC, Suen BY, Hirai HW, et al. Diagnostic accuracy of faecal immunochemical test for screening individuals with a family history of colorectal cancer. Aliment Pharmacol Ther 2013 Oct;38(7):835-41 Available from: http://www.ncbi.nlm.nih.gov/pubmed/23957462.
  18. ↑ Imperiale TF, Ransohoff DF, Itzkowitz SH, Levin TR, Lavin P, Lidgard GP, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med 2014 Apr 3;370(14):1287-97 Available from: http://www.ncbi.nlm.nih.gov/pubmed/24645800.
  19. ↑ 19.0 19.1 19.2 Khalid-de Bakker CA, Jonkers DM, Sanduleanu S, de Bruïne AP, Meijer GA, Janssen JB, et al. Test performance of immunologic fecal occult blood testing and sigmoidoscopy compared with primary colonoscopy screening for colorectal advanced adenomas. Cancer Prev Res (Phila) 2011 Oct;4(10):1563-71 Available from: http://www.ncbi.nlm.nih.gov/pubmed/21750209.
  20. ↑ 20.0 20.1 Brenner H, Haug U, Hundt S. Sex differences in performance of fecal occult blood testing. Am J Gastroenterol 2010 Nov;105(11):2457-64 Available from: http://www.ncbi.nlm.nih.gov/pubmed/20700114.
  21. ↑ Brenner H, Tao S. Superior diagnostic performance of faecal immunochemical tests for haemoglobin in a head-to-head comparison with guaiac based faecal occult blood test among 2235 participants of screening colonoscopy. Eur J Cancer 2013 Sep;49(14):3049-54 Available from: http://www.ncbi.nlm.nih.gov/pubmed/23706981.
  22. ↑ Chiu HM, Lee YC, Tu CH, Chen CC, Tseng PH, Liang JT, et al. Association between early stage colon neoplasms and false-negative results from the fecal immunochemical test. Clin Gastroenterol Hepatol 2013 Jul;11(7):832-8.e1-2 Available from: http://www.ncbi.nlm.nih.gov/pubmed/23376002.
  23. ↑ de Wijkerslooth TR, Stoop EM, Bossuyt PM, Meijer GA, van Ballegooijen M, van Roon AH, et al. Immunochemical fecal occult blood testing is equally sensitive for proximal and distal advanced neoplasia. Am J Gastroenterol 2012 Oct;107(10):1570-8 Available from: http://www.ncbi.nlm.nih.gov/pubmed/22850431.
  24. ↑ Elsafi SH, Alqahtani NI, Zakary NY, Al Zahrani EM. The sensitivity, specificity, predictive values, and likelihood ratios of fecal occult blood test for the detection of colorectal cancer in hospital settings. Clin Exp Gastroenterol 2015;8:279-84 Available from: http://www.ncbi.nlm.nih.gov/pubmed/26392783.
  25. ↑ Hernandez V, Cubiella J, Gonzalez-Mao MC, Iglesias F, Rivera C, Iglesias MB, et al. Fecal immunochemical test accuracy in average-risk colorectal cancer screening. World J Gastroenterol 2014 Jan 28;20(4):1038-47 Available from: http://www.ncbi.nlm.nih.gov/pubmed/24574776.
  26. ↑ Kato J, Morikawa T, Kuriyama M, Yamaji Y, Wada R, Mitsushima T, et al. Combination of sigmoidoscopy and a fecal immunochemical test to detect proximal colon neoplasia. Clin Gastroenterol Hepatol 2009 Dec;7(12):1341-6 Available from: http://www.ncbi.nlm.nih.gov/pubmed/19426835.
  27. ↑ Lee YC, Chiu HM, Chiang TH, Yen AM, Chiu SY, Chen SL, et al. Accuracy of faecal occult blood test and Helicobacter pylori stool antigen test for detection of upper gastrointestinal lesions. BMJ Open 2013 Oct 30;3(10):e003989 Available from: http://www.ncbi.nlm.nih.gov/pubmed/24176798.
  28. ↑ Lee YH, Hur M, Kim H, Jeon KN, Yun CH, Lee CH, et al. Optimal cut-off concentration for a faecal immunochemical test for haemoglobin by Hemo Techt NS-Plus C15 system for the colorectal cancer screening. Clin Chem Lab Med 2015 Feb;53(3):e69-71 Available from: http://www.ncbi.nlm.nih.gov/pubmed/25153599.
  29. ↑ Morikawa T, Kato J, Yamaji Y, Wada R, Mitsushima T, Shiratori Y. A comparison of the immunochemical fecal occult blood test and total colonoscopy in the asymptomatic population. Gastroenterology 2005 Aug;129(2):422-8 Available from: http://www.ncbi.nlm.nih.gov/pubmed/16083699.
  30. ↑ Omata F, Shintani A, Isozaki M, Masuda K, Fujita Y, Fukui T. Diagnostic performance of quantitative fecal immunochemical test and multivariate prediction model for colorectal neoplasms in asymptomatic individuals. Eur J Gastroenterol Hepatol 2011 Nov;23(11):1036-41 Available from: http://www.ncbi.nlm.nih.gov/pubmed/21897207.
  31. ↑ Parra-Blanco A, Gimeno-García AZ, Quintero E, Nicolás D, Moreno SG, Jiménez A, et al. Diagnostic accuracy of immunochemical versus guaiac faecal occult blood tests for colorectal cancer screening. J Gastroenterol 2010 Jul;45(7):703-12 Available from: http://www.ncbi.nlm.nih.gov/pubmed/20157748.
  32. ↑ Terhaar sive Droste JS, Oort FA, van der Hulst RW, van Heukelem HA, Loffeld RJ, van Turenhout ST, et al. Higher fecal immunochemical test cutoff levels: lower positivity rates but still acceptable detection rates for early-stage colorectal cancers. Cancer Epidemiol Biomarkers Prev 2011 Feb;20(2):272-80 Available from: http://www.ncbi.nlm.nih.gov/pubmed/21135261.
  33. ↑ Viana Freitas BR, Kibune Nagasako C, Pavan CR, Silva Lorena SL, Guerrazzi F, Saddy Rodrigues Coy C, et al. Immunochemical fecal occult blood test for detection of advanced colonic adenomas and colorectal cancer: comparison with colonoscopy results. Gastroenterol Res Pract 2013;2013:384561 Available from: http://www.ncbi.nlm.nih.gov/pubmed/24319453.
  34. ↑ Graser A, Stieber P, Nagel D, Schäfer C, Horst D, Becker CR, et al. Comparison of CT colonography, colonoscopy, sigmoidoscopy and faecal occult blood tests for the detection of advanced adenoma in an average risk population. Gut 2009 Feb;58(2):241-8 Available from: http://www.ncbi.nlm.nih.gov/pubmed/18852257.
  35. ↑ Hundt S, Haug U, Brenner H. Comparative evaluation of immunochemical fecal occult blood tests for colorectal adenoma detection. Ann Intern Med 2009 Feb 3;150(3):162-9 Available from: http://www.ncbi.nlm.nih.gov/pubmed/19189905.
  36. ↑ Levy BT, Bay C, Xu Y, Daly JM, Bergus G, Dunkelberg J, et al. Test characteristics of faecal immunochemical tests (FIT) compared with optical colonoscopy. J Med Screen 2014 Sep;21(3):133-43 Available from: http://www.ncbi.nlm.nih.gov/pubmed/24958730.
  37. ↑ Redwood DG, Asay ED, Blake ID, Sacco PE, Christensen CM, Sacco FD, et al. Stool DNA Testing for Screening Detection of Colorectal Neoplasia in Alaska Native People. Mayo Clin Proc 2016 Jan;91(1):61-70 Available from: http://www.ncbi.nlm.nih.gov/pubmed/26520415.
  38. ↑ Nakazako M. YH, Matsushita H., Sato K., Fujita K., Yamanaka Y., Imai Y.. Immunologic Fecal Occult Blood test for Colorectal cancer Screening. Japan med Assoc J 2006 Jun;49:203-7 Available from: http://www.med.or.jp/english/pdf/2006_05+/203_207.pdf.
  39. ↑ Ahlquist DA, Sargent DJ, Loprinzi CL, Levin TR, Rex DK, Ahnen DJ, et al. Stool DNA and occult blood testing for screen detection of colorectal neoplasia. Ann Intern Med 2008 Oct 7;149(7):441-50, W81 Available from: http://www.ncbi.nlm.nih.gov/pubmed/18838724.
  40. ↑ Annaházi A, Ábrahám S, Farkas K, Rosztóczy A, Inczefi O, Földesi I, et al. A pilot study on faecal MMP-9: a new noninvasive diagnostic marker of colorectal cancer. Br J Cancer 2016 Mar 29;114(7):787-92 Available from: http://www.ncbi.nlm.nih.gov/pubmed/26908323.
  41. ↑ 41.0 41.1 Church TR, Wandell M, Lofton-Day C, Mongin SJ, Burger M, Payne SR, et al. Prospective evaluation of methylated SEPT9 in plasma for detection of asymptomatic colorectal cancer. Gut 2014 Feb;63(2):317-25 Available from: http://www.ncbi.nlm.nih.gov/pubmed/23408352.
  42. ↑ Chen Y-Y, Chen T-H, Su M-Y, Ning H-C, Kuo C-J, Lin W-P, et al.. Accuracy of immunochemical fecal occult blood test for detecting colorectal neoplasms in individuals undergoing health check-ups. Advances in Digestive Medicine 2014 Sep;Volume 1, Issue 3, Pages 74–79 Available from: http://www.aidm-online.com/article/S2351-9797(14)00045-0/abstract.
  43. ↑ Lew, JB; St John, DJ; Xu, XM; Greuter, MJ; Caruana, M; Cenin, DR. Benefits, harms and cost-effectiveness of National Bowel Cancer Screening Program in Australia (manuscript submitted).; 2017.
  44. ↑ Wardle J, Pope R. The psychological costs of screening for cancer. J Psychosom Res 1992 Oct;36(7):609-24 Available from: http://www.ncbi.nlm.nih.gov/pubmed/1403996.
  45. ↑ Lindholm E, Berglund B, Kewenter J, Haglind E. Worry associated with screening for colorectal carcinomas. Scand J Gastroenterol 1997 Mar;32(3):238-45 Available from: http://www.ncbi.nlm.nih.gov/pubmed/9085461.
  46. ↑ Parker MA, Robinson MH, Scholefield JH, Hardcastle JD. Psychiatric morbidity and screening for colorectal cancer. J Med Screen 2002;9(1):7-10 Available from: http://www.ncbi.nlm.nih.gov/pubmed/11943790.
  47. ↑ Wardle J, Taylor T, Sutton S, Atkin W. Does publicity about cancer screening raise fear of cancer? Randomised trial of the psychological effect of information about cancer screening. BMJ (Clinical research ed) 1999;319:1037-8.
  48. ↑ Nakajima M, Saito H, Soma Y, Sobue T, Tanaka M, Munakata A. Prevention of advanced colorectal cancer by screening using the immunochemical faecal occult blood test: a case-control study. Br J Cancer 2003 Jul 7;89(1):23-8 Available from: http://www.ncbi.nlm.nih.gov/pubmed/12838295.
  49. ↑ Saito H, Soma Y, Nakajima M, et al.. A case-control study evaluating occult blood screening for colorectal cancer with hemoccult test and an immunochemical hemagglutination test. Oncology reports 2000;7:815-9.
  50. ↑ Saito H, Soma Y, Koeda J, Wada T, Kawaguchi H, Sobue T, et al. Reduction in risk of mortality from colorectal cancer by fecal occult blood screening with immunochemical hemagglutination test. A case-control study. Int J Cancer 1995 May 16;61(4):465-9 Available from: http://www.ncbi.nlm.nih.gov/pubmed/7759151.
  51. ↑ Australian Institute of Health and Welfare., Australian Government Department of Health.. Analysis of colorectal cancer outcomes for the Australian National Bowel Cancer Screening Program. Asia Pac J Clin Oncol 2016 Mar;12(1):22-32 Available from: http://www.ncbi.nlm.nih.gov/pubmed/26803949.
  52. ↑ National Health and Medical Research Council Australian Research Council Australian Vice-Chancellors' Committee. National Statement of Ethical Conduct in Human Research. Canberra, Australia: National Health and Medical Research Council; 2007. Report No.: ISBN: 1864962755.
  53. ↑ International Agency for Research on Cancer. European guidelines for quality assurance in colorectal cancer screening and diagnosis. First Edition: International Agency for Research on Cancer; 2010.
  54. ↑ van Rossum LG, van Rijn AF, Laheij RJ, van Oijen MG, Fockens P, van Krieken HH, et al. Random comparison of guaiac and immunochemical fecal occult blood tests for colorectal cancer in a screening population. Gastroenterology 2008 Jul;135(1):82-90 Available from: http://www.ncbi.nlm.nih.gov/pubmed/18482589.
  55. ↑ Cole SR, Young GP, Esterman A, Cadd B, Morcom J. A randomised trial of the impact of new faecal haemoglobin test technologies on population participation in screening for colorectal cancer. The Medical Journal of Australia 2003;175:195-8.
  56. ↑ Macrae FA, Hill DJ, St John DJ, Ambikapathy A, Garner JF. Predicting colon cancer screening behavior from health beliefs. Prev Med 1984 Jan;13(1):115-26 Available from: http://www.ncbi.nlm.nih.gov/pubmed/6718327.
  57. ↑ 57.0 57.1 Cole SR, Young GP. Effect of dietary restriction on participation in faecal occult blood test screening for colorectal cancer. Med J Aust 2001 Aug 20;175(4):195-8 Available from: http://www.ncbi.nlm.nih.gov/pubmed/11587278.
  58. ↑ 58.0 58.1 McCusker J, Morrow GR. Factors related to the use of cancer early detection techniques. Prev Med 1980 May;9(3):388-97 Available from: http://www.ncbi.nlm.nih.gov/pubmed/7208447.
  59. ↑ 59.0 59.1 Salkeld GP, Solomon MJ, Short L, Ward J. Measuring the importance of attributes that influence consumer attitudes to colorectal cancer screening. ANZ J Surg 2003 Mar;73(3):128-32 Available from: http://www.ncbi.nlm.nih.gov/pubmed/12608975.
  60. ↑ Grazzini G, Ventura L, Zappa M et al. Influence of seasonal variations in ambient temperatures on performance of immunochemical faecal occult blood test for colorectal cancer: observational study from Florence district. Gut 2010;59:1511-5.
  61. ↑ Australian Institute of Health and Welfare. National Bowel Cancer Screening Program monitoring report: phase 2, July 2008-June 2011. Canberra, Australia: Australian Institute of Health and Welfare; 2012.

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Appendices[edit source]

View NHMRC Evidence statement form PSC1a NHMRC Evidence statement form PSC1a

View Systematic review report PSC1a Systematic review report PSC1a

View NHMRC Evidence statement form PSC1b NHMRC Evidence statement form PSC1b

View Systematic review report PSC1b Systematic review report PSC1b

View Modelling report PSC1c Modelling report PSC1c

View Modelling report PSC1d Modelling report PSC1d

Referring to the large bowel, comprising the colon and rectum.

Performing tests to identify disease in people before any symptoms appear.

Also known as virtual colonoscopy, a medical imaging procedure that uses low dose radiation CT scanning to obtain an interior view of the colon (the large bowel) that is otherwise only seen with a more invasive procedure where an endoscope is inserted into the rectum and passed through the entire colon.

A study in which people are allocated at random (by chance alone) to receive one of several clinical interventions. One of these interventions is the standard of comparison or control.

A test that can detect microscopic amounts of blood in stools. Types of FOBT include immunochemical FOBTs (iFOBTs), which directly detect haemoglobin using antibodies specific for the globin moiety of human haemoglobin, and guaiac FOBTs (gFOBTs), which detect peroxidase activity, an indirect method for identification of haemoglobin.

An Australian screening program that aims to reduce illness and death from bowel cancer through early detection or prevention of the disease.

The National Bowel Cancer Screening Program. An Australian screening program that aims to reduce illness and death from bowel cancer through early detection or prevention of the disease.

A recommendation formulated after a systematic review of the evidence, indicating supporting references.

A recommendation formulated in the absence of quality evidence, after a systematic review of the evidence was conducted and failed to identify admissible evidence on the clinical question.

A recommendation on a subject that is outside the scope of the search strategy for the systematic review, based on expert opinion and formulated by a consensus process.

A medical professional who treats acute and chronic illnesses and provides preventive care and health education to a wide range of patients.

An examination of the large bowel using a camera on a flexible tube, which is passed through the anus.

A test that can detect microscopic amounts of blood in stools. Types of FOBT include immunochemical FOBTs (iFOBTs), which directly detect haemoglobin using antibodies specific for the globin moiety of human haemoglobin, and guaiac FOBTs (gFOBTs), which detect peroxidase activity, an indirect method for identification of haemoglobin.

The main part of the large bowel, which absorbs water and electrolytes from undigested food (solid waste). Its four parts are the ascending colon, transverse colon, descending colon and sigmoid colon.

The final section of the large bowel, ending at the anus.

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