Population screening: Evidence summary and recommendations (PSC1a-d)
Evidence summary table[edit source]
|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||, , , , , , , , , , |
|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|||
|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||, , , , , , |
|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|||
|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||, , , , , , , , , , , , , , , , , , , , , , , , |
|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||, , , |
|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||, , , |
|Screening cost effectiveness (PSC1c)|
|Assuming 100% adherence to screening recommendations, modelling predicted the most effective screening strategies would be:
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.
|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:
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.
|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.
|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.
|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.
|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: not applicable
^NHMRC classification of levels of evidence does not currently encompass modelling studies.
Overall population screening strategy[edit source]
Primary screening test[edit source]
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.
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.
Primary screening test
The use of flexible sigmoidoscopy as a primary screening test is not recommended for population screening in the average-risk population.
Frequency of testing[edit source]
Target age group[edit source]
Target age group
It is recommended that the age range for organised population screening continues to be 50–74 years.
Target age group
Starting at age 40 is not recommended for population screening as it is unlikely to be cost-effective.
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.
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).
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.
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.
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. 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.
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. Healthcare professionals must recognise the potential adverse psychological effects of screening, although several studies have shown no evidence of long-term harm after screening. 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.
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.
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.
Immunochemical versus guaiac occult blood tests[edit source]
There is supporting high-level evidence from one RCT of iFOBT, three large RCTs evaluating screening with guaiac faecal occult blood test (gFOBT) from the 1990s, as well as three case-control studies 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. 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. 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.
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) 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.
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.
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.
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.
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. Recent studies have demonstrated that several of these barriers can be at least partially overcome so as to improve participation.
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.
Appropriate public education and promotion is usually necessary to enhance participation rates.
In Australia, weather conditions and geographic factors may affect performance of iFOBTs. 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.
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