Fact sheet on bowel cancer screening programme

Transcription

1 Fact sheet on bowel cancer screening programme What does the bowel cancer screening programme involve? The bowel cancer screening programme focuses on men and women from 55 to 75 years of age. Every two years, they will receive an invitation to take part in the screening programme. Self-sampling test kits (ifobt) are sent to their home addresses. After taking a stool sample, they post it off for analysis. If a test produces an abnormal result, the person in question will be referred for further diagnosis (colonoscopy) and, if necessary, treatment. Thus bowel cancer can be detected at an early stage, enabling any precursors to be removed and/or improving the treatment prospects. 1 Clinical picture Malignant bowel tumours mainly occur in the colon (colon cancer: ICD-9 code 153; ICD-10 code C18) or the rectum (rectal cancer: ICD-9 code 154; ICD-10 code C19-C20). Malignant tumours in the small intestine are very rare and are not detected by the bowel cancer screening programme. Each member of the general population has a lifetime risk of 4% to 5% of getting bowel cancer. In 2014, bowel cancer was the third most common cancer in the Netherlands. Nine out of every ten cases occur in people aged 55 or above. There were more than 14,743 new cases of bowel cancer in Five-year survival for bowel cancer is highly dependent on the stage at which the tumour is detected (stage I: 94%; stage IV: 8%). The overall five-year survival rate for bowel cancer is approximately 59%. The risk of death from bowel cancer is 2% for men and 1.5% for women. In 2013, approximately 5,000 people died of bowel cancer. Bowel cancer usually starts as a benign polyp. Over the years, a small proportion of these polyps can continue growing and develop into a malignant tumour that invades the intestinal wall and eventually spreads via the bloodstream or lymph nodes. This usually involves a specific type of polyp, known as an adenoma. Approximately 30% of people over the age of 60 have adenomas. The symptoms of bowel cancer are determined by the site of the tumour. Tumours in the ascending colon (the first part of the colon) are known as proximal tumours. These are usually free of symptoms for a long period of time. Anaemia resulting from visually undetectable blood loss via stool material causes fatigue, which is often the first sign. Later on, intestinal cramps and pain may occur, shortly after meals, for example. In colon tumours that are located closer to the rectum (distal tumours), the main symptoms are usually blood loss and mucus loss via the anus and a change in the pattern of bowel movements. This is often accompanied by painful cramps, due to constipation. The most common symptom of a tumour in the rectum is a change in normal bowel movements (a feeling that the bowel does not empty completely, and blood loss). Version: July 2015 Status: Final version Page1 of 11

2 The main warning signs for bowel cancer are an inexplicable and persistent change in the pattern of bowel movements (constipation, diarrhoea) and the presence of blood in the stool. Most bowel cancer patients (approximately 80%) have no family history of bowel cancer. Approximately 5% of bowel cancer patients have an hereditary cancer syndrome (FAP or HNPCC). In the remaining group of people (about 15%), one or more first-degree relatives have (or have had) bowel cancer. The carriers of hereditary bowel cancer and some of those with bowel-cancer patients among their first-degree relatives are at such high risk of developing bowel cancer that the two-yearly check using an ifobt (Faecal Occult Blood Test) is insufficient, they need to be monitored much more intensively. Objective and target group Bowel cancer can be prevented, or detected and treated at an early stage, thanks to screening. If bowel cancer is detected early on, there is a better chance of curing it, and the treatment involved is less arduous. Alternatively, a precursor of bowel cancer may be found. If a precursor is treated, bowel cancer can be prevented. Men and women from 55 to 75 years of age are invited to take part in the bowel cancer screening programme every two years. Self-sampling test kits (ifobt) are sent to their home addresses. After taking a stool sample, they post it off to a laboratory. 2 Facts & Figures The phased introduction of the bowel cancer screening programme commenced in early The initial figures for the screening programme (see table) reflect the situation in the first year following its introduction. Halfway through that first year, the cut-off value was increased (from 88 ng/ml to 275 ng/ml). For those numbers that are sensitive to the cut-off value, an average over the year (i.e., of two cut-off values) is used. The figures do not yet reflect the screening programme s goal, which is to achieve a stable situation. Version: July 2015 Status: Final version Page2 of 11

3 Indicator Figures Figures expected in stable situation Burden of disease (incidence, number of cases per year) Burden of disease (deaths, number of cases per year) Men: 7,500 Women: 6,000 Men: 2,600 Women: 2,300 Size of target group (number invited) 741, million Number of screening tests 529,056 Participation rate 71.3% Percentage of referrals (positive test) 7.8% Detection rate (per 1,000 screened) Positive predictive value of colonoscopy False-positive referrals (<advanced adenoma) (per 1,000 screened) Risk of false-negative screening (CRC or advanced adenoma) * Timeliness of diagnosis (time between receipt of screening results and planned intake interview) 2.7 serrated polyp 12.5 non-advanced adenoma 22.7 advanced adenoma 4.7 cancer 7.8% cancer 45.7%> = advanced adenoma % 57.1% within 21 days Gain (number of preventable deaths per year) Data not available 2,400 * Source: Stegeman, IJC 2013, COCOS study Explanation of the numbers presented: Burden of disease (incidence): This is the number of newly diagnosed cases each year. Participation rate: The percentage of those invited who actually carried out a screening test. Percentage of referrals: The percentage of screened individuals who receive a referral to the hospital for further examination (colonoscopy). Over time, the percentage of referrals will fall. This is because the longer the screening programme has been running the greater the proportion of people being called for a second or later round. This will result in a fall in the number of abnormalities detected. Detection rate: The number of abnormalities, expressed per number of individuals screened. This is a measure of the risk that a relevant abnormality will be detected. Positive predictive value of referral: The risk that an abnormality (that is clinically relevant) will be found, following referral to the hospital. False-positive referrals: The number of people referred to hospital (expressed in terms of the number screened) in whom no abnormality (that is clinically relevant) is found. In other words, this is the risk that you will be referred to the hospital unnecessarily. The risk of false-negative screening: The risk that a relevant abnormality will be found during colonoscopy, following a negative screening. This is a measure of the screening test s sensitivity. Sensitivity at a single screening (ifobt) is 65% for bowel cancer and 27% for advanced adenomas. After two to three rounds, sensitivity is expected to rise to between 80% and 90% for bowel cancer. Version: July 2015 Status: Final version Page3 of 11

4 Gain: Given a participation rate of 60 percent, the number of deaths is expected to stabilise at about 2,400 per year by around Contracts have been signed with 103 colonoscopy centres, and 293 endoscopists are working for the screening programme. 3 Details about the phased introduction Given the size of the total target group, the screening programme will be introduced in phases. This will make it possible to build up the capacity required to implement the screening programme, as well as the diagnosis and treatment capacity of subsequent care. Phased introduction (starting in 2014) In 2014 (the first year of introduction), invitations will be sent to all men and women who turn 63, 65, 67, 75 or 76 in that year 1. Furthermore, in 2014, invitations were already sent to some of those born in The rest of those born in 1954 will follow in 2015, as well as those who turn 61, 63, 65, 67, 69 and 75 in According to this scheme, all age groups (55 to 75) will be invited in 2018, which is in keeping with the assessment that sufficient care capacity will be available by that time. In 2019, a previously uninvited age group will be included in the screening programme: those who turn 57 in that year, who had not been invited the previous year because they were still aged 56. This means that, in 2019, everyone aged from 55 to 75 will have received at least one invitation to take part in the screening programme. If there are problems of undercapacity during the phased introduction of the screening programme and increases in the waiting times for diagnosis and treatment, steps can be taken to manage the capacity issues in question. Depending on the nature of the steps in question, it may be necessary to extend the introduction over a longer period. 1 It was not possible to invite some of the 2014 target group that year, partly due to problems of undercapacity. They were shifted to 2015, and will be given priority when invitations are issued this year. Version: July 2015 Status: Final version Page4 of 11

5 4 Implementation The primary process involves the screening of men and women aged from 55 to 75 for bowel cancer (or its precursors). This process is represented diagrammatically in the figure below. Process Selection The screening organisations use data from the Municipal Personal Records Database when issuing invitations to men and women to take part in the screening programme. Invitation Each year (when the programme has been fully implemented), the screening organisation will invite half of the members of the target group to take part in the bowel cancer screening programme. This means that the entire target group will be invited every two years. The members of the target group receive a letter of invitation to take part in the screening programme, as well as a leaflet about the programme s purpose and methods (plus details of the benefits and disadvantages involved), and information about the exchange of personal data. The target group will also receive a self-sampling test kit (ifobt), instructions, a reply form, a bag and a return envelope. Those who are being invited for the first time will receive prior notification about 2 weeks before the invitation itself arrives. If the invitee has not responded within eight weeks, the screening organisation sends a one-time reminder. If the invitee again fails to respond, then no further action will be taken during this round of screening. Two years later, the person in question will be invited once again. Screening The participant takes a stool sample at home, fills in the necessary details on the reply form, places the sample and the reply form into the bag, then seals this into the preaddressed return envelope and posts it off to the laboratory by regular mail. The laboratory analyses the stool sample according to set protocols and sends the result to the screening organisation. Inform and refer In the event of a favourable outcome, the screening organisation sends the screened individual a letter containing the screening results. In the event of an unfavourable result (an ifobt value equal to or greater than the cutoff value) the screening organisation makes an appointment for an intake interview at a colonoscopy centre. The screening organisation sends participants a letter containing the screening results and a reference to an intake interview for a colonoscopy. The Version: July 2015 Status: Final version Page5 of 11

6 letter contains details of the appointment for the intake interview. It also contains an information leaflet on the further examination, and the associated benefits and disadvantages. The participants GPs are sent details of the screening results and the screening organisation s referral two days before the participants themselves are informed of the results. This gives the GPs the opportunity to decide for themselves whether to contact the participant to inform them about the unfavourable result, and to discuss the issue of which relevant medical data should be forwarded to the colonoscopy centre. Alternatively, the client can take the initiative and contact their GP. The participant can change or cancel the appointment for an intake interview at the colonoscopy centre, via the client portal or screening organisation. The screening organisation monitors developments to see whether the participant complies with the referral advice. If this is not the case, then the screening organisation sends the participant a reminder letter, asking them to make a new appointment for the intake interview. If the participant fails to respond to the reminder, then the only action the screening organisation takes is to inform the client s GP. The GP can then contact the participant to emphasise the importance of following up on the referral. Diagnosis During the intake interview for colonoscopy, a medical case history is taken and the patient is informed about the colonoscopy and how to prepare for it. In addition, an appointment is made for colonoscopy. On the day that the colonoscopy is to be carried out, the patient is instructed about the examination and is given sedation, if this had been agreed with the patient in advance. The colonoscopy centre informs the patient about the results of the colonoscopy, both verbally and in writing. If no abnormalities are detected, then the patient is informed of this immediately, both verbally and in writing. At this point, the patient is informed that they will be sent another invitation to take part in the screening programme in ten years time, unless he/she will be above the age of 75 by then. Within a period of one month after the colonoscopy, the colonoscopy centre calls the patient to inquire about any complications that may have occurred. It also verifies that the patient has fully understood the information they were given at the time of the colonoscopy. Their GP is also informed about the findings and the policy. If any abnormalities are observed during colonoscopy, then histological material (i.e., polyps or biopsies) is generally taken. After the colonoscopy, the patient is verbally informed about any abnormalities found. The colonoscopy centre sends the histological material, together with the relevant clinical data, to a pathology laboratory that meets the screening programme s quality requirements. The pathology laboratory assesses the preparations and notifies the colonoscopy centre (electronically) of the results. If a full colonoscopy is not an option, but a CT colonography is possible, then the colonoscopy centre refers the patient to a radiologist. The radiologist reports their findings to the colonoscopy centre. The colonoscopy centre informs the patient verbally and sends written confirmation of the result (unless cancer has been diagnosed). If appropriate, an appointment is scheduled to discuss the results of the pathological findings. The colonoscopy centre also informs the patient s GP about the results. If necessary, the colonoscopy centre will arrange for the patient to be transferred to the hospital of their choice for further diagnosis and treatment, and/or surveillance. The colonoscopy centre passes on the findings and results of colonoscopy, together with further diagnosis and details of the follow-up policy, to the screening organisation (electronically). Version: July 2015 Status: Final version Page6 of 11

7 Treatment and surveillance If treatment and/or surveillance are necessary, the colonoscopy centre sees to it that the patient and their data are properly transferred to the appropriate specialist. The colonoscopy centre sends a report to the screening organisation indicating that it has conducted a surveillance colonoscopy and giving details of the appropriate follow-up policy (involving either a return to the screening programme or a fresh surveillance colonoscopy). The screening organisation will subsequently send invitations to any patients who return to the screening programme, unless they are above the age of 75. Benefits and disadvantages The screening programme was implemented because the benefits outweigh the disadvantages at population level. Advantages Screening enables polyps to be detected and treated at an early stage. In some cases, this can prevent bowel cancer. The bowel cancer screening programme enables bowel cancer to be detected at an early stage. As a result, the treatment involved is often less arduous. Early detection increases the chance of a cure. This screening programme will ultimately reduce the number of people dying from bowel cancer. The stool material test is free. Further examination at the hospital or at an independent treatment centre is covered by the patient s health insurance. Accordingly, the health insurance excess also applies to the further examination in question. The test is easy to perform at home. The screening programme is directly linked to the healthcare system, so patients can quickly get an appointment for a further examination. Disadvantages The examination that follows an unfavourable ifobt result is mentally and physically challenging, while it is not always the case that bowel cancer (or its precursors) is detected. If any abnormalities are found during this further examination (colonoscopy) at the hospital, then a surgical procedure is usually required. This often involves the removal of polyps or a small amount of tissue. Complications can occur during a colonoscopy. Complications occur in about two out of every 1,000 colonoscopies. The risk of complications increases if the physician surgically removes tissue during the examination. The most common complication is bleeding. One rare and very serious complication is perforation of the intestinal wall. There is a very slight risk that colonoscopy may result in death. Nothing is yet known about the level of risk associated with colonoscopies resulting from screening programmes that are based on the use of self-sampling test kits. This is likely to be somewhere between 1 in 10,000 and 1 in 400,000. This is dependent on factors such as the presence and severity of any abnormalities, and the patient s health status. A screening programme does not always detect bowel cancer, or its precursors. The test provides no guarantee. If a man or woman has been aware for several years that they have bowel cancer, this could have an adverse psychological effect, especially if the diagnosis does not lead to an actual extension of life. Version: July 2015 Status: Final version Page7 of 11

8 In some participants (especially elderly ones), a screening programme can detect bowel cancer that will not produce any further symptoms for the remainder of their lives. This sometimes leads to overtreatment. Who is involved in the organisation and implementation of the screening programme and the subsequent diagnosis? The Ministry of Health, Welfare and Sport: mission, funding, and the licensing of the bowel cancer screening programme. The National Institute for Public Health and the Environment (RIVM) - Centre for Population Screening (CvB): national coordination of the screening programme on behalf of the Ministry of Health, Welfare and Sport. There are five regional screening organisations: the central-west screening programme, the south screening programme, the south-west screening programme, the north screening programme, and the east screening programme. These are tasked with regional implementation, referral for colonoscopy to centres that meet national quality requirements, the regional coordination of screening programmes and subsequent diagnosis, quality management of ifobt implementation, colonoscopy, and pathology of diagnosis by establishing reference functions. ifobt laboratories: process reply forms, analyse stool samples (using ifobt) and relaying the results to the screening organisations. General practices: providing information about the screening programme (on request), advising participants with an unfavourable ifobt result, and relaying relevant parts of the client s medical data to the colonoscopy centre. Colonoscopy centres: performing intake interviews and colonoscopies, coordinating diagnosis, surveillance, and transfer for treatment. Pathology laboratories: assessing histological material obtained during colonoscopy or follow-up treatment. Department of Radiology: performing CT colonography at the request of a colonoscopy centre. Programme Committee for Bowel Cancer: representatives of all participating parties advise the RIVM-CvB.2 Screening organisations, Association of Dutch Healthcare Insurers, the National Association of General Practitioners (LHV), Foundation for Patients with Cancer of the Digestive Tract (SPKS), Radiological Society of the Netherlands (NVvR), Dutch Society of Internal Medicine (NIV), Netherlands Society for Clinical Chemistry and Laboratory Medicine (NVKC), Dutch College of General Practitioners (NHG), Association of Comprehensive Cancer Centres (IKNL), The Association of Surgeons of the Netherlands (NVvH), Dutch Federation of University Medical Centres (NFU), the Dutch Psychiatric Association (NVVP), the Dutch Society for Clinical Genetics (VKGN), the Netherlands Association of Hepato-gastroenterologists (NVMDL) and the Dutch Nurses and Caregivers Association (V&UN). Link to the healthcare system Those participants in the screening programme who have unfavourable ifobt results are referred to the healthcare system for further diagnosis and, if necessary, treatment. The standard waiting time for a further examination at a colonoscopy centre is three weeks. There is a four-week waiting period for follow-up treatment. An effort will be made to keep waiting times as short as possible. The turnaround times for those men and women who have been referred will be monitored. This will make it possible to try out alternative introductory scenarios during the introductory phase if waiting times become excessive. 2The following parties are represented on the programme committee: Version: July 2015 Status: Final version Page8 of 11

9 5 History In a 2001 horizon-scanning report on bowel cancer screening programmes, the Health Council of the Netherlands concluded that the introduction of such a programme deserved serious consideration, but that a number of questions still needed to be answered. Reports issued by the Queen Wilhelmina Fund for Dutch Cancer Control (the Dutch Cancer Society) and the Netherlands Organisation for Health Research and Development (ZonMw) in 2004 and 2005 called for the rapid introduction of a bowel cancer screening programme. Two pilot projects (FOCUS and CORERO) carried out in 2006 explored effective screening methods for bowel cancer screening, as well as the feasibility of implementing such a screening programme in the Netherlands. Based on pre-randomisation, the FOCUS pilot project compared gfobt and ifobt, and the effect of these different tests on the screening programme s participation rate and yield. Pre-randomisation was used in the CORERO pilot project to compare three screening techniques: sigmoidoscopy, ifobt, and gfobt. CORERO-II examined the optimum screening interval between different rounds of screening. It also examined the effect that submitting two ifobt stool samples (instead of one) has on the screening programme s yield. The results of the trial population screening programmes were used in a 2009 Health Council advisory report (on the possible introduction of a bowel cancer screening programme) that had been requested by the Minister of Health, Welfare and Sport. In its advisory report, the Health Council concluded that a bowel cancer screening programme was both appropriate and feasible, assuming that the requisite care capacity could be developed in the following years. The Health Council stated that, at a participation rate of 60%, a screening programme could prevent an average of 1,428 deaths per year (calculated over the period from 2010 to 2039). The programme would also have a favourable cost-effectiveness ratio of EUR 2,200 per year of life gained. It recommended that a two-yearly bowel cancer screening programme be gradually introduced for men and women aged from 55 to 75. The recommended screening test was the ifobt (immunological Faecal Occult Blood Test), which involves the use of a self-sampling test kit. It based these recommendations on the results of the trial population screening programmes. The participation rate was 60%, and 6.4% of the participants were referred following an abnormal ifobt result (OC-Sensor with cut-off value above 75 ng/ml). Of those who underwent a colonoscopy, 8.2% were found to have bowel cancer, while 43.4% had advanced adenomas (source - Health Council advisory report: A National Colorectal Cancer Screening Programme, 2009). More than a quarter of this group were found to have other types of polyps or adenomas. In 2010, the Minister of Health, Welfare and Sport informed the Dutch House of Representatives of his views on bowel cancer screening, and endorsed the Health Council s advisory report. The Minister commissioned the RIVM-CvB to conduct a study into the feasibility of a bowel cancer screening programme. The purpose of the feasibility study was to identify the effects of introducing a bowel cancer screening programme, highlight any potential sticking points, and put forward proposals on how best to deal with these. In its feasibility study, the CvB concluded that the introduction and implementation of a nationwide bowel cancer screening programme in the Netherlands was certainly possible. There was broad support for the introduction of the bowel cancer screening programme. Thorough preparation is required to guarantee that the quality and capacity of the screening programme will be sufficient for its implementation, for further diagnosis and for care. The CvB recommends that a phased roll-out be adopted, in the form suggested by Version: July 2015 Status: Final version Page9 of 11

10 the Health Council. If this should lead to capacity shortfalls, implementation can be modified in line with various alternative scenarios that have been developed. On 25 May 2011, Edith Schippers, the Minister of Health, Welfare and Sport, decided to push ahead with the introduction of the bowel cancer screening programme. This decision was included in a national policy document on health entitled Health Close to People. On 10 April 2013, at the request of the Minister of Health, Welfare and Sport, the Health Council issued recommendations concerning the screening organisations application for a permit under the Population Screening Act (WBO), for the nationwide screening programme s pilot project. At this point, the Health Council expressed doubts about the clinical validity of the ifobt, which had emerged from the European public procurement process. The Minister of Health, Welfare and Sport s response was to hold an expert meeting. On 4 July 2013, the Minister ruled that the pilot could commence in September 2013, rather than in April of that year, as previously planned. On 5 September 2013, the Health Council recommended in favour of the screening organisations application for a WBO permit for a nationwide screening programme, with effect from January 2014, for a period of six years. The nationwide screening programme was launched in January Developments The main point of concern in the first few months of 2014 was the observation that the screening programme s risk (anxiety, unwarranted referrals, risk of complications) benefit (health gains) ratio was out of balance. For example, the participation rate was higher than expected. In addition, the percentage of participants undergoing colonoscopy following a positive ifobt was higher than average in the trial population screening programmes. Finally, the referral rate for colonoscopy was higher than had been assumed. The latter phenomenon was partly due to the fact that the older section of the screening programme s target group received their invitations in The programme started by inviting those aged 75 and 76. As a result of this finding, it was necessary to modify the programme. The national evaluator (Erasmus MC in collaboration with the Antoni van Leeuwenhoek hospital) performed several analyses, based on the available data. On that basis, the RIVM concluded there is strong evidence to suggest that the test is more sensitive than the authors of the Health Council s 2009 advisory report had expected. This means that, in absolute terms, more cases of cancer are detected. However, it also means that more people get false positive results. In an attempt to restore the balance between the risks and benefits, the decision was taken in mid-2014 to increase the ifobt cut-off value (from 88 ng/ml to 275 ng/ml). 7 Financial The screening programme is funded by central government. The screening organisations receive grants for the regional implementation of the screening programme, for the associated quality assurance activities, and for follow-up diagnosis. The RIVM s coordination role is funded by the Ministry of Health, Welfare and Sport. When fully implemented, it is estimated that the screening programme will cost approximately 22 million euros per year. The cost of the colonoscopy centres, treatment and surveillance are covered by the health insurance package. Version: July 2015 Status: Final version Page10 of 11

11 8 International Nationwide screening programmes for bowel cancer have been introduced in Britain, Belgium and Slovenia. Finland, Ireland, Estonia and Scotland are currently working on the phased introduction of nationwide population screening programmes. France, Germany, Spain, Italy and Sweden have population screening programmes in place at regional level. 9 Relevant websites Details about the screening programme are available from the following organisations: Reports: Feasibility study conducted by RIVM RIVM s implementation framework Information: Publications Erasmus MC, Nationwide monitoring of the bowel cancer screening programme: results during first half of Contact Ms M. van Wieren Programme coordinator Ms L.A.V. Paauw Programme coordinator Centre for Population Screening RIVM, mail bin 49 PO Box BA Bilthoven monique.van.wieren@rivm.nl, lydia.paauw@rivm.nl Version: July 2015 Status: Final version Page11 of 11