Screening for Colorectal Cancer in Germany: Guidelines and Reality

In Germany, as in other Western countries, colorectal cancer (CRC) is the second leading cause of cancer mortality. In 1997, 29 767 people died due to CRC - 2.3 % fewer than in the year before [[1]]. Approximately 6 % of the population will develop CRC during their lifetime, and the prognosis is particularly poor in advanced tumors. Improvement seems only to be attainable through screening and surveillance strategies for preventing cancer, or at least through early detection. The application of screening depends on the individual cancer risk, which is high in genetic syndromes or in those with personal history of colorectal neoplasms, and intermediate in individuals with a positive family history. Approximately 75 % of the population are at average risk, and are therefore potential candidates for screening.

The World Health Organization (WHO), the Agency for Health-Care Policy and Research (AHCPR), the American Cancer Society (ACS), and the American Gastroenterological Association (AGA) recommend combined annual fecal occult blood testing (FOBT) and sigmoidoscopy every five years in individuals at average risk beginning at age 50. Any positive test result should be followed by an accurate examination of the entire colon and rectum by colonoscopy or double-contrast enema, preferably with flexible sigmoidoscopy. The recommendation for FOBT is based on the results of three randomized controlled trials from Minnesota, Funen, and Nottingham which showed a significant reduction in the mortality rate of CRC of 33 % in the United States and 15 - 18 % in Europe [[2] [3] [4]]. The rationale for screening sigmoidoscopy is supported by direct evidence from two case-control studies reporting a reduction of the risk of death from distal CRC of approximately 60 % [[5] [6]]. There are strong theoretical reasons to believe that the recommended combination of FOBT and periodic sigmoidoscopy offers an added benefit, although this has not yet been scientifically proved.

The alternative approach, using one-off or periodic total colonic examination (TCE), is appealing, since the total colon can be examined and examinations are infrequent. There have been no randomized trials of TCE as a method of primary screening. However, TCE was recommended as an alternative to FOBT and sigmoidoscopy in the 1997 guidelines of the American Cancer Society [[7]]. The Committee accepted the premise that sigmoidoscopic screening reduces the mortality from distal CRC, and therefore regarded as reasonable the conclusion that the same screening modality, extended using a colonoscope, would also reduce mortality from proximal CRC.

Neither a national prospective controlled trial nor a cost-benefit analysis has been carried out to evaluate screening procedures for CRC in Germany. The current guidelines of the German Society of Gastroenterology and Metabolism are mainly based on the recommendations of the societies in the United States [[8]]. Screening in people at average risk is recommended beginning at age 45, although there is no evidence to show that the low incidence of colorectal neoplasms in those under the age of 50 is higher in Germany than in other Western countries. As in the WHO guidelines, a combination of annual FOBT and sigmoidoscopy every five years is suggested for screening. In contrast, in patients with a positive test result, double-contrast enema is only recommended as an alternative to colonoscopy when the cecum cannot be reached with the endoscope. The current German guidelines do not mention TCE as a screening method in individuals at average risk for CRC. Strategies for screening or surveillance of people who are at increased risk are comparable to the recommendations of the American societies. There are no ongoing controlled studies for further evaluation in Germany.

The German legal health insurance organizations established a program for early detection of cancers of the genital tract, breast, prostate, skin, and colorectum in 1971. The screening procedures for CRC include annual digital rectal examination and FOBT for women and men at average risk, beginning at age 45. At that time, the program was based more on hope and optimism than on scientific data. This would have been acceptable if the program had been prospectively evaluated with regard to its costs - a tremendous burden for the medical service - as well as the risks of screening. Unfortunately, the considerable opportunities offered by this approach have not been taken over a period of 27 years.

Participation in the program can be only calculated on the basis of the number of reimbursed tests. Recommendations for improvement of documentation have so far not been implemented. The latest report from the program was published in 1992 [[9]]. Approximately ten million people - 14 % of the men and 34 % of the women eligible for the program - undergo the recommended screening procedures. There are no data to show whether individuals undergo regular or occasional screening. The acceptance rate seems to be low in view of the approximately 470 million outpatient consultations and 14 million hospital admissions per year in Germany [[10]].

There is a lack of cost-benefit calculations, which is surprising in view of the limited budget and restrictions being introduced in other areas of the German health system. The program does not include a protocol for following up the participating individuals. Data on the effectiveness of the tests or the consequences of positive results are not available. The costs of the program relating to prevented deaths or life-years saved are therefore unknown, and cannot even be calculated. In the United States, detailed knowledge about these parameters is mandatory for the evaluation and acceptance of screening programs.

The fact that people can already participate at age 45, instead of 50 as suggested by the WHO, is an example of the way in which hope, rather than scientific evidence or even a simple cost-benefit analysis, formed the basis for this recommendation. Approximately five million Germans are aged 45 - 49 and are eligible for CRC screening [[10]]. Annual FOBTs can lead to a reduction in the CRC-related mortality of 15 - 18 %, according to the European trials [[2] [3] [4]]. The effect of this reduction can probably be expected in the five years after the beginning of screening. For the corresponding population aged between 50 and 55 years, nine hundred deaths caused by CRC were registered in Germany in 1997 [[1]]. According to this calculation, at least 31 250 people have to undergo 156 250 tests to prevent a single CRC-related death. Even if only 4 % of the participants are examined by colonoscopy for positive tests results, 1250 endoscopic examinations will have to be performed. In addition to this unacceptable cost-benefit ratio, thousands of participants may suffer the burden of false-positive tests in order to save life in a few patients.

Scientific developments and the results of recent trials had no impact on the program being operated by the legal health insurance organizations, which has remained unchanged since 1982. Annual digital rectal examination is still recommended in both men and women, although this inconvenient procedure has not been shown to be an effective way of screening for CRC. Neither colonoscopy nor even sigmoidoscopy has been integrated into the program, and reimbursement for the use of these procedures for screening purposes is therefore not possible. With regard to sigmoidoscopy, the guidelines of the German Society of Gastroenterology and Metabolism as weIl as the WHO can therefore not be fulfilled. The recommendations of the screening program do not take into account any recently evaluated risk factors, e. g., a positive family history of colorectal carcinomas or adenomas.

At present, the national professional associations in the fields of gastroenterology, surgery, and oncology are working out new guidelines for the management of CRC. In most respects, these correspond to the American recommendations, including screening colonoscopy as an alternative to annual FOBT and periodic sigmoidoscopy.

Theoretically, the German health system should be able to provide a reasonable endoscopy service. Every German general practitioner, internist, and surgeon is allowed to carry out sigmoidoscopy, since there is no need for special authorization. By contrast, physicians do require a qualification to carry out colonoscopy, and the requirements vary from state to state within Germany. There are usually few restrictions, with no need for documentation of a certain number of diagnostic or therapeutic procedures. In Germany, it is permissible to carry out colonoscopy without the option of polypectomy during the same session if there is limited experience or technical support. The prerequisites for performing endoscopy of the colorectum can therefore easily be fulfilled. However, there is little interest in this service, because the costs are inadequately reimbursed. To limit the cost of outpatient services, all medical services are evaluated using a point system. The higher the total number of points achieved is, the lower a single point will be reimbursed. In addition, the value of one point varies between different regions in Germany. On the assumption that the actual value of a point is Euro 0.028, sigmoidoscopy would be reimbursed at Euro 9.80, which is only Euro 2.50 more than payment for a digital rectal examination and FOBT. On this basis, colonoscopy would be reimbursed at Euro 60.50, which is within the lowest range in Western countries. These rates are in striking contrast to the high level of expenses for employees and technical equipment, with costs of approximately Euro 20 000 for a video colonoscope.

In conclusion, the German health-care system has invested billions of euros in a program for early detection of cancer over a period of more than 28 years. In spite of this long history, only every fifth potential candidate participates in this program. The recommended measurements do not take into account national and international guidelines for CRC screening, or the relevant scientific studies. The documentation is insufficient, and the cost-effectiveness has not been studied. National scientific medical associations are currently working on guidelines for the management of CRC that are mainly based on the international recommendations, due to a lack of national data. However, any new recommendations will only be able to be implemented in practice in terms of annual FOBTs, whereas periodic screening sigmoidoscopy or colonoscopy cannot be charged. In addition, new guidelines for improving quality control in endoscopy are under discussion. Practitioners who are unable to meet these requirements will thus have even less interest in providing this type of medical service since it is not profitable. Under these conditions, it will not be possible to carry out screening endoscopy in Germany on a large scale.

The national program needs to be urgently reevaluated, with close collaboration between the insurance companies and national gastroenterological associations. The huge budget should be only spent on a scientifically proved program providing adequate documentation, quality control and evaluation of cost-effectiveness. Colonoscopy should only be reimbursed when polypectomy can be performed during the same session. These strategies can save money, which should then be invested in providing appropriate reimbursement for endoscopic procedures, provided they meet the state-of-the-art guidelines for quality control.

Those receiving medical care are entitled to expect such improvements, not only in view of the potential opportunities but also with regard to the financial, medical, and psychological burdens of screening for cancer.

References

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