Key words
screening - asymptomatic persons - radiological imaging - radiation protection legislation
- informed decision
Introduction
Current strategies in the health care sector increasingly target the early detection
of frequent, severe, and costly diseases or the detection of their risk factors. In
principle, imaging methods can also be used for this purpose. The best-known example
is mammography screening for early detection of breast cancer. Based on promising
results of recent studies, the use of other radiological screening examinations is
currently being discussed [1] and promoted [2]. As a result of the impressive technological advances achieved in recent years,
particularly computed tomography (CT) offers promising potential for the early detection
of diseases, such as:
-
Lung cancer,
-
Intestinal polyps and malignant intestinal tumors,
-
Calcifications and stenoses of the coronary arteries.
These examinations are already offered by some practices and clinics in Germany as
individual health services in violation of the provisions of the Radiation Protection
Law.
There is a semantic as well as technical difference between preventive care (primary
prevention) and early detection (secondary prevention) ([Fig. 1]). The goal of preventive care is to prevent, lower the likelihood of, or delay disease.
In contrast, the goal of early detection is to detect an already existing disease
(e. g. cancer, coronary heart disease) at the earliest stage possible in a person
who is still asymptomatic in order to allow earlier treatment that is presumably more
effective and gentler. Of course, some types of screening can also include aspects
of preventive care. If, for example, adenomatous intestinal polyps are detected by
virtual CT colonoscopy, they can be subsequently endoscopically ablated to interrupt
the adenoma-carcinoma sequence. A further example is CT calcium scoring for determining
the individual risk of heart attack. If the calculated calcium score is slightly elevated,
a change in lifestyle, possibly in combination with medication for existing arterial
hypertension and/or hyperlipidemia, can prevent the clinical manifestation of coronary
heart disease. However, imaging itself always serves solely to detect a disease or
its precursors and risk factors and should therefore not be designated as a preventive
medical measure, particularly to avoid unreasonable expectations of potential test
participants.
Fig. 1 Contribution of radiological and nuclear medicine imaging to the primary (prophylaxis)
and secondary prevention (early detection) of diseases. The aim of early detection
is to initiate therapy of diseases at an earlier stage. Some tests may not only allow
early detection of diseases but may also have a primary preventive component. For
example, when precursors of cancer (e. g., colon polyps) are detected and subsequently
removed or when individual risks for developing a severe disease are detected and
reduced (e. g., coronary artery calcification). Ionizing radiation used for imaging
is itself a potentially noxious agent and thus should be minimized to the greatest
extent possible. The basic risks related to all screening procedures are summarized
in Table 1.
While only a small portion of screening participants will benefit from the examinations
due to the typically low prevalence of the considered diseases, all participants will
be subjected to the risks associated with the test. Therefore, the advantages and
disadvantages of early detection listed in [Table 1] must be carefully weighed by expert committees and every potential test participant
must be provided this information in detail so that an informed decision can be made
[3]. An important aspect that has to be addressed in the informed consent discussion
is the mental stress in the case of a finding requiring clarification. This is particularly
relevant, for example, in the case of CT screening for lung cancer since hereby detected
pulmonary nodules are frequently observed by CT over several months to assess their
growth behavior to determine whether they are malignant. Therefore, the patient must
live for an extended period in uncertainty about whether lung cancer is present.
Table 1
Advantages and disadvantages of radiodiagnostic screening. Except for the radiation-associated
risks, the mentioned aspects also hold true for early detection with MRI and ultrasound.
|
benefits
|
damage/risk
|
|
for the individual:
-
treatment is potentially more effective and gentler when the disease is detected at
an early stage.
-
better prognosis or at least longer life expectancy and improved quality of life.
-
identification of individual disease risks and any resulting preventive care measures
such as changes in lifestyle or medication.
for the target group or the general population:
-
reduction of disease-specific mortality.
-
lower treatment costs in the case of early detection of a disease.
-
reduction of indirect costs, e. g. by shortening disease-related inability to work
(“manager check”).
|
general aspects:
-
mental stress until clarification of a nonspecific finding, particularly if several
months of follow-up are indicated.
-
invasiveness of the diagnostic workup.
-
unnecessary diagnostic workup in the case of a false-positive finding with potentially
serious complications and relevant costs.
-
false sense of security in the case of a false-negative finding.
-
detection and treatment of a disease that never would have resulted in symptoms or
death without treatment (overdiagnosis/overtreatment).
additional imaging-specific aspects:
|
If the screening procedure involves the use of X-rays or a radiopharmaceutical, the
requirements for the justification for the examination are particularly high. Therefore,
article 55 para. 2 letter h of European Directive 2013/59/Euratom [4] requires “that member states shall ensure that any medical radiological procedure
on an asymptomatic individual, to be performed for the early detection of disease,
is part of a health screening program, or requires specific documented justification
for that individual by the practitioner, in consultation with the referrer, following
guidelines from relevant medical scientific societies and the competent authority.
Special attention shall be given to the provision of information to the individual
subject to medical exposure.” These requirements were implemented in Germany by the
Radiation Protection Law that came into effect on December 31, 2018 [5].
The goal of the present study is to (i) present the new legal regulations in Germany
regarding the early detection of non-communicable diseases using radiodiagnostic procedures
and (ii) to evaluate in detail representative services offered by radiology institutions
on the Internet using the three previously specified CT examinations as examples.
New legal framework for early detection using X-rays and radiopharmaceuticals
New legal framework for early detection using X-rays and radiopharmaceuticals
Radiation Protection Law [5]
[Fig. 2] provides an overview of the new legal regulations regarding the scientific assessment
as well as the permission and licensing of the early detection of non-communicable
diseases. These legal regulations and the associated tasks and obligations of the
involved parties are discussed in greater detail in the following.
Fig. 2 Key elements of the new German radiation protection legislation concerning the early
detection of non-communicable diseases by radiodiagnostic examinations as well as
the parties involved.
Legal definition (§ 5 para. 16): Early detection refers to the application of X-rays
or radioactive substances in the context of medical exposure (see § 2 para. 8 no. 1)
for the examination of persons who do not exhibit any symptoms and have no concrete
suspicion of disease (asymptomatic persons) in order to detect a specific disease.
In contrast to the previous regulations under which exclusively serial X-ray examinations
(such as the German mammography screening program) were permitted, the above definition
also takes into account individual screening examinations and the use of radiopharmaceuticals
in accordance with the EU Directive.
Scientific evaluation by the Federal Office for Radiation Protection (§ 84 para. 3):
Radiodiagnostic examinations for the early detection of diseases must be evaluated
by the Federal Office for Radiation Protection (Bundesamt für Strahlenschutz, BfS).
In collaboration with experts from different disciplines, the risks and benefits of
the screening measures must be weighed. The details of the scientific evaluation are
defined in a general administrative regulation issued by the Federal Ministry for
the Environment, Nature Conservation and Nuclear Safety in consultation with the Federal
Ministry of Health (see below). The scientific evaluation of the BfS is to be published.
Permission granted by the Federal Ministry for the Environment, Nature Conservation
and Nuclear Safety (§ 84 paras. 1, 2 and 5): Screening examinations are only permissible
when explicitly stated in a federal statutory ordinance. Under consideration of the
scientific evaluation by the BfS, the statutory ordinance must define which type of
early detection is permissible for detecting a disease for a particular group of persons
and under which conditions. Only the permissibility of screening examinations in which
a scientifically recognized examination method can detect a serious disease at an
early stage in order to allow more effective treatment of affected persons may be
regulated. If the screening is part of a program, exceptions to the requirement to
carry out justification on an individual level according to § 83 para. 3 can be allowed
if the type and scope of inclusion criteria render unnecessary a decision about whether
and how the screening is to be applied. To date, only mammography has been approved
by the Breast Cancer Early Detection Ordinance [6].
Obligation to apply for a license (§ 12 para. 1 nos. 3 and 4 in conjunction with § 14
para. 3 and § 19 para. 2 no. 4; § 16; appendix 2, part B, no. 6 letter d): The use
of ionizing radiation or radioactive substances for the early detection of diseases
requires a license. To obtain a license, the radiation protection supervisor of a
practice or clinic has to submit an application to the relevant competent authority
on a regional level. The application must include all necessary information that allows
the authority to check whether the requirements of § 14 para. 3 have been met.
Licensing by the competent authority (§ 14 para. 3): A license for a practice according
to § 12 para. 1 nos. 3 and 4 in conjunction with early detection may only be granted
by the regional competent authority (i) when the considered screening measure is approved
on a generic level by a federal statutory ordinance according to § 84 para. 2 (§ 14
para. 3 no. 1) and (ii) when it is ensured that the requirements stated in this ordinance
that take into account the state-of-art of medical science will be met in order to
achieve the required quality with the lowest possible exposure (§ 14 para. 3 no. 2).
The last requirement ensures in particular the specification of provisions that relate,
for example, to the definition of the target group, the necessary qualifications of
the medical and technical personnel, implementation and evaluation of the examination,
diagnostic workup, as well as documentation and evaluation. The maximum term of the
license is five years in order to allow adjustments to the state of the art and updating
of measures needed for quality improvement.
Breach of law (§ 194 para. 1 no. 1 letter a, para. 2): Breach of law refers to an
act in opposition to a federal statutory ordinance based on § 84 para. 2 with intent
or negligence. This can be punished by a fine of up to 50 000 Euros if the federal
statutory ordinance refers to the provision concerning fines in the Radiation Protection
Law for a certain offense.
Fifth Book of the Social Code [7]
When the Radiation Protection Law came into force, a new regulation regarding a check
of the assumption of the cost of radiodiagnostic screening examinations by the statutory
health insurance funds was added under para. 4a in § 25 section 4 of the Fifth Book
of the Social Code “services for detecting health risks and the early detection of
diseases”. It stipulates that after a federal statutory ordinance according to § 84
para. 2 of the Radiation Protection Law permits a specific type of screening examination,
the Federal Joint Committee, the highest decision-making body of the joint self-government
in the German health care system, checks within 18 months whether the costs for this
examination are to be covered by the statutory health insurance funds in accordance
with § 25 para. 1 or 2 of the Fifth Book of the Social Code. Regardless of the decision
of the Federal Joint Committee, screening examinations permitted in accordance with
the Radiation Protection Law can be provided as individual health services.
General Administrative Regulation Regarding the Scientific Evaluation of Screening
Examinations [8]
The general administrative regulation, which is based on the power to issue statutory
instruments defined in § 84 para. 3 of the Radiation Protection Law and also came
into effect at the end of 2018, defines the methodology for the scientific evaluation
of radiodiagnostic screening techniques for the early detection of non-communicable
diseases by the BfS. It defines a two-stage process: a preliminary review and a detailed
scientific assessment. A multidisciplinary group of experts is involved in both stages.
The BfS immediately informs the Federal Joint Committee of the result of a positive
preliminary review – including the reason. Prior to conclusion of the scientific assessment,
the BfS also requests that the relevant professional and scientific entities as well
as patient organizations according to § 140 f of the Fifth Book of the Social Code,
provide written comments regarding the assessment. Health economics do not play a
role in the two stages. This aspect is first taken into consideration in the assessment
by the Federal Joint Committee.
Preliminary review: This first step, which is to be repeated on an event-driven basis
or at least annually, is used for the preselection of radiodiagnostic examinations
that fulfill the basic requirements for the early detection of diseases and thus qualify
for detailed assessment. The following requirements must be examined for plausibility:
-
The examination method is recognized according to the current state of medical science.
-
The goal of early detection is to detect a serious disease whose spontaneous course
typically leads to death or severe impairment of health.
-
The disease can be detected at an early stage.
-
An effective treatment is established and available at an early stage of the disease.
-
A target group can be clearly defined under consideration of risk factors.
-
The level of prevalence of the disease is sufficiently high.
If there are multiple screening measures that qualify for detailed assessment, the
BfS in coordination with the Federal Ministry for the Environment, Nature Conservation
and Nuclear Safety determines the order in which they will be processed. The currently
available scientific data is an essential criterion here.
Detailed assessment: In the second step, the following aspects are to be evaluated
and presented in detail:
-
Generic risk-benefit assessment. Benefits and adverse effects of a screening examination
are to be evaluated on the basis of a systematic literature search based on the standards
of evidence-based medicine. The risk assessment relates in particular to the extent
of false-positive or false-negative examination results, the extent of overdiagnosis
and overtreatment, and the invasiveness of the diagnostic workup. The radiation risk
associated with the examinations is to be assessed on the basis of established age-,
sex-, and organ-specific risk models.
-
Conditions and requirements. To ensure that the benefit outweighs the risks of radiodiagnostic
screening (see [Table 1]), the target group (inclusion and exclusion criteria), the training and continuing
education of personnel, the required equipment (imaging technology), performance of
the examination (frequency, time intervals, imaging protocol), reading (scheme, double
or reference reading, reading at certified centers), the type and scope of diagnostic
workup depending on the finding, documentation, and quality assurance (organizational,
technical, and medical aspects) must be defined.
Reassessment: At least every five years, the BfS checks screening examinations approved
according to § 84 para. 2 of the Radiation Protection Law to determine whether the
state of scientific knowledge has developed further and whether a reassessment or
an adjustment of the conditions and requirements is necessary.
Evaluation of service offers by radiology institutions using CT screening as an example
Evaluation of service offers by radiology institutions using CT screening as an example
Method
In February 2019, radiology institutions in Germany offering CT for the prevention
or early detection of diseases were identified via an Internet search. The search
was performed separately for the three diseases named above, namely lung cancer (alternatively:
lung or smoker check), colon cancer (virtual colonoscopy or colon check), and coronary
heart disease (cardiac or heart check). For each of these three radiodiagnostic tests,
50 relevant websites were analyzed by two persons familiar with the subject independently
of one another with respect to the aspects listed in [Table 2], [3], [4]. In the case of a discrepant evaluation regarding one of these aspects, the relevant
website was analyzed again together until a consensus was reached.
Table 2
Evaluation of the information provided on 50 websites of radiology institutions in
Germany regarding the advertised individual CT screening procedures for lung cancer.
The figures in the second column indicate the number of websites without details regarding
each aspect and the figures in parentheses in the third column indicate those with
details.
|
aspect
|
details on the website
|
|
no
|
yes
|
|
target group
|
|
|
|
|
39
|
older than 40 (3), 50 (2), or 55 (6) years.
|
|
|
|
|
|
smoker
|
2
|
mentioned in general terms (39); more than 10 (4) or 30 (4) pack years; ≥ 10 of smoking
history (1).
|
|
ex-smoker
|
41
|
mentioned in general terms (2); more than 10 (5) or 30 (2) pack years.
|
|
passive smoker
|
48
|
mentioned in general terms (2).
|
|
other noxae
|
44
|
asbestos (5) and/or other cancer-causing substances (3).[1]
|
|
benefits
|
21
|
general statement in terms of "earlier equals better" (13); explicit or implicit reference
to results of ELCAP [14]
[15], NLST [16] or NELSON study (14); benefit not yet definitively proven (1); reference to American
guidelines (1).
|
|
risks
|
48
|
detailed and clear representation (1); given a nonspecific finding, there is a risk
of unnecessary interventions in the case of non-standardized workup (1).
|
|
radiation exposure
|
26
|
trivial (9); plausible with 0.2–1.0 mSv or 1/5 of the average natural radiation exposure
per year (4); false (11).
|
|
examination
|
|
|
|
|
38
|
annually (8); biennially (1); regularly (3).
|
|
|
45
|
(regular) examinations over 10 (3) or 15 years (2) after smoking cessation.
|
|
|
28
|
without (20); possibly with (2).
|
|
|
37
|
necessary (13).
|
|
reading
|
|
|
|
|
50
|
–
|
|
|
49
|
by radiologist and computer-assisted detection (1).
|
|
diagnostic workup
|
42
|
in the case of a nonspecific finding, one or more CT follow-up examinations at intervals
of multiple months, biopsy possibly necessary (7); emphasis on quality-assured and
standardized workup (2).1
|
|
smoking cessation
|
44
|
necessity mentioned (5); CT screening as alternative to smoking cessation (1).
|
1 Multiple entries.
Table 3
Evaluation of the information provided on 50 websites of radiology institutions in
Germany regarding the advertised individual CT screening procedures for colon cancer.
The figures in the second column indicate the number of websites without details regarding
each aspect and the figures in parentheses in the third column indicate those with
details.
|
aspect
|
details on the website
|
|
no
|
yes
|
|
target group
|
|
|
|
|
33
|
older than 40 (3), 45 (5), 50 (6) or 55 (2) years; already at a young age (1).
|
|
|
31
|
family predisposition, unhealthy diet (including consumption of meat), excessive alcohol
consumption, obesity, inactivity (19).[1]
|
|
|
24
|
intestinal adhesions, diverticula, inflammation, surgeries, increased risk of bleeding
(26).1
|
|
|
39
|
refusal to undergo conventional colonoscopy (11).
|
|
benefits
|
19
|
general statement in the sense of "comparable with conventional colonoscopy" (13);
quantitative information regarding study results from [17] among others (16); reference to recommendations or guidelines (2).
|
|
risks
|
47
|
uncertainty in the case of growths < 5 mm (1), 5 % false-negative findings (1), unnecessary
conventional colonoscopy in the case of a false-positive finding (1).
|
|
radiation exposure
|
26
|
trivial (19); plausible with 2–8 mSv or 1 to 2 times the average natural radiation
exposure per year (5).
|
|
advantages over conventional colonoscopy
|
11
|
no endoscope, pain-free, no sedation, no risk of intestinal perforation, visualization
of the entire length of the colon, ability to evaluate deep wall layers and surrounding
organs (39).1
|
|
disadvantages over conventional colonoscopy
|
25
|
no polypectomy and/or taking of tissue samples (25), no visualization of inflammatory
processes (1), radiation exposure (1), subsequent conventional colonoscopy needed
in case of a relevant finding (20)[2]
|
|
examination
|
|
|
|
|
44
|
every five years (4); depending on the finding, every five years when normal (2).
|
|
|
11
|
necessary (39).
|
|
|
17
|
necessary (33).
|
|
|
31
|
prone position (1), supine and prone position (15), supine and possibly prone position
(3).
|
|
|
24
|
without (5); with (12); possibly with, administration usually with change of position
(8); contradictory information (1).
|
|
reading
|
|
|
|
|
23
|
recorded (27).
|
|
|
44
|
second opinion from expert if needed (4); by radiologist and computer-assisted detection
(2).
|
|
diagnostic workup
|
38
|
guaranteed since clinic or gastroenterology center (7); in cooperation with external
gastroenterologist (5). Additional information: conventional colonoscopy performed
if necessary on the same day without repeat bowel cleanse (3).
|
1 Usually a number of the specified points.
2 Multiple entries.
Table 4
Evaluation of the information provided on 50 websites of radiology institutions in
Germany regarding the advertised individual CT screening procedures for coronary artery
calcification and stenoses. The figures in the second column indicate the number of
websites without details regarding each aspect and the figures in parentheses in the
third column indicate those with details.
|
aspect
|
details on the website
|
|
no
|
yes
|
|
target group
|
|
|
|
|
38
|
men/women older than 40/40 (1), 40/50 (7), 40/55 (1), 45/45 (1), 45/55 (2).
|
|
|
9
|
high blood pressure, elevated blood lipid levels, diabetes, smoking, obesity, inactivity,
family predisposition, etc. (41).[1]
|
|
benefits
|
16
|
general statement that the calcium score correlates with the individual infarction
risk (27); reference to studies on the Agatston Score [including 18, 19] (4); reference
to recommendations or guidelines (3).
|
|
risks
|
49
|
unnecessary cardiac catheterization in the case of a false-positive finding (1).
|
|
radiation exposure
|
23
|
trivial (13); plausible with 0.3–1.0 mSv (5); comparable with or less than natural
radiation exposure per year (3); less than in the case of cardiac catheterization
(6); false comparison with chest X-ray (1).[2]
|
|
advantages compared to cardiac catheterization
|
8
|
noninvasive, pain-free, no risk of vascular rupture, no prolonged bed rest, lower
radiation exposure compared to cardiac catheterization (36); visualization of soft-tissue
changes in the vascular wall as well as of soft and mixed plaque (4); ability to assess
myocardium, cardiac chambers, and cardiac valves (2) and pulmonary vessels (2).1
|
|
disadvantages compared to cardiac catheterization
|
42
|
In the case of a finding requiring workup or treatment, cardiac catheterization is
usually necessary (8).
|
|
examination
|
|
|
|
|
50
|
–
|
|
|
1
|
calcium scoring (45), contrast-enhanced coronary angiography (43).2
|
|
|
36
|
performed (12), recommended (1), additionally offered (1).
|
|
|
34
|
required, if pulse too high (16).
|
|
reading
|
|
|
|
|
49
|
recorded (1).
|
|
|
45
|
in every case (1), second reading if necessary (4).
|
|
diagnostic workup
|
27
|
in cooperation with internal (19) or external (4) cardiologists/internists.
|
1 Usually a number of the specified points.
2 Multiple entries.
3 If both calcium scoring and coronary angiography were offered on a website, it was
often not clear whether these are alternative examinations or whether both examinations
are performed and if yes in which cases.
Results
General aspects
Of the 150 analyzed websites, 110 belonged to practices, 18 to medical centers (some
with multiple locations) and 22 to clinics or groups of clinics. Although the Internet
search was preformed separately for the three analyzed screening examinations, 17 institutions
appeared in two samples and 13 even appeared in all three samples which confirms the
general impression that some institutions offer a broad spectrum of radiological screening
examinations. Only one website stated that “as of the end of 2018, examinations can
only be performed in the case of a concrete indication, i. e., in the case of suspicion
of a disease”. On all other sites, there was not even a hint of the lack of legal
conformity of the offered screening examinations. On the other hand, 94 websites provided
information stating that costs are typically reimbursed by private but not by statutory
health insurances. In the latter case, the services were therefore offered as individual
health services, in some cases at “reduced fixed prices”. The key terms used to communicate
with and facilitate the understanding of test participants, i. e., prevention, early
detection, and preventive care, were used largely synonymously.
The CT equipment used for screening was very heterogeneous according to the concrete
information on 106 websites – ranging from older 6-row systems to well-equipped (dual-source)
systems of the latest generation, which allow high-quality and dose-saving imaging
of moving organs, particularly the heart, due to the very short scan times.
Examination-specific aspects
The results of the Internet search are listed separately for the three analyzed early
detection measures in [Table 2], [3], [4]. The general findings are summarized in the following.
Data regarding the age of the target persons was provided only on 40 websites and
deviated significantly for the same screening examination. The discrepancy between
the age data for virtual colonoscopy and the exisiting age specification for early
detection via conventional colonoscopy is notable here. Information on risk factors
showed an inconsistent picture: it was either concrete but discrepant (e. g. pack
years of (ex-) smokers in lung cancer screening) or so general (colon and heart) that
it applied to the majority of persons in the considered age group and thus was not
suitable for useful preselection of test candidates to increase the pretest probability.
The benefit of early detection with CT was mostly described as “early equals better”
or “comparable with...” if mentioned at all. Concrete results of high-quality studies
were provided only on relatively few websites. The risk of false-negative or false-positive
findings as well as of overdiagnosis and overtreatment was also rarely addressed.
On the whole, the data on radiation exposure was also inadequate. If this aspect was
mentioned at all, statements were often limited to general and trivial information
(e. g. low-dose CT, dose today lower than before); concrete dose values were provided
on only a small number of websites. The values specified on the websites (and summarized
in [Table 2], [3], [4]) always related to a single examination and not to the cumulative dose over a typical
screening period of several years. The comparisons used to rate radiation exposure
(natural radiation exposure, annual limits for occupationally exposed persons, exposure
during air travel, chest X-ray, etc.) were grossly incorrect in some cases. Data regarding
the radiation risk was not provided on any website.
The advantages of CT for the early detection of colon cancer compared to conventional
colonoscopy and of CT examination of the cardiac vessels compared to cardiac catheterization
were described in detail on 39 and 42 websites, respectively. In contrast, the disadvantages
of these screening examinations, particularly the necessity for conventional colonoscopy
or heart catheterization in the case of a screening finding requiring further workup
or treatment, were only briefly mentioned on 25 and 8 websites, respectively.
It is especially surprising that there was no standardized procedure among service
providers even regarding the performance of the individual examinations. In the case
of virtual colonoscopy, the differences related, for example, to the positioning of
the person to be examined, the number of CT series, and the necessity for the administration
of contrast agent. For the examination of the coronary vessels, both calcium scoring
and coronary angiography were usually offered but often without more detailed information
as to whether these were alternative or supplementary examinations and according to
the criteria used to define the examination protocol in the individual case.
The handling of incidental findings outside the target organ is both ethically and
legally sensitive. Therefore, whether the participant would like to be informed of
such findings should be defined in writing during the informed consent discussion
[9]. Diagnostic assessment of incidental findings was mentioned on 28 of the analyzed
websites but as a fact and not as a process to be defined in a common dialog. Preliminary
information regarding the possible need for diagnostic workup depending on the concrete
screening finding, particularly regarding the type and invasiveness of these measures,
the obtaining of a second opinion, and the cooperation with other disciplines during
the workup was provided on distinctly less than half of the websites. The necessity
for a standardized and quality-assured diagnostic workup at certified centers, particularly
in lung cancer screening, was highlighted on only two websites.
In total, only a few websites provided comprehensive, valid and well-balanced information
regarding most, but unfortunately not all, relevant aspects of the particular screening
procedure.
Discussion
The new German Radiation Protection Law made it possible to use both X-ray and nuclear
medicine imaging techniques for individual screening. However, this requires a generic
permission for every type of radiodiagnostic screening examination by a federal statutory
ordinance defining the relevant requirements and conditions. The BfS in cooperation
with an expert group performs a comprehensive scientific evaluation as the basis for
this. In the preliminary review performed for the first time at the beginning of 2019
according to the specifications of the general administrative regulation, it was decided
in consensus between the BfS and the expert group as well as in coordination with
the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety to
prioritize a detailed evaluation of low-dose CT for the early detection of lung cancer
in smokers due to the availability of several studies of the highest evidence level
[10]. At present, however, none of the three CT screening examinations discussed in this
study and offered by numerous practices and clinics are approved on a generic level.
It is therefore illegal to perform them.
An exception from the necessity to carry out justification on the individual level
by a competent radiological practitioner according to § 83 para. 3 in conjunction
with § 2 para. 8 no. 1 of the Radiation Protection Law is only provided under the
conditions mentioned above, i. e., when screening examinations are performed as part
of a program. In contrast, a justification on the individual level must always be
carried out while satisfying the requirements and conditions of the federal statutory
ordinance in the case of individual screening examinations outside of a program. However,
the justifying process does not replace the lack of a permission. Moreover, it must
be taken into consideration that the formal necessity for carrying out the justifying
process on the individual level has no impact on the question whether the examination
is for the purpose of medical care or early detection. The answer to this question
is based solely on the health status of the person to be examined: the first case
refers to a person with disease symptoms while the latter case refers to an asymptomatic
person with a certain risk profile. To ensure a clear delineation between these two
categories of persons (e. g. in the case of a gradual transition of a score or laboratory
value used to assess the pretest probability from the risk to disease range), the
risk profile of screening participants is to be defined as concretely and with as
much detail as possible by the inclusion and exclusion criteria specified in the federal
statutory ordinance and is then to be individually verified as part of the justifying
process.
Since screening is not an urgent measure in the care of a specific individual and
is also associated with an individual benefit for only a small portion of participants,
there are particularly extensive requirements regarding the provision of information
and informed consent in the course of participative decision-making. A potential participant
can only make an informed decision if notified in a comprehensive, neutral, and professional
manner of the benefits and risks of radiodiagnostic screening, including any alternatives
and possible negative consequences ([Table 1]). The information in this regard provided on the evaluated websites was inadequate
in the broad majority of cases. In fact, some websites even included irrelevant, suggestive
and advertising statements (see info box). Apart from the fact that the offered CT
screening examinations are currently not approved on a generic level, there is a concern
that these problems are also not addressed in a personal consultation and that the
special features of early detection compared to conventional diagnostics in medical
care are not sufficiently reflected by service providers. The documented lack of information
has been confirmed by the results of a current representative survey among statutory
health insurance patients regarding screening measures [11]. According to survey participants, the information needed to make an informed decision
was not sufficiently provided by the doctors and the benefits were overemphasized
compared to the risks. It may play a role here that physicians “as providers of individual
health services” are “biased” [12].
However, the inadequacies shown here are not limited to the information provided to
potential test participants but also relate to the procedure itself. As [Table 2], [3], [4] show, the details regarding the age and risk factors of target persons, number and
timing of tests, performing of the examinations, and diagnostic workup differ among
service providers – if even provided. Thus there are inevitably deviations from the
protocols and inclusion criteria used in the published high-quality studies so that
benefit-risk assessments derived from these studies cannot be used as evidence of
the benefit of different institution-specific protocols [13].
Detailed information regarding the evaluated aspects of the three CT screening examinations
was usually available only on some of the 50 websites analyzed for each type of examination
so that the relative frequency of the diverging information on individual aspects
may not necessarily be representative for the total number of examinations performed
in Germany due to the low number of cases. However, the considerable and scientifically
unjustifiable discrepancy in central aspects is indisputable. Our Internet evaluation
thus clearly demonstrates the need to define standardized and binding regulations
in the form of federal statutory ordinances in order to ensure the benefit and quality
of radiological screening examinations as well as informed decision-making by potential
test participants. Binding requirements regarding the systematic evaluation of the
structure, process and outcome quality of screening measures are particularly important
here.
Examples of irrelevant, suggestive or advertising statements regarding CT screening
of diseases on the evaluated websites of radiology institutions. The quotes take into
account the tenor of the respective website.
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Preventive medical check-ups – individual health services: Color 3 D images allow
us to take a virtual journey through your body – your colon, heart, vascular system,
and lungs – and to look closely at every nook and cranny without you having to endure
unpleasant or painful interventions.
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A preventive care examination ... confirms your state of health independent of your
family doctor and allows you to get early treatment if needed. Good reason to receive
comprehensive preventive care!
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Examinations are allowed to be performed even if they are not covered by your health
insurance.
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Not just smokers want to rule out lung cancer.
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Get proactive and do something good for your health: Overview of our preventive care
services: ...Years of cigarette consumption increase your risk both for cancer and
heart attack. That's why we offer a heart-lung check in combination.
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People who are healthy go to the doctor to stay healthy. ...Prevent your risk for
lung cancer. ...An investment in your health is an investment worth making. ...Responsible
citizens should make their own decision about the benefit of this preventive care
service for their personal situation, possibly in coordination with their doctor.
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Avoid primary risk factors, particularly smoking, or at least take advantage of the
benefits of modern diagnostic imaging for preventive care.
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Choosing CT-guided virtual colonoscopy instead of conventional colonoscopy will provide
you with a comfortable and risk-free alternative with comparable diagnostic reliability.
CT-guided diagnostic imaging produces precise images of the intestinal wall and mucosa
that allow us to identify findings requiring treatment at the earliest stage.
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CT-guided virtual colonoscopy = gentle comprehensive preventive care – comfortable
and risk-free. ...CT colonoscopy is the state-of-the-art technique for examining the
colon. It combines gentle preparation with a pleasant and quick procedure.
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Particularly when your lifestyle is not one hundred percent "healthy", it is highly
recommended to have your personal risk clarified in a timely manner.
