Analysing the question shows that the main issue is in “organised population” screening (see PICO question). This implies the responsibility of the healthcare system (authority) for a recommendation. In most settings the “standard mode of care” means AAAs are found by accident or at a symptomatic stage. Healthcare providers may counsel individuals at high risk but there is no strong guidance and therefore high variability can be assumed.

• Respect for autonomy: the standard mode of care as well as organised population screening meets this criterion.
• Non-maleficence: the standard mode of care as well as an organised population screening meets this criterion. In an organised programme quality assurance and outcome evaluation should provide a higher degree of fulfilment. The organised programme with a definition of those eligible for screening reduces “waste of resources” for those at low risk. It could harm people outside the target group by reducing access to this preventive care intervention.
• Beneficence: balancing risks and cost with potential benefits can only be done at the national or local level (information on cost is national or local). To balance risks and potential benefits without regard to costs, the first step is to decide whether to look at the risks of ultrasound alone or – in the case of a positive finding – to consider the risks and decision problems of the subsequent chain of diagnostics and potential interventions. This will be done in the domain summary.
• Justice: looking at the healthcare system as an SSGI the dimension of justice gets a low value in the standard mode of care. Organised screening dramatically increases the value of the justice domain.

The AAA screening survey (see current use domain) shows that only Sweden provides organised AAA screening programme. Lithuania describes the situation as an opportunistic one. The description resembles the answer of Spain. In CUR7 the UK NHS is cited as having an organised screening tool. In most countries organised population-based screening would be a new proposal.

Ultrasound examinations of the abdomen are well established in all healthcare systems. The new items therefore would be the

• recommendation (and information) by the “health authority”
• definition of the target group (with an invitation system)
• evaluation of quality and outcome

As proposed in the section on quality assessment tools and criteria for this question a score using the four ethical dimensions should be collected.

The general approach on the EU level has to be put into operation at the local level. This could be done using an interactive participatory approach to HTA.

• Respect for autonomy: the standard mode of care as well as organised population screening meets this criterion.
• Non-maleficence: the standard mode of care as well as organised population screening meets this criterion. In an organised programme quality assurance and outcome evaluation should provide a higher degree of fulfilment. The organised programme with a definition of those eligible for screening reduces “waste of resources” for those at low risk. It could harm people outside the target group by reducing access to this preventive care intervention.
• Beneficence: balancing risks and cost with potential benefits can only be done at the local level (information on cost is local). To balance risks and potential benefits without regard to costs, the first step is to decide, whether to look at the risks of ultrasound alone or – in the case of a positive finding – to consider the risks and decision problems of the subsequent chain of diagnostics and potential interventions. This will be done in the domain summary.
• Justice: Looking at the healthcare system as a SSGI the dimension of justice gets a low value in the standard mode of care. Organised screening dramatically increases the value of the justice domain.

The main challenge in this question is finding a “threshold” of incidence or prevalence for screening in general and for gender-specific screening in particular.

• Respect for autonomy: organised population screening does not threaten autonomy.
• Non-maleficence: organised population screening meets this criterion. The organised programme with a definition of those eligible for screening reduces “waste of resources” for those at low risk. It could harm people outside the target group by reducing access to this preventive care intervention. This problem is particularly relevant if eligibility is linked to gender. Is the difference in incidence high enough to exclude women from this type of screening?
• Beneficence: balancing risks and cost with potential benefits can only be done at the local level (information on cost is local). To balance of risks and potential benefits without regard to costs, the first step is to decide whether to look at the risks of ultrasound alone or – in the case of a positive finding – to consider the risks and decision problems of the following chain of diagnostics and potential interventions. Gender differences in the overall pattern of diseases and differences in life expectancy are important.
• Justice: Excluding women from screening needs a strong argumentation.

The main problem is whether gender is a suitable criterion for determining eligibility for screening. This judgment should be based on results from the effectiveness and safety domain.

Judgement has to be used with regard to national/local epidemiology.

• • Respect for autonomy: organised population screening does not threaten autonomy. It addresses everyone in the same way using the invitation system. Depending on the framework and site of service provision, accessibility may differ for different patient groups – such as those in rural areas and provision in hospitals. In this question, the rights of healthcare providers to perform services (workload and income) should also be considered.
  • Non-maleficence: organised population screening addresses everyone in the same way using the invitation system.
  • Beneficence: balancing risks and costs with potential benefits can only be done at the local level (information on cost is local). The influence of the regional infrastructure for service provision, in particular, is a key determinant. The framework of the healthcare system should provide the arguments for the organisational decisions.
  • Justice: In this question the domain of justice not only addresses the people eligible for AAA screening but also the service providers. Allocating the service provision to general practice, hospitals or specialised units for ultrasound examinations involves decisions about quality, workload and income.

In general organised population screening should address all those eligible for the procedure equally. But the organisation and allocation of the service provision influences the accessibility and inflicts consequences on healthcare providers. So the framework of the healthcare system, geographical reality and the current state of infrastructure are highly important. Decisions can only be taken on a local level.

For each medical intervention informed consent is necessary. The common quality framework for SSGIs shows the responsibilities of a public authority in this context. So the information materials needed for informed consent should be provided by this authority. They should not only cover information on the ultrasound test but also on subsequent management in case of a positive finding. It should thus be possible to reach an informed decision about the test and about the subsequent management. This includes all activities in the field of quality management and evaluation – with a special focus on data use (data protection rights).

• Respect for autonomy: organised population screening does not threaten autonomy. The issuer of the recommendation has the responsibility to inform potential participants as comprehensively and extensively as possible
• Non-maleficence: information should include the following management and aspects of data use
• Beneficence: balancing risks and cost with potential benefits can only be done at the local level (information on cost is local). Organisational aspects are important
• Justice: In this question the domain of justice addresses not only the test procedure but also organisational aspects especially in evaluation

The information provided should be as comprehensive and as extensive as possible. The (political) accountability in the field of SSGIs, data protection issues and the local cultural background have the most impact. See SOC5 with regard to positive or negative emotional reactions of screening subjects. Due to differences in local cultural background it can be expected that these reactions will differ.

As already stated the organisational decisions accompanying the implementation of an AAA screening have an impact on the healthcare professionals at least on their workload and income

• Respect for autonomy: organised population screening reduces the autonomy of the individual healthcare professional. The performance of the service provision is standardised and monitored.
• Non-maleficence: standardisation is sometimes seen as destruction of the professional “art”. This was discussed during the scoping. The acceptance of standardisation varies due to cultural differences. Decisions about allocation of services have an impact on income or workload.
• Beneficence: balancing risks and cost with potential benefits can only be done at the local level (information on cost and organisational issues is local). Organisational aspects are important. Screening may bring additional money to the system.
• Justice: In this question the domain of justice addresses the political interests of the healthcare providers. The impact on different groups of providers depends on the type of organisational decision.

As professional autonomy is reduced by standardisation of  organised screening programme, and decisions about the type of organisation have an impact on workload and income, the acceptability of such a programme from the viewpoint of the healthcare providers will depend on the local setting. Early involvement and balancing pros and cons of different organisational settings are important. The interactive, participatory HTA approach (iHTA – see Ethical methodology 100906) should attach considerable weight to the opinions of the experts and the healthcare provider.

Human integrity has to be considered in any “public” intervention. In a healthcare system based on “solidarity” it is expressed in the root documents cited to define the principles of these ethical considerations that some responsibilities are allocated at the system level. Typically they address questions that individuals are not able to answer. This can derive from a different view on discounting the future, the broad public health perspective necessary or the access to data and methods for informing decision making. Just as in medicine where guidelines summarise the clinical evidence because individual medical doctors cannot read one billion publications a year (the expected number of entries in PubMed in 2012), public health policy, with democratic legitimacy, summarises the evidence and the preferences of their population.

So questions of democratic legitimacy and citizen or patient involvement in policy decisions have to be considered. The nine principles of the common quality framework for SSGIs should be followed.

Nevertheless the integrity or freedom of the healthcare professionals is reduced by standardisation of an organised screening programme. The definition of a screening programme, the data acquisition, the quality assurance, monitoring and evaluation challenge professional values and opinions.

• Respect for autonomy: organised population screening is an intervention recommended by “the public” and therefore reduces the autonomy of the individual healthcare professional. The performance of the service provision is standardised and monitored. The autonomy of the individual citizen in cases where a recommendation is made is not at stake.
• Non-maleficence: standardisation is sometimes seen as destruction of the professional “art”. In a pluralistic society a total consensus cannot be achieved. Decisions supported by majorities have to consider the right to abstain for minorities.
• Beneficence: balancing risks and cost with potential benefits can only be done at the local level (information on cost and organisational issues is local). On a societal level organised programmes secure access.
• Justice: In this question the domain of justice addresses the political interests of the healthcare providers. The impact on different groups of providers depends on the type of organisational decision. Organised programmes have the potential to reduce the gaps in access to care caused by lack of education and information.

The integrity of screening subjects is respected as there is no obligation to participate. But by standardisation of healthcare provision the integrity of healthcare providers can be reduced. In a healthcare system based on solidarity a restriction, for the healthcare providers, in their ability to live according their moral convictions, preferences or commitments is to some extent justified. The rules of SSGI should be followed and an inclusive discussion to gain broad acceptance and democratic legitimacy is necessary.

In organised screening the final decision about participation remains at the individual level. The healthcare system and the care provider are responsible only for the best possible information to permit informed decision making or informed consent.

• Respect for autonomy: organised population screening is recommended and provides information to support decision making on the individual level.
• Non-maleficence: effects on other aspects of the healthcare system are important. Sustainability and resource use, in particular, may influence decisions at the system level.
• Beneficence: balancing risks and cost with potential benefits can only be done at the local level (information on cost and organisational issues is local). A societal perspective – looking beyond the healthcare system perspective – is recommended.
• Justice: In this question, the domain of justice requires objective information to compare the different possible ways of investing public money.

The main challenge of (most) political decisions in healthcare is the conflicting goals and values not only in different policy areas but also on different levels within the system. In a pluralistic society such conflicts are normal. Usually the level of clinical medicine “belongs”  to the patient and the clinician. The level of the health system is the domain of “organisations” – the stakeholders (providers, payers, patient groups, industry and so on). The last level deals with the balance of interests between political fields such as education, the labour market, others... and health. It may be attributable to the fact that the issue of AAA screening is a multi-level, multi-stakeholder and diverse interest dilemma. The international dimension should also be taken into account – particularly the previously mentioned open method of coordination of the EU.

So the balancing of the benefits and harms can be done only at the local level because local current use has to be taken into account. The open method of coordination aims to harmonise  healthcare and public health priorities on the EU level.

In this question the dimension of justice is highlighted. So a summary of the previous findings is necessary.

Justice:

• ETH1: Looking at the healthcare system as an SSGI the dimension of justice is given a low value in the standard mode of care. Organised screening dramatically increases the value of the justice domain.
• ETH2: Excluding women from screening needs a strong argument.
• ETH3: In this question the domain of justice not only addresses the people eligible for AAA screening but also the service providers. Allocating the service provision to general practice, hospitals or specialised units for ultrasound examinations involves decisions about quality, workload and income.
• ETH4: In this question the domain of justice not only addresses the test procedure but also organisational aspects especially in evaluation
• ETH5: In this question the domain of justice addresses political interest of the healthcare providers. The impact on different groups of providers depends on the type of organisational decision.
• ETH6: In this question the domain of justice addresses the political interests of the healthcare providers. The impact on different groups of providers depends on the type of organisational decision. Organised programmes are able to reduce the gaps in access to care caused by lack of education and information.
• ETH7: In this question the domain of justice requires objective information to compare different possibilities of investing public money.

Justice addresses restriction to access for citizens by gender or other characteristics, the healthcare system as an SSGI, organisational aspects for providers, evaluation for citizens (data protection), and objective information needed both for informed consent (clinical level) and for system decisions (political level). At the moment a clear rule for prioritising screening procedures is not available, so decisions will follow national or local priorities and values.

The best possible and most objective information to permit informed decision making or informed consent is needed, not only with regard to the ultrasound test but also, in cases where there is a positive test, about the subsequent pathway of care. Information on the subsequent steps should provide both an overview and in depth information on demand.

• Respect for autonomy: organised population screening is a recommendation and provides information to support decision making on the individual level. Endpoints relevant for participants – their preferences and their fears – should be taken from qualitative surveys.
• Non-maleficence: comprehensive information is needed to ameliorate the reduction in quality of life in cases of positive test results.
• Beneficence: balancing risks and cost with potential benefits can only be done at the local level (information on cost and organisational issues is local). A societal perspective – looking beyond the healthcare system perspective – is recommended. The fears and preferences of citizens guide this balancing.
• Justice: In this question the domain of justice addresses mainly the question of citizen involvement in the decision-making process. Expert opinion is also needed, but the leading role stays with patients and citizens.

The result card A0009 “What aspects of the burden of disease are affected by AAA screening?” presents an overview of outcome measures found in the literature. It was not addressed whether these outcomes were chosen by experts or with patient involvement. This should be clarified.

The general approach on the EU level has to be put into operation at the local level. This could be done using an interactive participatory approach to HTA.

• Respect for autonomy: organised population screening is a recommendation and provides information to support decision making on the individual level. Endpoints relevant for participants – their preferences and their fears – should be taken from qualitative surveys.
• Non-maleficence: comprehensive information is needed to ameliorate the reduction in quality of life in cases of positive test results.
• Beneficence: balancing risks and cost with potential benefits can only be done at the local level (information on cost and organisational issues is local). A societal perspective – looking beyond the healthcare system perspective – is recommended. The fears and preferences of citizens are the guidance for this balancing.
• Justice: In this question the domain of justice addresses mainly the question of citizen involvement in the decision process. Expert opinion is also needed, but the leading role stays with patients and citizens.

At the moment a clear rule for prioritising screening procedures is not available. The decision process is mainly driven by scientific organisations of care providers. This expert opinion is based (hopefully) on clinical studies, clinical experience and a broad knowledge of the natural course of the disease. The definition of cut-off values for tests should be based on scientific evidence.

• Respect for autonomy: organised population screening is a recommendation and provides information to support decision making on the individual level. As well as the potential benefits and harms, the uncertainty associated with tests and prognoses also have to be addressed.
• Non-maleficence: comprehensive information is needed to deal with uncertainty.
• Beneficence: balancing risks and cost with potential benefits can only be done at the local level (information on cost and organisational issues is local). Uncertainty is part of every prognosis. So it must be stated that “more is not automatically better” and that is a key point when balancing different scales.
• Justice: In this question the domain of justice addresses potential restrictions deriving from the setting of cut-offs. Accuracy measures determine inclusion or exclusion of individuals or in a rule for prioritizing screening methods for healthy individuals according to age and /or gender need a clear rational.

Decisions about cut-off values need a valid scientific basis. The uncertainty associated with all decisions and prognoses has to be communicated. The degree of uncertainty acceptable in a healthcare system should be made explicit and is the subject of a value judgement.

The general approach on the EU level has to be put into operation at the local level. This could be done using an interactive participatory approach to HTA.

• Respect for autonomy: organised population screening is a recommendation and provides information to support decision making on the individual level. As well as potential benefits and harms, the uncertainty associated with tests and prognoses also have to be addressed.
• Non-maleficence: comprehensive information is needed to deal with uncertainty.
• Beneficence: balancing risks and cost with potential benefits can only be done at the local level (information on cost and organisational issues is local). Uncertainty is part of every prognosis. So it must be stated that “more is not automatically better “and that is a key point when balancing different scales.
• Justice: In this question the domain of justice addresses potential restrictions deriving from the setting of cut-offs. Accuracy measures determine inclusion or exclusion of individuals or in a rule for prioritizing screening methods for groups.