Disclaimer
This information collection is a core HTA, i.e. an extensive analysis of one or more health technologies using all nine domains of the HTA Core Model. The core HTA is intended to be used as an information base for local (e.g. national or regional) HTAs.

Abdominal Aorta Aneurysm Screening

AAA Screening compared to not doing anything in the screening of Abdominal Aorta Aneurysm (AAA) in elderly at moderate risk of developing AAA

(See detailed scope below)

HTA Core Model Application for Screening Technologies 1.0
Core HTA
Published
Tom Jefferson (age.na.s, Italy), Nicola Vicari (age.na.s, Italy), Katrine Bjørnebek Frønsdal (NOKC, Norway)
Claudia Wild, LBI-HTA (Health problem and current use); Daniela Pertl and Sophie Brunner-Ziegler, GÖG (Description and technical characteristics); Iñaki Imaz, ISCIII-AETS (Safety); Katrine Frønsdal and Ingvil Sæterdal, NOKC (Clinical effectiveness), Suvi Mäklin and Taru Haula, THL-FINOHTA (Costs and economic evaluation); Gottfried Endel, HVB (Ethical analysis); Kristi Liiv and Raul Kiivet, UTA (Organisational aspects); Anne Lee, Lotte Groth Jensen and Claus Loevschall, SDU/CAST (Social aspects); Ingrid Wilbacher, HVB (Legal aspects)
Agenzia nationale per i servizi sanitari regionali (age.na.s), Italy
Central Denmark (Denmark), GÖG (Austria), HVB (Austria), ISCIII – AETS (Spain), LBI-HTA (Austria), NOKC (Norway), SDU/CAST (Denmark), THL - FINOHTA (Finland), UTA (Estonia)
4.5.2011 15.16.00
31.1.2013 18.04.00
Jefferson T, Vicari N, Frønsdal K [eds.]. Abdominal Aorta Aneurysm Screening [Core HTA], Agenzia nationale per i servizi sanitari regionali (age.na.s), Italy; 2013. [cited 30 June 2022]. Available from: http://corehta.info/ViewCover.aspx?id=106

Abdominal Aorta Aneurysm Screening

<< Costs and economic evaluationOrganisational aspects >>

Ethical analysis

Authors: Gottfried Endel

Summary

On the European level there are statements of general values for the healthcare system. Taking these values as general principles an ethical analysis using principlism as its method can form a transferable core of information.

The local context is most important and so the first question relates to the question of usual care as information was collected by the CUR Domain. The dimension of change needed has to be evaluated. Other transferable questions are about endpoints and accuracy. These are prerequisites for balancing benefits and harms and resources used.

In most cases local values and opinions representing national/local cultural differences have to be applied. Stakeholders should be involved according to the local framework using the interactive, participatory health technology assessment (iHTA) approach in a transparent manner.

Introduction

Questions addressing (population) screening activities need a special approach in ethical analysis. The framework is different from that of usual treatment interventions:

  • The healthcare system recommends an intervention. So it is a system responsibility to provide the information needed for informed consent to participate. The best available evidence and open information about uncertainty should be made available.
  • The intervention addresses asymptomatic or “healthy” people. So issues of safety, quality and harm reduction have first priority. This influences the approach to a risk–benefit balance.
  • As it is a recommendation for the healthcare system the quality of the service provision should be monitored and the results evaluated. Results should be published and data made available.
  • The use of public resources needs special legitimisation (a clear rationale) and proof of evidence.

There is no information in the medical literature about the differences between healthcare systems and their impact on decision making.

The challenge in a core health technology assessment (HTA) is to be specific on a European level but to allow for the differences in the way that healthcare is organised in different member states, to outline the questions and principles addressed so that they can be applied at the local level.

Screening for abdominal aortic aneurysm is a topic discussed worldwide. The discussion and the need for assessment have increased priority because of the ageing population, the development of treatment possibilities and, at least in the developed countries, the availability of infrastructure for screening and treatment.

Methodology

Frame

A modified collection scope is used in this domain.

TechnologyAAA Screening
Description

Population-based systematic abdominal aortic aneurysm (AAA)screening. This includes one single invitation for the whole target population to do one ultrasound scan examination. Purpose of use: Detect abdominal aortic aneurysm in unruptured phase in order to treat those aneurysms with high risk of rupture.

Intended use of the technologyScreening

Screening programme for abdominal aortic aneurysm

Target condition
Abdominal Aorta Aneurysm (AAA)
Target condition description

All men and women aged 64 or more

Target population

Target population sex: Any. Target population age: elderly. Target population group: Possible future health condition.

Target population description

All men and women aged 64 or more

For: All men and women aged 64 or more.

There is some international variance in the prevalence of AAA. In the western countries the prevalence varies between 5 to 10 % for the 65 – 74 years old men.

In Japan the prevalence is 1 % for the same group of men. The prevalence increases with age.

In England the prevalence is 2 % for men aged 50 – 64 year and 12 % for men aged 80 years or older.

In Denmark the prevalence is 4 % for men aged 65 – 69 and 6 % for men aged 70 – 74 years old. The prevalence for women is significant lower than the prevalence for men.

Comparisonnot doing anything
Description

No population-based AAA screening.

This includes incidental detection of AAA without age or sex limitation while performing abdominal ultrasound examinations due to other/unclear clinical indications and various opportunistic AAA-screening practices

More information

From an ethical point of view the values for deciding about screening technologies have to be clear. An decision analytic framework to decide according to this values has to be in place

(Moved from old outcomes field:) Patient level outcomes are Life years gained, quality of live - reduction due to knowledge about illness without symptoms! -, resource use in this specific indication of screening and depletion of resoruces from other screening oportunities.

Assessment elements

TopicIssue RelevantResearch questions or rationale for irrelevance
F0001Principal questions about the ethical aspects of technologyIs the technology a new, innovative mode of care, an add-on to or modification of a standard mode of care or a replacement of a standard?yesIs organised Abdominal Aorta Aneurysm Screening a new, innovative mode of care, an add-on to or modification of a standard mode of care or a replacement of a standard?
F0002Principal questions about the ethical aspects of technologyCan the technology challenge religious, cultural or moral convictions or beliefs of some groups or change current social arrangements?yesCan Abdominal Aorta Aneurysm Screening challenge cultural or moral convictions or beliefs of some groups or change current social arrangements - especially gender related definition of the screening group?
F0003Principal questions about the ethical aspects of technologyWhat can be the hidden or unintended consequences of the technology and its applications for different stakeholders.nohidden or unintended consequences can only be considered on the local level. A general answer is not possible
F0005AutonomyIs the technology used for patients/people that are especially vulnerable?yesIs Abdominal Aorta Aneurysm Screening used for people that are especially vulnerable - consider carefully the inclusion or exclusion criteria in an recommendation?
F0006AutonomyCan the technology entail special challenges/risk that the patient/person needs to be informed of?yesCan Abdominal Aorta Aneurysm Screening entail special challenges/risk that the patient/person needs to be informed of?
F0007AutonomyDoes the implementation challenge or change professional values, ethics or traditional roles?yesDoes the implementation challenge or change professional values, ethics or traditional roles?
F0004AutonomyDoes the implementation or use of the technology challenge patient autonomy?noOrganised screening programs may put some pressure on people but usually the decisions and recommendations are transparent and there is no obligation to participate.
F0009Human integrityDoes the implementation or use of the technology affect human integrity?yesDoes the implementation or use of a systematic Abdominal Aorta Aneurysm Screening affect human integrity?
F0010Beneficence/nonmaleficenceWhat are the benefits and harms for patients, and what is the balance between the benefits and harms when implementing and when not implementing the technology? Who will balance the risks and benefits in practice and how?yesWhat are the benefits and harms for participants of the screening, and what is the balance between the benefits and harms when implementing and when not implementing Abdominal Aorta Aneurysm Screening ? Who will balance the risks and benefits in practice and how?
F0011Beneficence/nonmaleficenceCan the technology harm any other stakeholders? What are the potential benefits and harms for other stakeholders, what is the balance between them? Who will balance the risks and benefits in practice and how?noScreening usually does not influence other stakeholders. Ingeneral screening is financed from a different budget - not the budget for helth care provision (at least in Austria). So it is not a question of resources used and then missing for other fields of care.
F0012Justice and EquityWhat are the consequences of implementing / not implementing the technology on justice in the health care system? Are principles of fairness, justness and solidarity respected?yesWhat are the consequences of implementing / not implementing Abdominal Aorta Aneurysm Screening on justice in the health care system? Are principles of fairness, justness and solidarity respected? Is there a clear rule for prioriticing screening procedures?
F0013Justice and EquityHow are technologies presenting with relevantly similar (ethical) problems treated in health care system?noJustice already adresses the priorisation of screening procedures. So no additional technology has to be looked at.
F0017Questions about effectiveness and accuracyWhat are the proper end-points for assessment and how should they be investigated?yesWhat are the proper end-points for assessment and how should they be investigated?
F0018Questions about effectiveness and accuracyAre the accuracy measures decided and balanced on a transparent and acceptable way?yesAre the accuracy measures decided and balanced on a transparent and acceptable way?
F0008Human DignityDoes the implementation or use of the technology affect human dignity?noThe only aspect is the definition of the screening population. It is already adressed in other issues.
F0014RightsDoes the implementation or use of the technology affect the realisation of basic human rights?noScreening is not mandatory so no basic human right is affected.
F0016LegislationIs legislation and regulation to use the technology fair and adequate?yes

Methodology description

First the basic values applicable in a core HTA must be described.

The Treaty of Lisbon is the basic contract of the European Union (EU). The document FXAC07306ENC (http://bookshop.europa.eu/is-bin/INTERSHOP.enfinity/WFS/EU-Bookshop-Site/en_GB/-/EUR/ViewPublication-Start?PublicationKey=FXAC07306 downloaded on 17 November 2011) contains the text of the treaty. The text of article 1a is as follows:

“The Union is founded on the values of respect for human dignity, freedom, democracy, equality, the rule of law and respect for human rights, including the rights of persons belonging to minorities. These values are common to the Member States in a society in which pluralism, non-discrimination, tolerance, justice, solidarity and equality between women and men prevail.”

This basic statement is further expanded in the following articles. I have tried to extract those that are important for the design of healthcare systems.

Article 3b shows the EU position on centralisation and decentralisation.

1. The limits of Union competences are governed by the principle of conferral. The use of Union competences is governed by the principles of subsidiarity and proportionality.

2. Under the principle of conferral, the Union shall act only within the limits of the competences conferred upon it by the Member States in the Treaties to attain the objectives set out therein. Competences not conferred upon the Union in the Treaties remain with the Member States.

3. Under the principle of subsidiarity, in areas which do not fall within its exclusive competence, the Union shall act only if and insofar as the objectives of the proposed action cannot be sufficiently achieved by the Member States, either at central level or at regional and local level, but can rather, by reason of the scale or effects of the proposed action, be better achieved at Union level.

Article 5a first mentions health.

In defining and implementing its policies and activities, the Union shall take into account requirements linked to the promotion of a high level of employment, the guarantee of adequate social protection, the fight against social exclusion, and a high level of education, training and protection of human health.

There only the protection of health not healthcare is addressed. In article 152 there is new text under number 7.

7. Union action shall respect the responsibilities of the Member States for the definition of their health policy and for the organization and delivery of health services and medical care. The responsibilities of the Member States shall include the management of health services and medical care and the allocation of the resources assigned to them.

Article 35 of the “CHARTER OF FUNDAMENTAL RIGHTS OF THE EUROPEAN UNION (2000/C 364/01)” has the following text:

Everyone has the right of access to preventive health care and the right to benefit from medical treatment under the conditions established by national laws and practices. A high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities.”

The website of the European Commission Directorate General for Employment, Social Affairs and Inclusion includes the following statement ( http://ec.europa.eu/social/main.jsp?catId=754&langId=en accessed on 1 December 2011):

“The EU promotes the coordination of national healthcare policies through the open method of coordination with a particular focus on access, quality and sustainability. The key objectives in these three areas are:

Access to health promotion, disease prevention, and curative care:

  • shorter waiting times
  • reaching all parts of the population through universal insurance coverage and affordable care
  • reducing geographical differences in availability and quality of care
  • addressing cultural and language barriers to using services

Quality

• more patient-centred care

  • effective and safe treatment and equipment
  • greater use of evidence-based medicine and health technology assessment (EUnetHTA)
  • greater use of effective prevention programmes for cancer, cardiovascular diseases, and infectious diseases (vaccination) amongst others
  • better integration/coordination between: primary, out-patient and in-patient secondary and tertiary care; medical, nursing, social and palliative care

Sustainability

More rational use of financial resources via:

  • greater use of generic medicines
  • focusing on primary care – referral systems to secondary care
  • reducing in-patients, increasing out-patients
  • simplifying administrative procedures
  • concentrating specialised care in centres of excellence
  • strengthen health promotion and disease prevention

Avoiding under-resourcing of healthcare systems and establish a viable contribution base:

  • better coordination of care
  • ensure sufficient human resources for health through: good training; motivation and working conditions; addressing imbalances in different categories of staff

Reasons for coordinating healthcare at EU level

  1. Health outcomes in the EU are strikingly different according to where you live, your ethnicity, gender and socio-economic status.
  2. The EU is pursuing a "health-in-all-policies" approach. EU structural funds can be used to support healthcare reform and capacity-building in regions which need particular assistance.
  3. High demand for healthcare staff in some countries is draining qualified resources from others, underlining the need for an EU-wide approach.
  4. Some common challenges Ageing population

Access for all to technological progress and greater patient choice must be balanced against financial sustainability.

Spending on health care in EU countries is growing faster than their national wealth. Priorities have to be set, and greater value for money achieved.”

The arguments can be found under the title of Social Services of General Interest (SSGIs; http://ec.europa.eu/social/main.jsp?catId=794&langId=en accessed on 1 December 2011):

“In the EU, social services play a crucial role in improving quality of life and providing social protection. They include:

  • social security
  • employment and training services
  • social housing
  • child care
  • long-term care
  • social assistance services

These services are a vital means of meeting basic EU objectives such as social, economic and territorial cohesion, high employment, social inclusion and economic growth. The EU encourages cooperation and the exchange of good practice between EU countries to improve the quality of social services, and provides financial support for their development and modernisation (eg from the European Social Fund).”

At the European Committee for Standardization (CEN) a Common Quality Framework for SSGIs was developed. The nine principles can be found in a final report (http://www.best-quality.eu/fileadmin/News/Studie/BQ_FinalReport_ENGweb_81-100.pdf accessed 1 December 2011). In an explanatory text the following is stated:

“The European Commission See: Commission Communication "Implementing the Community Lisbon programme: Social Services of General Interest in the European Union" {SEC(2006) 516} identified two main categories of SSGIs:

1. Statutory and complementary social security schemes, organised in various ways (mutual or occupational organisations), covering the main risks of life, such as those linked to health, ageing, occupational accidents, unemployment, retirement and disability;

2. Other essential services provided directly to the person. ...”

This is also summarised in the EUnetHTA strategy (version 220612) as values of the European Union:

  • European Union values for health systems (universality, access to good quality care, equity and solidarity)
  • efficiency in HTA production
  • sustainability of the healthcare systems
  • the principle of subsidiarity of the European Union
  • the use of best evidence, common methodological standards, trust and transparency

This clarifies the values that guide European policy on social services and as part of them health services. The questions related to AAA screening are viewed on the basis of these values. This general level guides the choice of the methodology. Stakeholder involvement on the European level in the sense of an interactive, participatory approach could not reflect local opinions about priorities, organisational opportunities or sustainability in a particular setting. As stated by the citation of documents showing the principles of the EU, the approach is mainly a way of principlism. The conclusions and findings are then scrutinised by applying coherence analysis (see Ethical aspects: Mirella Marlow, Ilona Autti-Rämö, Bjørn Hofmann, Samuli Saarni, Sinikka Sihvo, Aleksandra Zagórska; Ethical Methodology draft 100906).

Result cards

Principal questions about the ethical aspects of technology

Result card for ETH1: "Is organised Abdominal Aorta Aneurysm Screening a new, innovative mode of care, an add-on to or modification of a standard mode of care or a replacement of a standard?"

View full card
ETH1: Is organised Abdominal Aorta Aneurysm Screening a new, innovative mode of care, an add-on to or modification of a standard mode of care or a replacement of a standard?
Method
Result
Comment

Importance: Important

Transferability: Completely

Result card for ETH2: "Can Abdominal Aorta Aneurysm Screening challenge cultural or moral convictions or beliefs of some groups or change current social arrangements - especially gender related definition of the screening group?"

View full card
ETH2: Can Abdominal Aorta Aneurysm Screening challenge cultural or moral convictions or beliefs of some groups or change current social arrangements - especially gender related definition of the screening group?
Method
Result
Comment

Importance: Critical

Transferability: Partially

Autonomy

Result card for ETH3: "Is Abdominal Aorta Aneurysm Screening used for people that are especially vulnerable - consider carefully the inclusion or exclusion criteria in an recommendation?"

View full card
ETH3: Is Abdominal Aorta Aneurysm Screening used for people that are especially vulnerable - consider carefully the inclusion or exclusion criteria in an recommendation?
Method
Result

Importance: Important

Transferability: Not

Result card for ETH4: "Can Abdominal Aorta Aneurysm Screening entail special challenges/risk that the patient/person needs to be informed of?"

View full card
ETH4: Can Abdominal Aorta Aneurysm Screening entail special challenges/risk that the patient/person needs to be informed of?
Method
Result

Importance: Important

Transferability: Partially

Result card for ETH5: "Does the implementation challenge or change professional values, ethics or traditional roles?"

View full card
ETH5: Does the implementation challenge or change professional values, ethics or traditional roles?
Method
Result

Importance: Critical

Transferability: Not

Human integrity

Result card for ETH6: "Does the implementation or use of a systematic Abdominal Aorta Aneurysm Screening affect human integrity?"

View full card
ETH6: Does the implementation or use of a systematic Abdominal Aorta Aneurysm Screening affect human integrity?
Method
Result

Importance: Important

Transferability: Not

Beneficence/nonmaleficence

Result card for ETH7: "What are the benefits and harms for participants of the screening, and what is the balance between the benefits and harms when implementing and when not implementing Abdominal Aorta Aneurysm Screening ? Who will balance the risks and benefits in practice and how?"

View full card
ETH7: What are the benefits and harms for participants of the screening, and what is the balance between the benefits and harms when implementing and when not implementing Abdominal Aorta Aneurysm Screening ? Who will balance the risks and benefits in practice and how?
Method
Result

Importance: Important

Transferability: Partially

Justice and Equity

Result card for ETH8: "What are the consequences of implementing / not implementing Abdominal Aorta Aneurysm Screening on justice in the health care system? Are principles of fairness, justness and solidarity respected? Is there a clear rule for prioriticing screening procedures?"

View full card
ETH8: What are the consequences of implementing / not implementing Abdominal Aorta Aneurysm Screening on justice in the health care system? Are principles of fairness, justness and solidarity respected? Is there a clear rule for prioriticing screening procedures?
Method
Result

Importance: Critical

Transferability: Partially

Questions about effectiveness and accuracy

Result card for ETH9: "What are the proper end-points for assessment and how should they be investigated?"

View full card
ETH9: What are the proper end-points for assessment and how should they be investigated?
Method
Result
Comment

Importance: Important

Transferability: Completely

Result card for ETH10: "Are the accuracy measures decided and balanced on a transparent and acceptable way?"

View full card
ETH10: Are the accuracy measures decided and balanced on a transparent and acceptable way?
Method
Result
Comment

Importance: Critical

Transferability: Completely

Discussion

Only three of the questions in this domain can be seen as completely transferable (ETH1, ETH9 and ETH10). Also the ethical judgment has to be based on the results of the other domains. But several questions are closely related and therefore cooperation in the scoping phase was necessary.

The main issues are that the points of view of different stakeholders are important. To balance these interests a combination of methodologies (see methodological guidance Mirella Marlow, Ilona Autti-Rämö, Bjørn Hofmann, Samuli Saarni, Sinikka Sihvo, Aleksandra Zagórska; Ethical Methodology draft 100906) is needed, drawing together:

  • Principlism (methodological guidance page 7) “...principles form a core dimension of all morals” – there the principles of the EU for healthcare and Services of General Interest were drawn together as values to judge the four dimensions in bioethics.
  • Interactive, participatory HTA approach –iHTA (methodological guidance page 6) “...integrates patients, professionals and other stakeholders’ perspectives...” As an interactive approach it allows national or local cultural differences to inform recommendations and decisions in the transformation of core HTA information into localised HTA documents.

To support a transparent process the value judgments in iHTA should be made with ratings giving a quantitative scale to the difference an introduction of the technology will make compared with usual care.

As the survey on AAA screening (CURx) shows there is high variability between healthcare systems. This variability reflects different cultural approaches and values in the design of healthcare. So the ETH domain informs only which questions should be answered and proposes how this might be done in the local context. Only ETH1 in the context of the survey in CURx allows a common view. ETH9 and ETH10 is related to EFF domain and should also be transferable.

References

  1. Birnbacher D. Bioethik zwischen Natur und Interesse. Frankfurt am Main Suhrkamp Verlag; 2006.
  2. Gesang B. Eine Verteidigung des Utilitarismus.
  3. Mirella Marlow IA-R, Bjørn Hofmann, Samuli Saarni, Sinikka Sihvo, Aleksandra Zagórska;. Ethical Methodology draft EUNetHTA online Tool2010.
  4. Ostrom E. Governing the Commons.
  5. Roger Brownsword JJE. The ethics of screening for abdominal aortic aneurysm in men. J Med Ethics 2010;36:827-30.
  6. Schröder-Beck P. Evidence based public health aus ethischer Perspektive: Gerhardus et al. ; 2010.
  7. Sudhir Anand FP, and Amartya Sen. Public Health, Ethics, and Equity; . Oxford University Press2004.
  8. Wallner J. Health Care zwischen Ethik und Recht: Facultas Verlag; 2007.
<< Costs and economic evaluationOrganisational aspects >>