Abdominal Aorta Aneurysm Screening

A. Health Problem and Current Use of the Technology

Target Condition

  • CUR1 [from A0001]: Which (potential) health problem will be addressed by AAA screening?
  • CUR2 [from A0002]: What, if any, is the precise definition/ characterization of AAA? Which diagnosis is given to the condition and according to which classification system (e.g. ICD-10)?
  • CUR3 [from A0003]: Which are the known risk factors for acquiring AAA?
  • CUR4 [from A0004]: What is the natural course of AAA?
  • CUR22 [from A0004]: What is the natural course of ruptured AAAs
  • CUR5 [from A0005]: What are the symptoms at different stages of AAA?
  • CUR20 [from A0005]: What is the risk of rupture at different stages of AAA?
  • CUR6 [from A0006]: What is the burden of diagnosed AAAs?
  • CUR21 [from A0006]: What is the burden of ruptured AAAs?
  • CUR8 [from A0009]: What aspects of the burden of disease are affected by AAA screening?

Target Population

  • CUR7 [from A0007]: What is the target population for AAA screening as well as guideline based opportunistic AAA screening in currently active mass screening programs (optionally limited to Europe)?
  • CUR19 [from A0023]: How many people belong to the target population in Europe?

Utilisation

  • CUR9 [from A0011]: Which countries use AAA screening?
  • CUR23 [from A0011]: How efficient is AAA screening (target population/actually screened population) in countries with screening programs?
  • CUR10 [from A0012]: What kind of variations in the use of screening are there across countries?
  • CUR24 [from A0012]: What kind of variations in current screening programs exist (mass screening / opportunistic screening)?

Current Management of the Condition

  • CUR11 [from A0013]: How is the AAA currently screened?
  • CUR25 [from A0013]: How is the AAA currently diagnosed?
  • CUR12 [from A0014]: How should AAA be diagnosed / screened according to published algorithms/guidelines?
  • CUR14 [from A0016]: How should AAA be managed according to published algorithms/guidelines?
  • CUR15 [from A0017]: What are the differences in the management of diagnosed AAA for different stages of disease?
  • CUR16 [from A0018]: What are the other evidence-based alternatives to AAA screening ?
  • CUR13 [from A0015]: How is the diagnosis of AAA currently managed?

Life-Cycle

  • CUR17 [from A0019]: In which phase is the development of AAA screening?

Regulatory Status

  • CUR18 [from A0021]: What is the reimbursement status of AAA screening across countries?

B. Description and technical characteristics of technology

Features of the technology

  • TEC1 [from B0001]: What is Screening?
  • TEC2 [from B0001]: Are there different strategies for Abdominal Aorta Aneurysm Screening?
  • TEC3 [from B0001]: Has any technical device for the detection of AAA established as internationally accepted golden standard?
  • TEC4 [from B0002]: Why is Abdominal Aorta Aneurysm Screening used?
  • TEC5 [from B0003]: What is the background of the golden standard technical device?
  • TEC6 [from B0004]: Which professionals use the technology and is there a difference between the screening strategies?
  • TEC7 [from B0005]: In what place and context are Abdominal Aorta Aneurysm Screening strategies intended to be used?
  • TEC8 [from B0006]: Are there any special features relevant to the golden standard technical device for Abdominal Aorta Aneurysm Screening?
  • TEC14 [from B0016]: To what population(s) will Abdominal Aorta Aneurysm Screening be used on?
  • TEC15 [from B0018]: Are the reference values or cut-off points for the diagnosis of AAA by the golden standard technical device clearly established?

Investments and tools required to use the technology

  • TEC9 [from B0007]: What material investments are needed to use the golden standard technical device for Abdominal Aorta Aneurysm Screening?
  • TEC10 [from B0009]: What equipment and supplies are needed to use the golden standard technical device for Abdominal Aorta Aneurysm Screening ?
  • TEC11 [from B0010]: What kind of information is needed to monitor the use of the technical device for Abdominal Aorta Aneurysm Screening ?

Training and information needed to use the technology

  • TEC12 [from B0012]: What kind of qualification, training and quality assurance processes are needed for the use or maintenance of the technical device for Abdominal Aorta Aneurysm Screening ?
  • TEC13 [from B0013]: What kind of training is needed for the personnel treating or investigating patients using the technical device for Abdominal Aorta Aneurysm Screening ?

C. Safety

Patient safety

  • SAF1 [from C0001]: What harms can Screening for AAA cause to the screened subjects and what are the characteristics of the harms?
  • SAF2 [from C0005]: Are there susceptible participant groups that are more likely to be harmed through use of the technology?
  • SAF3 [from C0006]: What are the consequences of false positive, false negative and incidental findings brought about using Screening for AAA from the viewpoint of safety?
  • SAF4 [from C0007]: What are the special features in using (applying/interpreting/maintaining) Screening for AAA that may increase safety risks?
  • SAF6 [from C0029]: Does the existence of harms influence tolerability or acceptability of Abdominal Aorta Aneurysm Screening?

Safety risk management

  • SAF7 [from C0060]: How does the safety profile of the technology vary between different kind of Screening programmes?
  • SAF8 [from C0061]: Is there evidence that harms increase or decrease in different organizational settings?
  • SAF9 [from C0062]: How can one reduce safety risks for screened subjects?

D. Clinical Effectiveness

Mortality

  • EFF1 [from D0001]: What is the effect of Abdominal Aorta Aneurysm Screening on overall mortality?
  • EFF2 [from D0002]: What is the effect of Abdominal Aorta Aneurysm Screening on the mortality caused by the target disease?
  • EFF4 [from D0003]: What is the effect of Abdominal Aorta Aneurysm Screening on the mortality due to other causes than the target disease?
  • EFF3 [from D0004]: What is the mortality related to the diagnostic test?

Morbidity

  • EFF5 [from D0005]: How does the use of Abdominal Aorta Aneurysm Screening modify the symptoms and findings of the target condition?
  • EFF6 [from D0006]: How does Abdominal Aorta Aneurysm Screening modify the progression of the target condition?
  • EFF7 [from D0008]: What is the morbidity directly related to Abdominal Aorta Aneurysm Screening ?
  • EFF21 [from D0026]: How does Abdominal Aorta Aneurysm Screening modify the effectiveness of subsequent Abdominal Aorta Aneurysm Screening s?

Function

  • EFF8 [from D0011]: What is the effect of Abdominal Aorta Aneurysm Screening on global function?
  • EFF11 [from D0014]: What is the effect of Abdominal Aorta Aneurysm Screening on return to work?
  • EFF12 [from D0015]: What is the effect of Abdominal Aorta Aneurysm Screening on return to previous living conditions?
  • EFF13 [from D0016]: How does use of Abdominal Aorta Aneurysm Screening affect activities of daily living?

Quality of life

  • EFF9 [from D0012]: What is the effect of Abdominal Aorta Aneurysm Screening on generic health-related quality of life?
  • EFF10 [from D0013]: What is the effect of Abdominal Aorta Aneurysm Screening on disease specific quality of life?
  • EFF25 [from D0030]: Does the knowledge of the test result affect the patient's non-health-related quality of life?

Patient satisfaction

  • EFF14 [from D0017]: Was the use of Abdominal Aorta Aneurysm Screening worthwhile?
  • EFF15 [from D0018]: Is the patient willing to use Abdominal Aorta Aneurysm Screening ?

Change-in management

  • EFF16 [from D0020]: Does use of the test lead to improved detection of the condition?
  • EFF17 [from D0021]: How does the use of the test change physicians' management decisions?
  • EFF18 [from D0022]: Does the test detect other potential health conditions that can impact the subsequent management decisions?
  • EFF19 [from D0023]: How does Abdominal Aorta Aneurysm Screening modify the need for other technologies and use of resources?
  • EFF20 [from D0024]: Is there an effective treatment for the condition the test is detecting?

Test accuracy

  • EFF22 [from D0027]: What are the negative consequences of further testing and delayed treatment in patients with false negative test result?
  • EFF23 [from D0028]: What are the negative consequences of further testing and treatments in patients with false positive test result?
  • EFF28 [from D1003]: What is the reference standard and how likely does it classify the target condition correctly?
  • EFF29 [from D1004]: What are the requirements for accuracy in the context Abdominal Aorta Aneurysm Screening will be used?
  • EFF30 [from D1005]: What is the optimal threshold value in this context?
  • EFF31 [from D1006]: Does the test reliably rule in or rule out the target condition?
  • EFF32 [from D1007]: How does test accuracy vary in different settings?
  • EFF33 [from D1008]: What is known about the intra- and inter-observer variation in test interpretation?

Benefit-harm balance

  • EFF24 [from D0029]: What are the overall benefits and harms of Abdominal Aorta Aneurysm Screening in health outcomes?

E. Costs and economic evaluation

Resource utilization

  • ECO1 [from E0001]: What types of resources are used when delivering population-based screening for Abdominal Aorta Aneurysm, or no systematic screening for AAA (resource use identification)?
  • ECO2 [from E0002]: What amounts of resources are used when delivering population-based screening for Abdominal Aorta Aneurysm, or no screening for AAA (resource use measurement)?

Unit costs

  • ECO3 [from E0003]: What are the unit costs of the resources used when delivering population-based screening for Abdominal Aorta Aneurysm, or no screening for AAA?

Outcomes

  • ECO4 [from E0005]: What are the incremental effects of population-based Abdominal Aorta Aneurysm Screening relative to no systematic screening?

Cost-effectiveness

  • ECO5 [from E0006]: What is the incremental cost-effectiveness ratio?
  • ECO6 [from E0007]: What is the appropriate time horizon?

F. Ethical analysis

Principal questions about the ethical aspects of technology

  • ETH1 [from F0001]: 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?
  • ETH2 [from F0002]: 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?

Autonomy

  • ETH3 [from F0005]: Is Abdominal Aorta Aneurysm Screening used for people that are especially vulnerable - consider carefully the inclusion or exclusion criteria in an recommendation?
  • ETH4 [from F0006]: Can Abdominal Aorta Aneurysm Screening entail special challenges/risk that the patient/person needs to be informed of?
  • ETH5 [from F0007]: Does the implementation challenge or change professional values, ethics or traditional roles?

Human integrity

  • ETH6 [from F0009]: Does the implementation or use of a systematic Abdominal Aorta Aneurysm Screening affect human integrity?

Beneficence/nonmaleficence

  • ETH7 [from F0010]: 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?

Justice and Equity

  • ETH8 [from F0012]: 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?

Questions about effectiveness and accuracy

  • ETH9 [from F0017]: What are the proper end-points for assessment and how should they be investigated?
  • ETH10 [from F0018]: Are the accuracy measures decided and balanced on a transparent and acceptable way?

G. Organisational aspects

Process

  • ORG1 [from G0001]: What kind of work flow, participant flow and other processes are needed when implementing AAA Screening?
  • ORG16 [from G0001]: What kind of changes are required in existing work processes when implementing AAA Screening?
  • ORG17 [from G0001]: What kind of changes are required in patients path when implementing AAA Screening?
  • ORG2 [from G0002]: What kind of patients (and relative) involvement in screening has to be mobilized when implementing AAA Screening?
  • ORG3 [from G0003]: What kind of staff, training and other human resources are required when using AAA Screening?
  • ORG4 [from G0004]: What kind of co-operation and communication of activities does AAA Screening require?
  • ORG15 [from G0012]: What kind of quality assurance is needed and how should it be organised?

Structure

  • ORG5 [from G0005]: How does de-centralisation or centralization requirements influence the implementation of AAA Screening?
  • ORG6 [from G0005]: What consequences will AAA Screening have for de-centralisation or centralisation?
  • ORG7 [from G0006]: What kinds of investments are needed (material or premises) when introducing AAA Screening?
  • ORG8 [from G0006]: Who are responsible for those investments?
  • ORG9 [from G0007]: What is the likely budget impact of the implementation of AAA Screening for the payers (e.g. government)?

Management

  • ORG10 [from G0008]: What management problems and opportunities are attached to AAA Screening?
  • ORG11 [from G0009]: Who decides which people are eligible for AAA Screening and on what basis?
  • ORG18 [from G0013]: What kind of monitoring requirements and opportunities are there for AAA Screening?

Culture

  • ORG12 [from G0010]: How is AAA screening accepted by clinicians?
  • ORG13 [from G0010]: How do the patients accept AAA Screening?
  • ORG14 [from G0010]: How do the financial management of the health care organizations accept AAA Screening?

H. Social aspects

Major life areas

  • SOC1 [from H0001]: Which social areas do the use of Abdominal Aorta Aneurysm Screening influence and how?
  • SOC2 [from H0002]: Who are the important others that may be affected, in addition to the individual participating in the Abdominal Aorta Aneurysm Screening Program ?
  • SOC12 [from H0003]: What kind of support and resources are needed for the patients if the programme for Abdominal Aorta Aneurysm Screening is implemented?
  • SOC3 [from H0004]: What kind of changes may participation in Abdominal Aorta Aneurysm Screening generate in the individual's role in the major life areas?

Individual

  • SOC4 [from H0005]: What kind of physical and psychological changes does the implementation and use of Abdominal Aorta Aneurysm Screening bring about, and what kind of changes do patients expect?
  • SOC5 [from H0006]: How does participating in Abdominal Aorta Aneurysm Screening, and their important others, react and act upon the result of the screening?
  • SOC11 [from H0012]: Are there factors that could prevent a group or person to participate in the program?

Communication

  • SOC6 [from H0007]: What is the knowledge and understanding of Abdominal Aorta Aneurysm Screening among patients?
  • SOC7 [from H0008]: How do patients perceive the information they receive or require about Abdominal Aorta Aneurysm Screening?
  • SOC8 [from H0009]: What influence patients’ decisions to participate in the Abdominal Aorta Aneurysm Screening Program?
  • SOC10 [from H0013]: What are the social obstacles or prospects in the communication about Abdominal Aorta Aneurysm Screening ?

I. Legal aspects

Autonomy of the patient

  • LEG1 [from I0002]: Is the voluntary participation of patients guaranteed properly?
  • LEG4 [from I0034]: Who is allowed to give consent for minors and incompetent persons?
  • LEG6 [from I0036]: Do laws/ binding rules require appropriate counseling and information to be given to the user or patient?

Privacy of the patient

  • LEG2 [from I0009]: Do laws/ binding rules require appropriate measures for securing patient data?

Equality in health care

  • LEG3 [from I0011]: Do laws/ binding rules require appropriate processes or resources to guarantee equal access to Abdominal Aorta Aneurysm Screening ?
  • LEG5 [from I0035]: Do laws/ binding rules require appropriate preventive or treatment measures available for all?