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 20 November 2019]. Available from: http://meka.thl.fi/ViewCover.aspx?id=106

Abdominal Aorta Aneurysm Screening

Collection summary

Background

Abdominal aortic aneurysm (AAA) is a pathological focal dilatation of the abdominal stem artery. AAA rupture is a dramatic emergency condition with a high risk of death.

Although it varies across European countries, the percentage of men at high risk of AAA has been increasing steadily over the last 20 years. Screening programmes for AAA have thus been considered as a potentially useful healthcare approach/intervention in European countries, even if in most countries no systematic nationwide screening programme has yet been implemented.

Screening programmes for AAA are used to identify individuals at a high risk of AAA rupture. Those identified are offered preventive surgery to reduce their individual risk of the negative consequences of a spontaneous rupture. For smaller aneurysms (3.0–3.9 cm) with a lower risk of rupture, medical therapy and watchful waiting is recommended while for medium-sized aneurysms (4.0–5.4 cm) elective surgery is indicated. In AAAs sized 5.5 cm or more in diameter the cut-off point of repair is reached. Whether to use an endovascular or an open surgical approach should be decided on an individual basis. Open surgery is indicated for patients with a low preoperative risk (younger patients). Endovascular surgery is indicated in patients with favourable anatomy and who are at high surgical risk.

Results

Safety of the technology (SAF)

AAA screening programmes can cause harm to the screened subjects due to the expected increase in the number of detected AAAs (increased incidence) and consequently in the number of surgical interventions to repair intact or non-ruptured AAAs suitable for repair. There are serious consequences in terms of mortality and morbidity, but also psychological effects related to a detected AAA. In addition, unnecessary stress may be engendered by false-positive findings using AAA screening, but literature is scarce.

Effectiveness of the technology (EFF)

Evidence from the literature indicates that AAA screening is beneficial in men over 65 years of age, as it reduces AAA-related mortality by nearly half in the mid- and long-term. In contrast to men, there are no reliable clinical data showing that women benefit from AAA screening.

AAA screening results in a decrease of emergency operations for ruptured AAA, which is counterbalanced by an increase in elective AAA surgery.

There is a need for further research in the area of screening intervals, risk-adjusted repeat screening, and training of sonographers for a better understanding of the effects of this technology.

Costs, economic evaluation of the technology (ECO)

The primary limitation of economic evaluation is the limited transferability of results from one setting to another and difficulty in combining the results in a reliable manner. A full cost-effectiveness analysis, based on data from the Finnish healthcare setting was produced, but not tested in different settings. Results of the cost-effectiveness of AAA screening are not directly transferable to other healthcare systems.

The majority of the available evidence, as well as our present evaluation, suggests that one-time ultrasound screening for AAA of 65-year-old men and women is cost-effective compared with a situation where no AAA screening is offered.

Ethical aspects of the technology (ETH)

There is high variability between healthcare systems; this variability reflects different cultural approaches and values in the design of healthcare. So the analysis of the ethical aspects informs only which questions should be answered and proposes how to do this in the local context. The main issue is that the points of view of different stakeholders are important. To balance these interests a combination of methodologies is needed.

Organisational aspects of the technology (ORG)

As only a few countries have a national systematic population-based AAA screening programme, most of the information in the analysis of organisational aspects comes from the UK setting. All organisational aspects (concerning healthcare systems’ staff and funding; demographic and geographic distribution of potential screening subjects) are more or less country specific. So the current overview can be used as a starting point for further research on the organisational impact of screening programmes.

Social aspects of the technology (SOC)

It is not possible to determine with certainty whether screening for AAA affects health-related quality of life among participants. Among those detected with a small AAA there are experiences of both limitations in daily life and distress as well as worries about an operation. Patient information in relation to AAA is limited, insufficient and difficult to understand. Though attendance rates for AAA screening are high, there are obstacles to participation among those at higher risk of AAA.

Legal aspects of the technology (LEG)

AAA screening via abdominal ultrasound is almost free of physical harm, discomfort or pain. The exceptions are the psychological aspect in the case of false-positive results or rupture in the case of false-negative results. Several pieces of legislation secure the right of access to (best) healthcare at the European Union (EU) level, and there are laws on appropriate counselling and information to be given to the user or patient.

Closing Remarks

The Core Model is not intended to provide a cookbook solution to all problems but to suggest a way in which information can be assembled and structured, and to facilitate its local adaptation. The information is assembled around the nine domains, each with several result cards in which questions and possible answers are reported.

The reasons for having a standardised but flexible content and layout are rooted in the way HTA is conducted in the EU and in the philosophy of the first EUnetHTA Joint Action (JA1) production experiment.

HTA is a complex multidisciplinary activity addressing a very complex reality – that of healthcare. Uniformly standardised evidence-based methods of conducting assessments for each domain do not exist (Corio M, Paone S, Ferroni E, Meier H, Jefferson TO, Cerbo M. Agenas – Systematic review of the methodological instruments used in Health Technology Assessment. Rome, July 2011.)). There are sometimes variations across and within Member States in how things are done and which aspects of the evaluation are privileged. This is especially so for the “softer” domains such as the ethical and social domains.

This test represents a useful lesson for methodological development in EUnetHTA Joint Action 2.

Collection methodology

Objective

To produce a Core Health Technology Assessment (HTA) assessing the effects of abdominal aortic aneurysm (AAA) screening based on the EUnetHTA Core Model and working within the Collaborative Model 2 (COLMOD 2) organisational framework.

Methods

The work was based on the HTA Core Model on screening technologies, which was developed during the EUnetHTA Joint Action 1 (JA1).

The first phase was the selection of the technology to be assessed using the Core Model; this phase was carried out through a three-step process that included surveys and questionnaires to Work Plan 4 (WP4) partners by email. At the same time, the Collaborative Model to be used in this Core HTA was chosen by WP4 Partners.

Then there was the check of Partners’ availability to assume responsibility, as an institution, to take the lead in one of the nine evaluation domains. At the same time, the nine domain teams were built-up in accordance with partners’ preferences and some general guidelines (i.e.: “each WP4/B Associated partner AP should be involved in at least one domain, indicating its interest for at least one domain”)

Finally the specific work plan was shared, according with the general WP4 3-years work plan and objectives. This specific work plan included the phases scheduled in the “HTA Core Model Handbook” (Production of Core HTAs and structured HTA information).

An editorial team was set up for discussion and major decisions on basic principles and solutions related to the content of core HTA .The editorial team was chaired by Tom Jefferson (Agenas),vice-chaired by Katrine B. Frønsdal (NOKC) and composed of all the primary investigators of the domains.

To allow collaboration between partners a draft protocol for Core Model use was agreed by the researchers involved. The research questions for each of the nine domains of the Core Model were formulated and the corresponding relevant assessment elements (AEs) were selected.

Overlaps between the domains were identified and assigned exclusively to one domain, by mutual agreement.

The research strategy was carried out by one of the domain team, collecting input from the others.

Evidence from published and manufacturer sources was identified, retrieved, assessed, and included according to pre-specified criteria, and summarised to answer each AE. Each domain assessment was made by a single agency (COLMOD2); researchers from different WP4 Partners reviewed and commented on the Core HTA.

Introduction to collection

This brief document provides background information on the preparation and development of the Core HTA on AAA screening. The core HTA document was produced during the course of the first EUnetHTA Joint Action (JA1) 2010-2012.

The idea behind EUnetHTA’s Core Model is to provide a framework for structuring relevant HTA information while at the same time facilitating local use and adaptation of the information or guiding its production.

The Model is based on nine dimensions or “domains” of evaluation:

  1. Health Problem and Current Use of the Technology (CUR)
  2. Description and technical characteristics of technology (TEC)
  3. Safety (SAF)
  4. Effectiveness (EFF)
  5. Costs and economic evaluation (ECO)
  6. Ethical analysis (ETH)
  7. Organisational aspects (ORG)
  8. Social aspects (SOC)
  9. Legal aspects  (LEG)

The Core Model application on screening was tested by assessing the effects of AAA screening, by producing a Core HTA structured in the nine documents that follow, one for each domain.

The AAA Core HTA was prepared using an experimental Collaborative Model (COLMOD) - so called COLMOD 2 - in which one of the national or sub-national HTA participating agencies took responsibility for the production of each domain. The experimental organisational model added an element of challenge but probably helped to forge strong links across participants.

In the next few months an intensive validation programme including interviews and consultations will elicit comments and feedback both from those who contributed to the Core HTA and from those who read it for the first time. This validation plan includes an internal audit within the Work Package 4 during which each partner will validate parts of the Core HTA they did not produce themselves and the Core HTA production process (collaborative models, on-line tool, etc.).

At the same time, as scheduled in the 3-year work plan, the Core HTA will be sent to the Stakeholder Advisory Group (SAG) for feedback before the final Public Consultation, during which the Core HTA will be made available.

The results from the Validation and SAG consultation should provide useful information to improve the product, supporting us in amending the Core HTA.

The following agencies contributed to the preparation of the document:

  • AAZ - Croatia
  • AETSA - Spain
  • Agenas - Italy
  • AHTAPol - Poland
  • Central Denmark - Denmark
  • GÖG - Austria
  • HVB - Austria
  • IQWiQ - Germany
  • ISCIII-AETS - Spain
  • Laziosanità - Italy
  • LBI-HTA - Austria
  • NICE – United Kingdom
  • NOKC - Norway
  • SDU/CAST - Denmark
  • SNHTA - Switzerland
  • THL - Finland
  • UTA - Estonia

Scope

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

Health Problem and Current Use of the Technology

Authors: Pseudo218 Pseudo218, Pseudo73 Pseudo73

Introduction

The following text gives a broad overview of the health problem of AAA (abdominal aortic aneurysm), the screening population and the current use of AAA screening in Europe.

Methodology

Frame

The 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

Assessment elements

TopicIssue RelevantResearch questions or rationale for irrelevance
A0001Target ConditionWhich disease/health problem/potential health problem will the technology be used for?yesWhich (potential) health problem will be addressed by AAA screening?
A0002Target ConditionWhat, if any, is the precise definition/ characterization of the target disease? Which diagnosis is given to the condition and according to which classification system (e.g. ICD-10)?yesWhat, 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)?
A0003Target ConditionWhich are the known risk factors for acquiring the condition?yesWhich are the known risk factors for acquiring AAA?
A0004Target ConditionWhat is the natural course of the condition?yesWhat is the natural course of AAA?
What is the natural course of ruptured AAAs
A0005Target ConditionWhat are the symptoms at different stages of the disease?yesWhat are the symptoms at different stages of AAA?
What is the risk of rupture at different stages of AAA?
A0006Target ConditionWhat is the burden of the condition?yesWhat is the burden of diagnosed AAAs?
What is the burden of ruptured AAAs?
A0009Target ConditionWhat aspects of the burden of disease are targeted by the technology?yesWhat aspects of the burden of disease are affected by AAA screening?
A0007Target PopulationWhat is the target population of the technology?yesWhat 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)?
A0023Target PopulationHow many people belong to the target population?yesHow many people belong to the target population in Europe?
A0011UtilisationHow much is the technology being used?yesWhich countries use AAA screening?
How efficient is AAA screening (target population/actually screened population) in countries with screening programs?
A0012UtilisationWhat kind of variations in use are there across countries/regions/settings?yesWhat kind of variations in the use of screening are there across countries?
What kind of variations in current screening programs exist (mass screening / opportunistic screening)?
A0013Current Management of the ConditionHow is the disease/health condition currently diagnosed or screened?yesHow is the AAA currently screened?
How is the AAA currently diagnosed?
A0014Current Management of the ConditionHow should the condition be diagnosed or screened according to published algorithms/guidelines?yesHow should AAA be diagnosed / screened according to published algorithms/guidelines?
A0015Current Management of the ConditionHow is the condition currently managed?yesHow is the diagnosis of AAA currently managed?
A0016Current Management of the ConditionHow should the condition be managed according to published algorithms/guidelines?yesHow should AAA be managed according to published algorithms/guidelines?
A0017Current Management of the ConditionWhat are the differences in the management for different stages of disease?yesWhat are the differences in the management of diagnosed AAA for different stages of disease?
A0018Current Management of the ConditionWhat are the other evidence-based alternatives to the current technology?yesWhat are the other evidence-based alternatives to AAA screening ?
A0019Life-CycleIn which phase is the development of the technology?yesIn which phase is the development of AAA screening?
A0021Regulatory StatusWhat is the reimbursement status of the technology across countries?yesWhat is the reimbursement status of AAA screening across countries?
A0020Regulatory StatusWhich market authorization status has the technology in other countries, or international authorities?noThis screening does not seem to undergo specific market authorization or approval processes

Methodology description

Information sources

Due to the diversity of the questions addressed in this chapter/domain and the broad focus on the health problem of AAA/abdominal aortic aneurysm, it did not seem appropriate to undertake a systematic search for all questions but rather an extensive hand search for sources covering the different issues.

Hand searches were carried out in Dec 2011 on

  • systematic search for guidelines on/for AAA-screening in Guidelines International Network and hand search
  • hand search within medical textbooks and epidemiological materials for descriptions of health problem, definitions and classifications, risks, natural course and symptoms, burden of disease
  • hand search for citation from peer reviewed literature, tertiary literature and technical literature for additional information on specific questions, complementing the information from medical textbooks, e.g. screening trials
  • EUnetHTA survey on AAA-screening and reimbursement in Europe
Quality assessment tools or criteria

No quality assessment tool were used, but the strategy was to use multiple sources in order to validate individual, possibly biased, sources.

Result cards

Target Condition

Result card for CUR1: "Which (potential) health problem will be addressed by AAA screening?"

View full card
CUR1: Which (potential) health problem will be addressed by AAA screening?
Result

Importance: Critical

Transferability: Completely

Result card for CUR2: "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)?"

View full card
CUR2: 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)?
Result
Comment

Importance: Important

Transferability: Partially

Result card for CUR3: "Which are the known risk factors for acquiring AAA?"

View full card
CUR3: Which are the known risk factors for acquiring AAA?
Result

Importance: Critical

Transferability: Partially

Result card for CUR4: "What is the natural course of AAA?" and CUR22: "What is the natural course of ruptured AAAs"

View full card
CUR4: What is the natural course of AAA?
Result

Importance: Critical

Transferability: Completely

CUR22: What is the natural course of ruptured AAAs
Result

Importance: Unspecified

Transferability: Unspecified

Result card for CUR5: "What are the symptoms at different stages of AAA?" and CUR20: "What is the risk of rupture at different stages of AAA?"

View full card
CUR5: What are the symptoms at different stages of AAA?
Result

Importance: Critical

Transferability: Completely

CUR20: What is the risk of rupture at different stages of AAA?
Result

Importance: Critical

Transferability: Completely

Result card for CUR6: "What is the burden of diagnosed AAAs?" and CUR21: "What is the burden of ruptured AAAs?"

View full card
CUR6: What is the burden of diagnosed AAAs?
Result
Comment

Importance: Critical

Transferability: Partially

CUR21: What is the burden of ruptured AAAs?
Result

Importance: Unspecified

Transferability: Unspecified

Result card for CUR8: "What aspects of the burden of disease are affected by AAA screening?"

View full card
CUR8: What aspects of the burden of disease are affected by AAA screening?
Result

Importance: Unspecified

Transferability: Unspecified

Target Population

Result card for CUR7: "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)?"

View full card
CUR7: 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)?
Result

Importance: Unspecified

Transferability: Unspecified

Result card for CUR19: "How many people belong to the target population in Europe?"

View full card
CUR19: How many people belong to the target population in Europe?
Result

Importance: Unspecified

Transferability: Unspecified

Utilisation

Result card for CUR9: "Which countries use AAA screening?" and CUR23: "How efficient is AAA screening (target population/actually screened population) in countries with screening programs?"

View full card
CUR9: Which countries use AAA screening?
Result

Importance: Unspecified

Transferability: Unspecified

CUR23: How efficient is AAA screening (target population/actually screened population) in countries with screening programs?
Result

Importance: Unspecified

Transferability: Unspecified

Result card for CUR10: "What kind of variations in the use of screening are there across countries?" and CUR24: "What kind of variations in current screening programs exist (mass screening / opportunistic screening)?"

View full card
CUR10: What kind of variations in the use of screening are there across countries?
Result

Importance: Unspecified

Transferability: Unspecified

CUR24: What kind of variations in current screening programs exist (mass screening / opportunistic screening)?
Result

Importance: Unspecified

Transferability: Unspecified

Current Management of the Condition

Result card for CUR11: "How is the AAA currently screened?" and CUR25: "How is the AAA currently diagnosed?"

View full card
CUR11: How is the AAA currently screened?
Result

Importance: Unspecified

Transferability: Unspecified

CUR25: How is the AAA currently diagnosed?
Result

Importance: Unspecified

Transferability: Unspecified

Result card for CUR12: "How should AAA be diagnosed / screened according to published algorithms/guidelines?"

View full card
CUR12: How should AAA be diagnosed / screened according to published algorithms/guidelines?
Result

Importance: Unspecified

Transferability: Unspecified

Result card for CUR13: "How is the diagnosis of AAA currently managed?"

View full card
CUR13: How is the diagnosis of AAA currently managed?
Result

Importance: Unspecified

Transferability: Unspecified

Result card for CUR14: "How should AAA be managed according to published algorithms/guidelines?"

View full card
CUR14: How should AAA be managed according to published algorithms/guidelines?
Result

Importance: Unspecified

Transferability: Unspecified

Result card for CUR15: "What are the differences in the management of diagnosed AAA for different stages of disease?"

View full card
CUR15: What are the differences in the management of diagnosed AAA for different stages of disease?
Result

Importance: Unspecified

Transferability: Unspecified

Result card for CUR16: "What are the other evidence-based alternatives to AAA screening ?"

View full card
CUR16: What are the other evidence-based alternatives to AAA screening ?
Result

Importance: Unspecified

Transferability: Unspecified

Life-Cycle

Result card for CUR17: "In which phase is the development of AAA screening?"

View full card
CUR17: In which phase is the development of AAA screening?
Result

Importance: Unspecified

Transferability: Unspecified

Regulatory Status

Result card for CUR18: "What is the reimbursement status of AAA screening across countries?"

View full card
CUR18: What is the reimbursement status of AAA screening across countries?
Result

Importance: Unspecified

Transferability: Unspecified

References

{1} Ouriel K, Green RM, Donayre C, Shortell CK, Elliott J, DeWeese JA. An evaluation of new methods of expressing aortic aneurysm size: relationship to rupture. J Vasc Surg. 1992 Jan;15(1):12-8; discussion 9-20.

{2} Sakalihasan N, Limet R, Defawe OD. Abdominal aortic aneurysm. Lancet. 2005 Apr 30-May 6;365(9470):1577-89.

{3} Michel JB, Martin-Ventura JL, Egido J, Sakalihasan N, Treska V, Lindholt J, et al. Novel aspects of the pathogenesis of aneurysms of the abdominal aorta in humans. Cardiovascular research. 2011 Apr 1;90(1):18-27.

{4} Mohler ER. Patient information: Abdominal aortic aneurysm 2011 {cited 2011-12-16}; Available from: http://www.uptodate.com/contents/patient-information-abdominal-aortic-aneurysm

{5} Fowkes G. Peripheral Vascular Disease - Health Care Needs Assessment - Third Series. 2007 {cited 2011-12-22; Available from: http://www.hcna.bham.ac.uk/documents/09_HCNA3_D2.pdf

{6} Bown MJ, Sutton AJ,BellPR,Sayers RD.A meta-analysis of 50 years of ruptured abdominal aortic aneurysm repair. The British journal of surgery. 2002 Jun;89(6):714-30.

{7} Greenhalgh RM, Brown LC, Kwong GP, Powell JT, Thompson SG. Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30-day operative mortality results: randomised controlled trial. Lancet. 2004 Sep 4-10;364(9437):843-8.

{8} World Health Organisation. International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) Version for 2010. 2010 {cited 2011-12-20}; Available from: http://apps.who.int/classifications/icd10/browse/2010/en#/I71

{9} National Library of Medicine. Aortic Aneurysm, Abdominal. 1993 {cited 2011-12-30}; Available from: http://www.ncbi.nlm.nih.gov/mesh/68017544

{10} Blanchard JF, Armenian HK, Friesen PP. Risk factors for abdominal aortic aneurysm: results of a case-control study. American journal of epidemiology. 2000 Mar 15;151(6):575-83.

{11} Kent KC, Zwolak RM, Egorova NN, Riles TS, Manganaro A, Moskowitz AJ, et al. Analysis of risk factors for abdominal aortic aneurysm in a cohort of more than 3 million individuals. J Vasc Surg. 2011 Sep;52(3):539-48.

{12} Robbins SL, Cotran RS, Kumar V, Schoen FJ. Robbins pathologic basis of disease. 5th ed/ed.Philadelphia;London: Saunders 1994.

{13} UKNational Screening Committee. NHS Abdominal Aortic Aneurysm (AAA) Screening Programme - Information for Health Professionals. 2010 {cited 2011-12-21; Available from: http://aaa.screening.nhs.uk/getdata.php?id=219

{14} Scott RA, Bridgewater SG, Ashton HA. Randomized clinical trial of screening for abdominal aortic aneurysm in women. The British journal of surgery. 2002 Mar;89(3):283-5.

{15} Ashton HA, Gao L, Kim LG, Druce PS, Thompson SG, Scott RA. Fifteen-year follow-up of a randomized clinical trial of ultrasonographic screening for abdominal aortic aneurysms. The British journal of surgery. 2007 Jun;94(6):696-701.

{16} Lindholt JS, Juul S, Fasting H, Henneberg EW. Screening for abdominal aortic aneurysms: single centre randomised controlled trial. BMJ (Clinical research ed. 2005 Apr 2;330(7494):750.

{17} Norman PE, Jamrozik K, Lawrence-Brown MM,LeMT, Spencer CA, Tuohy RJ, et al. Population based randomised controlled trial on impact of screening on mortality from abdominal aortic aneurysm. BMJ (Clinical research ed. 2004 Nov 27;329(7477):1259.

{18} Fleming C, Whitlock EP, Beil TL, Lederle FA. Screening for abdominal aortic aneurysm: a best-evidence systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2005 Feb 1;142(3):203-11.

{19} Cosford PA, Leng GC. Screening for abdominal aortic aneurysm. Cochrane Database Syst Rev. 2007(2):CD002945.

{20} Lindholt JS, Sorensen J, Sogaard R, Henneberg EW. Long-term benefit and cost-effectiveness analysis of screening for abdominal aortic aneurysms from a randomized controlled trial. The British journal of surgery. 2010 Jun;97(6):826-34.

{21} Lindholt JS, Juul S, Henneberg EW, Fasting H. Is screening for abdominal aortic aneurysm acceptable to the population? Selection and recruitment to hospital-based mass screening for abdominal aortic aneurysm. Journal of public health medicine. 1998 Jun;20(2):211-7.

{22} O'Kelly TJ, Heather BP. General practice-based population screening for abdominal aortic aneurysms: a pilot study. The British journal of surgery. 1989 May;76(5):479-80.

{23} Scott RA, Tisi PV, Ashton HA, Allen DR. Abdominal aortic aneurysm rupture rates: a 7-year follow-up of the entire abdominal aortic aneurysm population detected by screening. J Vasc Surg. 1998 Jul;28(1):124-8.

{24} Mastracci TM, Cina CS. Screening for abdominal aortic aneurysm inCanada: review and position statement of the Canadian Society for Vascular Surgery. J Vasc Surg. 2007 Jun;45(6):1268-76.

{25} U.S.Preventive Services Task Force. Screening for abdominal aortic aneurysm: recommendation statement. Ann Intern Med. 2005 Feb 1;142(3):198-202.

{26} Kent KC, Zwolak RM, Jaff MR, Hollenbeck ST, Thompson RW, Schermerhorn ML, et al. Screening for abdominal aortic aneurysm: a consensus statement. J Vasc Surg. 2004 Jan;39(1):267-9.

{27} United KingdomSmall Aneurysm Trial Participants. Long-term outcomes of immediate repair compared with surveillance of small abdominal aortic aneurysms. TheNew Englandjournal of medicine. 2002 May 9;346(19):1445-52.

{28} Stevenson. Essential Elements in Developing an Abdominal Aortic Aneurysm (AAA) Screening and Surveillance Programme. 2011 {cited 2011-09-19}; Available from: http://aaa.screening.nhs.uk/getdata.php?id=221

{29} Chaikof EL, Brewster DC, Dalman RL, Makaroun MS, Illig KA,SicardGA, et al. The care of patients with an abdominal aortic aneurysm: the Society for Vascular Surgery practice guidelines. J Vasc Surg. 2009 Oct;50(4 Suppl):S2-49.

Description and technical characteristics of technology

Authors: Daniela Pertl, Sophie Brunner-Ziegler

Summary

The main purpose of the present domain was to describe current screening strategies for abdominal aortic aneurysm (AAA) with special emphasis on the gold standard technical device, the ultrasound sonography device.

Generally, “screening” aims to identify pathological conditions in their preclinical and potentially curable stage. Basic criteria, published by the WHO in 1968, should ideally be fulfilled for a condition to qualify for screening. While population-based systematic screening concentrates systematically on the entire population or on subgroups of the entire population by using quality assured programmes, opportunistic screening practices are performed occasionally during individual routine healthcare examinations. Screening results of both types are used as a basis for potential further diagnostic assessments and therapies. Major limitations of screening involve the psycho-social burden of concerned people, and unnecessary investigations and treatment as a result of false positive results.

In the case of AAA current screening practices and funding policies differ between healthcare systems. With the exception of Sweden and the United Kingdom, no specific nationwide screening programmes have been implemented within European Countries. Instead, individualised care is strongly recommended for each patient. When the best-established and most used screening guidelines were compared, the highest rigor/quality score (AGREE score) was for the guidelines of the US Preventive Services Task Force from 2005 (score: nearly 80%), in contrast to the Society for Vascular Surgery practice guidelines, which scored only 25%. 

According to the US Preventive Services Task Force, all men, aged 65 to 75 years, who have ever smoked in their lifetime, should be screened by abdominal ultrasonography.

Introduction

The aim of the following domain is to give a short overview of screening in general and to characterise the technical details of the ultrasound sonography device, which has been internationally accepted as the gold standard methodology for abdominal aortic aneurysm (AAA) screening procedures. AAA is usually detected either during population based screening or during various opportunistic screening strategies.

First we consider the history, diverse definitions, strengths and limitations of screening in general, with special emphasis on the distinction between different screening strategies, such as population based and various opportunistic screening strategies. A survey of the different AAA screening approaches in the individual countries, in the context of their healthcare systems, was performed. The survey indicated that approaches vary not only in terms of the context in which screening takes place, but also in the target population, towards whom they are directed.

Second, technical details of ultrasound sonography are introduced: special features relevant to this technique, such as cut-off points and necessary material investments are discussed. Some information is described in detail in other domains, for example, qualifications needed, training and quality assurance processes and necessary investments.

Methodology

Frame

The 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

Assessment elements

TopicIssue RelevantResearch questions or rationale for irrelevance
B0001Features of the technologyWhat is this technology?yesWhat is Screening?
Are there different strategies for Abdominal Aorta Aneurysm Screening?
Has any technical device for the detection of AAA established as internationally accepted golden standard?
B0002Features of the technologyWhy is this technology used?yesWhy is Abdominal Aorta Aneurysm Screening used?
B0004Features of the technologyWho will apply this technology?yesWhich professionals use the technology and is there a difference between the screening strategies?
B0016Features of the technologyTo what population(s) will this technology be used on?yesTo what population(s) will Abdominal Aorta Aneurysm Screening be used on?
B0003Features of the technologyWhat is the phase of the technology?yesWhat is the background of the golden standard technical device?
B0006Features of the technologyAre there any special features relevant to this technology?yesAre there any special features relevant to the golden standard technical device for Abdominal Aorta Aneurysm Screening?
B0005Features of the technologyIn what place and context is the technology intended to be used?yesIn what place and context are Abdominal Aorta Aneurysm Screening strategies intended to be used?
B0018Features of the technologyAre the reference values or cut-off points clearly established?yesAre the reference values or cut-off points for the diagnosis of AAA by the golden standard technical device clearly established?
B0017Features of the technologyIs this technology field changing rapidly?noTechnology field is not changing rapidly. Even if technical details are minimally changing (by being updated), basic requirement of application does not change and there are no requirements fo re-training for the end-users.
B0007Investments and tools required to use the technologyWhat material investments are needed to use the technology?yesWhat material investments are needed to use the golden standard technical device for Abdominal Aorta Aneurysm Screening?
B0009Investments and tools required to use the technologyWhat equipment and supplies are needed to use the technology?yesWhat equipment and supplies are needed to use the golden standard technical device for Abdominal Aorta Aneurysm Screening ?
B0010Investments and tools required to use the technologyWhat kind of data and records are needed to monitor the use the technology?yesWhat kind of information is needed to monitor the use of the technical device for Abdominal Aorta Aneurysm Screening ?
B0008Investments and tools required to use the technologyWhat kind of special premises are needed to use the technology?noThere is no need for special premises for the usage of the technology, as there is no radiation exposure associated with ultrasonography. There is no need for usage of contrast media and the technology is even authorized for application in pregnant women. However, the technical device requires a person (medical doctor, medical technician assistent), who is well trained and highly experienced with the assessment procedure.
B0011Investments and tools required to use the technologyWhat kind of registers are needed to monitor the use the technology?noThere is no need for the establishment of registers, as there are internationally consistent guidelines for diagnosis of AAA by ultrasonography.
B0012Training and information needed to use the technologyWhat kind of qualification, training and quality assurance processes are needed for the use or maintenance of the technology?yesWhat kind of qualification, training and quality assurance processes are needed for the use or maintenance of the technical device for Abdominal Aorta Aneurysm Screening ?
B0013Training and information needed to use the technologyWhat kind of training is needed for the personnel treating or investigating patients using this technology?yesWhat kind of training is needed for the personnel treating or investigating patients using the technical device for Abdominal Aorta Aneurysm Screening ?
B0014Training and information needed to use the technologyWhat kind of training and information should be provided for the patient who uses the technology, or for his family/carer?noFor ultrasonographic assessment of the abdomen persons should be in a fasten condition. Special medication to make the intestine free from gas might be applicated the day before the assessment.
B0015Training and information needed to use the technologyWhat information of the technology should be provided for patients outside the target group and the general public?noPatients outside the target group are not invited for population based screening.

Methodology description

Domain frame

The project scope is applied in this domain:

Technology 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. Target condition: Abdominal aortic aneurysm (AAA) MeSH: ”Mass screening”.

Intended use of technology

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.

Comparison

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.

Outcome

All

Design

Systematic Reviews

HTA

RCT

national guidelines

grey literature

technical literature

Information sources

  • Basic systematic search

Basic search strategy

A basic search strategy to identify systematic reviews and randomised controlled trials to suit the overall project definition was developed by investigators from the different domains. This search strategy combined MeSH terms on the intervention exclusively. The search was performed by a research librarian from the Norwegian Knowledge Centre for the Health Services (NOKC) in the Cochrane Library, HTA, CENTRAL, CRD, DARE, EMBASE, MEDLINE and ISI databases. The search resulted in 167 titles (41 Systematic Reviews/HTAs, 126 RCTs).

Selection of literature from the basic search

Abstracts were scanned by each of the two assessors (Sophie Brunner-Ziegler and Daniela Pertl). Articles were included if considered relevant by one of the assessors (based on title and eventual abstract). The literature scan resulted in a net list of six publications, which were distributed among the assessors for further assessment and eventual inclusion in the result cards.

  • Hand search

(citations from peer reviewed literature, tertiary literature and technical literature)

The description and technical characteristics of the technology are rarely analysed within clinical studies, economic analysis, systematic reviews and HTA reports, so the analysis required additional search for national guidelines, grey literature and technical literature to answer the research questions of this domain.

Therefore, the Guidelines International Network (GIN), manufacturer’s websites and technical literature was scanned and 28 articles were included. Reports in the English and German languages were included. The search was done by Sophie Brunner-Ziegler and Daniela Pertl. 

  • Survey

Furthermore, a questionnaire to EUnetHTA partners internationally was used to get information about technical aspects of the technology because this information was not fully available in the basic literature search. Survey questions concerning the TEC domain contained six relevant questions (screening strategies, gold technical device, national guidelines, responsibilities).

Quality assessment tools or criteria

Quality assessment using criteria for clinical effectiveness is not pertinent in the investigation of this domain and other quality assessment criteria are not available. We therefore chose to use peer reviewed literature as the source.

Analysis and synthesis

We performed a descriptive analysis of the articles selected. The research questions were answered by cooperation between the two participants.

Result cards are covered by evidence issued from basic search, hand searched literature and survey results.  Appendix TEC-1 provides the list of result cards of this domain, related result cards of other domains and following agreements on assessments.

Result cards

Features of the technology

Result card for TEC1: "What is Screening?", TEC2: "Are there different strategies for Abdominal Aorta Aneurysm Screening? " and TEC3: "Has any technical device for the detection of AAA established as internationally accepted golden standard?"

View full card
TEC1: What is Screening?
Result

Importance: Critical

Transferability: Partially

TEC2: Are there different strategies for Abdominal Aorta Aneurysm Screening?
Result
Comment

Importance: Important

Transferability: Partially

TEC3: Has any technical device for the detection of AAA established as internationally accepted golden standard?
Result
Comment

Importance: Important

Transferability: Partially

Result card for TEC4: "Why is Abdominal Aorta Aneurysm Screening used?"

View full card
TEC4: Why is Abdominal Aorta Aneurysm Screening used?
Method
Result
Comment

Importance: Important

Transferability: Completely

Result card for TEC6: "Which professionals use the technology and is there a difference between the screening strategies?"

View full card
TEC6: Which professionals use the technology and is there a difference between the screening strategies?
Result
Comment

Importance: Important

Transferability: Partially

Result card for TEC14: "To what population(s) will Abdominal Aorta Aneurysm Screening be used on?"

View full card
TEC14: To what population(s) will Abdominal Aorta Aneurysm Screening be used on?
Result
Comment

Importance: Critical

Transferability: Partially

Result card for TEC5: "What is the background of the golden standard technical device?"

View full card
TEC5: What is the background of the golden standard technical device?
Result
Comment

Importance: Optional

Transferability: Completely

Result card for TEC8: "Are there any special features relevant to the golden standard technical device for Abdominal Aorta Aneurysm Screening?"

View full card
TEC8: Are there any special features relevant to the golden standard technical device for Abdominal Aorta Aneurysm Screening?
Result
Comment

Importance: Important

Transferability: Completely

Result card for TEC7: "In what place and context are Abdominal Aorta Aneurysm Screening strategies intended to be used?"

View full card
TEC7: In what place and context are Abdominal Aorta Aneurysm Screening strategies intended to be used?
Result
Comment

Importance: Optional

Transferability: Partially

Result card for TEC15: "Are the reference values or cut-off points for the diagnosis of AAA by the golden standard technical device clearly established?"

View full card
TEC15: Are the reference values or cut-off points for the diagnosis of AAA by the golden standard technical device clearly established?
Result

Importance: Critical

Transferability: Completely

Investments and tools required to use the technology

Result card for TEC9: "What material investments are needed to use the golden standard technical device for Abdominal Aorta Aneurysm Screening?"

View full card
TEC9: What material investments are needed to use the golden standard technical device for Abdominal Aorta Aneurysm Screening?
Result
Comment

Importance: Optional

Transferability: Completely

Result card for TEC10: "What equipment and supplies are needed to use the golden standard technical device for Abdominal Aorta Aneurysm Screening ?"

View full card
TEC10: What equipment and supplies are needed to use the golden standard technical device for Abdominal Aorta Aneurysm Screening ?
Result
Comment

Importance: Optional

Transferability: Completely

Result card for TEC11: "What kind of information is needed to monitor the use of the technical device for Abdominal Aorta Aneurysm Screening ?"

View full card
TEC11: What kind of information is needed to monitor the use of the technical device for Abdominal Aorta Aneurysm Screening ?
Result

Importance: Unspecified

Transferability: Unspecified

Training and information needed to use the technology

Result card for TEC12: "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 ?"

View full card
TEC12: 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 ?
Result

Importance: Unspecified

Transferability: Unspecified

Result card for TEC13: "What kind of training is needed for the personnel treating or investigating patients using the technical device for Abdominal Aorta Aneurysm Screening ?"

View full card
TEC13: What kind of training is needed for the personnel treating or investigating patients using the technical device for Abdominal Aorta Aneurysm Screening ?
Result

Importance: Unspecified

Transferability: Unspecified

Discussion

Ultrasonography, based on the principle of the Doppler effect, has been established world wide as a gold standard technical device not only for screening but also for monitoring potential size progression of AAAs. This non-invasive method is highly sensitive and specific, but the display of the images is not yet internationally standardised. Further strengths of this method include safety, portability and low costs. The investigation can be carried out not only by physicians, but also by medical technical assistants, however, intensive training and experience of the investigator is highly important to keep intraobserver reproducibility as low as possible.

For the present domain, literature on screening in general and on different screening practices was readily available, however as detailed technical information on ultrasonography was scarce in databases, such as Medline, educational books and manufactories websites had to be added to the literature research. Answers to the distributed questionnaire results on the present domain were helpful and demonstrated that actual screening practices differ in the participating countries. Population-based systematic screening programmes for AAA currently exist in only a few European countries (i.e. the NHS AAA Screening Programme in the United Kingdom). In most countries, AAA screening is performed by various opportunistic screening practices in the outpatient primary care setting.

References

  1. Raffle A, Grey MJA. Screening: Durchführung und Nutzen von Vorsorgeuntersuchungen. Bern: Hans Huber; 2009.
  2. UK Screening Portal UK National Screening Committee. What is screening?  2012  [cited Februar 2012 ]; Available from: http://www.screening.nhs.uk/screening
  3. Morabia A. ZF. History of medical screening; from concepts to action. Postgrad Med J. 2004;80:469.
  4. Wilson JMG, G. J. Principles and practice of screening for disease. 1968.
  5. NHS Abdominal Aortic Aneurysm Screening Programme. Essential Elements in Developing an Abdominal Aortic Aneurysm (AAA) Screening and Surveillance Programme. Version 30, 23 July 2011  2011  [cited January 2012]; Available from: http://aaa.screening.nhs.uk
  6. Engelgau MM. AR, Thompson TJ., Herman WH. Screening for NIDDM in nonpregnant adults. A review of principles, screening tests, and recommendations. Diabetes Care. 1995;Dec;(18(12)):1606-18.
  7. US Preventive Services Task Force. Screening for Abdominal Aortic Aneurysm. Recommendation Statement. Ann Intern Med. 2005;142:202.
  8. EUnetHTA Joint Action 1 Work Package 4 Core HTA. Abdominal Aortic Aneurysm Screening. Survey Report for retrieving information on the use of technology in European countries. 2012.
  9. Lederle FA. Screening for AAA in the USA. Scandinavian Journal of Surgery. 2008;2008(97):141.
  10. The Official US Government Site for Medicare. Abdominal Aortic Aneurysm (AAA) Screenings.  2012  [cited December 2011]; Available from: http://www.medicare.gov/(X(1)S(o4tc1j55vjeusa55ajsqfki2))/navigation/manage-your-health/preventive-services/abdominal-aortic-aneurysm.aspx?AspxAutoDetectCookieSupport=1
  11. Ferket BS, Grootenboer N, Colkesen EB, Visser JJ, van Sambeek MR, Spronk S, et al. Systematic review of guidelines on abdominal aortic aneurysm screening. Journal of vascular surgery : official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter. 2012 May;55(5):1296-304 e4.
  12. Appraisal of Guidelines for Research & Evaluation (AGREE). Introduction to AGREE II.  2012  [cited December 2011]; Available from: http://www.agreetrust.org/
  13. Debus ES, Kölbel T, Böckler D, Eckstein HH. Abdominelle Aortenaneurysmen. Gefässchirurgie. 2010;15(3):154-68.
  14. Eckstein HH, Bockler D, Flessenkamper I, Schmitz-Rixen T, Debus S, Lang W. Ultrasonographic screening for the detection of abdominal aortic aneurysms. Deutsches Arzteblatt international. 2009 Oct;106(41):657-63.
  15. Thanos J RM, Shragge BW, Urbach D,. Vascular Ultrasound Screening for Asymptomatic Abdominal Aortic Aneurysm. Vaskuläres Ultraschall-Screening bei Asymptomatischem Abdominalem Aortenaneurysma. Health Policy. 2008;2008 Nov(4(2)):83.
  16. Lindholt JS, Vammen S, Juul S, Henneberg EW, Fasting H. The validity of ultrasonographic scanning as screeninig method for abdominal aortic aneurysm. Eur J Vasc Endovasc Surg 1999;17:275
  17. Mastracci TM, Cina CS, Canadian Society for Vascular S. Screening for abdominal aortic aneurysm in Canada: review and position statement of the Canadian Society for Vascular Surgery. Journal of vascular surgery : official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter. 2007 Jun;45(6):1268-76.
  18. Giardina S PB, Spinella G, Cafueri G, Corbo M, Brasseur P,   . An economic evaluation of an abdominal aortic aneurysm screening program in Italy. Journal of vascular surgery : official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter. 2011;54(4):946.
  19. Sayyahmelli Sima RA. Screening for Abdominal Aortic Aneurysm. In: Reinhart T Grundmann, editor. Diagnosis and Treatment of Abdominal and Thoracic Aortic Aneurysms Including the Ascending Aorta and the Aortic Arch. Iran: InTech; 2011.
  20. DuBose TJ. BA. Confusion and Direction in Diagnostic Doppler Sonography. Journal of Diagnostic Medical Sonography. 2009;25 (3).
  21. GE Healthcare.  2012  [cited March 2012]; Available from: http://www3.gehealthcare.com/en
  22. Hartshorne TC, McCollum CN, Earnshaw JJ, Morris J, Nasim A. Ultrasound measurement of aortic diameter in a national screening programme. Eur J Vasc Endovasc Surg. 2011;42:199.
  23. Riegert-Johnson DL, Bruce CJ, Montori VM, Cook RJ, Spittell PC. Residents can be trained to detect abdominal aortic aneurysms using personal ultrasound imagers: A pilot study. Journal of the American Society of Echocardiography 2005;18(5).
  24. Beales L, Wolstenhulme S, Evans JA, West R, Scott DJ. Reproducibility of ultrasound measurement of the abdominal aorta. The British journal of surgery. 2011 Nov;98(11):1517-25.
  25. BMJ. John Wild. British Medical Journal. 2009;339:b4428
  26. Doppler Ultrasound History.  2012  [cited March 2012]; Available from: www.obgyn.net
  27. Sonesson B ST, Lanne T. . Abdominal aortic aneurysm wall mechanics and their relation to risk of rupture. . Eur J Vasc Endovasc Surg. 1999;18:493.
  28. US Food and Drug Administration. Radiological Health - Ultrasound Imaging.  2012  [cited January 2012]; Available from: http://www.fda.gov/default.htm
  29. Hangiandreou NJ. Physics Tutorial for Residents: Topics in US: B-mode US: Basic Concepts and New Technology Radiographics. 2003;23(4).
  30. Orenstein B. The ALARA Principle and Sonography. Radiology Today. 2011;12 (11).
  31. Brownsword R, Earnshaw JJ. The ethics of screening for abdominal aortic aneurysm in men. Journal of medical ethics. 2010 Dec;36(12):827-30.
  32. Robertson V. BK. A Review of Therapeutic Ultrasound: Effectiveness Studies. Physical Therapy. 2001;81(7):1350.
  33. Fillinger MF. MS, Raghavan ML., Kennedy FE. Prediction of rupture risk in abdominal aortic aneurysm during observation: wall stress versus diameter. Journal of Vascular Surgery. 2003;37 (4):732.
  34. Schäberle W. Ultraschall in der Gefäßdiagnostik. 3., vollst. überarb. und aktual. Aufl. ed. Berlin Springer; 2010.

Appendices

Appendix TEC-1 Result cards and related domains

Result card

Result card question

Related result cards

Features of the technology

B0001 (core)

What is Screening?

 

B0001 (core)

Are there different strategies for abdominal aortic aneurysm screening?

Partly related to A0012, D0029

B0001 (core)

Has any technical device for the detection of AAA established as internationally accepted golden standard?

Partly related to D0029, D0030

B0002 (core)

Why is abdominal aortic aneurysm screening used?

(Partly) related to A0001, A0009, B0001, C0008, D1019, D1007

B0003 (core)

What is the background of the golden standard technical device?

Partly related to A0019, A0020, F0001

B0004 (core)

Which professionals use the technology and is there a difference between the screening strategies?

Partly related to A0013, A0014

B0005 (core)

In what place and context are abdominal aortic aneurysm screening strategies intended to be used?

(Partly) related to G0001, G0005

B0006 (core)

Are there any special features relevant to the golden standard technical device for abdominal aortic aneurysm screening?

(Partly) related to C0007, C0060, D0022

B0016 (core)

To what population(s) will abdominal aortic aneurysm screening be used on?

(Partly) related to A0007, C0005, G0009

B0018 (core)

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

B0007 (core)

What material investments are needed to use the golden standard technical device for abdominal aortic aneurysm screening?

(Partly) related to B0010, E0001, E0002, G0006

B0009 (core)

What equipment and supplies are needed to use the golden standard technical device for abdominal aortic aneurysm screening?

(Partly) related to B0009, E0001, E0002, G0004

B0010 (core)

What kind of information is needed to monitor the use of the technical device for abdominal aortic aneurysm screening?

Related to G0008

Training and information needed to use the technology

B0012 (core)

What kind of qualification, training and quality assurance processes are needed for the use or maintenance of the technical device for abdominal aortic aneurysm screening?

Related to G0003, G0004, C0062, C0063

B0013 (core)

What kind of training is needed for the personnel treating or investigating patients using the technical device for abdominal aortic aneurysm screening?

Related to G0003, G0004, C0062, C0063


Safety

Authors: Iñaki Imaz, Sonia García-Pérez, Jesús González-Enríquez, Javiera Valdés, Andrés Fernández-Ramos, Carmen Bouza, Antonio Sarría-Santamera

Summary

We searched for studies that could provide us with information on the harms produced by the interventions that result from the implementation of an abdominal aortic aneurysm (AAA) screening programme, which are mainly the ultrasound diagnostic test and the surgical interventions to repair a detected AAA. We found large observational studies that describe the long-term consequences of the surgical repair of non-ruptured AAA. These studies describe large series of data that show what happens to subjects who undergo AAA repair without symptoms of rupture.

The harms include a short term (in-hospital and 30 days after surgery) overall mortality of between 1.15% and 4.8%, and a cumulative overall long-term mortality rate of 36% after 5 years of follow up. It has been reported that, after 8 years of follow up, of the deaths among patients who had an intact AAA repaired by endovascular aneurysm repair (EVAR), 24% were procedure-related and the rest (76%) were not related to surgical repair of the aneurysm.

Complications after intact AAA repairs are also frequent. After 4 years of follow-up, the rates of rupture were 1.8% after EVAR and 0.5% after open aneurysm repair (OAR); and the rate of AAA related interventions was 9% after EVAR and 1.7% after OAR, with 4 years of follow-up. Age, gender, preoperative morbidity, smoking and aneurysm size are relevant risk factors that predict outcomes in the elective AAA repairs that follow the detection of an AAA suitable for repair.

Ultrasonographic scanning is a highly accurate screening method for AAA. Close to 100% sensitivity and specificity values have been reported. The available information about harms indicates no relevant safety issues regarding the accuracy of the test used for AAA screening.

Inconsistent results have been found regarding psychological effects of an AAA screening programme. An appropriate design for measurement of changes in quality of life for participants versus not participants was not identified. Therefore, it is not possible to determine whether screening for AAA affects the health related quality of life among participants.

Relevant factors that can influence the safety profile of the AAA screening performance are hospital volume, surgeon volume, and surgeon´s specialisation in vascular surgery. The implementation of an AAA screening programme can increase the burden on local vascular surgical services by increasing the rate of elective repairs, but the need to operate on emergency ruptures can be reduced.

Introduction

The implementation of an abdominal aortic aneurysm (AAA) screening programme can cause harm to the screened subjects due to the expected increase in the number of detected AAAs (increase of incidence) and consequently in the number of surgical interventions to repair intact or non-ruptured AAAs suitable for repair. We have searched for information on AAA screening programme effects including psychological effects, on the impact of organisational issues on the screening effects and on the validity of the diagnostic tests. A search was focused on the effects produced by the interventions that come from the implementation of an AAA screening programme, which are mainly the surgical interventions to repair a detected AAA. The detection of an intact AAA may lead to a high risk surgical intervention to repair it. These interventions, carried out by EVAR (endovascular aneurysm repair) or OAR (open aneurysm repair), can cause serious harms in terms of mortality, morbidity and psychological effects. Some subjects may suffer early harms, even though the natural history of their AAA would not cause clinical problems during their lifetime.

The objective of this domain has been to describe the most important harms that derive for implement an AAA screening programme according to the available literature. We have considered that this information should come not only from articles that describe the performance of a screening programme but also from articles describing the surgical interventions to repair non-ruptured, elective, eligible, asymptomatic or intact AAAs. These terms are used as synonyms in the literature.

Methodology

Frame

The 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

Assessment elements

TopicIssue RelevantResearch questions or rationale for irrelevance
C0001Patient safetyWhat kind of harms can use of the technology cause to the patient; what are the incidence, severity and duration of harms?yesWhat harms can Screening for AAA cause to the screened subjects and what are the characteristics of the harms?
C0005Patient safetyAre there susceptible patient groups that are more likely to be harmed through use of the technology?yesAre there susceptible participant groups that are more likely to be harmed through use of the technology?
C0006Patient safetyWhat are the consequences of false positive, false negative and incidental findings brought about using the technology to the patients from the viewpoint of patient safety?yesWhat are the consequences of false positive, false negative and incidental findings brought about using Screening for AAA from the viewpoint of safety?
C0029Patient safetyDoes the existence of harms influence tolerability or acceptability of the technology?yesDoes the existence of harms influence tolerability or acceptability of Abdominal Aorta Aneurysm Screening?
C0007Patient safetyWhat are the special features in using (applying/interpreting/maintaining) the technology that may increase the risk of harmful events?yesWhat are the special features in using (applying/interpreting/maintaining) Screening for AAA that may increase safety risks?
C0002Patient safetyWhat is the dose relatedness of the harms to patients?noThis screening programme doesn't include different doses of intervention. The effects of diferent kind of Screening programmes will be assessed in the COO60 element of this domain.
C0003Patient safetyWhat is the timing of onset of harms to patients: immediate, early or late?noA precise description of harms, including their timing, will be included in the COOO1 element within this domain.
C0004Patient safetyIs the incidence of the harms to patients likely to change over time?noChanges over time dependant on the experience or learning curve performing the Screening Programme (i.e.: surgical interventions, diagnostic test, organizational issues) will be included in the C0007 element within this domain.
C0008Patient safetyWhat is the safety of the technology in comparison to alternative technologies used for the same purpose?noConsidering that mortality is the most relevant indicator to answer this question and that a comparison of mortality between screening and no screening is going to be provided in the “Clinical Effectiveness” domain (EFF1, EFF2, EFF3, EFF4, EFF24 questions), we consider this question already included in other Assessment Elements.
C0060Safety risk managementHow does the safety profile of the technology vary between different generations, approved versions or products?yesHow does the safety profile of the technology vary between different kind of Screening programmes?
C0061Safety risk managementIs there evidence that harms increase or decrease in different organizational settings?yesIs there evidence that harms increase or decrease in different organizational settings?
C0062Safety risk managementHow can one reduce safety risks for patients (including technology-, user-, and patient-dependent aspects)?yesHow can one reduce safety risks for screened subjects?
C0063Safety risk managementHow can one reduce safety risks for professionals (including technology-, user-, and patient-dependent aspects)?noThe introduction of a new health-care programme can affect organizations, including the health of their professionals. Those effects depend on the balance between new resources / new requirements allocated to the organization and how the organizations implement them. We have judged this issue irrelevant because it can be dealt with in a more coherent manner within the organizational domain.
C0064Safety risk managementHow can one reduce safety risks for environment (including technology-, user-, and patient-dependent aspects)?noThe procedures included in this screening programme don't cause relevant environmental risks.
C0020Occupational safetyWhat kind of occupational harms can occur when using the technology?noThe introduction of a new health-care programme can affect organizations, including the health of their professionals. Those effects depend on the balance between new resources / new requirements allocated to the organization and how the organizations implement them. We have judged this issue irrelevant because it can be dealt with in a more coherent manner within the organizational domain.
C0040Environmental safetyWhat kind of risks for public and environment may occur when using the technology?noThe procedures included in this screening programme don't cause relevant risks for public or environmental. Anyway, a precise description of harms will be included in the COOO1 element within this domain.

Methodology description

Information sources and selection criteria

In addition to the general bibliographic searches that were done for the whole project (Core HTA), four specific searches on Medline using OVID and Embase were also performed. The searches were limited to articles published after the year 1999. All the searches were done in June 2011.

The first search sought articles about harms and risks of AAA screening, including psychological aspects and test validity. Inclusion criteria:

  • Population-based systematic AAA screening that includes one single invitation for men and/or women aged 64 or over to do one ultrasound scan examination
  • OR opportunistic abdominal aneurysm screening suggested by the general practitioner for population at risk: smokers, apoplexy, arteriosclerosis, hypertension or chronic obstructive pulmonary disease (COPD)
  • AND describing harms associated with AAA screening including the psychological aspects, and ultrasonographic test validity.

The second search focused on effectiveness and adverse effects of AAA treatment, including open surgery and endovascular repair. Inclusion criteria:

  • Men and/or women aged 65 with non-ruptured AAA
  • AND AAA repair performed by open or endovascular surgery
  • AND describing harms, adverse effects and effectiveness of the AAA treatment.

The third search sought clinical trials and systematic reviews about health related effects of AAA screening. Inclusion criteria:

  • Population-based systematic AAA screening that includes one single invitation for men and/or women aged 64 or over to do one ultrasound scan examination
  • OR opportunistic abdominal aneurysm screening suggested by the general practitioner for population at risk: smokers, apoplexy, arteriosclerosis, hypertension or COPD
  • AND describing health related outcomes of screening AAA
  • AND randomised clinical trials or systematic review studies

The fourth search sought articles about the relationship between outcomes of AAA repair and characteristics of the health centre, surgeon and surgery team. Inclusion criteria:

  • Men and/or women aged 65 with non-ruptured AAA
  • AND AAA repair performed by open or endovascular surgery
  • AND describing the relationship between surgeon’s experience, surgery team’s experience, centre’s characteristics and risks and benefits of AAA surgical repair.

We retrieved also information from the general bibliographic searches that were done for the whole project (Core HTA for AAA Screening), and from other searches on the Cochrane and INAHTA databases, and from the references of the retrieved articles.

After reading the abstracts a list of 126 non-duplicated studies was available. The full texts of all of these articles were read and 52 of them were selected based on the inclusion criteria. The flow chart of the literature screening and selection process is shown in the figure {SAF Figure 1}.

106.SAF Figure 1

The template for study characteristics table (16 November 2011 version) that is proposed in the online tools was used to extract data from the articles. Individual tables of the included articles are available upon request.

Detailed methodology of the literature search, selection process and data extraction is available in {Appendix SAF-1}.

Result cards

Patient safety

Result card for SAF1: "What harms can Screening for AAA cause to the screened subjects and what are the characteristics of the harms?"

View full card
SAF1: What harms can Screening for AAA cause to the screened subjects and what are the characteristics of the harms?
Result
Comment

Importance: Critical

Transferability: Completely

Result card for SAF2: "Are there susceptible participant groups that are more likely to be harmed through use of the technology?"

View full card
SAF2: Are there susceptible participant groups that are more likely to be harmed through use of the technology?
Result

Importance: Critical

Transferability: Completely

Result card for SAF3: "What are the consequences of false positive, false negative and incidental findings brought about using Screening for AAA from the viewpoint of safety?"

View full card
SAF3: What are the consequences of false positive, false negative and incidental findings brought about using Screening for AAA from the viewpoint of safety?
Result

Importance: Critical

Transferability: Completely

Result card for SAF6: "Does the existence of harms influence tolerability or acceptability of Abdominal Aorta Aneurysm Screening?"

View full card
SAF6: Does the existence of harms influence tolerability or acceptability of Abdominal Aorta Aneurysm Screening?
Result

Importance: Optional

Transferability: Partially

Result card for SAF4: "What are the special features in using (applying/interpreting/maintaining) Screening for AAA that may increase safety risks?"

View full card
SAF4: What are the special features in using (applying/interpreting/maintaining) Screening for AAA that may increase safety risks?
Result

Importance: Important

Transferability: Partially

Safety risk management

Result card for SAF7: "How does the safety profile of the technology vary between different kind of Screening programmes?"

View full card
SAF7: How does the safety profile of the technology vary between different kind of Screening programmes?
Result

Importance: Optional

Transferability: Partially

Result card for SAF8: "Is there evidence that harms increase or decrease in different organizational settings?"

View full card
SAF8: Is there evidence that harms increase or decrease in different organizational settings?
Result

Importance: Optional

Transferability: Partially

Result card for SAF9: "How can one reduce safety risks for screened subjects?"

View full card
SAF9: How can one reduce safety risks for screened subjects?
Result

Importance: Important

Transferability: Partially

Discussion

The rationale for the screening is that early detection and treatment of asymptomatic AAA should extend life or improve quality of life compared with treatment at the time of symptomatic clinical diagnosis. However, the safety domain is focused on a description of the harms but not on the estimation of the effect of population-based AAA screening. To estimate the effect of the screening a comparison against a similar population must be done. This has not been the objective of our investigation given that the effectiveness domain covers those objectives.

Important sources of information for this domain have been large observational studies that describe what happens to patients who undergo the proposed intervention following screening within the programme. We have identified serious consequences for intact AAA repair in terms of mortality and morbidity and psychological effects.

Adverse events are variably and sometimes poor reported in randomised controlled trials {38,39}. We have identified real-world data from large observational studies describing the effect of the surgical repair of intact AAAs. We have found this information useful for estimating what might happen in a hypothetic situation if a screening programme was implemented in a European scenario. The implementation of an AAA screening programme in Europe would result in a high number of high-risk surgical interventions done in different kinds of healthcare systems, in different hospitals with different surgeons and to different patients.

The evidence table template for extracting data proposed in the online tool has been used. However, we found this template more oriented to clinical trials than observational studies. We did not find the assessment criteria proposed in that template completely applicable for our set of studies. The variability between methods and designs among our selected studies made it difficult to apply a systematic system for grading the evidence.

References

  1. European Society for Vascular Surgery. Second Vascular Surgery Database Report.  2008.  Dendrite Clinical Systems LTD.
  2. Schermerhorn ML, O'Malley AJ, Jhaveri A, Cotterill P, Pomposelli F, Landon BE. Endovascular vs. open repair of abdominal aortic aneurysms in the Medicare population. N Engl J Med 2008; 358(5):464-474.
  3. Koning G, Vallabhneni S, Marrewijk C, Leurs L, Laheij R, Buth J. Mortalidade relacionada ao tratamento endovascular do aneurisma da aorta abdominal com o uso dos modelos revisados. Revista Brasileira de Cirurgia Cardiovascular 2007; 22:7-14.
  4. Chaikof EL, Blankensteijn JD, Harris PL, White GH, Zarins CK, Bernhard VM et al. Reporting standards for endovascular aortic aneurysm repair. J Vasc Surg 2002; 35(5):1048-1060.
  5. Lindholt JS, Vammen S, Fasting H, Henneberg EW. Psychological consequences of screening for abdominal aortic aneurysm and conservative treatment of small abdominal aortic aneurysms. Eur J Vasc Endovasc Surg 2000; 20(1):79-83.
  6. Lucarotti ME, Heather BP, Shaw E, Poskitt KR. Psychological morbidity associated with abdominal aortic aneurysm screening. Eur J Vasc Endovasc Surg 1997; 14(6):499-501.
  7. Spencer CA, Norman PE, Jamrozik K, Tuohy R, Lawrence-Brown M, Spencer CA et al. Is screening for abdominal aortic aneurysm bad for your health and well-being? ANZ J Surg 2004; 74(12):1069-1075.
  8. Ashton HA, Buxton MJ, Day NE, Kim LG, Marteau TM, Scott RA et al. The Multicentre Aneurysm Screening Study (MASS) into the effect of abdominal aortic aneurysm screening on mortality in men: a randomised controlled trial. Lancet 2002; 360(9345):1531-1539.
  9. Marteau TM, Kim LG, Upton J, Thompson SG, Scott AP, Marteau TM et al. Poorer self assessed health in a prospective study of men with screen detected abdominal aortic aneurysm: a predictor or a consequence of screening outcome? J Epidemiol Community Health 2004; 58(12):1042-1046.
  10. Lederle FA, Johnson GR, Wilson SE, Acher CW, Ballard DJ, Littooy FN et al. Quality of life, impotence, and activity level in a randomized trial of immediate repair versus surveillance of small abdominal aortic aneurysm. J Vasc Surg 2003; 38(4):745-752.
  11. Chong T, Nguyen L, Owens CD, Conte MS, Belkin M. Suprarenal aortic cross-clamp position: a reappraisal of its effects on outcomes for open abdominal aortic aneurysm repair. J Vasc Surg 2009; 49(4):873-880.
  12. The UK Small Aneurysm Trial Participants. Long-Term Outcomes of Immediate Repair Compared with Surveillance of Small Abdominal Aortic Aneurysms. N Engl J Med 2002; 346(19):1445-1452.
  13. McPhee JT, Hill JS, Eslami MH. The impact of gender on presentation, therapy, and mortality of abdominal aortic aneurysm in the United States, 2001-2004. J Vasc Surg 2007; 45(5):891-899.
  14. Walschot LHB. Outcome after endovascular abdominal aortic aneurysm repair: A meta-analysis. J Endovasc Ther 2002; 9(1):82-89.
  15. Forbes TL, Lawlor DK, DeRose G, Harris KA. Gender differences in relative dilatation of abdominal aortic aneurysms. Ann Vasc Surg 2006; 20(5):564-568.
  16. Mastracci TM, Cina CS. Screening for abdominal aortic aneurysm in Canada: review and position statement of the Canadian Society for Vascular Surgery. J Vasc Surg 2007; 45(6):1268-1276.
  17. Brady AR, Fowkes FG, Greenhalgh RM, Powell JT, Ruckley CV, Thompson SG. Risk factors for postoperative death following elective surgical repair of abdominal aortic aneurysm: results from the UK Small Aneurysm Trial. On behalf of the UK Small Aneurysm Trial participants. Br J Surg 2000; 87(6):742-749.
  18. Egorova N, Giacovelli J, Gelijns A, Greco G, Moskowitz A, McKinsey J et al. Defining high-risk patients for endovascular aneurysm repair. J Vasc Surg 2009; 50(6):1271-1279.
  19. Wilmink AB, Forshaw M, Quick CR, Hubbard CS, Day NE, Wilmink ABM et al. Accuracy of serial screening for abdominal aortic aneurysms by ultrasound. J Med Screen 2002; 9(3):125-127.
  20. Lindholt JS, Vammen S, Juul S, Henneberg EW, Fasting H. The validity of ultrasonographic scanning as screening method for abdominal aortic aneurysm. Eur J Vasc Endovasc Surg 1999; 17(6):472-475.
  21. Beales L, Wolstenhulme S, Evans JA, West R, Scott DJ. Reproducibility of ultrasound measurement of the abdominal aorta. Br J Surg 2011; 98(11):1517-1525.
  22. Singh K, Jacobsen BK, Solberg S, Kumar S, Arnesen E. The difference between ultrasound and computed tomography (CT) measurements of aortic diameter increases with aortic diameter: analysis of axial images of abdominal aortic and common iliac artery diameter in normal and aneurysmal aortas. The Tromso Study, 1994-1995. Eur J Vasc Endovasc Surg 2004; 28(2):158-167.
  23. Karthikesalingam A, Hinchliffe RJ, Loftus IM, Thompson MM, Holt PJ, . Volume-outcome relationships in vascular surgery: the current status. J Endovasc Ther 2010; 17(3):356-365.
  24. Holt PJE. Meta-analysis and systematic review of the relationship between volume and outcome in abdominal aortic aneurysm surgery. Br J Surg 2007; 94(4):395-403.
  25. Young EL, Holt PJ, Poloniecki JD, Loftus IM, Thompson MM, Young EL et al. Meta-analysis and systematic review of the relationship between surgeon annual caseload and mortality for elective open abdominal aortic aneurysm repairs. J Vasc Surg 2007; 46(6):1287-1294.
  26. McPhee JT, Robinson WP, III, Eslami MH, Arous EJ, Messina LM, Schanzer A et al. Surgeon case volume, not institution case volume, is the primary determinant of in-hospital mortality after elective open abdominal aortic aneurysm repair. J Vasc Surg 2011; 53(3):591-599.
  27. Dimick JB, Cowan JA, Jr., Stanley JC, Henke PK, Pronovost PJ, Upchurch GR, Jr. Surgeon specialty and provider volumes are related to outcome of intact abdominal aortic aneurysm repair in the United States. J Vasc Surg 2003; 38(4):739-744.
  28. Pearce WH, Parker MA, Feinglass J, Ujiki M, Manheim LM. The importance of surgeon volume and training in outcomes for vascular surgical procedures. J Vasc Surg 1999; 29(5):768-776.
  29. Tu JV, Austin PC, Johnston KW, Tu JV, Austin PC, Johnston KW. The influence of surgical specialty training on the outcomes of elective abdominal aortic aneurysm surgery. J Vasc Surg 2001; 33(3):447-452.
  30. Thompson SG, Ashton HA, Gao L, Scott RA, Multicentre Aneurysm Screening Study Group., Thompson SG et al. Screening men for abdominal aortic aneurysm: 10 year mortality and cost effectiveness results from the randomised Multicentre Aneurysm Screening Study. BMJ 2009; 338:b2307.
  31. Jamrozik K, Norman PE, Spencer CA, Parsons RW, Tuohy R, Lawrence-Brown MM et al. Screening for abdominal aortic aneurysm: lessons from a population-based study. Med J Aust 2000; 173(7):345-350.
  32. Lindholt JS, Juul S, Henneberg EW, Fasting H. Is screening for abdominal aortic aneurysm acceptable to the population? Selection and recruitment to hospital-based mass screening for abdominal aortic aneurysm. J Public Health Med 1998; 20(2):211-217.
  33. Scott RA, Wilson NM, Ashton HA, Kay DN. Influence of screening on the incidence of ruptured abdominal aortic aneurysm: 5-year results of a randomized controlled study. Br J Surg 1995; 82(8):1066-1070.
  34. Jepson R, Clegg A, Forbes C, Lewis R, Sowden A, Kleijnen J. The determinants of screening uptake and interventions for increasing uptake: a systematic review. Health Technol Assess 2000; 4(14):i-133.
  35. Michie S, Smith D, Marteau TM. Patient decision making: An evaluation of two different methods of presenting information about a screening test. British Journal of Health Psychology 1997; 2(4):317-326.
  36. Guessous I, Dash C, Lapin P, Doroshenk M, Smith RA, Klabunde CN. Colorectal cancer screening barriers and facilitators in older persons. Prev Med 2010; 50(1-2):3-10.
  37. Couto E, Duffy SW, Ashton HA, Walker NM, Myles JP, Scott RA et al. Probabilities of progression of aortic aneurysms: estimates and implications for screening policy. J Med Screen 2002; 9(1):40-42.
  38. Ioannidis JPA, Lau J. Completeness of Safety Reporting in Randomized TrialsAn Evaluation of 7 Medical Areas. JAMA: The Journal of the American Medical Association 2001; 285(4):437-443.
  39. Pitrou I, Boutron I, Ahmad N, Ravaud P. Reporting of safety results in published reports of randomized controlled trials. Arch Intern Med 2009; 169(19):1756-1761.

Appendices

Appendix SAF-1 Safety domain specific search.

The following searches have been performed:

1. FIRST SEARCH

Search about harms and risks of AAA screening, including psychological aspects.

2. SECOND SEARCH

Search about effectiveness and adverse effects of AAA treatment, including open surgery and endovascular repair.

3. THIRD SEARCH

Search of clinical trials and systematic reviews about health related effects of AAA screening

4. FOURTH SEARCH

Search about the relation between Health Centre’s, surgeon’s and surgery team characteristics and risks and benefits of AAA repair.

The flow chart on the literature screen and selection process is included in the domain methodology section {SAF Figure 1}.

The first Medline search retrieved 144 references, 15 of them were selected after abstract screening and deletion of duplicates. The first Embase search retrieved 116 references, 4 of them were selected after abstract screening and deletion of duplicates.

The second Medline search retrieved 67 references, 40 of them were selected after abstract screening and deletion of duplicates. The second Embase search retrieved 22 references, 14 of them were selected after abstract screening and deletion of duplicates.

The third Medline search retrieved 88 references, 26 of them were selected after abstract screening and deletion of duplicates. The third Embase search retrieved 93 references, 3 of them were selected after abstract screening and deletion of duplicates.

The fourth Medline search retrieved 131 references, 28 of them were selected after abstract screening and deletion of duplicates. The fourth Embase search retrieved 40 references, 2 of them were selected after abstract screening and deletion of duplicates.

More references were retrieved and selected from other sources of information through searches on Cochrane, INAHTA databases, references from the articles retrieved and others sources.

After merging all of these sources of information a list of 126 non-duplicated  studies was available. The full texts of all of these articles were read by investigators of the domain, namely JGE, SGP, II, CA and CB. After reading all these articles 52 were selected because they met the inclusion criteria. The template for study characteristics table (version Nov 16 2011) that is proposed in the online tools was used to extract data from the articles. Individual tables of the articles are available upon request.

1. FIRST SEARCH

Search about harms and risks of AAA screening, including psychological aspects and test validity.

Inclusion criteria:

  • Population-based systematic AAA screening that includes one single invitation for men and/or women aged 64 or over to do one ultrasound scan examination OR
  • An opportunistic abdominal aneurysm screening suggested by the general practitioner for population at risk: smokers, apoplexy, arteriosclerosis, hypertension or COPD.
  • AND describing harms associated with AAA screening including the psychological aspect.

Name of the database or link/reference to other source: MEDLINE via OVID

Search string or search terms:

  1. Stress, psychological.sh .
  2. Anxiety.sh .
  3. (anxiety or anxious*) .ab.ti.
  4. Depression.sh .
  5. Depressive disorder .sh .
  6. depress*.ab.ti.
  7. harm* .ab.ti.
  8. adverse effect* .ab.ti .
  9. “Risk Assessment”
  10. “Predictive Value of Tests”
  11. “Attitude to Health”
  12. “Psychiatric Status Rating Scales”
  13. “Health Status”
  14. “Health Status Indicators”
  15. “Severity of Illness Index”
  16. “Quality of Life”
  17. false positive reactions.sh .
  18. false negative reactions .sh .
  19. or/1–18
  20. aortic aneurysm, abdominal .sh .
  21. mass screening.sh .
  22. screen* .ab.ti
  23. or/21–22
  24. 20 and 23
  25. 24 and 19
  26. Limits: Humans, Publication Date from 2000-current

Date of search 15/06/2011

Name and affiliation of person who performed the search: Javiera Valdés. AETS ISCIII.

Selection of studies

Number of references retrieved: 144

Abstract screen:

Number included 15

Name of the database or link/reference to other source: EMBASE

Search string or search terms

  1. stress/
  2. anxiety/
  3. (anxiety or anxious*).ti,ab.
  4. depression/
  5. "depress*".ti,ab.
  6. "adverse effect*".ti,ab.
  7. risk assessment/
  8. predictive value/
  9. attitude to health/
  10. psychological rating scale/
  11. health status/
  12. hospitalization/
  13. "quality of life"/
  14. laboratory diagnosis/
  15. 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12 or 13 or 14
  16. abdominal aorta aneurysm/
  17. mass screening/
  18. "screen*".ti,ab.
  19. 17 or 18
  20. 16 and 19
  21. 15 and 20
  22. limit 21 to (human and yr="2000 -Current")

Date of search 23/06/2011

Name and affiliation of person who performed the search Javiera Valdés. AETS ISCIII.

Selection of studies

Number of references retrieved: 116

Abstract screen:

Number included 4

Total selection for the first search after deletion of duplicates: 19 studies

2. SECOND SEARCH

Search about effectiveness and adverse effects of AAA treatment, including open surgery and endovascular repair.

Inclusion criteria:

  • Men and/or women aged 65 with non-ruptured AAA AND
  • AAA repair performed by open or endovascular surgery over AND
  • Describing harms, adverse effects and effectiveness of the AAA treatment.

Name of the database or link/reference to other source MEDLINE via OVID.

Search string or search terms

  1. safety management (MeSH) OR adverse effects.fs.
  2. "safety".ab.ti.tw.
  3. "adverse events".ab.ti.tw.
  4. 1 AND ( 2 or 3)
  5. ((Blood vessel prosthesis/ OR Blood vessel prosthesis implantation/ OR (endovascular repair.mp. OR evar.mp. OR Stents/) OR (vascular surgical procedures/ OR open surgery.mp.))
  6. (aortic aneurysm, abdominal).sh.
  7. 4 AND 5
  8. 7 AND 6
  9. limit 8 to humans and published 2000-current, (case reports or classical article or clinical trial, all or comparative study or controlled clinical trial or "corrected and republished article" or evaluation studies or introductory journal article or journal article or meta analysis or multicenter study or randomized controlled trial or "review" or "scientific integrity review" or technical report or validation studies)

Date of search 23/06/2011

Name and affiliation of person who performed the search Javiera Valdés. AETS ISCIII.

Selection of studies

Number of references retrieved: 67

Abstract screen:

Number included 40

Name of the database or link/reference to other source EMBASE

Search string or search terms

  1. safety/
  2. adverse drug reaction/ or adverse outcome/
  3. 1 or 2
  4. blood vessel prosthesis/ or blood vessel transplantation/
  5. interventional cardiovascular procedure/
  6. vascular surgery/
  7. abdominal aorta aneurysm/
  8. 3 or 4 or 5 or 6
  9. 7 and 8
  10. limit 9 to (human and (evidence based medicine or meta analysis or outcomes research or "systematic review") and (clinical trial or randomized controlled trial or controlled clinical trial or multicenter study) and yr="2000 -Current" and (article or journal or report or "review" or short survey))

Date of search 23/06/2011

Name and affiliation of person who performed the search Javiera Valdés. AETS ISCIII.

Selection of studies

Number of references retrieved: 22

Abstract screen:

Number included 14

Total selection for the second search after deletion of duplicates: 54 studies

3. THIRD SEARCH

Search of clinical trials and systematic reviews about health related effects of AAA screening

Inclusion criteria:

Clinical trials or systematic review studies about:

  • Population-based systematic AAA screening that includes one single invitation for men and/or women aged 64 or over to do one ultrasound scan examination OR
  • An opportunistic abdominal aneurysm screening suggested by the general practitioner for population at risk: smokers, apoplexy, arteriosclerosis, hypertension or COPD.
  • AND describing health related outcomes of screening AAA.

Name of the database or link/reference to other source : MEDLINE via OVID

Search string or search terms

  1. controlled clinical trials.sh .
  2. 2. randomized controlled trials.sh.
  3. multicenter studies.sh.
  4. 4. double-blind method .sh.
  5. meta-analysis.sh.
  6. random allocation .sh.
  7. 7. single-blind method.sh .
  8. controlled clinical trial. pt.
  9. meta analysis.pt .
  10. randomized controlled trial. pt.
  11. ( meta analy* OR metaanaly*) .ab.ti
  12. ( systematic* review* OR systematic* overview*).ab.ti.
  13. (quantitative* review* OR quantitative* overview*).ab.ti.
  14. evidence based review*.ab.ti.
  15. or/1-14
  16. Aortic aneurysm, abdominal .sh.
  17. 15 AND 16
  18. mass screening.sh.
  19. screen*.ab.ti.
  20. 17 AND (18 OR 19)
  21. 21. Limits: Humans, Publication Date from 2000-current

Date of search 13/06/2011

Name and affiliation of person who performed the search Javiera Valdés. AETS ISCIII.

Selection of studies

Number of references retrieved: 88

Abstract screen:

Number included 26

Name of the database or link/reference to other source: EMBASE

Search string or search terms

  1. controlled clinical trial/
  2. randomized controlled trial/
  3. multicenter study/
  4. double blind procedure/
  5. meta analysis/
  6. randomization/
  7. single blind procedure/
  8. (meta analy* or mataanaly*).ti,ab.
  9. (systematic* review* or systematic* overview*).ti,ab.
  10. (quantitative* review* or quantitative* overview*).ti,ab.
  11. "evidence based review*".ti,ab.
  12. 1 or 2 or 3 or 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11
  13. abdominal aorta aneurysm/
  14. 12 and 13
  15. mass screening/
  16. "scree*".ti,ab.
  17. 15 or 16
  18. 14 and 17
  19. limit 18 to (human and yr="2000 -Current")

Date of search 13/06/2011

Name and affiliation of person who performed the search Javiera Valdés. AETS ISCIII.

Selection of studies

Number of references retrieved: 93

Abstract screen:

Number included 3

Total selection for the third search after deletion of duplicates: 29

4. FOURTH SEARCH

Search about the relation between Health Centre’s, surgeon’s and surgery team characteristics and risks and benefits of AAA repair.

Inclusion criteria:

-

Name of the database or link/reference to other source MEDLINE via OVID

Search string or search terms

  1. learning curve.sh.
  2. "outcome and process assessment health care" .sh.
  3. clinical competence.sh.
  4. "standard of care".sh.
  5. health resources.sh.
  6. aortic aneurysm, abdominal.sh.
  7. 1 or 2 or 3 or 4 or 5
  8. 6 and 7
  9. limit 8 to humans and published 2000-current, (case reports or classical article or clinical trial, all or comparative study or controlled clinical trial or "corrected and republished article" or evaluation studies or introductory journal article or journal article or meta analysis or multicenter study or randomized controlled trial or "review" or "scientific integrity review" or technical report or validation studies)

Date of search 23/06/2011

Name and affiliation of person who performed the search Javiera Valdés. AETS ISCIII.

Selection of studies

Number of references retrieved: 131

Abstract screen:

Number included 28

Name of the database or link/reference to other source EMBASE

Search string or search terms

  1. learning curve/
  2. treatment outcome/
  3. clinical competence/
  4. health care planning/
  5. abdominal aorta aneurysm/
  6. 1 or 2 or 3 or 4
  7. 5 and 6
  8. limit 7 to (human and (evidence based medicine or meta analysis or outcomes research or "systematic review") and (clinical trial or randomized controlled trial or controlled clinical trial or multicenter study) and yr="2000 -Current" and (article or journal or report or "review" or short survey))

Date of search 23/06/2011

Name and affiliation of person who performed the search Javiera Valdés. AETS ISCIII.

Selection of studies

Number of references retrieved: 40

Abstract screen:

Number included 2

Total selection for the third search after deletion of duplicates: 30

LIST OF INCLUDED ARTICLES:

(1) Ashton HA, Buxton MJ, Day NE, Kim LG, Marteau TM, Scott RA et al. The Multicentre Aneurysm Screening Study (MASS) into the effect of abdominal aortic aneurysm screening on mortality in men: a randomised controlled trial. Lancet 2002; 360(9345):1531-1539.

(2) Ashton HA, Gao L, Kim LG, Druce PS, Thompson SG, Scott RA et al. Fifteen-year follow-up of a randomized clinical trial of ultrasonographic screening for abdominal aortic aneurysms. Br J Surg 2007; 94(6):696-701.

(3) Beales L, Wolstenhulme S, Evans JA, West R, Scott DJ. Reproducibility of ultrasound measurement of the abdominal aorta. Br J Surg 2011; 98(11):1517-1525.

(4) Becquemin JP, Pillet JC, Lescalie F, Sapoval M, Goueffic Y, Lermusiaux P et al. A randomized controlled trial of endovascular aneurysm repair versus open surgery for abdominal aortic aneurysms in low- to moderate-risk patients. J Vasc Surg 2011; 53(5):1167-1173.

(5) Brady AR, Fowkes FG, Greenhalgh RM, Powell JT, Ruckley CV, Thompson SG. Risk factors for postoperative death following elective surgical repair of abdominal aortic aneurysm: results from the UK Small Aneurysm Trial. On behalf of the UK Small Aneurysm Trial participants. Br J Surg 2000; 87(6):742-749.

(6) Chong T, Nguyen L, Owens CD, Conte MS, Belkin M. Suprarenal aortic cross-clamp position: a reappraisal of its effects on outcomes for open abdominal aortic aneurysm repair. J Vasc Surg 2009; 49(4):873-880.

(7) Coselli JS, Bozinovski J, LeMaire SA, Coselli JS, Bozinovski J, LeMaire SA. Open surgical repair of 2286 thoracoabdominal aortic aneurysms. Ann Thorac Surg 2007; 83(2):S862-S864.

(8) Couto E, Duffy SW, Ashton HA, Walker NM, Myles JP, Scott RA et al. Probabilities of progression of aortic aneurysms: estimates and implications for screening policy. J Med Screen 2002; 9(1):40-42.

(9) Dimick JB, Stanley JC, Axelrod DA, Kazmers A,Henke PK, Jacobs LA et al. Variation in death rate after abdominal aortic aneurysmectomy in theUnited States: impact of hospital volume, gender, and age. Ann Surg 2002; 235(4):579-585.

(10) Dimick JB, Cowan JA, Jr., Stanley JC, Henke PK, Pronovost PJ, Upchurch GR, Jr. Surgeon specialty and provider volumes are related to outcome of intact abdominal aortic aneurysm repair in the United States. J Vasc Surg 2003; 38(4):739-744.

(11) Dimick JB, Upchurch GR, Jr. Endovascular technology, hospital volume, and mortality with abdominal aortic aneurysm surgery. J Vasc Surg 2008; 47(6):1150-1154.

(12) Egorova N, Giacovelli J, Gelijns A, Greco G, Moskowitz A, McKinsey J et al. Defining high-risk patients for endovascular aneurysm repair. J Vasc Surg 2009; 50(6):1271-1279.

(13) Holt PJ, Poloniecki JD, Hofman D, Hinchliffe RJ, Loftus IM, Thompson MM et al. Re-interventions, readmissions and discharge destination: modern metrics for the assessment of the quality of care. Eur J Vasc Endovasc Surg 2010; 39(1):49-54.

(14) Holt PJE. Meta-analysis and systematic review of the relationship between volume and outcome in abdominal aortic aneurysm surgery. Br J Surg 2007; 94(4):395-403.

(15) Jamrozik K, Norman PE, Spencer CA, Parsons RW, Tuohy R, Lawrence-Brown MM et al. Screening for abdominal aortic aneurysm: lessons from a population-based study. Med J Aust 2000; 173(7):345-350.

(16) Jetty P, Hebert P, van Walraven C. Long-term outcomes and resource utilization of endovascular versus open repair of abdominal aortic aneurysms inOntario. J Vasc Surg 2010; 51(3):577-583.

(17) Jibawi A, Hanafy M, Guy A. Is there a minimum caseload that achieves acceptable operative mortality in abdominal aortic aneurysm operations? Eur J Vasc Endovasc Surg 2006; 32(3):273-276.

(18) Jim J, Rubin BG, Geraghty PJ, Criado FJ,Sanchez LA.Outcome of endovascular repair of small and large abdominal aortic aneurysms. Ann Vasc Surg 2011; 25(3):306-314.

(19) Kibbe MR, Matsumura JS, Excluder I. The Gore Excluder US multi-center trial: analysis of adverse events at 2 years. Semin Vasc Surg 2003; 16(2):144-150.

(20) Kim LG, Scott RA, Thompson SG, Collin J, Morris GE, Sutton GL et al. Implications of screening for abdominal aortic aneurysms on surgical workload. Br J Surg 2005; 92(2):171-176.

(21) Kim LG, RA PS, Ashton HA, Thompson SG, Multicentre Aneurysm Screening Study Group., Kim LG et al. A sustained mortality benefit from screening for abdominal aortic aneurysm.[Erratum appears in Ann Intern Med. 2007 Aug 7;147(3):216]. Ann Intern Med 2007; 146(10):699-706.

(22) Laheij RJ, van Marrewijk CJ, Buth J,Harris PL, EUROSTAR c. The influence of team experience on outcomes of endovascular stenting of abdominal aortic aneurysms. Eur J Vasc Endovasc Surg 2002; 24(2):128-133.

(23) Lederle FA, Johnson GR, Wilson SE, Acher CW, Ballard DJ, Littooy FN et al. Quality of life, impotence, and activity level in a randomized trial of immediate repair versus surveillance of small abdominal aortic aneurysm. J Vasc Surg 2003; 38(4):745-752.

(24) Lederle FA, Kane RL, MacDonald R, Wilt TJ. Systematic review: repair of unruptured abdominal aortic aneurysm. Ann Intern Med 2007; 146(10):735-741.

(25) Lederle FA, Freischlag JA, Kyriakides TC, Padberg FT, Jr., Matsumura JS, Kohler TR et al. Outcomes following endovascular vs open repair of abdominal aortic aneurysm: a randomized trial. JAMA 2009; 302(14):1535-1542.

(26) Lee WA, Carter JW, Upchurch G, Seeger JM, Huber TS. Perioperative outcomes after open and endovascular repair of intact abdominal aortic aneurysms in theUnited Statesduring 2001. Journal of Vascular Surgery 39[3], 491-496. 1-3-2004.

(27) Lindholt JS, Juul S, Henneberg EW, Fasting H. Is screening for abdominal aortic aneurysm acceptable to the population? Selection and recruitment to hospital-based mass screening for abdominal aortic aneurysm. J Public Health Med 1998; 20(2):211-217.

(28) Lindholt JS, Vammen S, Juul S, Henneberg EW, Fasting H. The validity of ultrasonographic scanning as screening method for abdominal aortic aneurysm. Eur J Vasc Endovasc Surg 1999; 17(6):472-475.

(29) Lindholt JS, Vammen S, Fasting H, Henneberg EW. Psychological consequences of screening for abdominal aortic aneurysm and conservative treatment of small abdominal aortic aneurysms. Eur J Vasc Endovasc Surg 2000; 20(1):79-83.

(30) Lovegrove REJ. A meta-analysis of 21,178 patients undergoing open or endovascular repair of abdominal aortic aneurysm. The British journal of surgery 2008; 95(6):677-684.

(31) Lucarotti ME, Heather BP, Shaw E, Poskitt KR. Psychological morbidity associated with abdominal aortic aneurysm screening. Eur J Vasc Endovasc Surg 1997; 14(6):499-501.

(32) Maher MMM. Abdominal aortic aneurysms: Elective endovascular repair versus conventional surgery - Evaluation with evidence-based medicine techniques. Radiology 2003; 228(3):647-658.

(33) Marteau TM, Kim LG, Upton J, Thompson SG, Scott AP, Marteau TM et al. Poorer self assessed health in a prospective study of men with screen detected abdominal aortic aneurysm: a predictor or a consequence of screening outcome? J Epidemiol Community Health 2004; 58(12):1042-1046.

(34) McPhee J, Eslami MH, Arous EJ, Messina LM, Schanzer A. Endovascular treatment of ruptured abdominal aortic aneurysms in theUnited States(2001-2006): a significant survival benefit over open repair is independently associated with increased institutional volume. J Vasc Surg 2009; 49(4):817-826.

(35) McPhee JT, Robinson WP, III, Eslami MH, Arous EJ, Messina LM, Schanzer A et al. Surgeon case volume, not institution case volume, is the primary determinant of in-hospital mortality after elective open abdominal aortic aneurysm repair. J Vasc Surg 2011; 53(3):591-599.

(36) McPhee JT, Hill JS, Eslami MH. The impact of gender on presentation, therapy, and mortality of abdominal aortic aneurysm in the United States, 2001-2004. J Vasc Surg 2007; 45(5):891-899.

(37) Nowygrod R, Egorova N, Greco G, Anderson P, Gelijns A, Moskowitz A et al. Trends, complications, and mortality in peripheral vascular surgery. J Vasc Surg 2006; 43(2):205-216.

(38) Polo-De Santos M, Luengo-Matos S, Munoz-Navarro B, Saz-Parkinson Z. Results from the monitoring use programme for endovascular repair of abdominal aortic aneurysms in Spain. Int Angiol 2009; 28(3):181-191.

(39) Prinssen M, Buskens E, Nolthenius RP, van Sterkenburg SM, Teijink JA, Blankensteijn JD. Sexual dysfunction after conventional and endovascular AAA repair: results of the DREAM trial. J Endovasc Ther 2004; 11(6):613-620.

(40) Schermerhorn ML, O'Malley AJ, Jhaveri A, Cotterill P, Pomposelli F, Landon BE. Endovascular vs. open repair of abdominal aortic aneurysms in the Medicare population. N Engl J Med 2008; 358(5):464-474.

(41) Scott RA, Wilson NM, Ashton HA, Kay DN. Influence of screening on the incidence of ruptured abdominal aortic aneurysm: 5-year results of a randomized controlled study. Br J Surg 1995; 82(8):1066-1070.

(42) Scott RA, Vardulaki KA, Walker NM, Day NE, Duffy SW, Ashton HA et al. The long-term benefits of a single scan for abdominal aortic aneurysm (AAA) at age 65. Eur J Vasc Endovasc Surg 2001; 21(6):535-540.

(43) Scott RA,BridgewaterSG, Ashton HA. Randomized clinical trial of screening for abdominal aortic aneurysm in women. Br J Surg 2002; 89(3):283-285.

(44) Spencer CA,NormanPE, Jamrozik K, Tuohy R, Lawrence-Brown M, Spencer CA et al. Is screening for abdominal aortic aneurysm bad for your health and well-being? ANZ J Surg 2004; 74(12):1069-1075.

(45) TheUKSmall Aneurysm Trial Participants. Long-Term Outcomes of Immediate Repair Compared with Surveillance of Small Abdominal Aortic Aneurysms. N Engl J Med 2002; 346(19):1445-1452.

(46) Thomas SM, Beard JD,IrelandM, Ayers S, Vascular Society ofGreat BritainandIreland, British Society of Interventional Radiology. et al. Results from the prospective registry of endovascular treatment of abdominal aortic aneurysms (RETA): mid term results to five years. Eur J Vasc Endovasc Surg 2005; 29(6):563-570.

(47) Thompson SG, Ashton HA, Gao L, Scott RA, Multicentre Aneurysm Screening Study Group., Thompson SG et al. Screening men for abdominal aortic aneurysm: 10 year mortality and cost effectiveness results from the randomised Multicentre Aneurysm Screening Study. BMJ 2009; 338:b2307.

(48) Tu JV,AustinPC, Johnston KW, Tu JV, Austin PC, Johnston KW. The influence of surgical specialty training on the outcomes of elective abdominal aortic aneurysm surgery. J Vasc Surg 2001; 33(3):447-452.

(49) van Marrewijk CJ, Leurs LJ, Vallabhaneni SR,Harris PL, Buth J, Laheij RJ et al. Risk-adjusted outcome analysis of endovascular abdominal aortic aneurysm repair in a large population: how do stent-grafts compare? J Endovasc Ther 2005; 12(4):417-429.

(50) Vardulaki KA, Walker NM, Couto E, Day NE, Thompson SG, Ashton HA et al. Late results concerning feasibility and compliance from a randomized trial of ultrasonographic screening for abdominal aortic aneurysm. Br J Surg 2002; 89(7):861-864.

(51) Walschot LHB. Outcome after endovascular abdominal aortic aneurysm repair: A meta-analysis. J Endovasc Ther 2002; 9(1):82-89.

(52) Wilmink AB, Forshaw M, Quick CR, Hubbard CS, Day NE, Wilmink ABM et al. Accuracy of serial screening for abdominal aortic aneurysms by ultrasound. J Med Screen 2002; 9(3):125-127.

LIST OF EXCLUDED ARTICLES:

(1)Abbruzzese TA, Kwolek CJ, Brewster DC, Chung TK, Kang J, Conrad MF et al. Outcomes following endovascular abdominal aortic aneurysm repair (EVAR): an anatomic and device-specific analysis. J Vasc Surg 2008; 48(1):19-28.

(2)Abularrage CJ, Sheridan MJ, Mukherjee D, Abularrage CJ, Sheridan MJ, Mukherjee D. Endovascular versus "fast-track'' abdominal aortic aneurysm repair. Vasc Endovascular Surg 2005; 39(3):229-236.

(3)Alonso-Perez M, Segura RJ, Sanchez J, Sicard G, Barreiro A, Garcia M et al. Factors increasing the mortality rate for patients with ruptured abdominal aortic aneurysms. Ann Vasc Surg 2001; 15(6):601-607.

(4)Becker GJ, Kovacs M, Mathison MN, Katzen BT, Benenati JF, Zemel G et al. Risk stratification and outcomes of transluminal endografting for abdominal aortic aneurysm: 7-year experience and long-term follow-up. J Vasc Interv Radiol 2001; 12(9):1033-1046.

(5)Becquemin JP, Allaire E, Desgranges P, Kobeiter H, Becquemin JP, Allaire E et al. Delayed complications following EVAR. Tech Vasc Interv Radiol 2005; 8(1):30-40.

(6)Blankensteijn JD, de Jong SE, Prinssen M, van der Ham AC, Buth J, van Sterkenburg SM et al. Two-year outcomes after conventional or endovascular repair of abdominal aortic aneurysms. N Engl J Med 2005; 352(23):2398-2405.

(7)Bosch JLK. Abdominal aortic aneurysms: Cost-effectiveness of elective endovascular and open surgical repair. Radiology 2002; 225(2):337-344.

(8)Bown MJS. A meta-analysis of 50 years of ruptured abdominal aortic aneurysm repair. Br J Surg 2002; 89(6):714-730.

(9)Buth J, Laheij RJ, Buth J, Laheij RJ. Early complications and endoleaks after endovascular abdominal aortic aneurysm repair: report of a multicenter study. J Vasc Surg 2000; 31(1 Pt1):134-146.

(10) Cau JR. Total Laparoscopic Aortic Repair for Occlusive and Aneurysmal Disease: First 95 Cases. Eur J Vasc Endovasc Surg 2006; 31(6):567-574.

(11) Chaikof EL, Chaikof EL. Caring for patients with an abdominal aortic aneurysm: data, knowledge, and wisdom. J Vasc Surg 2009; 50(4 Suppl):S1.

(12) Cho JS, Kim JY, Rhee RY, Gupta N, Marone LK, Dillavou ED et al. Contemporary results of open repair of ruptured abdominal aorto-iliac aneurysms: effect of surgeon volume on mortality. J Vasc Surg 2008; 48(1):10-17.

(13) Cuypers PW, Gardien M, Buth J, Charbon J, Peels CH, Hop W et al. Cardiac response and complications during endovascular repair of abdominal aortic aneurysms: a concurrent comparison with open surgery. J Vasc Surg 2001; 33(2):353-360.

(14) Davenport DL, O'Keeffe SD, Minion DJ, Sorial EE, Endean ED, Xenos ES et al. Thirty-day NSQIP database outcomes of open versus endoluminal repair of ruptured abdominal aortic aneurysms. J Vasc Surg 2010; 51(2):305-309.

(15) De Rango PC. Outcome after Endografting in Small and Large Abdominal Aortic Aneurysms: A Metanalysis. Eur J Vasc Endovasc Surg 2008; 35(2):162-172.

(16) Dzieciuchowicz L, Majewski W, Slowinski M, Krasinski Z, Jawien AA, Bieda K et al. Improved outcome after rupture of abdominal aortic aneurysm over an 18-year period. Ann Vasc Surg 2008; 22(1):25-29.

(17) Eckstein HH, Bockler D, Flessenkamper I, Schmitz-Rixen T, Debus S, Lang W et al. Ultrasonographic screening for the detection of abdominal aortic aneurysms. Dtsch 2009; 106(41):657-663.

(18) Enzler MA, van Marrewijk CJ, Buth J, Harris PL, Enzler MA, van Marrewijk CJ et al. [Endovascular therapy of aneurysms of the abdominal aorta: report of 4,291 patients of the Eurostar Register]. [German]. Vasa 2002; 31(3):167-172.

(19) Fassiadis NR. Is screening of abdominal aortic aneurysm effective in a general practice setting? International Angiology 2005;24(2):185-8.

(20) Flu WJ, van Kuijk JP, Merks EJ, Kuiper R, Verhagen HJ, Bosch JG et al. Screening for abdominal aortic aneurysms using a dedicated portable ultrasound system: early results. Eur J Echocardiogr 2009; 10(5):602-606.

(21) Forbes TL, DeRose G, Kribs SW, Harris KA, Forbes TL, DeRose G et al. Cumulative sum failure analysis of the learning curve with endovascular abdominal aortic aneurysm repair. J Vasc Surg 2004; 39(1):102-108.

(22) Forbes TL, DeRose G, Lawlor DK, Harris KA, Forbes TL, DeRose G et al. The association between a surgeon's learning curve with endovascular aortic aneurysm repair and previous institutional experience. Vasc Endovascular Surg 2007; 41(1):14-18.

(23) Giles KA, Hamdan AD, Pomposelli FB, Wyers MC, Dahlberg SE, Schermerhorn ML et al. Population-based outcomes following endovascular and open repair of ruptured abdominal aortic aneurysms. J Endovasc Ther 2009; 16(5):554-564.

(24) Greenberg R, Zenith I, Greenberg R, Zenith I. The Zenith AAA endovascular graft for abdominal aortic aneurysms: clinical update. Semin Vasc Surg 2003; 16(2):151-157.

(25) Hamerlynck JV, Legemate DA, Hooft L, Hamerlynck JVTH, Legemate DA, Hooft L. [From the Cochrane Library: ultrasonographic screening for abdominal aortic aneurysm in men aged 65 years and older: low risk of fatal aneurysm rupture]. [Dutch]. Ned Tijdschr Geneeskd 2008; 152(13):747-749.

(26) Harris PL, Vallabhaneni SR, Desgranges P, Becquemin JP, van Marrewijk C, Laheij RJ et al. Incidence and risk factors of late rupture, conversion, and death after endovascular repair of infrarenal aortic aneurysms: the EUROSTAR experience. European Collaborators on Stent/graft techniques for aortic aneurysm repair. J Vasc Surg 2000; 32(4):739-749.

(27) HobbsS.Claridge. Strategies to improve the effectiveness of abdominal aortic aneurysm screening programmes. J Med Screen 2004; 11(2):93-96.

(28) Hogh AG. False-positive findings in screening for abdominal aortic aneurysm. Ugeskr Laeger 2009; 171(43):3101-3102.

(29) IrvineCDS. A comparison of the mortality rate after elective repair of aortic aneurysms detected either by screening or incidentally. Eur J Vasc Endovasc Surg 2000; 20(4):374-378.

(30) Jim J, Rubin BG, Geraghty PJ, Criado FJ, Fajardo A, Sanchez LA. A 5-year comparison of EVAR for large and small aortic necks. J Endovasc Ther 2010; 17(5):575-584.

(31) Jordan WD, Jr., Moore WM, Jr., Melton JG, Brown OW, Carpenter JP, Endologix I, et al. Secure fixation following EVAR with the Powerlink XL System in wide aortic necks: results of a prospective, multicenter trial. J Vasc Surg 2009 Nov;50(5):979-86.

(32) Karthikesalingam A, Hinchliffe RJ, Loftus IM, Thompson MM, Holt PJ, . Volume-outcome relationships in vascular surgery: the current status. J Endovasc Ther 2010; 17(3):356-365.

(33) Lawrence-Brown MM, Norman PE, Jamrozik K, Semmens JB,DonnellyNJ, Spencer C et al. Initial results of ultrasound screening for aneurysm of the abdominal aorta inWestern Australia: relevance for endoluminal treatment of aneurysm disease. Cardiovasc Surg 2001; 9(3):234-240.

(34) Lederle FA, Johnson GR, Wilson SE, Chute EP, Hye RJ, Makaroun MS et al. The aneurysm detection and management study screening program: validation cohort and final results. Aneurysm Detection and Management Veterans Affairs Cooperative Study Investigators. Arch Intern Med 2000; 160(10):1425-1430.

(35) Lee ES, Pickett E, Hedayati N, Dawson DL, Pevec WC, Lee ES et al. Implementation of an aortic screening program in clinical practice: implications for the Screen For Abdominal Aortic Aneurysms Very Efficiently (SAAAVE) Act. J Vasc Surg 2009; 49(5):1107-1111.

(36) Lesperance K, Andersen C, Singh N, Starnes B, Martin MJ, Lesperance K et al. Expanding use of emergency endovascular repair for ruptured abdominal aortic aneurysms: disparities in outcomes from a nationwide perspective. J Vasc Surg 2008; 47(6):1165-1170.

(37) Lin PH, Bush RL, Milas M, Terramani TT, Dodson TF, Chen C et al. Impact of an endovascular program on the operative experience of abdominal aortic aneurysm in vascular fellowship and general surgery residency. Am J Surg 2003; 186(2):189-193.

(38) Lindholt JS, Vammen S, Henneberg EW, Fasting H, Juul S, Lindholt JS et al. [Optimal interval screening and observation of abdominal aortic aneurysms]. [Danish]. Ugeskr Laeger 2001; 163(37):5034-5037.

(39) Lindholt JS, Juul S, Fasting H, Henneberg EW, Lindholt JS, Juul S et al. Screening for abdominal aortic aneurysms: single centre randomised controlled trial.[Erratum appears in BMJ. 2005 Oct 15;331(7521):876]. BMJ 2005; 330(7494):750.

(40) Lindholt JS, Juul S, Fasting H, Henneberg EW. [Screening reduced abdominal aortic aneurysm mortality--secondary publication. Results from a Danish randomized screening trial]. Ugeskr Laeger 2005; 167(15):1641-1644.

(41) Lindholt JS, Juul S, Fasting H, Henneberg EW, Lindholt JS, Juul S et al. Preliminary ten year results from a randomised single centre mass screening trial for abdominal aortic aneurysm. Eur J Vasc Endovasc Surg 2006; 32(6):608-614.

(42) Lobato AC, Rodriguez-Lopez J, Diethrich EB, Lobato AC, Rodriguez-Lopez J, Diethrich EB. Learning curve for endovascular abdominal aortic aneurysm repair: evaluation of a 277-patient single-center experience. J Endovasc Ther 2002; 9(3):262-268.

(43) Londero H, Lev G, Bertoni H, Mendaro E, Santaera O, Martinez RL et al. Safety and feasibility of balloon-expandable stent implantation for the treatment of type I endoleaks following endovascular aortic abdominal aneurysm repair. Eurointervention 2011; 6(6):740-743.

(44) LottmanPE, Laheij RJ, Cuypers PW, Bender M, Buth J, Lottman PEM et al. Health-related quality of life outcomes following elective open or endovascular AAA repair: a randomized controlled trial. J Endovasc Ther 2004; 11(3):323-329.

(45) Mastracci TMG. Endovascular repair of ruptured abdominal aortic aneurysms: A systematic review and meta-analysis. J Vasc Surg 2008; 47(1):214-221.

(46) Matsumoto AH. What Randomized Controlled Trials Tell Us About Endovascular Repair of Abdominal Aortic Aneurysms. Journal of Vascular and Interventional Radiology 2008; 19(6 SUPPL.):S18-S21.

(47) Montreuil B, Brophy J, Montreuil B, Brophy J. Screening for abdominal aortic aneurysms in men: a Canadian perspective using Monte Carlo-based estimates. Can J Surg 2008; 51(1):23-34.

(48) Multicentre Aneurysm Screening Study Group. Multicentre aneurysm screening study (MASS): cost effectiveness analysis of screening for abdominal aortic aneurysms based on four year results from randomised controlled trial. BMJ 2002; 325(7373):1135.

(49) Muszbek NT. Systematic Review of Utilities in Abdominal Aortic Aneurysm. Eur J Vasc Endovasc Surg 2008; 36(3):283-289.

(50) Nordon IMH. Modern Treatment of Juxtarenal Abdominal Aortic Aneurysms with Fenestrated Endografting and Open Repair - A Systematic Review. Eur J Vasc Endovasc Surg 2009; 38(1):35-41.

(51) Norman PE, Jamrozik K, Lawrence-Brown MM, Le MT, Spencer CA, Tuohy RJ et al. Population based randomised controlled trial on impact of screening on mortality from abdominal aortic aneurysm.[Erratum appears in BMJ. 2005 Mar 12;330(7491):596]. BMJ 2004; 329(7477):1259.

(52) Ouriel K. Randomized clinical trials of endovascular repair versus surveillance for treatment of small abdominal aortic aneurysms. J Endovasc Ther 2009; 16 Suppl 1(pp I94-105):Feb.

(53) Pande RLB. Abdominal Aortic Aneurysm: Populations at Risk and How to Screen. Journal of Vascular and Interventional Radiology 2008; 19 (6 SUPPL):S2-S8.

(54) Rafii BY, Abilez OJ, Benharash P, Zarins CK, Rafii BY, Abilez OJ et al. Lateral movement of endografts within the aneurysm sac is an indicator of stent-graft instability. J Endovasc Ther 2008; 15(3):335-343.

(55) Reilly LM. Endovascular Repair of Abdominal Aortic Aneurysms Reduces Perioperative Morbidity and Mortality. Journal of Cardiothoracic and Vascular Anesthesia 2003; 17(5):655-658.

(56) Ricco JB, InterGard Silver Study Group., Ricco JB, InterGard Silver Study Group. InterGard silver bifurcated graft: features and results of a multicenter clinical study. J Vasc Surg 2006; 44(2):339-346.

(57) Rosenthal R, von Kanel O, Eugster T, Stierli P, Gurke L, Rosenthal R et al. Does specialization improve outcome in abdominal aortic aneurysm surgery?.[Erratum appears in Vascular. 2006 Jan-Feb;14(1):54]. Vascular 2005; 13(2):107-113.

(58) Roshanali F, Mandegar MH, Yousefnia MA, Mohammadi A, Baharvand B, Roshanali F et al. Abdominal aorta screening during transthoracic echocardiography. Echocardiography 2007; 24(7):685-688.

(59) Sadat UB. Endovascular vs open repair of acute abdominal aortic aneurysms-A systematic review and meta-analysis. J Vasc Surg 2008; 48(1):227-236.

(60) Salhab M, Farmer J, Osman I, Salhab M, Farmer J, Osman I. Impact of delay on survival in patients with ruptured abdominal aortic aneurysm. Vascular 2006; 14(1):38-42.

(61) Schmidt T, Muhlberger N, Chemelli-Steingruber IE, Strasak A, Kofler B, Chemelli A et al. Benefit, risks and cost-effectiveness of screening for abdominal aortic aneurysm. ROFO Fortschr Geb Rontgenstr Nuklearmed 2010; 182(7):573-580.

(62) Schmiedt W, Duber C, Pitton M, Neufang A, Dorweiler B, Herber S et al. [Endovascular aneurysm therapy--long-term treatment outcomes after 7 years]. [German]. Med Klin 2002; 97(4):204-208.

(63) Schunn CD, Krauss M, Heilberger P, Ritter W, Raithel D, Schunn CD et al. Aortic aneurysm size and graft behavior after endovascular stent-grafting: clinical experiences and observations over 3 years. J Endovasc Ther 2000; 7(3):167-176.

(64) Stella A, Freyrie A, Gargiulo M, Faggioli GL, Stella A, Freyrie A et al. The advantages of Anaconda endograft for AAA. J Cardiovasc Surg (Torino) 2009; 50(2):145-152.

(65) Stolberg HO. Treatment of abdominal aortic aneurysms: review with evidence-based methods. Radiology 2003; 228(3):614-616.

(66) Subramanian K, Woodburn KR, Travis SJ, Hancock J, Subramanian K, Woodburn KR et al. Secondary interventions following endovascular repair of abdominal aortic aneurysm. Diagn Interv Radiol 2006; 12(2):99-104.

(67) Sultan S, Hynes N. Clinical efficacy and cost per quality-adjusted life years of pararenal endovascular aortic aneurysm repair compared with open surgical repair. J Endovasc Ther 2011 Apr;18(2):181-96.

(68) Turnbull IC, Criado FJ, Sanchez L, Sadek M, Malik R, Ellozy SH, et al. Five-year results for the Talent enhanced Low Profile System abdominal stent graft pivotal trial including early and long-term safety and efficacy. J Vasc Surg 544 Mar;51(3):537-44.

(69) Vammen S, Lindholt JS, Ostergaard L, Fasting H, Henneberg EW. Randomized double-blind controlled trial of roxithromycin for prevention of abdominal aortic aneurysm expansion.[Erratum appears in Br J Surg 2002 Jan;89(1):120-1]. Br J Surg 2001; 88(8):1066-1072.

(70) van Gils PF, de Wit GA, Schuit AJ, van den Berg M. Screening for abdominal aortic aneurysm; effectivity and cost-effectiveness. Ned Tijdschr Geneeskd 2009; 153 (pp B383).

(71) van Walraven C, Wong J, Morant K, Jennings A, Jetty P, Forster AJ et al. Incidence, follow-up, and outcomes of incidental abdominal aortic aneurysms. J Vasc Surg 2010; 52(2):282-289.

(72) Vogel TR, Dombrovskiy VY, Graham AM, Vogel TR, Dombrovskiy VY, Graham AM. Elective abdominal aortic aneurysm repair: relationship of hospital teaching status to repair type, resource use, and outcomes. J Am Coll Surg 2009; 209(3):356-363.

(73) Wanhainen A, Rosen C, Rutegard J, Bergqvist D, Bjorck M, Wanhainen A et al. Low quality of life prior to screening for abdominal aortic aneurysm: a possible risk factor for negative mental effects. Ann Vasc Surg 2004; 18(3):287-293.

(74) Young EL, Holt PJ, Poloniecki JD, Loftus IM, Thompson MM, Young EL et al. Meta-analysis and systematic review of the relationship between surgeon annual caseload and mortality for elective open abdominal aortic aneurysm repairs. J Vasc Surg 2007; 46(6):1287-1294.

Appendix SAF-2. Table on complications from intact abdominal aortic aneurysm repairs

Table. Medicare reported complications data from 45,660 intact abdominal aortic aneurysm repairs performed by EVAR (endovascular aneurysm repair) and OAR (open aneurysm repair)*. With author’s permission.

 

EVAR (N=22,830)

OAR (N=22,830)

Medical Complications (% of patients)

  

Myocardial infarction

7

9.4

Pneumonia

9.3

17.4

Acute renal failure

5.5

10.9

Renal failure requiring dialysis

0.4

0.5

Deep-vein thrombosis or pulmonary embolism

1.1

1.7

Surgical complications (% of patients)

  

Conversion to open repair

1.6

-

Acute mesenteric ischemia

1.0

2.1

Reintervention for bleeding

0.8

1.2

Tracheostomy

0.2

1.5

Thrombectomy

0.4

0.2

Embolectomy

1.3

1.7

Repair of infected graft of graft-enteric fistula

0.01

0.09

Major amputation

0.04

0.13

Complications related to laparatomy

  

Lysis of adhesions without resection

0.1

1.2

Bowel resection

0.6

1.3

Ileus of bowel obstruction without resection of lysis of adhesions

5.1

16.7

Mean length of hospital stay (nº of days)

3.4 + 4.7

9.3 + 8.1

Discharge home (% of survivors)

94.5

81.6

  • Schermerhorn ML, O'Malley AJ, Jhaveri A, Cotterill P, Pomposelli F, Landon BE. Endovascular vs. open repair of abdominal aortic aneurysms in the Medicare population. N Engl J Med 2008; 358(5):464-474.

Clinical Effectiveness

Authors: Katrine Frønsdal, Stefan Sauerland and Ingvil Sæterdal

Summary

Available evidence indicates that screening for abdominal aortic aneurysm (AAA) can result in a reduction of AAA-related mortality both in the long term (after 7 to 15 years) and in the medium term (3.5 to 5 years) in men, but not in women. The evidence, however, does not support a reduction in long-term or medium term overall mortality as a result of AAA screening in men.

No systematic reviews (SRs) or randomised controlled trials (RCTs) have assessed whether AAA screening might modify the symptoms or findings of AAA. Although morbidities associated with the complications of surgery, such as distal embolus, haemorrhage and graft failure, coronary and cerebrovascular events or renal complications, were assessed in one of the included SRs, the authors did not find any relevant studies, and thus could not estimate the effect of AAA screening on these morbidity outcomes. Nevertheless, in terms of progression of the condition, there is evidence that AAA screening reduces the incidence of rupture AAA in men, but this is not the case in women. No evidence was provided on how AAA screening might modify the effectiveness of subsequent AAA screenings.

Whereas no SRs or RCTs have assessed functional outcomes related to global function, return to previous living conditions or activities of daily living, return to work was assessed in one of the included SRs, but the authors of this SR did not find any relevant studies, and thus did not estimate the effect of AAA screening on this outcome.

In terms of outcomes related to quality of life and patient satisfaction, there is evidence that supports reduced anxiety and depression in AAA-screened individuals (no information on gender indicated), but no change in mental quality of life. No SR or RCT, however, assessed the effect of AAA screening on disease-specific quality of life, studied whether knowledge of the ultrasound result might affect the patient’s life quality or determined whether AAA screening was worthwhile or not. Nevertheless, acceptance rates described in one SR provide an indication that overall, patients are willing to be screened for AAA. Acceptance of invitations to be screened is highest in men and women aged 65, and decreases with age.

Regarding outcomes related to change in management, no SR or RCT has assessed how use of the test may change physicians’ management decisions or whether AAA screening detects other potential health conditions that may impact subsequent management decisions. There is evidence, however, indicating that AAA screening modifies the need for other technologies and resources in terms of planned and emergency operations; the evidence indicates that AAA-screened men both in the long-term (7 to 15 years) and in the medium term (3.5 to 5 years) have more planned operations and fewer emergency operations that non-screened men.

Intra- and inter-observer variation in ultrasound aorta diameter measurements was the only outcome related to accuracy that was assessed in the included literature. One SR indicates overall acceptable intra-observer repeatability and acceptable inter-observer reproducibility. However, the evidence provided in the review is hampered by the fact that primary reliability and agreement studies could not be assessed systematically with regard to their quality. In addition, there were large variations in settings, examiner qualifications and training, sonography equipment and statistical analyses. The evidence does not allow any definite conclusions to be drawn about the importance of experience or background discipline.

Introduction

Abdominal aortic aneurysm (AAA) is discovered in 5% to 10% of men aged 65 to 79 years; its major complication is rupture, which calls for emergency surgery. After rupture, mortality is high, i.e. 80% for patients who reach hospital and 50% for patients who undergo surgery for emergency repair. Currently, for aneurysms found to be larger than 5.5 cm, elective surgical repair is recommended to prevent rupture (Cosford 2007, and references therein). For these reasons, there is increasing interest in AAA population screening to detect, monitor and repair abdominal aortic aneurysms before rupture.

The objectives of assessing the clinical effectiveness of population-based AAA screening were to determine whether such screening could improve clinical outcomes, in terms of mortality, morbidity, need for subsequent treatment, overall function, and outcomes related to quality of life (QoL) and patient satisfaction. Additional aims of this domain were to assess accuracy issues and issues related to possible changes in management.

Methodology

Frame

The 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

Assessment elements

TopicIssue RelevantResearch questions or rationale for irrelevance
D0001MortalityWhat is the effect of the intervention on overall mortality?yesWhat is the effect of Abdominal Aorta Aneurysm Screening on overall mortality?
D0002MortalityWhat is the effect of the intervention on the mortality caused by the target disease?yesWhat is the effect of Abdominal Aorta Aneurysm Screening on the mortality caused by the target disease?
D0003MortalityWhat is the effect of the intervention on the mortality due to other causes than the target disease?yesWhat is the effect of Abdominal Aorta Aneurysm Screening on the mortality due to other causes than the target disease?
D0004MortalityWhat is the mortality related to the diagnostic test?yesWhat is the mortality related to the diagnostic test?
D0005MorbidityHow does the use of the technology modify the symptoms and findings of the target condition?yesHow does the use of Abdominal Aorta Aneurysm Screening modify the symptoms and findings of the target condition?
D0006MorbidityHow does the technology modify the progression of the target condition?yesHow does Abdominal Aorta Aneurysm Screening modify the progression of the target condition?
D0026MorbidityHow does the technology modify the effectiveness of subsequent interventions?yesHow does Abdominal Aorta Aneurysm Screening modify the effectiveness of subsequent Abdominal Aorta Aneurysm Screening s?
D0008MorbidityWhat is the morbidity directly related to the technology?yesWhat is the morbidity directly related to Abdominal Aorta Aneurysm Screening ?
D0011FunctionWhat is the effect of the intervention on global function?yesWhat is the effect of Abdominal Aorta Aneurysm Screening on global function?
D0014FunctionWhat is the effect of the technology on return to work?yesWhat is the effect of Abdominal Aorta Aneurysm Screening on return to work?
D0015FunctionWhat is the effect of the technology on return to previous living conditions?yesWhat is the effect of Abdominal Aorta Aneurysm Screening on return to previous living conditions?
D0016FunctionHow does use of the technology affect activities of daily living?yesHow does use of Abdominal Aorta Aneurysm Screening affect activities of daily living?
D0012Quality of lifeWhat is the effect of the technology on generic health-related quality of life?yesWhat is the effect of Abdominal Aorta Aneurysm Screening on generic health-related quality of life?
D0013Quality of lifeWhat is the effect of the technology on disease specific quality of life?yesWhat is the effect of Abdominal Aorta Aneurysm Screening on disease specific quality of life?
D0030Quality of lifeDoes the knowledge of the test result affect the patient's non-health-related quality of life?yesDoes the knowledge of the test result affect the patient's non-health-related quality of life?
D0017Patient satisfactionWas the use of the technology worthwhile?yesWas the use of Abdominal Aorta Aneurysm Screening worthwhile?
D0018Patient satisfactionIs the patient willing to use the technology?yesIs the patient willing to use Abdominal Aorta Aneurysm Screening ?
D0020Change-in managementDoes use of the test lead to improved detection of the condition?yesDoes use of the test lead to improved detection of the condition?
D0021Change-in managementHow does the use of the test change physicians' management decisions?yesHow does the use of the test change physicians' management decisions?
D0024Change-in managementIs there an effective treatment for the condition the test is detecting?yesIs there an effective treatment for the condition the test is detecting?
D0022Change-in managementDoes the test detect other potential health conditions that can impact the subsequent management decisions?yesDoes the test detect other potential health conditions that can impact the subsequent management decisions?
D0023Change-in managementHow does the technology modify the need for other technologies and use of resources?yesHow does Abdominal Aorta Aneurysm Screening modify the need for other technologies and use of resources?
D1003Test accuracyWhat is the reference standard and how likely does it classify the target condition correctly?yesWhat is the reference standard and how likely does it classify the target condition correctly?
D1004Test accuracyWhat are the requirements for accuracy in the context the technology will be used?yesWhat are the requirements for accuracy in the context Abdominal Aorta Aneurysm Screening will be used?
D1005Test accuracyWhat is the optimal threshold value in this context?yesWhat is the optimal threshold value in this context?
D1006Test accuracyDoes the test reliably rule in or rule out the target condition?yesDoes the test reliably rule in or rule out the target condition?
D1007Test accuracyHow does test accuracy vary in different settings?yesHow does test accuracy vary in different settings?
D1008Test accuracyWhat is known about the intra- and inter-observer variation in test interpretation?yesWhat is known about the intra- and inter-observer variation in test interpretation?
D0027Test accuracyWhat are the negative consequences of further testing and delayed treatment in patients with false negative test result?yesWhat are the negative consequences of further testing and delayed treatment in patients with false negative test result?
D0028Test accuracyWhat are the negative consequences of further testing and treatments in patients with false positive test result?yesWhat are the negative consequences of further testing and treatments in patients with false positive test result?
D1001Test accuracyWhat is the accuracy of the test against reference standard?noUltrasound used for AAA-screening is the gold standard
D1002Test accuracyHow does the test compare to other optional tests in terms of accuracy measures?noUltrasound used for AAA-screening is the gold standard
D1019Test accuracyIs there evidence that the replacing test is more specific or safer than the old one?noUltrasound used for AAA-screening is the gold standard
D0029Benefit-harm balanceWhat are the overall benefits and harms of the technology in health outcomes?yesWhat are the overall benefits and harms of Abdominal Aorta Aneurysm Screening in health outcomes?

Methodology description

According to objectives of the domain, described above, assessment elements (AEs) corresponding to specific research questions were selected for inclusion in this health technology assessment (HTA; see Core HTA Protocol for Abdominal Aorta Aneurysm Screening, Protocol Design). Answers to the selected research questions are presented as result cards. An overview of these is shown in Table 2. Of note, the protocol was reviewed by the EUnetHTA Stakeholder Advisory Group (SAG) before the assessments of the research questions took place. Responses from the SAG for this domain are shown in Appendix EFF-1 Section 2.

In the protocol several research questions were closely related across domains. Which domains would cover which AEs was therefore agreed between the domains involved. An overview of these agreements is shown in Appendix EFF-1 Section 1.

As guidance on how to assess clinical effectiveness, the investigators used the Handbook for Summarising Evidence from the Norwegian Knowledge Centre for the Health Services (NOKC 2011), and guidelines from the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011).

Domain frame

The project scope was applied in this domain.

Information sources

The basic literature search

A basic search strategy to identify systematic reviews (SRs) and randomised controlled trials (RCTs) to suit the overall project definition was developed by investigators from the different domains. This search strategy combined MeSH terms on the intervention exclusively (Appendix EFF-1 Section 3a). Searches for SRs and RCTs were performed by a research librarian from NOKC in the Cochrane Database, DARE and HTA databases via the Cochrane Library and CRD, as well as in EMBASE, MEDLINE and ISI databases (Appendix EFF-1 Section 3b). All references from these searches, updating searches, and an additional hand search performed in PubMed are listed in Appendix EFF-3.

Selection of the literature from the basic search

Selection of SRs and RCTs was done according to criteria for relevance (see Inclusion criteria and Exclusion criteria below) and criteria for quality. Quality had to be assessed as medium or high using validated checklists suited for SRs and RCTs (Appendix EFF-1, Sections 4 and 5). All outcomes relevant to selected assessment elements were included.

Inclusion criteria

Study design: SR and RCT

Population: Men and women from 64

Intervention: Population-based AAA screening

Comparison: No population-based screening (this includes opportunistic screening and incidental AAA detection while performing abdominal ultrasound examination due to other indications)

Outcomes: All relevant to selected assessment elements

Exclusion criteria

Pure cost-effectiveness assessments

Languages other than English

Procedure for the literature selection

Titles and abstracts resulting from the literature searches were independently assessed by the two investigators (KF and IS). Articles considered to meet the inclusion criteria were further examined in full text and assessed based on the inclusion criteria and quality requirements (see Quality assessment tools and criteria below). Discrepancies were resolved through discussion.

Selection of relevant SRs of highest quality (STEP 1)

Selection of SRs satisfying criteria for relevance and quality is shown in the flow chart below (Figure 1). An update literature search performed in February 2012 did not lead to further included articles. Assessment of relevant SRs that satisfied the inclusion criteria and quality requirements according to the checklist for SRs resulted in the inclusion of five SRs in total. In cases where the same outcome (e.g. mortality) was assessed in more than one SR, results from the most recent SRs were reported for that particular outcome.

Figure 1: Flow chart showing the selection of relevant SRs or HTAs and output from these

106.EFF Fig 1

Selection of RCTs not covered in included SRs and/or RCTs assessing additional relevant populations and/or outcomes other than those in the included SRs (STEP 2)

Selection of RCTs satisfying criteria for relevance and study design is shown in the flow chart below (Figure 2). The update literature search performed in February 2012 did not lead to further included articles.

As shown in the flow chart, the last step in the selection process led to 30 articles that reported results from the four trials that were covered in the included SRs. These articles described updates of results from the RCTs or prospective studies (not RCTs) based on the population material taken from the four trials.

Hence no further results were assessed from the four RCTs since we did not include results from these trials for our research questions.

Figure 2: Flow chart showing the selection of relevant RCTs and output from these

106.EFF Fig 2

Quality assessment tools or criteria

Assessment of the methodological quality of selected SRs was done using the English version of the NOKC checklist for systematic reviews (Appendix EFF-1 Section 4). Included systematic reviews (5) with abstracts, study description and quality assessment are shown in Appendix EFF-2, Sections 1 and 2.

Strength of evidence for the different outcomes was assessed using the GRADE instrument (GRADE Working Group 2004), and is shown as GRADE profiles in Appendix EFF-2, Section 5.

Assessments of methodological quality and strength of evidence were performed by the two investigators (KF and IS) independently. Discrepancies were resolved through discussion.

Analysis and synthesis

Method for analysis and synthesis

All reporting of clinical effectiveness data was done according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA Statement 2012).

Description of included SRs from the basic search

A brief description of the five included SRs is shown in the table below (Table 1). Abstracts and descriptions are provided in Appendix EFF-2 Sections 1 and 2.

Table 1: Overview of the studies from the five included SRs including the selected population(s) and outcome(s)

Author

Year

Quality

Studies

Population

Selected outcomes

Beales

2011

Medium

9

observa-tional studies

Some studies describe the population, others do not

Large variability in number of measurements (10 to 112)

Intra- and inter-observer variability

(repeatability and reproducibility)

Collins

2011

High

1 RCT*

Men 65-74 years

State anxiety, depression, QoL

Takagi

2010

Medium

4 RCTs

Men from 65 years

AAA-related (long-term) mortality

Overall (long-term) mortality

Lindholt & Norman

2008

Medium

3 RCTs**

Men 64-83 years

AAA-related (medium term) mortality

Overall (medium term) mortality

Planned operations for AAA (medium term)

Emergency operations for AAA (medium term)

Planned operations for AAA (long-term)

Emergency operations for AAA (long-term)

Cosford

2007

High

1 RCT***

Men and women 65-80 years

AAA-related mortality (in women only)

Overall mortality (in women only)

Progression to (incidence of) ruptured AAA

*One of the 12 RCTs included in this SR involved screening for AAA (Ashton 2002)

**Three of the four RCTs included in this SR assessed operations for AAA (long-term)

***One of the four RCTs included in this SR involved women and the outcome, progression to (incidence of) ruptured AAA

As mentioned above, we chose to report the most recently reported effect estimates on relevant populations for relevant outcomes. Consequently, the review by Cosford et al. was included since it is the only SR that has included women and assessed incidence of ruptured AAA (Cosford 2007). Likewise, the  Lindholt & Norman review was the most recent review assessing surgery of AAA as well as medium term mortality (i.e. after 3.5 to 5 years) both due to AAA and all causes (overall mortality) (Lindholt & Norman 2008). The review by Tagaki et al. was the most recent review on long-term (i.e. after 7 to 15 years) mortality, both AAA-related and overall (Takagi 2010). Collins et al. was the only review that dealt with emotional and quality of life outcomes related to screening programs (Collins 2011); however only one RCT within this review considers these outcomes in the context of AAA screening (Ashton 2002). Finally we included one SR assessing reproducibility of ultrasound measurement of the abdominal aorta (Beales 2011).

Excluded articles from the basic search

Excluded literature including reasons for exclusion are listed in Appendix EFF-2, Sections 3 (SR search) and 4 (RCT search).

Result cards are covered by evidence issued from the basic search or additional literature searches

Table 2  shows the references, used to answer each assessment element (result card question). The references were derived mainly from the basic literature search,

Table 2: Source of evidence for each result card

Result card

Result card question

References

EFF1

(Mortality)

What is the effect of AAA screening on overall mortality?

Tagaki 2010 (SR)

Lindholt & Norman 2008 (SR)

Cosford 2007 (SR)

EFF2

(Mortality)

What is the effect of AAA screening on the mortality caused by the target disease?

Tagaki 2010 (SR)

Lindholt & Norman 2008 (SR)

Cosford 2007 (SR)

EFF4

(Mortality)

What is the effect of AAA screening on the mortality due to other causes than the target disease?

Not assessed in any of the included SRs or RCTs

EFF3

(Mortality)

What is the mortality related to the diagnostic test?

Not assessed in any of the included SRs or RCTs

EFF5

(Morbidity)

How does the use of AAA screening modify the symptoms and findings of the target condition?

Not assessed in any of the included SRs or RCTs

EFF6

(Morbidity)

How does AAA screening modify the progression of the target condition?

Cosford 2007 (SR)

EFF7

(Morbidity)

What is the morbidity directly related to AAA screening?

Assessed by Cosford 2007 (SR) but the SR did not identify RCTs for these outcomes i.e. complications of surgery (distal embolus, haemorrhage and graft failure, coronary and cerebrovascular events and renal complications)

EFF21

(Morbidity)

How does AAA screening modify the effectiveness of subsequent AAA screenings?

Not assessed in any of the included SRs or RCTs

EFF8

(Function)

What is the effect of AAA screening on global function?

Not assessed in any of the included SRs or RCTs

EFF11

(Function)

What is the effect of AAA screening on return to work?

Assessed by Cosford 2007 (SR) but  the SR did not find any RCTs for this research question

EFF12

(Function)

What is the effect of AAA screening on return to previous living conditions?

Not assessed in any of the included SRs or RCTs

EFF13

(Function)

How does use of AAA screening affect activities of daily living?

Not assessed in any of the included SRs or RCTs

EFF9

(QoL)

What is the effect of AAA screening on generic health-related quality of life?

Collins 2011 (SR)

EFF10

(QoL)

What is the effect of AAA screening on disease specific quality of life?

Not assessed in any of the included SRs or RCTs

EFF25

(QoL)

Does the knowledge of the test result affect the patient's non-health-related quality of life?

Not assessed in any of the included SRs or RCTs

EFF14

(Satisfaction)

Was the use of AAA screening worthwhile?

Not assessed in any of the included SRs or RCTs

EFF15

(Satisfaction)

Is the patient willing to use AAA screening?

Reported by Cosford 2007 (SR) but  the SR did include it as an outcome question

EFF16

(Management)

Does use of the test lead to improved detection of the condition?

Not assessed in any of the included SRs or RCTs

EFF17

(Management)

How does the use of the test change physicians' management decisions?

Not assessed in any of the included SRs or RCTs

EFF18

(Management)

Does the test detect other potential health conditions that can impact the subsequent management decisions?

Not assessed in any of the included SRs or RCTs

EFF19

(Management)

How does AAA screening modify the need for other technologies and use of resources?

Lindholt & Norman 2008 (SR)

EFF20

(Management)

Is there an effective treatment for the condition the test is detecting?

Not assessed in any of the included SRs or RCTs

EFF22

(Accuracy)

What are the negative consequences of further testing and delayed treatment in patients with false negative test result?

Not assessed in any of the included SRs or RCTs

EFF23

(Accuracy)

What are the negative consequences of further testing and treatments in patients with false positive test result?

Not assessed in any of the included SRs or RCTs

EFF28

(Accuracy)

What is the reference standard and how likely does it classify the target condition correctly?

Not assessed in any of the included SRs or RCTs

EFF29

(Accuracy)

What are the requirements for accuracy in the context AAA screening will be used?

Not assessed in any of the included SRs or RCTs

EFF30

(Accuracy)

What is the optimal threshold value in this context?

Not assessed in any of the included SRs or RCTs

EFF31

(Accuracy)

Does the test reliably rule in or rule out the target condition?

Not assessed in any of the included SRs or RCTs

EFF32

(Accuracy)

How does test accuracy vary in different settings?

Not assessed in any of the included SRs or RCTs

EFF33

(Accuracy)

What is known about the intra- and inter-observer variation in test interpretation?

Beales 2011 (SR)

EFF24

(Benefit-harm balance)

What are the overall benefits and harms of AAA screening in health outcomes?

Not assessed in any of the included SRs or RCTs


Result cards

Mortality

Result card for EFF1: "What is the effect of Abdominal Aorta Aneurysm Screening on overall mortality?"

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EFF1: What is the effect of Abdominal Aorta Aneurysm Screening on overall mortality?
Method
Result

Importance: Critical

Transferability: Completely

Result card for EFF2: "What is the effect of Abdominal Aorta Aneurysm Screening on the mortality caused by the target disease?"

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EFF2: What is the effect of Abdominal Aorta Aneurysm Screening on the mortality caused by the target disease?
Method
Result

Importance: Critical

Transferability: Completely

Result card for EFF4: "What is the effect of Abdominal Aorta Aneurysm Screening on the mortality due to other causes than the target disease?"

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EFF4: What is the effect of Abdominal Aorta Aneurysm Screening on the mortality due to other causes than the target disease?
Method
Result

Importance: Unspecified

Transferability: Unspecified

Result card for EFF3: "What is the mortality related to the diagnostic test?"

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EFF3: What is the mortality related to the diagnostic test?
Method
Result

Importance: Unspecified

Transferability: Completely

Morbidity

Result card for EFF5: "How does the use of Abdominal Aorta Aneurysm Screening modify the symptoms and findings of the target condition?"

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EFF5: How does the use of Abdominal Aorta Aneurysm Screening modify the symptoms and findings of the target condition?
Method
Result

Importance: Unspecified

Transferability: Unspecified

Result card for EFF6: "How does Abdominal Aorta Aneurysm Screening modify the progression of the target condition?"

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EFF6: How does Abdominal Aorta Aneurysm Screening modify the progression of the target condition?
Method
Result

Importance: Critical

Transferability: Completely

Result card for EFF21: "How does Abdominal Aorta Aneurysm Screening modify the effectiveness of subsequent Abdominal Aorta Aneurysm Screening s?"

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EFF21: How does Abdominal Aorta Aneurysm Screening modify the effectiveness of subsequent Abdominal Aorta Aneurysm Screening s?
Method
Result

Importance: Unspecified

Transferability: Unspecified

Result card for EFF7: "What is the morbidity directly related to Abdominal Aorta Aneurysm Screening ?"

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EFF7: What is the morbidity directly related to Abdominal Aorta Aneurysm Screening ?
Method
Result

Importance: Unspecified

Transferability: Completely

Change-in management

Result card for EFF16: "Does use of the test lead to improved detection of the condition?"

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EFF16: Does use of the test lead to improved detection of the condition?
Method
Result

Importance: Unspecified

Transferability: Completely

Result card for EFF17: "How does the use of the test change physicians' management decisions?"

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EFF17: How does the use of the test change physicians' management decisions?
Method
Result

Importance: Unspecified

Transferability: Unspecified

Result card for EFF20: "Is there an effective treatment for the condition the test is detecting?"

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EFF20: Is there an effective treatment for the condition the test is detecting?
Method
Result

Importance: Unspecified

Transferability: Completely

Result card for EFF18: "Does the test detect other potential health conditions that can impact the subsequent management decisions?"

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EFF18: Does the test detect other potential health conditions that can impact the subsequent management decisions?
Method
Result

Importance: Unspecified

Transferability: Unspecified

Result card for EFF19: "How does Abdominal Aorta Aneurysm Screening modify the need for other technologies and use of resources?"

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EFF19: How does Abdominal Aorta Aneurysm Screening modify the need for other technologies and use of resources?
Method
Result

Importance: Critical

Transferability: Completely

Function

Result card for EFF8: "What is the effect of Abdominal Aorta Aneurysm Screening on global function?"

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EFF8: What is the effect of Abdominal Aorta Aneurysm Screening on global function?
Method
Result

Importance: Unspecified

Transferability: Unspecified

Result card for EFF11: "What is the effect of Abdominal Aorta Aneurysm Screening on return to work?"

View full card
EFF11: What is the effect of Abdominal Aorta Aneurysm Screening on return to work?
Method
Result

Importance: Unspecified

Transferability: Completely

Result card for EFF12: "What is the effect of Abdominal Aorta Aneurysm Screening on return to previous living conditions?"

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EFF12: What is the effect of Abdominal Aorta Aneurysm Screening on return to previous living conditions?
Method
Result

Importance: Unspecified

Transferability: Completely

Result card for EFF13: "How does use of Abdominal Aorta Aneurysm Screening affect activities of daily living?"

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EFF13: How does use of Abdominal Aorta Aneurysm Screening affect activities of daily living?
Method
Result

Importance: Unspecified

Transferability: Completely

Quality of life

Result card for EFF9: "What is the effect of Abdominal Aorta Aneurysm Screening on generic health-related quality of life?"

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EFF9: What is the effect of Abdominal Aorta Aneurysm Screening on generic health-related quality of life?
Method
Result

Importance: Critical

Transferability: Completely

Result card for EFF10: "What is the effect of Abdominal Aorta Aneurysm Screening on disease specific quality of life?"

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EFF10: What is the effect of Abdominal Aorta Aneurysm Screening on disease specific quality of life?
Method
Result

Importance: Unspecified

Transferability: Completely

Result card for EFF25: "Does the knowledge of the test result affect the patient's non-health-related quality of life?"

View full card
EFF25: Does the knowledge of the test result affect the patient's non-health-related quality of life?
Method
Result

Importance: Unspecified

Transferability: Completely

Patient satisfaction

Result card for EFF14: "Was the use of Abdominal Aorta Aneurysm Screening worthwhile?"

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EFF14: Was the use of Abdominal Aorta Aneurysm Screening worthwhile?
Method
Result

Importance: Unspecified

Transferability: Completely

Result card for EFF15: "Is the patient willing to use Abdominal Aorta Aneurysm Screening ?"

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EFF15: Is the patient willing to use Abdominal Aorta Aneurysm Screening ?
Method
Result

Importance: Critical

Transferability: Completely

Test accuracy

Result card for EFF28: "What is the reference standard and how likely does it classify the target condition correctly?"

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EFF28: What is the reference standard and how likely does it classify the target condition correctly?
Method
Result

Importance: Unspecified

Transferability: Completely

Result card for EFF29: "What are the requirements for accuracy in the context Abdominal Aorta Aneurysm Screening will be used?"

View full card
EFF29: What are the requirements for accuracy in the context Abdominal Aorta Aneurysm Screening will be used?
Method
Result

Importance: Unspecified

Transferability: Unspecified

Result card for EFF30: "What is the optimal threshold value in this context?"

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EFF30: What is the optimal threshold value in this context?
Method
Result

Importance: Unspecified

Transferability: Unspecified

Result card for EFF31: "Does the test reliably rule in or rule out the target condition?"

View full card
EFF31: Does the test reliably rule in or rule out the target condition?
Method
Result

Importance: Unspecified

Transferability: Unspecified

Result card for EFF32: "How does test accuracy vary in different settings?"

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EFF32: How does test accuracy vary in different settings?
Method
Result

Importance: Unspecified

Transferability: Unspecified

Result card for EFF33: "What is known about the intra- and inter-observer variation in test interpretation?"

View full card
EFF33: What is known about the intra- and inter-observer variation in test interpretation?
Method
Result

Importance: Important

Transferability: Completely

Result card for EFF22: "What are the negative consequences of further testing and delayed treatment in patients with false negative test result?"

View full card
EFF22: What are the negative consequences of further testing and delayed treatment in patients with false negative test result?
Method
Result

Importance: Unspecified

Transferability: Completely

Result card for EFF23: "What are the negative consequences of further testing and treatments in patients with false positive test result?"

View full card
EFF23: What are the negative consequences of further testing and treatments in patients with false positive test result?
Method
Result

Importance: Unspecified

Transferability: Completely

Benefit-harm balance

Result card for EFF24: "What are the overall benefits and harms of Abdominal Aorta Aneurysm Screening in health outcomes?"

View full card
EFF24: What are the overall benefits and harms of Abdominal Aorta Aneurysm Screening in health outcomes?
Method
Result

Importance: Unspecified

Transferability: Completely

Discussion

Evidence from four high-quality RCTs included in several SRs indicates that AAA screening is beneficial in men over 65 years of age, as it reduces AAA-related mortality by nearly half in the mid- and long-term. The number needed to screen (NNS) to prevent one extra death in the male population over 65 years is 238 (Takagi 2010). Data also indicate that acceptance of screening sonography in the population under risk is high. AAA screening results in a decrease in emergency operations for ruptured AAA, which is counterbalanced by an increase in elective AAA surgery. Data on global function, activities of daily living and QoL is however poor, except for anxiety and depression, which appear to be reduced with AAA screening. Similarly, no data on morbidity after screening were found. However, it is clear that morbidity will mainly consist of complications caused by surgery. As risk-adjusted postoperative morbidity can be expected to be similar for screen-detected and non-screen-detected AAA patients, results on this outcome might be extrapolated from other data sources.

When establishing an AAA screening programme, the qualification of the sonographers could be important. Inter-observer repeatability and intra-observer reproducibility appear to be acceptable, but the evidence is hampered by the fact that the quality of the primary studies on this topic could not be assessed systematically. As the SR found the results of the primary studies to be heterogeneous, the need for careful selection and standard training of sonographers was emphasised. No data were found on diagnostic accuracy and the optimal threshold value. In the included RCTs, however, the usual threshold for referring men to a vascular surgeon ranges between 50 mm and 55 mm aortic diameter.

In contrast to men, there is no reliable clinical data to show that women benefit from AAA screening. Only one of the four RCTs included women in addition to men, but this did not detect a difference in AAA-related mortality in females. In this trial, the prevalence of AAA was six times lower in women than in men, so only very large trials would be able to detect a difference in this population. Recent data have shown a decline in AAA incidence in men (Anjum & Powell 2012, and references therein), which probably does not alter the relative effectiveness of screening measures, but clearly increases the NNS.

Future research should focus on optimising screening strategies in men. Screening intervals, risk-adjusted repeat screening, and training of sonographers could be valuable research topics.

References

  1. Anjum A, Powell JT. Is the incidence of abdominal aortic aneurysm declining in the 21st century? Mortality and hospital admissions for England & Wales and Scotland. Eur J Vasc Endovasc Surg. 2012;43(2):161-6.
  2. Ashton HA, Buxton MJ, Day NE, Kim LG, Marteau TM, Scott RAP et al.; The Multicentre Aneurysm Screening Study Group. The Multicentre Aneurysm Screening Study (MASS) into the effect of abdominal aortic aneurysm screening on mortality in men: a randomised controlled trial. Lancet. 2002;360:1531-1539.
  3. Beales L, Wolstenhulme S, Evans JA, West R, Scott DJ. Reproducibility of ultrasound measurement of the abdominal aorta. Br J Surg. 2011;98(11):1517-25.
  4. Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986;8:1(8476):307-10.
  5. Collins RE, Lopez LM, Marteau TM. Emotional impact of screening: a systematic review and meta-analysis. BMC Public Health. 2011;(11):603.
  6. Cosford PA, Leng GC, Thomas J. Screening for abdominal aortic aneurysm. Cochrane Database Syst Rev. 2007;(2)CD002945.
  7. Generalized Estimating Equations (GEE): Available from http://en.wikipedia.org/wiki/Generalized_estimating_equation (accessed May 2012).
  8. GRADE Working Group; Atkins D, Best D, Briss PA, Eccles M, Falck Ytter Y, Flottorp S, Guyatt GH, Harbour RT, Haugh MC, Henry D, Hill S, Jaeschke R, Leng G, Liberati A, Magrini N, Mason J, Middleton P, Mruko-wicz J, O’Connell D, Oxman AD, Phillips B, Schunemann HJ, Edejer TT, Varonen H, Vist GE, Williams JW Jr, Zaza S. Grading quality of evidence and strength of recommendations. BMJ. 2004;328(7454):1490.
  9. Grimshaw J, McAuley LM, Bero LA, Grilli R, Oxman AD, Ramsay C, Vale L, Zwarenstein M. Systematic reviews of the effectiveness of quality improvement strategies and programmes. Qual Saf Health Care. 2003;12:298-303.
  10. Higgins JPT, Green S (Editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration. 2011. Available from www.cochrane-handbook.org (accessed May 2012).
  11. Lindholt JS, Norman P. Screening for abdominal aortic aneurysm reduces overall mortality in men. A meta-analysis of the mid- and long-term effects of screening for abdominal aortic aneurysms. Eur J Vasc Endovasc Surg. 2008;36(2):167-71.
  12. National Health Service Abdominal Aneurysm Screening Programme (NAAASP 2009). Available from http://aaa.screening.nhs.uk/ (accessed June 2012).
  13. NOKC checklist: Nasjonalt kunnskapssenter for helsetjenesten. Slik oppsummerer vi forskning. Håndbok for Nasjonalt kunnskapssenter for helsetjenesten. 3. reviderte utg. Oslo: Nasjonalt kunnskapssenter for helsetjenesten. 2011. Available from http://www.kunnskapssenteret.no/Verkt%C3%B8y/Slik+oppsummerer+vi+forskning.2139.cms (accessed June 2012).
  14. Norman PE, Jamrozik K,Lawrence-Brown MED MER, Le MT, Spencer CA, Tuohy RJ, et al. Population based randomised controlled trial on impact of screening on mortality from abdominal aortic aneurysm. BMJ. 2004;329(7477):1259-1264.
  15. PRISMA Statement: http://prisma-statement.org (accessed March 2012)
  16. Scott RA, Wilson NM, Ashton HA, Kay DN. The 5-years results of a control study of screening of aortic aneurysm. Br J Surg. 1995;82:561.
  17. Spielberger CD, Gorsuch RL, Lushene RE. STAI: Manual for the State-Trait Anxiety Inventory (Self – Evaluation Questionnaire). Palo Alto, CA Consulting Psychologists. 1970.
  18. Takagi H, Goto SN, Matsui M, Manabe H, Umemoto T. A further meta-analysis of population-based screening for abdominal aortic aneurysm. J Vasc Surg. 2010;52(4):1103-8.
  19. Ware JE, Sherbourne CD. The Mos 36-Item Short-Form Health Survey (SF-36). 1. Conceptual-Framework and Item Selection. Medical Care. 1992;30(6):473-483
  20. Zigmond AS, Snait RP. The Hospital Anxiety and Depression Scale. Acta Psychiat Scand. 1983;67(6)361-370.

Appendices

Appendix EFF-1 - Overlapping EFF-AEs with AEs of other domains and following agreements on assessments

pdf106.EFF Appendix 1

Appendix EFF-2 - List of included literature with abstracts (5 SRs)

pdf106.EFF Appendix 2

Appendix EFF-3 - List of all references from the basic search for SRs/HTAs (41 references)

pdf106.EFF Appendix 3

Costs and economic evaluation

Authors: Suvi Mäklin, Taru Haula, Kristian Lampe, Jaana Leipälä, Ulla Saalasti-Koskinen

Summary

The systematic literature review and economic evaluation presented here provide information on the relative costs and cost-effectiveness of population-based abdominal aortic aneurysm (AAA) screening compared with no population-based screening for AAA. The cost-effectiveness analysis was performed from a Finnish healthcare payer perspective and based on recent Finnish clinical practices. The primary investments needed to start a new screening programme and the long-term consequences of possible surgical complications were not taken into account in this analysis.

A total of 26 cost-effectiveness analyses and four systematic reviews on cost-effectiveness were included in the systematic literature review. A positive effect overall over the lifetime of the screened population was observed in all of the included 26 cost-effectiveness analyses. Only a few of the studies included women. The life years gained (LYG) ranged from 0.013 to 0.097 for men and from 0.011 to 0.07 for women. The quality-adjusted life years (QALYs) gained ranged from 0.011 to 0.07 (reported only for men). The incremental cost-effectiveness ratio (ICER) varied across studies, from 157 €/LYG and 179 €/QALY to 43 485 €/QALY. This was to be expected because of differences in the study settings (e.g. healthcare setting, time horizon, included costs, and other modelling assumptions). The cost per LYG/QALY gained was lower than 10 000 € in 23 of the 26 studies. The four systematic reviews were not uniform in their conclusions. Three of the systematic reviews stated that AAA screening for men aged 65 years or older will probably gain additional life years and QALYs at acceptable extra costs but further analysis is needed. One of the reviews stated that most health economic evaluations have made optimistic assumptions in favour of AAA screening and the topic needs further analysis. Our current review contains seven studies that were published after the timelines of the four reviews.

According to our cost-effectiveness analysis, the incremental effectiveness of population-based one-time ultrasound screening for 65-year-old men in Finland would be 0.027 LYG compared with no screening (11.55 vs. 11.52 life years, respectively). The incremental effectiveness for women would be 0.013 LYG (15.69 vs. 15.67 for screening and no screening, respectively). The ICER for one-time screening of 65-year-old men would be 8433 €/LYG compared with no screening. The corresponding ICER for women would be 7198 €/LYG. These results correspond to the majority of the results from other analyses. The results for women should be interpreted with caution due to the limited evidence available for women. Most of the values used in the model for women were from studies concerning men.

In conclusion, currently available evidence and our cost-effectiveness analysis speak for the cost-effectiveness of AAA screening in the male population. Current evidence does not provide justification for excluding women from AAA screening either, but further research is needed on the effectiveness and cost-effectiveness of AAA screening in women.

Introduction

The analysis within the costs and economic evaluation domain aims to provide information about the relative costs and cost-effectiveness of population-based abdominal aortic aneurysm (AAA) screening compared with no population-based screening for AAA of 65-year-old men and women. The aim is to support decision making by comparing costs and outcomes of a technology with its comparator. In publicly funded healthcare systems, finite resources mean that all interventions cannot necessarily be provided in every situation for all who need or demand them. Choices must be made between effective healthcare interventions; the decision to fund one intervention may mean that others cannot be funded {1}.

First, this domain reviews previously published economic evaluations of AAA screening. The systematic review in this domain aims at giving an overview of published economic evaluations of AAA screening, instead of presenting a specific figure of cost-effectiveness based on the literature. We also present all economic evaluations we found, irrespective of their setting and timing. The evidence table (Appendix ECO-2) allows users to find the studies that could be relevant in their country or region, and study those more carefully.

In addition, a cost-effectiveness analysis from a Finnish healthcare payer perspective provides model-based estimates of effectiveness in terms of life years gained (LYG). However, the long-term health impacts and costs of possible surgical complications are excluded from the model. Testing of the model in different settings was beyond the scope of this work. Therefore the model and its results may not be directly applicable in different European settings.

Methodology

Frame

The 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

Assessment elements

TopicIssue RelevantResearch questions or rationale for irrelevance
E0001Resource utilizationWhat types of resources are used when delivering the assessed technology and its comparators (resource use identification)?yesWhat types of resources are used when delivering population-based screening for Abdominal Aorta Aneurysm, or no systematic screening for AAA (resource use identification)?
E0002Resource utilizationWhat amounts of resources are used when delivering the assessed technology and its comparators (resource use measurement)?yesWhat amounts of resources are used when delivering population-based screening for Abdominal Aorta Aneurysm, or no screening for AAA (resource use measurement)?
E0003Unit costsWhat are the unit costs of the resources used when delivering the assessed technology and its comparators?yesWhat are the unit costs of the resources used when delivering population-based screening for Abdominal Aorta Aneurysm, or no screening for AAA?
E0005OutcomesWhat are the incremental effects of the technology relative to its comparator(s)?yesWhat are the incremental effects of population-based Abdominal Aorta Aneurysm Screening relative to no systematic screening?
E0007Cost-effectivenessWhat is the appropriate time horizon?yesWhat is the appropriate time horizon?
E0006Cost-effectivenessWhat is the incremental cost-effectiveness ratio?yesWhat is the incremental cost-effectiveness ratio?
E0008Cost-effectivenessWhat is the method of analysis?noThis question should probably be removed from the model, since the method is explained always in the domain methodology chapter.
E0004Indirect CostsWhat is the impact of the technology on indirect costs?noThe analysis will be done from a health care providers' perspective, and only costs to health care will be included.

Methodology description

Information sources

Systematic literature review

A systematic literature search in CRD, NHS-EED and Medline databases until March 2012 was conducted (Appendix ECO-1) to find published articles on costs and cost-effectiveness of abdominal aortic aneurysm screening.

Cost-effectiveness analysis

Cost-effectiveness analysis was undertaken using a previously constructed model {2}, which was modified to be more in line with the Finnish perspective and clinical practices {3}. The parameters used were based mainly on existing literature, but also on Finnish data and on expert opinion if no other references were available.

Furthermore, a questionnaire sent to EUnetHTA partners in December 2011 (with reminders in 2012) was used to collect information on some of the issues in this domain. (Appendix COL-1)

Quality assessment tools or criteria

In the systematic review, only peer-reviewed cost-effectiveness analyses and systematic reviews of economic evaluations were included. Reviews, letters, comments, etc. were excluded.

The quality of the included studies was not formally assessed. The justification to refrain from formal quality assessment stems from the nature of economic analysis. The aim of economic evaluations, and this domain in a core health technology assessment (HTA), is to aid decision-making. However, the generalisability and transferability of economic evaluations are limited due to their context- and time-specific nature. For a specific context and setting, a systematic review of economic evaluations could be used to identify the most relevant studies to inform a particular decision. Even a high-quality economic study might be highly irrelevant for a particular question, if it focuses on a different kind of healthcare setting with different resources and costs, in a different kind of population, and/or was conducted a long time ago. (See for example Anderson R 2010; {4})

Thus the systematic review in this domain aims to give an overview of published economic evaluations of AAA screening, instead of presenting a specific figure of cost-effectiveness based on the literature. We also present all the economic evaluations found using our search strategy, irrespective of their setting and timing. From the evidence table (Appendix ECO-2) can be found studies that could be relevant in any particular country or region, and the reader is invited to study those more carefully.

Analysis and synthesis

Systematic literature review

A systematic literature search in CRD, NHS-EED and Medline databases until March 2012 was conducted (Appendix ECO-1 ) to find published articles on costs and cost-effectiveness of AAA screening. Full or partial economic evaluations focusing on population-based AAA screening using ultrasound, and systematic reviews about those, were included. Articles were excluded if screening was performed using techniques other than ultrasound (e.g. computed tomography [CT], magnetic resonance imaging [MRI]), or if 64-65-year-old people were not included. Letters, editorials, comments etc. were also excluded. There were no limitations placed on the language of abstracts and articles.

The systematic search strategy for this domain is presented in Appendix ECO-1. After excluding duplicates, 184 abstracts were read independently by two of the authors (TH, KL, SM, USK) and 69 articles were ordered for full-text evaluation. References were taken for full-text evaluation even when only one of the two authors selected it. One additional, study was identified apart from this, as Finohta´s own report on AAA screening {3} did not appear in the literature search. Two of the authors (SM, TH) read full-text articles independently and 30 were included in the review (Figure 1). Twenty-six of the included studies were cost-effectiveness analyses, and four were systematic reviews of economic evaluations. The included articles were summarised in an evidence table (SM, TH) (See Appendix ECO-2), presenting the aims, methods, results and conclusions of the included articles. Meta-analysis was not attempted. Four cost analyses are also presented in the table for information purposes, without analysing them further {5-8}.

106.ECO Fig 1

Figure 1. Flow chart showing the systematic literature review.

Cost-effectiveness analysis

A cost-effectiveness analysis was conducted from a Finnish healthcare payer perspective using a previously constructed Markov model (Figure 2 and Appendix ECO-3) {2, 3}. The model estimated the cost-effectiveness of one-time ultrasound screening offered to 65-year-old men or women, compared with no population-based AAA screening. The analysis was done separately for men and women. TreeAge Pro HealthCare (version 2011, TreeAge Software Inc.) was used to run the Markov cohort simulation model until all members of the cohort died from AAA-related causes or reached the end of their expected lifetime. Both the estimated future costs and effectiveness were discounted using a 3% discount rate. Probabilistic sensitivity analysis was performed. No health-related quality of life (HRQoL) data were included in the analysis (for HRQoL data, see for example result card RC-SAF1), and the outcomes are reported as LYG and incremental costs per LYG.

The model compared two alternative scenarios (population-based AAA screening vs. current practice, i.e. no population-based AAA screening). These, and the attendance to screening, were modelled in a decision tree and the further years were modelled in a Markov model (Figure 2). The Markov model comprised eight health states: no AAA (<3 cm); small AAA (3-4.4 cm); medium AAA (4.5-5.4 cm), large AAA (>5.5 cm); elective surgery; post-operative state after elective surgery; post-operative-state after emergency surgery; rupture of AAA; and death. The cycle length was one year. If a small or medium AAA is detected in screening, a person is followed-up using ultrasound once a year, and if a large AAA is detected, the person goes into elective surgery (open or endovascular).

The model included some key assumptions. First, it is assumed that if abdominal aorta is found to be normal (<3 cm) during screening, the person will not develop AAA in their remaining lifetime. Secondly, the sensitivity and specificity of ultrasound is assumed to be 100% (see result card RC-SAF3; {9}). Furthermore, the analysis of screening in women is mainly based on epidemiological and effectiveness data from studies on men because of a lack of such data on AAA in women.

Published evidence and national registers were mainly used to inform the model and its input parameters. Expert opinion was used when necessary. The parameter values and distributions used in the sensitivity analysis are presented in Table 1. The parameters related to ‘no population-based AAA screening’ were based on recent data from Finland, as currently no population-based screening for AAA has been implemented. Although the parameter values reported in Table 1 are similar for both arms, differences between the screening arm and the control arm exist as a result of the structure of the model (see Appendix ECO-3). For example, the probability of having elective surgery is similar for all those who have a large AAA detected. In the screening arm, most of the large AAAs are found and thus the number of elective procedures is greater than in the control arm, where only a minority of large AAAs are detected incidentally. And since most of the large AAAs in the screening arm are treated, the number of ruptures is lower than in the control arm. Furthermore, it is assumed that elective surgery is performed before rupture (if the person is eligible for surgery). This part concerning the risk of rupture is the major modification made to the original model by Ehlers et al. {2}.

The number of performed AAA-related surgical procedures, both elective and emergency, was taken from the national Hospital Discharge Register. The age-specific mortality rates for both genders were taken from the registries of Statistics Finland. The number of deaths due to AAA and ruptured AAA (rAAA) were taken from the national Cause of Death Register, and both of these registers were linked in order to estimate the number of deaths after AAA treatment (30 day mortality). Furthermore, it was assumed that long-term survival after elective and emergency surgery was similar to that of the general population and so the age-specific mortality rates were also used for the post-operative states in the model. The cost of invitation to screening was estimated according to the invitation costs of other screening programmes in Finland. Two different costs were estimated for ultrasound as it was assumed that the screening ultrasound would be performed in primary healthcare, and the ultrasound in follow-up would be hospital-based and thus more expensive. The costs of ultrasound and computer tomography were obtained from the hospital district of Helsinki and Uusimaa. The operation costs (elective and emergency) were based on the means of the actual costs of all AAA patients treated in the hospital district of Helsinki and Uusimaa in January-August 2010. The costs of primary investments needed when starting a new screening programme were not included in the analysis.

 106.ECO Fig 2

Figure 2. Structure of the model. Participation in screening is first modelled in a decision tree and then the cohort moves to the Markov model subtree. The Markov states are applicable to all of the three arms (attend screening; invited but do not attend screening; and not offered population-based screening).

Table 1. Parameter values used in the cost-effectiveness analysis.

Parameter

Value (base case)

Distribution used in the probabilistic sensitivity analysis*

Reference

Age (years)

65

-

The project scope

Compliance with screening

0.80

0.7-0.85

Thompson et al. 2009 {10}

Proportion of large AAAs eligible for surgery

0.81

Normal (α0.814, σ0.0256)

MASS 2002 {11}

Proportion of rAAAs reaching hospital alive

0.56

Normal (α 0.56, σ 0.025)

Laukontaus et al. 2007 {12}

Prevalence

   

Prevalence of AAA (>3 cm) (men/women)

0.06 /0.013

Normal (α0.06, σ0.0051)

Expert opinion based on: Lindholt et al.2005 {13}, Norman et al.2004 {14}, Ashton et al.2002 {15}, Hafez et al.2008 {16}, Scott et al.2002 {17}

Distribution of size of an AAA

   

Small AAA (3-4.4 cm)

0.71

 

MASS 2002 {11}

Medium AAA (4.5-5.4 cm)

0.17

 

MASS 2002 {11}

Large AAA (>5.5 cm)

0.12

 

MASS 2002 {11}

Annual probability of  growing

   

From small to medium

0.115/year

Normal (α0.115, σ0.005)

Henriksson & Lundgren 2005 {18}

From medium to large

0.159/year

Normal (α0.159, σ0.006)

Henriksson & Lundgren 2005 {18}

Risk of rupture per year

   

Small AAA

0.003

Normal (α0.003, σ0.0004)

Expert opinion based on: Powell & Brown 2001 {19}; Law et al. 1994 {20} , Vardulaki et al. 1998 {21}

Medium AAA

0.015

Normal (α0.015, σ0.0028)

Expert opinion based on: Powell & Brown 2001 {19}; Law et al. 1994 {20}, Vardulaki et al. 1998 {21}

Large AAA

0.065

Normal (α0.065, σ0.0123)

Expert opinion based on: Law et al. 1994 {20}, Lederle 2002 {22}

Mortality (men/women)

   

Emergency surgery (30 day)

0.39 / 0.56

Normal (α0.3965, σ0.065991)/Normal (α0.56, σ0.065991)

Cause of death –register

and

Hospital discharge register, Finland

Elective, endovascular

0.023 / 0.023

Normal (α0.023, σ0.003)

Cause of death –register

and

Hospital discharge register, Finland

Elective, open surgery

0.061 / 0.072

Normal (α0.0612, σ0.0078)

Cause of death –register

and

Hospital discharge register, Finland

Costs

   

Invitation to screening

6 €

Gamma ( α 9, λ1.5)

Expert opinion based on other screening programmes in Finland (Mäklin 2011 {3} )

Ultrasound in screening

60 €

Gamma ( α16, λ0.2667)

Hospital district of Helsinki and Uusimaa, Finland

Ultrasound in follow-up

90 €

Gamma( α 36, λ0.4)

Hospital district of Helsinki and Uusimaa, Finland

Computer tomography

235 €

Gamma( α 22.09, λ0.094)

Hospital district of Helsinki and Uusimaa, Finland

Emergency surgery

26 900 €

Gamma( α 1.158, λ0.00004)

Hospital district of Helsinki and Uusimaa, Finland

Elective, endovascular surgery

16 200 €

Gamma( α 7.142, λ0.0004)

Hospital district of Helsinki and Uusimaa, Finland

Elective, open surgery

16 300 €

Gamma( α 1.914, λ0.00012)

Hospital district of Helsinki and Uusimaa, Finland

Discount rate

3%

0-5%

National guideline, Finland (STM 2009 {23})

AAA=abdominal aortic aneurysm; rAAA=ruptured AAA.

  • Mean (α) and standard deviation (σ) are used for approximation for normal distribution. Gamma distribution (with α and λ) is used for costs.

Result cards

Resource utilization

Result card for ECO1: "What types of resources are used when delivering population-based screening for Abdominal Aorta Aneurysm, or no systematic screening for AAA (resource use identification)?"

View full card
ECO1: What types of resources are used when delivering population-based screening for Abdominal Aorta Aneurysm, or no systematic screening for AAA (resource use identification)?
Method
Result
Comment

Importance: Critical

Transferability: Partially

Result card for ECO2: "What amounts of resources are used when delivering population-based screening for Abdominal Aorta Aneurysm, or no screening for AAA (resource use measurement)?"

View full card
ECO2: What amounts of resources are used when delivering population-based screening for Abdominal Aorta Aneurysm, or no screening for AAA (resource use measurement)?
Method
Result

Importance: Critical

Transferability: Partially

Unit costs

Result card for ECO3: "What are the unit costs of the resources used when delivering population-based screening for Abdominal Aorta Aneurysm, or no screening for AAA?"

View full card
ECO3: What are the unit costs of the resources used when delivering population-based screening for Abdominal Aorta Aneurysm, or no screening for AAA?
Method
Result
Comment

Importance: Critical

Transferability: Partially

Outcomes

Result card for ECO4: "What are the incremental effects of population-based Abdominal Aorta Aneurysm Screening relative to no systematic screening?"

View full card
ECO4: What are the incremental effects of population-based Abdominal Aorta Aneurysm Screening relative to no systematic screening?
Method
Result
Comment

Importance: Critical

Transferability: Partially

Cost-effectiveness

Result card for ECO6: "What is the appropriate time horizon?"

View full card
ECO6: What is the appropriate time horizon?
Method
Result

Importance: Critical

Transferability: Partially

Result card for ECO5: "What is the incremental cost-effectiveness ratio?"

View full card
ECO5: What is the incremental cost-effectiveness ratio?
Method
Result
Comment

Importance: Critical

Transferability: Partially

Discussion

The present analysis of the cost-effectiveness of AAA screening is based on a combination of a systematic literature review and modelling.

We found four systematic literature reviews with somewhat conflicting conclusions. Our own literature review contains seven studies that were published after the four earlier reviews and hence it contains more recent data. Additionally, we included literature in any language and without time limits. This review is, therefore, likely to contain a more complete overall picture of the effectiveness and cost-effectiveness of AAA screening.

We have not included a systematic analysis of the quality of included studies, since it would have required a substantial amount of extra work and its utility would have remained somewhat controversial. The value of including such an analysis in a core HTA would be a useful discussion topic for the European health economics community.

The primary limitation and challenge in our literature review – as always in the field of health economics – is the limited transferability of results from one setting to another and the difficulty of combining the results in a reliable manner. We have addressed this challenge by including a full cost-effectiveness analysis in the analysis of this domain. Our original intention was to use as much data as possible directly from the other domains, however, many of the analyses in this domain are dependent on the final results and data from other domains. Limited timelines meant that these data were not available within a time frame that would permit analysis. For this reason, and because economic components are generally very context dependent, the analysis is based on data from the Finnish healthcare setting. While the results of this modelling, as such, may not be useful in different settings, the model itself will be made available to researchers from EUnetHTA member organisations. Unfortunately – and due to time and resource limitations – testing of the model in different settings was beyond the scope of this work. Hence we cannot be certain about the applicability of the model in different European settings.

We used a previously constructed model combining a decision-tree and a Markov model {2}, which we modified so that it would better match with clinical practice in Finland. Although the parameter values reported in Table 1 are similar for both arms, differences between the screening arm and the control arm exist as a result of the structure of the model (see Appendix ECO-3). For example, the probability of having elective surgery is similar for all those who have a large AAA detected. In the screening arm, most of the large AAAs are found and thus the number of elective procedures is greater than in the control arm, where only a minority of large AAAs are detected incidentally. And since most of the large AAAs in the screening arm are treated, the number of ruptures is lower than in the control arm. Furthermore, it is assumed that elective surgery is performed before rupture (if the person is eligible for surgery). This part concerning the risk of rupture is the major modification made to the original model by Ehlers et al. {2}. We conclude that this modification is the main explanation for the difference between our results and those of Ehlers et al. {2}.

We found that the ICER of population-based AAA screening in Finland would be 8433€ per life year gained, if ultrasound screening were offered once to 65-year-old men. The ICER for women would be lower, 7198€/LYG, due both to lower incremental costs and lower incremental effectiveness of AAA screening compared with no population-based AAA screening. The results for women should, however, be interpreted with caution as they are heavily based on data for men, and on assumptions that the natural course of AAA is similar in men and women. As is typical for most screening programmes, the largest costs of AAA screening would be manifest immediately at the beginning of the programme whereas the benefits would emerge far into the future. Our analysis has some limitations, for instance it did not include possible long-term consequences (e.g. costs of rehabilitation, decrement in quality of life) after the intervention. Also possible risk groups were not stratified but all patients were assumed to have the same risk for AAA.

Our results of the cost-effectiveness of AAA screening are not directly transferable to other healthcare systems (this can be seen e.g. on the unit cost card, ECO3). An important limitation of our assessment should be noted here: There have not been any local pilots or feasibility studies on AAA screening in Finland. Thus we had to base our assessment on a totally hypothetical perception of how the screening would be organised in Finland. Hence we refrained from including any primary investment costs for the screening in our modelling, for these costs would have been highly hypothetical in nature. If reliable information on the primary investment costs were available for instance from a local trial or pilot programme, including them in the model would of course improve the accuracy of the economic evaluation of the screening.

A major economic and organisational consequence of starting AAA screening would be a significant increase in the number of elective operations compared with the situation when screening is not offered. In Finland offering AAA screening to 65-year-old men, would more than double the number of these operations, and offering the screening also to 65-year-old women, these operations would triple in number. If the screening were to be started without sufficient resources for the operations, the treatment of other conditions needing vascular surgery could be endangered.

When deciding whether to start AAA or any screening, the question of prioritisation criteria may also arise. Such criteria have not been defined in Finland and to our knowledge not in most (if not all) European countries either. When considering AAA screening, especially the fact that it would prevent AAA-related deaths in a rather aged population might generate debate (the median age of a death due to AAA is 77 years in Finland). Furthermore, one could ask whether the effectiveness of screening compared with other preventive or health-promoting measures should be considered? For example: how effective is AAA screening compared with anti-smoking education in preventing AAA-related mortality?

In conclusion, the majority of the available evidence as well as our present evaluation suggest that one-time ultrasound screening for AAA of 65-year-old men and women is cost-effective compared with a situation where no AAA screening is offered. There is, however, only scarce evidence on AAA screening in women, and further research regarding women is needed.

References

1. Canadian Coordinating Office for Health Technology,Assessment. Guidelines for the economic evaluation of health technologies: Canada (3rd edition) (special). Ottawa: Canadian Coordinating Office for Health Technology Assessment (CCOHTA); 2006.

2. Ehlers L, Overvad K, Sorensen J, Christensen S, Bech M, Kjolby M. Analysis of cost effectiveness of screening danish men aged 65 for abdominal aortic aneurysm. BMJ. 2009;338:b2243.

3. Mäklin S, Laukontaus S, Salenius J, Romsi P, Roth W, Laitinen R, et al. Vatsa-aortan aneurysman seulonta suomessa [screening for abdominal aortic aneurysms in Finland]. [Screening for abdominal aortic aneurysm in Finland] ed. Helsinki: Terveyden ja hyvinvoinnin laitos; 2011.

4. Anderson R. Systematic reviews of economic evaluations: Utility or futility? Health Econ. 2010 Mar;19(3):350-64.

5. Duncan JL, Wolf B, Nichols DM, Lindsay SM, Cairns J, Godden DJ. Screening for abdominal aortic aneurysm in a geographically isolated area. Br J Surg. 2005 Aug;92(8):984-8.

6. Ishikawa S, Takahashi T, Sato Y, Suzuki M, Ohki S, Oshima K, et al. Screening cost for abdominal aortic aneurysms: Japan-based estimates. Surg Today. 2004;34(10):828-31.

7. Lindholt JS, Juul S, Henneberg EW, Fasting H. [Screening for abdominal aortic aneurysm]. Ugeskr Laeger. 1997 Mar 24;159(13):1915-9.

8. Lindholt JS, Fasting H, Henneberg EW, Juul S. [Preliminary results of screening for abdominal aortic aneurysm in the county of viborg]. Ugeskr Laeger. 1997 Mar 24;159(13):1920-3.

9. Wilmink AB, Forshaw M, Quick CR, Hubbard CS, Day NE. Accuracy of serial screening for abdominal aortic aneurysms by ultrasound. J Med Screen. 2002;9(3):125-7.

10. Thompson SG, Ashton HA, Gao L, Scott RA, Multicentre Aneurysm Screening Study Group. Screening men for abdominal aortic aneurysm: 10 year mortality and cost effectiveness results from the randomised multicentre aneurysm screening study. BMJ. 2009;338:b2307.

11. Multicentre Aneurysm Screening Study G. Multicentre aneurysm screening study (MASS): Cost effectiveness analysis of screening for abdominal aortic aneurysms based on four year results from randomised controlled trial. BMJ. 2002 Nov 16;325(7373):1135.

12. Laukontaus SJ, Aho PS, Pettila V, Alback A, Kantonen I, Railo M, et al. Decrease of mortality of ruptured abdominal aortic aneurysm after centralization and in-hospital quality improvement of vascular service. Ann Vasc Surg. 2007 Sep;21(5):580-5.

13. Lindholt JS, Juul S, Fasting H, Henneberg EW. Screening for abdominal aortic aneurysms: Single centre randomised controlled trial. BMJ. 2005 Apr 2;330(7494):750.

14. Norman PE, Jamrozik K, Lawrence-Brown MM, Le MT, Spencer CA, Tuohy RJ, et al. Population based randomised controlled trial on impact of screening on mortality from abdominal aortic aneurysm. BMJ. 2004 Nov 27;329(7477):1259.

15. Ashton HA, Buxton MJ, Day NE, Kim LG, Marteau TM, Scott RA, et al. The multicentre aneurysm screening study (MASS) into the effect of abdominal aortic aneurysm screening on mortality in men: A randomised controlled trial. Lancet. 2002 Nov 16;360(9345):1531-9.

16. Hafez H, Druce PS, Ashton HA. Abdominal aortic aneurysm development in men following a "normal" aortic ultrasound scan. Eur J Vasc Endovasc Surg. 2008 Nov;36(5):553-8.

17. Scott RA, Bridgewater SG, Ashton HA. Randomized clinical trial of screening for abdominal aortic aneurysm in women. Br J Surg. 2002 Mar;89(3):283-5.

18. Henriksson M, Lundgren F. Decision-analytical model with lifetime estimation of costs and health outcomes for one-time screening for abdominal aortic aneurysm in 65-year-old men. Br J Surg. 2005 Aug;92(8):976-83.

19. Powell JT, Brown LC, UK Small Aneurysm Trial. The natural history of abdominal aortic aneurysms and their risk of rupture. Adv Surg. 2001;35:173-85.

20. Law MR, Morris J, Wald NJ. Screening for abdominal aortic aneurysms. J Med Screen. 1994 discussion 115-6; Apr;1(2):110-5.

21. Vardulaki KA, Prevost TC, Walker NM, Day NE, Wilmink AB, Quick CR, et al. Growth rates and risk of rupture of abdominal aortic aneurysms. Br J Surg. 1998 Dec;85(12):1674-80.

22. Lederle FA, Johnson GR, Wilson SE, Ballard DJ, Jordan WD,Jr, Blebea J, et al. Rupture rate of large abdominal aortic aneurysms in patients refusing or unfit for elective repair. JAMA. 2002 Jun 12;287(22):2968-72.

23. Sosiaali- ja terveysministeriön asetus lääkkeiden hintalautakunnalle tehtävästä hakemuksesta ja hintailmoituksesta. liite: Ohje terveystaloudellisen selvityksen laatimiseksi. 2001/2009. http://www.finlex.fi/fi/laki/alkup/2009/20090201

24. Badger SA, Jones C, Murray A, Lau LL, Young IS. Implications of attendance patterns in northern ireland for abdominal aortic aneurysm screening. Eur J Vasc Endovasc Surg. 2011 Oct;42(4):434-9.

25. Spronk S, van Kempen BJ, Boll AP, Jorgensen JJ, Hunink MG, Kristiansen IS. Cost-effectiveness of screening for abdominal aortic aneurysm in the netherlands and norway. Br J Surg. 2011 Nov;98(11):1546-55.

26. Lindholt JS, Sorensen J, Sogaard R, Henneberg EW. Long-term benefit and cost-effectiveness analysis of screening for abdominal aortic aneurysms from a randomized controlled trial. Br J Surg. 2010 Jun;97(6):826-34.

27. Wanhainen A, Lundkvist J, Bergqvist D, Bjorck M. Cost-effectiveness of different screening strategies for abdominal aortic aneurysm. J Vasc Surg. 2005 May;41(5):741-51.

28. Giardina S, Pane B, Spinella G, Cafueri G, Corbo M, Brasseur P, et al. An economic evaluation of an abdominal aortic aneurysm screening program in italy. J Vasc Surg. 2011 Oct;54(4):938-46.

29. Montreuil B, Brophy J. Screening for abdominal aortic aneurysms in men: A Canadian perspective using monte carlo-based estimates. Can J Surg. 2008 Feb;51(1):23-34.

30. Henriksson M, Lundgren F, Carlsson P. Informing the efficient use of health care and health care research resources: The case of screening for abdominal aortic aneurysm in Sweden. Health Economics. 2006 30 Apr;15(12):1311-22.

31. Silverstein MD, Pitts SR, Chaikof EL, Ballard DJ. Abdominal aortic aneurysm (AAA): Cost-effectiveness of screening, surveillance of intermediate-sized AAA, and management of symptomatic AAA. Baylor Univ Med Cent Proc. 2005 Oct;18(4):345-67.

32. Wanhainen A, Lundkvist J, Bergqvist D, Bjorck M. Cost-effectiveness of screening women for abdominal aortic aneurysm. J Vasc Surg. 2006 May;43(5):908-14.

33. Russell JG. Is screening for abdominal aortic aneurysm worthwhile?. Clin Radiol. 1990 Mar;41(3):182-4.

34. Ehlers L, Sorensen J, Jensen LG, Bech M, Kjolby M. Is population screening for abdominal aortic aneurysm cost-effective?. BMC Cardiovasc Disord. 2008;8:32.

35. Kim LG, P Scott RA, Ashton HA, Thompson SG, Multicentre Aneurysm Screening Study Group. A sustained mortality benefit from screening for abdominal aortic aneurysm. Ann.Intern.Med. 2007 May 15;146(10):699-706.

36. Boll AP, Severens JL, Verbeek AL, van der Vliet JA. Mass screening on abdominal aortic aneurysm in men aged 60 to 65 years in the netherlands: Impact on life expectancy and cost-effectiveness using a markov model. . 2003 04 Apr;26(1):74-80.

37. Wilmink AB, Quick CR, Hubbard CS, Day NE. Effectiveness and cost of screening for abdominal aortic aneurysm: Results of a population screening program. J Vasc Surg. 2003 Jul;38(1):72-7.

38. Frame PS, Fryback DG, Patterson C. Screening for abdominal aortic aneurysm in men ages 60 to 80 years. A cost-effectiveness analysis. Ann Intern Med. 1993 Sep 1;119(5):411-6.

39. Bengtsson H, Bergqvist D, Jendteg S, Lindgren B, Persson U. Ultrasonographic screening for abdominal aortic aneurysm: Analysis of surgical decisions for cost-effectiveness. World J Surg. 1989 May-Jun;13(3):266-71.

40. St Leger AS, Spencely M, McCollum CN, Mossa M. Screening for abdominal aortic aneurysm: A computer assisted cost-utility analysis. Eur J Vasc Endovasc Surg. 1996 Feb;11(2):183-90.

41. Schmidt T, Muhlberger N, Chemelli-Steingruber IE, Strasak A, Kofler B, Chemelli A, et al. Benefit, risks and cost-effectiveness of screening for abdominal aortic aneurysm. ROFO Fortschr Geb Rontgenstr Nuklearmed. 2010 Jul;182(7):573-80.

42. van Gils PF, de Wit GA, Schuit AJ, van den Berg M. [Screening for abdominal aortic aneurysm; effectivity and cost-effectiveness]. Ned Tijdschr Geneeskd. 2009;153:B383.

43. Cosford PA, Leng GC. Screening for abdominal aortic aneurysm. Cochrane Database Syst Rev. 2007(2):002945.

44. Buxton MJ. Screening for abdominal aortic aneurysm. BMJ. 2009;338:b2185.

45. Jensen LP, Lindholt JS. The danish health economic modelling study on AAA screening is flawed. BMJ 10 July 2009.

46. Thompson S. So is aaa screening cost-effective? BMJ. 2009 29 June 2009.

47. Kim LG, Thompson SG, Briggs AH, Buxton MJ, Campbell HE. How cost-effective is screening for abdominal aortic aneurysms? J.Med.Screen. 2007;14(1):46-52.

48. Henriksson M, Lundgren F, Carlsson P. Informing the efficient use of health care and health care research resources: the case of screening for abdominal aortic aneurysm in Sweden. Health Economics 2006 30 Apr;15(12):1311-1322.

49. Lindholt JS, Juul S, Fasting H, Henneberg EW. Cost-effectiveness analysis of screening for abdominal aortic aneurysms based on five year results from a randomised hospital based mass screening trial. Eur.J.Vasc.Endovasc.Surg. 2006 Jul;32(1):9-15.

Appendices

Appendix ECO-1 Literature search strategy.

pdf106.ECO-1 Appendix 1

Appendix ECO-2 Evidence table.

pdf106.ECO-2 Appendix 2

Appendix ECO-3 Structure of the model.

106.ECO-3 Appendix 3

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?"

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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?"

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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?"

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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?"

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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?"

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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?"

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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?"

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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?"

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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.

Organisational aspects

Authors: Janek Saluse, Kristi Liiv, Raul-Allan Kiivet

Summary

A national systematic population-based abdominal aortic aneurysm (AAA) screening programme has been implemented in the European Union (EU)  in the UK and Sweden. Most of the information used in the current domain originates from the UK.

Based on clinical effectiveness studies is AAA screening offered for men aged 65 years. In the UK men older than 65can participate in the screening programme by self-referral. For better availability screening is organised through local screening centres that are located in local healthcare facilities (clinics, hospitals, primary care facilities). Screening is carried out by a sonographer using an ultrasound machine. Results are highly accurate and are communicated to men immediately after the procedure. For men with normal results no re-screening is offered. For men who have a small aneurysm an invitation for follow-up screening is given. Men with a large aneurysm (diameter over 5.5 cm) are referred to a vascular surgeon to discuss treatment. Possible treatment options include elective surgery and endovascular aneurysm repair (EVAR). Because of the relatively high risk of death (5%) during surgery a minimum of 20 elective operations per unit is defined as the quality standard.

As a result of screening fewer emergency operations and more elective operations are needed.

The quality of screening should be guaranteed by applying quality criteria – appropriate training of staff, standardised calibration of equipment, and monitoring of screening outcome and of performance (AAA related morbidity and mortality). All monitoring processes are carried out using information technology (identification and collation of screening cohort; management of administration, screening and referral process; recording of AAA surgery and outcomes).

Human resources for AAA screening include: clinical staff (director/clinical lead, ultrasound clinician, consultants in vascular units), screening staff (ultrasound screening technicians, clinical skills trainer, nurse practitioner), management/administrative/technical staff (coordinator, clerical officer, medical physicist, information technology (IT) lead, governance (strategic health authorities, primary care trusts, primary care providers, local screening programme, diagnostic and treatment services).

Costs of AAA screening include: administration costs (salaries of administrative workers), screening and treatment costs (resources for maintenance of equipment; costs of ultrasound exam, elective operation and emergency surgery), and capital costs (ultrasound machines and computers, premises for administrative and diagnostic purposes or mobile screening unit). Screening programmes are usually financed directly by national or local government. But it is also possible to apply cost-sharing.

AAA screening is relatively well accepted by both patients and vascular surgeons.

Introduction

The organisational domain assesses what types of resources (material, human skills, knowledge, money, etc) must be mobilised and organised when implementing a new technology, and what changes or consequences the use can cause in an organisation. In this core health technology assessment (HTA) the new technology is systematic population-based abdominal aortic aneurysm (AAA) screening and the objective is to assess the organisational effects of AAA screening introduction compared with the situation without AAA screening (which includes opportunistic screening and incidental detection of AAA without age or sex limitation while performing abdominal ultrasound examinations for indications other than AAA or unclear clinical indications.

Based on the material found while working on the current domain, systematic population-based AAA screening for healthy individuals has been implemented only in two European countries – the UK and Sweden. No written and freely available materials about the AAA screening organisation in Sweden were found. Therefore this domain is mainly based on UK guidelines and other UK National Health Service (NHS) materials about AAA screening.

Methodology

Frame

The 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

Assessment elements

TopicIssue RelevantResearch questions or rationale for irrelevance
G0001ProcessWhat kind of work flow, participant flow and other processes are needed?yesWhat kind of work flow, participant flow and other processes are needed when implementing AAA Screening?
What kind of changes are required in existing work processes when implementing AAA Screening?
What kind of changes are required in patients path when implementing AAA Screening?
G0012ProcessWhat kind of quality assurance is needed and how should it be organised?yesWhat kind of quality assurance is needed and how should it be organised?
G0002ProcessWhat kind of involvement has to be mobilized for participants and important others?yesWhat kind of patients (and relative) involvement in screening has to be mobilized when implementing AAA Screening?
G0003ProcessWhat kind of staff, training and other human resources are required?yesWhat kind of staff, training and other human resources are required when using AAA Screening?
G0004ProcessWhat kind of co-operation and communication of activities have to be mobilised?yesWhat kind of co-operation and communication of activities does AAA Screening require?
G0005StructureHow does de-centralisation or centralization requirements influence the implementation of the technology?yesHow does de-centralisation or centralization requirements influence the implementation of AAA Screening?
What consequences will AAA Screening have for de-centralisation or centralisation?
G0006StructureWhat kinds of investments are needed (material or premises) and who are responsible for those?yesWhat kinds of investments are needed (material or premises) when introducing AAA Screening?
Who are responsible for those investments?
G0007StructureWhat is the likely budget impact of the implementation of the technology for the payers (e.g. government)?yesWhat is the likely budget impact of the implementation of AAA Screening for the payers (e.g. government)?
G0008ManagementWhat management problems and opportunities are attached to the technology?yesWhat management problems and opportunities are attached to AAA Screening?
G0013ManagementWhat kind of monitoring requirements and opportunities are there for the technology?yesWhat kind of monitoring requirements and opportunities are there for AAA Screening?
G0009ManagementWho decides which people are eligible for the technology and on what basis?yesWho decides which people are eligible for AAA Screening and on what basis?
G0010CultureHow is the technology accepted?yesHow is AAA screening accepted by clinicians?
How do the patients accept AAA Screening?
How do the financial management of the health care organizations accept AAA Screening?
G0011CultureHow are the other interest groups taken into account in the planning / implementation of the technology?no

Methodology description

Information sources

Specific organisational aspects other than just naming the resources needed and their costs are rarely analysed within clinical studies, economic analysis and HTA reports, so the current analysis required several activities. Systematic review of the literature was not enough to answer the research questions of this domain. So grey literature and national guidelines were added. The search strategy is described below. Since organisational aspects are strictly linked to country contexts, it is useful to integrate results with the experience of local experts in this area. For this purpose the results of the survey of AAA screening in European countries (EUnetHTA, 2012) were used.

Literature search

Published literature was obtained by searching MEDLINE, CDSR (Cochrane Database of Systematic Reviews), CCRCT (Cochrane Central Register of Controlled Trials), and DARE (Database of Abstract of Reviews of Effects), all by using EBSCO-HOST as search engine; and HTA Database CRD (Centre of Reviews and Dissemination). Multiple search strategies were used {ORG-1}. From scientific and HTA report databases no relevant information about organisational aspects of AAA screening was found. Additional searches on Internet Google search engine were done for national guidelines of AAA screening. The author of the current domain is sufficiently competent only in Estonian and English languages, so the search was run in English (it was known by the author that in Estonia systematic population-based screening has not been implemented). Going through reference lists of publications found on the Internet and the websites where they were uploaded gave a few additional sources.

Methods

For the whole domain a specific search on the Internet was performed (Google) – “abdominal aorta aneurysm screening” and “abdominal aorta aneurysm screening guidelines” were used as search phrases. The search was done in 13 March 2012 by Kristi Liiv (UTA). The website of the UK AAA screening programme (http://aaa.screening.nhs.uk/) was widely used for additional information. For research questions that could not be answered using the above described search results, more specific searches were carried out (in these cases the search strategy is described in the result card).

Quality assessment tools or criteria

Quality assessment using criteria for clinical effectiveness is not pertinent in the investigation of organisational aspects. We are currently not aware of suitable formal instrument of classifications using explicit quality criteria for articles looking at healthcare organisation.

Result cards

Process

Result card for ORG1: "What kind of work flow, participant flow and other processes are needed when implementing AAA Screening?", ORG16: "What kind of changes are required in existing work processes when implementing AAA Screening?" and ORG17: "What kind of changes are required in patients path when implementing AAA Screening?"

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ORG1: What kind of work flow, participant flow and other processes are needed when implementing AAA Screening?
Result

Importance: Critical

Transferability: Partially

ORG16: What kind of changes are required in existing work processes when implementing AAA Screening?
Result

Importance: Important

Transferability: Partially

ORG17: What kind of changes are required in patients path when implementing AAA Screening?
Result

Importance: Optional

Transferability: Completely

Result card for ORG15: "What kind of quality assurance is needed and how should it be organised?"

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ORG15: What kind of quality assurance is needed and how should it be organised?
Result

Importance: Important

Transferability: Partially

Result card for ORG2: "What kind of patients (and relative) involvement in screening has to be mobilized when implementing AAA Screening?"

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ORG2: What kind of patients (and relative) involvement in screening has to be mobilized when implementing AAA Screening?
Result

Importance: Optional

Transferability: Partially

Result card for ORG3: "What kind of staff, training and other human resources are required when using AAA Screening?"

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ORG3: What kind of staff, training and other human resources are required when using AAA Screening?
Result

Importance: Important

Transferability: Partially

Result card for ORG4: "What kind of co-operation and communication of activities does AAA Screening require?"

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ORG4: What kind of co-operation and communication of activities does AAA Screening require?
Result

Importance: Optional

Transferability: Partially

Structure

Result card for ORG5: "How does de-centralisation or centralization requirements influence the implementation of AAA Screening?" and ORG6: "What consequences will AAA Screening have for de-centralisation or centralisation?"

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ORG5: How does de-centralisation or centralization requirements influence the implementation of AAA Screening?
Result

Importance: Optional

Transferability: Partially

ORG6: What consequences will AAA Screening have for de-centralisation or centralisation?
Result

Importance: Unspecified

Transferability: Unspecified

Result card for ORG7: "What kinds of investments are needed (material or premises) when introducing AAA Screening?" and ORG8: "Who are responsible for those investments?"

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ORG7: What kinds of investments are needed (material or premises) when introducing AAA Screening?
Result

Importance: Critical

Transferability: Not

ORG8: Who are responsible for those investments?
Result

Importance: Important

Transferability: Partially

Result card for ORG9: "What is the likely budget impact of the implementation of AAA Screening for the payers (e.g. government)?"

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ORG9: What is the likely budget impact of the implementation of AAA Screening for the payers (e.g. government)?
Method
Result

Importance: Important

Transferability: Not

Management

Result card for ORG10: "What management problems and opportunities are attached to AAA Screening?"

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ORG10: What management problems and opportunities are attached to AAA Screening?
Result

Importance: Optional

Transferability: Partially

Result card for ORG18: "What kind of monitoring requirements and opportunities are there for AAA Screening?"

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ORG18: What kind of monitoring requirements and opportunities are there for AAA Screening?
Result

Importance: Important

Transferability: Partially

Result card for ORG11: "Who decides which people are eligible for AAA Screening and on what basis?"

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ORG11: Who decides which people are eligible for AAA Screening and on what basis?
Result

Importance: Important

Transferability: Completely

Culture

Result card for ORG12: "How is AAA screening accepted by clinicians?", ORG13: "How do the patients accept AAA Screening?" and ORG14: "How do the financial management of the health care organizations accept AAA Screening?"

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ORG12: How is AAA screening accepted by clinicians?
Result

Importance: Optional

Transferability: Partially

ORG13: How do the patients accept AAA Screening?
Result

Importance: Optional

Transferability: Partially

ORG14: How do the financial management of the health care organizations accept AAA Screening?
Result

Importance: Unspecified

Transferability: Unspecified

Discussion

Based on the guidelines from the UK a fairly complete overview of organisational aspects of AAA screening is given. However, this overview is specific to UK clinical practice and it is unclear how transferable these guidelines are to other EU countries. All organisational aspects (concerning healthcare systems staff and funding; demographic and geographic distribution of potential screening subjects) are more or less country specific. So the current overview can be used as starting point, but it is crucial to take into consideration country-specific aspects (carrying out research or analysing information already available) when implementing AAA screening.

References

  1. NHS. AAA Screening pathway. (2010).
  2. NHS Abdominal Aortic Aneurysm Screening Programme. Essential elements in developing an Abdominal Aortic Aneurysm (AAA) Screening and Surveillance Programme. Version 3.0; 2011.
  3. CMO and Public Health Directorate: Health Improvement Strategy Division. Scottish Abdominal Aortic Aneurysm Screening Programme; 2010.
  4. Lindholt JS, Norman P. Screening for Abdominal Aortic Aneurysm Reduces Overall Mortality in Men. A Meta-analysis of the Mid- and Long-term Effects of Screening for Abdominal Aortic Aneurysms. Eur J Vasc Endovasc Surg 2008;36:167–171.
  5. Mani K, Lees T, Beiles B, et al. Treatment of abdominal aortic aneurysm in nine countries 2005-2009: a vascunet report. Eur J Vasc Endovasc Surg 2011;42:598–607.
  6. The Vascular Society of Great Britain and Ireland. Framework for improving the results of elective AAA repair; 2011.
  7. Berman L, Curry L, Gusberg R, et al. Informed consent for abdominal aortic aneurysm repair: The patient’s perspective. J Vasc Surg 2008;48:296–302.
  8. Timmermans D, Molewijk B, Stiggelbout A, Kievit J. Different formats for communication surgical risks to patients and the effect on choice of treatment. Patient Educ Couns 2004;54:255–263.
  9. Lindholt JS, Juul S, Henneberg EW, Fasting H. Is screening for abdominal aneurysm acceptable to the population? Selection and recruitment to hospital-based mass screening for abdominal aortic aneurysm. J Public Health Med 1998;20:211–217.
  10. Multicentre aneurysm screening study (MASS). Cost effectiveness analysis of screening for abdominal aortic aneurysms based on four year results from randomised controlled trial. BMJ 2002;325:1135.
  11. Eunethta (WP4 Strand B). AAA Screening Survey Results; 2012.
  12. Mohler ER. Patient information: Abdominal aortic aneurysm 2011  [cited 2011-12-16]; Available from: http://www.uptodate.com/contents/patient-information-abdominal-aortic-aneurysm
  13. UK National Screening Committee. Structured review for the UK National Screening Committee appraising the viability, effectiveness and appropriateness of an abdominal aortic aneurysm screening programme (Appendix 1); 2004.

Appendices

Appendix {ORG-1}. Abdominal aortic aneurysm basic search

Databases: Cochrane Library: Cochrane Database of Systematic Reviews (CDSR), Database of Abstract of Reviews of Effects (Other Reviews), Health Technology Assessments D. (HTA), Central Register of Controlled Trials (CENTRAL). Centre for Reviews and Dissemination, EMBASE (Ovid), Ovid MEDLINE

Search date: 25.10.2011

Study design: Systematic Reviews, (Randomised) Controlled Trials

References: total: 167 total (243 including duplic.)

41 SR/HTA

126 RCT

Searched by: Ingrid Harboe, research librarian

Database: Cochrane Library

Results: Cochrane Reviews [2], Other Reviews [2], Clinical Trials [63], Methods Studies [1], Technology Assessments [11]

Search strategy:

1

MeSH descriptor Aortic Aneurysm, Abdominal, this term only

503

2

(Abdominal Aort* Aneurysm*):ti,ab,kw

681

3

(#1 OR #2)

681

4

MeSH descriptor Mass Screening, this term only

3415

5

screen*:ti,ab,kw

14943

6

(#4 OR #5)

14943

7

(#3 AND #6)

102

Database: for Reviews and Dissemination

Results: 12 SR/HTA

Search strategy:

1

MeSH DESCRIPTOR Aortic Aneurysm, Abdominal EXPLODE ALL TREES

154

2

("Abdominal Aortic Aneurysm") IN DARE, HTA

68

3

#1 OR #2

174

4

MeSH DESCRIPTOR Mass Screening EXPLODE ALL TREES

1704

5

("Mass Screening") IN DARE, HTA

720

6

#4 OR #5

1785

7

#3 AND #6

32

8

(#7) IN DARE, HTA

12

Database: Embase 1980 to 2011 Week 42 &

Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations and Ovid MEDLINE(R) 1948 to Present

  • Search filter:
  • Systematic Reviews: reviews (maximises specificity) & systematic* review*.ti,ab.

Randomised controlled trials: therapy (best balance of sensitivity and specificity)

Search strategy:

1

abdominal aorta aneurysm/use emez

15240

2

Aortic Aneurysm, Abdominal/use prmz

11591

3

abdominal aort* aneurysm*.tw.

23463

4

or/1-3

32698

5

mass screening/

114617

6

screen*.tw.

819044

7

or/5-6

858256

8

4 and 7

1925

9

remove duplicates from 8

1148

10

9 use emez [Embase]

1017

11

9 use prmz [Medline]

131

12

limit 11 to "reviews (maximises specificity)"

3

13

limit 10 to "reviews (maximises specificity)"

25

14

9 and systematic* review*.ti,ab.

22

15

or/12-14

29

16

limit 10 to "therapy (best balance of sensitivity and specificity)"

121

17

limit 11 to "therapy (best balance of sensitivity and specificity)"

15

18

or/16- 17

136

19

15 use emez

26

20

15 use prmz

3


Social aspects

Authors: Lotte Groth Jensen, Claus Loevschall, Anne Lee

Summary

There is no evidence that participation in abdominal aortic aneurysm (AAA) screening has a substantial effect on quality of life. Among those detected with a small AAA there are experiences of both limitations in daily life and distress as well as worries about an operation. Patient information in relation to AAA is limited, insufficient and difficult to understand. Though the attendance rate for AAA screening is high, there are obstacles to participation among those at higher risk for AAA.

Introduction

Assessment of the social aspects of abdominal aortic aneurysm (AAA) screening is important since the use of the technology involves some activities on behalf of the person being invited for the screening and because the screening programme might have a significant impact on the person who decides to attend. This domain investigates aspects of information and acceptance of participation in the different parts of the screening programme as well as how participants experience it and how it affects their life and quality of life (QoL).

Methodology

Frame

The 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

Assessment elements

TopicIssue RelevantResearch questions or rationale for irrelevance
H0001Major life areasWhich social areas does the use of the technology influence?yesWhich social areas do the use of Abdominal Aorta Aneurysm Screening influence and how?
H0002Major life areasWho are the important others that may be affected, in addition to the individual using the technology?yesWho are the important others that may be affected, in addition to the individual participating in the Abdominal Aorta Aneurysm Screening Program ?
H0004Major life areasWhat kind of changes may the use of the technology generate in the individual's role in the major life areas?yesWhat kind of changes may participation in Abdominal Aorta Aneurysm Screening generate in the individual's role in the major life areas?
H0003Major life areasWhat kind of support and resources are needed for the patient or citizen as the technology is introduced?yesWhat kind of support and resources are needed for the patients if the programme for Abdominal Aorta Aneurysm Screening is implemented?
H0010Major life areasWhat kind of social support and resources are needed for the providers as the technology is introduced?noThe question is considered of greater relevance for the organizational aspects
H0011Major life areasWhat kinds of reactions and consequences can the introduction of the technology cause at the overall societal level?noAbdominal Aorta Screening includes a large proportion of the population (only gender and age are inclucion criterias) and a condition not considered to imply stigmatisation
H0005IndividualWhat kind of physical and psychological changes does the implementation and use of the technology bring about and what kind of changes do patients or citizens expect?yesWhat 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?
H0006IndividualHow do patients, citizens and the important others using the technology react and act upon the technology?yesHow does participating in Abdominal Aorta Aneurysm Screening, and their important others, react and act upon the result of the screening?
H0012IndividualAre there factors that could prevent a group or persons to participate?yesAre there factors that could prevent a group or person to participate in the program?
H0007CommunicationWhat is the knowledge and understanding of the technology in patients and citizens?yesWhat is the knowledge and understanding of Abdominal Aorta Aneurysm Screening among patients?
H0008CommunicationHow do patients and citizens perceive the information they receive or require about the technology?yesHow do patients perceive the information they receive or require about Abdominal Aorta Aneurysm Screening?
H0013CommunicationWhat are the social obstacles or prospects in the communication about the technology?yesWhat are the social obstacles or prospects in the communication about Abdominal Aorta Aneurysm Screening ?
H0009CommunicationWhat influences patients’ or citizens’ decisions to use the technology?yesWhat influence patients’ decisions to participate in the Abdominal Aorta Aneurysm Screening Program?

Methodology description

Domain frame

The project scope is applied in this domain. This is supplemented by an understanding of the technology as a programme: the patient is invited for scanning and depending on the outcome eventually for some further actions e.g. watchful waiting (observation by regular scanning), or elective AAA repair (operation either by open aneurysm repair (OAR) or endovascular aneurysm repair (EVAR). Further information on the programme is provided by the organisational domain (see result card RC-ORG1).

Information sources

The literature search

A domain-specific literature search was conducted in October/November 2011. The search was conducted in the following databases: PsychInfo, Cinahl, EMBASE, Cochrane, PubMed, Sociological Abstract, PsycArticles, DARE (Database of Abstract of Reviews of Effect), NHS EED (NHS Economic Evaluation Database) and HTA database CDR (Centre of Reviews and Dissemination). The search resulted in 589 titles after excluding duplicates.

The search was conducted using both thesaurus and free text terms. The main search terms were: abdominal aortic aneurysm, aortic aneurysm, abdominal, AAA, quality of life, codes of ethics, anxiety, false positive reactions, false negative reactions, patient rights and adaptation psychological.

The specific combination of search terms and search strategy is available at {SOC-1}.

Selection of the literature

Selection of literature was done according to criteria for relevance (see also Inclusion criteria and Exclusion criteria below) and by using quality validated checklists.

Inclusion criteria

Study design: No preferences

Population: Men and women from age 64

Intervention: Population screening for AAA

Comparison: No systematic screening for AAA

Outcomes: Quality of life, social impact, information guidelines and psychological effect

Exclusion criteria

The only limitations on the search were language and time of publication. The search included articles publicised from 1995 to 2011, which were in English, German or Scandinavian languages.

Procedure for literature selection

Titles and abstracts resulting from the literature searches were independently assessed by two investigators. Articles were included if considered relevant by one of the investigators resulting in a gross list of 102 publications. The gross list was then further scanned by each of the three investigators transferring articles chosen by two out of three and resulting in a net list of 88 publications.

Articles considered as meeting the inclusion criteria were examined in full text and assessed by two of the three investigators based on the inclusion criteria and quality requirements (see Quality assessment tools and criteria below). Discrepancies were resolved through discussion.

Quality assessment tools or criteria

Each of the 88 studies in the net list was read and evaluated (relevance and internal/external validity) by two of three assessors. A table of studies included was completed by agreement describing each study. For the evaluation different checklists were used depending on the design and methods of the specific study: The Danish National Board of Health provides five checklists from the Danish Secretariat of Clinical Guidelines (DSCG) based on internationally recognised tools and with explanatory notes. Available in Danish only at: http://www.sst.dk/upload/checkliste.doc

An additional and specific search for studies on Patient Participation was conducted in May 2012 identifying further two publications, see appendix {SOC-1}.

 106.Figure1

Figure 1: Flow chart showing the selection of relevant studies

Analysis and synthesis

Descriptive analysis was done. Responsibility for the assessment of the included issues was divided between the three participants, each issue and research question being answered by cooperation between two participants.

Result cards

Major life areas

Result card for SOC1: "Which social areas do the use of Abdominal Aorta Aneurysm Screening influence and how?"

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SOC1: Which social areas do the use of Abdominal Aorta Aneurysm Screening influence and how?
Result

Importance: Important

Transferability: Completely

Result card for SOC2: "Who are the important others that may be affected, in addition to the individual participating in the Abdominal Aorta Aneurysm Screening Program ?"

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SOC2: Who are the important others that may be affected, in addition to the individual participating in the Abdominal Aorta Aneurysm Screening Program ?
Result

Importance: Important

Transferability: Completely

Result card for SOC3: "What kind of changes may participation in Abdominal Aorta Aneurysm Screening generate in the individual&#39;s role in the major life areas?"

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SOC3: What kind of changes may participation in Abdominal Aorta Aneurysm Screening generate in the individual&#39;s role in the major life areas?
Result
Comment

Importance: Important

Transferability: Partially

Result card for SOC12: "What kind of support and resources are needed for the patients if the programme for Abdominal Aorta Aneurysm Screening is implemented?"

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SOC12: What kind of support and resources are needed for the patients if the programme for Abdominal Aorta Aneurysm Screening is implemented?
Result
Comment

Importance: Important

Transferability: Partially

Individual

Result card for SOC4: "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?"

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SOC4: 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?
Result

Importance: Critical

Transferability: Completely

Result card for SOC5: "How does participating in Abdominal Aorta Aneurysm Screening, and their important others, react and act upon the result of the screening?"

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SOC5: How does participating in Abdominal Aorta Aneurysm Screening, and their important others, react and act upon the result of the screening?
Result
Comment

Importance: Critical

Transferability: Completely

Result card for SOC11: "Are there factors that could prevent a group or person to participate in the program?"

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SOC11: Are there factors that could prevent a group or person to participate in the program?
Result

Importance: Important

Transferability: Partially

Communication

Result card for SOC6: "What is the knowledge and understanding of Abdominal Aorta Aneurysm Screening among patients?"

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SOC6: What is the knowledge and understanding of Abdominal Aorta Aneurysm Screening among patients?
Result
Comment

Importance: Optional

Transferability: Partially

Result card for SOC7: "How do patients perceive the information they receive or require about Abdominal Aorta Aneurysm Screening?"

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SOC7: How do patients perceive the information they receive or require about Abdominal Aorta Aneurysm Screening?
Result
Comment

Importance: Critical

Transferability: Partially

Result card for SOC10: "What are the social obstacles or prospects in the communication about Abdominal Aorta Aneurysm Screening ?"

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SOC10: What are the social obstacles or prospects in the communication about Abdominal Aorta Aneurysm Screening ?
Result
Comment

Importance: Important

Transferability: Partially

Result card for SOC8: "What influence patients’ decisions to participate in the Abdominal Aorta Aneurysm Screening Program?"

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SOC8: What influence patients’ decisions to participate in the Abdominal Aorta Aneurysm Screening Program?
Result

Importance: Critical

Transferability: Partially

Discussion

Overall, it is not possible to determine with certainty whether screening for AAA affects the health- related QoL of participants. The optimal design for measuring changes in QoL among screening participants is to compare the participants with a control group that does not take part in screening. Such a comparison should be performed in the time period during which screening takes places. Such a study design has not been identified.

Based on studies in which the participants' QoL was assessed primarily by comparing the participants’ QoL before and after screening, or by comparing the relevant patients with other groups of patients also participating in screening it should be emphasised that participation in AAA screening does not seem to have any substantial effect on QoL.

Most changes in QoL are registered within the relatively large group of participants who are diagnosed with a small AAA. However, the changes in QoL are still limited. The available treatment option for this group of patients comprises participation in a process that includes regular follow-up. Depending on the size and growth rate of the aneurysm, the patients will participate in the monitoring process until the aneurysm requires surgery or until the patient dies of other causes.

Qualitative research points to experiences of distress after being diagnosed with an AAA and feelings of disillusionment when the AAA is growing, as well as worries about an eventual operation. It is possible that the qualitative studies capture some of the psychological effects of screening for AAA, which are not captured in the generic measurements of QoL. Extra attention and support may be needed for the participants offered regular follow-up after an initial AAA screening.

The attendance rate for AAA screening is considered as generally high though there seems to be obstacles for participation (older age, men living alone, men in lower social groups and long travel distance).

Thorough information should be provided to the individual patient  before and after screening as well as in connection with follow-up and the decision about the operation. Nevertheless, studies show patient information in relation to AAA to be limited, insufficient and difficult to understand. Patients differ in relation to how much information they desire and how they best understand information on an asymptomatic condition with uncertain outcomes and distinct risk profiles. Particular attention may be needed for the oldest people among the attendees and for those with little desire for involvement. There is a need to develop guidelines describing how best to provide an initial invitation, optimal risk-benefit information and how to undertake shared decision making for individuals offered AAA screening

In general there is limited evidence showing how patients are affected by AAA screening, how they experience and handle participation in the programme and how best to inform them and support their decisions, which may be initiated by their participation in screening.

References

1. Berterö, Carlsson P, Lundgren F. Screening for abdominal aortic aneurysm, a one-year follow up: An interview study. Journal of Vascular Nursing. 2010;28(3):97-101.

2. Letterstal A, Eldh AC, Olofsson P, Forsberg C. Patients experience of open repair of abdominal aortic aneurysm--Preoperative information, hospital care and recovery. Journal of Clinical Nursing. 2010;19(21-22):3112-22.

3. Collin J. The Oxford Screening Program for aortic aneurysm and screening first-order male siblings of probands with abdominal aortic aneurysm. Ann N YAcad Sci. 1996;800:36-43.

4. Khaira HS, Herbert LM, Crowson MC. Screening for abdominal aortic aneurysms does not increase psychological morbidity. Ann RColl Surg Engl. 1998;80(5):341-2.

5. Wanhainen A, Rosen C, Rutegard J, Bergqvist D, Bjorck M. Low quality of life prior to screening for abdominal aortic aneurysm: a possible risk factor for negative mental effects. Ann Vasc Surg. 2004;18(3):287-93.

6. Ashton HA, Buxton MJ, Day NE, Kim LG, Marteau TM, Scott RA, et al. The Multicentre Aneurysm Screening Study (MASS) into the effect of abdominal aortic aneurysm screening on mortality in men: a randomised controlled trial. Lancet. 2002;360(9345):1531-9.

7. Lindholt JS, Vammen S, Fasting H, Henneberg EW. Psychological consequences of screening for abdominal aortic aneurysm and conservative treatment of small abdominal aortic aneurysms. EurJ Vasc Endovasc Surg. 2000;20(1):79-83.

8. Lucarotti ME, Heather BP, Shaw E, Poskitt KR. Psychological morbidity associated with abdominal aortic aneurysm screening. EurJ Vasc Endovasc Surg. 1997;14(6):499-501.

9. Spencer CA, Norman PE, Jamrozik K, Tuohy R, Lawrence-Brown M. Is screening for abdominal aortic aneurysm bad for your health and well-being? ANZ J Surg. 2004;74(12):1069-75.

10. Korhonen SJ, Kantonen I, Pettila V, Keranen J, Salo JA, Lepantalo M. Long-term survival and health-related quality of life of patients with ruptured abdominal aortic aneurysm. EurJ Vasc Endovasc Surg. 2003;25(4):350-3.

11. Hennessy A, Barry MC, McGee H, O'Boyle C, Hayes DB, Grace PA. Quality of life following repair of ruptured and elective abdominal aortic aneurysms. EurJ Surg. 1998;164(9):673-7.

12. Hinterseher I, Saeger HD, Koch R, Bloomenthal A, Ockert D, Bergert H. Quality of life and long-term results after ruptured abdominal aortic aneurysm. EurJ Vasc Endovasc Surg. 2004;28(3):262-9.

13. Joseph AY, Fisher JB, Toedter LJ, Balshi JD, Granson MA, Meir-Levi D. Ruptured abdominal aortic aneurysm and quality of life. Vasc Endovascular Surg. 2002;36(1):65-70.

14. Laukontaus SJ, Pettila V, Kantonen I, Salo JA, Ohinmaa A, Lepantalo M. Utility of surgery for ruptured abdominal aortic aneurysm. Ann Vasc Surg. 2006;20(1):42-8.

15. Hill AB, Palerme LP, Brandys T, Lewis R, Steinmetz OK. Health-related quality of life in survivors of open ruptured abdominal aortic aneurysm repair: a matched, controlled cohort study. J Vasc Surg. 2007;46(2):223-9.

16. Tambyraja AL, Fraser SC, Murie JA, Chalmers RT. Functional outcome after open repair of ruptured abdominal aortic aneurysm. J Vasc Surg. 2005;41(5):758-61.

17. Eskandari MK, Bowle SA, Webster MW, Steed DL, Makaroun MS, Muluk SC, et al. Ruptured abdominal aortic aneurysms in the 1990s: Resource utilization, long-term survival, and quality of life after repair. Vascular Surgery. 1998;32(5):415-424.

18. Tambyraja AL, Fraser SC, Murie JA, Chalmers RT. Quality of life after repair of ruptured abdominal aortic aneurysm. European Journal of Vascular and Endovascular Surgery. 2004;28:229-33.

19. Kurz M, Meier T, Pfammatter T, mann-Vesti BR. Quality of life survey after endovascular abdominal aortic aneurysm repair in octogenarians. Int Angiol. 2010;29(3):249-54.

20. De Rango P, Verzini F, Parlani G, Cieri E, Romano L, Loschi D, et al. Quality of life in patients with small abdominal aortic aneurysm: the effect of early endovascular repair versus surveillance in the CAESAR trial. EurJ Vasc Endovasc Surg. 2011;41(3):324-31.

21. Sandstrom V, Bjorvell H, Olofsson P. Functional status and well-being in a group of patients with abdominal aortic aneurysm. Scandinavian Journal of Caring Sciences. 1996;10(3):186-91.

22. Lederle FA, Johnson GR, Wilson SE, Acher CW, Ballard DJ, Littooy FN, et al. Quality of life, impotence, and activity level in a randomized trial of immediate repair versus surveillance of small abdominal aortic aneurysm. J Vasc Surg. 2003;38(4):745-52.

23. Health service costs and quality of life for early elective surgery or ultrasonographic surveillance for small abdominal aortic aneurysms. UK Small Aneurysm Trial Participants. Lancet. 1998;352(21):1656-60.

24. Pettersson M, Bergbom I. The drama of being diagnosed with an aortic aneurysm and undergoing surgery for two different procedures: open repair and endovascular techniques. J Vasc Nurs. 2010;28(1):2-10.

25. Langenberg D, Abholz HH. How do patients cope with controllable abdominal aneurysm?. [German]. Zeitschrift fur Allgemeinmedizin. 2003;79:32-35.

26. Brannstrom M, Bjorck M, Strandberg G, Wanhainen A. Patients' experiences of being informed about having an abdominal aortic aneurysm - a follow-up case study five years after screening. J Vasc Nurs. 2009;27(3):70-4.

27. Berman L, Curry L, Gusberg R, Dardik A, Fraenkel L. Informed consent for abdominal aortic aneurysm repair: The patient's perspective. J Vasc Surg. 2008;48(2):296-302.

28. Berman L, Dardik A, Bradley EH, Gusberg RJ, Fraenkel L. Informed consent for abdominal aortic aneurysm repair: assessing variations in surgeon opinion through a national survey. J Vasc Surg. 2008;47(2):287-95.

29. Letterstal A, Sandstrom V, Olofsson P, Forsberg C. Postoperative mobilization of patients with abdominal aortic aneurysm. Journal of Advanced Nursing. 2004;48(6):560-8.

30. Timmermans D, Molewijk B, Stiggelbout A, Kievit J. Different formats for communicating surgical risks to patients and the effect on choice of treatment. Patienteducationand counseling. 2004;54:255-63.

31. Knops AM, Ubbink DT, Legemate DA, de Haes JC, Goossens A. Information communicated with patients in decision making about their abdominal aortic aneurysm. EurJ Vasc Endovasc Surg. 2010;39(6):708-13.

32. Stiggelbout AM, Molewijk AC, Otten W, van Bockel JH, Bruijninckx CM, Van dSI, et al. The impact of individualized evidence-based decision support on aneurysm patients' decision making, ideals of autonomy, and quality of life. Med Decis Making. 2008;28(5):751-62.

33. Berman L, Curry L, Goldberg C, Gusberg R, Fraenkel L. Pilot testing of a decision support tool for patients with abdominal aortic aneurysms. Journal of vascular surgery : official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter. 2011;53(2):285-92.

34. Chaikof EL BD, Dalmon RL, Makuroun MS, Illig KA, Sicard GA, et al. SVS practice guidelines for the care of patients with an abdominal aortic aneurysm: Executive summary. Journal of Vascular Surgery. 2009;50(85).

35. Lindholt JS, Juul S, Henneberg EW, Fasting H. Is screening for abdominal aortic aneurysm acceptable to the population? Selection and recruitment to hospital-based mass screening for abdominal aortic aneurysm. Journal of public health medicine. 1998;20:211-7.

36. Armstrong PA, Back MR, Bandyk DF, Lopez AS, Cannon SK, Johnson BL, et al. Optimizing compliance, efficiency, and safety during surveillance of small abdominal aneurysms. Journal of Vascular Surgery. 2007;46(2):190-6.

Appendices

Appendix SOC-1 Search history for the social domain on AAA screening

PsychInfo: Search history, conducted October 31st, 2011

Search number

Searches

Result

1

("Abdominal aortic aneurysm" or "aortic aneurysm, abdominal" or AAA).mp. [mp=title, abstract, heading word, table of contents, key concepts, original title, tests & measures]

161

2

limit 1 to (peer reviewed journal and human and (360 middle age <age 40 to 64 yrs> or "380 aged <age 65 yrs and older>") and (Danish or English or German or Norwegian or Swedish) and human and yr="1995 - 2011")

34

Cinahl: Search history, conducted October 31st, 2011 and May 2012 (search number 3)

Search number

Searches

Result

1

"Aortic Aneurysm, Abdominal (Thesaurus)

1151

2

"Aortic Aneurysm, Abdominal Published Date from: 19950101-20111031; Peer Reviewed; Human; Language: Danish, English, German, Norwegian, Swedish; Age Groups: Middle Aged: 45-64 years, Aged: 65+ years

257

3

Aortic Aneurysm, Abdominal (Thesaurus) and participation

8

EMBASE: Search history, conducted October 31st, 2011

Search number

Searches

Result

1

abdominal aorta aneurysm (Thesaurus)

15266

2

("Abdominal aortic aneurysm" or "aortic aneurysm, abdominal" or AAA).mp. [mp=title, abstract, subject headings, heading word, drug trade name, original title, device manufacturer, drug manufacturer, device trade name, keyword]

13963

3

1 or 2

20355

4

quality of life (Thesaurus)

176695

5

life satisfaction (Thesaurus)

4763

6

ethics or medical ethics (Thesaurus)

124214

7

anxiety (Thesaurus)

87147

8

false positive result (Thesaurus)

7686

9

false negative result (Thesaurus)

4563

10

patient information (Thesaurus)

15799

11

Information (Thesaurus)

10237

12

patient right (Thesaurus)

10282

13

coping behaviour (Thesaurus)

26229

14

psychological well being (Thesaurus)

3480

15

4 or 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12 or 13 or 14

442767

16

3 and 15

316

17

limit 16 to (human and (Danish or English or German or Norwegian or Swedish) and yr="1995 - 2011" and (adult <18 to 64 years> or aged <65+ years>))

123

Cochrane: Search history, conducted October 31st, 2011

Search number

Searches

Result

1

Aortic Aneurysm, Abdominal (Thesaurus)

503

2

"abdominal aortic aneurysm" OR "aortic aneurysm, abdimonal" OR AAA

615

3

(#1 OR #2)

748

4

Quality of Life (Thesaurus)

11312

5

Ethics (Thesaurus)

431

6

False Positive Reactions (Thesaurus)

444

7

False Negative Reactions (Thesaurus)

297

8

Adaptation, Psychological (Thesaurus)

3126

9

Anxiety (Thesaurus)

4273

10

(#4 OR #5 OR #6 OR #7 OR #8 OR #9)

18778

11

"patient information" OR information

48632

12

(#10 OR #11)

64991

13

(#3 AND #12), from 1995 to 2011

175

PubMed: Search history, conducted October 31st, 2011 and May 2012 (search number 6)

Search number

Searches

Result

1

Aortic Aneurysm, Abdominal (Thesaurus)

11379

2

“abdominal aortic aneurysm" OR "aortic aneurysm, abdominal" OR AAA

17611

3

(#2) OR #3

17611

4

Quality of Life OR Codes of Ethics OR Anxiety OR False Positive Reactions OR False Negative Reactions OR Patient Rights OR Adaptation, Psychological (Thesaurus)

308158

5

(#4) AND #13 Limits: Humans, English, German, Danish, Norwegian, Swedish, Middle Aged: 45-64 years, Aged: 65+ years, Publication Date from 1995/01/01 to 2011/10/31

113

6

Aortic Aneurysm, Abdominal (Thesaurus) and participation

23

NHS EED, DARE and HTA CDR: Search history, conducted November 2nd, 2011

Search number

Searches

Result

1

Aortic Aneurysm, Abdominal (Thesaurus)

154

2

Quality of Life (Thesaurus)

1440

3

Codes of Ethics (Thesaurus)

0

4

Anxiety (Thesaurus)

134

5

False Positive Reactions (Thesaurus)

95

6

False Negative Reactions (Thesaurus)

51

7

Patient Rights (Thesaurus)

38

8

#2 OR #3 OR #4 OR #5 OR #6 OR #7

1697

9

#1 AND #8

7

Sociological Abstract: Search history, conducted October 31st, 2011

Search number

Searches

Result

1

"abdominal aortic aneurysm" OR "aortic aneurysm, abdominal"

6

Psych articles: Search history, conducted September 28th, 2011

Search number

Searches

Result

1

(("Cancer Screening" OR "Genetic Testing" OR "Health Screening" OR "HIV Testing" OR "Physical Examination") ) OR ("population screening" OR "mass screening")) OR (("opportunistic screening" OR "opportunistic detection"))

Limits: Journal, Peer Reviewed Journal, Journal Article, Review-book; Middle Age (40-64 Yrs), Aged (65 Yrs & Older)

55


Authors: Pseudo108 Pseudo108

Summary

- Legally there should be no problem in guaranteeing that the participation of patients in AAA screening is voluntary.

- Appropriate measures should already be implemented to ensure, in a legally controlled manner, that patient data are secure.

- Laws or binding rules require that people have equal access to the technology, but the regulation of appropriate processes (such as in AAA screening) allows room for interpretation.

- Giving consent for minors and incompetent persons is legally regulated. No clear legislation exists about the limits and refusal of healthcare. Court decisions about overcoming the guardian or confirming the refusal by the guardian aim to achieve the best balance of benefit for the patient – in the case of AAA screening this will affect cases of positive screening results where there is a need for an open extensive surgical procedure.

- Laws or binding rules require that appropriate preventative or treatment measures are available for all. In the case of AAA a positive result requires the availability of high-level complex heart surgery structures, which can meet the epidemiological burden. Reimbursement by the national health system for necessary treatment abroad is decided by a court case. Structural limitations such as waiting lists or lack of resources need to be solved on a health system or governmental level.

- Laws or binding rules require appropriate counselling and information to be given to the user or patient. In the case of AAA screening appropriate information must be available, especially about the consequences of a positive result. Part of appropriate care is adherence to recommended follow-up examinations. Patients' adherence is not regulated legally, except on a contract level.

Introduction

The focus of the domain is to detect rules and regulations that have been established to protect the patient’s rights and societal interests. They may be part of patient rights legislation, data protection legislation, or provisions concerning healthcare personnel and their rights and duties in general. They may also incorporate prior approval processes by competent bodies. Finally, human rights law is interested in equal and non-discriminatory access to screening.

Methodology

Frame

The 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

Assessment elements

TopicIssue RelevantResearch questions or rationale for irrelevance
I0002Autonomy of the patientIs the voluntary participation of patients guaranteed properly?yesIs the voluntary participation of patients guaranteed properly?
I0034Autonomy of the patientWho is allowed to give consent for minors and incompetent persons?yesWho is allowed to give consent for minors and incompetent persons?
I0036Autonomy of the patientDo laws/ binding rules require appropriate counseling and information to be given to the user or patient?yesDo laws/ binding rules require appropriate counseling and information to be given to the user or patient?
I0009Privacy of the patientDo laws/ binding rules require appropriate measures for securing patient data?yesDo laws/ binding rules require appropriate measures for securing patient data?
I0008Privacy of the patientDo laws/ binding rules require informing relatives about the results?noAltough genetic associations are reported for AAA there is no clear genetic definition to require further tests for relatives
I0011Equality in health careDo laws/ binding rules require appropriate processes or resources to guarantee equal access to the technology?yesDo laws/ binding rules require appropriate processes or resources to guarantee equal access to Abdominal Aorta Aneurysm Screening ?
I0035Equality in health careDo laws/ binding rules require appropriate preventive or treatment measures available for all?yesDo laws/ binding rules require appropriate preventive or treatment measures available for all?
I0012Equality in health careIs the technology subsidized by the society?noUltrasound is a known technology
I0015Authorisation and safetyHas the technology national/EU level authorisation (marketing authorisation, registration, certification of safety, monitoring, qualification control, quality control)?noUltrasound is a known and used technology
I0019Ownership and liabilityDoes the technology infringe some intellectual property right?noUltrasound is an already well implemented technology

Methodology description

Domain frame
Search international legislation:

EurLex

International Health Law and Ethics, André Exter, ISBN 978-90-466-0259-1

Journal References in the Core Model of Screening, chapter legal domain

European Union

RIS (for examples of national legislations)

Google

Information sources

The search was done according to the questions in a structured (international law - international court decisions - national law - national court decisions) non-systematic way (no database exists like that for medical literature) by keywords and/or starting in the overview-book from Exter. Additionally the references found were searched in detail and journal articles cited in the core model were used. The results are mainly cited by the database-link.

Quality assessment tools or criteria

Peer Review was done by Dr. Gottfried Endel (medical view), and by Dr. Herta Baumann (layer in HVB organisation).

Analysis and synthesis

Interpretation of the legal text/papers/court decisions according to the HTA questions.

Result cards

Autonomy of the patient

Result card for LEG1: "Is the voluntary participation of patients guaranteed properly?"

View full card
LEG1: Is the voluntary participation of patients guaranteed properly?
Result
Comment

Importance: Important

Transferability: Partially

Result card for LEG4: "Who is allowed to give consent for minors and incompetent persons?"

View full card
LEG4: Who is allowed to give consent for minors and incompetent persons?
Result
Comment

Importance: Important

Transferability: Completely

Result card for LEG6: "Do laws/ binding rules require appropriate counseling and information to be given to the user or patient?"

View full card
LEG6: Do laws/ binding rules require appropriate counseling and information to be given to the user or patient?
Result
Comment

Importance: Important

Transferability: Partially

Privacy of the patient

Result card for LEG2: "Do laws/ binding rules require appropriate measures for securing patient data?"

View full card
LEG2: Do laws/ binding rules require appropriate measures for securing patient data?
Result
Comment

Importance: Important

Transferability: Completely

Equality in health care

Result card for LEG3: "Do laws/ binding rules require appropriate processes or resources to guarantee equal access to Abdominal Aorta Aneurysm Screening ?"

View full card
LEG3: Do laws/ binding rules require appropriate processes or resources to guarantee equal access to Abdominal Aorta Aneurysm Screening ?
Result
Comment

Importance: Important

Transferability: Completely

Result card for LEG5: "Do laws/ binding rules require appropriate preventive or treatment measures available for all?"

View full card
LEG5: Do laws/ binding rules require appropriate preventive or treatment measures available for all?
Result
Comment

Importance: Important

Transferability: Completely

Discussion

Who is responsible for a nationwide good quality screening?

"...some European countries-e.g., France and Germany-have recently come up with a new damage interpretation called loss of chance, i.e., the missed opportunity to get a more favorable outcome through different or more timely and efficient therapies.” (Molinelli 2011) {60}The authors are referring to the situation in ophthalmology in Italy, but this could also be relevant to screening for AAA.

Member States are responsible for the organisation and the delivery of healthcare. {61} Physicians have a responsibility, as guardians, for the quality of medical care. {62–65}

Conclusions:

- National governments are responsible for organisational quality.

- The physicians are responsible for the quality of AAA screening (appropriate examination,  interpretation and information).

References

1 WMA Declaration of Lisbon on the Rights of the Patient, Adopted by the 34th World Medical Assembly, Lisbon, Portugal, September/October 1981 and amended by the 47th WMA General Assembly, Bali, Indonesia, September 1995 and editorially revised by the 171st WMA Council Session, Santiago, Chile, October 2005;http://www.wma.net/en/30publications/10policies/l4/

2 Charter of Fundamental Rights of the European Union (2007/C 303/01); Article 34 (Social Security & Assistance) + Article 35 (Health Care) http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2007:303:0001:0016:EN:PDF

3 WMA Declaration of Lisbon on the Rights of the Patient, Adopted by the 34th World Medical Assembly, Lisbon, Portugal, September/October 1981 and amended by the 47th WMA General Assembly, Bali, Indonesia, September 1995 and editorially revised by the 171st WMA Council Session, Santiago, Chile, October 2005;http://www.wma.net/en/30publications/10policies/l4/

4 §§27, 28, 29 Berufsordnung (Satzung) of the Germans Physicians, Musterberufsordnung der Ärzte (MBO), Heilmittelwerbegesetz (HWG), Gesetz gegen den unlauteren Wettbewerb (UWG) http://www.aeksh.de/aerzte/arzt_und_recht/rechtsgrundlagen/berufsordnung/berufsordnung_satzung.htmland http://www.bvgd-online.de/media/039-0043_BVGD02-09_Heberer.pdf (2012-01-24)

5 §53 ÄrzteG 1998, BGBl. I 169/1998, Austria; http://www.ris.bka.gv.at/Dokument.wxe?Abfrage=Bundesnormen&Dokumentnummer=NOR30004852

6 VfGH RdM 1997/32, Austria: V56/00 ua http://www.ris.bka.gv.at/Dokument.wxe?Abfrage=Gesamtabfrage&Dokumentnummer=JFT_09988999_00V00056_00&ResultFunctionToken=2af216b9-0402-441c-9fd2-9e9429477464&SearchInAsylGH=&SearchInBegut=&SearchInBgblAlt=&SearchInBgblAuth=&SearchInBgblPdf=&SearchInBks=&SearchInBundesnormen=&SearchInDok=&SearchInDsk=&SearchInEbm=&SearchInEbmj=&SearchInGemeinderecht=&SearchInJustiz=&SearchInLgbl=&SearchInLrBgld=&SearchInLrK=&SearchInLrNo=&SearchInLrOO=&SearchInLrSbg=&SearchInLrStmk=&SearchInLrT=&SearchInLrVbg=&SearchInLrW=&SearchInNormenliste=&SearchInPvak=&SearchInRegV=&SearchInUbas=&SearchInUmse=&SearchInUvs=&SearchInVerg=&SearchInVfgh=&SearchInVwgh=&ImRisSeit=Undefined&ResultPageSize=100&Suchworte=werbung (27.09.2011)

7 www.doctorix.eu

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9 International Covenant on Economic, Social and Cultural Rights (1966); Article 12; http://www2.ohchr.org/english/law/cescr.htm

10 European Code of Social Security (Revised); Article 8 + Article 10; http://conventions.coe.int/treaty/en/Treaties/Html/139.htm

11 A Declaration on the Promotion of Patients' Rights in Europe, WHO 1994; http://www.who.int/genomics/public/eu_declaration1994.pdf

12 criminal law on national level;i.e. A: §§ 83–88 StGB; D: § 223-§ 231, § 340 StGB; Pl: Dz.U. 1997 nr 88 poz. 553 - Kodeks karny;

13 German Court, Bundesgerichtshof 2 StR 454/09) 25th June 2010; Wet toetsing levensbeëindiging op verzoek en hulp bij zelfdoding http://www.st-ab.nl/wetten/0829_Wet_toetsing_levensbeeindiging_op_verzoek_en_hulp_bij_zelfdoding.htm

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14 Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health Purposes; Articles 1 - 22 and Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Genetic Testing for Health Purposes; Articles 1 - 24; http://conventions.coe.int/treaty/en/treaties/html/203.htm

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16 Court decision (OGH-Urteil vom 11. 12. 2007) 5Ob148/07m, Austria; http://www.ris.bka.gv.at/Dokument.wxe?Abfrage=Justiz&Dokumentnummer=JJT_20071211_OGH0002_0050OB00148_07M0000_000

17  Dementia – Etiology and Epidemiology: A systematic Review. Vol 1 June 2008. The Swedish Council on Technology Assessment in Health Care. Available at:  http://www.sbu.se/upload/Publikationer/Content1/1/Dementia_vol1.pdf  (04.10.2011)

18 http://www.cks.nhs.uk/dementia/background_information/epidemiology_and_societal_burden (04.10.2011)

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20 Dissertation Mag. jur. Birgit Stranz. Die rechtliche Stellung minderjähriger Patienten im Wandel der Zeit unter besonderer Berücksichtigung der Einwilligung in medizinische Behandlungen (20./21. Jh.). http://othes.univie.ac.at/13759/1/2010-06-27_0001014.pdf

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22 Charter of Fundamental Rights of the European Union (2007/C 303/01); Articles 1 - 4; 7,8; http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2007:303:0001:0016:EN:PDF

23 Charter of Fundamental Rights of the European Union (2007/C 303/01); Articles 1 - 4; 7,8 http://eur-lex.europa.eu/en/treaties/dat/32007X1214/htm/C2007303EN.01000101.htm

24 Referring to Austrian legislation http://ingridriedl.net/01_patienten_info/Patientenrecht.htm, interpreted by Ingrid Wilbacher

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29 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31995L0046:en:NOT

30 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31995L0046:en:NOT

31 i.e.:  D: Bundesdatenschutzgesetz (BDSG), Art. 1 G vom 14. August 2009 (BGBl. I S. 2814); A: DSG 2000, 30. Dezember 2009 (BGBl 135/2009); CH: DSG, AS 2007 4983. http://www.admin.ch/ch/d/as/2007/4983.pdf; UK: Data Protection Act 1998, 16th June 1998(Royal Assent); http://hrmgt.co.uk/law.htm

32 DIRECTIVE 2011/24/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 March 2011 on the application of patients' rights in cross-border healthcare http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:088:0045:0065:EN:PDF

33 International Convention on the Elimination of all forms of Racial Discrimination; Article 5; http://www2.ohchr.org/english/law/cerd.htm

34 International Convention on the Protection of the Rights of All Migrant Workers and Members of their Families (1990), Art. 28; http://www2.ohchr.org/english/law/cmw.htm

35 Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine; Oviedo, 1997, European Treaty Series - No. 164; http://conventions.coe.int/Treaty/en/Treaties/html/164.htm

36 Charter of Fundamental Rights of the European Union (2007/C 303/01), Article 35; http://eur-lex.europa.eu/en/treaties/dat/32007X1214/htm/C2007303EN.01000101.htm

37 Council Regulations (EC) No 1408/71of 14 June on the application of social security schemes to employed persons, to self-employed persons and to members of their families moving within the Community; especially Article 22A.; http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1971R1408:20060428:en:PDF

38 A Declaration on the Promotion of Patients' Rights in Europe, WHO 1994; http://www.who.int/genomics/public/eu_declaration1994.pdf

39 World Medical Association Statement on Access to Health Care. Adopted by the 40th World medical Assembly Vienna, Austria, September 1988 and revised by the WMA General Assembly, Pilanesberg, South Africa, October 2006. http://www.wma.net/en/30publications/20journal/pdf/wmj16.pdf

40 States Parties are countries which have adhered to the World Heritage Convention. http://whc.unesco.org/en/statesparties

41 Convention on the Elimination of all Forms of Discrimination against Women; Article 12; http://www.childinfo.org/files/childmarriage_cedaw.pdf

42 https://wcd.coe.int/ViewDoc.jsp?id=955747

43 Recommendation No. R(98) 71 of the Committee of Ministers to Member States concerning the ethical and organisational aspects of health care in prison; https://wcd.coe.int/com.instranet.InstraServlet?command=com.instranet.CmdBlobGet&InstranetImage=530914&SecMode=1&DocId=463258&Usage=2

44 Council Regulations (EC) No 1408/71of 14 June on the application of social security schemes to employed persons, to self-employed persons and to members of their families moving within the Community; especially Art. 22A; http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1971R1408:20060428:en:PDF

45 Regulations (EEC) No 1408/71 from 14th June 1971; http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1971R1408:20070102:EN:PDF

No  547/72 from 21st March 1972; http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:1997:176:0001:0016:en:PDF

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No 988/2009; http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32009R0988:en:NOT

46 DIRECTIVE 2011/24/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 March 2011 on the application of patients' rights in cross-border healthcare http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:088:0045:0065:EN:PDF

47 Charter of Fundamental Rights of the European Union (2007/C 303/01); Articles 1 - 4; 7,8; http://eur-lex.europa.eu/en/treaties/dat/32007X1214/htm/C2007303EN.01000101.htm

48 Flannery FT ; Parikh PD ; Oetgen WJ. Characteristics of medical professional liability claims in patients treated by family medicine physicians. J Am Board Fam Med. 2010 Nov-Dec;23(6):753-61.

49 Oetgen WJ ; Parikh PD ; Cacchione JG ; Casale PN ; Dove JT ; Harold JG ; Hindle BL ; Maglaras M ; Rodgers GP ; Wright JS Characteristics of medical professional liability claims in patients with cardiovascular diseases. Am J Cardiol. 2010 Mar 1;105(5):745-52.

50 WMA Declaration of Lisbon on the Rights of the Patient, Adopted by the 34th World Medical Assembly, Lisbon, Portugal, September/October 1981 and amended by the 47th WMA General Assembly, Bali, Indonesia, September 1995 and editorially revised by the 171st WMA Council Session, Santiago, Chile, October 2005;http://www.wma.net/en/30publications/10policies/l4/

51 Perlin ML. "Too stubborn to ever be governed by enforced insanity": Some therapeutic jurisprudence dilemmas in the representation of criminal defendants in incompetency and insanity cases. Int J Law Psychiatry. 2010 Nov-Dec;33(5-6):475-81. Epub 2010 Oct 14.

52 Rezende EJ ; Melo Mdo C ; Tavares EC ; Santos Ade F ; Souza C. [Ethics and eHealth: reflections for a safe practice]. Rev Panam Salud Publica. 2010 Jul;28(1):58-65.

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55 P7_TA(2010)0152

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57 Judgment of the Court (Grand Chamber) of 16 May 2006. The Queen, on the application of Yvonne Watts v Bedford Primary Care Trust and Secretary of State for Health. Reference for a preliminary ruling: Court of Appeal (England & Wales) (Civil Division) - United Kingdom. Social security - National health system funded by the State - Medical expenses incurred in another Member State - Articles 48 EC to 50 EC and 152(5) EC - Article 22 of Regulation (EEC) No 1408/71. Case C-372/04.   http://eur-lex.europa.eu/Notice.do?val=426362:cs&lang=de&list=432665:cs,439339:cs,427772:cs,426362:cs,420145:cs,418803:cs,418258:cs,401136:cs,417775:cs,401132:cs,&pos=4&page=6&nbl=64&pgs=10&hwords=&checktexte=checkbox&visu=#texte (5.10.2011)

58 Consolidated versions of the Treaty on European Union and the Treaty on the Functioning of the European Union Official Journal C 115 , 09/05/2008 P. 0001 - 0388; http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2008:115:0001:01:en:HTML

59 Directive 2011/24 of the European Parliament and of the Council on the application of patients' rights in cross-border healthcare. Commission of the European Communities (Articles 1 - 22). http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:088:0045:0065:EN:PDF

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65 World Medical Association Declaration on Patient Safety, adopted by the WMA General Assembly, Washington 2002; http://www.wma.net/en/30publications/10policies/p6/

Collection appendices

Appendix COL-1

Abdominal Aortic Aneurysm Screening: Survey Report for retrieving information on the use of technology in European countries

This document describes the process of retrieving information on the Abdominal Aortic Aneurysm Screening technology made via a survey sent to European Countries through EUnetHTA Partner Agencies.

This survey form an integral part of EUnetHTA Joint Action 1-  Work Package 4 Core HTA.

pdf106.COL Appendix 1

Appendix COL-2

AAA abdominal aortic aneurysm

AE assessment element

AGREE Appraisal of Guidelines Research and Evaluation

ALARA as low as reasonably achievable

AP anteroposterior

CEA cost-effectiveness analysis

CEN European Committee for Standardization

CI confidence interval

COLMOD collaborative model

COPD chronic obstructive pulmonary disease

CT computed tomography

CUA cost-utility analysis

CUR Health problem and current use of the technology

DSA digital subtraction angiography

DSCG Danish Secretariat of Clinical Guidelines

ECO Costs and economic evaluation of the technology

EFF Effectiveness of the technology

ETH Ethical aspects of the technology

EU European Union

EVAR endovascular aortic aneurysm repair

FEV1 forced expiratory volume in 1 second

GEE generalised estimating equations

GP general practitioner

HADS state hospital anxiety and depression scale

HDR National Hospital Discharge Register (Finland)

HDU high dependency unit

HR hazard ratio

HRQoL health-related quality of life

HTA health technology assessment

ICD10 International Classification of Diseases (10th edition)

ICER incremental cost-effectiveness ratio

iHTA interactive, participatory HTA approach –

IT information technology

ITI inner to inner diameter (excluding the arterial wall)

ITO between aortic inner and outer layers

ITU intensive treatment unit

JA1 first EUnetHTA Joint Action

LEG Legal aspects of the technology

LYG life-years gained

MRI magnetic resonance imaging

NHS National Health Service (UK)

NNS  number needed to screen

NOKC Norwegian Knowledge Centre for the Health Services

OAR open aortic aneurysm repair

OR odds ratio

ORG Organisational aspects of the technology

OTO outer to outer diameter (including the arterial wall)

QA quality assurance

QALY quality adjusted life year

QoL quality of life

RCT randomised controlled trial

SAF Safety of the technology

SAG stakeholder advisory group

SOC Social aspects of the technology

SoF summary of findings

SOP standard operating procedures

SR systematic review

SSGI Social Services of General Interest

STAI  state scale of the state-trait anxiety inventory

Std.MD standard mean difference

TS transversal

USPSTF US Preventive Services Task Force

WP4 Work Plan 4