NHS AAA Screening Programme Data Linkage With HES and ONS Datasets

NCT03407664 | Unknown

• 1 other identifier: 0652
• Study Type: observational
• Target: 1,000,000
• Locations: 1 country
• Sites: 1

Brief Summary

An abdominal aortic aneurysm (AAA) is a dilation of the aorta, defined as an aortic diameter of ≥3cm. It is a significant cause of death internationally and in England each year causes c.4,000 deaths with 8,000 patients undergoing preventative surgery. AAA are often asymptomatic and there is a latent period between development and rupture. This represents an opportunity to screen by ultrasound which has been shown in trials to reduce AAA related mortality by half. In England this evidence is based on a randomised trial data from the late nineties, however, since these data were published the number of men identified with AAA has fallen to a current prevalence of just over 1%. Furthermore, similarly designed randomised trials in Western Australia demonstrated no meaningful differences in AAA or cardiovascular deaths. The first aim of our research is to follow men who have been screened for AAA in England in order to establish the medium (5 years) and long term (10+ years) impact of AAA screening on the risk of a AAA, cardiovascular and all-cause morbidity/mortality in a non-trial setting. Men with sub-aneurysms will be examined (Aorta=2.5-2.9cm) as several studies suggest this group is at risk of late rupture. The role of patient pathways to improve uptake of the screening programme will be examined. Current data suggests that the most 'deprived' men in England are the least likely to turn up for screening but the most likely to have an abdominal aneurysm. Outcomes in this group will be analysed including the benefit of a new patient pathway to improve uptake nationally. Lastly, several large studies have demonstrated that a larger aortic diameter may be associated with cardiovascular risk. The addition of aortic diameter to current risk prediction models could improve the accuracy of these models and will be examined.

Conditions

AAA

Outcome Measures

Primary Outcomes (2)

• AAA related mortality in men invited for AAA screening

  Mortality

  10 years

• AAA related morbidity in men invited for AAA screening

  Admissions to Hospital

  10 years

Secondary Outcomes (3)

• Medium term mortality

  5 years

• Cardiovascular risk in men screened for AAA

  10 years

• Medium term morbidity

  5 years

Study Arms (1)

Men Screened for AAA in England

Men invited into the NHS AAA Screening programme in England in the years 2013-2017.

Other: this field is not applicable

Interventions

this field is not applicable OTHER

We will not be testing an intervention. Only the long term outcomes of men screened for AAA in England.

Men Screened for AAA in England

Eligibility Criteria

• Age: 65 Years - 65 Years
• Sex: male
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Men screened for AAA within the NHS AAA Screening programme in England for the period covering 2013-2017; specifically, screening years 2013/14, 2014/15, 2015/16 and 2016/17.

You may qualify if:

• All men invited to the NHS AAA screening programme in England between the period of 2013-2017
• Aged 65 years of age at the time of their invitation to the NHS AAA screening programme
• All men who have consented for their data to be used for the purposes of research

You may not qualify if:

• \. All men who do not consent for their data to be used for the purposes of research

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (1)

University of Leicester

Leicester, LE3 9QP, United Kingdom

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: January 23, 2018
• Study Start: July 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: March 10, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)