Background: The aim was to estimate long-term mortality benefits and cost-effectiveness of screening for abdominal aortic aneurysm (AAA) in men aged 64–73 years.Methods: All men aged 64–73 years living in Viborg County were randomized to be controls (n = 6306) or invited for abdominal ultrasonography at a regional hospital (n = 6333). Mortality and AAA-related interventions were recorded in national databases. The cost of initial screening was based on actual costs of the programme. Incremental cost-effectiveness ratios (ICERs) were calculated on gains in life years and Quality Adjusted Life Years (QALY). Discounting (3 per cent) was applied to both costs and effects, and all costs were adjusted to euros at 2007 prices.Results: The relative risk reduction of the screening programme in AAA-related mortality was 66 per cent (hazard ratio 0·34, 95 per cent confidence interval (c.i.) 0·20 to 0·57). The corresponding risk reduction in all-cause mortality was 2 per cent (hazard ratio 0·98, 95 per cent c.i. 0·93 to 1·03). The ICER was estimated at €157 (−3292 to 4401) per life year gained and €179 (−4083 to 4682) per QALY gained. Screening was found to be cost effective at a probability above 0·97 for a willingness-to-pay threshold of only €5000. One-way sensitivity analysis demonstrated that this result was robust to various alternative assumptions, as the probability did not drop below 0·90 for any scenario.Conclusion: The mortality benefit of screening for AAA in men aged 64–73 years was maintained in the longer term and screening was cost effective. Registration number: ISRCTN65822028 (http://www.controlled-trials.com).
Background: Abdominal aortic aneurysm (AAA) screening has been introduced into some health systems and could easily be supplemented with broader vascular screening. The aim of this study was to evaluate the screening set-up and investigate combined screening for AAA, peripheral arterial disease (PAD) and possible hypertension (HT), and detection rates. Methods: This observational study was based on the intervention arm of a screening trial in 25 083 Danish men aged 65–74 years. A combined screening programme for AAA, PAD and HT was offered at local hospitals. Participants with positive test results were offered secondary prophylaxis and/or referred to their general practitioner. The programme set-up included decentralized screening by three mobile teams at 14 venues. Diagnostic criteria were: aortic diameter at least 30 mm for AAA, ankle : brachial pressure index below 0·9 or above 1·4 for PAD, and BP exceeding 160/100 mmHg for HT. Results: Overall, 18 749 men (uptake 74·7 per cent) attended the screening. An AAA was diagnosed in 3·3 (95 per cent c.i. 3·0 to 3·6) per cent, PAD in 10·9 (10·5 to 11·4) per cent and HT in 10·5 (10·0 to 10·9) per cent. Lipid-lowering and/or antiplatelet treatment was initiated in 34·8 per cent of the participants. Conclusion: Preventive actions were started in one-third of the attenders. The long-term effect of this on morbidity and mortality is an important part of future analysis. The trial confirms that the prevalence of AAA in Denmark has decreased only slightly in the past decade, from 4·0 to 3·3 per cent, in contrast to other nations.
The significant increase in the average life expectancy has increased the societal challenge of managing serious age-related diseases, especially cancer and cardiovascular diseases. A routine check by a general practitioner is not sufficient to detect incipient cardiovascular disease. Population-based randomized clinically controlled screening trial. Participants: 45,000 Danish men aged 65–74 years living on the Island of Funen, or in the surrounding communities of Vejle and Silkeborg. No exclusion criteria are used. Interventions: One-third will be invited to cardiovascular seven-faceted screening examinations at one of four locations. The screening will include: (1) low-dose non-contrast CT scan to detect coronary artery calcification and aortic/iliac aneurysms, (2) brachial and ankle blood pressure index to detect peripheral arterial disease and hypertension, (3) a telemetric assessment of the heart rhythm, and (4) a measurement of the cholesterol and plasma glucose levels. Up-to-date cardiovascular preventive treatment is recommended in case of positive findings. Objective: To investigate whether advanced cardiovascular screening will prevent death and cardiovascular events, and whether the possible health benefits are cost effective. Outcome: Registry-based follow-up on all cause death (primary outcome), and costs after 3, 5 and 10 years (secondary outcome). Randomization: Each of the 45,000 individuals is, by EPIDATA, given a random number from 1–100. Those numbered 67+ will be offered screening; the others will act as a control group. Blinding: Only those randomized to the screening will be invited to the examination;the remaining participants will not. Numbers randomized: A total of 45,000 men will be randomized 1:2. Recruitment: Enrollment started October 2014. Outcome: A 5 % reduction in overall mortality (HR = 0.95), with the risk for a type 1 error = 5 % and the risk for a type II error = 80 %, is expected. We expect a 2-year enrollment, a 10-year follow-up, and a median survival of 15 years among the controls. The attendance to screening is assumed to be 70 %. The primary aim of this so far stand-alone population-based, randomized trial will be to evaluate the health benefits and costeffectiveness of using non-contrast full truncus computer tomography (CT) scans (to measure coronary artery calcification (CAC) and identify aortic/iliac aneurysms) and measurements of the ankle brachial blood pressure index (ABI) as part of a multifocal screening and intervention program for CVD in men aged 65–74. Attendance rate and compliance to initiated preventive actions must be expected to become of major importance. Current Controlled Trials: ISRCTN12157806 (21 March 2015).
Objectives To examine the long-term efficacy at the 36-month follow-up of an early psychosocial counselling and support programme lasting 8–12 months for community-dwelling patients with mild Alzheimer's disease and their caregivers. Design Multicentre, randomised, controlled, rater-blinded trial. Setting Primary care and memory clinics in five Danish districts. Participants 330 home-dwelling patients with mild Alzheimer's disease and their primary caregivers (dyads). Interventions Dyads were randomised to receive intervention during the first year after diagnosis. Both intervention and control groups had follow-up visits at 3, 6, 12 and 36 months. Main outcome measures Primary outcomes for the patients assessed at 36-month follow-up were changes from baseline in global cognitive function (Mini-Mental State Examination), depressive symptoms (Cornell Depression Scale) and proxy-rated EuroQoL quality of life on visual analogue scale. The primary outcomes for the caregivers were changes from baseline in depressive symptoms (Geriatric Depression Scale) and self-rated EuroQoL quality of life on a visual analogue scale. The secondary outcome measures for the patient were proxy-rated Quality of Life Scale for Alzheimer's disease (QoL-AD), Neuropsychiatric Inventory-Questionnaire, Alzheimer's disease Cooperative Study Activities of Daily Living Scale, all-cause mortality and nursing home placement. Results At a 36-month follow-up, 2 years after the completion of the Danish Alzheimer Intervention Study (DAISY), the unadjusted positive effects previously detected at the 12-month follow-up in one patient primary outcome (Cornell depression score) and one patient secondary outcome (proxy-rated QoL-AD) disappeared (Cornell depression score, p=0.93; proxy-rated QoL-AD, p=0.81). No long-term effect of DAISY intervention on any other primary and secondary outcomes was found at the 36-month follow-up. Conclusions For patients with very mild Alzheimer's disease and their caregivers, an intensive, multi-component, semitailored psychosocial intervention programme with counselling, education and support during the first year after diagnosis did not show any positive long-term effect on primary and secondary outcomes. Trial registration The study was registered in the Clinical Trial Database (http://www.controlled-trials.com/ISRCTN74848736).
Screening for abdominal aortic aneurysm (AAA) of men aged 65-74 years reduces the AAA-related mortality and is generally considered cost effective. Despite of this only a few national health care services have implemented permanent programs.