Five-Year Outcomes of the Danish Cardiovascular Screening (DANCAVAS) Trial.

BACKGROUND: Limited data suggest a benefit of population-based screening for cardiovascular disease with respect to the risk of death. METHODS: We performed a population-based, parallel-group, randomized, controlled trial involving men 65 to 74 years of age living in 15 Danish municipalities. The participants were randomly assigned in a 1:2 ratio to undergo screening (the invited group) or not to undergo screening (the control group) for subclinical cardiovascular disease. Randomization was based on computer-generated random numbers and stratified according to municipality. Only the control group was unaware of the trial-group assignments. Screening included noncontrast electrocardiography-gated computed tomography to determine the coronary-artery calcium score and to detect aneurysms and atrial fibrillation, ankle-brachial blood-pressure measurements to detect peripheral artery disease and hypertension, and a blood sample to detect diabetes mellitus and hypercholesterolemia. The primary outcome was death from any cause. RESULTS: A total of 46,611 participants underwent randomization. After exclusion of 85 men who had died or emigrated before being invited to undergo screening, there were 16,736 men in the invited group and 29,790 men in the control group; 10,471 of the men in the invited group underwent screening (62.6%). In intention-to-treat analyses, after a median follow-up of 5.6 years, 2106 men (12.6%) in the invited group and 3915 men (13.1%) in the control group had died (hazard ratio, 0.95; 95% confidence interval [CI], 0.90 to 1.00; P = 0.06). The hazard ratio for stroke in the invited group, as compared with the control group, was 0.93 (95% CI, 0.86 to 0.99); for myocardial infarction, 0.91 (95% CI, 0.81 to 1.03); for aortic dissection, 0.95 (95% CI, 0.61 to 1.49); and for aortic rupture, 0.81 (95% CI, 0.49 to 1.35). There were no significant between-group differences in safety outcomes. CONCLUSIONS: After more than 5 years, the invitation to undergo comprehensive cardiovascular screening did not significantly reduce the incidence of death from any cause among men 65 to 74 years of age. (Funded by the Southern Region of Denmark and others; DANCAVAS ISRCTN Registry number, ISRCTN12157806.).

User-defined outcomes of the Danish cardiovascular screening (DANCAVAS) trial: A post hoc analyses of a population-based, randomised controlled trial.

BACKGROUND: The Danish cardiovascular screening (DANCAVAS) trial, a nationwide trial designed to investigate the impact of cardiovascular screening in men, did not decrease all-cause mortality, an outcome decided by the investigators. However, the target group may have varied preferences. In this study, we aimed to evaluate whether men aged 65 to 74 years requested a CT-based cardiovascular screening examination and to assess its impact on outcomes determined by their preferences. METHODS AND FINDINGS: This is a post hoc study of the randomised DANCAVAS trial. All men 65 to 74 years of age residing in specific areas of Denmark were randomised (1:2) to invitation-to-screening (16,736 men, of which 10,471 underwent screening) or usual-care (29,790 men). The examination included among others a non-contrast CT scan (to assess the coronary artery calcium score and aortic aneurysms). Positive findings prompted preventive treatment with atorvastatin, aspirin, and surveillance/surgical evaluation. The usual-care group remained unaware of the trial and the assignments. The user-defined outcome was based on patient preferences and determined through a survey sent in January 2023 to a random sample of 9,095 men from the target group, with a 68.0% response rate (6,182 respondents). Safety outcomes included severe bleeding and mortality within 30 days after cardiovascular surgery. Analyses were performed on an intention-to-screen basis. Prevention of stroke and myocardial infarction was the primary motivation for participating in the screening examination. After a median follow-up of 6.4 years, 1,800 of 16,736 men (10.8%) in the invited-to-screening group and 3,420 of 29,790 (11.5%) in the usual-care group experienced an event (hazard ratio (HR), 0.93 (95% confidence interval (CI), 0.88 to 0.98; p = 0.010); number needed to invite at 6 years, 148 (95% CI, 80 to 986)). A total of 324 men (1.9%) in the invited-to-screening group and 491 (1.7%) in the usual-care group had an intracranial bleeding (HR, 1.17; 95% CI, 1.02 to 1.35; p = 0.029). Additionally, 994 (5.9%) in the invited-to-screening group and 1,722 (5.8%) in the usual-care group experienced severe gastrointestinal bleeding (HR, 1.02; 95% CI, 0.95 to 1.11; p = 0.583). No differences were found in mortality after cardiovascular surgery. The primary limitation of the study is that exclusive enrolment of men aged 65 to 74 renders the findings non-generalisable to women or men of other age groups. CONCLUSION: In this comprehensive population-based cardiovascular screening and intervention program, we observed a reduction in the user-defined outcome, stroke and myocardial infarction, but entail a small increased risk of intracranial bleeding. TRIAL REGISTRATION: ISRCTN Registry number, ISRCTN12157806 https://www.isrctn.com/ISRCTN12157806.

Relevance of the Viborg Population Based Screening Programme (VISP) for Cardiovascular Conditions Among 67 Year Olds: Attendance Rate, Prevalence, and Proportion of Initiated Cardiovascular Medicines Stratified By Sex.

OBJECTIVE: To report sex specific overall attendance rate, prevalence of screen detected cardiovascular conditions, proportion of unknown conditions before screening, and proportion initiating prophylactic medicine among 67 year olds in Denmark. DESIGN: Cross sectional cohort study. METHODS: Since 2014, all 67 year olds in Viborg, Denmark, have been invited to screening for abdominal aortic aneurysm (AAA), peripheral arterial disease (PAD), carotid plaque (CP), hypertension, cardiac disease, and type 2 diabetes. Individuals with AAA, PAD, and or CP are recommended cardiovascular prophylaxis. Combining data with registries has facilitated estimation of unknown screen detected conditions. Up to August 2019, 5 505 had been invited; registry data were available for the first 4 826 who were invited. RESULTS: The attendance rate was 83.7%, without sex difference. Screen detected prevalence was significantly lower among women than men: AAA, 5 (0.3%) vs. 38 (1.9%) (p < .001); PAD, 90 (4.5%) vs. 134 (6.6%) (p = .011); CP, 641 (31.8%) vs. 907 (44.8%) (p < .001); arrhythmia, 26 (1.4%) vs. 77 (4.2%) (p < .001); blood pressure ≥ 160/100 mmHg, 277 (13.8%) vs. 346 (17.1%) (p = .004); and HbA1c ≥ 48 mmol/mol, 155 (7.7%) vs. 198 (9.8%) (p = .019), respectively. Pre-screening proportions of unknown conditions were particularly high for AAA (95.4%) and PAD (87.5%). AAA, PAD, and or CP were found in 1 623 (40.2%), of whom 470 (29.0%) received pre-screening antiplatelets and 743 (45.8%) lipid lowering therapy. Furthermore, 413 (25.5%) started antiplatelet therapy and 347 (21.4%) started lipid lowering therapy. Only smoking was significantly associated with all vascular conditions in multivariable analysis: odds ratios (ORs) for current smoking were AAA 8.11 (95% CI 2.27 - 28.97), PAD 5.60 (95% CI 3.61 - 8.67) and CP 3.64 (95% CI 2.95 - 4.47). CONCLUSION: The attendance rate signals public acceptability for attending cardiovascular screening. Men had more screen detected conditions than women, but prophylactic medicine was started equally frequently in both sexes. Sex specific cost effectiveness follow up is warranted.

Cost effectiveness of population screening vs. no screening for cardiovascular disease: the Danish Cardiovascular Screening trial (DANCAVAS).

AIMS: A recent trial has shown that screening of men for cardiovascular disease (CVD) may reduce all-cause mortality. This study assesses the cost effectiveness of such screening vs. no screening from the perspective of European healthcare systems. METHODS AND RESULTS: Randomized controlled trial-based cost-effectiveness evaluation with a mean 5.7 years of follow-up. Screening was based on low-dose computed tomography to detect coronary artery calcification and aortic/iliac aneurysms, limb blood pressure measurement to detect peripheral artery disease and hypertension, telemetric assessment of the heart rhythm to detect atrial fibrillation, and measurements of the cholesterol and HgbA1c levels. Censoring-adjusted incremental costs, life years (LY), and quality-adjusted LY (QALY) were estimated and used for cost-effectiveness analysis. The incremental cost of screening for the entire health care sector was €207 [95% confidence interval (CI) -24; 438, P = 0.078] per invitee for which gains of 0.019 LY (95% CI -0.007; 0.045, P = 0.145) and 0.023 QALY (95% CI -0.001; 0.046, P = 0.051) were achieved. The corresponding incremental cost-effectiveness ratios were of €10 812 per LY and €9075 per QALY, which would be cost effective at probabilities of 0.73 and 0.83 for a willingness to pay of €20 000. Assessment of population heterogeneity showed that cost effectiveness could be more attractive for younger men without CVD at baseline. CONCLUSIONS: Comprehensive screening for CVD is overall cost effective at conventional thresholds for willingness to pay and also competitive to the cost effectiveness of common cancer screening programmes. The screening target group, however, needs to be settled.

Geographical Variation in the Management of Peripheral Arterial Occlusive Disease: A Nationwide Danish Cohort Study.

OBJECTIVE: Equal access for equal needs is a key goal for many healthcare systems but geographical variation research has shown that this is often not the case in areas other than vascular surgery. This study assessed the variation across specialised vascular centres of an entire healthcare system in the costs and outcomes for patients having first time revascularisation for peripheral arterial occlusive disease. METHODS: This was a national study of all first time revascularisations performed in the Danish healthcare system between 2009 and 2014. Episodes were identified in the Danish Vascular Registry (n = 10 300) and data on one year follow up in terms of the costs of specialised healthcare (€) and amputation status were acquired from national registers. Generalised gamma and logit regressions were used to predict margins between centres while adjusting for population heterogeneity (age, sex, education, smoking, hypertension, diabetes, use of prophylactic pharmacological therapy, indication and type of revascularisation). Cost effectiveness frontiers were used to identify efficient providers and to illustrate the cost of reducing the system level risk of amputation. RESULTS: For each of the indications of chronic limb threatening and acute limb ischaemia, the one year amputation risks varied from 11% to 16% across centres (p = .003, p = .006) whereas for intermittent claudication there was no significant difference across centres. The corresponding costs of care varied across centres for all indications (p = .027, p = .028, p = .030). Linking costs and outcomes, three of seven centres were observed to provide poorer quality at higher costs. Exponentially increasing costs to obtain the maximum reduction of the amputation risk were observed. CONCLUSION: The results suggest that there is substantial variation in the clinical management of peripheral arterial occlusive disease across the Danish healthcare system and that this results in very different levels of efficiency - on top of potentially unequal treatment for equal needs. Further research is warranted.

Clinical Benefit, Harm, and Cost Effectiveness of Screening Men for Peripheral Artery Disease: A Markov Model Based on the VIVA Trial.

OBJECTIVE: Although screening for peripheral arterial disease (PAD) seems obvious due to its two to three times increased mortality, high prevalence in the elderly, ease of detection, and relatively harmless prevention, the evidence is sparse. METHODS: A Markov decision model was created to model the lifetime effectiveness and cost effectiveness of general population PAD screening and relevant intervention in 65 year old men. The model was informed by original estimates from the VIVA trial data except for ankle brachial systolic blood pressure index test accuracy, quality of life, and background mortality, which were adopted from the literature. A Markov model was designed for 65 year old men, who were distributed in the starting states of no/detected/undetected PAD. The main outcomes were life years, quality adjusted life years, and costs of healthcare. RESULTS: Screening for PAD reduced the rates of amputations and stroke by 10.9% and 2.4%, respectively, while it increased the rates of revascularisation, acute myocardial infarction, and major bleeding by 5.5%, 7.1%, and 4.3% respectively. The overall life expectancy was increased by 14 days per invited subject. The cost per life year/quality adjusted life year was estimated at €16 717/€20 673. On the addition of low dose rivaroxaban reduced the costs per life year gained by 40%. If the model ran for only five follow up years, screening reduced relative mortality by 1.71%, suggesting PAD screening accounts for one fourth of the reported overall 7% relative mortality risk reduction of combined abdominal aortic aneurysm, PAD, and hypertension screening. CONCLUSION: Screening of men for PAD is likely to be both clinically effective and cost effective in a lifetime perspective.

Instrumental variable-based assessment of the effect of psychotherapy on suicide attempts, health, and economic outcomes in schizophrenia.

The literature on the effect of psychotherapy for schizophrenia is limited and characterized by small samples and possible bias from risk selection. We examined the effects of psychotherapy on suicide attempts and health and economic outcomes using an instrumental variable (IV) approach that exploits the variation in the propensities of hospital departments to prescribe psychotherapy. This was supplemented with naïve probit models as exogeneity could not be ruled out for all of the outcomes. The validity of the instrument was examined by distributional plots and various tests. The assumed randomness in referring patients to providers with high versus low propensities to psychotherapy appeared to be a critical aspect. Splitting the sample into homogeneous provider types did not substantially alter the results. Based on the IV results, we found no support for the effect of psychotherapy on suicide attempt, psychiatric readmission, assisted living, or labor market attachment. However, we cannot rule out smaller effects due to confidence intervals including the probit estimates. The main contribution of this study is new evidence on a broad range of outcomes and a large and representative population.

Organisational determinants and consequences of diagnostic discrepancy in two large patient groups in the emergency departments: a national study of consecutive episodes between 2008 and 2016.

BACKGROUND: Diagnostic discrepancy (DD) is a common phenomenon in healthcare, but little is known about its organisational determinants and consequences. Thus, the aim of the study was to evaluate this among selected emergency department (ED) patients. METHOD: We conducted an observational study including all consecutive ED patients (hip fracture or erysipelas) in the Danish healthcare sector admitted between 2008 and 2016. DD was defined as a discrepancy between discharge and admission diagnoses. Episode and department statistics were retrieved from Danish registers. We conducted a survey among all 21 Danish EDs to gather information about organisational determinants. To estimate the results while adjusting for episode- and department-level heterogeneity, we used mixed effect models of ED organisational determinants and 30-day readmission, 30-day mortality and episode costs (2018-DKK) of DDs. RESULTS: DD was observed in 2308 (3.3%) of 69,928 hip fracture episodes and 3206 (8.5%) of 37,558 erysipelas episodes. The main organisational determinant of DD was senior physicians (nonspecific medical specialty) being employed at the ED (hip fracture: odds ratio (OR) 2.74, 95% confidence interval (CI) 2.15-3.51; erysipelas: OR 3.29, 95% CI 2.65-4.07). However, 24-h presence of senior physicians (nonspecific medical specialty) (hip fracture) and availability of external senior physicians (specific medical specialty) (both groups) were negatively associated with DD. DD was associated with increased 30-day readmission (hip fracture, mean 9.45% vs 13.76%, OR 1.46, 95% CI 1.28-1.66, p < 0.001) and episode costs (hip fracture, 61,681 DKK vs 109,860 DKK, log cost 0.58, 95% CI 0.53-0.63, p < 0.001; erysipelas, mean 20,818 DKK vs 56,329 DKK, log cost 0.97, 95% CI 0.92-1.02, p < 0.001) compared with episodes without DD. CONCLUSION: DD was found to have a negative impact on two out of three study outcomes, and particular organisational characteristics seem to be associated with DD. Yet, the complexity of organisations and settings warrant further studies into these associations.

Pharmacological Preventive Potential Among Attenders at Vascular Screening: Findings from the VIVA Trial.

OBJECTIVE: Findings from the Viborg Vascular (VIVA) trial show a mortality benefit of multi-faceted vascular screening which was mainly ascribed to the initiation of prophylactic medication. However, the pharmacological preventive potential, which exists when individuals have a positive screening test result and do not already use statins and anti-platelet agents, has not been analysed. The aim of this study was to investigate factors associated with a pharmacological preventive potential of statins and anti-platelet agents among attenders vascular screening for abdominal aortic aneurysm (AAA) and peripheral arterial disease (PAD). METHODS: This cross-sectional study used data from the VIVA trial screening arm including 25 074 men aged 64-75 years recruited between October 2008 and January 2011. Explanatory variables comprised socio-demographic- and socio-economic characteristics, comorbidities, medication use, and travel distance derived from nationwide registries. Outcomes included a positive screening test result, a pharmacological preventive potential, and attendance. Associations between the explanatory variables and the outcomes were investigated using the chi-square test and multivariate logistic regression. RESULTS: The factors most likely to be associated with a pharmacological preventive potential for positive AAA screening comprised age >70 years (odds ratio (OR) 1.23, 95% confidence interval 1.00-1.51), existing chronic obstructive pulmonary disease (COPD) (OR 2.22, 95% CI 1.38-3.57), and use of anti-hypertensives (OR 1.37, 95% CI 1.09-1.71). For positive PAD screening age >70 years (OR 1.41, 95% CI 1.25-1.60), living alone (OR 1.34, 95% CI 1.14-1.56), low income, COPD (OR 2.13, 95% CI 159-283), use of anti-hypertensives (OR 1.14, 95% CI 1.00-1.29) or anti-diabetics (OR 1.12, 95% CI 1.01-1.28), and short travel distance were associated with a pharmacological preventive potential. For combined vascular screening, age >70 years, living alone, low income, COPD, and use of anti-hypertensives were associated with a pharmacological preventive potential. Among these subgroups, lower attendance was associated with age >70 years, living alone, low income, COPD, and use of anti-diabetics. CONCLUSION: Future vascular screening programmes might benefit from tailoring information to subgroups who are more likely to benefit from screening but less likely to accept an offer.

Case manager-assisted rehabilitation for lumbar spinal fusion patients: an economic evaluation alongside a randomized controlled trial with two-year follow-up.

OBJECTIVE: To examine the cost-effectiveness of case manager-assisted rehabilitation as an add-on to usual physical rehabilitation after lumbar spinal fusion, given the lack of any clinical benefits found on analysing the clinical data. DESIGN: Economic evaluation alongside a randomized controlled trial with two-year follow-up. SETTING: Patients from the outpatient clinics of a university hospital and a general hospital. SUBJECTS: A total of 82 lumbar spinal fusion patients. INTERVENTIONS: Patients were randomized one-to-one to case manager-assisted rehabilitation programme as an add-on to usual physical rehabilitation or to usual physical rehabilitation. MAIN MEASURES: Oswestry Disability Index and EuroQol 5-dimension. Danish preference weights were used to estimate quality-adjusted life years. Costs were estimated from micro costing and national registries. Multiple imputation was used to handle missing data. Costs and effects were presented with means (95% confidence interval (CI)). The incremental net benefit was estimated for a range of hypothetical values of willingness to pay per gain in effects. RESULTS: No impact of case manager-assisted rehabilitation on the Oswestry Disability Index or estimate quality-adjusted life years was observed. Intervention cost was Euros 3984 (3468; 4499), which was outweighed by average reductions in inpatient resource use and sickness leave. A cost reduction of Euros 1716 (-16,651; 20,084) was found in the case manager group. Overall, the probability for the case manager-assisted rehabilitation programme being cost-effective did not exceed a probability of 56%, regardless of willingness to pay. Sensitivity analysis did not change the conclusion. CONCLUSION: This case manager-assisted rehabilitation programme was unlikely to be cost-effective.

Does adding case management to standard rehabilitation affect functional ability, pain, or the rate of return to work after lumbar spinal fusion? A randomized controlled trial with two-year follow-up.

OBJECTIVE: To examine the effect of a case manager-assisted rehabilitation programme as an add-on to usual physical rehabilitation in patients undergoing lumbar spinal fusion. DESIGN: A randomized controlled trial with a two-year follow-up. SETTINGS: Outpatient clinics of a university hospital and a general hospital. SUBJECTS: In total, 82 patients undergoing lumbar spinal fusion. INTERVENTIONS: The patients were randomized one-to-one to case manager-assisted rehabilitation (case manager group) or no case manager-assisted rehabilitation (control group). Both groups received usual physical rehabilitation. The case manager-assisted rehabilitation programme included a preoperative meeting with a case manager to determine a rehabilitation plan, postsurgical meetings, phone meetings, and voluntary workplace visits or roundtable meetings. MAIN MEASURES: Primary outcome was the Oswestry Disability Index. Secondary outcomes were back pain, leg pain, and return to work. RESULTS: Of the 41 patients in the case manager group, 49% were men, with the mean age of 46.1 (±8.7 years). In the control group, 51% were male, with the mean age of 47.4 (±8.9 years). No statistically significant between-group differences were found regarding any outcomes. An overall group effect of 4.1 points (95% confidence interval (CI): -1.8; 9.9) was found on the Oswestry Disability Index, favouring the control group. After two years, the relative risk of return to work was 1.18 (95% CI: 0.8; 1.7), favouring the case manager group. CONCLUSION: The case manager-assisted rehabilitation programme had no effect on the patients' functional disability or back and leg pain compared to usual physical rehabilitation. The study lacked power to evaluate the impact on return to work.

Assessment of Inequality Alongside Policy-oriented Trials: An Empirical Framework Based on the Case of Screening.

BACKGROUND: Despite the dual objectives of many health care systems of improving total health and reducing health inequality, trial designs seem to ignore the assessment of inequality effects. Our study aimed to illustrate an empirical framework for the assessment of inequality effects alongside policy-oriented trials to inform a possible efficiency versus equality trade-off. METHODS: We measured inequality in the concentrations of all-cause and disease-related mortality and hospital admissions across ranks of socioeconomic status in a randomized controlled trial that tested the efficacy of general population screening of men for vascular disease. We used alternative definitions of inequality (relative/absolute, in attainment/shortfall, ranked by education/income), and supplemented the classical "frequentist" approach to statistical inference with Bayesian posterior probabilities. Equality contours for health improvement that leave inequality unaffected are illustrated graphically. We used bootstrapping for interpretation. RESULTS: We estimated the posterior probability of screening increasing inequality to be between 0.21 and 0.93 depending on the inequality definition. Income-ranked inequality appeared to be generally higher than education-ranked inequality but less affected by screening. For the shortfall-relative index based on education-rank, the mean health improvement of a 7% relative reduction in all-cause mortality generated by screening incurred a mean relative increase in inequality of 28%. For the income-based indices, there was no evidence of a trade-off. DISCUSSION: We illustrated how decision uncertainty can be reduced by explicit assessment of inequality alongside trials and found some evidence of a possible equity-efficiency trade-off in the context of screening, although this depended on the definition of equality.

Adherence to Prescribed Drugs Among 65-74 Year Old Men Diagnosed with Abdominal Aortic Aneurysm or Peripheral Arterial Disease in a Screening Trial: A VIVA Substudy.

OBJECTIVE: Adherence to antiplatelet and statin therapy in participants diagnosed with abdominal aortic aneurysm (AAA) or peripheral arterial disease (PAD) was examined in a vascular screening trial. METHODS: This was a population based cohort study. The study population consisted of 65-74 year old men diagnosed with AAA or PAD in the Viborg Vascular (VIVA) multifaceted screening trial for CVD. Data from the VIVA screening cohort were linked to data from Danish registers from 2007 to 2016. Initiation of antiplatelet and statin treatment was measured within 120 days after screening. Persistence was defined as no treatment gap >100 days between two prescription renewals after screening. A proportion of days covered ≥80% over five years of follow up was used as a categorical cut off for adherence. RESULTS: Among the 18,748 screened participants, 618 with AAA and 2051 with PAD were identified. Among non-users at baseline, 65% and 62% initiated antiplatelet and statin treatment, 57% and 59% persisted with antiplatelet and statin use, and 60% and 57% were adherent, respectively. Among users at baseline, 73% and 69% had filled an antiplatelet or statin prescription, respectively, within 120 days after screening. Further, 79% and 73% persisted with their antiplatelet and statin treatment, and 89% and 83% were adherent, respectively. CONCLUSION: In a vascular screening trial, six of every 10 non-users initiated preventive treatment; among these, the adherence rate was 57-60%. Among users at baseline, the five year adherence to antiplatelet and statin treatment exceeded 80%. The effectiveness of screening initiatives might be improved by measures to improve the fulfilment of preventive medication.

High quality of care did not imply increased hospital spending- nationwide cohort study among hip fracture patients.

OBJECTIVE: To examine whether fulfilment of process performance measures reflecting national guidelines is associated with in-hospital costs among hip fracture patients. DESIGN: Nationwide, population-based follow-up study. SETTING: Public hospitals in Denmark. PARTICIPANTS: A total of 20 458 patients 65 years or older admitted with a hip fracture between 2010 and 2013. INTERVENTION: Quality of care defined as fulfilment of process performance measures reflecting recommendations from national clinical guidelines, which previously have been shown to be associated with lower mortality and readmission risk. The measures included systematic pain assessment; mobilisation within 24 h post-operatively; assessment of basic mobility before admission and discharge; and receiving a rehabilitation programme before discharge, anti-osteoporotic medication and fall prevention. MAIN OUTCOME MEASURES: Total costs defined as the sum of hospital costs used for treating the individual patients according to the Danish Reference Cost Database. RESULTS: Within the index admission, fulfilling 50 to >75% of the performance measures was associated with lower adjusted costs (EUR 2643) than was fulfilling 0-50% of these measures (EUR 3544). The lower costs were mainly due to savings on further treatment and fewer bed days. Mobilisation within 24 h after surgery and assessment for need of anti-osteoporotic medication were associated with the largest cost differences, corresponding to adjusted cost differences of EUR 3030 and EUR 3538, respectively. The cost difference was lower when all costs related to hospitalisation within the first year were considered. CONCLUSIONS: These findings indicate that high quality of care does not imply higher hospital spending and may be associated with cost savings.

Population screening and intervention for vascular disease in Danish men (VIVA): a randomised controlled trial.

BACKGROUND: Abdominal aortic aneurysm is the only cardiovascular disease targeted by population screening. In this study, we test the effect of screening and subsequent intervention for abdominal aortic aneurysm, peripheral arterial disease, and hypertension combined. METHODS: In this randomised controlled trial, we randomly allocated (1:1) all men aged 65-74 years living in the Central Denmark Region to screening for abdominal aortic aneurysm, peripheral arterial disease, and hypertension, or to no screening. We based allocation on computer-generated random numbers from 1 to 100 in blocks of 1067 to 4392, stratified by 19 municipalities. Only the non-screening group and the investigator assessing outcomes were masked. We invited participants who were found to have abdominal aortic aneurysm or peripheral arterial disease back for confirmation and eventual initiation of relevant pharmacological therapy. We further offered participants with abdominal aortic aneurysm annual control or surgical repair. We referred participants with suspected hypertension to their general practitioner. The primary outcome was all-cause mortality, assessed 5 years after randomisation, analysed in all randomly allocated participants except for those who had incorrect person identification numbers. This trial is registered at ClinicalTrials.gov, number NCT00662480. FINDINGS: Between Oct 8, 2008, and Jan 11, 2011, we randomly allocated 50 156 participants, with 25 078 (50%) each in the screening and non-screening groups. Four (<1%) participants in the screening group were lost to follow-up. After a median follow-up of 4·4 years (IQR 3·9-4·8), 2566 (10·2%) of 25 074 participants in the screening group and 2715 (10·8%) of 25 078 in the non-screening group had died. This finding resulted in a significant hazard ratio of 0·93 (95% CI 0·88-0·98; p=0·01), an absolute risk reduction of 0·006 (0·001-0·011), and a number needed to invite of 169 (89-1811). Incidences of diabetes (3995 per 100 000 person-years in the screening group vs 4129 per 100 000 person-years in the non-screening group), intracerebral haemorrhage (146 vs 140), renal failure (612 vs 649), cancer (3578 vs 3719), or 30 day mortality after cardiovascular surgery (44·57 vs 39·33) did not differ between groups. INTERPRETATION: The observed reduction of mortality risk from abdominal aortic aneurysm, peripheral arterial disease, and hypertension has never been seen before in the population screening literature and can be linked primarily to initiation of pharmacological therapy. Health policy makers should consider implementing combined screening whether no screening or isolated abdominal aortic aneurysm screening is currently offered. FUNDING: The 7th European Framework Programme, Central Denmark Region, Viborg Hospital, and the Danish Council for Independent Research.

Role of Experience With Preventive Medication and Personal Risk Attitude in Non-Attendance at Triple Vascular Screening.

BACKGROUND: Non-attendance for vascular screening potentially restricts the overall benefit of screening at population level, but may be the result of rational judgment on the part of invitees who might not consider their risk to be relevant. The aim of this study was to investigate the role of current use of preventive medication and personal risk attitude as potential factors explaining non-attendance at triple vascular screening. METHODS: This was a case control study across 25,078 men offered screening and intervention for abdominal aortic aneurysm, peripheral artery disease, and hypertension in the Viborg Vascular (VIVA) screening trial. Data on socio-demographic and socio-economic characteristics, diagnoses, and use of preventive medication were extracted from national registries. A proxy for personal risk attitude was constructed. Logistic regression was used to estimate odds ratios with 95% confidence intervals. RESULTS: Use of statins (0.78; 95% CI 0.71-0.85), antihypertensives (1.26, 95% CI 1.13-1.41), or antithrombotics (1.13, 95% CI 1.04-1.23) were all associated with non-attendance. With regards to personal risk attitude, a statistically significant association was found between users of preventive medication with no recent diagnosis of cardiovascular disease and non-attendance (0.82, 95% CI 0.72-0.94). The role of traditional factors explaining non-attendance at vascular screening, such as low socio-economic status and comorbidity, was confirmed. CONCLUSION: Non-attendance at triple vascular screening is influenced by use of preventive medications and traditional explanatory factors of non-attendance at vascular screening, including existing CVD comorbidity. Attendance rates might benefit from rethinking risk communication alongside screening invitations according to varying invitee profiles and clinical risk scenarios, and from providing interventions targeted at individuals with lower levels of health literacy.

Effectiveness of Screening Postmenopausal Women for Cardiovascular Diseases: A Population Based, Prospective Parallel Cohort Study.

OBJECTIVES: To investigate the effectiveness of systematic screening for multifaceted cardiovascular disease (CVD) in postmenopausal women on all cause mortality and, secondarily, on CVD morbidity. Effectiveness was also evaluated across age strata. METHODS: This was a population based, prospective, parallel cohort study. In total, 107,491 women born in 1936-1951 living in the Central Denmark region were identified in the Danish Civil Registration System. From this population, all women born in 1936, 1941, 1946, and 1951 (n = 1984) living in the Viborg municipality were invited to attend screening. Of those invited to the screening, 1474 (74.3%) attended. The control group included all women from the general population born in 1936-1951 and living in the Central Denmark Region, excluding those invited for the screening. Information on medication and comorbidities prior to inclusion and study outcomes were retrieved from national registries for both groups. The screening included examination for abdominal aortic aneurysm (AAA), peripheral arterial disease (PAD), carotid plaque (CP), potential hypertension (HT), atrial fibrillation (AF), diabetes mellitus (DM), and dyslipidaemia. The adjusted Cox proportional hazards model with the intention to screen principle was used to assess effectiveness for the total population and across age groups. RESULTS: During follow up (median 3.3 years, IQR 2.9-3.9), the adjusted hazard ratios (HRs) for invited versus controls were the following: all cause mortality, 0.89 (95% CI 0.71-1.12); myocardial infarction (MI), 1.26 (95% CI 0.52-3.07); ischaemic heart disease (IHD), 0.72 (95% CI 0.49-1.05); PAD, 1.07 (95% CI 0.49-2.31); and ischaemic stroke, 1.20 (95% CI 0.78-1.85). A substantial number of women with AAA, PAD, and/or CP declined prophylactic therapy: 45% for antiplatelet and 35% for cholesterol lowering agents. CONCLUSIONS: This multifaceted screening offer to a general population sample of postmenopausal women had no effects on all cause mortality or hospital admission for MI, IHD, PAD, and stroke within a short-term follow up period.

Cost-Effectiveness Evaluation of Heparin Coated Versus Standard Graft for Bypass Surgery in Peripheral Artery Disease Alongside a Randomised Controlled Trial.

OBJECTIVE/BACKGROUND: Heparin coating has recently been shown to reduce the risk of graft failure in arterial revascularisation, at least transiently. The aim of this study was to assess the cost-effectiveness of heparin coated versus standard polytetrafluoroethylene grafts for bypass surgery in peripheral artery disease from a long-term healthcare system perspective. METHODS: Cost-effectiveness evaluation was conducted alongside the Danish part of the Scandinavian Propaten trial in which 431 patients planned for femoro-femoral or femoro-popliteal bypass surgery were randomised to either type of graft and followed for 5 years. Based on the intention to treat principle, the differences in healthcare costs (general practice, prescription medication, hospital admission, rehabilitation, and long-term care in 2015 Euros), life years (LYs), and quality adjusted life years (QALYs) were analysed as arithmetic means with bootstrapped 95% confidence intervals. Cost-effectiveness acceptability curves were used to illustrate the probability of cost-effectiveness for a range of threshold values of willingness to pay (WTP). RESULTS: No statistically significant differences between the randomisation groups were observed for costs or gains of LYs or QALYs. The average cost per QALY was estimated at €10,792. For a WTP threshold of €40,000 per QALY, the overall probability of cost-effectiveness was estimated at 62%, but owing to cost savings in patients with critical ischaemia (cost per QALY <€0), it increased to 89% for this subgroup. CONCLUSION: Until further evidence, heparin coated grafts appear overall, to be cost-effective over standard grafts, but important heterogeneity between claudication and critical ischaemia should be noted. While the optimal choice for claudication remains uncertain, heparin coated grafts should be used for critical ischaemia.