Vascular Research Unit, Department of Vascualr Surgery, Viborg Regional Hospital, Viborg, Denmark
Institute for Clinical Medicine, Aarhus Universitet Health, Aarhus, Denmark.
BMJ Open. 2023 Feb 28;13(2):e063335. doi: 10.1136/bmjopen-2022-063335.
The prevalence of cardiovascular disease (CVD) is increasing. Furthermore, asymptomatic individuals may not receive timely preventive initiatives to minimise the risk of further CVD events. Paradoxically, 80% of CVD events are preventable by early detection, followed by prophylactic initiatives. Consequently, we introduced the population-based Viborg Screening Programme (VISP) for subclinical and manifest CVD, focusing on commonly occurring, mainly asymptomatic conditions, followed by prophylactic initiatives.The aim of the VISP was to evaluate the health benefits, harms and cost-effectiveness of the VISP from a healthcare sector perspective. Furthermore, we explored the participants' perspectives.
From August 2014 and currently ongoing, approximately 1100 men and women from the Viborg municipality, Denmark, are annually invited to screening for abdominal aortic aneurysm, peripheral arterial disease, carotid plaque, hypertension, diabetes mellitus and cardiac arrhythmia on their 67th birthday. A population from the surrounding municipalities without access to the VISP acts as a control. The VISP invitees and the controls are followed on the individual level by nationwide registries. The primary outcome is all-cause mortality, while costs, hospitalisations and deaths from CVD are the secondary endpoints.Interim evaluations of effectiveness and cost-effectiveness are planned every 5 years using propensity score matching followed by a Cox proportional hazards regression analysis by the 'intention-to-treat' principle. Furthermore, censoring-adjusted incremental costs, life-years and quality-adjusted life-years are estimated. Finally, the participants' perspectives are explored by semistructured face-to-face interviews, with participant selection representing participants with both negative and positive screening results.
The VISP is not an interventional trial. Therefore, approval from a regional scientific ethical committee is not needed. Data collection from national registries was approved by the Regional Data Protection Agency (record no. 1-16-02-232-15). We ensure patient and public involvement in evaluating the acceptability of VISP by adopting an interviewing approach in the study.
NCT03395509.
心血管疾病（CVD）的患病率正在上升。此外，无症状个体可能无法及时接受预防措施，以最大程度地降低进一步发生 CVD 事件的风险。矛盾的是，80%的 CVD 事件可通过早期发现加以预防，并采取预防措施。因此，我们引入了基于人群的维堡筛查计划（VISP），以筛查亚临床和显性 CVD，重点关注常见的、主要为无症状的疾病，并采取预防措施。VISP 的目的是从医疗保健部门的角度评估 VISP 的健康效益、危害和成本效益。此外，我们还探讨了参与者的观点。
自 2014 年 8 月以来，丹麦维堡市每年约有 1100 名男性和女性受邀参加筛查，以检测腹主动脉瘤、外周动脉疾病、颈动脉斑块、高血压、糖尿病和心律失常，年龄为 67 岁。来自周边没有机会参加 VISP 的市镇的人群作为对照组。VISP 的受邀者和对照组在个体层面上通过全国性登记册进行随访。主要结局是全因死亡率，而成本、因 CVD 住院和死亡则是次要结局。每 5 年计划进行一次有效性和成本效益的中期评估，使用倾向评分匹配，然后根据“意向治疗”原则进行 Cox 比例风险回归分析。此外，还估计了校正后的增量成本、生命年和质量调整生命年。最后，通过半结构化的面对面访谈探讨参与者的观点，参与者的选择代表了具有阴性和阳性筛查结果的参与者。
VISP 不是一项干预性试验。因此，不需要向地区科学伦理委员会申请批准。从全国性登记册收集的数据获得了地区数据保护局的批准（记录号 1-16-02-232-15）。我们通过在研究中采用访谈方法，确保患者和公众参与评估 VISP 的可接受性。
NCT03395509。
