HCD Economics, The Innovation Centre, Keckwick Lane, Daresbury, Warrington, England, UK.
Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
BMC Gastroenterol. 2021 Dec 4;21(1):456. doi: 10.1186/s12876-021-02028-5.
Ulcerative colitis (UC) is an inflammatory bowel disease with increasing prevalence worldwide. Current treatment strategies place considerable economic and humanistic burdens on patients. The aim of this study was to determine the socioeconomic burden of UC in adult patients in European countries in a real-world setting.
In this retrospective, cross-sectional and observational pan-European study, patients with moderate or severe UC were assigned to ARM 1 and patients who had moderate or severe UC but achieved mild or remission status 12 months before index date (or clinical consultation date), were assigned to ARM 2. Clinical and medical resource use data were collected via electronic case report forms, and data on non-medical and indirect costs, and health-related quality of life (HRQoL) were collected via patient and public involvement and engagement (PPIE) questionnaires. Per-patient annual total costs per ARM and per country were calculated using the collated resource use in the last 12 months (between the start of the documentation period and patient consultation or index date) and country specific unit costs. Quality of life was described by arm and by country.
In the physician-reported eCRF population (n = 2966), the mean annual direct medical cost was €4065 in ARM 1 (n = 1835) and €2935 in ARM 2 (n = 1131). In the PPIE population (ARM 1, n = 1001; ARM 2, n = 647), mean annual direct cost was €4526 in ARM 1 and €3057 in ARM 2, mean annual direct non-medical cost was €1162 in ARM 1 and €1002 in ARM 2, mean annual indirect cost was €3098 in ARM 1 and €2309 ARM 2, and mean annual total cost was in €8787 in ARM 1 and €6368 in ARM 2. HRQoL scores showed moderate to high burden of UC in both groups.
The cost and HRQoL burden were high in patients in both ARM 1 and ARM 2 indicating unmet needs in the UC active population.
溃疡性结肠炎(UC)是一种炎症性肠病,在全球的患病率呈上升趋势。目前的治疗策略给患者带来了相当大的经济和人文负担。本研究的目的是在真实环境中确定欧洲国家成年 UC 患者的社会经济学负担。
在这项回顾性、横断面和观察性的泛欧研究中,将中重度 UC 患者分配到 ARM1,将中重度 UC 但在指数日期(或临床就诊日期)前 12 个月达到轻度或缓解状态的患者分配到 ARM2。通过电子病例报告表收集临床和医疗资源使用数据,并通过患者和公众参与和参与(PPIE)问卷收集非医疗和间接成本以及健康相关生活质量(HRQoL)数据。使用最后 12 个月(从文件记录期开始到患者就诊或指数日期)收集的 ARM 中每个患者的年度总费用和每个国家的资源使用情况,以及每个国家的特定单位成本。根据 ARM 和国家描述生活质量。
在医生报告的 eCRF 人群(n=2966)中,ARM1(n=1835)的年直接医疗费用为 4065 欧元,ARM2(n=1131)为 2935 欧元。在 PPIE 人群(ARM1,n=1001;ARM2,n=647)中,ARM1 的年直接费用为 4526 欧元,ARM2 为 3057 欧元,年直接非医疗费用 ARM1 为 1162 欧元,ARM2 为 1002 欧元,年间接费用 ARM1 为 3098 欧元,ARM2 为 2309 欧元,年总成本 ARM1 为 8787 欧元,ARM2 为 6368 欧元。HRQoL 评分显示两组 UC 负担均较重。
ARM1 和 ARM2 中两组患者的成本和 HRQoL 负担均较高,表明 UC 活跃人群的需求未得到满足。