PHMR Limited, Berkeley Works, Berkley Grove, London, NW1 8XY, UK.
Takeda Pharmaceuticals International GmbH, Zurich, Switzerland.
Patient. 2019 Jun;12(3):339-348. doi: 10.1007/s40271-018-0352-2.
Perianal fistulae are a common complication of Crohn's disease (CD) and pose a substantial burden on quality of life. Data capturing health-related utility associated with perianal fistulae in CD are scarce. The current study aims to value health states related to different stages of the disease to quantitatively evaluate the impact of complex perianal fistulae on CD patients' quality of life.
Eight health state descriptions associated with complex perianal fistulae in CD were developed following qualitative research with patients and validation by clinicians. Following pre-testing, a survey was administered online in two samples of UK respondents: the general population and patients with CD. A choice-based valuation technique, the time trade-off (TTO), was used for direct utility measurement. CD patients also valued their current health state using the TTO. Exclusion criteria for respondents displaying logical inconsistencies were applied.
Usable responses were received from 835 respondents, reflective of the UK population in age and sex, in the general population survey and 162 CD patients in the patient survey. Non-remission states were valued much lower than the remission state by both samples, ranging from 0.20 for proctectomy with a negative outcome to 0.66 for chronic symptomatic fistulae with mild symptoms. Patients currently experiencing fistulae reported lower values for current health than those without fistulae.
Low utility values were assigned to the non-remission health states for perianal fistulae in CD by the general public and patients with CD. This demonstrates the high humanistic burden of inadequately managed perianal fistula in CD.
肛周瘘是克罗恩病(CD)的常见并发症,对生活质量造成了巨大负担。肛周瘘与 CD 相关的健康效用数据很少。本研究旨在评估与疾病不同阶段相关的健康状况,以定量评估复杂肛周瘘对 CD 患者生活质量的影响。
根据患者的定性研究和临床医生的验证,开发了 8 种与 CD 复杂肛周瘘相关的健康状况描述。在预测试后,在英国两个受访者样本中进行了在线调查:一般人群和 CD 患者。使用时间权衡(TTO)作为直接效用测量的选择基础估值技术。CD 患者也使用 TTO 评估他们当前的健康状况。对显示逻辑不一致的受访者应用排除标准。
一般人群调查收到了 835 名受访者的有效回复,反映了英国人口在年龄和性别方面的情况,而患者调查则收到了 162 名 CD 患者的回复。非缓解状态的价值比缓解状态低得多,范围从直肠切除术的负结果 0.20 到慢性有症状瘘伴轻度症状的 0.66。目前患有瘘管的患者报告的当前健康状况值低于没有瘘管的患者。
一般公众和 CD 患者都对 CD 肛周瘘的非缓解健康状态赋予了较低的效用值。这表明 CD 中未得到适当管理的肛周瘘具有高度的人文负担。