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一项时间权衡研究,旨在确定伴有或不伴有耐药性的难治性巨细胞病毒感染移植受者的健康状态效用。

A time trade-off study to determine health-state utilities of transplant recipients with refractory cytomegalovirus infection with or without resistance.

机构信息

PHMR Ltd, London, UK.

Takeda UK Ltd, London, UK.

出版信息

Health Qual Life Outcomes. 2024 Mar 6;22(1):24. doi: 10.1186/s12955-024-02239-w.

Abstract

BACKGROUND

Health-state utility values (HSUVs) for post-transplant refractory cytomegalovirus (CMV) infection (with or without resistance [R/R]) were determined using a time trade-off (TTO) survey completed by 1,020 members of the UK general public.

METHODS

Existing literature and qualitative interviews with clinicians experienced in treating R/R CMV were used to develop initial draft vignettes of health states. The vignettes were refined to describe three clinical states of R/R CMV: clinically significant and symptomatic (CS-symptomatic CMV); clinically significant and asymptomatic (CS-asymptomatic CMV); and non-clinically significant (non-CS CMV). Each clinical state was valued independently and combined with three events of interest: graft-versus-host disease; kidney graft loss; and lung graft loss to generate twelve vignettes. The final vignettes were evaluated by a sample of the UK general public using an online TTO survey. Exclusion criteria were applied to the final data to ensure that responses included in the analysis met pre-defined quality control criteria.

RESULTS

Overall, 738 participants met the inclusion criteria and were included in the analysis. The sample was representative of the UK general population in terms of age and sex. Non-CS CMV had the highest mean HSUV (95% confidence interval) (0.815 [0.791, 0.839]), followed by CS-asymptomatic CMV (0.635 [0.602, 0.669]), and CS-symptomatic CMV (0.443 [0.404, 0.482]). CS-symptomatic CMV with lung graft loss had the lowest mean HSUV (0.289), with none of the health states considered on average worse than dead.

CONCLUSIONS

Post transplant R/R CMV has substantial impact on the health-related quality of life of patients. The utility values obtained in this study may be used to support economic evaluations of therapies for R/R CMV infection.

摘要

背景

通过对 1020 名英国普通公众进行时间权衡(TTO)调查,确定了移植后难治性巨细胞病毒(CMV)感染(有或无耐药性[R/R])的健康状态效用值(HSUV)。

方法

利用现有文献和对治疗 R/R CMV 经验丰富的临床医生的定性访谈,开发了初始健康状态草案描述。对病例进行了改进,以描述 R/R CMV 的三种临床状态:具有临床意义和症状(CS-有症状 CMV);具有临床意义和无症状(CS-无症状 CMV);和非临床意义(非-CS CMV)。每个临床状态都进行了独立评估,并与三个感兴趣的事件相结合:移植物抗宿主病;肾移植丧失;和肺移植丧失,产生了 12 个病例。最终病例由英国普通公众的样本使用在线 TTO 调查进行评估。对最终数据应用了排除标准,以确保分析中包含的响应符合预先定义的质量控制标准。

结果

总体而言,738 名参与者符合纳入标准并纳入分析。该样本在年龄和性别方面代表了英国普通人群。非-CS CMV 的平均 HSUV(95%置信区间)最高(0.815[0.791,0.839]),其次是 CS-无症状 CMV(0.635[0.602,0.669]),CS-有症状 CMV(0.443[0.404,0.482])。肺移植丧失的 CS-有症状 CMV 具有最低的平均 HSUV(0.289),没有一个健康状态被认为平均比死亡差。

结论

移植后 R/R CMV 对患者的健康相关生活质量有重大影响。本研究中获得的效用值可用于支持对 R/R CMV 感染治疗的经济评估。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f904/10919023/cf5ac14fdd93/12955_2024_2239_Fig1_HTML.jpg

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