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第二眼白内障手术的临床疗效与成本效益:一项系统评价与经济学评估

The clinical effectiveness and cost-effectiveness of second-eye cataract surgery: a systematic review and economic evaluation.

作者信息

Frampton Geoff, Harris Petra, Cooper Keith, Lotery Andrew, Shepherd Jonathan

机构信息

Southampton Health Technology Assessments Centre (SHTAC), University of Southampton, Southampton, UK.

Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.

出版信息

Health Technol Assess. 2014 Nov;18(68):1-205, v-vi. doi: 10.3310/hta18680.

Abstract

BACKGROUND

Elective cataract surgery is the most commonly performed surgical procedure in the NHS. In bilateral cataracts, the eye with greatest vision impairment from cataract is operated on first. First-eye surgery can improve vision and quality of life. However, it is unclear whether or not cataract surgery on the second eye provides enough incremental benefit to be considered clinically effective and cost-effective.

OBJECTIVE

To conduct a systematic review of clinical effectiveness and analysis of cost-effectiveness of second-eye cataract surgery in England and Wales, based on an economic model informed by systematic reviews of cost-effectiveness and quality of life.

DATA SOURCES

Twelve electronic bibliographic databases, including MEDLINE, EMBASE, Web of Science, The Cochrane Library and the Centre for Reviews and Dissemination databases were searched from database inception to April 2013, with searches updated in July 2013. Reference lists of relevant publications were also checked and experts consulted.

REVIEW METHODS

Two reviewers independently screened references, extracted and checked data from the included studies and appraised their risk of bias. Based on the review of cost-effectiveness, a de novo economic model was developed to estimate the cost-effectiveness of second-eye surgery in bilateral cataract patients. The model is based on changes in quality of life following second-eye surgery and includes post-surgical complications.

RESULTS

Three randomised controlled trials (RCTs) of clinical effectiveness, three studies of cost-effectiveness and 10 studies of health-related quality of life (HRQoL) met the inclusion criteria for the systematic reviews and, where possible, were used to inform the economic analysis. Heterogeneity of studies precluded meta-analyses, and instead data were synthesised narratively. The RCTs assessed visual acuity, contrast sensitivity, stereopsis and several measures of HRQoL. Improvements in binocular visual acuity and contrast sensitivity were small and unlikely to be of clinical significance, but stereopsis was improved to a clinically meaningful extent following second-eye surgery. Studies did not provide evidence that second-eye surgery significantly affected HRQoL, apart from an improvement in the mental health component of HRQoL in one RCT. In the model, second-eye surgery generated 0.68 incremental quality-adjusted life-years with an incremental cost-effectiveness ratio of £1964. Model results were most sensitive to changes in the utility gain associated with second-eye surgery, but otherwise robust to changes in parameter values. The probability that second-eye surgery is cost-effective at willingness-to-pay thresholds of £10,000 and £20,000 is 100%.

LIMITATIONS

Clinical effectiveness studies were all conducted more than 9 years ago. Patients had good vision pre surgery which may not represent all patients eligible for second-eye surgery. For some vision-related patient-reported outcomes and HRQoL measures, thresholds for determining important clinical effects are either unclear or have not been determined.

CONCLUSIONS

Second-eye cataract surgery is generally cost-effective based on the best available data and under most assumptions. However, more up-to-date data are needed. A well-conducted RCT that reflects current populations and enables the estimation of health state utility values would be appropriate. Guidance is required on which vision-related, patient-reported outcomes are suitable for assessing effects of cataract surgery in the NHS and how these measures should be interpreted clinically.

STUDY REGISTRATION

This project is registered as PROSPERO CRD42013004211.

FUNDING

This project was funded by the National Institute for Health Research Health Technology Assessment programme.

摘要

背景

选择性白内障手术是英国国民医疗服务体系(NHS)中最常开展的外科手术。对于双侧白内障患者,先对白内障导致视力损害最严重的眼睛进行手术。第一眼手术可改善视力和生活质量。然而,尚不清楚第二眼白内障手术是否能带来足够的额外益处,从而被视为具有临床有效性和成本效益。

目的

基于对成本效益和生活质量的系统评价所构建的经济模型,对英格兰和威尔士第二眼白内障手术的临床有效性进行系统评价,并分析其成本效益。

数据来源

检索了12个电子文献数据库,包括MEDLINE、EMBASE、科学引文索引(Web of Science)、考克兰图书馆以及评价与传播中心数据库,检索时间从数据库建立至2013年4月,并于2013年7月更新检索。还查阅了相关出版物的参考文献列表并咨询了专家。

综述方法

两名综述作者独立筛选参考文献,从纳入研究中提取并核对数据,评估其偏倚风险。基于对成本效益的综述,构建了一个全新的经济模型,以估计双侧白内障患者第二眼手术的成本效益。该模型基于第二眼手术后生活质量的变化,并纳入了术后并发症。

结果

三项临床有效性随机对照试验(RCT)、三项成本效益研究以及十项健康相关生活质量(HRQoL)研究符合系统评价的纳入标准,并在可能的情况下用于为经济分析提供信息。研究的异质性使得无法进行荟萃分析,因此改为采用叙述性方式综合数据。RCT评估了视力、对比敏感度、立体视觉以及多项HRQoL指标。双眼视力和对比敏感度的改善较小,不太可能具有临床意义,但第二眼手术后立体视觉有了具有临床意义的改善。除一项RCT中HRQoL的心理健康部分有所改善外,研究未提供证据表明第二眼手术对HRQoL有显著影响。在模型中,第二眼手术产生了0.68个增量质量调整生命年,增量成本效益比为1964英镑。模型结果对与第二眼手术相关的效用增益变化最为敏感,但在其他方面对参数值的变化具有稳健性。在支付意愿阈值为10000英镑和20000英镑时,第二眼手术具有成本效益的概率为100%。

局限性

临床有效性研究均在9年多以前进行。患者术前视力良好,这可能无法代表所有符合第二眼手术条件的患者。对于一些与视力相关的患者报告结局和HRQoL指标,确定重要临床效果的阈值尚不清楚或尚未确定。

结论

基于现有最佳数据和大多数假设,第二眼白内障手术总体上具有成本效益。然而,需要更新的数据。开展一项反映当前人群并能估计健康状态效用值的高质量RCT将是合适的。需要就哪些与视力相关的、患者报告的结局适用于评估NHS中白内障手术的效果以及这些指标应如何进行临床解读提供指导。

研究注册

该项目已在国际前瞻性系统评价注册库(PROSPERO)注册,注册号为CRD42013004211。

资助

该项目由英国国家卫生研究院卫生技术评估项目资助。

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