Antony Katja, Genser Dieter, Fröschl Barbara
ÖBIG - Österreichisches Bundesinstitut für Gesundheitswesen, Wien, Österreich.
GMS Health Technol Assess. 2007 Feb 7;3:Doc01.
About 950,000 people are affected by glaucoma in Germany, about 50% of which are undiagnosed. The German Ophthalmological Society and the German Association of Ophthalmologists recommend a screening for glaucoma according to their guidelines. The Federal Joint Committee disapproved a glaucoma-screening program on expense of the compulsory health insurance in 2004.
Primary open angle glaucoma is diagnosed by evaluation of the optic disc, the retinal fibre layer and the visual field. The main examinations are ophthalmoscopy, scanning laser polarimetry, confocal scanning laser ophthalmoscopy, retinal thickness analysis and optical coherence tomography. Scotomas are diagnosed by perimetry (standard automated perimetry, short wavelength automated perimetry and frequency doubling perimetry). The intraocular pressure is the most important treatable risk factor and is measured by (contact or non-contact) tonometry.
The aim of this HTA-report is to investigate the diagnostic validity and cost effectiveness of diagnostic techniques or combinations of these methods with respect to the use in a screening setting in Germany.
A systematic literature research was performed in 35 international databases and yielded 2602 articles. Overall 57 publications were included for assessment, according to predefined selection criteria.
The 55 medical articles deal mainly with frequency doubling perimetry, confocal scanning laser ophthalmoscopy and scanning laser polarimetry. Few articles cover short wavelength automated perimetry, tonometry and ophalmocopic evaluations by ophthalmologists. The quality of the papers is generally low, as far as the evidence in respect of screening is concerned. No single method exists with both, high sensitivity and high specificity for screening purpose. Data are also not sufficient to recommend combinations of methods. Only two economic models on cost-effectivenes of screening investigations could be identified. No economic evaluations of the most recent methods can be found in the published literature. A British cost-effectiveness analysis calculates cost per true positives and favours a combination of ophthalmoscopy, tonometry and perimetry either for people at high risk for glaucoma or for the total population as an initial examination. A Canadian HTA-report models the cost per year of blindness avoided. The report concludes that because of a high degree of uncertainty with respect to the benefits and the high costs involved, the setting-up of a glaucoma-screening program cannot be supported.
The literature shows that combinations of methods have to be used for screening of glaucoma in order to get reasonable values of sensitivity and specificity. Presently no combination of methods and no algorithm can be presented for glaucoma screening with sufficient evidence. Also no conclusions about cost-effectiveness for Germany can be made based on the available literature.
In order to find the optimal combination of methods for glaucoma-screening, population-based studies have to be performed. Therefore also no final conclusions can be drawn with respect to cost-effectiveness of glaucoma-screening methods. The economic evaluation of a clinical effective screening-method should consider the effects of blindness avoided, as well as effects on the prevention of visual impairment.
德国约有95万人受青光眼影响,其中约50%未被诊断出来。德国眼科学会和德国眼科医生协会根据其指南建议对青光眼进行筛查。联邦联合委员会在2004年否决了一项由法定医疗保险出资的青光眼筛查项目。
原发性开角型青光眼通过对视盘、视网膜纤维层和视野的评估来诊断。主要检查方法有检眼镜检查、扫描激光偏振仪、共焦扫描激光检眼镜、视网膜厚度分析和光学相干断层扫描。通过视野计(标准自动视野计、短波长自动视野计和频率加倍视野计)诊断暗点。眼压是最重要的可治疗危险因素,通过(接触式或非接触式)眼压测量法进行测量。
本卫生技术评估报告的目的是研究诊断技术或这些方法的组合在德国筛查环境中的诊断有效性和成本效益。
在35个国际数据库中进行了系统的文献研究,共得到2602篇文章。根据预先确定的选择标准,总共纳入了57篇出版物进行评估。
55篇医学文章主要涉及频率加倍视野计、共焦扫描激光检眼镜和扫描激光偏振仪。很少有文章涉及短波长自动视野计、眼压测量法以及眼科医生的检眼镜评估。就筛查证据而言,这些论文的质量普遍较低。不存在一种对筛查目的兼具高灵敏度和高特异性的单一方法。数据也不足以推荐方法组合。仅能找到两个关于筛查研究成本效益的经济模型。在已发表的文献中未发现对最新方法的经济评估。一项英国的成本效益分析计算了每个真阳性的成本,并支持对青光眼高危人群或总人口采用检眼镜检查、眼压测量法和视野计检查相结合的方法作为初始检查。一份加拿大卫生技术评估报告模拟了避免失明的每年成本。该报告得出结论,由于在益处方面存在高度不确定性且成本高昂,无法支持设立青光眼筛查项目。
文献表明,必须采用方法组合来筛查青光眼,以便获得合理的灵敏度和特异性值。目前,没有足够证据支持用于青光眼筛查的方法组合或算法。根据现有文献,也无法得出关于德国成本效益的结论。
为了找到青光眼筛查的最佳方法组合,必须开展基于人群的研究。因此,关于青光眼筛查方法的成本效益也无法得出最终结论。对临床有效的筛查方法进行经济评估时,应考虑避免失明的效果以及对预防视力损害的影响。