The diagnostic accuracy and cost-effectiveness of magnetic resonance spectroscopy and enhanced magnetic resonance imaging techniques in aiding the localisation of prostate abnormalities for biopsy: a systematic review and economic evaluation
The diagnostic accuracy and cost-effectiveness of magnetic resonance spectroscopy and enhanced magnetic resonance imaging techniques in aiding the localisation of prostate abnormalities for biopsy: a systematic review and economic evaluation
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DOI：
10.3310/hta17200
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发表时间：
2013-05-01
影响因子：
3.6
通讯作者：
Tassie, E.
中科院分区：
文献类型：
--
作者：
Mowatt, G.;Scotland, G.;Tassie, E.
背景：在英国，前列腺癌(PC)是男性最常见的癌症。只有在前列腺活检后才能确认诊断。许多男性发现自己的前列腺特异性抗原(PSA)水平升高，活检呈阴性。管理这些男性的最佳方法仍然不确定。目标：评估磁共振波谱(MRS)和增强磁共振成像(MRI)技术[动态对比增强MRI(DCE-MRI)，弥散加权MRI(DW-MRI)]的诊断准确性，以及使用它们的策略的临床有效性和成本效益，这些策略涉及帮助定位前列腺异常以便对临床上仍怀疑有恶性肿瘤的患者进行活检。数据来源：数据库搜索-MEDLINE(1946-2012年3月)，MEDLINE in-Process&其他非索引引文(2012年3月)，EMBASE(1980-2012年3月)，Bioscience Information Service(BIOSIS；科学引文索引(SCI；1995年至2012年3月)、Cochrane图书馆(2012年第3期)、效果综述摘要数据库(DARE；2012年3月)、Medion(2012年3月)和卫生技术评估数据库(2012年3月)。综述方法：研究类型：报告诊断结果的直接研究/随机对照试验。指标测试：MRS、DCE-MRI和DW-MRI。对照：T2加权磁共振成像(T2-MRI)、经直肠超声引导下活检(TRUS/Bx)。参考标准：活检组织的组织病理学评估。建立马尔可夫模型来评估替代MRS/MRI序列与系统扩展核心TRUS引导活检的成本-效果。研究采用卫生服务提供者的视角，对成本和结果采用3.5%的建议贴现率。结果：共纳入51项研究。在合并估计中，MRS的敏感性[95%可信区间(CI)]最高(92%；95%可信区间86%至95%)。TRUS(影像试验)的特异度最高(81%；95%CI为77%~85%)。终生费用从3895英镑(使用系统的TRUS引导的活检)到4056英镑(使用T2-MRI或DCE-MRI的结果)直接活检(60岁队列，癌症患病率24%)不等。T2-MRI的基础病例增量成本-效果比为30,000英镑/QALY(所有队列)。概率敏感度分析显示，T2-MRI在中度流行队列中的增量成本-效果具有很高的不确定性。与T2-MRI和TRUS相比，MRS的成本-效果对几个关键参数敏感。限制：排除非英语语言的研究。很少有研究报道DCE-MRI/DW-MRI。可供选择的策略的相对诊断准确性、重复活检时发现的癌症自然病史以及诊断和治疗对疾病进展和健康相关生活质量的影响等方面的有限数据阻碍了建模。结论：MRS比T2-MRI具有更高的敏感性和特异性。替代战略的相对成本效益对关键参数/假设很敏感。在某些情况下，T2-MRI可能比系统的TRUS更具成本效益。如果MRS和DW-MRI能够被证明对检测中/高风险癌症具有高敏感性，而拒绝接受非癌症/低风险疾病的患者接受活检，那么它们的使用可能是一种具有成本效益的诊断方法。然而，由于可靠数据的相对缺乏，还需要进一步的研究。特别是，需要对疑似前列腺癌和PSA水平升高但以前活检阴性的男性进行前瞻性研究，比较多参数磁共振(MR)方法(MRS、DCE-MRI和DW-MRI)与MR引导/定向活检和扩展的14核TRUS引导活检方案的单独和组合组件的有效性，以及通过饱和活检、模板活检或前列腺切除标本获得的活检组织的组织病理学评估的参考标准。
Background: In the UK, prostate cancer (PC) is the most common cancer in men. A diagnosis can be confirmed only following a prostate biopsy. Many men find themselves with an elevated prostate-specific antigen (PSA) level and a negative biopsy. The best way to manage these men remains uncertain.Objectives: To assess the diagnostic accuracy of magnetic resonance spectroscopy (MRS) and enhanced magnetic resonance imaging (MRI) techniques [dynamic contrast-enhanced MRI (DCE-MRI), diffusion-weighted MRI (DW-MRI)] and the clinical effectiveness and cost-effectiveness of strategies involving their use in aiding the localisation of prostate abnormalities for biopsy in patients with prior negative biopsy who remain clinically suspicious for harbouring malignancy.Data sources: Databases searched - MEDLINE (1946 to March 2012), MEDLINE In-Process & Other NonIndexed Citations (March 2012), EMBASE (1980 to March 2012), Bioscience Information Service (BIOSIS; 1995 to March 2012), Science Citation Index (SCI; 1995 to March 2012), The Cochrane Library (Issue 3 2012), Database of Abstracts of Reviews of Effects (DARE; March 2012), Medion (March 2012) and Health Technology Assessment database (March 2012).Review methods: Types of studies: direct studies/randomised controlled trials reporting diagnostic outcomes. Index tests: MRS, DCE-MRI and DW-MRI. Comparators: T2-weighted magnetic resonance imaging (T2-MRI), transrectal ultrasound-guided biopsy (TRUS/Bx). Reference standard: histopathological assessment of biopsied tissue. A Markov model was developed to assess the cost-effectiveness of alternative MRS/MRI sequences to direct TRUS-guided biopsies compared with systematic extended-cores TRUS-guided biopsies. A health service provider perspective was adopted and the recommended 3.5% discount rate was applied to costs and outcomes.Results: A total of 51 studies were included. In pooled estimates, sensitivity [95% confidence interval (CI)] was highest for MRS (92%; 95% CI 86% to 95%). Specificity was highest for TRUS (imaging test) (81%; 95% CI 77% to 85%). Lifetime costs ranged from 3895 pound using systematic TRUS-guided biopsies to 4056 pound using findings on T2-MRI or DCE-MRI to direct biopsies (60-year-old cohort, cancer prevalence 24%). The base-case incremental cost-effectiveness ratio for T2-MRI was < 30,000 pound per QALY (all cohorts). Probabilistic sensitivity analysis showed high uncertainty surrounding the incremental cost-effectiveness of T2-MRI in moderate prevalence cohorts. The cost-effectiveness of MRS compared with T2-MRI and TRUS was sensitive to several key parameters.Limitations: Non-English-language studies were excluded. Few studies reported DCE-MRI/DW-MRI. The modelling was hampered by limited data on the relative diagnostic accuracy of alternative strategies, the natural history of cancer detected at repeat biopsy, and the impact of diagnosis and treatment on disease progression and health-related quality of life.Conclusions: MRS had higher sensitivity and specificity than T2-MRI. Relative cost-effectiveness of alternative strategies was sensitive to key parameters/assumptions. Under certain circumstances T2-MRI may be cost-effective compared with systematic TRUS. If MRS and DW-MRI can be shown to have high sensitivity for detecting moderate/high-risk cancer, while negating patients with no cancer/low-risk disease to undergo biopsy, their use could represent a cost-effective approach to diagnosis. However, owing to the relative paucity of reliable data, further studies are required. In particular, prospective studies are required in men with suspected PC and elevated PSA levels but previously negative biopsy comparing the utility of the individual and combined components of a multiparametric magnetic resonance (MR) approach (MRS, DCE-MRI and DW-MRI) with both a MR-guided/-directed biopsy session and an extended 14-core TRUS-guided biopsy scheme against a reference standard of histopathological assessment of biopsied tissue obtained via saturation biopsy, template biopsy or prostatectomy specimens.