Meta-analysis of the technical performance of an imaging procedure: Guidelines and statistical methodology

Meta-analysis of the technical performance of an imaging procedure: Guidelines and statistical methodology
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DOI:
10.1177/0962280214537394
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发表时间:
2015-02-01
影响因子:
2.3
通讯作者:
Zahlmann, Gudrun
Zahlmann, Gudrun
中科院分区:
医学3区
文献类型:
--
作者:
Huang, Erich P.;Wang, Xiao-Feng;Zahlmann, Gudrun

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医学成像在病人护理和药物审批过程中发挥着许多作用,包括评估治疗反应和指导治疗决定。这些作用通常涉及定量成像生物标记物,即来自医学图像的潜在解剖结构或生化过程的客观测量特征。在定量成像生物标记物被接受用于这种作用之前,获得它的成像程序必须经过对其技术性能的评估,这需要对诸如定量成像生物标记物的重复性和再现性等性能指标进行评估。理想情况下,这种评估将包括对多项研究结果的量化总结,以克服由于技术性能研究的样本量通常较小而造成的限制,和/或包括更广泛的临床环境和患者群体。本文对这类评价的荟萃分析程序进行了综述,包括确定合适的研究、评估和总结绩效指标的统计方法以及对结果的完整和透明的报告。这篇综述讨论了技术绩效的荟萃分析的典型挑战,特别是小规模的研究,这往往会导致违反标准的荟萃分析技术的假设。还提出了解决这些困难的替代方法;模拟研究表明,当一些研究较小时,它们的表现优于标准技术。为说明起见,本文提出的荟萃分析方法也适用于实际的[18F]-氟代脱氧葡萄糖正电子发射断层扫描(FDG-PET)测试-重测重复性数据。
Medical imaging serves many roles in patient care and the drug approval process, including assessing treatment response and guiding treatment decisions. These roles often involve a quantitative imaging biomarker, an objectively measured characteristic of the underlying anatomic structure or biochemical process derived from medical images. Before a quantitative imaging biomarker is accepted for use in such roles, the imaging procedure to acquire it must undergo evaluation of its technical performance, which entails assessment of performance metrics such as repeatability and reproducibility of the quantitative imaging biomarker. Ideally, this evaluation will involve quantitative summaries of results from multiple studies to overcome limitations due to the typically small sample sizes of technical performance studies and/or to include a broader range of clinical settings and patient populations. This paper is a review of meta-analysis procedures for such an evaluation, including identification of suitable studies, statistical methodology to evaluate and summarize the performance metrics, and complete and transparent reporting of the results. This review addresses challenges typical of meta-analyses of technical performance, particularly small study sizes, which often causes violations of assumptions underlying standard meta-analysis techniques. Alternative approaches to address these difficulties are also presented; simulation studies indicate that they outperform standard techniques when some studies are small. The meta-analysis procedures presented are also applied to actual [18F]-fluorodeoxyglucose positron emission tomography (FDG-PET) test-retest repeatability data for illustrative purposes.