Nguyen Tram, Baun Christina, Høilund-Carlsen Poul Flemming
Department of Nuclear Medicine, Odense University Hospital, Odense Department of Applied Mathematics and Computer Science, Technical University of Denmark, Kongens Lyngby Clinical Physiology and Nuclear Medicine, University of Southern Denmark, Odense, Denmark.
Medicine (Baltimore). 2018 Sep;97(37):e12312. doi: 10.1097/MD.0000000000012312.
Reproducibility is essential to clinical application of positron emission tomography (PET) quantification. Human lapses in data registration and protocol compliance are pervasive sources of intrasite quantification variability. Although rarely assessed or reported, these lapses are ultimately a limitation to harmonization in multicenter clinical trials. A comprehensive account of their possible extent is relayed here.This is a retrospective audit of errors in manual registration of study parameters and in protocol adherence across a sample of in-center research projects over one year (201 patients, 222 PET/CT scans). Discrepancies in patient height and weight; tracer type; dose; injection; and scan times were listed. Correspondent variances in standardized uptake values (SUVs) normalized by body weight, SUV (BW), and body surface area, SUV (BSA), were assessed.Manual misregistrations totalled 41.8%. These were mainly small, but with a few large deviations, and most significant in weight (range: -1-100 kg) and dose (-19 to 12 MBq). Errors were more frequent and generally larger in non-routine studies. This also applied to protocol compliance. A 50.7% noncompliance was found with significant deviations in dose (-106 to 208 MBq) and especially in early scan uptake times (-37 to 54 min). Although misregistrations did not overall translate into significant SUV variability, noncompliance did. These errors contributed a factor 0.02 to 1.45 and 0.71 to 3.09 SUV (BW) change, respectively. SUV (BSA) saw a significant 21% to 22% decrease with mistyped height and weight.Inconsistency was frequent but less prominent in data entry than in protocol compliance. As both caused some substantial SUV variances, intra-site assessments and data checking are required for clinical trials.
可重复性对于正电子发射断层扫描（PET）定量分析的临床应用至关重要。数据配准和方案依从性方面的人为失误是同一研究机构内定量分析变异性的普遍来源。尽管这些失误很少被评估或报告，但它们最终限制了多中心临床试验的一致性。本文全面阐述了这些失误可能达到的程度。
这是一项回顾性审计，针对一年内中心内研究项目样本（201例患者，222次PET/CT扫描）中研究参数手动配准和方案依从性方面的错误。列出了患者身高、体重、示踪剂类型、剂量、注射情况和扫描时间方面的差异。评估了按体重标准化的标准化摄取值（SUV）即SUV（BW）以及按体表面积标准化的SUV即SUV（BSA）的相应方差。
手动配准错误总计41.8%。这些错误大多较小，但有一些偏差较大，在体重（范围：-1至100千克）和剂量（-19至12兆贝可）方面最为显著。在非常规研究中，错误更频繁且通常更大。这也适用于方案依从性。发现50.7%的情况不符合方案，在剂量（-106至208兆贝可）方面有显著偏差，尤其是在早期扫描摄取时间（-37至54分钟）方面。尽管配准错误总体上未转化为显著的SUV变异性，但不符合方案则导致了这种变异性。这些错误分别导致SUV（BW）变化的因素为0.02至1.45以及0.71至3.09。当身高和体重输入错误时，SUV（BSA）显著下降了21%至22%。
数据录入中的不一致情况很常见，但不如方案依从性方面突出。由于两者都会导致一些显著的SUV方差，因此临床试验需要进行机构内评估和数据检查。
