Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, Germany.
J Nucl Med. 2012 Jul;53(7):1016-25. doi: 10.2967/jnumed.111.101089. Epub 2012 Jun 7.
Randomized controlled trials (RCTs) add important information to diagnostic accuracy studies in the evaluation of PET and PET/CT. We evaluated how many RCTs on PET existed, which clinical topics they addressed, and what their design and quality were.
We searched MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (Clinical Trials) up to August 2010. We also searched in ClinicalTrials.gov and the International Clinical Trials Registry Platform for ongoing RCTs up to March 2011. Titles and abstracts and full texts were screened independently by 2 reviewers. Study characteristics were extracted with standard extraction sheets for ongoing and published RCTs, and risk of bias was assessed for published ones.
We identified 54 RCTs, 12 of which were published. The main topics in published studies were non-small cell lung cancer and colorectal cancer; only 3 were conducted in nononcologic fields (this trend was similar in ongoing studies, in which the most common topic was Hodgkin disease). The main indications in the oncologic PET studies were staging in published studies and restaging (mostly including an early assessment of treatment response) in ongoing ones. All except 1 of the published studies applied a marker-based strategy design, whereas about 43% (18/42) of ongoing studies use a more efficient design (Enrichment Design or Marker by Treatment Interaction Design).
A relatively high number of ongoing RCTs of PET in several oncologic fields are expected to produce robust results over the next few years. For nononcologic topics, further high-quality studies are still needed to ascertain the benefit of this technique for patients. As funding is usually difficult in nondrug topics, alternative concepts of funding, which should also involve the manufacturers of diagnostic devices, but also more efficient study designs, should be applied to bridge the evidence gap on PET in the near future.
在评估 PET 和 PET/CT 的诊断准确性研究中，随机对照试验（RCT）提供了重要信息。我们评估了现有的 PET 随机对照试验数量、它们所涉及的临床主题、以及它们的设计和质量。
我们检索了 MEDLINE、EMBASE 和 Cochrane 对照试验中心注册库（临床试验），检索截至 2010 年 8 月。我们还在 ClinicalTrials.gov 和国际临床试验注册平台上检索了截至 2011 年 3 月的正在进行的 RCT。两名评审员独立筛选标题和摘要及全文。使用标准的正在进行和已发表 RCT 提取表提取研究特征，并对已发表 RCT 进行偏倚风险评估。
我们确定了 54 项 RCT，其中 12 项已发表。已发表研究的主要主题是非小细胞肺癌和结直肠癌；只有 3 项在非肿瘤领域进行（正在进行的研究中也存在类似的趋势，最常见的主题是霍奇金病）。肿瘤 PET 研究的主要适应症是已发表研究中的分期和再分期（主要包括对治疗反应的早期评估），而正在进行的研究中几乎所有研究都采用了基于标志物的策略设计，而约 43%（18/42）的研究采用了更有效的设计（富集设计或标志物与治疗相互作用设计）。
预计未来几年将有相当数量的正在进行的多项肿瘤领域的 PET 随机对照试验产生强有力的结果。对于非肿瘤学课题，仍需要进一步进行高质量的研究，以确定该技术对患者的益处。由于在非药物课题中通常难以获得资金，因此应该应用替代的资金概念，这些概念不仅应涉及诊断设备的制造商，还应涉及更有效的研究设计，以在不久的将来缩小 PET 技术的证据差距。
