Bekelman Justin E, Yahalom Joachim
Department of Radiation Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
Int J Radiat Oncol Biol Phys. 2009 Feb 1;73(2):492-8. doi: 10.1016/j.ijrobp.2008.04.058. Epub 2008 Sep 17.
Standards for the reporting of radiotherapy details in randomized controlled trials (RCTs) are lacking. Although radiotherapy (RT) is an important component of curative therapy for Hodgkin's lymphoma (HL) and non-Hodgkin's lymphoma (NHL), we postulated that RT reporting may be inadequate in Phase III HL and NHL trials.
We searched PubMed and the Cochrane registry for reports of RCTs involving RT and either HL or NHL published between 1998 and 2007. We screened 133 titles and abstracts to identify relevant studies. We included a total of 61 reports. We assessed these reports for the presence of six quality measures: target volume, radiation dose, fractionation, radiation prescription, quality assurance (QA) process use, and adherence to QA (i.e., reporting of major or minor deviations).
Of 61 reports, 23 (38%) described the target volume. Of the 42 reports involving involved-field RT alone, only 8 (19%) adequately described the target volume. The radiation dose and fractionation was described in most reports (54 reports [89%] and 39 reports [64%], respectively). Thirteen reports specified the RT prescription point (21%). Only 12 reports (20%) described using a RT QA process, and 7 reports (11%) described adherence to the QA process.
Reporting of RT in HL and NHL RCTs is deficient. Because the interpretation, replication, and application of RCT results depend on adequate description and QA of therapeutic interventions, consensus standards for RT reporting should be developed and integrated into the peer-review process.
随机对照试验(RCT)中缺乏放疗细节报告的标准。尽管放射治疗(RT)是霍奇金淋巴瘤(HL)和非霍奇金淋巴瘤(NHL)根治性治疗的重要组成部分,但我们推测在III期HL和NHL试验中RT报告可能不充分。
我们在PubMed和Cochrane注册库中搜索了1998年至2007年间发表的涉及RT以及HL或NHL的RCT报告。我们筛选了133篇标题和摘要以确定相关研究。我们共纳入了61篇报告。我们评估这些报告是否存在六项质量指标:靶区体积、放射剂量、分割方式、放疗处方、质量保证(QA)流程的使用以及对QA的依从性(即主要或次要偏差的报告)。
在61篇报告中,23篇(38%)描述了靶区体积。在仅涉及累及野RT的42篇报告中,只有8篇(19%)充分描述了靶区体积。大多数报告描述了放射剂量和分割方式(分别为54篇报告[89%]和39篇报告[64%])。13篇报告明确了RT处方点(21%)。只有12篇报告(20%)描述了使用RT QA流程,7篇报告(11%)描述了对QA流程的依从性。
HL和NHL RCT中RT的报告存在不足。由于RCT结果的解释、重复和应用取决于治疗干预的充分描述和QA,应制定RT报告的共识标准并将其纳入同行评审过程。