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聚焦 SBRT/放射外科前瞻性研究中的报告预期质量:30 年来我们已经走了多远?

Focus on the expected quality of reporting in SBRT/radiosurgery prospective studies: how far have we come in 30 years?

机构信息

Department of Radiotherapy, Lucien Neuwirth Cancer Institute, Saint-Priest en Jarez, France.

Department of radiotherapy, Babol University of Medical Sciences, Babol, Mazandaran Province, Iran.

出版信息

Br J Radiol. 2021 May 1;94(1121):20200115. doi: 10.1259/bjr.20200115. Epub 2021 Apr 16.

Abstract

OBJECTIVES

We aimed at describing and assessing the quality of reporting in all published prospective trials about radiosurgery (SRS) and stereotactic body radiotherapy (SBRT).

METHODS

The Medline database was searched for. The reporting of study design, patients' and radiotherapy characteristics, previous and concurrent cancer treatments, acute and late toxicities and assessment of quality of life were collected.

RESULTS

114 articles - published between 1989 and 2019 - were analysed. 21 trials were randomised (18.4%). Randomisation information was unavailable in 59.6% of the publications. Data about randomisation, ITT analysis and whether the study was multicentre or not, had been significantly less reported during the 2010-2019 publication period than before (respectively 29.4% 57.4% ( < 0.001), 20.6% 57.4% ( < 0.001), 48.5% 68.1% ( < 0.001). 89.5% of the articles reported the number of included patients. Information about radiation total dose was available in 86% of cases and dose fraction in 78.1%. Regarding the method of dose prescription, the prescription isodose was the most reported information (58.8%). The reporting of radiotherapy characteristics did not improve during the 2010 s-2019s. Acute and late high-grade toxicity was reported in 37.7 and 30.7%, respectively. Their reporting decreased in recent period, especially for all-grade late toxicities ( = 0.044).

CONCLUSION

It seems necessary to meet stricter specifications to improve the quality of reporting.

ADVANCES IN KNOWLEDGE

Our work results in one of the rare analyses of radiosurgery and SBRT publications. Literature must include necessary information to first, ensure treatments can be compared and reproduced and secondly, to permit to decide on new standards of care.

摘要

目的

本研究旨在描述和评估所有已发表的关于放射外科(SRS)和立体定向体放射治疗(SBRT)的前瞻性试验的报告质量。

方法

检索 Medline 数据库。收集研究设计、患者和放射治疗特征、既往和同期癌症治疗、急性和晚期毒性以及生活质量评估的报告情况。

结果

共分析了 114 篇发表于 1989 年至 2019 年的文章。21 项试验为随机对照试验(18.4%)。59.6%的出版物未提供随机分组信息。在 2010-2019 年发表的文章中,关于随机分组、意向治疗分析以及研究是否为多中心的报道明显少于之前(分别为 29.4% 57.4%(<0.001)、20.6% 57.4%(<0.001)、48.5% 68.1%(<0.001))。89.5%的文章报告了纳入患者的数量。86%的病例报道了放射总剂量,78.1%的病例报道了剂量分割。关于剂量处方方法,等剂量线是最常报道的信息(58.8%)。2010 年代以来,放射治疗特征的报告并没有改善。急性和晚期 3/4 级毒性的发生率分别为 37.7%和 30.7%。最近,这些报道有所减少,特别是所有级别的晚期毒性(=0.044)。

结论

似乎有必要制定更严格的规范来提高报告质量。

知识进展

本研究是对放射外科和 SBRT 文献的罕见分析之一。文献必须包含必要的信息,首先是为了确保治疗方法可以相互比较和重复,其次是为了确定新的治疗标准。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1704/8506168/ff9ad949d299/bjr.20200115.g001.jpg

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