Department of Oncology, Aarhus University Hospital, Denmark.
Department of Radiation Oncology, Comprehensive Cancer Center, Medical University of Vienna/General Hospital of Vienna, Austria.
Int J Radiat Oncol Biol Phys. 2019 Dec 1;105(5):957-967. doi: 10.1016/j.ijrobp.2019.08.040. Epub 2019 Aug 27.
The purpose of this review was to evaluate the current status of reporting prospectively assessed late morbidity after curative radiation therapy in large clinical studies.
A descriptive review on publications from 10 high-impact journals with a primary or partial focus on radiation therapy published between December 1, 2015, and November 30, 2017, was conducted. Publications were considered eligible if they reported prospectively assessed late morbidity after curative radiation therapy and included ≥200 patients with cancer of any type. Full text publication and supplementary material were analyzed according to items based on extensions to the Consolidated Standards of Reporting Trials (CONSORT) statement regarding reporting of harms and patient reported outcomes.
Overall, 802 publications were identified in PubMed; of these, 69 met the eligibility criteria. Mild and moderate morbidity were reported in 40% and 57% of publications; aggregated endpoints instead of individual endpoints were reported in 23%. In 43% of publications, crude incidence of worst grade of morbidity was used as the only statistical method for summarizing physician-assessed morbidity. Duration of morbidity or recurrent events were not reported in any of the publications.
Comprehensive, quantitative reporting of late morbidity after radiation therapy is challenging because of the high dimensionality and time evolution of the range of normal tissue effects. The following suggestions and recommendations are proposed: (1) report on individual severity grades, including moderate and mild; (2) use patient reported outcomes in complement to physician-assessed morbidity; (3) report on individual symptoms/endpoints on top of aggregated endpoints; (4) report on duration of morbidity or recurrent events; (5) take steps toward a consensus on severity grading scales/patient questionnaires; (6) use time to event analysis and prevalence rates; (7) report or use statistical methods accounting for pretreatment morbidity when relevant.
本综述旨在评估在大型临床研究中前瞻性评估根治性放疗后迟发性并发症的报告现状。
对 2015 年 12 月 1 日至 2017 年 11 月 30 日期间发表于 10 种高影响力期刊的以放射治疗为主要或部分重点的出版物进行描述性综述。如果出版物报告了根治性放疗后前瞻性评估的迟发性并发症，并纳入了≥200 例任何类型癌症患者，则认为其符合入选标准。根据 CONSORT 声明中关于伤害和患者报告结局报告的扩展项目，对全文出版物和补充材料进行分析。
在 PubMed 中总共确定了 802 篇出版物；其中，69 篇符合入选标准。40%和 57%的出版物报告了轻度和中度并发症；23%的出版物报告了汇总终点而非个体终点。在 43%的出版物中，最严重的并发症发生率被用作医生评估并发症发生率的唯一统计方法。没有一篇出版物报告了迟发性并发症的持续时间或复发事件。
由于正常组织效应的高维性和时间演变，全面、定量报告放疗后迟发性并发症具有挑战性。我们提出以下建议：（1）报告个体严重程度等级，包括中度和轻度；（2）使用患者报告结局补充医生评估的并发症；（3）在汇总终点之上报告个体症状/终点；（4）报告迟发性并发症或复发事件的持续时间；（5）朝着达成严重程度分级量表/患者问卷共识的方向努力；（6）使用时间事件分析和流行率；（7）在相关时报告或使用考虑预处理并发症的统计方法。
