Introduction: Randomised controlled trials (RCTs) continue to provide the best evidence for treatment options, but the quality of reporting in RCTs and the completeness rate of reporting of surgical outcomes and complication data vary widely. The aim of this study was to measure the quality of reporting of the surgical outcome and complication data in RCTs of rectal cancer treatment and whether this quality has changed over time. Methods: Eligible articles with the keywords (“rectal cancer” OR “rectal carcinoma”) AND (“radiation” OR “radiotherapy”) that were RCTs and published in the English, German, Polish, or Italian language were identified by reviewing all abstracts published from 1982 through 2022. Two authors independently screened and analysed all studies. The quality of the surgical outcome and complication data was assessed based on fourteen criteria, and the quality of RCTs was evaluated based on a modified Jadad scale. The primary outcome was the quality of reporting in RCTs and the completeness rate of reporting of surgical results and complication data. Results: A total of 340 articles reporting multimodal therapy outcomes for 143,576 rectal cancer patients were analysed. A total of 7 articles (2%) met all 14 reporting criteria, 13 met 13 criteria, 27 met from 11 to 12 criteria, 36 met from 9 to 10 criteria, 76 met from 7 to 8 criteria, and most articles met fewer than 7 criteria (mean 5.5 criteria). Commonly underreported criteria included complication severity (15% of articles), macroscopic integrity of mesorectal excision (17% of articles), length of stay (18% of articles), number of lymph nodes (21% of articles), distance between the tumour and circumferential resection margin (CRM) (26% of articles), surgical radicality according to the site of the primary tumour (R0 vs. R1 + R2) (29% of articles), and CRM status (38% of articles). Conclusion: Inconsistent surgical outcome and complication data reporting in multimodal rectal cancer treatment RCTs is standard. Standardised reporting of clinical and oncological outcomes should be established to facilitate comparing studies and results of related research topics.
引言：随机对照试验（RCT）持续为治疗方案提供最佳证据，但RCT的报告质量以及手术结果与并发症数据的报告完整率存在显著差异。本研究旨在评估直肠癌治疗RCT中手术结果与并发症数据的报告质量，并探究该质量是否随时间发生变化。方法：通过系统回顾1982年至2022年间发表的所有摘要，筛选出包含关键词（"直肠癌"或"直肠癌"）与（"放射"或"放射治疗"）、研究类型为RCT、且以英文、德文、波兰文或意大利文发表的合格文献。由两位研究者独立完成文献筛选与分析。手术结果与并发症数据的报告质量依据十四项标准进行评估，RCT整体质量采用改良Jadad量表评价。主要观察指标为RCT报告质量及手术结果与并发症数据的报告完整率。结果：共纳入340篇文献，涉及143,576例接受多模式治疗的直肠癌患者。其中仅7篇文献（2%）满足全部14项报告标准，13篇满足13项标准，27篇满足11-12项标准，36篇满足9-10项标准，76篇满足7-8项标准，多数文献（平均5.5项）满足标准不足7项。常见报告缺失项目包括：并发症严重程度（15%文献未报告）、直肠系膜切除宏观完整性（17%）、住院时长（18%）、淋巴结检出数量（21%）、肿瘤与环周切缘距离（26%）、基于原发肿瘤部位的手术根治性（R0与R1+R2分类）（29%）以及环周切缘状态（38%）。结论：多模式直肠癌治疗RCT中手术结果与并发症数据的报告不一致现象普遍存在。应建立临床与肿瘤学结果的标准化报告体系，以促进相关研究课题间的比较分析。
肿瘤(癌症)患者之家