CAJ | 학술논문

目的：评价国内期刊腹腔镜胃癌手术随机对照试验（RCT）文献的方法学质量。方法检索国内主要中文数据库，获得腹腔镜胃癌手术的 RCT 文献，依据临床试验报告统一标准（CONSORT 2010）声明对文献质量进行评价。结果纳入37篇文献，发表时间为2006-2013年。纳入文献在结构式（100%）、科学背景（83.78%）、试验设计描述（97.30%）、干预措施描述（89.19%）、统计学方法（94.59%）、结局指标估计值（100%）和结果解释（91.89%）等方面报告详尽，但在样本量确定（0%）、随机方法（8.11%）、试验局限性（8.11%）等方面报告不详尽或未见报告。核心期刊（14篇）与非核心期刊（23篇）、作者单位为三级医院（21篇）与非三级医院（16篇）发表的文献，其 CONSORT 2010清单25个条目差异均无统计学意义（P ＞0.05）。结论国内期刊发表的腹腔镜胃癌手术的 RCT 文献报告质量总体水平相对较低，与CONSORT 2010声明差距较大，这一领域迫切需要设计、实施和报告均有高水准的随机对照研究。
목적：평개국내기간복강경위암수술수궤대조시험（RCT）문헌적방법학질량。방법검색국내주요중문수거고，획득복강경위암수술적 RCT 문헌，의거림상시험보고통일표준（CONSORT 2010）성명대문헌질량진행평개。결과납입37편문헌，발표시간위2006-2013년。납입문헌재결구식（100%）、과학배경（83.78%）、시험설계묘술（97.30%）、간예조시묘술（89.19%）、통계학방법（94.59%）、결국지표고계치（100%）화결과해석（91.89%）등방면보고상진，단재양본량학정（0%）、수궤방법（8.11%）、시험국한성（8.11%）등방면보고불상진혹미견보고。핵심기간（14편）여비핵심기간（23편）、작자단위위삼급의원（21편）여비삼급의원（16편）발표적문헌，기 CONSORT 2010청단25개조목차이균무통계학의의（P ＞0.05）。결론국내기간발표적복강경위암수술적 RCT 문헌보고질량총체수평상대교저，여CONSORT 2010성명차거교대，저일영역박절수요설계、실시화보고균유고수준적수궤대조연구。
Objective To evaluate the methodological quality of reports of randomized controlled trials (RCT)on laparoscopic gastrectomy for gastric cancer published in China. Methods The RCT literatures related to laparoscopic gastrectomy for gastric cancer published in Chinese academic journals were searched in domestic database. The quality of literatures was evaluated according to the CONSORT 2010 statement. Results 37 RCT literatures were included, published from 2006 to 2013. Most of the 37 literatures reported exhaustive details in structured abstract (100%),background (83.78%),experimental design (97.30% ),intervention description (89.19% ),statistical methods (94.59% ),outcomes and estimations (100%),and the interpretation of results (91.89%). However,few literatures reported sample size estimation(0%),random allocation sequence generation(8.11%),and limitation of the trials(8.11%). There was no significant difference (P > 0.05)in 25 items of CONSORT 2010 checklist neither between literatures in core (14)and non-core (23)journals nor between literatures written by authors from tertiary (21)and non-tertiary (16)hospital (P > 0.05). Conclusion The RCT on laparoscopic gastrectomy for gastric cancer published in chinese academic journals were inadequately reported, rarely met the standards of CONSORT 2010 statement. More RCT with high quality in designing, conducting and reporting are urgently needed in the related field.