国内期刊腹腔镜胃癌手术随机对照试验报告质量评价

Quality assessment of the reports of randomized controlled trials of laparoscopic gastrectomy for gastric cancer published in China

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(CONSORT2010)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。纳入文献在结构式摘要(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。

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.