Cui Qi, Tian Jinhui, Song Xuping, Yang Kehu
The First Hospital of Lanzhou University, Lanzhou University, Lanzhou, China.
J Eval Clin Pract. 2014 Dec;20(6):827-33. doi: 10.1111/jep.12200. Epub 2014 Jun 11.
The extension of the Consolidated Standards of Reporting Trials (CONSORT) statement provides reporting guidelines to improve the reporting quality of randomized controlled trials (RCTs). This present study was aim to assess the reporting quality of abstracts of RCTs on clinical pathway.
Eight databases were searched from inception to November 2012 to identify RCTs. We extracted basic information and CONSORT items from abstracts. Each abstract was assessed independently by two reviewers. Statistical analyses were performed with SPSS 13.0. Level of significance was set at P < 0.05.
328 abstracts were included. 300 (91.5%) were published in Chinese, of which 292 were published on high impact factor journals. 28 English abstracts were all published on Science Citation Index (SCI) journals. (1) Intervention, objective and outcome were almost fully reported in all abstracts, while recruitment and funding were never reported. (2) There are nine items (P < 0.05) in Chinese that were of low quality compared with in English. There was statistically difference on total score between Chinese and English abstracts (P < 0.00001). (3) There was no difference in any items between high and low impact factor journal in China. (4) In SCI journals, there were significant changes in reporting for three items trial design (P = 0.026), harms (P = 0.039) and trial registration (P = 0.019) in different periods (pre- and post-CONSORT), but only the numbers of randomized (P = 0.003) changed in Chinese abstracts.
The reporting quality of abstracts of RCTs on clinical pathway still should be improved. After the publication of CONSORT for abstracts guideline, the RCT abstracts reporting quality were improvement to some extent. The abstracts in Chinese journals showed non-adherence to the CONSORT for abstracts guidelines.
理论依据、目的和目标：《试验报告统一标准》（CONSORT）声明的扩展提供了报告指南，以提高随机对照试验（RCT）的报告质量。本研究旨在评估临床路径RCT摘要的报告质量。
检索了8个数据库，从建库至2012年11月，以识别RCT。我们从摘要中提取基本信息和CONSORT项目。由两名审阅者独立评估每篇摘要。使用SPSS 13.0进行统计分析。显著性水平设定为P < 0.05。
纳入328篇摘要。300篇（91.5%）发表于中文期刊，其中292篇发表于高影响因子期刊。28篇英文摘要均发表于科学引文索引（SCI）期刊。（1）所有摘要中干预、目的和结果几乎均有完整报告，而招募和资金情况从未报告。（2）中文摘要中有9项（P < 0.05）质量低于英文摘要。中文和英文摘要的总分存在统计学差异（P < 0.00001）。（3）中国高、低影响因子期刊的任何项目均无差异。（4）在SCI期刊中，不同时期（CONSORT之前和之后）试验设计（P = 0.026）、危害（P = 0.039）和试验注册（P = 0.019）这三个项目的报告有显著变化，但中文摘要中只有随机分组的数量（P = 0.003）发生了变化。
临床路径RCT摘要的报告质量仍需提高。CONSORT摘要指南发布后，RCT摘要报告质量有一定程度的提高。中文期刊摘要未遵循CONSORT摘要指南。
