林小婷 1李海民 1齐国卿 1柳文杰 1张圆 1胡庆 1柯法永 1马彬1
作者信息
- 1. 兰州大学循证医学中心,兰州大学基础医学院,兰州,730000
- 折叠
摘要
Abstract
Objective To determine whether the use of the Consolidated Standards of Reporting Trials( CONSORT) statement is associated with the improvement in the reporting quality of RCTs published in Chinese pediatric journals. Methods Six core Chinese pediatric journals including Journal of Clinical Pediatrics, Chinese Journal of Contemporary Pediatrics, Chinese Journal of Practical Pediatrics, Chinese Journal of Evidence-based Pediatrics, Chinese Journal of Pediatrics, Chinese Journal of Pediatric Surgery, were hand-searched from inception to Dec. 2010. The CONSORT checklists were used to assess reporting quality. Other important data such as reporting of ethics review and informed consent, involving research centers, clinical trials registry and sample size were extracted as well. Given CONSORT statement was firstly introduced into China in 1997,the identified studies were grouped in two publication periods, I.e. Before 1996 ( pre-CONSORT ), and 1997 - 2010( post-CONSORT ). Data were summarized using descriptive statistics such as frequency, median and interquartile range ( IQR ). Results A total of 619 RCTs were identified and 157 of them were published before 1997 when CONSORT statement was firstly introduced into China. Even though the reporting quality of RCTs published in Chinese pediatric journals changed significantly in some of the aspects such as introduction, recruitment, baseline data and ancillary analyses ( P <0. 05 ) etc, some important methodological components were still incompletely reported, such as sample size calculation method ( 0. 6% vs. 1. 1% ), sequence generation for randomization (3.2% vs 7.6% ), allocation concealment ( 0 vs 1.1% ) or blinding ( 0 vs 2. 6% ). Moreover, none of RCTs published in Chinese pediatric journals reported the following items, such as important changes to methods after trial commencement, changes to trials outcomes after the trials commencement and presentation of both absolute and relative effect sizes for binary outcomes. Assessing 9 RCTs published in Chinese Journal of Evidence-based Pediatrics which uniquely adopted CONSORT statement in its instructions to authors, it indicated that its reporting of sample size calculating method, sequence generation, allocation concealment, blinding and implementation was higher than other journals'. Conclusions Overall, the reporting quality of RCTs has not substantially improved since the introduction of CONSORT statement in China. The quality of reporting RCTs is still generally poor and often not adequate to allow readers to assess the validity of trials.关键词
随机对照试验/方法学/报告质量/CONSORT声明/儿科Key words
Randomized controlled trials/Methodology/Reporting quality/CONSORT/Pediatrics
