《中华儿科杂志》发表的治疗性研究文献质量评价

Assessment of the quality of clinical therapeutic research published in Chinese Journal of Pediatrics

目的了解《中华儿科杂志》发表的临床治疗性研究文献存在的方法学问题，了解国内儿科医师对CONSORT声明及Jadad评分量表的了解与熟悉程度。方法手工检索《中华儿科杂志》1999、2000、2001、2009、2010、2011年6个年度共72期发表的随机对照试验（RCT）、非随机对照试验（non—RCT）文献，应用CONSORT声明及Jadad评分量表对发表的RCT文献进行质量评价，应用四川大学流行病教研室制定的评价标准与分析评价表对发表的non．RCT文献进行质量评价。并对A组（1999至2001年度）和B组（2009至2011年度）的文献质量进行对比分析。结果共纳入17篇RCT文献，样本量的计算、基线情况、随机化原则、盲法、失访及依从性描述等CONSORT标准评价项目的报告率均低于50％，受试者合格标准报告率82．4％，干预措施报告率64．7％，不良反应报告率88．2％。A组同B组相比，RCT文献重要方法学项目的质量并没有明显提高。17篇RCT文献Jadad评分结果，仅有2篇（11．8％）为高质量文献（3—5分）。共纳入37篇11013-RCT文献，采用评价标准与分析评价表进行方法学质量分析，在一些重点评价条目上同样存在不足。结论《中华儿科杂志》刊出的治疗性研究论文，用CONSORT声明及Jadad评分量表评价，还存在明显不足，且前后间隔10年比较无明显提高，国内儿科医师对CONSORT声明及Jadad评分量表甚少了解，尚需进行这方面的继续教育工作。

Objective To evaluate the methodological qualities of clinical therapeutic research papers published in Chinese Journal of Pediatrics and find out the weaknesses and defects in the literature of clinical therapeutic research in China. Methods The clinical therapeutic research articles from Chinese Journal of Pediatrics, which were published in the years 1999, 2000, 2001, 2009, 2010 and 2011, were analyzed manually, after dividing into randomized controlled trials （RCT） and non-randomized controlled trials. The methodological quality of RCT articles were evaluated by Consolidated Standards for Reporting of Trials （CONSORT） and Jadad scale, while non-RCT reports were assessed by specific evaluation standard criteria and analytical table. And the group A （1999-2001） and group B （2009-2011） of the quality documents were compared and analyzed. Results Seventeen RCTs were included. Based on the items in the CONSORT statement, the reporting quality of sample size determination, demographic baseline, random principle, blinding, lost to follow-up were all lower than 50%. Fourteen （82.4%） in the 17 RCTs mentioned ＇eligibility criteria for participants＇, 11 （64.7% RCTs mentioned ＇details of the interventions＇ , 15 （88.2%） RCTs mentioned ＇adverse effects＇. Compared with RCT reports in the year of 1999, 2000 and 2001, the methodological qualities of those in 2009, 2010 and 2011 were not improved. In the 17 RCTs, the total score achieved based on the Jadad scale, only 11.8% （2 out of 17） were high- quality trials （ ≥3 points）. Analysis of the 28 non-RCTs, which were included and assessed by evaluation criteria and evaluation table, also showed some disadvantages on some key items. Conclusions The methodological quality of clinical therapeutic research reports should be consistent with the standards of international evaluation, pediatric clinicians should improve know ledgein clinical epidemiology, clinical trial methodology, and improve the quality of research reports.