CAJ | 학술논문

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、201 1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201 1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non-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.
목적 료해《중화인과잡지》발표적림상치료성연구문헌존재적방법학문제,료해국내인과의사대CONSORT성명급Jadad평분량표적료해여숙실정도.방법 수공검색《중화인과잡지》1999、2000、2001、2009、2010、201 1년6개년도공72기발표적수궤대조시험(RCT)、비수궤대조시험(non-RCT)문헌,응용CONSORT성명급Jadad평분량표대발표적RCT문헌진행질량평개,응용사천대학류행병교연실제정적평개표준여분석평개표대발표적non-RCT문헌진행질량평개.병대A조(1999지2001년도)화B조(2009지201 1년도)적문헌질량진행대비분석.결과 공납입17편RCT문헌,양본량적계산、기선정황、수궤화원칙、맹법、실방급의종성묘술등CONSORT표준평개항목적보고솔균저우50％,수시자합격표준보고솔82.4％,간예조시보고솔64.7％,불량반응보고솔88.2％.A조동B조상비,RCT문헌중요방법학항목적질량병몰유명현제고.17편RCT문헌Jadad평분결과,부유2편(11.8％)위고질량문헌(3～5분).공납입37편non-RCT문헌,채용평개표준여분석평개표진행방법학질량분석,재일사중점평개조목상동양존재불족.결론 《중화인과잡지》간출적치료성연구논문,용CONSORT성명급Jadad평분량표평개,환존재명현불족,차전후간격10년비교무명현제고,국내인과의사대CONSORT성명급Jadad평분량표심소료해,상수진행저방면적계속교육공작.
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 highquality 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.