中国循证医学杂志
中國循證醫學雜誌
중국순증의학잡지
CHINESE JOURNAL OF EVIDENCE-BASED MEDICINE
2010年
3期
362-366
,共5页
CONSORT声明%中国循证医学杂志%中医药%随机对照试验%文献质量评价
CONSORT聲明%中國循證醫學雜誌%中醫藥%隨機對照試驗%文獻質量評價
CONSORT성명%중국순증의학잡지%중의약%수궤대조시험%문헌질량평개
CONSORT statement%Chinese Journal of Evidence-Based Medicine%Traditional Chinese medicine%Randomized controlled trial%Quality assessment of literature
目的 应用CONSORT声明修订版和Jadad评分标准等评价<中国循证医学杂志>发表的中医药随机对照试验(RCT)的报告质量,并与前期调查结果进行比较.了解中医药RCT报告质量的改善情况.方法 手工检索<中国循证医学杂志)2001～2008年刊载的中医药RCT,采用CONSORT标准修订版Jadad评分量表和自拟指标进行质量评价.结果 共检索出RCT 57篇,其中中医药RCT17篇. 摘要、纳入/排除标准、干预措施的具体实施、随机化顺序产生、统计方法描述、基线描述、结果与估计及解释结果等CONSORT标准评价项目的 报告率均达100%;随机化分配隐藏、随机化实施、流程图的使用及依从性等项目的 报告率明显高于本课题组前期研究结果;仅3篇有了致谢(17.6%),有1篇未记录中医证型,采用模拟剂的仅有4篇(23.5%). 17篇RCT的Jadad总评分为4.35±1.11,有11篇评分达到5分(64.7%).结论 <中国循证医学杂志>2001～2008年发表的中医药RCT的报告质量高于本课题组前期对13种中医药期刊在1999～2004年发表的RCT质量.可见,随着CONSORT标准的不断完善和中医药CONSORT声明(CONSORT for traditional Chinese medicine,CONSORT for TCM)的发表,中医药RCT质量在提高,我们期待中医药临床试验报告规范不断完善.
目的 應用CONSORT聲明脩訂版和Jadad評分標準等評價<中國循證醫學雜誌>髮錶的中醫藥隨機對照試驗(RCT)的報告質量,併與前期調查結果進行比較.瞭解中醫藥RCT報告質量的改善情況.方法 手工檢索<中國循證醫學雜誌)2001～2008年刊載的中醫藥RCT,採用CONSORT標準脩訂版Jadad評分量錶和自擬指標進行質量評價.結果 共檢索齣RCT 57篇,其中中醫藥RCT17篇. 摘要、納入/排除標準、榦預措施的具體實施、隨機化順序產生、統計方法描述、基線描述、結果與估計及解釋結果等CONSORT標準評價項目的 報告率均達100%;隨機化分配隱藏、隨機化實施、流程圖的使用及依從性等項目的 報告率明顯高于本課題組前期研究結果;僅3篇有瞭緻謝(17.6%),有1篇未記錄中醫證型,採用模擬劑的僅有4篇(23.5%). 17篇RCT的Jadad總評分為4.35±1.11,有11篇評分達到5分(64.7%).結論 <中國循證醫學雜誌>2001～2008年髮錶的中醫藥RCT的報告質量高于本課題組前期對13種中醫藥期刊在1999～2004年髮錶的RCT質量.可見,隨著CONSORT標準的不斷完善和中醫藥CONSORT聲明(CONSORT for traditional Chinese medicine,CONSORT for TCM)的髮錶,中醫藥RCT質量在提高,我們期待中醫藥臨床試驗報告規範不斷完善.
목적 응용CONSORT성명수정판화Jadad평분표준등평개<중국순증의학잡지>발표적중의약수궤대조시험(RCT)적보고질량,병여전기조사결과진행비교.료해중의약RCT보고질량적개선정황.방법 수공검색<중국순증의학잡지)2001～2008년간재적중의약RCT,채용CONSORT표준수정판Jadad평분량표화자의지표진행질량평개.결과 공검색출RCT 57편,기중중의약RCT17편. 적요、납입/배제표준、간예조시적구체실시、수궤화순서산생、통계방법묘술、기선묘술、결과여고계급해석결과등CONSORT표준평개항목적 보고솔균체100%;수궤화분배은장、수궤화실시、류정도적사용급의종성등항목적 보고솔명현고우본과제조전기연구결과;부3편유료치사(17.6%),유1편미기록중의증형,채용모의제적부유4편(23.5%). 17편RCT적Jadad총평분위4.35±1.11,유11편평분체도5분(64.7%).결론 <중국순증의학잡지>2001～2008년발표적중의약RCT적보고질량고우본과제조전기대13충중의약기간재1999～2004년발표적RCT질량.가견,수착CONSORT표준적불단완선화중의약CONSORT성명(CONSORT for traditional Chinese medicine,CONSORT for TCM)적발표,중의약RCT질량재제고,아문기대중의약림상시험보고규범불단완선.
Objective To assess the quality of reporting of randomized controlled trials (RCTs) related to traditional Chinese medicine (TCM) published in the Chinese Journal of Evidence-Based Medicine by CONSORT statement and Jadad scale. Methods We handsearched the Chinese Journal of Evidence-Based Medicine to identify TCM RCTs.The revised CONSORT statement and Jadad scale combined with self-established criteria were applied. Results A total of 57 RCTs were identified of which there were 17 TCM RCTs. Some items in CONSORT checklist were completely reported in all TCM RCTs, such as abstract, inclusion and exclusion criteria, intervention, randomization sequence generation, description of statistic method, description of baseline data, outcomes and estimation, and explain results .Compared with the previous findings, there were more trials in this study to report allocation concealment, randomization implementation, use of flow chart and appliance. Only 3 RCTs (17.6%) reported acknowledgements. One RCT did not describe syndrome type of TCM, and 4 RCTs (23.5%) carded out dummy. The mean Jadad score was 4.35±1.11 in alltrials, of which 11 RCTs (64.7) ranked 5 points. Conclusion The comprehensive quality of reporting of TCM RCTs published in the Chinese Journal of Evidence-Based Medicine from 2001 to 2008 has been improved. After the publication of CONSORT statement and CONSORT for traditional Chinese medicine, the quality of reporting of TCM RCTs is improved. We are looking forward to improving the CONSORT for TCM.
