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恶性肿瘤临床路径的随机对照试验中文文献分析
The analysis of Chinese documents on the randomized controlled trials of Cancer clinical pathway
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DOI:
作者:
马超
Ma Chao
作者单位:
上海中医药大学附属龙华医院临床评价中心
Clinical Evaluation Center, Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
关键词:
恶性肿瘤;临床路径;随机对照试验;文献分析;方法学质量
cancer; clinical pathway; randomized controlled trials; document analysis; methodological quality
摘要:
目的:对已发表的恶性肿瘤临床路径随机对照试验的相关文献进行研究,评价临床试验的方法学质量及整体研究水平,为这一领域的临床研究提供参考。 方法:检索“万方中文期刊数据库”(1998-2011.7)、“维普中文科技期刊数据库”(1989-2011.7)国内已发表文献,以“临床路径”为检索词,进行题名或关键词检索,再以“肿瘤”或“癌”为检索词,进行题名或关键词的二次检索,搜集所有文献信息,对文献中临床研究的一般性指标及方法学质量进行综合评价。 结果:共检出116篇文献,排除非随机对照文献52篇,最终纳入64篇RCT。整体来看,研究方向前三位集中在乳腺癌(18篇,28.13%),宫颈癌(6篇,9.38%),肝癌和喉癌(各5篇,7.81%)等恶性肿瘤;52篇RCT(81.25%)为近五年发表;61篇(95.31%)采用的临床路径为科室内部自制;前五位结局指标依次为:患者满意度(50篇,78.13%),健康教育效果(49篇,76.56%),住院天数(36篇,56.25%),住院费用(28篇,43.75%),不良反应及并发症(11篇,17.19%)。方法学评价方面,采用改良Jadad评分量表对64篇RCT逐一进行打分,全部文献均为低质量文献;纳入病例数为0~100例的RCT有46篇(71.88%);36篇RCT(56.25%)在未提及进行正态性检验计算步骤的情况下,直接应用t检验分析;10篇RCT(15.63%)未注明采用何种统计方法,即得出试验组与对照组存在显著性差异的统计结果。 结论:恶性肿瘤临床路径的随机对照试验中文文献,在方法学质量、临床试验设计等方面存在严重问题,对试验结果产生较大影响,应当引起我们的足够重视。
AIM: By analyzing the Chinese documents on the randomized controlled trials of cancer clinical pathway, to evaluate the methodological quality and overall research level of clinical trials, providing a reference for clinical researches in this area. METHODS: published Chinese documents were retrieved in "Wanfang Chinese Periodical Database" (1998-2011.7), "VIP Chinese Science and Technology Periodical Database" (1989-2011.7) with “Clinical Pathway” as the search terms and "Tumor" or" Cancer" as the secondary search terms in the title or keyword retrieval. Then the whole texts were read to get all-related information. The general and methodological quality indicators of clinical research in the documents were comprehensively evaluated. RESULTS: 116 documents were retrieved and 64 RCTs were finally included in the analyses with 52 documents excluded. In general, the top three diseases focused on breast cancer (18 RCTs, 28.13%), cervical cancer (6 RCTs , 9.38%), liver and laryngeal cancer (5 RCTs, 7.81%);52 RCTs(81.25%) were published in the past five years;61 clinical pathways(95.31%) were established by the departments;the top five outcome indicators were: patient satisfaction (50 RCTs, 78.13%), health education (49 RCTs, 76.56%), hospital days(36 RCTs, 56.25%), hospital costs (28 RCTs, 43.75%), adverse reactions and complications (11 RCTs, 17.19%). As for methodology evaluation, we scored 64 RCTs one by one using Modified Jadad score scale, and all the documents were low-quality RCTs;The number of cases in 46 RCTs(71.88%)was less than 100;36 RCTs(56.25%)used t test for data analysis without the normality test;10 RCTs (15.63%)obtained the result of significant differences between experimental and control group without mentioning what kind of statistical methods were used. CONCLUSION: the Chinese documents on the randomized controlled trials of cancer clinical pathway had serious problems of methodological quality and clinical trial design, which would have a great impact on the test results. We should pay more attention on it.
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