李静;孙欢;李永弘;
LI Jing;SUN Huan;LI Yong-hong;Research Center of Evidence Based Medicine and Clinical Epidemiology,West China Hospital,Sichuan University;

• 1:四川大学华西医院循证医学与临床流行病学研究中心

摘要(Abstract)：

随机对照试验是评估不同干预措施疗效和常见不良反应的标准设计方案,但我国随机对照试验在研究设计、实施、效应指标选择、数据分析和结果解释等方面仍有提升空间。本文从随机对照试验实施的关键技术、结果展示和结果解读3方面分析了6点常见误区,期望帮助临床研究者明确随机化概念,正确实施随机分配方法和分配方案隐藏、正确理解随机对照试验中的基线平衡问题、合理选择效应指标、正确解读研究结果的统计学意义和临床意义,以生产更多高质量的随机对照试验证据,同时避免被误导。
A well-conducted randomized controlled trial( RCT) is considered the gold standard for comparing the efficacy and common adverse events of different interventions. However,for China's RCTs,there is still room for the improvement in research design,implementation,selection of effective measures,data analysis,and interpretation of results. In this article,we present six misunderstandings or errors to help clinicians in clarifying the concept of randomization,correctly implementing the process of randomization and concealment of allocation,understanding the baseline imbalance in RCTs,reasonably selecting effective measuers,and correctly interpreting the statistical significance and clinical significance in an effort to produce more RCTs of highquality and protect clinicians from potentially misleading presentations and interpretations of research findings.

关键词(KeyWords)： 随机对照试验;分配方案隐藏;比值比;风险比;亚组分析
randomized controlled trial;allocation concealment;odds ratio;risk ratio;subgroup analysis

Abstract:

Keywords:

基金项目(Foundation): 公益性行业科研专项(201502024)

作者(Author): 李静;孙欢;李永弘;
LI Jing;SUN Huan;LI Yong-hong;Research Center of Evidence Based Medicine and Clinical Epidemiology,West China Hospital,Sichuan University;

Email:

DOI:

参考文献(References)：

• [1]陈耀龙,杨克虎.正确理解、制订和使用临床实践指南[J].协和医学杂志,2018,9:367-373.
• [2]Hu Y,Huang Y,Ding J,et al.Status of clinical research in China[J].Lancet,2011,377:124-125.
• [3]王长通,郭启勇.中、美、日三国医学基础研究与临床研究类论文发表现状及影响因素分析[J].中华医学科研管理杂志,2018,31:219-223.
• [4]Ahmed Ali U,Reiber BMM,Ten Hove JR,et al.Journal impact factor and methodological quality of surgical randomized controlled trials:an empirical study[J].Langenbecks Arch Surg,2017,402:1015-1022.
• [5]Gonzalez GZ,Moseley AM,Maher CG,et al.Methodologic Quality and Statistical Reporting of Physical Therapy Randomized Controlled Trials Relevant to Musculoskeletal Conditions[J].Arch Phys Med Rehabil,2018,99:129-136.
• [6]Schulz KF,Chalmers I,Hayes RJ,et al.Empirical evidence of bias.Dimensions of methodological quality associated with estimates of treatment effects in controlled trials[J].JAMA,1995,273:408-412.
• [7]Moher D,Pham B,Jones A,et al.Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses?[J].Lancet,1998,352:609-613.
• [8]Schulz KF,Chalmers I,Altman DG,et al.Allocation concealment:the evolution and adoption of a methodological term[J].J R Soc Med,2018,111:216-224.
• [9]Schulz KF,Chalmers I,Grimes DA,et al.Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals[J].JAMA,1994,272:125-128.
• [10]Higgins JP,Altman DG,Gotzsche PC,et al.The Cochrane Collaboration's tool for assessing risk of bias in randomised trials[J].BMJ,2011,343:d5928.
• [11]Nissen SE,Tuzcu EM,Libby P,et al.Effect of antihypertensive agents on cardiovascular events in patients with coronary disease and normal blood pressure:the CAMELOT study:a randomized controlled trial[J].JAMA,2004,292:2217-2225.
• [12]Zhao W,Berger V.Imbalance control in clinical trial subject randomization-from philosophy to strategy[J].J Clin Epidemiol,2018,101:116-118.
• [13]Chu R,Walter SD,Guyatt G,et al.Assessment and implication of prognostic imbalance in randomized controlled trials with a binary outcome-a simulation study[J].PLoS One,2012,7:e36677.
• [14]Taves DR.The use of minimization in clinical trials[J].Contemp Clin Trials,2010,31:180-184.
• [15]吴春芳,许金芳,陆健,等.临床试验最小随机化的方法概况和研究前景[J].中国新药杂志,2010,19:823-826,831.
• [16]Knol MJ,Duijnhoven RG,Grobbee DE,et al.Potential misinterpretation of treatment effects due to use of odds ratios and logistic regression in randomized controlled trials[J].PLoSOne,2011,6:e21248.
• [17]Balasubramanian H,Ananthan A,Rao S,et al.Odds ratio vs risk ratio in randomized controlled trials[J].Postgrad Med,2015,127:359-367.
• [18]Shah S,Youngquist S.Part 20:on odds and risk ratios[J].Air Med J,2013,32:8-9.
• [19]Tajeu GS,Sen B,Allison DB,et al.Misuse of odds ratios in obesity literature:an empirical analysis of published studies[J].Obesity(Silver Spring),2012,20:1726-1731.
• [20]Wasserstein RL,Lazar NA.The ASA's Statement on p-Values:Context,Process,and Purpose[J].Am Stat,2016,70:129-131.
• [21]Fox KA,Poole-Wilson PA,Henderson RA,et al.Interventional versus conservative treatment for patients with unstable angina or non-ST-elevation myocardial infarction:the British Heart Foundation RITA 3 randomised trial.Randomized Intervention Trial of unstable Angina[J].Lancet,2002,360:743-751.
• [22]Clayton TC,Pocock SJ,Henderson RA,et al.Do men benefit more than women from an interventional strategy in patients with unstable angina or non-ST-elevation myocardial infarction?The impact of gender in the RITA 3 trial[J].Eur Heart J,2004,25:1641-1650.
• [23]Schulz KF,Grimes DA.Multiplicity in randomised trials II:subgroup and interim analyses[J].Lancet,2005,365:1657-1661.
• [24]Rothwell PM.Treating individuals 2.Subgroup analysis in randomised controlled trials:importance,indications,and interpretation[J].Lancet,2005,365:176-186.
• [25]Sun X,Ioannidis JP,Agoritsas T,et al.How to use a subgroup analysis:users'guide to the medical literature[J].JA-MA,2014,311:405-411.
• [26]Guo Y,Yin F,Fan C,et al.Gender difference in clinical outcomes of the patients with coronary artery disease after percutaneous coronary intervention:A systematic review and meta-analysis[J].Medicine(Baltimore),2018,97:e11644.