Volume 10 Issue 2
Sep.  2020
Turn off MathJax
Article Contents
Jing LI, Huan SUN, Yong-hong LI. Common Misconceptions in Randomized Controlled Trials[J]. Medical Journal of Peking Union Medical College Hospital, 2019, 10(2): 166-171. doi: 10.3969/j.issn.1674-9081.2019.02.016
Citation: Jing LI, Huan SUN, Yong-hong LI. Common Misconceptions in Randomized Controlled Trials[J]. Medical Journal of Peking Union Medical College Hospital, 2019, 10(2): 166-171. doi: 10.3969/j.issn.1674-9081.2019.02.016

Common Misconceptions in Randomized Controlled Trials

doi: 10.3969/j.issn.1674-9081.2019.02.016
  • Received Date: 2018-09-17
  • Publish Date: 2020-09-18
  • 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 high-quality and protect clinicians from potentially misleading presentations and interpretations of research findings.
  • loading
  • [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. doi:  10.3969/j.issn.1674-9081.2018.04.015
    [2] Hu Y, Huang Y, Ding J, et al.Status of clinical research in China[J].Lancet, 2011, 377: 124-125. doi:  10.1016/S0140-6736(11)60017-2
    [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. doi:  10.3760/cma.j.issn.1006-1924.2018.03.014
    [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. doi:  10.1007/s00423-017-1593-6
    [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. doi:  10.1016/j.apmr.2017.08.485
    [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. doi:  10.1001/jama.1995.03520290060030
    [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. doi:  10.1016/S0140-6736(98)01085-X
    [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. doi:  10.1177/0141076818776604
    [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. doi:  10.1001/jama.1994.03520020051014
    [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. https://www.bmj.com/content/bmj/343/7829/Research_Methods_Reporting.full.pdf
    [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. doi:  10.1001/jama.292.18.2217
    [12] Zhao W, Berger V.Imbalance control in clinical trial subject randomization-from philosophy to strategy[J].J Clin Epidemiol, 2018, 101: 116-118. doi:  10.1016/j.jclinepi.2018.02.022
    [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. http://pubmedcentralcanada.ca/pmcc/articles/PMC3358303/
    [14] Taves DR.The use of minimization in clinical trials[J].Contemp Clin Trials, 2010, 31: 180-184. doi:  10.1016/j.cct.2009.12.005
    [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. http://www.wanfangdata.com.cn/details/detail.do?_type=perio&id=zgxyzz201010003
    [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].PLoS One, 2011, 6: e21248. http://www.wanfangdata.com.cn/details/detail.do?_type=perio&id=Open J-Gate000003877164
    [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. doi:  10.1080/00325481.2015.1022494
    [18] Shah S, Youngquist S.Part 20: on odds and risk ratios[J].Air Med J, 2013, 32: 8-9. doi:  10.1016/j.amj.2012.10.006
    [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. http://www.nature.com/oby/journal/vaop/ncurrent/abs/oby201271a.html
    [20] Wasserstein RL, Lazar NA.The ASA's Statement on p-Values: Context, Process, and Purpose[J].Am Stat, 2016, 70: 129-131. doi:  10.1080/00031305.2016.1154108
    [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. doi:  10.1016/S0140-6736(02)09894-X
    [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. doi:  10.1016/j.ehj.2004.07.032
    [23] Schulz KF, Grimes DA.Multiplicity in randomised trials II: subgroup and interim analyses[J].Lancet, 2005, 365: 1657-1661. doi:  10.1016/S0140-6736(05)66516-6
    [24] Rothwell PM.Treating individuals 2.Subgroup analysis in randomised controlled trials: importance, indications, and interpretation[J].Lancet, 2005, 365: 176-186. doi:  10.1016/S0140-6736(05)17709-5
    [25] Sun X, Ioannidis JP, Agoritsas T, et al.How to use a subgroup analysis: users' guide to the medical literature[J].JAMA, 2014, 311: 405-411. doi:  10.1001/jama.2013.285063
    [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. http://www.ncbi.nlm.nih.gov/pubmed/30045311
  • 加载中

Catalog

    通讯作者: 陈斌, bchen63@163.com
    • 1. 

      沈阳化工大学材料科学与工程学院 沈阳 110142

    1. 本站搜索
    2. 百度学术搜索
    3. 万方数据库搜索
    4. CNKI搜索

    Tables(2)

    Article Metrics

    Article views (551) PDF downloads(272) Cited by()
    Proportional views
    Related

    /

    DownLoad:  Full-Size Img  PowerPoint
    Return
    Return