Search JIM Advanced Search

Journal of Chinese Integrative Medicine ›› 2010, Vol. 8 ›› Issue (7): 604-612.doi: 10.3736/jcim20100702

• Biomedical Publication • Previous Articles     Next Articles

CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials (Chinese version)

Kenneth F Schulza,Douglas G Altmanb,David Moherc,the CONSORT Group   

  1. a Family Health International, Research Triangle Park, NC 27709, USA
    b Centre for Statistics in Medicine, University of Oxford,Wolf son College,Oxford,UK
    c Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada
  • Received:2010-05-24 Online:2010-07-20 Published:2010-07-15
  • Contact: Kenneth F Schulz E-mail:kschulz@fhi.org

The CONSORT statement is used worldwide to improve the reporting of randomised controlled trials. Kenneth Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience. To encourage dissemination of the CONSORT 2010 Statement, this article is freely accessible on bmj.com and will also be published in the Lancet, Obstetrics and Gynecology, PLoS Medicine, Annals of Internal Medicine, Open Medicine, Journal of Clinical Epidemiology, BMC Medicine, and Trials.

Key words: Clinical trials, Randomized controlled trials, Guidelines, CONSORT

Figure 1

Flow diagram of the progress through the phases of a parallel randomised trial of two groups (that is, enrolment, intervention allocation, follow-up, and data analysis)"

"

[1] Jüni P, Altman DG, Egger M . Systematic reviews in health care: assessing the quality of controlled clinical trials[J]. BMJ, 2001,323(7303):42-46
doi: 10.1136/bmj.323.7303.42 pmid: 11440947
[2] Chan AW, Altman DG . Epidemiology and reporting of randomised trials published in PubMed journals[J]. Lancet, 2005,365(9465):1159-1162
doi: 10.1016/S0140-6736(05)71879-1
[3] Glasziou P, Meats E, Heneghan C, Shepperd S . What is missing from descriptions of treatment in trials and reviews?[J]. BMJ, 2008,336(7659):1472-1474
doi: 10.1136/bmj.39590.732037.47 pmid: 2440840
[4] Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan AW, Cronin E, Decullier E, Easterbrook PJ, Von Elm E, Gamble C, Ghersi D, Ioannidis JP, Simes J, Williamson PR . Systematic review of the empirical evidence of study publication bias and outcome reporting bias[J]. PLoS One, 2008,3(8):e3081
doi: 10.1371/journal.pone.0003081
[5] Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, Pitkin R, Rennie D, Schulz KF, Simel D, Stroup DF . Improving the quality of reporting of randomized controlled trials. The CONSORT statement[J]. JAMA, 1996,276(8):637-639
doi: 10.1001/jama.1996.03540080059030
[6] Moher D, Schulz KF, Altman DG . The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials[J]. Lancet, 2001,357(9263):1191-1194
doi: 10.1016/S0140-6736(00)04337-3
[7] Moher D, Schulz KF, Altman DG . The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials[J]. Ann Intern Med, 2001,134(8):657-662
doi: 10.7326/0003-4819-134-8-200104170-00011
[8] Moher D, Schulz KF, Altman D . The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials[J]. JAMA, 2001,285(15):1987-1991
doi: 10.1001/jama.285.15.1987
[9] Plint AC, Moher D, Morrison A, Schulz K, Altman DG, Hill C, Gaboury Ⅰ . Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review[J]. Med J Aust, 2006,185(5):263-267
[10] Hopewell S, Dutton S, Yu LM, Chan AW , Altman DG.The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed by PubMed[J]. BMJ,2010,340: c723
doi: 10.1136/bmj.c723
[11] Campbell MK, Elbourne DR, Altman DG; CONSORT group.CONSORT statement: extension to cluster randomised trials[J]. BMJ, 2004,328(7441):702-708
doi: 10.1136/bmj.328.7441.702
[12] Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ . Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement[J]. JAMA, 2006,295(10):1152-1160
doi: 10.1001/jama.295.10.1152
[13] Moher D, Hopewell S, Schulz KF, Montori V, Gtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG.CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials[J]. BMJ,2010,340: c869
doi: 10.1136/bmj.c869
[14] Schulz KF, Chalmers I, Hayes RJ, Altman DG . Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials[J]. JAMA, 1995,273(5):408-412
doi: 10.1001/jama.1995.03520290060030
[15] Moher D, Pham B, Jones A, Cook DJ, Jadad AR, Moher M, Tugwell P, Klassen TP . Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses?[J]. Lancet, 1998,352(9128):609-613
doi: 10.1016/S0140-6736(98)01085-X
[16] Moher D, Liberati A, Tetzlaff J, Altman DG, for the PRISMA Group.Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement[J].BMJ , 2009, 339: b2535
doi: 10.14306/renhyd.18.3.114 pmid: 21145753
[17] Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, Lijmer JG, Moher D , Rennie D, de Vet HC, Standards for Reporting of Diagnostic Accuracy.Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative[J]. BMJ, 2003,326(7379):41-44
doi: 10.1136/bmj.326.7379.41
[18] von Elm E, Altman DG, Egger M, Pocock SJ, Gtzsche PC, Vandenbroucke JP, for the STROBE Initiative . Strengthening the reporting of observational studies in epidemiology(STROBE) statement: guidelines for reporting observational studies[J]. BMJ, 2007,335(7624):806-808
doi: 10.1136/bmj.39335.541782.AD
[19] Standards of Reporting Trials Group. A proposal for structured reporting of randomized controlled trials[J]. JAMA, 1994,272(24):1926-1931
doi: 10.1001/jama.1994.03520240054041
[20] Rennie D . Reporting randomized controlled trials. An experiment and a call for responses from readers[J]. JAMA, 1995,273(13):1054-1055
doi: 10.1001/jama.1995.03520370096044
[21] Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF, CONSORT Group . CONSORT for reporting randomised trials in journal and conference abstracts[J]. Lancet, 2008,371(9609):281-283
doi: 10.1016/S0140-6736(07)61835-2 pmid: 18221781
[22] Chan AW , Hr bjartsson A, Haahr MT, G tzsche PC, Altman DG.Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles[J]. JAMA, 2004,291(20):2457-2465
doi: 10.1001/jama.291.20.2457
[23] Sackett DL . Commentary: Measuring the success of blinding in RCTs: don’t, must, can’t or needn’t?[J]. Int J Epidemiol, 2007,36(3):664-665
doi: 10.1093/ije/dym088
[24] Schulz KF, Grimes DA . Blinding in randomised trials: hiding who got what[J]. Lancet, 2002,359(9307):696-700
doi: 10.1016/S0140-6736(02)07816-9 pmid: 11879884
[25] Montori VM, Devereaux PJ, Adhikari NK, Burns KE, Eggert CH, Briel M, Lacchetti C, Leung TW, Darling E, Bryant DM, Bucher HC, Schünemann HJ, Meade MO, Cook DJ, Erwin PJ, Sood A, Sood R, Lo B, Thompson CA, Zhou Q, Mills E, Guyatt GH . Randomized trials stopped early for benefit: a systematic review[J]. JAMA, 2005,294(17):2203-2209
doi: 10.1001/jama.294.17.2203
[26] Hollis S, Campbell F . What is meant by intention to treat analysis? Survey of published randomised controlled trials[J]. BMJ, 1999,319(7211):670-674
doi: 10.1136/bmj.319.7211.670 pmid: 10480822
[27] Nuovo J, Melnikow J, Chang D . Reporting number needed to treat and absolute risk reduction in randomized controlled trials.[J]. JAMA, 2002,287(21):2813-2814
doi: 10.1001/jama.287.21.2813 pmid: 12038920
[28] Ioannidis JP, Evans SJ , G tzsche PC, O’Neill RT, Altman DG, Schulz K, Moher D; CONSORT Group.Better reporting of harms in randomized trials: an extension of the CONSORT statement[J]. Ann Intern Med, 2004,141(10):781-788
doi: 10.7326/0003-4819-141-10-200411160-00009 pmid: 15545678
[29] De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, Weyden MB; International Committee of Medical Journal Editors.Clinical trial registration: a statement from the International Committee of Medical Journal Editors[J]. Lancet, 2004,364(9438):911-912
doi: 10.1016/S0140-6736(04)17034-7
[30] Lexchin J, Bero LA, Djulbegovic B, Clark O . Pharmaceutical industry sponsorship and research outcome and quality: systematic review[J]. BMJ, 2003,326(7400):1167-1170
doi: 10.1136/bmj.326.7400.1167 pmid: 156458
[31] Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF, CONSORT Group . CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration[J]. PLoS Med, 2008,5(1):e20
doi: 10.1371/journal.pmed.0050020
[32] Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P . Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration[J]. Ann Intern Med, 2008,148(4):295-309
doi: 10.7326/0003-4819-148-4-200802190-00008
[33] Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C . Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement[J]. Ann Intern Med, 2006,144(5):364-367
doi: 10.7326/0003-4819-144-5-200603070-00013
[34] Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D , CONSORT group, Pragmatic Trials in Healthcare (Practihc) group.Improving the reporting of pragmatic trials: an extension of the CONSORT statement[J]. BMJ, 2008,11(337):a2390
[1] Arthur Yin Fan, Hui Ouyang, Xinru Qian, Hui Wei, David Dehui Wang, Deguang He, Haihe Tian, Changzhen Gong, Amy Matecki, Sarah Faggert Alemi. Discussions on real-world acupuncture treatments for chronic low-back pain in older adults. Journal of Integrative Medicine, 2019, 17(2): 71-76.
[2] Chang-quan Ling, Jia Fan, Hong-sheng Lin, Feng Shen, Zhen-ye Xu, Li-zhu Lin, Shu-kui Qin, Wei-ping Zhou, Xiao-feng Zhai, Bai Li, Qing-hui Zhou, on behalf of the Chinese Integrative Therapy of Primary Liver Cancer Working Group. Clinical practice guidelines for the treatment of primary liver cancer with integrative traditional Chinese and Western medicine. Journal of Integrative Medicine, 2018, 16(4): 236-248.
[3] Shahnaz Karkon Varnosfaderani, Fataneh Hashem-Dabaghian, Gholamreza Amin, Mahbubeh Bozorgi, Ghazaleh Heydarirad, Esmaeil Nazem, Mohsen Nasiri Toosi, Seyed Hamdollah Mosavat. Efficacy and safety of Amla (Phyllanthus emblica L.) in non-erosive reflux disease: A double-blind, randomized, placebo-controlled clinical trial. Journal of Integrative Medicine, 2018, 16(2): 126-131.
[4] Yoshiharu Motoo, Takashi Hakamatsuka, Nobuo Kawahara, Ichiro Arai, Kiichiro Tsutani. Standards of Reporting Kampo Products (STORK) in research articles. Journal of Integrative Medicine, 2017, 15(3): 182-185.
[5] Maria T.Chao, AlexandraChang, SanjayReddy, James D.Harrison, JosephAcquah, MiriaToveg, TrilceSantana, Frederick M.Hecht. Adjunctive acupuncture for pain and symptom management in the inpatient setting: Protocol for a pilot hybrid effectiveness-implementation study. Journal of Integrative Medicine, 2016, 14(3): 228-238.
[6] Nouran A. Aleyeidi, Khaled S. Aseri, Shadia M. Matbouli, Albaraa A. Sulaiamani, Sumayyah A. Kobeisy. Effects of wet-cupping on blood pressure in hypertensive patients: A randomized controlled trial. Journal of Integrative Medicine, 2015, 13(6): 391-399.
[7] Zhong-liang Liu, Wei-rong Zhu, Wen-chao Zhou, Hai-feng Ying, Lan Zheng, Yuan-biao Guo, Jing-xian Chen, Xiao-heng Shen. Traditional Chinese medicinal herbs combined with epidermal growth factor receptor tyrosine kinase inhibitor for advanced non-small cell lung cancer: A systematic review and meta-analysis. Journal of Integrative Medicine, 2014, 12(4): 346-358.
[8] Zhi-yi Zhou, Ling Xu, He-gen Li, Jian-hui Tian, Li-jing Jiao, Sheng-fu You, Zhi-fen Han, Yi Jiang, Hui-ru Guo​, Hui Liu​. Chemotherapy in conjunction with traditional Chinese medicine for survival of elderly patients with advanced non-small-cell lung cancer: Protocol for a randomized double-blind controlled trial. Journal of Integrative Medicine, 2014, 12(3): 175-181.
[9] Subhranil Saha​, Munmun Koley​, Subhasish Ganguly​, Prasanta Rath​, Pulak Roy Chowdhury, Seikh Intaj Hossain. Developing the criteria for evaluating quality of individualization in homeopathic clinical trialreporting: A preliminary study. Journal of Integrative Medicine, 2014, 12(1): 13-19.
[10] Jian Liu, Chuan-bing Huang, Yuan Wang, Gui-qin Xu, Yuan-yuan Cheng, Yun-xia Feng, Lei Liu, Ya-jun Qi. Chinese herbal medicine Xinfeng Capsule in treatment of rheumatoid arthritis: Study protocol of a multicenter randomized controlled trial. Journal of Chinese Integrative Medicine, 2013, 11(6): 428-434.
[11] Tian-zhan Wang, Yu Chen, Yan-ming He, Xiao-dong Fu, Wang Yi, Yan-qiu Xu, Hong-jie Yang, Hong-li Xue, Yi Liu, Xiao-tao Feng, Teng Zhang, Wen-jian Wang. Effects of Chinese herbal medicine Yiqi Huaju Qingli Formula in metabolic syndrome patients with microalbuminuria: a randomized placebo-controlled trial. Journal of Chinese Integrative Medicine, 2013, 11(3): 175-183.
[12] Chung-wah Cheng, Shu-fei Fu, Qing-hui Zhou, Tai-xiang Wu, Hong-cai Shang, Xu-dong Tang, Zhi-shun Liu, Jia Liu, Zhi-xiu Lin, Lixing Lao, Ai-ping Lü, Bo-li Zhang, Bao-yan Liu, Zhao-xiang Bian. Extending the CONSORT Statement to moxibustion. Journal of Chinese Integrative Medicine, 2013, 11(1): 54-63.
[13] Hui Luo, Jian-ping Liu, Qing Li. Methodological issues and suggestions for improvement in randomized controlled trials of Chinese herbal medicine for recurrent miscarriage. Journal of Chinese Integrative Medicine, 2012, 10(6): 604-614.
[14] Ming-xing Zhao, Zhen-hua Dong, Zhong-hai Yu, Shi-yuan Xiao, Ya-ming Li . Effects of Ginkgo biloba extract in improving episodic memory of patients with mild cognitive impairment: A randomized controlled trial. Journal of Chinese Integrative Medicine, 2012, 10(6): 628-634.
[15] Christoph A. Doenitz, Ana Anjos, Thomas Efferth , Tobias Greten, Henry J. Greten. Can heat and cold be parameterized? Clinical data of a preliminary study. Journal of Chinese Integrative Medicine, 2012, 10(5): 532-537.
Viewed
Full text


Abstract

Cited

  Shared   
  Discussed   
[1] Xue-mei Liu, Qi-fu Huang, Yun-ling Zhang, Jin-li Lou, Hong-sheng Liu, Hong Zheng. Effects of Tribulus terrestris L. saponion on apoptosis of cortical neurons induced by hypoxia-reoxygenation in rats. Journal of Chinese Integrative Medicine, 2008, 6(1): 45-50
[2] SUN Ming-yu, ZUO Jian, DUAN Ji-feng, HAN Jun, FAN Shi-ming, ZHANG Wei, ZHU Li-fang, YAO Ming-hui. Antitumor activities of kushen flavonoids in vivo and in vitro. Journal of Chinese Integrative Medicine, 2008, 6(1): 51-59
[3] Wei Zhang, Xiang-feng Lu, Xiao-mei Zhang, Jian-jun Wu, Liang-duo Jiang. A rat model of pulmonary fibrosis induced by infusing bleomycin quickly through tracheal intubation. Journal of Chinese Integrative Medicine, 2008, 6(1): 60-67
[4] Liang-ping Hu , Xiao-lei Bao, Xue Guan. Statistical inference and experimental design of univariate qualitative data of single-group design. Journal of Chinese Integrative Medicine, 2010, 8(11): 1085-1089
[5] Zhi-mei Wang, Bin Zhang. A study on translation of ellipses in Huangdi Neijing from perspective of hermeneutic theory. Journal of Chinese Integrative Medicine, 2010, 8(11): 1097-1100
[6] Rui Jin, Bing Zhang. A complexity analysis of Chinese herbal property theory: the multiple formations of herbal property (Part 1). Journal of Chinese Integrative Medicine, 2012, 10(11): 1198-1205
[7] Gui Yu, Jie Wang. Thinking on building the network cardiovasology of Chinese medicine. Journal of Chinese Integrative Medicine, 2012, 10(11): 1206-1210
[8] Pedro Saganha João, Doenitz Christoph, Greten Tobias, Efferth Thomas, J. Greten Henry. Qigong therapy for physiotherapists suffering from burnout: a preliminary study. Journal of Chinese Integrative Medicine, 2012, 10(11): 1233-1239
[9] Ming-qing Wei , Jin-zhou Tian , Jing Shi , Fu-yun Ma , Ying-chun Miao , Yong-yan Wang. Effects of Chinese medicine for promoting blood circulation and removing blood stasis in treating patients with mild to moderate vascular dementia: a randomized, double-blind and parallel-controlled trial. Journal of Chinese Integrative Medicine, 2012, 10(11): 1240-1246
[10] Samadder Asmita, Das Jayeeta, Das Sreemanti, Biswas Raktim, Rahman Khuda-Bukhsh Anisur. Ameliorative potentials of Syzygium jambolanum extract against arsenic-induced stress in L6 cells in vitro. Journal of Chinese Integrative Medicine, 2012, 10(11): 1293-1302