CONSORT 2010说明与详述：报告平行对照随机临床试验指南的更新

doi:10.3736/jcim20100801

Abstract

Overwhelming evidence shows the quality of reporting of randomised controlled trials (RCTs) is not optimal. Without transparent reporting, readers cannot judge the reliability and validity of trial findings nor extract information for systematic reviews. Recent methodological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which are considered the gold standard for evaluating interventions because of their ability to minimise or avoid bias.
A group of scientists and editors developed the CONSORT (Consolidated Standards of Reporting Trials) statement to improve the quality of reporting of RCTs. It was first published in 1996 and updated in 2001. The statement consists of a checklist and flow diagram that authors can use for reporting an RCT. Many leading medical journals and major international editorial groups have endorsed the CONSORT statement. The statement facilitates critical appraisal and interpretation of RCTs.
During the 2001 CONSORT revision, it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports. A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement.
After an expert meeting in January 2007, the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement. This update improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition, such as selective outcome reporting bias.
This explanatory and elaboration document — intended to enhance the use, understanding, and dissemination of the CONSORT statement — has also been extensively revised. It presents the meaning and rationale for each new and updated checklist item providing examples of good reporting and, where possible, references to relevant empirical studies. Several examples of flow diagrams are included.
The CONSORT 2010 Statement, this revised explanatory and elaboration document, and the associated website (www.consort-statement.org) should be helpful resources to improve reporting of randomised trials.

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

David Moher, Sally Hopewell, Kenneth F Schulz, Victor Montori, Peter C Gtzsche, P J Devereaux, Diana Elbourne, Matthias Egger, Douglas G Altman. CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials (Chinese version). Journal of Chinese Integrative Medicine, 2010, 8(8): 701-741.

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URL: http://www.jcimjournal.com/EN/10.3736/jcim20100801

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Figures/Tables 7

论文章节/主题	条目号	对照检查的条目	报告页码
文题和摘要
	1a	文题能识别是随机临床试验	________
	1b	结构式摘要,包括试验设计、方法、结果、结论几个部分（具体的指导建议参见“CONSORT for abstracts”^{[45, 65]}）	________
引言
背景和目的	2a	科学背景和对试验理由的解释	________
	2b	具体目的或假设	________
方法
试验设计	3a	描述试验设计（诸如平行设计、析因设计）,包括受试者分配入各组的比例	________
	3b	试验开始后对试验方法所作的重要改变（如合格受试者的挑选标准）,并说明原因	________
受试者	4a	受试者合格标准	________
	4b	资料收集的场所和地点	________
干预措施	5	详细描述各组干预措施的细节以使他人能够重复,包括它们实际上是在何时、如何实施的	________
结局指标	6a	完整而确切地说明预先设定的主要和次要结局指标,包括它们是在何时、如何测评的	________
	6b	试验开始后对结局指标是否有任何更改,并说明原因	________
样本量	7a	如何确定样本量	________
	7b	必要时,解释中期分析和试验中止原则	________
随机方法：
序列的产生	8a	产生随机分配序列的方法	________
	8b	随机方法的类型,任何限定的细节（如怎样分区组和各区组样本多少）	________
分配隐藏机制	9	用于执行随机分配序列的机制（例如按序编码的封藏法）,描述干预措施分配之前为隐藏序列号所采取的步骤	________
实施	10	谁产生随机分配序列,谁招募受试者,谁给受试者分配干预措施	________
盲法	11a	如果实施了盲法,分配干预措施之后对谁设盲（例如受试者、医护提供者、结局评估者）,以及盲法是如何实施的	________
	11b	如有必要,描述干预措施的相似之处	________
统计学方法	12a	用于比较各组主要和次要结局指标的统计学方法	________
	12b	附加分析的方法,诸如亚组分析和校正分析	________
结果
受试者流程（极力推荐使用流程图）	13a	随机分配到各组的受试者例数,接受已分配治疗的例数,以及纳入主要结局分析的例数	________
	13b	随机分组后,各组脱落和被剔除的例数,并说明原因	________
招募受试者	14a	招募期和随访时间的长短,并说明具体日期	________
	14b	为什么试验中断或停止	________
基线资料	15	用一张表格列出每一组受试者的基线数据,包括人口学资料和临床特征	________
纳入分析的例数	16	各组纳入每一种分析的受试者数目（分母）,以及是否按最初的分组分析	________
结局和估计值	17a	各组每一项主要和次要结局指标的结果,效应估计值及其精确性（如95%可信区间）	________
	17b	对于二分类结局,建议同时提供相对效应值和绝对效应值	________
辅助分析	18	所做的其他分析的结果,包括亚组分析和校正分析,指出哪些是预先设定的分析,哪些是新尝试的分析	________
危害	19	各组出现的所有严重危害或意外效应（具体的指导建议参见“CONSORT for harms”^[42]）	________
讨论
局限性	20	试验的局限性,报告潜在偏倚和不精确的原因,以及出现多种分析结果的原因（如果有这种情况的话）	________
可推广性	21	试验结果被推广的可能性（外部可靠性,实用性）	________
解释	22	与结果相对应的解释,权衡试验结果的利弊,并且考虑其他相关证据	________
其他信息
试验注册	23	临床试验注册号和注册机构名称	________
试验方案	24	如果有的话,在哪里可以获取完整的试验方案	________
资助	25	资助和其他支持（如提供药品）的来源,提供资助者所起的作用	________

References 313

[1]	Rennie D . CONSORT revised — improving the reporting of randomized trials[J]. JAMA, 2001,285(15):2006-2007 doi: 10.1001/jama.285.15.2006
[2]	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
[3]	Moher D . CONSORT: an evolving tool to help improve the quality of reports of randomized controlled trials. Consolidated Standards of Reporting Trials[J]. JAMA, 1998,279(18):1489-1491 doi: 10.1001/jama.279.18.1489
[4]	Kjaergard LL, Villumsen J, Gluud C .Quality of randomised clinical trials affects estimates of intervention efficacy(7th. Cochrane Colloquium)[M].Rome:Italy, 1999,( 7th. Cochrane Colloquium)
[5]	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
[6]	Veldhuyzen van Zanten SJ, Cleary C, Talley NJ, Peterson TC, Nyrén O, Bradley LA, Verlinden M, Tytgat GN . Drug treatment of functional dyspepsia: a systematic analysis of trial methodology with recommendations for design of future trials[J]. Am J Gastroenterol, 1996,91(4):660-673
[7]	Talley NJ, Owen BK, Boyce P, Paterson K . Psychological treatments for irritable bowel syndrome: a critique of controlled treatment trials[J]. Am J Gastroenterol, 1996,91(2):277-283
[8]	Adetugbo K, Williams H . How well are randomized controlled trials reported in the dermatology literature?[J]. Arch Dermatol, 2000,136(3):381-385
[9]	Kjaergard LL, Nikolova D, Gluud C . Randomized clinical trials in HEPATOLOGY: predictors of quality[J]. Hepatology, 1999,30(5):1134-1138 doi: 10.1002/hep.510300510 pmid: 10534332
[10]	Schor S, Karten I . Statistical evaluation of medical journal manuscripts[J]. JAMA, 1966,195(13):1123-1128 doi: 10.1001/jama.195.13.1123 pmid: 5952081
[11]	Gore SM, Jones IG, Rytter EC . Misuse of statistical methods: critical assessment of articles in BMJ from January to March 1976[J]. Br Med J, 1977,1(6053):85-87 doi: 10.1136/bmj.1.6053.85 pmid: 832023
[12]	Hall JC, Hill D, Watts JM . Misuse of statistical methods in the Australasian surgical literature[J]. Aust N Z J Surg, 1982,52(5):541-543 doi: 10.1111/j.1445-2197.1982.tb06050.x pmid: 6959608
[13]	Altman DG . Statistics in medical journals[J]. Stat Med, 1982,1(1):59-71 doi: 10.1002/(ISSN)1097-0258
[14]	Pocock SJ, Hughes MD, Lee RJ . Statistical problems in the reporting of clinical trials. A survey of three medical journals[J]. N Engl J Med, 1987,317(7):426-432 doi: 10.1056/NEJM198708133170706
[15]	Altman DG . The scandal of poor medical research[J]. BMJ, 1994,308(6924):283-284 doi: 10.1136/bmj.308.6924.283 pmid: 8124111
[16]	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
[17]	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 in PubMed[J]. BMJ, 2010,340(c723):
[18]	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
[19]	Lai TY, Wong VW, Lam RF, Cheng AC, Lam DS, Leung GM . Quality of reporting of key methodological items of randomized controlled trials in clinical ophthalmic journals[J]. Ophthalmic Epidemiol, 2007,14(6):390-398 doi: 10.1080/09286580701344399
[20]	Moher D, Fortin P, Jadad AR, Jüni P, Klassen T, Le Lorier J, Liberati A, Linde K, Penna A . Completeness of reporting of trials published in languages other than English: implications for conduct and reporting of systematic reviews[J]. Lancet, 1996,347(8998):363-366 doi: 10.1016/S0140-6736(96)90538-3
[21]	Junker CA . Adherence to published standards of reporting: a comparison of placebo-controlled trials published in English or German[J]. JAMA, 1998,280(3):247-249 doi: 10.1001/jama.280.3.247
[22]	Altman DG . Randomisation[J]. BMJ, 1991,302(6791):1481-1482 doi: 10.1136/bmj.302.6791.1481
[23]	Schulz KF, Chalmers I, Grimes DA, Altman DG . Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals[J]. JAMA, 1994,272(2):125-128 doi: 10.1001/jama.1994.03520020051014
[24]	. Streptomycin treatment of pulmonary tuberculosis: a Medical Research Council investigation[J].BMJ, 1948, 2: 769-782 doi: 10.1136/bmj.2.4582.769
[25]	Schulz KF . Randomized controlled trials[J]. Clin Obstet Gynecol, 1998,41(2):245-256 doi: 10.1097/00003081-199806000-00005
[26]	Greenland S . Randomization, statistics, and causal inference[J]. Epidemiology, 1990,1(6):421-429 doi: 10.1097/00001648-199011000-00003
[27]	Armitage P . The role of randomization in clinical trials[J]. Stat Med, 1982,1(4):345-352 doi: 10.1002/sim.4780010412 pmid: 7187102
[28]	Kleijnen J, Gøtzsche PC, Kunz R, Oxman AD, Chalmers I .So what’s so special about randomisation. In: Maynard A, Chalmers I, eds. Non-random reflections on health services research[J].BMJ Books,1997: 93-106
[29]	Chalmers I . Assembling comparison groups to assess the effects of health care[J]. J R Soc Med, 1997,90(7):379-386 doi: 10.1177/014107689709000706
[30]	Nicolucci A, Grilli R, Alexanian AA, Apolone G, Torri V, Liberati A . Quality, evolution, and clinical implications of randomized, controlled trials on the treatment of lung cancer. A lost opportunity for meta-analysis[J]. JAMA, 1989,262(15):2101-2107 doi: 10.1001/jama.1989.03430150069028
[31]	Ah-See KW, Molony NC . A qualitative assessment of randomized controlled trials in otolaryngology[J]. J Laryngol Otol, 1998,112(5):460-463
[32]	Altman DG, Doré CJ . Randomisation and baseline comparisons in clinical trials[J]. Lancet, 1990,335(8682):149-153 doi: 10.1016/0140-6736(90)90014-V pmid: 0001967441
[33]	Thornley B, Adams C . Content and quality of 2000 controlled trials in schizophrenia over 50 years[J]. BMJ, 1998,317(7167):1181-1184 doi: 10.1136/bmj.317.7167.1181 pmid: 9794850
[34]	DerSimonian R, Charette LJ, McPeek B, Mosteller F . Reporting on methods in clinical trials[J]. N Engl J Med, 1982,306(22):1332-1337 doi: 10.1056/NEJM198206033062204
[35]	A proposal for structured reporting of randomized controlled trials. The Standards of Reporting Trials Group[J]. JAMA, 1994,272(24):1926-1931 doi: 10.1001/jama.1994.03520240054041
[36]	Call for comments on a proposal to improve reporting of clinical trials in the biomedical literature. Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature[J]. Ann Intern Med, 1994,121(11):894-895 doi: 10.7326/0003-4819-121-11-199412010-00015
[37]	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
[38]	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
[39]	Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ; CONSORT Group . 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
[40]	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
[41]	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, 337: a2390 doi: 10.1136/bmj.a2390 pmid: 3266844
[42]	Ioannidis JP, Evans SJ, Gøtzsche 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
[43]	Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P; CONSORT Group . 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
[44]	Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C; CONSORT Group . 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
[45]	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
[46]	Siegel JE, Weinstein MC, Russell LB, Gold MR . Recommendations for reporting cost-effectiveness analyses. Panel on Cost-Effectiveness in Health and Medicine[J]. JAMA, 1996,276(16):1339-1341 doi: 10.1001/jama.1996.03540160061034
[47]	Drummond MF, Jefferson TO . Guidelines for authors and peer reviewers of economic submissions to the BMJ. The BMJ Economic Evaluation Working Party[J]. BMJ, 1996,313(7052):275-283 doi: 10.1136/bmj.313.7052.275
[48]	Lang TA, Secic M .How to report statistics in medicine. Annotated guidelines for authors, editors, reviewers[J].ACP, 1997 doi: 10.1038/nm0697-692
[49]	Davidoff F . News from the International Committee of Medical Journal Editors[J]. Ann Intern Med, 2000,133(3):229-231 doi: 10.7326/0003-4819-133-3-200008010-00017
[50]	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
[51]	Egger M, Jüni P, Bartlett C; CONSORT Group ( Consolidated Standards of Reporting of Trials).Value of flow diagrams in reports of randomized controlled trials[J]. JAMA, 2001,285(15):1996-1999 doi: 10.1001/jama.285.15.1996
[52]	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
[53]	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
[54]	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
[55]	Chan AW, Hróbjartsson A, Haahr MT, Gøtzsche 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
[56]	Al-Marzouki S, Roberts I, Evans S, Marshall T . Selective reporting in clinical trials: analysis of trial protocols accepted by The Lancet[J]. Lancet, 2008,372(9634):201 doi: 10.1016/S0140-6736(08)61060-0 pmid: 18640445
[57]	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
[58]	Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gøtzsche PC, Lang T; CONSORT GROUP (Consolidated Standards of Reporting Trials) .The revised CONSORT statement for reporting randomized trials: explanation and elaboration[J]. Ann Intern Med, 2001,134(8):663-694 doi: 10.7326/0003-4819-134-8-200104170-00012 pmid: 11304107
[59]	Schulz KF, Altman DG, Moher D; CONSORT Group.CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials[J]. Trials,2010,11: 32 doi: 10.1186/1745-6215-11-32
[60]	Pocock SJ.Clinical trials: a practical approach[J].John Wiley, 1983 doi: 10.2307/2531186
[61]	Meinert CL. Clinical trials: design, conduct and analysis[J].Oxford University Press,1986 doi: 10.1001/jama.1987.03390090119041
[62]	Friedman LM, Furberg CD, DeMets DL .Fundamentals of clinical trials(3rd ed)[M]. Springer, 1998,( 3rd ed)
[63]	Bolliger CT, Zellweger JP, Danielsson T, van Biljon X, Robidou A, Westin A, Perruchoud AP, Säwe U .Smoking reduction with oral nicotine inhalers: double blind, randomised clinical trial of efficacy and safety[J]. BMJ, 2000,321(7257):329-333 doi: 10.1136/bmj.321.7257.329
[64]	Dickersin K, Manheimer E, Wieland S, Robinson KA, Lefebvre C, McDonald S .Development of the Cochrane Collaboration’s CENTRAL Register of controlled clinical trials[J]. Eval Health Prof, 2002,25(1):38-64
[65]	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
[66]	The impact of open access upon public health. PLoS Med[J]. 2006,3(5):e252
[67]	Harbourt AM, Knecht LS, Humphreys BL . Structured abstracts in MEDLINE, 1989-1991[J]. Bull Med Libr Assoc, 1995,83(2):190-195
[68]	Harris AH, Standard S, Brunning JL, Casey SL, Goldberg JH, Oliver L, Ito K, Marshall JM . The accuracy of abstracts in psychology journals[J]. J Psychol, 2002,136(2):141-148 doi: 10.1080/00223980209604145 pmid: 12081089
[69]	Pitkin RM, Branagan MA, Burmeister LF . Accuracy of data in abstracts of published research articles[J]. JAMA, 1999,281(12):1110-1111 doi: 10.1001/jama.281.12.1110 pmid: 10188662
[70]	Ward LG, Kendrach MG, Price SO . Accuracy of abstracts for original research articles in pharmacy journals[J]. Ann Pharmacother, 2004,38(7-8):1173-1177 doi: 10.1345/aph.1D416
[71]	G?tzsche PC . Believability of relative risks and odds ratios in abstracts: cross sectional study[J]. BMJ, 2006,333(7561):231-234 doi: 10.1136/bmj.38895.410451.79 pmid: 16854948
[72]	Ioannidis JP, Lau J . Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas[J]. JAMA, 2001,285(4):437-443 doi: 10.1001/jama.285.4.437
[73]	Haynes RB, Mulrow CD, Huth EJ, Altman DG, Gardner MJ . More informative abstracts revisited[J]. Ann Intern Med, 1990,113(1):69-76 doi: 10.7326/0003-4819-113-1-69
[74]	Taddio A, Pain T, Fassos FF, Boon H, Ilersich AL, Einarson TR . Quality of nonstructured and structured abstracts of original research articles in the British Medical Journal, the Canadian Medical Association Journal and the Journal of the American Medical Association[J]. CMAJ, 1994,150(10):1611-1615
[75]	Wager E, Middleton P .Technical editing of research reports in biomedical journals[J].Cochrane Database Syst Rev, 2008: MR000002 doi: 10.1002/14651858.MR000002 pmid: 18843753
[76]	Hartley J, Sydes M, Blurton A . Obtaining information accurately and quickly: Are structured abstracts more efficient?[J]. J Inform Sci, 1996,22(5):349-356 doi: 10.1177/016555159602200503
[77]	Gilligan D, Nicolson M, Smith I, Groen H, Dalesio O, Goldstraw P, Hatton M, Hopwood P, Manegold C, Schramel F, Smit H, van Meerbeeck J, Nankivell M, Parmar M, Pugh C, Stephens R .Preoperative chemotherapy in patients with resectable non-small cell lung cancer: results of the MRC LU22/NVALT 2/EORTC 08012 multicentre randomised trial and update of systematic review[J]. Lancet, 2007,369(9577):1929-1937 doi: 10.1016/S0140-6736(07)60714-4
[78]	Sandler AD, Sutton KA, DeWeese J, Girardi MA, Sheppard V, Bodfish JW .Lack of benefit of a single dose of synthetic human secretin in the treatment of autism and pervasive developmental disorder[J]. N Engl J Med, 1999,341(24):1801-1806 doi: 10.1056/NEJM199912093412404
[79]	World Medical Association. Declaration of Helsinki: ethical principle for medical research involving human subjects. 59th WMA General Assembly, Seoul 2008(accessed 2 June 2009) doi: 10.1515/9783110208856.233 pmid: 19886379
[80]	Lau J, Antman EM, Jimenez-Silva J, Kupelnick B, Mosteller F, Chalmers TC . Cumulative meta-analysis of therapeutic trials for myocardial infarction[J]. N Engl J Med, 1992,327(4):248-254 doi: 10.1056/NEJM199207233270406 pmid: 1614465
[81]	Fergusson D, Glass KC, Hutton B, Shapiro S . Randomized controlled trials of aprotinin in cardiac surgery: could clinical equipoise have stopped the bleeding?[J]. Clin Trials, 2005,2(3):218-229 doi: 10.1191/1740774505cn085oa
[82]	Savulescu J, Chalmers I, Blunt J . Are research ethics committees behaving unethically? Some suggestions for improving performance and accountability[J]. BMJ, 1996,313(7069):1390-1393 doi: 10.1136/bmj.313.7069.1390
[83]	Sadler LC, Davison T, McCowan LM .A randomised controlled trial and meta-analysis of active management of labour[J]. BJOG, 2000,107(7):909-915 doi: 10.1111/j.1471-0528.2000.tb11091.x pmid: 10901564
[84]	Bath FJ, Owen VE, Bath PM . Quality of full and final publications reporting acute stroke trials: a systematic review[J]. Stroke, 1998,29(10):2203-2210 doi: 10.1161/01.STR.29.10.2203
[85]	Blumer JL, Findling RL, Shih WJ, Soubrane C, Reed MD . Controlled clinical trial of zolpidem for the treatment of insomnia associated with attention-deficit/ hyperactivity disorder in children 6 to 17 years of age[J]. Pediatrics, 2009,123(5):e770-e776 doi: 10.1542/peds.2008-2945
[86]	Sabatine MS, Antman EM, Widimsky P, Ebrahim IO, Kiss RG, Saaiman A, Polasek R, Contant CF, McCabe CH, Braunwald E .Otamixaban for the treatment of patients with non-ST-elevation acute coronary syndromes(SEPIA-ACS1 TIMI 42): a randomised, double-blind, active-controlled, phase 2 trial[J]. Lancet, 2009,374(9692):787-795 doi: 10.1016/S0140-6736(09)61454-9
[87]	Grant AM, Altman DG, Babiker AB, Campbell MK, Clemens FJ, Darbyshire JH, Elbourne DR, McLeer SK, Parmar MK, Pocock SJ, Spiegelhalter DJ, Sydes MR, Walker AE, Wallace SA; DAMOCLES study group.Issues in data monitoring and interim analysis of trials[J].Health Technol Assess, 2005, 9(7):1-238, iii-iv doi: 10.1093/heapol/czi016 pmid: 15763038
[88]	Gallo P, Krams M . PhRMA Working Group on adaptive designs, “White Paper”[J]. Drug Inf J, 2006,40(4):421-482 doi: 10.1177/216847900604000407
[89]	Brown CH, Ten Have TR, Jo B, Dagne G, Wyman PA, Muthen B, Gibbons RD .Adaptive designs for randomized trials in public health[J].Annu Rev Public Health, 2009, 30: 1-25 doi: 10.1146/annurev.publhealth.031308.100223 pmid: 2778326
[90]	Kelly PJ, Sooriyarachchi MR, Stallard N, Todd S . A practical comparison of group-sequential and adaptive designs[J]. J Biopharm Stat, 2005,15(4):719-738 doi: 10.1081/BIP-200062859 pmid: 16022175
[91]	Pildal J, Chan AW, Hróbjartsson A, Forfang E, Altman DG, Gøtzsche PC .Comparison of descriptions of allocation concealment in trial protocols and the published reports: cohort study[J]. BMJ, 2005,330(7499):1049 doi: 10.1136/bmj.38414.422650.8F
[92]	Chan AW, Hróbjartsson A, Jórgensen KJ, Gótzsche PC, Altman DG .Discrepancies in sample size calculations and data analyses reported in randomised trials: comparison of publications with protocols[J].BMJ, 2008, 337: a2299 doi: 10.1136/bmj.a2299
[93]	Ndekha MJ, van Oosterhout JJ, Zijlstra EE, Manary M, Saloojee H, Manary MJ .Supplementary feeding with either ready-to-use fortified spread or corn-soy blend in wasted adults starting antiretroviral therapy in Malawi: randomised, investigator blinded controlled trial[J].BMJ, 2009, 338: b1867 doi: 10.1136/bmj.b1867
[94]	Rothwell PM . External validity of randomised controlled trials: “to whom do the results of this trial apply?”[J]. Lancet, 2005,365(9453):82-93 doi: 10.1016/S0140-6736(04)17670-8
[95]	Fuks A, Weijer C, Freedman B, Shapiro S, Skrutkowska M, Riaz A . A study in contrasts: eligibility criteria in a twenty-year sample of NSABP and POG clinical trials. National Surgical Adjuvant Breast and Bowel Program. Pediatric Oncology Group[J]. J Clin Epidemiol, 1998,51(2):69-79 doi: 10.1016/S0895-4356(97)00240-0
[96]	Shapiro SH, Weijer C, Freedman B . Reporting the study populations of clinical trials. Clear transmission or static on the line?[J]. J Clin Epidemiol, 2000,53(10):973-979 doi: 10.1016/S0895-4356(00)00227-4
[97]	Gandhi M, Ameli N, Bacchetti P, Sharp GB, French AL, Young M, Gange SJ, Anastos K, Holman S, Levine A, Greenblatt RM . Eligibility criteria for HIV clinical trials and generalizability of results: the gap between published reports and study protocols[J]. AIDS, 2005,19(16):1885-1896 doi: 10.1097/01.aids.0000189866.67182.f7
[98]	Hall JC, Mills B, Nguyen H, Hall JL . Methodologic standards in surgical trials.[J]. Surgery, 1996,119(4):466-472 doi: 10.1016/S0039-6060(96)80149-8 pmid: 8644014
[99]	Weiss NS, Koepsell TD, Psaty BM . Generalizability of the results of randomized trials[J]. Arch Intern Med, 2008,168(2):133-135 doi: 10.1001/archinternmed.2007.30
[100]	POISE Study Group, Devereaux PJ, Yang H, Yusuf S, Guyatt G, Leslie K, Villar JC, Xavier D, Chrolavicius S, Greenspan L, Pogue J, Pais P, Liu L, Xu S, Málaga G, Avezum A, Chan M, Montori VM, Jacka M, Choi P . Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery(POISE trial): a randomised controlled trial[J]. Lancet, 2008,371(9627):1839-1847 doi: 10.1016/S0140-6736(08)60601-7
[101]	Rannou F, Dimet J, Boutron I, Baron G, Fayad F, Macé Y, Beaudreuil J, Richette P, Ravaud P, Revel M, Poiraudeau S . Splint for base-of-thumb osteoarthritis: a randomized trial[J]. Ann Intern Med, 2009,150(10):661-669 doi: 10.7326/0003-4819-150-10-200905190-00003
[102]	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
[103]	Mease PJ, Goffe BS, Metz J, VanderStoep A, Finck B, Burge DJ .Etanercept in the treatment of psoriatic arthritis and psoriasis: a randomised trial[J]. Lancet, 2000,356(9227):385-390 doi: 10.1016/S0140-6736(00)02530-7 pmid: 10972371
[104]	McDowell I, Newell C . Measuring health: a guide to rating scales and questionnaires(3rd ed)[M]. New York: Oxford University Press,2006,(3rd ed)
[105]	Streiner D, Norman C. Health measurement scales: a practical guide to their development and use(3rd ed)[M]. Oxford: Oxford University Press,2003,(3rd ed)
[106]	Clarke M. .Standardising outcomes for clinical trials and systematic reviews[J].Trials, 2007, 8: 39 doi: 10.1186/1745-6215-8-39 pmid: 18039365
[107]	Sanders C, Egger M, Donovan J, Tallon D, Frankel S . Reporting on quality of life in randomised controlled trials: bibliographic study[J]. BMJ, 1998,317(7167):1191-1194 doi: 10.1136/bmj.317.7169.1353p pmid: 9794853
[108]	Gøtzsche PC . Methodology and overt and hidden bias in reports of 196 double-blind trials of nonsteroidal antiinflammatory drugs in rheumatoid arthritis[J]. Control Clin Trials, 1989,10(1):31-56 doi: 10.1016/0197-2456(89)90017-2
[109]	Marshall M, Lockwood A, Bradley C, Adams C, Joy C, Fenton M .Unpublished rating scales: a major source of bias in randomised controlled trials of treatments for schizophrenia[J].Br J Psychiatry, 2000, 176: 249-252 doi: 10.1192/bjp.176.3.249
[110]	Jadad AR, Boyle M, Cunnigham C, Kim M, Schachar R . Treatment of Attention-Deficit/Hyperactivity Disorder. Evidence Report/Technology Assessment No. 11. Rockville, MD: U.S. Department of Health and Human Services, Public Health Service, Agency for Healthcare Research and Quality. AHQR publication No. 00-E005. 1999
[111]	Schachter HM, Pham B, King J, Langford S, Moher D .The efficacy and safety of methylphenidate in attention deficit disorder: A systematic review and meta-analyis[J].Prepared for the Therapeutics Initiative, Vancouver, B.C., the British Columbia Ministry for Children and Families, 2000
[112]	Dargie HJ . Effect of carvedilol on outcome after myocardial infarction in patients with left-ventricular dysfunction: the CAPRICORN randomised trial[J]. Lancet, 2001,357(9266):1385-1390 doi: 10.1016/S0140-6736(00)04560-8
[113]	Chan AW, Krleza-Jeric K, Schmid I, Altman DG .Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research[J]. CMAJ, 2004,171(7):735-740 doi: 10.1503/cmaj.1041086
[114]	Vermeulen H, Hofland J, Legemate DA, Ubbink DT .Intravenous fluid restriction after major abdominal surgery: a randomized blinded clinical trial[J].Trials, 2009, 10: 50 doi: 10.1186/1745-6215-10-50 pmid: 2717956
[115]	Fox K, Ford I, Steg PG, Tendera M, Ferrari R; BEAUTIFUL Investigators . Ivabradine for patients with stable coronary artery disease and left-ventricular systolic dysfunction(BEAUTIFUL): a randomised, double-blind, placebo-controlled trial[J]. Lancet, 2008,372(9641):807-816 doi: 10.1016/S0140-6736(08)61170-8
[116]	Campbell MJ, Julious SA, Altman DG . Estimating sample sizes for binary, ordered categorical, and continuous outcomes in two group comparisons[J]. BMJ, 1995,311(7013):1145-1148 doi: 10.1136/bmj.311.7013.1145
[117]	Guyatt GH, Mills EJ, Elbourne D . In the era of systematic reviews, does the size of an individual trial still matter[J]. PLoS Med, 2008,5(1):e4 doi: 10.1371/journal.pmed.0050004 pmid: 18177203
[118]	Schulz KF, Grimes DA . Sample size calculations in randomised trials: mandatory and mystical[J]. Lancet, 2005,365(9467):1348-1353 doi: 10.1016/S0140-6736(05)61034-3 pmid: 15823387
[119]	Halpern SD, Karlawish JH, Berlin JA . The continuing unethical conduct of underpowered clinical trials[J]. JAMA, 2002,288(3):358-362 doi: 10.1001/jama.288.3.358 pmid: 12117401
[120]	Altman DG, Bland JM . Absence of evidence is not evidence of absence[J]. BMJ, 1995,311(7003):485 doi: 10.1136/bmj.311.7003.485
[121]	Moher D, Dulberg CS, Wells GA . Statistical power, sample size, and their reporting in randomized controlled trials[J]. JAMA, 1994,272(2):122-124 doi: 10.1097/00008506-199501000-00018 pmid: 8015121
[122]	Freiman JA, Chalmers TC, Smith H Jr, Kuebler RR . The importance of beta, the type Ⅱ error and sample size in the design and interpretation of the randomized control trial. Survey of 71 “negative” trials[J]. N Engl J Med, 1978,299(13):690-694 doi: 10.1056/NEJM197809282991304
[123]	Charles P, Giraudeau B, Dechartres A, Baron G, Ravaud P .Reporting of sample size calculation in randomised controlled trials: review[J].BMJ, 2009, 338: b1732 doi: 10.1136/bmj.b1732 pmid: 2680945
[124]	Yusuf S, Collins R, Peto R . Why do we need some large, simple randomized trials?[J]. Stat Med, 1984,3(4):409-422 doi: 10.1002/sim.4780030421 pmid: 6528136
[125]	Goodman SN, Berlin JA . The use of predicted confidence intervals when planning experiments and the misuse of power when interpreting results[J]. Ann Intern Med, 1994,121(3):200-206 doi: 10.7326/0003-4819-121-3-199408010-00008
[126]	Galgiani JN, Catanzaro A, Cloud GA, Johnson RH, Williams PL, Mirels LF, Nassar F, Lutz JE, Stevens DA, Sharkey PK, Singh VR, Larsen RA, Delgado KL, Flanigan C, Rinaldi MG . Comparison of oral fluconazole and itraconazole for progressive, nonmeningeal coccidioidomycosis. A randomized, double-blind trial. Mycoses Study Group[J]. Ann Intern Med, 2000,133(9):676-686 doi: 10.7326/0003-4819-133-9-200011070-00009
[127]	Connolly SJ, Pogue J, Hart RG, Hohnloser SH, Pfeffer M, Chrolavicius S . Effect of clopidogrel added to aspirin in patients with atrial fibrillation[J]. N Engl J Med, 2009,360(20):2066-2078 doi: 10.1056/NEJMoa0901301 pmid: 19336502
[128]	Geller NL, Pocock SJ . Interim analyses in randomized clinical trials: ramifications and guidelines for practitioners[J]. Biometrics, 1987,43(1):213-223 doi: 10.2307/2531962 pmid: 3567306
[129]	Berry DA . Interim analyses in clinical trials: classical vs. Bayesian approaches[J]. Stat Med, 1985,4(4):521-526 doi: 10.1002/sim.4780040412 pmid: 4089353
[130]	Pocock SJ . When to stop a clinical trial[J]. BMJ, 1992,305(6847):235-240 doi: 10.1136/bmj.305.6847.235 pmid: 1392975
[131]	DeMets DL, Pocock SJ, Julian DG . The agonising negative trend in monitoring of clinical trials[J]. Lancet, 1999,354(9194):1983-1988 doi: 10.1016/S0140-6736(99)03464-9 pmid: 10622312
[132]	Buyse M . Interim analyses, stopping rules and data monitoring in clinical trials in Europe[J]. Stat Med, 1993,12(5-6):509-520 doi: 10.1002/sim.4780120517 pmid: 8493429
[133]	Sydes MR, Altman DG, Babiker AB, Parmar MK, Spiegelhalter DJ; DAMOCLES Group . Reported use of data monitoring committees in the main published reports of randomized controlled trials: a cross-sectional study[J]. Clin Trials, 2004,1(1):48-59 doi: 10.1191/1740774504cn003oa
[134]	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
[135]	Coutinho IC, Ramos de Amorim MM, Katz L, Bandeira de Ferraz AA .Uterine exteriorization compared with in situ repair at cesarean delivery: a randomized controlled trial[J]. Obstet Gynecol, 2008,111(3):639-647 doi: 10.1097/AOG.0b013e31816521e2
[136]	Jüni P, Altman DG, Egger M . Assessing the quality of controlled clinical trials. In: Egger M, Davey Smith G, Altman DG, eds. Systematic reviews in health care: meta-analysis in context. BMJ Books. 2001
[137]	Creinin MD, Meyn LA, Borgatta L, Barnhart K, Jensen J, Burke AE, Westhoff C, Gilliam M, Dutton C, Ballagh SA . Multicenter comparison of the contraceptive ring and patch: a randomized controlled trial[J]. Obstet Gynecol, 2008,111(2 pt 1):267-277 doi: 10.1097/01.AOG.0000298338.58511.d1
[138]	Tate DF, Jackvony EH, Wing RR . Effects of internet behavioral counseling on weight loss in adults at risk for type 2 diabetes: a randomized trial[J]. JAMA, 2003,289(14):1833-1836 doi: 10.1001/jama.289.14.1833
[139]	Lachin JM . Properties of simple randomization in clinical trials[J]. Control Clin Trials, 1988,9(4):312-326 doi: 10.1016/0197-2456(88)90046-3 pmid: 3203523
[140]	Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG .Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design[J]. Br J Cancer, 1976,34(6):585-612 doi: 10.1038/bjc.1976.220
[141]	Schulz KF, Grimes DA .The Lancet handbook of essential concepts in clinical research[J].Elsevier, 2006
[142]	Altman DG, Bland JM . How to randomise[J]. BMJ, 1999,319(7211):703-704
[143]	Schulz KF . Subverting randomization in controlled trials[J]. JAMA, 1995,274(18):1456-1458 doi: 10.1001/jama.274.18.1456 pmid: 7474192
[144]	Enas GG, Enas NH, Spradlin CT, Wilson MG, Wiltse CG . Baseline comparability in clinical trials: prevention of poststudy anxiety[J]. Drug Inf J, 1990,24(541-548):
[145]	Treasure T, MacRae KD .Minimisation: the platinum standard for trials?. Randomisation doesn't guarantee similarity of groups; minimisation does[J]. BMJ, 1998,317(7155):362-363 doi: 10.1136/bmj.317.7155.362
[146]	Sinei SK, Schulz KF, Lamptey PR, Grimes DA, Mati JK, Rosenthal SM, Rosenberg MJ, Riara G, Njage PN, Bhullar VB , et al. Preventing IUCD-related pelvic infection: the efficacy of prophylactic doxycycline at insertion[J]. Br J Obstet Gynaecol, 1990,97(5):412-419 doi: 10.1111/j.1471-0528.1990.tb01828.x pmid: 2196934
[147]	Radford JA, Landorf KB, Buchbinder R, Cook C .Effectiveness of low-Dye taping for the short-term treatment of plantar heel pain: a randomised trial[J].BMC Musculoskelet Disord, 2006, 7: 64 doi: 10.1186/1471-2474-7-64
[148]	Chalmers TC, Levin H, Sacks HS, Reitman D, Berrier J, Nagalingam R . Meta-analysis of clinical trials as a scientific discipline. I: Control of bias and comparison with large co-operative trials[J]. Stat Med, 1987,6(3):315-328 doi: 10.1002/(ISSN)1097-0258
[149]	Pocock SJ . Statistical aspects of clinical trial design[J]. Statistician, 1982,31(1):1-18 doi: 10.2307/2988097
[150]	Haag U .Technologies for automating randomized treatment assignment in clinical trials[J].Drug Information Journal, 1998, 32: 11
[151]	Piaggio G, Elbourne D, Schulz KF, Villar J, Pinol AP, Gülmezoglu AM; WHO Research Group to evaluate Misoprostol in the Management of the Third Stage of Labour.The reporting of methods for reducing and detecting bias: an example from the WHO Misoprostol Third Stage of Labour equivalence randomised controlled trial[J].BMC Med Res Methodol, 2003, 3: 19 doi: 10.1186/1471-2288-3-19
[152]	Pildal J, Hróbjartsson A, Jórgensen KJ, Hilden J, Altman DG, Gøtzsche PC .Impact of allocation concealment on conclusions drawn from meta-analyses of randomized trials[J]. Int J Epidemiol, 2007,36(4):847-857 doi: 10.1093/ije/dym087
[153]	Wood L, Egger M, Gluud LL, Schulz KF, Jüni P, Altman DG, Gluud C, Martin RM, Wood AJ, Sterne JA . Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study[J]. BMJ, 2008,336(7644):601-605
[154]	McCandlish R, Bowler U, van Asten H, Berridge G, Winter C, Sames L, Garcia J, Renfrew M, Elbourne D . A randomised controlled trial of care of the perineum during second stage of normal labour[J]. Br J Obstet Gynaecol, 1998,105(12):1262-1272 doi: 10.1111/j.1471-0528.1998.tb10004.x pmid: 9883917
[155]	Webster J, Clarke S, Paterson D, Hutton A, van Dyk S, Gale C, Hopkins T .Routine care of peripheral intravenous catheters versus clinically indicated replacement: randomised controlled trial[J].BMJ, 2008, 337: a339 doi: 10.1136/bmj.a339
[156]	Smith SA, Shah ND, Bryant SC, Christianson TJ, Bjornsen SS, Giesler PD, Krause K, Erwin PJ, Montori VM; Evidens Research Group . Chronic care model and shared care in diabetes: randomized trial of an electronic decision support system[J]. Mayo Clin Proc, 2008,83(7):747-757 doi: 10.4065/83.7.747
[157]	Sacks FM, Bray GA, Carey VJ, Smith SR, Ryan DH, Anton SD, McManus K, Champagne CM, Bishop LM, Laranjo N, Leboff MS, Rood JC, de Jonge L, Greenway FL, Loria CM, Obarzanek E, Williamson DA .Comparison of weight-loss diets with different compositions of fat, protein, and carbohydrates[J]. N Engl J Med, 2009,360(9):859-873 doi: 10.1056/NEJMoa0804748
[158]	Kaptchuk TJ . Intentional ignorance: a history of blind assessment and placebo controls in medicine[J]. Bull Hist Med, 1998,72(3):389-433 doi: 10.1353/bhm.1998.0159 pmid: 9780448
[159]	Guyatt GH, Pugsley SO, Sullivan MJ, Thompson PJ, Berman L, Jones NL, Fallen EL, Taylor DW . Effect of encouragement on walking test performance[J]. Thorax, 1984,39(11):818-822 doi: 10.1136/thx.39.11.818
[160]	G?tzsche PC . Blinding during data analysis and writing of manuscripts[J]. Control Clin Trials, 1996,17(4):285-290 doi: 10.1016/0197-2456(95)00263-4
[161]	Karlowski TR, Chalmers TC, Frenkel LD, Kapikian AZ, Lewis TL, Lynch JM . Ascorbic acid for the common cold. A prophylactic and therapeutic trial[J]. JAMA, 1975,231(10):1038-1042 doi: 10.1001/jama.1975.03240220018013
[162]	Noseworthy JH, Ebers GC, Vandervoort MK, Farquhar RE, Yetisir E, Roberts R . The impact of blinding on the results of a randomized, placebo-controlled multiple sclerosis clinical trial[J]. Neurology, 1994,44(1):16-20 doi: 10.1212/WNL.44.1.16
[163]	Carley SD, Libetta C, Flavin B, Butler J, Tong N, Sammy I . An open prospective randomised trial to reduce the pain of blood glucose testing: ear versus thumb[J]. BMJ, 2000,321(7252):20 doi: 10.1136/bmj.321.7252.20
[164]	Schulz KF, Chalmers I, Altman DG . The landscape and lexicon of blinding in randomized trials[J]. Ann Intern Med, 2002,136(3):254-259 doi: 10.7326/0003-4819-136-3-200202050-00022 pmid: 11827510
[165]	Day SJ, Altman DG . Statistics notes: blinding in clinical trials and other studies[J]. BMJ, 2000,321(7259):504 doi: 10.1136/bmj.321.7259.504 pmid: 0010948038
[166]	Montori VM, Bhandari M, Devereaux PJ, Manns BJ, Ghali WA, Guyatt GH . In the dark: the reporting of blinding status in randomized controlled trials[J]. J Clin Epidemiol, 2002,55(8):787-790 doi: 10.1016/S0895-4356(02)00446-8
[167]	Cheng K, Smyth RL, Motley J, O'Hea U, Ashby D .Randomized controlled trials in cystic fibrosis(1966-1997) categorized by time, design, and intervention[J]. Pediatr Pulmonol, 2000,29(1):1-7 doi: 10.1002/(ISSN)1099-0496
[168]	Lang T . Masking or blinding? An unscientific survey of mostly medical journal editors on the great debate[J]. MedGenMed, 2000,2(1):E25
[169]	Devereaux PJ, Manns BJ, Ghali WA, Quan H, Lacchetti C, Montori VM, Bhandari M, Guyatt GH . Physician interpretations and textbook definitions of blinding terminology in randomized controlled trials[J]. JAMA, 2001,285(15):2000-2003 doi: 10.1001/jama.285.15.2000
[170]	Haahr MT, Hróbjartsson A . Who is blinded in randomized clinical trials? A study of 200 trials and a survey of authors[J]. Clin Trials, 2006,3(4):360-365 doi: 10.1177/1740774506069153 pmid: 17060210
[171]	Meinert CL . Masked monitoring in clinical trials—blind stupidity?[J]. N Engl J Med, 1998,338(19):1381-1382 doi: 10.1056/NEJM199805073381911 pmid: 9571262
[172]	Mills E, Prousky J, Raskin G, Gagnier J, Rachlis B, Montori VM, Juurlink D .The safety of over-the-counter niacin. A randomized placebo-controlled trial [ISRCTN18054903][J].BMC Clin Pharmacol, 2003, 3: 4 doi: 10.1186/1472-6904-3-4 pmid: 14614780
[173]	Schulz KF, Grimes DA, Altman DG, Hayes RJ . Blinding and exclusions after allocation in randomised controlled trials: survey of published parallel group trials in obstetrics and gynaecology[J]. BMJ, 1996,312(7033):742-744 doi: 10.1136/bmj.312.7033.742
[174]	Fergusson D, Glass KC, Waring D, Shapiro S . Turning a blind eye: the success of blinding reported in a random sample of randomised, placebo controlled trials[J]. BMJ, 2004,328(7437):432 doi: 10.1136/bmj.328.74327.37952.631667.EE
[175]	Sackett DL . Turning a blind eye: why we don’t test for blindness at the end of our trials[J]. BMJ, 2004,328(7448):1136
[176]	Astrup A, Rössner S, Van Gaal L, Rissanen A, Niskanen L, Al Hakim M, Madsen J, Rasmussen MF, Lean ME; NN8022-1807 Study Group.Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study[J]. Lancet, 2009,374(9701):1606-1616 doi: 10.1016/S0140-6736(09)61375-1
[177]	Altman DG, Gore SM, Gardner MJ, Pocock SJ . Statistical guidelines for contributors to medical journals. In: Altman DG, Machin D, Bryant TN, Gardner MJ, eds. Statistics with confidence: confidence intervals and statistical guidelines. 2nd ed. BMJ Books. 2000: 171-190. doi: 10.2307/29510828 pmid: 6405856
[178]	Altman DG, Bland JM . Statistics notes. Units of analysis[J]. BMJ, 1997,314(7098):1874 doi: 10.1136/bmj.314.7098.1874 pmid: 9224131
[179]	Bolton S . Independence and statistical inference in clinical trial designs: a tutorial review[J]. J Clin Pharmacol, 1998,35(8):408-412
[180]	Greenland S . Principles of multilevel modelling[J]. Int J Epidemiol, 2000,29(1):158-167 doi: 10.1093/ije/29.1.158
[181]	Albert CM, Cook NR, Gaziano JM, Zaharris E, MacFadyen J, Danielson E, Buring JE, Manson JE .Effect of folic acid and B vitamins on risk of cardiovascular events and total mortality among women at high risk for cardiovascular disease: a randomized trial[J]. JAMA, 2008,299(17):2027-2036 doi: 10.1001/jama.299.17.2027
[182]	Matthews JN, Altman DG .Interaction 3: How to examine heterogeneity[J]. BMJ, 1996,313(7061):862 doi: 10.1136/bmj.313.7061.862
[183]	Assmann SF, Pocock SJ, Enos LE, Kasten LE . Subgroup analysis and other(mis)uses of baseline data in clinical trials[J]. Lancet, 2000,355(9209):1064-1069 doi: 10.1016/S0140-6736(00)02039-0 pmid: 10744093
[184]	Matthews JN, Altman DG . Subgroup analysis and other(mis)uses of baseline data in clinical trials[J]. Lancet, 2000,355(9209):1064-1069 doi: 10.1016/S0140-6736(00)02039-0 pmid: 10744093
[185]	Oxman AD, Guyatt GH . A consumer’s guide to subgroup analyses[J]. Ann Intern Med, 1992,116(1):78-84 doi: 10.7326/0003-4819-116-1-78
[186]	Steyerberg EW, Bossuyt PM, Lee KL . Clinical trials in acute myocardial infarction: should we adjust for baseline characteristics?[J]. Am Heart J, 2000,139(5):745-751 doi: 10.1016/S0002-8703(00)90001-2 pmid: 10783203
[187]	Altman DG . Adjustment for covariate imbalance. In: Armitage P, Colton T, eds. Encyclopedia of biostatistics. John Wiley. 1998:1000-1005
[188]	Müllner M, Matthews H, Altman DG . Reporting on statistical methods to adjust for confounding: a cross-sectional survey[J]. Ann Intern Med, 2002,136(2):122-126 doi: 10.7326/0003-4819-136-2-200201150-00009 pmid: 11790063
[189]	Concato J, Feinstein AR, Holford TR . The risk of determining risk with multivariable models[J]. Ann Intern Med, 1993,118(3):201-210 doi: 10.7326/0003-4819-118-3-199302010-00009
[190]	Bender R, Grouven U . Logistic regression models used in medical research are poorly presented[J]. BMJ, 1996,313(7057):628 doi: 10.1136/bmj.313.7057.628
[191]	Khan KS, Chien PF, Dwarakanath LS . Logistic regression models in obstetrics and gynecology literature[J]. Obstet Gynecol, 1999,93(6):1014-1020 doi: 10.1016/S0029-7844(98)00537-7 pmid: 10362173
[192]	Sackett DL, Gent M . Controversy in counting and attributing events in clinical trials[J]. N Engl J Med, 1979,301(26):1410-1412 doi: 10.1056/NEJM197912273012602 pmid: 514321
[193]	May GS, DeMets DL, Friedman LM, Furberg C, Passamani E .The randomized clinical trial: bias in analysis[J]. Circulation, 1981,64(4):669-673 doi: 10.1161/01.CIR.64.4.669
[194]	Altman DG, Cuzick J, Peto J . More on zidovudine in asymptomatic HIV infection[J]. N Engl J Med, 1994,330(24):1758-1759 doi: 10.1056/NEJM199406163302415 pmid: 0008190146
[195]	Meinert CL . Beyond CONSORT: need for improved reporting standards for clinical trials. Consolidated Standards of Reporting Trials[J]. JAMA, 1998,279(18):1487-1489 doi: 10.1001/jama.279.18.1487 pmid: 9600487
[196]	Grant AM, Wileman SM, Ramsay CR, Mowat NA, Krukowski ZH, Heading RC, Thursz MR, Campbell MK; REFLUX Trial Group.Minimal access surgery compared with medical management for chronic gastro-oesophageal reflux disease: UK collaborative randomised trial[J].BMJ, 2008, 337: a2664 doi: 10.1136/bmj.a2664
[197]	van Loon AJ, Mantingh A, Serlier EK, Kroon G, Mooyaart EL, Huisjes HJ . Randomised controlled trial of magnetic-resonance pelvimetry in breech presentation at term[J]. Lancet, 1997,350(9094):1799-1804 doi: 10.1016/S0140-6736(97)05431-7 pmid: 9428250
[198]	Brown MJ, Palmer CR, Castaigne A, de Leeuw PW, Mancia G, Rosenthal T, Ruilope LM .Morbidity and mortality in patients randomised to double-blind treatment with a long-acting calcium-channel blocker or diuretic in the International Nifedipine GITS study: Intervention as a Goal in Hypertension Treatment(INSIGHT)[J]. Lancet, 2000,356(9227):366-372 doi: 10.1016/S0140-6736(00)02527-7
[199]	LaCroix AZ, Ott SM, Ichikawa L, Scholes D, Barlow WE . Low-dose hydrochlorothiazide and preservation of bone mineral density in older adults. A randomized, double-blind, placebo-controlled trial[J]. Ann Intern Med, 2000,133(7):516-526 doi: 10.7326/0003-4819-133-7-200010030-00010
[200]	Shuster JJ . Median follow-up in clinical trials[J]. J Clin Oncol, 1991,9(1):191-192 doi: 10.1200/JCO.1991.9.1.191 pmid: 1985169
[201]	Altman DG, De Stavola BL, Love SB, Stepniewska KA . Review of survival analyses published in cancer journals[J]. Br J Cancer, 1995,72(2):511-518 doi: 10.1038/bjc.1995.364 pmid: 7640241
[202]	Auvert B, Taljaard D, Lagarde E, Sobngwi-Tambekou J, Sitta R, Puren A . Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial[J]. PLoS Med, 2005,2(11):e298 doi: 10.1371/journal.pmed.0020298
[203]	Diggle L, Deeks J . Effect of needle length on incidence of local reactions to routine immunisation in infants aged 4 months: randomised controlled trial[J]. BMJ, 2000,321(7266):931-933 doi: 10.1136/bmj.321.7266.931
[204]	Pocock S, White I . Trials stopped early: too good to be true?[J]. Lancet, 1999,353(9157):943-944 doi: 10.1016/S0140-6736(98)00379-1 pmid: 10459899
[205]	Hughes MD, Pocock SJ . Stopping rules and estimation problems in clinical trials[J]. Stat Med, 1988,7(12):1231-1242 doi: 10.1002/sim.4780071204 pmid: 3231947
[206]	Kiri A, Tonascia S, Meinert CL . Treatment effects monitoring committees and early stopping in large clinical trials[J]. Clin Trials, 2004,1(1):40-47 doi: 10.1191/1740774504cn014oa pmid: 16281461
[207]	Psaty BM, Rennie D . Stopping medical research to save money: a broken pact with researchers and patients[J]. JAMA, 2003,289(16):2128-2131 doi: 10.1001/jama.289.16.2128 pmid: 12709471
[208]	Temple R . FDA perspective on trials with interim efficacy evaluations[J]. Stat Med, 2006,25(19):3245-3249 doi: 10.1002/sim.2631 pmid: 16847824
[209]	Telmisartan Randomised AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease(TRANSCEND)Investigators, Yusuf S, Teo K, Anderson C, Pogue J, Dyal L, Copland I, Schumacher H, Dagenais G, Sleight P . Effects of the angiotensin-receptor blocker telmisartan on cardiovascular events in high-risk patients intolerant to angiotensin-converting enzyme inhibitors: a randomised controlled trial[J]. Lancet, 2008,372(9644):1174-1183 doi: 10.1016/S0140-6736(08)61242-8
[210]	Senn S . Base logic: tests of baseline balance in randomized clinical trials[J]. Clin Res Regulatory Affairs, 1995,12(3):171-182 doi: 10.3109/10601339509019426
[211]	Altman DG . Comparability of randomised groups[J]. Statistician, 1985,34(1):125-136 doi: 10.2307/2987510
[212]	Heit JA, Elliott CG, Trowbridge AA, Morrey BF, Gent M, Hirsh J . Ardeparin sodium for extended out-of-hospital prophylaxis against venous thromboembolism after total hip or knee replacement. A randomized, double-blind, placebo-controlled trial[J]. Ann Intern Med, 2000,132(11):853-861
[213]	Haderslev KV, Tjellesen L, Sorensen HA, Staun M . Alendronate increases lumbar spine bone mineral density in patients with Crohn's disease[J]. Gastroenterology, 2000,119(3):639-646 doi: 10.1053/gast.2000.16518 pmid: 10982756
[214]	Fields WS, Maslenikov V, Meyer JS, Hass WK, Remington RD, Macdonald M . Joint study of extracranial arterial occlusion. V. Progress report of prognosis following surgery or nonsurgical treatment for transient cerebral ischemic attacks and cervical carotid artery lesions[J]. JAMA, 1970,211(12):1993-2003 doi: 10.1001/jama.1970.03170120039008
[215]	Lee YJ, Ellenberg JH, Hirtz DG, Nelson KB . Analysis of clinical trials by treatment actually received: is it really an option?[J]. Stat Med, 1991,10(10):1595-1605 doi: 10.1002/sim.4780101011 pmid: 0001947515
[216]	Lewis JA, Machin D . Intention to treat--who should use ITT?[J]. Br J Cancer, 1993,68(4):647-650 doi: 10.1038/bjc.1993.402
[217]	Lachin JL . Statistical considerations in the intent-to-treat principle[J]. Control Clin Trials, 2000,21(5):526 doi: 10.1016/S0197-2456(00)00092-1
[218]	Sheiner LB, Rubin DB . Intention-to-treat analysis and the goals of clinical trials[J]. Clin Pharmacol Ther, 1995,57(1):6-15 doi: 10.1016/0009-9236(95)90260-0
[219]	Nagelkerke N, Fidler V, Bernsen R, Borgdorff M . Estimating treatment effects in randomized clinical trials in the presence of non-compliance[J]. Stat Med, 2000,19(14):1849-1864 doi: 10.1002/(ISSN)1097-0258
[220]	Melander H, Ahlqvist-Rastad J, Meijer G, Beermann B . Evidence b(i)ased medicine--selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications[J]. BMJ, 2003,326(7400):1171-1173 doi: 10.1136/bmj.326.7400.1171
[221]	Gravel J, Opatrny L, Shapiro S . The intention-to-treat approach in randomized controlled trials: are authors saying what they do and doing what they say?[J]. Clin Trials, 2007,4(4):350-356 doi: 10.1177/1740774507081223
[222]	Kruse RL, Alper BS, Reust C, Stevermer JJ, Shannon S, Williams RH . Intention-to-treat analysis: who is in? Who is out?[J]. J Fam Pract, 2002,51(11):969-971
[223]	Herman A, Botser IB, Tenenbaum S, Chechick A . Intention-to-treat analysis and accounting for missing data in orthopaedic randomized clinical trials[J]. J Bone Joint Surg Am, 2009,91(9):2137-2143 doi: 10.2106/JBJS.H.01481
[224]	Ruiz-Canela M, Martínez-González MA, de Irala-Estévez J .Intention to treat analysis is related to methodological quality[J]. BMJ, 2000,320(7240):1007-1008 doi: 10.1136/bmj.320.7240.1007
[225]	Altman DG . Missing outcomes in randomized trials: addressing the dilemma[J]. Open Med, 2009,3(2):e51-e53 pmid: 19946393
[226]	Wood AM, White IR, Thompson SG . Are missing outcome data adequately handled? A review of published randomized controlled trials in major medical journals[J]. Clin Trials, 2004,1(4):368-376 doi: 10.1191/1740774504cn032oa
[227]	Streiner DL . Missing data and the trouble with LOCF[J]. Evid Based Ment Health, 2008,11(1):3-5 doi: 10.1136/ebmh.11.1.3-a pmid: 18223040
[228]	Molnar FJ, Hutton B, Fergusson D . Does analysis using "last observation carried forward" introduce bias in dementia research?[J]. CMAJ, 2008,179(8):751-753 doi: 10.1503/cmaj.080820 pmid: 18838445
[229]	Ware JH . Interpreting incomplete data in studies of diet and weight loss[J]. N Engl J Med, 2003,348(21):2136-2137 doi: 10.1056/NEJMe030054 pmid: 12761370
[230]	Streiner DL . The case of the missing data: methods of dealing with dropouts and other research vagaries[J]. Can J Psychiatry, 2002,47(1):68-75 doi: 10.1192/bjp.180.2.190 pmid: 11873711
[231]	Lane P . Handling drop-out in longitudinal clinical trials: a comparison of the LOCF and MMRM approaches[J]. Pharm Stat, 2008,7(2):93-106 doi: 10.1002/(ISSN)1539-1612
[232]	Abraha I, Montedori A, Romagnoli C .Modified intention to treat: frequency, definition and implication for clinical trials [abstract][M].Sao Paulo, Brazil: XV Cochrane Colloquium, 2007: 86-87
[233]	Altman DG . Confidence intervals in practice. In: Altman DG, Machin D, Bryant TN, Gardner MJ, eds. Statistics with confidence. 2nd ed. BMJ Books. 2000: 6-14.
[234]	van Linschoten R, van Middelkoop M, Berger MY, Heintjes EM, Verhaar JA, Willemsen SP, Koes BW, Bierma-Zeinstra SM .Supervised exercise therapy versus usual care for patellofemoral pain syndrome: an open label randomised controlled trial[J].BMJ, 2009, 339: b4074 doi: 10.1136/bmj.b4074
[235]	Altman DG . Clinical trials and meta-analyses. In: Altman DG, Machin D, Bryant TN, Gardner MJ, eds. Statistics with confidence. 2nd ed. BMJ Books. 2000: 120-138.
[236]	Uniform requirements for manuscripts submitted to biomedical journals. International Committee of Medical Journal Editors[J]. Ann Intern Med, 1997,126(1):36-47 doi: 10.1111/j.1365-2923.1999.00339.x
[237]	Gardner MJ, Altman DG . Confidence intervals rather than P values: estimation rather than hypojournal testing[J]. BMJ, 1986,292(6522):746-750 doi: 10.1136/bmj.292.6522.746 pmid: 3082422
[238]	Bailar JC 3rd, Mosteller F . Guidelines for statistical reporting in articles for medical journals. Amplifications and explanations[J]. Ann Intern Med, 1988,108(2):266-273 doi: 10.7326/0003-4819-108-2-266
[239]	Bland JM . Quoting intermediate analyses can only mislead[J]. BMJ, 1997,314(7098):1907-1908 doi: 10.1136/bmj.314.7098.1907a pmid: 9224157
[240]	Cook RJ, Sackett DL . The number needed to treat: a clinically useful measure of treatment effect[J]. BMJ, 1995,310(6977):452-454 doi: 10.1136/bmj.310.6977.452
[241]	Altman DG, Andersen PK . Calculating the number needed to treat for trials where the outcome is time to an event[J]. BMJ, 1999,319(7223):1492-1495 doi: 10.1136/bmj.319.7223.1492 pmid: 10582940
[242]	The OSIRIS Collaborative Group . Early versus delayed neonatal administration of a synthetic surfactant—the judgment of OSIRIS(open study of infants at high risk of or with respiratory insufficiency—the role of surfactant)[J]. Lancet, 1992,340(8832):1363-1369 doi: 10.1016/0020-7292(93)90650-L
[243]	Sorensen L, Gyrd-Hansen D, Kristiansen IS, Nexøe J, Nielsen JB .Laypersons' understanding of relative risk reductions: randomised cross-sectional study[J].BMC Med Inform Decis Mak, 2008, 8: 31 doi: 10.1186/1472-6947-8-31 pmid: 2494548
[244]	Bobbio M, Demichelis B, Giustetto G . Completeness of reporting trial results: effect on physicians' willingness to prescribe[J]. Lancet, 1994,343(8907):1209-1211 doi: 10.1016/S0140-6736(94)92407-4 pmid: 7909875
[245]	Naylor CD, Chen E, Strauss B . Measured enthusiasm: does the method of reporting trial results alter perceptions of therapeutic effectiveness?[J]. Ann Intern Med, 1992,117(11):916-921 doi: 10.7326/0003-4819-117-11-916
[246]	Tukey JW . Some thoughts on clinical trials, especially problems of multiplicity[J]. Science, 1977,198(4318):679-684 doi: 10.1126/science.333584 pmid: 333584
[247]	Yusuf S, Wittes J, Probstfield J, Tyroler HA . Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials[J]. JAMA, 1991,266(1):93-98 doi: 10.1001/jama.1991.03470010097038
[248]	Hahn S, Williamson PR, Hutton JL, Garner P, Flynn EV . Assessing the potential for bias in meta-analysis due to selective reporting of subgroup analyses within studies[J]. Stat Med, 2000,19(24):3325-3336 doi: 10.1002/(ISSN)1097-0258
[249]	Bhandari M, Devereaux PJ, Li P, Mah D, Lim K, Schünemann HJ, Tornetta P 3rd .Misuse of baseline comparison tests and subgroup analyses in surgical trials[J].Clin Orthop Relat Res, 2006, 447: 247-251 doi: 10.1097/01.blo.0000218736.23506.fe pmid: 16672904
[250]	Levin M, Quint PA, Goldstein B, Barton P, Bradley JS, Shemie SD, Yeh T, Kim SS, Cafaro DP, Scannon PJ, Giroir BP . Recombinant bactericidal/permeability-increasing protein(rBPI21) as adjunctive treatment for children with severe meningococcal sepsis: a randomised trial. rBPI21 Meningococcal Sepsis Study Group[J]. Lancet, 2000,356(9234):961-967 doi: 10.1016/S0140-6736(00)02712-4
[251]	Scharf O, Colevas AD . Adverse event reporting in publications compared with sponsor database for cancer clinical trials[J]. J Clin Oncol, 2006,24(24):3933-3938 doi: 10.1200/JCO.2005.05.3959
[252]	Pitrou I, Boutron I, Ahmad N, Ravaud P . Reporting of safety results in published reports of randomized controlled trials[J]. Arch Intern Med, 2009,169(19):1756-1761 doi: 10.1001/archinternmed.2009.306 pmid: 19858432
[253]	Boden WE, O'Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ, Knudtson M, Dada M, Casperson P, Harris CL, Chaitman BR, Shaw L, Gosselin G, Nawaz S, Title LM, Gau G, Blaustein AS, Booth DC, Bates ER, Spertus JA, Berman DS, Mancini GB, Weintraub WS; COURAGE Trial Research Group .Optimal medical therapy with or without PCI for stable coronary disease[J]. N Engl J Med, 2007,356(15):1503-1516 doi: 10.1007/s12170-007-0044-2
[254]	Horton R . The rhetoric of research[J]. BMJ, 1995,310(6985):985-987 doi: 10.1136/bmj.310.6985.985
[255]	Annals of Internal Medicine. Information for authors. Available at (accessed 15 Jan 2008).
[256]	Docherty M, Smith R . The case for structuring the discussion of scientific papers[J]. BMJ, 1999,318(7193):1224-1225 doi: 10.1136/bmj.318.7193.1224 pmid: 10231230
[257]	Purcell GP, Donovan SL, Davidoff F . Changes to manuscripts during the editorial process: characterizing the evolution of a clinical paper[J]. JAMA, 1998,280(3):227-228 doi: 10.1001/jama.280.3.227
[258]	Ioannidis JP . Limitations are not properly acknowledged in the scientific literature[J]. J Clin Epidemiol, 2007,60(4):324-329 doi: 10.1016/j.jclinepi.2006.09.011 pmid: 17346604
[259]	Kiviluoto T, Sirén J, Luukkonen P, Kivilaakso E . Randomised trial of laparoscopic versus open cholecystectomy for acute and gangrenous cholecystitis[J]. Lancet, 1998,351(9099):321-325 doi: 10.1016/S0140-6736(97)08447-X
[260]	Hupperets MD, Verhagen EA, van Mechelen W .Effect of unsupervised home based proprioceptive training on recurrences of ankle sprain: randomised controlled trial[J].BMJ, 2009, 339: b2684 doi: 10.1136/bmj.b2684
[261]	Garber J, Clarke GN, Weersing VR, Beardslee WR, Brent DA, Gladstone TR, DeBar LL, Lynch FL, D'Angelo E, Hollon SD, Shamseddeen W, Iyengar S .Prevention of depression in at-risk adolescents: a randomized controlled trial[J]. JAMA, 2009,301(21):2215-2224 doi: 10.1001/jama.2009.788
[262]	CAMPBELL DT . Factors relevant to the validity of experiments in social settings[J]. Psychol Bull, 1957,54(4):297-312 doi: 10.1037/h0040950 pmid: 13465924
[263]	Rothwell PM . Factors that can affect the external validity of randomised controlled trials[J]. PLoS Clin Trials, 2006,1(1):e9 doi: 10.1371/journal.pctr.0010009
[264]	King M, Nazareth I, Lampe F, Bower P, Chandler M, Morou M, Sibbald B, Lai R .Conceptual framework and systematic review of the effects of participants' and professionals' preferences in randomised controlled trials[J].Health Technol Assess, 2005, 9(35):1-186, iii-iv
[265]	Djulbegovic B, Lacevic M, Cantor A, Fields KK, Bennett CL, Adams JR, Kuderer NM, Lyman GH . The uncertainty principle and industry-sponsored research[J]. Lancet, 2000,356(9230):635-638 doi: 10.1016/S0140-6736(00)02605-2 pmid: 10968436
[266]	Dans AL, Dans LF, Guyatt GH, Richardson S . Users' guides to the medical literature: XIV. How to decide on the applicability of clinical trial results to your patient. Evidence-Based Medicine Working Group[J]. JAMA, 1998,279(7):545-549 doi: 10.1001/jama.279.7.545
[267]	Smith GD, Egger M . Who benefits from medical interventions?[J]. BMJ, 1994,308(6921):72-74 doi: 10.1136/bmj.308.6921.72 pmid: 0008298415
[268]	McAlister FA . Applying the results of systematic reviews at the bedside. In: Egger M, Davey Smith G, Altman DG, eds. Systematic reviews in health care: meta-analysis in context. BMJ Books. 2001.
[269]	Bartlett C, Doyal L, Ebrahim S, Davey P, Bachmann M, Egger M, Dieppe P .The causes and effects of socio-demographic exclusions from clinical trials[J].Health Technol Assess, 2005, 9(38):iii-iv, ix-x, 1-152 doi: 10.3310/hta9380 pmid: 16181564
[270]	Bonell C, Oakley A, Hargreaves J, Strange V, Rees R . Assessment of generalisability in trials of health interventions: suggested framework and systematic review[J]. BMJ, 2006,333(7563):346-349 doi: 10.1136/bmj.333.7563.346
[271]	Bornh?ft G, Maxion-Bergemann S, Wolf U, Kienle GS, Michalsen A, Vollmar HC, Gilbertson S, Matthiessen PF .Checklist for the qualitative evaluation of clinical studies with particular focus on external validity and model validity[J].BMC Med Res Methodol, 2006, 6: 56 doi: 10.1186/1471-2288-6-56
[272]	Laupacis A, Sackett DL, Roberts RS . An assessment of clinically useful measures of the consequences of treatment[J]. N Engl J Med, 1988,318(26):1728-1733 doi: 10.1056/NEJM198806303182605 pmid: 3374545
[273]	Altman DG . Confidence intervals for the number needed to treat[J]. BMJ, 1998,317(7168):1309-1312 doi: 10.1136/bmj.317.7168.1309
[274]	Fanaroff AA, Korones SB, Wright LL, Wright EC, Poland RL, Bauer CB, Tyson JE, Philips JB 3rd, Edwards W, Lucey JF, et al .A controlled trial of intravenous immune globulin to reduce nosocomial infections in very-low-birth-weight infants. National Institute of Child Health and Human Development Neonatal Research Network[J]. N Engl J Med, 1994,330(16):1107-1113 doi: 10.1056/NEJM199404213301602
[275]	. Randomised trial of intravenous atenolol among 16 027 cases of suspected acute myocardial infarction: ISIS-1. First International Study of Infarct Survival Collaborative Group among 16 027 cases of suspected acute myocardial infarction: ISIS-1. First International Study of Infarct Survival Collaborative Group[J]. Lancet, 1986,2(8498):57-66
[276]	Gøtzsche PC, Gjørup I, Bonnén H, Brahe NE, Becker U, Burcharth F . Somatostatin v placebo in bleeding oesophageal varices: randomised trial and meta-analysis[J]. BMJ, 1995,310(6993):1495-1498 doi: 10.1136/bmj.310.6993.1495 pmid: 7787594
[277]	Clarke M, Hopewell S, Chalmers I . Reports of clinical trials should begin and end with up-to-date systematic reviews of other relevant evidence: a status report[J]. J R Soc Med, 2007,100(4):187-190 doi: 10.1177/014107680710011415
[278]	Goodman SN . Toward evidence-based medical statistics. 1: The P value fallacy[J]. Ann Intern Med, 1999,130(12):995-1004 doi: 10.7326/0003-4819-130-12-199906150-00008 pmid: 10383371
[279]	Gøtzsche PC . Reference bias in reports of drug trials[J]. BMJ, 1987,295(6599):654-656 doi: 10.1136/bmj.295.6599.654 pmid: 0003117277
[280]	Papp K, Bissonnette R, Rosoph L, Wasel N, Lynde CW, Searles G, Shear NH, Huizinga RB, Maksymowych WP . Efficacy of ISA247 in plaque psoriasis: a randomised, multicentre, double-blind, placebo-controlled phase III study[J]. Lancet, 2008,371(9621):1337-1342 doi: 10.1016/S0140-6736(08)60593-0
[281]	Dickersin K . How important is publication bias? A synjournal of available data[J]. AIDS Educ Prev, 1997,9(1 Suppl):15-21 doi: 10.1097/00001888-199702000-00027 pmid: 9083596
[282]	Song F, Eastwood AJ, Gilbody S, Duley L, Sutton AJ . Publication and related biases[J]. Health Technol Assess, 2000,4(10):1-115
[283]	Williamson PR, Gamble C . Identification and impact of outcome selection bias in meta-analysis[J]. Stat Med, 2005,24(10):1547-1561 doi: 10.1002/sim.2025 pmid: 15580591
[284]	Tramèr MR, Reynolds DJ, Moore RA, McQuay HJ .Impact of covert duplicate publication on meta-analysis: a case study[J]. BMJ, 1997,315(7109):635-640 doi: 10.1136/bmj.315.7109.635 pmid: 9310564
[285]	Simes RJ . Publication bias: the case for an international registry of clinical trials[J]. J Clin Oncol, 1986,4(10):1529-1541 doi: 10.1200/JCO.1986.4.10.1529 pmid: 3760920
[286]	Chalmers I . From optimism to disillusion about commitment to transparency in the medico-industrial complex[J]. J R Soc Med, 2006,99(7):337-341 doi: 10.1258/jrsm.99.7.337 pmid: 16816262
[287]	Tonks A . A clinical trials register for Europe[J]. BMJ, 2002,325(7376):1314-1315 doi: 10.1136/bmj.325.7376.1314 pmid: 12468459
[288]	Dickersin K, Rennie D . Registering clinical trials[J]. JAMA, 2003,290(4):516-523 doi: 10.1001/jama.290.4.516
[289]	Whittington CJ, Kendall T, Fonagy P, Cottrell D, Cotgrove A, Boddington E . Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data[J]. Lancet, 2004,363(9418):1341-1345 doi: 10.1016/S0140-6736(04)16043-1
[290]	De Angelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, Van Der Weyden MB; International Committee of Medical Journal Editors .Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors[J]. Lancet, 2005,365(9474):1827-1829 doi: 10.1016/S0140-6736(05)66588-9
[291]	Zarin DA, Ide NC, Tse T, Harlan WR, West JC, Lindberg DA . Issues in the registration of clinical trials[J]. JAMA, 2007,297(19):2112-2120 doi: 10.1001/jama.297.19.2112 pmid: 17507347
[292]	Hopewell S, Altman DG, Moher D, Schulz KF .Endorsement of the CONSORT Statement by high impact factor medical journals: a survey of journal editors and journal 'Instructions to Authors'A[J].Trials, 2008, 9: 20 doi: 10.1186/1745-6215-9-20
[293]	Russell JA, Walley KR, Singer J, Gordon AC, Hébert PC, Cooper DJ, Holmes CL, Mehta S, Granton JT, Storms MM, Cook DJ, Presneill JJ, Ayers D; VASST Investigators . Vasopressin versus norepinephrine infusion in patients with septic shock[J]. N Engl J Med, 2008,358(9):877-887 doi: 10.1056/NEJMoa067373 pmid: 18305265
[294]	Chan AW, Tetzlaff J, Altman D, Gøtzsche PC, Hróbjartsson A, Krleza-Jeric K , et al. The SPIRIT initiative: defining standard protocol items for randomised trials. Oral presentation at the 16th Cochrane Colloquium: Evidence in the era of globalisation; 2008 Oct 3-7; Freiburg, Germany [abstract]. Zeitschrift fur Evidenz, Fortbildung und Qualitat im Gesundheitswesen, 2008; 102: 27.
[295]	Gregson S, Adamson S, Papaya S, Mundondo J, Nyamukapa CA, Mason PR, Garnett GP, Chandiwana SK, Foster G, Anderson RM . Impact and process evaluation of integrated community and clinic-based HIV-1 control: a cluster-randomised trial in eastern Zimbabwe[J]. PLoS Med, 2007,4(3):e102 doi: 10.1371/journal.pmed.0040102
[296]	Shaddy RE, Boucek MM, Hsu DT, Boucek RJ, Canter CE, Mahony L, Ross RD, Pahl E, Blume ED, Dodd DA, Rosenthal DN, Burr J, LaSalle B, Holubkov R, Lukas MA, Tani LY; Pediatric Carvedilol Study Group . Carvedilol for children and adolescents with heart failure: a randomized controlled trial[J]. JAMA, 2007,298(10):1171-1179 doi: 10.1001/jama.298.10.1171
[297]	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
[298]	Kjaergard LL, Als-Nielsen B . Association between competing interests and authors' conclusions: epidemiological study of randomised clinical trials published in the BM[J]. BMJ, 2002,325(7358):249 doi: 10.1136/bmj.325.7358.249
[299]	Bero L, Oostvogel F, Bacchetti P, Lee K . Factors associated with findings of published trials of drug-drug comparisons: why some statins appear more efficacious than others[J]. PLoS Med, 2007,4(6):e184 doi: 10.1371/journal.pmed.0040184
[300]	Sismondo S . Pharmaceutical company funding and its consequences: a qualitative systematic review[J]. Contemp Clin Trials, 2008,29(2):109-113 doi: 10.1016/j.cct.2007.08.001 pmid: 17919992
[301]	Als-Nielsen B, Chen W, Gluud C, Kjaergard LL . Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events?[J]. JAMA, 2003,290(7):921-928 doi: 10.1001/jama.290.7.921
[302]	Ross JS, Hill KP, Egilman DS, Krumholz HM . Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation[J]. JAMA, 2008,299(15):1800-1812 doi: 10.1001/jama.299.15.1800
[303]	McAlister FA, Straus SE, Sackett DL, Altman DG . Analysis and reporting of factorial trials: a systematic review[J]. JAMA, 2003,289(19):2545-2553 doi: 10.1001/jama.289.19.2545
[304]	Senn S .Crossover trials in clinical research(2nd ed) [M].Wiley: 2002,( 2nd ed)
[305]	Deeks JJ, Dinnes J, D'Amico R, Sowden AJ, Sakarovitch C, Song F, Petticrew M, Altman DG; International Stroke Trial Collaborative Group; European Carotid Surgery Trial Collaborative Group .Evaluating non-randomised intervention studies[J].Health Technol Assess, 2003, 7(27):iii- x, 1-173 doi: 10.3310/hta7270 pmid: 14499048
[306]	Kunz R, Vist G, Oxman AD . Randomisation to protect against selection bias in healthcare trials. Cochrane Database Syst Rev 2007. MR000012.
[307]	Collins R, MacMahon S .Reliable assessment of the effects of treatment on mortality and major morbidity, I: clinical trials[J]. Lancet, 2001,357(9253):373-380 doi: 10.1016/S0140-6736(00)03651-5
[308]	Schulz KF . Randomised trials, human nature, and reporting guidelines[J]. Lancet, 1996,348(9027):596-598 doi: 10.1016/S0140-6736(96)01201-9 pmid: 8774577
[309]	Murray GD . Promoting good research practice[J]. Stat Methods Med Res, 2000,9(1):17-24 doi: 10.1177/096228020000900103
[310]	Narahari SR, Ryan TJ, Aggithaya MG, Bose KS, Prasanna KS . Evidence-based approaches for the Ayurvedic traditional herbal formulations: toward an Ayurvedic CONSORT model[J]. J Altern Complement Med, 2008,14(6):769-776 doi: 10.1089/acm.2007.0818
[311]	Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, Lijmer JG, Moher D, Rennie D, de Vet HCW .Towards complete and accurate reporting of studies of diagnostic accuracy: The STARD Initiative[J]. Ann Intern Med, 2003,138(1):40-44 doi: 10.7326/0003-4819-138-1-200301070-00010
[312]	von Elm E, Altman DG, Egger M, Pocock SJ, G?tzsche PC, Vandenbroucke JP . The Strengthening the Reporting of Observational Studies in Epidemiology(STROBE) statement: guidelines for reporting observational studies[J]. Ann Intern Med, 2007,147(8):573-577 doi: 10.7326/0003-4819-147-8-200710160-00010
[313]	Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van't Veer M, Klauss V, Manoharan G, Engstrøm T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators .Fractional flow reserve versus angiography for guiding percutaneous coronary intervention[J]. N Engl J Med, 2009,360(3):213-224 doi: 10.1056/NEJMoa0807611

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项目	描述
作者	通讯作者的详细联系信息
试验设计	试验设计的描述（例如平行试验、群组试验、非劣效试验等）
方法：
受试者	受试者的合格标准和数据采集的场所
干预措施	各组拟实施的干预措施
目的	具体目的或假设
结局指标	清楚地说明该项研究的主要结局指标
随机方法	如何分配受试者进入各干预组
盲法(遮蔽）	是否将分组情况对受试者、医护提供者以及结局测评者设盲
结果：
随机分组的例数	随机分入各组的受试者人数
招募受试者	临床试验状态
纳入分析的例数	每组纳入数据分析的受试者数目
结局	各组主要结局指标的结果及其效应估计值和精确性
危害	重要的不良事件或副作用
结论	对结果的概括性解释
试验注册	临床试验注册号和注册机构名称
资助	资助来源

阶段	纳入人数	未纳入或排除的人数	理由
招募受试者	已评价的招募对象人数	不符合纳入标准的人数或符合纳	这些数字反映参加试验的受试者对全体就诊患者的代表性;它
		入标准但拒绝参加试验的人数	们仅与评价外部真实性相关,它们常常未予报告。
随机分配	随机分配的受试者人数		用于定义试验大小和评价试验是否经意向性治疗分析的关键数字
分配治疗	按分配完成治疗的受试者	未按分配完成治疗的受试者人	用于评价内部真实性和解释结果的重要数字;应该给出未接受
	人数,按组分别列出	数,按组分别列出	分配的治疗的原因。
随访	按分配完成治疗的受试者	未按分配完成治疗的受试者人	用于评价内部真实性和解释结果的重要数字;应该给出未完成
	人数,按组分别列出	数,按组分别列出	治疗或随访的原因。
	按计划完成随访的受试者	未按计划完成随访的受试者人
	人数,按组分别列出	数,按组分别列出
分析	纳入主要分析的受试者人	未纳入主要分析的受试者人数,	用于评价试验是否经意向性治疗分析的关键数字;应该给出排
	数,按组分别列出	按组分别列出	除受试者的原因。

	替米沙坦（N=2 954)	安慰剂（N=2 972)
年龄(岁）	66.9 (7.3)	66.9 (7.4)
性别(女性）	1 280 (43. 3%)	1 267 (42. 6%)
吸烟情况：
还在吸烟	293 (9.9%)	289 (9.7%)
过去吸烟	1 273 (43. 1%)	1 283 (43.2%)
人种：
亚洲	637 (21. 6%)	624 (21.0%)
阿拉伯	37 (1. 3%)	40 (1. 3%)
非洲	51 (1.7%)	55 (1.9%)
欧洲	1 801 (61. 0%)	1 820 (61.2%)
土著	390 (13.2%)	393 (13.2%)
其他	38 (1. 3%)	40 (1.3%)
血压（mm Hg)	140.7 (16.8/81.8) (10.1)	141.3 (16.4/82.0) (10.2)
心率(次/分）	68.8 (11.5)	68.8 (12.1)
胆固醇(mmol/L):
总胆固醇	5.09 (1.18)	5.08 (1.15)
低密度脂蛋白胆固醇	3.02 (1.01)	3.03 (1.02)
高密度脂蛋白胆固醇	1.27 (0.37)	1.28 (0.41)
冠状动脉疾病	2 211 (74.8%)	2 207 (74. 3%)
心肌梗死	1 381 (46.8%)	1 360 (45.8%)
心绞痛	1 412 (47.8%)	1 412 (47.5%)
外周动脉疾病	349 (11.8%)	323 (10.9%)
高血压	2 259 (76. 5%)	2 269 (76. 3%)
糖尿病	1 059 (35.8%)	1 059 (35. 6%)

CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials (Chinese version)

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