Home LiteratureArticle Details
PMID: 20332511 Published · epublish English Journal Article Research Support, Non-U.S. Gov't

CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials.

BMJ (Clinical research ed.) ·Vol. 340 ·2010-03-23 ·Pages c869

Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG

Abstract

暂无摘要

MeSH Terms
Consensus Practice Guidelines as Topic/standards Randomized Controlled Trials as Topic/standards Research Design/standards
Authors & Affiliations
9 authors, click to expand affiliations / ORCID
Moher David
Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa Hospital, Ottawa, Ontario, Canada. [email protected]
Hopewell Sally
Schulz Kenneth F
Montori Victor
Gøtzsche Peter C
Devereaux P J
Elbourne Diana
Egger Matthias
Altman Douglas G
References (283)
283 references, click to expand
  1. 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.
    JAMA. 2008 May 7;299(17):2027-36 PMID: 18460663
  2. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials.
    JAMA. 2001 Apr 18;285(15):1987-91 PMID: 11308435
  3. Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research.
    CMAJ. 2004 Sep 28;171(7):735-40 PMID: 15451835
  4. Methodology and overt and hidden bias in reports of 196 double-blind trials of nonsteroidal antiinflammatory drugs in rheumatoid arthritis.
    Control Clin Trials. 1989 Mar;10(1):31-56 PMID: 2702836
  5. Randomized trials stopped early for benefit: a systematic review.
    JAMA. 2005 Nov 2;294(17):2203-9 PMID: 16264162
  6. Effect of needle length on incidence of local reactions to routine immunisation in infants aged 4 months: randomised controlled trial.
    BMJ. 2000 Oct 14;321(7266):931-3 PMID: 11030682
  7. Reporting on quality of life in randomised controlled trials: bibliographic study.
    BMJ. 1998 Oct 31;317(7167):1191-4 PMID: 9794853
  8. Publication bias: the case for an international registry of clinical trials.
    J Clin Oncol. 1986 Oct;4(10):1529-41 PMID: 3760920
  9. Chronic care model and shared care in diabetes: randomized trial of an electronic decision support system.
    Mayo Clin Proc. 2008 Jul;83(7):747-57 PMID: 18613991
  10. News from the International Committee of Medical Journal Editors.
    Ann Intern Med. 2000 Aug 1;133(3):229-31 PMID: 10906840
  11. 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.
    CMAJ. 1994 May 15;150(10):1611-5 PMID: 8174031
  12. The agonising negative trend in monitoring of clinical trials.
    Lancet. 1999 Dec 4;354(9194):1983-8 PMID: 10622312
  13. Epidemiology and reporting of randomised trials published in PubMed journals.
    Lancet. 2005 Mar 26-Apr 1;365(9465):1159-62 PMID: 15794971
  14. CONSORT for reporting randomised trials in journal and conference abstracts.
    Lancet. 2008 Jan 26;371(9609):281-3 PMID: 18221781
  15. Intention to treat--who should use ITT?
    Br J Cancer. 1993 Oct;68(4):647-50 PMID: 8398686
  16. Quality of full and final publications reporting acute stroke trials: a systematic review.
    Stroke. 1998 Oct;29(10):2203-10 PMID: 9756604
  17. How to randomise.
    BMJ. 1999 Sep 11;319(7211):703-4 PMID: 10480833
  18. 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 Clin Epidemiol. 1998 Feb;51(2):69-79 PMID: 9474067
  19. Factors relevant to the validity of experiments in social settings.
    Psychol Bull. 1957 Jul;54(4):297-312 PMID: 13465924
  20. Intravenous fluid restriction after major abdominal surgery: a randomized blinded clinical trial.
    Trials. 2009 Jul 07;10:50 PMID: 19583868
  21. Randomised trials, human nature, and reporting guidelines.
    Lancet. 1996 Aug 31;348(9027):596-8 PMID: 8774577
  22. Evaluating non-randomised intervention studies.
    Health Technol Assess. 2003;7(27):iii-x, 1-173 PMID: 14499048
  23. Intention-to-treat analysis and accounting for missing data in orthopaedic randomized clinical trials.
    J Bone Joint Surg Am. 2009 Sep;91(9):2137-43 PMID: 19723990
  24. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration.
    Ann Intern Med. 2008 Feb 19;148(4):295-309 PMID: 18283207
  25. Randomized controlled trials of aprotinin in cardiac surgery: could clinical equipoise have stopped the bleeding?
    Clin Trials. 2005;2(3):218-29; discussion 229-32 PMID: 16279145
  26. Randomisation and baseline comparisons in clinical trials.
    Lancet. 1990 Jan 20;335(8682):149-53 PMID: 1967441
  27. Psychological treatments for irritable bowel syndrome: a critique of controlled treatment trials.
    Am J Gastroenterol. 1996 Feb;91(2):277-83 PMID: 8607493
  28. Drug treatment of functional dyspepsia: a systematic analysis of trial methodology with recommendations for design of future trials.
    Am J Gastroenterol. 1996 Apr;91(4):660-73 PMID: 8677926
  29. Guidelines for authors and peer reviewers of economic submissions to the BMJ. The BMJ Economic Evaluation Working Party.
    BMJ. 1996 Aug 3;313(7052):275-83 PMID: 8704542
  30. Somatostatin v placebo in bleeding oesophageal varices: randomised trial and meta-analysis.
    BMJ. 1995 Jun 10;310(6993):1495-8 PMID: 7787594
  31. Logistic regression models in obstetrics and gynecology literature.
    Obstet Gynecol. 1999 Jun;93(6):1014-20 PMID: 10362173
  32. A randomised controlled trial and meta-analysis of active management of labour.
    BJOG. 2000 Jul;107(7):909-15 PMID: 10901564
  33. Selective reporting in clinical trials: analysis of trial protocols accepted by The Lancet.
    Lancet. 2008 Jul 19;372(9634):201 PMID: 18640445
  34. Efficacy of ISA247 in plaque psoriasis: a randomised, multicentre, double-blind, placebo-controlled phase III study.
    Lancet. 2008 Apr 19;371(9621):1337-42 PMID: 18424323
  35. Turning a blind eye: why we don't test for blindness at the end of our trials.
    BMJ. 2004 May 8;328(7448):1136 PMID: 15130997
  36. Effects of Internet behavioral counseling on weight loss in adults at risk for type 2 diabetes: a randomized trial.
    JAMA. 2003 Apr 9;289(14):1833-6 PMID: 12684363
  37. Quality, evolution, and clinical implications of randomized, controlled trials on the treatment of lung cancer. A lost opportunity for meta-analysis.
    JAMA. 1989 Oct 20;262(15):2101-7 PMID: 2677423
  38. Calculating the number needed to treat for trials where the outcome is time to an event.
    BMJ. 1999 Dec 4;319(7223):1492-5 PMID: 10582940
  39. External validity of randomised controlled trials: "to whom do the results of this trial apply?".
    Lancet. 2005 Jan 1-7;365(9453):82-93 PMID: 15639683
  40. Adherence to published standards of reporting: a comparison of placebo-controlled trials published in English or German.
    JAMA. 1998 Jul 15;280(3):247-9 PMID: 9676671
  41. Statistics notes: blinding in clinical trials and other studies.
    BMJ. 2000 Aug 19-26;321(7259):504 PMID: 10948038
  42. Blinding during data analysis and writing of manuscripts.
    Control Clin Trials. 1996 Aug;17(4):285-90; discussion 290-3 PMID: 8889343
  43. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials.
    BMJ. 2010 Mar 23;340:c332 PMID: 20332509
  44. Randomisation to protect against selection bias in healthcare trials.
    Cochrane Database Syst Rev. 2007 Apr 18;(2):MR000012 PMID: 17443633
  45. Reported use of data monitoring committees in the main published reports of randomized controlled trials: a cross-sectional study.
    Clin Trials. 2004 Feb;1(1):48-59 PMID: 16281462
  46. 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.
    N Engl J Med. 1978 Sep 28;299(13):690-4 PMID: 355881
  47. Issues in the registration of clinical trials.
    JAMA. 2007 May 16;297(19):2112-20 PMID: 17507347
  48. The impact of blinding on the results of a randomized, placebo-controlled multiple sclerosis clinical trial.
    Neurology. 1994 Jan;44(1):16-20 PMID: 8290055
  49. Are research ethics committees behaving unethically? Some suggestions for improving performance and accountability.
    BMJ. 1996 Nov 30;313(7069):1390-3 PMID: 8956711
  50. Lack of benefit of a single dose of synthetic human secretin in the treatment of autism and pervasive developmental disorder.
    N Engl J Med. 1999 Dec 9;341(24):1801-6 PMID: 10588965
  51. Factors that can affect the external validity of randomised controlled trials.
    PLoS Clin Trials. 2006 May;1(1):e9 PMID: 16871331
  52. Etanercept in the treatment of psoriatic arthritis and psoriasis: a randomised trial.
    Lancet. 2000 Jul 29;356(9227):385-90 PMID: 10972371
  53. Analysis and reporting of factorial trials: a systematic review.
    JAMA. 2003 May 21;289(19):2545-53 PMID: 12759326
  54. Adverse event reporting in publications compared with sponsor database for cancer clinical trials.
    J Clin Oncol. 2006 Aug 20;24(24):3933-8 PMID: 16921045
  55. Statistical problems in the reporting of clinical trials. A survey of three medical journals.
    N Engl J Med. 1987 Aug 13;317(7):426-32 PMID: 3614286
  56. From optimism to disillusion about commitment to transparency in the medico-industrial complex.
    J R Soc Med. 2006 Jul;99(7):337-41 PMID: 16816262
  57. In the era of systematic reviews, does the size of an individual trial still matter.
    PLoS Med. 2008 Jan 3;5(1):e4 PMID: 18177203
  58. Interpreting incomplete data in studies of diet and weight loss.
    N Engl J Med. 2003 May 22;348(21):2136-7 PMID: 12761370
  59. Trials stopped early: too good to be true?
    Lancet. 1999 Mar 20;353(9157):943-4 PMID: 10459899
  60. Randomisation.
    BMJ. 1991 Jun 22;302(6791):1481-2 PMID: 1855013
  61. When to stop a clinical trial.
    BMJ. 1992 Jul 25;305(6847):235-40 PMID: 1392832
  62. The reporting of methods for reducing and detecting bias: an example from the WHO Misoprostol Third Stage of Labour equivalence randomised controlled trial.
    BMC Med Res Methodol. 2003 Oct 03;3:19 PMID: 14525622
  63. Association between competing interests and authors' conclusions: epidemiological study of randomised clinical trials published in the BMJ.
    BMJ. 2002 Aug 3;325(7358):249 PMID: 12153921
  64. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design.
    Br J Cancer. 1976 Dec;34(6):585-612 PMID: 795448
  65. Controversy in counting and attributing events in clinical trials.
    N Engl J Med. 1979 Dec 27;301(26):1410-2 PMID: 514321
  66. Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review.
    Med J Aust. 2006 Sep 4;185(5):263-7 PMID: 16948622
  67. Who benefits from medical interventions?
    BMJ. 1994 Jan 8;308(6921):72-4 PMID: 8298415
  68. Structured abstracts in MEDLINE, 1989-1991.
    Bull Med Libr Assoc. 1995 Apr;83(2):190-5 PMID: 7599584
  69. Statistics notes. Units of analysis.
    BMJ. 1997 Jun 28;314(7098):1874 PMID: 9224131
  70. Believability of relative risks and odds ratios in abstracts: cross sectional study.
    BMJ. 2006 Jul 29;333(7561):231-4 PMID: 16854948
  71. Stopping medical research to save money: a broken pact with researchers and patients.
    JAMA. 2003 Apr 23-30;289(16):2128-31 PMID: 12709471
  72. The role of randomization in clinical trials.
    Stat Med. 1982 Oct-Dec;1(4):345-52 PMID: 7187102
  73. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials.
    Lancet. 2001 Apr 14;357(9263):1191-4 PMID: 11323066
  74. Ascorbic acid for the common cold. A prophylactic and therapeutic trial.
    JAMA. 1975 Mar 10;231(10):1038-42 PMID: 163386
  75. Randomization, statistics, and causal inference.
    Epidemiology. 1990 Nov;1(6):421-9 PMID: 2090279
  76. Turning a blind eye: the success of blinding reported in a random sample of randomised, placebo controlled trials.
    BMJ. 2004 Feb 21;328(7437):432 PMID: 14761905
  77. A randomised controlled trial of care of the perineum during second stage of normal labour.
    Br J Obstet Gynaecol. 1998 Dec;105(12):1262-72 PMID: 9883917
  78. Prevention of depression in at-risk adolescents: a randomized controlled trial.
    JAMA. 2009 Jun 3;301(21):2215-24 PMID: 19491183
  79. Confidence intervals for the number needed to treat.
    BMJ. 1998 Nov 7;317(7168):1309-12 PMID: 9804726
  80. Methodologic standards in surgical trials.
    Surgery. 1996 Apr;119(4):466-72 PMID: 8644014
  81. More on zidovudine in asymptomatic HIV infection.
    N Engl J Med. 1994 Jun 16;330(24):1758-9 PMID: 8190146
  82. Impact of allocation concealment on conclusions drawn from meta-analyses of randomized trials.
    Int J Epidemiol. 2007 Aug;36(4):847-57 PMID: 17517809
  83. The use of predicted confidence intervals when planning experiments and the misuse of power when interpreting results.
    Ann Intern Med. 1994 Aug 1;121(3):200-6 PMID: 8017747
  84. Evidence-based approaches for the Ayurvedic traditional herbal formulations: toward an Ayurvedic CONSORT model.
    J Altern Complement Med. 2008 Jul;14(6):769-76 PMID: 18684081
  85. Reference bias in reports of drug trials.
    Br Med J (Clin Res Ed). 1987 Sep 12;295(6599):654-6 PMID: 3117277
  86. Generalizability of the results of randomized trials.
    Arch Intern Med. 2008 Jan 28;168(2):133-5 PMID: 18227357
  87. Checklist for the qualitative evaluation of clinical studies with particular focus on external validity and model validity.
    BMC Med Res Methodol. 2006 Dec 11;6:56 PMID: 17156475
  88. Evidence b(i)ased medicine--selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications.
    BMJ. 2003 May 31;326(7400):1171-3 PMID: 12775615
  89. Ardeparin sodium for extended out-of-hospital prophylaxis against venous thromboembolism after total hip or knee replacement. A randomized, double-blind, placebo-controlled trial.
    Ann Intern Med. 2000 Jun 6;132(11):853-61 PMID: 10836911
  90. Stopping rules and estimation problems in clinical trials.
    Stat Med. 1988 Dec;7(12):1231-42 PMID: 3231947
  91. Statistics notes. Interaction 2: Compare effect sizes not P values.
    BMJ. 1996 Sep 28;313(7060):808 PMID: 8842080
  92. The uncertainty principle and industry-sponsored research.
    Lancet. 2000 Aug 19;356(9230):635-8 PMID: 10968436
  93. Interim analyses, stopping rules and data monitoring in clinical trials in Europe.
    Stat Med. 1993 Mar;12(5-6):509-20 PMID: 8493429
  94. Better reporting of harms in randomized trials: an extension of the CONSORT statement.
    Ann Intern Med. 2004 Nov 16;141(10):781-8 PMID: 15545678
  95. The number needed to treat: a clinically useful measure of treatment effect.
    BMJ. 1995 Feb 18;310(6977):452-4 PMID: 7873954
  96. Median follow-up in clinical trials.
    J Clin Oncol. 1991 Jan;9(1):191-2 PMID: 1985169
  97. Statistical considerations in the intent-to-treat principle.
    Control Clin Trials. 2000 Jun;21(3):167-89 PMID: 10822117
  98. Systematic reviews in health care: Assessing the quality of controlled clinical trials.
    BMJ. 2001 Jul 7;323(7303):42-6 PMID: 11440947
  99. The causes and effects of socio-demographic exclusions from clinical trials.
    Health Technol Assess. 2005 Oct;9(38):iii-iv, ix-x, 1-152 PMID: 16181564
  100. Towards complete and accurate reporting of studies of diagnostic accuracy: The STARD Initiative.
    Ann Intern Med. 2003 Jan 7;138(1):40-4 PMID: 12513043
  101. Early versus delayed neonatal administration of a synthetic surfactant--the judgment of OSIRIS. The OSIRIS Collaborative Group (open study of infants at high risk of or with respiratory insufficiency--the role of surfactant.
    Lancet. 1992 Dec 5;340(8832):1363-9 PMID: 1360087
  102. A qualitative assessment of randomized controlled trials in otolaryngology.
    J Laryngol Otol. 1998 May;112(5):460-3 PMID: 9747475
  103. Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation.
    JAMA. 2008 Apr 16;299(15):1800-12 PMID: 18413874
  104. More informative abstracts revisited.
    Ann Intern Med. 1990 Jul 1;113(1):69-76 PMID: 2190518
  105. Multicenter comparison of the contraceptive ring and patch: a randomized controlled trial.
    Obstet Gynecol. 2008 Feb;111(2 Pt 1):267-77 PMID: 18238962
  106. Independence and statistical inference in clinical trial designs: a tutorial review.
    J Clin Pharmacol. 1998 May;38(5):408-12 PMID: 9602951
  107. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement.
    Ann Intern Med. 2006 Mar 7;144(5):364-7 PMID: 16520478
  108. The case for structuring the discussion of scientific papers.
    BMJ. 1999 May 8;318(7193):1224-5 PMID: 10231230
  109. Randomized clinical trials in HEPATOLOGY: predictors of quality.
    Hepatology. 1999 Nov;30(5):1134-8 PMID: 10534332
  110. FDA perspective on trials with interim efficacy evaluations.
    Stat Med. 2006 Oct 15;25(19):3245-9; discussion 3326-47 PMID: 16847824
  111. Randomised controlled trial of magnetic-resonance pelvimetry in breech presentation at term.
    Lancet. 1997 Dec 20-27;350(9094):1799-804 PMID: 9428250
  112. A clinical trials register for Europe.
    BMJ. 2002 Dec 7;325(7376):1314-5 PMID: 12468459
  113. 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.
    N Engl J Med. 1994 Apr 21;330(16):1107-13 PMID: 8133853
  114. Effectiveness of low-Dye taping for the short-term treatment of plantar heel pain: a randomised trial.
    BMC Musculoskelet Disord. 2006 Aug 09;7:64 PMID: 16895612
  115. Handling drop-out in longitudinal clinical trials: a comparison of the LOCF and MMRM approaches.
    Pharm Stat. 2008 Apr-Jun;7(2):93-106 PMID: 17351897
  116. Analysis of clinical trials by treatment actually received: is it really an option?
    Stat Med. 1991 Oct;10(10):1595-605 PMID: 1947515
  117. Subgroup analysis and other (mis)uses of baseline data in clinical trials.
    Lancet. 2000 Mar 25;355(9209):1064-9 PMID: 10744093
  118. Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events?
    JAMA. 2003 Aug 20;290(7):921-8 PMID: 12928469
  119. Uterine exteriorization compared with in situ repair at cesarean delivery: a randomized controlled trial.
    Obstet Gynecol. 2008 Mar;111(3):639-47 PMID: 18310366
  120. Quoting intermediate analyses can only mislead.
    BMJ. 1997 Jun 28;314(7098):1907-8 PMID: 9224157
  121. Quality of reporting of key methodological items of randomized controlled trials in clinical ophthalmic journals.
    Ophthalmic Epidemiol. 2007 Nov-Dec;14(6):390-8 PMID: 18161613
  122. Accuracy of data in abstracts of published research articles.
    JAMA. 1999 Mar 24-31;281(12):1110-1 PMID: 10188662
  123. Estimating treatment effects in randomized clinical trials in the presence of non-compliance.
    Stat Med. 2000 Jul 30;19(14):1849-64 PMID: 10867675
  124. Treatment effects monitoring committees and early stopping in large clinical trials.
    Clin Trials. 2004 Feb;1(1):40-7 PMID: 16281461
  125. The scandal of poor medical research.
    BMJ. 1994 Jan 29;308(6924):283-4 PMID: 8124111
  126. Statistical evaluation of medical journal manuscripts.
    JAMA. 1966 Mar 28;195(13):1123-8 PMID: 5952081
  127. Review of survival analyses published in cancer journals.
    Br J Cancer. 1995 Aug;72(2):511-8 PMID: 7640241
  128. 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.
    Ann Intern Med. 1994 Dec 1;121(11):894-5 PMID: 7978706
  129. Intention to treat analysis is related to methodological quality.
    BMJ. 2000 Apr 8;320(7240):1007-8 PMID: 10753165
  130. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies.
    Ann Intern Med. 2007 Oct 16;147(8):573-7 PMID: 17938396
  131. STREPTOMYCIN treatment of pulmonary tuberculosis.
    Br Med J. 1948 Oct 30;2(4582):769-82 PMID: 18890300
  132. Blinding and exclusions after allocation in randomised controlled trials: survey of published parallel group trials in obstetrics and gynaecology.
    BMJ. 1996 Mar 23;312(7033):742-4 PMID: 8605459
  133. Assessing the quality of randomization from reports of controlled trials published in obstetrics and gynecology journals.
    JAMA. 1994 Jul 13;272(2):125-8 PMID: 8015122
  134. Guidelines for statistical reporting in articles for medical journals. Amplifications and explanations.
    Ann Intern Med. 1988 Feb;108(2):266-73 PMID: 3341656
  135. Confidence intervals rather than P values: estimation rather than hypothesis testing.
    Br Med J (Clin Res Ed). 1986 Mar 15;292(6522):746-50 PMID: 3082422
  136. A consumer's guide to subgroup analyses.
    Ann Intern Med. 1992 Jan 1;116(1):78-84 PMID: 1530753
  137. Randomized controlled trials.
    Clin Obstet Gynecol. 1998 Jun;41(2):245-56 PMID: 9646957
  138. A practical comparison of group-sequential and adaptive designs.
    J Biopharm Stat. 2005;15(4):719-38 PMID: 16022175
  139. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial.
    PLoS Med. 2005 Nov;2(11):e298 PMID: 16231970
  140. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials.
    JAMA. 1995 Feb 1;273(5):408-12 PMID: 7823387
  141. Completeness of reporting trial results: effect on physicians' willingness to prescribe.
    Lancet. 1994 May 14;343(8907):1209-11 PMID: 7909875
  142. Content and quality of 2000 controlled trials in schizophrenia over 50 years.
    BMJ. 1998 Oct 31;317(7167):1181-4 PMID: 9794850
  143. An assessment of clinically useful measures of the consequences of treatment.
    N Engl J Med. 1988 Jun 30;318(26):1728-33 PMID: 3374545
  144. Absence of evidence is not evidence of absence.
    BMJ. 1995 Aug 19;311(7003):485 PMID: 7647644
  145. The accuracy of abstracts in psychology journals.
    J Psychol. 2002 Mar;136(2):141-8 PMID: 12081089
  146. Reporting of safety results in published reports of randomized controlled trials.
    Arch Intern Med. 2009 Oct 26;169(19):1756-61 PMID: 19858432
  147. Eligibility criteria for HIV clinical trials and generalizability of results: the gap between published reports and study protocols.
    AIDS. 2005 Nov 4;19(16):1885-96 PMID: 16227797
  148. Impact of covert duplicate publication on meta-analysis: a case study.
    BMJ. 1997 Sep 13;315(7109):635-40 PMID: 9310564
  149. Reporting on methods in clinical trials.
    N Engl J Med. 1982 Jun 3;306(22):1332-7 PMID: 7070458
  150. The landscape and lexicon of blinding in randomized trials.
    Ann Intern Med. 2002 Feb 5;136(3):254-9 PMID: 11827510
  151. Assessment of generalisability in trials of health interventions: suggested framework and systematic review.
    BMJ. 2006 Aug 12;333(7563):346-9 PMID: 16902217
  152. Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data.
    Lancet. 2004 Apr 24;363(9418):1341-5 PMID: 15110490
  153. The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed.
    BMJ. 2010 Mar 23;340:c723 PMID: 20332510
  154. Randomised trial of laparoscopic versus open cholecystectomy for acute and gangrenous cholecystitis.
    Lancet. 1998 Jan 31;351(9099):321-5 PMID: 9652612
  155. Subverting randomization in controlled trials.
    JAMA. 1995 Nov 8;274(18):1456-8 PMID: 7474192
  156. Factors associated with findings of published trials of drug-drug comparisons: why some statins appear more efficacious than others.
    PLoS Med. 2007 Jun;4(6):e184 PMID: 17550302
  157. 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.
    JAMA. 1998 Feb 18;279(7):545-9 PMID: 9480367
  158. The risk of determining risk with multivariable models.
    Ann Intern Med. 1993 Feb 1;118(3):201-10 PMID: 8417638
  159. Masking or blinding? An unscientific survey of mostly medical journal editors on the great debate.
    MedGenMed. 2000 Mar 13;2(1):E25 PMID: 11104471
  160. A proposal for structured reporting of randomized controlled trials. The Standards of Reporting Trials Group.
    JAMA. 1994 Dec 28;272(24):1926-31 PMID: 7990245
  161. Discrepancies in sample size calculations and data analyses reported in randomised trials: comparison of publications with protocols.
    BMJ. 2008 Dec 04;337:a2299 PMID: 19056791
  162. Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas.
    JAMA. 2001 Jan 24-31;285(4):437-43 PMID: 11242428
  163. Reporting of sample size calculation in randomised controlled trials: review.
    BMJ. 2009 May 12;338:b1732 PMID: 19435763
  164. An open prospective randomised trial to reduce the pain of blood glucose testing: ear versus thumb.
    BMJ. 2000 Jul 1;321(7252):20 PMID: 10875827
  165. Logistic regression models used in medical research are poorly presented.
    BMJ. 1996 Sep 7;313(7057):628 PMID: 8806274
  166. Clinical trials in acute myocardial infarction: should we adjust for baseline characteristics?
    Am Heart J. 2000 May;139(5):745-51 PMID: 10783203
  167. The intention-to-treat approach in randomized controlled trials: are authors saying what they do and doing what they say?
    Clin Trials. 2007;4(4):350-6 PMID: 17848496
  168. Reports of clinical trials should begin and end with up-to-date systematic reviews of other relevant evidence: a status report.
    J R Soc Med. 2007 Apr;100(4):187-90 PMID: 17404342
  169. Properties of simple randomization in clinical trials.
    Control Clin Trials. 1988 Dec;9(4):312-26 PMID: 3203523
  170. The randomized clinical trial: bias in analysis.
    Circulation. 1981 Oct;64(4):669-73 PMID: 7023743
  171. Low-dose hydrochlorothiazide and preservation of bone mineral density in older adults. A randomized, double-blind, placebo-controlled trial.
    Ann Intern Med. 2000 Oct 3;133(7):516-26 PMID: 11015164
  172. Comparison of descriptions of allocation concealment in trial protocols and the published reports: cohort study.
    BMJ. 2005 May 7;330(7499):1049 PMID: 15817527
  173. Accuracy of abstracts for original research articles in pharmacy journals.
    Ann Pharmacother. 2004 Jul-Aug;38(7-8):1173-7 PMID: 15150375
  174. Missing data and the trouble with LOCF.
    Evid Based Ment Health. 2008 Feb;11(1):3-5 PMID: 18223040
  175. How important is publication bias? A synthesis of available data.
    AIDS Educ Prev. 1997 Feb;9(1 Suppl):15-21 PMID: 9083596
  176. Effect of unsupervised home based proprioceptive training on recurrences of ankle sprain: randomised controlled trial.
    BMJ. 2009 Jul 09;339:b2684 PMID: 19589822
  177. Recommendations for reporting cost-effectiveness analyses. Panel on Cost-Effectiveness in Health and Medicine.
    JAMA. 1996 Oct 23-30;276(16):1339-41 PMID: 8861994
  178. Alendronate increases lumbar spine bone mineral density in patients with Crohn's disease.
    Gastroenterology. 2000 Sep;119(3):639-46 PMID: 10982756
  179. Effect of encouragement on walking test performance.
    Thorax. 1984 Nov;39(11):818-22 PMID: 6505988
  180. The revised CONSORT statement for reporting randomized trials: explanation and elaboration.
    Ann Intern Med. 2001 Apr 17;134(8):663-94 PMID: 11304107
  181. Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors.
    Lancet. 2005 May 28-Jun 3;365(9474):1827-9 PMID: 15924965
  182. Changes to manuscripts during the editorial process: characterizing the evolution of a clinical paper.
    JAMA. 1998 Jul 15;280(3):227-8 PMID: 9676663
  183. Some thoughts on clinical trials, especially problems of multiplicity.
    Science. 1977 Nov 18;198(4318):679-84 PMID: 333584
  184. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention.
    N Engl J Med. 2009 Jan 15;360(3):213-24 PMID: 19144937
  185. Comparison of oral fluconazole and itraconazole for progressive, nonmeningeal coccidioidomycosis. A randomized, double-blind trial. Mycoses Study Group.
    Ann Intern Med. 2000 Nov 7;133(9):676-86 PMID: 11074900
  186. Cumulative meta-analysis of therapeutic trials for myocardial infarction.
    N Engl J Med. 1992 Jul 23;327(4):248-54 PMID: 1614465
  187. Does analysis using "last observation carried forward" introduce bias in dementia research?
    CMAJ. 2008 Oct 7;179(8):751-3 PMID: 18838445
  188. Statistical power, sample size, and their reporting in randomized controlled trials.
    JAMA. 1994 Jul 13;272(2):122-4 PMID: 8015121
  189. The case of the missing data: methods of dealing with dropouts and other research vagaries.
    Can J Psychiatry. 2002 Feb;47(1):68-75 PMID: 11873711
  190. CONSORT revised--improving the reporting of randomized trials.
    JAMA. 2001 Apr 18;285(15):2006-7 PMID: 11308440
  191. Misuse of statistical methods in the Australasian surgical literature.
    Aust N Z J Surg. 1982 Oct;52(5):541-3 PMID: 6959608
  192. Optimal medical therapy with or without PCI for stable coronary disease.
    N Engl J Med. 2007 Apr 12;356(15):1503-16 PMID: 17387127
  193. Conceptual framework and systematic review of the effects of participants' and professionals' preferences in randomised controlled trials.
    Health Technol Assess. 2005 Sep;9(35):1-186, iii-iv PMID: 16153352
  194. Promoting good research practice.
    Stat Methods Med Res. 2000 Feb;9(1):17-24 PMID: 10826155
  195. The continuing unethical conduct of underpowered clinical trials.
    JAMA. 2002 Jul 17;288(3):358-62 PMID: 12117401
  196. Laypersons' understanding of relative risk reductions: randomised cross-sectional study.
    BMC Med Inform Decis Mak. 2008 Jul 17;8:31 PMID: 18631406
  197. Unpublished rating scales: a major source of bias in randomised controlled trials of treatments for schizophrenia.
    Br J Psychiatry. 2000 Mar;176:249-52 PMID: 10755072
  198. 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).
    Lancet. 2000 Jul 29;356(9227):366-72 PMID: 10972368
  199. Carvedilol for children and adolescents with heart failure: a randomized controlled trial.
    JAMA. 2007 Sep 12;298(10):1171-9 PMID: 17848651
  200. Are missing outcome data adequately handled? A review of published randomized controlled trials in major medical journals.
    Clin Trials. 2004;1(4):368-76 PMID: 16279275
  201. Improving the quality of reporting of randomized controlled trials. The CONSORT statement.
    JAMA. 1996 Aug 28;276(8):637-9 PMID: 8773637
  202. Uniform requirements for manuscripts submitted to biomedical journals. International Committee of Medical Journal Editors.
    Ann Intern Med. 1997 Jan 1;126(1):36-47 PMID: 8992922
  203. Standardising outcomes for clinical trials and systematic reviews.
    Trials. 2007 Nov 26;8:39 PMID: 18039365
  204. Misuse of baseline comparison tests and subgroup analyses in surgical trials.
    Clin Orthop Relat Res. 2006 Jun;447:247-51 PMID: 16672904
  205. Pharmaceutical industry sponsorship and research outcome and quality: systematic review.
    BMJ. 2003 May 31;326(7400):1167-70 PMID: 12775614
  206. The impact of open access upon public health.
    PLoS Med. 2006 May;3(5):e252 PMID: 16719556
  207. Ivabradine for patients with stable coronary artery disease and left-ventricular systolic dysfunction (BEAUTIFUL): a randomised, double-blind, placebo-controlled trial.
    Lancet. 2008 Sep 6;372(9641):807-16 PMID: 18757088
  208. 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.
    Lancet. 2007 Jun 9;369(9577):1929-37 PMID: 17544497
  209. Reporting the study populations of clinical trials. Clear transmission or static on the line?
    J Clin Epidemiol. 2000 Oct;53(10):973-9 PMID: 11027928
  210. Reporting on statistical methods to adjust for confounding: a cross-sectional survey.
    Ann Intern Med. 2002 Jan 15;136(2):122-6 PMID: 11790063
  211. Systematic review of the empirical evidence of study publication bias and outcome reporting bias.
    PLoS One. 2008 Aug 28;3(8):e3081 PMID: 18769481
  212. Effect of clopidogrel added to aspirin in patients with atrial fibrillation.
    N Engl J Med. 2009 May 14;360(20):2066-78 PMID: 19336502
  213. What is missing from descriptions of treatment in trials and reviews?
    BMJ. 2008 Jun 28;336(7659):1472-4 PMID: 18583680
  214. Impact and process evaluation of integrated community and clinic-based HIV-1 control: a cluster-randomised trial in eastern Zimbabwe.
    PLoS Med. 2007 Mar 27;4(3):e102 PMID: 17388666
  215. Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials.
    JAMA. 1991 Jul 3;266(1):93-8 PMID: 2046134
  216. In the dark: the reporting of blinding status in randomized controlled trials.
    J Clin Epidemiol. 2002 Aug;55(8):787-90 PMID: 12384193
  217. Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study.
    Lancet. 2009 Nov 7;374(9701):1606-16 PMID: 19853906
  218. Assessing the potential for bias in meta-analysis due to selective reporting of subgroup analyses within studies.
    Stat Med. 2000 Dec 30;19(24):3325-36 PMID: 11122498
  219. Smoking reduction with oral nicotine inhalers: double blind, randomised clinical trial of efficacy and safety.
    BMJ. 2000 Aug 5;321(7257):329-33 PMID: 10926587
  220. Value of flow diagrams in reports of randomized controlled trials.
    JAMA. 2001 Apr 18;285(15):1996-9 PMID: 11308437
  221. Limitations are not properly acknowledged in the scientific literature.
    J Clin Epidemiol. 2007 Apr;60(4):324-9 PMID: 17346604
  222. CONSORT: an evolving tool to help improve the quality of reports of randomized controlled trials. Consolidated Standards of Reporting Trials.
    JAMA. 1998 May 13;279(18):1489-91 PMID: 9600488
  223. Minimisation: the platinum standard for trials?. Randomisation doesn't guarantee similarity of groups; minimisation does.
    BMJ. 1998 Aug 8;317(7155):362-3 PMID: 9694748
  224. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials.
    Ann Intern Med. 2001 Apr 17;134(8):657-62 PMID: 11304106
  225. Preventing IUCD-related pelvic infection: the efficacy of prophylactic doxycycline at insertion.
    Br J Obstet Gynaecol. 1990 May;97(5):412-9 PMID: 2196934
  226. Completeness of reporting of trials published in languages other than English: implications for conduct and reporting of systematic reviews.
    Lancet. 1996 Feb 10;347(8998):363-6 PMID: 8598702
  227. Pharmaceutical company funding and its consequences: a qualitative systematic review.
    Contemp Clin Trials. 2008 Mar;29(2):109-13 PMID: 17919992
  228. Comparison of weight-loss diets with different compositions of fat, protein, and carbohydrates.
    N Engl J Med. 2009 Feb 26;360(9):859-73 PMID: 19246357
  229. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study.
    BMJ. 2008 Mar 15;336(7644):601-5 PMID: 18316340
  230. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration.
    PLoS Med. 2008 Jan 22;5(1):e20 PMID: 18215107
  231. The rhetoric of research.
    BMJ. 1995 Apr 15;310(6985):985-7 PMID: 7728037
  232. Routine care of peripheral intravenous catheters versus clinically indicated replacement: randomised controlled trial.
    BMJ. 2008 Jul 08;337:a339 PMID: 18614482
  233. Effect of carvedilol on outcome after myocardial infarction in patients with left-ventricular dysfunction: the CAPRICORN randomised trial.
    Lancet. 2001 May 5;357(9266):1385-90 PMID: 11356434
  234. Minimal access surgery compared with medical management for chronic gastro-oesophageal reflux disease: UK collaborative randomised trial.
    BMJ. 2008 Dec 15;337:a2664 PMID: 19074946
  235. Estimating sample sizes for binary, ordered categorical, and continuous outcomes in two group comparisons.
    BMJ. 1995 Oct 28;311(7013):1145-8 PMID: 7580713
  236. The safety of over-the-counter niacin. A randomized placebo-controlled trial [ISRCTN18054903].
    BMC Clin Pharmacol. 2003 Nov 13;3:4 PMID: 14614780
  237. Effects of the angiotensin-receptor blocker telmisartan on cardiovascular events in high-risk patients intolerant to angiotensin-converting enzyme inhibitors: a randomised controlled trial.
    Lancet. 2008 Sep 27;372(9644):1174-83 PMID: 18757085
  238. Intentional ignorance: a history of blind assessment and placebo controls in medicine.
    Bull Hist Med. 1998 Fall;72(3):389-433 PMID: 9780448
  239. Reporting randomized controlled trials. An experiment and a call for responses from readers.
    JAMA. 1995 Apr 5;273(13):1054-5 PMID: 7897791
  240. Interim analyses in clinical trials: classical vs. Bayesian approaches.
    Stat Med. 1985 Oct-Dec;4(4):521-6 PMID: 4089353
  241. How well are randomized controlled trials reported in the dermatology literature?
    Arch Dermatol. 2000 Mar;136(3):381-5 PMID: 10724201
  242. Principles of multilevel modelling.
    Int J Epidemiol. 2000 Feb;29(1):158-67 PMID: 10750618
  243. Who is blinded in randomized clinical trials? A study of 200 trials and a survey of authors.
    Clin Trials. 2006;3(4):360-5 PMID: 17060210
  244. Meta-analysis of clinical trials as a scientific discipline. I: Control of bias and comparison with large co-operative trials.
    Stat Med. 1987 Apr-May;6(3):315-28 PMID: 2887023
  245. Measured enthusiasm: does the method of reporting trial results alter perceptions of therapeutic effectiveness?
    Ann Intern Med. 1992 Dec 1;117(11):916-21 PMID: 1443954
  246. Masked monitoring in clinical trials--blind stupidity?
    N Engl J Med. 1998 May 7;338(19):1381-2 PMID: 9571262
  247. 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.
    Lancet. 2009 Sep 5;374(9692):787-95 PMID: 19717184
  248. Vasopressin versus norepinephrine infusion in patients with septic shock.
    N Engl J Med. 2008 Feb 28;358(9):877-87 PMID: 18305265
  249. Beyond CONSORT: need for improved reporting standards for clinical trials. Consolidated Standards of Reporting Trials.
    JAMA. 1998 May 13;279(18):1487-9 PMID: 9600487
  250. Issues in data monitoring and interim analysis of trials.
    Health Technol Assess. 2005 Mar;9(7):1-238, iii-iv PMID: 15763038
  251. Intention-to-treat analysis: who is in? Who is out?
    J Fam Pract. 2002 Nov;51(11):969-71 PMID: 12485553
  252. 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.
    JAMA. 1970 Mar 23;211(12):1993-2003 PMID: 5467158
  253. Identification and impact of outcome selection bias in meta-analysis.
    Stat Med. 2005 May 30;24(10):1547-61 PMID: 15580591
  254. Statistics in medical journals.
    Stat Med. 1982 Jan-Mar;1(1):59-71 PMID: 7187083
  255. Publication and related biases.
    Health Technol Assess. 2000;4(10):1-115 PMID: 10932019
  256. Recombinant bactericidal/permeability-increasing protein (rBPI21) as adjunctive treatment for children with severe meningococcal sepsis: a randomised trial. rBPI21 Meningococcal Sepsis Study Group.
    Lancet. 2000 Sep 16;356(9234):961-7 PMID: 11041396
  257. Supervised exercise therapy versus usual care for patellofemoral pain syndrome: an open label randomised controlled trial.
    BMJ. 2009 Oct 20;339:b4074 PMID: 19843565
  258. Randomised trial of intravenous atenolol among 16 027 cases of suspected acute myocardial infarction: ISIS-1. First International Study of Infarct Survival Collaborative Group.
    Lancet. 1986 Jul 12;2(8498):57-66 PMID: 2873379
  259. Endorsement of the CONSORT Statement by high impact factor medical journals: a survey of journal editors and journal 'Instructions to Authors'.
    Trials. 2008 Apr 18;9:20 PMID: 18423021
  260. Sample size calculations in randomised trials: mandatory and mystical.
    Lancet. 2005 Apr 9-15;365(9467):1348-53 PMID: 15823387
  261. Intention-to-treat analysis and the goals of clinical trials.
    Clin Pharmacol Ther. 1995 Jan;57(1):6-15 PMID: 7828382
  262. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles.
    JAMA. 2004 May 26;291(20):2457-65 PMID: 15161896
  263. What is meant by intention to treat analysis? Survey of published randomised controlled trials.
    BMJ. 1999 Sep 11;319(7211):670-4 PMID: 10480822
  264. Toward evidence-based medical statistics. 1: The P value fallacy.
    Ann Intern Med. 1999 Jun 15;130(12):995-1004 PMID: 10383371
  265. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial.
    Lancet. 2008 May 31;371(9627):1839-47 PMID: 18479744
  266. Physician interpretations and textbook definitions of blinding terminology in randomized controlled trials.
    JAMA. 2001 Apr 18;285(15):2000-3 PMID: 11308438
  267. Randomized controlled trials in cystic fibrosis (1966-1997) categorized by time, design, and intervention.
    Pediatr Pulmonol. 2000 Jan;29(1):1-7 PMID: 10613779
  268. Splint for base-of-thumb osteoarthritis: a randomized trial.
    Ann Intern Med. 2009 May 19;150(10):661-9 PMID: 19451573
  269. Technical editing of research reports in biomedical journals.
    Cochrane Database Syst Rev. 2008 Oct 08;(4):MR000002 PMID: 18843753
  270. Why do we need some large, simple randomized trials?
    Stat Med. 1984 Oct-Dec;3(4):409-22 PMID: 6528136
  271. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement.
    JAMA. 2006 Mar 8;295(10):1152-60 PMID: 16522836
  272. Improving the reporting of pragmatic trials: an extension of the CONSORT statement.
    BMJ. 2008 Nov 11;337:a2390 PMID: 19001484
  273. Development of the Cochrane Collaboration's CENTRAL Register of controlled clinical trials.
    Eval Health Prof. 2002 Mar;25(1):38-64 PMID: 11868444
  274. Interim analyses in randomized clinical trials: ramifications and guidelines for practitioners.
    Biometrics. 1987 Mar;43(1):213-23 PMID: 3567306
  275. Interaction 3: How to examine heterogeneity.
    BMJ. 1996 Oct 5;313(7061):862 PMID: 8870577
  276. Registering clinical trials.
    JAMA. 2003 Jul 23;290(4):516-23 PMID: 12876095
  277. CONSORT statement: extension to cluster randomised trials.
    BMJ. 2004 Mar 20;328(7441):702-8 PMID: 15031246
  278. Controlled clinical trial of zolpidem for the treatment of insomnia associated with attention-deficit/ hyperactivity disorder in children 6 to 17 years of age.
    Pediatrics. 2009 May;123(5):e770-6 PMID: 19403468
  279. 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.
    BMJ. 2009 May 22;338:b1867 PMID: 19465470
  280. Assembling comparison groups to assess the effects of health care.
    J R Soc Med. 1997 Jul;90(7):379-86 PMID: 9290419
  281. Reliable assessment of the effects of treatment on mortality and major morbidity, I: clinical trials.
    Lancet. 2001 Feb 3;357(9253):373-80 PMID: 11211013
  282. Misuse of statistical methods: critical assessment of articles in BMJ from January to March 1976.
    Br Med J. 1977 Jan 8;1(6053):85-7 PMID: 832023
  283. Adaptive designs for randomized trials in public health.
    Annu Rev Public Health. 2009;30:1-25 PMID: 19296774
Article Info
Journal
BMJ (Clinical research ed.)
Abbr.
BMJ
ISSN
1756-1833
Published
2010-03-23
Epub
2010-00-23
Pages
c869
Language
English
Region
England
NLM ID
8900488
PMCID
PMC2844943
Subset
IM
Grants
Canadian Institutes of Health Research · Canada
Corrections
CommentIn
Analysis Services
Analysis Services

Contact

No. 2 Wenbo Road, Zhangqiu District, Jinan, Shandong

Qilu Normal University · Genelibs Bioinformatics Lab

750 Shunhua Rd, Jinan

2F, Bldg F, University Science Park

Tel: 0531-88819269

WeChat Official Account

Follow our WeChat subscription account for real-time updates and the latest in medical and biological research.


Business Email

E-mail: [email protected]