- CONSORT Statement
- CONSORT Statement Extensions
- Evidence underpinning CONSORT
- Accrual and sample size
- Attitudes to trials
- Adverse events (Harms)
- Baseline data
- Blinding
- Compliance
- Early stopping
- Eligibility
- Follow-up
- Funding
- Harms
- Generalizability
- Intention to treat
- Interpretation
- Interventions
- Outcome reporting
- Random allocation
- Recruitment
- Statistical analysis
- Statistical methods
- Trial design issues
- Trial registration
- Uptake of CONSORT by journals
- Impact of and adherence to CONSORT
- Endorsement of CONSORT
Outcome reporting
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Berlin JA, Wacholtz MC. Selective reporting, publication bias and clinical trial registry: an industry perspective. International Journal of Pharmaceutical Medicine 2005; 19:277-284.
Chan AW, Hrobjartsson A, Haahr MT, Gøtzsche PC, Altman DG.
Empirical evidence for selective reporting of outcomes in randomized trials:
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Chan AW, Altman DG. Identifying outcome reporting bias in
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2005; 330(7494):753.
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Chan AW, Krleza-Jeric K, Schmid I, Altman DG. Outcome
reporting bias in randomized trials funded by the Canadian Institutes of Health
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Chappell L, Alfirevich Z, Chien P, Jarvis S, Thornton JG. A comparison of the published version of randomized controlled trials in a specialist clinical journal with the original trial protocols [abstract]. International Congress on Peer Review and Biomedical Publication ; 2005 Sept 16 18 ; Chicago , Illinois , USA 2005;27.
Clifford TJ, Moher D, Barrowman N. Absence of associations between funding source, trial outcome, and quality score: a benefit of financial disclosure? 4th International Congress on Peer Review in Biomedical Publication, September 14 16, 2001 in Barcelona, Spain 2001.
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Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan AW, Cronin E, Decullier E, Easterbrook PJ, Von EE, Gamble C, Ghersi D, Ioannidis JP, Simes J, Williamson PR. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PLoS ONE 2008; 3(8):e3081.
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Ghersi D, Clarke M, Simes J. Selective reporting of the
primary outcomes of clinical trials: a follow-up study [abstract]. XIV Cochrane
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Gøtzsche PC. Reference bias in reports of drug trials. Br
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Gøtzsche PC. Reporting of outcomes in arthritis trials
measured on ordinal and interval scales is inadequate in relation to
meta-analysis. Ann Rheum Dis 2001; 60(4):349-352.
PMID: 11247864
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. Stat Med 2000; 19(24):3325-3336.
PMID: 11122498
Hahn S, Williamson PR, Hutton JL. Investigation of
within-study selective reporting in clinical research: follow-up of
applications submitted to a local research ethics committee. J Eval Clin Pract
2002; 8(3):353-359.
PMID: 12164983
Haidich AB, Ioannidis JP. Effect of early patient
enrollment on the time to completion and publication of randomized controlled
trials. Am J Epidemiol 2001; 154(9):873-880.
PMID: 11682370
Ioannidis JP. Effect of the statistical significance of
results on the time to completion and publication of randomized efficacy
trials. JAMA 1998; 279(4):281-286.
PMID: 9450711
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. Br J Psychiatry 2000; 176:249-252.
PMID: 10755072
Moja PL, Moschetti I, D'Amico R. Outcome reporting bias in
government-funded RCTs. CMAJ 2005; 172(7):857.
PMID: 15795393
Punt CJ, Buyse M, Kohne CH, Hohenberger P, Labianca R,
Schmoll HJ, Pahlman L, Sobrero A, Douillard JY. Endpoints in adjuvant treatment
trials: a systematic review of the literature in colon cancer and proposed
definitions for future trials. J Natl Cancer Inst 2007; 99(13):998-1003.
PMID: 17596575
Riechelmann RP, Dounaevskaia V, Krzyzanowska MK. Quality of reporting primary outcomes in phase II cancer trials. J Clin Oncol 2008; 26(33):5486-5488.
PMID: 18955436 [New]
Roland M, Torgerson D. Understanding controlled trials:
what outcomes should be measured? BMJ 1998; 317(7165):1075.
PMID: 9774302
Sanders C, Egger M, Donovan J, Tallon D, Frankel S.
Reporting on quality of life in randomised controlled trials: bibliographic
study. BMJ 1998; 317(7167):1191-1194.
PMID: 9794853
Soares HP, Daniels S, Kumar A, Clarke M, Scott C, Swann S,
Djulbegovic B. Bad reporting does not mean bad methods for randomised trials:
observational study of randomised controlled trials performed by the Radiation
Therapy Oncology Group. BMJ 2004; 328(7430):22-24.
PMID: 14703540
Thornley B, Adams C. Content and quality of 2000 controlled
trials in schizophrenia over 50 years. BMJ 1998; 317(7167):1181-1184.
PMID: 9794850
Von EE, Huwiler K, Witschi M, Rollin A, Senessie C, Low N, Egger M. Reporting of study outcomes in comparative drug trials: evidence from proposals submitted to a research ethics committee and corresponding full publications [abstract]. International Congress on Peer Review and Biomedical Publication ; 2005 Sept 16 18 ; Chicago , Illinois , USA 2005;26-27.
Williamson PR, Gamble C. Application and investigation of a
bound for outcome reporting bias. Trials 2007; 8:9.
PMID: 17341316
Williamson PR, Gamble C. Identification and impact of
outcome selection bias in meta-analysis. Stat Med 2005; 24(10):1547-1561.
PMID: 15580591
Williamson PR, Gamble C, Altman DG, Hutton JL. Outcome
selection bias in meta-analysis. Stat Methods Med Res 2005; 14(5):515-524.
PMID: 16248351
Page last edited: 06 May 2009

