- 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
Harms
Aronson JK, Derry S, Loke YK. Adverse drug reactions:
keeping up to date. Fundam Clin Pharmacol 2002; 16(1):49-56.
PMID: 11903512
Derry S, Kong LY, Aronson JK. Incomplete evidence: the
inadequacy of databases in tracing published adverse drug reactions in clinical
trials. BMC Med Res Methodol 2001; 1:7.
PMID: 11591220
Ethgen M, Boutron I, Baron G, Giraudeau B, Sibilia J,
Ravaud P. Reporting of harm in randomized, controlled trials of
nonpharmacologic treatment for rheumatic disease. Ann Intern Med 2005;
143(1):20-25.
PMID: 15998751
Hazell L, Shakir SA. Under-reporting of adverse drug
reactions : a systematic review. Drug Saf 2006; 29(5):385-396.
PMID: 16689555
Ioannidis JP, Contopoulos-Ioannidis DG.
Reporting of safety data from randomised trials. Lancet 1998;
352(9142):1752-1753.
PMID: 9848355
Ioannidis JP, Lau J. Improving safety reporting from randomised
trials. Drug Saf 2002; 25(2):77-84.
PMID: 11888350
Ioannidis JP, Lau J. Completeness of safety reporting in
randomized trials: an evaluation of 7 medical areas. JAMA 2001; 285(4):437-443.
PMID: 11242428
Ioannidis JP, Lau J. Improving safety reporting from randomised trials. Drug Saf 2002; 25(2):77-84.
PMID: 11888350 [New]
Jørgensen KJ, Klahn AB, Gøtzsche PC. Are benefits and harms
in mammography screening given equal attention in scientific articles? A
cross-sectional study. BMC Med 2007; 5(1):12.
PMID: 17537243
Loke YK, Derry S. Reporting of adverse drug reactions in
randomised controlled trials - a systematic survey. BMC Clin Pharmacol 2001;
1:3.
PMID: 11591227
Loke YK, Derry S, Aronson JK. A comparison of three
different sources of data in assessing the frequencies of adverse reactions to
amiodarone. Br J Clin Pharmacol 2004; 57(5):616-621.
PMID: 15089815
Martin RC, Brennan MF, Jaques DP. Quality of complication
reporting in the surgical literature. Ann Surg 2002; 235(6):803-813.
PMID: 12035036
Papanikolaou PN, Churchill R, Wahlbeck K, Ioannidis JP.
Safety reporting in randomized trials of mental health interventions. Am J
Psychiatry 2004; 161(9):1692-1697.
PMID: 15337661
Papanikolaou PN, Christidi GD, Ioannidis JP. Comparison of
evidence on harms of medical interventions in randomized and nonrandomized
studies. CMAJ 2006; 174(5):635-641.
PMID: 16505459
Rief W, Avorn J, Barsky AJ. Medication-attributed adverse
effects in placebo groups: implications for assessment of adverse effects. Arch
Intern Med 2006; 166(2):155-160.
PMID: 16432082
Scharf O, Colevas AD. Adverse event reporting in
publications compared with sponsor database for cancer clinical trials. J Clin
Oncol 2006; 24(24):3933-3938.
PMID: 16921045
Page last edited: 06 May 2009
