Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement

@article{Ioannidis2004BetterRO,
  title={Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement},
  author={J. Ioannidis and S. Evans and P. Gtzsche and R. O’Neill and D. Altman and K. Schulz and D. Moher},
  journal={Annals of Internal Medicine},
  year={2004},
  volume={141},
  pages={781-788}
}
Reporting harms may cause more trouble and discredit than the fame and glory associated with successful reporting of benefits (1). The CONSORT (Consolidated Standards of Reporting Trials) statement, a checklist (Table 1) flow diagram first published in 1996 and revised 5 years later (2, 3), is an effort to standardize, and thereby improve, published reports of randomized, controlled trials (RCTs). One of the additions to the 2001 revision was an item about reporting adverse events. This single… Expand
Reporting of harms data in RCTs: a systematic review of empirical assessments against the CONSORT harms extension
Objective To determine the standard of reporting of harms-related data, in randomised controlled trials (RCTs) according to the Consolidated Standards of Reporting Trials (CONSORT) statementExpand
Adherence to CONSORT harms-reporting recommendations in publications of recent analgesic clinical trials: An ACTTION systematic review
TLDR
Assessing harms reporting in 3 major pain journals to determine whether harms reporting improved following publication of the 2004 CONSORT recommendations and to examine study factors associated with adequacy of harms reporting found greater improvement is needed. Expand
Asymmetric Reporting of Harms and Benefits in Randomized Controlled Trials
TLDR
Current patterns in RCT reporting of harms compared to benefits are evaluated and it is determined if funding, region, specialty, or type of intervention influences AE reporting. Expand
The Reporting of Harms in Randomized Controlled Trials of Hypertension Using the CONSORT Criteria for Harm Reporting
The aim of this study was to assess the quality of reporting of harms in hypertension clinical trials identified from the Cochrane Database using the Consolidated Standards of Reporting TrialsExpand
The quality of safety reporting in trials is still suboptimal: survey of major general medical journals.
TLDR
The use of the Extension of the CONSORT statement may be associated with improving the quality of safety reporting in RCTs, but there are still deficiencies that need to be corrected to use quantitative objective evidence for harms in performing meta-analyses and making therapeutic decisions. Expand
Reporting of harms by randomised controlled trials in ophthalmology
TLDR
Harms reporting in published reports of trials of intravitreal therapies for diabetic macular oedema is still not entirely adequate despite increased attention and efforts to standardise it. Expand
CONSORT for Reporting Randomized Controlled Trials in Journal and Conference Abstracts: Explanation and Elaboration
TLDR
A minimum list of essential items, which authors should consider when reporting the results of a RCT in any journal or conference abstract, is developed to improve reporting of abstracts of RCTs published in journal articles and conference proceedings. Expand
Assessment of the quality of harms reporting in non-randomised studies and randomised controlled studies of topiramate for the treatment of epilepsy using CONSORT criteria
TLDR
There is a need to improve the reporting of harms in both NRSs and RCTs of antiepileptic drugs, but is suboptimal overall and has not improved since the publication of CONSORT extension for harms in 2004. Expand
CONSORT 2010 statement: extension checklist for reporting within person randomised trials
TLDR
The CONSORT extension to within person trials is presented, which extends 16 items of the CONSORT 2010 checklist and introduces a modified flowchart and baseline table to enhance transparency. Expand
CONSORT 2010 statement: extension checklist for reporting within person randomised trials
TLDR
The CONSORT extension to within person trials is presented, which extends 16 items of the CONSORT 2010 checklist and introduces a modified flowchart and baseline table to enhance transparency. Expand
...
1
2
3
4
5
...

References

SHOWING 1-10 OF 74 REFERENCES
The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials
TLDR
The revised CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results. Expand
The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration
TLDR
The CONSORT statement (or simply CONSORT) comprises a checklist of essential items that should be included in reports of RCTs and a diagram for documenting the flow of participants through a trial, aimed at first reports of two-group parallel designs. Expand
Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles.
TLDR
The reporting of trial outcomes is not only frequently incomplete but also biased and inconsistent with protocols and Published articles, as well as reviews that incorporate them, may therefore be unreliable and overestimate the benefits of an intervention. Expand
Reporting of adverse drug reactions in randomised controlled trials – a systematic survey
TLDR
Trial reports often failed to provide details on how adverse drug reactions were defined or recorded, and the absence of such methodological information makes comparative evaluation of adverse reaction rates potentially unreliable. Expand
Safety reporting in randomized trials of mental health interventions.
TLDR
Safety reporting is largely neglected across trials of mental-health-related interventions, thus hindering the assessment of risk-benefit ratios for rational decision making in mental health care. Expand
Japanese and American reports of randomized trials: differences in the reporting of adverse effects.
TLDR
The reporting of adverse reactions in clinical trials is inadequate in both the United States and Japanese literature, and clinical research into drug safety in both countries could be improved through the adoption of simple standards of clarity and consistency in the monitoring and reporting of drug adverse effects. Expand
Reporting on quality of life in randomised controlled trials: bibliographic study
TLDR
A plethora of instruments was used in different studies, and the reporting of methods and results was often inadequate, suggesting standards for the measurement and reporting of quality of life in clinical trials research need to be developed. Expand
Improving Safety Reporting from Randomised Trials
TLDR
The use of standardised scales for adverse effects is a prerequisite for improved reporting on safety in randomised trials and electronic publication, publication of raw databases, large database research, meta-analytic approaches, and prospective registration of clinical trials and of their databases may further improve the safety insights the authors can gain from randomised clinical trials. Expand
Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas.
TLDR
Current standards for safety reporting in randomized trials should be revised to address this inadequacy, as generalizable data on drug safety reporting are sparse and largely inadequate. Expand
Discussion sections in reports of controlled trials published in general medical journals.
TLDR
There was no evidence of progress in the proportion of reports of trials published in general medical journals that discussed the new results within the context of, or with reference to, up-to-date systematic reviews of relevant evidence from other controlled trials between 1997 and 2001. Expand
...
1
2
3
4
5
...