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

  title={Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement},
  author={John P. A. Ioannidis and Stephen J.W. Evans and Peter C. Gtzsche and Robert T. O’Neill and Douglas G. Altman and Kenneth F. Schulz and David Moher},
  journal={Annals of Internal Medicine},
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… 

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) statement

Asymmetric Reporting of Harms and Benefits in Randomized Controlled Trials

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.

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 Trials

Reporting of harms by randomised controlled trials in ophthalmology

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.

Improving the reporting of randomised trials: the CONSORT Statement and beyond

The history of reporting guidelines for randomised trials culminating in the CONSORT Statement in 1996 is described and the subsequent development and extension of CONSORT and related initiatives aimed at improving the reliability of the medical research literature are considered.

CONSORT for Reporting Randomized Controlled Trials in Journal and Conference Abstracts: Explanation and Elaboration

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.

CONSORT 2010 statement: extension checklist for reporting within person randomised trials

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.



The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials

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.

The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration

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.

Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles.

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.

Reporting of adverse drug reactions in randomised controlled trials – a systematic survey

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.

Safety reporting in randomized trials of mental health interventions.

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.

Reporting on quality of life in randomised controlled trials: bibliographic study

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.

Improving Safety Reporting from Randomised Trials

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.

Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas.

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.