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 extension for harms.


METHODS
Systematic review.


METHODS
The Cochrane library, Ovid MEDLINE, Scopus and ISI Web of Knowledge were searched for relevant literature.


METHODS
We included publications of studies that used the CONSORT harms extension to assess the reporting of harms in RCTs.


RESULTS
We identified 7 studies which included between 10 and 205 RCTs. The clinical areas of the 7 studies were: hypertension (1), urology (1), epilepsy (1), complimentary medicine (2) and two not restricted to a clinical topic. Quality of the 7 studies was assessed by a risk of bias tool and was found to be variable. Adherence to the CONSORT harms criteria reported in the 7 studies was inadequate and variable across the items in the checklist. Adverse events are poorly defined, with 6 studies failing to exceed 50% adherence to the items in the checklist.


CONCLUSIONS
Readers of RCT publications need to be able to balance the trade-offs between benefits and harms of interventions. This systematic review suggests that this is compromised due to poor reporting of harms which is evident across a range of clinical areas. Improvements in quality could be achieved by wider adoption of the CONSORT harms criteria by journals reporting RCTs.
Department of Biostatistics, MRC North West Hub for Trials Methodology Research, University of Liverpool, Liverpool, UK.
Alex
A
Hodkinson
Jamie J
JJ
Kirkham
Catrin
C
Tudur-Smith
Carrol
C
Gamble
Biostatistics; Clinical Trial Methodology; General Medicine (see Internal Medicine)