biostudies-literatureHodkinson AMedical Research Councile003436https://www.ebi.ac.uk/biostudies/studies/S-EPMC3787508biostudies-literatureUnknown3(9)<h4>Objective</h4>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.<h4>Design</h4>Systematic review.<h4>Data sources</h4>The Cochrane library, Ovid MEDLINE, Scopus and ISI Web of Knowledge were searched for relevant literature.<h4>Eligibility criteria for selecting studies</h4>We included publications of studies that used the CONSORT harms extension to assess the reporting of harms in RCTs.<h4>Results</h4>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.<h4>Conclusions</h4>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.BMJ openReporting of harms data in RCTs: a systematic review of empirical assessments against the CONSORT harms extension.PMC37875081247324Kirkham JJGamble CHodkinson ATudur-Smith CfalseReporting of harms data in RCTs: a systematic review of empirical assessments against the CONSORT harms extension.<h4>Objective</h4>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.<h4>Design</h4>Systematic review.<h4>Data sources</h4>The Cochrane library, Ovid MEDLINE, Scopus and ISI Web of Knowledge were searched for relevant literature.<h4>Eligibility criteria for selecting studies</h4>We included publications of studies that used the CONSORT harms extension to assess the reporting of harms in RCTs.<h4>Results</h4>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.<h4>Conclusions</h4>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.2013-01-01T00:00:00Z2013 Sep2025-04-29T11:01:22.519Z2019-03-27T01:16:44ZS-EPMC37875082407875210.1136/bmjopen-2013-003436