Reporting of harms data in RCTs: a systematic review of empirical assessments against the CONSORT harms extension

Alex Hodkinson, Jamie J Kirkham, Catrin Tudur-Smith, Carrol Gamble

Research output: Contribution to journalArticlepeer-review


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.

DESIGN: Systematic review.

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

ELIGIBILITY CRITERIA FOR SELECTING STUDIES: 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.

Original languageEnglish
Pages (from-to)e003436
JournalBMJ Open
Issue number9
Publication statusPublished - 27 Sept 2013


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