Article Text

Reporting of harms data in RCTs: a systematic review of empirical assessments against the CONSORT harms extension
  1. Alex Hodkinson,
  2. Jamie J Kirkham,
  3. Catrin Tudur-Smith,
  4. Carrol Gamble
  1. Department of Biostatistics, MRC North West Hub for Trials Methodology Research, University of Liverpool, Liverpool, UK
  1. Correspondence to Alex Hodkinson; ahoddy{at}


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.

  • General Medicine (see Internal Medicine)
  • Clinical Trial Methodology
  • Biostatistics

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 3.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See:

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