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. 2013 Sep 27;3(9):e003436.
doi: 10.1136/bmjopen-2013-003436.

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

Alex Hodkinson  1 , Jamie J Kirkham, Catrin Tudur-Smith, Carrol Gamble
Affiliations

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

Alex Hodkinson et al. BMJ Open. .

Abstract

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.

Keywords: Biostatistics; Clinical Trial Methodology; General Medicine (see Internal Medicine).

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Figures

Figure 1
Figure 1
Flow diagram of study identification and selection.
See this image and copyright information in PMC

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