Quality of reporting of harms in randomised controlled trials of pharmacological interventions for rheumatoid arthritis: a systematic review

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The quality of reporting of harms data in randomised controlled trials (RCTs) has been reported to be suboptimal. Rheumatoid arthritis (RA) has seen a massive growth in novel pharmacotherapies in the last decade.


The aim of this study was to assess the quality of reporting of harms-related data in RCTs evaluating pharmacological interventions for RA according to the CONSORT (Consolidated Standards of Reporting Trials) statement on harms reporting extension.

Study selection

RCTs published between January 2011 and August 2016 in the five highest impact factor journals in general medicine and two in rheumatology subject categories as per 2015 Journal Citation Reports were included. Reports of secondary, supplementary or exploratory analyses of RCTs and non-inferiority trials were excluded. Two reviewers independently extracted data using a structured, pilot-tested, 18-item questionnaire developed based on CONSORT harms extension recommendations.


68 RCTs were included in the review. Out of a maximum harms reporting score of 18, the mean (SD) score was 8.51 (3.5) (range=0–15). More than half (56.5%) of the RCTs reported ≤50% of items and only three (4.3%) RCTs reported more than 70% (score ≥14) of the items. Multilinear regression analyses found that region of trial origin (p=0.01), sample size (p=0.001) and whether the study was a long-term extension of a trial or not (p=0.04) were independent predictors associated with higher total harms reporting score.


The adherence to CONSORT harms extension was poor in recently published RCTs of pharmacological interventions for RA. There is a need to improve quality of harms reporting in RCTs to allow transparent and balanced assessment of the benefit-risk ratio in clinical decision making.

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