The Reporting of Harms in Randomized Controlled Trials of Hypertension Using the CONSORT Criteria for Harm Reporting

Abstract

The aim of this study was to assess the quality of reporting of harms in hypertension clinical trials identified from the Cochrane Database using the Consolidated Standards of Reporting Trials (CONSORT) extension for harms reporting. Forty-one hypertension trials were included in the study. On average trials reported less than half of the items recommended by the CONSORT extension for harms (mean 9.83 items; 95% confidence interval = 8.06, 11.60). Trialists need to address the perceived shortcomings in measurement, analysis, and reporting of harms data so that the available trial data can be considered as a balanced and reliable source of evidence.

• harm
• adverse event
• CONSORT
• CONSORT extension
• drug safety

ACKOWLEDGMENT

Mr. Doug Salzwedel’s helped in searching the Cochrane database with relevant keywords.

Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.