title: 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.
authors.affiliation: Clinical Development, Novartis Horsham Research Centre, Horsham, UK. drnitinbb@yahoo.co.uk
authors.forename: Nitin Babulal
authors.initials: NB
authors.lastname: Bagul
authors.forename: Jamie J
authors.initials: JJ
authors.lastname: Kirkham
mesh_terms: D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D016001:Confidence Intervals; D006801:Humans; D006973:Hypertension / Q000188:drug therapy*; D017410:Practice Guidelines as Topic / Q000592:standards; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design; D006113:United Kingdom; D014956:Writing / Q000592:standards*
chemical_list: D000959:Antihypertensive Agents