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

被引：23

作者：

Bagul, Nitin Babulal ^{[1
]}

Kirkham, Jamie J. ^{[2
]}

机构：

[1] Novartis Horsham Res Ctr, Horsham RH12 5AB, W Sussex, England

[2] Univ Liverpool, Dept Biostat, Liverpool L69 3GS, Merseyside, England

来源：

CLINICAL AND EXPERIMENTAL HYPERTENSION | 2012年 / 34卷 / 08期

关键词：

harm; adverse event; CONSORT; CONSORT extension; drug safety; ADVERSE EVENTS; QUALITY; STATEMENT; IMPROVE;

D O I：

10.3109/10641963.2012.681724

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

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.

引用

页码：548 / 554

页数：7

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