Elsevier

Thrombosis Research

Volume 126, Issue 3, September 2010, Pages 164-165
Thrombosis Research

Editorial
Pooled analysis of trials may, in the presence of heterogeneity inadvertently lead to fragile conclusions due to the importance of clinically relevant variables being either hidden or lost when the findings are pooled

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Clinical perspectives

There is striking evidence of clinical heterogeneity among the three trials which casts doubt on the authors conclusions. The trials RE-NOVATE [3], which evaluated patients undergoing elective hip surgery, and RE-MOBILIZE [4] and RE-MODEL [5], which evaluated patients undergoing elective knee surgery, were randomized double-blind non-inferiority trials, comparing the efficacy and safety of dabigatran (150 mg or 220 mg once daily) starting post-operatively, with subcutaneous enoxaparin. While the

Statistical perspectives

A critical issue regarding pooling the findings of individual trials is the presence or absence of heterogeneity [7], [8]. To establish whether heterogeneity was or was not present, the authors assessed heterogeneity of the common risk difference amongst the studies using Cochrane's X2 (Q statistic) and the I2 statistic. Statistically significant heterogeneity was considered to be present if P < 0.10 was observed and where I2 was greater than 50% heterogeneity was also considered to be

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