系统评价者忽视了因试验因获益而提前终止所导致的偏倚。

Systematic reviewers neglect bias that results from trials stopped early for benefit.

作者信息

Bassler Dirk, Ferreira-Gonzalez Ignacio, Briel Matthias, Cook Deborah J, Devereaux P J, Heels-Ansdell Diane, Kirpalani Haresh, Meade Maureen O, Montori Victor M, Rozenberg Anna, Schünemann Holger J, Guyatt Gordon H

机构信息

The Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.

出版信息

J Clin Epidemiol. 2007 Sep;60(9):869-73. doi: 10.1016/j.jclinepi.2006.12.006. Epub 2007 Apr 11.

DOI:10.1016/j.jclinepi.2006.12.006

PMID:17689802

Abstract

OBJECTIVE

To examine how authors of systematic reviews that include randomized clinical trials (RCTs) that are stopped early for benefit (truncated RCTs-tRCTs) address the potential for overestimation of treatment effects and to determine the weight of the tRCTs on pooled results.

STUDY DESIGN AND SETTING

We searched the Cochrane Library and MEDLINE and evaluated systematic reviews that include at least one tRCT. We documented approaches that authors used to address potential overestimates of treatment effect introduced by including tRCTs. We assessed the impact of tRCTs in meta-analyses on the outcomes that led to their early termination.

RESULTS

Of 96 systematic reviews that included at least one tRCT, 44 (46%) included >1 tRCT, 68 (71%) did not mention truncation at all, and 2 (2%) documented early stopping for benefit as a criterion for methodological quality. Of 47 meta-analyses in which authors reported, or we could calculate the contribution of the tRCTs to the pooled result, the tRCTs contributed more than 40% of the weight in 16/47 (34%).

CONCLUSION

Most systematic reviews and meta-analyses including tRCTs fail to consider the possible overestimates of effect that may result from early stopping for benefit. We recommend safeguards that address this possibility.

摘要