Abstract Details
Activity Number:
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536
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Type:
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Contributed
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Date/Time:
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Wednesday, August 7, 2013 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #310247 |
Title:
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Inclusion of Zero-Event Trials Using Continuity Correction in Meta-Analyses of Rare Events
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Author(s):
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Tianyue Zhou*+
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Companies:
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Sanofi
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Keywords:
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meta analysis ;
fixed effects ;
Mantel-Haenszel method ;
continuity correction
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Abstract:
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Meta-analysis has been widely used to combine data with low event rate across comparative clinical studies. When dealing with rare events, a substantial proportion of studies may not have any events of interest. In common practice, meta-analyses on a relative scale (relative risk or odds ratio [OR]) remove zero-event studies while meta-analyses using risk difference [RD] as the effect measure include them. The impact of zero-event trials on estimates of OR and RD in terms of bias, coverage and length of 95% confidence interval [CI], power of the test and type 1 error was examined through simulation. Mantel-Haenszel method is chosen to pool the estimates. Zero-event studies are included in analysis through 2 types of continuity corrections. For OR, zero-event trials had little impact on analysis of the treatment effect when 'treatment arm' continuity correction constrained to sum to 0.01 was used. However, zero-event trials should be included when the percentage of such trials was high (>=40%) to avoid huge CIs. For RD, zero-event trials should be included using constant continuity correction of 0.5 or 'treatment arm' continuity correction constrained to 1 to control type 1 error.
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Authors who are presenting talks have a * after their name.
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