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7. NOT: Other bias
If not an issue with internal validity
• Grey literature (e.g. conference abstract or thesis)
• No trial registration
• Funding – record this in characteristics only
• Imprecision
• Heterogeneity
• Ethics approval
• Power/sample size calculation
7. Other bias
A trial of Elonva vs. daily FSH. “The study was funded by Merck & Co” (owners of Elonva)
+
1
+- 3
The study compared IUI with intercourse for three months. The - primary outcome was biochemical pregnancy. Participants in the
IUI group were monitored during their cycles and hcg blood tests
were undertaken 16 days after IUI. Participants in the control
group were asked to take home pregnancy tests if they missed a period.
“The trial was terminated early after interim analysis showed 2 that the predetermined threshold for breast cancer had been
reached...”
“An interim analysis led to an amendment to the protocol to target recruitment at a particular sub-group of patients”
4
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PRECONGRESS COURSE 17 I VIENNA, AUSTRIA – 23 JUNE 2019 63