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Mamatha Chivukula1, Rohit Bhargava1, Adam Brufsky2, Urvashi Surti3 and David J Dabbs1Received 23 July 2007; Revised 5 December 2007; Accepted 7 December 2007; Published online 1 February 2008. The 2 group is considered equivocal, since gene amplification is observed in some but not others. The aim of our study is to ascertain if there is clinical significance to heterogeneity of HER2 immunohistologic expression in breast core needle biopsies vs surgical resection specimens.

We propose the difference between these two effect sizes (patient self rating and clinician derived) to be an indirect measure of bias. If patients had a prodrug bias, this method would be invalid. However the response rate from studies with active placebo suggest a patient prodrug bias is unlikely.

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For the purpose of pooled analyses, we also recorded statistics that could be used to estimate the variance of the outcome measures.Statistical analysesFor each trial, we calculated the treatment effect for outcomes. In crossover trials, the treatment effect was the difference in outcomes between the end of the reduced salt period and the end of the usual salt (control) period. In parallel trials, the treatment effect was the difference between the two treatment groups in the change in outcomes from baseline to the end of follow up.For each trial, we also calculated the variance of the treatment effect for outcomes.

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