Authors' reply to Marjoribanks and colleagues, Rossouw and colleagues, Schroll and Lundh, and McPherson

In: BMJ · 2012 · vol. 345(dec03 2) , pp. e8164 · doi:10.1136/bmj.e8164 · W2066181825
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The authors acknowledge performance and detection bias in open-label trials, particularly for mortality-driven endpoints, and note that no HRT trials in women with a uterus are fully blinded.

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Abstract

We are grateful for all of the interest in our paper1; more extensive answers are available at bmj.com (www.bmj.com/content/345/bmj.e6409/rr/612351). Although randomisation is an important part of any trial, we acknowledge that performance and detection bias exist in open label trials,2 3 but these biases are less important when endpoints are driven by mortality. Furthermore, no trial of hormone replacement therapy (HRT)—including the Women’s Health Initiative—conducted in women with a uterus is completely blinded.4 5 …

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