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Comment & Response
March 2014

Establishing Comparable Requirements and Treatment Groups Before Applying Statistical Comparison—Reply

Author Affiliations
  • 1Division of Cardiology, St Lukes-Roosevelt Hospital, Mount Sinai Health System, New York, New York
  • 2Department of Medicine, New York Medical College–Metropolitan Hospital Center, New York, New York
  • 3Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy
  • 4Division of Cardiology, University of Texas Southwestern, Dallas, Texas
JAMA Neurol. 2014;71(3):371-372. doi:10.1001/jamaneurol.2013.6003

In Reply We thank Stöllberger and Finsterer as well as Kallistratos et al for their interest in our article.1 Stöllberger and Finsterer have pointed out that recent intracranial, intraocular, spinal, retroperitoneal, or atraumatic intra-articular bleeding were exclusion criteria for included randomized clinical trials (RCTs) of the new oral anticoagulants (NOACs), and they have suggested the pooled rates of intracranial hemorrhages (ICHs) may have been a misrepresentation owing to lower baseline risk for ICH. We would point out that the older warfarin trials had also excluded patients with recent bleeds including ICH.2 Clinical pragmatism should preclude such patients from being enrolled in such RCTs. In addition, we wonder how many clinicians would be comfortable in prescribing long-term warfarin to any patient who has had a clinically relevant ICH. Accordingly, this operational choice of included studies and our meta-analysis represented de facto routine clinical practice.

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