Wednesday, January 13, 2016

I typically expect rigorous review from NEJM and to see a study of convalescent plasma trial in patients with EVD ( in which historical controls are used (Chronology Bias) and the administered product is not quantitated in any way (ELISA, Neut titers etc) to evaluate for virus specific activity prior to patient administration (Issues of internal validity) is disappointing ( The wrong question was asked to begin with. It should not be, “Does convalescent serum administration improve patient outcome in EVD?” It should be “Does convalescent serum with activity X given at dose X during acute phase X of EVD improve patient outcome?”
The authors share some of the blame for poor study design, but they did what they could with what they had to work with – rigorous clinical research during an outbreak in a developing nation is a formidable task.  I put the bulk of the responsibility squarely on the shoulders of the editors and reviewers. Why let this through? On what basis was publication recommended? The journal has incentive to publish on “hot topics”, but this should not be done at the expense of the quality of science.  Now we have two papers in the EVD literature using survivor blood products (convalescent whole blood-, and convalescent plasma- NEJM), neither of which was done correctly, and neither of which provides informative, generalizable data for use by clinicians or researchers.

It appears that the topical nature of Ebola virus disease is the underlying reason for such high profile journal publications, not the quality of the work.  It begs the question of whether or not my EBOV related publications fall into the same category. I don't think that this is the case since my work is purely observational and designed to generate testable hypotheses about pathogenesis rather than prove causality...but maybe i'm wrong?

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