• More on Generalizability

    The latest issue of the Archives of Internal Medicine has two papers on the unwarranted exclusion of patients from Heart Failure research and the negative effects that such exclusions have on the evidence-base that informs patient care. The primary issue is the exclusion of older patients, who constitute the vast majority of persons with Heart Failure.  Cherubini and colleagues found that around 1 in 4 Heart Failure studies they reviewed (underway and included in the World Health Organization Clinical Trials Registry database on Dec. 1, 2008) had arbitrary age exclusions that kept elderly persons out of studies.  Further, around 4 in 10 had at least one poorly justified exclusion criteria that indirectly kept elderly persons out of such studies. In an invited commentary, Gurwitz and Goldberg (no abstract, just the first 150 words, paper is not available without a subscription) lay out the problems with the evidence-base for treating Heart Failure that currently exist because of such exclusions.  For example, they note that around 40% of Medicare beneficiaries who survive a hospitalization for Heart Failure would have been excluded from the major trials testing the different therapies available for such patients.

    I wrote about this yesterday in the context of COPD. This issue appears to be gaining traction, and goes directly to the question of how do we best spend our finite research dollars. One answer is that we better make sure that the populations being studied are similar enough to the populations being treated to give research the maximum chance to be useful.

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    • It looks like the problem here is that the research is being driven by pharma. They want to design studies which will show their drugs in the best light and this leads to odd criteria which limit the usefulness of the research for clinicians in the real world (but does not limit the pharma marketing message).
      I don’t think we should consider pharma research as part of our “finite research dollars”. They will never be on board with the kind of studies we need.