Outcomes Research

Emphasizing the Burden of Proof

“…11 The Institute of Medicine has published a report warning about inferring the effect of a drug or food on people based on its effect on surrogate outcomes and biomarkers. 12 A focus on what the patient experiences forms the core of outcomes research 13,14 ; the ultimate test of any intervention or policy is its effects on people. 15,16 We are increasingly appreciating that drugs have many effects, and changes in single biomarkers do not always capture the full range of a drug's impact on individuals.…”

The Privilege of Editorship

“…We have audacious hopes for this endeavor; please join us in making it a success." I authored several pieces on outcomes research, including those that examined common misunderstandings about the field, 23 the responsibilities of clinician-scientists to question conventional wisdom, 24 and the role of CQO as a vehicle for such change. "If your work is done well and your conclusions follow your arguments and data, you will not be disqualified because your conclusions are at odds with conventional wisdom.…”

Tools for Guiding Clinical Practice From the American Heart Association and the American College of Cardiology

“…22 The Comparative Effectiveness Research Act of 2008 that is under consideration by Congress (http://thomas.loc.gov/) and the 4 outcomes centers supported by the AHA may provide further support for the studies needed to provide the evidence on relative benefits and costs of various therapeutic options in the real world. 23,24 Second, CPGs and AUC must become living documents, continually updated to summarize best evidence in a timely and accurate manner. The CPGs have already made great strides to do this with routine evaluation of the results of recently released clinical trials.…”