http://content.healthaffairs.org/cgi/content/abstract/24/6/1571

Reporting Clinical Trial Results To Inform Providers, Payers, And Consumers

Rodney A. Hayward, David M. Kent, Sandeep Vijan and Timothy P. Hofer

Results of randomized clinical trials are the preferred "evidence" for establishing the benefits and safety of medical treatments. We present evidence suggesting that the conventional approach to reporting clinical trials has fundamental flaws that can result in overlooking identifiable subgroups harmed by a treatment while underestimating benefits to others. A risk-stratified approach can dramatically reduce the chances of such errors. Since professional and economic incentives reward advocating treatments for as broad a patient population as possible, we suggest that payers and regulatory bodies might need to act to motivate prompt, routine adoption of risk-stratified assessments of medical treatments’ safety and benefits.

One of the more salient articles on the pros and cons of heterogeneity and usual sub-group anlaysis, apologies if others had already shared this with the list.

Dan Sontheimer, MD

Springfield, MO