Editor’s note: The Disruptive Women in Health Care blog recently compiled an ebook exploring the issue of Comparative Effectiveness Research (CER) from a variety of viewpoints and perspective. We invite you to download the ebook or read the original posts.

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By Liz Scherer. Comparative effectiveness research (CER): it’s the buzzword of the new decade.  In fact, Congress recently passed legislation to provide more than $1B to support CER  in hopes of improving utilization of existing therapies while simultaneously holding down healthcare costs. The ultimate goal of CER goes even further and paints a rosy vision of patient-centered care and personalized medicine.

However, perhaps these goals are loftier than originally imagined.  Newly- published data appearing in this week’s JAMA show that the very research that is supposed to be forging the path for our nation’s health is filled with ills of its own.

An analysis of randomized and observational studies and meta-analyses published in six “high-impact” journals (i.e. NEJM, Lancet, JAMA, Annals of Internal Medicine, BMJ and Archives of Internal Medicine) demonstrated that there is a dearth of CER studies to guide policymaking or clinical decisions. Granted, this underscores the need to expand funding, preferably public funding to fill the gap. However, key findings also showed that only 32% of evaluable medication studies met the criteria for CER, efficacy outcomes were generally emphasized to a substantially greater extent than safety outcomes (only 19% of studies focused on safety), and that a critical element for promoting effective and efficient healthcare, i.e. cost-effective analyses, appeared in only 2% of the studies. Moreover, less than 50% of studies had active comparators and of these, less than a quarter used non-inferiority analyses, thereby obviating the ability to effectively evaluate and compare similar agents with different side effects profiles.

These data raise as many questions as they do answers. Although they provide an essential framework for moving the Nation’s mandate forward, they clearly raise a red flag; as Patrick Conway MD and Carolyn Claney MD write in an accompanying editorial, the decisions that originally guided nationally mandated priorities for CER “had no clear inventory of published studies or research in progress to inform their deliberations.”

With over $1B at stake in an already stressed economy, doesn’t it make sense to take a step back, reevaluate our mandates and fill in the gaps before moving forward too quickly? While it is true that there is insufficient research being devoted to CER, it appears that the research itself (and perhaps even the policy driving it) may also be insufficient.

Source:

Hochman M, McCormick D. Characteristics of published comparative effectiveness studies of medications. JAMA. 2010; 303: 951-958.

Conway PH, Clancy C. Charting a path from comparative effectiveness funding to improved patient-centered health care. JAMA. 2010;303: 985-986.

Related posts:

1. Disruptive Women’s Comparative Effectiveness Research eBook Is Available
2. Comparative Effectiveness Research: Thinking outside the box
3. Comparative Effectiveness Research Smack Down: June 22nd Kicks Off A Policy Challenge through the Eyes of Disruptive Women in Health Care
4. Comparative Effectiveness Research: What a Difference an X Should Make
5. Comparative Effectiveness Research from the Health Care Provider Perspective – A Glass Half Full

This entry was posted on Wednesday, March 10th, 2010 at 8:31 am and is filed under Comparative Effectiveness Research. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.