Thursday, May 27, 2010

Comparative Effectiveness Research: How We Could Make It Effective

Yesterday's Disease Management Care Blog post on the impact of physician professional autonomy in health reform generated some readership consternation, including some personal feedback that it must have been written after a recent excess of additional research in this topic area.

Not true, says the DMCB. But it thinks the same charge could be leveled at the authors of this utopian viewpoint on the topic Comparative Effectiveness Research (CER) that recently appeared as a Commentary in the Amercian Journal of Managed Care.

According to Dr. Sox et al, CER will usher in a new age of enlightened medicine in the United States, enabling it to join other civilized nations with the means to scientifically assess every corner of health care. Those means are two fold: 1) money printing presses that finance the research and 2) experts to assess that research and make recommendations. As a result, policy makers will be informed, uncertainties will wane and patients and physicans will choose wisely. Medical Journals that recognize this will be doing their part to make a healthier and happier world.

In order for this supposed nirvana of knowledge, this cornucopia of comprehension, this era of excellence to occur, however, the CER will need to be scientific, conducted under protocol, use representative populations, registered, peer reviewed, open accessed, published in traditional upper tier journals and be accompanied by descriptions of the research limitations and disclosures of author conflict of interest.

The problem? The DMCB notes plenty of research is already subject to protocol, representative, peer reviewed, open accessed, published and transparent. More of the same, thanks to $1.1 billion, isn't any more likely than the current system to sigificantly influence physicians. Case in point is the CER poster child ALLHAT Study (also detailed in the prior post) that met all the CER criteria favored by Cox et al and still failed after publication in JAMA to increase water pill prescribing vs. other more expensive medications for hypertension.

What CER really represents is a 10 figure gravy train for the academic-medical-publishing industrial complex courtesy of the U.S. taxpayers. There will be some benefit, thinks the DMCB, but it doubts we're going to get our money's worth.

Fortunately, the DMCB has some additional suggestions that will help increase the odds that CER could actually have an impact:

1) the research protocols should be explicitly translational. In other words, the interventions that are being tested should include features that help us understand how they can be best disseminated into mainstream care settings. For example, ALLHAT could have included a thiazide plus disease management/value-based insurance design treatment arm. It's not only important to understand what but how.

2) the outcomes should not only appear in traditional medical journal "channels," but be actively and freely disseminated in nontraditional venues used by health care professionals as well as consumers, including, but not limited to, on-line web sites, discussion boards, blogs and other social media. There should be a routine methodology to deconstruct the complex outcomes results into language that can be accessed and understood by lay persons. A good start is the Annals of Internal Medicine's patient information section.

3) speaking of lay persons, it's not enough to "open access" the summary results of CER. The individual level data itself - within the limits of current interpretations of the need to respect privacy - should be open sourced. There are plenty of lay scientists with the skill and the interest to look for and find problems that may have been missed by the authors, reviewers and editors. An example is the initially missed excess number of heart attacks among Vioxx users in this paper that was published in the New England Journal.

4) candidacy for research funding should not be limited to traditional members of the academic community with a track record, but favor initiatives that involve partnerships that include, but are not limited to, community and faith-based organizations, health insurers, purchasers, buyers and patient advocacy groups like this.

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