Life Science Compliance Update

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November 08, 2010

Surviving Sepsis Campaign: Continuing Medical Education Saving Lives

A recent study looked at “The Surviving Sepsis Campaign (SSC or “the Campaign”), which developed guidelines for management of severe sepsis and septic shock.  This Campaign was a performance improvement initiative targeted at changing clinical behavior (process improvement) via bundles based on key SSC guideline recommendations.

The campaign was a multifaceted intervention to facilitate compliance with selected guideline recommendations in the intensive care unit, emergency department, and wards of individual hospitals and regional hospital networks. These guidelines were implemented voluntarily in the United States, Europe, and South America. Elements of the guidelines were “bundled” into two sets of targets to be completed within 6 hrs and within 24 hrs. An analysis was conducted on data submitted from January 2005 through March 2008. The study analyzed a total of 15,022 subjects at 165 sites to determine the compliance with bundle targets and association with hospital mortality.

The impact of the campaign was analyzed in the Critical Care Medicine Journal, and found that the unadjusted hospital mortality decreased from 37% to 30.8% over 2 years. As a result, the study concluded that the Campaign was associated with sustained, continuous quality improvement in sepsis care. Accordingly, the authors noted that the “implications of this study may serve as an impetus for similar improvement efforts.”

It is important to recognize that the Campaign is partially funded through commercial support. In fact, as noted in article from 2007, medical societies on behalf of SSC applied for and received industry-sponsored educational grants to conduct sepsis-related educational initiatives. The author noted that such industry sponsored educational grants were critical to the success of the Campaign and improving patient outcomes because government does not fund such education.

With respect to the development of the 2004 guidelines, the author noted that industry support was limited to funds for logistic planning. No industry representatives participated in the conference or reviewed the guidelines in any form before peer-review and acceptance for publication.

Moreover, the author noted that the “inability to translate top quality research into medical practice has been identified as a major failing of representative healthcare agencies worldwide". Accordingly, he recognized that industry sponsored grants “have enabled the SSC to develop the components of a global performance improvement program to elicit significant and rapid clinical change.”

He emphasized the fact that “without such sponsorship, an ambitious project of this scale would not have been possible in the present funding climate.” It is also important to note that such “sources of funding have always been prominently disclosed, including in the 2004 guidelines publication itself.” Additionally, the medical societies that received the grants maintained full control over their use, and the societies’ ethical safeguards and transparency in governance ensured that any misuse would have been identified.

Consequently, this study reveals that industry supported educational programs improve patient outcomes including saving lives by better adherence to guidelines.

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