Seeing in these bundles a potentially powerful vehicle for promoting their products, pharmaceutical and medical-device companies have begun to invest in influencing the adoption of guidelines that serve their own financial goals. A case in point is the development of guidelines for the treatment of sepsis, which was orchestrated as an extension of a pharmaceutical marketing campaign.1,2 Although its advocates viewed this effort as an important approach to reducing sepsis-related mortality, the campaign appears to have usurped guideline development for commercial purposes, possibly compromising highly regarded, third-party arbiters of medical quality in the process. Such intrusion into an initiative to benefit public health is of particular concern...
And on it goes. And the results of this marketing campaign disguised as EBM? Reduced mortality and better guideline adherence!
About this time last year the results were presented at the SCCM annual meeting (related post here). Now, a year later, we have formal publication of the results in the February issue of Critical Care Medicine:
Measurements and Main Results: Data from 15,022 subjects at 165 sites were analyzed to determine the compliance with bundle targets and association with hospital mortality. Compliance with the entire resuscitation bundle increased linearly from 10.9% in the first site quarter to 31.3% by the end of 2 yrs (p less than .0001). Compliance with the entire management bundle started at 18.4% in the first quarter and increased to 36.1% by the end of 2 yrs (p = .008). Compliance with all bundle elements increased significantly, except for inspiratory plateau pressure, which was high at baseline. Unadjusted hospital mortality decreased from 37% to 30.8% over 2 yrs (p = .001). The adjusted odds ratio for mortality improved the longer a site was in the Campaign, resulting in an adjusted absolute drop of 0.8% per quarter and 5.4% over 2 yrs (95% confidence interval, 2.5–8.4).
The mortality was still dropping at two years indicating even better results had the campaign continued longer. Baseline mortality rates among hospitals that entered the campaign at varying points in time were similar, suggesting that the mortality reduction attributable to the campaign was real, rather than a result of other factors.
So this is one of many studies that tell us guideline adherence matters, but it's more. This is the first study ever to record patient outcomes following the introduction of an industry supported promotion. The outcomes were good. The pharmascolds were wrong.