that is more directly relevant to everyday clinical decisions. Stewart views the EHR as a transforming technology and suggests several ways in which appropriate design and utilization of this tool and surrounding support systems can allow researchers to tap into and learn from the heterogeneity of patients, treatment effects, and the clinical environment to accelerate the generation and application of evidence in a learning healthcare system.

Perhaps one of the most substantial considerations will be how these quicker, practice-based opportunities to generate evidence might affect evidentiary standards. Steven Pearson’s paper outlines how the current process of assessing bodies of evidence to inform the coverage decision process might not be able to meet future needs, and the potential utility of a means to consider factors such as clinical circumstance in the process. He discusses possible unintended consequences of approaches such as Coverage with Evidence Development (CED) and suggests concepts and processes associated with coverage decisions in need of development and better definition. Finally, Robert Galvin discusses the employer’s dilemma of how to get true innovations in healthcare technology to populations of benefit as quickly as possible but guard against the harms that could arise from inadequate evaluation. He suggests that a “cycle of unaccountability” has hampered efforts to balance the need to foster innovation while controlling costs, and discusses some of the issues facing technology developers in the current system and a recent initiative by General Electric (GE), UnitedHealthcare, and InSightec to apply the CED approach to a promising treatment for uterine fibroids. Although this initiative has potential to substantially expand the capacity for evidence generation while accelerating access and innovation, challenges to be overcome include those related to methodology, making the case to employers to participate, and confronting the culture of distrust between payers and innovators.


Brent James, M.D., M.Stat.

Intermountain Healthcare

Quality improvement was introduced to health care in the late 1980s. Intermountain Healthcare, one of the first groups to attempt clinical improvement using these new tools, had several early successes (Classen et al. 1992; James 1989 [2005, republished as a “classics” article]). While those experiences showed that Deming’s process management methods could work within healthcare delivery, they highlighted a major challenge: the results did not, on their own, spread. Success in one location did not lead to widespread adoption, even among Intermountain’s own facilities.

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