The United States must substantially strengthen its capacity for scientific inquiry into evidence on what is known and not known about what works in health care. Under the status quo, there is not enough objective and credible information identifying which health services work best, for whom, and under what circumstances (Medicare Payment Advisory Commission, 2007). Interest in a national comparative clinical effectiveness program is growing. Recently, the Medicare Payment Advisory Commission concluded unanimously that because information on clinical effectiveness can benefit all users and is a public good, the federal government should act to produce unbiased information and make it publicly available (Medicare Payment Advisory Commission, 2007). Other stakeholders and analysts agree (America’s Health Insurance Plans, 2007; BCBSA, 2007b; Congressional Budget Office, 2007; IOM, 2007; Kupersmith et al., 2005; Shortell et al., 2007; Wilensky, 2006).

The previous chapters examined three essential functions—priority setting, evidence assessment (systematic review), and developing clinical practice guidelines—of a national clinical effectiveness assessment program (“the Program”). This chapter explores how best to approach establishing an infrastructure for organizing the three functions. It first reviews the foundational principles that the committee adopted to guide its analysis and then assesses three alternatives (i.e., the status quo, a central agency model, and a hybrid model). The chapter concludes with the committee’s recommendations regarding the program infrastructure.

GUIDING PRINCIPLES

During the course of this study, a number of important themes emerged that led the committee to establish a set of guiding principles for building the Program. These themes include convincing evidence (described in the previous chapters) that financial and other types of conflicts of interest may compromise the integrity of research findings and related clinical recommendations, indications that a meaningful proportion of evidence reviews frequently lack scientific rigor, and current efforts fall far short of addressing patients’ and health professionals’ need for current, trustworthy information on clinical effectiveness. The committee particularly wants to ensure that its recommended Program will be stable over the long term, that its output be judged as objective and meeting broadly accepted standards of scientific rigor, that it will be useful to stakeholders, that it is without conflict of interest or bias,1 and that its operations be independent of external political pressures.

1

The term “bias” has different meaning depending on the context in which it is used. Here it refers to “bias” due to conflicts of interest. In discussions regarding systematic review methods,



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