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Is a given health care intervention effective or not? Is it appropriate in a given clinical context or not? Should it be covered by health insurance or not?
The search for answers to these questions leads to investment in comparative effectiveness research, the development of guidelines and appropriateness criteria, and payment systems aimed at ensuring delivery of appropriate care and reducing inappropriate care. Although such work is useful, the output has become overwhelming — without resulting in a high-value health care system.
One fundamental problem may be a misguided perspective that health care is a binary world in which interventions are either effective or ineffective, appropriate or inappropriate. In truth, there are large gray zones in which an intervention is neither clearly effective nor clearly ineffective — zones where benefits are unknown or uncertain and value may depend on patients' preferences and available alternatives. Much health care occurs in these gray zones, which are expanding despite insights gained from comparative effectiveness research.
Since gray zones will always be part of health care, we need a strategy that goes beyond trying to shrink them. We need payment and incentive systems that don't ignore or merely acknowledge gray zones but are designed to work within them.
Gray zones often expand because of progress: new technologies may cause fewer side effects than their predecessors, lowering the threshold for intervention and expanding the candidate pool to include patients who might not benefit measurably but would risk no obvious harm. The question for clinicians then becomes, why not?
The history of percutaneous coronary intervention (PCI) provides a useful case study in this phenomenon, illustrating how a technology can increase the scope for overuse. Trial evidence shows that PCI provides tremendous benefit to patients with myocardial infarction who undergo rapid reperfusion. But when PCI is used later in the course of an infarction or in lower-risk patients, its benefit shrinks and may approach zero. The problem of consuming minimal-benefit care is compounded by insurance, which insulates patients...