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William H. Shrank is formerly of the Center for Medicare & Medicaid Innovation, Centers of Medicare and Medicaid Services.
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In a rapidly transforming healthcare environment, policy makers and providers are increasingly challenged to make timely evidence-based decisions on complex evolving issues such as payment policies, care management improvements, or delivery system implementations. Rapid cycle evaluation (RCE) has been proposed as a strategy for the Centre for Medicare and Medicaid Innovations (CMMI) to accelerate health system innovations (1;2), but the details of how to align the stages of health system decision making with the stages of emerging evidence have yet to be clarified (Figure 1a). RCE is increasingly feasible as methods have emerged for collecting, and managing massive amounts of data from multiple sources in "real-time" (3-5), which allows for sequentially repeated and increasingly automated analyses of the effectiveness of interventions and products each time the data refresh (6-11).
Figure 1.
Rapid-cycle evaluation and HTA decision making.
[Figure Omitted; See PDF]
The traditional approach of health technology assessment (HTA)--to base initial decisions on pre-approval data and then wait several years until effectiveness testing is complete before evaluating results and making policy decisions--is not consistent with the pressures on policy makers and providers for more timely decisions. Initial HTA is about efficacy and often involves clinically irrelevant comparison groups (e.g., placebo or an intervention that is not an available alternative), unrealistic assumptions about routine clinical care (e.g., close to 100 percent adherence or optimal program implementation), and selected populations that do not reflect the populations that will be exposed to the new technology. HTA of "real-world" effectiveness requires ongoing updates of evidence as use of the technology evolves and spreads to different populations and contexts.
Using one-time HTA methods to evaluate programs or policies can be fruitful but, if programs evolve over time and across contexts, slow evaluations are often obsolescent before they are finalized. With the emergence of methods for real-time monitoring of very large cohorts of patients, the window of observation now can be so shortened that the evaluation results become available while still relevant to the current program decision makers. Then rigorous HTA methods can be exploited rapidly as long as the knowledge transfer to decision makers is efficient.
Historically, knowledge...