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Quality, clinical practice improvement, and the episode of care.

To improve routine clinical practice, we must measure patients treated in routine practice (effectiveness research), not in specially controlled circumstances (efficacy research). We describe a new study methodology, Clinical Practice Improvement (CPI), designed to develop data-driven, analytically-based protocols to achieve desirable outcomes at the lowest essential cost over the continuum of care. Measurement in CPI encompasses a comprehensive view of care management: patient characteristics, process steps, and outcomes. All three classes of data are considered simultaneously, providing a basis for meaningful analyses of significant associations between processes and outcomes. We present an example of a CPI pediatric asthma study.