A new learning environment: combining clinical research with quality improvement.

The emphasis provided by quality improvement strategies on performance measurement and evaluation often results in our understanding of processes of care and, perhaps, better outcomes. There are different references for process evaluation: external peers, regional profiles of performance or a trending of one's own performance patterns. This paper proposes a methodology that enables learning from the daily practice of medicine by comparing alternative care processes and outcomes. Since it is estimated that 15-20% of medical practices are based on rigorous scientific data establishing their effectiveness, we have much to learn. We propose to learn from our daily practice by combining clinical research methods with quality improvement tools. The products comprise modified clinical trial and case-control studies. In a modified clinical trial, we would use a practice guideline as a control group and modify the guideline to create an experimental group. This method would maintain the internal validity of efficacy research while maintaining the external validity of effectiveness research. In the case-control method, it is possible to quantitate risk for a given outcome and focus improvement effort on factors associated with that outcome. We believe physicians will accept this learning approach because it is a more valid learning method than traditional quality improvement and, unlike randomized clinical trials, learning will occur in the daily practice of medicine.