Challenges conducting comparative effectiveness research: the Clinical and Health Outcomes Initiative in Comparative Effectiveness (CHOICE) experience

The Clinical and Health Outcomes Initiative in Comparative Effectiveness (CHOICE) program, which includes 12 ongoing comparative effectiveness research (CER) trials funded by the Agency for Healthcare Research and Quality under the American Recovery and Reinvestment Act of 2009, has had firsthand experience in dealing with the unique challenges of conducting CER since the trials started in the fall of 2010. This paper will explore the collective experience of the CHOICE program and discuss common challenges and successes the CHOICE investigators have experienced conducting CER research in the United States. The specific aims of this paper are to describe the common features of the CHOICE award studies (observational studies and trials), to summarize the strategies undertaken to address the challenges in conducting comparative effectiveness pragmatic trials and observational studies from the patient, physician, and administrative perspective, and to provide recommendations for improving the efficiency and feasibility of conducting prospective CER studies in the future.