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S15: Conducting Pragmatic Trials with Complementary and Integrative Interventions: Lessons Learned

10:30 - 12:00, Ashe Auditorium, Third Floor

Wendy Weber (1), Jeffery Dusek (2), Partap Khalsa (1), Lynn DeBar (3), Laura Lee Johnson (1), Jason Gerson (4)

(1): National Institutes of Health (NIH), National Center for Complementary and Alternative Medicine (NCCAM), United States   

(2): Penny George Institute for Health and Healing, Allina Health, United States

(3): Kaiser Permanente Center for Health Research, United States

(4): Patient-Centered Outcomes Research Institute (PCORI), United States



In the last few years there has been a growing interest by the public and the scientific community in clinical trials that will test research hypotheses, which will directly inform the health care system.  This interest has been driven by a number of factors including the high cost of traditional efficacy studies and the exclusion of many individuals from efficacy trials resulting in results that do not generalize to many patients.  This symposium includes presentations that will provide definitions of pragmatic and comparative effectiveness research (CER) studies, and describe circumstances when these study designs are appropriate.  NCCAM and PCORI representatives will highlight an overview of funding opportunities and priorities for pragmatic and CER studies.  Two investigators will present an overview of ongoing pragmatic research studies. One is designed as a prospective observational study design conducted within a hospital care system utilizing electronic health records to gather outcome data.  The second study is a cluster randomized pragmatic trial examining treatments for chronic pain in multiple health care systems. Presenters will discuss an overview of the challenges encountered in conducting these studies and how they have overcome these challenges.  The final presenter will be a statistician who will provide a summary of the statistical and data quality concerns that need to be addressed in pragmatic studies including: sites needed for cluster randomization, data quality in electronic health records, and confounding and bias in observational designs. The session will close with a panel discussion with all presenters to answer questions from the audience.