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S26: Practical Considerations in Planning and Implementing Individual and Group Intervention Studies: Strategies That Can Help (or Hurt) Scientific Rigor

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

Qian Li (1), Laura Lee Johnson (1), Robyn Bent (1), Wendy Weber (1), Christine Wishnoff (1)

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

 

 

Study teams strive for rigorous study designs to address research questions despite numerous challenges.  While it may appear simple to plan a randomized, controlled, double-blind study, implementation can be challenging.  Based on implementation challenges commonly noted in trials of yoga, tai chi, meditation and whole systems studies, this workshop will guide attendees through the study design and implementation process, and assist in the recognition of common pitfalls. It starts by proposing a series of research questions and discussing several study design options such as group, cluster or individual level randomization; interactions between the study team, participants, and intervention delivery; and basic statistical considerations including intent-to-treat or per protocol analysis populations and missing data. Attendees will work in groups to define a study question, hypotheses to test, and study design strategies. Choices made by the groups will determine the potential study planning and implementation problems that the groups will encounter on their path to successful study completion. The small groups will then be challenged with an implementation hurdle such as difficulties recruiting, retaining, blinding, or randomizing participants; differential participant retention and follow-up; or other issues with study conduct. These challenges will be shared with all the workshop attendees to get feedback and additional perspectives through guided discussion.  At the end of the workshop, choices for final study design and determination of which questions can be answered based on that design will be shared with workshop attendees. This will be a highly interactive and engaging session sharing creative and best practices in addition to lessons learned across communities. Upon completion of the workshop, participants and presenters should have an expanded perspective on potential study implementation and interpretation issues and potential solutions that can be used in designing their own studies, reviewing study proposals, evaluating the literature, and developing new research recommendations.