- •Pragmatic pain trials are important to address clinical practice gaps.
- •Pragmatic trials must ensure that flexibility does not compromise treatment fidelity.
- •Principles for balancing flexibility and fidelity in pragmatic trials are highlighted.
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Research reported in this publication was made possible by grant number U24 AT009769 from the National Institutes of Health (NIH) National Center for Complementary and Integrative Health (NCCIH), and the NIH Office of Behavioral and Social Sciences Research (OBSSR). Additional support was provided for some authors. For Drs. Fritz and Rhon, support was also provided by the following UG3/UH3 cooperative agreements from NCCIH (AT009761 and AT009763), and the Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, through the Pain Management Collaboratory - Pragmatic Clinical Trials Demonstration Project Awards (W81XWH-18-2-0003, W81XWH-18-2-0007 and W81XWH-18-2-0008) and the U.S. Department of Veterans Affairs, Health Services Research and Development Service (SDR-17-306). For Dr. George, support was provided by NCCIH (UH3AT00970). For Drs. Taylor and Zeliadt, support was provided by the Veterans Health Administration Office of Research and Development (SDR-17-306). For Dr. Vining, support was provided by NCCIH (UH3AT009761). For Dr. Keefe, support was provided by the National Institute on Aging (R01AG058702, UH3AG067493, R01AG064947), the National Cancer Institute (R01CA237892, R01CA229425, UG1CA189824), NCCIH (UH3AT009790), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (UH3AR077360), the National Institute of Nursing Research (UG3NR019196), the National Institute of Diabetes and Digestive and Kidney Diseases (U01DK123813), and the American Cancer Society (RSG-20-134-01-PCSM).
The authors have no conflicts of interest to declare.