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Medical Rehabilitation: Guidelines to Advance the Field With High-Impact Clinical Trials
Authors:Marcas M Bamman  Gary R Cutter  David M Brienza  John Chae  Daniel M Corcos  Stephanie DeLuca  Edelle Field-Fote  Mona N Fouad  Catherine E Lang  Anne Lindblad  Robert W Motl  Carla G Perna  Darcy Reisman  Kenneth M Saag  Sean I Savitz  Kathryn H Schmitz  Jennifer Stevens-Lapsley  John Whyte  Mary E Michel
Institution:1. NIH National Rehabilitation Research Resource to Enhance Clinical Trials (REACT, P2CHD086851), Birmingham, AL;2. UAB Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, AL;3. Department of Cell, Developmental, and Integrative Biology, University of Alabama at Birmingham, Birmingham, AL;4. Section on Research Methods and Clinical Trials, Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL;5. Department of Rehabilitation Science and Technology and McGowan Institute for Regenerative Medicine, University of Pittsburgh Medical Center, Pittsburgh, PA;6. Department of Physical Medicine and Rehabilitation, Case Western Reserve University, Cleveland, OH;7. Department of Physical Therapy and Human Movement Sciences, Northwestern University, Chicago, IL;8. Virginia Tech Carilion Research Institute, Roanoke, VA;9. Virginia C. Crawford Research Institute, Shepherd Center, Atlanta, GA and Division of Physical Therapy, Emory University School of Medicine, Atlanta, GA;10. Division of Preventive Medicine, Department of Medicine and Minority Health and Health Disparities Research Center, University of Alabama at Birmingham, Birmingham, AL;11. Physical Therapy, Occupational Therapy, and Neurology, Washington University School of Medicine, St. Louis, MO;12. The Emmes Corporation, Rockville, MD;13. Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL;14. Department of Physical Therapy, University of Delaware, Newark, DE;15. Division of Clinical Immunology and Rheumatology, Department of Medicine and Center for Outcomes and Effectiveness Research and Education, University of Alabama at Birmingham, Birmingham, AL;p. Department of Neurology, University of Texas Health Science Center, Houston, TX;q. Department of Public Health Sciences, Pennsylvania State University, State College, PA;r. Physical Therapy Program, University of Colorado, Denver, CO;s. Moss Rehabilitation Research Institute, Einstein Medical Center, Philadelphia, PA;t. Division of Biokinesiology and Physical Therapy, University of Southern California, Los Angeles, CA;u. National Center for Medical Rehabilitation Research, National Institutes of Health, Bethesda, MD
Abstract:The purpose of this Special Communication is to summarize guidelines and recommendations stemming from an expert panel convened by the National Institutes of Health, National Center for Medical Rehabilitation Research (NCMRR) for a workshop entitled The Future of Medical Rehabilitation Clinical Trials, held September 29-30, 2016, at the NCMRR offices in Bethesda, Maryland. The ultimate goal of both the workshop and this summary is to offer guidance on clinical trials design and operations to the medical rehabilitation research community, with the intent of maximizing the effect of future trials.
Keywords:Clinical trial  Guideline  Rehabilitation  AE  adverse event  DSMB  data and safety monitoring board  CRC  clinical research coordinator  CRF  case report form  GCP  good clinical practice  ICH  International Council on Harmonization  IRB  institutional review board  MOP  manual of procedures  NCMRR  National Center for Medical Rehabilitation Research  PCT  pragmatic clinical trial  PI  principal investigator  PRECIS  Pragmatic-Explanatory Continuum Indicator Summary  REACT  Rehabilitation Research Resource to Enhance Clinical Trials  RCT  randomized controlled trial  SCI  spinal cord injury  SCT  social cognitive theory  SMART  sequential  multiple assignment  randomized trial
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