Methods for pragmatic randomized clinical trials of pain therapies: IMMPACT statement

David Hohenschurz-Schmidt, Pain Research, Department of Surgery & Cancer, Faculty of Medicine, Imperial College London, United Kingdom.
Dan Cherkin, Osher Center for Integrative Health, Department of Family Medicine, University of Washington, Seattle, WA, United States.
Andrew S. Rice, Pain Research, Department of Surgery & Cancer, Faculty of Medicine, Imperial College London, United Kingdom.
Robert H. Dworkin, Department of Anesthesiology and Perioperative Medicine, University of Rochester Medical Center, Rochester, NY, United States.
Dennis C. Turk, Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, United States.
Michael P. McDermott, Department of Biostatistics and Computational Biology, University of Rochester, Rochester, NY, United States.
Matthew J. Bair, VA Center for Health Information and Communication, Regenstrief Institute, and Indiana University School of Medicine, Indianapolis, IN, United States.
Lynn L. DeBar, Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States.
Robert R. Edwards, Harvard Medical School, Boston, MA, United States.
Scott R. Evans, Biostatistics Center and the Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, George Washington University, Rockville, MD, United States.
John T. Farrar, Department of Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia, PA, United States.
Robert D. Kerns, Department of Psychiatry, Yale School of Medicine, New Haven, CT, United States.
Michael C. Rowbotham, Department of Anesthesia, University of California San Francisco School of Medicine, San Francisco, CA, United States.
Ajay D. Wasan, Departments of Anesthesiology & Perioperative Medicine, and Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, United States.
Penney Cowan, American Chronic Pain Association, Rocklin, CA, United States.
McKenzie Ferguson, Department of Pharmacy Practice, Southern Illinois University Edwardsville, Edwardsville, IL, United States.
Roy Freeman, Department of Neurology, Harvard Medical School, Boston, MA, United States.
Jennifer S. Gewandter, Department of Anesthesiology and Perioperative, University of Rochester, Rochester, NY, United States.
Ian Gilron, Departments of Anesthesiology & Perioperative Medicine, Biomedical & Molecular Sciences, Centre for Neuroscience Studies, and School of Policy Studies, Queen's University, Kingston Health Sciences Centre, Kingston, ON, Canada.
Hanna Grol-Prokopczyk, Department of Sociology, University at Buffalo, State University of New York, Buffalo, NY, United States.
Smriti Iyengar, Eli Lilly and Company, Indianapolis, IN, United States.
Cornelia Kamp, Center for Health and Technology (CHeT), Clinical Materials Services Unit (CMSU), University of Rochester Medical Center, Rochester, NY, United States.
Barbara I. Karp, National Institutes of Health, Bethesda, MD, United States.
Bethea A. Kleykamp, University of Maryland, School of Medicine, Baltimore, MD, United States.
John D. Loeser, Departments of Neurological Surgery and Anesthesia and Pain Medicine, University of Washington, Seattle, WA, United States.
Sean Mackey, Stanford University School of Medicine, Department of Anesthesiology, Perioperative, and Pain Medicine, Neurosciences and Neurology, Palo Alto, CA, United States.
Richard Malamut, Chief Medical Officer, MedinCell, Jacou, France.
Ewan McNicol, Department of Pharmacy Practice, Massachusetts College of Pharmacy and Health Sciences University, Boston, MA, United States.
Kushang V. Patel, Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, United States.
Kenneth Schmader, Department of Medicine-Geriatrics, Center for the Study of Aging, Duke University Medical Center, and Geriatrics Research Education and Clinical Center, Durham VA Medical Center, Durham, NC, United States.
Lee Simon, SDG, LLC, Cambridge, MA, United States.
Deborah J. Steiner, Eli Lilly and Company, Indianapolis, IN, United States.

Document Type

Journal Article

Publication Date

5-3-2024

Journal

Pain

DOI

10.1097/j.pain.0000000000003249

Abstract

Pragmatic, randomized, controlled trials hold the potential to directly inform clinical decision making and health policy regarding the treatment of people experiencing pain. Pragmatic trials are designed to replicate or are embedded within routine clinical care and are increasingly valued to bridge the gap between trial research and clinical practice, especially in multidimensional conditions, such as pain and in nonpharmacological intervention research. To maximize the potential of pragmatic trials in pain research, the careful consideration of each methodological decision is required. Trials aligned with routine practice pose several challenges, such as determining and enrolling appropriate study participants, deciding on the appropriate level of flexibility in treatment delivery, integrating information on concomitant treatments and adherence, and choosing comparator conditions and outcome measures. Ensuring data quality in real-world clinical settings is another challenging goal. Furthermore, current trials in the field would benefit from analysis methods that allow for a differentiated understanding of effects across patient subgroups and improved reporting of methods and context, which is required to assess the generalizability of findings. At the same time, a range of novel methodological approaches provide opportunities for enhanced efficiency and relevance of pragmatic trials to stakeholders and clinical decision making. In this study, best-practice considerations for these and other concerns in pragmatic trials of pain treatments are offered and a number of promising solutions discussed. The basis of these recommendations was an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) meeting organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks.

Department

Biostatistics and Bioinformatics

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