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Report of the National Institutes of Health Task Force on Research Standards for Chronic Low Back Pain
Authors:Richard A. Deyo  Samuel F. Dworkin  Dagmar Amtmann  Gunnar Andersson  David Borenstein  Eugene Carragee  John Carrino  Roger Chou  Karon Cook  Anthony DeLitto  Christine Goertz  Partap Khalsa  John Loeser  Sean Mackey  James Panagis  James Rainville  Tor Tosteson  Dennis Turk  Michael Von Korff  Debra K. Weiner
Affiliation:1. Professor, Department of Family Medicine, Oregon Health & Science University, Portland, OR;2. Professor, Department of Medicine, Oregon Health & Science University, Portland, OR;3. Professor, Department of Public Health & Community Medicine, Oregon Health & Science University, Portland, OR;4. Professor, Department of Oral Medicine, Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA;5. Research Associate Professor, Department of Rehabilitation Medicine, University of Washington, Seattle, WA;6. Professor, Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL;g Clinical Professor, Department of Medicine, George Washington University Medical Center, Washington, DC;h Professor, Department of Orthopaedic Surgery, Stanford University School of Medicine, Stanford, CA;i Associate Professor, Department of Radiology, Johns Hopkins University, Baltimore, MD;j Professor, Department of Medicine, Oregon Health and Science University, Portland, OR;k Professor, Department of Medical Informatics and Clinical Epidemiology, Oregon Health and Science University, Portland, OR;l Research Associate Professor, Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL;m Professor, Department of Physical Therapy, University of Pittsburgh, Pittsburgh, PA;n Vice Chancellor of Research & Health Policy, Palmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport, IA;o Deputy Director, National Institutes of Health, Division of Extramural Research, National Center for Complementary and Alternative Medicine, Bethesda, MD;p Professor Emeritus, Department of Neurological Surgery, University of Washington, Seattle, WA;q Professor Emeritus, Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA;r Professor, Department of Anesthesia and Pain Management, Stanford University, Stanford, CA;s Program Director, National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH, Orthopaedics Research Program, Bethesda, MD;t Chief, Department of Physical Medicine and Rehabilitation, New England Baptist Hospital, Roxbury Crossing, MA;u Professor, Department of Community and Family Medicine and The Dartmouth Institute, Geisel School of Medicine at Dartmouth, Hanover, NH;v Senior Investigator, Group Health Research Institute, Seattle, WA;w Professor, Department of Medicine, University of Pittsburgh, Pittsburgh, PA;x Professor, Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA;y Professor, Department of Anesthesiology; University of Pittsburgh, Pittsburgh, PA. Geriatric Research, Educational and Clinical Center, VA Pittsburgh Healthcare System, Pittsburgh, PA
Abstract:

Objectives

Despite rapidly increasing intervention, functional disability due to chronic low back pain (cLBP) has increased in recent decades. We often cannot identify mechanisms to explain the major negative impact cLBP has on patients' lives. Such cLBP is often termed nonspecific and may be due to multiple biologic and behavioral etiologies. Researchers use varied inclusion criteria, definitions, baseline assessments, and outcome measures, which impede comparisons and consensus. The purpose of this article is to disseminate the report of the National Institutes of Health (NIH) task force on research standards for cLBP.

Methods

The NIH Pain Consortium charged a research task force (RTF) to draft standards for research on cLBP. The resulting multidisciplinary panel developed a 3-stage process, each with a 2-day meeting.

Results

The panel recommended using 2 questions to define cLBP; classifying cLBP by its impact (defined by pain intensity, pain interference, and physical function); use of a minimal data set to describe research subjects (drawing heavily on the Patient Reported Outcomes Measurement Information System methodology); reporting “responder analyses” in addition to mean outcome scores; and suggestions for future research and dissemination. The Pain Consortium has approved these recommendations, which investigators should incorporate into NIH grant proposals.

Conclusions

The RTF believes that these recommendations will advance the field, help to resolve controversies, and facilitate future research addressing the genomic, neurologic, and other mechanistic substrates of cLBP. Greater consistency in reporting should facilitate comparisons among studies and the development of phenotypes. We expect the RTF recommendations will become a dynamic document and undergo continual improvement.
Keywords:Low Back Pain   Chronic Pain   Patient Outcome Assessment   Research Design
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