Frederick Wolfe1, Daniel J Clauw2, Mary-Ann Fitzcharles3, Don L Goldenberg4, Winfried Häuser5, Robert L Katz6, Philip J Mease7, Anthony S Russell8, Irwin Jon Russell9, Brian Walitt10. 1. National Data Bank for Rheumatic Diseases, 1035 N Emporia, Ste 288, Wichita, KS 67214; University of Kansas School of Medicine, Wichita, KS. Electronic address: fwolfe@arthritis-research.org. 2. Chronic Pain and Fatigue Research Center, University of Michigan Medical School, Ann Arbor, MI. 3. Division of Rheumatology, McGill University Health Center, Montreal, Quebec, Canada. 4. Oregon Health Science University, Portland, OR; Tufts University School of Medicine, Boston, MA. 5. Department Internal Medicine 1, Saarbrücken, Germany; Department Psychosomatic Medicine and Psychotherapy, Technische Universität München, München, Germany. 6. Rheumatology, Rush Medical College, Chicago, IL. 7. Swedish Medical Center, Seattle, WA; University of Washington, Seattle, WA. 8. Department of Medicine, University of Alberta, Edmonton, Alberta, Canada. 9. Fibromyalgia Research and Consulting, San Antonio, TX. 10. National Institute of Nursing Research, National Institutes of Health, Bethesda, MD.
Abstract
OBJECTIVES: The provisional criteria of the American College of Rheumatology (ACR) 2010 and the 2011 self-report modification for survey and clinical research are widely used for fibromyalgia diagnosis. To determine the validity, usefulness, potential problems, and modifications required for the criteria, we assessed multiple research reports published in 2010-2016 in order to provide a 2016 update to the criteria. METHODS: We reviewed 14 validation studies that compared 2010/2011 criteria with ACR 1990 classification and clinical criteria, as well as epidemiology, clinical, and databank studies that addressed important criteria-level variables. Based on definitional differences between 1990 and 2010/2011 criteria, we interpreted 85% sensitivity and 90% specificity as excellent agreement. RESULTS: Against 1990 and clinical criteria, the median sensitivity and specificity of the 2010/2011 criteria were 86% and 90%, respectively. The 2010/2011 criteria led to misclassification when applied to regional pain syndromes, but when a modified widespread pain criterion (the "generalized pain criterion") was added misclassification was eliminated. Based on the above data and clinic usage data, we developed a (2016) revision to the 2010/2011 fibromyalgia criteria. Fibromyalgia may now be diagnosed in adults when all of the following criteria are met: CONCLUSIONS: The fibromyalgia criteria have good sensitivity and specificity. This revision combines physician and questionnaire criteria, minimizes misclassification of regional pain disorders, and eliminates the previously confusing recommendation regarding diagnostic exclusions. The physician-based criteria are valid for individual patient diagnosis. The self-report version of the criteria is not valid for clinical diagnosis in individual patients but is valid for research studies. These changes allow the criteria to function as diagnostic criteria, while still being useful for classification.
OBJECTIVES: The provisional criteria of the American College of Rheumatology (ACR) 2010 and the 2011 self-report modification for survey and clinical research are widely used for fibromyalgia diagnosis. To determine the validity, usefulness, potential problems, and modifications required for the criteria, we assessed multiple research reports published in 2010-2016 in order to provide a 2016 update to the criteria. METHODS: We reviewed 14 validation studies that compared 2010/2011 criteria with ACR 1990 classification and clinical criteria, as well as epidemiology, clinical, and databank studies that addressed important criteria-level variables. Based on definitional differences between 1990 and 2010/2011 criteria, we interpreted 85% sensitivity and 90% specificity as excellent agreement. RESULTS: Against 1990 and clinical criteria, the median sensitivity and specificity of the 2010/2011 criteria were 86% and 90%, respectively. The 2010/2011 criteria led to misclassification when applied to regional pain syndromes, but when a modified widespread pain criterion (the "generalized pain criterion") was added misclassification was eliminated. Based on the above data and clinic usage data, we developed a (2016) revision to the 2010/2011 fibromyalgia criteria. Fibromyalgia may now be diagnosed in adults when all of the following criteria are met: CONCLUSIONS: The fibromyalgia criteria have good sensitivity and specificity. This revision combines physician and questionnaire criteria, minimizes misclassification of regional pain disorders, and eliminates the previously confusing recommendation regarding diagnostic exclusions. The physician-based criteria are valid for individual patient diagnosis. The self-report version of the criteria is not valid for clinical diagnosis in individual patients but is valid for research studies. These changes allow the criteria to function as diagnostic criteria, while still being useful for classification.
Authors: Andrew Schrepf; Vy Phan; J Quentin Clemens; William Maixner; David Hanauer; David A Williams Journal: J Pain Date: 2019-05-30 Impact factor: 5.820