Comparative Effectiveness Review Number 158 Diagnosis of Gout Comparative Effectiveness Review Number 158 Diagnosis of Gout Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 5600 Fishers Lane Rockville, MD 20857 www.ahrq.gov Contract No. 290-2012-00006-I Prepared by: Southern California Evidence-based Practice Center Santa Monica, CA Investigators: Sydne J. Newberry, Ph.D. John FitzGerald, M.D., Ph.D. Margaret A. Maglione, M.P.P. Claire E. O’Hanlon, M.P.P. Dan Han, M.P.A. Marika Booth, M.S. Aneesa Motala, B.A. Abdul Tariq, B.S. Whitney Dudley, B.S. Roberta Shanman, M.L.S. Paul G. Shekelle, M.D, Ph.D. AHRQ Publication No. 15(16)-EHC026-EF February 2016 Addendum October 2016 Addendum – October 2016 An update search was conducted to prepare a manuscript based on the report (end date of update search February 29, 2016) and identified six new studies that met inclusion criteria. Five addressed Key Question (KQ) 1 (validity) (three reported on algorithms [Jatuworapruk et al., 2016; Taylor et al., 2015; Neogi et al., 2016] and two reported on imaging [Löffler et al., 2015; Pascal et al., 2015]). One addressed KQ2 (adverse events [Taylor et al., 2016]). KQ1 Validity of Diagnostic Methods One study reported on the development and validation of the new American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) gout classification criteria (Neogi et al., 2016). Using monosodium urate (MSU) crystal analysis as the reference standard, the classification criteria had a sensitivity of 92 percent and a specificity of 89 percent (including clinical and imaging domains) or 85 percent and 78 percent (excluding imaging). Thus, imaging findings improved both the sensitivity and specificity of clinical and laboratory criteria (study quality high). Two studies further validated existing classification and diagnostic algorithms in different populations (Jatuworapruk, et al., 2015; Taylor et al., 2015). Based on these additional studies, the strength of evidence for the use of Janssens’ Diagnostic Rule (the Netherlands criteria) or the Clinical Gout Diagnosis criteria was raised from low to moderate. Two studies further validated the use of the ultrasound double contour sign to diagnose gout (Löffler et al., 2015; Pascal et al., 2015). The pooled sensitivity and specificity for the double contour sign from the three studies in the original report and one of the two new studies (464 joints) were 74 percent (95% confidence interval [CI] 52, 88) and 88 percent (95% CI 68, 96), respectively. The strength of evidence supporting the use of ultrasound for gout diagnosis remains low. No new studies were identified that report on the use of dual energy computerized tomography or x ray. KQ2. Adverse Events Associated with Gout Diagnostic Methods One new study identified one serious adverse event after synovial fluid aspiration (septic arthritis 11 days post arthrocentesis, event rate 0.1%, 95% CI 0, 0.34) and 11 nonserious adverse events (mostly mild pain following the procedure; event rate 1.4%, 95% CI 0.6–2.1) (Taylor et al., 2016). More information is located in the Annals of Internal Medicine manuscript: http://annals.org/aim/article/doi/10.7326/M16-0462. References Jatuworapruk K, Lhakum P, Pattamapaspong N, et al. Performance of the existing classification criteria for gout in Thai patients presenting with acute arthritis. Medicine (Baltimore). 2016;95(5):e27jatu30. Epub 6 Feb 2016. doi: 10.1097/md.0000000000002730. PMID: 2684451. Löffler C, Sattler H, Peters L, et al. Distinguishing gouty arthritis from calcium pyrophosphate disease and other arthritides. Journal of Rheumatology. 2015;42(3):513-20. PMID: 2015796981. http://dx.doi.org/10.3899/jrheum.140634. Neogi T, Jansen TL, Dalbeth N, et al. 2015 Gout classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Annals of the Rheumatic Diseases. 2015;74(10):1789-98. Epub 12 Sept 2015. doi: 10.1136/annrheumdis-2015- 208237. PubMed PMID: 26359487; PMCID: PMCPmc4602275. Pascal Z, Valcov R, Fabreguet I, et al. A prospective evaluation of ultrasound as a diagnostic tool in acute microcrystalline arthritis. Arthritis research & therapy. 2015;17:188. Epub 23 July 2015. doi: 10.1186/s13075-015-0701-7. PMID: 26198435; PMCID: PMCPmc4511437. Taylor WJ, Fransen J, Dalbeth N, et al. Diagnostic arthrocentesis for suspicion of gout is safe and well tolerated. The Journal of rheumatology. 2016;43(1):150-3. Epub 2015 Dec 3. doi: 10.3899/jrheum.150684. PMID: 26628602. Taylor WJ, Fransen J, Jansen TL, et al. Study for Updated Gout Classification Criteria (SUGAR): identification of features to classify gout. Arthritis care & research. 2015. Epub 18 Mar 2015. doi: 10.1002/acr.22585. PMID: 25777045. This report is based on research conducted by the Southern California Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2012-00006-I). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services. None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report. The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients. This report is made available to the public under the terms of a licensing agreement between the author and the Agency for Healthcare Research and Quality. This report may be used and reprinted without permission except those copyrighted materials that are clearly noted in the report. Further reproduction of those copyrighted materials is prohibited without the express permission of the copyright holders. AHRQ or U.S. Department of Health and Human Services endorsement of any derivative products that may be developed from this report, such as clinical practice guidelines, other quality enhancement tools, or reimbursement or coverage policies, may not be stated or implied. This report may periodically be assessed for the currency of conclusions. If an assessment is done, the resulting surveillance report describing the methodology and findings will be found on the Effective Health Care Program Web site at www.effectivehealthcare.ahrq.gov. Search on the title of the report. Persons using assistive technology may not be able to fully access information in this report. For assistance contact [email protected]. Suggested citation: Newberry SJ, FitzGerald J, Maglione MA, O’Hanlon CE, Han D, Booth M, Motala A, Tariq A, Dudley W, Shanman R, Shekelle PG. Diagnosis of Gout. Comparative Effectiveness Review No. 158. (Prepared by the Southern California Evidence-based Practice Center under Contract No. 290-2012-00006-I.) AHRQ Publication No. 15(16)-EHC026-EF. Rockville, MD: Agency for Healthcare Research and Quality; February 2016. Addendum October 2016. www.effectivehealthcare.ahrq.gov/reports/final.cfm. ii Preface The Agency for Healthcare Research and Quality (AHRQ), through its Evidence-based Practice Centers (EPCs), sponsors the development of systematic reviews to assist public- and private-sector organizations in their efforts to improve the quality of health care in the United States. These reviews provide comprehensive, science-based information on common, costly medical conditions, and new health care technologies and strategies. Systematic reviews are the building blocks underlying evidence-based practice; they focus attention on the strength and limits of evidence from research studies about the effectiveness and safety of a clinical intervention. 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Richard G. Kronick, Ph.D. Arlene S. Bierman, M.D., M.S. Director Director Agency for Healthcare Research and Quality Center for Evidence and Practice Improvement Agency