Sydne J. Newberry, PhD; John D. FitzGerald, MD, PhD; Aneesa Motala, BA; Marika Booth, MS; Margaret A. Maglione, MPP; Dan Han, MPA; Abdul Tariq, BS; Claire E. O'Hanlon, MPP; Roberta Shanman, MLS; Whitney Dudley, BS; Paul G. Shekelle, MD, PhD
Disclaimer: The authors of this manuscript are responsible for its content. Statements in the manuscript should not be construed as endorsement by the AHRQ or U.S. Department of Health and Human Services. The AHRQ retains a license to display, reproduce, and distribute the data and the report from which this manuscript was derived under the terms of the agency's contract with the author.
Acknowledgment: The authors acknowledge Patricia Smith for her administrative assistance on the project. In addition, the authors acknowledge the guidance provided by the key informants and technical expert panel members on the evidence report: Hyon K. Choi, MD, PhD; Nicola Dalbeth, MD; Russell Harris, MD, MPH; David Hoelting, MD; Sanford S. Kaplan, DDS; Gerald D. Levy, MD; Esther Myers, PhD, RD; Savvas Nicolaou, MD; Ralf G. Thiele, MD; Richard Treger MD; Daniel Waxman, MD, PhD; Lee Ann Weintraub, MS, RD; and Neil Wenger, MD.
Financial Support: The evidence report was funded under contract 290-2012-00006I from the AHRQ, U.S. Department of Health and Human Services.
Disclosures: Ms. Booth and Ms. Shanman report grants from AHRQ during the conduct of the study. Ms. O'Hanlon reports a contract with AHRQ during the conduct of the study. Dr. Shekelle reports grants from AHRQ, personal fees from ECRI Institute, and royalties from UpToDate. Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M16-0462.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.
Reproducible Research Statement:Study protocol: Available at https://effectivehealthcare.ahrq.gov/ehc/products/564/1937/gout-protocol-140716.pdf. Statistical code and data set: Not available.
Requests for Single Reprints: Sydne J. Newberry, PhD, RAND Corporation, 1776 Main Street, Santa Monica, CA 90401; e-mail, firstname.lastname@example.org.
Current Author Addresses: Drs. Newberry, FitzGerald, and Shekelle; Ms. Motala; Ms. Booth; Ms. Maglione; Mr. Han; Mr. Tariq; Ms. O'Hanlon; Ms. Shanman; and Ms. Dudley: RAND Corporation, 1776 Main Street, Santa Monica, CA 90401.
Author Contributions: Conception and design: A. Motala, M.A. Maglione.
Analysis and interpretation of the data: J.D. FitzGerald, M. Booth, C.E. O'Hanlon, W. Dudley.
Drafting of the article: M. Booth.
Critical revision for important intellectual content: J.D. FitzGerald, A. Motala, M.A. Maglione, P.G. Shekelle.
Final approval of the article: S.J. Newberry, J.D. FitzGerald, A. Motala, M. Booth, M.A. Maglione, D. Han, A. Tariq, C.E. O'Hanlon, R. Shanman, W. Dudley, P.G. Shekelle.
Statistical expertise: M. Booth.
Obtaining of funding: P.G. Shekelle.
Collection and assembly of data: A. Motala, M. Booth, M.A. Maglione, C.E. O'Hanlon, R. Shanman, W. Dudley.
Newberry SJ, FitzGerald JD, Motala A, Booth M, Maglione MA, Han D, et al. Diagnosis of Gout: A Systematic Review in Support of an American College of Physicians Clinical Practice Guideline. Ann Intern Med. 2017;166:27-36. doi: 10.7326/M16-0462
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Published: Ann Intern Med. 2017;166(1):27-36.
Published at www.annals.org on 1 November 2016
Alternative strategies exist for diagnosing gout that do not rely solely on the documentation of monosodium urate (MSU) crystals.
To summarize evidence regarding the accuracy of clinical tests and classification algorithms compared with that of a reference standard of MSU crystals in joint aspirate for diagnosing gout.
Several electronic databases from inception to 29 February 2016.
21 prospective cohort, cross-sectional, and case–control studies including participants with joint inflammation and no previous definitive gout diagnosis who had MSU analysis of joint aspirate.
Data extraction and risk-of-bias assessment by 2 reviewers independently; overall strength of evidence (SOE) judgment by group.
Recently developed algorithms including clinical, laboratory, and imaging criteria demonstrated good sensitivity (up to 88%) and fair to good specificity (up to 96%) for diagnosing gout (moderate SOE). Three studies of dual-energy computed tomography (DECT) showed sensitivities of 85% to 100% and specificities of 83% to 92% for diagnosing gout (low SOE). Six studies of ultrasonography showed sensitivities of 37% to 100% and specificities of 68% to 97%, depending on the ultrasonography signs assessed (pooled sensitivity and specificity for the double contour sign: 74% [95% CI, 52% to 88%] and 88% [CI, 68% to 96%], respectively [low SOE]).
Important study heterogeneity and selection bias; scant evidence in primary and urgent care settings and in patients with conditions that may be confused with or occur with gout.
Multidimensional algorithms, which must be validated in primary and urgent care settings, may help clinicians make a provisional diagnosis of gout. Although DECT and ultrasonography also show promise for gout diagnosis, accessibility to these methods may be limited.
Agency for Healthcare Research and Quality. (Protocol registration: https://effectivehealthcare.ahrq.gov/ehc/products/564/1937/gout-protocol-140716.pdf)
Literature flow diagram.
Table 1. Summary of Components of Clinical Algorithms for Diagnosing Gout*
Table 2. Summary of Findings
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Jasvinder A. Singh, MBBS, MPH, Kenneth G. Saag
University of Alabama at Birmingham
November 15, 2016
Urate lowering in Gout
We commend the authors of the recent ACP gout clinical practice guideline (CPG) 1. We also agree with the accompanying editorial by Neogi and Mikuls recommending that similar to diabetes mellitus, treatment of gout must not rely solely on symptom-relief, since prevention of joint destruction and disability is important. We are concerned that this CPG takes a step back in the treatment of high serum urate (sUA), the underlying defect in gout. The authors cite a lack of knowledge about cost and harms vs. benefits of a treat-to-target strategy, a strategy that is widely accepted in the gout practice community, and they offer an alternate, unproven, new strategy, “treat to avoid symptoms”. The authors fail to cite any literature showing more harms with a higher final dose of allopurinol or febuxostat in gout management. Achieving a target sUA <6 mg/dl is associated with reduction of gout flares, tophi and medical care costs. Three randomized trials of febuxostat2 and pegloticase3, showed that achieving sUA target <6 mg/dl reduced tophi, which regrettably were not included in the AHRQ evidence report for this CPG. Tophi are strongly associated with bony erosions, reduced hand function, and have a negative physical and psychological impact. No evidence is provided to support the “treat to avoid symptoms” strategy proposed. Allopurinol use is actually cost-saving in patients with gout with two or more attacks a year4, a rare finding in the cost-effectiveness literature, primarily related to low-price of generic allopurinol ($10 for 90-day supply at discount pharmacies). SUA is an inexpensive test that costs <$20. Thus, we believe the benefit-harms-cost equation based on an evidence-based medicine approach greatly favors a treat-to-target strategy. Faced with a similar dilemma for treating lipid levels to target in patients with diabetes, the 2004 ACP CPG recommended a shared decision between the physician and the patient5, which would have been a preferred approach for gout. Documentation of joint pain, gout flares and their severity and functional limitations in routine clinical care, which would be necessary in the “treat to symptom” strategy proposed, is a rare phenomenon with low widespread feasibility. While we laude the ACP’s interest in gout management, we believe this gout CPG will have adverse public health consequences and move us in the wrong direction at a time when a more aggressive approach is needed. We suggest the guideline panel critically re-evaluate these recommendations to avoid doing more harm than good. References:1. Qaseem A, McLean R, Starkey M, Forciea MA. Management of Acute and Recurrent Gout: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2017;[Epub ahead of print].2. Becker MA, Schumacher HR, Jr., Wortmann RL, MacDonald PA, Eustace D, Palo WA, et al. Febuxostat compared with allopurinol in patients with hyperuricemia and gout. N Engl J Med. 2005;353(23):2450-61.3. Sundy JS, Baraf HS, Yood RA, Edwards NL, Gutierrez-Urena SR, Treadwell EL, et al. Efficacy and tolerability of pegloticase for the treatment of chronic gout in patients refractory to conventional treatment: two randomized controlled trials. JAMA. 2011;306(7):711-20.4. Ferraz MB, O'Brien B. A cost effectiveness analysis of urate lowering drugs in nontophaceous recurrent gouty arthritis. J Rheumatol. 1995;22(5):908-14.5. Snow V, Aronson MD, Hornbake ER, Mottur-Pilson C, Weiss KB, Clinical Efficacy Assessment Subcommittee of the American College of P. Lipid control in the management of type 2 diabetes mellitus: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2004;140(8):644-9.
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