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Diagnosis of Gout
Comparative Effectiveness Reviews, No. 158
Investigators: Sydne J Newberry, PhD, John FitzGerald, MD, PhD, Margaret A Maglione, MPP, Claire E O'Hanlon, MPP, Dan Han, MPA, Marika Booth, MS, Aneesa Motala, BA, Abdul Tariq, BS, Whitney Dudley, BS, Roberta Shanman, MLS, and Paul G Shekelle, MD, PhD.
Author Information and AffiliationsStructured Abstract
Objectives:
The aim of this review is to assess the evidence for the accuracy and safety of tests to diagnose gout in patients with no prior diagnosis of gout. The review also assesses factors that affect accuracy of diagnostic tests. Tests include algorithms that combine clinical signs and symptoms, dual-energy computed tomography (DECT), ultrasound, and plain x ray, with particular emphasis on tests that can be conducted in primary and acute (urgent and emergent) care settings.
Data sources:
We searched Medline® (from 1946), Embase® (from 1972), the Cochrane Library (from 1945), and the Web of Science™ (from 1980) to November 7, 2014, for published studies. We also searched ClinicalTrials.gov and the Web of Science and contacted manufacturers of imaging equipment and test kits for unpublished data on gout diagnosis.
Review methods:
We reviewed published and unpublished prospective cohort, cross-sectional, and case-control studies, as well as prior systematic reviews on the accuracy (sensitivity and specificity) of diagnostic tests for gout compared with a validated reference standard in patients without a prior gout diagnosis. We also reviewed studies and prior reviews of factors affecting the accuracy of monosodium urate crystal assessment in synovial fluid. We reviewed prospective cohort, cross-sectional, and case-control studies; case reports of any size; and systematic reviews that reported adverse events associated with diagnostic tests for gout and outcomes of gout misdiagnosis. A standardized protocol with predefined criteria was used to extract details on study design, interventions, outcomes, and study quality, and to assess the strength of evidence for each conclusion.
Results:
Six clinical algorithms comprising clinical signs and symptoms have been tested for diagnostic accuracy against the presence of monosodium urate crystals in synovial fluid aspirated from affected joints. Most studies were conducted with small groups of patients in academic rheumatology departments. Two recently developed clinical algorithms, the Diagnostic Rule, which is the only one developed and validated with primary care physicians and patients, and the Clinical Gout Diagnosis (CGD), demonstrated sensitivities of 88 percent and 97 percent, respectively, and specificities of 75 percent and 96 percent, respectively, in patients with shorter (2 years or less) and longer durations of symptoms, and they are simple to administer. However, the strength of evidence supporting their use is low, as validation of these tools remains limited. Three studies of DECT that enrolled patients without a previous gout diagnosis revealed sensitivities ranging from 85 percent to 100 percent and specificities ranging from 83 percent to 92 percent in diagnosing gout; the strength of evidence regarding the use of DECT for gout diagnosis is low. Four studies of ultrasound that enrolled patients without a previous diagnosis showed sensitivities ranging from 37 percent to 100 percent and specificities ranging from 68 percent to 97 percent, depending on the ultrasound signs assessed; the strength of evidence is low for the utility of ultrasound in diagnosing gout. A small number of studies examined factors that affected the accuracy of tests for the diagnosis of gout. The accuracy of monosodium urate analysis in synovial fluid varies widely among practitioners, but evidence on the effects of skill and experience is insufficient. No studies examined differences among practitioners in the rate of successful joint aspiration. No studies reported adverse events directly associated with techniques used to diagnose gout. However in one small study, missed gout diagnosis resulted in unnecessary surgery, longer hospital stays, and delay in appropriate treatment.
Conclusions:
Promising diagnostic clinical algorithms such as the Diagnostic Rule and CGD need to be validated more broadly in primary and urgent care settings. A clinical algorithm with high diagnostic accuracy ideally can form part of a diagnostic decision tree, with referral of more clinically challenging cases to rheumatologists for more invasive tests or imaging. Research is needed to assess the incremental value of synovial fluid monosodium urate crystal analysis and imaging over that of a diagnostic clinical algorithm.
Contents
- Preface
- Acknowledgments
- Key Informants
- Technical Expert Panel
- Peer Reviewers
- Executive Summary
- Introduction
- Methods
- Criteria for Inclusion/Exclusion of Studies in the Review
- Literature Search Strategies for Identification of Relevant Studies To Answer the Key Questions
- Data Abstraction and Data Management
- Assessment of Methodological Quality of Individual Studies
- Data Synthesis/Analysis
- Grading the Strength of the Body of Evidence for Each Key Question
- Applicability
- Peer Review and Public Commentary
- Results
- Introduction
- Results of Literature Searches
- Key Question 1 a. What is the accuracy of clinical signs and symptoms and other diagnostic tests (such as serum uric acid, ultrasound, CT scan, DECT, and plain x-ray), alone or in combination, compared with synovial fluid analysis in the diagnosis of acute gouty arthritis, and how does the accuracy affect clinical decisionmaking, clinical outcomes and complications, and patient centered outcomes?
b. How does the diagnostic accuracy of clinical signs and symptoms and other tests vary by affected joint site and number of joints?
c. Does the accuracy of diagnostic tests for gout vary by duration of symptoms (i.e., time from the beginning of a flare) - KQ1d Does the accuracy of synovial fluid aspiration and crystal analysis Differ by (i) the type of practitioner who is performing the aspiration and (ii) the type of practitioner who is performing the crystal analysis?
- Key Question 2 What are the adverse effects (including pain, infection at the aspiration site, radiation exposure) or harms (related to false positives, false negatives, indeterminate results) associated with tests used to diagnose gout?
- Discussion
- References
- Abbreviations/Acronyms
- Appendix A Search Strategy
- Appendix B List of Excluded Studies
- Appendix C Evidence Table
- Appendix D Data Abstraction Tools
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1. Contract No. 290-2012-00006-I. Prepared by: Southern California Evidence-based Practice Center, Santa Monica, CA
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. www.effectivehealthcare.ahrq.gov/reports/final.cfm.
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.
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.
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