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Gout: HELP
Articles by N. Lawrence Edwards
Based on 35 articles published since 2008
||||

Between 2008 and 2019, N. L. Edwards wrote the following 35 articles about Gout.
 
+ Citations + Abstracts
Pages: 1 · 2
1 Guideline 2012 American College of Rheumatology guidelines for management of gout. Part 2: therapy and antiinflammatory prophylaxis of acute gouty arthritis. 2012

Khanna, Dinesh / Khanna, Puja P / Fitzgerald, John D / Singh, Manjit K / Bae, Sangmee / Neogi, Tuhina / Pillinger, Michael H / Merill, Joan / Lee, Susan / Prakash, Shraddha / Kaldas, Marian / Gogia, Maneesh / Perez-Ruiz, Fernando / Taylor, Will / Lioté, Frédéric / Choi, Hyon / Singh, Jasvinder A / Dalbeth, Nicola / Kaplan, Sanford / Niyyar, Vandana / Jones, Danielle / Yarows, Steven A / Roessler, Blake / Kerr, Gail / King, Charles / Levy, Gerald / Furst, Daniel E / Edwards, N Lawrence / Mandell, Brian / Schumacher, H Ralph / Robbins, Mark / Wenger, Neil / Terkeltaub, Robert / Anonymous2310738. ·University of Michigan, Ann Arbor, MI, USA. ·Arthritis Care Res (Hoboken) · Pubmed #23024029.

ABSTRACT: -- No abstract --

2 Guideline 2012 American College of Rheumatology guidelines for management of gout. Part 1: systematic nonpharmacologic and pharmacologic therapeutic approaches to hyperuricemia. 2012

Khanna, Dinesh / Fitzgerald, John D / Khanna, Puja P / Bae, Sangmee / Singh, Manjit K / Neogi, Tuhina / Pillinger, Michael H / Merill, Joan / Lee, Susan / Prakash, Shraddha / Kaldas, Marian / Gogia, Maneesh / Perez-Ruiz, Fernando / Taylor, Will / Lioté, Frédéric / Choi, Hyon / Singh, Jasvinder A / Dalbeth, Nicola / Kaplan, Sanford / Niyyar, Vandana / Jones, Danielle / Yarows, Steven A / Roessler, Blake / Kerr, Gail / King, Charles / Levy, Gerald / Furst, Daniel E / Edwards, N Lawrence / Mandell, Brian / Schumacher, H Ralph / Robbins, Mark / Wenger, Neil / Terkeltaub, Robert / Anonymous2300738. ·University of Michigan, Ann Arbor, MI, USA. ·Arthritis Care Res (Hoboken) · Pubmed #23024028.

ABSTRACT: -- No abstract --

3 Guideline 2011 Recommendations for the diagnosis and management of gout and hyperuricemia. 2011

Hamburger, Max / Baraf, Herbert S B / Adamson, Thomas C / Basile, Jan / Bass, Lewis / Cole, Brent / Doghramji, Paul P / Guadagnoli, Germano A / Hamburger, Frances / Harford, Regine / Lieberman, Joseph A / Mandel, David R / Mandelbrot, Didier A / McClain, Bonny P / Mizuno, Eric / Morton, Allan H / Mount, David B / Pope, Richard S / Rosenthal, Kenneth G / Setoodeh, Katy / Skosey, John L / Edwards, N Lawrence / Anonymous4710712. ·Rheumatology Associates of Long Island, Melville, NY 11747, USA. mcapacious@aol.com ·Postgrad Med · Pubmed #22156509.

ABSTRACT: Gout is a major health problem in the United States; it affects 8.3 million people, which is approximately 4% of the adult population. Gout is most often diagnosed and managed in primary care physician practices. Primary care physicians have a significant opportunity to diagnose and manage patients with gout and improve patient outcomes. Following publication of the 2006 European League Against Rheumatism (EULAR) gout guidelines, significant evidence on gout has accumulated and new treatments for patients with gout have become available. It is the objective of these 2011 recommendations for the diagnosis and management of gout and hyperuricemia to update the 2006 EULAR guidelines, paying special attention to the needs of primary care physicians, who manage most patients with gout. The revised 2011 recommendations are based on the Grading of Recommendations Assessment, Development, and Evaluation approach as an evidence-based strategy for rating quality of evidence and grading strength of recommendation in clinical practice. A total of 26 key recommendations for diagnosis (n = 10) and management (n = 16) were evaluated. Presence of tophus (proven or suspected) and response to colchicine had the highest clinical diagnostic value (likelihood ratio [LR], 15.56 [95% CI, 2.11-114.71] and LR, 4.33 [95% CI, 1.16-16.16], respectively). The key aspect of effective management of an acute gout attack is initiation of treatment within hours of onset of first symptoms. Low-dose colchicine is better tolerated than and is as effective as high-dose colchicine (number needed to treat [NNT], 5 [95% CI, 3-13] and NNT, 6 [95% CI, 3-72], respectively). For urate-lowering therapy, allopurinol in combination with probenecid was shown to be more effective than either agent alone (effect size [ES], 5.51 for combination; ES, 4.46 for probenecid; and ES, 2.80 for allopurinol). Febuxostat, also a xanthine oxidase inhibitor, has a slightly different mechanism of action and can be prescribed at unchanged doses for patients with mild-to-moderate renal or hepatic impairment. Febuxostat 40 mg versus 80 mg (NNT, 6 [95% CI, 4-11]) and 120 mg (NNT, 6 [95% CI, 3-26]) both demonstrated long-term efficacy. The target of urate-lowering therapy should be a serum uric acid level of ≤ 6 mg/dL. For patients with refractory and tophaceous gout, intravenous pegloticase is a new treatment option.

4 Editorial Treatment-failure gout: a moving target. 2008

Edwards, N Lawrence. · ·Arthritis Rheum · Pubmed #18759307.

ABSTRACT: -- No abstract --

5 Review Overview of Serum Uric Acid Treatment Targets in Gout: Why Less Than 6 mg/dL? 2016

Ruoff, Gary / Edwards, N Lawrence. ·a Department of Family Practice , Michigan State University , Kalamazoo , MI , USA. · b Department of Medicine , University of Florida , Gainesville , FL , USA. ·Postgrad Med · Pubmed #27558643.

ABSTRACT: Gout is a progressive, painful, debilitating form of inflammatory arthritis. It is caused by factors that elevate the concentration of serum uric acid (sUA), leading to hyperuricemia (sUA >6.8 mg/dL). Continued elevated sUA can result in monosodium urate (MSU) crystal deposition in joints and soft tissues, and can cause acute and chronic inflammation. The prevalence of hyperuricemia and gout has increased over the last few decades, likely due to an aging population, changes in lifestyles and diet, and an increase in gout-associated comorbidities. Untreated or improperly treated gout can lead to chronic manifestation of the disease, including persistent inflammation, increased number of flares, development of tophi, and structural joint damage. Data show that even when patients are asymptomatic, ongoing inflammation and subsequent damage occurs locally at the joint and systemically. The aim of long-term treatment of gout is to reduce sUA levels to <6 mg/dL, which is below the saturation point of MSU (6.8 mg/dL), to inhibit formation of new crystals and to promote dissolution of existing crystals. Gout treatment should improve disease outcomes by eliminating gout flares, inducing long-term resolution of tophi, and more effectively managing comorbidities, many of which are associated with hyperuricemia. A number of studies have demonstrated that treating to the target of <6 mg/dL, by using effective therapies to lower sUA, results in reduction in the incidence of gout flares as well as shrinkage and eventual disappearance of tophi. Gout is often poorly managed due to a number of factors including lack of physician and patient adherence to treatment guidelines. Patients need to be educated about their diagnosis and management of the disease, such as the influence of diet and the importance of compliance with long-term treatment. With treatment, regular sUA monitoring, and patient adherence, gout is a curable disease.

6 Review Emerging therapies for gout. 2014

Edwards, N Lawrence / So, Alexander. ·Department of Medicine, University of Florida College of Medicine, 1600 South West Archer Road, Gainesville, FL 32610-0277, USA. Electronic address: edwarnl@medicine.ufl.edu. · Service de Rhumatologie, CHUV, Avenue Pierre Decker, Lausanne 1011, Switzerland. ·Rheum Dis Clin North Am · Pubmed #24703353.

ABSTRACT: Over the past decade much has been learned about the mechanisms of crystal-induced inflammation and renal excretion of uric acid, which has led to more specific targeting of gout therapies and a more potent approach to future management of gout. This article outlines agents being developed for more aggressive lowering of urate and more specific anti-inflammatory activity. The emerging urate-lowering therapies include lesinurad, arhalofenate, ulodesine, and levotofisopam. Novel gout-specific anti-inflammatories include the interleukin-1β inhibitors anakinra, canakinumab, and rilonacept, the melanocortins, and caspase inhibitors. The historic shortcomings of current gout treatment may, in part, be overcome by these novel approaches.

7 Review 2011 recommendations for the diagnosis and management of gout and hyperuricemia. 2011

Hamburger, Max / Baraf, Herbert S B / Adamson, Thomas C / Basile, Jan / Bass, Lewis / Cole, Brent / Doghramji, Paul P / Guadagnoli, Germano A / Hamburger, Frances / Harford, Regine / Lieberman, Joseph A / Mandel, David R / Mandelbrot, Didier A / McClain, Bonny P / Mizuno, Eric / Morton, Allan H / Mount, David B / Pope, Richard S / Rosenthal, Kenneth G / Setoodeh, Katy / Skosey, John L / Edwards, N Lawrence. ·SUNY Stony Brook, NY, USA. mcapacious@aol.com ·Phys Sportsmed · Pubmed #22293773.

ABSTRACT: Gout is a major health problem in the United States; it affects 8.3 million people, which is approximately 4% of the adult population. Gout is most often diagnosed and managed in primary care practices; thus, primary care physicians have a significant opportunity to improve patient outcomes. Following publication of the 2006 European League Against Rheumatism (EULAR) gout guidelines, significant new evidence has accumulated, and new treatments for patients with gout have become available. It is the objective of these 2011 recommendations to update the 2006 EULAR guidelines, paying special attention to the needs of primary care physicians. The revised 2011 recommendations are based on the Grading of Recommendations Assessment, Development, and Evaluation approach as an evidence-based strategy for rating quality of evidence and grading the strength of recommendation formulated for use in clinical practice. A total of 26 key recommendations, 10 for diagnosis and 16 for management, of patients with gout were evaluated, resulting in important updates for patient care. The presence of monosodium urate crystals and/or tophus and response to colchicine have the highest clinical diagnostic value. The key aspect of effective management of an acute gout attack is initiation of treatment within hours of symptom onset. Low-dose colchicine is better tolerated and is as effective as a high dose. When urate-lowering therapy (ULT) is indicated, the xanthine oxidase inhibitors allopurinol and febuxostat are the options of choice. Febuxostat can be prescribed at unchanged doses for patients with mild-to-moderate renal or hepatic impairment. The target of ULT should be a serum uric acid level that is ≤ 6 mg/dL. For patients with refractory and tophaceous gout, intravenous pegloticase is a new treatment option. This article is a summary of the 2011 clinical guidelines published in Postgraduate Medicine. This article provides a streamlined, accessible overview intended for quick review by primary care physicians, with the full guidelines being a resource for those seeking additional background information and expanded discussion.

8 Review Serum urate as a soluble biomarker in chronic gout-evidence that serum urate fulfills the OMERACT validation criteria for soluble biomarkers. 2011

Stamp, Lisa K / Zhu, Xiaoyu / Dalbeth, Nicola / Jordan, Sarah / Edwards, N Lawrence / Taylor, William. ·Department of Medicine, University of Otago, Christchurch, New Zealand. lisa.stamp@cdhb.govt.nz ·Semin Arthritis Rheum · Pubmed #21056459.

ABSTRACT: OBJECTIVES: To determine whether serum urate (SU) fulfills the Outcome measures in Rheumatology (OMERACT) soluble biomarker criteria. METHODS: The OMERACT soluble biomarker criteria were adapted for use in chronic gout. Potential outcome measures for use in chronic gout were identified. The literature was reviewed to determine which of the potential outcome measures were appropriate and whether there was evidence within the current literature to fulfill the OMERACT biomarker criteria. RESULTS: The assay for measurement of SU is reliable, internationally standardized, and readily accessible for use in clinical practice. The effects of sources of variability, including age, sex, ethnicity, circadian rhythms, body mass index, renal/hepatic function, and fasting, are well documented. Tophus regression was identified as appropriate structural outcome measure; however, given that not all patients have clinically apparent tophi, the number of gout flares is also identified as a key outcome measure. CONCLUSIONS: Serum urate fulfills all the OMERACT biomarker criteria with the exception of its effects on outcome measures. Further analysis of existing and new data sets to determine whether a reduction in SU predicts a reduction in gout flares, the number/size of tophi, and patient reported outcomes using validated measures for these outcomes are required.

9 Review Gout. Hyperuricemia and cardiovascular disease: how strong is the evidence for a causal link? 2009

Gaffo, Angelo L / Edwards, N Lawrence / Saag, Kenneth G. ·Birmingham VA Medical Center, 700 19th St. S, Birmingham, AL 35233, USA. agaffo@uab.edu ·Arthritis Res Ther · Pubmed #19725932.

ABSTRACT: An association between high levels of serum urate and cardiovascular disease has been proposed for many decades. However, it was only recently that compelling basic science data, small clinical trials, and epidemiological studies have provided support to the idea of a true causal effect. In this review we present recently published data that study the association between hyperuricemia and selected cardiovascular diseases, with a final conclusion about the possibility of this association being causal.

10 Review Febuxostat: a new treatment for hyperuricaemia in gout. 2009

Edwards, N Lawrence. ·Department of Medicine, University of Florida, Gainesville, FL 32610, USA. edwarnl@medicine.ufl.edu ·Rheumatology (Oxford) · Pubmed #19447778.

ABSTRACT: Febuxostat is a new non-purine xanthine oxidase inhibitor that is more potent than allopurinol 300 mg daily. In two Phase III trials, significantly more febuxostat-treated gout patients met the primary endpoint [serum urate (sUA) <6 mg/dl (<360 mumol/l) at the last three visits] (48 and 53% with 80 mg; 65 and 62% with 120 mg), compared with those receiving allopurinol 300 mg (22 and 21%; P < 0.001 in both studies). Febuxostat was more effective than allopurinol in the subset with impaired renal function; no dose adjustment is required in mild-to-moderate renal impairment. Long-term extension studies confirmed the efficacy and tolerability of febuxostat. In patients who achieved the sUA target of 6 mg/dl (360 mumol/l), the incidence of gout flares fell steadily and tophi resolved in many patients. The incidence of adverse events such as dizziness, diarrhoea, headache and nausea with febuxostat was similar to allopurinol. The incidence of cardiovascular side-effects (Antiplatelet Trialists Collaboration events) was numerically higher with febuxostat than with allopurinol, but this was not statistically significant. Co-administration of febuxostat with AZA or 6-mercaptopurine is not recommended. Prophylaxis (colchicine and/or NSAIDs) against acute attacks should be used for at least the first 6 months, since early mobilization flares were observed in the clinical trials. In conclusion, febuxostat is more effective than allopurinol 300 mg daily in reducing sUA levels <6 mg/dl (360 mumol/l), the target recommended by EULAR, and offers a new option for the long-term treatment of gout.

11 Review Pain management in gout. 2008

Kirby, Brian S / McTigue, Joan C / Edwards, N Lawrence. ·Edwards@medicine.ufl.edu ·Curr Pain Headache Rep · Pubmed #18973734.

ABSTRACT: Gout is currently the most common form of inflammatory arthritis in men. The overall incidence of gout has increased rapidly in the past 20 years. Clinicians in all fields are likely to experience a patient with acute gout in their career. Uncontrolled gout and hyperuricemia can lead to joint destruction and significant morbidity. Fortunately, these diseases can be readily treated and long-term sequelae can be prevented. Recent advances in understanding the role of the innate immune system in acute gout have provided new treatment options. This article addresses the epidemiology, inflammatory pathophysiology, pain management techniques (including recent advances), and treatment of the underlying disease itself.

12 Clinical Trial Improved health-related quality of life and physical function in patients with refractory chronic gout following treatment with pegloticase: evidence from phase III randomized controlled trials. 2012

Strand, Vibeke / Khanna, Dinesh / Singh, Jasvinder A / Forsythe, Anna / Edwards, N Lawrence. ·Division of Immunology and Rheumatology, Stanford University School of Medicine, 306 Ramona Road, Portola Valley, CA 94028, USA. vstrand@stanford.edu ·J Rheumatol · Pubmed #22660805.

ABSTRACT: OBJECTIVE: To assess the efficacy of pegloticase on pain, physical function, and health-related quality of life (HRQOL) in patients with refractory chronic gout. METHODS: Subjects in 2 replicate, 6-month, randomized controlled phase III trials received intravenous infusions of pegloticase 8 mg twice monthly (biweekly group), pegloticase alternating with placebo (8-mg monthly group), or placebo. Medical Outcomes Study Short Form-36 (SF-36), Health Assessment Questionnaire-Disability Index (HAQ-DI), patient global assessment of disease activity (PtGA), and pain by visual analog scale were completed at weeks 1 (baseline), 13, 19, and 25. Prespecified pooled analyses of patient-reported outcomes were performed by combining values for each treatment group (biweekly treatment, monthly treatment, and placebo) at Week 25. RESULTS: Of 212 patients enrolled, 157 (74.1%) completed treatment. At entry, mean age was 55.4 years (range 23-89 yrs) and mean plasma uric acid was 9.7 mg/dl; most were male (81.6%) and white (67.5%). Subjects reported an average of 9.8 flares in the previous 18 months. Baseline SF-36 physical component summary (PCS) scores were > 1.5 SD below US normative values. At Week 25, mean changes from baseline in PtGA, pain, HAQ-DI, and PCS scores were statistically significant and exceeded minimum clinically important differences (MCID) in the biweekly treatment group, compared with little to no improvement in placebo group. Statistically significant improvements greater than or equal to MCID were reported in 6 of 8 SF-36 domains. Monthly pegloticase resulted in significantly improved PtGA, HAQ-DI, PCS, and 3 SF-36 domains. CONCLUSION: Pegloticase therapy resulted in statistically significant and clinically meaningful improvements in PtGA, pain, physical function, and HRQOL.

13 Article Experience of finding footwear and factors contributing to footwear choice in people with gout: a mixed methods study using a web-based survey. 2019

Brenton-Rule, Angela / Dalbeth, Nicola / Edwards, N Lawrence / Rome, Keith. ·1Department of Podiatry, Health and Rehabilitation Research Institute, Auckland University of Technology, Private Bag 92006, Auckland, 1142 New Zealand. · 0000 0001 0705 7067 · grid.252547.3 · 2Faculty of Medical and Health Sciences, The University of Auckland, Private Bag 92019, Auckland, 1142 New Zealand. · 0000 0004 0372 3343 · grid.9654.e · 3Department of Rheumatology, Auckland District Health Board, P.O. Box 92189, Auckland, New Zealand. · 0000 0001 0042 379X · grid.414057.3 · 4Department of Medicine, University of Florida, Gainesville, USA. · 0000 0004 1936 8091 · grid.15276.37 ·J Foot Ankle Res · Pubmed #30636975.

ABSTRACT: Background: Gout frequently affects the foot, particularly the first metatarsophalangeal joint. People with gout commonly wear ill-fitting footwear that lacks cushioning and support, which may further contribute to foot pain and disability. Footwear with good cushioning and motion control may be an effective non-pharmacological intervention. Currently, there is limited understanding about the footwear experience in people with gout. The aim was to understand footwear characteristics, experience of finding footwear, and factors contributing to footwear choice, in people with gout. Methods: A web-based survey of people visiting a gout education website. Participants self-reported a diagnosis of gout. The 17-item survey included questions to elicit demographic and clinical characteristics, type of footwear worn, level of difficulty finding appropriate footwear, and factors contributing to choices about footwear. A mixed quantitative and qualitative methodology was used to report survey findings. Results: Survey respondents ( Conclusions: People with gout need comfortable shoes that conform to the foot, have a wide opening, made from pliable materials with adjustable straps. The main barriers related to footwear include difficulty finding shoes that are wide enough, suitable for work and aesthetically pleasing. These findings provide clinicians with important insights into the priorities and needs of people with gout that should be considered when developing footwear interventions.

14 Article A cross-sectional internet-based patient survey of the management strategies for gout. 2016

Singh, Jasvinder A / Shah, Nipam / Edwards, N Lawrence. ·Medicine Service, Birmingham VA Medical Center, Birmingham, AL, USA. Jasvinder.md@gmail.com. · Department of Medicine at School of Medicine, and Division of Epidemiology at School of Public Health, University of Alabama, Faculty Office Tower 805B, 510 20th Street S, Birmingham, AL, 35294, USA. Jasvinder.md@gmail.com. · Department of Orthopedic Surgery, Mayo Clinic College of Medicine, Rochester, MN, USA. Jasvinder.md@gmail.com. · Department of Medicine at School of Medicine, and Division of Epidemiology at School of Public Health, University of Alabama, Faculty Office Tower 805B, 510 20th Street S, Birmingham, AL, 35294, USA. · Department of Medicine, University of Florida, Gainesville, FL, USA. ·BMC Complement Altern Med · Pubmed #26931313.

ABSTRACT: BACKGROUND: Almost half of the patients with gout are not prescribed urate-lowering therapy (ULT) by their health care provider and >50 % use complementary and alternative therapies. Diet modification is popular among gout patients due to known associations of certain foods with gout flares. The interplay of the use of dietary supplements, diet modification, and ULT adherence in gout patients is not known. Despite the recent interest in diet and supplements, there are limited data on their use. Our objective was to assess ULT use and adherence and patient preference for non-pharmacological interventions by patients with gout, using a cross-sectional survey. METHODS: People who self-reported physician-diagnosed gout during their visit to a gout website ( http://gouteducation.org ) were invited to participate in a brief anonymous cross-sectional Internet survey between 08/11/2014 to 04/14/2015 about the management of their gout. The survey queried ULT prescription, ULT adherence, the use of non-pharmacological interventions (cherry extract, diet modification) and the likelihood of making a lifelong diet modification for gout management. RESULTS: A total of 499 respondents with a mean age 56.3 years were included; 74% were males and 74% were White. Of these, 57% (285/499) participants were prescribed a ULT for gout, of whom 88% (251/285) were currently taking ULT. Of those using ULT, 78% (97/251) reported ULT adherence >80%. Gender, race, and age were not significantly associated with the likelihood of receiving a ULT prescription or ULT adherence >80%. Fifty-six percent of patients with gout preferred ULT as a lifelong treatment for gout, 24% preferred cherry extract and 16% preferred diet modification (4% preferred none). Men had significantly lower odds of preferring ULT as the lifelong treatment choice for gout vs. other choices (p = 0.03). We found that 38.3% participants were highly motivated to make a lifelong dietary modification to improve their gout (score of 9-10 on a 0-10 likelihood scale). Older age was significantly associated with high level of willingness to modify diet (p = 0.02). CONCLUSION: We found that only 57% of gout patients reported being prescribed ULT. 40% of gout patients preferred non- pharmacological interventions such as cherry extract and diet modification for gout management. The latter finding requires further investigation.

15 Article 2015 Gout classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. 2015

Neogi, Tuhina / Jansen, Tim L Th A / Dalbeth, Nicola / Fransen, Jaap / Schumacher, H Ralph / Berendsen, Dianne / Brown, Melanie / Choi, Hyon / Edwards, N Lawrence / Janssens, Hein J E M / Lioté, Frédéric / Naden, Raymond P / Nuki, George / Ogdie, Alexis / Perez-Ruiz, Fernando / Saag, Kenneth / Singh, Jasvinder A / Sundy, John S / Tausche, Anne-Kathrin / Vaquez-Mellado, Janitzia / Yarows, Steven A / Taylor, William J. ·Boston University School of Medicine, Boston, Massachusetts, USA. · Viecuri Medical Center, Venlo, The Netherlands Radboud University Medical Center, Nijmegen, The Netherlands. · University of Auckland, Auckland, New Zealand. · Radboud University Medical Center, Nijmegen, The Netherlands. · University of Pennsylvania, Philadelphia, Pennsylvania, USA. · University of Otago, Wellington, New Zealand. · University of Florida, Gainesville, Florida, USA. · INSERM UMR 1132, Hôpital Lariboisière, AP-HP, and Université Paris Diderot, Sorbonne Paris Cité, Paris, France. · McMaster University Medical Centre, Hamilton, Ontario, Canada. · University of Edinburgh, Edinburgh, UK. · Hospital Universitario Cruces and BioCruces Health Research Institute, Vizcaya, Spain. · University of Alabama at Birmingham, Birmingham, Alabama, USA. · Birmingham VA Medical Center and University of Alabama at Birmingham, and Mayo Clinic College of Medicine, Rochester, Minnesota, USA. · Duke University and Duke University Medical Center, Durham, North Carolina, USA Gilead Sciences, Foster City, California, USA. · University Hospital Carl Gustav Carus, Dresden, Germany. · Hospital General de Mexico, Mexico City, Mexico. · University of Michigan Health System, Chelsea. ·Ann Rheum Dis · Pubmed #26359487.

ABSTRACT: OBJECTIVE: Existing criteria for the classification of gout have suboptimal sensitivity and/or specificity, and were developed at a time when advanced imaging was not available. The current effort was undertaken to develop new classification criteria for gout. METHODS: An international group of investigators, supported by the American College of Rheumatology and the European League Against Rheumatism, conducted a systematic review of the literature on advanced imaging of gout, a diagnostic study in which the presence of monosodium urate monohydrate (MSU) crystals in synovial fluid or tophus was the gold standard, a ranking exercise of paper patient cases, and a multi-criterion decision analysis exercise. These data formed the basis for developing the classification criteria, which were tested in an independent data set. RESULTS: The entry criterion for the new classification criteria requires the occurrence of at least one episode of peripheral joint or bursal swelling, pain, or tenderness. The presence of MSU crystals in a symptomatic joint/bursa (ie, synovial fluid) or in a tophus is a sufficient criterion for classification of the subject as having gout, and does not require further scoring. The domains of the new classification criteria include clinical (pattern of joint/bursa involvement, characteristics and time course of symptomatic episodes), laboratory (serum urate, MSU-negative synovial fluid aspirate), and imaging (double-contour sign on ultrasound or urate on dual-energy CT, radiographic gout-related erosion). The sensitivity and specificity of the criteria are high (92% and 89%, respectively). CONCLUSIONS: The new classification criteria, developed using a data-driven and decision-analytic approach, have excellent performance characteristics and incorporate current state-of-the-art evidence regarding gout.

16 Article 2015 Gout Classification Criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. 2015

Neogi, Tuhina / Jansen, Tim L Th A / Dalbeth, Nicola / Fransen, Jaap / Schumacher, H Ralph / Berendsen, Dianne / Brown, Melanie / Choi, Hyon / Edwards, N Lawrence / Janssens, Hein J E M / Lioté, Frédéric / Naden, Raymond P / Nuki, George / Ogdie, Alexis / Perez-Ruiz, Fernando / Saag, Kenneth / Singh, Jasvinder A / Sundy, John S / Tausche, Anne-Kathrin / Vazquez-Mellado, Janitzia / Yarows, Steven A / Taylor, William J. ·Boston University School of Medicine, Boston, Massachusetts. · Viecuri Medical Center, Venlo, The Netherlands, and Radboud University Medical Center, Nijmegen, The Netherlands. · University of Auckland, Auckland, New Zealand. · Radboud University Medical Center, Nijmegen, The Netherlands. · University of Pennsylvania, Philadelphia. · University of Otago, Wellington, New Zealand. · University of Florida, Gainesville. · Frédéric Lioté, MD, PhD: INSERM UMR 1132, Hôpital Lariboisière, AP-HP, and Université Paris Diderot, Sorbonne Paris Cité, Paris, France. · McMaster University Medical Centre, Hamilton, Ontario, Canada. · University of Edinburgh, Edinburgh, UK. · Hospital Universitario Cruces and BioCruces Health Research Institute, Vizcaya, Spain. · University of Alabama at Birmingham. · Birmingham VA Medical Center and University of Alabama at Birmingham, and Mayo Clinic College of Medicine, Rochester, Minnesota. · Gilead Sciences, Foster City, California). · University Hospital Carl Gustav Carus, Dresden, Germany. · Hospital General de Mexico, Mexico City, Mexico. · University of Michigan Health System, Chelsea. ·Arthritis Rheumatol · Pubmed #26352873.

ABSTRACT: OBJECTIVE: Existing criteria for the classification of gout have suboptimal sensitivity and/or specificity, and were developed at a time when advanced imaging was not available. The current effort was undertaken to develop new classification criteria for gout. METHODS: An international group of investigators, supported by the American College of Rheumatology and the European League Against Rheumatism, conducted a systematic review of the literature on advanced imaging of gout, a diagnostic study in which the presence of monosodium urate monohydrate (MSU) crystals in synovial fluid or tophus was the gold standard, a ranking exercise of paper patient cases, and a multicriterion decision analysis exercise. These data formed the basis for developing the classification criteria, which were tested in an independent data set. RESULTS: The entry criterion for the new classification criteria requires the occurrence of at least 1 episode of peripheral joint or bursal swelling, pain, or tenderness. The presence of MSU crystals in a symptomatic joint/bursa (i.e., synovial fluid) or in a tophus is a sufficient criterion for classification of the subject as having gout, and does not require further scoring. The domains of the new classification criteria include clinical (pattern of joint/bursa involvement, characteristics and time course of symptomatic episodes), laboratory (serum urate, MSU-negative synovial fluid aspirate), and imaging (double-contour sign on ultrasound or urate on dual-energy computed tomography, radiographic gout-related erosion). The sensitivity and specificity of the criteria are high (92% and 89%, respectively). CONCLUSION: The new classification criteria, developed using a data-driven and decision analytic approach, have excellent performance characteristics and incorporate current state-of-the-art evidence regarding gout.

17 Article An internet survey of common treatments used by patients with gout including cherry extract and juice and other dietary supplements. 2015

Singh, Jasvinder A / Bharat, Aseem / Edwards, N Lawrence. ·From the *Medicine Service, Birmingham VA Medical Center, and †Department of Medicine at School of Medicine and Division of Epidemiology at School of Public Health, University of Alabama, Birmingham, AL; ‡Department of Orthopedic Surgery, Mayo Clinic College of Medicine, Rochester, MN; and §Department of Medicine, University of Florida, Gainesville, FL. ·J Clin Rheumatol · Pubmed #26010189.

ABSTRACT: -- No abstract --

18 Article Application of the OMERACT filter to measures of core outcome domains in recent clinical studies of acute gout. 2014

Taylor, William J / Redden, David / Dalbeth, Nicola / Schumacher, H Ralph / Edwards, N Lawrence / Simon, Lee S / John, Markus R / Essex, Margaret N / Watson, Douglas J / Evans, Robert / Rome, Keith / Singh, Jasvinder A. ·From the Department of Medicine, University of Otago, Wellington, New Zealand; Department of Biostatistics, School of Public Health, University of Alabama at Birmingham, Birmingham, Alabama, USA; Department of Medicine, University of Auckland, Auckland, New Zealand; University of Pennsylvania and Veterans Affairs (VA) Medical Center, Philadelphia, Pennsylvania, USA; Department of Medicine, University of Florida, Gainesville, Florida, USA; SDG LLC, Cambridge, Massachusetts, USA; and Integrated Hospital Care Franchise, Immunology, Novartis Pharma AG, Basel, Switzerland; Pfizer Inc., New York, New York, USA; Epidemiology, Merck Sharp & Dohme Corp., Whitehouse Station, New Jersey, USA; Clinical Sciences, Regeneron Pharmaceuticals, Tarrytown, New Jersey, USA; Health & Rehabilitation Research Institute and School of Podiatry, Auckland University of Technology, Auckland, New Zealand; and Birmingham VA Medical Center and University of Alabama at Birmingham, Birmingham, Alabama, USA. ·J Rheumatol · Pubmed #24429178.

ABSTRACT: OBJECTIVE: To determine the extent to which instruments that measure core outcome domains in acute gout fulfill the Outcome Measures in Rheumatology (OMERACT) filter requirements of truth, discrimination, and feasibility. METHODS: Patient-level data from 4 randomized controlled trials of agents designed to treat acute gout and 1 observational study of acute gout were analyzed. For each available measure, construct validity, test-retest reliability, within-group change using effect size, between-group change using the Kruskall-Wallis statistic, and repeated measures generalized estimating equations were assessed. Floor and ceiling effects were also assessed and minimal clinically important difference was estimated. These analyses were presented to participants at OMERACT 11 to help inform voting for possible endorsement. RESULTS: There was evidence for construct validity and discriminative ability for 3 measures of pain [0 to 4 Likert, 0 to 10 numeric rating scale (NRS), 0 to 100 mm visual analog scale (VAS)]. Likewise, there appears to be sufficient evidence for a 4-point Likert scale to possess construct validity and discriminative ability for physician assessment of joint swelling and joint tenderness. There was some evidence for construct validity and within-group discriminative ability for the Health Assessment Questionnaire as a measure of activity limitations, but not for discrimination between groups allocated to different treatment. CONCLUSION: There is sufficient evidence to support measures of pain (using Likert, NRS, or VAS), joint tenderness, and swelling (using Likert scale) as fulfilling the requirements of the OMERACT filter. Further research on a measure of activity limitations in acute gout clinical trials is required.

19 Article OMERACT endorsement of measures of outcome for studies of acute gout. 2014

Singh, Jasvinder A / Taylor, William J / Dalbeth, Nicola / Simon, Lee S / Sundy, John / Grainger, Rebecca / Alten, Rieke / March, Lyn / Strand, Vibeke / Wells, George / Khanna, Dinesh / McQueen, Fiona / Schlesinger, Naomi / Boonen, Annelies / Boers, Maarten / Saag, Kenneth G / Schumacher, H Ralph / Edwards, N Lawrence. ·From Birmingham Veterans Affairs Medical Center and University of Alabama at Birmingham, Birmingham, Alabama, USA; Department of Medicine, University of Otago, Wellington; Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand; SDG LLC, Cambridge, Massachusetts,; Duke University School of Medicine, Durham, North Carolina, USA, and Duke-National University of Singapore Graduate Medical School, Singapore; Schlosspark-Klinik Teaching Hospital of the Charité, University Medicine Berlin, Berlin, Germany; University of Sydney Institute of Bone and Joint Research and Department of Rheumatology, Royal North Shore Hospital, Sydney, Australia; Stanford University Division of Immunology and Rheumatology, Portolo Valley, California, USA; University of Ottawa, London, Ontario, Canada; University of Michigan Medical School, Ann Arbor, Michigan, USA; University of Auckland, Department of Molecular Medicine and Pathology, Grafton, Auckland, New Zealand; Rutgers-Robert Wood Johnson Medical School, New Brunswick, New Jersey, USA; Maastricht University Medical Center, Division of Rheumatology, and Caphri Research Institute, University Maastricht; VU University Medical Center, Amsterdam, the Netherlands; University of Pennsylvania and Philadelphia Veterans Affairs Medical Center, Philadelphia, Pennsylvania; Department of Rheumatology, University of Florida, Gainsville, Florida, USA. ·J Rheumatol · Pubmed #24334651.

ABSTRACT: OBJECTIVE: To determine the extent to which participants at the Outcome Measures in Rheumatology (OMERACT) 11 meeting agree that instruments used in clinical trials to measure OMERACT core outcome domains in acute gout fulfill OMERACT filter requirements of truth, discrimination, and feasibility; and where future research efforts need to be directed. METHODS: Results of a systematic literature review and analysis of individual-level data from recent clinical studies of acute gout were presented to OMERACT participants. The information was discussed in breakout groups, and opinion was defined by subsequent voting in a plenary session. Endorsement was defined as at least 70% of participants voting in agreement with the proposition (where the denominator excluded those participants who did not vote or who voted "don't know"). RESULTS: The following measures were endorsed for use in clinical trials of acute gout: (1) 5-point Likert scale and/or visual analog scale (0 to 100 mm) to measure pain; (2) 4-point Likert scale for joint swelling; (3) 4-point Likert scale for joint tenderness; and (4) 5-point Likert scale for patient global assessment of response to treatment. Measures for the activity limitations domain were not endorsed. CONCLUSION: Measures of pain, joint swelling, joint tenderness, and patient global assessment in acute gout were endorsed at OMERACT 11. These measures should now be used in clinical trials of acute gout.

20 Article A delphi exercise to identify characteristic features of gout - opinions from patients and physicians, the first stage in developing new classification criteria. 2013

Prowse, Rebecca L / Dalbeth, Nicola / Kavanaugh, Arthur / Adebajo, Adewale O / Gaffo, Angelo L / Terkeltaub, Robert / Mandell, Brian F / Suryana, Bagus P P / Goldenstein-Schainberg, Claudia / Diaz-Torne, Cèsar / Khanna, Dinesh / Lioté, Frederic / Mccarthy, Geraldine / Kerr, Gail S / Yamanaka, Hisashi / Janssens, Hein / Baraf, Herbert F / Chen, Jiunn-Horng / Vazquez-Mellado, Janitzia / Harrold, Leslie R / Stamp, Lisa K / Van De Laar, Mart A / Janssen, Matthijs / Doherty, Michael / Boers, Maarten / Edwards, N Lawrence / Gow, Peter / Chapman, Peter / Khanna, Puja / Helliwell, Philip S / Grainger, Rebecca / Schumacher, H Ralph / Neogi, Tuhina / Jansen, Tim L / Louthrenoo, Worawit / Sivera, Francisca / Taylor, William J / Alten, Rieke. ·University of Otago, Dunedin, New Zealand. ·J Rheumatol · Pubmed #23418379.

ABSTRACT: OBJECTIVE: To identify a comprehensive list of features that might discriminate between gout and other rheumatic musculoskeletal conditions, to be used subsequently for a case-control study to develop and test new classification criteria for gout. METHODS: Two Delphi exercises were conducted using Web-based questionnaires: one with physicians from several countries who had an interest in gout and one with patients from New Zealand who had gout. Physicians rated a list of potentially discriminating features that were identified by literature review and expert opinion, and patients rated a list of features that they generated themselves. Agreement was defined by the RAND/UCLA disagreement index. RESULTS: Forty-four experienced physicians and 9 patients responded to all iterations. For physicians, 71 items were identified by literature review and 15 more were suggested by physicians. The physician survey showed agreement for 26 discriminatory features and 15 as not discriminatory. The patients identified 46 features of gout, for which there was agreement on 25 items as being discriminatory and 7 items as not discriminatory. CONCLUSION: Patients and physicians agreed upon several key features of gout. Physicians emphasized objective findings, imaging, and patterns of symptoms, whereas patients emphasized severity, functional results, and idiographic perception of symptoms.

21 Article Efficacy and tolerability of pegloticase for the treatment of chronic gout in patients refractory to conventional treatment: two randomized controlled trials. 2011

Sundy, John S / Baraf, Herbert S B / Yood, Robert A / Edwards, N Lawrence / Gutierrez-Urena, Sergio R / Treadwell, Edward L / Vázquez-Mellado, Janitzia / White, William B / Lipsky, Peter E / Horowitz, Zeb / Huang, William / Maroli, Allan N / Waltrip, Royce W / Hamburger, Steven A / Becker, Michael A. ·Duke Clinical Research Unit, Duke University Medical Center, Durham, North Carolina, USA. ·JAMA · Pubmed #21846852.

ABSTRACT: CONTEXT: Patients with chronic disabling gout refractory to conventional urate-lowering therapy need timely treatment to control disease manifestations related to tissue urate crystal deposition. Pegloticase, monomethoxypoly(ethylene glycol)-conjugated mammalian recombinant uricase, was developed to fulfill this need. OBJECTIVE: To assess the efficacy and tolerability of pegloticase in managing refractory chronic gout. DESIGN, SETTING, AND PATIENTS: Two replicate, randomized, double-blind, placebo-controlled trials (C0405 and C0406) were conducted between June 2006 and October 2007 at 56 rheumatology practices in the United States, Canada, and Mexico in patients with severe gout, allopurinol intolerance or refractoriness, and serum uric acid concentration of 8.0 mg/dL or greater. A total of 225 patients participated: 109 in trial C0405 and 116 in trial C0406. INTERVENTION: Twelve biweekly intravenous infusions containing either pegloticase 8 mg at each infusion (biweekly treatment group), pegloticase alternating with placebo at successive infusions (monthly treatment group), or placebo (placebo group). MAIN OUTCOME MEASURE: Primary end point was plasma uric acid levels of less than 6.0 mg/dL in months 3 and 6. RESULTS: In trial C0405 the primary end point was reached in 20 of 43 patients in the biweekly group (47%; 95% CI, 31%-62%), 8 of 41 patients in the monthly group (20%; 95% CI, 9%-35%), and in 0 patients treated with placebo (0/20; 95% CI, 0%-17%; P < .001 and <.04 for comparisons between biweekly and monthly groups vs placebo, respectively). Among patients treated with pegloticase in trial C0406, 16 of 42 in the biweekly group (38%; 95% CI, 24%-54%) and 21 of 43 in the monthly group (49%; 95% CI, 33%-65%) achieved the primary end point; no placebo-treated patients reached the primary end point (0/23; 95% CI, 0%-15%; P = .001 and < .001, respectively). When data in the 2 trials were pooled, the primary end point was achieved in 36 of 85 patients in the biweekly group (42%; 95% CI, 32%-54%), 29 of 84 patients in the monthly group (35%; 95% CI, 24%-46%), and 0 of 43 patients in the placebo group (0%; 95% CI, 0%-8%; P < .001 for each comparison). Seven deaths (4 in patients receiving pegloticase and 3 in the placebo group) occurred between randomization and closure of the study database (February 15, 2008). CONCLUSION: Among patients with chronic gout, elevated serum uric acid level, and allopurinol intolerance or refractoriness, the use of pegloticase 8 mg either every 2 weeks or every 4 weeks for 6 months resulted in lower uric acid levels compared with placebo. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00325195.

22 Article Bringing it all together: a novel approach to the development of response criteria for chronic gout clinical trials. 2011

Taylor, William J / Singh, Jasvinder A / Saag, Kenneth G / Dalbeth, Nicola / MacDonald, Patricia A / Edwards, N Lawrence / Simon, Lee S / Stamp, Lisa K / Neogi, Tuhina / Gaffo, Angelo L / Khanna, Puja P / Becker, Michael A / Schumacher, H Ralph. ·Department of Medicine, University of Otago, Wellington, New Zealand. will.taylor@otago.ac.nz ·J Rheumatol · Pubmed #21724718.

ABSTRACT: OBJECTIVE: To review a novel approach for constructing composite response criteria for use in chronic gout clinical trials that implements a method of multicriteria decision-making. METHODS: Preliminary work with paper patient profiles led to a restricted set of core-set domains that were examined using 1000Minds™ by rheumatologists with an interest in gout, and (separately) by OMERACT registrants prior to OMERACT 10. These results and the 1000Minds approach were discussed during OMERACT 10 to help guide next steps in developing composite response criteria. RESULTS: There were differences in how individual indicators of response were weighted between gout experts and OMERACT registrants. Gout experts placed more weight upon changes in uric acid levels, whereas OMERACT registrants placed more weight upon reducing flares. Discussion highlighted the need for a "pain" domain to be included, for "worsening" to be an additional level within each indicator, for a group process to determine the decision-making within a 1000Minds exercise, and for the value of patient involvement. CONCLUSION: Although there was not unanimous support for the 1000Minds approach to inform the construction of composite response criteria, there is sufficient interest to justify ongoing development of this methodology and its application to real clinical trial data.

23 Article Serum urate in chronic gout--will it be the first validated soluble biomarker in rheumatology? 2011

Stamp, Lisa K / Khanna, Puja P / Dalbeth, Nicola / Boers, Maarten / Maksymowych, Walter P / Schumacher, H Ralph / Becker, Michael A / MacDonald, Patricia A / Edwards, N Lawrence / Singh, Jasvinder A / Simon, Lee S / McQueen, Fiona M / Neogi, Tuhina / Gaffo, Angelo L / Strand, Vibeke / Taylor, William J. ·Department of Medicine, University of Otago, Christchurch, New Zealand. lisa.stamp@cdhb.govt.nz ·J Rheumatol · Pubmed #21724717.

ABSTRACT: OBJECTIVE: To summarize evidence for and endorsement of serum urate (SU) as having fulfilled the OMERACT filter as a soluble biomarker in chronic gout at the 2010 Outcome Measures in Rheumatology Meeting (OMERACT 10). METHODS: Data were presented to support the use of SU as a soluble biomarker in chronic gout and specifically the ability to utilize it to predict future patient-reported outcomes. RESULTS: SU was accepted as having fulfilled the OMERACT filter by 78% of voters. However, consensus was not obtained regarding its use as a soluble biomarker in chronic gout. Although the majority of the criteria for a soluble biomarker were fulfilled, the key criterion of association of the biomarker with outcomes was not agreed upon. It was agreed that the appropriate choice of endpoint must be linked to its clinical importance to the individual with the disorder and its temporal relationship to the intervention. Appropriate outcomes in chronic gout may therefore include gout flares, reduction in tophi, and patient-reported outcomes. CONCLUSION: SU is a critical outcome measure. It has the potential to fulfil criteria for a soluble biomarker. Further analyses of existing data from randomized controlled trials will be required to determine whether SU can predict future important outcomes, in particular disability.

24 Article Tophus measurement as an outcome measure for clinical trials of chronic gout: progress and research priorities. 2011

Dalbeth, Nicola / McQueen, Fiona M / Singh, Jasvinder A / MacDonald, Patricia A / Edwards, N Lawrence / Schumacher, H Ralph / Simon, Lee S / Stamp, Lisa K / Neogi, Tuhina / Gaffo, Angelo L / Khanna, Puja P / Becker, Michael A / Taylor, William J. ·Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand. n.dalbeth@auckland.ac.nz ·J Rheumatol · Pubmed #21724716.

ABSTRACT: Despite the recognition that tophus regression is an important outcome measure in clinical trials of chronic gout, there is no agreed upon method of tophus measurement. A number of methods have been used in clinical trials of chronic gout, from simple physical measurement techniques to more complex advanced imaging methods. This article summarizes methods of tophus measurement and discusses their properties. Physical measurement using Vernier calipers meets most aspects of the Outcome Measures in Rheumatology (OMERACT) filter. Rigorous testing of the complex methods, particularly with respect to reliability and sensitivity to change, is needed to determine the appropriate use of these methods. Further information is also required regarding which method of physical measurement is best for use in future clinical trials. The need to develop and test a patient-reported outcome measure of tophus burden is also highlighted.

25 Article Patient-reported outcomes in chronic gout: a report from OMERACT 10. 2011

Singh, Jasvinder A / Taylor, Will J / Simon, Lee S / Khanna, Puja P / Stamp, Lisa K / McQueen, Fiona M / Neogi, Tuhina / Gaffo, Angelo L / Becker, Michael A / MacDonald, Patricia A / Dabbous, Omar / Strand, Vibeke / Dalbeth, Nicola D / Aletaha, Daniel / Edwards, N Lawrence / Schumacher, H Ralph. ·Medicine Service, Birmingham Veterans Affairs (VA) Medical Center and Division of Rheumatology, Department of Medicine, University of Alabama, Birmingham, AL 35294, USA. jasvinder.md@gmail.com ·J Rheumatol · Pubmed #21724715.

ABSTRACT: OBJECTIVE: To summarize the endorsement of measures of patient-reported outcome (PRO) domains in chronic gout at the 2010 Outcome Measures in Rheumatology Meeting (OMERACT 10). METHODS: During the OMERACT 10 gout workshop, validation data were presented for key PRO domains including pain [pain by visual analog scale (VAS)], patient global (patient global VAS), activity limitation [Health Assessment Questionnaire-Disability Index (HAQ-DI)], and a disease-specific measure, the Gout Assessment Questionnaire version 2.0 (GAQ v2.0). Data were presented on all 3 aspects of the OMERACT filters of truth, discrimination, and feasibility. One PRO, health-related quality of life measurement with the Medical Outcomes Study Short-form 36 (SF-36), was previously endorsed at OMERACT 9. RESULTS: One measure for each of the 3 PRO of pain, patient global, and activity limitation was endorsed by > 70% of the OMERACT delegates to have appropriate validation data. Specifically, pain measurement by VAS was endorsed by 85%, patient global assessment by VAS by 73%, and activity limitation by HAQ-DI by 71%. GAQ v2.0 received 30% vote and was not endorsed due to several concerns including low internal consistency and lack of familiarity with the measure. More validation studies are needed for this measure. CONCLUSION: With the endorsement of one measure each for pain, patient global, SF-36, and activity limitation, all 4 PRO for chronic gout have been endorsed. Future validation studies are needed for the disease-specific measure, GAQ v2.0. Validation for PRO for acute gout will be the focus of the next validation exercise for the OMERACT gout group.

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