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preserveAspectRatio="none"><path fill="none" stroke="#000" stroke-width="36" stroke-linecap="round" style="fill:#FFF" d="m320,350a153,153 0 1,0-2,2l170,170m-91-117 110,110-26,26-110-110"></path></svg></a><a id="jr-fip-done" class="wsprkl btn" title="Dismiss find">✘</a></nav><nav id="jr-fip-info-p"><a id="jr-fip-prev" class="wsprkl btn" title="Jump to previuos match">◀</a><button id="jr-fip-matches">no matches yet</button><a id="jr-fip-next" class="wsprkl btn" title="Jump to next match">▶</a></nav></nav></div><div id="jr-epub-interstitial" class="hidden"></div><div id="jr-content"><article data-type="main"><div class="main-content lit-style"><div class="fm-sec bkr_bottom_sep"><div class="bkr_thumb"><a href="https://www.nice.org.uk" title="National Institute for Health and Care Excellence (NICE)" class="img_link icnblk_img" ref="pagearea=logo&targetsite=external&targetcat=link&targettype=publisher"><img class="source-thumb" src="/corehtml/pmc/pmcgifs/bookshelf/thumbs/th-niceng219er11-lrg.png" alt="Cover of Evidence review for the best serum urate level target to use when treating-to-target in gout?" /></a></div><div class="bkr_bib"><h1 id="_NBK589580_"><span itemprop="name">Evidence review for the best serum urate level target to use when treating-to-target in gout?</span></h1><div class="subtitle">Gout: diagnosis and management</div><p><b>Evidence review K</b></p><p><i>NICE Guideline, No. 219</i></p><div class="half_rhythm">London: <a href="https://www.nice.org.uk" ref="pagearea=meta&targetsite=external&targetcat=link&targettype=publisher"><span itemprop="publisher">National Institute for Health and Care Excellence (NICE)</span></a>; <span itemprop="datePublished">2022 Jun</span>.<div class="small">ISBN-13: <span itemprop="isbn">978-1-4731-4603-7</span></div></div><div><a href="/books/about/copyright/">Copyright</a> © NICE 2022.</div></div><div class="bkr_clear"></div></div><div id="niceng219er11.s1"><h2 id="_niceng219er11_s1_">1. The best serum urate level target to use when treating-to-target in gout?</h2><div id="niceng219er11.s1.1"><h3>1.1. Review question: What is the best serum urate level target to use when treating-to-target in gout?</h3><div id="niceng219er11.s1.1.1"><h4>1.1.1. Introduction</h4><p>‘Treat-to-target’ urate-lowering therapy (ULT) involves starting ULT at low-dose and increasing the dose gradually until serum urate has been lowered below an agreed target level. Monosodium urate crystals form once the level of urate in blood and body tissues exceeds the physiological saturation threshold for urate (approximately 380micromoles/L). National and international rheumatology society guidelines have proposed different targets to ensure urate is lowered to well below this physiological threshold. The British Society for Rheumatology guideline advocates a target below 300micromoles/L (5mg/dL) whereas the European League Against Rheumatism and American College of Rheumatology agree a target below 360micromoles/L (6mg/dL).</p><p>In current clinical practice, only one-third of people with gout in primary care are offered urate-lowering therapy and only one-third of these achieve a target serum urate level below 360micromol/L. A national audit of management of gout by UK rheumatologists found that by one year after a new out-patient appointment in rheumatology, only 45% and 25% of patients had achieved target serum urate levels below 360micromol/L and 300micromol/L, respectively.</p><p>This evidence review will determine which is the best serum urate level target for ‘treat-to-target’ ULT.</p></div><div id="niceng219er11.s1.1.2"><h4>1.1.2. Summary of the protocol</h4><p>For full details see the review protocol in <a href="#niceng219er11.appa">Appendix A</a>.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng219er11tab1"><a href="/books/NBK589580/table/niceng219er11.tab1/?report=objectonly" target="object" title="Table 1" class="img_link icnblk_img figpopup" rid-figpopup="figniceng219er11tab1" rid-ob="figobniceng219er11tab1"><img class="small-thumb" src="/books/NBK589580/table/niceng219er11.tab1/?report=thumb" src-large="/books/NBK589580/table/niceng219er11.tab1/?report=previmg" alt="Table 1. PICO characteristics of review question." /></a><div class="icnblk_cntnt"><h4 id="niceng219er11.tab1"><a href="/books/NBK589580/table/niceng219er11.tab1/?report=objectonly" target="object" rid-ob="figobniceng219er11tab1">Table 1</a></h4><p class="float-caption no_bottom_margin">PICO characteristics of review question. </p></div></div></div><div id="niceng219er11.s1.1.3"><h4>1.1.3. Methods and process</h4><p>This evidence review was developed using the methods and process described in <a href="https://www.nice.org.uk/process/pmg20/chapter/introduction-and-overview" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Developing NICE guidelines: the manual</a>. Methods specific to this review question are described in the review protocol in <a href="#niceng219er11.appa">Appendix A</a> and the methods document.</p><p>Declarations of interest were recorded according to <a href="https://www.nice.org.uk/about/who-we-are/policies-and-procedures" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">NICE’s conflicts of interest policy</a>.</p></div><div id="niceng219er11.s1.1.4"><h4>1.1.4. Effectiveness evidence</h4><div id="niceng219er11.s1.1.4.1"><h5>1.1.4.1. Included studies</h5><p>No relevant clinical studies comparing different serum urate target levels were identified.</p><p>See also the study selection flow chart in <a href="#niceng219er11.appc">Appendix C</a>.</p></div><div id="niceng219er11.s1.1.4.2"><h5>1.1.4.2. Excluded studies</h5><p>See the excluded studies list in <a href="#niceng219er11.appj">Appendix J</a>.</p></div></div><div id="niceng219er11.s1.1.5"><h4>1.1.5. Summary of studies included in the effectiveness evidence</h4><p>No evidence was identified for this review.</p></div><div id="niceng219er11.s1.1.6"><h4>1.1.6. Summary of the effectiveness evidence</h4><p>No evidence was identified for this review.</p></div><div id="niceng219er11.s1.1.7"><h4>1.1.7. Economic evidence</h4><div id="niceng219er11.s1.1.7.1"><h5>1.1.7.1. Included studies</h5><p>No health economic studies were included.</p></div><div id="niceng219er11.s1.1.7.2"><h5>1.1.7.2. Excluded studies</h5><p>No relevant health economic studies were excluded due to assessment of limited applicability or methodological limitations.</p><p>See also the health economic study selection flow chart in <a href="#niceng219er11.appg">Appendix G</a>.</p></div></div><div id="niceng219er11.s1.1.8"><h4>1.1.8. Economic model</h4><p>This area was not prioritised for new cost-effectiveness analysis.</p></div><div id="niceng219er11.s1.1.9"><h4>1.1.9. Unit costs</h4><p>Relevant unit costs are provided below to aid consideration of cost effectiveness.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng219er11tab2"><a href="/books/NBK589580/table/niceng219er11.tab2/?report=objectonly" target="object" title="Table 2" class="img_link icnblk_img figpopup" rid-figpopup="figniceng219er11tab2" rid-ob="figobniceng219er11tab2"><img class="small-thumb" src="/books/NBK589580/table/niceng219er11.tab2/?report=thumb" src-large="/books/NBK589580/table/niceng219er11.tab2/?report=previmg" alt="Table 2. Unit costs." /></a><div class="icnblk_cntnt"><h4 id="niceng219er11.tab2"><a href="/books/NBK589580/table/niceng219er11.tab2/?report=objectonly" target="object" rid-ob="figobniceng219er11tab2">Table 2</a></h4><p class="float-caption no_bottom_margin">Unit costs. </p></div></div></div><div id="niceng219er11.s1.1.10"><h4>1.1.10. Evidence statements</h4><div id="niceng219er11.s1.1.10.1"><h5>Effectiveness/Qualitative</h5><ul><li class="half_rhythm"><div>No relevant published evidence was identified.</div></li></ul></div><div id="niceng219er11.s1.1.10.2"><h5>Economic</h5><ul><li class="half_rhythm"><div>No relevant economic evaluations were identified.</div></li></ul></div></div><div id="niceng219er11.s1.1.11"><h4>1.1.11. The committee's discussion and interpretation of the evidence</h4><div id="niceng219er11.s1.1.11.1"><h5>1.1.11.1. The outcomes that matter most</h5><p>The committee considered the following outcomes as important for decision making health-related quality of life, patient global assessment of treatment success, pain, joint swelling/joint inflammation, joint tenderness, proportion of participants who reach serum urate target level, frequency of flares, tophi, admission (hospital and A&E/urgent care) and GP visits. Proportion of participants who reach serum urate target level, frequency of flares and tophi would have been most important in the committee’s decision process if there had been any evidence. Reducing flares and tophi were thought to be highly indicative of the efficacy of achieving the target serum urate level.</p><p>The committee decided to combine joint swelling and joint inflammation as they agreed that these outcomes are synonymous for people with gout. The committee also agreed to categorise time-points reported in the included studies by short-term (less than three months), medium-term (three to twelve months) and long-term (more than twelve months).</p></div><div id="niceng219er11.s1.1.11.2"><h5>1.1.11.2. The quality of the evidence</h5><p>No clinical evidence was identified for the best serum urate level target when treating-to-target in gout. The committee decided to make a consensus recommendation based on their clinical experience.</p></div><div id="niceng219er11.s1.1.11.3"><h5>1.1.11.3. Benefits and harms</h5><p>The committee discussed that currently there are different national and international recommendations for the serum urate target level. The British Society of Rheumatology recommendation is <300µmol/L (5mg/dl) and the European League Against Rheumatism (EULAR) guidelines recommend <360µmol/L (6 mg/dl). The committee agreed that a serum urate level of <360µmol/L (6mg/dl) would be more appropriate as it is more attainable and requires lower doses of ULT, which may improve patient adherence. The committee also acknowledged aiming for a target of below 360µmol/L reflected practice within primary care. However, the committee also noted that to assist faster dissolution of crystal deposits a lower serum urate level should be recommended if the person has tophi or chronic gouty arthritis or continues to have ongoing frequent flares despite achieving a target level below 6mg/dL (360µmol/L). People with tophi, chronic gouty arthritis or frequent flares are likely to have a higher burden of crystal deposition, meaning that treatment response would take longer. Hence, a lower target level is likely to bring about more rapid response to treatment. The committee suggested that the target serum urate levels should be the same in people with CKD.</p><p>The committee agreed a discussion with the patient should take place to explain the benefits of lowering serum urate levels to a target level. While the aim would usually be to titrate the dose to achieve 360µmol/L, a personalised approach should be taken according to the person’s symptoms and tolerability to ULT. Given the lack of evidence the committee made a strong consensus recommendation in line with current practice and a weaker consider recommendation for the lower serum urate target. The committee agreed a research recommendation should be made on the best serum urate level target to use when treating to target.</p></div><div id="niceng219er11.s1.1.11.4"><h5>1.1.11.4. Cost effectiveness and resource use</h5><p>No economic evidence was identified for this review question. Unit costs were presented to aid to committee consideration of cost effectiveness.</p><p>The committee discussed the clinical benefits and costs associated with the two target serum levels being compared (less than 300µmol/L and less than 360µmol/L). The committee noted that for most people, once they achieve a target serum urate level of less 360µmol/L (and above 300µmol/L), lowering target serum urate levels further will not alter the number of flares people experience. The committee did however acknowledge that a small proportion of people will experience more flares than would be expected at a target level of less than 360µmol/L, and for those group of people a target level of less than 300µmol/L would be more appropriate.</p><p>The cost of achieving a target serum urate level of less than 360µmol/L will likely be cheaper than the cost of achieving a target serum urate level of less than 300µmol/. This is due to the fact that achieving a lower target serum urate level is likely to be associated with more appointment costs and blood tests when a treat-to-target management strategy is employed.</p><p>The committee did however emphasise, that people with more severe gout (for example, those still experiencing gout flares at a target level of 360 µmol/L and people with tophi) may benefit of a target level of less than 300µmol/L. The committee acknowledged that in these instances, the additional costs of employing a target serum urate level of less than 300µmol/L would be offset by the cost savings observed from people not experiencing gout flares in the form of fewer GP appointments and medications prescribed for treatment of a gout flare. Subsequently the committee made a consensus recommendation for people with gout receiving ULT to obtain a target serum urate level of 360µmol/L, stipulating that in some instances a target level of 300µmol/L may be more appropriate.</p><p>This recommendation is largely reflective of current practice and therefore not expected to result in a substantial resource impact.</p></div><div id="niceng219er11.s1.1.11.5"><h5>1.1.11.5. Recommendations supported by this evidence review</h5><p>This evidence review supports recommendations 1.5.6 to 1.5.7 and the research recommendation on, what is the best target serum urate level when using a treat-to-target strategy to treat gout.</p></div></div><div id="niceng219er11.rl.r1"><h4>1.1.12. References</h4><dl class="temp-labeled-list"><dl class="bkr_refwrap"><dt>1.</dt><dd><div class="bk_ref" id="niceng219er11.ref1">Beecham
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J, Curtis
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L. Unit costs of health and social care
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2020. Canterbury. Personal Social Services Research Unit University of Kent, 2020. Available from: <a href="https://www.pssru.ac.uk/project-pages/unit-costs/" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">https://www<wbr style="display:inline-block"></wbr>​.pssru.ac<wbr style="display:inline-block"></wbr>​.uk/project-pages/unit-costs/</a></div></dd></dl><dl class="bkr_refwrap"><dt>2.</dt><dd><div class="bk_ref" id="niceng219er11.ref2">Gamala
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M, Jacobs
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JWG, Linn-Rasker
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SF, Nix
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M, Heggelman
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BGF, Pasker-de Jong
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PCM
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The performance of dual-energy CT in the classification criteria of gout: a prospective study in subjects with unclassified arthritis. Rheumatology. 2020; 59(4):845–851 [<a href="https://pubmed.ncbi.nlm.nih.gov/31504985" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31504985</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>3.</dt><dd><div class="bk_ref" id="niceng219er11.ref3">Li-Yu
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J, Clayburne
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G, Sieck
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M, Beutler
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A, Rull
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M, Eisner
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Treatment of chronic gout. Can we determine when urate stores are depleted enough to prevent attacks of gout?
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Journal of Rheumatology. 2001; 28(3):577–580 [<a href="https://pubmed.ncbi.nlm.nih.gov/11296962" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 11296962</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>4.</dt><dd><div class="bk_ref" id="niceng219er11.ref4">Mak
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A, Ho
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RCM, Tan
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JYS, Teng
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GG, Lahiri
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M, Lateef
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Atherogenic serum lipid profile is an independent predictor for gouty flares in patients with gouty arthropathy. Rheumatology. 2009; 48(3):262–265 [<a href="https://pubmed.ncbi.nlm.nih.gov/19151029" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 19151029</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>5.</dt><dd><div class="bk_ref" id="niceng219er11.ref5">National Institute for Health and Care Excellence. Developing NICE guidelines: the manual [updated October 2020]. London. National Institute for Health and Care Excellence, 2014. Available from: <a href="http://www.nice.org.uk/article/PMG20/chapter/1%20Introduction%20and%20overview" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">http://www<wbr style="display:inline-block"></wbr>​.nice.org.uk<wbr style="display:inline-block"></wbr>​/article/PMG20/chapter<wbr style="display:inline-block"></wbr>​/1%20Introduction%20and%20overview</a></div></dd></dl><dl class="bkr_refwrap"><dt>6.</dt><dd><div class="bk_ref" id="niceng219er11.ref6">NHS England and NHS Improvement. National Cost Collection Data Publication 2019–2020. London. 2020. Available from: <a href="https://www.england.nhs.uk/wp-content/uploads/2021/06/National-Cost-Collection-2019-20-Report-FINAL.pdf" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">https://www<wbr style="display:inline-block"></wbr>​.england.nhs<wbr style="display:inline-block"></wbr>​.uk/wp-content/uploads<wbr style="display:inline-block"></wbr>​/2021/06/National-Cost-Collection-2019-20-Report-FINAL<wbr style="display:inline-block"></wbr>​.pdf</a></div></dd></dl><dl class="bkr_refwrap"><dt>7.</dt><dd><div class="bk_ref" id="niceng219er11.ref7">Perez-Ruiz
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F, Calabozo
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M, Pijoan
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JI, Herrero-Beites
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AM, Ruibal
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A. Effect of uratelowering therapy on the velocity of size reduction of tophi in chronic gout. Arthritis and Rheumatism. 2002; 47(4):356–360 [<a href="https://pubmed.ncbi.nlm.nih.gov/12209479" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 12209479</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>8.</dt><dd><div class="bk_ref" id="niceng219er11.ref8">Perez Ruiz
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F, Richette
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P, Stack
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AG, Karra Gurunath
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R, Garcia de Yebenes
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MJ, Carmona
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L. Failure to reach uric acid target of <0.36 mmol/L in hyperuricaemia of gout is associated with elevated total and cardiovascular mortality. RMD Open. 2019; 5(2):e001015 [<a href="/pmc/articles/PMC6803010/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC6803010</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/31673414" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31673414</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>9.</dt><dd><div class="bk_ref" id="niceng219er11.ref9">Sheer
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R, Null
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KD, Szymanski
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KA, Sudharshan
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L, Banovic
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J, Pasquale
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MK. Predictors of reaching a serum uric acid goal in patients with gout and treated with febuxostat. Clinicoeconomics & Outcomes Research. 2017; 9:629–639 [<a href="/pmc/articles/PMC5644566/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC5644566</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/29066924" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 29066924</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>10.</dt><dd><div class="bk_ref" id="niceng219er11.ref10">Shoji
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A, Yamanaka
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H, Kamatani
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N. A retrospective study of the relationship between serum urate level and recurrent attacks of gouty arthritis: evidence for reduction of recurrent gouty arthritis with antihyperuricemic therapy. Arthritis and Rheumatism. 2004; 51(3):321–325 [<a href="https://pubmed.ncbi.nlm.nih.gov/15188314" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 15188314</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>11.</dt><dd><div class="bk_ref" id="niceng219er11.ref11">Te Kampe
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R, van Durme
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C, Janssen
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M, van Eijk-Hustings
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Y, Boonen
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A, Jansen
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TL. Comparative study of real-life management strategies in gout: Data from two protocolized gout clinics. Arthritis Care and Research. 2020; 72(8):1169–1176 [<a href="https://pubmed.ncbi.nlm.nih.gov/31150161" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31150161</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>12.</dt><dd><div class="bk_ref" id="niceng219er11.ref12">Trontzas
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P, Kamper
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EF, Potamianou
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A, Kyriazis
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NC, Kritikos
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H, Stavridis
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J. Comparative study of serum and synovial fluid interleukin-11 levels in patients with various arthritides. Clinical Biochemistry. 1998; 31(8):673–679 [<a href="https://pubmed.ncbi.nlm.nih.gov/9876901" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 9876901</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>13.</dt><dd><div class="bk_ref" id="niceng219er11.ref13">Wasserman
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A, Shnell
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M, Boursi
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B, Guzner-Gur
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H. Prognostic significance of serum uric acid in patients admitted to the Department of Medicine. American Journal of the Medical Sciences. 2010; 339(1):15–21 [<a href="https://pubmed.ncbi.nlm.nih.gov/19996731" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 19996731</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>14.</dt><dd><div class="bk_ref" id="niceng219er11.ref14">Yamanaka
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H, Togashi
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R, Hakoda
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M, Terai
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C, Kashiwazaki
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S, Dan
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Optimal range of serum urate concentrations to minimize risk of gouty attacks during antihyperuricemic treatment. Advances in Experimental Medicine and Biology. 1998; 431:13–18 [<a href="https://pubmed.ncbi.nlm.nih.gov/9598023" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 9598023</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>15.</dt><dd><div class="bk_ref" id="niceng219er11.ref15">Yokose
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C, Jorge
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A, D'Silva
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K, Serling-Boyd
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N, Matza
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M, Nasrallah
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M
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et al
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Using electronic visits (E-visits) to achieve goal serum urate levels in patients with gout in a rheumatology practice: A pilot study. Seminars in Arthritis and Rheumatism. 2020; [<a href="/pmc/articles/PMC7492421/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC7492421</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/32359694" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 32359694</span></a>]</div></dd></dl></dl></div></div></div><div id="appendixesappgroup1"><h2 id="_appendixesappgroup1_">Appendices</h2><div id="niceng219er11.appa"><h3>Appendix A. Review protocols</h3><p id="niceng219er11.appa.et1"><a href="/books/NBK589580/bin/niceng219er11-appa-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (229K)</span></p></div><div id="niceng219er11.appb"><h3>Appendix B. Literature search strategies</h3><ul><li class="half_rhythm"><div>What is the best serum urate level target to use when treating-to-target in gout?</div></li></ul><p>The literature searches for this review are detailed below and complied with the methodology outlined in Developing NICE guidelines: the manual.<a class="bibr" href="#niceng219er11.ref5" rid="niceng219er11.ref5"><sup>5</sup></a></p><p>For more information, please see the Methodology review published as part of the accompanying documents for this guideline.</p><p id="niceng219er11.appb.et1"><a href="/books/NBK589580/bin/niceng219er11-appb-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">B.1. Clinical search literature search strategy</a><span class="small"> (PDF, 200K)</span></p><p id="niceng219er11.appb.et2"><a href="/books/NBK589580/bin/niceng219er11-appb-et2.pdf" class="bk_dwnld_icn bk_dwnld_pdf">B.2. Health Economics literature search strategy</a><span class="small"> (PDF, 163K)</span></p></div><div id="niceng219er11.appc"><h3>Appendix C. Effectiveness evidence study selection</h3><p id="niceng219er11.appc.et1"><a href="/books/NBK589580/bin/niceng219er11-appc-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (116K)</span></p></div><div id="niceng219er11.appd"><h3>Appendix D. Effectiveness evidence</h3><p>No studies were included</p></div><div id="niceng219er11.appe"><h3>Appendix E. Forest plots</h3><p>No studies were included</p></div><div id="niceng219er11.appf"><h3>Appendix F. GRADE tables</h3><p>No studies were included</p></div><div id="niceng219er11.appg"><h3>Appendix G. Economic evidence study selection</h3><p id="niceng219er11.appg.et1"><a href="/books/NBK589580/bin/niceng219er11-appg-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (167K)</span></p></div><div id="niceng219er11.apph"><h3>Appendix H. Economic evidence tables</h3><p>None</p></div><div id="niceng219er11.appi"><h3>Appendix I. Health economic model</h3><p>No original economic modelling was undertaken for this review question.</p></div><div id="niceng219er11.appj"><h3>Appendix J. Excluded studies</h3><div id="niceng219er11.appj.s1"><h4>Clinical studies</h4><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng219er11appjtab1"><a href="/books/NBK589580/table/niceng219er11.appj.tab1/?report=objectonly" target="object" title="Table 5" class="img_link icnblk_img figpopup" rid-figpopup="figniceng219er11appjtab1" rid-ob="figobniceng219er11appjtab1"><img class="small-thumb" src="/books/NBK589580/table/niceng219er11.appj.tab1/?report=thumb" src-large="/books/NBK589580/table/niceng219er11.appj.tab1/?report=previmg" alt="Table 5. Studies excluded from the clinical review." /></a><div class="icnblk_cntnt"><h4 id="niceng219er11.appj.tab1"><a href="/books/NBK589580/table/niceng219er11.appj.tab1/?report=objectonly" target="object" rid-ob="figobniceng219er11appjtab1">Table 5</a></h4><p class="float-caption no_bottom_margin">Studies excluded from the clinical review. </p></div></div></div><div id="niceng219er11.appj.s2"><h4>Health Economic studies</h4><p>None.</p></div></div><div id="niceng219er11.appk"><h3>Appendix K. Research recommendations – full details</h3><div id="niceng219er11.appk.s1"><h4>K.1. Research recommendation</h4><p>What is the best and most cost effective target serum urate level when using a treat-to-target strategy to treat gout, including in people with chronic kidney disease?</p></div><div id="niceng219er11.appk.s2"><h4>K.2. Why this is important</h4><p>Gout is frequently under-treated with only a minority of patients receiving definitive treat-to-target urate-lowering therapy to lower the serum urate level below a target level. Treat-to-target has been shown to prevent gout flares, shrink tophi and improve quality of life. Only 30–40% of people with gout in primary care are offered urate-lowering therapy and only one-third of these achieve a target serum urate level below 360micromol/L. A national audit of management of gout by UK rheumatologists found that by one year after a new out-patient appointment in rheumatology, only 45% and 25% of patients had achieved target serum urate levels below 360micromol/L and 300micromol/L, respectively.</p><p>Possible explanations for under-treatment are uncertainty about what the optimum target level should be and disagreement between specialist society guidelines. The British Society for Rheumatology guideline recommends reducing the serum urate level to below 300micromol/L whereas the American College of Rheumatology and European League Against Rheumatism guidelines advocate a target level below 360micromol/L. A lower serum urate target requires higher drug doses and greater healthcare resource to achieve the target. In the review of evidence for the best serum urate target level, the committee found no relevant studies comparing different target serum urate levels. A better understanding of the optimum target serum urate level would provide certainty for patients and clinicians, guiding more frequent uptake of treat-to-target urate-lowering therapy and reducing frequent pain and disability associated with under-treated gout.</p></div><div id="niceng219er11.appk.s3"><h4>K.3. Rationale for research recommendation</h4><p id="niceng219er11.appk.et1"><a href="/books/NBK589580/bin/niceng219er11-appk-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (129K)</span></p></div><div id="niceng219er11.appk.s4"><h4>K.4. Modified PICO table</h4><p id="niceng219er11.appk.et2"><a href="/books/NBK589580/bin/niceng219er11-appk-et2.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (120K)</span></p></div></div></div></div><div class="fm-sec"><div><p>Final version</p></div><div><p>Evidence reviews underpinning recommendations 1.5.6 to 1.5.7 and research recommendations in the NICE guideline</p><p>National Institute for Health and Care Excellence</p></div><div><p><b>Disclaimer</b>: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.</p><p>Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.</p><p>NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the <a href="http://wales.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Welsh Government</a>, <a href="http://www.scotland.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Scottish Government</a>, and <a href="http://www.northernireland.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Northern Ireland Executive</a>. All NICE guidance is subject to regular review and may be updated or withdrawn.</p></div><div class="half_rhythm"><a href="/books/about/copyright/">Copyright</a> © NICE 2022.</div><div class="small"><span class="label">Bookshelf ID: NBK589580</span><span class="label">PMID: <a href="https://pubmed.ncbi.nlm.nih.gov/36921075" title="PubMed record of this title" ref="pagearea=meta&targetsite=entrez&targetcat=link&targettype=pubmed">36921075</a></span></div></div><div class="small-screen-prev"></div><div class="small-screen-next"></div></article><article data-type="table-wrap" id="figobniceng219er11tab1"><div id="niceng219er11.tab1" class="table"><h3><span class="label">Table 1</span><span class="title">PICO characteristics of review question</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK589580/table/niceng219er11.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng219er11.tab1_lrgtbl__"><table><tbody><tr><th id="hd_b_niceng219er11.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Population</th><td headers="hd_b_niceng219er11.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Inclusion: Adults (18 years and older) with gout taking urate-lowering therapies</p>
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<p>Strata:<ul><li class="half_rhythm"><div>People with CKD (stage 3)</div></li><li class="half_rhythm"><div>People with CKD (stages 4–5)</div></li><li class="half_rhythm"><div>People without CKD or people with CKD stages 1–2</div></li><li class="half_rhythm"><div>Mixed population (people with CKD and people without CKD)</div></li></ul></p>
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<p>Exclusion: People with calcium pyrophosphate crystal deposition, including pseudogout</p>
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</td></tr><tr><th id="hd_b_niceng219er11.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Intervention(s)</th><td headers="hd_b_niceng219er11.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Different serum urate target levels, for example:<ul><li class="half_rhythm"><div>British Society for Rheumatology recommendation – 300 micromol/L</div></li><li class="half_rhythm"><div>European and international guidelines recommendation – less than 360 micromol/L</div></li></ul></td></tr><tr><th id="hd_b_niceng219er11.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Comparison(s)</th><td headers="hd_b_niceng219er11.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul><li class="half_rhythm"><div>Compared to each other</div></li><li class="half_rhythm"><div>No serum urate target level</div></li></ul>
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</td></tr><tr><th id="hd_b_niceng219er11.tab1_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Outcomes</th><td headers="hd_b_niceng219er11.tab1_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>All outcomes are considered equally important for decision making and therefore have all been rated as critical:<ul><li class="half_rhythm"><div>health-related quality of life (e.g. as described by SF-36, Gout Assessment Questionnaire (GAQ) and the Gout Impact Scale (GIS) or other validated gout-specific HRQoL measures</div></li><li class="half_rhythm"><div>patient global assessment of treatment success (response to treatment) (e.g. Likert scales, visual analogue scales (VAS), numerical ratings scales (NRS))</div></li><li class="half_rhythm"><div>pain (measured on a visual analogue scale (VAS) or numerical rating scale such as the five-point Likert scale, or reported as pain relief of 50% or greater)</div></li><li class="half_rhythm"><div>joint swelling/joint inflammation</div></li><li class="half_rhythm"><div>joint tenderness</div></li><li class="half_rhythm"><div>proportion of participants who reach serum urate target level</div></li><li class="half_rhythm"><div>frequency of flares</div></li><li class="half_rhythm"><div>tophi</div></li><li class="half_rhythm"><div>admissions (hospital and A&E/urgent care)</div></li><li class="half_rhythm"><div>GP visits</div></li></ul></p>
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<p>Timepoints: short-term (less than three months), medium-term (three to 12 months) and long-term (more than 12 months) duration.</p>
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</td></tr><tr><th id="hd_b_niceng219er11.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Study design</th><td headers="hd_b_niceng219er11.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>RCT</p>
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<p>Systematic reviews of RCTs</p>
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<p>If insufficient RCT evidence is available (no or little evidence for interventions/comparisons), non-randomised studies (prospective and retrospective cohort studies) will be considered if they adjust for key confounders:<ul><li class="half_rhythm"><div>Age</div></li><li class="half_rhythm"><div>Gender</div></li></ul></p>
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<p>Published NMAs will be considered for inclusion.</p>
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</td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobniceng219er11tab2"><div id="niceng219er11.tab2" class="table"><h3><span class="label">Table 2</span><span class="title">Unit costs</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK589580/table/niceng219er11.tab2/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng219er11.tab2_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng219er11.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Resource</th><th id="hd_h_niceng219er11.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Unit costs</th></tr></thead><tbody><tr><td headers="hd_h_niceng219er11.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Primary care Practice Nurse, cost per hour<sup>(a)</sup></td><td headers="hd_h_niceng219er11.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£42</td></tr><tr><td headers="hd_h_niceng219er11.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">General Practitioner, cost per 9.22 min consultation<sup>(a)</sup></td><td headers="hd_h_niceng219er11.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£39</td></tr><tr><td headers="hd_h_niceng219er11.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cost of blood test (excluding time to take blood)<sup>(b)</sup></td><td headers="hd_h_niceng219er11.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£3–£4</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt>(a)</dt><dd><div id="niceng219er11.tab2_1"><p class="no_margin">Source: PSSRU 2020 <a class="bibr" href="#niceng219er11.ref1" rid="niceng219er11.ref1"><sup>1</sup></a></p></div></dd></dl><dl class="bkr_refwrap"><dt>(b)</dt><dd><div id="niceng219er11.tab2_2"><p class="no_margin">Source: NHS reference costs 2019/2020<a class="bibr" href="#niceng219er11.ref6" rid="niceng219er11.ref6"><sup>6</sup></a>: directly accessed pathology services, haematology and phlebotomy respectively.</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng219er11appjtab1"><div id="niceng219er11.appj.tab1" class="table"><h3><span class="label">Table 5</span><span class="title">Studies excluded from the clinical review</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK589580/table/niceng219er11.appj.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng219er11.appj.tab1_lrgtbl__"><table><thead><tr><th id="hd_h_niceng219er11.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Study</th><th id="hd_h_niceng219er11.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Exclusion reason</th></tr></thead><tbody><tr><td headers="hd_h_niceng219er11.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Mak 2009<a class="bibr" href="#niceng219er11.ref4" rid="niceng219er11.ref4"><sup>4</sup></a></td><td headers="hd_h_niceng219er11.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Incorrect analysis/incorrect comparison - risk factors (such as age, gender, comorbidities etc) predictive of gout flares were studied using regression models</td></tr><tr><td headers="hd_h_niceng219er11.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Gamala 2020<a class="bibr" href="#niceng219er11.ref2" rid="niceng219er11.ref2"><sup>2</sup></a></td><td headers="hd_h_niceng219er11.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Incorrect population/incorrect analysis - patients with acute, unclassified mono or oligoarthritic, study aimed to establish performance of 2015 ACR/EULAR gout classification criteria in patients with unclassified arthritis, sensitivity and specificity of dual-energy CT was analysed</td></tr><tr><td headers="hd_h_niceng219er11.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Li-Yu 2001<a class="bibr" href="#niceng219er11.ref3" rid="niceng219er11.ref3"><sup>3</sup></a></td><td headers="hd_h_niceng219er11.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Incorrect analysis/incorrect comparison - study compared patients with SUA >6mg/dl vs patients with SUA =< 6 mg/dl, study aimed to determine if lowering serum uric acid will result in depletion of urate crystals from the knee joints</td></tr><tr><td headers="hd_h_niceng219er11.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Perez Ruiz 2019<a class="bibr" href="#niceng219er11.ref8" rid="niceng219er11.ref8"><sup>8</sup></a></td><td headers="hd_h_niceng219er11.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Incorrect analysis/incorrect comparison - study aimed to determine impact of achieving serum uric acid of <0.36mmol/L on overall and cardiovascular mortality in patients with gout</td></tr><tr><td headers="hd_h_niceng219er11.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Perez-Ruiz 2002<a class="bibr" href="#niceng219er11.ref7" rid="niceng219er11.ref7"><sup>7</sup></a></td><td headers="hd_h_niceng219er11.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Incorrect intervention/incorrect comparison - study evaluated the relationship between serum urate lowering therapy (allopurinol vs benzbromarone vs allopurinol plus benzbromarone) and velocity of reduction of tophi, no multivariate analysis. Mean serum urate levels were compared during follow-up in three treatment groups</td></tr><tr><td headers="hd_h_niceng219er11.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Sheer 2017<a class="bibr" href="#niceng219er11.ref9" rid="niceng219er11.ref9"><sup>9</sup></a></td><td headers="hd_h_niceng219er11.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Incorrect analysis - study assessed impact of predictor variables on achieving serum urate level (<6 mg/dL)</td></tr><tr><td headers="hd_h_niceng219er11.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Shoji 2004<a class="bibr" href="#niceng219er11.ref10" rid="niceng219er11.ref10"><sup>10</sup></a></td><td headers="hd_h_niceng219er11.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Incorrect analysis/incorrect comparison - linear regression model of average serum urate level and recurrent gout attacks, no multivariate analysis</td></tr><tr><td headers="hd_h_niceng219er11.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Te Kampe 2020<a class="bibr" href="#niceng219er11.ref11" rid="niceng219er11.ref11"><sup>11</sup></a></td><td headers="hd_h_niceng219er11.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Incorrect comparison- intervention group was aiming for a serum urate level of <0.3mmol/L, and the majority of the comparator group (60.5%) was aiming for the same level due to having tophi. Results for the remainder of the group who were aiming for <0.36mmol/L were not reported separately therefore the comparison reported for the study was the centre/ mode of monitoring rather than serum urate level.</td></tr><tr><td headers="hd_h_niceng219er11.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Trontzas 1998<a class="bibr" href="#niceng219er11.ref12" rid="niceng219er11.ref12"><sup>12</sup></a></td><td headers="hd_h_niceng219er11.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Incorrect analysis/incorrect comparison - serum and synovial fluid interleukin-11 levels were measured and Spearman correlation coefficient was calculated in patients with RA (31 people), seronegative spondylarthritis (20 people), gout (14 people), osteoarthritis (20 people)</td></tr><tr><td headers="hd_h_niceng219er11.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Wasserman 2010<a class="bibr" href="#niceng219er11.ref13" rid="niceng219er11.ref13"><sup>13</sup></a></td><td headers="hd_h_niceng219er11.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Incorrect population - only 2% of included patients in this study had gout</td></tr><tr><td headers="hd_h_niceng219er11.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Yamanaka 1998<a class="bibr" href="#niceng219er11.ref14" rid="niceng219er11.ref14"><sup>14</sup></a></td><td headers="hd_h_niceng219er11.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Incorrect analysis - study assessed risk of gout attack within the serum urate level (4.6–6.6 mg/l) as opposed to outside this level</td></tr><tr><td headers="hd_h_niceng219er11.appj.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Yokose 2020<a class="bibr" href="#niceng219er11.ref15" rid="niceng219er11.ref15"><sup>15</sup></a></td><td headers="hd_h_niceng219er11.appj.tab1_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Incorrect analysis/incorrect comparison - patients enrolled in the gout E-visit program were compared to historical controls. The primary outcome was proportion of patients achieving SU target of less than 6mg/dL at six months</td></tr></tbody></table></div></div></article></div><div id="jr-scripts"><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/libs.min.js"> </script><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.min.js"> </script></div></div>
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