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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-niceng219er10-lrg.png" alt="Cover of Evidence reviews for treat-to-target management" /></a></div><div class="bkr_bib"><h1 id="_NBK583522_"><span itemprop="name">Evidence reviews for treat-to-target management</span></h1><div class="subtitle">Gout: diagnosis and management</div><p><b>Evidence review J</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="niceng219er10.s1"><h2 id="_niceng219er10_s1_">1. Treat-to-target management</h2><div id="niceng219er10.s1.1"><h3>1.1. Review question: What is the clinical and cost effectiveness of a ‘treat-to-target’ urate lowering management strategy compared with usual care for gout?</h3><div id="niceng219er10.s1.1.1"><h4>1.1.1. Introduction</h4><p>Long-term management of gout involves taking urate-lowering therapy (ULT) such as allopurinol or febuxostat to lower serum urate levels, preventing formation of new monosodium urate crystals and dissolving existing crystals. As a result, gout flares cease, tophi reduce in size and eventually disappear, and long-term joint damage can be prevented. ‘Treat-to-target’ ULT involves starting medication at low-dose and increasing the dose gradually until serum urate has been lowered below an agreed target level.</p><p>In clinical practice, only one-third of people with gout receive ULT and most of these remain on a fixed low dose and do not have the dose increased to achieve a target serum urate level. Consequently, many people with gout continue to suffer avoidable gout flares, joint pain, and disability.</p><p>This evidence review will compare the clinical and cost effectiveness of a treat-to-target approach to ULT with usual clinical care.</p></div><div id="niceng219er10.s1.1.2"><h4>1.1.2. Summary of the protocol</h4><p>For full details see the review protocol in <a href="#niceng219er10.appa">Appendix A</a>.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng219er10tab1"><a href="/books/NBK583522/table/niceng219er10.tab1/?report=objectonly" target="object" title="Table 1" class="img_link icnblk_img figpopup" rid-figpopup="figniceng219er10tab1" rid-ob="figobniceng219er10tab1"><img class="small-thumb" src="/books/NBK583522/table/niceng219er10.tab1/?report=thumb" src-large="/books/NBK583522/table/niceng219er10.tab1/?report=previmg" alt="Table 1. PICO characteristics of review question." /></a><div class="icnblk_cntnt"><h4 id="niceng219er10.tab1"><a href="/books/NBK583522/table/niceng219er10.tab1/?report=objectonly" target="object" rid-ob="figobniceng219er10tab1">Table 1</a></h4><p class="float-caption no_bottom_margin">PICO characteristics of review question. </p></div></div></div><div id="niceng219er10.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="#niceng219er10.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="niceng219er10.s1.1.4"><h4>1.1.4. Effectiveness evidence</h4><div id="niceng219er10.s1.1.4.1"><h5>1.1.4.1. Included studies</h5><p>Two RCTs were included in the review.<a class="bibr" href="#niceng219er10.ref8" rid="niceng219er10.ref8"><sup>8</sup></a><sup>,</sup>
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<a class="bibr" href="#niceng219er10.ref22" rid="niceng219er10.ref22"><sup>22</sup></a> These are summarised in <a class="figpopup" href="/books/NBK583522/table/niceng219er10.tab2/?report=objectonly" target="object" rid-figpopup="figniceng219er10tab2" rid-ob="figobniceng219er10tab2">Table 2</a> below. Evidence from these studies is summarised in the clinical evidence summary below (<a class="figpopup" href="/books/NBK583522/table/niceng219er10.tab3/?report=objectonly" target="object" rid-figpopup="figniceng219er10tab3" rid-ob="figobniceng219er10tab3">Table 3</a>).</p><p>Both RCTs compared ‘treat-to-target’ management strategies with usual care for gout.</p><p>See also the study selection flow chart in <a href="#niceng219er10.appc">Appendix C</a>, study evidence tables in <a href="#niceng219er10.appd">Appendix D</a>, forest plots in <a href="#niceng219er10.appe">Appendix E</a> and GRADE tables in <a href="#niceng219er10.appf">Appendix F</a></p></div><div id="niceng219er10.s1.1.4.2"><h5>1.1.4.2. Excluded studies</h5><p>RCTs were the preferred study design but only two RCTs were found, so we also searched for cohort studies to provide more evidence. No cohort studies matched the protocol, so they were excluded.</p><p>See the excluded studies list in <a href="#niceng219er10.appj">Appendix J</a>.</p></div></div><div id="niceng219er10.s1.1.5"><h4>1.1.5. Summary of studies included in the effectiveness evidence</h4><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng219er10tab2"><a href="/books/NBK583522/table/niceng219er10.tab2/?report=objectonly" target="object" title="Table 2" class="img_link icnblk_img figpopup" rid-figpopup="figniceng219er10tab2" rid-ob="figobniceng219er10tab2"><img class="small-thumb" src="/books/NBK583522/table/niceng219er10.tab2/?report=thumb" src-large="/books/NBK583522/table/niceng219er10.tab2/?report=previmg" alt="Table 2. Summary of studies included in the evidence review." /></a><div class="icnblk_cntnt"><h4 id="niceng219er10.tab2"><a href="/books/NBK583522/table/niceng219er10.tab2/?report=objectonly" target="object" rid-ob="figobniceng219er10tab2">Table 2</a></h4><p class="float-caption no_bottom_margin">Summary of studies included in the evidence review. </p></div></div><p>See <a href="#niceng219er10.appd">Appendix D</a> for full evidence tables.</p></div><div id="niceng219er10.s1.1.6"><h4>1.1.6. Summary of the effectiveness evidence</h4><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng219er10tab3"><a href="/books/NBK583522/table/niceng219er10.tab3/?report=objectonly" target="object" title="Table 3" class="img_link icnblk_img figpopup" rid-figpopup="figniceng219er10tab3" rid-ob="figobniceng219er10tab3"><img class="small-thumb" src="/books/NBK583522/table/niceng219er10.tab3/?report=thumb" src-large="/books/NBK583522/table/niceng219er10.tab3/?report=previmg" alt="Table 3. Clinical evidence summary: Treat-to-target versus usual care." /></a><div class="icnblk_cntnt"><h4 id="niceng219er10.tab3"><a href="/books/NBK583522/table/niceng219er10.tab3/?report=objectonly" target="object" rid-ob="figobniceng219er10tab3">Table 3</a></h4><p class="float-caption no_bottom_margin">Clinical evidence summary: Treat-to-target versus usual care. </p></div></div><p>See <a href="#niceng219er10.appf">Appendix F</a> for full GRADE tables</p></div><div id="niceng219er10.s1.1.7"><h4>1.1.7. Economic evidence</h4><div id="niceng219er10.s1.1.7.1"><h5>1.1.7.1. Included studies</h5><p>One health economic study with the relevant comparison was included in this review<a class="bibr" href="#niceng219er10.ref8" rid="niceng219er10.ref8"><sup>8</sup></a>. This is summarised in the health economic evidence profile below (<a class="figpopup" href="/books/NBK583522/table/niceng219er10.tab4/?report=objectonly" target="object" rid-figpopup="figniceng219er10tab4" rid-ob="figobniceng219er10tab4">Table 4</a>) and the health economic evidence table in <a href="#niceng219er10.apph">Appendix H</a>.</p></div><div id="niceng219er10.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="#niceng219er10.appg">Appendix G</a>.</p></div></div><div id="niceng219er10.s1.1.8"><h4>1.1.8. Summary of included economic evidence</h4><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng219er10tab4"><a href="/books/NBK583522/table/niceng219er10.tab4/?report=objectonly" target="object" title="Table 4" class="img_link icnblk_img figpopup" rid-figpopup="figniceng219er10tab4" rid-ob="figobniceng219er10tab4"><img class="small-thumb" src="/books/NBK583522/table/niceng219er10.tab4/?report=thumb" src-large="/books/NBK583522/table/niceng219er10.tab4/?report=previmg" alt="Table 4. Health economic evidence profile: Target-to-treat management versus usual care." /></a><div class="icnblk_cntnt"><h4 id="niceng219er10.tab4"><a href="/books/NBK583522/table/niceng219er10.tab4/?report=objectonly" target="object" rid-ob="figobniceng219er10tab4">Table 4</a></h4><p class="float-caption no_bottom_margin">Health economic evidence profile: Target-to-treat management versus usual care. </p></div></div></div><div id="niceng219er10.s1.1.9"><h4>1.1.9. Economic model</h4><p>This area was not prioritised for new cost-effectiveness analysis.</p></div><div id="niceng219er10.s1.1.10"><h4>1.1.10. 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="figniceng219er10tab5"><a href="/books/NBK583522/table/niceng219er10.tab5/?report=objectonly" target="object" title="Table 5" class="img_link icnblk_img figpopup" rid-figpopup="figniceng219er10tab5" rid-ob="figobniceng219er10tab5"><img class="small-thumb" src="/books/NBK583522/table/niceng219er10.tab5/?report=thumb" src-large="/books/NBK583522/table/niceng219er10.tab5/?report=previmg" alt="Table 5. Urate-lowering therapy costs." /></a><div class="icnblk_cntnt"><h4 id="niceng219er10.tab5"><a href="/books/NBK583522/table/niceng219er10.tab5/?report=objectonly" target="object" rid-ob="figobniceng219er10tab5">Table 5</a></h4><p class="float-caption no_bottom_margin">Urate-lowering therapy costs. </p></div></div><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng219er10tab6"><a href="/books/NBK583522/table/niceng219er10.tab6/?report=objectonly" target="object" title="Table 6" class="img_link icnblk_img figpopup" rid-figpopup="figniceng219er10tab6" rid-ob="figobniceng219er10tab6"><img class="small-thumb" src="/books/NBK583522/table/niceng219er10.tab6/?report=thumb" src-large="/books/NBK583522/table/niceng219er10.tab6/?report=previmg" alt="Table 6. Staff costs." /></a><div class="icnblk_cntnt"><h4 id="niceng219er10.tab6"><a href="/books/NBK583522/table/niceng219er10.tab6/?report=objectonly" target="object" rid-ob="figobniceng219er10tab6">Table 6</a></h4><p class="float-caption no_bottom_margin">Staff costs. </p></div></div></div><div id="niceng219er10.s1.1.11"><h4>1.1.11. Evidence statements</h4><div id="niceng219er10.s1.1.11.1"><h5>Economic</h5><p>• One cost–utility analysis found that treat-to-target was cost effective compared to usual care for treating gout (ICER: £5,066 per QALY gained at 2 years, £285 per QALY gained at 3 years, and dominant [less costly and more effective] at 5 and 10 years). This analysis was assessed as partially applicable with potentially serious limitations.</p></div></div><div id="niceng219er10.s1.1.12"><h4>1.1.12. The committee’s discussion and interpretation of the evidence</h4><div id="niceng219er10.s1.1.12.1"><h5>1.1.12.1. The outcomes that matter most</h5><p>In this review the committee considered the following outcomes as critical for decision-making: health-related quality of life, pain, joint swelling/joint inflammation, joint tenderness, frequency of flares, patient global assessment of treatment success, adverse events (cardiovascular, renal and gastrointestinal), adverse events (renal stones, tophi), admission (hospital and A&E/urgent care) and GP visits. The committee considered outcomes for health related quality of life, joint swelling and tenderness, pain and adverse events to be the most informative, in terms of the impact of a treat to target approach.</p><p>The committee agreed to combine joint swelling and joint inflammation as 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 12 months). A timepoint of less than 3 months was considered less useful because starting ULT can trigger flares and an increase in the number of flares in the first year of ULT would not be unusual, therefore the committee agreed outcomes reported at longer time-points were more useful in terms of decision making.</p><p>No clinical evidence was identified for the following outcomes: adverse events (radiographic joint damage and renal stones), admissions (hospital and A&E/urgent care) and GP visits. There were no short-term or medium-term outcomes reported, all studies were long-term (1 or 2 years).</p></div><div id="niceng219er10.s1.1.12.2"><h5>1.1.12.2. The quality of the evidence</h5><p>Two randomised controlled trials (RCTs), evaluating treat-to-target management strategies using urate-lowering therapies (ULT) compared to usual care, were included in this review. Usual care in the included studies could be any available option, chosen by the health care provider, such as continuing their current dose of allopurinol, febuxostat or no treatment. The committee noted that in one study the usual arm was not clearly reported so it was unknown whether or how many people in the usual care arm were following the treat-to-target approach (dependent on the G.P. and their usual care). This study could be comparing treat-to target with itself which could potentially skew the results. However, the authors noted that this group had low levels of ULT use at baseline, typical of usual care in the UK, which is generally considered to have low treat-to-target use.</p><p>The quality of evidence for all outcomes included in this review ranged from very low to high, but mostly moderate to low. The main reasons for downgrading were risk of bias and imprecision. There was a lack of blinding in the studies, due to the nature of the interventions. The intervention was delivered by a study healthcare practitioner and titration to a certain serum urate level would be obvious to both patient and practitioner, which led to a high risk of bias for many outcomes. Furthermore, the treat-to-target group maximum dosage of allopurinol was 900mg, which is not typical of current clinical practice in the UK, and this was unlikely to be the dosage in the GP-led arm. However, this is part of the study’s treat-to-target strategy and is testing what may be done to improve outcomes. Only one outcome could be meta-analysed (frequency of flares at 1 year) and this had a high degree of heterogeneity, which could not be resolved by subgroup analysis as there were only two studies included. However, it should be noted that one study reported 1 or more flares at one year and the other 2 or more flares at one year which may have caused a difference. This outcome was downgraded for inconsistency.</p><p>The treat-to-target arm in one of the trials included a nurse-led individualised package of care (gout information booklet, individualised education, and engagement of participants) in addition to the treat-to-target strategy. The comparison group was provided with a gout information booklet and was GP-led. The committee discussed whether it was the whole package of care that improves outcomes rather than the titration of ULT to achieve a target. However, the committee also acknowledged elements of the package of care, such as explaining the treat to target approach and discussing the benefits with the person would reflect current good practice and could be considered part of a treat-to-target strategy. The committee therefore did not think this to be a source of bias and had confidence in the results. It was also noted that there was a protocol adjustment for the usual care group and patients were given a financial incentive to complete the questionnaire and assessment to the 2 years.</p><p>The committee noted the second line treatment option in one of the studies was the use of either febuxostat or benzbromarone, with febuxostat being taken by more patients in the nurse-led group than in the usual care group at 2 years (14% compared to 3%). Four patients in the nurse-led group and 1 in the usual-care group received uricosurics (benzbromarone) at 2 years. This Benzbromarone is a uricosuric drug not available in the UK, unless under special arrangement for use as a urate-lowering therapy in people who are resistant to or are intolerant of allopurinol of febuxostat. The committee noted the choice of drug may be based on the clinical practice of the investigators. The committee was unclear whether this would introduce bias for the intervention arm.</p></div><div id="niceng219er10.s1.1.12.3"><h5>1.1.12.3. Benefits and harms</h5><p>The evidence showed a clinically important difference in favour of a treat-to-target management approach when compared to usual care for quality of life (SF-36 physical component at 1 year, GIS gout concern overall and unmet gout treatment need components at 1 and 2 years), frequency of flares (2 or more flares) and complications of gout (presence of tophi) at 2 years. The committee noted that there was some uncertainty around the effect size for the quality of life measures (SF-36 physical component at 1 year and GIS – gout concern overall at 1 year). There was no uncertainty found for other quality of life outcomes that showed clinical benefit.</p><p>The evidence showed a clinical harm for treat-to-target management, when compared to usual care, for frequency of flares at 1 year, however frequency of flares at 2 years showed a clinically important benefit for the treat-to-target management approach. It should be noted that the year one data included 2 studies, and at 2 years was just 1 study. The committee noted that there was some uncertainty around the effect size as the confidence interval crossed the MID threshold and there was inconsistency. The committee discussed the reasons for clinical harm at one year compared to a clinical benefit of two years. It was agreed that any increase in dosage could set off a flare so lowering serum urate can increase flares initially (the first year) but by the second year the dose would be stabilised, and the number of flares would reduce. This was particularly relevant to one study in which very few participants were given prophylaxis. The committee agreed this could have contributed to the frequency of flares in the first year. There was no evidence in the short or medium-term to assess flares at shorter time frames.</p><p>The higher number of people on second line Febuxostat (80mg up to 120mg once daily) in one study was also noted as not reflecting current practice. However, if treating to target with higher doses of allopurinol (maximum allowed dosage was 900mg) there is likely to be a higher incidence of adverse events which may lead to an increased use of Febuxostat. The committee noted that frequency of flares may be of less importance to a patient than the severity of the flare as this could have a greater impact on the person’s quality of life than someone who has mild flares, however this is difficult to quantify in a study.</p><p>The evidence suggested that there was no clinically important difference for the SF-36 physical component at 2 years (although this was very close to being clinically important) and for the SF-36 mental component at 1 year and 2 years. However, SF-36 was thought to be insensitive for musculoskeletal conditions. There were no clinically important differences at 1 year for the health assessment questionnaire (HAQ), the pain (VAS) change score, joint swelling, joint tenderness, cardiovascular adverse events, renal and urinary adverse events, gastrointestinal adverse events, allopurinol specific adverse events and adverse events. Complications of gout (presence of tophi) and resolution of measurable tophi showed no difference at 1 year; however, the treat-to-target strategy showed clinically significant less presence of tophi at 2 years. The committee noted that it is possible to see an improvement in tophi in the first year of treatment, but it may be longer for crystals to have dissolved enough for tophi to noticeably reduce in size. The committee acknowledged the similar finding for frequency of flares at 2 years, indicating the long-term effect of a treat-to-target strategy. The committee also noted one of the studies included a population with a particularly high prevalence (52%) of stage 3 CKD or greater, providing evidence of the safety and efficacy of a treat-to-target strategy in people with CKD.</p><p>Overall, the committee agreed, based on the benefits shown for quality of life outcomes and frequency of flares in the longer term, that the evidence and the consensus of the group supported a treat-to target approach.</p><div id="niceng219er10.s1.1.12.3.1"><h5>Treatment options</h5><p>The committee discussed the two different delivery methods for treat-to-target management described in the studies. One study included nurse-led care in the intervention arm and usual GP care in the comparator arm and another study used Rheumatologist-led care. The committee pointed out that in current UK practice treat-to-target is usually delivered by GPs however the committee acknowledged a treat to target management approach is uncommonly used in primary care. The nurse-led service was shown to be effective, and the committee discussed that this method of delivery could improve care for gout patients and be more efficient, because appointment times could be longer than a GP consultation allowing more time for the patient to ask questions and the nurse to provide advice and information. The committee discussed that the individualised package of care delivered by a nurse was very comprehensive, including a holistic assessment, discussion and information on gout as well as follow-up assessments and telephone contact between appointments if wanted. The committee agreed that elements of what is included in the nurse-led group, such as assessment, discussion and information about gout reflected current best practice, and it was appropriate to draw upon this evidence when considering recommendations.</p><p>Although the nurse-led delivery approach was of interest to the committee they agreed people with gout often have co-morbidities and their treatment can be more complex and would often require management by a GP.</p><p>The committee agreed a starting dose of 100mg of allopurinol is accepted practice. For people with severe CKD, usual practice would be to start at a lower dose and titration would be with smaller increments up to same serum urate target as in people without CKD. This allows the clinician to monitor for any adverse events.</p><p>The committee agreed to recommend a treat-to-target approach for patients choosing to take urate lowering therapy as the evidence and their consensus supported a treat to target approach with better outcomes for people treated in this way. When considering the recommendation the committee drew upon the body of evidence they had considered for ULT, including evidence review G on ULT for long-term management of gout and the health economic evidence analysis demonstrating cost-effectiveness. Overall, because the committee considered the strategies described within the studies broadly reflected best practice and was shown to be effective, further research evaluating different strategies was not a priority and they decided a research recommendation was not necessary.</p><p>The committee also decided to specify that treat-to-target should involve starting serum urate lowering therapy at a low dose and up-titrating according to serum urate level at monthly intervals with the aim of achieving target serum urate level. The committee based the recommendation for monitoring serum urate monthly on their clinical experience and agreed this reflected usual practice. They also noted both studies reported increasing ULT at 3–4 week intervals according to serum urate levels which indicated making a recommendation to monitor monthly was a reasonable frequency.</p></div></div><div id="niceng219er10.s1.1.12.4"><h5>1.1.12.4. Cost effectiveness and resource use</h5><p>One cost-utility analysis comparing a treat-to-target management strategy with usual care from an NHS and PSS perspective was identified for this review. This cost-utility analysis comprised of a within-trial cost effectiveness analysis up to the timepoint of 2 years and results were extrapolated for years 3, 5, and 10.</p><p>The within-trial cost effectiveness analysis was based on one of the two studies included in the clinical review (Doherty 2018) and demonstrated that treat-to-target was cost effective compared to usual care with an ICER of £5,066 per QALY. In addition, when the results were extrapolated, an ICER of £285 per QALY was observed at year 3. At years 5 and 10 treat-to-target was the dominant strategy (less costly and more effective).</p><p>The committee discussed the potential limitations with the study but concluded the data inputs used in the model were reasonable and of the best available evidence. Of note, the committee also acknowledged the high cost of a gout flare used in the analysis but noted when the cost of a gout flare was decreased to £50 the cost per QALY was £6,144, and therefore a treat-to-target management strategy was still cost effective.</p><p>The committee discussed the appropriateness of the comparators in the study noting the treat-to-target arm was representative of how a treat-to-target management strategy should be conducted in clinical practice – people should be up titrated at monthly intervals and provided information on the benefits of a treat-to-target management strategy. The committee noted that current practice varies and acknowledged care is sub-optimal, whereby the majority of people are likely to receive usual care (a non-treat-to-target management strategy). In current practice usual care consists of people being prescribed an initial dose of 100mg allopurinol, with the dose not being escalated further, or conversely, the dose is escalated beyond the starting dose, but is not sufficient to achieve target serum urate levels. Overall, based on the proportion of people receiving different doses of allopurinol and achieving target serum urate levels in the Doherty trial, the committee concluded the usual care arm was representative of current practice.</p><p>The committee also discussed the evidence presented for the treat-to-target review alongside the evidence presented in Evidence review G. Evidence review G illustrated a fixed dose of 300mg allopurinol was cost effective compared to no treatment. As detailed above, the committee concluded a comparator of 300mg is not representative of what is observed in clinical practice. However, the committee acknowledged that Evidence review G provides additional merit illustrating a treat-to-target management strategy is cost effective.</p><p>The committee acknowledged the Doherty trial did not compare a fixed dose of allopurinol to a treat-to-target management strategy. Over the study duration of the Doherty trial increasing numbers of people initiated ULT in the usual care arm (at baseline 38.93% of people were receiving ULT, at one year 46.83% of people were receiving ULT, and at two years 56.13% of people were receiving ULT). The committee acknowledged these proportions are what would be expected in clinical practice because a number of people not receiving treatment will start to experience more frequent or troublesome flares and therefore wish to initiate ULT. The committee discussed that in Doherty the proportion of people receiving each dose of allopurinol remained relatively constant over the two-year time horizon of the study. The proportion of people receiving 100mg of allopurinol was 31% at baseline and 33% in year two, the proportion of people receiving 200mg was 19% at baseline and 16% in year two, the proportion of people receiving 300mg 42% at baseline and 41% in year two, the proportion of people receiving 400mg was 7% at baseline and 8% in year two, and the proportion of people receiving ≥500mg was 1% at baseline and 2% in year two. Although the Doherty trial did not compare a specific fixed dose of allopurinol, the committee noted this is reflective of current practice – noting usual care is predominately a fixed dose strategy because the proportion of people receiving different doses of allopurinol does not change significantly. The committee concluded this demonstrated a treat-to-target management strategy was cost effective compared to no treatment because the doses were relatively constant over time.</p><p>Based on the clinical and health economic evidence presented the committee made a recommendation to treat people receiving ULT with a treat-to-target management strategy.</p><p>Due to the increased amount of people receiving a treat-to-target management strategy as a result of this recommendation there is expected to be an initial substantial resource impact. Increase in resources will be seen as a result of additional staff time required in the form of appointments for up titration and measuring of serum urate levels. Additional money will be spent because a higher proportion of people will be receiving higher doses of allopurinol and subsequently receive prophylaxis for a greater period of time. The committee did however note the benefits of a treat-to-target management strategy will likely offset the additional costs in the form of reduced flares in the long-term due to a greater proportion of people achieving target serum urate levels. The committee also acknowledged that fewer flares results in a better quality of life for people because gout flares are extremely painful and debilitating.</p></div></div><div id="niceng219er10.s1.1.13"><h4>1.1.13. Recommendations supported by this evidence review</h4><p>This evidence review supports recommendations 1.5.5.</p></div></div></div><div id="niceng219er10.rl.r1"><h2 id="_niceng219er10_rl_r1_">1.1.14. References</h2><dl class="temp-labeled-list"><dl class="bkr_refwrap"><dt>1.</dt><dd><div class="bk_ref" id="niceng219er10.ref1">Andres
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M, Sivera
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F, Falzon
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L, van der Heijde
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DM, Carmona
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L. Treatment target and followup measures for patients with gout: a systematic literature review. Journal of Rheumatology - Supplement. 2014; 92:55–62 [<a href="https://pubmed.ncbi.nlm.nih.gov/25180129" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25180129</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>2.</dt><dd><div class="bk_ref" id="niceng219er10.ref2">Arroll
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B, Bennett
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M, Dalbeth
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N, Hettiarachchi
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D, Ben
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C, Shelling
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G. More allopurinol is needed to get gout patients < 0.36 mmol/l: a gout audit in the form of a before-after trial. Journal of Primary Health Care. 2009; 1(4):315–318 [<a href="https://pubmed.ncbi.nlm.nih.gov/20690341" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 20690341</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>3.</dt><dd><div class="bk_ref" id="niceng219er10.ref3">Bai
|
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XS, Wang
|
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M, Cui
|
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LL, He
|
|
YW, Wang
|
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C, Li
|
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XD
|
|
et al
|
|
Treat-to-Target urate-lowering therapy in primary gout patients: A real-world retrospective study at a dedicated gout clinic in China. Technology and Health Care. 2021; 29(1):121–131 [<a href="https://pubmed.ncbi.nlm.nih.gov/32444582" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 32444582</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>4.</dt><dd><div class="bk_ref" id="niceng219er10.ref4">Baker
|
|
JF, Schumacher
|
|
HR, Krishnan
|
|
E. Serum uric acid level and risk for peripheral arterial disease: analysis of data from the multiple risk factor intervention trial. Angiology. 2007; 58(4):450–457 [<a href="https://pubmed.ncbi.nlm.nih.gov/17875958" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 17875958</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>5.</dt><dd><div class="bk_ref" id="niceng219er10.ref5">Beecham
|
|
J, Curtis
|
|
L. Unit costs of health and social care 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>6.</dt><dd><div class="bk_ref" id="niceng219er10.ref6">BMJ Group and the Royal Pharmaceutical Society of Great Britain. British National Formulary. Available from: <a href="https://bnf.nice.org.uk/" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">https://bnf<wbr style="display:inline-block"></wbr>​.nice.org.uk/</a> Last accessed: 17/03/2022.</div></dd></dl><dl class="bkr_refwrap"><dt>7.</dt><dd><div class="bk_ref" id="niceng219er10.ref7">Dalbeth
|
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N, Billington
|
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K, Doyle
|
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A, Frampton
|
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C, Tan
|
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P, Aati
|
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O
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et al
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Effects of allopurinol dose escalation on bone erosion and urate volume in gout: A dual-energy computed tomography imaging study within a randomized, controlled trial. Arthritis & Rheumatology. 2019; 71(10):1739–1746 [<a href="https://pubmed.ncbi.nlm.nih.gov/31081595" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31081595</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>8.</dt><dd><div class="bk_ref" id="niceng219er10.ref8">Doherty
|
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M, Jenkins
|
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W, Richardson
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H, Sarmanova
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A, Abhishek
|
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A, Ashton
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D
|
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et al
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Efficacy and cost-effectiveness of nurse-led care involving education and engagement of patients and a treat-to-target urate-lowering strategy versus usual care for gout: a randomised controlled trial. Lancet. 2018; 392(10156):1403–1412 [<a href="/pmc/articles/PMC6196879/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC6196879</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/30343856" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 30343856</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>9.</dt><dd><div class="bk_ref" id="niceng219er10.ref9">Goldfien
|
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R, Pressman
|
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A, Jacobson
|
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A, Ng
|
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M, Avins
|
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A. A pharmacist-staffed, virtual gout management clinic for achieving target serum uric acid levels: A randomized clinical trial. Permanente Journal. 2016; 20(3):15–234 [<a href="/pmc/articles/PMC4991910/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC4991910</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/27352414" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 27352414</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>10.</dt><dd><div class="bk_ref" id="niceng219er10.ref10">Kannangara
|
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DR W, Graham
|
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GG, Wright
|
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DF B, Stocker
|
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SL, Portek
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I, Pile
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KD
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et al
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Individualising the dose of allopurinol in patients with gout. British Journal of Clinical Pharmacology. 2017; 83(9):2015–2026 [<a href="/pmc/articles/PMC5555877/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC5555877</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/28417592" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 28417592</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>11.</dt><dd><div class="bk_ref" id="niceng219er10.ref11">Kim
|
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WJ, Song
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JS, Choi
|
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ST. The role of a "treat-to-target" approach in the long-term renal outcomes of patients with gout. Journal of Clinical Medicine. 2019; 8(7) [<a href="/pmc/articles/PMC6678146/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC6678146</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/31330801" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31330801</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>12.</dt><dd><div class="bk_ref" id="niceng219er10.ref12">Lim
|
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AY, Shen
|
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L, Tan
|
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CH, Lateef
|
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A, Lau
|
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TC, Teng
|
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GG. Achieving treat to target in gout: a clinical practice improvement project. Scandinavian Journal of Rheumatology. 2012; 41(6):450–457 [<a href="https://pubmed.ncbi.nlm.nih.gov/22839705" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 22839705</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>13.</dt><dd><div class="bk_ref" id="niceng219er10.ref13">Machado
|
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PM, Deodhar
|
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A. Treat-to-target in axial spondyloarthritis: gold standard or fools’ gold?
|
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Current Opinion in Rheumatology. 2019; 31(4):344–348 [<a href="https://pubmed.ncbi.nlm.nih.gov/31090589" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31090589</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>14.</dt><dd><div class="bk_ref" id="niceng219er10.ref14">Muller
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FO, Schall
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R, Groenewoud
|
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G, Hundt
|
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HK, van der Merwe
|
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JC, van Dyk
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M. The effect of benzbromarone on allopurinol/oxypurinol kinetics in patients with gout. European Journal of Clinical Pharmacology. 1993; 44(1):69–72 [<a href="https://pubmed.ncbi.nlm.nih.gov/8436158" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 8436158</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>15.</dt><dd><div class="bk_ref" id="niceng219er10.ref15">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> [<a href="https://pubmed.ncbi.nlm.nih.gov/26677490" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 26677490</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>16.</dt><dd><div class="bk_ref" id="niceng219er10.ref16">Novella-Navarro
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M, Cabrera-Alarcon
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JL, Diaz-Torne
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C, Aramburu-Munoz
|
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F, Janta
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I, Ortega de la
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OM C
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et al
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A treat-to-target approach for gout confers renoprotective effect in patients with chronic kidney disease stage 3. Rheumatology International. 2020; 40(7):1081–1087 [<a href="https://pubmed.ncbi.nlm.nih.gov/31982955" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31982955</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>17.</dt><dd><div class="bk_ref" id="niceng219er10.ref17">Organisation for Economic Co-operation and Development (OECD). Purchasing power parities (PPP). 2012. Available from: <a href="http://www.oecd.org/std/ppp" ref="pagearea=cite-ref&targetsite=external&targetcat=link&targettype=uri">http://www<wbr style="display:inline-block"></wbr>​.oecd.org/std/ppp</a> Last accessed: 17/03/2022.</div></dd></dl><dl class="bkr_refwrap"><dt>18.</dt><dd><div class="bk_ref" id="niceng219er10.ref18">Stamp
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L, Morillon
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MB, Taylor
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WJ, Dalbeth
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N, Singh
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JA, Lassere
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M
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et al
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Serum urate as surrogate endpoint for flares in people with gout: A systematic review and meta-regression analysis. Seminars in Arthritis and Rheumatism. 2018; 48(2):293–301 [<a href="https://pubmed.ncbi.nlm.nih.gov/29566967" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 29566967</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>19.</dt><dd><div class="bk_ref" id="niceng219er10.ref19">Stamp
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LK, Chapman
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PT, Barclay
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M, Horne
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A, Frampton
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C, Tan
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P
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et al
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Allopurinol dose escalation to achieve serum urate below 6 mg/dL: an open-label extension study. Annals of the Rheumatic Diseases. 2017; 76(12):2065–2070 [<a href="https://pubmed.ncbi.nlm.nih.gov/28830881" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 28830881</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>20.</dt><dd><div class="bk_ref" id="niceng219er10.ref20">Stamp
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LK, Chapman
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PT, Barclay
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M, Horne
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A, Frampton
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C, Tan
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P
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et al
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Can we predict inadequate response to allopurinol dose escalation?
|
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Analysis of a randomised controlled trial. Rheumatology. 2018; 57(12):2183–2189 [<a href="https://pubmed.ncbi.nlm.nih.gov/30107437" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 30107437</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>21.</dt><dd><div class="bk_ref" id="niceng219er10.ref21">Stamp
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LK, Chapman
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PT, Barclay
|
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M, Horne
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A, Frampton
|
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C, Tan
|
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P
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et al
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The effect of kidney function on the urate lowering effect and safety of increasing allopurinol above doses based on creatinine clearance: a post hoc analysis of a randomized controlled trial. Arthritis Research & Therapy. 2017; 19(1):283 [<a href="/pmc/articles/PMC5740867/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC5740867</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/29268756" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 29268756</span></a>]</div></dd></dl><dl class="bkr_refwrap"><dt>22.</dt><dd><div class="bk_ref" id="niceng219er10.ref22">Stamp
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LK, Chapman
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PT, Barclay
|
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ML, Horne
|
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A, Frampton
|
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C, Tan
|
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P
|
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et al
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A randomised controlled trial of the efficacy and safety of allopurinol dose escalation to achieve target serum urate in people with gout. Annals of the Rheumatic Diseases. 2017; 76(9):1522–1528 [<a href="https://pubmed.ncbi.nlm.nih.gov/28314755" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 28314755</span></a>]</div></dd></dl></dl></div><div id="appendixesappgroup1"><h2 id="_appendixesappgroup1_">Appendices</h2><div id="niceng219er10.appa"><h3>Appendix A. Review protocols</h3><p id="niceng219er10.appa.et1"><a href="/books/NBK583522/bin/niceng219er10-appa-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Review protocol for treat-to-target management</a><span class="small"> (PDF, 230K)</span></p><p id="niceng219er10.appa.et2"><a href="/books/NBK583522/bin/niceng219er10-appa-et2.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Health economic review protocol</a><span class="small"> (PDF, 136K)</span></p></div><div id="niceng219er10.appb"><h3>Appendix B. Literature search strategies</h3><ul><li class="half_rhythm"><div>What is the clinical and cost effectiveness of a ‘treat-to-target’ urate lowering management strategy compared with usual care for 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="#niceng219er10.ref15" rid="niceng219er10.ref15"><sup>15</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="niceng219er10.appb.et1"><a href="/books/NBK583522/bin/niceng219er10-appb-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">B.1. Clinical search lirerature search strategy</a><span class="small"> (PDF, 218K)</span></p><p id="niceng219er10.appb.et2"><a href="/books/NBK583522/bin/niceng219er10-appb-et2.pdf" class="bk_dwnld_icn bk_dwnld_pdf">B.2. Health Economics literature search strategy</a><span class="small"> (PDF, 168K)</span></p></div><div id="niceng219er10.appc"><h3>Appendix C. Effectiveness evidence study selection</h3><p id="niceng219er10.appc.et1"><a href="/books/NBK583522/bin/niceng219er10-appc-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (111K)</span></p></div><div id="niceng219er10.appd"><h3>Appendix D. Effectiveness evidence</h3><p id="niceng219er10.appd.et1"><a href="/books/NBK583522/bin/niceng219er10-appd-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (275K)</span></p></div><div id="niceng219er10.appe"><h3>Appendix E. Forest plots</h3><p id="niceng219er10.appe.et1"><a href="/books/NBK583522/bin/niceng219er10-appe-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">E.1. Treat-to-target versus usual care</a><span class="small"> (PDF, 126K)</span></p></div><div id="niceng219er10.appf"><h3>Appendix F. GRADE tables</h3><p id="niceng219er10.appf.et1"><a href="/books/NBK583522/bin/niceng219er10-appf-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (262K)</span></p></div><div id="niceng219er10.appg"><h3>Appendix G. Economic evidence study selection</h3><p id="niceng219er10.appg.et1"><a href="/books/NBK583522/bin/niceng219er10-appg-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (142K)</span></p></div><div id="niceng219er10.apph"><h3>Appendix H. Economic evidence tables</h3><p id="niceng219er10.apph.et1"><a href="/books/NBK583522/bin/niceng219er10-apph-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (186K)</span></p></div><div id="niceng219er10.appi"><h3>Appendix I. Health economic model</h3><p>No original economic modelling was undertaken for this review question.</p></div><div id="niceng219er10.appj"><h3>Appendix J. Excluded studies</h3><div id="niceng219er10.appj.s1"><h4>Clinical studies</h4><p id="niceng219er10.appj.et1"><a href="/books/NBK583522/bin/niceng219er10-appj-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (119K)</span></p></div><div id="niceng219er10.appj.s2"><h4>Health Economic studies</h4><p>None.</p></div></div></div></div><div class="fm-sec"><div><p>Final version</p></div><div><p>Evidence reviews underpinning recommendation 1.5.5 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: NBK583522</span><span class="label">PMID: <a href="https://pubmed.ncbi.nlm.nih.gov/36063470" title="PubMed record of this title" ref="pagearea=meta&targetsite=entrez&targetcat=link&targettype=pubmed">36063470</a></span></div></div><div class="small-screen-prev"></div><div class="small-screen-next"></div></article><article data-type="table-wrap" id="figobniceng219er10tab1"><div id="niceng219er10.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/NBK583522/table/niceng219er10.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng219er10.tab1_lrgtbl__"><table><tbody><tr><th id="hd_b_niceng219er10.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Population</th><td headers="hd_b_niceng219er10.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul><li class="half_rhythm"><div>Inclusion: adults (18 years and older) with gout</div></li><li class="half_rhythm"><div>Strata: None</div></li><li class="half_rhythm"><div>Exclusion: people with calcium pyrophosphate crystal deposition, including pseudogout</div></li></ul>
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</td></tr><tr><th id="hd_b_niceng219er10.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Intervention(s)</th><td headers="hd_b_niceng219er10.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul><li class="half_rhythm"><div>Treat-to-target management strategy using urate-lowering therapies (ULT)</div></li><li class="half_rhythm"><div>Different timing will be combined, e.g. testing every 4 weeks and testing every 8 weeks</div></li></ul>
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</td></tr><tr><th id="hd_b_niceng219er10.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Comparison(s)</th><td headers="hd_b_niceng219er10.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>Usual care</div></li><li class="half_rhythm"><div>No ULT</div></li><li class="half_rhythm"><div>ULT not using treat-to-target approach (fixed dose)</div></li></ul>
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</td></tr><tr><th id="hd_b_niceng219er10.tab1_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Outcomes</th><td headers="hd_b_niceng219er10.tab1_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul><li class="half_rhythm"><div>All outcomes are considered equally important for decision making and therefore have all been rated as critical:</div></li><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>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>frequency of flares</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>adverse events – (1) cardiovascular, (2) renal and (3) gastrointestinal (e.g. diarrhoea) (total adverse events will be reported if the specific types of adverse events are not reported)</div></li><li class="half_rhythm"><div>adverse events and complications of gout:<ul class="circle"><li class="half_rhythm"><div>Radiographic joint damage</div></li><li class="half_rhythm"><div>renal stones</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><li class="half_rhythm"><div>Timepoints: short-term (less than three months), medium-term (three to 12 months) and long-term (more than 12 months) duration.</div></li></ul></div></li></ul>
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</td></tr><tr><th id="hd_b_niceng219er10.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Study design</th><td headers="hd_b_niceng219er10.tab1_1_1_5_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul><li class="half_rhythm"><div>Randomised Controlled Trials (RCTs)</div></li><li class="half_rhythm"><div>Systematic reviews of RCTs</div></li><li class="half_rhythm"><div>If insufficient RCT evidence is available (no or little evidence for interventions/comparisons), search for non-randomised studies (prospective and retrospective cohort studies will be considered if they adjust for key confounders:<ul class="circle"><li class="half_rhythm"><div>Age</div></li><li class="half_rhythm"><div>Gender</div></li><li class="half_rhythm"><div>Published NMAs will be considered for inclusion.</div></li></ul></div></li></ul>
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</td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobniceng219er10tab2"><div id="niceng219er10.tab2" class="table"><h3><span class="label">Table 2</span><span class="title">Summary of studies included in the evidence review</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK583522/table/niceng219er10.tab2/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng219er10.tab2_lrgtbl__"><table><thead><tr><th id="hd_h_niceng219er10.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Study</th><th id="hd_h_niceng219er10.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Intervention and comparison</th><th id="hd_h_niceng219er10.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Population</th><th id="hd_h_niceng219er10.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng219er10.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Comments</th></tr></thead><tbody><tr><td headers="hd_h_niceng219er10.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Doherty 2018<a class="bibr" href="#niceng219er10.ref8" rid="niceng219er10.ref8"><sup>8</sup></a></td><td headers="hd_h_niceng219er10.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Intervention (n=255)</p>
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<p>Treat to target management plus nurse-led care(first-line treatment was oral allopurinol, started at 100 mg once per day and titrated upwards in 100 mg increments every 3–4 weeks according to serum urate concentrations, to a maximum of 900 mg once per day. As second-line options, oral febuxostat could be started at 80mg and if required increased to the maximum dose of 120 mg once per day or benzbromarone could be started at 50 mg and titrated up in 50 mg increments to a maximum of 200 mg once per day.</p>
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<p>in addition to the treat-to-target strategy:</p>
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<p>a nurse-led individualised package of care comprising of a holistic assessment, gout information booklet, individualised education, and engagement of participants by discussion of illness perceptions, and shared decision making</p>
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<p>Taking urate lowering therapy at baseline n (%): 101(40%) (Allopurinol 101(100%))</p>
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<p>Prophylaxis – 3 people received Colchicine</p>
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<p>Comparison (n=262)</p>
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<p>Usual care - Patients assigned to continue usual GP-led care were given the gout information booklet from Arthritis Research UK.</p>
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<p>Treatment of flares could be discussed by the research nurse at baseline and at yearly assessments, but if participants enquired about other aspects of management, they were advised to ask their GP.</p>
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<p>Taking urate lowering therapy at baseline n (%): 102 (39%)</p>
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<p>(Allopurinol 101 (99%); sulfinpyrazone 1 (1%))</p>
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</td><td headers="hd_h_niceng219er10.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>n=517</p>
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<p>Adult patients with diagnosis of gout.</p>
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<p>Age mean years (SD): Treat to target (Nurse led care) 62.01 (10.81); Usual care 63.69 (11.91)</p>
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<p>Gender (M/F): Nurse led care (treat to target) 229/26; Usual care 232/30</p>
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<p>Ethnicity: not reported</p>
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<p>UK</p>
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</td><td headers="hd_h_niceng219er10.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Quality of life - SF36 physical component at 1 year;</p>
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<p>Quality of life - SF36 physical component at 2 years;</p>
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<p>Quality of life - SF36 mental component at 1 year;</p>
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<p>Quality of life - SF36 mental component at 2 years;</p>
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<p>Quality of life - Gout impact scale score (GIS) – gout concern overall at 1 year;</p>
|
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<p>Quality of life - Gout impact scale score (GIS) – gout concern overall at 2 years;</p>
|
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<p>Quality of life - Gout impact scale score (GIS) – unmet gout treatment need at 1 year;</p>
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<p>Quality of life - Gout impact scale score (GIS) – unmet gout treatment need at 2 years;</p>
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<p>Frequency of flares – two or more flares at 1 year;</p>
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<p>Frequency of flares – two or more flares at 2 years;</p>
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<p>Adverse events – presence of tophi at 1 year;</p>
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<p>Adverse events – presence of tophi at 2 years.</p>
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</td><td headers="hd_h_niceng219er10.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">CKD stage 3 in treat to target group 53 (23%) and in usual care group 63 24%)</td></tr><tr><td headers="hd_h_niceng219er10.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Stamp 2017<a class="bibr" href="#niceng219er10.ref22" rid="niceng219er10.ref22"><sup>22</sup></a></td><td headers="hd_h_niceng219er10.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Intervention (n=90)</p>
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<p>Treat to target - In the dose escalation (DE) group (Treat to target), allopurinol was increased monthly until SU was <6 mg/dL on three consecutive visits or there were AEs. For example, if SU was <6 mg/dL allopurinol was not escalated but if at the following month urate was >6 mg/dL allopurinol was increased unless there was evidence of poor adherence. The dose was increased by 50 mg/d for those with CrCL <60 mL/min and 100 mg/d in those with CrCL ≥60 mL/min.</p>
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<p>Baseline Allopurinol dose mg/day n (%):</p>
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<p>100 – 200 mg 37 (41.1%)</p>
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<p>>200 – 300 mg 47(52.2%)</p>
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<p>>300 mg 7(7.7%)</p>
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<p>Baseline prophylaxis n (%):</p>
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<p>Any anti-inflammatory prophylaxis - 51 (57%)</p>
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<p>Colchicine - 34 (38%)</p>
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<p>NSAIDs 15 (17%)</p>
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<p>Prednisolone - 12 (13%)</p>
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<p>Control group (n=93)</p>
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<p>Usual care - In the control group, participants continued on the same allopurinol dose throughout the study period. Anti-inflammatory prophylaxis and treatment of gout flares were at the discretion of the investigator.</p>
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<p>Baseline allopurinol dose mg/day n (%):</p>
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<p>100 – 200 mg 31 (33.3%)</p>
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<p>>200 – 300 mg 50 (53.4%)</p>
|
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<p>>300 mg 12 (12.9%)</p>
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<p>Baseline prophylaxis n (%): Any anti – inflammatory prophylaxis – 45 (48%)</p>
|
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<p>Colchicine – 35 (38%)</p>
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<p>NSAIDs - 9 (10%)</p>
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<p>Prednisolone – 12 (13%)</p>
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</td><td headers="hd_h_niceng219er10.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>n=183</p>
|
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<p>Adult patients with diagnosis of gout.</p>
|
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<p>Age: mean years (SD): Dose escalation group (treat-to target): 59.5 (12.1), Control: 60.9 (12.8)</p>
|
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<p>Gender (M/F): Dose escalation group (treat-to-target): 82/8, Control: 78/5</p>
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<p>Ethnicity: Dose escalation group: NZ European: 41%, Maori: 32%, Pacific island: 21%, Asian: 6%, Other: 0%.</p>
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<p>Control group: NZ European: 42%, Maori: 24%, Pacific island: 29%, Asian: 4%, Other:1%.</p>
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<p>New Zealand</p>
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</td><td headers="hd_h_niceng219er10.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Quality of life – HAQ (health assessment questionnaire);</p>
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<p>Pain (VAS- change score at 12 months;</p>
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<p>Joint swelling – swollen joint count at 12 months;</p>
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<p>Joint tenderness – tender joint count at 12 months;</p>
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<p>Frequency of flares – self reported gout flares at 12 months;</p>
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<p>Adverse events – cardiovascular at 12 months;</p>
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<p>Adverse events – renal and urinary disorders at 12 months;</p>
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<p>Adverse events – gastrointestinal disorders at 12 months;</p>
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<p>Adverse events – allopurinol-specific at 12 months;</p>
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<p>Adverse events and complications of gout - complete resolution of tophi at 12 months.</p>
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</td><td headers="hd_h_niceng219er10.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Population has high prevalence of comorbid conditions, particularly CKD (52% having CrCL< 60mL/min and at least some of these having CKD stage 3 or higher) as well as severe gout (44% with tophi)</p>
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<p>Cardiovascular adverse events included: cardiac disorders, vascular disorders and venous disorders</p>
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<p>Renal and urinary adverse events included: not specified</p>
|
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<p>Gastrointestinal adverse events included: not specified</p>
|
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<p>Allopurinol -specific adverse events included: nausea/vomiting and abdominal pain</p>
|
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<p>Only the non-laboratory treatment emergent adverse events data were reported. Data on participants with at least one serious adverse event was not reported.</p>
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</td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobniceng219er10tab3"><div id="niceng219er10.tab3" class="table"><h3><span class="label">Table 3</span><span class="title">Clinical evidence summary: Treat-to-target versus usual care</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK583522/table/niceng219er10.tab3/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng219er10.tab3_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng219er10.tab3_1_1_1_1" rowspan="2" colspan="1" headers="hd_h_niceng219er10.tab3_1_1_1_1" style="text-align:left;vertical-align:bottom;">Outcomes</th><th id="hd_h_niceng219er10.tab3_1_1_1_2" rowspan="2" colspan="1" headers="hd_h_niceng219er10.tab3_1_1_1_2" style="text-align:left;vertical-align:bottom;">
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<p>N<u>o</u> of participants (studies)</p>
|
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<p>Follow up</p>
|
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</th><th id="hd_h_niceng219er10.tab3_1_1_1_3" rowspan="2" colspan="1" headers="hd_h_niceng219er10.tab3_1_1_1_3" style="text-align:left;vertical-align:bottom;">Certainty of the evidence (GRADE)</th><th id="hd_h_niceng219er10.tab3_1_1_1_4" rowspan="2" colspan="1" headers="hd_h_niceng219er10.tab3_1_1_1_4" style="text-align:left;vertical-align:bottom;">Relative effect (95% CI)</th><th id="hd_h_niceng219er10.tab3_1_1_1_5" colspan="2" rowspan="1" style="text-align:left;vertical-align:bottom;">Anticipated absolute effects</th></tr><tr><th headers="hd_h_niceng219er10.tab3_1_1_1_5" id="hd_h_niceng219er10.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk with usual care</th><th headers="hd_h_niceng219er10.tab3_1_1_1_5" id="hd_h_niceng219er10.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Risk difference with Treat to target</th></tr></thead><tbody><tr><td headers="hd_h_niceng219er10.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Quality of life SF-36 Physical component at 1 year (0–100 scale; better indicated by higher score)</td><td headers="hd_h_niceng219er10.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>517</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_niceng219er10.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">LOW<sup>a</sup><sup>,</sup><sup>b</sup><sup>,</sup><sup>e</sup></td><td headers="hd_h_niceng219er10.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean quality of life SF-36 Physical component at 1 year was 36.54</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>MD 3.92 higher</p>
|
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<p>(1.48 higher to 6.36 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng219er10.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Quality of life SF-36 Physical component at 2 years (0–100 scale; better indicated by higher score)</td><td headers="hd_h_niceng219er10.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>517</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_niceng219er10.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">LOW<sup>a</sup><sup>,</sup><sup>b</sup><sup>,</sup><sup>e</sup></td><td headers="hd_h_niceng219er10.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean quality of life SF-36 Physical component at 2 years was 37.43</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
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<p>MD 3.58 higher</p>
|
|
<p>(0.86 higher to 6.3 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng219er10.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Quality of life SF-36 mental component at 1 year (0–100 scale; better indicated by higher score)</td><td headers="hd_h_niceng219er10.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>517</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_niceng219er10.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MODERATE<sup>a</sup><sup>,</sup><sup>e</sup></td><td headers="hd_h_niceng219er10.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean quality of life SF-36 mental component at 1 year was 54.01</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MD 0.55 lower</p>
|
|
<p>(2.13 lower to 1.03 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng219er10.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Quality of life SF-36 mental component at 2 years (0–100 scale; better indicated by higher score)</td><td headers="hd_h_niceng219er10.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>517</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_niceng219er10.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MODERATE<sup>a</sup><sup>,</sup><sup>e</sup></td><td headers="hd_h_niceng219er10.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean quality of life SF-36 mental component at 2 years was 54.02</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MD 1.1 lower</p>
|
|
<p>(3.19 lower to 0.99 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng219er10.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Quality of life - Gout impact scale (GIS) - Gout concern overall - at 1 year (0–100 scale; better indicated by lower score)</td><td headers="hd_h_niceng219er10.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>517</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_niceng219er10.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">LOW<sup>a</sup><sup>,</sup><sup>b</sup><sup>,</sup><sup>e</sup></td><td headers="hd_h_niceng219er10.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean quality of life - Gout impact scale (GIS) - Gout concern overall - at 1 year was 57.79</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MD 9.01 lower</p>
|
|
<p>(13.46 lower to 4.56 lower)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng219er10.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Quality of life - Gout impact scale (GIS) - Gout concern overall - at 2 years (0–100 scale; better indicated by lower score)</td><td headers="hd_h_niceng219er10.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>517</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_niceng219er10.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MODERATE<sup>a</sup><sup>,</sup><sup>e</sup></td><td headers="hd_h_niceng219er10.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean quality of life - Gout impact scale (GIS) - Gout concern overall - at 2 years was 53.62</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MD 16.08 lower</p>
|
|
<p>(20.56 lower to 11.6 lower)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng219er10.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Quality of life - Gout impact scale (GIS) - unmet gout treatment need - at 1 year (0–100 scale; better indicated by lower score)</td><td headers="hd_h_niceng219er10.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>517</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_niceng219er10.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MODERATE<sup>a</sup><sup>,</sup><sup>e</sup></td><td headers="hd_h_niceng219er10.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean quality of life - Gout impact scale (GIS) - unmet gout treatment need - at 1 year was 36.29</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MD 10.67 lower</p>
|
|
<p>(13.86 lower to 7.48 lower)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng219er10.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Quality of life - Gout impact scale (GIS) - unmet gout treatment need - at 2 years (0–100 scale; better indicated by lower score)</td><td headers="hd_h_niceng219er10.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>517</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_niceng219er10.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MODERATE<sup>a</sup><sup>,</sup><sup>e</sup></td><td headers="hd_h_niceng219er10.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean quality of life - Gout impact scale (GIS) - unmet gout treatment need - at 2 years was 33.71</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MD 12.68 lower</p>
|
|
<p>(15.76 lower to 9.6 lower)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng219er10.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Quality of life - health assessment questionnaire (HAQ) at 1 year (0–3 scale; better indicated by lower score)</td><td headers="hd_h_niceng219er10.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>143</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_niceng219er10.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MODERATE<sup>a</sup></td><td headers="hd_h_niceng219er10.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean quality of life - health assessment questionnaire (HAQ) at 1 year was 0.51</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MD 0.11 higher</p>
|
|
<p>(0.14 lower to 0.36 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng219er10.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Pain (VAS) change score at 1 year (0–10 scale; better indicated by lower score)</td><td headers="hd_h_niceng219er10.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>143</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_niceng219er10.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MODERATE<sup>a</sup></td><td headers="hd_h_niceng219er10.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean pain (VAS) change score at 1 year was 2.04</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MD 0.11 lower</p>
|
|
<p>(0.48 lower to 0.26 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng219er10.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Joint swelling - swollen joint count at 1 year (0–3 scale; better indicated by lower score)</td><td headers="hd_h_niceng219er10.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>143</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_niceng219er10.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MODERATE<sup>b</sup></td><td headers="hd_h_niceng219er10.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean joint swelling - swollen joint count at 1 year was 1.58</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MD 0.57 lower</p>
|
|
<p>(0.93 lower to 0.21 lower)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng219er10.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Joint tenderness - tender joint count at 1 year (0–3 scale; better indicated by lower score)</td><td headers="hd_h_niceng219er10.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>143</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_niceng219er10.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">HIGH</td><td headers="hd_h_niceng219er10.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">-</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">The mean joint tenderness - tender joint count at 1 year was 2.07</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>MD 0.34 lower</p>
|
|
<p>(0.92 lower to 0.24 higher)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng219er10.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Frequency of flares 1 or more flares at 1 year (better indicated by lower score)</td><td headers="hd_h_niceng219er10.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>700</p>
|
|
<p>(2 RCTs)</p>
|
|
</td><td headers="hd_h_niceng219er10.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">VERY LOW<sup>b</sup><sup>,</sup><sup>c</sup><sup>,</sup><sup>e</sup></td><td headers="hd_h_niceng219er10.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 1.13 (0.77 to 1.66)</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">448 per 1,000</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>58 more per 1,000</p>
|
|
<p>(103 fewer to 296 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng219er10.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Frequency of flares- 2 or more flares at 2 years (better indicated by lower score)</td><td headers="hd_h_niceng219er10.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>517</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_niceng219er10.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">HIGH<sup>e</sup></td><td headers="hd_h_niceng219er10.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 0.32 (0.20 to 0.51)</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">244 per 1,000</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>166 fewer per 1,000</p>
|
|
<p>(195 fewer to 120 fewer)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng219er10.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Adverse events-cardiovascular disorders<sup>d</sup> at 1 year (better indicated by lower score)</td><td headers="hd_h_niceng219er10.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>183</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_niceng219er10.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">LOW<sup>b</sup></td><td headers="hd_h_niceng219er10.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 0.86 (0.46 to 1.60)</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">194 per 1,000</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>27 fewer per 1,000</p>
|
|
<p>(105 fewer to 116 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng219er10.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Adverse events - renal and urinary disorders at 1 year (better indicated by lower score)</td><td headers="hd_h_niceng219er10.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>183</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_niceng219er10.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">LOW<sup>b</sup></td><td headers="hd_h_niceng219er10.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Peto OR 7.73 (0.48 to 124.51)</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">0 per 1,000</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>0 fewer per 1,000</p>
|
|
<p>(0 fewer to 0 fewer)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng219er10.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Adverse events - gastrointestinal disorders at 1 year (better indicated by lower score)</td><td headers="hd_h_niceng219er10.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>183</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_niceng219er10.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">LOW<sup>b</sup></td><td headers="hd_h_niceng219er10.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 0.89 (0.51 to 1.55)</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">226 per 1,000</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>25 fewer per 1,000</p>
|
|
<p>(111 fewer to 124 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng219er10.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Adverse events - allopurinol specific disorders at 1 year (better indicated by lower score)</td><td headers="hd_h_niceng219er10.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>183</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_niceng219er10.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">LOW<sup>b</sup></td><td headers="hd_h_niceng219er10.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 0.89 (0.43 to 1.81)</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">151 per 1,000</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>17 fewer per 1,000</p>
|
|
<p>(86 fewer to 122 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng219er10.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Adverse events and complications of gout - presence of tophi at 1 year (better indicated by lower score)</td><td headers="hd_h_niceng219er10.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>517</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_niceng219er10.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">MODERATE<sup>b</sup><sup>,</sup><sup>e</sup></td><td headers="hd_h_niceng219er10.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 0.68 (0.39 to 1.21)</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">103 per 1,000</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>33 fewer per 1,000</p>
|
|
<p>(63 fewer to 22 more)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng219er10.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Adverse events and complications of gout - presence of tophi at 2 years (better indicated by lower score)</td><td headers="hd_h_niceng219er10.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>517</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_niceng219er10.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">HIGH<sup>e</sup></td><td headers="hd_h_niceng219er10.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 0.24 (0.11 to 0.54)</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">115 per 1,000</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>87 fewer per 1,000</p>
|
|
<p>(102 fewer to 53 fewer)</p>
|
|
</td></tr><tr><td headers="hd_h_niceng219er10.tab3_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Adverse events - resolution of measurable tophi at 1 year (better indicated by lower score)</td><td headers="hd_h_niceng219er10.tab3_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>75</p>
|
|
<p>(1 RCT)</p>
|
|
</td><td headers="hd_h_niceng219er10.tab3_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">LOW<sup>a</sup></td><td headers="hd_h_niceng219er10.tab3_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">RR 1.01 (0.39 to 2.62)</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">186 per 1,000</td><td headers="hd_h_niceng219er10.tab3_1_1_1_5 hd_h_niceng219er10.tab3_1_1_2_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
|
|
<p>2 more per 1,000</p>
|
|
<p>(113 fewer to 301 more)</p>
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|
</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="niceng219er10.tab3_1"><p class="no_margin">Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias</p></div></dd></dl><dl class="bkr_refwrap"><dt>b</dt><dd><div id="niceng219er10.tab3_2"><p class="no_margin">Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs. Established MIDs for SF-36 physical/mental- 3.75; GAQ - 6.5; GIS: gout concern overall – 7.2, GIS: unmet gout treatment need – 6.9, GIS: gout well-being during attack – 5.2 and GIS: gout concern during attack – 7.6; SF-6D – 0.041; MOS 20 – 20% change in scores; AIMS – 20% change in scores, HAQ – 0.22; Pain (VAS) was improvement of ≥10 points; GRADE default MIDs used for all other outcomes. For dichotomous outcomes MIDs were taken to be RRs of 0.8 and 1.25. For continuous outcomes 0.5 × baseline SD for continuous outcomes. For joint swelling the MID was 0.655, for joint tenderness the MID was 0.96. Clinical benefit or harm MCIDs: frequency of flares: 100 fewer per 1,000 patients = clinical benefit of intervention; Adverse events: 50 more per 1,000 patients = clinical harm of intervention; Renal stones: 50 more per 1,000 patients = clinical harm of intervention; tophi: 50 fewer per 1,000 patients = clinical benefit of intervention; admission: 100 fewer per 1,000 patients = clinical benefit of intervention; GP visits: 100 fewer per 1,000 patients = clinical benefit of intervention.</p></div></dd></dl><dl class="bkr_refwrap"><dt>c</dt><dd><div id="niceng219er10.tab3_3"><p class="no_margin">Downgraded by 2 increments because the point estimate varies widely across studies and I<sup>2</sup>=83%, subgroup analysis could not be performed as only 2 studies included in the analysisso a random effects model was used.</p></div></dd></dl><dl class="bkr_refwrap"><dt>d</dt><dd><div id="niceng219er10.tab3_4"><p class="no_margin">The study reported cardiac disorders, vascular disorders and venous disorders, which were combined for the analysis.</p></div></dd></dl><dl class="bkr_refwrap"><dt>e</dt><dd><div id="niceng219er10.tab3_5"><p class="no_margin">One study was treat-to-target plus nurse-led individualised care package compared to usual care (GP care).</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng219er10tab4"><div id="niceng219er10.tab4" class="table"><h3><span class="label">Table 4</span><span class="title">Health economic evidence profile: Target-to-treat management versus usual care</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK583522/table/niceng219er10.tab4/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng219er10.tab4_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng219er10.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Study</th><th id="hd_h_niceng219er10.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Applicability</th><th id="hd_h_niceng219er10.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Limitations</th><th id="hd_h_niceng219er10.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Other comments</th><th id="hd_h_niceng219er10.tab4_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Incremental cost</th><th id="hd_h_niceng219er10.tab4_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Incremental effects</th><th id="hd_h_niceng219er10.tab4_1_1_1_7" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Cost effectiveness</th><th id="hd_h_niceng219er10.tab4_1_1_1_8" rowspan="1" colspan="1" style="text-align:left;vertical-align:bottom;">Uncertainty</th></tr></thead><tbody><tr><td headers="hd_h_niceng219er10.tab4_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Doherty 2018<a class="bibr" href="#niceng219er10.ref8" rid="niceng219er10.ref8"><sup>8</sup></a>([UK])</td><td headers="hd_h_niceng219er10.tab4_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Partially applicable <sup>(a)</sup></td><td headers="hd_h_niceng219er10.tab4_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Potentially serious limitations <sup>(b)</sup></td><td headers="hd_h_niceng219er10.tab4_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul><li class="half_rhythm"><div>Within-RCT analysis (Efficacy and cost-effectiveness of nurse-led care involving education and engagement of patients and a treat-to-target urate-lowering strategy versus usual care for gout: a randomised controlled trial / Doherty 2018<a class="bibr" href="#niceng219er10.ref8" rid="niceng219er10.ref8"><sup>8</sup></a>)</div></li><li class="half_rhythm"><div>Cost-utility analysis (QALYs)</div></li><li class="half_rhythm"><div>Population: Adults with gout</div></li><li class="half_rhythm"><div>Comparators: Treat-to-target versus usual care</div></li><li class="half_rhythm"><div>ULTs in the treat-to-target arm: 84% allopurinol, 14% febuxostat, 2% other. ULTs in the usual care arm: 96% allopurinol, 3% febuxostat, 1% other</div></li><li class="half_rhythm"><div>Time horizon: 24 months (within-trial analysis), data extrapolation used to calculate outcomes at 3, 5, and 10 years</div></li></ul>
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</td><td headers="hd_h_niceng219er10.tab4_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>24 months: £84<sup>(c)</sup></p>
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<p>3 years: £10<sup>(c)</sup></p>
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<p>5 years: −£126<sup>(c)</sup></p>
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<p>10 years: −£412<sup>(c)</sup></p>
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</td><td headers="hd_h_niceng219er10.tab4_1_1_1_6" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>24 months: 0.0165 QALYs</p>
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<p>3 years: 0.036 QALYs</p>
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<p>5 years: 0.073 QALYs</p>
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<p>10 years: 0.148 QALYs</p>
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</td><td headers="hd_h_niceng219er10.tab4_1_1_1_7" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>24 months: £5,066 per QALY gained</p>
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<p>3 years: £285 per QALY gained</p>
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<p>5 years: Dominant</p>
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<p>10 years: Dominant</p>
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</td><td headers="hd_h_niceng219er10.tab4_1_1_1_8" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Probability treat-to-target cost effective (£20/£30K threshold): NR</p>
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<p>Sensitivity analyses were conducted: decreasing the cost of a gout flare, increasing nurse-time in the treat-to-target strategy, and decreasing the efficacy of the intervention. At time points 3,5, and 10 years treat-to-target was still cost effective at NICEs £20,000 threshold. The largest cost per QALY observed in these scenario analyses was at 3 years when the cost of a gout flare was decreased to £50 per flare resulting in cost per QALY of £6,144.</p>
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</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin">Abbreviations: 95% CI= 95% confidence interval; CUA= cost-utility analysis; ICER= incremental cost-effectiveness ratio; NA= not applicable; NR= not reported; QALY= quality-adjusted life years; RCT= randomised controlled trial</p></div></dd></dl><dl class="bkr_refwrap"><dt>(a)</dt><dd><div id="niceng219er10.tab4_1"><p class="no_margin">Baseline health state utilities obtained by mapping SF-36 data from the current trial</p></div></dd></dl><dl class="bkr_refwrap"><dt>(b)</dt><dd><div id="niceng219er10.tab4_2"><p class="no_margin">Method of eliciting disutility values for flares was unclear. This study was based on one single centre RCT. Unit costs were obtained from a NICE TA conducted several years ago; it is unclear what the primary sources for this analysis were and the cost of a gout flare is significantly higher compared to the estimated costs in Evidence review G (£295 compared to £27.19 – £55.60). Assumed flares observed in months 13 to 24 were applicable to the remainder of the modelling period. Minimal interpretation is provided for the rate of flares per serum urate level band. Total costs and QALYs not reported, only incremental values. No probabilistic analysis undertaken.</p></div></dd></dl><dl class="bkr_refwrap"><dt>(c)</dt><dd><div id="niceng219er10.tab4_3"><p class="no_margin">2015/16 UK pounds. Cost components incorporated: drug costs, appointment costs, cost of a gout flare, nurse training, face-to-face nurse-led appointments, laboratory tests serum urate level, glomerular filtration rate, tophi..</p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng219er10tab5"><div id="niceng219er10.tab5" class="table"><h3><span class="label">Table 5</span><span class="title">Urate-lowering therapy costs</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK583522/table/niceng219er10.tab5/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng219er10.tab5_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng219er10.tab5_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Resource</th><th id="hd_h_niceng219er10.tab5_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Cost per unit</th><th id="hd_h_niceng219er10.tab5_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Dosage</th></tr></thead><tbody><tr><td headers="hd_h_niceng219er10.tab5_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Allopurinol 100mg tablet</td><td headers="hd_h_niceng219er10.tab5_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£0.04</td><td headers="hd_h_niceng219er10.tab5_1_1_1_3" rowspan="2" colspan="1" style="text-align:center;vertical-align:top;">100mg – 900mg per day</td></tr><tr><td headers="hd_h_niceng219er10.tab5_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Allopurinol 300mg tablet</td><td headers="hd_h_niceng219er10.tab5_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£0.05</td></tr><tr><td headers="hd_h_niceng219er10.tab5_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Febuxostat 80mg tablet</td><td headers="hd_h_niceng219er10.tab5_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£0.09</td><td headers="hd_h_niceng219er10.tab5_1_1_1_3" rowspan="2" colspan="1" style="text-align:center;vertical-align:top;">80mg – 120mg per day</td></tr><tr><td headers="hd_h_niceng219er10.tab5_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Febuxostat 120mg tablet</td><td headers="hd_h_niceng219er10.tab5_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£0.87</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin">Source: British National Formulary, February 2022<a class="bibr" href="#niceng219er10.ref6" rid="niceng219er10.ref6"><sup>6</sup></a></p></div></dd></dl></dl></div></div></div></article><article data-type="table-wrap" id="figobniceng219er10tab6"><div id="niceng219er10.tab6" class="table"><h3><span class="label">Table 6</span><span class="title">Staff costs</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK583522/table/niceng219er10.tab6/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng219er10.tab6_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng219er10.tab6_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Resource</th><th id="hd_h_niceng219er10.tab6_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_niceng219er10.tab6_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Primary care Practice Nurse (Band 5), cost per hour<sup>(a)</sup></td><td headers="hd_h_niceng219er10.tab6_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£42</td></tr><tr><td headers="hd_h_niceng219er10.tab6_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">General Practitioner, cost per consultation (9.22 minutes)<sup>(a)</sup></td><td headers="hd_h_niceng219er10.tab6_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">£37</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin">Source: PSSRU 2020<a class="bibr" href="#niceng219er10.ref5" rid="niceng219er10.ref5"><sup>5</sup></a></p></div></dd></dl><dl class="bkr_refwrap"><dt>(a)</dt><dd><div id="niceng219er10.tab6_1"><p class="no_margin">Including qualification costs but excluding individual and productivity costs.</p></div></dd></dl></dl></div></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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