Cover of Evidence reviews for what are the most accurate and cost-effective approaches to diagnosing gout, in particular serum urate level compared with joint aspiration?

Evidence reviews for what are the most accurate and cost-effective approaches to diagnosing gout, in particular serum urate level compared with joint aspiration?

Gout: diagnosis and management

Evidence review C

NICE Guideline, No. 219

London: National Institute for Health and Care Excellence (NICE); .
ISBN-13: 978-1-4731-4603-7
Copyright © NICE 2022.

1. Approaches to diagnosing gout

1.1. Review question: What are the most accurate and cost-effective approaches to diagnosing gout, in particular serum urate level compared with joint aspiration?

1.1.1. Introduction

In the UK, 95-99% of people with gout have their diagnosis made in primary care following an acute presentation via a detailed history and examination of the affected joint(s). Clinical diagnosis is subsequently confirmed with the use of a clinical investigation.

Currently, the investigation of choice in primary care is a serum urate level. Where there is diagnostic uncertainty, a person may be referred to rheumatology services, where in addition to serum urate levels, joint aspiration and other diagnostic imaging investigations are more likely to be performed. This evidence review evaluates the diagnostic accuracy of the different approaches to diagnosing gout.

1.1.2. Summary of the protocol

For full details see the review protocol in Appendix A.

Table 1. PICO characteristics of review question.

Table 1

PICO characteristics of review question.

1.1.3. Methods and process

This evidence review was developed using the methods and process described in Developing NICE guidelines: the manual. Methods specific to this review question are described in the review protocol in Appendix A and the methods document.

Declarations of interest were recorded according to NICE’s conflicts of interest policy.

1.1.4. Diagnostic evidence

1.1.4.1. Included studies

A search was conducted for cross-sectional studies which assess the accuracy of diagnostic approaches for identifying gout. No studies were found for clinical assessment or serum urate level. Nine studies were included in the review. Ahmad, 2016,1 Christiansen 2021,17 Elsaman 2016,24 Glazebrook 2011,31 Lamers-Karnebeck 2014,44 Loffler 2015,50 Ogdie 2017,61 Pattamapaspong 201765 and Singh 2021.75 One study included radiography, 3 studies investigated DECT and 7 studies included ultrasound. Particular ultrasound features (images produced from the ultrasound waves) are associated with gout, such as snow-storm sign, double contour (DC) sign and tophi. The sensitivity and the specificity of the ultrasound features (determined by the individual studies) were investigated.

The studies are summarised in Table 2 below. Evidence from these studies is summarised in the clinical evidence summary below in Table 3 and references in 1.1.13 References . The assessment of the evidence quality was conducted with emphasis on test sensitivity and specificity as this was identified by the committee as the primary measure in guiding decision-making and both being equally important. The committee set clinical decision thresholds as sensitivity/specificity of 0.8 above which a test would be recommended and 0.5 below which a test is of no clinical use.

1.1.4.2. Excluded studies

See the excluded studies list in Appendix I.

1.1.5. Summary of studies included in the diagnostic evidence

Table 2. Summary of studies included in the evidence review.

Table 2

Summary of studies included in the evidence review.

See Appendix D for full evidence tables

1.1.6. Summary of the diagnostic evidence

Table 3. Clinical evidence summary: diagnostic test accuracy for radiography.

Table 3

Clinical evidence summary: diagnostic test accuracy for radiography.

Table 4. Clinical evidence summary: diagnostic test accuracy for dual-energy CT (DECT).

Table 4

Clinical evidence summary: diagnostic test accuracy for dual-energy CT (DECT).

Particular features can be detected, on the images produced by the high frequency sound waves, in order to diagnose gout with ultrasound. These features, determined by the studies, included: snowstorm (ultrasound lesions with a snowstorm appearance); double contour sign (hyperechoic linear density on the surface of the articular cartilage), tophi (tophaceous deposits with a sugar lump appearance), aggregates (hyperechoic aggregates), erosions, synovial hypertrophy (abnormal hypoechoic); doppler activity, echogenic foci (floating echogenic foci in effusion fluid). This review investigated the diagnostic accuracy of the various features, or combinations of features as the person with suspected gout may have one or a few of these features.

Table 5. Clinical evidence summary: diagnostic test accuracy for Ultrasound.

Table 5

Clinical evidence summary: diagnostic test accuracy for Ultrasound.

1.1.7. Economic evidence

1.1.7.1. Included studies

No health economic studies were included.

1.1.7.2. Excluded studies

No relevant health economic studies were excluded due to assessment of limited applicability or methodological limitations.

See also the health economic study selection flow chart in Appendix F.

1.1.8. Economic model

This area was not prioritised for new cost-effectiveness analysis.

1.1.9. Unit costs

Relevant unit costs are provided below to aid consideration of cost effectiveness.

Table 4. Cost of diagnostic tests.

Table 4

Cost of diagnostic tests.

Table 5. Cost of staff time.

Table 5

Cost of staff time.

1.1.10. Evidence statements

Economic
  • No relevant economic evaluations were identified.

1.1.11. The committee’s discussion and interpretation of the evidence

1.1.11.1. The outcomes that matter most

The committee considered sensitivity and specificity would be the best outcomes for judging the diagnostic accuracy of the different diagnostic approaches. The committee set clinical decision thresholds as sensitivity/specificity of 0.8, above which a test would be recommended. This is because a high level of sensitivity is important to avoid people with gout being missed and not getting access to treatment. A high level of specificity is important to avoid people without gout being misdiagnosed as having it and being treated unnecessarily. This could lead to people without gout taking medications, with their associated harms, for a substantial period of time. Sensitivity/specificity of 0.5 was identified as the point below which a test is of no clinical use, as the results could be due to chance.

1.1.11.2. The quality of the evidence

Only one small (n=55) study was included assessing the diagnostic accuracy of radiography, this was graded low. Three studies assessed the diagnostic accuracy of Dual energy CT (DECT), and although meta-analysed there were few participants (n=134) included. There was also inconsistency and imprecision, with an overall very low-quality grading so there was low confidence in the results. Most of the studies (n=7) included in the review assessed the accuracy of ultrasonography. A variety of signs associated with gout that could be identified by the ultrasonography were reported across the studies. These signs included DC sign, tophi, aggregates, erosions, synovial hypertrophy, doppler activity, echogenic foci, snowstorm and combinations of these. The number of signs meant the evidence was disparate. The committee thought that any of these features can be seen on ultrasound when looking for gout, however not all these features will be seen in each patient, and it is more likely to be a combination of some of them. The committee felt that studies should have looked at all of the established features for diagnosing gout on ultrasound, but most did not. The quality of the evidence assessing ultrasound varied from very low to high.

There were no studies available for clinical assessment or serum urate levels, or both combined for diagnosing gout.

1.1.11.3. Benefits and harms

There was no evidence for clinical assessment of the person with suspected gout, or for serum urate level testing or both combined. The committee considered the combination of clinical assessment and serum urate testing to be the most commonly used means of diagnosing gout, as most people with gout present to and are diagnosed in primary care.

Even though there was no evidence for the diagnostic accuracy of these, the committee agreed in their experience a combination of clinical assessment and serum urate testing is an effective and accessible method of diagnosing gout, providing that practitioners have the knowledge of the signs and symptoms to look out for. See evidence review B for further information on signs and symptoms. The committee agreed if a person presents with typical features of gout, such as rapid onset of severe pain, redness and swelling in the big toe or tophi, it would normally be unnecessary to carry out further tests other than measuring serum urate which should always be carried out to confirm hyperuricaemia. Therefore, the committee decided to recommend clinical assessment and serum urate testing initially when gout is suspected. As this is usual, good practice a research recommendation was not thought necessary.

Joint aspiration of synovial fluid analysis is considered to be the gold standard for diagnosing gout and is typically carried out when there is diagnostic uncertainty after clinical assessment and serum urate level measurement. A definitive diagnosis of gout can be made if urate crystals are observed in the synovial fluid or tophi, but this procedure is not generally indicated unless a diagnosis of gout is in doubt or infection is suspected. Joint aspiration is not a simple option and is rarely conducted in primary care because practitioners may not have the necessary expertise to carry out the procedure, and also because the samples need to be analysed quickly and protected from light to prevent deterioration. Joint aspiration of synovial fluid is therefore usually carried out in secondary care. In addition, the committee noted any decision to undertake this procedure is dependent on the joint affected, because if the affected joint is small, it may not be possible to aspirate.

Where there is uncertainty in the diagnosis after clinical assessment and urate testing, joint aspiration of synovial fluid should be undertaken to confirm or refute the diagnosis and the committee made a recommendation to reflect this. However, the committee agreed that if this was not possible, such as where the joint is too small to aspirate, then imaging modalities could be considered. There was very high specificity (1.0) for radiography (plain X-ray), with no misdiagnosis of gout when compared to those identified by joint aspiration of synovial fluid. However, the sensitivity was low which means that many existing cases did not have radiographic features of gout and were missed. The committee acknowledged radiography is often the first choice to diagnose gout because it is easily accessible, and quick to undertake saving time in obtaining a result. However, because the sensitivity is poor this could lead to inefficiencies if a negative result would require further investigation. If radiography (plain x-ray) results are negative ultrasound is commonly used to confirm the diagnosis.

Dual energy CT (DECT) was found to be highly sensitive (0.95), and the specificity almost reached the 0.80 threshold (0.78), therefore the committee agreed this appeared a good alternative when joint aspiration of synovial fluid was not possible. However, the committee noted the quality of the evidence was very low and included only three small studies. The committee commented that there is very limited access to DECT in current practice. It is only available in secondary care and even then, access is limited due to lack of availability.

The studies assessing ultrasound reported a variety of signs associated with gout. These signs had varying sensitivity and specificity. As there were so many different signs with a range of quality the committee found this evidence difficult to interpret for the overall benefit of ultrasound in diagnosing gout. However, the committee agreed that in their experience ultrasound is useful in some settings, especially where DECT is not available. Ultrasound is more sensitive than plain X-ray. It has better diagnostic ability to confirm or refute the diagnosis. Similarly, to DECT access to joint ultrasound is limited, and typically only available in specialist MSK radiology services.

There was not an overwhelming confidence in the results or convincing case for one imaging modality over another, and in the committee’s experience some may be more available depending on the healthcare/hospital settings, therefore they agreed to recommend all as options for the diagnosis of gout.

1.1.11.4. Cost effectiveness and resource use

No economic evaluations were identified for this review question. Unit costs were presented to aid consideration of cost effectiveness.

The committee discussed the clinical evidence and unit costs presented noting no clinical evidence was identified for diagnosing gout through history and examination assessment and serum urate level testing. The committee noted than in clinical practice gout is commonly diagnosed in primary care. However, if after assessment the diagnosis remains uncertain, the person in question will be referred to rheumatology services. The committee noted that in current practice 1% - 5% of people with gout are referred to rheumatology with around 50% of these people being referred due to diagnostic uncertainty. The committee estimated that approximately two-thirds of people that are referred to rheumatology because of diagnostic uncertainty will have obtained a partial diagnosis of gout prior to referral.

Gout is typically diagnosed in general practice by taking a detailed history and physical examination and taking a serum urate level test (blood test) to measure serum urate concentrations. When there is diagnostic uncertainty joint aspiration can be undertaken. However, joint aspiration is rarely conducted in primary care because the aspirated samples need to be tested quickly and protected from light to ensure effective sample testing. In addition, in current practice, most GP practices only have samples collected once daily. Therefore, people with suspected gout need to have their joint aspirated close to the time of collections to ensure effective sample testing. Effective collection of primary care aspirated samples is also more challenging in rural settings because of the duration of time it takes for samples to reach testing facilities.

Joint aspiration is therefore more commonly performed in specialist musculoskeletal settings when the diagnosis of gout remains uncertain. The committee noted that joint aspiration is the most effective test to diagnose gout when there is diagnostic uncertainty. Therefore, upon referral to specialist settings, joint aspiration should be conducted if the affected joint is of sufficient size.

In instances where joint aspiration cannot be conducted (for example, because the affected joint is too small), or the diagnosis of gout remains uncertain, diagnostic imaging can be used to diagnose gout. X-ray can be used to detect any long-term damage in the affected joint(s) and rule out other diagnoses. The committee noted that DECT has good sensitivity and specificity to confirm or exclude a diagnosis of gout, but its availability is limited in current UK clinical practice. Ultrasound is more likely to be available, if required, to aid in the diagnosis of gout.

The recommendations made by the committee are reflective of current practice and therefore are not expected to result in a substantial resource impact.

1.1.12. Recommendations supported by this evidence review

This evidence review supports recommendations 1.1.6 to 1.1.8.

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Appendices

Appendix B. Literature search strategies

  • What are the most accurate and cost-effective approaches to diagnosing gout, in particular serum urate level compared with joint aspiration?

The literature searches for this review are detailed below and complied with the methodology outlined in Developing NICE guidelines: the manual.54

For more information, please see the Methodology review published as part of the accompanying documents for this guideline.

B.1. Clinical search literature search strategy (PDF, 305K)

B.2. Health Economics literature search strategy (PDF, 301K)

Appendix D. Diagnostic evidence

Download PDF (415K)

Appendix E. Forest plots

E.1. Coupled sensitivity and specificity forest plots (PDF, 373K)

E.2. ROC curves (PDF, 305K)

Appendix F. Economic evidence study selection

Figure 29. Flow chart of health economic study selection for the guideline (PDF, 281K)

Appendix G. Economic evidence tables

None.

Appendix H. Health economic model

No original economic modelling was undertaken for this review question.

Appendix I. Excluded studies

Clinical studies

Download PDF (265K)

Health Economic studies

None.