Diagnosis

National Clinical Guideline Centre (UK)

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National Clinical Guideline Centre (UK). Osteoarthritis: Care and Management in Adults. London: National Institute for Health and Care Excellence (UK); 2014 Feb. (NICE Clinical Guidelines, No. 177.)

A new version of this title is available

Update information: December 2020: in the recommendation on adding opioid analgesics NICE added links to other NICE guidelines and resources that support discussion with patients about opioid prescribing and safe withdrawal management. For the current recommendations, see www.nice.org.uk/guidance/CG177/chapter/recommendations.

Update information: December 2020: in the recommendation on adding opioid analgesics NICE added links to other NICE guidelines and resources that support discussion with patients about opioid prescribing and safe withdrawal management. For the current recommendations, see www.nice.org.uk/guidance/CG177/chapter/recommendations.

Osteoarthritis: Care and Management in Adults.

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5Diagnosis

5.1. Introduction

In CG59 (2008) the GDG considered the following to represent a clinician’s working diagnosis of peripheral joint osteoarthritis:

persistent joint pain that is worse with use
age 45 years old and over
morning stiffness lasting no more than half an hour.

This working diagnosis is very similar to the American College of Rheumatologists’ clinical diagnostic criteria for osteoarthritis of the knee that were designed to differentiate between an inflammatory arthritis such as rheumatoid arthritis and osteoarthritis (Altman et al. 1986).

No disagreement with this working definition was raised at consultation or publication on the last guideline or in the public consultation on the update review undertaken prior to the commissioning of this update. As this definition is in line with other international definitions, the GDG have chosen not to undertake a review on the diagnostic accuracy of this working diagnosis. However, the GDG have clarified the criteria to avoid ambiguity. The revised wording is that osteoarthritis should be diagnosed clinically without investigations if a person:

is 45 or over and
has activity-related joint pain and
has no morning joint-related stiffness, or morning stiffness that lasts no longer than 30 minutes.

The GDG generally felt that patients meeting their working diagnosis of osteoarthritis did not normally require radiological investigations but considered it important to review the available evidence in this area to identify whether there was any additional benefit to imaging patients as part of the diagnostic pathway. The clinical guideline update scope required the GDG to assess the role of imaging as part of the clinical diagnosis. The GDG considered it important to reassure clinicians that by not undertaking routine imaging in patients with a clinical diagnosis of osteoarthritis, no signs and symptoms (red flags) or serious underlying pathologies would be missed. The GDG therefore pre-specified potential signs and symptoms and underlying pathologies that they felt that missing would be of concern to clinicians and undertook a review to identify how many serious pathologies/red flag symptoms had been identified in imaging studies of osteoarthritis.

Other symptoms and examination findings that the GDG considered add to diagnostic certainty are discussed in Section 5.1.5, Recommendations and link to evidence.

The working diagnosis of osteoarthritis excludes the following joint disorders which are not addressed in these guidelines: inflammatory arthritis (including rheumatoid and psoriatic arthritis, ankylosing spondylitis, gout and reactive arthritis) and connective tissue disorder with associated arthritides. However, it is important to recognise that many patients with inflammatory arthritis have secondary osteoarthritis and that these guidelines could also apply to these patients.

5.1.1. In a person with suspected clinical OA (including knee pain) when would the addition of imaging be indicated to confirm additional or alternative diagnoses (particularly to identify red flags) such as

-: Crystal arthritis (gout or CPPD)
-: Inflammatory arthritis (including rheumatoid arthritis, psoriatic arthritis)
-: Infection
-: Cancer, usually secondary metastases?

The GDG identified signs and symptoms in a patient with suspected OA that might indicate other serious underlying pathology. The presence of these signs or symptoms (“red flags”) may warrant further investigation or referral (see table 8 for details).

Table 8

Red flags for further investigation or referral.

The GDG reviewed the literature about the use of imaging patients with signs or symptoms of other serious underlying pathology in patients with suspected OA.

The red flags identified by the GDG are listed in the table below.

Table 9

Possible serious underlying pathologies.

For full details see review protocol in Appendix C.

Table 10PICO characteristics of review question

Review Question	In a person with suspected clinical OA (including knee pain) when would the addition of imaging be indicated to confirm additional or alternative diagnoses (particularly to identify red flags) such as: Crystal arthritis (gout or CPPD) Inflammatory arthritis (including rheumatoid arthritis, psoriatic arthritis) Infection Cancer, usually secondary metastases
Population	Adults with a suspected diagnosis of OA (including knee pain)
Intervention/s	X-ray MRI Ultrasound CT Scintigraphy
Comparison/s	Clinical diagnosis + imaging Clinical diagnosis alone
Outcomes	Endpoints will be reported as per study. Sensitivity Specificity Likelihood ratio Diagnostic accuracy Other clinical management outcomes (e.g. referral)
Study design	Systematic reviews and meta-analyses RCTs Observational studies

5.1.2. Clinical evidence

This evidence review has been structured in two parts:

Part 1 will aim to look at the use of imaging in the diagnosis of OA compared to clinical diagnosis. The main focus is to explore the correlation or agreement between imaging (e.g. x-ray) and clinical diagnosis.
Part 2 aims to look at the prevalence/incidence of abnormalities detected by imaging people with OA or joint pain. So, for example, a study may be using x-rays on people with OA and has reported the incidence of different abnormalities, which are potentially warning signs or signs of serious underlying pathologies.

Evidence from these are summarised in the clinical GRADE evidence profile below. See also the study selection flow chart in Appendix D, forest plots in Appendix I, study evidence tables in Appendix G and exclusion list in Appendix J.

5.1.2.1. Part 1: The use of imaging in the diagnosis of OA compared to clinical diagnosis

Seven studies were included in this part of the review²⁰⁹^,²³⁶^,²⁴⁰^,²⁴⁵^,²⁴⁶^,³⁵⁸^,⁴⁰⁶: Two systematic reviews compared radiographic diagnostic criteria to clinical diagnostic criteria²⁴⁰^,⁴⁰⁶; one systematic review ²³⁶ and two studies published after the systematic review ²⁰⁹^,²⁴⁶ compared ultrasound (US) assessment to clinical diagnostic criteria, and two studies assessed the use of MRI in diagnosis compared to clinical examination ²⁴⁵^,³⁵⁸. The studies included in this review are summarised in table 11.

Table 11

Summary of studies included in the review (part 1).

Radiography versus clinical +/− radiographic examination

Schiphof presented the sensitivity and specificity of radiographic vs clinical and radiographic vs radiographic+clinical criteria; the details are presented in clinical evidence tables (appendix G). Two studies included in Schiphof (2008) matched our protocol ¹⁴²^,²⁵⁶

LaValley (2001) assessed the sensitivity and specificity of three different clinical assessment methods/instruments and radiographic assessment compared to radiographic assessment alone.

The radiographic criteria used in the study were: Kellgren and Lawrence score ≥ grade 2 for tibiofemoral compartment, or ≥ grade 2osteophyte or ≥ grade 2 JSN and ≥ grade 1 osteophyte for patellofemoral compartment and positive answer to the question “do you have pain on most days in either knee?”

The clinical assessment instruments used were:

Sensitive instrument: screening questions (1) pain or discomfort when walking ¼ mile and Screening question (2) how long does the stiffness take to wear off? And screening question (3) have you had knee pain on more than 2 occasions in the last year?
Specific instrument: Exam and screening question (1) pain or discomfort when walking ¼ mile and screening question 2 “has a Dr ever told you you have arthritis in your knees?”
Efficient instrument: Screening question (1) pain or discomfort when walking ¼ mile

The sensitivity and specificity ranged from 46.2% to 84.2% and 72.8 to 94.1% respectively, and the positive and negative likelihood ratios ranged from 3.1 to 7.83 and 0.28 to 0.57 respectively for clinical assessment + radiographic criteria vs radiographic assessment alone.

The study by Felson (1997) compared radiographic criteria vs radiographic + clinical criteria. The clinical criteria (reported in Schiphof 2008) were knee symptoms and crepitus on physical examination. The different radiographic+ clinical criteria were:

Kellgren-Lawrence score ≥2
Alternate radiographic definition 1: Osteophytes ≥ grade 2 or Joint Space Narrowing (JSN) ≥ grade 2 (grade 0–3) with either sclerosis, cysts or grade 1 osteophyte
Alternate radiographic definition 2: same as alternate definition 1 or osteophytes grade 1 and any sclerosis or JSN
Alternate radiographic definition 3: same as alternate definition 1 or sum of individual radiographic features ≥ grade 2

The sensitivity and specificity ranged from 59.1% to 77.4% and 37.1% to 76.6%, and the positive and negative likelihood ratios ranged from 1.23 to 2.53 and 0.53 to 0.67 respectively for radiographic criteria vs radiographic + clinical criteria.

Kinds (2011)²⁴⁰ reported that out of 39 studies, 4 (10%) reported agreement between clinical and radiological criteria for diagnosing hip and knee OA, 7 (18%) reported no agreement between clinical and radiological criteria for diagnosing hip and knee OA and 28 (72%) reported inconsistent agreement between clinical and radiological criteria for diagnosing hip and knee OA

Ultrasound (US) versus clinical examination

The results from the systematic review from Keen (2009) are presented in Table 12.

Table 13

Results from Keen (2009): agreement of US compared to clinical diagnosis.

Keen (2009)²³⁶ noted that there was no consistent relationship between clinical symptoms and US detected pathology. They also stated that there were several limitations to the data:

The definition of OA was not consistent and was not reported in 50% of the studies included in the review
There was a lack of definition of pathology and imaging appearance.

Of the two studies published after the systematic review, one reported that there was a statistically significant correlation between total ultrasound score and both VAS and Lequesne index scores²⁰⁹. The other study reported the percentage (%) agreement between US or power Doppler and clinical examination: For US compared to clinical exam there was 72.7% agreement for detecting inflammation and 62.6% agreement for detecting tenderness, for Power Doppler vs clinical exam there was 74.1% agreement for detecting inflammation and 65.3% agreement for detecting tenderness²⁴⁶

MRI versus clinical examination

Of the two studies reporting MRI vs clinical examination, one study³⁵⁸ reported the diagnoses made by the referring physician and the study physician before and after MRI, results are presented in Table 14.

Table 15

Number of diagnoses of OA/degenerative joint disease before and after MRI (Petron 2010).

Kornaat (2006)²⁴⁵ reported the association between clinical assessment and MRI findings (see Forest plot in Appendix I). There was no clear or consistent association between clinical assessment and MRI assessment in detecting any abnormality except a grade 2 or 3 effusion.

Table 16

Modified GRADE table for the use of imaging (radiography, ultrasound, MRI) compared to clinical assessment in the diagnosis of OA.

5.1.2.2. Part 2: The frequency of abnormalities detected by imaging people with OA or joint pain

Ten studies were included in this part of the review ³⁵^,⁶⁵^,¹⁰⁵^,¹²⁹^,¹⁸³^,²⁰⁹^,²⁴⁵^,²⁹⁴^,³⁰⁸^,³⁵⁸, one study was only available in abstract form ³⁰⁸. Data on the incidence of the abnormalities found on imaging have been extracted from the ten studies included in this review and are presented in Table 17.

Table 18

Summary of studies included in the review (part 2).

The studies included in the review were heterogeneous with regards to study design, population, intervention and outcomes reported:

Table 19

Results summary: abnormalities identified by imaging.

Table 20

Modified GRADE table for the use of imaging in the differential diagnosis of OA.

5.1.3. Economic evidence

Published literature

No relevant economic evaluations comparing imaging with a clinical diagnosis alone/clinical diagnosis plus imaging were identified.

Unit costs

In the absence of recent UK cost-effectiveness analysis, relevant unit costs are provided below to aid consideration of cost effectiveness.

Table 21

Imaging costs.

5.1.4. Evidence statements

Clinical

Part 1 review

Two systematic reviews reported on the use of radiographic imaging+/− clinical assessment vs clinical assessment in the diagnosis of OA.
- One study included in the systematic review reported that using clinical + radiological diagnostic criteria (reference test) compared to radiological diagnosis alone resulted in a range of sensitivities and specificities of 46.2–84.2% and 72.8–94.1% respectively and a range of positive and negative likelihood ratios of 3.1–7.86 and 0.28 – 0.57 respectively.
- Another study included in the systematic review that compared radiographic vs clinical diagnosis criteria (reference test) resulted in a range of sensitivities and specificities of 59.1–77.4% and 37.1–76.6% respectively, and a range of positive and negative likelihood ratios of 1.23–2.53 and 0.53–0.67 respectively.
- A further systematic review reported that there was agreement between radiological and clinical diagnosis in 4/39 studies, there was no agreement between radiological and clinical diagnosis in 7/39 studies and there was inconsistent agreement between radiological and clinical diagnosis in 28/39 studies
One systematic review, which included 47 studies, suggested that there was no consistent agreement between US imaging (of cartilage, tendon and ligament, cortical or synovial structures) and clinical diagnosis of OA. One small study (n=18) reported that the percentage agreement between US and clinical diagnosis was 72.7% for inflammation and 62.6% for tenderness, and the percentage agreement between Power Doppler and clinical diagnosis was 74.1% for inflammation and 65.3% for tenderness. A second study (n=82) reported that there was statistically significant agreement between both the US score, the VAS pain score and the Lequesne index score.
Two studies (n=310) suggested that there was inconsistent agreement between MRI and clinical diagnosis of OA

Part 2 review

Four studies (n=510) showed that the incidence of Baker’s cysts detected with imaging (MRI, CT, US or x-ray) was 20.8%, with a range of 3 to 46.8% [LOW QUALITY].
One study (n= 41) showed that the incidence of Rheumatoid Arthritis detected with imaging (MRI and bone scintigraphy) was 31.7%; Two studies (n=118) showed that the incidence of inflammatory arthritis was 15.7%, with a range of 9.1 to 26.8% [VERY LOW QUALITY].
One study (n=220) showed that the incidence of trochanteric bursitis or tendonitis detected with imaging (x-ray) was 10%; one study (n=101) showed that the incidence of infrapatellar bursistis and anserine tendinobursitis detected with imaging (ultrasound) was 8.6% and 6.2% respectively [LOW QUALITY].
One study (n=220) showed that the incidence of neurological disorder detected with imaging (x-ray) was 2.3% [MODERATE QUALITY].
Three studies (n=330) showed that the incidence of subchondral cysts detected with x-ray was 18.6%; the incidence detected with CT was 45% and the incidence detected with MRI was 45.3% [VERY LOW QUALITY].
Four studies (n= 510) showed that the incidence of effusion (including suprapatellar, synovial effusion and Grade 2 or 3 effusion) detected with imaging (x-ray, US or MRI) was 21.7%, with a range of 2.6 to 79% [VERY LOW QUALITY].
One study (n=82) showed that the incidence of cartilage abnormalities detected with ultrasound imaging was 75.6% [MODERATE QUALITY].
Four studies (n=330) showed that the incidence of meniscal abnormalities or injury (including meniscal lesion, tears and subluxation) detected with imaging (US and MRI) was 70%, with a range of 23 to 95% [VERY LOW QUALITY].
Three studies (n=217) showed that the incidence of ligament abnormalities or injury (including MCL or LCL grade 3 sprain, ACL or PCL oedema or sprain or complete tear) detected with MRI was 79.4%, with a range of 0.86 to 40% [LOW QUALITY].
Two studies (n=120) showed that the incidence of sclerosis (medial, lateral and patellofemoral) detected with x-ray was 58.2% (range 10 to 63%), the incidence detected with CT was 5% and the incidence detected with MRI was 15% [LOW QUALITY].
One study (n=117) showed that the incidence of synovitis detected with MRI was 1.3% [LOW QUALITY].
One study (n=210) showed that the incidence of bone marrow oedema (grade 2 or 3) detected with MRI was 17.6% % [VERY LOW QUALITY].
One study (n=100) showed that no incidences of internal derangement were detected with MRI [LOW QUALITY].
Two studies (n=177) showed that the incidence of OA or degenerative changes detected with imaging (MRI and a protocol that included static imaging and SPECT/CT) was 41.2%, with a range of 40 to 68.8% [VERY LOW QUALITY].
One study (n=77) showed that the incidence of fractures detected with an imaging protocol that included static imaging and SPECT/CT was 7.8% % [VERY LOW QUALITY].
One study (n=77) showed that the no incidences of bony metastases were detected with an imaging protocol that included static imaging and SPECT/CT [VERY LOW QUALITY].
One study (n=77) showed that the no incidences of osteomyelitis were detected with an imaging protocol that included static imaging and SPECT/CT [VERY LOW QUALITY].

Economic

No relevant economic evaluations were identified.

5.1.5. Recommendations and link to evidence

Recommendations	1. Diagnose osteoarthritis clinically without investigations if a person: is 45 or over and has activity-related joint pain and has either no morning joint-related stiffness or morning stiffness that lasts no longer than 30 minutes. [new 2014] 2. Be aware that atypical features, such as a history of trauma, prolonged morning joint-related stiffness, rapid worsening of symptoms or the presence of a hot swollen joint, may indicate alternative or additional diagnoses. Important differential diagnoses include gout, other inflammatory arthritides (for example, rheumatoid arthritis), septic arthritis and malignancy (bone pain). [new 2014]
Relative values of different outcomes	The GDG considered that the critical outcomes for decision-making were sensitivity, specificity and incidence/prevalence of abnormalities. Associations/correlations between clinical and radiological findings were also considered important to decision-making.
Trade off between clinical benefits and harms	The GDG considered that people presenting to health professionals with osteoarthritis complain of joint pain, not of radiological change. The GDG recognised that many of the studies reviewed will have only included participants with symptomatic radiological osteoarthritis and that they are inferring any positive or negative treatment effects apply equally to those with or without radiological change. The GDG felt that patients meeting the working diagnosis of osteoarthritis as stated in the above recommendation do not normally require radiological or laboratory investigations. This working diagnosis is very similar to the American College of Rheumatologists’ clinical diagnostic criteria for osteoarthritis of the knee that were designed to differentiate between an inflammatory arthritis such as rheumatoid arthritis and osteoarthritis Part 1 of this review looked at the correlation of radiographic, ultrasonograpghic and MRI diagnosis compared to a clinical assessment, and found no consistent agreement between imaging modalities and clinical diagnosis. Radiography Two systematic reviews assessing the use of radiographic imaging +/− clinical assessment reported that using clinical + radiological diagnostic criteria compared to radiological diagnosis alone resulted in a wide range of sensitivities and specificities of 46.2–84.2% and 72.8–94.1% respectively and a range of positive and negative likelihood ratios of 3.1–7.86 and 0.28 – 0.57 respectively. Ultrasonography One systematic review which included 47 studies suggested that there was no consistent agreement between US imaging (of cartilage, tendon and ligament, cortical or synovial structures) and clinical diagnosis of OA MRI Two studies suggested that there was inconsistent agreement between MRI and clinical diagnosis of OA Part 2 of this review attempted to identify the frequency of abnormalities other than OA detected by imaging people with OA, suspected OA or joint pain. Within the ten studies identified, a variety of additional or alternative diagnoses were identified including trochanteric bursitis, rheumatoid arthritis and neurological disorders. The GDG felt that most of the evidence was of very low quality and that incidences quoted were too wide ranging to recommend any imaging modality to routinely detect alternative abnormalities.
Economic considerations	The costs of the various diagnostic imaging techniques can vary from £29 (x-ray) to almost £200 depending on the type of imaging. The GDG felt that a clinical diagnosis is sufficient to diagnose OA and additional imaging procedures would increase costs with no significant benefits. Where imaging may be helpful is to confirm a differential diagnosis. Whether the addition of imaging is cost effective depends upon the sensitivity and specificity of the imaging techniques in diagnosing OA, and also upon the prevalence of the disease. In other words, the prior probability of someone having OA affects how certain you are that someone has OA when a scan indicates OA. Thus, if a clinical diagnosis is sufficient to indicate OA, then those patients for whom the clinician is not sure of the diagnosis and sends for imaging, are probably not very likely to have OA, and is incurring costs by confirming a likely diagnosis that could have been made clinically. There is utility associated with a correct diagnosis, and also disutility associated with an incorrect diagnosis. Imaging would be helpful if a differential diagnosis is being considered, and where the pre-test prevalence is not very rare. Thus this patient will experience disutility if they are diagnosed as having OA when actually it is something else, and they are missing out on treatment, which they could be benefitting from, as well as disutility from this incorrect prognosis and delayed diagnosis of the actual problem. The GDG experts advised that more MRI scans are being done than necessary, especially in those over the age of 45. This is a concern in terms of resource use because more imaging is being done without being sure of the diagnosis. The GDG felt that this should be addressed because the evidence shows that the sensitivity and specificity of imaging for unsuspected diagnoses is not high enough to use imaging where no clinical diagnosis has been made.
Quality of evidence	Part 1 of this review looked at the correlation of radiographic, ultrasonograpghic and MRI diagnosis compared to a clinical assessment, and found no consistent agreement between imaging modalities and clinical diagnosis. The quality of this evidence from systematic reviews ranged from moderate to low. Part 2 of this review attempted to identify the prevalence or incidence of abnormalities other than OA detected by imaging people with OA, suspected OA or joint pain. Within the ten studies identified a variety of additional or alternative diagnoses were identified including trochanteric bursitis, rheumatoid arthritis and neurological disorders, and may not be relevant clinically. The GDG felt that the incidence rates quoted were wide ranging and the vast majority of the evidence was of too low quality to recommend any imaging modality to routinely detect alternative abnormalities.
Other considerations	Other symptoms and examination findings that the GDG considered that add to diagnostic certainty include: Inactivity pain and stiffness, known as “gelling”. This is very common, for example after prolonged sitting, and should be distinguished from locking, which is a feature normally associated with prevention of limb straightening during gait, and suggests meniscal pathology Examination findings of crepitus or bony swelling Radiological evidence of osteoarthritis (joint space loss, osteophyte formation, subchondral bone thickening or cyst formation) Absence of clinical or laboratory evidence of inflammation such acutely inflamed joints or markers of inflammation (raised erythrocyte sedimentation rate, C-reactive protein or plasma viscosity). However, the GDG commented that additional tests should only be considered where there is an unusual presentation or an alternative diagnosis is being considered. The GDG identified a number of atypical features that might raise concern and a number of differential diagnoses that clinicians should be aware of when considering making a diagnosis of OA and chose to make a recommendation in this regard to inform an appropriate diagnosis. They did not recommend any subsequent diagnostic or treatment strategies as these would not be relevant to this guideline. With reference to recommendation 1, as outlined in the introduction to this chapter, the GDG advised that the use of the working diagnosis used in CG59 should be formalised into a recommendation for the purposes of this update. They noted that this definition is in line with other international definitions and chose not to undertake a review on the diagnostic accuracy of this working diagnosis. They asserted a thorough clinical history and appropriate examination were the most important features of an assessment to make a positive diagnosis of osteoarthritis and, from the evidence presented, the addition of investigations did not provide benefit over and above the clinical diagnosis.

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