Rheumatology

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Rheumatology 2001; 40: 896-906
© 2001 British Society for Rheumatology

Report

Outcome measures and classification criteria for the rheumatic diseases. A compilation of data from OMERACT (Outcome Measures for Arthritis Clinical Trials), ILAR (International League of Associations for Rheumatology), regional leagues and other groups

P. Brooks, M. Hochberg¹ and for ILAR and OMERACT

The University of Queensland, Edith Cavell Building, Royal Brisbane Hospital, Herston, Queensland 4029, Australia and
¹ Division of Rheumatology and Immunology, University of Maryland, Baltimore, MD 21201, USA

	Introduction

Top Introduction Outcome measures for rheumatoid... Outcome measures for... Outcome measures for ankylosing... Outcomes measures for systemic... Outcome measures for... Criteria for the classification... Behcet's disease [12] Churg-Strauss syndrome [13] Fibromyalgia [14] Giant cell arteritis [15] Gout [16] Henoch-Schonlein purpura [17] Hypersensitivity vasculitis [18] Kawasaki syndrome [19] Osteoarthritis of the hand... Osteoarthritis of the hip... Osteoarthritis of the knee... Polyarteritis nodosa [23] Polymyalgia rheumatica [24] Polymyositis and dermatomyositis... Reiter's syndrome [26] Rheumatic fever [27] Rheumatoid arthritis [28] Sjogren's syndrome [29] Spondyloarthropathies [30] Systemic lupus erythematosus... Systemic sclerosis [33] Takayasu's arteritis [34] Wegener's granulomatosis [35] Preliminary criteria for the... References

 
The International League of Associations for Rheumatology (ILAR) has been meeting with the World Health Organization (WHO) on a regular basis to discuss issues of mutual interest. Over the last few years these meetings have focused on the development of outcome measures in the rheumatic diseases, principally driven through OMERACT (Outcome Measures for Arthritis Clinical Trials). OMERACT has now held five meetings addressing a number of important areas in rheumatology, including clinical and imaging outcome measures, health economics and drug safety. The advantage of the WHO/ILAR Task Force Meeting has been to ratify these measures and allow them to be promulgated widely around the world.

This paper summarizes discussions which took place at the Sixth Joint WHO/ILAR Task Force Meeting on Rheumatic Diseases which was held in Geneva on 16 January 2000. This meeting reviewed a number of outcome measures for rheumatic diseases that had been developed over the past few years under the aegis of OMERACT. The WHO/ILAR meeting formally endorsed these outcome measures and acknowledged them as the gold standard for outcome measures in these conditions.

At the same meeting, a series of criteria for the classification of rheumatic diseases was also reviewed. These criteria have also been established through discussion by a number of different organizations, including ILAR, the American College of Rheumatology and EULAR (the European League of Associations for Rheumatology). These classification criteria have been put together by experts and have been adopted widely throughout the world. The meeting recommended that WHO/ILAR adopt these well-recognized classification criteria and encourage their use in clinical and epidemiological studies. It should be noted that classification criteria should not be used as diagnostic criteria but for the purposes of classifying patients in studies. An understanding of this concept will help in the interpretation of many clinical studies.

	Outcome measures for rheumatoid arthritis

Top Introduction Outcome measures for rheumatoid... Outcome measures for... Outcome measures for ankylosing... Outcomes measures for systemic... Outcome measures for... Criteria for the classification... Behcet's disease [12] Churg-Strauss syndrome [13] Fibromyalgia [14] Giant cell arteritis [15] Gout [16] Henoch-Schonlein purpura [17] Hypersensitivity vasculitis [18] Kawasaki syndrome [19] Osteoarthritis of the hand... Osteoarthritis of the hip... Osteoarthritis of the knee... Polyarteritis nodosa [23] Polymyalgia rheumatica [24] Polymyositis and dermatomyositis... Reiter's syndrome [26] Rheumatic fever [27] Rheumatoid arthritis [28] Sjogren's syndrome [29] Spondyloarthropathies [30] Systemic lupus erythematosus... Systemic sclerosis [33] Takayasu's arteritis [34] Wegener's granulomatosis [35] Preliminary criteria for the... References

 
The outcome measures for rheumatoid arthritis clinical trials were developed at OMERACT 1 [1] and are very similar to those developed by the ACR [2]. The recommendations for the preliminary core set were:

acute-phase reactants

disability

joint pain/tenderness

joint swelling

pain

patient global assessment

physician global assessment

radiographs for studies of 1 yr or longer.

	Outcome measures for osteoarthritis

Top Introduction Outcome measures for rheumatoid... Outcome measures for... Outcome measures for ankylosing... Outcomes measures for systemic... Outcome measures for... Criteria for the classification... Behcet's disease [12] Churg-Strauss syndrome [13] Fibromyalgia [14] Giant cell arteritis [15] Gout [16] Henoch-Schonlein purpura [17] Hypersensitivity vasculitis [18] Kawasaki syndrome [19] Osteoarthritis of the hand... Osteoarthritis of the hip... Osteoarthritis of the knee... Polyarteritis nodosa [23] Polymyalgia rheumatica [24] Polymyositis and dermatomyositis... Reiter's syndrome [26] Rheumatic fever [27] Rheumatoid arthritis [28] Sjogren's syndrome [29] Spondyloarthropathies [30] Systemic lupus erythematosus... Systemic sclerosis [33] Takayasu's arteritis [34] Wegener's granulomatosis [35] Preliminary criteria for the... References

 
These outcome measures for future phase III clinical studies in hip, knee and hand osteoarthritis were developed at OMERACT 3 and were published in the Journal of Rheumatology [3]. The core set of outcome measures in osteoarthritis should be:

pain

physical function

patient global assessment

joint imaging (using standardized methods for taking and rating radiographs, or any demonstrably superior imaging technique) for studies of 1 yr or longer.

Quality of life and/or utility measures are also strongly recommended, but further work should be carried out to assess the usefulness of biological markers, stiffness, measures of inflammation and other assessments such as performance-based measures, time to surgery, flares or analgesic consumption before they are accepted as core measures.

	Outcome measures for ankylosing spondylitis

Top Introduction Outcome measures for rheumatoid... Outcome measures for... Outcome measures for ankylosing... Outcomes measures for systemic... Outcome measures for... Criteria for the classification... Behcet's disease [12] Churg-Strauss syndrome [13] Fibromyalgia [14] Giant cell arteritis [15] Gout [16] Henoch-Schonlein purpura [17] Hypersensitivity vasculitis [18] Kawasaki syndrome [19] Osteoarthritis of the hand... Osteoarthritis of the hip... Osteoarthritis of the knee... Polyarteritis nodosa [23] Polymyalgia rheumatica [24] Polymyositis and dermatomyositis... Reiter's syndrome [26] Rheumatic fever [27] Rheumatoid arthritis [28] Sjogren's syndrome [29] Spondyloarthropathies [30] Systemic lupus erythematosus... Systemic sclerosis [33] Takayasu's arteritis [34] Wegener's granulomatosis [35] Preliminary criteria for the... References

 
This core set of endpoints in ankylosing spondylitis clinical trials was developed at OMERACT 4 and published in the Journal of Rheumatology [4]. Defined core sets have been developed for use in four settings: disease-controlling anti-rheumatic therapy (DC-ART), symptom-modifying anti-rheumatic drugs (SM-ARD) and physical therapy, and for clinical record keeping. These are as follows:

SM-ARD and physical therapy

physical function

spinal stiffness

patient global assessment

spinal mobility and pain

Clinical record keeping

add acute-phase reactants and peripheral joints/ entheses

DC-ART

add fatigue

hip radiograph

spine radiograph.

	Outcomes measures for systemic lupus erythematosus

Top Introduction Outcome measures for rheumatoid... Outcome measures for... Outcome measures for ankylosing... Outcomes measures for systemic... Outcome measures for... Criteria for the classification... Behcet's disease [12] Churg-Strauss syndrome [13] Fibromyalgia [14] Giant cell arteritis [15] Gout [16] Henoch-Schonlein purpura [17] Hypersensitivity vasculitis [18] Kawasaki syndrome [19] Osteoarthritis of the hand... Osteoarthritis of the hip... Osteoarthritis of the knee... Polyarteritis nodosa [23] Polymyalgia rheumatica [24] Polymyositis and dermatomyositis... Reiter's syndrome [26] Rheumatic fever [27] Rheumatoid arthritis [28] Sjogren's syndrome [29] Spondyloarthropathies [30] Systemic lupus erythematosus... Systemic sclerosis [33] Takayasu's arteritis [34] Wegener's granulomatosis [35] Preliminary criteria for the... References

 
A core set of outcome measures and response criteria were developed during OMERACT 4 and published in the Journal of Rheumatology [5, 6].

The core outcome domains to be measured in both randomized clinical trials and longitudinal observation studies in systemic lupus erythematosus are:

disease activity

health-related quality of life

damage

toxicity/adverse events.

	Outcome measures for osteoporosis

Top Introduction Outcome measures for rheumatoid... Outcome measures for... Outcome measures for ankylosing... Outcomes measures for systemic... Outcome measures for... Criteria for the classification... Behcet's disease [12] Churg-Strauss syndrome [13] Fibromyalgia [14] Giant cell arteritis [15] Gout [16] Henoch-Schonlein purpura [17] Hypersensitivity vasculitis [18] Kawasaki syndrome [19] Osteoarthritis of the hand... Osteoarthritis of the hip... Osteoarthritis of the knee... Polyarteritis nodosa [23] Polymyalgia rheumatica [24] Polymyositis and dermatomyositis... Reiter's syndrome [26] Rheumatic fever [27] Rheumatoid arthritis [28] Sjogren's syndrome [29] Spondyloarthropathies [30] Systemic lupus erythematosus... Systemic sclerosis [33] Takayasu's arteritis [34] Wegener's granulomatosis [35] Preliminary criteria for the... References

 
The core endpoints for osteoporosis trials were discussed at OMERACT 3 and subsequently published in the Journal of Rheumatology [7].

The outcome measures for osteoporosis trials were discussed according to two broad groupings of trials: randomized trials where prevention of rapid bone loss was the primary aim and randomized trials where prevention of fractures may be a feasible outcome because patients were already at high risk of osteoporotic fractures either on the basis of low bone mass or previous osteoporotic fracture.

Randomized trials where prevention of rapid bone loss was the primary aim
Two core outcome measures of clinical benefit were considered appropriate:

(a) bone minimum density (measured at two sites: the lumbar spine and proximal femur);

(b) biochemical markers which should include at least one resorption marker (which should be based on a urinary cross-linked excretion) and at least one formation marker.

Non-core outcome measures of clinical benefit were considered to be:

(a) fractures;

(b) quality of life;

(c) change in height (measured in a standardized manner).

Randomized trials of fracture prevention in high-risk populations
The core outcome measures of benefit were:

(a) fracture;

(b) hip and spine bone mineral density;

(c) biochemical markers;

(d) change in height.

The non-core outcome measures of benefit in these studies would include:

(a) quality of life instrument;

(b) back pain measure;

(c) economic evaluation, including health service utilization such as hospitalization, cotherapy, etc.;

(d) measure of incident falls.

It was recommended that these studies should be of 3–5 yr duration.

	Criteria for the classification of rheumatic diseases

Top Introduction Outcome measures for rheumatoid... Outcome measures for... Outcome measures for ankylosing... Outcomes measures for systemic... Outcome measures for... Criteria for the classification... Behcet's disease [12] Churg-Strauss syndrome [13] Fibromyalgia [14] Giant cell arteritis [15] Gout [16] Henoch-Schonlein purpura [17] Hypersensitivity vasculitis [18] Kawasaki syndrome [19] Osteoarthritis of the hand... Osteoarthritis of the hip... Osteoarthritis of the knee... Polyarteritis nodosa [23] Polymyalgia rheumatica [24] Polymyositis and dermatomyositis... Reiter's syndrome [26] Rheumatic fever [27] Rheumatoid arthritis [28] Sjogren's syndrome [29] Spondyloarthropathies [30] Systemic lupus erythematosus... Systemic sclerosis [33] Takayasu's arteritis [34] Wegener's granulomatosis [35] Preliminary criteria for the... References

 
Ankylosing spondylitis
The 1961 Rome criteria for ankylosing spondylitis [8]

Low back pain and stiffness for more than 3 months not relieved by rest;

Pain and stiffness of the thoracic region;

Limited motion in lumbar spine;

Limited chest expansion;

Evidence or history of iritis or its sequelae.

Requirements: either positive radiographs (bilateral SI) and one or more clinical criteria, or four out of five clinical criteria.

The 1966 New York criteria for ankylosing spondylitis [9]

(1) Presence of history of pain at dorsolumbar junction or in lumbar spine;

(2) Limitation of motion in anterior flexion, lateral flexion and extension;

(3) Limitation of chest expansion to 1 inch (2.5 cm) or less at the fourth intercostal space.

Requirements: either positive radiographs (grade 3–4 bilateral sacroiliac) and one or more clinical criteria, or grade 3–4 unilateral or grade 2 bilateral SI with clinical criterion (2) or with clinical criteria (1) and (3).

The European Spondyloarthropathy Study Group classification for spondyloarthropathy [10]

Inflammatory spinal pain

or

synovitis

   asymmetric

   predominantly in the lower limbs

and one or more of the following:

alternate buttock pain;

sacroiliitis;

enthesopathy;

positive family history;

psoriasis;

inflammatory bowel disease;

urethritis or cervicitis or acute diarrhoea occurring within 1 month before arthritis.

   Domains of the core sets for SM-ARD/physical therapy, clinical record keeping and DC-ART as endorsed by Assessment in Ankylosing Spondylitis Working Group/OMERACT/ILAR [11]
Level 1, SM-ARD/physical therapy:

physical function;

pain;

spinal mobility;

spinal stiffness;

patient global assessment.

Level 2, Clinical record keeping:

acute-phase reactants;

peripheral joints/entheses.

Level 3, DC-ART:

spine radiograph;

hip radiograph;

fatigue.

	Behçet's disease [12]

Top Introduction Outcome measures for rheumatoid... Outcome measures for... Outcome measures for ankylosing... Outcomes measures for systemic... Outcome measures for... Criteria for the classification... Behcet's disease [12] Churg-Strauss syndrome [13] Fibromyalgia [14] Giant cell arteritis [15] Gout [16] Henoch-Schonlein purpura [17] Hypersensitivity vasculitis [18] Kawasaki syndrome [19] Osteoarthritis of the hand... Osteoarthritis of the hip... Osteoarthritis of the knee... Polyarteritis nodosa [23] Polymyalgia rheumatica [24] Polymyositis and dermatomyositis... Reiter's syndrome [26] Rheumatic fever [27] Rheumatoid arthritis [28] Sjogren's syndrome [29] Spondyloarthropathies [30] Systemic lupus erythematosus... Systemic sclerosis [33] Takayasu's arteritis [34] Wegener's granulomatosis [35] Preliminary criteria for the... References

 

Criteria Definition Recurrent oral ulceration Minor aphthous, major aphthous, or herpetiform ulceration observed by physician or patient, which recurred at least three times in one 12-month period Plus two of: Recurrent genital Aphthous ulceration or scarring, observed ulceration by physician or patient Eye lesions Anterior uveitis, posterior uveitis, or cells in vitreous on slit lamp examination; or retinal vasculitis observed by ophthalmologist Skin lesions Erythema nodosum observed by physician or patient, pseudofolliculitis, or papulopustular lesions; or acneiform nodules observed by physician in post-adolescent patients not on corticosteroid treatment Positive pathergy test Read by physician at 24–48 h

Findings applicable only in the absence of other clinical explanations.

	Churg–Strauss syndrome [13]

Top Introduction Outcome measures for rheumatoid... Outcome measures for... Outcome measures for ankylosing... Outcomes measures for systemic... Outcome measures for... Criteria for the classification... Behcet's disease [12] Churg-Strauss syndrome [13] Fibromyalgia [14] Giant cell arteritis [15] Gout [16] Henoch-Schonlein purpura [17] Hypersensitivity vasculitis [18] Kawasaki syndrome [19] Osteoarthritis of the hand... Osteoarthritis of the hip... Osteoarthritis of the knee... Polyarteritis nodosa [23] Polymyalgia rheumatica [24] Polymyositis and dermatomyositis... Reiter's syndrome [26] Rheumatic fever [27] Rheumatoid arthritis [28] Sjogren's syndrome [29] Spondyloarthropathies [30] Systemic lupus erythematosus... Systemic sclerosis [33] Takayasu's arteritis [34] Wegener's granulomatosis [35] Preliminary criteria for the... References

 

Criteria Definition Asthma History of wheezing or diffuse high-pitched rales on expiration Eosinophilia Eosinophilia>10% on white blood cell differential count History of allergya History of seasonal allergy (e.g. allergic rhinitis) or other documented allergies, including food, contactants, and other, except drug allergy Mononeuropathy or Development of mononeuropathy, multi    polyneuropathy iple mononeuropathies, or polyneuropathy (i.e. glove/stocking distribution) attributable to a systemic vasculitis Pulmonary infiltrates, Migratory or transitory pulmonary infil    non-fixed trates on radiographs (not including fixed infiltrates), attributable to a systemic vasculitis Paranasal sinus History of acute or chronic paranasal    abnormality sinus pain or tenderness or radiographic opacification of the paranasal sinuses Extravascular Biopsy including artery, arteriole, or    eosinophils venule, showing accumulations of eosinophils in extravascular areas

^aHistory of allergy, other than asthma or drug-related, is included only in the tree classification criteria set and not in the traditional format criteria set, which requires four or more of the six other items listed here.

	Fibromyalgia [14]

Top Introduction Outcome measures for rheumatoid... Outcome measures for... Outcome measures for ankylosing... Outcomes measures for systemic... Outcome measures for... Criteria for the classification... Behcet's disease [12] Churg-Strauss syndrome [13] Fibromyalgia [14] Giant cell arteritis [15] Gout [16] Henoch-Schonlein purpura [17] Hypersensitivity vasculitis [18] Kawasaki syndrome [19] Osteoarthritis of the hand... Osteoarthritis of the hip... Osteoarthritis of the knee... Polyarteritis nodosa [23] Polymyalgia rheumatica [24] Polymyositis and dermatomyositis... Reiter's syndrome [26] Rheumatic fever [27] Rheumatoid arthritis [28] Sjogren's syndrome [29] Spondyloarthropathies [30] Systemic lupus erythematosus... Systemic sclerosis [33] Takayasu's arteritis [34] Wegener's granulomatosis [35] Preliminary criteria for the... References

 
History of widespread pain

Definition: Pain is considered widespread when all of the following are present: pain in the left side of the body, pain in the right side of the body, pain above the waist, and pain below the waist. In addition, axial skeletal pain (cervical spine or anterior chest or thoracic spine or low back) must be present. In this definition, shoulder and buttock pain is considered as pain for each involved. ‘Low back’ pain is considered lower segment pain.

Pain in 11 of 18 tender point sites on digital palpation
Definition: Pain, on digital palpation, must be present in at least 11 of the following 18 tender point sites:

occiput—bilateral, at the suboccipital muscle insertions;

low cervical—bilateral, at the anterior aspects of the intertransverse spaces at C5–C7;

trapezius—bilateral, at the midpoint of the upper border;

supraspinatus—bilateral, at origins, above the scapula spine near the medial border;

second rib—bilateral, at the second costochondral junctions, just lateral to the junctions on upper surfaces;

lateral epicondyle—bilateral, 2 cm distal to the epicondyles;

gluteal—bilateral, in upper outer quadrants of buttocks in anterior fold of muscle;

knee—bilateral, at the medial fat pad proximal to the joint line.

Digital palpation should be performed with an approximate force of 4 kg.

For a tender point to be considered ‘positive’ the subject must state that the palpation was painful. ‘Tender’ is not to be considered ‘painful’.

For classification purposes, patients will be said to have fibromyalgia if both criteria are satisfied. Widespread pain must have been present for at least 3 months. The presence of a second clinical disorder does not exclude the diagnosis of fibromyalgia.

	Giant cell arteritis [15]

Top Introduction Outcome measures for rheumatoid... Outcome measures for... Outcome measures for ankylosing... Outcomes measures for systemic... Outcome measures for... Criteria for the classification... Behcet's disease [12] Churg-Strauss syndrome [13] Fibromyalgia [14] Giant cell arteritis [15] Gout [16] Henoch-Schonlein purpura [17] Hypersensitivity vasculitis [18] Kawasaki syndrome [19] Osteoarthritis of the hand... Osteoarthritis of the hip... Osteoarthritis of the knee... Polyarteritis nodosa [23] Polymyalgia rheumatica [24] Polymyositis and dermatomyositis... Reiter's syndrome [26] Rheumatic fever [27] Rheumatoid arthritis [28] Sjogren's syndrome [29] Spondyloarthropathies [30] Systemic lupus erythematosus... Systemic sclerosis [33] Takayasu's arteritis [34] Wegener's granulomatosis [35] Preliminary criteria for the... References

 
The 1990 criteria for the classification of giant cell (temporal) arteritis (traditional format)

Criteria Definition (1) Age at disease Development of symptoms or findings    onset50 yr beginning at age 50 yr or older (2) New headache New onset of or new type of localized pain in the head (3) Temporal artery Temporal artery tenderness to palpation    abnormality decreased pulsation, unrelated to arteriosclerosis of cervical arteries (4) Elevated erythrocyte Erythrocyte sedimentation rate50 mm/h    sedimentation rate by the Westergren method (5) Abnormal artery Biopsy specimen with artery showing    biopsy vasculitis characterized by a predom-    inance of mononuclear cell infiltration or    granulomatous inflammation, usually with    multinucleated giant cells

For the purposes of classification, a patient shall be said to have giant cell (temporal) arteritis if at least three of these five criteria are present. The presence of any three or more criteria yields a sensitivity of 93.5% and a specificity of 91.2%.

Criteria and definitions used for the classification of giant cell (temporal) arteritis (tree format)

Criteria Definition (1) Age at disease Development of symptoms or findings    onset50 yr beginning at age 50 yr or older (2) New headachea New onset of or new type of localized pain in the head (3) Claudication of jaw, Development or worsening of fatigue or    tongue, or on discomfort in the muscles of mastication, tongue, or swallowing muscles while eating (4) Temporal artery Temporal artery tenderness to palpation    abnormality or decreased pulsation, unrelated to arter- iosclerosis of cervical arteries (5) Scalp tenderness or Development of tender areas or nodules    nodulesa over the scalp, away from the temporal artery or other cranial arteries (6) Abnormal artery Biopsy specimen with artery showing    biopsy vasculitis characterized by a predom- inance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells

^aUsed as a surrogate if artery biopsy is not available [criterion (2)] or if temporal artery abnormality is not present [criterion (5)].

	Gout [16]

Top Introduction Outcome measures for rheumatoid... Outcome measures for... Outcome measures for ankylosing... Outcomes measures for systemic... Outcome measures for... Criteria for the classification... Behcet's disease [12] Churg-Strauss syndrome [13] Fibromyalgia [14] Giant cell arteritis [15] Gout [16] Henoch-Schonlein purpura [17] Hypersensitivity vasculitis [18] Kawasaki syndrome [19] Osteoarthritis of the hand... Osteoarthritis of the hip... Osteoarthritis of the knee... Polyarteritis nodosa [23] Polymyalgia rheumatica [24] Polymyositis and dermatomyositis... Reiter's syndrome [26] Rheumatic fever [27] Rheumatoid arthritis [28] Sjogren's syndrome [29] Spondyloarthropathies [30] Systemic lupus erythematosus... Systemic sclerosis [33] Takayasu's arteritis [34] Wegener's granulomatosis [35] Preliminary criteria for the... References

 

(a) The presence of characteristic urate crystals in the joint fluid, and/or

(b) a tophus proved to contain urate crystals by chemical or polarized light microscopic means, and/or

(c) the presence of six of the 12 clinical, laboratory, and X-ray phenomena listed below:

 maximum inflammation in 1 day;

 more than one attack;

 monoarticular arthritis;

 redness;

 first metatarsophalangeal joint (MTP) pain or swelling;

 unilateral first MTP;

 unilateral tarsal;

 suspected tophus;

 hyperuricaemia;

 asymmetric swelling;

 subcortical cysts, no erosions;

 negative organisms on culture.

	Henoch–Schönlein purpura [17]

Top Introduction Outcome measures for rheumatoid... Outcome measures for... Outcome measures for ankylosing... Outcomes measures for systemic... Outcome measures for... Criteria for the classification... Behcet's disease [12] Churg-Strauss syndrome [13] Fibromyalgia [14] Giant cell arteritis [15] Gout [16] Henoch-Schonlein purpura [17] Hypersensitivity vasculitis [18] Kawasaki syndrome [19] Osteoarthritis of the hand... Osteoarthritis of the hip... Osteoarthritis of the knee... Polyarteritis nodosa [23] Polymyalgia rheumatica [24] Polymyositis and dermatomyositis... Reiter's syndrome [26] Rheumatic fever [27] Rheumatoid arthritis [28] Sjogren's syndrome [29] Spondyloarthropathies [30] Systemic lupus erythematosus... Systemic sclerosis [33] Takayasu's arteritis [34] Wegener's granulomatosis [35] Preliminary criteria for the... References

 
The 1990 criteria for the classification of Henoch–Schönlein purpura (traditional format)

Criteria Definition Palpable purpura Slightly raised ‘palpable’ haemorrhagic skin lesions, not related to thrombocytopenia Age20 yr at disease Patient 20 yr or younger at onset of first    onset symptoms Bowel angina Diffuse abdominal pain, worse after meals, or the diagnosis of bowel ischaemia, usually including bloody diarrhoea Wall granulocytes on Histological changes showing granulocytes    biopsy in the walls of arterioles or venules

For the purposes of classification, a patient shall be said to have Henoch–Schönlein purpura if at least two of these four criteria are present. The presence of any two or more criteria yields a sensitivity of 87.1% and a specificity of 87.7%.

Criteria and definitions used for the classification of Henoch–Schönlein purpura (tree format)

Criteria Definition Palpable purpura Slightly raised, ‘palpable’ haemorrhagic skin lesions; not related to thrombocyto- penia Age20 yr at disease Patient 20 yr or younger at onset of first    onset symptoms Gastrointestinal bleeding The passage of melena, grossly bloody stool, or a positive result for occult blood in stool (usually by the guaiac method) Extravascular or Histological changes showing granulo-    perivascular cytes in a perivascular cuff around arter-    granulocytes on biopsy ioles or venules, or in an extravascular location

	Hypersensitivity vasculitis [18]

Top Introduction Outcome measures for rheumatoid... Outcome measures for... Outcome measures for ankylosing... Outcomes measures for systemic... Outcome measures for... Criteria for the classification... Behcet's disease [12] Churg-Strauss syndrome [13] Fibromyalgia [14] Giant cell arteritis [15] Gout [16] Henoch-Schonlein purpura [17] Hypersensitivity vasculitis [18] Kawasaki syndrome [19] Osteoarthritis of the hand... Osteoarthritis of the hip... Osteoarthritis of the knee... Polyarteritis nodosa [23] Polymyalgia rheumatica [24] Polymyositis and dermatomyositis... Reiter's syndrome [26] Rheumatic fever [27] Rheumatoid arthritis [28] Sjogren's syndrome [29] Spondyloarthropathies [30] Systemic lupus erythematosus... Systemic sclerosis [33] Takayasu's arteritis [34] Wegener's granulomatosis [35] Preliminary criteria for the... References

 
The 1990 criteria for the classification of hypersensitivity vasculitis (traditional format)

Criteria Definition Age at disease Development of symptoms after age 16 yr    onset>16 yr Medication at disease Medication was taken at the onset of    onset symptoms that may have been a precip- itating factor Palpable purpura Slightly elevated purpuric rash over one or more areas of the skin; does not blanch with pressure and is not related to thrombocytopenia Maculopapular rash Flat and raised lesions of various sizes over one or more areas of the skin Biopsy including arteriole Histological changes showing granulo-    and venule cytes in a perivascular or extravascular location

For the purposes of classification, a patient shall be said to have hypersensitivity vasculitis if at least three of these five criteria are present. The presence of any three or more criteria yields a sensitivity of 71.0% and a specificity of 83.9%.

Criteria and definitions used for the classification of hypersensitivity vasculitis (tree format)

Criteria Definition Age at disease Development of symptoms after age 16 yr    onset>16 yr Medication at disease Medication was taken at the onset of onset symptoms that may have been a precip- itating factor Palpable purpura Slightly elevated purpuric rash over one or more areas of the skin; does not blanch with pressure and is not related to thrombocytopenia Maculopapular rash Flat and raised lesions of various sizes over one or more areas of the skin Polymorphonuclear Biopsy demonstrating granulocytes in the neutrophils in wall of a venule or arteriole vessel wall Eosinophils in biopsy Biopsy demonstrating eosinophils in a venule or arteriole at any location

	Kawasaki syndrome [19]

Top Introduction Outcome measures for rheumatoid... Outcome measures for... Outcome measures for ankylosing... Outcomes measures for systemic... Outcome measures for... Criteria for the classification... Behcet's disease [12] Churg-Strauss syndrome [13] Fibromyalgia [14]