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] 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

 
Principal symptoms
Fever lasting from 1 to 2 weeks and not responding to antibiotics

Bilateral congestion of ocular conjunctivae

Changes in lips and oral cavity:

dryness, redness and fissuring of lips;

protuberance of tongue papillae (strawberry tongue);

diffuse reddening of oral and pharyngeal mucosa.

Changes in peripheral extremities:

reddening of palms and soles (initial stage);

indurative oedema (initial stage);

membranous desquamation from fingertips (convalescent stage).

Polymorphous exanthema of body trunk without vesicles or crusts

Acute non-purulent swelling of cervical lymph nodes of 1.5 cm or more in diameter

Other significant symptoms or findings
Carditis, especially myocarditis and pericarditis

Diarrhoea

Arthralgia or arthritis

Proteinuria and increase of leucocytes in urine sediment

Changes in blood tests:

leucocytosis with shift to the left;

slight decrease in erythrocyte and haemoglobin levels;

increased erythrocyte sedimentation rate;

positive C-reactive protein;

increased ₂-globulin;

negative anti streptolysin-O titre

Changes occasionally observed:

aseptic meningitis;

mild jaundice or slight increase in serum transaminase

	Osteoarthritis of the hand [20]

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

 
Classification criteria for osteoarthritis of the hand (traditional format)
Hand pain, aching, or stiffness and three or four of the following features:

hard tissue enlargement of two or more of 10 selected joints;

hard tissue enlargement of two or more distal interphalangeal joints;

fewer than three swollen metacarpophalangeal (MCP) joints;

deformity of at least one of 10 selected joints.

The 10 selected joints are the second and third distal interphalangeal, the second and third proximal interphalangeal (PIP), and the first carpometacarpal joints of both hands. This classification method yields a sensitivity of 94% and a specificity of 87%.

	Osteoarthritis of the hip [21]

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

 
Combined clinical (history, physical examination, laboratory) and radiographic classification criteria for osteoarthritis of the hip (traditional format)
Hip pain and

at least two of the following three features:

erythrocyte sedimentation rate < 20 mm/h;

radiographic femoral or acetabular osteophytes;

radiographic joint space narrowing (superior, axial, and/or medial).

This classification method yields a sensitivity of 89% and a specificity of 91%.

Combined clinical (history, physical examination, laboratory) and radiographic classification criteria for osteoarthritis of the hip (classification tree format)
Hip pain and

Femoral and/or acetabular osteophytes on radiograph or

Erythrocyte sedimentation rate 20 mm/h and

Axial joint space narrowing on radiograph

This classification method yields a sensitivity of 91% and a specificity of 89%.

	Osteoarthritis of the knee [22]

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 for the classification of idiopathic osteoarthritis of the knee

Clinical and laboratory Clinical and radiographic Clinicala Knee pain + Knee pain + Knee pain + at least five of nine: at least one of three: at least three of six: age>50 yr age>50 yr age>50 yr stiffness<30 min stiffness<30 min stiffness<30 min crepitus crepitus + crepitus bony tenderness osteophytes bony tenderness bony enlargement bony enlargement no palpable warmth no palpable warmth ESR<40 mm/h RF<1:40 SF OA 92% sensitive 91% sensitive 95% sensitive 75% specific 86% specific 69% specific

ESR, erythrocyte sedimentation rate (Westergren); RF, rheumatoid factor; SF OA, synovial fluid signs of osteoarthritis (clear, viscous, or white blood cell count<2000/mm³).

^aAn alternative for the clinical category would be four of six, which is 85% sensitive and 89% specific.

	Polyarteritis nodosa [23]

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 polyarteritis nodosa (traditional format)

Criteria Definition Weight loss4 kg Loss of 4 kg or more of body weight since illness began, not due to dieting or other factors Livedo reticularis Mottled reticular pattern over the skin of portions of the extremities or torso Testicular pain or Pain or tenderness of the testicles, not due    tenderness to infection, trauma, or other causes Myalgias, weakness, or Diffuse myalgias (excluding shoulder and    leg tenderness hip girdle) or weakness of muscles or tenderness of leg muscles Mononeuropathy or Development of mononeuropathy, multi-    polyneuropathy ple mononeuropathies, or polyneuropathy Diastolic blood pressure Development of hypertension with diasto-    >90 mm Hg lic blood pressure higher than 90 mm Hg Elevated BUN or Elevation of BUN>40 mg/dl or creatinine    creatinine >1.5 mg/dl, not due to dehydration or obstruction Hepatitis B virus Presence of hepatitis B surface antigen or antibody in serum Arteriographic Arteriogram showing aneurysms or occlu-    abnormality sions of the visceral arteries, not due to arteriosclerosis, fibromuscular dysplasia, or other non-inflammatory causes Biopsy of small or Histological changes showing the presence    medium-sized of granulocytes or granulocytes and    artery containing mononuclear leucocytes in the artery wall PMN

BUN, blood urea nitrogen; PMN, polymorphonuclear neutrophils.

For classification purposes, a patient shall be said to have polyarteritis nodosa if at least three of these 10 criteria are present. The presence of any three or more criteria yields a sensitivity of 82.2% and a specificity of 86.6%.

	Polymyalgia rheumatica [24]

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

 
Characteristics
Shoulder pain and/or stiffness bilaterally

Onset of illness of <2 weeks’ duration (refers to time  taken for symptoms to reach their full-blown picture)

Initial erythrocyte sedimentation rate 40 mm/h

Morning stiffness duration >1 h

Age >65 yr

Depression and/or loss of weight

Upper arm tenderness bilaterally

	Polymyositis and dermatomyositis [25]

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

(1) Skin lesions:

(a) heliotrope rash (red purple erythema on the upper palpebra);

(b) Gottron's sign (red purple keratotic, atrophic erythema, or macules on the extensor surface of finger joints);

(c) erythema on the extensor surface of extremity joints: slightly raised red purple erythema over elbows or knees.

(2) Proximal muscle weakness (upper or lower extremity and trunk).

(3) Elevated serum creatine kinase or aldolase level.

(4) Muscle pain on grasping or spontaneous pain.

(5) Myogenic changes on EMG (short duration, polyphasic motor unit potentials with spontaneous fibrillation potentials).

(6) Positive anti-Jo-1 (histadyl tRNA synthetase) antibody.

(7) Non-destructive arthritis or arthralgias.

(8) Systemic inflammatory signs (fever: more than 37°C at axilla, elevated serum C-reactive protein level or accelerated erythrocyte sedimentation rate of more than 20 mm/h by the Westergren method).

(9) Pathological findings compatible with inflammatory myositis (inflammatory infiltration of skeletal muscle with degeneration or necrosis of muscle fibres; active phagocytosis, central nuclei, or evidence of active regeneration may be seen).

A patient is said to have dermatomyositis if at least one item from (1) and at least four items from (2) to (9) are present. The sensitivity is 94.1% (127/135), and the specificity of skin lesions against systemic lupus erythematosus and systemic sclerosis is 90.3% (214/237). A patient is said to have polymyositis if at least four items from (2) to (9) are present. The sensitivity is 98.9% (180/182) and the specificity of polymyositis and dermatomyositis against all control diseases combined is 95.2% (373/392).

	Reiter's syndrome [26]

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

 
Percentage sensitivity and specificity of various criteria for typical Reiter's syndrome (initial episode)

Method of classification Sensitivity Specificity Episode of arthritis of more than 84.3% (70/83) 98.2% (163/166)    1 month with urethritis    and/or cervicitis Episode of arthritis of more than 85.5% (71/83) 96.4% (160/166)    1 month and either urethritis    or cervicitis, or bilateral    conjunctivitis Episode of arthritis, conjunctivitis, 50.6% (42/83) 98.8% (164/166) and urethritis Episode of arthritis of more than    1 month, conjunctivitis, and urethritis

The numbers in parentheses indicate the number of patients correctly classified/the number tested.

	Rheumatic fever [27]

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

 
Guidelines for the diagnosis of an initial attack of rheumatic fever (Jones criteria, 1992 update)
Major manifestations

Carditis

Polyarthritis

Chorea

Erythema marginatum

Subcutaneous nodules

Minor manifestations
Clinical findings:

arthralgia;

fever.

Laboratory findings:

elevated acute-phase reactants

erythrocyte sedimentation rate

C-reactive protein

prolonged PR interval

Supporting evidence of antecedent group A streptococcal infections

Positive throat culture or rapid streptococcal antigen test

Elevated or rising streptococcal antibody titre

If supported by evidence of preceding group A streptococcal infection, the presence of two major manifestations or of one major and two minor manifestations indicates a high probability of acute rheumatic fever.

	Rheumatoid arthritis [28]

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 1987 revised criteria for the classification of rheumatoid arthritis (traditional format)

Criteria Definition (1) Morning stiffness Morning stiffness in and around the joints, lasting at least 1 h before maximal improvement (2) Arthritis of three or more joint areas At least three joint areas simultaneously have had soft tissue swelling or fluid (not bony overgrowth alone) observed by a physician. The 14 possible areas are right or left proximal interphalangeal (PIP), MCP, wrist, elbow, knee, ankle, and MTP joints (3) Arthritis of hand joints At least one area swollen (as defined above) in a wrist, MCP, or PIP joint (4) Symmetric arthritis Simultaneous involvement of the same joint areas [as defined in (2)] on both sides of the body (bilateral involvement of PIPs, MCPs, or MTPs is acceptable without absolute symmetry) (5) Rheumatoid nodules Subcutaneous nodules, over bony prominences, or extensor surfaces, or in juxta-articular regions, observed by a physician (6) Serum rheumatoid factor Demonstration of abnormal amounts of serum rheumatoid factor by any method for which the result has been positive in<5% of normal control subjects (7) Radiographic changes Radiographic changes typical of rheumatoid arthritis on posteroanterior hand and wrist radiographs, which must include erosions or unequivocal bony decalcification localized in or most marked adjacent to the involved joints (osteoarthritis changes alone do not qualify)

For classification purposes, a patient shall be said to have rheumatoid arthritis if he/she has satisfied at least four of these seven criteria. Criteria (1)–(4) must have been present for at least 6 weeks. Patients with two clinical diagnoses are not excluded. Designation as classic, definite, or probable rheumatoid arthritis is not to be made.

	Sjögren's syndrome [29]

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

 
Preliminary criteria for the classification of Sjögren's syndrome
Ocular symptoms

Definition: a positive response to at least one of the following three questions:

(a) Have you had daily, persistent, troublesome dry eyes for more than 3 months?

(b) Do you have a recurrent sensation of sand or gravel in the eyes?

(c) Do you use tear substitutes more than three times a day?

Oral symptoms

Definition: a positive response to at least one of the following three questions:

(a) Have you had a daily feeling of dry mouth for more than 3 months?

(b) Have you had recurrent or persistently swollen salivary glands as an adult?

(c) Do you frequently drink liquids to aid in swallowing dry foods?

Ocular signs

Definition: objective evidence of ocular involvement, determined on the basis of a positive result on at least one of the following two tests:

(a) Schirmer-1 test (5 mm in 5 min);

(b) Rose Bengal score (4, according to the van Bijsterveld scoring system).

Histopathological features

Definition: focus score 1 on minor salivary gland biopsy (focus defined as an agglomeration of at least 50 mononuclear cells; focus score defined as the number of foci in 4 mm² of glandular tissue).

Salivary gland involvement

Definition: objective evidence of salivary gland involvement, determined on the basis of a positive result on at least one of the following three tests:

(a) Salivary scintigraphy;

(b) Parotid sialography;

(c) Unstimulated salivary flow (1.5 ml in 15 min).

Autoantibodies

Definition: presence of at least one of the following serum autoantibodies:

(a) Antibodies to Ro/SS-A or La/SS-B antigens;

(b) Antinuclear antibodies;

(c) Rheumatoid factor.

Exclusion criteria: pre-existing lymphoma, acquired immunodeficiency syndrome, sarcoidosis, or graft-vs-host disease.

	Spondyloarthropathies [30]

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

 
Inflammatory spinal pain or synovitis

asymmetric or predominantly

in the lower limbs

and one or more of the following:

positive family history;

psoriasis;

inflammatory bowel disease;

urethritis, cervicitis, or acute diarrhoea within 1 month before arthritis;

buttock pain alternating between right and left gluteal areas;

enthesopathy;

sacroiliitis.

	Systemic lupus erythematosus [31, 32]

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 1982 revised criteria for the classification of systemic lupus erythematosus

Criteria Definition Malar rash Fixed erythema, flat or raised, over the malar eminences, tending to spare the nasolabial folds Discoid rash Erythematous raised patches with adherent keratotic scaling and follicular plugging; atrophic scarring may occur in older lesions Photosensitivity Skin rash as a result of unusual reaction to sunlight, by patient history or physician observation Oral ulcers Oral or nasopharyngeal ulceration, usually painless, observed by a physician Arthritis Non-erosive arthritis involving two or more peripheral joints, characterized by tenderness, swelling, or effusion Serositis (a) Pleuritis: convincing history of pleuritic pain or rub head by a physician or evidence of pleural effusion; or (b) Pericarditis: documented by ECG or rub or evidence of pericardial effusion Renal disorder (a) Persistent proteinuria greater than 0.5 g/day or greater than 3+ if quantitation not performed; or (b) Cellular casts: may be red cell, haemoglobin, granular, tubular, or mixed Neurological (a) Seizures: in the absence of offending    disorder drugs or known metabolic derangements; e.g. uraemia, ketoacidosis, or electrolyte imbalance; or (b) Psychosis: in the absence of offending drugs or known metabolic derangements, e.g. uraemia, ketoacidosis, or electrolyte imbalance Haematological (a) Haemolytic anaemia with reticulo    disorder cytosis; or (b) Leucopenia: less than 4.00/mm3 total on two or more occasions; or (c) Lymphopenia: less than 1.55/mm3 on two or more occasions; or (d) Thrombocytopenia: less than 100 000/mm3 in the absence of offending drugs Immunological disorder (modified (a) Anti-DNA: antibody to native DNA in    disorder (modified abnormal titre; or    1997 [32]) (b) Anti-Sm: presence of antibody to Sm nuclear antigen; or (c) Positive finding of antiphospholipid antibodies based on: (1) an abnormal serum level of IgG or IgM anticardiolipin antibodies; (2) a positive test result for lupus anticoagulant using a standard method; or (3) a false-positive serological test for syphilis known to be positive for at least 6 months and confirmed by Treponema pallidum immobilization or fluorescent treponemal antibody absorption test Antinuclear antibody An abnormal titre of antinuclear antibody by immunofluorescence or an equivalent assay at any point in time and in the absence of drugs known to be associated with ‘drug-induced lupus’ syndrome

The proposed classification is based on 11 criteria. For the purpose of identifying patients in clinical studies, a person shall be said to have systemic lupus erythematosus if any four or more of the 11 criteria are present, serially or simultaneously, during any interval of observation.

	Systemic sclerosis [33]

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

 
American Rheumatism Association Scleroderma Criteria Cooperative Study (SCCS): preliminary clinical criteria for systemic sclerosis (excludes localized scleroderma and pseudosclerodermatous disorders)
Proximal scleroderma is the single major criterion; sensitivity was 91% and specificity was over 99%.

Sclerodactyly, digital pitting scars of fingertips or loss of substance of the distal finger pad, and bibasilar pulmonary fibrosis contributed further as minor criteria in the absence of proximal scleroderma.

One major or two or more minor criteria were found in 97% of definite systemic sclerosis patients, but only in 2% of the comparison patients with systemic lupus erythematosus, polymyositis/dermatomyositis, or Raynaud's phenomenon.

	Takayasu's arteritis [34]

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 Takayasu's arteritis (traditional format)

Criteria Definition Age at disease onset40 yr Development of symptoms or findings    onset40 yr related to Takayasu's arteritis at age40 yr Claudication of Development and worsening of fatigue    extremities Development and worsening of fatigue and discomfort in muscles of one or more extremity while in use, especially the upper extremities Decreased brachial Decreased pulsation of one or both    artery pulse brachial arteries Blood pressure difference Difference of>10 mm Hg in systolic    >10 mm Hg blood pressure between arms Bruit over subclavia Bruit audible on auscultation over one or    arteries or aorta both subclavian arteries or abdominal aorta Arteriogram abnormality Arteriographic narrowing or occlusion of the entire aorta, its primary branches, or large arteries in the proximal upper or lower extremities, not due to arteriosclerosis, fibromuscular dysplasia, or similar causes: changes usually focal or segmental

For the purposes of classification, a patient shall be said to have Takayasu's arteritis if at least three of these six criteria are present. The presence of any three or more criteria yields a sensitivity of 90.5% and a specificity of 97.8%.

	Wegener's granulomatosis [35]

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 Wegener's granulomatosis (traditional format)

Criteria Definition Nasal or oral Development of painful or painless oral    inflammation ulcers or purulent or bloody nasal discharge Abnormal chest Chest radiograph showing the presence of    radiograph nodules, fixed infiltrates, or cavities Urinary sediment Microhaematuria (>5 red blood cells per high power field) or red cell casts in urine sediment Granulomatous Histological changes showing granulo    inflammation on biopsy matous inflammation within the wall of    biopsy an artery or in the perivascular or extravascular area (artery or arteriole)

For the purposes of classification, a patient shall be said to have Wegener's granulomatosis if at least two of these four criteria are present. The presence of any two or more criteria yields a sensitivity of 88.2% and a specificity of 92.0%.

Criteria and definitions used for the classification of Wegener's granulomatosis (tree format)

Criteria Definition Nasal or oral Development of painful or painless    inflammation oral ulcers or purulent or bloody nasal discharge Haemoptysisa Haemoptysis during illness Abnormal chest Chest radiograph showing the presence of    radiograph nodules, fixed infiltrates, or cavities Urinary sediment Microhaematuria (>5 red blood cells per high power field) or red cell casts in urine sediment Granulomatous Histological changes showing granulo    inflammation on matous inflammation within the wall of    biopsy an artery or in the perivascular or extravascular area (artery or arteriole)

^aUsed as a surrogate if biopsy data are not available.

	Preliminary criteria for the classification of juvenile ideopathic 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

 
A proposal for the development of classification criteria for idiopathic arthritides in childhood had been drawn up by a Standing Committee of ILAR and published in the Journal of Rheumatology in 1995 [36]. These proposed classification criteria were then revised at a meeting in Durban in 1997 and again published in the Journal of Rheumatology in 1998 [37].

Classification of juvenile idiopathic arthritis
Systemic oligoarthritis:

persistent

extended

Polyarthritis (rheumatoid factor negative)

Polyarthritis (rheumatoid factor positive)

Psoriatic arthritis

Enthesitis-related arthritis

Other arthritis:

fits no other category

fits more than one category

	Notes

 
Correspondence to: P. Brooks.

	References

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

 

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Submitted 19 September 2000; Accepted 5 March 2001

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