European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) SLE classification criteria item performance

Background/objectivesThe European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria for systemic lupus erythematosus system showed high specificity, while attaining also high sensitivity. We hereby analysed the performance of the individual criteria items and their contribution to the overall performance of the criteria.MethodsWe combined the EULAR/ACR derivation and validation cohorts for a total of 1197 systemic lupus erythematosus (SLE) and n=1074 non-SLE patients with a variety of conditions mimicking SLE, such as other autoimmune diseases, and calculated the sensitivity and specificity for antinuclear antibodies (ANA) and the 23 specific criteria items. We also tested performance omitting the EULAR/ACR criteria attribution rule, which defines that items are only counted if not more likely explained by a cause other than SLE.ResultsPositive ANA, the new entry criterion, was 99.5% sensitive, but only 19.4% specific, against a non-SLE population that included other inflammatory rheumatic, infectious, malignant and metabolic diseases. The specific criteria items were highly variable in sensitivity (from 0.42% for delirium and 1.84% for psychosis to 75.6% for antibodies to double-stranded DNA), but their specificity was uniformly high, with low C3 or C4 (83.0%) and leucopenia <4.000/mm³ (83.8%) at the lowest end. Unexplained fever was 95.3% specific in this cohort. Applying the attribution rule improved specificity, particularly for joint involvement.ConclusionsChanging the position of the highly sensitive, non-specific ANA to an entry criterion and the attribution rule resulted in a specificity of >80% for all items, explaining the higher overall specificity of the criteria set.

SAT0071 SUBCLINICAL SYNOVITIS IN ARTHRALGIA: HOW OFTEN DOES IT RESULT IN CLINICAL ARTHRITIS? A LONGITUDINAL STUDY TO REFLECT ON STARTING POINTS FOR DMARD TREATMENT

Background:Clinically apparent arthritis is mandatory for diagnosing and classifying RA. It is often used as endpoint in arthralgia cohorts and as a starting point for DMARD therapy in clinical practice. In recent literature subclinical synovitis, visualized with MRI or ultrasound, is increasingly used as a starting point for DMARD therapy in absence of clinically apparent arthritis. However, not all patients with a subclinical synovitis will develop clinically apparent arthritis, and thus may be overtreated. It has even been suggested to replace the entry-criterion of clinical arthritis by subclinical synovitis within the 2010 classification criteria for RA to diminish overtreatment. However this might lead to an overclassification of the disease. Because of aforementioned reasoning we aimed to evaluate the risk of overtreatment of these approaches and therefore performed a longitudinal study in three observational arthralgia cohorts.Objectives:To determine the frequency of non-progression to clinical arthritis in patients with subclinical synovitis, also after considering the 2010-criteria.Methods:Three individual cohorts of arthralgia patients without clinically apparent arthritis (n=166, 473 and 168) were followed for 1-year on the development of inflammatory arthritis (IA). At baseline subclinical synovitis in hands or feet was visualized with ultrasound (US) (defined as greyscale≥2 and/or power-doppler≥1) in cohort 1 and 3 and MRI (synovitis score ≥1 by two readers) in cohort 2. For all patients with subclinical synovitis the proportion of progressors (‘true positives’) and non-progressors (‘false positives’) were determined. The same analysis was done in the subgroup of patients that fulfilled the 2010 criteria for RA, if subclinical synovitis was used as entry criterion. Analyses were stratified for ACPA.Results:At baseline 36%, 41% and 31% of patients had subclinical synovitis. Of the ACPA-positive arthralgia patients with subclinical synovitis 46%, 56% and 29% respectively developed IA, whereas 54%, 44% and 71% did not progress. Within ACPA-negative arthralgia patients with subclinical synovitis 34%, 15% and 10% developed IA; whereas 66%, 85% and 90% did not progress (Figure 1A). Similar results were seen in the subgroup of patients that fulfilled the 2010 criteria with subclinical synovitis as entry criterion (Figure 1B).Figure 1.Percentage of arthralgia patients with subclinical synovitis that did and did not develop IA, in three independent cohorts:(A) Percentage of patients with subclinical synovitis that did and did not progress to IA after one-year follow-up, stratified for ACPA status. (B) Percentage of patients with subclinical synovitis and ≥6 points at baseline that did and did not progress to IA after one-year follow-up stratified for ACPA status.Conclusion:Replacing clinical arthritis by subclinical synovitis in arthralgia introduces a high false-positive rate: 44-71% (ACPA-pos) and 66-90% (ACPA-neg) of patients with subclinical synovitis did not develop clinically apparent arthritis within one year. Applying the 2010-criteria in this setting did not diminish the false positive rate. Starting DMARDs in patients without clinical synovitis may therefore introduce considerable overtreatment.Acknowledgments *:C Rogier and F Wouters contributed equal to this studyDisclosure of Interests:None declared

2019 European League Against Rheumatism/American College of Rheumatology classification criteria for systemic lupus erythematosus

ObjectiveTo develop new classification criteria for systemic lupus erythematosus (SLE) jointly supported by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR).MethodsThis international initiative had four phases. (1) Evaluation of antinuclear antibody (ANA) as an entry criterion through systematic review and meta-regression of the literature and criteria generation through an international Delphi exercise, an early patient cohort and a patient survey. (2) Criteria reduction by Delphi and nominal group technique exercises. (3) Criteria definition and weighting based on criterion performance and on results of a multi-criteria decision analysis. (4) Refinement of weights and threshold scores in a new derivation cohort of 1001 subjects and validation compared with previous criteria in a new validation cohort of 1270 subjects.ResultsThe 2019 EULAR/ACR classification criteria for SLE include positive ANA at least once as obligatory entry criterion; followed by additive weighted criteria grouped in seven clinical (constitutional, haematological, neuropsychiatric, mucocutaneous, serosal, musculoskeletal, renal) and three immunological (antiphospholipid antibodies, complement proteins, SLE-specific antibodies) domains, and weighted from 2 to 10. Patients accumulating ≥10 points are classified. In the validation cohort, the new criteria had a sensitivity of 96.1% and specificity of 93.4%, compared with 82.8% sensitivity and 93.4% specificity of the ACR 1997 and 96.7% sensitivity and 83.7% specificity of the Systemic Lupus International Collaborating Clinics 2012 criteria.ConclusionThese new classification criteria were developed using rigorous methodology with multidisciplinary and international input, and have excellent sensitivity and specificity. Use of ANA entry criterion, hierarchically clustered and weighted criteria reflect current thinking about SLE and provide an improved foundation for SLE research.

Grazing criteria for perennial peanut (Arachis pintoi cv. Amarillo) consumed by sheep in rotational stocking

ABSTRACT The objective of work was to study the productive profile of perennial peanut in a rotational stocking environment under different criteria. The treatments corresponded to pre-grazing height of 14 and 18cm or 95% of light interception (LI) distributed in a completely randomized design. The studied variables were forage mass, percentage of structural components, forage mass and the structural components in the lower and upper canopy strata. The entrance criterion of 18cm in height, despite having higher forage mass, presented lower percentage of leaves and higher percentage of stems and forage losses. The criteria of 14cm and 95% light interception presented similar production between them and the highest rate of forage accumulation. In all criteria, in the upper strata of pasture a higher percentage of leaves were found. The criteria of 95% LI and 14cm in height presented the best productive performances. The entry criterion of 18cm presented a higher mass of pre-grazing forage with lower percentage of dead material, but with higher forage losses, resulting from senescent leaves. Due to changes in the structural components, as grazing cycles increase, the interception of 95% of the incident light by the perennial peanut occurs at lower heights.

The Use of the Revised Trauma Score as an Entry Criterion in Traumatic Hemorrhagic Shock Studies: Data from the DCLHb Clinical Trials

IntroductionThe Revised Trauma Score (RTS) has been proposed as an entry criterion to identify patients with mid-range survival probability for traumatic hemorrhagic shock studies.Hypothesis/ProblemDetermination of which of four RTS strata (1-3.99, 2-4.99, 1-4.99, and 2-5.99) identifies patients with predicted and actual mortality rates near 50% for use as an entry criterion in traumatic hemorrhagic shock clinical trials.MethodsExisting database analysis in which demographic and injury severity data from two prior international Diaspirin Cross-Linked Hemoglobin (DCLHb) clinical trials were used to identify an RTS range that could be an optimal entry criterion in order to find the population of trauma patients with mid-range predicted and actual mortality rates.ResultsOf 208 study patients, the mean age was 37 years, 65% sustained blunt trauma, 49% received DCLHb, and 57% came from the European Union study arm. The mean values were: ISS, 31 (SD = 18); RTS, 5.6 (SD = 1.8); and Glasgow Coma Scale (GCS), 10.4 (SD = 4.8). The mean TRISS-predicted mortality was 34% and the actual 28-day mortality was 35%. The initially proposed 1-3.99 RTS range (n = 41) had the highest predicted (79%) and actual (71%) mortality rates. The 2-5.99 RTS range (n = 79) had a 62% predicted and 53% actual mortality, and included 76% blunt trauma patients. Removal of GCS <5 patients from this RTS 2-5.99 subgroup caused a 48% further reduction in eligible patients, leaving 41 patients (20% of 208 total patients), 66% of whom sustained a blunt trauma injury. This subgroup had 54% predicted and 49% actual mortality rates. Receiver operator curve (ROC) analysis found the GCS to be as predictive of mortality as the RTS, both in the total patient population and in the RTS 2-5.99 subgroup.ConclusionThe use of an RTS 2-5.99 inclusion criterion range identifies a traumatic hemorrhagic shock patient subgroup with predicted and actual mortality that approach the desired 50% rate. The exclusion of GCS <5 from this RTS 2-5.99 subgroup patients yields a smaller, more uniform patient subgroup whose mortality is more likely related to hemorrhagic shock than traumatic brain injury. Future studies should examine whether the RTS or other physiologic criteria such as the GCS score are most useful as traumatic hemorrhagic shock study entry criteria.Sloan EP, Koenigsberg M, Clark JM, Desai A. The use of the Revised Trauma Score as an entry criterion in traumatic hemorrhagic shock studies: data from the DCLHb clinical trials. Prehosp Disaster Med. 2012;27(4):1-15.