Rheumatology Clinical Trials Research Articles

Concordance and Prognostic Relevance of Different Definitions of Systemic Sclerosis Interstitial Lung Disease Progression.

Interstitial lung disease (ILD) in systemic sclerosis (SSc) is a common complication that has varied progression rate and prognosis. Different progression definitions are available: include minimal clinically important worsening of forced vital capacity (FVC MCIW), EUSTAR (EUropean Scleroderma Trials and Research group) progression, OMERACT (Outcome Measures in Rheumatology Clinical Trials) progression, and Erice ILD working group progression. Pulmonary function and symptoms changes may act as specific confounding factors applying these definitions in SSc. To assess the concordance and prognostic value of four different definitions in SSc-ILD patients overall and specific clinical groups. Progression status in consecutive SSc-ILD patients was assessed over 24 months, 60-month disease-related mortality risk was compared between progressors and non-progressors using the four definitions. Among 245 patients, 26 SSc-related deaths were reported. Mortality was linked to progression for FVC MCIW (HR 2.27, 95% CI 1.03-4.97), OMERACT (HR 2.90, 95% CI 1.28-6.57), and Erice definitions (HR 11.02, 95% CI 2.38-51.08). The association between progression and mortality was poor in patients with disease duration ≥3 years, mild functional impairment, and pulmonary artery systolic pressure (PASP)≥40 mmHg. Erice criteria appeared superior in patients with duration ≥3 years, limited cutaneous variant, and PASP<40 mmHg. OMERACT criteria performed better in diffuse cutaneous variant patients with severe functional impairment. The four evaluated definitions of progression in SSc-ILD are not interchangeable, resulting in up to a third of cases being classified differently based on the adopted criteria, and presenting different prognostic values, particularly within specific clinical groups.

Navigating the path of progress: The OMERACT 2023 emerging leaders program

ObjectivesThe Outcome Measures in Rheumatology Clinical Trials (OMERACT) Emerging Leaders Program (ELP) aims to cultivate a cohort of skilled leaders within the OMERACT community empowering them with expertise and knowledge to help shape and steer the organization into the future. This publication highlights the significance of the ELP in driving leadership excellence, its impact on OMERACT's evolution, and the outcomes and learnings from the OMERACT 2023 ELP. MethodsInsights from the 2018 ELP report informed 2023 program improvements. Engagement was measured by attendance and WhatsApp interactions. Positive program aspects, areas for improvement and ideas for enhancing future ELPs were captured via anonymous survey and participant focus groups. ResultsEngagement with the ELP was high with 9 participants, 96 % attendance at all workshops, 154 WhatsApp interactions. All program components were highly rated, with the highest being the ‘Psychological Safety’ and ‘Methodology/Process/Politics’ workshops. Future enhancements included creating further networking, connection and support activities, practical leadership and methodological skill development opportunities, and a new stream focussing on organisational advancement. ConclusionsThe 2023 OMERACT ELP was well received and successfully addressed areas previously identified as requiring improvement. New educational enhancements were valued, and the importance of fostering psychological safety at all levels was highlighted. The ELP fortifies OMERACT by nurturing a diverse array of skilled leaders who embody OMERACTs core values. Continuing to refine and evolve the ELP over time will help OMERACT sustain its global influence in patient-centered outcome research.

How to Monitor Disease Activity of Axial Spondyloarthritis in Clinical Practice.

Treatment guided by periodic and quantitative data assessment results in better outcomes compared to using clinical gestalt. While validated generic as well as specific disease activity measures for axial spondyloarthritis (axSpA) are available, there is vast scope to improve their actual utilization in routine clinical practice. In this review, we discuss available disease activity measures for axSpA, describe results from the survey conducted among general rheumatologists as well as Spondyloarthritis Research and Treatment Network (SPARTAN) members about disease activity measurement in daily practice, and discuss ways to improve axSpA disease activity using technological advances. We also discuss the definitions of active disease and target for the treatment of axSpA. The 2019 American College of Rheumatology (ACR)/Spondylitis Association of America (SAA)/Spondyloarthritis Research and Treatment Network (SPARTAN) axSpA treatment guidelines conditionally recommend the regular monitoring of disease activity using a validated measure such as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) or Ankylosing Spondylitis Disease Severity Index (ASDAS). Assessment of Spondyloarthritis International Society (ASAS)-European Alliance of Associations for Rheumatology (EULAR) guidelines recommend ASDAS as the most appropriate instrument for the assessment of disease activity, preferably calculated using C-reactive protein (CRP). ASAS has selected a core set of variables which were updated recently and have been endorsed by the Outcome Measures in Rheumatology Clinical Trials (OMERACT) group in order to bring homogeneity in assessment of axSpA. In a recent study, Patient-Reported Outcomes Measurement Information System (PROMIS®) measures were able to discriminate inactive, moderate, and high-very high ASDAS activity groups. A newly developed semi-objective index P4 (pain, physical function, patient global, and physician global) correlates well with BASDAI and ASDAS in axSpA and can also be used for other rheumatic diseases in busy clinical practices. Regular disease activity monitoring is critical for long-term management of axSpA and shared decision-making. The integration of electronic health records and smart devices provides a great opportunity to capture patient-reported data. Automated capture of electronic patient-reported outcome measures (ePROMs) is a highly efficient way and results in consistent regular monitoring and may improve the long-term outcomes. While currently used measures focus only on musculoskeletal symptoms of axSpA, a composite disease activity measure that can also incorporate extra-articular manifestations may provide a better assessment of disease activity.

Evaluation of major salivary glands with ultrasonography in multiple sclerosis patients

BackgroundThis study aimed to investigate the homogeneity of the major salivary glands in multiple sclerosis (MS) patients using ultrasonography (USG), assess DMFT indices, measure resting salivary flow rates, and compare these values with healthy individuals.MethodsIn this study, 20 individuals diagnosed with Relapsing-Remitting Multiple Sclerosis (RRMS) (mean age 36.15 ± 8.51) and 20 systemically healthy individuals (mean age 35.7 ± 9.22) were included. Oral and radiologic examinations were performed in all individuals. The parotid and submandibular salivary glands were examined using USG, and their homogeneity was assessed based on the scoring system recommended by the Outcome Measures in Rheumatology Clinical Trials (OMERACT) study group. Resting salivary flow rates and DMFT indices were measured, and the obtained data were subjected to statistical analysis.ResultsThe parotid glands exhibited more heterogeneity on USG within the MS patient group than the control group, with a statistically significant difference between the two groups (p = 0.015). A statistically significant correlation was observed in total homogeneity values between the patient and control groups (p = 0.021). Furthermore, the MS patient group exhibited higher DMFT indices and lower salivary flow rates than the control group. The difference between the DMFT indices and salivary flow rate between the patient groups was statistically significant (p = 0.004 and p = 0.002 respectively).ConclusionsThe parenchyma of the major salivary glands in MS patients exhibited decreased homogeneity than the healthy controls. Additionally, the MS group showed a decrease in salivary flow rate and an increase in the DMFT index. Autonomic dysfunction and medications used for MS are thought to cause salivary gland hypofunction and dry mouth. It can be interpreted that hyposalivation and motor skill losses in MS patients lead to an increase in DMFT index.

Improvement of active salivary gland ultrasonography findings in Sjögren's syndrome in response to short-term glucocorticoid treatment: A case report and review of the literature.

Salivary gland ultrasonography is a non-invasive imaging technique that helps in the diagnosis and assessment of disease activity in Sjögren's syndrome. However, it remains unclear whether the salivary gland ultrasonography findings are reversible in response to treatment. We present a case of a woman in her 20s who presented with parotid swelling and pain lasting for 3 months. The patient was diagnosed with anti-SS-A antibody-positive Sjögren's syndrome with active sialadenitis, and short-term glucocorticoid treatment resulted in resolution of clinical symptoms and improvement of salivary gland ultrasonography findings by the Outcome Measures in Rheumatology Clinical Trials scoring system. Notably, the anechoic/hypoechoic foci and vascular signals in the parotid and submandibular glands were reduced after treatment. Furthermore, peak systolic blood flow velocity of the facial artery entering the submandibular gland was decreased. Our case highlights that the findings of 'inflammatory' structural changes and vascularisation on salivary gland ultrasonography, including the Outcome Measures in Rheumatology Clinical Trials scoring system, reflect the disease active of Sjögren's syndrome and are reversible with treatment. Salivary gland ultrasonography has the potential to be a useful tool for monitoring treatment response and stratifying patients by disease activity in Sjögren's syndrome; therefore, further research is needed on the relationship of salivary gland ultrasonography findings with the pathophysiological mechanisms of sialadenitis and long-term clinical outcomes.

The Role of Major Salivary Gland Ultrasound in the Diagnostic Workup of Sicca Syndrome: A Large Single-Centre Study.

(1) Objective: To determine the diagnostic accuracy of major salivary gland ultrasonography (SGUS) in primary Sjogren's syndrome (SS), we used the Outcome Measures in Rheumatology Clinical Trials (OMERACT) scoring system on a large single-centre cohort of patients with sicca syndrome. (2) Method: We retrospectively collected the clinical, imaging and serological data of all the patients referred with a suspicion of SS who underwent SGUS and minor salivary glands biopsy. (3) Results: A total of 132 patients were included. The SGUS scores were correlated between the two sides (p < 0.001). The diagnostic cut-off for SS (AUROC: 0.7408) was 6 for the SGUS-global sum (sensitivity: 32.43%; specificity: 96.84%). The cut-off with the highest specificity for SS diagnosis was 7. In the patients with a final diagnosis of SS, the mean SGUS score was significantly higher (p < 0.001) than that of the non-SS patients (3.73 vs. 1.32 for the SGUS-global sum). A significant correlation was demonstrated between the SGUS scores and final SS diagnosis (p < 0.001), biopsy positivity (p < 0.001), ANA positivity (p = 0.016), Ro-SSA positivity (p = 0.01), and gland fibrosis (p = 0.02). (4) Conclusions: SGUS, using the OMERACT scoring system, has moderate sensitivity and high specificity for the diagnosis of SS. The scoring showed a strong and direct correlation with all the clinical hallmarks of SS diagnosis, such as the positivity of a labial salivary gland biopsy, ANA and Ro-SSA statuses, and salivary gland fibrosis. Because of its high specificity, a SGUS-global score > 6 could be therefore employed for the diagnosis of SS in the case of ANA negativity or the unavailability of a biopsy.

The importance of ultrasound examination in care of juvenile idiopathic arthritis patients: 9 months follow-up study.

Juvenile idiopathic arthritis (JIA) is a group of rare musculoskeletal disorders with chronic inflammation of joints, typically manifesting before the age of 16 years. The assessment of disease activity remains pivotal in JIA treatment decisions, particularly during clinical remission. While musculoskeletal ultrasound (MSUS) has shown promise in detecting subclinical synovitis, longitudinal data on MSUS features in JIA remains limited. The aim of this study was to evaluate the prevalence of subclinical synovitis observed in MSUS over a follow-up period in JIA patients. Additionally, it sought to assess the consistency and correlation between clinical findings, standardized composite clinical score (JADAS10), and MSUS-detected synovitis during 9 months follow-up. a prospective single-center study was conducted, enrolling all consecutive JIA patients (excluding systemic JIA) seen at the study center in one year period. At three-months intervals over a 9 months period (M0, M3, M6 and M9), patients underwent clinical examination, laboratory tests, and MSUS assessment. Data on demographic characteristics, disease profile, and treatment were collected. Patients were categorized into active disease (ACT) or remission (REM) groups based on Wallace criteria and JADAS10 scores using previously validated thresholds. The ultrasound assessments adhered to the Outcome Measures in Rheumatology Clinical Trials (OMERACT) pediatric group, covering 40 joints, were performed by two ultrasonographers at every visit. Subclinical synovitis was defined as synovitis detected exclusively by MSUS. Spearman's correlation coefficients (rs) were used to evaluate the association between MSUS, clinical data, and outcome measures, such as active joint count (ACJ), patient's/parent's global assessment of disease activity (PaGA), physician's global assessment of disease activity (PhGA) and JADAS10. subclinical synovitis was evident in 5.2% of all joints and in 80.6% of the patients at baseline. During the follow-up period, signs of subclinical synovitis decreased to 3.8% of joints, however, the proportion of affected patients remained high (67.7%), with the majority in REM group. Despite the consistent strong correlation between PaGA and PhGA throughout the study (rs > 0.895; p < 0.001), both measures displayed moderate (rs = 0.647; p < 0.001) to weak (rs = 0.377; p = 0.04) correlations with MSUS findings. Notably, PaGA remained significantly correlated with MSUS at the M9 visit (rs = 0.377, p = 0.04), while PhGA showed no correlation (p = 0.094). The study results indicate the persistence of subclinical inflammation detected by MSUS in a significant proportion of JIA patients, even during clinical remission. Moreover, the findings suggest that conventional measurements of JIA activity may be insufficient for assessing patients in clinical remission.

Stakeholder endorsement advancing the implementation of a patient-reported domain for harms in rheumatology clinical trials: Outcome of the OMERACT Safety Working Group

To develop an understanding of the concept of safety/harms experienced by patients involved in clinical trials for their rheumatic and musculoskeletal diseases (RMDs) and to seek input from the OMERACT community before moving forward to developing or selecting an outcome measurement instrument. OMERACT 2023 presented and discussed interview results from 34 patients indicating that up to 171 items might be important for patients' harm-reporting. Domain was defined in detail and supported by qualitative work. Participants in the Special-Interest-Group endorsed (96%) that enough qualitative data are available to start Delphi survey(s). We present a definition of safety/harms that represents the patient voice (i.e., patients' perception of safety) evaluating the symptomatic treatment-related adverse events for people with RMDs enrolled in clinical trials.

Diagnostic value of ultrasound evaluation of major salivary glands for Sjögren’s syndrome based on the novel OMERACT scoring system

ObjectiveThe novel Outcome Measures in Rheumatology Clinical Trials (OMERACT) scoring system was used to evaluate the diagnostic effectiveness of major salivary gland ultrasonography (SGUS) for Sjögren's syndrome (SS). Materials and methodsSGUS was performed on the parotid glands (PGs) and submandibular glands of 242 patients (145 patients with SS and 97 patients without SS) using the OMERACT scoring system (grade 0–3). We also evaluated the association of SGUS scores with unstimulated whole salivary flow rate (UWSF), stimulated whole salivary flow rate (SWSF), and labial salivary gland biopsy (LSGB) results. ResultsThe SGUS scores were significantly higher for the SS group than for the non-SS group (p < 0.001). Using a cutoff value of 8 for the total score yielded the highest sensitivity (76%), specificity (90%), and area under the receiver operating characteristic curve (AUC, 0.828). The correlation between SGUS scores and salivary gland function was moderate to good. A cutoff value of 10 for the total score was more effective in predicting SWSF outcomes than UWSF outcomes (sensitivity: 73% > 58%, specificity: 98% > 87%, and AUC: 0.856 > 0.723). The association of OMERACT scores with LSGB results was fair to moderate. Among 61 anti-SSA-negative patients, 17 had positive PG scores (including ten SS and seven non-SS patients), and 44 had negative PG scores (including 37 non-SS and seven SS patients). ConclusionThe OMERACT scoring system had good sensitivity and excellent specificity, demonstrating excellent diagnostic potential for SS and efficacy in assessing salivary gland function. Negative SGUS results may help reduce unnecessary biopsies in anti-SSA-negative patients.

The effects of hyperbaric oxygen on MRI findings in rheumatoid arthritis: A pilot study

Background: Rheumatoid arthritis is a debilitating and destructive disease for which limited therapeutic options exist. Objective: This report summarizes serial magnetic resonance imaging (MRI) findings from nine study participants treated with hyperbaric oxygen (HBO2) therapy and expands upon an earlier pilot study that showed improvement in disease activity and joint pain as determined by multiple, validated clinical measures. Methods: Rheumatoid arthritis patients received 30 hyperbaric oxygen treatments over six to 10 weeks. MRI with and without contrast was completed at baseline, and at three- and six-month intervals following initiation of HBO2 therapy. Ratings were based on Outcome Measures in Rheumatology Clinical Trials (OMERACT) Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) criteria, the standard method for quantification of inflammation and damage by MRI in RA trials. Results: Using RAMRIS criteria, nine of nine patients demonstrated no radiologic progression of erosions, synovitis, or bone marrow edema at three- and six-month scans. Conclusion: Our findings suggest that HBO2 therapy may be useful as an adjunctive or alternative treatment to disease-modifying drugs for rheumatoid arthritis.

Rubus idaeus extract improves symptoms in knee osteoarthritis patients: results from a phase II double-blind randomized controlled trial

BackgroundOsteoarthritis (OA) is the most frequent cause of disability in elderly people. In daily practice, the main objective of the physician is to reduce patient symptoms using treatments without adverse effects. However, the most prescribed treatment to manage OA symptoms remains nonsteroidal anti-inflammatory drugs which are associated with severe adverse effects. Therefore, we need a safe alternative to managing OA. One candidate is Rubus idaeus leaf extracts known to inhibit inflammatory responses.ObjectiveThis study aimed to evaluate the effects of a 12-weeks intervention with an ethanolic extract from Rubus idaeus leaf on symptoms of knee osteoarthritis.MethodThe study was a randomized, double-blind, placebo-controlled, monocentric trial of 198 participants with femorotibial osteoarthritis. Participants were randomized equally to receive one daily during 3 months either 1 capsule of Rubus idaeus leaf extract 400 mg, 1 capsule of Rubus idaeus leaf extract 200 mg, or 1 capsule of placebo. The participants were assessed at baseline and after one and three months of treatment. The primary endpoint was an absolute change of the Western Ontario McMaster osteoarthritis index (WOMAC) pain subscale. The secondary endpoints were WOMAC global score, stiffness and function sub-scales, knee pain VAS score at walking, the Short Form (SF)-36, the Short Physical Performance Battery (SPPB), the 20-m walk test, and the International Physical Activity Questionnaire (IPAQ) and Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) responders rate. Statistical analyses were conducted on the intent-to-treat (ITT) population.ResultsIn the Intention-to-treat population, WOMAC pain was not significantly modified by Rubus idaeus leaf extract compared to placebo. In contrast, Rubus idaeus leaf extract 400 mg after 12 weeks of treatment significantly reduced pain measured by the VAS. The mean pain decrease induced by Rubus ideaus leaf extract was over -7 mm which is clinically relevant and reached a clinically statistical difference compared to placebo with the highest dose. Rubus Ideaus was not significantly more efficient than the placebo on WOMAC global score, stiffness, and physical function subscores, IPAQ, SF-36, walking distance in treadmill test, SPPB, and evaluation of associated treatments needed to manage OA.ConclusionRubus idaeus leaf extract was well tolerated and effective to relieve pain in a patient with knee osteoarthritis.Trial registrationNCT03703024 (11/10/2018).

Magnetic resonance imaging assessment of juvenile idiopathic arthritis using OMERACT and EuroTMjoint classifications

This retrospective case–control study compared inflammatory and structural damage in the temporomandibular joint of patients with juvenile idiopathic arthritis (JIA) and its subtypes and healthy patients using the Outcome Measures in Rheumatology Clinical Trials (OMERACT) and EuroTMjoint classifications. Correlations between the scores of the two classifications and time of diagnosis were evaluated. Twenty-nine JIA patients and 48 age-matched healthy participants were examined. TMJ images on each side were considered individually. Oligoarticular and polyarticular subtypes were present in 44.8% and 55.2% of patients, respectively. The JIA group presented a higher frequency and more severe signs of inflammatory and structural changes (P < 0.05), except for effusion (P = 0.83). The polyarticular subtype showed a higher change intensity. The time of JIA diagnosis was not correlated with inflammatory and structural changes. Positive correlations between inflammation and bone deformity scores were observed for the EuroTMjoint classification (r = 0.462, P < 0.001; low correlation) and OMERACT classification (r = 0.737, P < 0.001; high correlation). Positive correlations between the OMERACT and EuroTMjoint classifications were found for inflammation score (r = 0.907, P < 0.001; very high correlation) and bone deformity score (r = 0.854, P < 0.001; high correlation). Both classifications showed a higher frequency and intensity of inflammation and bone deformity in JIA patients. The results of this study suggest that the appropriate management of inflammation may reduce the potential for structural damage to the TMJ.

Ultrasound remission in patients with rheumatoid arthritis in clinical remission.

ObjectivesThe aim of the study was to assess ultrasound (US) remission in patients with rheumatoid arthritis (RA) in clinical remission using different definitions.Material and methodsThis was a cross-sectional study including patients with RA in clinical remission defined by disease activity score (DAS28)-erythrocyte rate (ESR) ≤ 2.6 for at least 6 months. Each patient underwent B-mode and power Doppler (PD) assessments of 42 joints and 20 tendons. B-mode and PD signal for synovitis and tenosynovitis (TS) were defined and graded semi-quantitatively (0–3) according to the outcome measures in rheumatology clinical trials (OMERACT). Several different definitions of US remission were examined: the absence of synovial hypertrophy (SH), TS on B-mode and PD signal, the absence of SH and PD signal, a grade ≤ 1 of SH and the absence of PD, a grade ≤ 1 of SH and PD, the absence of PD, or a grade of PD ≤ 1. The DAS28, clinical disease activity index (CDAI), simple disease activity index (SDAI), and the Boolean American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) remission criteria were compared.ResultsThirty-seven patients were enrolled. The rate of remission according to the different composite indices was 70.2% for the SDAI, 64.8% for the CDAI, and 54% for the ACR/EULAR Boolean criteria. Synovial hypertrophy and TS in B-mode were detected in 94.6% and 40.5% of patients, respectively. Synovitis with PD signal was found in 59.5% and 13.5% of patients had TS with PD, respectively. Ultrasound remission at joints and tendons was found in 5.4–62.2% of patients. For the other remission criteria: CDAI, SDAI, and ACR/EULAR Boolean criteria, 7.7–60% of patients showed US remission at joints and tendons.ConclusionsClinical remission, even classified by strict composite indices, does not seem to be the closest method to the concept of absence of inflammatory activity; hence the interest of integrating US in assessing remission in practice.

Ultrasonography of Shoulder in Rheumatoid Arthritis: A Reliability Exercise Using Consensual Definitions among Maghrebian Rheumatologists

The shoulder may be affected in a large portion of patients with rheumatoid arthritis (RA) worldwide. However, this joint does not receive the attention required during follow-up. Indeed, although numerous clinical tests for diagnosis of a painful shoulder are available, differentiating articular from peri-articular lesions may be difficult in daily practice. Fortunately, the precise diagnosis of shoulder pain in RA has benefited from a reliable imaging modality used to detect its exact origin-ultrasonography (US). This study was aimed at assessing the intra- and inter-observer reliability of ultrasonographic findings for patients with established RA with shoulder pain in a patient-based exercise as a clinical challenge among Maghrebian rheumatologist experts in US. A total of 7 operators examined 10 patients in two rounds independently and blindly of each other. Before beginning the session, all of the rheumatologists reached a consensus on sites and US settings by performing a brief exercise on a normal shoulder. Outcome Measures in Rheumatology Clinical Trials (OMERACT) definitions of US-detected pathologies were used. Each patient underwent US scanning of the painful shoulder in predefined sites based on US technical guidelines of the European Society of Musculoskeletal Radiology: long head of biceps (LHB), subscapularis recess, posterior recess and axillary recess. The presence of subdeltoid or subcoracoid bursitis or full rupture of the suprasupinatus was identified if present. Intra- and inter-observer reliability measures were calculated using the κ coefficient. Intra-observer reliability was good for gray-scale (GS) synovitis in subscapularis and posterior recesses (κ=0.77 and 0.73, respectively). It was moderate in the presence of GS synovitis and effusion in LHB (κ =0.53 and 0.40, respectively), posterior and subscapularis recess effusion (κ=0.56 and 0.60, respectively) and GS and power Doppler (PD) synovitis in axillary recesses (κ=0.58 and 0.49, respectively). Inter-observer reliability was good for PD for LHB signals (κ=0.78). It was moderate for GS for LHB synovitis (κ=0.54). Inter-observer agreement was poor for effusion and GS synovitis for subscapularis, posterior and axillary recesses, and very poor for PD signals in these recesses. US was a reliable imaging tool for detecting tenosynovitis in the LHB. However, reliability was moderate to poor in detecting synovitis in subscapularis, posterior and axillary recesses. These findings could be optimized by standardization of sites to assess.

Salivary gland ultrasonography in primary Sj\xf6gren\u2019s syndrome from diagnosis to clinical stratification: a multicentre study

BackgroundTo determine the diagnostic accuracy of major salivary gland ultrasonography (SGUS) in primary Sjögren’s syndrome (pSS) using the novel Outcome Measures in Rheumatology Clinical Trials (OMERACT) scoring system in a large-scale multicentre study.MethodsSGUS was conducted for 246 pSS patients, 140 control subjects with conditions other than SS and 27 healthy control subjects. The echostructure features from the parotid and submandibular glands on both sides were graded using the novel OMERACT scoring system. Receiver operating characteristic curves were used to describe the diagnostic accuracy of the scoring system for pSS. The associations between the SGUS and disease characteristics were analysed to evaluate the clinical value of SGUS for pSS.ResultsThe US scores in the pSS group were significantly higher than those in the non-pSS group (p < 0.001). The level of diagnostic accuracy was comparable with the scores of all four glands (AUC=0.908) when only the parotid and submandibular glands on either side were scored (AUC=0.910, 0.904, respectively). The optimal cut-off value for the left (right) parotid gland and the left (right) submandibular gland was 4, with maximal sensitivity (75.6% and 77.2%, respectively) and specificity (91.6% and 92.2%, respectively). The pSS patients with positive SGUS results presented a longer disease duration, parotid enlargement, dental loss and higher levels of serological markers, such as anti-SSA, anti-SSB, positive RF, IgG and γ-globulin%.ConclusionsSGUS with the OMERACT scoring system yields high sensitivity and specificity, demonstrating high diagnostic feasibility for pSS. The SGUS may have implications for deciding disease severity and treatment efficacy.

Correlation and agreement between physical and ultrasound examination after a training session dedicated to the standardization of synovitis assessment in rheumatoid arthritis patients

ObjectivesAssessing disease activity in rheumatoid arthritis (RA) patients requires comprehensive quantification of tender and swollen joints. We aimed to evaluate the correlation and agreement between rheumatologists after a training session dedicated to the standardization of synovitis assessment and compare its performance with a reference imaging modality such as musculoskeletal ultrasonography (MSUS).MethodsIn this cross-sectional study, a total of 28 and 10 joints in RA patients were evaluated by physical examination and ultrasound (US), respectively. After participating in a training session, individual joint assessment for tenderness and swelling was performed by three rheumatologists. MSUS examination was performed separately by an experimented radiologist in a standardized manner, evaluating findings according to the Outcome Measures in Rheumatology Clinical Trial (OMERACT) guidelines.ResultsA total of 80 RA patients were included, with a mean Disease Activity Score based on 28 joints (DAS28)-ESR of 4.02. The interobserver overall agreement and concordance rate in a total of 2240 joints assessed was 81.7% (k = 0.449, p < 0.0001) for tender joints and 66% (k = 0.227, p < 0.0001) for swollen joints. The overall concordance rate was fair (Fleiss' kappa = 0.21, p = 0.027) with an overall agreement of 67.18% yet, more joints were found to be swollen by the US assessment, compared to the physical examination (43% vs 39%).ConclusionIn our study population, joint tenderness showed better interobserver agreement, correlation, and concordance rate than joint swelling. When comparing the US assessment to the physical examination, a fair overall concordance rate supports the need for the implementation of training sessions dedicated to standardization in rheumatology clinics.

Whole-body magnetic resonance imaging vs. clinical evaluation of enthesitis in patients with spondyloarthritis

Whole-body magnetic resonance imaging vs. clinical evaluation of enthesitis in patients with spondyloarthritis

Patient preferences to value health outcomes in rheumatology clinical trials: Report from the OMERACT special interest group✰

ObjectiveTo inform a research plan for future studies by obtaining stakeholder input on the application of preference-based methods to clinical trial design. MethodsWe conducted a virtual OMERACT session to encourage stakeholder engagement. We developed materials for the session to facilitate discussion based on identified case examples and feedback sessions. ResultsParticipants prioritized incorporating patient preferences in all aspects of trial design with an emphasis on outcome selection. Participants highlighted the need for careful consideration around preference heterogeneity and equity factors. ConclusionIncluding patient preferences in trial design was considered a priority requiring further exploration to develop comprehensive guidance.

OMERACT consensus-based operational definition of contextual factors in rheumatology clinical trials: A mixed methods study

ObjectivesTo develop an operational definition of contextual factors (CF) [1]. MethodsBased on previously conducted interviews, we presented three CF types in a Delphi survey; Effect Modifying -, Outcome Influencing - and Measurement Affecting CFs. Subsequently, a virtual Special Interest Group (SIG) session was held for in depth discussion of Effect Modifying CFs. ResultsOf 161 Delphi participants, 129 (80%) completed both rounds. After two rounds, we reached consensus (≥70% agreeing) for all but two statements. The 45 SIG participants were broadly supportive. ConclusionThrough consensus we developed an operational definition of CFs, which was well received by OMERACT members.

Osteoarthritis of the hand: clinical and ultrasound parallels

Osteoarthritis of the hand: clinical and ultrasound parallels