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"Observational study registry"
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POS1244 ROLE OF MINOR SALIVARY GLAND HISTOLOGY IN PATIENTS WITH SJÖGREN’S SYNDROME: A MONOCENTRIC CROSS-SECTIONAL OBSERVATIONAL STUDY
by
Villa, M.
,
Mastromanno, L.
,
Conti, F.
in
Observational studies/ registry
,
Prognostic factors
,
Scientific Abstracts
2024
Background:In patients with Sjögren’s Syndrome (SS), the biopsy of minor salivary glands (MSG) is a fundamental diagnostic and prognostic tool. However, there is still variability in the histological parameters considered, and the clinical/laboratory associations are yet to be clarified.Objectives:Aim of this study is to investigate in a large monocentric cohort of primary SS patients (Sjogren Clinic at University of Rome Sapienza), the predictive value of MSG histology versus the main clinical, clinimetric and laboratory features.Methods:Primary SS patients undergoing MSG biopsy between 2016 and 2023 were retrospectively enrolled and the histological/clinical/clinimetric/laboratory data were collected. Histological analysis comprised: focus score (FS) and n° of foci calculation, germinal centers (GCs) [nodular aggregates (H&E), confirmed by CD21+ or Bcl6+ (IHC)] and lymphoepithelial lesions (LEL) (CD20+ IHC in ducts) detection and fibrosis (H&E) recognition. Logistic and linear regression analyses were performed to evaluate the predictive value of histology on clinical/clinimetric/laboratory parameters.Results:Two-hundred and thirty-two SS patients were enrolled [mean age 53.6 years (±13.6), F=223/M=9] (figure 1). Both the FS and the n° of foci were predictive of anti-La/SSB, RF, hypergammaglobulinemia and were positively correlated with the ESSDAI. Wile the FS was predictive for low C4 levels, the n° of foci was predictive for anti-Ro/SSA, monoclonal component, biologic and glandular ESSDAI domains. As we recently published [1], a lower FS and n° of foci was predictive for the presence of autoimmune thyroiditis. We found a large agreement between CD21+ and Bcl6+ staining. The presence of GCs (either CD21+ or Bcl6+) was predictive for those serological features associated with a more severe disease. GCs were also predictive of specific ESSDAI domains linked with higher risk of lymphoproliferative complications (Figure 1). Both the CD21+ and the Bcl6+ stainings were predictive of an higher ESSDAI score. Compared to GCs, LEL were even more predictive of different serological features and ESSDAI domains (Figure 1). Interestingly, the presence of fibrosis was associated with a lack of anti-Ro/SSA-La/SSB antibodies. Three patients developed MALT lymphoma; all of them had GCs (CD21+/Bcl6+) and LEL in their MSG biopsies, none had fibrosis [n° of foci: mean=8.3 (SD:5-13); FS mean=3.6 (SD=2.12-4.88)].Conclusion:This is one of the largest studies evaluating the predictive value of histology versus different clinical, clinimetric and laboratory parameters of patients with primary SS. Our data confirm the association between a higher FS and the presence of both serological features known to be linked to a more severe disease and higher ESSDAI score values. Compared to the FS, the number of foci revealed additional associations such as the biological and glandular ESSDAI domains. We confirm the association between GCs and those serological/clinical features accompanying a more systemic and active disease and we provide evidence of the same, and also additional associations, for the LEL. Finally, we demonstrate for the first time that the presence of fibrosis may be predictive of seronegative patients; this relevant finding, is currently under validation on a larger cohort.REFERENCES:[1] Colafrancesco S, et al. Clinical and histological features of patients with primary Sjögren’s syndrome and autoimmune thyroiditis: a national multicentre cross-sectional study. Clin Exp Rheumatol. 2023;41(12):2389-2396.Acknowledgements:NIL.Disclosure of Interests:None declared.
Journal Article
AB1722 IMPACT OF ABCG2 (RS2231142) AND MTHFR (RS1801133) GENE POLYMORPHISMS ON JUVENILE GOUT AND FEBUXOSTAT TREATMENT RESPONSE
by
Zhu, R.
,
Chen, X.
,
Zheng, S.
in
Genetics
,
Observational studies/ registry
,
Scientific Abstracts
2024
Background:Gout is the most common inflammatory arthritis caused by hyperuricemia. And the incidence of juvenile gout was rising worldwide. The specific mechanisms and treatment strategies remain unclear. Febuxostat is commonly used to lower blood uric acid levels in adult gout patients, but its efficacy in juvenile gout patients with different genetic backgrounds has not been adequately studied. Numerous prior studies have indicated that the T allele genotype at the C677T site of the MTHFR gene increases hyperuricemia risk by elevating plasma homocysteine levels. Similarly, the ABCG2 gene, implicated in gout susceptibility, affects uric acid levels through the regulation of renal excretion and reabsorption.Objectives:This study aims to investigate the relationship between variations of MTHFR and ABCG2 gene and both the gout onset in children and the efficacy of Febuxostat.Methods:These studies were approved by theInstitutional Review Board of Guangdong Second provincial General Hospital.The study enrolled 31 pediatric gout patients, 18 of whom received Febuxostat treatment regularly(40mg per day) for 12 weeks, alongside 16 non-gout children (aged 10 to 18 years, male). EDTA whole blood samples were collected for genetic testing of the ABCG2 gene c.421C>A (rs2231142) and the MTHFR gene c.677C>T (rs1801133). Participants were categorized based on these gene sites into three groups: homozygous defect (AA), heterozygous defect (CA), and full-function (CC) for ABCG2; and similarly for MTHFR. Treatment efficacy was determined based on blood uric acid levels, with levels exceeding 420 μmol/L classified as a “poor response” and levels at or below 420 μmol/L as a “good response.” The Chi-square test was employed for statistical analysis.Results:Significant differences were observed in ABCG2 (rs2231142) between juvenile gout and non-gout group (p=0.0043), but no correlation was noted in the response to Febuxostat treatment (Table 1). The juvenile gout group contained 10 cases in the homozygous defect group (AA), 17 in the heterozygous defect group (CA), and 4 in the full-function group (CC). In contrast, the non-gout group had 0, 8, and 8 cases, respectively. A statistically significant difference was found in MTHFR (rs1801133) between groups with varying responses to Febuxostat treatment (p=0.035), with a higher proportion of CT and CC genotypes in the good response group (Table 2). However, no statistical difference was noted in ABCG2 (A) rs2231142 between the two Febuxostat treatment groups.Conclusion:Our results showed that ABCG2 genotyping played an important role in the risk of gout in juvenile. When predicting or evaluating the efficacy of febuxostat, MTHFR genotyping may have a certain guiding role in the selection of research plans.REFERENCES:[1] Ciferska, H, Pavelcova, K, Vachek, J, et al. POS0354 DETECTION OF ABCG2 VARIANTS IN ENCODING OF uric acid TRANSPORTERS ASSOCIATED WITH THE HYPERURICEMIA IN HAEMODIALYSIS PATIENTS ANN RHEUM DIS. 2021; 80 (Suppl 1): 407.2-408. doi: 10.1136/annrheumdis-2021-eular.2084.[2] van der Pol, KH, Nijenhuis, M, Soree, B, et al. Dutch pharmacogenetics working group guideline for the gene-drug interaction of ABCG2, HLA-B and Allopurinol, and MTHFR, folic acid and methotrexate. EUR J HUM GENET. 2022; doi: 10.1038/s41431-022-01180-0.Acknowledgements:This study was supported by Medical Scientific Research Foundation of Guangdong Province(B2022162, A2023045).Disclosure of Interests:None declared.
Journal Article
AB0308 COMPARATIVE STUDY OF BONE MINERAL DENSITY BY MeaSUREMENT SITE IN POSTMENOPAUSAL OSTEOPOROSIS PATIENTS UNDERGOING BONE FRACTURE SURGERY
2024
Background:Osteoporosis is defined as a bone mineral density (BMD) of at least 2.5 standard deviations below the young adult mean (YAM) (T-score ≤2.5) according to World Health Organization criteria, or a BMD of 70% or lower than YAM (YAM% ≤70) according to the Japanese Society for Bone and Mineral Research (JSBMR)criteria. The primary aim of osteoporosis treatment is to decrease fracture incidences; however, untreated cases may persist due to undiagnosed osteoporosis. In our 2019 report, we found that 38% of menopausal patients diagnosed with osteoporosis solely at the distal radius, without prior fracture surgery, did not exhibit osteoporosis at either the hip or lumbar spine. Moreover, the decrease in YAM% occurred significantly earlier than that observed in the hip and lumbar spine. These findings suggest that relying solely on BMD measurements at the hip and lubar spine may be insufficient for diagnosing osteoporosis. The present study aimed to investigate the correlations of BMD among three skeletal sites in female patients undergoing surgery for proximal femur fracture (PFF) or distal radius fracture (DRF) and assess the necessity of measuring BMD at the distal radius.Objectives:We enrolled 116 PFF female patients (mean age 81.1) and 47 DRF female patients (mean age 71.2) who underwent surgery between 2021 and 2023.Methods:BMDs of the distal radius, hip, and lumbar spine were measured by dual energy X-ray absorptiometry (Prodigy, GE Healthcare UK Ltd.). The cut-off values for the diagnosis of osteoporosis according to JSBMR criteria were used. Correlations between BMDs of skeletal sites (distal radius and hip, distal radius and lumbar spine, and hip and lumbar spine) were assessed using t-test.Results:In PFF patients, YAM% of the distal radius (57.7%) was significantly lower than that of the hip (61.9%, P < 0.019) and lumbar spine (68.9%, p < 0.001). Correlation coefficients of BMD between the distal radius and hip, distal radius and lumbar spine, and hip and lumbar spine were 0.50001, 0.46403, and 0.52521, respectively.In DRF patients, YAM% of the distal radius (70.1%) was lower than that of the hip (75.1%, P < 0.045) and lumbar spine (76%, P < 0.020). Correlation coefficients of BMD between the distal radius and hip, distal radius and lumbar spine, and hip and lumbar spine were 0.55303, 0.36069, and 0.44750, respectively. Among the 90 PFF patients diagnosed as osteoporotic at the distal radius, 13 (14.4%) were not osteoporotic at either the lumbar spine or hip, 3 (3.3%) were osteoporotic at the hip but not lumbar spine, 21 (23.3%) were osteoporotic at the lumbar spine but not hip, and 53 (59.0%) were osteoporotic at both the lumbar spine and hip. Among the 27 DRF patients diagnosed as osteoporotic at the distal radius, 10 (37.1%) were not osteoporotic at either the lumbar spine or hip, six (22.2%) were osteoporotic at the hip but not lumbar spine, six (22.2%) were osteoporotic at the lumbar spine but not hip, and five (18.5%) were osteoporotic at both the hip and lumbar spine.Conclusion:Among DRF patients with distal radius YAM% lower than 70%, 38.5% of patients had both hip and lumbar spine YAM% of 70% or > 70%, which was higher than that of PFF patients. Our findings suggest that there was a period of earlier decline in BMD of the distal radius in fracture patients than in the hip and lumbar spine, which may have led to DRF. Sakai et al. reported that 58% of Colles’ fracture patients had lumbar spine YAM% of 70% or higher. Furthermore, the patients in this study who developed DRF with a distal radius YAM% < 70% were not diagnosed with osteoporosis and did not receive any therapeutic intervention. Thus, measuring the BMD of the distal radius is essential to avoid underestimating the actual value of BMD for the diagnosis of osteoporosis.REFERENCES:[1] Nakaseko K. Bone Mineral Density of the Spine, Hip, and Distal Radius in Patients with Postmenopausal Osteoporosis. Arthritis & Rheumatology 2019; 71: 3901-3903.[2] Sakai A, et al. Association of bone mineral density with deformity of the distal radius in low-energy Colles’ fractures in Japanese women above 50 years of age. J Hand Surg Am 2008; 33(6): 820-826.Acknowledgements:NIL.Disclosure of Interests:None declared.
Journal Article
POS0204 EFFECTIVENESS OF TNF INHIBITION IN VERY EARLY AXIAL SPONDYLOARTHRITIS (LESS THAN ONE YEAR OF AXIAL SYMPTOM DURATION): RESULTS FROM A LARGE NATIONAL OBSERVATIONAL COHORT
by
Hügle, T.
,
Micheroli, R.
,
Moeller, B.
in
biological DMARD
,
Observational studies/ registry
,
Scientific Abstracts
2024
Background:It remains uncertain whether the concept of a “window of opportunity”, as defined for rheumatoid arthritis, applies to axial spondyloarthritis (axSpA). The Assessment in SpondyloArthritis international Society (ASAS) has published a consensus definition for “early” axSpA, which relies on axial symptom duration of ≤2 years [1]. Recent research using this definition has indicated that the effectiveness of treatment with tumor necrosis factor inhibitors (TNFi) is comparable in early and established disease [2]. To further explore the potential for improved outcomes in patients diagnosed and treated at an earlier stage, we here evaluate a shorter cut-off for the definition of early axial symptom duration.Objectives:To analyze the effectiveness of treatment with a first TNFi in patients with “very early” axSpA, defined as an axial symptom duration ≤1 year, in comparison to patients with established axSpA (axial symptom duration >2 years).Methods:Patients from a large national observational cohort of patients diagnosed as having axSpA were included in the current study if data on duration of axial symptoms was available and a first TNFi initiated between 2004 and 2023. Patients were stratified according to axial symptom duration: very early axSpA (≤1 year), early axSpA (>1 year and ≤2 years), and established axSpA (≥2 years). Drug retention was analyzed using Cox proportional hazards models, adjusting for age, sex, human leucocyte antigen B27 (HLA-B27) positivity, body mass index (BMI), education, smoking status, elevated C-reactive protein (CRP), and inflammation on magnetic resonance imaging (MRI) of the sacroiliac joints in patients with complete covariate information. Adjusted logistic regression analyses were employed to determine the achievement of the Bath Ankylosing Spondylitis Disease Activity Index criteria for 50% improvement (BASDAI50) at 12±6 months (intention-to-treat analyses in patients with available visits).Results:A total of 1080 patients met the inclusion criteria, with 131 in the very early axSpA group (12.1%), 75 in the early axSpA group (6.9%) and 874 in the established axSpA group. Characteristics of patients at the initiation of the first TNFi are presented in Table 1. Patients in the very early axSpA group were significantly younger, and had less impairment of spinal mobility. TNFi retention was analyzed in 594 patients with available covariate information (75 patients with very early axSpA, 31 patients with early axSpA and 488 patients with established disease; Table 2). We did not find evidence for a difference in retention between very early and established axSpA (HR for drug discontinuation 0.84, 95% CI 0.62-1.15, Table 2). Adjusted BASDAI50 response at 1 year was investigated in 422 patients with complete covariate data (55 patients with very early axSpA, 18 patients with early axSpA and 349 patients with non-early axSpA). A comparable BASDAI50 response was observed in very early vs. established axSpA (OR 0.85, 95% 0.44-1.64), and in early vs. established axSpA (OR 0.79, 95% 0.27-2.25).Table 1. Characteristics of axSpA patients with very early disease and non-early disease at initiation of the first tumor necrosis factor inhibitor. ASDAS = Ankylosing Spondylitis Disease Activity Score; axSpA = axial spondyloarthritis; BASDAI = Bath Ankylosing Spondylitis Disease Activity Index; BASFI = Bath Ankylosing Spondylitis Functional Index; BASMI = Bath Ankylosing Spondylitis Metrology Index; CRP = C-reactive protein; HLA-B27 = human leucocyte antigen-B27; MRI = magnetic resonance imaging).Table 2. Comparison of TNFi retention in patients with very early and early axSpA versus patients with established axSpA.Conclusion:Potential differences in effectiveness of TNFi in patients with very early and established axSpA are probably of a modest effect size, since, in our cohort, we did not find evidence for a difference between the two groups.REFERENCES:[1] Ann Rheum Dis 2023;doi:10.1136/ard-2023-224.232.[2] RMD Open 2023;9:e003455.Acknowledgements:NIL.Disclosure of Interests:Adrian Ciurea: None declared, Andrea Goetschi: None declared, Burkhard Moeller Speaking fees Janssen, Novartis, Pfizer, Eli Lilly, Grant/research support from Amgen, Michael J. Nissen Speaking fees from AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer, Consulting fees from AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, Research grant from Novartis and Pfizer, Kristina Buerki: None declared, René Braem: None declared, Michael Andor: None declared, Thomas Hügle Payments for lectures and presentations from Pfizer, Fresenius Kabi, AbbVie, Merck Sharp and Dohme, Galapagos, Eli Lilly, Novartis, Holds stocks or stock options from Atreon SA and Vtuls, royalties from Curmed, Participated on Advisory board for DETECTRA, Andrea Rubbert-Roth Honoraria for lectures from AbbVie, Janssen, Novartis, Pfizer, Consulting fees from AbbVie, Janssen, Pfizer, Support for attending meetings from Janssen, Pfizer, Diego Kyburz Honoraria for presentations from AbbVie, Eli Lilly, Participation on advisory boards from AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, Roche, Research grant from AbbVie, support for attending meetings from Janssen and Eli Lilly, Sabine Adler: None declared, Oliver Distler: None declared, Almut Scherer Employed by Bristol-Myers-Squib in 2007-2008, Raphael Micheroli Honoraria for lectures or presentations from AbbVie, Eli Lilly, Janssen, Gilead, and Pfizer.
Journal Article
Scoping review of registration of observational studies finds inadequate registration policies, increased registration, and a debate converging toward proregistration
2025
We aimed to examine a) the policies of national and international clinical trial registries regarding observational studies; b) the time trends of observational study registration; and c) the published arguments for and against observational study registration.
Scoping review of registry practices and published arguments. We searched the websites and databases of all 19 members of the World Health Organization's Registry Network to identify policies relating to observational studies and the number of observational studies registered annually from the beginning of the registries to 2022. Regarding documents with arguments, we searched Medline, Embase, Google Scholar, and top medical and epidemiological journals from 2009 to 2023. We classified arguments as “main” based on the number (n ≥ 3) of documents they occurred in.
Of 19 registries, 15 allowed observational study registration, of which seven (35%) had an explicit policy regarding what to register and two (11%) about when to register. The annual number of observational study registrations increased over time in all registries; for example, ClinicalTrials.gov increased from 313 in 1999 to 9775 in 2022. Fifty documents provided arguments concerning observational study registration: 31 argued for, 18 against, and one was neutral. Since 2012, 19 out of 25 documents argued for. We classified nine arguments as main: five for and four against. The two most prevalent arguments for were the prevention of selective reporting of outcomes (n = 16) and publication bias (n = 12), and against were that it will hinder exploration of new ideas (n = 17) and it will waste resources (n = 6).
Few registries have policies regarding observational studies; an increasing number of observational studies were registered; there was a lively debate on the merits of registration of observational studies, which, since 2012, seems to converge toward proregistration.
•Only 7 (35%) study registries had an explicit policy for observational studies.•Only 2 (11%) registries specified when to register observational studies.•The annual number of observational study registration increased in all registries.•The debate on observational study registration converges toward pro-registration.
Journal Article
AB0279 A HIGH PROPORTION OF NORWEGIAN WOMEN WITH JUVENILE IDIOPATHIC ARTHRITIS (JIA) ARE BREASTFEEDING
by
Birkeland, T.
,
Størdal, Å.
,
Wallenius, M.
in
Nursing
,
Observational studies/ registry
,
Pregnancy and reproduction
2024
Background:Juvenile idiopathic arthritis (JIA) represents challenges for women during pregnancy and breastfeeding. Limited research exists on breastfeeding practices among women with JIA. To our knowledge, there are no publications so far investigating the proportion of breastfeeding in mothers with JIA, and if breastfeeding affects disease related factors.Objectives:This study aimed to explore the proportion of women with JIA breastfeeding at 6 weeks, 6 months and 12 months postpartum, as well as examining demographic and disease related factors, and the use of medications, comparing the breastfeeding and the non-breastfeeding groups.Methods:Data from the Norwegian nationwide quality register RevNatus, collecting data about women with inflammatory rheumatic diseases in relation to pregnancy, were analyzed. The data were collected from clinical documentation and self-reported material during visits at the outpatient clinic. All women with JIA with a live birth and attending at least the control 6 weeks postpartum, were included in the study.Results:Among 304 live births in 227 women, 85,5% were breastfed at 6 weeks, 70% at 6 months and 30% at 12 months postpartum. Breastfeeding women had higher educational level, longer pregnancy duration, a lower prevalence of C-sections, lower scores for VAS pain, VAS fatigue and VAS total, and used less conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) compared to women not breastfeeding. 14 women did not specify their breastfeeding status.Conclusion:In the present study, we observed a high proportion of women with JIA breastfeeding at 6 weeks and 6 months postpartum. Based on our findings, women with JIA should be encouraged by health professionals to breastfeed.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of Interests:None declared.
Journal Article
EVALUATING ORGAN DAMAGE IN SYSTEMIC LUPUS ERYTHEMATOSUS USING REGISTER DATA
by
Parodis, Ioannis
,
Arkema, E.
,
Gomez, A.
in
Epidemiology
,
Observational studies/ registry
,
Outcome measures
2024
Background : One of the key therapeutic goals in systemic lupus erythematosus (SLE) is the prevention of organ damage. This core domain outcome is often evaluated with the Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index (SDI). Access to longitudinal organ damage data on large populations of unselected SLE patients, which currently remain unavailable, would enable real-world investigations of interventions on organ damage accrual.
Objectives : We aimed to develop a register-based organ damage index (RBODI) using International Classification of Diseases (ICD)-coded register data, and to evaluate its accuracy to estimate SDI scores from a well-characterised cohort. Furthermore, we used the RBODI to describe rates of organ damage accrual, as well as associations with mortality, in newly diagnosed patients with SLE in a population-based nationwide cohort in Sweden.
Methods : In collaboration with practitioners from six medical specialties, we translated original SDI items into ICD-10, Swedish Classification of Surgical and Medical Procedures (KVÅ), and Anatomical Therapeutic Chemical (ATC) codes to calculate a global organ damage score. These codes were retrieved from the National Patient Register (inpatient and outpatient visits) and Prescribed Drug Register, and the RBODI was calculated using similar rules as the SDI, i.e., using the same weighting system, and scoring damage occurring since SLE diagnosis only. Using SDI data from prevalent SLE cases from the Clinical Lupus Register in North-Eastern Gothia cohort (KLURING; 2021) as the gold standard for validation of the RBODI, we estimated the positive predictive value (PPV), sensitivity and specificity to detect the presence of organ damage (SDI=0 versus SDI >0). Among newly diagnosed patients with SLE from the National Patient Register (2005–2022; N=4421), we estimated 5-year cumulative incidences of organ damage overall, and by patient characteristics (age, sex, and year of diagnosis). Cox models were used to estimate the age- and sex-adjusted hazard ratio (HR) of first organ damage accrual (RBODI>0) five years after diagnosis associated with patient characteristics. Lastly, aiming to compare with previous reports from Sweden, among patients with SLE living in Sweden five years after diagnosis (N=3013) we estimated the association between presence of organ damage within the first five years of diagnosis and mortality.
Results : We identified 271 prevalent SLE cases with available SDI data in 2021 from KLURING (mean age at diagnosis 41.0±16.4 years, 86.7% female, mean time since diagnosis 16.7±9.1 years, and 62.7% had developed any organ damage). The RBODI displayed good accuracy to discriminate the presence of organ damage as scored with SDI, with a PPV of 85% (95%CI: 79–90%), sensitivity of 81% (95%CI: 74–86%), and specificity of 76% (95%CI: 67–84%; Figure 1). Among newly diagnosed patients with SLE in the nationwide cohort (mean age at diagnosis 47.5±19.8 years, 82.3% female), males (HR: 1.2; 95%CI: 1.1–1.4) and older individuals (>45 years versus ≤45 years; HR 3.4; 95%CI 3.1–3.8) had an increased risk of developing damage within 5 years of diagnosis, while there was no association with year of diagnosis (Figure 2). Patients with organ damage within the first five years of diagnosis had a 3-fold higher hazard of mortality compared with patients with a RBODI=0 during the same period (HR 2.7; 95%CI: 2.0–3.6).
Conclusion : Our novel RBODI accurately estimates SDI scores, and allows us to describe long-term trends in damage accrual in the largest cohort of incident SLE to date. The strong association between damage accrual early in the disease course and future mortality highlights the need for treat-to-target strategies that incorporate early and efficient interventions to prevent organ damage.
Journal Article
AB0146 PAIN ASSESSMENT IN HOSPITALIZED OLDER ADULTS: COMPARISON OF TWO PAIN SCALES: THE VERBAL RATING SCALE (VRS) AND THE VISUAL ANALOG SCALE (VAS)
by
Bejia, I.
,
Bergaoui, N.
,
Grassa, R.
in
Analgesics
,
Observational studies/ registry
,
Older people
2024
Background:Positive diagnosis and assessment of pain are crucial in the elderly, a population where pain is often underestimated. The literature suggests various tools commonly used in clinical practice, including the Visual Analog Scale (VAS) and the Verbal Rating Scale (VRS).Objectives:This study aimed to investigate the correlation and degree of agreement between VRS and VAS in pain assessment among hospitalized elderly subjects and establish potential recommendations for interchangeable use of the two scales.Methods:This was a monocentric, cross-sectional, diagnostic, and comparative study conducted in December 2019 at various departments of Fattouma Bourguiba Hospital in Monastir over a period of seven consecutive days.Results:Forty-three patients were included, of whom 62.8% were male. All these patients sought consultation for a painful condition. A surgical cause was found in 83.7% of cases, followed by medical causes in 16.3% of cases. Upon admission, the mean VAS score was 58.6 ± 17.8. Forty-two percent of patients had severe pain according to VAS. In contrast, 67.4% of patients rated their pain as severe according to VRS (mean 2.63 ± 0.69). The correlation study between VRS and VAS measurements at admission revealed a strong positive linear correlation (n=43, r=0.805, p <0.001). Additionally, the correlation remained strong after analgesic treatment (n=43, r=0.822, p <0.001). The degree of agreement assessed by the Kappa test found good (measure of agreement of 0.876 with p <0.001) to moderate (measure of agreement between 0.4 and 0.6) concordance between VAS and VRS. Regarding preference, VRS was preferred by more than half of the patients (72% of cases), mainly due to its ease of understanding.Conclusion:Based on these tests and results, it can be concluded that the Visual Analog Scale (VAS) and Verbal Rating Scale (VRS) are strongly correlated and concordant, allowing for interchangeable use. Indeed, these two measurement scales have proven to be reliable and effective, demonstrating practical equivalence in the elderly and offering similar performance in terms of effectiveness.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of Interests:None declared.
Journal Article
AB0432 CLINICAL CHARACTERISTICS OF “SEVERE” PERIPHERAL PSORIATIC ARTHRITIS: A RETROSPECTIVE ANALYSIS OF A LONGITUDINAL COHORT
by
Scriffignano, S.
,
Perrotta, F. M.
,
Lubrano, E.
in
Observational studies/ registry
,
Outcome measures
,
Patient Reported Outcome Measures
2024
Background:The concept of severity in a multidomain disease such as Psoriatic Arthritis (PsA) is still not well defined and often can be confused with disease activity. In this context, no validated severity indices for PsA have been publishedObjectives:The aims of this study were to identify patients with severe PsA symptoms in a cohort of PsA patients with peripheral joint involvement, to evaluate the presence of clinical differences among severe and non-severe PsA patients and to evaluate the presence of clinical factors associated to severe PsAMethods:Retrospective analysis of a longitudinal cohort of peripheral PsA patients. Demographic and clinical characteristics of patients were collected at baseline and at last follow-up. We defined the severe population using the modified Composite Psoriatic Disease Activity Index (mCPDAI - which excludes ankylosing spondylitis quality of life scale) domain [1]. Hence, patients with a score of 3 (the highest score) in at least one domain were defined as having severe PsA. Clinical characteristics of patients fulfilling the definition of severe PsA were compared to those not severe at baseline and at last follow-up.Results:177 PsA patients with peripheral involvement (M/F: 98/76) were evaluated. Of these, 64 (36.1%) were identified as severe according to the mCPDAI criteria, at baseline. Of the 64 severe patients, 42 (65.6%) were identified as severe by the peripheral arthritis domain, 11 (16.1%) by the dactylitis domain, 8 (11.7%) by skin involvement domain and 3 (4.4%) by entheseal domain. At follow-up visit, only 18 (10.1%) PsA patients still met the definition of severe PsA in almost one domain. At last follow-up visit, severe PsA patients were only males (18/18, p<0.01), showing worse outcomes in terms of disease activity, pain, function and impact of disease (Table 1). Male sex and the severity of skin involvement assessed by PASI at baseline were identified as factors associated to the presence of severe PsA at last follow-up, independently by other factors (Table 2). Moreover, the agreement between the presence of severe PsA at last follow-up defined with mCPDAI and the absence of MDA was slight [Cohen’s k: 0.174 (0.084-0.264)].Conclusion:Our study showed that severe PsA patients had more disease activity, pain and impact of disease than non-severe patients. They also tend to have higher disease activity, pain and impact of disease during the course of follow-up. Furthermore, we demonstrated that severity and disease activity in PsA are not interchangeable concepts, open the way for further studies in this field.REFERENCES:[1] Kameda H, Hagimori K, Morisaki Y, Holzkämper T, Konomi A, Dobashi H. Ixekizumab Efficacy in Patients with Severe Peripheral Psoriatic Arthritis: A Post Hoc Analysis of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (SPIRIT-P1). Rheumatol Ther 2023. doi: 10.1007/s40744-023-00605-6Acknowledgements:NIL.Disclosure of Interests:None declared.
Journal Article
AB0645 CHOROIDAL VASCULARITY INDEX AND SUBFOVEAL CHOROIDAL THICKNESS IN RHEUMATOID ARTHRITIS ASSESSED WITH ENHANCED-DEPTH IMAGING OPTICAL COHERENCE TOMOGRAPHY
2024
Background:Systemic vasculitis due to rheumatoid arthritis can also affect the choroidal tissue, which has a rich vascular network. Retinal vasculitis and choroiditis can be seen in rheumatoid arthritis.Objectives:To evaluate the effects of rheumatoid arthritis (RA) on choroidal vascularity index (CVI) and subfoveal choroidal thickness (SFCT).Methods:The study included 56 eyes of 28 rheumatoid arthritis patients and 65 eyes of 65 age- and sex-matched healthy normal participants. CVIs of all participants were measured by transferring enhanced depth imaging optical coherence tomography (EDI-OCT) images to the image J program and compared between the 2 groups. SFCT, central macular thickness (CMT) and optic disc parameters of all participants were measured with spectral domain OCT and compared.Results:The mean CVI values of the RA and control groups were 65.9±1.52 and 68.56±1.62, respectively, and were significantly lower in the RA group (p:0.001). Mean SFCT values of the RA and control groups were 290.11±15.18 and 332.88±11.04, respectively, and SFCT was significantly lower in the RA group (p:0.001). There was no significant difference between the two groups in terms of CMT and optic disc parameters.Conclusion:RA patients have lower CVI and thinner SFCT than healthy participants.REFERENCES: NIL.Acknowledgements:I thank all the authors for their contributions.Disclosure of Interests:None declared.
Journal Article