Laboratory investigation results influence Physician’s Global Assessment (PGA) of disease activity in SLE

2020 ◽  
pp. annrheumdis-2019-216753 ◽  
Author(s):  
Cynthia Aranow ◽  
Anca Askanase ◽  
Shereen Oon ◽  
Molla Huq ◽  
Alicia Calderone ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Disease Activity ◽  
Lupus Erythematosus ◽  
Global Assessment ◽  
Intraclass Correlation ◽  
Physician Global Assessment ◽  
Systemic Lupus ◽  
Laboratory Test Results ◽  
Laboratory Results ◽  
The Impact

ObjectiveTo evaluate the impact of laboratory results on scoring of the Physician Global Assessment (PGA) of disease activity in systemic lupus erythematosus.MethodsFifty clinical vignettes were presented via an online survey to a group of international lupus experts. For each case, respondents scored the PGA pre and post knowledge of laboratory test results (pre-lab and post-lab PGAs). Agreement between individual assessors and relationships between pre-lab and post-lab PGAs, and PGAs and Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) were determined. Respondents were also asked about factors they incorporate into their PGA determinations.ResultsSixty surveys were completed. The inter-rater PGA reliability was excellent (pre-lab intraclass correlation coefficient (ICC) 0.98; post-lab ICC 0.99). Post-lab PGAs were higher than pre-lab PGAs: median (IQR) pre-lab PGA 0.5 (1.05), post-lab PGA 1 (1.3) (p<0.001), with a median (IQR) difference of 0.2 (0.45). In general, all abnormal labs including elevated anti-double stranded DNA antibody level (dsDNA) and low complement impacted PGA assessment. Cases with weakest correlations between pre-lab and post-lab PGA were characterised by laboratory results revealing nephritis and/or haematological manifestations. Both pre-lab and post-lab PGAs correlated with SLEDAI-2K. However, a significantly stronger correlation was observed between post-lab PGA and SLEDAI-2K. Multiple factors influenced PGA determinations. Some factors were considered by an overwhelming majority of lupus experts, with less agreement on others.ConclusionsWe found excellent inter-rater reliability for PGAs in a group of international lupus experts. Post-lab PGA scores were higher than pre-lab PGA scores, with a significantly stronger correlation with the SLEDAI-2K. Our findings indicate that PGA scoring should be performed with knowledge of pertinent laboratory results.

scholarly journals POS0758 DOES EXPERIENCE IN SYSTEMIC LUPUS ERYTHEMATOSUS INFLUENCE THE PHYSICIAN GLOBAL ASSESSMENT SCORING? A CROSS-SECTIONAL STUDY ON TWO EUROPEAN COHORTS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 632.1-632
Author(s):  
E. Chessa ◽  
M. Piga ◽  
F. Sagez ◽  
R. Felten ◽  
A. Floris ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Lupus Erythematosus ◽  
Global Assessment ◽  
Intraclass Correlation ◽  
Cross Sectional Study ◽  
Physician Global Assessment ◽  
Systemic Lupus ◽  
Cross Sectional ◽  
Rater Reliability ◽  
Outcome Instrument

Background:The Physician Global Assessment (PGA) is an outcome instrument based on physician judgement of disease activity in patients with Systemic Lupus Erythematosus (SLE). Due to the subjectivity of the score and lack of standardization, the PGA could represent a source of heterogeneity, because the same manifestations could be rated differently by physicians with different backgrounds (1).Objectives:The purpose of this study was to evaluate the inter-rater reliability of PGA between a rheumatology trainee and rheumatologists expert in SLE from 2 european countries.Methods:SLE patients classified according to SLICC 2012 criteria were enrolled between May 2019 and December 2019 during a SLEuro traineeship program. Demographic, clinical (SLEDAI-2k, PGA), serological and ongoing medication data were collected. PGA was evaluated before (pre-lab) and after (post-lab) knowledge of laboratory exams, using a Visual Analogue Scale (VAS) ranging from 0 to 3, anchored at point 1 (mild), 2 (moderate) and 3 (severe activity). A trainee in Rheumatology (EC) and three rheumatologists experts in SLE (LA, MP, FS) independently scored the PGA for each patient.The trainee preliminarily received a standardization training with her tutor (MP), consisting of a shared discussion about 10 consecutive SLE outpatients to increase reliability in PGA scoring.Inter-rater reliability was analysed using the intraclass correlation coefficient (ICC) with a two-way single-rating model (2,1); 95% confidence interval (CI) was calculated.Results:Fifty-seven patients (86% female) affected from SLE (29 belonging to a French cohort and 28 to an Italian cohort) with a mean (SD) age 43.2 (15.9) years and a median [IQR] disease duration 6.4 [2.0-15.4] years were enrolled. Clinical features are presented in table 1. Pre-lab PGA scores were obtained from all patients and ranged from 0 to 2.3; post-lab PGA scores were obtained from 51 patients and ranged from 0 to 2.9. Inter-rater reliability of the PGA among the trainee was good to excellent for each lupus expert comparison: a) pre-lab PGA ICC 0.94, 95% CI 0.87-0.97; post-lab PGA ICC 0.94, 95% CI 0.87-0.97 (MP); b) pre-lab PGA ICC 0.84, 95% CI 0.63-0.93; post-lab PGA ICC 0.96 CI 0.88-0.99 (LA); c) pre-lab PGA ICC 0.91, 95% CI 0.65-0.98; post-lab PGA ICC 0.91, 95% CI 0.65-0.98 (FS).Conclusion:After an adequate standardization, PGA scoring reaches good to excellent reliability between trainee and experts.References:[1]Chessa E, Piga M, Floris A, Devilliers H, Cauli A, Arnaud L. Use of Physician Global Assessment in systemic lupus erythematosus: a systematic review of its psychometric properties. Rheumatology (Oxford). 2020 Dec 1;59(12):3622-3632.Clinical DataCaucasian44 (77.2%)anti-dsDNA titre (median,IQR)14 (0-75)Hypocomplementemia (n,%)30 (54%)SLEDAI≥6 (n,%)18 (31.6%)SLEDAI (median,IQR)4 (2-6)Flares (n,%)18 (31.6%)Ongoing prednisone treatment (n,%)41 (71.9%)Prednisone dose mg (mean±sd)5 (0 - 8.9)Hydroxychloroquine (n,%)44 (77.2%)Immunosuppressant (n,%)35 (61.4%)Acknowledgements:Elisabetta Chessa gratefully acknowledges the SLEuro European Lupus Society for its financial support in her traineeship in Strasbourg.Disclosure of Interests:None declared

scholarly journals Use of Physician Global Assessment in systemic lupus erythematosus: a systematic review of its psychometric properties

Rheumatology ◽  
2020 ◽  
Vol 59 (12) ◽  
pp. 3622-3632
Author(s):  
Elisabetta Chessa ◽  
Matteo Piga ◽  
Alberto Floris ◽  
Hervé Devilliers ◽  
Alberto Cauli ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Literature Review ◽  
Disease Activity ◽  
Psychometric Properties ◽  
Systematic Literature Review ◽  
Lupus Erythematosus ◽  
Global Assessment ◽  
Physician Global Assessment ◽  
Systemic Lupus ◽  
Wide Range

Abstract Objective The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician’s judgement of overall SLE disease activity. The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. Methods This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. All articles published through 1 July 2019 in PubMed were screened, with no limitation on year of publication, language or patients’ age. Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. Results The literature search identified 91 studies. Face validity was reported in all the articles retrieved in which the PGA was used alone or as part of composite indices (Systemic Responder Index, Safety of Estrogen in Lupus Erythematosus National Assessment Flare Index, Lupus Low Disease Activity State, Definitions of Remission in Systemic Lupus Erythematosus criteria). Content validity was reported in 89 studies. Construct validity was demonstrated by a good correlation (r ≥ 0.50) between the PGA with the SLEDAI (12 studies), SLAM (4 studies), LAI, BILAG and ECLAM (2 studies each). Criterion validity was assessed exploring the PGA correlation with quality of life measurements, biomarker levels and treatment changes in 28 studies, while no study has evaluated correlation with damage. A good responsiveness for PGA was shown in eight studies. A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.67–0.98). Conclusion PGA is a valid, responsive and feasible instrument, though its reliability was impacted by the scale adopted, suggesting the major need for standardization of its scoring.

Associations between physicians’ global assessment of disease activity and patient-reported outcomes in patients with systemic lupus erythematosus: A longitudinal study

Lupus ◽  
2021 ◽  
pp. 096120332110279
Author(s):  
Worawit Louthrenoo ◽  
Nuntana Kasitanon ◽  
Eric Morand ◽  
Rangi Kandane-Rathnayake
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Disease Activity ◽  
Lupus Erythematosus ◽  
Global Assessment ◽  
Patient Reported Outcomes ◽  
Global Rating ◽  
Physician Global Assessment ◽  
Systemic Lupus ◽  
Patient Reported ◽  
Longitudinal Associations

Objective To determine longitudinal associations between Physician Global Assessment (PGA) and patient-reported outcomes (PROs) in patients with systemic lupus erythematosus (SLE). Methods Patients attending a rheumatology clinic between 2013 and 2017 completed specific (SLEQOL) and generic (SF36) health-related quality of life (HRQoL) surveys and rated their global rating of change (GRC) at each visit. PGA, SLEDAI-2K and SLE Flare Index (SFI) were also captured on all visits. Generalised estimating equations (GEE) methods were used to examine longitudinal associations of PGA with PROs and clinical indicators. Results 337 patients were followed for a median [IQR] of 3.2 [1.6, 3.4] years (2,059 visits). High PGA (>1) was strongly associated with high SLEDAI-2K scores, the presence of flares and poor PROs. Odd ratios (OR) [95% CI] of PGA > 1 in patients with SLEDAI-2K >4 & <10 and SLEDAI-2K ≥10, compared to SLEDAI-2K ≤ 4, were 3.46 [2.36, 5.08], p < 0.001 and 6.39 [4.30, 9.49], p < 0.001, respectively. OR [95% CI] of PGA > 1 in patients with mild-to-moderate or severe flares were 2.09 [1.62, 2.71], p < 0.001 and 4.42 [3.21, 6.07], p < 0.001, respectively. Mental components of both SLEQOL (mood, self-image) and SF36 (MCS) surveys demonstrated significant associations with high PGA. After adjusting for SLEDAI-2K, one-point increase in PGA was associated with reductions in SLEQOL total score and SF36-MCS by 2.33 (regression coefficient (RC) [95% CI] = −2.33 [−3.77, −0.88], p = 0.002), and 4.16 (RC [95% CI] = −4.16 [−5.19, −3.13], p < 0.001) points, respectively. Associations of some physical components (SLEQOL-symptoms, and SF36-PCS) with PGA attenuated when adjusted for SLEDAI-2K. Patients who rated low scores of GRC, which indicate health deterioration, were twice as likely to have PGA > 1 (OR [95%CI] 1.99 [1.25, 3.16], p = 0.004). Conclusion High PGA was strongly associated with poor mental health, high disease activity and flares. This study confirms the value of PGA as an efficient assessment tool for SLE.

scholarly journals Fatigue in Systemic Lupus Erythematosus: An Update on Its Impact, Determinants and Therapeutic Management

2021 ◽  
Vol 10 (17) ◽  
pp. 3996
Author(s):  
Lou Kawka ◽  
Aurélien Schlenckerv ◽  
Philippe Mertz ◽  
Thierry Martin ◽  
Laurent Arnaud
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Disease Activity ◽  
Lupus Erythematosus ◽  
Lifestyle Changes ◽  
Systemic Lupus ◽  
Targeted Interventions ◽  
Beneficial Effects ◽  
Bothersome Symptom ◽  
Reduced Physical Activity ◽  
The Impact

Fatigue is a complex and multifactorial phenomenon which is often neglected by clinicians. The aim of this review was to analyze the impact, determinants and management of fatigue in patients with Systemic Lupus Erythematosus (SLE). Fatigue is one of the most prevalent symptoms in SLE, reported by 67% to 90% of patients. It is also described as the most bothersome symptom, considering that it may impair key aspects of health-related quality of life, while also leading to employment disability. It is a multifactorial phenomenon involving psychological factors, pain, lifestyle factors such as reduced physical activity, whereas the contribution of disease activity remains controversial. The management of fatigue in patients with SLE should rely upon a person-centered approach, with targeted interventions. Some pharmacological treatments used to control disease activity have demonstrated beneficial effects upon fatigue and non-pharmacological therapies such as psychological interventions, pain reduction and lifestyle changes, and each of these should be incorporated into fatigue management in SLE.

SAT0311 The Comparability of Patient and Physician Global Assessment in Early and Non-Early Systemic Lupus Erythematosus Patients

2016 ◽  
Vol 75 (Suppl 2) ◽  
pp. 780.2-780
Author(s):  
M. Pasali ◽  
V. Sadovici-Bobeica ◽  
M. Cebanu ◽  
V. Salaru ◽  
L. Mazur-Nicorici ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Lupus Erythematosus ◽  
Global Assessment ◽  
Physician Global Assessment ◽  
Systemic Lupus

scholarly journals Pregnancy outcomes between pregnant systemic lupus erythematosus patients with clinical remission and those with low disease activity: A comparative study

2021 ◽  
Author(s):  
Worawit Louthrenoo ◽  
Thananant Trongkamolthum ◽  
Nuntana Kasitanon ◽  
Antika Wongthanee
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Disease Activity ◽  
Lupus Erythematosus ◽  
Pregnancy Outcomes ◽  
Clinical Remission ◽  
Activity Index ◽  
Physician Global Assessment ◽  
Systemic Lupus ◽  
Low Disease Activity ◽  
Significant Difference

Objectives: This study aims to compare pregnancy outcomes between systemic lupus erythematosus (SLE) patients who attained clinical remission based on the Definition of Remission in SLE (DORIS) and those with lupus low disease activity based on Low Lupus Disease Activity State (LLDAS). Patients and methods: Between January 1993 and June 2017, a total of 90 pregnancies (one twin pregnancy) from 77 patients (mean age: 6.9±4.8 years; range, 17.9 to 37.3 years) were included in the study. The clinical remission and the LLDAS groups were modified into modified clinical remission and LLDAS groups, respectively by omitting Physician Global Assessment (PGA). The clinical SLE disease activity index (cSLEDAI) score was used for LLDAS. Results: Pregnancies in 49 patients occurred, when they were in modified clinical remission and in 57 in modified LLDAS. There was no significant difference in demographic characteristics, disease activity, or medication received at conception between the two groups. Pregnancy outcomes were similar between the modified clinical remission and the modified LLDAS groups in terms of successful pregnancy (83.67% vs. 84.21%), full-term births (38.78% vs. 38.60%), fetal losses (16.33% vs. 15.79%), spontaneous abortions (14.29% vs. 14.04%), small for gestational age infants (18.37% vs. 19.30%), low birth weight infants (42.86% vs. 40.35%), maternal complications (46.94% vs. 49.12%), and maternal flares (36.73% vs. 40.35%). The agreement of pregnancy outcomes was very high between the two groups (91.11% agreement). Conclusion: Pregnancy outcomes in SLE patients who achieved modified clinical remission and modified LLDAS were comparable.

Fatigue in SLE: diagnostic and pathogenic impact of anti-N-methyl-D-aspartate receptor (NMDAR) autoantibodies

2019 ◽  
Vol 78 (9) ◽  
pp. 1226-1234 ◽  
Author(s):  
Andreas Schwarting ◽  
Tamara Möckel ◽  
Freya Lütgendorf ◽  
Konstantinos Triantafyllias ◽  
Sophia Grella ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Disease Activity ◽  
Lupus Erythematosus ◽  
Activity Index ◽  
Neuronal Cell ◽  
Disease Activity Index ◽  
Systemic Lupus ◽  
Serum Samples ◽  
Aspartate Receptor ◽  
The Impact

ObjectivesWe explored the impact of circulating anti-N-methyl-D-aspartate receptor (NMDAR) antibodies on the severity of fatigue in patients with systemic lupus erythematosus (SLE).MethodsSerum samples of 426 patients with SLE were analysed for the presence of antibodies to the NR2 subunit of the NMDAR. In parallel, the severity of fatigue was determined according to the Fatigue Scale for Motor and Cognitive functions questionnaire. In a subgroup of patients with SLE, the hippocampal volume was correlated with the levels of anti-NR2 antibodies. Isolated immunoglobulin G from patients with anti-NR2 antibodies were used for murine immunohistochemical experiments and functional assays on neuronal cell lines. Treatment effects were studied in 86 patients with lupus under belimumab therapy.ResultsWe found a close correlation between the titre of anti-NR2 antibodies, the severity of fatigue, the clinical disease activity index (Systemic Lupus Erythematosus Disease Activity Index 2000) and anti-double stranded DNA antibodies—independently of the presence of neuropsychiatric lupus manifestations. Pathogenic effects could be demonstrated by (1) detection of anti-NR2 antibodies in the cerebrospinal fluid, (2) in situ binding of anti-NR2 antibodies to NMDAR of the hippocampus area and (3) distinct functional effects in vitro: downregulating the energy metabolism of neuronal cells without enhanced cytotoxicity. Treatment with belimumab for at least 6 months affected both the severity of fatigue and the levels of anti-NR2 antibodies.ConclusionThe presence of anti-NR2 antibodies in patients with SLE with fatigue is a helpful diagnostic tool and may offer a major approach in the therapeutic management of this important disabling symptom in patients with SLE.

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