disease activity in SLE, with the Physician Global Assessment (PGA) being the only one included in the updated EULAR recommendations for the management of SLE.11. http://oml.eular.org/glossary (31 January. inflammation (duration and severity of morning stiffness as measured by BASDAI). A PGA 2 correlated with a risk of pregnancy loss (29% vs 8%, P=0.005) [49]. , Smiley A. Askanase AD , Oon S Mina R , Beaumont JL The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). The Janus kinase (Jak)/signal transducer and activating protein (STAT) pathways mediate the intracellular signaling of cytokines in a wide spectrum of cellular processes. Lead Medical Director heading up the global collaboration with Pfizer for Enbrel trials. , Gomez A , Gladman DD Faculty Publications: Feb. 23-March 2 et al. et al. The literature search identified 93 articles, and 12 additional articles were retrieved from the reference list of those publications. , Ko T The aim of this systematic review is to describe and analyse the measurement properties of the PGA, including the validity, reliability, responsiveness and feasibility. Nevertheless, despite the fact that the PGA was considered the reference in 39 studies involving other indices, it was used as the sole instrument in only 2 of them. HRQoL: Health-related Quality of Life; ICAM: intercellular adhesion molecule; VCAM: vascular cell adhesion molecule; MCP-1: monocyte chemoattractant protein-1; NC: non-calcified; suPAR: soluble urokinase plasminogen activator receptor; LFA-REAL: Lupus Foundation of America Rapid Evaluation of Activity in Lupus; CES-D: Centers for Epidemiological StudiesDepression scale; SLAQ: Systemic Lupus Erythematosus Activity Questionnaire; NA: not acquired; NS: not significant. et al. Petri M This may be explored through convergent and divergent validity. Lai J-S This property is reported across all articles selected through this systematic review [24, 913, 21103]. National Library of Medicine Published by Oxford University Press on behalf of the British Society for Rheumatology. Measurement properties of the PGA were analysed according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) terminology [19]. . Physician global assessments for disease activity in rheumatoid arthritis are all over the map! At least 1 issue from each virtual tour. (PGA), physician global assessment of disease activity (PHGA), C3, C4, and Anti-ds . , Chizzolini C (Open Access) Development and assessment of a computerized index of Tyk2 Targeting in Immune-Mediated Inflammatory Diseases , Magder LS , Clowse M. Moorthy LN Vashisht P Forbess LJ Bookshelf Background: Physician Global Assessment (PGA) is a visual analogue score (VAS) that reflects the clinician's judgment of overall Systemic Lupus Erythematosus (SLE) disease activity. Parodis I , Glassman DS On stratifying the results by individual clinician, values ranged from 0.61 to 0.90, except for those reported by . disease activity). Oxford Textbook of Neuropsychiatry - 2020 | PDF | Psychiatry , Petri MA watch for seizures after the procedure. Trusted for over 30 years to provide and transform technology into complete solutions that advance the value of IT. , Kostopoulou M Objective: To examine the feasibility of using Physician Global Assessment (PGA) scores to collect and track patient acne and . , Terwee CB Visual Analog Scale Assessments Can Reliably Assess Disease Severity in SLE A total of 91 articles were included in the study (Fig. Systemic lupus erythematosus (SLE) is a multisystem autoimmune rheumatic disease (ARD) characterized by flares and remissions. However, the PGA allows for the measurement of disease activity in a global way (content validity). , Mohan C. Giangreco D , Urowitz MB Reviews and case series with fewer than five patients were excluded. Akhter E AB - The Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus (PISCOS) study aimed to obtain an evidence . PGA; disease activity; physician global assessment; psychometrics; systemic lupus erythematosus. , Weisman MH. How should lupus flares be measured? , Petri M. Furie RA Brunner HI physician global assessment Latest Research Papers | ScienceGate et al. , Esdaile JM. [2, 21, 24] recommended PGA assessment prior to reviewing serological data, based only on the clinical visit. A PGA >1 was predictive of polymorphic light cutaneous eruption (P=0.02) [59] and correlated negatively with LLDAS attainment [37]. The PGA was introduced in 1998 by a US Food and Drug Administration panel as the preferred tool to assess and record the severity of disease in clinical studies, and typically rates a patient's disease from 'clear' to 'severe' or 'very severe' [1, 2]. et al. Jesus D BILAGAB . Elevation of erythrocyte sedimentation rate is associated with disease activity and damage accrual, The systemic lupus activity measure-revised, the Mexican systemic lupus erythematosus disease activity index (SLEDAI), and a modified SLEDAI-2K are adequate instruments to measure disease activity in systemic lupus erythematosus, Small changes in outpatients lupus activity are better detected by clinical instruments than by laboratory tests, Development and initial validation of the systemic lupus erythematosus disease activity index 2000 responder index 50, Sensitivity to change of 3 systemic lupus erythematosus disease activity indices: international validation, Systemic Lupus Erythematosus Disease Activity Index 2000 Responder Index 50: sensitivity to response at 6 and 12 months, Validation of the functional assessment of chronic illness therapy-fatigue scale in patients with moderately to severely active systemic lupus erythematosus, participating in a clinical trial, Psychological distress and changes in the activity of systemic lupus erythematosus, The rating scale preference measure as an evaluative measure in systemic lupus erythematosus, Comparison of the validity and sensitivity to change of 5 activity indices in systemic lupus erythematosus, Treatment of systemic lupus erythematosus with dehydroepiandrosterone: 50 patients treated up to 12 months, Soluble urokinase plasminogen activator receptor levels reflect organ damage in systemic lupus erythematosus, Epratuzumab for patients with moderate to severe flaring SLE: health-related quality of life outcomes and corticosteroid use in the randomized controlled ALLEVIATE trials and extension study SL0006, Measuring systemic lupus erythematosus activity during pregnancy: validation of the lupus activity index in pregnancy scale, Autoantibodies against albumin in patients with systemic lupus erythematosus, Association of depression with socioeconomic status, anticardiolipin antibodies, and organ damage in patients with systemic lupus erythematosus: results from the KORNET registry, Placebo-controlled randomized clinical trial of fish oils impact on fatigue, quality of life, and disease activity in systemic lupus erythematosus, Serum free light chains, interferon-alpha, and interleukins in systemic lupus erythematosus, Vitamin D levels in Chinese patients with systemic lupus erythematosus: relationship with disease activity, vascular risk factors and atherosclerosis, Systemic lupus erythematosus disease activity index 2000 responder index-50: a reliable index for measuring improvement in disease activity, Testosterone patches in the management of patients with mild/moderate systemic lupus erythematosus, Turkish LupusPRO: cross-cultural validation study for lupus, Cross-cultural validation of a disease-specific patient-reported outcome measure for lupus in Philippines, Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial, Sensitivity and specificity of plasma and urine complement split products as indicators of lupus disease activity, The TNF locus is altered in monocytes from patients with systemic lupus erythematosus, Effect of pregnancy on disease flares in patients with systemic lupus erythematosus, Frequency of lupus flare in pregnancy: the Hopkins Lupus Pregnancy Center experience, Morbidity of systemic lupus erythematosus: role of race and socioeconomic status, Classification and definition of major flares in SLE clinical trials, Efficacy and safety of epratuzumab in patients with moderate/severe active systemic lupus erythematosus: results from EMBLEM, a phase IIb, randomised, double-blind, placebo-controlled, multicentre study, COSMIN guideline for systematic reviews of patient-reported outcome measures, Validity and reliability in social science research, Understanding the minimum clinically important difference: a review of concepts and methods, Statistical significant change versus relevant or important change in (quasi) experimental design: some conceptual and methodological problems in estimating magnitude of intervention-related change in health services research, Minimum important difference between patients with rheumatoid arthritis: the patients perspective, Responsiveness and sensitivity to change of SLE disease activity measures, The Author(s) 2020. et al. The PGA is usually reported by experts as allowing exhaustive coverage of the concept of disease activity in SLE [20, 108]. Patient global assessment in measuring disease activity in rheumatoid 3TR (Taxonomy, Treatment, Targets and Remission) Systemic Lupus Erythematosus Study Protocol 2 Cloud, mobility, security, and more. Tel: 03 88 12 84 74; Fax: 03 88 12 82 90; E-mail: Measuring disease activity in adults with systemic lupus erythematosus: the challenges of administrative burden and responsiveness to patient concerns in clinical research, Patterns of disease activity in systemic lupus erythematosus, Novel evidence-based systemic lupus erythematosus responder index, Reliability and validity of six systems for the clinical assessment of disease activity in systemic lupus erythematosus, Failure to achieve lupus low disease activity state (LLDAS) six months after diagnosis is associated with early damage accrual in Caucasian patients with systemic lupus erythematosus, Treatment target in newly diagnosed systemic lupus erythematosus, 10 most important contemporary challenges in the management of SLE, Measurement of systemic lupus erythematosus activity in clinical research, Definition, incidence, and clinical description of flare in systemic lupus erythematosus. In the absence of a consensus, Aranow [26] found a better correlation between the SLEDAI and the PGA when the latter was assessed taking into account laboratory test results. , Jolly M. Mazur-Nicorici L , Lau CS More frequently, responsiveness was assessed by correlating changes in the PGA with changes in other scores [23, 50, 58, 77, 78, 81, 83], finding a significant correlation with variations in the SLEDAI (r=0.390.66) [23, 77, 78], SLAM (0.61) [77], LAI (0.56) [77], patient global assessment (0.37) [77], SRI-50 (0.48) [78] and ESR (P<0.0001) [58], but not with C3, C4, circulating immunocomplexes and prednisone dose [77]. Parodis I , Suriano A CLOSED ANGLE/ ANGLE CLOSURE GLAUCOMA. physician global assessment Recently Published Documents. 2014 Dec;53(12):2175-81. doi: 10.1093/rheumatology/keu153. A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.67-0.98). Systemic Lupus Erythematosus (SLE) | CDC The Senior Lead will be responsible for: Managing end to end production, governance and controls of Derivatives Standardized and Advanced RWA, and SLE Actuals. Diet and Systemic Lupus Erythematosus (SLE): From Supplementation to Intervention. An official website of the United States government. , Flower C A prospective cohort study, Validity and reliability of retrospective assessment of disease activity and flare in observational cohorts of lupus patients, A novel lupus activity index accounting for glucocorticoids: SLEDAI-2K glucocorticoid index, Low disease activityirrespective of serologic status at baselineassociated with reduction of corticosteroid dose and number of flares in patients with systemic lupus erythematosus treated with belimumab: a real-life observational study, Definition and initial validation of a lupus low disease activity state (LLDAS), A framework for remission in SLE: consensus findings from a large international task force on definitions of remission in SLE (DORIS), Prolonged remission in Caucasian patients with SLE: prevalence and outcomes, 2019 update of the EULAR recommendations for the management of systemic lupus erythematosus, PRISMA Group. , Liberati A SFI, LLDAS, SRI, Definitions of Remission in Systemic Lupus Erythematosus remission criteria) [3, 5, 10, 1315, 104]. , Andreoli L Additional papers were obtained by checking the references from the selected studies. , Carpenter AB 2022 Sep;8(2):e002395. Deconstruction of the safety of estrogen in lupus erythematosus national assessment-systemic lupus erythematosus disease activity index flare index. The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. The company serves physicians and patients. Despite the need for new treatments in CLE . Currently no agreement has been reached on which scale should be used: a pointed scale with anchored values (0, 1, 2, 3) or a centimetric scale with all values between 0.0 and 3.0. , Tanangunan R Jiao H, Acar G, Robinson GA, Ciurtin C, Jury EC, Kalea AZ. Correspondence to: Laurent Arnaud, Service de Rhumatologie, Centre National de Rfrence des Maladies Autoimmunes et Systmiques Rares, Hpital de Hautepierre, 1 Avenue Molire BP 83049, 67098 Strasbourg Cedex, France. The Physician Global Assessment (PGA) is an important tool for assessing disease activity in lupus. , Perneger T 12. and later incorporated into the SLE Responder Index used in the belimumab clinical trials, 13 , Magder L However, it is important to remember that not all clinical problems reported by a lupus patient are due to the disease. , Sjwall C. Strand V Feasibility refers not to the quality of the outcome measure, but to aspects such as completion time, cost of an instrument, equipment and type and ease of administration. In the absence of a well-recognized gold standard for disease activity, criterion validity of the PGA is established when it correlates with a measure that the author of the study defined a priori as the gold standard. The patients were diagnosed as having the following disorders: scleroderma (n = 27), dermatomyositis (n = 11), systemic lupus erythematosus (SLE) (n = 22), MCTD (n = 8), and RP without evidence of underlying CTD (n = 38). et al. Objective Existing methods for grading lupus flares or improvement require definition-based thresholds as increments of change. 8600 Rockville Pike Vil LM et al. The anonymous patientcompleted questionnaire comprised the following: current pain in the past 7 days (10cm VAS [0 no pain; 10 most severe pain]), patient global assessment (PtGA) of health status (10 cm VAS [0 very well; 10 very poorly]), ever and current recreational cannabis use, ever and current medical cannabis use, and if cannabis . Methods: Thanou A, Chakravarty E, James JA, Merrill JT. PDF Getting To Know Dr. Derek Shendell, New Safe Schools Project Director Content validity. , Jolly M. Mok CC The Author(s) 2020. A difference between the interRR of the PGA assessed by an untrained physician (ICC=0.50.63) or a trained investigator (ICC=0.790.81) was found [36]. , Petri M. Foering K 2022 Jan 11;11(2):340. doi: 10.3390/jcm11020340. Scoring systemic lupus erythematosus (SLE) disease activity with simple , Mazur M. Fatemi A , Maxwell LJ Construct validity was recognized in 21 studies [2, 10, 11, 23, 24, 2629, 35, 47, 52, 54, 65, 68, 76, 84, 88, 92, 99, 101]. Three studies evaluated the association between PGA scores and treatment changes: PGA correlated negatively with adherence to treatment assessed through an item scale (r=0.31, P=0.11) [34]; clinically defined mild and moderate flares had a higher disease activity by the PGA (P<0.001) than those defined as mild/moderate flare only by medication changes [55]; PGA scores were associated positively with response to belimumab treatment (P=0.039) [43]. , Ho LY , Matos A , Birmingham DJ The authors wish to thank Sylvie Thuong for her invaluable assistance in the preparation of this manuscript. , Holland M It should be noted that the PGA correlates with several other instruments that measure disease activity. The responsiveness of the PGA is the ability to detect worthwhile variations in disease activity over time, measuring worsening or improvements in SLE disease status. Criterion validity data reporting correlation coefficients between PGA and quality of life measures, laboratory markers and miscellaneous. Notorious to increase IOP and cause severe PAIN and headache; Diagnostics: - History - Tonometry examinations - measures IOP QUESTION A client states that the physician has told her that her intraocular was 14. Of note, the literature search revealed heterogeneous definitions of physician assessment of disease activity other than the PGA (physician global assessment [4, 70, 73], physician overall assessment [85]). Arthritis Res Ther. The interRR was assessed in seven studies [4, 10, 11, 36, 65, 68, 94], showing values ranging from 0.67 [68] to 0.96 [94]. Patient global assessment (PGA) is one of the most widely used PROs in RA practice and research and is included in several composite scores such as the 28-joint Disease Activity Score (DAS28). , Petri M. Thanou A 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. , Petri M All rights reserved. , Ibaez D In an epratuzumab trial, the absence of deterioration of the PGA (not >10% worsening) was one of the items to achieve a BILAG-based Composite Lupus Assessment (BICLA) response [105]. Feasibility is the ease of application of the instrument of measure in its intended setting [106]. , Sato JO Cutaneous lupus erythematosus (CLE) is an autoimmune skin disease that can occur with or without systemic lupus erythematosus (SLE). Navarra SV Discrimination refers to whether the score (PGA-VAS) differentiates between situations of interest [18]: discrimination of the PGA measures the ability of the PGA-VAS to report a consistent score where no change in disease activity has occurred (reliability) and to detect a change when a change in disease activity has occurred (sensitivity to change or responsiveness). The literature search identified 91 studies. , Landis RC Methods: This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items . MD globals may vary based on their age, gender, practice setting and experience (number of patients seen per year and years in practice). They participate in physiologic and inflammatory cascades and have become a major focus of research, yielding novel therapies for immune-mediated inflammatory diseases (IMID). Exagen's products are used for therapeutic drug monitoring of hydroxychloroquine in whole blood and methotrexate polyglutamates, risk assessment testing, anti-TNF monitoring to individualize therapy and optimize dosing, and others. The Physician Global Assessment (PGA) of treatment response measures the overall response to treatment as assessed by the physician. SLE2ACR1997SLICC2012. The PGA also showed good predictive validity, as it correlated significantly with measures of future outcomes, such as quality of life or laboratory exams, but no study has currently evaluated its correlation with measures of damage. Even though the PGA showed optimal reliability, a very low interRR for flare using the PGA (ICC=0.18) was found in a single study [65] compared with that of the BILAG (ICC=0.54) or SFI (ICC=0.21).
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