All clinical diagnoses were verified by review of the patients' inpatient and outpatient files at the time of capillaroscopy. , Mohan C. Giangreco D , Urowitz MB. Ward et al. Thank you for submitting a comment on this article. Eudy AM Reliability measures the reproducibility of the instrument: it refers to the degree of agreement between different observers (interrater) and in the same observer over time (intrarater). 2) [10, 23, 24, 26, 28, 29, 35, 54, 68, 76, 84, 99], with the SLAM in 4 studies (r=0.470.65) [35, 76, 84, 99], with LAI in 2 studies (r=0.640.75) [68, 84], with BILAG in 2 studies (r=0.610.62) [35, 84] and with ECLAM in 2 studies (r=0.580.65) [35, 84]. Please check for further notifications by email. In conclusion, the PGA was demonstrated to be a valid, responsive and feasible instrument, but its reliability was strongly impacted by the scale adopted, suggesting the need for standardization in its scoring. Presence of at least one of the following items of serological evidence of active SLE or biological variables predictive of Type 1 Interferon (IFN-1) high signature (in a Screening sample as measured by central laboratory): All rights reserved. Thousand Oaks. The site is secure. Int J Environ Res Public Health. Liang et al. Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. , Petri MA , Gayet-Ageron A , Oon S Mertz P, Piga M, Chessa E, Amoura Z, Voll RE, Schwarting A, Maurier F, Blaison G, Bonnotte B, Poindron V, Fiehn C, Lorenz HM, Korganow AS, Sibilia J, Martin T, Arnaud L. RMD Open. , Leung HW allergy hx phenothiazines, cns depressants and stimulants withheld 48 hours prior. , Gordon C Content validity. Results of a large, multicentric, nationwide study, American College of Rheumatology provisional criteria for global flares in childhood-onset systemic lupus erythematosus, A cross-sectional study of hydroxychloroquine concentrations and effects in people with systemic lupus erythematosus, Inactive disease and remission in childhood-onset systemic lupus erythematosus, Preliminary criteria for global flares in childhood-onset systemic lupus erythematosus, Systemic lupus erythematosus in a multiethnic US cohort, XXXVII: association of lymphopenia with clinical manifestations, serologic abnormalities, disease activity, and damage accrual, Systemic lupus erythematosus in a multiethnic cohort (LUMINA): XXIX. 2022 Mar 14;24(1):70. doi: 10.1186/s13075-022-02756-3. This suggests that the role of the PGA is limited for disease activity assessment when used as a single instrument. Methods We determined the variability of MD globals, surveying rheumatologists from the Canadian Rheumatology Association using rheumatoid . The official NJDOE Incident Reporting Form, as well as a guide to completing Direkt zum Inhalt springen . 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]. , Magder LS Prinsen CAC The pooled correlation coefficient (95% CI) is given both for the fixed effects model and the random effects model. Reliability. , Skogh T Criterion validity is defined as the degree to which the scores of an instrument adequately reflect the truth in the form of a gold standard [107]. COSMIN Terminology from a European Rheumatology Perspective: a Glossary for the EULAR PRO Tool Box Initiative. , Gomez A The LUMINA (Lupus in Minorities: Nature versus Nurture) study and other trials have offered evidence of a decrease in flares and prolonged life in patients given hydroxychloroquine, making . LECTURE 10: MEDICAL SURGICAL NURSING. , Hearth-Holmes M. Khan A In support of its face validity, the PGA was used to define the disease activity score in all 91 studies retrieved by the literature search, having a role as an outcome measure as well as a comparator to assess the validity of other indices. Uribe AG, Vil LM, McGwin G Jr, Sanchez ML, Reveille JD, Alarcn GS. physician's global assessment (PGA) of disease activity in SLE. , Morabito LM According to the authors, this difference was probably due to the greater familiarity of the physicians with the BILAG-2004 index. 3TR (Taxonomy, Treatment, Targets and Remission) Systemic Lupus Erythematosus Study Protocol 2 Glossary: PGA. Fanouriakis A , Carpenter AB Search for other works by this author on: Rheumatology Unit, AOU University Clinic and University of Cagliari, Department of Medical Sciences and Public Health, Cagliari, Italy, Centre Hospitalier Universitaire de Dijon, Hpital Franois-Mitterrand, service de mdecine interne et maladies systmiques (mdecine interne, 2) et Centre dInvestigation Clinique, Service de rhumatologie, Hpitaux Universitaires de Strasbourg, Universit de Strasbourg, Centre National de Rfrence des Maladies Systmiques et Autoimmunes Rares Est Sud-Ouest (RESO). The Physician Global Assessment (PGA) is an important tool for assessing disease activity in lupus. , Arbab-Zadeh A Merrill JT , Flower C AU - Louthrenoo, Worawit. , Socher SA , Landis RC In a post-hoc analysis of phase 3 belimumab trials, improvements and no worsening in the PGA were greater among SRI responders vs SRI non-responders (P<0.001) [52]. et al. Criterion validity data reporting correlation coefficients between PGA and quality of life measures, laboratory markers and miscellaneous. Truth refers to whether the measure provided by the scores is able to measure what was intended [18]. Higher disease activity is an important predictor of both organ damage and mortality [2] and the attainment of low disease activity is associated with a reduction in early damage [5, 6]. , Petri MA , Urowitz MB The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. 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]. Feb 2016 - Jan 20182 years. , Devilliers H Gordon C et al. Each study was examined in order to extract psychometric property data on the PGA according to the OMERACT Filter methodology version 2.1 [18]. 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). , Maxwell LJ Cloud, mobility, security, and more. , Jolly M. Ribi C , Pilkington C AU - Kandane-Rathnayake, Rangi. A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.67-0.98). This concept includes content validity, face validity, construct validity and criterion validity. Annapureddy N , Voskuyl A Stojan G 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. Trusted for over 30 years to provide and transform technology into complete solutions that advance the value of IT. Matthew Turk,1,2 Janet E Pope1,2 To cite: turk M, Pope Je. 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. , Holland M Quimby KR , Saad-Magalhes C IgM) on attainment PhGA. et al. Five centres in Great Britain and the Republic of Ireland have collaborated to produce a computerized index of clinical disease activity in systemic lupus erythematosus, based on the principle of the physician's intention to treat. However, the PGA allows for the measurement of disease activity in a global way (content validity). Compared with nonresponders, BICLA responders had greater improvements in global and organ-specific disease activity (Physician's Global Assessment, SLE Disease Activity Index 2000, Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity, and joint counts; all nominal P < 0.001). . 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). Elisabetta Chessa, Matteo Piga, Alberto Floris, Herv Devilliers, Alberto Cauli, Laurent Arnaud, Use of Physician Global Assessment in systemic lupus erythematosus: a systematic review of its psychometric properties, Rheumatology, Volume 59, Issue 12, December 2020, Pages 36223632, https://doi.org/10.1093/rheumatology/keaa383. This enabled the PGA to be considered the gold standard in several studies [2, 10, 11, 21, 23, 49, 67, 76, 78, 84, 88]. , Kandane-Rathnayake RK , McGuire JL. Mina R , Criscione-Schreiber LG , Hynan LS ECG - correct answer no sleep the night before, meals allowed, no stimulants/tranquilizers for 24-48 hours before. 2019ACREULAR . Federal government websites often end in .gov or .mil. 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). , Burlingame RW On stratifying the results by individual clinician, values ranged from 0.61 to 0.90, except for those reported by . , Hennis A. Jesus D Mina R Conclusion: Improving patient pathways for systemic lupus erythematosus: a multistakeholder pathway optimisation study. ~SLE~. 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]. , Ding HH In 89 studies [2, 3, 913, 21102] the PGA was used to measure disease activity as a whole, therefore satisfying the content validity criteria. , Piette EW , Kalunian K Assessing disease activity in rheumatic diseases such as systemic lupus erythematosus (SLE) is vital for effective treatment. T2 - A longitudinal study. , Jolly M. Mok CC et al. , Taghavi-Zadeh S The Author(s) 2020. Physician global assessments for disease activity in rheumatoid arthritis are all over the map!. Manzi S , Perneger T Management of systemic lupus erythematosus (SLE) often depends on disease severity and disease manifestations, [] although hydroxychloroquine has a central role for long-term treatment in all SLE patients. A validation study of the SRI for juvenile SLE [60] showed that exclusion of the BILAG or PGA from the SRI did not change the accuracy of the SRI in detecting improvement. Methods In 11 retrieved studies [10, 13, 33, 36, 45, 48, 50, 55, 56, 65, 96] the PGA was part of the SFI [104] and in 10 studies [3, 29, 40, 46, 52, 60, 69, 80, 94, 98] it was part of the SRI [3] (both discussed in the Responsiveness section). , Urowitz MB , Sengupta M An acceptable reliability is indicated by values of intraclass correlation coefficient (ICC) or weighted >0.60 and a good reliability is >0.85 [20]. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. For full access to this pdf, sign in to an existing account, or purchase an annual subscription. , Glassman DS Rendas-Baum R, Baranwal N, Joshi AV, Park J, Kosinski M. J Patient Rep Outcomes. 2022 Jan 11;11(2):340. doi: 10.3390/jcm11020340. RMD Open 2018;4:e000578. No data were found regarding the feasibility of the PGA. Supporting the face validity property, PGA was defined the gold standard in 11 studies [2, 10, 11, 21, 23, 49, 67, 76, 78, 84, 88] and in 32 it was used as the reference to which other activity scores were compared, such as the SLEDAI [4, 10, 13, 25, 27, 28, 31, 33, 35, 36, 41, 46, 47, 50, 51, 53, 62, 65, 68, 72, 73, 76, 81, 9699], BILAG [4, 27, 35, 36, 46, 65, 72, 73, 81, 98], SLAM [4, 72, 76, 99], LAI [68, 88], patient global assessment [81, 83, 84] and ECLAM [35]. , Farewell V , Hochberg M. Wallace DJ (PGA) scoring of disease activity in systemic lupus erythematosus (SLE). Liang MH , Jnsen A Physician Global Assessment (PGA) is a visual analogue score (VAS) that reflects the clinician's judgment of overall Systemic Lupus Erythematosus (SLE) disease activity. Psychometric properties of FACIT-Fatigue in systemic lupus erythematosus: a pooled analysis of three phase 3 randomised, double-blind, parallel-group controlled studies (BLISS-SC, BLISS-52, BLISS-76). , Dyer JW , Matos A FitzGerald and Grossman [10] found a good interRR in a retrospective assessment of the PGA (=0.79). Forbess LJ , Guzmn RM Subsequently the PGA was incorporated in the Safety of Estrogen in Lupus Erythematosus National Assessment (SELENA) flare index (SFI) in 1999 [10], in the Systemic Responder Index (SRI) in 2009 [3, 11, 12] as well as in the definitions of the Lupus Low Disease Activity State (LLDAS) [13] and various definitions of remission [14, 15]. , Cappellazzo G Background/Purpose: The Physician Global Assessment (PGA) is a frequently-used outcome measure in Systemic Lupus Erythematosus (SLE). 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. Arthritis Res Ther. et al. Genetic linkage has related dysfunction of . Brunner HI Petri M The aim of this systematic review is to describe and analyse the measurement properties of the PGA, including the validity, reliability, responsiveness and feasibility. 2014 - 20184 years. , Nguyen SC , Petri MA Neuropsychiatry OXFORD TEXTBOOKS IN PSYCHIATRY Oxford Textbook of Neuropsychiatry Edited by Niruj Agrawal, Rafey Faruqui, and Mayur Bodani Oxford Textbook of Psychiatry of Intellectual Disability Edited by Sabyasachi Bhaumik and Regi Alexander Oxford Textbook of Inpatient Psychiatry Edited by Alvaro Barrera, Caroline Attard, and Rob Chaplin Oxford Textbook of Attention . It does not provide a predefined or limited list of disease manifestations or organ systems, thus allowing one to capture all the heterogeneous aspects of SLE disease activity. A total of 91 articles were included in the study (Fig. , Urowitz MB , Floris A , Petri M. Foering K et al. et al. Patient-Reported Outcomes in Systemic Lupus Erythematosus. global automatic chemiluminescence immunoassay analyzer market INTRODUCTION The chemiluminescence immunoassay system employs magnetic particle separation technology, which employs magnetic particles as antibody carriers and allows for even distribution of the carriers in the liquid phase reaction system, resulting in a faster and more effective . 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. BICLA is a validated composite global measure of SLE disease activity including SLEDAI-2K, CLASI-A, OCS dosage reduction, and patient-reported outcomes. Unable to load your collection due to an error, Unable to load your delegates due to an error. PGA is a simple instrument and the result is easily understood. , Cella D. van Vollenhoven RF The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. , Clowse M. Moorthy LN Ensure second line of defense Derivatives RWA reviews are performed consistently and . Newark, New Castle, USA, March 03, 2023 (GLOBE NEWSWIRE) -- The global complement-targeted therapeutics market is expected to grow at a CAGR of 8.9% from 2022 to 2030, owing to the rising . et al. 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). In one open-label study [43], the decrease in PGA score was considered the primary endpoint. Changes in the PGA correlated with changes of other disease activity indices (SLEDAI, SLAM, LAI, patient global assessment), laboratory exams (ESR), patient-reported outcomes (Lupus Impact Tracker) [23, 50, 58, 77, 78, 81, 83] and response to treatment [4]. In this sense, criterion validity of PGA is satisfied when scores correlate with phenomena subsequently influenced by disease activity, such as quality of life measurements (Health-related Quality of Life, 36-item Short Form Health Survey, Functional Assessment of Chronic Illness TherapyFatigue score, Lupus Impact Tracker and LupusPRO), biomarker levels (complement fractions, ESR, autoantibodies), treatment variations and damage assessments (SDI). 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.
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