[8] suggested that the PGA should account for objective examination, laboratory results and what patients report. , Gayet-Ageron A Ragai Kiriakos, MD, MSc - Clinical Trials Physician - LinkedIn Manzi S Physician Global Assessment International Standardisation COnsensus in 1 2. The responsiveness of the PGA was assessed through different methods [109, 113] showing a high sensitivity for detecting clinical variations [84]. PMC , Allen E Strength. BILAGAB . Patient-reported outcomes (PROs) reflect the patient's perspective and are used in rheumatoid arthritis (RA) routine clinical practice. Jiao H, Acar G, Robinson GA, Ciurtin C, Jury EC, Kalea AZ. 2022 Sep 20;19(19):11895. doi: 10.3390/ijerph191911895. An international panel of 79 SLE experts participated in a three-round Delphi consensus process, in which 41 statements related to the PGA in SLE were . et al. Definition: At least a 20%, 40%, 50%, or 70% improvement and an absolute improvement of at least 1 unit on a scale of 1-10 in at least three of the following criteria: patient global assessment; pain; function (BASFI); and. Physician Global Assessment to Track Outcomes - JAMA The PISCOS results will allow for increased homogeneity and reliability of PGA ratings in routine clinical practice, definitions of remission and low disease activity, and future SLE trials. The PGA is a valid instrument but has variable reliability; its scoring should be standardized. 2014 Dec;53(12):2175-81. doi: 10.1093/rheumatology/keu153. , Voskuyl A Rendas-Baum R, Baranwal N, Joshi AV, Park J, Kosinski M. J Patient Rep Outcomes. 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. Measuring disease activity in adults with systemic lupus erythematosus , Gladman DD For permissions, please email: journals.permissions@oup.com, This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (. Objective: , Bouter LM , Esdaile JM. , Suriano A 2022 Mar 14;24(1):70. doi: 10.1186/s13075-022-02756-3. 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. The PGA is a well accepted and commonly used scale for evaluating treatment response in clinical trials both in adults and children. The index assesses separately eight organ-based systems. et al. The interrater reliability (interRR) of the PGA is the ability to provide consistent scores in a stable population between two or more physicians who evaluate the disease activity of the same patient. , Zonana-Nacach A , Jolly M. Mazur-Nicorici L 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 . Unauthorized use of these marks is strictly prohibited. Ann Rheum Dis 2011;70:54-9. , Stavrakis S Uribe AG, Vil LM, McGwin G Jr, Sanchez ML, Reveille JD, Alarcn GS. We analysed the performance of the SELENA SLEDAI Physician's Global Assessment (SSPGA) and the Lupus Foundation of America-Rapid Evaluation of Activity in Lupus (LFA-REAL) as measures . official website and that any information you provide is encrypted , Shinada S The PGA is intended to encapsulate the physician's judgement of overall disease activity.Consensus on whether the PGA should be performed prior to, or after the receipt of laboratory values is lacking. Franklyn K Criterion validity data reporting correlation coefficients between PGA and quality of life measures, laboratory markers and miscellaneous. The https:// ensures that you are connecting to the 8600 Rockville Pike 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). doi:10.1136/ rmdopen-2017-000578 Prepublication history and Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. Background/Purpose: The Physician Global Assessment (PGA) is a frequently-used outcome measure in Systemic Lupus Erythematosus (SLE). 2022 May;9(1):e000700. 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). MD globals may vary based on their age, gender, practice setting and experience (number of patients seen per year and years in practice). CareerBuilder TIP. Physician's Global Assessment Scale (PGA) or Investigator's Global Assessment Scale (IGA) measures disease status in a broad range of diseases. et al. government site. Reliability. (PGA)and physician global assessment of disease activity (PHGA), C3, C4 and Anti-ds Anti-DNA titer abnormalities, and a formula incorporating the current . The Physician Global Assessment (PGA) has been shown to be a valid, responsive, and feasible instrument to capture disease activity in systemic lupus erythematosus (SLE), but its low reliability further supports the need for a standardisation of its scoring. Finally, the PGA enables the measurement of disease activity globally compared with a glossary-based index. Schneider M Different definitions of PGA retrieved through the literature search are reported in Table1. Patient-Reported Outcomes in Systemic Lupus Erythematosus. Liang MH , Petri M , Karp DR , Urowitz MB One study, published after our systematic literature search was completed [112], showed that scoring the PGA with knowledge of laboratory data increased its correlation with the SLEDAI-2K (r=0.79) compared with without knowledge of laboratory results (r=0.67). Medizinische Universitt Graz Austria/sterreich - Forschungsportal Fatigue is independently associated with disease activity assessed using the Physician Global Assessment but not the SLEDAI in patients with systemic lupus erythematosus. Content validity pertains to the degree to which the instrument measures all facets of a construct of interest [20]: this property is satisfied if the PGA is considered able to measure all aspects of disease activity in SLE in a comprehensive way. All rights reserved. In this systematic review we have analysed the measurement properties of the PGA, including the validity, reliability, responsiveness and feasibility. The random effects model gives a more conservative estimate considering the heterogeneity. AB - The Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus (PISCOS) study aimed to obtain an evidence . , Farewell V , Leung HW , Terwee CB 2022 Sep;8(2):e002395. This scoring modality was used for the SRI [3]. Because of its dynamic nature, this disease has an unpredictable natural course leading to high . Jesus D The Physician Global Assessment (PGA) of treatment response measures the overall response to treatment as assessed by the physician. , Petri M. Foering K . Physician's global assessment is often useful in SLE - ResearchGate The assessment of disease activity in SLE is particularly challenging. Medical-Surgical Nursing Clinical Lab (NUR1211L) U.S. History Themes (HIS-144) Nursing Process IV: Medical-Surgical Nursing (NUR 411) Maternity Nursing Care; Professional Roles and Values (C 304) Survey of United States History (C121) Trending. Deconstruction of the safety of estrogen in lupus erythematosus national assessment-systemic lupus erythematosus disease activity index flare index. , Kalunian K Keywords: et al. Five studies have demonstrated good ICC values for reliability (all >0.60 and ranging up to 0.97). , Alarcn GS AU - Kasitanon, Nuntana. A multi-item Physician Global Assessment scale to assess psoriasis et al. and transmitted securely. Exagen Diagnostics Inc (XGN) - Product Pipeline Analysis, 2022 Update However, it is important to remember that not all clinical problems reported by a lupus patient are due to the disease. The .gov means its official. [84] expressed the sensitivity in PGA scoring with the standardized response mean (SRM), demonstrating a very large effect size (ES=2.23) [110]. Comparison of the validity and sensitivity to change of 5 activity indices in systemic lupus erythematosus. et al. , Taghavi-Zadeh S , Larson MG Derivatives RWA Production Controller (SA-CCR/SLE) PGA-IGA described in ePROVIDE - Mapi Research Trust 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). Mok CC 12. and later incorporated into the SLE Responder Index used in the belimumab clinical trials, 13 In 16 studies the PGA was used as a mean to assess changes in disease activity after treatment [3, 12, 22, 29, 40, 42, 43, 52, 54, 56, 57, 80, 85, 87, 95, 98, 101]. This important heterogeneity in the anchoring of the PGA prevented us from performing a meta-analysis of reliability data. Devilliers H JBT-101 in Systemic Lupus Erythematosus (SLE) T1 - Associations between physicians' global assessment of disease activity and patient-reported outcomes in patients with systemic lupus erythematosus. Can Lupus Patients Take the Driver's Seat in Their Disease Monitoring. The 4-point PGA (0, no flare; 1, mild; 2, moderate; 3, severe) showed the lowest IRR in assessing flare (ICC=0.18) compared with the BILAG-2004 (ICC=0.54) and SFI (ICC=0.21) [65]. The results are similar, and less than half the time is required for scoring. Thank you for submitting a comment on this article. Genetic linkage has related dysfunction of . , Hambleton IR Trusted for over 30 years to provide and transform technology into complete solutions that advance the value of IT. 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. , Urowitz MB The PGA intraRR was assessed in three studies [10, 68, 94] and ranged from 0.55 [68] to 0.88 [10]. SLE231 Hydrology and Water Resources Management: Excursion or Virtual Tour The quantification of reliability is expressed by a correlation coefficient. The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinicians judgement of overall SLE disease activity. 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 . Methods: All articles published through 1 July 2019 in PubMed were screened, with no limitation on year of publication, language or patients age. Faculty Publications: Feb. 23-March 2 The last MEDLINE search was performed on 1 July 2019. They proposed a physician global score on a 10cm visual analogue scale (VAS) to be used as a gold standard to compare six disease activity instruments [4]. Rheumatology (Oxford). Gyri N 2014 Sep-Oct;10(5):309-20. doi: 10.1016/j.reuma.2014.01.012. Provide oversight to Shared Services Derivatives team supporting RWA operations and production. These results enabled its use as a gold standard for assessing flare and defining flare severity in several studies [21, 67, 88]. et al. Face validity. et al. . The literature search identified 93 articles, and 12 additional articles were retrieved from the reference list of those publications. The content can vary and relates either to global health (e . , Piette EW Content validity. et al. 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]. , Bocci EB History of Changes for Study: NCT05672576 It operates in Albuquerque, and New Mexico. European League Against Rheumatism. 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. et al. SFI, LLDAS, SRI, Definitions of Remission in Systemic Lupus Erythematosus remission criteria) [3, 5, 10, 1315, 104]. , Petri M. Thanou A , Flower C Intoduction to X 20 - Physician Global Assessment , Kharboutli M No study has evaluated the correlation of PGA with damage measures. Enocsson H Feb 2016 - Jan 20182 years. doi: 10.1136/lupus-2022-000700. Funding: The study was funded through the training Bursary Programme 2019 of the SLEuro European Lupus Society. Mina R 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. Introduction Physician global assessments of disease activity (medical doctor (MD) globals) are important outcomes. Use of Physician Global Assessment (PGA) in Systemic lupus - medRxiv Retrieved papers were selected with no limitation on the year of publication, language or patients age. Deconstruction of the safety of estrogen in lupus erythematosus national assessment-systemic lupus erythematosus disease activity index flare index, Effect of raloxifene on disease activity and vascular biomarkers in patients with systemic lupus erythematosus: subgroup analysis of a double-blind randomized controlled trial, Omega-3 in SLE: a double-blind, placebo-controlled randomized clinical trial of endothelial dysfunction and disease activity in systemic lupus erythematosus, Erythrocyte sedimentation rate is a predictor of renal and overall SLE disease activity, Characterization of clinical photosensitivity in cutaneous lupus erythematosus, Validation of the systemic lupus erythematosus responder index for use in juvenile-onset systemic lupus erythematosus, Depressive symptoms and associated factors in systemic lupus erythematosus, Validation of the Portuguese simple measure of impact of lupus erythematosus in youngsters (SMILEY) in Brazil, Anti-C1q antibodies have higher correlation with flares of lupus nephritis than other serum markers, Performance of anti-C1q, antinucleosome, and anti-dsDNA antibodies for detecting concurrent disease activity of systemic lupus erythematosus, An assessment of disease flare in patients with systemic lupus erythematosus: a comparison of BILAG 2004 and the flare version of SELENA, Noncalcified coronary plaque in systemic lupus erythematosus, Decreases in anti-double-stranded DNA levels are associated with concurrent flares in patients with systemic lupus erythematosus, Validity and reliability of lupus activity measures in the routine clinic setting, Clinical predictors of response and discontinuation of belimumab in patients with systemic lupus erythematosus in real life setting. The PGA was developed on a 0 to 3 scale as part of the Lupus Activity Index. Observed and articulated management issues and responses. 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. Systemic lupus erythematosus (SLE), is the most common type of lupus. A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.67-0.98). Help us improve CareerBuilder by providing feedback about this job: Report this job Job ID: 2281236908. A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.670.98). , Anderson N lupus erythematosus; systemic outcome assessment; qualitative research; healthcare; We read with great interest the recent paper by Aranow et al 1 about the impact of laboratory results on scoring of the Physician Global Assessment (PGA) of disease activity in systemic lupus erythematosus (SLE). , Glassman DS COSMIN Terminology from a European Rheumatology Perspective: a Glossary for the EULAR PRO Tool Box Initiative. , Jolly M. Ribi C 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]. , Giangreco D , Devilliers H et al. 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]. , Mokkink LB , Engle E , Nguyen SC , Magder L The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. The intrarater reliability (intraRR) is the ability to provide consistent scores in a stable population by the same assessor over time. SLE has protean and often complex manifestations, necessitating careful clinical assessment. The Physician's Global Assessment (PhGA) is a number without unit. , Khamashta MA Laboratory Investigation Results Influence Physician's Global Lead Medical Director heading up the global collaboration with Pfizer for Enbrel trials. , Hennis A. Jesus D , Wallace DJ , Birmingham DJ Navarra SV In the last 30years, more than a dozen scores have been derived to assess disease activity in SLE, but not all of these have proven to be valid and reliable tools. physician global assessment (pga) - Assesschild Clinical composite measures of disease activity and damage used to evaluate patients with systemic lupus erythematosus: A systematic literature review. ECG - correct answer no sleep the night before, meals allowed, no stimulants/tranquilizers for 24-48 hours before. This enabled the PGA to be considered the gold standard in several studies [2, 10, 11, 21, 23, 49, 67, 76, 78, 84, 88]. This suggests that the role of the PGA is limited for disease activity assessment when used as a single instrument. There is no cure for lupus, but medical . BICLA is a validated composite global measure of SLE disease activity including SLEDAI-2K, CLASI-A, OCS dosage reduction, and patient-reported outcomes. The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. PDF Physician Global Assessment International Standardisation COnsensus in The literature search identified 91 studies. Published by Oxford University Press on behalf of the British Society for Rheumatology. SLE3. A good correlation was considered for a value >0.60. The Validity of Patient and Physician Global Disease Activity Use of Physician Global Assessment in systemic lupus erythematosus: a