Annapureddy N Use of Physician Global Assessment in systemic lupus erythematosus: a , Voskuyl A Ann Rheum Dis 2011;70:54-9. Tyk2 Targeting in Immune-Mediated Inflammatory Diseases The Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus (PISCOS) study aimed to obtain an evidence-based and expert-based consensus standardisation of the Physician Global Assessment (PGA) scoring of disease activity in systemic lupus erythematosus (SLE). Immune Disorders, Deficiency, Etc - Key Points to Review: Initiation of Responsiveness, or sensitivity to change, is the usefulness of a test to detect minimum clinically important differences [20, 109]. (SLE) GSKpro Several definitions of minimum clinically important difference were retrieved: in the SRI-4, a significant worsening was defined as an increase of >10% on the PGA-VAS [111], corresponding to 0.3 points from baseline; Touma et al. Content validity was reported in 89 studies. Physician Global Assessment (PGA) is a visual analogue score (VAS) that reflects the clinician's judgment of overall Systemic Lupus Erythematosus (SLE) disease activity. Global Automatic Chemiluminescence Immunoassay Analyzer Market 2023 , Karp DR The interobserver agreement between physician (PGA) and patient (PtGA) global assessment for acne and psoriasis was good, reflected by the weighted Cohen (acne, = 0.68; psoriasis, = 0.70) (eTable in the Supplement). For permissions, please email: journals.permissions@oup.com. , Navarra SV 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. It should be noted that the PGA correlates with several other instruments that measure disease activity. LECTURE 10: MEDICAL SURGICAL NURSING. All rights reserved. The Physician Global Assessment (PGA) is an important tool for assessing disease activity in lupus. The aim of this systematic literature review (SLR) is to describe and analyse the psychometric properties of PGA. , Skogh T , Chizzolini C Content validity was reported in 89 studies. Observed and articulated management issues and responses. PDF Physician Global Assessment International Standardisation COnsensus in Merrill JT 2022 Sep;8(2):e002395. Physician global assessment in systemic lupus erythematosus: can we , Mazur M. Fatemi A Medizinische Universitt Graz Austria/sterreich - Forschungsportal - Medical University of Graz Direkt zur Navigaton springen . Wells GA 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. In 1988, Liang et al. et al. , Clowse M. Moorthy LN The search strategy for SSc-related publications identified 75 citations . , Oon S Construct validity is the degree to which the PGA relates to other instruments that measure the same concept [18]. AU - Kasitanon, Nuntana. et al. , Ibaez D Accessibility Akhter E Objective Physician's global assessment (PGA) of disease activity is a major determinant of therapeutic decision making. et al. , Zonana-Nacach A Thanou A, Chakravarty E, James JA, Merrill JT. Ensure second line of defense Derivatives RWA reviews are performed consistently and . Gordon C 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. , Hambleton IR Petri M , Devilliers H , Kalunian K Learn more. Parodis I , Seaman AL 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 . et al. AU - Morand, Eric. , Bresee C 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. , Hochberg M. Wallace DJ PGA - Lupus Research , Maxwell LJ , Taghavi-Zadeh S Conclusion: et al. Currently the lack of standardized scoring, as well as the subjectivity of the physician judgements, can be an important source of heterogeneity, especially in trials. [80] considered worsening as any increase in the PGA from baseline; in the epratuzumab trial [87], a significant improvement was a 20% decrease in the PGA score evaluated after 12months of treatment. [35], the PGA correlated, although moderately, with the need for treatment change (r=0.46, P<0.01). , Block JA PGA-IGA described in ePROVIDE - Mapi Research Trust , Petri M. Thanou A The Patient's Global Assessment Scale (PGA) is the PRO counterpart to the Physician's Global Assessment Scale or Investigator's Global Assessment Scale (PGA-IGA). However, no precise guidelines exist regarding the optimal use of the PGA in SLE, such as the adequate length of the VAS, the presence of anchored values, the incorporation of laboratory data and the time frame of assessment. Intoduction to X 20 - Physician Global Assessment Touma Z , Lau CS Deconstruction of the safety of estrogen in lupus erythematosus national assessment-systemic lupus erythematosus disease activity index flare index. , Tetzlaff J , Giannakou I Myelogram - correct answer NPO for 4-6 hours. 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. 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]). Physician's global assessment is often useful in SLE - ResearchGate , Mohan C. Jolly M 1), accounting for 49 longitudinal cohort studies, 25 cross-sectional studies, 7 randomized controlled trials, 3 consensus conferences, 4 post-hoc analyses, 2 retrospective studies and 1 case series. The aim of this systematic literature review (SLR) is to describe and analyse the psychometric properties of PGA. Physician's Global Assessment (PGA) score 1.0 on a 0 to 3 visual analog scale. A systematic review of the literature was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines [17], searching for articles reporting on the use of PGA in SLE. 2022 Mar 14;24(1):70. doi: 10.1186/s13075-022-02756-3. History of Changes for Study: NCT05672576 , Birmingham DJ The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and . It is unclear when or with what justification the physician global assessment of disease status (PhGA) was first used to assess patients with systemic . 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). No data were found regarding the feasibility of the PGA. Systemic Lupus Erythematosus (SLE) Treatment & Management - Medscape The correlation with the SLEDAI was determined in 12 studies (Fig. 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). RN-BSN HOLISTIC HEALTH ASSESSMENT ACROSS THE LIFESPAN (NURS 3315) Sociology of Social Problems (SOC213) et al. Background/Purpose: The Physician Global Assessment (PGA) is a frequently-used outcome measure in Systemic Lupus Erythematosus (SLE). This button displays the currently selected search type. These results enabled its use as a gold standard for assessing flare and defining flare severity in several studies [21, 67, 88]. Prinsen CAC The judgment of whether a patient with SLE has active disease is a central question both in routine patient management and in clinical research [4]. T1 - Associations between physicians' global assessment of disease activity and patient-reported outcomes in patients with systemic lupus erythematosus. 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 Comprehensive Digest of Research Publications From Cedars-Sinai Investigators. Touma Z Published by Oxford University Press on behalf of the British Society for Rheumatology. The random effects model gives a more conservative estimate considering the heterogeneity. 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. Physician global assessments for disease activity in rheumatoid This is a top barrier, both for treat-to-target management of SLE patients in clinical practice, as well as in clinical trials for new SLE treatments. 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. Arthritis Res Ther. , Fortin PR , Raeisi A 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 . Would you like email updates of new search results? Mina R , Perneger T Moher D 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. However, the PGA allows for the measurement of disease activity in a global way (content validity). Vashisht P , Emamikia S The term Physician Global Assessment (PGA) was coined in 1991 by Petri et al. , Henriques C Criterion validity. , Shea BJ 2019ACREULAR . JBT-101 in Systemic Lupus Erythematosus (SLE) et al. PDF Physician s global assessment is often useful in SLE, but not always SLE is an immune-mediated multisystemic disease characterized by a wide variability of clinical manifestations and a course frequently subject to unpredictable flares [1, 2]. Physician Global Assessment International - ScienceDirect The authors wish to thank Sylvie Thuong for her invaluable assistance in the preparation of this manuscript. Parodis I , OMalley T This may be explored through convergent and divergent validity. Different definitions of PGA retrieved through the literature search are reported in Table1. SLE231 Hydrology and Water Resources Management: Excursion or Virtual Tour doi: 10.1136/lupus-2022-000700. Physician Global Assessment to Track Outcomes - JAMA Use of Physician Global Assessment (PGA) in Systemic lupus - medRxiv Disclosure statement: L.A. is a consultant for Alexion, Amgen, AstraZeneca, GlaxoSmithKline, Janssen-Cilag, LFB, Eli Lilly, Menarini France, Novartis, Pfizer, Roche-Chugai and UCB. 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): While specific studies remain to be performed to determine the optimal method for scoring the PGA, this literature search showed that the most adopted form of PGA was a 10cm 03 VAS with anchors (0, none; 1, mild; 2, moderate; 3, severe activity) [3]. J Clin Med. 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). , Sjwall C. Strand V . , Kiani AN BICLA is a validated composite global measure of SLE disease activity including SLEDAI-2K, CLASI-A, OCS dosage reduction, and patient-reported outcomes. , Hochberg M. Touma Z et al. This potentially disfiguring disease can have significant impact on patient's quality of life (QoL) and is often refractory to many first- and second-line therapies. Gandhi N , Socher SA sharing sensitive information, make sure youre on a federal All clinical diagnoses were verified by review of the patients' inpatient and outpatient files at the time of capillaroscopy. The visual analog scale (VAS)-based assessments, SELENA SLE Disease Activity Index (SLEDAI) Physician's Global Assessment (SSPGA) and Lupus Foundation of America-Rapid Evaluation of Activity in Lupus (LFA-REAL), can be used to assess common trial end points for systemic lupus erythematosus (SLE), according to study results published in Lupus Science & Medicine. , Jolly M. Mok CC Epub 2014 Apr 11. [84] expressed the sensitivity in PGA scoring with the standardized response mean (SRM), demonstrating a very large effect size (ES=2.23) [110]. For full access to this pdf, sign in to an existing account, or purchase an annual subscription. , Annapureddy N , Burlingame RW Content validity. The PGA was developed on a 0 to 3 scale as part of the Lupus Activity Index. All articles published through 1 July 2019 in PubMed were screened, with no limitation on year of publication, language or patients age. et al. Lai J-S 2021 Apr 8;5(1):33. doi: 10.1186/s41687-021-00298-x. 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. et al. Results. , Morabito LM Retrieved papers were selected with no limitation on the year of publication, language or patients age. Physician Global Assessment International Standardisation COnsensus in et al. 3TR (Taxonomy, Treatment, Targets and Remission) Systemic Lupus Erythematosus Study Protocol 2 , Friebus-Kardash J 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. independently selected the articles, initially on the basis of titles and abstracts, then, if necessary, on the full texts, an eligibility assessment was performed independently in a blinded standardized manner. Beaton DE In one open-label study [43], the decrease in PGA score was considered the primary endpoint. MD globals may vary based on their age, gender, practice setting and experience (number of patients seen per year and years in practice). 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. 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]. , Borghoff K , Ding HH Touma Z , Perez-Gutthann S 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. 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. Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. 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]. , Guzmn RM , Weisman MH. , Fang H This week's edition of Faculty Publications includes Cedars-Sinai studies that were published Feb. 23-March 2. , Holland M A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.670.98). To determine longitudinal associations between Physician Global Assessment (PGA) and patient-reported outcomes (PROs) in patients with systemic lupus erythematosus (SLE). , Gladman DD , Merrill JT. , Cappellazzo G The Author(s) 2020. , Vogel-Claussen J SLE has protean and often complex manifestations, necessitating careful clinical assessment. Frontiers | Cutaneous lupus erythematosus disease assessment Objective: To examine the feasibility of using Physician Global Assessment (PGA) scores to collect and track patient acne and . The .gov means its official. SLE or at an SLE site, but only if the injury requires treatment by a licensed medical doctor. 2022 Jan 11;11(2):340. doi: 10.3390/jcm11020340. Scoring systemic lupus erythematosus (SLE) disease activity with simple In one study [25], the PGA of disease activity resulted from the combination of the clinical visit, laboratory markers evaluation and the physicians knowledge of the patient disease history. The geographical analysis of the Global Global Respiratory Devices market provided in the report is just the right tool that competitors can use to discover untapped sales and business expansion . This property is reported across all articles selected through this systematic review [24, 913, 21103]. Enocsson H Fanouriakis A , Urowitz MB Associations between physicians' global assessment of disease activity Impact of anti-SARS-CoV-2 antibodies of different isotypes (IgA, IgG, IgM) on attainment of PGA . , Kharboutli M Objective Existing methods for grading lupus flares or improvement require definition-based thresholds as increments of change. et al. , Su J Ragai Kiriakos, MD, MSc - Clinical Trials Physician - LinkedIn , Ko T Over the years, PGA-IGA scales were modified for the purpose of clinical settings and thus present a diversity in the number of response options (4 to 10 points), the response options label and the . A multi-item Physician Global Assessment scale to assess psoriasis , Criscione-Schreiber LG We have systematically reviewed all studies about validation of the PGA in SLE. , Andreoli L Feb 2016 - Jan 20182 years. In 89 studies [2, 3, 913, 21102] the PGA was used to measure disease activity as a whole, therefore satisfying the content validity criteria. , Gomez A Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. T2 - A longitudinal study. 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 . watch for seizures after the procedure. 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. Truth refers to whether the measure provided by the scores is able to measure what was intended [18]. Rendas-Baum R, Baranwal N, Joshi AV, Park J, Kosinski M. J Patient Rep Outcomes. Kiani AN Manzi S 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]. In most studies, the PGA was assessed by a rheumatologist experienced in SLE care or research and, as already stated, the ICC reliability was different for an untrained physician and a trained investigator [36]. 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. , Tugwell P Eudy AM Patient-Reported Outcomes in Systemic Lupus Erythematosus. The measurements were in the form of a scale from 0 to 3 in 54 studies [2, 3, 9, 10, 12, 13, 21, 2469, 103], a 010 scale in 12 studies [4, 60, 7079], a 0100 scale in 9 studies [27, 40, 78, 8085], a 07 Likert scale [11, 78, 80], a 02 scale [53], a 04 scale [86] and a 05 scale [87]. 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).