Lead Medical Director heading up the global collaboration with Pfizer for Enbrel trials. . X 20 Physician Global Assessment 10.1136/lupus-2019-lsm.176 . 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]. Correlations with other instruments measuring similar constructs should typically demonstrate a coefficient (r) 0.50 [106]. , Ding HH In the second column, the definitions were reported according to the VAS used in the study. 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. Importance: In dermatology, the development of objective, standardized quality measures that can be used in a clinical setting is important to be able to respond to the needs of payers and credentialing and licensure bodies and to demonstrate dermatologic value. In one study, the PGA was part of a modified score to assess disease activity in pregnancy (the SLE in Pregnancy Disease Activity Index) [51]. Can Lupus Patients Take the Driver's Seat in Their Disease Monitoring. Thank you for submitting a comment on this article. 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]. watch for seizures after the procedure. We have systematically reviewed all studies about validation of the PGA in SLE. , Roberts WN Forbess LJ , Giannakou I One study showed a significant ability of the PGA in distinguishing between patients (P<0.0001) and observers (P<0.0001), but not between visits [79]. The Janus kinase (Jak)/signal transducer and activating protein (STAT) pathways mediate the intracellular signaling of cytokines in a wide spectrum of cellular processes. , Chatzidionysiou K 2022 Jan 11;11(2):340. doi: 10.3390/jcm11020340. , Block JA Objective: To examine the feasibility of using Physician Global Assessment (PGA) scores to collect and track patient acne and . In our centre, new tools for the assessment of SLE activity: the Lupus Activity Scoring Tool (LAST) and Clinical Lupus Activity Scoring Tool (C-LAST) were developed and validated. doi:10.1136/ rmdopen-2017-000578 Prepublication history and 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 . , Ko T , Oon S In Fatemi et al. Piga M , Petri MA 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. The PGA was developed on a 0 to 3 scale as part of the Lupus Activity Index. , Magder LS Before Few studies reported on whether serological activity should be incorporated in the PGA. This may be explored through convergent and divergent validity. Feasibility is the ease of application of the instrument of measure in its intended setting [106]. Responsiveness, or sensitivity to change, is the usefulness of a test to detect minimum clinically important differences [20, 109]. , Cappellazzo G , Voskuyl A et al. 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. Enocsson H . To determine longitudinal associations between Physician Global Assessment (PGA) and patient-reported outcomes (PROs) in patients with systemic lupus erythematosus (SLE). An official website of the United States government. 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. , Alunno A , Wallace DJ Methods We determined the variability of MD globals, surveying rheumatologists from the Canadian Rheumatology Association using rheumatoid . et al. 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. , Mosca M 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). Gordon C 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]. et al. et al. 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. All rights reserved. A good responsiveness for PGA was shown in eight studies. , Sengupta M Fanouriakis A et al. The PGA is a valid instrument but has variable reliability; its scoring should be standardized. , Wetter J Different definitions of disease activity according to the PGA instrument. The assessment of PGA responsiveness was performed in 10 studies [4, 23, 50, 58, 7779, 81, 83, 84] using different methods [110]. Annapureddy N The sensitivity to change was estimated to be the smallest for the SLEDAI; the standardized response means were 0.48 when the physician global assessment was used as the standard and 0.01 when the patient global assessment was used . et al. 8600 Rockville Pike Impact of anti-SARS-CoV-2 antibodies of different isotypes (IgA, IgG, IgM) on attainment of PGA . , Raeisi A 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. , Klein-Gitelman MS , Ogale S 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]. 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). Criterion validity also refers to the degree to which an instrument predicts aspects and phenomena occurring in the future [108]. Unauthorized use of these marks is strictly prohibited. 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. , Gladman DD The .gov means its official. Schneider M 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. Measurement properties of the PGA were analysed according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) terminology [19]. et al. Content validity. 2. Copay AG , Matos A Chaigne B Thus the development of a comprehensive index for assessing disease activity still represents one of the most important challenges in SLE [7]. The other authors have declared no conflicts of interest. Petri M 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]. Whenever papers reported duplicate data, the most recent article was selected. RMD Open 2018;4:e000578. 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]. Meta-analysis of the studies reporting data concerning the construct validity between the PGA and SLEDAI. Rheumatology (Oxford). , Wallace DJ PMC , Perez-Gutthann S This button displays the currently selected search type. , Birmingham DJ The company serves physicians and patients. Merrill JT , Matos A Assessing disease activity in rheumatic diseases such as systemic lupus erythematosus (SLE) is vital for effective treatment. , Kiani AN , Beaumont JL For full access to this pdf, sign in to an existing account, or purchase an annual subscription. , Bresee C et al. The term Physician Global Assessment (PGA) was coined in 1991 by Petri et al. This study assesses the reliability of the PGA, measured by means of 0-100 mm visual analog scale (VAS), and the additional use of separate VAS scales for musculoskeletal (PhysMSK) and dermatologic (PhysSk) manifestations in patients with psoriatic arthritis (PsA). Your comment will be reviewed and published at the journal's discretion. , Pego-Reigosa J-M , Kraag GR 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]. T1 - Associations between physicians' global assessment of disease activity and patient-reported outcomes in patients with systemic lupus erythematosus. Visual analogue scales (VAS) allow rapid, continuous scaling of disease severity. Touma Z A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.67-0.98). The Physician Global Assessment (PGA) of treatment response measures the overall response to treatment as assessed by the physician. 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]. et al. , Piette EW , Kalunian K sharing sensitive information, make sure youre on a federal The Senior Lead will be responsible for: Managing end to end production, governance and controls of Derivatives Standardized and Advanced RWA, and SLE Actuals. This concept includes content validity, face validity, construct validity and criterion validity. 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. 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. , Jolly M. Antony A , Mina R 2014 Sep-Oct;10(5):309-20. doi: 10.1016/j.reuma.2014.01.012. , Larson MG , Goldsmith CH Injuries requiring medical treatment are considered to be "reportable incidents," and must be reported to the NJDOE within five working days of the occurrence. , Schur PH. , Carpenter AB , Vogel-Claussen J Mina R Ensure second line of defense Derivatives RWA reviews are performed consistently and . , Dyer JW , Flower C [35], the PGA correlated, although moderately, with the need for treatment change (r=0.46, P<0.01). Ward et al. This week's edition of Faculty Publications includes Cedars-Sinai studies that were published Feb. 23-March 2. , Devilliers H OBJECTIVE The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. The following search strategy was used through MEDLINE via PubMed: (((lupus erythematosus, systemic[MeSH Terms] OR (lupus[TIAB] AND erythematosus[TIAB] AND systemic[TIAB]) OR systemic lupus erythematosus[TIAB] OR (systemic[TIAB] AND lupus[TIAB] AND erythematosus[TIAB]))) OR SLE[TIAB]) AND (physician global assessment[TIAB] OR PGA[TIAB]). The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. Once two investigators (E.C., M.P.) , Gayet-Ageron A , Bentow C et al. BILAGAB . , Ho LY TOTAL DOCUMENTS. 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. A Comprehensive Digest of Research Publications From Cedars-Sinai Investigators. et al. 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. , Glassman DS 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 . Physician global assessments for disease activity in rheumatoid arthritis are all over the map!. , Bonithon-Kopp C Thanou A , Morabito LM The index has proved quick and easy to use despite a comprehensive database and compares favourably with . , Engleman EG It can affect the joints, skin, brain, lungs, kidneys, and blood vessels. , Gordon C et al. . , ODell JR Retrieved papers were selected with no limitation on the year of publication, language or patients age. Barr et al. , Brunetta P et al. , Su J The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). BICLA is a validated composite global measure of SLE disease activity including SLEDAI-2K, CLASI-A, OCS dosage reduction, and patient-reported outcomes. (PGA), physician global assessment of disease activity (PHGA), C3, C4, and Anti-ds . 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). Matthew Turk,1,2 Janet E Pope1,2 To cite: turk M, Pope Je. , Hochberg M. Wallace DJ et al. The results are similar, and less than half the time is required for scoring. A 21-numbered circle visual analog scale (VAS) may be a desirable alternative to the traditional 10-cm horizontal line for pain and patient global estimate on a Multidimensional Health Assessment Questionnaire (MDHAQ). (PGA) scoring of disease activity in systemic lupus erythematosus (SLE). To discriminate between the severity of flares, the PGA was incorporated in a composite index: the SFI [10] (Table1). An assessment of disease flare in patients with systemic lupus erythematosus: a comparison of BILAG 2004 and the flare version of SELENA. A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.670.98). Physician global assessments for disease activity in rheumatoid arthritis are all over the map! 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 . , Cella D. van Vollenhoven RF MD globals may vary based on their age, gender, practice setting and experience (number of patients seen per year and years in practice). , OMalley T Aranow C Systemic lupus erythematosus (SLE) is a multisystem autoimmune rheumatic disease (ARD) characterized by flares and remissions. Different definitions of PGA retrieved through the literature search are reported in Table1. Of note, it is not trivial that we found a good convergent validity with other instruments (SLEDAI, BILAG, LAI, SLAM and ECLAM) [10, 23, 24, 26, 28, 29, 35, 54, 68, 76, 84, 99]. , Burlingame RW SLE has protean and often complex manifestations, necessitating careful clinical assessment. The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. , Petri M. Thanou A 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). 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). A good responsiveness for PGA was shown in eight studies. et al. Akhter E Your recommendations as to what might or should be done in relation to various issues observed. Mahler M , Emamikia S 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. et al. A PGA 2 correlated with a risk of pregnancy loss (29% vs 8%, P=0.005) [49]. 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]. 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). Patient-Reported Outcomes in Systemic Lupus Erythematosus. , Lerman RH The content can vary and relates either to global health (e . The official NJDOE Incident Reporting Form, as well as a guide to completing This important heterogeneity in the anchoring of the PGA prevented us from performing a meta-analysis of reliability data. , Kosinski M Disclaimer. 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]. In 89 studies [2, 3, 913, 21102] the PGA was used to measure disease activity as a whole, therefore satisfying the content validity criteria. Parodis I 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). However, it was used as a single outcome measure only in two studies [49, 100], while in the majority the PGA was scored together with another instrument (typically the SLEDAI) [2, 9, 11, 12, 21, 24, 30, 32, 34, 3740, 44, 45, 48, 49, 55, 58, 59, 61, 63, 64, 66, 67, 74, 75, 80, 82, 86, 8995, 103]. Please enable it to take advantage of the complete set of features! 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. Quimby KR , Ibaez D , Zonana-Nacach A Objective: Liang MH Mokkink LB physician global assessment Recently Published Documents. , Holland M According to the OMERACT, face validity is the degree to which the instrument appears to match with the target domain, according to experts [18]. , Mokkink LB No study has evaluated the feasibility of the PGA in SLE to date. JSS Medical Research. For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. 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. et al. It was published in 1977 and was initially designed for the measurement of self-assessed pain in rheumatoid arthritis although it has since been used to evaluate RA more globally. , Petri M. Isenberg DA Brunner HI Prinsen CAC European League Against Rheumatism. Data regarding divergent validity are lacking for the PGA. , Magder LS 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. 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). , Nguyen SC 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. 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. official website and that any information you provide is encrypted Physician's Global Assessment (PGA) score 1.0 on a 0 to 3 visual analog scale. The OMERACT defines an instrument as an outcome measure if it passes the three pillars of evidence: truth (that refers to validity), discrimination (that includes reliability and responsiveness) and feasibility. However, the PGA allows for the measurement of disease activity in a global way (content validity). van Vollenhoven R Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. Pincus and colleagues conducted a study of . Construct validity is the degree to which the PGA relates to other instruments that measure the same concept [18]. 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). 'Not at target': prevalence and consequences of inadequate disease control in systemic lupus erythematosus-a multinational observational cohort study. Moreover, there is uncertainty as to whether the best timing of assessment is prior to or after reviewing laboratory exams [26]. , James JA et al. The quantification of reliability is expressed by a correlation coefficient. , Petri M. Foering K Montreal, Canada Area. , Magder LS et al. Jesus D . Mok CC AU - Kandane-Rathnayake, Rangi. Careers. et al. 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