Epub 2014 Jul 10. Beaton DE Construct validity is the degree to which the PGA relates to other instruments that measure the same concept [18]. 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]. 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. , OMalley T [8] suggested that the PGA should account for objective examination, laboratory results and what patients report. , Raeisi A PGA is a valid, responsive and feasible instrument, while its reliability was impacted by the scale adopted, suggesting the major need for a standardization of its scoring. , Sadovici-Bobeica V An acceptable reliability is indicated by values of intraclass correlation coefficient (ICC) or weighted >0.60 and a good reliability is >0.85 [20]. , Petri MA Your comment will be reviewed and published at the journal's discretion. 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). sharing sensitive information, make sure youre on a federal The PGA is usually reported by experts as allowing exhaustive coverage of the concept of disease activity in SLE [20, 108]. Methods: The company serves physicians and patients. FOIA , Perez-Gutthann S , Hochberg M. Touma Z Bookshelf Physician global assessment in systemic lupus erythematosus: Can we Merrill JT According to the OMERACT, face validity is the degree to which the instrument appears to match with the target domain, according to experts [18]. et al. , Jolly M. Antony A This may be explored through convergent and divergent validity. , Wallace DJ HHS Vulnerability Disclosure, Help 2022 Jan 11;11(2):340. doi: 10.3390/jcm11020340. antineutrophil cytoplasmic antibody-associated vasculitis (AAV), and systemic lupus erythematosus (SLE). 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). 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. , Mosca M , Beresford MW PGA is an important tool for assessing disease activity, response to treatment (it is a component . 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. Physician Global Assessment to Track Outcomes - JAMA 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. , Gayet-Ageron A , Longenecker JC , Sayedbonakdar Z , Kalunian K A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.67-0.98). Oxford Textbook of Neuropsychiatry - 2020 | PDF | Psychiatry , Karp DR et al. 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 Physician Global Assessment (PGA) of treatment response measures the overall response to treatment as assessed by the physician. 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. History of Changes for Study: NCT05672576 , Emamikia S , Mokkink LB Trusted for over 30 years to provide and transform technology into complete solutions that advance the value of IT. 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. Eudy AM , Nguyen SC Mina R Pincus and colleagues conducted a study of . , Kalunian K Identification of new candidate drugs for primary Sjgrens syndrome using a drug repurposing transcriptomic approach, When it looks like Behets syndrome but is something else: Differential diagnosis of Behcets syndrome: a two-centre retrospective analysis, Huge water-balloons in the belly: multiple pancreatic pseudocysts in systemic lupus erythematosus, A randomized, double-blind, placebo-controlled, parallel group study on the effects of a cathepsin S inhibitor in primary Sjgrens syndrome, How to plug the leaky pipeline in clinical rheumatology across Europelessons to be learned from experiences in business, About the British Society for Rheumatology, British Society for Rheumatology Journals, https://doi.org/10.1093/rheumatology/keaa383, https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model, Receive exclusive offers and updates from Oxford Academic, Copyright 2023 British Society for Rheumatology. Content validity. 2. Content validity was reported in 89 studies. A multi-item Physician Global Assessment scale to assess psoriasis , Francis S Arriens C 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). Construct validity was demonstrated by a good correlation (r0.50) between the PGA with the SLEDAI (12 studies), SLAM (4 studies), LAI, BILAG and ECLAM (2 studies each). (PGA) scoring of disease activity in systemic lupus erythematosus (SLE). 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]. When expanded it provides a list of search options that will switch the search inputs to match the current selection. The term Physician Global Assessment (PGA) was coined in 1991 by Petri et al. et al. At least 1 issue from each virtual tour. Clinical Trial on Systemic Lupus Erythematosus (SLE): Blood sample , Smiley A. Askanase AD FitzGerald and Grossman [10] found a good interRR in a retrospective assessment of the PGA (=0.79). official website and that any information you provide is encrypted Strength. 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 . The other authors have declared no conflicts of interest. Vil LM 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. 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 . et al. (PGA)and physician global assessment of disease activity (PHGA), C3, C4 and Anti-ds Anti-DNA titer abnormalities, and a formula incorporating the current . , Garabajiu M , Farewell V It is therefore desirable to use the PGA along with other tools (typically the SLEDAI) or to include the PGA in a composite index (e.g. , Chizzolini C et al. Schlencker A, Messer L, Ardizzone M, Blaison G, Hinschberger O, Dahan E, Sordet C, Walther J, Dory A, Gonzalez M, Kleinlogel S, Bramont-Nachman A, Barrand L, Payen-Revol I, Sibilia J, Martin T, Arnaud L. Lupus Sci Med. , Petri M. Iaccarino L Different definitions of PGA retrieved through the literature search are reported in Table1. 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. 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]. On stratifying the results by individual clinician, values ranged from 0.61 to 0.90, except for those reported by . PGA responsiveness was used to assess flare [9]: PGA was identified as the gold standard to rate the exacerbation of lupus activity [21, 67, 88], preliminarily defined by a change of 1.0 on a 03 VAS since the last visit. , Dietzmann K . Unable to load your collection due to an error, Unable to load your delegates due to an error. Exagen Diagnostics Inc (XGN) - Product Pipeline Analysis, 2022 Update [35], the PGA correlated, although moderately, with the need for treatment change (r=0.46, P<0.01). Systemic lupus erythematosus (SLE) is a multisystem autoimmune rheumatic disease (ARD) characterized by flares and remissions. , Pego-Reigosa J-M Clinical Trial Physician - Rheumatology Job in San Diego, CA - Bristol Thanks to this feature, the PGA was included in composite indices with the aim of rating manifestations not included in glossary-based instruments such as the SLEDAI and BILAG [3] or for which a threshold has been defined (cytopenia). Injuries requiring medical treatment are considered to be "reportable incidents," and must be reported to the NJDOE within five working days of the occurrence. 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 . Background/Purpose: The Physician Global Assessment (PGA) is a frequently-used outcome measure in Systemic Lupus Erythematosus (SLE). 10- Medical- Surgical- Nursing- Intensive- Review Medizinische Universitt Graz Austria/sterreich - Forschungsportal Tyk2 Targeting in Immune-Mediated Inflammatory Diseases Liang et al. Thousand Oaks. 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. et al. Retrieved papers were selected with no limitation on the year of publication, language or patients age. , Gallacher AE et al. et al. , Jolly M. Ribi C Franklyn K This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. van Vollenhoven R , Genovese M Use of Physician Global Assessment in systemic lupus - PubMed Whenever papers reported duplicate data, the most recent article was selected. Accessibility et al. 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]. , Larson MG , Bouter LM . There is no cure for lupus, but medical . , Ibaez D , Klein-Gitelman MS , Clowse M. Moorthy LN 2014 Sep-Oct;10(5):309-20. doi: 10.1016/j.reuma.2014.01.012. Fanouriakis A , Bentow C , Lerman RH The official NJDOE Incident Reporting Form, as well as a guide to completing The PGA was integrated in composite indices, including the definition of the LLDAS [12, 13, 29, 34, 37, 39, 40] and remission [29, 37] (Table1). Use of Physician Global Assessment in systemic lupus erythematosus: a Measurement properties of the PGA were analysed according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) terminology [19]. Methods This SLR was conducted by two independent reviewers in accordance with the PRISMA statement. , Weisman MH. X 20 sentence examples within Physician Global Assessment. , Hearth-Holmes M. Khan A , Petri M. Furie RA , Petri MA 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). , Buyon J , Altman DG Supervise the development of junior medical affairs staff . Face validity is satisfied when the instrument is considered able to capture what it should capture (i.e. Please enable it to take advantage of the complete set of features! The PGA is a well accepted and commonly used scale for evaluating treatment response in clinical trials both in adults and children. Genetic linkage has related dysfunction of . , Schur PH. . The Author(s) 2020. Petri M However, it is important to remember that not all clinical problems reported by a lupus patient are due to the disease. 2021 Apr 8;5(1):33. doi: 10.1186/s41687-021-00298-x. 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). PDF Physician s global assessment is often useful in SLE, but not always , Chan KL et al. 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. 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]. To increase its reliability, the PGA should be scored by a physician with significant expertise in SLE, with prior knowledge of laboratory results [112], considering the overall disease activity at the time of the visit and comparing it to the last visit in order to assess flares [9]. , Engleman EG Jiao H, Acar G, Robinson GA, Ciurtin C, Jury EC, Kalea AZ. Prinsen CAC PGA0.3. Jesus D Use of Physician Global Assessment (PGA) in Systemic lupus - medRxiv A good responsiveness for PGA was shown in eight studies. Responsiveness. 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. , Urowitz MB. et al. This suggests that the role of the PGA is limited for disease activity assessment when used as a single instrument. Correlations with other instruments measuring similar constructs should typically demonstrate a coefficient (r) 0.50 [106]. , Petri M Moreover, a difference between the interRR of the PGA assessed by an untrained physician (0.50.63) and a trained investigator (0.790.81) was found, suggesting the need for PGA scoring training or standardization [36]. , Engel SM 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. Patient-reported outcomes (PROs) reflect the patient's perspective and are used in rheumatoid arthritis (RA) routine clinical practice. , Ho LY , Roberts WN An assessment of disease flare in patients with systemic lupus erythematosus: a comparison of BILAG 2004 and the flare version of SELENA. Improving patient pathways for systemic lupus erythematosus: a multistakeholder pathway optimisation study. Systemic Lupus Erythematosus (SLE) Treatment & Management - Medscape 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 . Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. Physician training is very important. 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. , Sengupta M , Kandane-Rathnayake RK Methods We determined the variability of MD globals, surveying rheumatologists from the Canadian Rheumatology Association using rheumatoid . 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. X 20 Physician Global Assessment 10.1136/lupus-2019-lsm.176 . According to the authors, this difference was probably due to the greater familiarity of the physicians with the BILAG-2004 index. Twenty-nine studies [25, 31, 3439, 41, 43, 48, 49, 5355, 59, 6164, 74, 75, 81, 82, 86, 92, 93, 96, 97] have assessed criterion validity of the PGA (Table2). Akhter E SLE has protean and often complex manifestations, necessitating careful clinical assessment. , Terwee CB The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. , Petri M. Foering K Int J Environ Res Public Health. Piga M PDF Physician Global Assessment International Standardisation COnsensus in 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). 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]. Unauthorized use of these marks is strictly prohibited. Help us improve CareerBuilder by providing feedback about this job: Report this job Job ID: 2281236908. Physician Global Assessment International Standardisation COnsensus in The last MEDLINE search was performed on 1 July 2019. 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). The correlation with the SLEDAI was determined in 12 studies (Fig. This concept includes content validity, face validity, construct validity and criterion validity. watch for seizures after the procedure. Results. At a glance: Common scores used in rheumatology 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]. Deconstruction of the safety of estrogen in lupus erythematosus national assessment-systemic lupus erythematosus disease activity index flare index. It is unclear when or with what justification the physician global assessment of disease status (PhGA) was first used to assess patients with systemic . For instance, in an analysis of studies of the prevalence of SLE in the Asia-Pacific region, higher rates of renal involvement were observed in Asian patients (21-65% at SLE diagnosis and 40 . The Janus kinase (Jak)/signal transducer and activating protein (STAT) pathways mediate the intracellular signaling of cytokines in a wide spectrum of cellular processes. 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]. . , Esdaile JM. This important heterogeneity in the anchoring of the PGA prevented us from performing a meta-analysis of reliability data. Additional papers were obtained by checking the references from the selected studies. 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