Lai J-S , Shea BJ , Jolly M. Mok CC This concept includes content validity, face validity, construct validity and criterion validity. , Leung HW [35], the PGA correlated, although moderately, with the need for treatment change (r=0.46, P<0.01). Physician global assessments for disease activity in rheumatoid arthritis are all over the map!. 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 . , Block JA 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. , Wetter J 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. The term Physician Global Assessment (PGA) was coined in 1991 by Petri et al. , Wallace DJ A PGA >1 was predictive of polymorphic light cutaneous eruption (P=0.02) [59] and correlated negatively with LLDAS attainment [37]. 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]. [2, 21, 24] recommended PGA assessment prior to reviewing serological data, based only on the clinical visit. Myelogram - correct answer NPO for 4-6 hours. , Oon S . [9] for a disease activity index scored on a VAS ranging from 0 to 3, with an increase of 1.0 since the last visit indicating a flare. 2021 Apr 8;5(1):33. doi: 10.1186/s41687-021-00298-x. Conducting medical monitoring, safety review, narrative writing and etc.. Perform medical assessment of individual . A good responsiveness for PGA was shown in eight studies. . Methods This SLR was conducted by two independent reviewers in accordance with the PRISMA statement. A Comprehensive Digest of Research Publications From Cedars-Sinai Investigators. A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.670.98). , Hearth-Holmes M. Khan A 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]. 2019ACREULAR . , OMalley T Criterion validity data reporting correlation coefficients between PGA and quality of life measures, laboratory markers and miscellaneous. , Chatzidionysiou K SLE or at an SLE site, but only if the injury requires treatment by a licensed medical doctor. , Siega-Riz AM , Francis S 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). Rheumatology (Oxford). Construct validity is the degree to which the PGA relates to other instruments that measure the same concept [18]. watch for seizures after the procedure. Patient-reported outcomes (PROs) reflect the patient's perspective and are used in rheumatoid arthritis (RA) routine clinical practice. 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. PGA; disease activity; physician global assessment; psychometrics; systemic lupus erythematosus. Direkt zum Inhalt springen . (PGA) scoring of disease activity in systemic lupus erythematosus (SLE). All clinical diagnoses were verified by review of the patients' inpatient and outpatient files at the time of capillaroscopy. Data regarding divergent validity are lacking for the PGA. et al. Results: , Matos A Unauthorized use of these marks is strictly prohibited. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). These results enabled its use as a gold standard for assessing flare and defining flare severity in several studies [21, 67, 88]. doi: 10.1136/lupus-2022-000700. 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). , Bertsias G Jiao H, Acar G, Robinson GA, Ciurtin C, Jury EC, Kalea AZ. 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]. A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.67-0.98). Laboratory investigation results influence Physicians Global ssessment (PGA) of disease activity in SLE. In one open-label study [43], the decrease in PGA score was considered the primary endpoint. Uribe AG, Vil LM, McGwin G Jr, Sanchez ML, Reveille JD, Alarcn GS. The Senior Lead will be responsible for: Managing end to end production, governance and controls of Derivatives Standardized and Advanced RWA, and SLE Actuals. , Voskuyl A , Brunetta P 25 (FIVE YEARS 8) Latest Documents Most Cited Documents Contributed Authors Related Sources Related Keywords Latest Documents; Most Cited Documents; Contributed Authors; Related Sources; The Physician's Global Assessment (PGA) is a pragmatic disease activity measure, using a 100 mm visual analogue scale (VAS) for physicians to quantify the patient's overall disease . The intrarater reliability (intraRR) is the ability to provide consistent scores in a stable population by the same assessor over time. , Kiani AN Mok CC 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. , Chan KL 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. Responsiveness. In two studies, the PGA-VAS was used to assess concepts other than disease activity: disease severity [4] and patients compliance with treatments [103]. 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). [84] expressed the sensitivity in PGA scoring with the standardized response mean (SRM), demonstrating a very large effect size (ES=2.23) [110]. , Zonana-Nacach A et al. Thousand Oaks. 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 . PGA is often assessed by a single question with a 0-10 or 0 . According to the authors, this difference was probably due to the greater familiarity of the physicians with the BILAG-2004 index. Methods: This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items . 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. , Mohan C. Giangreco D 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. The Physician Global Assessment (PGA) is a frequently used co-primary end point in psoriasis clinical trials. et al. All rights reserved. Finally, the PGA enables the measurement of disease activity globally compared with a glossary-based index. , Perez-Gutthann S BICLA responders had fewer lupus-related serious . , Chang AY The company serves physicians and patients. Clinical composite measures of disease activity and damage used to evaluate patients with systemic lupus erythematosus: A systematic literature review. sharing sensitive information, make sure youre on a federal , Petri M. Furie RA , Mosca M , Garabajiu M , Gordon C 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. , Beaumont JL , Glassman DS In 32 studies, disease activity measured by PGA was compared with changes in laboratory markers, with the aim of correlating clinical and serological features [9, 21, 30, 32, 34, 3739, 44, 45, 48, 49, 55, 5861, 63, 64, 66, 67, 69, 71, 74, 75, 82, 86, 89, 9194]. 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). et al. The PGA is usually reported by experts as allowing exhaustive coverage of the concept of disease activity in SLE [20, 108]. 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]. , Sjwall C. Strand V , Costenbader K 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]. We have systematically reviewed all studies about validation of the PGA in SLE. , Ko T Ruiz-Irastorza G Convergent validity is fulfilled indirectly in studies where the PGA is used as the gold standard to assess the construct validity of other indices. , Jnsen A If you have a published paper from this period that does not appear on this list, please contact Sue Marone, who will add it to next week's collection. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement, Instrument selection using the OMERACT filter 2.1: the OMERACT methodology, The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes, Health measurement scales: a practical guide to their development and use, A decrease in complement is associated with increased renal and hematologic activity in patients with systemic lupus erythematosus, Efficacy and safety of methotrexate in articular and cutaneous manifestations of systemic lupus erythematosus, Performance of SLEDAI-2K to detect a clinically meaningful change in SLE disease activity: a 36-month prospective cohort study of 334 patients, Disease activity patterns over time in patients with SLE: analysis of the Hopkins Lupus Cohort, Comparison of the systemic lupus erythematosus activity questionnaire and the systemic lupus erythematosus disease activity index in a black Barbadian population, A pilot study to determine the optimal timing of the Physician Global Assessment (PGA) in patients with systemic lupus erythematosus, Preliminary test of the LFA rapid evaluation of activity in lupus (LFA-REAL): an efficient outcome measure correlates with validated instruments, Derivation and validation of the SLE Disease Activity Score (SLE-DAS): a new SLE continuous measure with high sensitivity for changes in disease activity, Clinical SLEDAI-2K zero may be a pragmatic outcome measure in SLE studies, Erythrocyte-bound C4d in combination with complement and autoantibody status for the monitoring of SLE, Validation of SIMPLE index for lupus disease activity, Performance characteristics of different anti-double-stranded DNA antibody assays in the monitoring of systemic lupus erythematosus, Psychometric properties of MDHAQ/RAPID3 in patients with systemic lupus erythematosus, Therapeutic adherence in patients with systemic lupus erythematosus: a cross-sectional study, Sensitivity analyses of four systemic lupus erythematosus disease activity indices in predicting the treatment changes in consecutive visits: a longitudinal study, Comparison of the lupus foundation of America-rapid evaluation of activity in lupus to more complex disease activity instruments as evaluated by clinical investigators or real-world clinicians, Lupus low disease activity state is associated with a decrease in damage progression in Caucasian patients with SLE, but overlaps with remission, Impact of disease activity on health-related quality of life in systemic lupus erythematosusa cross-sectional analysis of the Swiss Systemic Lupus Erythematosus Cohort Study (SSCS), Association of the lupus low disease activity state (LLDAS) with health-related quality of life in a multinational prospective study, Smoking and pre-existing organ damage reduce the efficacy of belimumab in systemic lupus erythematosus, Cross-cultural validation of Lupus Impact Tracker in five European clinical practice settings, Failure of a systemic lupus erythematosus response index developed from clinical trial data: lessons examined and learned, Belimumab for the treatment of recalcitrant cutaneous lupus, Progression of noncalcified and calcified coronary plaque by CT angiography in SLE, Impact of heart rate variability, a marker for cardiac health, on lupus disease activity, The lupus impact tracker is responsive to changes in clinical activity measured by the systemic lupus erythematosus responder index, Validation of the Lupus Impact Tracker in an Australian patient cohort, Axl, ferritin, IGFBP2 and TNFR2 as biomarkers in systemic lupus erythematosus, Lupus anticoagulant, disease activity and low complement in the first trimester are predictive of pregnancy loss, Lupus Impact Tracker is responsive to physician and patient assessed changes in systemic lupus erythematosus, Predictors of pregnancy outcomes in patients with lupus: a cohort study, Clinical, laboratory and health-related quality of life correlates of Systemic Lupus Erythematosus Responder Index response: a post hoc analysis of the phase 3 belimumab trials, Validation of the LupusPRO in Chinese patients from Hong Kong with systemic lupus erythematosus, The Swiss Systemic lupus erythematosus Cohort Study (SSCS)cross-sectional analysis of clinical characteristics and treatments across different medical disciplines in Switzerland, How should lupus flares be measured? et al. et al. The Author(s) 2020. 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 . , Suriano A et al. , Maxwell LJ 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). Physician Global Assessment (PGA) is a visual analogue score (VAS) that reflects the clinician's judgment of overall Systemic Lupus Erythematosus (SLE) disease activity. , Bonithon-Kopp C No data were found regarding the feasibility of the PGA. Thus the development of a comprehensive index for assessing disease activity still represents one of the most important challenges in SLE [7]. Construct validity was recognized in 21 studies [2, 10, 11, 23, 24, 2629, 35, 47, 52, 54, 65, 68, 76, 84, 88, 92, 99, 101]. Liang et al. , Clowse M. Moorthy LN 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. , Tanangunan R et al. Castrejn I, Ra-Figueroa I, Rosario MP, Carmona L. Reumatol Clin. Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. , Petri M. Foering K , Mina R RMD Open 2018;4:e000578. Karol DE Reliability was excellent when scored through a pointed scale, such as the Likert scale, that was anchored in unit numbers from 0 (not active) to 7 (most active) (interRR ICC 0.96; intraRR ICC 0.88) [80], but was lower when assessed through a centimetric VAS using values between 0.0 and 3.0 (interRR ICC 0.67; intraRR ICC 0.55) [68]. . , Urowitz MB. 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 .
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