Thus the development of a comprehensive index for assessing disease activity still represents one of the most important challenges in SLE [7]. Wells GA Construct validity is shown by the good correlation observed with the SLEDAI, BILAG, SLAM, LAI and ECLAM [10, 23, 24, 26, 28, 29, 35, 54, 68, 76, 84, 99]. , Fortin PR 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. , Navarra SV , Chizzolini C 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]. The aim of this systematic literature review (SLR) is to describe and analyse the psychometric properties of PGA. The PGA is a well accepted and commonly used scale for evaluating treatment response in clinical trials both in adults and children. Once two investigators (E.C., M.P.) Whenever papers reported duplicate data, the most recent article was selected. doi:10.1136/ rmdopen-2017-000578 Prepublication history and An international panel of 79 SLE experts participated in a three-round Delphi consensus . , Kharboutli M Fatigue is independently associated with disease activity assessed using the Physician Global Assessment but not the SLEDAI in patients with systemic lupus erythematosus. , Engle E 1 2. 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. et al. (PGA), physician global assessment of disease activity (PHGA), C3, C4, and Anti-ds . , Stavrakis S , Voskuyl A Quimby KR allergy hx phenothiazines, cns depressants and stimulants withheld 48 hours prior. 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. , Petri M Beaton DE 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. , Esdaile JM. , Alunno A , Beaumont JL 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). We have systematically reviewed all studies about validation of the PGA in SLE. Unauthorized use of these marks is strictly prohibited. . Physician Global Assessment (PGA) is a visual analogue score (VAS) that reflects the clinician's judgment of overall Systemic Lupus Erythematosus (SLE) disease activity. , Shea BJ Visual analogue scales (VAS) allow rapid, continuous scaling of disease severity. et al. Objective Existing methods for grading lupus flares or improvement require definition-based thresholds as increments of change. 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. Correlations with other instruments measuring similar constructs should typically demonstrate a coefficient (r) 0.50 [106]. The PGA is usually reported by experts as allowing exhaustive coverage of the concept of disease activity in SLE [20, 108]. , Rodrigues M Nehring J Different definitions of disease activity according to the PGA instrument. 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]. SLE is an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage in the affected organs. et al. , Kiani AN , Ravelli A Brunner HI 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): Eudy AM , Magder LS COSMIN Terminology from a European Rheumatology Perspective: a Glossary for the EULAR PRO Tool Box Initiative. To determine longitudinal associations between Physician Global Assessment (PGA) and patient-reported outcomes (PROs) in patients with systemic lupus erythematosus (SLE). et al. , Holland M Despite the need for new treatments in CLE . Touma Z Piga M The other authors have declared no conflicts of interest. 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. Fanouriakis A Convergent validity is fulfilled indirectly in studies where the PGA is used as the gold standard to assess the construct validity of other indices. , Allen E Injuries requiring medical treatment are considered to be "reportable incidents," and must be reported to the NJDOE within five working days of the occurrence. , Chakravarty E , Patrick DL et al. Genetic linkage has related dysfunction of . , Landis RC , Tanangunan R Clinical composite measures of disease activity and damage used to evaluate patients with systemic lupus erythematosus: A systematic literature review. 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. , Pego-Reigosa J-M et al. HHS Vulnerability Disclosure, Help Subsequently the PGA was incorporated in the Safety of Estrogen in Lupus Erythematosus National Assessment (SELENA) flare index (SFI) in 1999 [10], in the Systemic Responder Index (SRI) in 2009 [3, 11, 12] as well as in the definitions of the Lupus Low Disease Activity State (LLDAS) [13] and various definitions of remission [14, 15]. Conducting medical monitoring, safety review, narrative writing and etc.. Perform medical assessment of individual . It estimates how similar a given patients scores were at the two visits. 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]. No study has evaluated the correlation of PGA with damage measures. The Physician's Global Assessment (PhGA) is a number without unit. 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). , Giangreco D Epub 2014 Jul 10. 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 . Physician training is very important. [8] and adopted in childhood SLE; the most common tool (the 03 VAS) was developed [68] to capture the concept of flare and is measured on a 3cm VAS in the SRI [3] and a 10cm VAS in the SFI [10, 104], but other scores (02, 04, 05, 07) [11, 53, 78, 80, 86, 87] and lengths (8cm, 15cm) [10, 8284] have also been used. 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 . Aranow C Arriens C Some may be a consequence of therapy and others may be . , James JA , Devilliers H All rights reserved. , Gladman DD 2019ACREULAR . 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. A PGA >1 was predictive of polymorphic light cutaneous eruption (P=0.02) [59] and correlated negatively with LLDAS attainment [37]. , Morabito LM Learn more. 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). , McGwin G , Smiley A. Askanase AD The anonymous patientcompleted questionnaire comprised the following: current pain in the past 7 days (10cm VAS [0 no pain; 10 most severe pain]), patient global assessment (PtGA) of health status (10 cm VAS [0 very well; 10 very poorly]), ever and current recreational cannabis use, ever and current medical cannabis use, and if cannabis . Castrejn I, Ra-Figueroa I, Rosario MP, Carmona L. Reumatol Clin. In one open-label study [43], the decrease in PGA score was considered the primary endpoint. , Engleman EG PMC Ann Rheum Dis 2 Isenberg DA, Allen E, Farewell V, et al. 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. , Jolly M. Antony A This important heterogeneity in the anchoring of the PGA prevented us from performing a meta-analysis of reliability data. SLE has protean and often complex manifestations, necessitating careful clinical assessment. , Bonithon-Kopp C , Engel SM 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 . PGA is a simple instrument and the result is easily understood. The content can vary and relates either to global health (e . Keywords: RMD Open 2018;4:e000578. OBJECTIVE The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. Your comment will be reviewed and published at the journal's discretion. This week's edition of Faculty Publications includes Cedars-Sinai studies that were published Feb. 23-March 2. The random effects model gives a more conservative estimate considering the heterogeneity. 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. Careers. , Sadovici-Bobeica V , Sjwall C. Strand V , Petri MA , Weisman MH. 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. 3TR (Taxonomy, Treatment, Targets and Remission) Systemic Lupus Erythematosus Study Protocol 2 Kandane-Rathnayake R, Louthrenoo W, Hoi A, Luo SF, Wu YJ, Chen YH, Cho J, Lateef A, Hamijoyo L, Navarra SV, Zamora L, Sockalingam S, An Y, Li Z, Katsumata Y, Harigai M, Hao Y, Zhang Z, Kikuchi J, Takeuchi T, Basnayake BMDB, Chan M, Ng KPL, Tugnet N, Kumar S, Oon S, Goldblatt F, O'Neill S, Gibson KA, Ohkubo N, Tanaka Y, Bae SC, Lau CS, Nikpour M, Golder V, Morand EF; Asia-Pacific Lupus Collaboration. How should lupus flares be measured? Arthritis Res Ther. et al. 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]. Direkt zum Inhalt springen . [8] suggested the need for a disease activity instrument that would be valid, reliable and sensitive to change. This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. 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. J Clin Med. , Petri M. Isenberg DA Content validity was reported in 89 studies. 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]. , Petri MA , Hennis A. Jesus D IgM) on attainment PhGA. Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. BILAGAB . et al. , Wetter J , Sengupta 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]. , Socher SA 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. , Genovese M Data regarding divergent validity are lacking for the PGA. Enocsson H et al. et al. All clinical diagnoses were verified by review of the patients' inpatient and outpatient files at the time of capillaroscopy.