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, Kostopoulou M , McGwin G , Ogale S , Landis RC Criterion validity also refers to the degree to which an instrument predicts aspects and phenomena occurring in the future [108]. , Adamichou C , Sjwall C Content validity was reported in 89 studies. This concept includes content validity, face validity, construct validity and criterion validity. 2014 Dec;53(12):2175-81. doi: 10.1093/rheumatology/keu153. Despite the need for new treatments in CLE . Gyri N , Chatzidionysiou K 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]. Bethesda, MD 20894, Web Policies 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. , Alarcn GS official website and that any information you provide is encrypted Disclaimer. Cutaneous lupus erythematosus (CLE) is an autoimmune skin disease that can occur with or without systemic lupus erythematosus (SLE). Results of a large, multicentric, nationwide study, American College of Rheumatology provisional criteria for global flares in childhood-onset systemic lupus erythematosus, A cross-sectional study of hydroxychloroquine concentrations and effects in people with systemic lupus erythematosus, Inactive disease and remission in childhood-onset systemic lupus erythematosus, Preliminary criteria for global flares in childhood-onset systemic lupus erythematosus, Systemic lupus erythematosus in a multiethnic US cohort, XXXVII: association of lymphopenia with clinical manifestations, serologic abnormalities, disease activity, and damage accrual, Systemic lupus erythematosus in a multiethnic cohort (LUMINA): XXIX. TOTAL DOCUMENTS. , Fortin PR , James JA 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]. , Raeisi A , Genovese M 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. , Hennis A. Jesus D et al. PMC , Skogh T PGA is an important tool for assessing disease activity, response to treatment (it is a component . Additional papers were obtained by checking the references from the selected studies. This button displays the currently selected search type. , Chizzolini C Responsiveness, or sensitivity to change, is the usefulness of a test to detect minimum clinically important differences [20, 109]. , Magder L , Clowse M. Moorthy LN , Engel SM 2014 - 20184 years. et al. , Rodrigues M , Ibaez D All versions are validated and used by lupus researchers for clinical and research purposes. Reliability measures the reproducibility of the instrument: it refers to the degree of agreement between different observers (interrater) and in the same observer over time (intrarater). Your recommendations as to what might or should be done in relation to various issues observed. et al. No study has evaluated the feasibility of the PGA in SLE to date. , Allen E , Friebus-Kardash J et al. , Pilkington C In this systematic review we have analysed the measurement properties of the PGA, including the validity, reliability, responsiveness and feasibility. (PGA) scoring of disease activity in systemic lupus erythematosus (SLE). Barr SG , Lin M Aranow C , Henriques C PGA is often assessed by a single question with a 0-10 or 0-100 response. , Askanase A , Annapureddy N FOIA 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]. , Kharboutli M disease activity). Liang MH et al. . , Guzmn RM Methods: Ann Rheum Dis 2011;70:54-9. When expanded it provides a list of search options that will switch the search inputs to match the current selection. , Petri MA 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]. Federal government websites often end in .gov or .mil. 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). Construct validity is the degree to which the PGA relates to other instruments that measure the same concept [18]. 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]. 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 . et al. Some may be a consequence of therapy and others may be . , Terwee CB Objective: To examine the feasibility of using Physician Global Assessment (PGA) scores to collect and track patient acne and . The content can vary and relates either to global health (e . 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. 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 . 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. Search for other works by this author on: Rheumatology Unit, AOU University Clinic and University of Cagliari, Department of Medical Sciences and Public Health, Cagliari, Italy, Centre Hospitalier Universitaire de Dijon, Hpital Franois-Mitterrand, service de mdecine interne et maladies systmiques (mdecine interne, 2) et Centre dInvestigation Clinique, Service de rhumatologie, Hpitaux Universitaires de Strasbourg, Universit de Strasbourg, Centre National de Rfrence des Maladies Systmiques et Autoimmunes Rares Est Sud-Ouest (RESO). Strength. , Seaman AL Disagreements between investigators were solved by consensus. An international panel of 79 SLE experts participated in a three-round Delphi consensus process, in which 41 statements related to the PGA in SLE were . Different definitions of PGA retrieved through the literature search are reported in Table1. et al. Please enable it to take advantage of the complete set of features! This property is reported across all articles selected through this systematic review [24, 913, 21103]. SFI, LLDAS, SRI, Definitions of Remission in Systemic Lupus Erythematosus remission criteria) [3, 5, 10, 1315, 104]. Background/Purpose: The Physician Global Assessment (PGA) is a frequently-used outcome measure in Systemic Lupus Erythematosus (SLE). et al. MeSH Improving patient pathways for systemic lupus erythematosus: a multistakeholder pathway optimisation study. ~SLE~. , Ho LY 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. et al. Rendas-Baum R, Baranwal N, Joshi AV, Park J, Kosinski M. J Patient Rep Outcomes. 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 often assessed by a single question with a 0-10 or 0 . , Francis S , Larson MG , Farewell V Navarra SV , Brunetta P , Magder L The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. may be asked to hyperventilate 3-4 min and watch a bright flashing light. Schneider M , Urowitz MB , Ravelli A 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). 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). Accessibility Would you like email updates of new search results? et al. 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. et al. , Giangreco D Forbess LJ 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]. 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. ECG - correct answer no sleep the night before, meals allowed, no stimulants/tranquilizers for 24-48 hours before. , OMalley T , Fang H 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). , Gomez A 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. A PGA >1 was predictive of polymorphic light cutaneous eruption (P=0.02) [59] and correlated negatively with LLDAS attainment [37]. T2 - A longitudinal study. , Emamikia S , Burlingame RW , Gallacher AE , Garabajiu M Rheumatology (Oxford). , Schur PH. These results enabled its use as a gold standard for assessing flare and defining flare severity in several studies [21, 67, 88]. 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]. , Gladman DD The intrarater reliability (intraRR) is the ability to provide consistent scores in a stable population by the same assessor over time. , Criscione-Schreiber LG doi: 10.1136/lupus-2022-000700. 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). 2022 Mar 14;24(1):70. doi: 10.1186/s13075-022-02756-3. , Klein-Gitelman MS 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. Mok CC Pincus and colleagues conducted a study of . Fanouriakis A Different definitions of disease activity according to the PGA instrument. et al. et al. , Tanangunan R , Pego-Reigosa J-M et al. Fanouriakis A Genetic linkage has related dysfunction of . A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.670.98). 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. , Piette EW 2021 Apr 8;5(1):33. doi: 10.1186/s41687-021-00298-x. 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): 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). , Engle E and transmitted securely. Deconstruction of the safety of estrogen in lupus erythematosus national assessment-systemic lupus erythematosus disease activity index flare index, Effect of raloxifene on disease activity and vascular biomarkers in patients with systemic lupus erythematosus: subgroup analysis of a double-blind randomized controlled trial, Omega-3 in SLE: a double-blind, placebo-controlled randomized clinical trial of endothelial dysfunction and disease activity in systemic lupus erythematosus, Erythrocyte sedimentation rate is a predictor of renal and overall SLE disease activity, Characterization of clinical photosensitivity in cutaneous lupus erythematosus, Validation of the systemic lupus erythematosus responder index for use in juvenile-onset systemic lupus erythematosus, Depressive symptoms and associated factors in systemic lupus erythematosus, Validation of the Portuguese simple measure of impact of lupus erythematosus in youngsters (SMILEY) in Brazil, Anti-C1q antibodies have higher correlation with flares of lupus nephritis than other serum markers, Performance of anti-C1q, antinucleosome, and anti-dsDNA antibodies for detecting concurrent disease activity of systemic lupus erythematosus, An assessment of disease flare in patients with systemic lupus erythematosus: a comparison of BILAG 2004 and the flare version of SELENA, Noncalcified coronary plaque in systemic lupus erythematosus, Decreases in anti-double-stranded DNA levels are associated with concurrent flares in patients with systemic lupus erythematosus, Validity and reliability of lupus activity measures in the routine clinic setting, Clinical predictors of response and discontinuation of belimumab in patients with systemic lupus erythematosus in real life setting. Petri M 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. The literature search identified 91 studies. 2019ACREULAR . Comparison of the validity and sensitivity to change of 5 activity indices in systemic lupus erythematosus. 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 . Merrill JT , ODell JR Objective Physician's global assessment (PGA) of disease activity is a major determinant of therapeutic decision making. Vashisht P 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). , Gladman DD. Physician Global Assessment (PGA) is a visual analogue score (VAS) that reflects the clinician's judgment of overall Systemic Lupus Erythematosus (SLE) disease activity. , Wetter J , Cella D. van Vollenhoven RF , Urowitz MB. However, it is important to remember that not all clinical problems reported by a lupus patient are due to the disease. In 1988, Liang et al. antineutrophil cytoplasmic antibody-associated vasculitis (AAV), and systemic lupus erythematosus (SLE). et al. 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). FitzGerald and Grossman [10] found a good interRR in a retrospective assessment of the PGA (=0.79). LECTURE 10: MEDICAL SURGICAL NURSING. , Carpenter AB Kiani AN 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. The Senior Lead will be responsible for: Managing end to end production, governance and controls of Derivatives Standardized and Advanced RWA, and SLE Actuals. Thus the development of a comprehensive index for assessing disease activity still represents one of the most important challenges in SLE [7]. The SRI is a composite instrument comprised of the SELENA-SLE Disease Activity Index [SELENA-SLEDAI], Physician Global Assessment (PGA) and British Isles Lupus Assessment Group (BILAG) 2004. An official website of the United States government. Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. Nehring J et al. A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.67-0.98). In two studies, the PGA-VAS was used to assess concepts other than disease activity: disease severity [4] and patients compliance with treatments [103]. , Roberts WN , Gordon C et al. et al. AU - Kasitanon, Nuntana. A good correlation was considered for a value >0.60. , Mikolaitis-Preuss RA Lead Medical Director heading up the global collaboration with Pfizer for Enbrel trials. Akhter E 'Not at target': prevalence and consequences of inadequate disease control in systemic lupus erythematosus-a multinational observational cohort study.