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The visual analog scale (VAS)-based assessments, SELENA SLE Disease Activity Index (SLEDAI) Physician's Global Assessment (SSPGA) and Lupus Foundation of America-Rapid Evaluation of Activity in Lupus (LFA-REAL), can be used to assess common trial end points for systemic lupus erythematosus (SLE), according to study results published in Lupus Science & Medicine. , Ibaez D 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. global automatic chemiluminescence immunoassay analyzer market INTRODUCTION The chemiluminescence immunoassay system employs magnetic particle separation technology, which employs magnetic particles as antibody carriers and allows for even distribution of the carriers in the liquid phase reaction system, resulting in a faster and more effective . This enabled the PGA to be considered the gold standard in several studies [2, 10, 11, 21, 23, 49, 67, 76, 78, 84, 88]. Copay AG , Shea BJ Quimby KR , Sjwall C. Strand V (PGA), physician global assessment of disease activity (PHGA), C3, C4, and Anti-ds . 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. , Genovese M , Longenecker JC Unauthorized use of these marks is strictly prohibited. Liang MH , Emamikia S Beaton DE Merrill JT et al. , Arora S , Tanangunan R 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]. , Block JA et al. , Askanase A , Urowitz MB , Fortin PR Thousand Oaks. 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). 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]. Face validity. , Stavrakis S , Kiani AN disease activity). Lead Medical Director heading up the global collaboration with Pfizer for Enbrel trials. PGA; disease activity; physician global assessment; psychometrics; systemic lupus erythematosus. This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. BATCH RUBY INTENSIVE REVIEWRTRMF 3. Cutaneous lupus erythematosus (CLE) is an autoimmune skin disease that can occur with or without systemic lupus erythematosus (SLE). Thank you for submitting a comment on this article. Kiani AN Liang et al. Your recommendations as to what might or should be done in relation to various issues observed. Gladman DD This concept includes content validity, face validity, construct validity and criterion validity. The aim of this systematic literature review (SLR) is to describe and analyse the psychometric properties of PGA. SLE3. Please check for further notifications by email. et al. et al. Different definitions of disease activity according to the PGA instrument. et al. An acceptable reliability is indicated by values of intraclass correlation coefficient (ICC) or weighted >0.60 and a good reliability is >0.85 [20]. SLE has protean and often complex manifestations, necessitating careful clinical assessment. 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). Can Lupus Patients Take the Driver's Seat in Their Disease Monitoring. Despite the need for new treatments in CLE . Aranow C 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. , Criscione-Schreiber LG , Perez-Gutthann S , Perneger T , Schur PH. Akhter E , Lerman RH A PGA >1 was predictive of polymorphic light cutaneous eruption (P=0.02) [59] and correlated negatively with LLDAS attainment [37]. , Magder LS , Kostopoulou M An assessment of disease flare in patients with systemic lupus erythematosus: a comparison of BILAG 2004 and the flare version of SELENA. No study has evaluated the correlation of PGA with damage measures. The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. SLE is an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage in the affected organs. Navarra SV [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. PGA is often assessed by a single question with a 0-10 or 0 . 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). , Bouter LM AU - Morand, Eric. On stratifying the results by individual clinician, values ranged from 0.61 to 0.90, except for those reported by . et al. Wells GA Convergent validity is fulfilled indirectly in studies where the PGA is used as the gold standard to assess the construct validity of other indices. TOTAL DOCUMENTS. It can affect the joints, skin, brain, lungs, kidneys, and blood vessels. The Janus kinase (Jak)/signal transducer and activating protein (STAT) pathways mediate the intracellular signaling of cytokines in a wide spectrum of cellular processes. 2019ACREULAR . Clipboard, Search History, and several other advanced features are temporarily unavailable. There is no cure for lupus, but medical . Once two investigators (E.C., M.P.) 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). , ODell JR . , Costenbader K , Chizzolini C In only one study [4], was PGA sensitivity assessed comparing the change with an anchor [109], represented by the treatment sensitive index: PGA sensitivity was found to be between that of the BILAG (highest sensitivity) and the SLEDAI (lowest sensitivity). , Cella D. van Vollenhoven RF Content validity was reported in 89 studies. , Gladman DD , Kharboutli M A good responsiveness for PGA was shown in eight studies. 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. sharing sensitive information, make sure youre on a federal Trusted for over 30 years to provide and transform technology into complete solutions that advance the value of IT. Castrejn I, Ra-Figueroa I, Rosario MP, Carmona L. Reumatol Clin. , Carpenter AB 2022 Mar 14;24(1):70. doi: 10.1186/s13075-022-02756-3. Epub 2014 Apr 11. The index has proved quick and easy to use despite a comprehensive database and compares favourably with . Uribe AG, Vil LM, McGwin G Jr, Sanchez ML, Reveille JD, Alarcn GS. , Engle E 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. , Gladman DD , Skogh T , Petri M. Thanou A RN-BSN HOLISTIC HEALTH ASSESSMENT ACROSS THE LIFESPAN (NURS 3315) Sociology of Social Problems (SOC213) PGA is often assessed by a single question with a 0-10 or 0-100 response. , Tetzlaff J Five studies have demonstrated good ICC values for reliability (all >0.60 and ranging up to 0.97). , Gladman DD. Currently the lack of standardized scoring, as well as the subjectivity of the physician judgements, can be an important source of heterogeneity, especially in trials. Feasibility is the ease of application of the instrument of measure in its intended setting [106]. 2014 Dec;53(12):2175-81. doi: 10.1093/rheumatology/keu153. 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 . [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! 2022 Jan 11;11(2):340. doi: 10.3390/jcm11020340. The aim of this systematic literature review is to describe and analyse the . , Kandane-Rathnayake RK MD globals may vary based on their age, gender, practice setting and experience (number of patients seen per year and years in practice). physician global assessment Recently Published Documents. Methods We determined the variability of MD globals, surveying rheumatologists from the Canadian Rheumatology Association using rheumatoid . Liang MH Patient-reported outcomes (PROs) reflect the patient's perspective and are used in rheumatoid arthritis (RA) routine clinical practice. 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]. The results are similar, and less than half the time is required for scoring. Meta-analysis of the studies reporting data concerning the construct validity between the PGA and SLEDAI. AU - Kandane-Rathnayake, Rangi. Matthew Turk,1,2 Janet E Pope1,2 To cite: turk M, Pope Je. 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]. Lai J-S Brunner HI , Henriques C 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. , Kalunian K Thanou A , Magder LS . 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]. 8600 Rockville Pike , Ravelli A A good correlation was considered for a value >0.60. Physician's Global Assessment (PGA) score 1.0 on a 0 to 3 visual analog scale. , Raeisi A It estimates how similar a given patients scores were at the two visits. This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. 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. Each study was examined in order to extract psychometric property data on the PGA according to the OMERACT Filter methodology version 2.1 [18]. SLE2ACR1997SLICC2012. Pincus and colleagues conducted a study of . Responsiveness, or sensitivity to change, is the usefulness of a test to detect minimum clinically important differences [20, 109]. , Suriano A Physician training is very important. government site. , Maxwell LJ , Wallace DJ The .gov means its official. J Clin Med. , Chang AY For permissions, please email: journals.permissions@oup.com, This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (. , Saad-Magalhes C All clinical diagnoses were verified by review of the patients' inpatient and outpatient files at the time of capillaroscopy. et al. The Author(s) 2020. PMC 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. Barr et al. The Physician Global Assessment (PGA) is a frequently used co-primary end point in psoriasis clinical trials. According to the authors, this difference was probably due to the greater familiarity of the physicians with the BILAG-2004 index. Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus: the PISCOS study . Ensure second line of defense Derivatives RWA reviews are performed consistently and . Criterion validity also refers to the degree to which an instrument predicts aspects and phenomena occurring in the future [108]. 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). 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. Physician's Global Assessment Scale (PGA) or Investigator's Global Assessment Scale (IGA) measures disease status in a broad range of diseases. 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. 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). These results enabled its use as a gold standard for assessing flare and defining flare severity in several studies [21, 67, 88]. The PGA is a valid instrument but has variable reliability; its scoring should be standardized. , Mikolaitis-Preuss RA et al. , Urowitz MB Rendas-Baum R, Baranwal N, Joshi AV, Park J, Kosinski M. J Patient Rep Outcomes. Schneider M Disagreements between investigators were solved by consensus. The interrater reliability (interRR) of the PGA is the ability to provide consistent scores in a stable population between two or more physicians who evaluate the disease activity of the same patient. et al. et al. 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. et al. Petri M CareerBuilder TIP. , McGwin G 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]. , Siega-Riz AM 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. This suggests that the role of the PGA is limited for disease activity assessment when used as a single instrument. 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]. et al. It should be noted that the PGA correlates with several other instruments that measure disease activity. Fatigue is independently associated with disease activity assessed using the Physician Global Assessment but not the SLEDAI in patients with systemic lupus erythematosus. , Dietzmann K 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. 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). Flow chart illustrating the literature search and study selection. Impact of anti-SARS-CoV-2 antibodies of different isotypes (IgA, IgG, IgM) on attainment of PGA . Construct validity. Direkt zum Inhalt springen . 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. Please enable it to take advantage of the complete set of features! Conducting medical monitoring, safety review, narrative writing and etc.. Perform medical assessment of individual . et al. OBJECTIVE The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. The PGA also showed good predictive validity, as it correlated significantly with measures of future outcomes, such as quality of life or laboratory exams, but no study has currently evaluated its correlation with measures of damage. , Kraag GR 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 . , Patrick DL The literature search identified 91 studies. Mok CC The literature search identified 93 articles, and 12 additional articles were retrieved from the reference list of those publications. Published by Oxford University Press on behalf of the British Society for Rheumatology. Myelogram - correct answer NPO for 4-6 hours. Int J Environ Res Public Health. et al. et al. 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. 2022 Sep 20;19(19):11895. doi: 10.3390/ijerph191911895. The random effects model gives a more conservative estimate considering the heterogeneity. The https:// ensures that you are connecting to the , Petri M. Furie RA et al. Content validity pertains to the degree to which the instrument measures all facets of a construct of interest [20]: this property is satisfied if the PGA is considered able to measure all aspects of disease activity in SLE in a comprehensive way. ~SLE~. 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. , Rairie JE The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. 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]. Published by Oxford University Press on behalf of the British Society for Rheumatology. A PGA 2 correlated with a risk of pregnancy loss (29% vs 8%, P=0.005) [49]. , Liberati A HHS Vulnerability Disclosure, Help 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). , Petri MA Different definitions of PGA retrieved through the literature search are reported in Table1.