et al. Gandhi N , Gladman DD 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 (. For permissions, please email: journals.permissions@oup.com. However, it is important to remember that not all clinical problems reported by a lupus patient are due to the disease. . Published by Oxford University Press on behalf of the British Society for Rheumatology. , Urowitz MB Elevation of erythrocyte sedimentation rate is associated with disease activity and damage accrual, The systemic lupus activity measure-revised, the Mexican systemic lupus erythematosus disease activity index (SLEDAI), and a modified SLEDAI-2K are adequate instruments to measure disease activity in systemic lupus erythematosus, Small changes in outpatients lupus activity are better detected by clinical instruments than by laboratory tests, Development and initial validation of the systemic lupus erythematosus disease activity index 2000 responder index 50, Sensitivity to change of 3 systemic lupus erythematosus disease activity indices: international validation, Systemic Lupus Erythematosus Disease Activity Index 2000 Responder Index 50: sensitivity to response at 6 and 12 months, Validation of the functional assessment of chronic illness therapy-fatigue scale in patients with moderately to severely active systemic lupus erythematosus, participating in a clinical trial, Psychological distress and changes in the activity of systemic lupus erythematosus, The rating scale preference measure as an evaluative measure in systemic lupus erythematosus, Comparison of the validity and sensitivity to change of 5 activity indices in systemic lupus erythematosus, Treatment of systemic lupus erythematosus with dehydroepiandrosterone: 50 patients treated up to 12 months, Soluble urokinase plasminogen activator receptor levels reflect organ damage in systemic lupus erythematosus, Epratuzumab for patients with moderate to severe flaring SLE: health-related quality of life outcomes and corticosteroid use in the randomized controlled ALLEVIATE trials and extension study SL0006, Measuring systemic lupus erythematosus activity during pregnancy: validation of the lupus activity index in pregnancy scale, Autoantibodies against albumin in patients with systemic lupus erythematosus, Association of depression with socioeconomic status, anticardiolipin antibodies, and organ damage in patients with systemic lupus erythematosus: results from the KORNET registry, Placebo-controlled randomized clinical trial of fish oils impact on fatigue, quality of life, and disease activity in systemic lupus erythematosus, Serum free light chains, interferon-alpha, and interleukins in systemic lupus erythematosus, Vitamin D levels in Chinese patients with systemic lupus erythematosus: relationship with disease activity, vascular risk factors and atherosclerosis, Systemic lupus erythematosus disease activity index 2000 responder index-50: a reliable index for measuring improvement in disease activity, Testosterone patches in the management of patients with mild/moderate systemic lupus erythematosus, Turkish LupusPRO: cross-cultural validation study for lupus, Cross-cultural validation of a disease-specific patient-reported outcome measure for lupus in Philippines, Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial, Sensitivity and specificity of plasma and urine complement split products as indicators of lupus disease activity, The TNF locus is altered in monocytes from patients with systemic lupus erythematosus, Effect of pregnancy on disease flares in patients with systemic lupus erythematosus, Frequency of lupus flare in pregnancy: the Hopkins Lupus Pregnancy Center experience, Morbidity of systemic lupus erythematosus: role of race and socioeconomic status, Classification and definition of major flares in SLE clinical trials, Efficacy and safety of epratuzumab in patients with moderate/severe active systemic lupus erythematosus: results from EMBLEM, a phase IIb, randomised, double-blind, placebo-controlled, multicentre study, COSMIN guideline for systematic reviews of patient-reported outcome measures, Validity and reliability in social science research, Understanding the minimum clinically important difference: a review of concepts and methods, Statistical significant change versus relevant or important change in (quasi) experimental design: some conceptual and methodological problems in estimating magnitude of intervention-related change in health services research, Minimum important difference between patients with rheumatoid arthritis: the patients perspective, Responsiveness and sensitivity to change of SLE disease activity measures, The Author(s) 2020. 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. , Petri M. Isenberg DA Improving patient pathways for systemic lupus erythematosus: a multistakeholder pathway optimisation study. 1 2. Physician Global Assessment International Standardisation COnsensus in et al. , Petri MA , Klein-Gitelman MS inflammation (duration and severity of morning stiffness as measured by BASDAI). Laboratory Investigation Results Influence Physician's Global All articles published through 1 July 2019 in PubMed were screened, with no limitation on year of publication, language or patients age. The Physician's Global Assessment (PhGA) is a number without unit. 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]. [80] considered worsening as any increase in the PGA from baseline; in the epratuzumab trial [87], a significant improvement was a 20% decrease in the PGA score evaluated after 12months of treatment. 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. Criterion validity was assessed exploring the PGA correlation with quality of life measurements, biomarker levels and treatment changes in 28 studies, while no study has evaluated correlation with damage. et al. The correlation with the SLEDAI was determined in 12 studies (Fig. Reliability. 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. Different definitions of disease activity according to the PGA instrument. Arriens C In most studies, the PGA was assessed by a rheumatologist experienced in SLE care or research and, as already stated, the ICC reliability was different for an untrained physician and a trained investigator [36]. PGA is a simple instrument and the result is easily understood. et al. 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). , Seaman AL Global Automatic Chemiluminescence Immunoassay Analyzer Market 2023 Flow chart illustrating the literature search and study selection. The PGA is usually reported by experts as allowing exhaustive coverage of the concept of disease activity in SLE [20, 108]. Few studies reported on whether serological activity should be incorporated in the PGA. , Mikolaitis-Preuss RA Of note, it is not trivial that we found a good convergent validity with other instruments (SLEDAI, BILAG, LAI, SLAM and ECLAM) [10, 23, 24, 26, 28, 29, 35, 54, 68, 76, 84, 99]. et al. 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). , Kostopoulou M [2, 21, 24] recommended PGA assessment prior to reviewing serological data, based only on the clinical visit. Before , Hochberg M. Wallace DJ Construct validity. Epub 2014 Apr 11. The PGA is a well accepted and commonly used scale for evaluating treatment response in clinical trials both in adults and children. Oxford Textbook of. Disagreements between investigators were solved by consensus. Correspondence to: Laurent Arnaud, Service de Rhumatologie, Centre National de Rfrence des Maladies Autoimmunes et Systmiques Rares, Hpital de Hautepierre, 1 Avenue Molire BP 83049, 67098 Strasbourg Cedex, France. 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). This suggests that the role of the PGA is limited for disease activity assessment when used as a single instrument. Systemic lupus erythematosus (SLE) is a multisystem autoimmune rheumatic disease (ARD) characterized by flares and remissions. Touma Z This property is reported across all articles selected through this systematic review [24, 913, 21103]. 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 . PGA is often assessed by a single question with a 0-10 or 0 . A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.670.98). Mina R Direkt zum Inhalt springen . A multi-item Physician Global Assessment scale to assess psoriasis , Henriques C 25 (FIVE YEARS 8) Latest Documents Most Cited Documents Contributed Authors Related Sources Related Keywords Latest Documents; Most Cited Documents; Contributed Authors; Related Sources; , Friebus-Kardash J 3TR (Taxonomy, Treatment, Targets and Remission) Systemic Lupus Erythematosus Study Protocol 2 Feasibility is the ease of application of the instrument of measure in its intended setting [106]. , Perez-Gutthann S official website and that any information you provide is encrypted JSS Medical Research. The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. 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? RMD Open 2018;4:e000578. 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 . 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]. , Farewell V Physician training is very important. , Weisman MH. It operates in Albuquerque, and New Mexico. ~SLE~. , Jolly M. Mok CC An official website of the United States government. 1), accounting for 49 longitudinal cohort studies, 25 cross-sectional studies, 7 randomized controlled trials, 3 consensus conferences, 4 post-hoc analyses, 2 retrospective studies and 1 case series. , Ding HH Mayara Torres Silva de Oliveira, MD, MBA on LinkedIn: #medicinanuclear Thanou A Tyk2 Targeting in Immune-Mediated Inflammatory Diseases 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. Treatment of lupus nephritis: consensus, evidence and perspectives This button displays the currently selected search type. The interRR was assessed in seven studies [4, 10, 11, 36, 65, 68, 94], showing values ranging from 0.67 [68] to 0.96 [94]. , Klein-Gitelman MS 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]. 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 . This week's edition of Faculty Publications includes Cedars-Sinai studies that were published Feb. 23-March 2. et al. 2021 Apr 8;5(1):33. doi: 10.1186/s41687-021-00298-x. , Buyon J et al. et al. No study has evaluated the feasibility of the PGA in SLE to date. A new tool -- the Lupus Activity Scoring Tool (LAST) - has been proposed to join the ranks of current disease activity indices. The literature search identified 93 articles, and 12 additional articles were retrieved from the reference list of those publications. Careers. [35], the PGA correlated, although moderately, with the need for treatment change (r=0.46, P<0.01). When expanded it provides a list of search options that will switch the search inputs to match the current selection. 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). Arthritis Res Ther. PGA is an important tool for assessing disease activity, response to treatment (it is a component . , Jolly M. Mazur-Nicorici L Petri M J Clin Med. , Devilliers H , Rairie JE (SLE) GSKpro , Gomez A Uribe AG, Vil LM, McGwin G Jr, Sanchez ML, Reveille JD, Alarcn GS. PDF Physician global assessments for disease activity in rheumatoid , Carpenter AB 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. The last MEDLINE search was performed on 1 July 2019. , Engel SM The Janus kinase (Jak)/signal transducer and activating protein (STAT) pathways mediate the intracellular signaling of cytokines in a wide spectrum of cellular processes. , Arora S Systemic lupus erythematosus (SLE), is the most common type of lupus. Barr SG Parodis I [PDF] Use of Physician Global Assessment in systemic lupus , Urowitz MB. et al. , Chakravarty E 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]. The pooled correlation coefficient (95% CI) is given both for the fixed effects model and the random effects model. 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 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. Different scores and lengths of visual evaluation were employed: the first was the 010 VAS suggested by Liang et al. 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). et al. 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. 2019ACREULAR . X 20 sentence examples within Physician Global Assessment. , Annapureddy N Thousand Oaks. , Petri MA Ahmed S. - Managing Director/ Medical Lead - Global Bio-pharma Different definitions of PGA retrieved through the literature search are reported in Table1. , Kalunian K Truth refers to whether the measure provided by the scores is able to measure what was intended [18]. , Arbab-Zadeh A , Maxwell LJ In Fatemi et al. 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]. The term Physician Global Assessment (PGA) was coined in 1991 by Petri 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 . The PGA intraRR was assessed in three studies [10, 68, 94] and ranged from 0.55 [68] to 0.88 [10]. et al. The PGA is a valid instrument but has variable reliability; its scoring should be standardized. Exagen Diagnostics Inc (XGN) - Product Pipeline Analysis, 2022 Update Using the Physician Global Assessment in a clinical setting to - PubMed 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. Compared with nonresponders, BICLA responders had greater improvements in global and organ-specific disease activity (Physician's Global Assessment, SLE Disease Activity Index 2000, Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity, and joint counts; all nominal P < 0.001). watch for seizures after the procedure. 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]. 2. CLOSED ANGLE/ ANGLE CLOSURE GLAUCOMA. , Criscione-Schreiber LG According to the OMERACT, face validity is the degree to which the instrument appears to match with the target domain, according to experts [18]. , Petri M. Thanou A 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. , Socher SA , Goldsmith CH 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): , Tanangunan R Thank you for submitting a comment on this article. , Kharboutli M 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. Ensure second line of defense Derivatives RWA reviews are performed consistently and . , Navarra SV 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). BILAGAB . , Giannakou I , Devilliers H 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. 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]. , Birmingham DJ , Chizzolini C Kiani AN Merrill JT , Fang H All versions are validated and used by lupus researchers for clinical and research purposes. It estimates how similar a given patients scores were at the two visits. Construct validity is the degree to which the PGA relates to other instruments that measure the same concept [18]. The aim of this systematic literature review (SLR) is to describe and analyse the psychometric properties of PGA. van Vollenhoven R Physician Global Assessment (PGA) is a visual analogue score (VAS) that reflects the clinician's judgment of overall Systemic Lupus Erythematosus (SLE) disease activity. , Urowitz MB 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.