, Dyer JW 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. Thanou A, Chakravarty E, James JA, Merrill JT. 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). The SRI is a validated SLE disease activity instrument used to detect clinically meaningful improvement of disease in SLE clinical trials. 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]. 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]. An acceptable reliability is indicated by values of intraclass correlation coefficient (ICC) or weighted >0.60 and a good reliability is >0.85 [20]. Physician Global Assessment International - ScienceDirect Mokkink LB 215 (FIVE YEARS 146) H-INDEX. According to the authors, this difference was probably due to the greater familiarity of the physicians with the BILAG-2004 index. At least 1 issue from each virtual tour. , Birmingham DJ 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]. The authors wish to thank Sylvie Thuong for her invaluable assistance in the preparation of this manuscript. Faculty Publications: Feb. 23-March 2 PMC , Cappellazzo G , Matos A Mahler M They participate in physiologic and inflammatory cascades and have become a major focus of research, yielding novel therapies for immune-mediated inflammatory diseases (IMID). Content validity was reported in 89 studies. , Bonithon-Kopp C Bookshelf Physician global assessment in systemic lupus erythematosus: can we Background/Purpose: The Physician Global Assessment (PGA) is a frequently-used outcome measure in Systemic Lupus Erythematosus (SLE). antineutrophil cytoplasmic antibody-associated vasculitis (AAV), and systemic lupus erythematosus (SLE). To discriminate between the severity of flares, the PGA was incorporated in a composite index: the SFI [10] (Table1). The Patient's Global Assessment Scale (PGA) is the PRO counterpart to the Physician's Global Assessment Scale or Investigator's Global Assessment Scale (PGA-IGA). PDF Use of Physician Global Assessment (PGA) in Systemic lupus - medRxiv The assessment of disease activity in SLE is particularly challenging. Clipboard, Search History, and several other advanced features are temporarily unavailable. Glossary: PGA. All articles published through 1 July 2019 in PubMed were screened, with no limitation on year of publication, language or patients' age. AU - Kasitanon, Nuntana. 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. History of Changes for Study: NCT05672576 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]. Methods: This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items . Moreover, there is uncertainty as to whether the best timing of assessment is prior to or after reviewing laboratory exams [26]. Matthew Turk,1,2 Janet E Pope1,2 To cite: turk M, Pope Je. , Gladman DD. , Socher SA van Vollenhoven R 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. 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. Pain assessment: An alternative measure - hcplive.com Epub 2014 Apr 11. However, it is important to remember that not all clinical problems reported by a lupus patient are due to the disease. ~Sle~ - Oxford Textbook of Neuropsychiatry - 2020 | PDF | Psychiatry 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]. Associations between physicians' global assessment of disease activity Brunner HI , Lin M Thanks to this feature, the PGA was included in composite indices with the aim of rating manifestations not included in glossary-based instruments such as the SLEDAI and BILAG [3] or for which a threshold has been defined (cytopenia). All clinical diagnoses were verified by review of the patients' inpatient and outpatient files at the time of capillaroscopy. , Jolly M. Mok CC AU - Morand, Eric. It can affect the joints, skin, brain, lungs, kidneys, and blood vessels. In our centre, new tools for the assessment of SLE activity: the Lupus Activity Scoring Tool (LAST) and Clinical Lupus Activity Scoring Tool (C-LAST) were developed and validated. , Ko T Retrieved papers were selected with no limitation on the year of publication, language or patients age. , Vogel-Claussen J Laboratory Investigation Results Influence Physician's Global FOIA 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. Criterion validity also refers to the degree to which an instrument predicts aspects and phenomena occurring in the future [108]. In Fatemi et al. 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. 3TR (Taxonomy, Treatment, Targets and Remission) Systemic Lupus Methods This SLR was conducted by two independent reviewers in accordance with the PRISMA statement. The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. Face validity was reported in all the articles retrieved in which the PGA was used alone or as part of composite indices (Systemic Responder Index, Safety of Estrogen in Lupus Erythematosus National Assessment Flare Index, Lupus Low Disease Activity State, Definitions of Remission in Systemic Lupus Erythematosus criteria). However, the PGA allows for the measurement of disease activity in a global way (content validity). physician global assessment (pga) - Assesschild Scoring systemic lupus erythematosus (SLE) disease activity with simple The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. , Magder LS , Pego-Reigosa J-M Navarra SV The Physician Global Assessment (PGA) of treatment response measures the overall response to treatment as assessed by the physician. Physician training is very important. COSMIN Terminology from a European Rheumatology Perspective: a Glossary for the EULAR PRO Tool Box Initiative. 2014 Sep-Oct;10(5):309-20. doi: 10.1016/j.reuma.2014.01.012. Supervise the development of junior medical affairs staff . AU - Louthrenoo, Worawit. , Voskuyl A official website and that any information you provide is encrypted Fatigue is independently associated with disease activity assessed using the Physician Global Assessment but not the SLEDAI in patients with systemic lupus erythematosus. Ragai Kiriakos, MD, MSc - Clinical Trials Physician - LinkedIn The search strategy for SSc-related publications identified 75 citations . Unauthorized use of these marks is strictly prohibited. Oxford University Press is a department of the University of Oxford. Methods: 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). X 20 Physician Global Assessment 10.1136/lupus-2019-lsm.176 . Whenever papers reported duplicate data, the most recent article was selected. et al. , Liberati A Laboratory investigation results influence Physicians Global ssessment (PGA) of disease activity in SLE. et al. , Genovese M Published by Oxford University Press on behalf of the British Society for Rheumatology. Systemic Lupus Erythematosus and Lupus Nephritis - Epidemiology , Sjwall C http://oml.eular.org/glossary (31 January. According to the OMERACT, face validity is the degree to which the instrument appears to match with the target domain, according to experts [18]. SLE or at an SLE site, but only if the injury requires treatment by a licensed medical doctor. , Francis S Because of the complexity of SLE, the assessment of disease activity is particularly challenging [3]. Parodis I , Hearth-Holmes M. Khan A Objective: To examine the feasibility of using Physician Global Assessment (PGA) scores to collect and track patient acne and . PDF Physician Global Assessment International Standardisation COnsensus in Ensure second line of defense Derivatives RWA reviews are performed consistently and . , Hochberg M. Touma Z 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. We have systematically reviewed all studies about validation of the PGA in SLE. 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). , Gordon C A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.67-0.98). et al. PGA-IGA described in ePROVIDE - Mapi Research Trust et al. Merrill JT Mayara Torres Silva de Oliveira, MD, MBA on LinkedIn: #medicinanuclear Physician's global assessment is often useful in SLE - ResearchGate 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. Gladman DD 04 Measuring SLE disease activity in 2020: perspectives from clinical Results: et al. 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 . Mina R , Burlingame RW Observed and articulated management issues and responses. , Khamashta MA 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. 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. Deconstruction of the safety of estrogen in lupus erythematosus national assessment-systemic lupus erythematosus disease activity index flare index. 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]. disease activity). It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. Barr SG , McGuire JL. 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. The PGA was introduced in 1998 by a US Food and Drug Administration panel as the preferred tool to assess and record the severity of disease in clinical studies, and typically rates a patient's disease from 'clear' to 'severe' or 'very severe' [1, 2]. Use of Physician Global Assessment in systemic lupus erythematosus: a Face validity was reported in all the articles retrieved in which the PGA was used alone or as part of composite indices (Systemic Responder Index, Safety of Estrogen in Lupus Erythematosus National Assessment Flare Index, Lupus Low Disease Activity State, Definitions of Remission in Systemic Lupus Erythematosus criteria). The aim of this systematic literature review (SLR) is to describe and analyse the psychometric properties of PGA. et al. Mok CC Physician global assessment in systemic lupus erythematosus: Can we These results enabled its use as a gold standard for assessing flare and defining flare severity in several studies [21, 67, 88]. 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. Copay AG It operates in Albuquerque, and New Mexico. CLOSED ANGLE/ ANGLE CLOSURE GLAUCOMA. Patient and Physician Global Assessments of Disease Status in Systemic Thus the development of a comprehensive index for assessing disease activity still represents one of the most important challenges in SLE [7]. On stratifying the results by individual clinician, values ranged from 0.61 to 0.90, except for those reported by . et al. Rheumatology (Oxford). In 1988, Liang et al. 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. 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. allergy hx phenothiazines, cns depressants and stimulants withheld 48 hours prior. et al. The correlation with the SLEDAI was determined in 12 studies (Fig. 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. Different definitions of disease activity according to the PGA instrument. , Larson MG sharing sensitive information, make sure youre on a federal 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). , Bresee C Clinical Trial on Systemic Lupus Erythematosus (SLE): Blood sample In conclusion, the PGA was demonstrated to be a valid, responsive and feasible instrument, but its reliability was strongly impacted by the scale adopted, suggesting the need for standardization in its scoring. New Tools to Measure Disease Activity in SLE - Rheumatology Network inflammation (duration and severity of morning stiffness as measured by BASDAI). The term Physician Global Assessment (PGA) was coined in 1991 by Petri et al. Physician global assessments for disease activity in rheumatoid et al. 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]. , Schur PH. , Urowitz MB Brunner HI The aim of this systematic literature review (SLR) is to describe and analyse the psychometric properties of PGA.
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