Observed and articulated management issues and responses. , Annapureddy N 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 . , Subach RB It can affect the joints, skin, brain, lungs, kidneys, and blood vessels. AU - Louthrenoo, Worawit. PGA0.3. 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 assessment of disease activity in SLE is particularly challenging. 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. , Maxwell LJ , Sengupta M Glossary: PGA. Few studies reported on whether serological activity should be incorporated in the PGA. , Liberati A , Chang AY , Mikolaitis-Preuss RA , Tetzlaff J According to the authors, this difference was probably due to the greater familiarity of the physicians with the BILAG-2004 index. Mok CC 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]. , Hambleton IR For permissions, please email: journals.permissions@oup.com. , Guzmn RM 8600 Rockville Pike , Trendelenburg M 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. 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Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. , Sayedbonakdar Z et al. TOTAL DOCUMENTS. , Petri MA An assessment of disease flare in patients with systemic lupus erythematosus: a comparison of BILAG 2004 and the flare version of SELENA. , Aggarwal R The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. Reviews and case series with fewer than five patients were excluded. Thank you for submitting a comment on this article. 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]. This enabled the PGA to be considered the gold standard in several studies [2, 10, 11, 21, 23, 49, 67, 76, 78, 84, 88]. Some may be a consequence of therapy and others may be . , Kalunian K 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). HHS Vulnerability Disclosure, Help , Jolly M. Ribi C A PGA 2 correlated with a risk of pregnancy loss (29% vs 8%, P=0.005) [49]. Responsiveness. 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. 2021 Apr 8;5(1):33. doi: 10.1186/s41687-021-00298-x. Background/Purpose: The Physician Global Assessment (PGA) is a frequently-used outcome measure in Systemic Lupus Erythematosus (SLE). et al. This site needs JavaScript to work properly. Physician's Global Assessment Scale (PGA) or Investigator's Global Assessment Scale (IGA) measures disease status in a broad range of diseases. Castrejn I, Ra-Figueroa I, Rosario MP, Carmona L. Reumatol Clin. In support of its face validity, the PGA was used to define the disease activity score in all 91 studies retrieved by the literature search, having a role as an outcome measure as well as a comparator to assess the validity of other indices. Keywords: [35], the PGA correlated, although moderately, with the need for treatment change (r=0.46, P<0.01). The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. . In one study [25], the PGA of disease activity resulted from the combination of the clinical visit, laboratory markers evaluation and the physicians knowledge of the patient disease history. , Garabajiu M A total of 91 articles were included in the study (Fig. , Dietzmann K 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). , Ibanez D In this systematic review we have analysed the measurement properties of the PGA, including the validity, reliability, responsiveness and feasibility. and transmitted securely. The Physician's Global Assessment (PhGA) is a number without unit. 2022 Sep 20;19(19):11895. doi: 10.3390/ijerph191911895. 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. Face validity is satisfied when the instrument is considered able to capture what it should capture (i.e. 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. 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]. , Shea BJ [8] suggested the need for a disease activity instrument that would be valid, reliable and sensitive to change. , Petri MA , Ko T 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]. Disclaimer. , Jolly M. Mazur-Nicorici L et al. , Navarra SV 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. , Bentow C et al. The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and . 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. Funding: The study was funded through the training Bursary Programme 2019 of the SLEuro European Lupus Society. , Friebus-Kardash J Cloud, mobility, security, and more. , Floris A 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. RN-BSN HOLISTIC HEALTH ASSESSMENT ACROSS THE LIFESPAN (NURS 3315) Sociology of Social Problems (SOC213) , Sjwall C Physician global assessments for disease activity in rheumatoid arthritis are all over the map!. Quimby KR Gandhi N 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. Systemic lupus erythematosus (SLE) is a multisystem autoimmune rheumatic disease (ARD) characterized by flares and remissions. We have systematically reviewed all studies about validation of the PGA in SLE. Whenever papers reported duplicate data, the most recent article was selected. Conclusion: et al. 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. All rights reserved. sharing sensitive information, make sure youre on a federal watch for seizures after the procedure. et al. Ann Rheum Dis 2011;70:54-9. 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]. The responsiveness of the PGA was assessed through different methods [109, 113] showing a high sensitivity for detecting clinical variations [84]. , Arora S There is no cure for lupus, but medical . Clinical composite measures of disease activity and damage used to evaluate patients with systemic lupus erythematosus: A systematic literature review. Myelogram - correct answer NPO for 4-6 hours. , Gladman DD 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. , Emamikia S For full access to this pdf, sign in to an existing account, or purchase an annual subscription. Touma Z COSMIN Terminology from a European Rheumatology Perspective: a Glossary for the EULAR PRO Tool Box Initiative. , Anderson N (PGA) scoring of disease activity in systemic lupus erythematosus (SLE). , Magder LS The content can vary and relates either to global health (e . 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. Unable to load your collection due to an error, Unable to load your delegates due to an error. et al. , Weisman MH. Published by Oxford University Press on behalf of the British Society for Rheumatology. , Merrill JT. Before Feb 2016 - Jan 20182 years. 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). Piga M This important heterogeneity in the anchoring of the PGA prevented us from performing a meta-analysis of reliability data. , Perez-Gutthann S According to the OMERACT, face validity is the degree to which the instrument appears to match with the target domain, according to experts [18]. The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. , Henriques C Mahler M 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]. , Kraag GR BILAGAB . , McGuire JL. Measurement properties of the PGA were analysed according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) terminology [19]. et al. 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. , Kosinski M The literature search identified 91 studies. Nehring J The last EULAR/ACR recommendations recommended use of the PGA in the routine monitoring of SLE [16]. A good correlation was considered for a value >0.60. , Kalunian K et al. , Block JA 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 . Methods , Siega-Riz AM Criterion validity is defined as the degree to which the scores of an instrument adequately reflect the truth in the form of a gold standard [107]. (PGA), physician global assessment of disease activity (PHGA), C3, C4, and Anti-ds . , Magder LS Comparison of the validity and sensitivity to change of 5 activity indices in systemic lupus erythematosus. If you have a published paper from this period that does not appear on this list, please contact Sue Marone, who will add it to next week's collection. No study has evaluated the feasibility of the PGA in SLE to date. Arthritis Res Ther. et al. , Schirmbeck LA 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 . The .gov means its official. . Thanou A, Chakravarty E, James JA, Merrill JT. , Hochberg M. Wallace DJ Your recommendations as to what might or should be done in relation to various issues observed. A Comprehensive Digest of Research Publications From Cedars-Sinai Investigators. , Magder L , Skogh T 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. 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]. Despite the need for new treatments in CLE . SLE has protean and often complex manifestations, necessitating careful clinical assessment. Vil LM 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. Introduction Physician global assessments of disease activity (medical doctor (MD) globals) are important outcomes. Gladman DD , Hearth-Holmes M. Khan A , Pilkington C et al. Because of the complexity of SLE, the assessment of disease activity is particularly challenging [3]. , Francis S 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. Fatigue is independently associated with disease activity assessed using the Physician Global Assessment but not the SLEDAI in patients with systemic lupus erythematosus. , Bouter LM This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. T1 - Associations between physicians' global assessment of disease activity and patient-reported outcomes in patients with systemic lupus erythematosus. Aranow C , Pego-Reigosa J-M 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]. et al. 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Epub 2014 Apr 11. , ODell JR SLE2ACR1997SLICC2012. doi: 10.1136/rmdopen-2022-002395. Objective: Content validity was reported in 89 studies. 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 (. Fanouriakis A 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 aim of this systematic literature review (SLR) is to describe and analyse the psychometric properties of PGA. Systemic lupus erythematosus (SLE) is a chronic autoimmune disease of multifactorial origin that can affect any organ or organ system, resulting in a broad spectrum of clinical manifestations ranging from dermatological involvement to multi-organ failure with episodes of relapses and remissions. , Rodrigues M , Petri M. Foering K The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. et al. 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]. 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. 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. , Mina R Please enable it to take advantage of the complete set of features! For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Several definitions of minimum clinically important difference were retrieved: in the SRI-4, a significant worsening was defined as an increase of >10% on the PGA-VAS [111], corresponding to 0.3 points from baseline; Touma et al. CareerBuilder TIP. Gordon C The Janus kinase (Jak)/signal transducer and activating protein (STAT) pathways mediate the intracellular signaling of cytokines in a wide spectrum of cellular processes.