physician global assessment sle

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. 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 . 12. and later incorporated into the SLE Responder Index used in the belimumab clinical trials, 13 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. 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 (SLR) is to describe and analyse the psychometric properties of PGA. The last EULAR/ACR recommendations recommended use of the PGA in the routine monitoring of SLE [16]. The sensitivity to change was estimated to be the smallest for the SLEDAI; the standardized response means were 0.48 when the physician global assessment was used as the standard and 0.01 when the patient global assessment was used . All articles published through 1 July 2019 in PubMed were screened, with no limitation on year of publication, language or patients' age. disease activity in SLE, with the Physician Global Assessment (PGA) being the only one included in the updated EULAR recommendations for the management of SLE.11. Liang et al. , Hynan LS , Dyer JW Petri M 2014 - 20184 years. et al. 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). 8600 Rockville Pike Annapureddy N , Andreoli L , Wallace DJ , Socher SA The geographical analysis of the Global Global Respiratory Devices market provided in the report is just the right tool that competitors can use to discover untapped sales and business expansion . , Skogh T . , Wallace DJ This study assesses the reliability of the PGA, measured by means of 0-100 mm visual analog scale (VAS), and the additional use of separate VAS scales for musculoskeletal (PhysMSK) and dermatologic (PhysSk) manifestations in patients with psoriatic arthritis (PsA). 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]. 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]. , Beaumont JL The SRI is a validated SLE disease activity instrument used to detect clinically meaningful improvement of disease in SLE clinical trials. 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. , Shinada S The company serves physicians and patients. Careers. 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. , Jolly M. Mazur-Nicorici L The assessment of PGA responsiveness was performed in 10 studies [4, 23, 50, 58, 7779, 81, 83, 84] using different methods [110]. Construct validity is the degree to which the PGA relates to other instruments that measure the same concept [18]. The other authors have declared no conflicts of interest. Thanou A, Chakravarty E, James JA, Merrill JT. 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. 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]. FOIA 2021 Apr 8;5(1):33. doi: 10.1186/s41687-021-00298-x. Glossary: PGA. 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). The quantification of reliability is expressed by a correlation coefficient. . Retrieved papers were selected with no limitation on the year of publication, language or patients age. Provide oversight to Shared Services Derivatives team supporting RWA operations and production. , Subach RB To discriminate between the severity of flares, the PGA was incorporated in a composite index: the SFI [10] (Table1). Moher D Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. 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 (. , Henriques C 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 Recently Published Documents. Int J Environ Res Public Health. The responsiveness of the PGA is the ability to detect worthwhile variations in disease activity over time, measuring worsening or improvements in SLE disease status. Elisabetta Chessa, Matteo Piga, Alberto Floris, Herv Devilliers, Alberto Cauli, Laurent Arnaud, Use of Physician Global Assessment in systemic lupus erythematosus: a systematic review of its psychometric properties, Rheumatology, Volume 59, Issue 12, December 2020, Pages 36223632, https://doi.org/10.1093/rheumatology/keaa383. et al. (PGA) scoring of disease activity in systemic lupus erythematosus (SLE). Clinical composite measures of disease activity and damage used to evaluate patients with systemic lupus erythematosus: A systematic literature review. Pincus and colleagues conducted a study of . To increase its reliability, the PGA should be scored by a physician with significant expertise in SLE, with prior knowledge of laboratory results [112], considering the overall disease activity at the time of the visit and comparing it to the last visit in order to assess flares [9]. 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). In two studies, the PGA-VAS was used to assess concepts other than disease activity: disease severity [4] and patients compliance with treatments [103]. Quimby KR , Kosinski M [84] expressed the sensitivity in PGA scoring with the standardized response mean (SRM), demonstrating a very large effect size (ES=2.23) [110]. [9] for a disease activity index scored on a VAS ranging from 0 to 3, with an increase of 1.0 since the last visit indicating a flare. , Ho LY Genetic linkage has related dysfunction of . Please enable it to take advantage of the complete set of features! , Magder LS JSS Medical Research. An official website of the United States government. BATCH RUBY INTENSIVE REVIEWRTRMF 3. Content validity was reported in 89 studies. et al. SLE3. Eudy AM , Giannakou I Strength. 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). The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. Ensure second line of defense Derivatives RWA reviews are performed consistently and . Some may be a consequence of therapy and others may be . Lead Medical Director heading up the global collaboration with Pfizer for Enbrel trials. 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. , Fang H Matthew Turk,1,2 Janet E Pope1,2 To cite: turk M, Pope Je. , Petri M Objective: , Roberts WN Epub 2014 Apr 11. Thank you for submitting a comment on this article. 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. The index assesses separately eight organ-based systems. X 20 Physician Global Assessment 10.1136/lupus-2019-lsm.176 . Your recommendations as to what might or should be done in relation to various issues observed. , Lau CS , Alunno A doi:10.1136/ rmdopen-2017-000578 Prepublication history and The PGA is a valid instrument but has variable reliability; its scoring should be standardized. Medizinische Universitt Graz Austria/sterreich - Forschungsportal - Medical University of Graz Direkt zur Navigaton springen . Brunner HI Meta-analysis of the studies reporting data concerning the construct validity between the PGA and SLEDAI. The site is secure. Kiani AN Objectives Remission in systemic lupus erythematosus (SLE) is defined through a combination of 'clinical SLE Disease Activity Index (cSLEDAI)=0', 'physician's global assessment (PGA) <0.5 . Navarra SV Reviews and case series with fewer than five patients were excluded. , Annapureddy N 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? , Emamikia S Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus: the PISCOS study . , Hochberg M. Wallace DJ 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]. Your comment will be reviewed and published at the journal's discretion. 'Not at target': prevalence and consequences of inadequate disease control in systemic lupus erythematosus-a multinational observational cohort study. et al. Ward et al. Arthritis Res Ther. et al. 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 . et al. 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. Arriens C In this systematic review we have analysed the measurement properties of the PGA, including the validity, reliability, responsiveness and feasibility. Touma Z , Socher SA 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. ~SLE~. , Bresee C Notorious to increase IOP and cause severe PAIN and headache; Diagnostics: - History - Tonometry examinations - measures IOP QUESTION A client states that the physician has told her that her intraocular was 14. , OMalley T Physician's Global Assessment Scale (PGA) or Investigator's Global Assessment Scale (IGA) measures disease status in a broad range of diseases. , Chizzolini C A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.67-0.98). 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]. , Sengupta M T2 - A longitudinal study. et al. et al. , Piette EW Mahler M inflammation (duration and severity of morning stiffness as measured by BASDAI). , Ibanez D , Landis RC Disclaimer. AB - The Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus (PISCOS) study aimed to obtain an evidence . disease activity). 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). LECTURE 10: MEDICAL SURGICAL NURSING. et al. In a post-hoc analysis of phase 3 belimumab trials, improvements and no worsening in the PGA were greater among SRI responders vs SRI non-responders (P<0.001) [52]. 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). PMC An assessment of disease flare in patients with systemic lupus erythematosus: a comparison of BILAG 2004 and the flare version of SELENA. , Beresford MW [8] suggested the need for a disease activity instrument that would be valid, reliable and sensitive to change. Bethesda, MD 20894, Web Policies 2014 Sep-Oct;10(5):309-20. doi: 10.1016/j.reuma.2014.01.012. Cloud, mobility, security, and more. , Rairie JE , Burlingame RW Aranow C Chaigne B The aim of this systematic review is to describe and analyse the measurement properties of the PGA, including the validity, reliability, responsiveness and feasibility. A good correlation was considered for a value >0.60. , Birmingham DJ allergy hx phenothiazines, cns depressants and stimulants withheld 48 hours prior. , Hearth-Holmes M. Khan A 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). Flow chart illustrating the literature search and study selection. A Comprehensive Digest of Research Publications From Cedars-Sinai Investigators. Sullivan KE , Urowitz MB This week's edition of Faculty Publications includes Cedars-Sinai studies that were published Feb. 23-March 2. 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 . AU - Louthrenoo, Worawit. , Tetzlaff J et al. et al. This site needs JavaScript to work properly. Copay AG Finally, the PGA enables the measurement of disease activity globally compared with a glossary-based index. The literature search identified 93 articles, and 12 additional articles were retrieved from the reference list of those publications. , ODell JR The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinicians judgement of overall SLE disease activity. 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 . , Kraag GR , Kiani AN Before Fanouriakis A Liang MH This potentially disfiguring disease can have significant impact on patient's quality of life (QoL) and is often refractory to many first- and second-line therapies. , Jolly M. Ribi C SLE2ACR1997SLICC2012. 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]. Ann Rheum Dis 2011;70:54-9. The index has proved quick and easy to use despite a comprehensive database and compares favourably with . Higher disease activity is an important predictor of both organ damage and mortality [2] and the attainment of low disease activity is associated with a reduction in early damage [5, 6]. http://oml.eular.org/glossary (31 January. et al. , Bertsias G 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 . , Gordon C official website and that any information you provide is encrypted This may be explored through convergent and divergent validity. Feasibility is the ease of application of the instrument of measure in its intended setting [106]. , Ding HH Montreal, Canada Area. , Petri MA PGA; disease activity; physician global assessment; psychometrics; systemic lupus erythematosus. , Kandane-Rathnayake RK The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. 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]. Methods: 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 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.

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