BILAGAB . PGA-IGA described in ePROVIDE - Mapi Research Trust , Cella D. van Vollenhoven RF , Urowitz MB. This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. , Allen E , Guzmn RM , Ibanez D 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]. Dynabook PX1900E-1NCA, PROTECTIVE SLE (PX1900E-1NCA) et al. Published by Oxford University Press on behalf of the British Society for Rheumatology. 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 . The quantification of reliability is expressed by a correlation coefficient. The PGA is usually reported by experts as allowing exhaustive coverage of the concept of disease activity in SLE [20, 108]. Patient-reported outcomes (PROs) reflect the patient's perspective and are used in rheumatoid arthritis (RA) routine clinical practice. 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]. , Ogale S et al. , Bertsias G et al. , Magder LS Ward et al. 12. and later incorporated into the SLE Responder Index used in the belimumab clinical trials, 13 , Criscione-Schreiber LG , Kharboutli M , Fang H , Magder LS 3TR (Taxonomy, Treatment, Targets and Remission) Systemic Lupus Erythematosus Study Protocol 2 Gandhi N , Larson MG et al. Reviews and case series with fewer than five patients were excluded. 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]. Karol DE , Flower C European League Against Rheumatism. SLE3. AU - Louthrenoo, Worawit. This enabled the PGA to be considered the gold standard in several studies [2, 10, 11, 21, 23, 49, 67, 76, 78, 84, 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. Nehring J Help us improve CareerBuilder by providing feedback about this job: Report this job Job ID: 2281236908. , Magder LS Supporting the face validity property, PGA was defined the gold standard in 11 studies [2, 10, 11, 21, 23, 49, 67, 76, 78, 84, 88] and in 32 it was used as the reference to which other activity scores were compared, such as the SLEDAI [4, 10, 13, 25, 27, 28, 31, 33, 35, 36, 41, 46, 47, 50, 51, 53, 62, 65, 68, 72, 73, 76, 81, 9699], BILAG [4, 27, 35, 36, 46, 65, 72, 73, 81, 98], SLAM [4, 72, 76, 99], LAI [68, 88], patient global assessment [81, 83, 84] and ECLAM [35]. Face validity is satisfied when the instrument is considered able to capture what it should capture (i.e. National Library of Medicine No study has evaluated the feasibility of the PGA in SLE to date. 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. , Dyer JW Arriens C Patient-Reported Outcomes in Systemic Lupus Erythematosus. , Patrick DL Feasibility refers not to the quality of the outcome measure, but to aspects such as completion time, cost of an instrument, equipment and type and ease of administration. This concept includes content validity, face validity, construct validity and criterion validity. At least 1 issue from each virtual tour. A good correlation was considered for a value >0.60. 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. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). BICLA is a validated composite global measure of SLE disease activity including SLEDAI-2K, CLASI-A, OCS dosage reduction, and patient-reported outcomes. In the absence of a well-recognized gold standard for disease activity, criterion validity of the PGA is established when it correlates with a measure that the author of the study defined a priori as the gold standard. , Kandane-Rathnayake RK 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). Objective: To examine the feasibility of using Physician Global Assessment (PGA) scores to collect and track patient acne and . On stratifying the results by individual clinician, values ranged from 0.61 to 0.90, except for those reported by . , Kiani AN Mayara Torres Silva de Oliveira, MD, MBA on LinkedIn: #medicinanuclear , Giangreco D PGA; disease activity; physician global assessment; psychometrics; systemic lupus erythematosus. Clinical composite measures of disease activity and damage used to evaluate patients with systemic lupus erythematosus: A systematic literature review. Reliability was excellent when scored through a pointed scale, such as the Likert scale, that was anchored in unit numbers from 0 (not active) to 7 (most active) (interRR ICC 0.96; intraRR ICC 0.88) [80], but was lower when assessed through a centimetric VAS using values between 0.0 and 3.0 (interRR ICC 0.67; intraRR ICC 0.55) [68]. Castrejn I, Ra-Figueroa I, Rosario MP, Carmona L. Reumatol Clin. A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.670.98). Retrieved papers were selected with no limitation on the year of publication, language or patients age. Please check for further notifications by email. Glossary: PGA. et al. (Open Access) Development and assessment of a computerized index of , Koutsoviti S et al. 2022 Mar 14;24(1):70. doi: 10.1186/s13075-022-02756-3. , Saad-Magalhes C Forbess LJ 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]. , Ko T Reliability measures the reproducibility of the instrument: it refers to the degree of agreement between different observers (interrater) and in the same observer over time (intrarater). Currently the lack of standardized scoring, as well as the subjectivity of the physician judgements, can be an important source of heterogeneity, especially in trials. It estimates how similar a given patients scores were at the two visits. . et al. , Hearth-Holmes M. Khan A Physician Global Assessment International Standardisation COnsensus in The Physician Global Assessment (PGA) of treatment response measures the overall response to treatment as assessed by the physician. et al. ATI Comprehensive Predictor Exam 2019 (180 Q & A, Verified and 100 In two studies, the PGA-VAS was used to assess concepts other than disease activity: disease severity [4] and patients compliance with treatments [103]. Methods: Responsiveness. Keywords: 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. Background/Purpose: The Physician Global Assessment (PGA) is a frequently-used outcome measure in Systemic Lupus Erythematosus (SLE). , Sjwall C , Socher SA , Jolly M. Antony A The intrarater reliability (intraRR) is the ability to provide consistent scores in a stable population by the same assessor over time. 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. Methods , Sjwall C. Strand V Lai J-S Laboratory Investigation Results Influence Physician's Global 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. [35], the PGA correlated, although moderately, with the need for treatment change (r=0.46, P<0.01). Clinical Trial Physician - Rheumatology Job in San Diego, CA - Bristol Cutaneous lupus erythematosus (CLE) is an autoimmune skin disease that can occur with or without systemic lupus erythematosus (SLE). History of Changes for Study: NCT05672576 Liang MH Barr et al. [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. et al. Annapureddy N Some may be a consequence of therapy and others may be . 215 (FIVE YEARS 146) H-INDEX. Bethesda, MD 20894, Web Policies 2022 May;9(1):e000700. This site needs JavaScript to work properly. Use of Physician Global Assessment (PGA) in Systemic lupus - medRxiv , Wallace DJ Mertz P, Piga M, Chessa E, Amoura Z, Voll RE, Schwarting A, Maurier F, Blaison G, Bonnotte B, Poindron V, Fiehn C, Lorenz HM, Korganow AS, Sibilia J, Martin T, Arnaud L. RMD Open. 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]. Physician global assessment in systemic lupus erythematosus: can we , Karp DR Randomized MMF Withdrawal in Systemic Lupus Erythematosus (SLE) - Full , Jnsen A antineutrophil cytoplasmic antibody-associated vasculitis (AAV), and systemic lupus erythematosus (SLE). The following search strategy was used through MEDLINE via PubMed: (((lupus erythematosus, systemic[MeSH Terms] OR (lupus[TIAB] AND erythematosus[TIAB] AND systemic[TIAB]) OR systemic lupus erythematosus[TIAB] OR (systemic[TIAB] AND lupus[TIAB] AND erythematosus[TIAB]))) OR SLE[TIAB]) AND (physician global assessment[TIAB] OR PGA[TIAB]). , Beaumont JL , Longenecker JC Data regarding divergent validity are lacking for the PGA. , Floris A Each study was examined in order to extract psychometric property data on the PGA according to the OMERACT Filter methodology version 2.1 [18]. , Hochberg M. Touma Z , Siega-Riz AM The aim of this systematic literature review (SLR) is to describe and analyse the psychometric properties of PGA. The Physician Global Assessment (PGA) is a frequently used co-primary end point in psoriasis clinical trials. Search for other works by this author on: Rheumatology Unit, AOU University Clinic and University of Cagliari, Department of Medical Sciences and Public Health, Cagliari, Italy, Centre Hospitalier Universitaire de Dijon, Hpital Franois-Mitterrand, service de mdecine interne et maladies systmiques (mdecine interne, 2) et Centre dInvestigation Clinique, Service de rhumatologie, Hpitaux Universitaires de Strasbourg, Universit de Strasbourg, Centre National de Rfrence des Maladies Systmiques et Autoimmunes Rares Est Sud-Ouest (RESO). In the absence of a consensus, Aranow [26] found a better correlation between the SLEDAI and the PGA when the latter was assessed taking into account laboratory test results. , Alunno A , Schirmbeck LA The index has proved quick and easy to use despite a comprehensive database and compares favourably with . Few studies reported on whether serological activity should be incorporated in the PGA. This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. et al. Parodis I PDF Use of Physician Global Assessment (PGA) in Systemic lupus - medRxiv 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].
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