et al. This property is reported across all articles selected through this systematic review [24, 913, 21103]. 2022 Sep;8(2):e002395. , Jolly M. Ribi C This concept includes content validity, face validity, construct validity and criterion validity. The PGA is usually reported by experts as allowing exhaustive coverage of the concept of disease activity in SLE [20, 108]. Mina R , Wetter J Petri M All versions are validated and used by lupus researchers for clinical and research purposes. 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 . SLE2ACR1997SLICC2012. , Allen E 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. 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. Content validity pertains to the degree to which the instrument measures all facets of a construct of interest [20]: this property is satisfied if the PGA is considered able to measure all aspects of disease activity in SLE in a comprehensive way. Objective: , Kharboutli M , Jolly M. Mazur-Nicorici L , Ibanez D For permissions, please email: journals.permissions@oup.com. In the second column, the definitions were reported according to the VAS used in the study. 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. . OBJECTIVE The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. Of note, the literature search revealed heterogeneous definitions of physician assessment of disease activity other than the PGA (physician global assessment [4, 70, 73], physician overall assessment [85]). Can Lupus Patients Take the Driver's Seat in Their Disease Monitoring. Objective Existing methods for grading lupus flares or improvement require definition-based thresholds as increments of change. All rights reserved. The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall 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. Federal government websites often end in .gov or .mil. , Devilliers H , Askanase A antineutrophil cytoplasmic antibody-associated vasculitis (AAV), and systemic lupus erythematosus (SLE). The Physician Global Assessment (PGA) is a frequently used co-primary end point in psoriasis clinical trials. , Maxwell LJ 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. Ward et al. 'Not at target': prevalence and consequences of inadequate disease control in systemic lupus erythematosus-a multinational observational cohort study. et al. , Perneger T In two studies, the PGA-VAS was used to assess concepts other than disease activity: disease severity [4] and patients compliance with treatments [103]. This may be explored through convergent and divergent validity. , OMalley T , Pego-Reigosa J-M CareerBuilder TIP. 2014 Dec;53(12):2175-81. doi: 10.1093/rheumatology/keu153. Thanou A Navarra SV A PGA 2 correlated with a risk of pregnancy loss (29% vs 8%, P=0.005) [49]. 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. , Rodrigues M , Seaman AL et al. , Shea BJ Cutaneous lupus erythematosus (CLE) is an autoimmune skin disease that can occur with or without systemic lupus erythematosus (SLE). et al. The Author(s) 2020. All articles published through 1 July 2019 in PubMed were screened, with no limitation on year of publication, language or patients age. Chaigne B , Kandane-Rathnayake RK 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]. , Friebus-Kardash J These results enabled its use as a gold standard for assessing flare and defining flare severity in several studies [21, 67, 88]. , Bouter LM Laboratory investigation results influence Physicians Global ssessment (PGA) of disease activity in SLE. The Physician's Global Assessment (PhGA) is a number without unit. et al. , Farewell V No study has evaluated the feasibility of the PGA in SLE to date. This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. , McGuire JL. doi: 10.1136/lupus-2022-000700. Psychometric properties of FACIT-Fatigue in systemic lupus erythematosus: a pooled analysis of three phase 3 randomised, double-blind, parallel-group controlled studies (BLISS-SC, BLISS-52, BLISS-76). AU - Morand, Eric. Systemic lupus erythematosus (SLE), is the most common type of lupus. PGA0.3. , Petri M. Isenberg DA , Francis S Stojan G FOIA PMC Truth refers to whether the measure provided by the scores is able to measure what was intended [18]. Kiani AN Additional papers were obtained by checking the references from the selected studies. It can affect the joints, skin, brain, lungs, kidneys, and blood vessels. J Clin Med. , Mohan C. Giangreco D For full access to this pdf, sign in to an existing account, or purchase an annual subscription. 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 . The .gov means its official. et al. Conducting medical monitoring, safety review, narrative writing and etc.. Perform medical assessment of individual . , Gordon C 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 . 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]. The PGA intraRR was assessed in three studies [10, 68, 94] and ranged from 0.55 [68] to 0.88 [10]. , Patrick DL Jiao H, Acar G, Robinson GA, Ciurtin C, Jury EC, Kalea AZ. On stratifying the results by individual clinician, values ranged from 0.61 to 0.90, except for those reported by . Ensure second line of defense Derivatives RWA reviews are performed consistently and . et al. , Buyon J [84] expressed the sensitivity in PGA scoring with the standardized response mean (SRM), demonstrating a very large effect size (ES=2.23) [110]. The content can vary and relates either to global health (e . , Block JA 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. COSMIN Terminology from a European Rheumatology Perspective: a Glossary for the EULAR PRO Tool Box Initiative. 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 . 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]. Objective Physician's global assessment (PGA) of disease activity is a major determinant of therapeutic decision making. Feasibility is the ease of application of the instrument of measure in its intended setting [106]. 12. and later incorporated into the SLE Responder Index used in the belimumab clinical trials, 13 Prinsen CAC Unauthorized use of these marks is strictly prohibited. Reliability. , Nguyen SC National Library of Medicine 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]. , Tetzlaff J 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]. , Sayedbonakdar Z Methods Patients attending a rheumatology clinic between 2013 and 2017 completed specific (SLEQOL) and generic (SF36) health-related quality of life (HRQoL) surveys and rated . Brunner HI However, the PGA allows for the measurement of disease activity in a global way (content validity). 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 aim of this systematic literature review (SLR) is to describe and analyse the psychometric properties of PGA. The other authors have declared no conflicts of interest. , Magder LS 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]. Touma Z Improving patient pathways for systemic lupus erythematosus: a multistakeholder pathway optimisation study. , Nelson S This week's edition of Faculty Publications includes Cedars-Sinai studies that were published Feb. 23-March 2. Methods: et al. [35], the PGA correlated, although moderately, with the need for treatment change (r=0.46, P<0.01). Criterion validity. SFI, LLDAS, SRI, Definitions of Remission in Systemic Lupus Erythematosus remission criteria) [3, 5, 10, 1315, 104]. 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. , Sato JO et al. Feb 2016 - Jan 20182 years. Enocsson H Your comment will be reviewed and published at the journal's discretion. 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]. Your recommendations as to what might or should be done in relation to various issues observed. Clipboard, Search History, and several other advanced features are temporarily unavailable. et al. The Physician Global Assessment (PGA) of treatment response measures the overall response to treatment as assessed by the physician. 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]. Definition: At least a 20%, 40%, 50%, or 70% improvement and an absolute improvement of at least 1 unit on a scale of 1-10 in at least three of the following criteria: patient global assessment; pain; function (BASFI); and. physician's global assessment (PGA) of disease activity in SLE. There is no cure for lupus, but medical . , Engel SM 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]. Merrill JT , Kostopoulou M et al. , Chang AY Ann Rheum Dis 2011;70:54-9. TOTAL DOCUMENTS. Rheumatology (Oxford). Lead Medical Director heading up the global collaboration with Pfizer for Enbrel trials. A difference between the interRR of the PGA assessed by an untrained physician (ICC=0.50.63) or a trained investigator (ICC=0.790.81) was found [36]. Sullivan KE , Larson MG Flow chart illustrating the literature search and study selection. Discrimination refers to whether the score (PGA-VAS) differentiates between situations of interest [18]: discrimination of the PGA measures the ability of the PGA-VAS to report a consistent score where no change in disease activity has occurred (reliability) and to detect a change when a change in disease activity has occurred (sensitivity to change or responsiveness). Medizinische Universitt Graz Austria/sterreich - Forschungsportal - Medical University of Graz Direkt zur Navigaton springen . et al. 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. . Injuries requiring medical treatment are considered to be "reportable incidents," and must be reported to the NJDOE within five working days of the occurrence. , McGwin G A 21-numbered circle visual analog scale (VAS) may be a desirable alternative to the traditional 10-cm horizontal line for pain and patient global estimate on a Multidimensional Health Assessment Questionnaire (MDHAQ). [8] and adopted in childhood SLE; the most common tool (the 03 VAS) was developed [68] to capture the concept of flare and is measured on a 3cm VAS in the SRI [3] and a 10cm VAS in the SFI [10, 104], but other scores (02, 04, 05, 07) [11, 53, 78, 80, 86, 87] and lengths (8cm, 15cm) [10, 8284] have also been used. Eudy AM , Hochberg M. Wallace DJ Physician's Global Assessment (PGA) score 1.0 on a 0 to 3 visual analog scale. 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). 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. Meta-analysis of the studies reporting data concerning the construct validity between the PGA and SLEDAI. In 1988, Liang et al. , Matos A , Rairie JE et al. Copay AG et al. ~SLE~. , Morabito LM 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 . Keywords: It does not provide a predefined or limited list of disease manifestations or organ systems, thus allowing one to capture all the heterogeneous aspects of SLE disease activity. , Klein-Gitelman MS 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. Rendas-Baum R, Baranwal N, Joshi AV, Park J, Kosinski M. J Patient Rep Outcomes. PGA is a valid, responsive and feasible instrument, while its reliability was impacted by the scale adopted, suggesting the major need for a standardization of its scoring. , Weisman MH. , Petri M. Furie RA In this systematic review we have analysed the measurement properties of the PGA, including the validity, reliability, responsiveness and feasibility. 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. , Jolly M. Mok CC Provide oversight to Shared Services Derivatives team supporting RWA operations and production. The PISCOS results will allow for increased homogeneity and reliability of PGA ratings in routine clinical practice, definitions of remission and low disease activity, and future SLE trials. et al. HHS Vulnerability Disclosure, Help The PGA was developed on a 0 to 3 scale as part of the Lupus Activity Index. An international panel of 79 SLE experts participated in a three-round Delphi consensus . Three studies evaluated the association between PGA scores and treatment changes: PGA correlated negatively with adherence to treatment assessed through an item scale (r=0.31, P=0.11) [34]; clinically defined mild and moderate flares had a higher disease activity by the PGA (P<0.001) than those defined as mild/moderate flare only by medication changes [55]; PGA scores were associated positively with response to belimumab treatment (P=0.039) [43]. , Liberati A , Chakravarty E Methods , Kiani AN et al. Wells GA 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). The quantification of reliability is expressed by a correlation coefficient. , Raeisi A 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). Arthritis Res Ther. LECTURE 10: MEDICAL SURGICAL NURSING. According to the authors, this difference was probably due to the greater familiarity of the physicians with the BILAG-2004 index. Face validity. 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 anonymous patientcompleted questionnaire comprised the following: current pain in the past 7 days (10cm VAS [0 no pain; 10 most severe pain]), patient global assessment (PtGA) of health status (10 cm VAS [0 very well; 10 very poorly]), ever and current recreational cannabis use, ever and current medical cannabis use, and if cannabis . The Senior Lead will be responsible for: Managing end to end production, governance and controls of Derivatives Standardized and Advanced RWA, and SLE Actuals. et al. European League Against Rheumatism. , Borghoff K The aim of this systematic literature review is to describe and analyse the . lupus erythematosus; systemic outcome assessment; qualitative research; healthcare; We read with great interest the recent paper by Aranow et al 1 about the impact of laboratory results on scoring of the Physician Global Assessment (PGA) of disease activity in systemic lupus erythematosus (SLE). Parodis I 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. The pooled correlation coefficient (95% CI) is given both for the fixed effects model and the random effects model. , Alunno A government site. 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 . 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]. 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 .