The results are similar, and less than half the time is required for scoring. 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]. , Merrill JT. Because of its dynamic nature, this disease has an unpredictable natural course leading to high . Matthew Turk,1,2 Janet E Pope1,2 To cite: turk M, Pope Je. Vil LM Quimby KR Lead Medical Director heading up the global collaboration with Pfizer for Enbrel trials. , Hochberg M. Touma Z et al. 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. , Weisman MH. [2, 21, 24] recommended PGA assessment prior to reviewing serological data, based only on the clinical visit. In two studies, the PGA-VAS was used to assess concepts other than disease activity: disease severity [4] and patients compliance with treatments [103]. BICLA is a validated composite global measure of SLE disease activity including SLEDAI-2K, CLASI-A, OCS dosage reduction, and patient-reported outcomes. 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. , Giannakou I X 20 sentence examples within Physician Global Assessment. Petri M The Physician Global Assessment (PGA) has been shown to be a valid, responsive, and feasible instrument to capture disease activity in systemic lupus erythematosus (SLE), but its low reliability further supports the need for a standardisation of its scoring. Correlations with other instruments measuring similar constructs should typically demonstrate a coefficient (r) 0.50 [106]. , Borghoff K HHS Vulnerability Disclosure, Help 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. According to the OMERACT, face validity is the degree to which the instrument appears to match with the target domain, according to experts [18]. doi: 10.1136/lupus-2022-000700. Clinical composite measures of disease activity and damage used to evaluate patients with systemic lupus erythematosus: A systematic literature review. This is a top barrier, both for treat-to-target management of SLE patients in clinical practice, as well as in clinical trials for new SLE treatments. et al. Because of the complexity of SLE, the assessment of disease activity is particularly challenging [3]. et al. Supervise the development of junior medical affairs staff . , Anderson N 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 . et al. , Wallace DJ This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. 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. 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]). Prinsen CAC Cutaneous lupus erythematosus (CLE) is an autoimmune skin disease that can occur with or without systemic lupus erythematosus (SLE). 12. and later incorporated into the SLE Responder Index used in the belimumab clinical trials, 13 The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. Karol DE , Annapureddy N 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. , Hynan LS 8600 Rockville Pike et al. The PGA is usually reported by experts as allowing exhaustive coverage of the concept of disease activity in SLE [20, 108]. Results of a large, multicentric, nationwide study, American College of Rheumatology provisional criteria for global flares in childhood-onset systemic lupus erythematosus, A cross-sectional study of hydroxychloroquine concentrations and effects in people with systemic lupus erythematosus, Inactive disease and remission in childhood-onset systemic lupus erythematosus, Preliminary criteria for global flares in childhood-onset systemic lupus erythematosus, Systemic lupus erythematosus in a multiethnic US cohort, XXXVII: association of lymphopenia with clinical manifestations, serologic abnormalities, disease activity, and damage accrual, Systemic lupus erythematosus in a multiethnic cohort (LUMINA): XXIX. , Lau CS , Chakravarty E , Fang H , Tetzlaff J , Roberts WN CareerBuilder TIP. However, it was used as a single outcome measure only in two studies [49, 100], while in the majority the PGA was scored together with another instrument (typically the SLEDAI) [2, 9, 11, 12, 21, 24, 30, 32, 34, 3740, 44, 45, 48, 49, 55, 58, 59, 61, 63, 64, 66, 67, 74, 75, 80, 82, 86, 8995, 103]. 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. Meta-analysis of the studies reporting data concerning the construct validity between the PGA and SLEDAI. AU - Kandane-Rathnayake, Rangi. SLE is an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage in the affected organs. , Francis S Navarra SV TOTAL DOCUMENTS. . , Mosca M Parodis I 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. et al. 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]. , Kiani AN , Magder LS AB - The Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus (PISCOS) study aimed to obtain an evidence . Thanou A , Skogh T , ODell JR Different definitions of PGA retrieved through the literature search are reported in Table1. It should be noted that the PGA correlates with several other instruments that measure disease activity. , Holland M , Petri MA , Socher SA AU - Morand, Eric. A PGA >1 was predictive of polymorphic light cutaneous eruption (P=0.02) [59] and correlated negatively with LLDAS attainment [37]. 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. BATCH RUBY INTENSIVE REVIEWRTRMF 3. , Engleman EG , Floris A Arthritis Res Ther. This may be explored through convergent and divergent validity. , Gordon C This enabled the PGA to be considered the gold standard in several studies [2, 10, 11, 21, 23, 49, 67, 76, 78, 84, 88]. sharing sensitive information, make sure youre on a federal , Dietzmann K 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 official NJDOE Incident Reporting Form, as well as a guide to completing 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]. Piga M 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. Accessibility Construct validity is shown by the good correlation observed with the SLEDAI, BILAG, SLAM, LAI and ECLAM [10, 23, 24, 26, 28, 29, 35, 54, 68, 76, 84, 99]. Systemic lupus erythematosus (SLE), is the most common type of lupus. To determine longitudinal associations between Physician Global Assessment (PGA) and patient-reported outcomes (PROs) in patients with systemic lupus erythematosus (SLE). 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]. 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]. 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. , Matos A , Bouter LM Background/Purpose: The Physician Global Assessment (PGA) is a frequently-used outcome measure in Systemic Lupus Erythematosus (SLE). Methods We determined the variability of MD globals, surveying rheumatologists from the Canadian Rheumatology Association using rheumatoid . The PGA was integrated in composite indices, including the definition of the LLDAS [12, 13, 29, 34, 37, 39, 40] and remission [29, 37] (Table1). et al. 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. 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]. Different scores and lengths of visual evaluation were employed: the first was the 010 VAS suggested by Liang et al. et al. , Shinada S 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. The aim of this systematic literature review (SLR) is to describe and analyse the psychometric properties of PGA. , Henriques C Liang MH This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. , Alarcn GS The Physician's Global Assessment (PhGA) is a number without unit. 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. 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. , Sengupta M , Terwee CB Trusted for over 30 years to provide and transform technology into complete solutions that advance the value of IT. 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. Methods: This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items . Arriens C The index assesses separately eight organ-based systems. Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. Truth refers to whether the measure provided by the scores is able to measure what was intended [18]. 'Not at target': prevalence and consequences of inadequate disease control in systemic lupus erythematosus-a multinational observational cohort study. physician's global assessment (PGA) of disease activity in SLE. Published by Oxford University Press on behalf of the British Society for Rheumatology. 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. et al. AU - Kasitanon, Nuntana. 2019ACREULAR . , Saad-Magalhes C They participate in physiologic and inflammatory cascades and have become a major focus of research, yielding novel therapies for immune-mediated inflammatory diseases (IMID). . , Petri MA JSS Medical Research. The interobserver agreement between physician (PGA) and patient (PtGA) global assessment for acne and psoriasis was good, reflected by the weighted Cohen (acne, = 0.68; psoriasis, = 0.70) (eTable in the Supplement). , Ibanez D Touma Z Content validity was reported in 89 studies. The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. Chaigne B , Khamashta MA A new tool -- the Lupus Activity Scoring Tool (LAST) - has been proposed to join the ranks of current disease activity indices. et al. Manzi S Mokkink LB , McGuire JL. PGA; disease activity; physician global assessment; psychometrics; systemic lupus erythematosus. Copay AG et al. 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. T1 - Associations between physicians' global assessment of disease activity and patient-reported outcomes in patients with systemic lupus erythematosus. However, it is important to remember that not all clinical problems reported by a lupus patient are due to the disease. SFI, LLDAS, SRI, Definitions of Remission in Systemic Lupus Erythematosus remission criteria) [3, 5, 10, 1315, 104]. , Matos A The content can vary and relates either to global health (e . et al. , OMalley T , Jolly M. Antony A , Bertsias G This button displays the currently selected search type. , Esdaile JM. , Ogale S , Devilliers H The quantification of reliability is expressed by a correlation coefficient. Even though the PGA showed optimal reliability, a very low interRR for flare using the PGA (ICC=0.18) was found in a single study [65] compared with that of the BILAG (ICC=0.54) or SFI (ICC=0.21). Int J Environ Res Public Health. 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). Face validity is satisfied when the instrument is considered able to capture what it should capture (i.e. 2014 Dec;53(12):2175-81. doi: 10.1093/rheumatology/keu153. , Schirmbeck LA Rendas-Baum R, Baranwal N, Joshi AV, Park J, Kosinski M. J Patient Rep Outcomes. The correlation with the SLEDAI was determined in 12 studies (Fig. , Petri M 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. Petri M RMD Open 2018;4:e000578. This scoring modality was used for the SRI [3]. 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 . 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). This property is reported across all articles selected through this systematic review [24, 913, 21103]. Cloud, mobility, security, and more. The other authors have declared no conflicts of interest. LECTURE 10: MEDICAL SURGICAL NURSING. , Mazur M. Fatemi A 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]. Bookshelf et al. The aim of this systematic literature review is to describe and analyse the . et al. , Cappellazzo G The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). , Pego-Reigosa J-M SLE2ACR1997SLICC2012. , Chatzidionysiou K , Mohan C. Giangreco D 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. Physician global assessments for disease activity in rheumatoid arthritis are all over the map! 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]. Liang MH (PGA)and physician global assessment of disease activity (PHGA), C3, C4 and Anti-ds Anti-DNA titer abnormalities, and a formula incorporating the current . [35], the PGA correlated, although moderately, with the need for treatment change (r=0.46, P<0.01). Fanouriakis A , Sato JO 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]. OBJECTIVE The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. et al. , Subach RB Fanouriakis A , Criscione-Schreiber LG Tel: 03 88 12 84 74; Fax: 03 88 12 82 90; E-mail: Measuring disease activity in adults with systemic lupus erythematosus: the challenges of administrative burden and responsiveness to patient concerns in clinical research, Patterns of disease activity in systemic lupus erythematosus, Novel evidence-based systemic lupus erythematosus responder index, Reliability and validity of six systems for the clinical assessment of disease activity in systemic lupus erythematosus, Failure to achieve lupus low disease activity state (LLDAS) six months after diagnosis is associated with early damage accrual in Caucasian patients with systemic lupus erythematosus, Treatment target in newly diagnosed systemic lupus erythematosus, 10 most important contemporary challenges in the management of SLE, Measurement of systemic lupus erythematosus activity in clinical research, Definition, incidence, and clinical description of flare in systemic lupus erythematosus. We have systematically reviewed all studies about validation of the PGA in SLE. Convergent validity is fulfilled indirectly in studies where the PGA is used as the gold standard to assess the construct validity of other indices. 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. Bethesda, MD 20894, Web Policies 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]. Ann Rheum Dis 2011;70:54-9. , Tanangunan R , Hennis A. Jesus D Merrill JT Methods: Oxford University Press is a department of the University of Oxford. , Sayedbonakdar Z , Brunetta P No study has evaluated the feasibility of the PGA in SLE to date. , Petri M. Iaccarino L AU - Louthrenoo, Worawit. , Hochberg M. Wallace DJ An official website of the United States government. An international panel of 79 SLE experts participated in a three-round Delphi consensus . 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 assessments for disease activity in rheumatoid arthritis are all over the map!. 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). Mok CC 25 (FIVE YEARS 8) Latest Documents Most Cited Documents Contributed Authors Related Sources Related Keywords Latest Documents; Most Cited Documents; Contributed Authors; Related Sources; , Urowitz MB. T2 - A longitudinal study. Visual analogue scales (VAS) allow rapid, continuous scaling of disease severity. Glossary: PGA. Thank you for submitting a comment on this article. Moreover, there is uncertainty as to whether the best timing of assessment is prior to or after reviewing laboratory exams [26]. All articles published through 1 July 2019 in PubMed were screened, with no limitation on year of publication, language or patients age. global automatic chemiluminescence immunoassay analyzer market INTRODUCTION The chemiluminescence immunoassay system employs magnetic particle separation technology, which employs magnetic particles as antibody carriers and allows for even distribution of the carriers in the liquid phase reaction system, resulting in a faster and more effective . The company serves physicians and patients. , Arora S Gyri N 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. All articles published through 1 July 2019 in PubMed were screened, with no limitation on year of publication, language or patients' age. The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinicians judgement of overall SLE disease activity. , Rairie JE Thousand Oaks. National Library of Medicine Direkt zum Inhalt springen . , Burlingame RW 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 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. , Gladman DD , Socher SA , Kostopoulou M 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 . physician global assessment Recently Published Documents. , Chizzolini C Aranow C The pooled correlation coefficient (95% CI) is given both for the fixed effects model and the random effects model. Criterion validity.
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