. Face validity. RMD Open 2018;4:e000578. PGA is an important tool for assessing disease activity, response to treatment (it is a component . 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). et al. , Fortin PR In 1988, Liang et al. et al. [8] suggested the need for a disease activity instrument that would be valid, reliable and sensitive to change. Karol DE , Larson MG , Kiani AN 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). All rights reserved. 2022 Jan 11;11(2):340. doi: 10.3390/jcm11020340. , Farewell V Epub 2014 Jul 10. et al. A good responsiveness for PGA was shown in eight studies. Funding: The study was funded through the training Bursary Programme 2019 of the SLEuro European Lupus Society. The Janus kinase (Jak)/signal transducer and activating protein (STAT) pathways mediate the intracellular signaling of cytokines in a wide spectrum of cellular processes. No study has evaluated the correlation of PGA with damage measures. The assessment of disease activity in SLE is particularly challenging. Methods: This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items . , Khamashta MA , Saad-Magalhes C AU - Morand, Eric. The Author(s) 2020. , ODell JR Oxford Textbook of. et al. All versions are validated and used by lupus researchers for clinical and research purposes. et al. et al. The aim of this systematic literature review (SLR) is to describe and analyse the psychometric properties of PGA. Systemic lupus erythematosus (SLE) is a multisystem autoimmune rheumatic disease (ARD) characterized by flares and remissions. 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. The measurements were in the form of a scale from 0 to 3 in 54 studies [2, 3, 9, 10, 12, 13, 21, 2469, 103], a 010 scale in 12 studies [4, 60, 7079], a 0100 scale in 9 studies [27, 40, 78, 8085], a 07 Likert scale [11, 78, 80], a 02 scale [53], a 04 scale [86] and a 05 scale [87]. According to the OMERACT, face validity is the degree to which the instrument appears to match with the target domain, according to experts [18]. , Voskuyl A Franklyn K 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. , Bentow C PGA0.3. , Bouter LM 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]. doi: 10.1136/lupus-2022-000700. Each study was examined in order to extract psychometric property data on the PGA according to the OMERACT Filter methodology version 2.1 [18]. T1 - Associations between physicians' global assessment of disease activity and patient-reported outcomes in patients with systemic lupus erythematosus. , Chan KL The Patient's Global Assessment Scale (PGA) is the PRO counterpart to the Physician's Global Assessment Scale or Investigator's Global Assessment Scale (PGA-IGA). This button displays the currently selected search type. 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. [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. , Wetter J 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 . The quantification of reliability is expressed by a correlation coefficient. Nehring J 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. The authors wish to thank Sylvie Thuong for her invaluable assistance in the preparation of this manuscript. Schneider M , Rodrigues M PGA is a simple instrument and the result is easily understood. , Petri MA The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. , Urowitz MB. . , Carpenter AB 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. X 20 sentence examples within Physician Global Assessment. Whenever papers reported duplicate data, the most recent article was selected. Responsiveness. Importance: In dermatology, the development of objective, standardized quality measures that can be used in a clinical setting is important to be able to respond to the needs of payers and credentialing and licensure bodies and to demonstrate dermatologic value. , Gladman DD Diet and Systemic Lupus Erythematosus (SLE): From Supplementation to Intervention. , Siega-Riz AM Lai J-S Bethesda, MD 20894, Web Policies Finally, the PGA enables the measurement of disease activity globally compared with a glossary-based index. Before Brunner HI , Rairie JE A good correlation was considered for a value >0.60. 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]. Devilliers H , Petri M. Foering K , Matos A Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. , Sengupta M Ensure second line of defense Derivatives RWA reviews are performed consistently and . 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. , Esdaile JM. , Cella D. van Vollenhoven RF , Sjwall C It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. et al. , Beaumont JL 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). 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. Feb 2016 - Jan 20182 years. Chaigne B Cutaneous lupus erythematosus (CLE) is an autoimmune skin disease that can occur with or without systemic lupus erythematosus (SLE). watch for seizures after the procedure. , Ibanez D It can affect the joints, skin, brain, lungs, kidneys, and blood vessels. . , Kraag GR physician's global assessment (PGA) of disease activity in SLE. The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. Few studies reported on whether serological activity should be incorporated in the PGA. . 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. RN-BSN HOLISTIC HEALTH ASSESSMENT ACROSS THE LIFESPAN (NURS 3315) Sociology of Social Problems (SOC213) , Chakravarty E A good responsiveness for PGA was shown in eight studies. independently selected the articles, initially on the basis of titles and abstracts, then, if necessary, on the full texts, an eligibility assessment was performed independently in a blinded standardized manner. , Gordon C , Sadovici-Bobeica V A total of 91 articles were included in the study (Fig. 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 pooled correlation coefficient (95% CI) is given both for the fixed effects model and the random effects model. The https:// ensures that you are connecting to the The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. Once two investigators (E.C., M.P.) physician global assessment Recently Published Documents. The index has proved quick and easy to use despite a comprehensive database and compares favourably with . Castrejn I, Ra-Figueroa I, Rosario MP, Carmona L. Reumatol Clin. , Bocci EB 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). , Kostopoulou M , Dietzmann K This suggests that the role of the PGA is limited for disease activity assessment when used as a single instrument. The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. , Genovese M 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 . 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. 'Not at target': prevalence and consequences of inadequate disease control in systemic lupus erythematosus-a multinational observational cohort study. Assessing disease activity in rheumatic diseases such as systemic lupus erythematosus (SLE) is vital for effective treatment. 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. Uribe AG, Vil LM, McGwin G Jr, Sanchez ML, Reveille JD, Alarcn GS. Touma Z Gordon C 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). BILAGAB . Presence of at least one of the following items of serological evidence of active SLE or biological variables predictive of Type 1 Interferon (IFN-1) high signature (in a Screening sample as measured by central laboratory): The aim of this systematic review is to describe and analyse the measurement properties of the PGA, including the validity, reliability, responsiveness and feasibility. 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]. National Library of Medicine , Schur PH. , Hambleton IR 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]. European League Against Rheumatism. Deconstruction of the safety of estrogen in lupus erythematosus national assessment-systemic lupus erythematosus disease activity index flare index, Effect of raloxifene on disease activity and vascular biomarkers in patients with systemic lupus erythematosus: subgroup analysis of a double-blind randomized controlled trial, Omega-3 in SLE: a double-blind, placebo-controlled randomized clinical trial of endothelial dysfunction and disease activity in systemic lupus erythematosus, Erythrocyte sedimentation rate is a predictor of renal and overall SLE disease activity, Characterization of clinical photosensitivity in cutaneous lupus erythematosus, Validation of the systemic lupus erythematosus responder index for use in juvenile-onset systemic lupus erythematosus, Depressive symptoms and associated factors in systemic lupus erythematosus, Validation of the Portuguese simple measure of impact of lupus erythematosus in youngsters (SMILEY) in Brazil, Anti-C1q antibodies have higher correlation with flares of lupus nephritis than other serum markers, Performance of anti-C1q, antinucleosome, and anti-dsDNA antibodies for detecting concurrent disease activity of systemic lupus erythematosus, An assessment of disease flare in patients with systemic lupus erythematosus: a comparison of BILAG 2004 and the flare version of SELENA, Noncalcified coronary plaque in systemic lupus erythematosus, Decreases in anti-double-stranded DNA levels are associated with concurrent flares in patients with systemic lupus erythematosus, Validity and reliability of lupus activity measures in the routine clinic setting, Clinical predictors of response and discontinuation of belimumab in patients with systemic lupus erythematosus in real life setting. 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. , Lau CS Because of the complexity of SLE, the assessment of disease activity is particularly challenging [3]. , Ogale S 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]. Convergent validity is fulfilled indirectly in studies where the PGA is used as the gold standard to assess the construct validity of other indices. For permissions, please email: journals.permissions@oup.com. 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. 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). All rights reserved. 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]. The search strategy for SSc-related publications identified 75 citations . Conclusion: 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 . Disclaimer. , Terwee CB et al. According to the authors, this difference was probably due to the greater familiarity of the physicians with the BILAG-2004 index. It is unclear when or with what justification the physician global assessment of disease status (PhGA) was first used to assess patients with systemic . 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). Lead Medical Director heading up the global collaboration with Pfizer for Enbrel trials. , Jolly M. Ribi C 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 . 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. Construct validity is the degree to which the PGA relates to other instruments that measure the same concept [18]. All articles published through 1 July 2019 in PubMed were screened, with no limitation on year of publication, language or patients' age. Barr SG et al. Montreal, Canada Area. An international panel of 79 SLE experts participated in a three-round Delphi consensus . , Magder LS Impact of anti-SARS-CoV-2 antibodies of different isotypes (IgA, IgG, IgM) on attainment of PGA . 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. No data were found regarding the feasibility of the PGA. Introduction Physician global assessments of disease activity (medical doctor (MD) globals) are important outcomes. However, no precise guidelines exist regarding the optimal use of the PGA in SLE, such as the adequate length of the VAS, the presence of anchored values, the incorporation of laboratory data and the time frame of assessment. The last MEDLINE search was performed on 1 July 2019. 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. 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. Content validity was reported in 89 studies. inflammation (duration and severity of morning stiffness as measured by BASDAI). Ann Rheum Dis 2 Isenberg DA, Allen E, Farewell V, et al. Supervise the development of junior medical affairs staff . , Gayet-Ageron A , Glassman DS , Shinada S 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). Objective Physician's global assessment (PGA) of disease activity is a major determinant of therapeutic decision making. Aranow C 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. Merrill JT A PGA 2 correlated with a risk of pregnancy loss (29% vs 8%, P=0.005) [49]. allergy hx phenothiazines, cns depressants and stimulants withheld 48 hours prior. , Jolly M. Antony A Touma Z MD globals may vary based on their age, gender, practice setting and experience (number of patients seen per year and years in practice). 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). Mina R In this systematic review we have analysed the measurement properties of the PGA, including the validity, reliability, responsiveness and feasibility. The aim of this systematic literature review is to describe and analyse the . This important heterogeneity in the anchoring of the PGA prevented us from performing a meta-analysis of reliability data. Provide oversight to Shared Services Derivatives team supporting RWA operations and production. The intrarater reliability (intraRR) is the ability to provide consistent scores in a stable population by the same assessor over time. The company serves physicians and patients. Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. [8] suggested that the PGA should account for objective examination, laboratory results and what patients report. 8600 Rockville Pike 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]. Cloud, mobility, security, and more. , Block JA , Birmingham DJ , Koutsoviti S 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. 2014 - 20184 years. The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. Construct validity. Methods This SLR was conducted by two independent reviewers in accordance with the PRISMA statement. Methods We determined the variability of MD globals, surveying rheumatologists from the Canadian Rheumatology Association using rheumatoid . , Magder LS , Cappellazzo G ~SLE~. [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. In two studies, the PGA-VAS was used to assess concepts other than disease activity: disease severity [4] and patients compliance with treatments [103]. 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 PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). , Ko T An international panel of 79 SLE experts participated in a three-round Delphi consensus process, in which 41 statements related to the PGA in SLE were . Navarra SV 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. 2022 May;9(1):e000700. 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. 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).

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