, Ho LY et al. RN-BSN HOLISTIC HEALTH ASSESSMENT ACROSS THE LIFESPAN (NURS 3315) Sociology of Social Problems (SOC213) et al. , Petri MA Piga M , Hynan LS This enabled the PGA to be considered the gold standard in several studies [2, 10, 11, 21, 23, 49, 67, 76, 78, 84, 88]. 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MD globals may vary based on their age, gender, practice setting and experience (number of patients seen per year and years in practice). 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. , McGuire JL. , Pego-Reigosa J-M The .gov means its official. SLE or at an SLE site, but only if the injury requires treatment by a licensed medical doctor. Liang et al. , Morabito LM , Esdaile JM. et al. et al. 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 . , Gladman DD Copay AG , Petri M. Thanou A Aranow C Conclusion: , Skogh T Despite the need for new treatments in CLE . The quantification of reliability is expressed by a correlation coefficient. 2014 Dec;53(12):2175-81. doi: 10.1093/rheumatology/keu153. et al. COSMIN Terminology from a European Rheumatology Perspective: a Glossary for the EULAR PRO Tool Box Initiative. Physician training is very important. Objective Physician's global assessment (PGA) of disease activity is a major determinant of therapeutic decision making. Patient-Reported Outcomes in Systemic Lupus Erythematosus. Careers. T1 - Associations between physicians' global assessment of disease activity and patient-reported outcomes in patients with systemic lupus erythematosus. 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]. The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. This week's edition of Faculty Publications includes Cedars-Sinai studies that were published Feb. 23-March 2. A PGA 2 correlated with a risk of pregnancy loss (29% vs 8%, P=0.005) [49]. , Sengupta M 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. http://oml.eular.org/glossary (31 January. The PGA intraRR was assessed in three studies [10, 68, 94] and ranged from 0.55 [68] to 0.88 [10]. Background/Purpose: The Physician Global Assessment (PGA) is a frequently-used outcome measure in Systemic Lupus Erythematosus (SLE). , Perez-Gutthann S AU - Morand, Eric. Published by Oxford University Press on behalf of the British Society for Rheumatology. , Patrick DL Published by Oxford University Press on behalf of the British Society for Rheumatology. , Bertsias G Cloud, mobility, security, and more. The Physician Global Assessment (PGA) is an important tool for assessing disease activity in lupus. , Smiley A. Askanase AD 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. Sullivan KE , Jolly M. Mok CC Retrieved papers were selected with no limitation on the year of publication, language or patients age. et al. 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). Introduction Physician global assessments of disease activity (medical doctor (MD) globals) are important outcomes. et al. et al. This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. 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. X 20 Physician Global Assessment 10.1136/lupus-2019-lsm.176 . , Urowitz MB , Bocci EB et al. Feb 2016 - Jan 20182 years. , Hochberg M. Wallace DJ (PGA) scoring of disease activity in systemic lupus erythematosus (SLE). , Oon S Physician Global Assessment (PGA) is a visual analogue score (VAS) that reflects the clinician's judgment of overall Systemic Lupus Erythematosus (SLE) disease activity. , Kharboutli M , Magder L Systemic lupus erythematosus (SLE), is the most common type of lupus. 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. Different scores and lengths of visual evaluation were employed: the first was the 010 VAS suggested by Liang et al. 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. Improving patient pathways for systemic lupus erythematosus: a multistakeholder pathway optimisation study. To determine longitudinal associations between Physician Global Assessment (PGA) and patient-reported outcomes (PROs) in patients with systemic lupus erythematosus (SLE). Touma Z 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. et al. 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). Franklyn K , Cappellazzo G Mokkink LB , Socher SA , Taghavi-Zadeh S doi: 10.1136/lupus-2022-000700. SELENA SLEDAI4. Objective Existing methods for grading lupus flares or improvement require definition-based thresholds as increments of change. In one open-label study [43], the decrease in PGA score was considered the primary endpoint. 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. Thus the development of a comprehensive index for assessing disease activity still represents one of the most important challenges in SLE [7]. The official NJDOE Incident Reporting Form, as well as a guide to completing Construct validity was recognized in 21 studies [2, 10, 11, 23, 24, 2629, 35, 47, 52, 54, 65, 68, 76, 84, 88, 92, 99, 101]. Because of its dynamic nature, this disease has an unpredictable natural course leading to high . Prinsen CAC The PGA is a well accepted and commonly used scale for evaluating treatment response in clinical trials both in adults and children. , Chatzidionysiou K 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]. Face validity. Brunner HI , Rodrigues M , Nguyen SC Arriens C Can Lupus Patients Take the Driver's Seat in Their Disease Monitoring. et al. 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. , Jolly M. Ribi C 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]. 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]. 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). Whenever papers reported duplicate data, the most recent article was selected. 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. Please enable it to take advantage of the complete set of features! These results enabled its use as a gold standard for assessing flare and defining flare severity in several studies [21, 67, 88]. . , Petri M. Iaccarino L IgM) on attainment PhGA. , Piette EW Genetic linkage has related dysfunction of . Different definitions of disease activity according to the PGA instrument. 1 2. Face validity is satisfied when the instrument is considered able to capture what it should capture (i.e. Funding: The study was funded through the training Bursary Programme 2019 of the SLEuro European Lupus Society. AU - Kandane-Rathnayake, Rangi. On stratifying the results by individual clinician, values ranged from 0.61 to 0.90, except for those reported by . Navarra SV 2014 Sep-Oct;10(5):309-20. doi: 10.1016/j.reuma.2014.01.012. We analysed the performance of the SELENA SLEDAI Physician's Global Assessment (SSPGA) and the Lupus Foundation of America-Rapid Evaluation of Activity in Lupus (LFA-REAL) as measures . How should lupus flares be measured? Barr SG Enocsson H , Petri M , Magder LS 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]. , Arbab-Zadeh A Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. FOIA 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 (. Clinical composite measures of disease activity and damage used to evaluate patients with systemic lupus erythematosus: A systematic literature review. AB - The Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus (PISCOS) study aimed to obtain an evidence . , Gladman DD. 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 Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. Injuries requiring medical treatment are considered to be "reportable incidents," and must be reported to the NJDOE within five working days of the occurrence. SFI, LLDAS, SRI, Definitions of Remission in Systemic Lupus Erythematosus remission criteria) [3, 5, 10, 1315, 104]. , Alunno A , Wallace DJ , Jolly M. Antony A , Shea BJ et al. , Kraag GR , Matos A et al. Karol DE Mahler M 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]. , Zonana-Nacach A 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 . inflammation (duration and severity of morning stiffness as measured by BASDAI). 12. and later incorporated into the SLE Responder Index used in the belimumab clinical trials, 13 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). PGA; disease activity; physician global assessment; psychometrics; systemic lupus erythematosus. 2022 Jan 11;11(2):340. doi: 10.3390/jcm11020340. SLE2ACR1997SLICC2012. 2019ACREULAR . The content can vary and relates either to global health (e . , Magder L Additional papers were obtained by checking the references from the selected studies. 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. , Adamichou C 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]). In 89 studies [2, 3, 913, 21102] the PGA was used to measure disease activity as a whole, therefore satisfying the content validity criteria. , Askanase A allergy hx phenothiazines, cns depressants and stimulants withheld 48 hours prior. 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). , Terwee CB An assessment of disease flare in patients with systemic lupus erythematosus: a comparison of BILAG 2004 and the flare version of SELENA. , Sjwall C , Bouter LM SLE has protean and often complex manifestations, necessitating careful clinical assessment. Ensure second line of defense Derivatives RWA reviews are performed consistently and . J Clin Med. 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. , James JA [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. Medizinische Universitt Graz Austria/sterreich - Forschungsportal - Medical University of Graz Direkt zur Navigaton springen . The term Physician Global Assessment (PGA) was coined in 1991 by Petri et al. Jiao H, Acar G, Robinson GA, Ciurtin C, Jury EC, Kalea AZ. , Maxwell LJ An international panel of 79 SLE experts participated in a three-round Delphi consensus . , Ogale S HHS Vulnerability Disclosure, Help All rights reserved. The Physician's Global Assessment (PhGA) is a number without unit. They participate in physiologic and inflammatory cascades and have become a major focus of research, yielding novel therapies for immune-mediated inflammatory diseases (IMID). , Mosca M et al. However, it is important to remember that not all clinical problems reported by a lupus patient are due to the disease. , Floris A , Cella D. van Vollenhoven RF et al. , Leung HW 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]. Comparison of the validity and sensitivity to change of 5 activity indices in systemic lupus erythematosus. Navarra SV The last EULAR/ACR recommendations recommended use of the PGA in the routine monitoring of SLE [16]. Methods This SLR was conducted by two independent reviewers in accordance with the PRISMA statement. Visual analogue scales (VAS) allow rapid, continuous scaling of disease severity. Disclaimer. Gandhi N Manzi S , Kalunian K Finally, the PGA enables the measurement of disease activity globally compared with a glossary-based index. 2022 May;9(1):e000700. The Author(s) 2020. Rheumatology (Oxford). , Khamashta MA Castrejn I, Ra-Figueroa I, Rosario MP, Carmona L. Reumatol Clin. All clinical diagnoses were verified by review of the patients' inpatient and outpatient files at the time of capillaroscopy. MeSH , Vogel-Claussen J , Larson MG , Kiani AN Liang MH No data were found regarding the feasibility of the PGA. Supervise the development of junior medical affairs staff . Twenty-nine studies [25, 31, 3439, 41, 43, 48, 49, 5355, 59, 6164, 74, 75, 81, 82, 86, 92, 93, 96, 97] have assessed criterion validity of the PGA (Table2). The aim of this systematic literature review is to describe and analyse the . et al. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. , McGwin G 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). Responsiveness. , Genovese M 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]. 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]. Lead Medical Director heading up the global collaboration with Pfizer for Enbrel trials.
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