et al. 12. and later incorporated into the SLE Responder Index used in the belimumab clinical trials, 13 , Kiani AN , Bonithon-Kopp C , McGwin G , Perneger T All versions are validated and used by lupus researchers for clinical and research purposes. 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. 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. , Beaumont JL , Siega-Riz AM The authors wish to thank Sylvie Thuong for her invaluable assistance in the preparation of this manuscript. Thus the development of a comprehensive index for assessing disease activity still represents one of the most important challenges in SLE [7]. Immune Disorders, Deficiency, Etc - Key Points to Review: Initiation of 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 . Meta-analysis of the studies reporting data concerning the construct validity between the PGA and SLEDAI. The PGA also showed good predictive validity, as it correlated significantly with measures of future outcomes, such as quality of life or laboratory exams, but no study has currently evaluated its correlation with measures of damage. Ruiz-Irastorza G , Wallace DJ , Devilliers H official website and that any information you provide is encrypted Thanou A While specific studies remain to be performed to determine the optimal method for scoring the PGA, this literature search showed that the most adopted form of PGA was a 10cm 03 VAS with anchors (0, none; 1, mild; 2, moderate; 3, severe activity) [3]. Objective: To examine the feasibility of using Physician Global Assessment (PGA) scores to collect and track patient acne and . Medical Cannabis Use by Rheumatology Patients Following Recreational 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. 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]. Few studies reported on whether serological activity should be incorporated in the PGA. Construct validity. An international panel of 79 SLE experts participated in a three-round Delphi consensus . According to the OMERACT, face validity is the degree to which the instrument appears to match with the target domain, according to experts [18]. , Ibaez D , Chakravarty E The content can vary and relates either to global health (e . How should lupus flares be measured? Sullivan KE , Maxwell LJ 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): A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.67-0.98). Gandhi N 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]. , Beresford MW This button displays the currently selected search type. All articles published through 1 July 2019 in PubMed were screened, with no limitation on year of publication, language or patients' age. The SRI is a composite instrument comprised of the SELENA-SLE Disease Activity Index [SELENA-SLEDAI], Physician Global Assessment (PGA) and British Isles Lupus Assessment Group (BILAG) 2004. A PGA 2 correlated with a risk of pregnancy loss (29% vs 8%, P=0.005) [49]. AB - The Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus (PISCOS) study aimed to obtain an evidence . 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. Ann Rheum Dis 2 Isenberg DA, Allen E, Farewell V, et al. Devilliers H , Wetter J Correlations with other instruments measuring similar constructs should typically demonstrate a coefficient (r) 0.50 [106]. 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 . et al. A good responsiveness for PGA was shown in eight studies. 2022 Sep 20;19(19):11895. doi: 10.3390/ijerph191911895. Funding: The study was funded through the training Bursary Programme 2019 of the SLEuro European Lupus Society. , Urowitz MB Scoring systemic lupus erythematosus (SLE) disease activity with simple BILAGAB . , Kosinski M 2014 Dec;53(12):2175-81. doi: 10.1093/rheumatology/keu153. , Perez-Gutthann S Epub 2014 Jul 10. , Gladman DD Physician Global Assessment to Track Outcomes - JAMA Physician's Global Assessment in Psoriatic Arthritis: A Multicenter , Terwee CB Results: Please enable it to take advantage of the complete set of features! Rendas-Baum R, Baranwal N, Joshi AV, Park J, Kosinski M. J Patient Rep Outcomes. Navarra SV , Bocci EB 2. 10- Medical- Surgical- Nursing- Intensive- Review 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). , Tugwell P et al. J Clin Med. An official website of the United States government. Content validity. The assessment of PGA responsiveness was performed in 10 studies [4, 23, 50, 58, 7779, 81, 83, 84] using different methods [110]. Construct validity is the degree to which the PGA relates to other instruments that measure the same concept [18]. 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. , Karp DR , Guzmn RM Kiani AN Objectives Remission in systemic lupus erythematosus (SLE) is defined through a combination of 'clinical SLE Disease Activity Index (cSLEDAI)=0', 'physician's global assessment (PGA) <0.5 . This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. This enabled the PGA to be considered the gold standard in several studies [2, 10, 11, 21, 23, 49, 67, 76, 78, 84, 88]. PGA-IGA described in ePROVIDE - Mapi Research Trust The literature search identified 91 studies. BICLA is a validated composite global measure of SLE disease activity including SLEDAI-2K, CLASI-A, OCS dosage reduction, and patient-reported outcomes. 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. , Socher SA In 1988, Liang et al. government site. , Gladman DD. The literature search identified 91 studies. Face validity is satisfied when the instrument is considered able to capture what it should capture (i.e. Beaton DE Barr et al. 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 (. . Montreal, Canada Area. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. Treatment of lupus nephritis: consensus, evidence and perspectives Whenever papers reported duplicate data, the most recent article was selected. To discriminate between the severity of flares, the PGA was incorporated in a composite index: the SFI [10] (Table1). , Wallace DJ , Petri M. Thanou A Mina R Strength. doi: 10.1136/lupus-2022-000700. , Engel SM , Friebus-Kardash J Rheumatology (Oxford). Epub 2014 Apr 11. Intoduction to X 20 - Physician Global Assessment The quantification of reliability is expressed by a correlation coefficient. SLE has protean and often complex manifestations, necessitating careful clinical assessment. et al. T2 - A longitudinal study. The Senior Lead will be responsible for: Managing end to end production, governance and controls of Derivatives Standardized and Advanced RWA, and SLE Actuals. , Jolly M. Ribi C 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 . Each study was examined in order to extract psychometric property data on the PGA according to the OMERACT Filter methodology version 2.1 [18]. . Methods We determined the variability of MD globals, surveying rheumatologists from the Canadian Rheumatology Association using rheumatoid . 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). For permissions, please email: journals.permissions@oup.com. 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]. Lead Medical Director heading up the global collaboration with Pfizer for Enbrel trials. Jesus D Annapureddy N Myelogram - correct answer NPO for 4-6 hours. , Magder LS Objective Physician's global assessment (PGA) of disease activity is a major determinant of therapeutic decision making. (PGA) scoring of disease activity in systemic lupus erythematosus (SLE). Clinical Trial Physician - Rheumatology Job in San Diego, CA - Bristol 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. 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. , OMalley T European League Against Rheumatism. A PGA >1 was predictive of polymorphic light cutaneous eruption (P=0.02) [59] and correlated negatively with LLDAS attainment [37]. , Andreoli L , Cella D. van Vollenhoven RF , Altman DG Use of Physician Global Assessment in systemic lupus - PubMed , Petri M. Furie RA , Magder LS BATCH RUBY INTENSIVE REVIEWRTRMF 3. , Annapureddy N , Adamichou C PGA0.3. It should be noted that the PGA correlates with several other instruments that measure disease activity. , Henriques C AU - Kasitanon, Nuntana. Accessibility The PGA is usually reported by experts as allowing exhaustive coverage of the concept of disease activity in SLE [20, 108]. , Lerman RH , Sengupta M PGA is an important tool for assessing disease activity, response to treatment (it is a component . The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. The site is secure. 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. Chaigne B Help us improve CareerBuilder by providing feedback about this job: Report this job Job ID: 2281236908. , James JA Physician global assessment in systemic lupus erythematosus: Can we SLE is an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage in the affected organs. , Roberts WN Vashisht P et al. PGA is a simple instrument and the result is easily understood. 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). Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus: the PISCOS study . The PGA was developed on a 0 to 3 scale as part of the Lupus Activity Index. 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. , Skogh T et al. , Longenecker JC 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. JBT-101 in Systemic Lupus Erythematosus (SLE) Global Respiratory Devices Market Size, Growth, Source Analysis, Top Akhter E Feb 2016 - Jan 20182 years. Learn more. PDF Physician global assessments for disease activity in rheumatoid It can affect the joints, skin, brain, lungs, kidneys, and blood vessels. et al. , McGuire JL. The aim of this systematic literature review is to describe and analyse the . According to the authors, this difference was probably due to the greater familiarity of the physicians with the BILAG-2004 index. Some may be a consequence of therapy and others may be . , Chatzidionysiou K 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]. Disagreements between investigators were solved by consensus. The company serves physicians and patients. Conclusion: PDF Physician s global assessment is often useful in SLE, but not always In 11 retrieved studies [10, 13, 33, 36, 45, 48, 50, 55, 56, 65, 96] the PGA was part of the SFI [104] and in 10 studies [3, 29, 40, 46, 52, 60, 69, 80, 94, 98] it was part of the SRI [3] (both discussed in the Responsiveness section). Criterion validity also refers to the degree to which an instrument predicts aspects and phenomena occurring in the future [108]. No study has evaluated the feasibility of the PGA in SLE to date. may be asked to hyperventilate 3-4 min and watch a bright flashing light. , Sjwall C. Strand V Measurement properties of the PGA were analysed according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) terminology [19]. AU - Kandane-Rathnayake, Rangi. Barr SG (PGA)and physician global assessment of disease activity (PHGA), C3, C4 and Anti-ds Anti-DNA titer abnormalities, and a formula incorporating the current . Touma Z , Sayedbonakdar Z Physician global assessments for disease activity in rheumatoid arthritis are all over the map! , Hynan LS Laboratory investigation results influence Physicians Global ssessment (PGA) of disease activity in SLE. , Jolly M. Antony A 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. Complement-Targeted Therapeutics Market Report (2022 to 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). The responsiveness of the PGA is the ability to detect worthwhile variations in disease activity over time, measuring worsening or improvements in SLE disease status. No study has evaluated the correlation of PGA with damage measures. 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. TOTAL DOCUMENTS. Schneider M The index has proved quick and easy to use despite a comprehensive database and compares favourably with . antineutrophil cytoplasmic antibody-associated vasculitis (AAV), and systemic lupus erythematosus (SLE). Castrejn I, Ra-Figueroa I, Rosario MP, Carmona L. Reumatol Clin. Different definitions of disease activity according to the PGA instrument. The aim of this systematic literature review (SLR) is to describe and analyse the psychometric properties of PGA. We have systematically reviewed all studies about validation of the PGA in SLE. Petri M et al. Deconstruction of the safety of estrogen in lupus erythematosus national assessment-systemic lupus erythematosus disease activity index flare index. 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. , Suriano A , Brunetta P Systemic Lupus Erythematosus (SLE) | CDC Systemic Lupus Erythematosus (SLE) Treatment & Management - Medscape SLE231 Hydrology and Water Resources Management: Excursion or Virtual Tour This suggests that the role of the PGA is limited for disease activity assessment when used as a single instrument. Cloud, mobility, security, and more. HHS Vulnerability Disclosure, Help , Engleman EG , Giannakou I et al. Published by Oxford University Press on behalf of the British Society for Rheumatology. Careers. , Saad-Magalhes C This may be explored through convergent and divergent validity. , Kalunian K Visual Analog Scale Assessments Can Reliably Assess Disease Severity in SLE Medizinische Universitt Graz Austria/sterreich - Forschungsportal 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. These results enabled its use as a gold standard for assessing flare and defining flare severity in several studies [21, 67, 88]. 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. 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. 2014 - 20184 years. , Shinada S et al. Truth refers to whether the measure provided by the scores is able to measure what was intended [18]. 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. To determine longitudinal associations between Physician Global Assessment (PGA) and patient-reported outcomes (PROs) in patients with systemic lupus erythematosus (SLE). Measuring disease activity in adults with systemic lupus erythematosus , Chang AY 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. A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.670.98). , Rairie JE SFI, LLDAS, SRI, Definitions of Remission in Systemic Lupus Erythematosus remission criteria) [3, 5, 10, 1315, 104]. Diet and Systemic Lupus Erythematosus (SLE): From Supplementation to Intervention. et al. Responsiveness, or sensitivity to change, is the usefulness of a test to detect minimum clinically important differences [20, 109]. , Ko T physician global assessment Recently Published Documents. AU - Louthrenoo, Worawit. Improving patient pathways for systemic lupus erythematosus: a multistakeholder pathway optimisation study. The OMERACT defines an instrument as an outcome measure if it passes the three pillars of evidence: truth (that refers to validity), discrimination (that includes reliability and responsiveness) and feasibility. 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. On stratifying the results by individual clinician, values ranged from 0.61 to 0.90, except for those reported by . , Costenbader K Systemic Lupus Erythematosus and Lupus Nephritis - Epidemiology 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]. . et al. 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. Pincus and colleagues conducted a study of . Thanks to this feature, the PGA was included in composite indices with the aim of rating manifestations not included in glossary-based instruments such as the SLEDAI and BILAG [3] or for which a threshold has been defined (cytopenia).
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