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, Trendelenburg M , Francis S , Merrill JT. Laboratory investigation results influence Physicians Global ssessment (PGA) of disease activity in SLE. Gladman DD 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 index assesses separately eight organ-based systems. All articles published through 1 July 2019 in PubMed were screened, with no limitation on year of publication, language or patients' age. , Mina R 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]. , Engel SM In one open-label study [43], the decrease in PGA score was considered the primary endpoint. , Seaman AL 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). 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 . 2014 Sep-Oct;10(5):309-20. doi: 10.1016/j.reuma.2014.01.012. PGA-IGA described in ePROVIDE - Mapi Research Trust , Sjwall C. Strand V Epub 2014 Apr 11. 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). Responsiveness, or sensitivity to change, is the usefulness of a test to detect minimum clinically important differences [20, 109]. Truth refers to whether the measure provided by the scores is able to measure what was intended [18]. , Criscione-Schreiber LG allergy hx phenothiazines, cns depressants and stimulants withheld 48 hours prior. SLE is an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage in the affected organs. The literature search identified 91 studies. Systemic lupus erythematosus (SLE), is the most common type of lupus. It operates in Albuquerque, and New Mexico. 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. ECG - correct answer no sleep the night before, meals allowed, no stimulants/tranquilizers for 24-48 hours before. PDF Physician Global Assessment International Standardisation COnsensus in , Devilliers H et al. 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. Piga M Physician's global assessment is often useful in SLE - ResearchGate 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. Assessing disease activity in rheumatic diseases such as systemic lupus erythematosus (SLE) is vital for effective treatment. 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). , Sjwall C To discriminate between the severity of flares, the PGA was incorporated in a composite index: the SFI [10] (Table1). Aranow C , Chizzolini C , Dietzmann K , McGwin G Chaigne B Pain assessment: An alternative measure - hcplive.com Vashisht P (PGA)and physician global assessment of disease activity (PHGA), C3, C4 and Anti-ds Anti-DNA titer abnormalities, and a formula incorporating the current . 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. Physician's Global Assessment in Psoriatic Arthritis: A Multicenter A Comprehensive Digest of Research Publications From Cedars-Sinai Investigators. The aim of this systematic literature review is to describe and analyse the . [35], the PGA correlated, although moderately, with the need for treatment change (r=0.46, P<0.01). 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 . What Does It Mean to Be a British Isles Lupus Assessment Group-Based , Chatzidionysiou K The company serves physicians and patients. , Bentow C The correlation with the SLEDAI was determined in 12 studies (Fig. However, it is important to remember that not all clinical problems reported by a lupus patient are due to the disease. , Smiley A. Askanase AD Please check for further notifications by email. , Gayet-Ageron A FitzGerald and Grossman [10] found a good interRR in a retrospective assessment of the PGA (=0.79). 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. , Matos A An assessment of disease flare in patients with systemic lupus erythematosus: a comparison of BILAG 2004 and the flare version of SELENA. , Block JA , Beresford MW Clinical composite measures of disease activity and damage used to evaluate patients with systemic lupus erythematosus: A systematic literature review. Dynabook PX1900E-1NCA, PROTECTIVE SLE (PX1900E-1NCA) , Urowitz MB. 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). , Urowitz MB. et al. Elevation of erythrocyte sedimentation rate is associated with disease activity and damage accrual, 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, Small changes in outpatients lupus activity are better detected by clinical instruments than by laboratory tests, Development and initial validation of the systemic lupus erythematosus disease activity index 2000 responder index 50, Sensitivity to change of 3 systemic lupus erythematosus disease activity indices: international validation, Systemic Lupus Erythematosus Disease Activity Index 2000 Responder Index 50: sensitivity to response at 6 and 12 months, Validation of the functional assessment of chronic illness therapy-fatigue scale in patients with moderately to severely active systemic lupus erythematosus, participating in a clinical trial, Psychological distress and changes in the activity of systemic lupus erythematosus, The rating scale preference measure as an evaluative measure in systemic lupus erythematosus, Comparison of the validity and sensitivity to change of 5 activity indices in systemic lupus erythematosus, Treatment of systemic lupus erythematosus with dehydroepiandrosterone: 50 patients treated up to 12 months, Soluble urokinase plasminogen activator receptor levels reflect organ damage in systemic lupus erythematosus, Epratuzumab for patients with moderate to severe flaring SLE: health-related quality of life outcomes and corticosteroid use in the randomized controlled ALLEVIATE trials and extension study SL0006, Measuring systemic lupus erythematosus activity during pregnancy: validation of the lupus activity index in pregnancy scale, Autoantibodies against albumin in patients with systemic lupus erythematosus, Association of depression with socioeconomic status, anticardiolipin antibodies, and organ damage in patients with systemic lupus erythematosus: results from the KORNET registry, Placebo-controlled randomized clinical trial of fish oils impact on fatigue, quality of life, and disease activity in systemic lupus erythematosus, Serum free light chains, interferon-alpha, and interleukins in systemic lupus erythematosus, Vitamin D levels in Chinese patients with systemic lupus erythematosus: relationship with disease activity, vascular risk factors and atherosclerosis, Systemic lupus erythematosus disease activity index 2000 responder index-50: a reliable index for measuring improvement in disease activity, Testosterone patches in the management of patients with mild/moderate systemic lupus erythematosus, Turkish LupusPRO: cross-cultural validation study for lupus, Cross-cultural validation of a disease-specific patient-reported outcome measure for lupus in Philippines, Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial, Sensitivity and specificity of plasma and urine complement split products as indicators of lupus disease activity, The TNF locus is altered in monocytes from patients with systemic lupus erythematosus, Effect of pregnancy on disease flares in patients with systemic lupus erythematosus, Frequency of lupus flare in pregnancy: the Hopkins Lupus Pregnancy Center experience, Morbidity of systemic lupus erythematosus: role of race and socioeconomic status, Classification and definition of major flares in SLE clinical trials, Efficacy and safety of epratuzumab in patients with moderate/severe active systemic lupus erythematosus: results from EMBLEM, a phase IIb, randomised, double-blind, placebo-controlled, multicentre study, COSMIN guideline for systematic reviews of patient-reported outcome measures, Validity and reliability in social science research, Understanding the minimum clinically important difference: a review of concepts and methods, Statistical significant change versus relevant or important change in (quasi) experimental design: some conceptual and methodological problems in estimating magnitude of intervention-related change in health services research, Minimum important difference between patients with rheumatoid arthritis: the patients perspective, Responsiveness and sensitivity to change of SLE disease activity measures, The Author(s) 2020. , Taghavi-Zadeh S physician global assessment Recently Published Documents. [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. The other authors have declared no conflicts of interest. 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). , Petri M , Kalunian K government site. , Tugwell P 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). The Janus kinase (Jak)/signal transducer and activating protein (STAT) pathways mediate the intracellular signaling of cytokines in a wide spectrum of cellular processes. , Raeisi A 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. , Allen E (SLE) GSKpro This property is reported across all articles selected through this systematic review [24, 913, 21103]. Oxford University Press is a department of the University of Oxford. SLE2ACR1997SLICC2012. Using the Physician Global Assessment in a clinical setting to - PubMed In 1988, Liang et al. 'Not at target': prevalence and consequences of inadequate disease control in systemic lupus erythematosus-a multinational observational cohort study. Oxford Textbook of. Vil LM [PDF] Use of Physician Global Assessment in systemic lupus , Chang AY , Genovese M , Perneger T , Buyon J 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. , Tanangunan R (PGA) scoring of disease activity in systemic lupus erythematosus (SLE). Faculty Publications: Feb. 23-March 2 Devilliers H , Esdaile JM. In conclusion, the PGA was demonstrated to be a valid, responsive and feasible instrument, but its reliability was strongly impacted by the scale adopted, suggesting the need for standardization in its scoring. ATI Comprehensive Predictor Exam 2019 (180 Q & A, Verified and 100 , Kostopoulou M et al. Fatigue is independently associated with disease activity assessed using the Physician Global Assessment but not the SLEDAI in patients with systemic lupus erythematosus. 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 . The quantification of reliability is expressed by a correlation coefficient. (Open Access) Development and assessment of a computerized index of et al. , Hochberg M. Touma Z 3TR (Taxonomy, Treatment, Targets and Remission) Systemic Lupus Erythematosus Study Protocol 2 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]. , Petri M. Iaccarino L , Jolly M. Mok CC , Gladman DD , Block JA Complement-Targeted Therapeutics Market Report (2022 to , Wallace DJ sharing sensitive information, make sure youre on a federal Clinical Trial Physician - Rheumatology Job in San Diego, CA - Bristol PGA is a simple instrument and the result is easily understood. , Dyer JW T1 - Associations between physicians' global assessment of disease activity and patient-reported outcomes in patients with systemic lupus erythematosus. , Jolly M. Mazur-Nicorici L Thanou A, Chakravarty E, James JA, Merrill JT. , Liberati A Genetic linkage has related dysfunction of . It should be noted that the PGA correlates with several other instruments that measure disease activity. Mok CC 2021 Apr 8;5(1):33. doi: 10.1186/s41687-021-00298-x. 2022 Sep 20;19(19):11895. doi: 10.3390/ijerph191911895. Objective: , Ogale S 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. Physician global assessments for disease activity in rheumatoid , Annapureddy N Careers. , Gladman DD The interrater reliability (interRR) of the PGA is the ability to provide consistent scores in a stable population between two or more physicians who evaluate the disease activity of the same patient. , James JA , Matos A CareerBuilder TIP. In an epratuzumab trial, the absence of deterioration of the PGA (not >10% worsening) was one of the items to achieve a BILAG-based Composite Lupus Assessment (BICLA) response [105]. OBJECTIVE The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. Gandhi N Sullivan KE 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]. Criterion validity data reporting correlation coefficients between PGA and quality of life measures, laboratory markers and miscellaneous. , Mokkink LB [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. , Klein-Gitelman MS The last MEDLINE search was performed on 1 July 2019. Gyri N 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. The Handheld Dermatoscope as a Nail-Fold Capillaroscopic Instrument - JAMA 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]. Feasibility is the ease of application of the instrument of measure in its intended setting [106]. , Stavrakis S , Kiani AN How does one assess and monitor patients with systemic lupus 25 (FIVE YEARS 8) Latest Documents Most Cited Documents Contributed Authors Related Sources Related Keywords Latest Documents; Most Cited Documents; Contributed Authors; Related Sources; Use of Physician Global Assessment in systemic lupus - PubMed Fanouriakis A Associations between physicians' global assessment of disease activity Learn more. Your recommendations as to what might or should be done in relation to various issues observed. Treatment of lupus nephritis: consensus, evidence and perspectives , Ibanez D , Birmingham DJ 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. , Larson MG To determine longitudinal associations between Physician Global Assessment (PGA) and patient-reported outcomes (PROs) in patients with systemic lupus erythematosus (SLE). 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. 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). Eudy AM et al. Before , Piette EW Background/Purpose: The Physician Global Assessment (PGA) is a frequently-used outcome measure in Systemic Lupus Erythematosus (SLE). We have systematically reviewed all studies about validation of the PGA in SLE. Additional papers were obtained by checking the references from the selected studies. AU - Kandane-Rathnayake, Rangi. doi:10.1136/ rmdopen-2017-000578 Prepublication history and et al. Physician Global Assessment International - ScienceDirect Keywords: 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). 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. 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.