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 . Clinical Trial on Systemic Lupus Erythematosus (SLE): Blood sample The index assesses separately eight organ-based systems. , Cappellazzo G 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). Flow chart illustrating the literature search and study selection. 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). The responsiveness of the PGA was assessed through different methods [109, 113] showing a high sensitivity for detecting clinical variations [84]. 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. What Does It Mean to Be a British Isles Lupus Assessment Group-Based , Tugwell P Gyri N The index has proved quick and easy to use despite a comprehensive database and compares favourably with . Measurement properties of the PGA were analysed according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) terminology [19]. HHS Vulnerability Disclosure, Help Associations between physicians' global assessment of disease activity The Physician's Global Assessment (PhGA) is a number without unit. Thank you for submitting a comment on this article. , Ho LY Direkt zum Inhalt springen . Arriens C 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. et al. 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. , Mikolaitis-Preuss RA The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. , Navarra SV The Janus kinase (Jak)/signal transducer and activating protein (STAT) pathways mediate the intracellular signaling of cytokines in a wide spectrum of cellular processes. PGA is often assessed by a single question with a 0-10 or 0-100 response. 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]. Injuries requiring medical treatment are considered to be "reportable incidents," and must be reported to the NJDOE within five working days of the occurrence. 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. AU - Kasitanon, Nuntana. CareerBuilder TIP. 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. These results enabled its use as a gold standard for assessing flare and defining flare severity in several studies [21, 67, 88]. , Skogh T BICLA responders had fewer lupus-related serious . 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). sharing sensitive information, make sure youre on a federal A total of 91 articles were included in the study (Fig. Vil LM Can Lupus Patients Take the Driver's Seat in Their Disease Monitoring. et al. When expanded it provides a list of search options that will switch the search inputs to match the current selection. Vashisht P This enabled the PGA to be considered the gold standard in several studies [2, 10, 11, 21, 23, 49, 67, 76, 78, 84, 88]. , Magder LS Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. , Urowitz MB Comparison of the validity and sensitivity to change of 5 activity indices in systemic lupus erythematosus. 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. MD globals may vary based on their age, gender, practice setting and experience (number of patients seen per year and years in practice). , Raeisi A PGA is often assessed by a single question with a 0-10 or 0 . ~SLE~. . Trusted for over 30 years to provide and transform technology into complete solutions that advance the value of IT. , Emamikia S Face validity. (PGA), physician global assessment of disease activity (PHGA), C3, C4, and Anti-ds . official website and that any information you provide is encrypted , Sato JO , Jolly M. Ribi C AB - The Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus (PISCOS) study aimed to obtain an evidence . PDF Getting To Know Dr. Derek Shendell, New Safe Schools Project Director 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]. , Francis S , Urowitz MB. , Bonithon-Kopp C No study has evaluated the feasibility of the PGA in SLE to date. The intrarater reliability (intraRR) is the ability to provide consistent scores in a stable population by the same assessor over time. 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]. Devilliers H Because of its dynamic nature, this disease has an unpredictable natural course leading to high . 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. 2022 Sep 20;19(19):11895. doi: 10.3390/ijerph191911895. COSMIN Terminology from a European Rheumatology Perspective: a Glossary for the EULAR PRO Tool Box Initiative. , Taghavi-Zadeh S However, it is important to remember that not all clinical problems reported by a lupus patient are due to the disease. 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. Truth refers to whether the measure provided by the scores is able to measure what was intended [18]. , Lau CS Myelogram - correct answer NPO for 4-6 hours. Supervise the development of junior medical affairs staff . Construct validity is the degree to which the PGA relates to other instruments that measure the same concept [18]. AU - Morand, Eric. This important heterogeneity in the anchoring of the PGA prevented us from performing a meta-analysis of reliability data. , Carpenter AB Medizinische Universitt Graz Austria/sterreich - Forschungsportal - Medical University of Graz Direkt zur Navigaton springen . et al. SLE3. , Landis RC Laboratory investigation results influence Physicians Global ssessment (PGA) of disease activity in SLE. , Dyer JW 1 2. The site is secure. Jiao H, Acar G, Robinson GA, Ciurtin C, Jury EC, Kalea AZ. 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]. Criterion validity. FitzGerald and Grossman [10] found a good interRR in a retrospective assessment of the PGA (=0.79). Deconstruction of the safety of estrogen in lupus erythematosus national assessment-systemic lupus erythematosus disease activity index flare index. 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 . Dynabook PX1900E-1NCA, PROTECTIVE SLE (PX1900E-1NCA) et al. , Stavrakis S Piga M 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). , Khamashta MA Thanou A, Chakravarty E, James JA, Merrill JT. Mahler M , Magder LS et al. Some may be a consequence of therapy and others may be . 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]. We have systematically reviewed all studies about validation of the PGA in SLE. Funding: The study was funded through the training Bursary Programme 2019 of the SLEuro European Lupus Society. 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. Petri M Physician's Global Assessment (PGA) score 1.0 on a 0 to 3 visual analog scale. In one open-label study [43], the decrease in PGA score was considered the primary endpoint. 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. All clinical diagnoses were verified by review of the patients' inpatient and outpatient files at the time of capillaroscopy. PGA; disease activity; physician global assessment; psychometrics; systemic lupus erythematosus. , Koutsoviti S 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. , Liberati A 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 . , Leung HW A systematic review of the literature was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines [17], searching for articles reporting on the use of PGA in SLE. The literature search identified 93 articles, and 12 additional articles were retrieved from the reference list of those publications. A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.67-0.98). Improving patient pathways for systemic lupus erythematosus: a multistakeholder pathway optimisation study. et al. Patient and Physician Global Assessments of Disease Status in Systemic An international panel of 79 SLE experts participated in a three-round Delphi consensus . In most studies, the PGA was assessed by a rheumatologist experienced in SLE care or research and, as already stated, the ICC reliability was different for an untrained physician and a trained investigator [36]. Epub 2014 Apr 11. The results are similar, and less than half the time is required for scoring. Gladman DD Beaton DE Objective Physician's global assessment (PGA) of disease activity is a major determinant of therapeutic decision making. Clinical composite measures of disease activity and damage used to evaluate patients with systemic lupus erythematosus: A systematic literature review. Using the Physician Global Assessment in a clinical setting to - PubMed Identification of new candidate drugs for primary Sjgrens syndrome using a drug repurposing transcriptomic approach, When it looks like Behets syndrome but is something else: Differential diagnosis of Behcets syndrome: a two-centre retrospective analysis, Huge water-balloons in the belly: multiple pancreatic pseudocysts in systemic lupus erythematosus, A randomized, double-blind, placebo-controlled, parallel group study on the effects of a cathepsin S inhibitor in primary Sjgrens syndrome, How to plug the leaky pipeline in clinical rheumatology across Europelessons to be learned from experiences in business, About the British Society for Rheumatology, British Society for Rheumatology Journals, https://doi.org/10.1093/rheumatology/keaa383, https://academic.oup.com/journals/pages/open_access/funder_policies/chorus/standard_publication_model, Receive exclusive offers and updates from Oxford Academic, Copyright 2023 British Society for Rheumatology. Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus: the PISCOS study . SLE231 Hydrology and Water Resources Management: Excursion or Virtual Tour , Socher SA et al. et al. physician global assessment Recently Published Documents. Schneider M 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. Arthritis Res Ther. Convergent validity is fulfilled indirectly in studies where the PGA is used as the gold standard to assess the construct validity of other indices. , Jnsen A BILAGAB . , Wetter J , Farewell V The random effects model gives a more conservative estimate considering the heterogeneity. et al. , Magder L , Magder L 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. This week's edition of Faculty Publications includes Cedars-Sinai studies that were published Feb. 23-March 2. Physician Global Assessment International Standardisation COnsensus in The aim of this systematic literature review (SLR) is to describe and analyse the psychometric properties of PGA. , Clowse M. Moorthy LN Oxford Textbook of Neuropsychiatry - 2020 | PDF | Psychiatry , Ibaez D et al. Cloud, mobility, security, and more. Fatigue is independently associated with disease activity assessed using the Physician Global Assessment but not the SLEDAI in patients with systemic lupus erythematosus. Of note, the literature search revealed heterogeneous definitions of physician assessment of disease activity other than the PGA (physician global assessment [4, 70, 73], physician overall assessment [85]). 215 (FIVE YEARS 146) H-INDEX. , Bouter LM The Validity of Patient and Physician Global Disease Activity MeSH 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]. , Perez-Gutthann S The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. [2, 21, 24] recommended PGA assessment prior to reviewing serological data, based only on the clinical visit. Medizinische Universitt Graz Austria/sterreich - Forschungsportal doi: 10.1136/rmdopen-2022-002395. et al. , Chakravarty E Results. Laboratory Investigation Results Influence Physician's Global 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]. Once two investigators (E.C., M.P.) 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]. Annapureddy N The pooled correlation coefficient (95% CI) is given both for the fixed effects model and the random effects model. 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). 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. Prinsen CAC Different definitions of PGA retrieved through the literature search are reported in Table1. et al. Physician global assessments for disease activity in rheumatoid , Glassman DS 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). Franklyn K , Henriques C , Smiley A. Askanase AD , Rodrigues M X 20 Physician Global Assessment 10.1136/lupus-2019-lsm.176 . Touma Z et al. doi:10.1136/ rmdopen-2017-000578 Prepublication history and T1 - Associations between physicians' global assessment of disease activity and patient-reported outcomes in patients with systemic lupus erythematosus. CLOSED ANGLE/ ANGLE CLOSURE GLAUCOMA. et al. Bethesda, MD 20894, Web Policies Physician Global Assessment International Standardisation COnsensus in 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). It was published in 1977 and was initially designed for the measurement of self-assessed pain in rheumatoid arthritis although it has since been used to evaluate RA more globally. Objective: The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. The company serves physicians and patients. 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). , Zonana-Nacach A Int J Environ Res Public Health. Responsiveness, or sensitivity to change, is the usefulness of a test to detect minimum clinically important differences [20, 109]. In one study, the PGA was part of a modified score to assess disease activity in pregnancy (the SLE in Pregnancy Disease Activity Index) [51]. , Kraag GR Epub 2014 Jul 10. et al. , Su J The PGA is usually reported by experts as allowing exhaustive coverage of the concept of disease activity in SLE [20, 108]. Content validity was reported in 89 studies. 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. , Jolly M. Mazur-Nicorici L , Birmingham DJ 2019ACREULAR . disease activity). Global Automatic Chemiluminescence Immunoassay Analyzer Market 2023 Please check for further notifications by email. TOTAL DOCUMENTS. 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. Whenever papers reported duplicate data, the most recent article was selected. , Chatzidionysiou K Mina R SELENA SLEDAI4. , Brunetta P , Terwee CB , Annapureddy N , Altman DG A good responsiveness for PGA was shown in eight studies. Moher D Fanouriakis A , Borghoff K This site needs JavaScript to work properly. , Andreoli L How does one assess and monitor patients with systemic lupus Reviews and case series with fewer than five patients were excluded. (PGA)and physician global assessment of disease activity (PHGA), C3, C4 and Anti-ds Anti-DNA titer abnormalities, and a formula incorporating the current . The judgment of whether a patient with SLE has active disease is a central question both in routine patient management and in clinical research [4]. Gordon C Unauthorized use of these marks is strictly prohibited. In Fatemi et al. , Arora S , Flower C RN-BSN HOLISTIC HEALTH ASSESSMENT ACROSS THE LIFESPAN (NURS 3315) Sociology of Social Problems (SOC213) The Physician Global Assessment (PGA) is a frequently used co-primary end point in psoriasis clinical trials. [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. , Petri MA , Fang H Complement-Targeted Therapeutics Market Report (2022 to New Tools to Measure Disease Activity in SLE - Rheumatology Network et al. Introduction Physician global assessments of disease activity (medical doctor (MD) globals) are important outcomes. , McGwin G Global Respiratory Devices Market Size, Growth, Source Analysis, Top In two studies, the PGA-VAS was used to assess concepts other than disease activity: disease severity [4] and patients compliance with treatments [103]. van Vollenhoven R , Matos A 12. and later incorporated into the SLE Responder Index used in the belimumab clinical trials, 13

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