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The aim of this systematic literature review is to describe and analyse the . , Engleman EG Assessing disease activity in rheumatic diseases such as systemic lupus erythematosus (SLE) is vital for effective treatment. 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). Accessibility , Bouter LM The Senior Lead will be responsible for: Managing end to end production, governance and controls of Derivatives Standardized and Advanced RWA, and SLE Actuals. This property is reported across all articles selected through this systematic review [24, 913, 21103]. Face validity. , Block JA et al. Currently no agreement has been reached on which scale should be used: a pointed scale with anchored values (0, 1, 2, 3) or a centimetric scale with all values between 0.0 and 3.0. . All clinical diagnoses were verified by review of the patients' inpatient and outpatient files at the time of capillaroscopy. , Kraag GR 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. , Magder LS It should be noted that the PGA correlates with several other instruments that measure disease activity. , Cappellazzo G , Magder LS , Devilliers H 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 . , Jnsen A According to the OMERACT, face validity is the degree to which the instrument appears to match with the target domain, according to experts [18]. 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. The Author(s) 2020. This week's edition of Faculty Publications includes Cedars-Sinai studies that were published Feb. 23-March 2. , Esdaile JM. et al. et al. Content validity was reported in 89 studies. Arriens C In two studies, the PGA-VAS was used to assess concepts other than disease activity: disease severity [4] and patients compliance with treatments [103]. , Ibanez D In 32 studies, disease activity measured by PGA was compared with changes in laboratory markers, with the aim of correlating clinical and serological features [9, 21, 30, 32, 34, 3739, 44, 45, 48, 49, 55, 5861, 63, 64, 66, 67, 69, 71, 74, 75, 82, 86, 89, 9194]. et al. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement, Instrument selection using the OMERACT filter 2.1: the OMERACT methodology, The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes, Health measurement scales: a practical guide to their development and use, A decrease in complement is associated with increased renal and hematologic activity in patients with systemic lupus erythematosus, Efficacy and safety of methotrexate in articular and cutaneous manifestations of systemic lupus erythematosus, Performance of SLEDAI-2K to detect a clinically meaningful change in SLE disease activity: a 36-month prospective cohort study of 334 patients, Disease activity patterns over time in patients with SLE: analysis of the Hopkins Lupus Cohort, Comparison of the systemic lupus erythematosus activity questionnaire and the systemic lupus erythematosus disease activity index in a black Barbadian population, A pilot study to determine the optimal timing of the Physician Global Assessment (PGA) in patients with systemic lupus erythematosus, Preliminary test of the LFA rapid evaluation of activity in lupus (LFA-REAL): an efficient outcome measure correlates with validated instruments, Derivation and validation of the SLE Disease Activity Score (SLE-DAS): a new SLE continuous measure with high sensitivity for changes in disease activity, Clinical SLEDAI-2K zero may be a pragmatic outcome measure in SLE studies, Erythrocyte-bound C4d in combination with complement and autoantibody status for the monitoring of SLE, Validation of SIMPLE index for lupus disease activity, Performance characteristics of different anti-double-stranded DNA antibody assays in the monitoring of systemic lupus erythematosus, Psychometric properties of MDHAQ/RAPID3 in patients with systemic lupus erythematosus, Therapeutic adherence in patients with systemic lupus erythematosus: a cross-sectional study, Sensitivity analyses of four systemic lupus erythematosus disease activity indices in predicting the treatment changes in consecutive visits: a longitudinal study, Comparison of the lupus foundation of America-rapid evaluation of activity in lupus to more complex disease activity instruments as evaluated by clinical investigators or real-world clinicians, Lupus low disease activity state is associated with a decrease in damage progression in Caucasian patients with SLE, but overlaps with remission, Impact of disease activity on health-related quality of life in systemic lupus erythematosusa cross-sectional analysis of the Swiss Systemic Lupus Erythematosus Cohort Study (SSCS), Association of the lupus low disease activity state (LLDAS) with health-related quality of life in a multinational prospective study, Smoking and pre-existing organ damage reduce the efficacy of belimumab in systemic lupus erythematosus, Cross-cultural validation of Lupus Impact Tracker in five European clinical practice settings, Failure of a systemic lupus erythematosus response index developed from clinical trial data: lessons examined and learned, Belimumab for the treatment of recalcitrant cutaneous lupus, Progression of noncalcified and calcified coronary plaque by CT angiography in SLE, Impact of heart rate variability, a marker for cardiac health, on lupus disease activity, The lupus impact tracker is responsive to changes in clinical activity measured by the systemic lupus erythematosus responder index, Validation of the Lupus Impact Tracker in an Australian patient cohort, Axl, ferritin, IGFBP2 and TNFR2 as biomarkers in systemic lupus erythematosus, Lupus anticoagulant, disease activity and low complement in the first trimester are predictive of pregnancy loss, Lupus Impact Tracker is responsive to physician and patient assessed changes in systemic lupus erythematosus, Predictors of pregnancy outcomes in patients with lupus: a cohort study, Clinical, laboratory and health-related quality of life correlates of Systemic Lupus Erythematosus Responder Index response: a post hoc analysis of the phase 3 belimumab trials, Validation of the LupusPRO in Chinese patients from Hong Kong with systemic lupus erythematosus, The Swiss Systemic lupus erythematosus Cohort Study (SSCS)cross-sectional analysis of clinical characteristics and treatments across different medical disciplines in Switzerland, How should lupus flares be measured? IgM) on attainment PhGA. 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). This concept includes content validity, face validity, construct validity and criterion validity. Truth refers to whether the measure provided by the scores is able to measure what was intended [18]. Your recommendations as to what might or should be done in relation to various issues observed. Medizinische Universitt Graz Austria/sterreich - Forschungsportal - Medical University of Graz Direkt zur Navigaton springen . 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. , Cella D. van Vollenhoven RF The random effects model gives a more conservative estimate considering the heterogeneity. , Kharboutli M , Merrill JT. , Henriques C (PGA) scoring of disease activity in systemic lupus erythematosus (SLE). , Ding HH Fanouriakis A The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. , Borghoff K Construct validity was demonstrated by a good correlation (r0.50) between the PGA with the SLEDAI (12 studies), SLAM (4 studies), LAI, BILAG and ECLAM (2 studies each). The assessment of PGA responsiveness was performed in 10 studies [4, 23, 50, 58, 7779, 81, 83, 84] using different methods [110]. The literature search identified 91 studies. The responsiveness of the PGA was assessed through different methods [109, 113] showing a high sensitivity for detecting clinical variations [84]. Touma Z Touma Z The content can vary and relates either to global health (e . [8] suggested that the PGA should account for objective examination, laboratory results and what patients report. PGA0.3. Chaigne B , Genovese M , Hynan LS Because of the complexity of SLE, the assessment of disease activity is particularly challenging [3]. 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. Systemic lupus erythematosus (SLE), is the most common type of lupus. , Emamikia S TOTAL DOCUMENTS. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. 215 (FIVE YEARS 146) H-INDEX. 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. Eudy AM This site needs JavaScript to work properly. RMD Open 2018;4:e000578. , Burlingame RW Patient-reported outcomes (PROs) reflect the patient's perspective and are used in rheumatoid arthritis (RA) routine clinical practice. , Shea BJ 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. 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 . Reviews and case series with fewer than five patients were excluded. , Tetzlaff J The aim of this systematic literature review (SLR) is to describe and analyse the psychometric properties of PGA. 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 . PGA is often assessed by a single question with a 0-10 or 0 . A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.67-0.98). ECG - correct answer no sleep the night before, meals allowed, no stimulants/tranquilizers for 24-48 hours before. It operates in Albuquerque, and New Mexico. , Ogale S et al. 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. Please check for further notifications by email. Once two investigators (E.C., M.P.) 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. SLE has protean and often complex manifestations, necessitating careful clinical assessment. 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. Unable to load your collection due to an error, Unable to load your delegates due to an error. , Koutsoviti S In one open-label study [43], the decrease in PGA score was considered the primary endpoint. . . Results. These results enabled its use as a gold standard for assessing flare and defining flare severity in several studies [21, 67, 88]. , Hochberg M. Touma Z SLE2ACR1997SLICC2012. et al. 'Not at target': prevalence and consequences of inadequate disease control in systemic lupus erythematosus-a multinational observational cohort study. Objective Existing methods for grading lupus flares or improvement require definition-based thresholds as increments of change. Thanou A, Chakravarty E, James JA, Merrill JT. This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Laboratory investigation results influence Physicians Global ssessment (PGA) of disease activity in SLE. [84] expressed the sensitivity in PGA scoring with the standardized response mean (SRM), demonstrating a very large effect size (ES=2.23) [110]. 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]. 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). 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]. 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 . , Khamashta MA Results: Physician's Global Assessment Scale (PGA) or Investigator's Global Assessment Scale (IGA) measures disease status in a broad range of diseases. , Annapureddy N 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. 2022 Sep 20;19(19):11895. doi: 10.3390/ijerph191911895. , Nelson S , Bertsias G PGA is an important tool for assessing disease activity, response to treatment (it is a component . 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]. 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). The pooled correlation coefficient (95% CI) is given both for the fixed effects model and the random effects model. , Liberati A Conducting medical monitoring, safety review, narrative writing and etc.. Perform medical assessment of individual . , Schirmbeck LA Physician global assessments for disease activity in rheumatoid arthritis are all over the map!. Gladman DD , Taghavi-Zadeh S , Engel SM , Hearth-Holmes M. Khan A Disagreements between investigators were solved by consensus. 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]. Quimby KR Provide oversight to Shared Services Derivatives team supporting RWA operations and production. This enabled the PGA to be considered the gold standard in several studies [2, 10, 11, 21, 23, 49, 67, 76, 78, 84, 88]. Parodis I In Fatemi et al. , Adamichou C The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinicians judgement of overall SLE disease activity. 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]. et al. et al. Criterion validity also refers to the degree to which an instrument predicts aspects and phenomena occurring in the future [108]. 3TR (Taxonomy, Treatment, Targets and Remission) Systemic Lupus Erythematosus Study Protocol 2 MeSH , Subach RB Face validity is satisfied when the instrument is considered able to capture what it should capture (i.e. All articles published through 1 July 2019 in PubMed were screened, with no limitation on year of publication, language or patients' age. 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). The index assesses separately eight organ-based systems. 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]. Moreover, a difference between the interRR of the PGA assessed by an untrained physician (0.50.63) and a trained investigator (0.790.81) was found, suggesting the need for PGA scoring training or standardization [36]. Careers. The PGA was developed on a 0 to 3 scale as part of the Lupus Activity Index. In 89 studies [2, 3, 913, 21102] the PGA was used to measure disease activity as a whole, therefore satisfying the content validity criteria. The Janus kinase (Jak)/signal transducer and activating protein (STAT) pathways mediate the intracellular signaling of cytokines in a wide spectrum of cellular processes. , Karp DR et al. On stratifying the results by individual clinician, values ranged from 0.61 to 0.90, except for those reported by . The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. Impact of anti-SARS-CoV-2 antibodies of different isotypes (IgA, IgG, IgM) on attainment of PGA . , Skogh T , ODell JR et al. AU - Kasitanon, Nuntana. 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]. The last MEDLINE search was performed on 1 July 2019. , Petri MA Comparison of the validity and sensitivity to change of 5 activity indices in systemic lupus erythematosus. The .gov means its official. , Petri MA 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. Conclusion: 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. Mina R Ensure second line of defense Derivatives RWA reviews are performed consistently and . Physician Global Assessment (PGA) is a visual analogue score (VAS) that reflects the clinician's judgment of overall Systemic Lupus Erythematosus (SLE) disease activity. The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. 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). FOIA There is no cure for lupus, but medical . , Leung HW 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. The SELENA-SLEDAI assesses systemic lupus erythematosus (SLE) disease activity and categorizes mild/moderate or severe flares based on changes in the SLEDAI score, the Physician's Global Assessment (PGA), medication use (prednisone, Nonsteroidal anti-inflammatory drugs, Plaquenil, major immunosuppressives), other disease activity criteria, and . Petri M Objective Physician's global assessment (PGA) of disease activity is a major determinant of therapeutic decision making. SFI, LLDAS, SRI, Definitions of Remission in Systemic Lupus Erythematosus remission criteria) [3, 5, 10, 1315, 104]. , Magder L T1 - Associations between physicians' global assessment of disease activity and patient-reported outcomes in patients with systemic lupus erythematosus. AU - Kandane-Rathnayake, Rangi. Gyri N Ruiz-Irastorza G 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. , Chang AY HRQoL: Health-related Quality of Life; ICAM: intercellular adhesion molecule; VCAM: vascular cell adhesion molecule; MCP-1: monocyte chemoattractant protein-1; NC: non-calcified; suPAR: soluble urokinase plasminogen activator receptor; LFA-REAL: Lupus Foundation of America Rapid Evaluation of Activity in Lupus; CES-D: Centers for Epidemiological StudiesDepression scale; SLAQ: Systemic Lupus Erythematosus Activity Questionnaire; NA: not acquired; NS: not significant. SLE3. , Beresford MW , Mosca M Visual analogue scales (VAS) allow rapid, continuous scaling of disease severity. , Carpenter AB , Wallace DJ et al. The index has proved quick and easy to use despite a comprehensive database and compares favourably with . Glossary: PGA. 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