All rights reserved. Responsiveness. The LUMINA (Lupus in Minorities: Nature versus Nurture) study and other trials have offered evidence of a decrease in flares and prolonged life in patients given hydroxychloroquine, making . , Friebus-Kardash J Systemic Lupus Erythematosus (SLE) Treatment & Management - Medscape PGA or SGA described in ePROVIDE - Mapi Research Trust 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. , Seaman AL 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). , Ho LY PGA is often assessed by a single question with a 0-10 or 0-100 response. 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. , Voskuyl A AU - Kasitanon, Nuntana. Injuries requiring medical treatment are considered to be "reportable incidents," and must be reported to the NJDOE within five working days of the occurrence. Physician Global Assessment International - ScienceDirect 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. Medizinische Universitt Graz Austria/sterreich - Forschungsportal 2022 Jan 11;11(2):340. doi: 10.3390/jcm11020340. 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. 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. CareerBuilder TIP. 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). Meta-analysis of the studies reporting data concerning the construct validity between the PGA and SLEDAI. 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. Objective: The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. PGA is an important tool for assessing disease activity, response to treatment (it is a component . , Magder LS 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. [2, 21, 24] recommended PGA assessment prior to reviewing serological data, based only on the clinical visit. Forbess LJ , Mazur M. Fatemi A Use of Physician Global Assessment (PGA) in Systemic lupus FOIA Epub 2014 Jul 10. , James JA (PGA)and physician global assessment of disease activity (PHGA), C3, C4 and Anti-ds Anti-DNA titer abnormalities, and a formula incorporating the current . Content validity. , Dyer JW Objective Physician's global assessment (PGA) of disease activity is a major determinant of therapeutic decision making. Face validity is satisfied when the instrument is considered able to capture what it should capture (i.e. Ann Rheum Dis 2 Isenberg DA, Allen E, Farewell V, et al. et al. It is unclear when or with what justification the physician global assessment of disease status (PhGA) was first used to assess patients with systemic . OBJECTIVE The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. , Criscione-Schreiber LG The interobserver agreement between physician (PGA) and patient (PtGA) global assessment for acne and psoriasis was good, reflected by the weighted Cohen (acne, = 0.68; psoriasis, = 0.70) (eTable in the Supplement). , Carpenter AB 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]. Criterion validity also refers to the degree to which an instrument predicts aspects and phenomena occurring in the future [108]. Compared with nonresponders, BICLA responders had greater improvements in global and organ-specific disease activity (Physician's Global Assessment, SLE Disease Activity Index 2000, Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity, and joint counts; all nominal P < 0.001). et al. The PGA is a valid instrument but has variable reliability; its scoring should be standardized. A new tool -- the Lupus Activity Scoring Tool (LAST) - has been proposed to join the ranks of current disease activity indices. 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. , Gladman DD , Hearth-Holmes M. Khan A Pain assessment: An alternative measure - hcplive.com 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 https:// ensures that you are connecting to the , Zonana-Nacach A , Merrill JT. The company serves physicians and patients. 2022 May;9(1):e000700. Systemic lupus erythematosus (SLE), is the most common type of lupus. . 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. Dynabook PX1900E-1NCA, PROTECTIVE SLE (PX1900E-1NCA) , Askanase A , Gomez A PDF Physician Global Assessment International Standardisation COnsensus in There is no cure for lupus, but medical . BICLA responders had fewer lupus-related serious . 2022 Sep;8(2):e002395. Karol DE , Mosca M Pincus and colleagues conducted a study of . , Pego-Reigosa J-M et al. This enabled the PGA to be considered the gold standard in several studies [2, 10, 11, 21, 23, 49, 67, 76, 78, 84, 88]. 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 . , Rodrigues M The authors wish to thank Sylvie Thuong for her invaluable assistance in the preparation of this manuscript. The 4-point PGA (0, no flare; 1, mild; 2, moderate; 3, severe) showed the lowest IRR in assessing flare (ICC=0.18) compared with the BILAG-2004 (ICC=0.54) and SFI (ICC=0.21) [65]. PDF Physician s global assessment is often useful in SLE, but not always 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. , Beaumont JL Thanou A PDF Use of Physician Global Assessment (PGA) in Systemic lupus - medRxiv PGA0.3. BILAGAB . 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). In 89 studies [2, 3, 913, 21102] the PGA was used to measure disease activity as a whole, therefore satisfying the content validity criteria. , Perez-Gutthann S The Physician Global Assessment (PGA) of treatment response measures the overall response to treatment as assessed by the physician. A good correlation was considered for a value >0.60. AU - Louthrenoo, Worawit. 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]). 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): 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 . et al. , Garabajiu M Disclaimer. et al. , Magder LS Liang et al. PGA - Lupus Research physician's global assessment (PGA) of disease activity in SLE. , Su J Funding: The study was funded through the training Bursary Programme 2019 of the SLEuro European Lupus Society. 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. ~SLE~. 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). Data regarding divergent validity are lacking for the PGA. Some may be a consequence of therapy and others may be . Jiao H, Acar G, Robinson GA, Ciurtin C, Jury EC, Kalea AZ. , Allen E This button displays the currently selected search type. Flow chart illustrating the literature search and study selection. 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. , Engle E , Bertsias G , Chang AY PGA is often assessed by a single question with a 0-10 or 0 . et al. , Kharboutli M , Buyon J Prinsen CAC , Farewell V In Fatemi et al. 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. , Chizzolini C The aim of this systematic review is to describe and analyse the measurement properties of the PGA, including the validity, reliability, responsiveness and feasibility. et al. Nehring J RMD Open 2018;4:e000578. Patient-reported outcomes (PROs) reflect the patient's perspective and are used in rheumatoid arthritis (RA) routine clinical practice. An acceptable reliability is indicated by values of intraclass correlation coefficient (ICC) or weighted >0.60 and a good reliability is >0.85 [20]. , Holland M This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. , Bouter LM , Jnsen A PGA-IGA described in ePROVIDE - Mapi Research Trust The content can vary and relates either to global health (e . Franklyn K , Hochberg M. Wallace DJ , Genovese M Mok CC The aim of this systematic literature review (SLR) is to describe and analyse the psychometric properties of PGA. Moreover, there is uncertainty as to whether the best timing of assessment is prior to or after reviewing laboratory exams [26]. A prospective cohort study, Validity and reliability of retrospective assessment of disease activity and flare in observational cohorts of lupus patients, A novel lupus activity index accounting for glucocorticoids: SLEDAI-2K glucocorticoid index, Low disease activityirrespective of serologic status at baselineassociated with reduction of corticosteroid dose and number of flares in patients with systemic lupus erythematosus treated with belimumab: a real-life observational study, Definition and initial validation of a lupus low disease activity state (LLDAS), A framework for remission in SLE: consensus findings from a large international task force on definitions of remission in SLE (DORIS), Prolonged remission in Caucasian patients with SLE: prevalence and outcomes, 2019 update of the EULAR recommendations for the management of systemic lupus erythematosus, PRISMA Group. Gyri N Assessing disease activity in rheumatic diseases such as systemic lupus erythematosus (SLE) is vital for effective treatment. The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. 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? , Smiley A. Askanase AD The results are similar, and less than half the time is required for scoring. , Petri M. Thanou A , Socher SA Your comment will be reviewed and published at the journal's discretion. 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]. , Block JA Physician global assessments for disease activity in rheumatoid arthritis are all over the map! 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]. Devilliers H 215 (FIVE YEARS 146) H-INDEX. Objective Existing methods for grading lupus flares or improvement require definition-based thresholds as increments of change. New Tools to Measure Disease Activity in SLE - Rheumatology Network Reliability. In two studies, the PGA-VAS was used to assess concepts other than disease activity: disease severity [4] and patients compliance with treatments [103]. 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. , Koutsoviti S , Klein-Gitelman MS Deconstruction of the safety of estrogen in lupus erythematosus national assessment-systemic lupus erythematosus disease activity index flare index. Changes in the PGA correlated with changes of other disease activity indices (SLEDAI, SLAM, LAI, patient global assessment), laboratory exams (ESR), patient-reported outcomes (Lupus Impact Tracker) [23, 50, 58, 77, 78, 81, 83] and response to treatment [4]. , Altman DG 2019ACREULAR . , Kosinski M According to the OMERACT, face validity is the degree to which the instrument appears to match with the target domain, according to experts [18]. , Siega-Riz AM The Validity of Patient and Physician Global Disease Activity Medical-Surgical Nursing Clinical Lab (NUR1211L) U.S. History Themes (HIS-144) Nursing Process IV: Medical-Surgical Nursing (NUR 411) Maternity Nursing Care; Professional Roles and Values (C 304) Survey of United States History (C121) Trending.
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