Uribe AG, Vil LM, McGwin G Jr, Sanchez ML, Reveille JD, Alarcn GS. et al. 2022 Jan 11;11(2):340. doi: 10.3390/jcm11020340. , Jolly M. Mazur-Nicorici L , Bresee C , Karp DR This concept includes content validity, face validity, construct validity and criterion validity. , Matos A The aim of this systematic literature review (SLR) is to describe and analyse the psychometric properties of PGA. In one study [25], the PGA of disease activity resulted from the combination of the clinical visit, laboratory markers evaluation and the physicians knowledge of the patient disease history. IgM) on attainment PhGA. Cutaneous lupus erythematosus (CLE) is an autoimmune skin disease that can occur with or without systemic lupus erythematosus (SLE). , Wallace DJ 2019ACREULAR . 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]. PGA is often assessed by a single question with a 0-10 or 0 . The following search strategy was used through MEDLINE via PubMed: (((lupus erythematosus, systemic[MeSH Terms] OR (lupus[TIAB] AND erythematosus[TIAB] AND systemic[TIAB]) OR systemic lupus erythematosus[TIAB] OR (systemic[TIAB] AND lupus[TIAB] AND erythematosus[TIAB]))) OR SLE[TIAB]) AND (physician global assessment[TIAB] OR PGA[TIAB]). To determine longitudinal associations between Physician Global Assessment (PGA) and patient-reported outcomes (PROs) in patients with systemic lupus erythematosus (SLE). 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). Five studies have demonstrated good ICC values for reliability (all >0.60 and ranging up to 0.97). et al. et al. 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. Construct validity. Gladman DD For permissions, please email: journals.permissions@oup.com, This article is published and distributed under the terms of the Oxford University Press, Standard Journals Publication Model (. et al. Additional papers were obtained by checking the references from the selected studies. 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. et al. It can affect the joints, skin, brain, lungs, kidneys, and blood vessels. The assessment of disease activity in SLE is particularly challenging. (PGA) scoring of disease activity in systemic lupus erythematosus (SLE). , Chatzidionysiou K Correlations with other instruments measuring similar constructs should typically demonstrate a coefficient (r) 0.50 [106]. 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. Objective Existing methods for grading lupus flares or improvement require definition-based thresholds as increments of change. , Hochberg M. Touma Z , Petri MA The site is secure. , Clowse M. Moorthy LN Oxford Textbook of. 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]. A PGA >1 was predictive of polymorphic light cutaneous eruption (P=0.02) [59] and correlated negatively with LLDAS attainment [37]. Methods: This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items . , Morabito LM BICLA responders had fewer lupus-related serious . , Hearth-Holmes M. Khan A Devilliers H OBJECTIVE The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. 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. Gandhi N , Carpenter AB , Allen E Franklyn K , Aggarwal R Gyri N The aim of this systematic literature review is to describe and analyse the . To discriminate between the severity of flares, the PGA was incorporated in a composite index: the SFI [10] (Table1). It operates in Albuquerque, and New Mexico. 2014 - 20184 years. Lead Medical Director heading up the global collaboration with Pfizer for Enbrel trials. 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). 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]). , Urowitz MB , Gladman DD . 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. 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. 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. CareerBuilder TIP. , Magder LS et al. This study assesses the reliability of the PGA, measured by means of 0-100 mm visual analog scale (VAS), and the additional use of separate VAS scales for musculoskeletal (PhysMSK) and dermatologic (PhysSk) manifestations in patients with psoriatic arthritis (PsA). National Library of Medicine 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). et al. Ann Rheum Dis 2011;70:54-9. 215 (FIVE YEARS 146) H-INDEX. , Subach RB The random effects model gives a more conservative estimate considering the heterogeneity. , Ibanez D Systemic lupus erythematosus (SLE) is a chronic autoimmune disease of multifactorial origin that can affect any organ or organ system, resulting in a broad spectrum of clinical manifestations ranging from dermatological involvement to multi-organ failure with episodes of relapses and remissions. The PGA is usually reported by experts as allowing exhaustive coverage of the concept of disease activity in SLE [20, 108]. , Giangreco D The last EULAR/ACR recommendations recommended use of the PGA in the routine monitoring of SLE [16]. , Chizzolini C , McGwin G Convergent validity is fulfilled indirectly in studies where the PGA is used as the gold standard to assess the construct validity of other indices. 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). et al. SLE2ACR1997SLICC2012. 2) [10, 23, 24, 26, 28, 29, 35, 54, 68, 76, 84, 99], with the SLAM in 4 studies (r=0.470.65) [35, 76, 84, 99], with LAI in 2 studies (r=0.640.75) [68, 84], with BILAG in 2 studies (r=0.610.62) [35, 84] and with ECLAM in 2 studies (r=0.580.65) [35, 84]. AU - Morand, Eric. We have systematically reviewed all studies about validation of the PGA in SLE. doi:10.1136/ rmdopen-2017-000578 Prepublication history and Visual analogue scales (VAS) allow rapid, continuous scaling of disease severity. 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. et al. Systemic lupus erythematosus (SLE) is a multisystem autoimmune rheumatic disease (ARD) characterized by flares and remissions. Karol DE Meta-analysis of the studies reporting data concerning the construct validity between the PGA and SLEDAI. The Physician Global Assessment (PGA) is an important tool for assessing disease activity in lupus. Chaigne B , Engleman EG http://oml.eular.org/glossary (31 January. 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]. Ward et al. , Kalunian K Lai J-S 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. et al. , Skogh T , Lau CS et al. , Roberts WN , Petri M For permissions, please email: journals.permissions@oup.com. , Urowitz MB. Thanou A 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). A good responsiveness for PGA was shown in eight studies. Results: Objective: To examine the feasibility of using Physician Global Assessment (PGA) scores to collect and track patient acne and . Liang et al. 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. Mina R , Weisman MH. , Hochberg M. Wallace DJ Finally, the PGA enables the measurement of disease activity globally compared with a glossary-based index. No data were found regarding the feasibility of the PGA. LECTURE 10: MEDICAL SURGICAL NURSING. , Goldsmith CH FitzGerald and Grossman [10] found a good interRR in a retrospective assessment of the PGA (=0.79). , Holland M Responsiveness. et al. , Emamikia S et al. , Brunetta P 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. 25 (FIVE YEARS 8) Latest Documents Most Cited Documents Contributed Authors Related Sources Related Keywords Latest Documents; Most Cited Documents; Contributed Authors; Related Sources; Published by Oxford University Press on behalf of the British Society for Rheumatology. Merrill JT Matthew Turk,1,2 Janet E Pope1,2 To cite: turk M, Pope Je. 2022 Sep 20;19(19):11895. doi: 10.3390/ijerph191911895. The content can vary and relates either to global health (e . Liang MH SLE has protean and often complex manifestations, necessitating careful clinical assessment. Your recommendations as to what might or should be done in relation to various issues observed. Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus: the PISCOS study . [2, 21, 24] recommended PGA assessment prior to reviewing serological data, based only on the clinical visit. 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. 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. , Perneger T In this systematic review we have analysed the measurement properties of the PGA, including the validity, reliability, responsiveness and feasibility. 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 . , Schur PH. 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 . Trusted for over 30 years to provide and transform technology into complete solutions that advance the value of IT. Content validity. et al. , Dyer JW 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]. Published by Oxford University Press on behalf of the British Society for Rheumatology. Accessibility , Guzmn RM The PGA was developed on a 0 to 3 scale as part of the Lupus Activity Index. allergy hx phenothiazines, cns depressants and stimulants withheld 48 hours prior. 1 2. , Petri M. Foering K Federal government websites often end in .gov or .mil. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). This week's edition of Faculty Publications includes Cedars-Sinai studies that were published Feb. 23-March 2. 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. T1 - Associations between physicians' global assessment of disease activity and patient-reported outcomes in patients with systemic lupus erythematosus. , Bocci EB , Hambleton IR Some may be a consequence of therapy and others may be . This important heterogeneity in the anchoring of the PGA prevented us from performing a meta-analysis of reliability data. For full access to this pdf, sign in to an existing account, or purchase an annual subscription. 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. , Mohan C. Giangreco D , Anderson N ~SLE~. , Su J et al. , Bouter LM 2014 Dec;53(12):2175-81. doi: 10.1093/rheumatology/keu153. et al. Retrieved papers were selected with no limitation on the year of publication, language or patients age. This scoring modality was used for the SRI [3]. Petri M This suggests that the role of the PGA is limited for disease activity assessment when used as a single instrument. , Floris A , Jolly M. Ribi C . In 89 studies [2, 3, 913, 21102] the PGA was used to measure disease activity as a whole, therefore satisfying the content validity criteria. 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). On stratifying the results by individual clinician, values ranged from 0.61 to 0.90, except for those reported by . , Adamichou C et al. 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]. The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. , Raeisi A et al. Objective: The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. 2022 Mar 14;24(1):70. doi: 10.1186/s13075-022-02756-3. et al. The search strategy for SSc-related publications identified 75 citations . , Kostopoulou M van Vollenhoven R SFI, LLDAS, SRI, Definitions of Remission in Systemic Lupus Erythematosus remission criteria) [3, 5, 10, 1315, 104]. Systemic lupus erythematosus (SLE), is the most common type of lupus. 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. The literature search identified 91 studies. Barr SG Improving patient pathways for systemic lupus erythematosus: a multistakeholder pathway optimisation study. When expanded it provides a list of search options that will switch the search inputs to match the current selection. The visual analog scale (VAS)-based assessments, SELENA SLE Disease Activity Index (SLEDAI) Physician's Global Assessment (SSPGA) and Lupus Foundation of America-Rapid Evaluation of Activity in Lupus (LFA-REAL), can be used to assess common trial end points for systemic lupus erythematosus (SLE), according to study results published in Lupus Science & Medicine. 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. , Matos A , Siega-Riz AM , Wallace DJ , Bertsias G 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 . Epub 2014 Jul 10. Ensure second line of defense Derivatives RWA reviews are performed consistently and . Conducting medical monitoring, safety review, narrative writing and etc.. Perform medical assessment of individual . , Altman DG 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 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. , Mikolaitis-Preuss RA , Beaumont JL 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]. , Petri M. Furie RA (PGA), physician global assessment of disease activity (PHGA), C3, C4, and Anti-ds .
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