Ruiz-Irastorza G et al. Beaton DE Patient-reported outcomes (PROs) reflect the patient's perspective and are used in rheumatoid arthritis (RA) routine clinical practice. et al. et al. A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.67-0.98). doi:10.1136/ rmdopen-2017-000578 Prepublication history and 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. , Allen E Quimby KR , OMalley T , Roberts WN doi: 10.1136/lupus-2022-000700. , Siega-Riz AM , Henriques C et al. , Schur PH. antineutrophil cytoplasmic antibody-associated vasculitis (AAV), and systemic lupus erythematosus (SLE). Nevertheless, despite the fact that the PGA was considered the reference in 39 studies involving other indices, it was used as the sole instrument in only 2 of them. Diet and Systemic Lupus Erythematosus (SLE): From Supplementation to Intervention. 1 2. Gandhi N , Askanase A The aim of this systematic literature review is to describe and analyse the . , Emamikia S Feasibility is the ease of application of the instrument of measure in its intended setting [106]. , Alarcn GS It is therefore desirable to use the PGA along with other tools (typically the SLEDAI) or to include the PGA in a composite index (e.g. The Janus kinase (Jak)/signal transducer and activating protein (STAT) pathways mediate the intracellular signaling of cytokines in a wide spectrum of cellular processes. Mok CC et al. Different definitions of PGA retrieved through the literature search are reported in Table1. 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]. A good responsiveness for PGA was shown in eight studies. PGA is often assessed by a single question with a 0-10 or 0 . , Brunetta P However, the PGA allows for the measurement of disease activity in a global way (content validity). , Guzmn RM Construct validity is the degree to which the PGA relates to other instruments that measure the same concept [18]. Epub 2014 Jul 10. , Jolly M. Antony A Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. Thank you for submitting a comment on this article. , Perez-Gutthann S et al. 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]. The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. Uribe AG, Vil LM, McGwin G Jr, Sanchez ML, Reveille JD, Alarcn GS. , McGuire JL. Ward et al. et al. Wells GA , Block JA The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). , Gomez A In one open-label study [43], the decrease in PGA score was considered the primary endpoint. Clipboard, Search History, and several other advanced features are temporarily unavailable. [35], the PGA correlated, although moderately, with the need for treatment change (r=0.46, P<0.01). , Landis RC IgM) on attainment PhGA. , Adamichou C A good responsiveness for PGA was shown in eight studies. , Magder L Fanouriakis A , Engel SM SLE is an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage in the affected organs. 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]. X 20 sentence examples within Physician Global Assessment. Psychometric properties of FACIT-Fatigue in systemic lupus erythematosus: a pooled analysis of three phase 3 randomised, double-blind, parallel-group controlled studies (BLISS-SC, BLISS-52, BLISS-76). , Esdaile JM. et al. 25 (FIVE YEARS 8) Latest Documents Most Cited Documents Contributed Authors Related Sources Related Keywords Latest Documents; Most Cited Documents; Contributed Authors; Related Sources; et al. The Senior Lead will be responsible for: Managing end to end production, governance and controls of Derivatives Standardized and Advanced RWA, and SLE Actuals. , Socher SA The https:// ensures that you are connecting to the 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. Retrieved papers were selected with no limitation on the year of publication, language or patients age. Flow chart illustrating the literature search and study selection. Search for other works by this author on: Rheumatology Unit, AOU University Clinic and University of Cagliari, Department of Medical Sciences and Public Health, Cagliari, Italy, Centre Hospitalier Universitaire de Dijon, Hpital Franois-Mitterrand, service de mdecine interne et maladies systmiques (mdecine interne, 2) et Centre dInvestigation Clinique, Service de rhumatologie, Hpitaux Universitaires de Strasbourg, Universit de Strasbourg, Centre National de Rfrence des Maladies Systmiques et Autoimmunes Rares Est Sud-Ouest (RESO). Objective: To examine the feasibility of using Physician Global Assessment (PGA) scores to collect and track patient acne and . 12. and later incorporated into the SLE Responder Index used in the belimumab clinical trials, 13 Improving patient pathways for systemic lupus erythematosus: a multistakeholder pathway optimisation study. et al. (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 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]). , Aggarwal R , Petri M. Furie RA Accessibility The results are similar, and less than half the time is required for scoring. , Fang H Sullivan KE , Cella D. van Vollenhoven RF , Magder LS In the second column, the definitions were reported according to the VAS used in the study. Kiani AN Reviews and case series with fewer than five patients were excluded. PMC Oxford Textbook of. Mokkink LB A total of 91 articles were included in the study (Fig. 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). , Mina R 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 . BICLA responders had fewer lupus-related serious . Some may be a consequence of therapy and others may be . , Smiley A. Askanase AD Piga M Importance: In dermatology, the development of objective, standardized quality measures that can be used in a clinical setting is important to be able to respond to the needs of payers and credentialing and licensure bodies and to demonstrate dermatologic value. , Kandane-Rathnayake RK 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. 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 responsiveness of the PGA was assessed through different methods [109, 113] showing a high sensitivity for detecting clinical variations [84]. et al. Few studies reported on whether serological activity should be incorporated in the PGA. BATCH RUBY INTENSIVE REVIEWRTRMF 3. Direkt zum Inhalt springen . In Fatemi et al. , Carpenter AB The PGA was developed on a 0 to 3 scale as part of the Lupus Activity Index. [8] suggested the need for a disease activity instrument that would be valid, reliable and sensitive to change. Thus the development of a comprehensive index for assessing disease activity still represents one of the most important challenges in SLE [7]. Please check for further notifications by email. et al. 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. Careers. Methods: , Suriano A (PGA) scoring of disease activity in systemic lupus erythematosus (SLE). T1 - Associations between physicians' global assessment of disease activity and patient-reported outcomes in patients with systemic lupus erythematosus. FOIA , Annapureddy N The company serves physicians and patients. Touma Z 2021 Apr 8;5(1):33. doi: 10.1186/s41687-021-00298-x. Your recommendations as to what might or should be done in relation to various issues observed. 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. , Lau CS , Block JA J Clin Med. The pooled correlation coefficient (95% CI) is given both for the fixed effects model and the random effects model. , Wallace DJ Because of its dynamic nature, this disease has an unpredictable natural course leading to high . et al. European League Against Rheumatism. According to the OMERACT, face validity is the degree to which the instrument appears to match with the target domain, according to experts [18]. Cloud, mobility, security, and more. , Fortin PR Feasibility refers not to the quality of the outcome measure, but to aspects such as completion time, cost of an instrument, equipment and type and ease of administration. 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. , Hambleton IR Five studies have demonstrated good ICC values for reliability (all >0.60 and ranging up to 0.97). More frequently, responsiveness was assessed by correlating changes in the PGA with changes in other scores [23, 50, 58, 77, 78, 81, 83], finding a significant correlation with variations in the SLEDAI (r=0.390.66) [23, 77, 78], SLAM (0.61) [77], LAI (0.56) [77], patient global assessment (0.37) [77], SRI-50 (0.48) [78] and ESR (P<0.0001) [58], but not with C3, C4, circulating immunocomplexes and prednisone dose [77]. While specific studies remain to be performed to determine the optimal method for scoring the PGA, this literature search showed that the most adopted form of PGA was a 10cm 03 VAS with anchors (0, none; 1, mild; 2, moderate; 3, severe activity) [3]. , Gladman DD 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]. The last EULAR/ACR recommendations recommended use of the PGA in the routine monitoring of SLE [16]. The Physician Global Assessment (PGA) is an important tool for assessing disease activity in lupus. The SRI is a composite instrument comprised of the SELENA-SLE Disease Activity Index [SELENA-SLEDAI], Physician Global Assessment (PGA) and British Isles Lupus Assessment Group (BILAG) 2004. , Raeisi A Results. Trusted for over 30 years to provide and transform technology into complete solutions that advance the value of IT. 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. This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. van Vollenhoven R 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]. Visual analogue scales (VAS) allow rapid, continuous scaling of disease severity. , Mosca M In 89 studies [2, 3, 913, 21102] the PGA was used to measure disease activity as a whole, therefore satisfying the content validity criteria. Thousand Oaks. This property is reported across all articles selected through this systematic review [24, 913, 21103]. , Engleman EG 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. et al. Reliability was excellent when scored through a pointed scale, such as the Likert scale, that was anchored in unit numbers from 0 (not active) to 7 (most active) (interRR ICC 0.96; intraRR ICC 0.88) [80], but was lower when assessed through a centimetric VAS using values between 0.0 and 3.0 (interRR ICC 0.67; intraRR ICC 0.55) [68]. Results: Published by Oxford University Press on behalf of the British Society for Rheumatology. The PISCOS results will allow for increased homogeneity and reliability of PGA ratings in routine clinical practice, definitions of remission and low disease activity, and future SLE trials. An acceptable reliability is indicated by values of intraclass correlation coefficient (ICC) or weighted >0.60 and a good reliability is >0.85 [20]. Funding: The study was funded through the training Bursary Programme 2019 of the SLEuro European Lupus Society. 2019ACREULAR . , Chan KL The Physician Global Assessment International Standardisation COnsensus in Systemic Lupus Erythematosus (PISCOS) study aimed to obtain an evidence-based and expert-based consensus standardisation of the Physician Global Assessment (PGA) scoring of disease activity in systemic lupus erythematosus (SLE). , Devilliers H sharing sensitive information, make sure youre on a federal 2022 May;9(1):e000700. Methods This SLR was conducted by two independent reviewers in accordance with the PRISMA statement. Conclusion: Responsiveness. Petri M (PGA), physician global assessment of disease activity (PHGA), C3, C4, and Anti-ds . SLE3. Arthritis Res Ther. Discrimination refers to whether the score (PGA-VAS) differentiates between situations of interest [18]: discrimination of the PGA measures the ability of the PGA-VAS to report a consistent score where no change in disease activity has occurred (reliability) and to detect a change when a change in disease activity has occurred (sensitivity to change or responsiveness). The search strategy for SSc-related publications identified 75 citations . 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. , Wallace DJ , Burlingame RW SELENA SLEDAI4. et al. may be asked to hyperventilate 3-4 min and watch a bright flashing light. Liang MH 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 . The assessment of PGA responsiveness was performed in 10 studies [4, 23, 50, 58, 7779, 81, 83, 84] using different methods [110]. , Maxwell LJ Brunner HI 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 . , Saad-Magalhes C Deconstruction of the safety of estrogen in lupus erythematosus national assessment-systemic lupus erythematosus disease activity index flare index. Introduction Physician global assessments of disease activity (medical doctor (MD) globals) are important outcomes. , Larson MG Mina R Rendas-Baum R, Baranwal N, Joshi AV, Park J, Kosinski M. J Patient Rep Outcomes. , Patrick DL 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. For full access to this pdf, sign in to an existing account, or purchase an annual subscription. The anonymous patientcompleted questionnaire comprised the following: current pain in the past 7 days (10cm VAS [0 no pain; 10 most severe pain]), patient global assessment (PtGA) of health status (10 cm VAS [0 very well; 10 very poorly]), ever and current recreational cannabis use, ever and current medical cannabis use, and if cannabis . Arriens C et al. et al. , Friebus-Kardash J Each study was examined in order to extract psychometric property data on the PGA according to the OMERACT Filter methodology version 2.1 [18]. Keywords: , Su J JSS Medical Research. , Buyon J Brunner HI Lai J-S , Kostopoulou M , Anderson N 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]. , Bouter LM TOTAL DOCUMENTS. 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. , Hennis A. Jesus D , Farewell V National Library of Medicine However, it is important to remember that not all clinical problems reported by a lupus patient are due to the disease. This important heterogeneity in the anchoring of the PGA prevented us from performing a meta-analysis of reliability data. , Longenecker JC The Physician Global Assessment (PGA) is a frequently used co-primary end point in psoriasis clinical trials. They participate in physiologic and inflammatory cascades and have become a major focus of research, yielding novel therapies for immune-mediated inflammatory diseases (IMID). , Klein-Gitelman MS A good correlation was considered for a value >0.60. , Chakravarty E PGA is an important tool for assessing disease activity, response to treatment (it is a component . et al. physician's global assessment (PGA) of disease activity in SLE. RN-BSN HOLISTIC HEALTH ASSESSMENT ACROSS THE LIFESPAN (NURS 3315) Sociology of Social Problems (SOC213) et al. Objective Existing methods for grading lupus flares or improvement require definition-based thresholds as increments of change. , Urowitz MB. HHS Vulnerability Disclosure, Help 2022 Mar 14;24(1):70. doi: 10.1186/s13075-022-02756-3.