, Alunno A Schneider M , Socher SA , Voskuyl A , Altman DG The Author(s) 2020. BICLA responders had fewer lupus-related serious . , Weisman MH. Content validity was reported in 89 studies. , Urowitz MB. Gordon C PGA0.3. Assessing disease activity in rheumatic diseases such as systemic lupus erythematosus (SLE) is vital for effective treatment. , Tetzlaff J , Wallace DJ Supervise the development of junior medical affairs staff . This site needs JavaScript to work properly. A good correlation was considered for a value >0.60. PGA is often assessed by a single question with a 0-10 or 0-100 response. , Jnsen A , Petri M. Thanou A , Askanase A , Leung HW 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 high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.67-0.98). The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinicians judgement of overall SLE disease activity. 2014 - 20184 years. Five studies have demonstrated good ICC values for reliability (all >0.60 and ranging up to 0.97). van Vollenhoven R 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. [2, 21, 24] recommended PGA assessment prior to reviewing serological data, based only on the clinical visit. 2021 Apr 8;5(1):33. doi: 10.1186/s41687-021-00298-x. . 1 2. Published by Oxford University Press on behalf of the British Society for Rheumatology. 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 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). , Lerman RH , Sadovici-Bobeica V , Ko T SLE or at an SLE site, but only if the injury requires treatment by a licensed medical doctor. The quantification of reliability is expressed by a correlation coefficient. Objective Existing methods for grading lupus flares or improvement require definition-based thresholds as increments of change. 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. 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. , Cella D. van Vollenhoven RF IgM) on attainment PhGA. Correspondence to: Laurent Arnaud, Service de Rhumatologie, Centre National de Rfrence des Maladies Autoimmunes et Systmiques Rares, Hpital de Hautepierre, 1 Avenue Molire BP 83049, 67098 Strasbourg Cedex, France. 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. et al. The literature search identified 91 studies. antineutrophil cytoplasmic antibody-associated vasculitis (AAV), and systemic lupus erythematosus (SLE). , Ho LY 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. Laboratory investigation results influence Physicians Global ssessment (PGA) of disease activity in SLE. Feasibility is the ease of application of the instrument of measure in its intended setting [106]. 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. Arriens C All versions are validated and used by lupus researchers for clinical and research purposes. The content can vary and relates either to global health (e . et al. Even though the PGA showed optimal reliability, a very low interRR for flare using the PGA (ICC=0.18) was found in a single study [65] compared with that of the BILAG (ICC=0.54) or SFI (ICC=0.21). , Hochberg M. Wallace DJ Vil LM et al. , Gladman DD T2 - A longitudinal study. , Clowse M. Moorthy LN The Senior Lead will be responsible for: Managing end to end production, governance and controls of Derivatives Standardized and Advanced RWA, and SLE Actuals. However, no precise guidelines exist regarding the optimal use of the PGA in SLE, such as the adequate length of the VAS, the presence of anchored values, the incorporation of laboratory data and the time frame of assessment. Piga M , Lau CS The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). , Kraag GR 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]. Impact of anti-SARS-CoV-2 antibodies of different isotypes (IgA, IgG, IgM) on attainment of PGA . Exagen's products are used for therapeutic drug monitoring of hydroxychloroquine in whole blood and methotrexate polyglutamates, risk assessment testing, anti-TNF monitoring to individualize therapy and optimize dosing, and others. Accessibility JSS Medical Research. 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]. , Urowitz MB 8600 Rockville Pike 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. , Floris A 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. Methods 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). , Kalunian K In the last 30years, more than a dozen scores have been derived to assess disease activity in SLE, but not all of these have proven to be valid and reliable tools. Face validity. It estimates how similar a given patients scores were at the two visits. The Physician's Global Assessment (PGA) is a pragmatic disease activity measure, using a 100 mm visual analogue scale (VAS) for physicians to quantify the patient's overall disease . , Urowitz MB Wells GA Meta-analysis of the studies reporting data concerning the construct validity between the PGA and SLEDAI. et al. , Bertsias G , Buyon J The results are similar, and less than half the time is required for scoring. Would you like email updates of new search results? Glossary: PGA. 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. Published by Oxford University Press on behalf of the British Society for Rheumatology. 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): 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]. , Borghoff K MD globals may vary based on their age, gender, practice setting and experience (number of patients seen per year and years in practice). It operates in Albuquerque, and New Mexico. Liang MH The assessment of PGA responsiveness was performed in 10 studies [4, 23, 50, 58, 7779, 81, 83, 84] using different methods [110]. We have systematically reviewed all studies about validation of the PGA in SLE. This may be explored through convergent and divergent validity. The sensitivity to change was estimated to be the smallest for the SLEDAI; the standardized response means were 0.48 when the physician global assessment was used as the standard and 0.01 when the patient global assessment was used . RN-BSN HOLISTIC HEALTH ASSESSMENT ACROSS THE LIFESPAN (NURS 3315) Sociology of Social Problems (SOC213) European League Against Rheumatism. ECG - correct answer no sleep the night before, meals allowed, no stimulants/tranquilizers for 24-48 hours before. The official NJDOE Incident Reporting Form, as well as a guide to completing It is unclear when or with what justification the physician global assessment of disease status (PhGA) was first used to assess patients with systemic . [84] expressed the sensitivity in PGA scoring with the standardized response mean (SRM), demonstrating a very large effect size (ES=2.23) [110]. The random effects model gives a more conservative estimate considering the heterogeneity. No data were found regarding the feasibility of the PGA. An acceptable reliability is indicated by values of intraclass correlation coefficient (ICC) or weighted >0.60 and a good reliability is >0.85 [20]. , Liberati A , Hochberg M. Touma Z , Klein-Gitelman MS et al. may be asked to hyperventilate 3-4 min and watch a bright flashing light. Different definitions of disease activity according to the PGA instrument. AU - Kasitanon, Nuntana. et al. , Fang H There is no cure for lupus, but medical . , Pego-Reigosa J-M . , Block JA , Petri M et al. , Piette EW PGA is a simple instrument and the result is easily understood. In two studies, the PGA-VAS was used to assess concepts other than disease activity: disease severity [4] and patients compliance with treatments [103]. , Engle E Once two investigators (E.C., M.P.) 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. 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. The responsiveness of the PGA was assessed through different methods [109, 113] showing a high sensitivity for detecting clinical variations [84]. SLE3. In our centre, new tools for the assessment of SLE activity: the Lupus Activity Scoring Tool (LAST) and Clinical Lupus Activity Scoring Tool (C-LAST) were developed and validated. et al. 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]). Merrill JT Touma Z Montreal, Canada Area. Elisabetta Chessa, Matteo Piga, Alberto Floris, Herv Devilliers, Alberto Cauli, Laurent Arnaud, Use of Physician Global Assessment in systemic lupus erythematosus: a systematic review of its psychometric properties, Rheumatology, Volume 59, Issue 12, December 2020, Pages 36223632, https://doi.org/10.1093/rheumatology/keaa383. , Suriano A Thousand Oaks. The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. Can Lupus Patients Take the Driver's Seat in Their Disease Monitoring. Cloud, mobility, security, and more. The last EULAR/ACR recommendations recommended use of the PGA in the routine monitoring of SLE [16]. 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]. Criterion validity is defined as the degree to which the scores of an instrument adequately reflect the truth in the form of a gold standard [107]. , Beaumont JL The Physician Global Assessment (PGA) is a frequently used co-primary end point in psoriasis clinical trials. 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. Flow chart illustrating the literature search and study selection. 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]. Whenever papers reported duplicate data, the most recent article was selected. 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). 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 . , Mokkink LB Management of systemic lupus erythematosus (SLE) often depends on disease severity and disease manifestations, [] although hydroxychloroquine has a central role for long-term treatment in all SLE patients. , Pilkington C et al. The correlation with the SLEDAI was determined in 12 studies (Fig. , Dietzmann K , Jolly M. Mok CC Federal government websites often end in .gov or .mil. , James JA 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]. et al. Sullivan KE A PGA >1 was predictive of polymorphic light cutaneous eruption (P=0.02) [59] and correlated negatively with LLDAS attainment [37]. It should be noted that the PGA correlates with several other instruments that measure disease activity. For full access to this pdf, sign in to an existing account, or purchase an annual subscription. 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. Systemic lupus erythematosus (SLE), is the most common type of lupus. , Mosca M No study has evaluated the feasibility of the PGA in SLE to date. , Devilliers H Responsiveness, or sensitivity to change, is the usefulness of a test to detect minimum clinically important differences [20, 109]. Thanou A, Chakravarty E, James JA, Merrill JT. , Gladman DD. The Physician's Global Assessment (PhGA) is a number without unit. Navarra SV 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 . Reliability. et al. PMC 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. Barr et al. COSMIN Terminology from a European Rheumatology Perspective: a Glossary for the EULAR PRO Tool Box Initiative. The last MEDLINE search was performed on 1 July 2019. 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. Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. Physician Global Assessment (PGA) is a visual analogue score (VAS) that reflects the clinician's judgment of overall Systemic Lupus Erythematosus (SLE) disease activity. 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]. et al. 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). , Rodrigues M et al. An official website of the United States government. , Magder L Rendas-Baum R, Baranwal N, Joshi AV, Park J, Kosinski M. J Patient Rep Outcomes. 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). doi: 10.1136/lupus-2022-000700. The site is secure. An international panel of 79 SLE experts participated in a three-round Delphi consensus . et al. Responsiveness. et al. Clinical composite measures of disease activity and damage used to evaluate patients with systemic lupus erythematosus: A systematic literature review. Uribe AG, Vil LM, McGwin G Jr, Sanchez ML, Reveille JD, Alarcn GS. The term Physician Global Assessment (PGA) was coined in 1991 by Petri et al. Karol DE Your comment will be reviewed and published at the journal's discretion. Epub 2014 Jul 10. et al. Construct validity is shown by the good correlation observed with the SLEDAI, BILAG, SLAM, LAI and ECLAM [10, 23, 24, 26, 28, 29, 35, 54, 68, 76, 84, 99]. , Engleman EG 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]. Deconstruction of the safety of estrogen in lupus erythematosus national assessment-systemic lupus erythematosus disease activity index flare index. The pooled correlation coefficient (95% CI) is given both for the fixed effects model and the random effects model. , Goldsmith CH Deconstruction of the safety of estrogen in lupus erythematosus national assessment-systemic lupus erythematosus disease activity index flare index, Effect of raloxifene on disease activity and vascular biomarkers in patients with systemic lupus erythematosus: subgroup analysis of a double-blind randomized controlled trial, Omega-3 in SLE: a double-blind, placebo-controlled randomized clinical trial of endothelial dysfunction and disease activity in systemic lupus erythematosus, Erythrocyte sedimentation rate is a predictor of renal and overall SLE disease activity, Characterization of clinical photosensitivity in cutaneous lupus erythematosus, Validation of the systemic lupus erythematosus responder index for use in juvenile-onset systemic lupus erythematosus, Depressive symptoms and associated factors in systemic lupus erythematosus, Validation of the Portuguese simple measure of impact of lupus erythematosus in youngsters (SMILEY) in Brazil, Anti-C1q antibodies have higher correlation with flares of lupus nephritis than other serum markers, Performance of anti-C1q, antinucleosome, and anti-dsDNA antibodies for detecting concurrent disease activity of systemic lupus erythematosus, An assessment of disease flare in patients with systemic lupus erythematosus: a comparison of BILAG 2004 and the flare version of SELENA, Noncalcified coronary plaque in systemic lupus erythematosus, Decreases in anti-double-stranded DNA levels are associated with concurrent flares in patients with systemic lupus erythematosus, Validity and reliability of lupus activity measures in the routine clinic setting, Clinical predictors of response and discontinuation of belimumab in patients with systemic lupus erythematosus in real life setting.

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