, Lau CS 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]. AU - Kandane-Rathnayake, Rangi. 2014 - 20184 years. , Block JA Systemic lupus erythematosus (SLE) is a multisystem autoimmune rheumatic disease (ARD) characterized by flares and remissions. , Siega-Riz AM et al. Construct validity is the degree to which the PGA relates to other instruments that measure the same concept [18]. 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. Gyri N Criterion validity data reporting correlation coefficients between PGA and quality of life measures, laboratory markers and miscellaneous. 2022 Sep;8(2):e002395. [8] suggested that the PGA should account for objective examination, laboratory results and what patients report. JSS Medical Research. SLE2ACR1997SLICC2012. 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. Additional papers were obtained by checking the references from the selected studies. The SRI is a validated SLE disease activity instrument used to detect clinically meaningful improvement of disease in SLE clinical trials. The literature search identified 91 studies. and transmitted securely. Rheumatology (Oxford). , Hynan LS , Sato JO Enocsson H Flow chart illustrating the literature search and study selection. An official website of the United States government. Clipboard, Search History, and several other advanced features are temporarily unavailable. , Engel SM Conclusion: TOTAL DOCUMENTS. , Stavrakis S 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]. Content validity. The other authors have declared no conflicts of interest. , Askanase A Mina R et al. 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. 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). . PGA is often assessed by a single question with a 0-10 or 0 . , Dietzmann K , Gomez A Prinsen CAC inflammation (duration and severity of morning stiffness as measured by BASDAI). et al. Annapureddy N Finally, the PGA enables the measurement of disease activity globally compared with a glossary-based index. SLE has protean and often complex manifestations, necessitating careful clinical assessment. 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]). 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]. 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. , Petri M. Foering K , Brunetta P AU - Louthrenoo, Worawit. SLE3. , Chang AY , Birmingham DJ [2, 21, 24] recommended PGA assessment prior to reviewing serological data, based only on the clinical visit. Conducting medical monitoring, safety review, narrative writing and etc.. Perform medical assessment of individual . 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]. Moreover, there is uncertainty as to whether the best timing of assessment is prior to or after reviewing laboratory exams [26]. This button displays the currently selected search type. , Klein-Gitelman MS Impact of anti-SARS-CoV-2 antibodies of different isotypes (IgA, IgG, IgM) on attainment of PGA . 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 . The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 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 . . This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. PGA is an important tool for assessing disease activity, response to treatment (it is a component . An assessment of disease flare in patients with systemic lupus erythematosus: a comparison of BILAG 2004 and the flare version of SELENA. Epub 2014 Jul 10. 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. 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. , Petri M , Chizzolini C , Floris A Schlencker A, Messer L, Ardizzone M, Blaison G, Hinschberger O, Dahan E, Sordet C, Walther J, Dory A, Gonzalez M, Kleinlogel S, Bramont-Nachman A, Barrand L, Payen-Revol I, Sibilia J, Martin T, Arnaud L. Lupus Sci Med. , Piette EW Construct validity was demonstrated by a good correlation (r 0.50) between the PGA with the SLEDAI (12 studies), SLAM (4 studies), LAI, BILAG and ECLAM (2 studies each). , Block JA , Hochberg M. Touma Z 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. SELENA SLEDAI4. 'Not at target': prevalence and consequences of inadequate disease control in systemic lupus erythematosus-a multinational observational cohort study. Genetic linkage has related dysfunction of . Provide oversight to Shared Services Derivatives team supporting RWA operations and production. , Perneger T doi:10.1136/ rmdopen-2017-000578 Prepublication history and In an epratuzumab trial, the absence of deterioration of the PGA (not >10% worsening) was one of the items to achieve a BILAG-based Composite Lupus Assessment (BICLA) response [105]. European League Against Rheumatism. , Gordon C Eudy AM The PGA is a well accepted and commonly used scale for evaluating treatment response in clinical trials both in adults and children. Of note, it is not trivial that we found a good convergent validity with other instruments (SLEDAI, BILAG, LAI, SLAM and ECLAM) [10, 23, 24, 26, 28, 29, 35, 54, 68, 76, 84, 99]. , Khamashta MA Meta-analysis of the studies reporting data concerning the construct validity between the PGA and SLEDAI. All rights reserved. , Lin M , Schur PH. Glossary: PGA. The correlation with the SLEDAI was determined in 12 studies (Fig. , Socher SA Bethesda, MD 20894, Web Policies 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. et al. Parodis I Background/Purpose: The Physician Global Assessment (PGA) is a frequently-used outcome measure in Systemic Lupus Erythematosus (SLE). , Kalunian K Patient-reported outcomes (PROs) reflect the patient's perspective and are used in rheumatoid arthritis (RA) routine clinical practice. , Mokkink LB disease activity in SLE, with the Physician Global Assessment (PGA) being the only one included in the updated EULAR recommendations for the management of SLE.11. The last MEDLINE search was performed on 1 July 2019. 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 . 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). et al. , Glassman DS The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinicians judgement of overall SLE disease activity. 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): , Liberati A , Kostopoulou M Face validity. Wells GA [8] suggested the need for a disease activity instrument that would be valid, reliable and sensitive to change. , McGuire JL. , Henriques C et al. 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). Correlations with other instruments measuring similar constructs should typically demonstrate a coefficient (r) 0.50 [106]. CLOSED ANGLE/ ANGLE CLOSURE GLAUCOMA. Kiani AN X 20 Physician Global Assessment 10.1136/lupus-2019-lsm.176 . 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 . J Clin Med. , Wallace DJ 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. Petri M , Magder LS Navarra SV 2022 May;9(1):e000700. Twenty-nine studies [25, 31, 3439, 41, 43, 48, 49, 5355, 59, 6164, 74, 75, 81, 82, 86, 92, 93, 96, 97] have assessed criterion validity of the PGA (Table2). According to the OMERACT, face validity is the degree to which the instrument appears to match with the target domain, according to experts [18]. Criterion validity also refers to the degree to which an instrument predicts aspects and phenomena occurring in the future [108]. Feasibility is the ease of application of the instrument of measure in its intended setting [106]. et al. et al. , Raeisi A They participate in physiologic and inflammatory cascades and have become a major focus of research, yielding novel therapies for immune-mediated inflammatory diseases (IMID). 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. et al. There is no cure for lupus, but medical . Supporting the face validity property, PGA was defined the gold standard in 11 studies [2, 10, 11, 21, 23, 49, 67, 76, 78, 84, 88] and in 32 it was used as the reference to which other activity scores were compared, such as the SLEDAI [4, 10, 13, 25, 27, 28, 31, 33, 35, 36, 41, 46, 47, 50, 51, 53, 62, 65, 68, 72, 73, 76, 81, 9699], BILAG [4, 27, 35, 36, 46, 65, 72, 73, 81, 98], SLAM [4, 72, 76, 99], LAI [68, 88], patient global assessment [81, 83, 84] and ECLAM [35]. , Pilkington C A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.67-0.98). , Magder LS 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. et al. 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. Barr SG , Giannakou I Published by Oxford University Press on behalf of the British Society for Rheumatology. 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). , Alarcn GS FOIA , Allen E et al. et al. [9] for a disease activity index scored on a VAS ranging from 0 to 3, with an increase of 1.0 since the last visit indicating a flare. et al. Systemic lupus erythematosus (SLE), is the most common type of lupus. , Mina R National Library of Medicine , Nguyen SC For permissions, please email: journals.permissions@oup.com. , Tugwell P , Garabajiu M Help us improve CareerBuilder by providing feedback about this job: Report this job Job ID: 2281236908. Mok CC 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. 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). , Gladman DD , Ravelli A et al. Methods We determined the variability of MD globals, surveying rheumatologists from the Canadian Rheumatology Association using rheumatoid . Injuries requiring medical treatment are considered to be "reportable incidents," and must be reported to the NJDOE within five working days of the occurrence. The company serves physicians and patients. Manzi S , Jolly M. Ribi C , Urowitz MB. 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). Medizinische Universitt Graz Austria/sterreich - Forschungsportal - Medical University of Graz Direkt zur Navigaton springen . A total of 91 articles were included in the study (Fig. 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. Keywords: Disclaimer. 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]. et al. The index assesses separately eight organ-based systems. These results enabled its use as a gold standard for assessing flare and defining flare severity in several studies [21, 67, 88]. Over the years, PGA-IGA scales were modified for the purpose of clinical settings and thus present a diversity in the number of response options (4 to 10 points), the response options label and the . 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). Jesus D 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). may be asked to hyperventilate 3-4 min and watch a bright flashing light. , Tetzlaff J 2. Physician training is very important. Castrejn I, Ra-Figueroa I, Rosario MP, Carmona L. Reumatol Clin. , Jolly M. Antony A , Rairie JE Your recommendations as to what might or should be done in relation to various issues observed. Unauthorized use of these marks is strictly prohibited. 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]. Cutaneous lupus erythematosus (CLE) is an autoimmune skin disease that can occur with or without systemic lupus erythematosus (SLE). BILAGAB . et al. 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]. , McGwin G A good correlation was considered for a value >0.60. 1 2. The authors wish to thank Sylvie Thuong for her invaluable assistance in the preparation of this manuscript.
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