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. 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 (. The content can vary and relates either to global health (e . doi: 10.1136/lupus-2022-000700. 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]. 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. 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. 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. , Cella D. van Vollenhoven RF In one open-label study [43], the decrease in PGA score was considered the primary endpoint. , Hochberg M. Touma Z 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]. Additional papers were obtained by checking the references from the selected studies. , Gayet-Ageron A Objective: To examine the feasibility of using Physician Global Assessment (PGA) scores to collect and track patient acne and . , Block JA These results enabled its use as a gold standard for assessing flare and defining flare severity in several studies [21, 67, 88]. et al. , Magder L The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. The https:// ensures that you are connecting to the et al. The Physician's Global Assessment (PhGA) is a number without unit. Annapureddy N How should lupus flares be measured? , Petri M. Foering K In two studies, the PGA-VAS was used to assess concepts other than disease activity: disease severity [4] and patients compliance with treatments [103]. Direkt zum Inhalt springen . , James JA The PGA intraRR was assessed in three studies [10, 68, 94] and ranged from 0.55 [68] to 0.88 [10]. If you have a published paper from this period that does not appear on this list, please contact Sue Marone, who will add it to next week's collection. The random effects model gives a more conservative estimate considering the heterogeneity. , Siega-Riz AM 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 . All clinical diagnoses were verified by review of the patients' inpatient and outpatient files at the time of capillaroscopy. , Mokkink LB In Fatemi 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. , McGwin G , Magder LS , Taghavi-Zadeh S Ensure second line of defense Derivatives RWA reviews are performed consistently and . 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). Content validity was reported in 89 studies. doi: 10.1136/rmdopen-2022-002395. Mokkink LB , Skogh T http://oml.eular.org/glossary (31 January. All rights reserved. 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. T1 - Associations between physicians' global assessment of disease activity and patient-reported outcomes in patients with systemic lupus erythematosus. 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]. 1 2. 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. Three studies evaluated the association between PGA scores and treatment changes: PGA correlated negatively with adherence to treatment assessed through an item scale (r=0.31, P=0.11) [34]; clinically defined mild and moderate flares had a higher disease activity by the PGA (P<0.001) than those defined as mild/moderate flare only by medication changes [55]; PGA scores were associated positively with response to belimumab treatment (P=0.039) [43]. Tel: 03 88 12 84 74; Fax: 03 88 12 82 90; E-mail: Measuring disease activity in adults with systemic lupus erythematosus: the challenges of administrative burden and responsiveness to patient concerns in clinical research, Patterns of disease activity in systemic lupus erythematosus, Novel evidence-based systemic lupus erythematosus responder index, Reliability and validity of six systems for the clinical assessment of disease activity in systemic lupus erythematosus, Failure to achieve lupus low disease activity state (LLDAS) six months after diagnosis is associated with early damage accrual in Caucasian patients with systemic lupus erythematosus, Treatment target in newly diagnosed systemic lupus erythematosus, 10 most important contemporary challenges in the management of SLE, Measurement of systemic lupus erythematosus activity in clinical research, Definition, incidence, and clinical description of flare in systemic lupus erythematosus. Chaigne B Myelogram - correct answer NPO for 4-6 hours. HHS Vulnerability Disclosure, Help Objective: , Jolly M. Ribi C [8] suggested the need for a disease activity instrument that would be valid, reliable and sensitive to change. AU - Kandane-Rathnayake, Rangi. Manzi S Physician Global Assessment (PGA) is a visual analogue score (VAS) that reflects the clinician's judgment of overall Systemic Lupus Erythematosus (SLE) disease activity. Pincus and colleagues conducted a study of . , Kalunian K , Askanase A 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). Disagreements between investigators were solved by consensus. 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). Ann Rheum Dis 2011;70:54-9. , Wetter J lupus erythematosus; systemic outcome assessment; qualitative research; healthcare; We read with great interest the recent paper by Aranow et al 1 about the impact of laboratory results on scoring of the Physician Global Assessment (PGA) of disease activity in systemic lupus erythematosus (SLE). Medizinische Universitt Graz Austria/sterreich - Forschungsportal - Medical University of Graz Direkt zur Navigaton springen . , Lerman RH The Senior Lead will be responsible for: Managing end to end production, governance and controls of Derivatives Standardized and Advanced RWA, and SLE Actuals. et al. 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. The Janus kinase (Jak)/signal transducer and activating protein (STAT) pathways mediate the intracellular signaling of cytokines in a wide spectrum of cellular processes. Montreal, Canada Area. , Petri M. Iaccarino L et al. 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). , Pego-Reigosa J-M Accessibility , Francis S Diet and Systemic Lupus Erythematosus (SLE): From Supplementation to Intervention. No data were found regarding the feasibility of the PGA. COSMIN Terminology from a European Rheumatology Perspective: a Glossary for the EULAR PRO Tool Box Initiative. , Su J , Raeisi A No study has evaluated the correlation of PGA with damage measures. , Tugwell P et al. 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. Reviews and case series with fewer than five patients were excluded. , Kosinski M (PGA) scoring of disease activity in systemic lupus erythematosus (SLE). 25 (FIVE YEARS 8) Latest Documents Most Cited Documents Contributed Authors Related Sources Related Keywords Latest Documents; Most Cited Documents; Contributed Authors; Related Sources; Content validity. Thanou A , Bentow C [35], the PGA correlated, although moderately, with the need for treatment change (r=0.46, P<0.01). 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). 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). Physician global assessments for disease activity in rheumatoid arthritis are all over the map! Objective Physician's global assessment (PGA) of disease activity is a major determinant of therapeutic decision making. All rights reserved. [8] and adopted in childhood SLE; the most common tool (the 03 VAS) was developed [68] to capture the concept of flare and is measured on a 3cm VAS in the SRI [3] and a 10cm VAS in the SFI [10, 104], but other scores (02, 04, 05, 07) [11, 53, 78, 80, 86, 87] and lengths (8cm, 15cm) [10, 8284] have also been used. Parodis I Patient-reported outcomes (PROs) reflect the patient's perspective and are used in rheumatoid arthritis (RA) routine clinical practice. , Perez-Gutthann S . 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]. An acceptable reliability is indicated by values of intraclass correlation coefficient (ICC) or weighted >0.60 and a good reliability is >0.85 [20]. , Wallace DJ Published by Oxford University Press on behalf of the British Society for Rheumatology. , Brunetta P doi:10.1136/ rmdopen-2017-000578 Prepublication history and et al. BILAGAB . et al. , Kraag GR Responsiveness, or sensitivity to change, is the usefulness of a test to detect minimum clinically important differences [20, 109]. The Physician Global Assessment (PGA) is a frequently used co-primary end point in psoriasis clinical trials. , Subach RB Injuries requiring medical treatment are considered to be "reportable incidents," and must be reported to the NJDOE within five working days of the occurrence. , Socher SA Mok CC OBJECTIVE The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. , Chakravarty E Despite the need for new treatments in CLE . 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. 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 . The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. This button displays the currently selected search type. , Kostopoulou M MeSH 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. , Klein-Gitelman MS Petri M SLE2ACR1997SLICC2012. et al. Ward et al. Aranow C Copay AG Rheumatology (Oxford). , Magder LS Mina R et al. FOIA , Ogale S Each study was examined in order to extract psychometric property data on the PGA according to the OMERACT Filter methodology version 2.1 [18]. , Costenbader K , Glassman DS 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. Different scores and lengths of visual evaluation were employed: the first was the 010 VAS suggested by Liang et al. , Gladman DD. Help us improve CareerBuilder by providing feedback about this job: Report this job Job ID: 2281236908. 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 . , Urowitz MB. Castrejn I, Ra-Figueroa I, Rosario MP, Carmona L. Reumatol Clin. , Chang AY Clipboard, Search History, and several other advanced features are temporarily unavailable. LECTURE 10: MEDICAL SURGICAL NURSING. , Block JA BICLA responders had fewer lupus-related serious . 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. The assessment of disease activity in SLE is particularly challenging. , Lin M et al. 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. , Hynan LS . 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]). et al. . A new tool -- the Lupus Activity Scoring Tool (LAST) - has been proposed to join the ranks of current disease activity indices. allergy hx phenothiazines, cns depressants and stimulants withheld 48 hours prior. PMC , Koutsoviti S . et al. , Piette EW , Merrill JT. The PGA was integrated in composite indices, including the definition of the LLDAS [12, 13, 29, 34, 37, 39, 40] and remission [29, 37] (Table1). No study has evaluated the feasibility of the PGA in SLE to date. , Hambleton IR Currently no agreement has been reached on which scale should be used: a pointed scale with anchored values (0, 1, 2, 3) or a centimetric scale with all values between 0.0 and 3.0. , Shea BJ , Landis RC , Gladman DD , Bouter LM 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 . J Clin Med. The index assesses separately eight organ-based systems. 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? , Genovese M 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. Enocsson H , Terwee CB 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). 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. 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 . , Engel SM 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. An official website of the United States government. , Ibaez D et al. Brunner HI This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Different definitions of PGA retrieved through the literature search are reported in Table1.