, Giannakou I 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). How should lupus flares be measured? , Andreoli L 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]. and transmitted securely. Would you like email updates of new search results? 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. , Kraag GR Face validity is satisfied when the instrument is considered able to capture what it should capture (i.e. SLE has protean and often complex manifestations, necessitating careful clinical assessment. FOIA et al. Montreal, Canada Area. There is no cure for lupus, but medical . Despite the need for new treatments in CLE . doi: 10.1136/rmdopen-2022-002395. 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. Epub 2014 Jul 10. , Sato JO The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Jesus D [84] expressed the sensitivity in PGA scoring with the standardized response mean (SRM), demonstrating a very large effect size (ES=2.23) [110]. This button displays the currently selected search type. The PGA was developed on a 0 to 3 scale as part of the Lupus Activity Index. 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]. BATCH RUBY INTENSIVE REVIEWRTRMF 3. . 2014 - 20184 years. Liang MH A new tool -- the Lupus Activity Scoring Tool (LAST) - has been proposed to join the ranks of current disease activity indices. Petri M The Physician Global Assessment (PGA) is a frequently used co-primary end point in psoriasis clinical trials. Content validity was reported in 89 studies. , Magder L [35], the PGA correlated, although moderately, with the need for treatment change (r=0.46, P<0.01). 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). Accessibility Thus the development of a comprehensive index for assessing disease activity still represents one of the most important challenges in SLE [7]. 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). All rights reserved. Liang et al. Five studies have demonstrated good ICC values for reliability (all >0.60 and ranging up to 0.97). 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. et al. (PGA), physician global assessment of disease activity (PHGA), C3, C4, and Anti-ds . van Vollenhoven R , Pego-Reigosa J-M , Carpenter AB X 20 Physician Global Assessment 10.1136/lupus-2019-lsm.176 . , James JA , Shinada S , Genovese M National Library of Medicine SLE or at an SLE site, but only if the injury requires treatment by a licensed medical doctor. [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. . Can Lupus Patients Take the Driver's Seat in Their Disease Monitoring. Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. Cloud, mobility, security, and more. , Urowitz MB Navarra SV RN-BSN HOLISTIC HEALTH ASSESSMENT ACROSS THE LIFESPAN (NURS 3315) Sociology of Social Problems (SOC213) 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]. This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. [80] considered worsening as any increase in the PGA from baseline; in the epratuzumab trial [87], a significant improvement was a 20% decrease in the PGA score evaluated after 12months of treatment. , Petri M. Isenberg DA Cutaneous lupus erythematosus (CLE) is an autoimmune skin disease that can occur with or without systemic lupus erythematosus (SLE). , Magder LS Unauthorized use of these marks is strictly prohibited. BICLA responders had fewer lupus-related serious . Thanou A, Chakravarty E, James JA, Merrill JT. The aim of this systematic literature review is to describe and analyse the . Your recommendations as to what might or should be done in relation to various issues observed. , Schirmbeck LA 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). , McGwin G , Petri M. Iaccarino L Thanou A 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 . Mertz P, Piga M, Chessa E, Amoura Z, Voll RE, Schwarting A, Maurier F, Blaison G, Bonnotte B, Poindron V, Fiehn C, Lorenz HM, Korganow AS, Sibilia J, Martin T, Arnaud L. RMD Open. Newark, New Castle, USA, March 03, 2023 (GLOBE NEWSWIRE) -- The global complement-targeted therapeutics market is expected to grow at a CAGR of 8.9% from 2022 to 2030, owing to the rising . This may be explored through convergent and divergent validity. Five centres in Great Britain and the Republic of Ireland have collaborated to produce a computerized index of clinical disease activity in systemic lupus erythematosus, based on the principle of the physician's intention to treat. A high variability in scales was found, causing a wide range of reliability (intraclass correlation coefficient 0.670.98). Published by Oxford University Press on behalf of the British Society for Rheumatology. Bookshelf et al. 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. The random effects model gives a more conservative estimate considering the heterogeneity. Your comment will be reviewed and published at the journal's discretion. , Socher SA SLE is an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage in the affected organs. Manzi S official website and that any information you provide is encrypted Published by Oxford University Press on behalf of the British Society for Rheumatology. , Bouter LM Epub 2014 Apr 11. , Urowitz MB , Ho LY 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). , Suriano A inflammation (duration and severity of morning stiffness as measured by BASDAI). The intrarater reliability (intraRR) is the ability to provide consistent scores in a stable population by the same assessor over time. The PGA is usually reported by experts as allowing exhaustive coverage of the concept of disease activity in SLE [20, 108]. Petri M , Emamikia S , Seaman AL et al. HRQoL: Health-related Quality of Life; ICAM: intercellular adhesion molecule; VCAM: vascular cell adhesion molecule; MCP-1: monocyte chemoattractant protein-1; NC: non-calcified; suPAR: soluble urokinase plasminogen activator receptor; LFA-REAL: Lupus Foundation of America Rapid Evaluation of Activity in Lupus; CES-D: Centers for Epidemiological StudiesDepression scale; SLAQ: Systemic Lupus Erythematosus Activity Questionnaire; NA: not acquired; NS: not significant. , Perez-Gutthann S , Su J , Block JA Disclosure statement: L.A. is a consultant for Alexion, Amgen, AstraZeneca, GlaxoSmithKline, Janssen-Cilag, LFB, Eli Lilly, Menarini France, Novartis, Pfizer, Roche-Chugai and UCB. Matthew Turk,1,2 Janet E Pope1,2 To cite: turk M, Pope Je. , Kalunian K Objective: , Bresee C et al. Mahler M , Chizzolini C , Liberati A , Rairie JE , Garabajiu M Assessing disease activity in rheumatic diseases such as systemic lupus erythematosus (SLE) is vital for effective treatment. Moreover, there is uncertainty as to whether the best timing of assessment is prior to or after reviewing laboratory exams [26]. 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. 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). et al. , Sayedbonakdar Z Laboratory investigation results influence Physicians Global ssessment (PGA) of disease activity in SLE. SLE2ACR1997SLICC2012. LECTURE 10: MEDICAL SURGICAL NURSING. The authors wish to thank Sylvie Thuong for her invaluable assistance in the preparation of this manuscript. , Klein-Gitelman MS CLOSED ANGLE/ ANGLE CLOSURE GLAUCOMA. 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. A good responsiveness for PGA was shown in eight studies. Meta-analysis of the studies reporting data concerning the construct validity between the PGA and SLEDAI. The last EULAR/ACR recommendations recommended use of the PGA in the routine monitoring of SLE [16]. , Navarra SV , Mohan C. Jolly M et al. Parodis I Improving patient pathways for systemic lupus erythematosus: a multistakeholder pathway optimisation study. watch for seizures after the procedure. et al. The Author(s) 2020. , Dyer JW 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). , Lin M Gordon C , Farewell V , Annapureddy N 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. Fanouriakis A , Bocci EB They participate in physiologic and inflammatory cascades and have become a major focus of research, yielding novel therapies for immune-mediated inflammatory diseases (IMID). et al. Lead Medical Director heading up the global collaboration with Pfizer for Enbrel trials. For permissions, please email: journals.permissions@oup.com. [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. To discriminate between the severity of flares, the PGA was incorporated in a composite index: the SFI [10] (Table1). . 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. , Beresford MW Please enable it to take advantage of the complete set of features! , Taghavi-Zadeh S , Maxwell LJ In two studies, the PGA-VAS was used to assess concepts other than disease activity: disease severity [4] and patients compliance with treatments [103]. In one open-label study [43], the decrease in PGA score was considered the primary endpoint. All articles published through 1 July 2019 in PubMed were screened, with no limitation on year of publication, language or patients age. Medizinische Universitt Graz Austria/sterreich - Forschungsportal - Medical University of Graz Direkt zur Navigaton springen . , OMalley T , Burlingame RW , Zonana-Nacach A Results: On stratifying the results by individual clinician, values ranged from 0.61 to 0.90, except for those reported by . These results enabled its use as a gold standard for assessing flare and defining flare severity in several studies [21, 67, 88]. T2 - A longitudinal study. Quimby KR 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. , Raeisi A et al. 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. , Jolly M. Antony A 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]. Stojan G Psychometric properties data were analysed according to the OMERACT Filter methodology version 2.1. Criterion validity also refers to the degree to which an instrument predicts aspects and phenomena occurring in the future [108]. Methods: This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items . , Giangreco D , Chan KL Disagreements between investigators were solved by consensus. OBJECTIVE The Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. 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]. However, it is important to remember that not all clinical problems reported by a lupus patient are due to the disease. , Mazur M. Fatemi A 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]. 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. 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. 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]. SELENA SLEDAI4. 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. 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. Myelogram - correct answer NPO for 4-6 hours. . Learn more. 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]. The literature search identified 93 articles, and 12 additional articles were retrieved from the reference list of those publications. et al. The aim of this systematic review is to describe and analyse the measurement properties of the PGA, including the validity, reliability, responsiveness and feasibility. This site needs JavaScript to work properly. The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. 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 . Vashisht P , Engle E , Matos A 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). The aim of this systematic literature review is to describe and analyse the psychometric properties of the PGA. The index has proved quick and easy to use despite a comprehensive database and compares favourably with . , Sengupta M 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]. HHS Vulnerability Disclosure, Help Chaigne B Because of its dynamic nature, this disease has an unpredictable natural course leading to high . Some may be a consequence of therapy and others may be . Federal government websites often end in .gov or .mil. FitzGerald and Grossman [10] found a good interRR in a retrospective assessment of the PGA (=0.79). , Landis RC et al. 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 . 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]. Liang MH IgM) on attainment PhGA. The correlation with the SLEDAI was determined in 12 studies (Fig. et al. . , Piette EW X 20 sentence examples within Physician Global Assessment. , Aggarwal R et al. , Holland M Observed and articulated management issues and responses. , Longenecker JC Visual analogue scales (VAS) allow rapid, continuous scaling of disease severity. The site is secure. The Physician Global Assessment (PGA) is an important tool for assessing disease activity in lupus. Pincus and colleagues conducted a study of . government site. 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 Physician Global Assessment (PGA) is a visual analogue score that reflects the clinician's judgement of overall SLE disease activity. 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. , Mohan C. Giangreco D PGA; disease activity; physician global assessment; psychometrics; systemic lupus erythematosus. , Vogel-Claussen J Methods This SLR was conducted by two independent reviewers in accordance with the PRISMA statement. , Altman DG , Criscione-Schreiber LG Different definitions of disease activity according to the PGA instrument. Mina R 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. 2022 Sep;8(2):e002395. Objective Physician's global assessment (PGA) of disease activity is a major determinant of therapeutic decision making. Thousand Oaks. Beaton DE , Dietzmann K , Subach RB 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]. The SRI is a validated SLE disease activity instrument used to detect clinically meaningful improvement of disease in SLE clinical trials. Castrejn I, Ra-Figueroa I, Rosario MP, Carmona L. Reumatol Clin. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. Arriens C Kiani AN All clinical diagnoses were verified by review of the patients' inpatient and outpatient files at the time of capillaroscopy. Systemic lupus erythematosus (SLE), is the most common type of lupus. MeSH et al. In Fatemi et al. 2022 Mar 14;24(1):70. doi: 10.1186/s13075-022-02756-3. [8] suggested that the PGA should account for objective examination, laboratory results and what patients report. This systematic literature review was conducted by two independent reviewers in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. , Cappellazzo G , Magder LS Please check for further notifications by email. Content validity. 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]. , Petri MA , Askanase A SLE3. Barr et al. Thank you for submitting a comment on this article. , Matos A 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. , Koutsoviti S may be asked to hyperventilate 3-4 min and watch a bright flashing light. , Weisman MH. Fatigue is independently associated with disease activity assessed using the Physician Global Assessment but not the SLEDAI in patients with systemic lupus erythematosus. 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 . The other authors have declared no conflicts of interest. 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. This concept includes content validity, face validity, construct validity and criterion validity. et al. , Kharboutli M , Urowitz MB. et al. 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.
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