scholarly journals Development and validation of an alternative ankylosing spondylitis disease activity score when patient global assessment is unavailable

Rheumatology ◽  
2020 ◽  
Author(s):  
Augusta Ortolan ◽  
Sofia Ramiro ◽  
Floris van Gaalen ◽  
Tore K Kvien ◽  
Robert B M Landewe ◽  
...  

Abstract Objective To develop an alternative Ankylosing Spondylitis Disease Activity Score (ASDAS) to be used in research settings in axial SpA (axSpA) when Patient Global Assessment (PGA) is unavailable in databases. Methods Longitudinal data from four axSpA cohorts and two randomized controlled trials were combined. Observations were randomly split in a development (N = 1026) and a validation cohort (N = 1059). Substitutes of PGA by BASDAI total score, single or combined individual BASDAI questions, and a constant value, were established in the development cohort. Conversion factors for each substitute were defined by Generalized Estimating Equations, obtaining seven ‘alternative’ formulae. Validation was performed in the validation cohort according to the OMERACT filter, taking into consideration: (i) truth (agreement with original-ASDAS in the continuous score, by intraclass correlation coefficient and in disease activity states, by weighted kappa); (ii) discrimination [standardized mean difference of ASDAS scores between high/low disease activity states defined by external anchors, e.g. Patient Acceptable Symptom State; agreement (kappa) in the percentage of patients reaching ASDAS improvement criteria according to alternative vs original formulae]; and (iii) feasibility. Results Comparing various options, alternative-ASDAS using BASDAI total as PGA replacement proved to be: truthful (intraclass correlation coefficient = 0.98, kappa = 0.90), discriminative [ASDAS scores between Patient Acceptable Symptom State no/yes: standardized mean difference = 1.37 (original-ASDAS standardized mean difference = 1.43); agreement with original-ASDAS in major improvement/clinically important improvement criteria: kappa = 0.93/0.88] and feasible (BASDAI total often available, as questions required for the ASDAS; conversion coefficient ≈ 1). Conclusion Alternative-ASDAS using BASDAI total score as PGA replacement is the most truthful, discriminative and feasible instrument.

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 6-6
Author(s):  
A. Ortolan ◽  
S. Ramiro ◽  
F. A. Van Gaalen ◽  
T. K. Kvien ◽  
R. B. M. Landewé ◽  
...  

Background:Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index measuring disease activity in axial spondyloarthritis (axSpA). It includes questions from the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Patient Global Assessment (PGA), and inflammation biomarkers. However, ASDAS calculation is not always possible because PGA is sometimes not collected.Objectives:To develop an alternative ASDAS to be used in research settings when PGA is unavailable.Methods:Longitudinal data from 4 axSpA cohorts and 2 RCTs were combined. Observations were randomly split in a development (N=1026) and a validation cohort (N=1059). Substitutes of PGA by BASDAI total score, single or combined individual BASDAI questions, and a constant value, were considered. In the development cohort, conversion factors for each substitute were defined by Generalized Estimating Equations. Validation was performed in the validation cohort according to the OMERACT filter, taking into consideration: 1) Truth (agreement with original-ASDAS in the continuous score, by intraclass correlation coefficient -ICC- and in disease activity states, by weighted kappa) 2) Discrimination (standardized mean difference –SMD- of ASDAS scores between high/low disease activity states defined by external anchors e.g Patient Acceptable Symptom State –PASS-; agreement -kappa- in the % of patients reaching ASDAS improvement criteria according to alternative vs. original formulae) 3) Feasibility.Results:Taking all psychometric properties into account and comparing the different formulae (Table), alternative-ASDAS using BASDAI total as PGA replacement proved to be: 1) truthful (agreement with original-ASDAS: ICC=0.98, kappa=0.90); 2) discriminative: it could discriminate between high/low disease activity states (e.g. scores between PASS no/yes: SMD=1.37 versus original-ASDAS SMD=1.43) and was sensitive to change (agreement with original-ASDAS in major improvement/clinically important improvement criteria: kappa=0.93/0.88; 3) feasible (BASDAI total often available; conversion coefficient≈1).Table.Psychometric properties of alternative ASDAS formulaeConclusion:Alternative-ASDAS using BASDAI total score as PGA replacement is the most truthful, discriminative and feasible instrument. This index enables ASDAS calculation in existing cohorts without PGA.Disclosure of Interests:Augusta Ortolan: None declared, Sofia Ramiro: None declared, Floris A. van Gaalen: None declared, Tore K. Kvien Grant/research support from: Received grants from Abbvie, Hospira/Pfizer, MSD and Roche (not relevant for this abstract)., Consultant of: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Paid instructor for: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Speakers bureau: Have received personal fees from Abbvie, Biogen, BMS, Celltrion, Eli Lily, Hospira/Pfizer, MSD, Novartis, Orion Pharma, Roche, Sandoz, UCB, Sanofi and Mylan (not relevant for this abstract)., Robert B.M. Landewé Consultant of: AbbVie; AstraZeneca; Bristol-Myers Squibb; Eli Lilly & Co.; Galapagos NV; Novartis; Pfizer; UCB Pharma, Pedro M Machado Consultant of: PMM: Abbvie, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Speakers bureau: PMM: Abbvie, BMS, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Adeline Ruyssen-Witrand Grant/research support from: Abbvie, Pfizer, Consultant of: Abbvie, BMS, Lilly, Mylan, Novartis, Pfizer, Sandoz, Sanofi-Genzyme, Astrid van Tubergen Consultant of: Novartis, Caroline Bastiaenen: None declared, Désirée van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead Sciences, Inc., Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology BV


2020 ◽  
Vol 14 (2) ◽  
pp. 62-66
Author(s):  
Abhijit Datta ◽  
Minhaj Rahim Choudhury ◽  
Md Abu Shahin ◽  
Md Nazrul Islam ◽  
Shamim Ahmed ◽  
...  

Ankylosing Spondylitis Disease Activity Score (ASDAS) is a very important tool for measuring disease activity in patients with axial spondyloarthritis (axSpA). This study was aimed to develop a culturally adapted, valid and reliable Bengali version of questionnaire for the ASDAS. The original English ASDAS was translated into Bangla and adapted in the local socio-cultural context, following standard international recommendations. Content validity of the adapted Bangla version was assessed by the item-level & scale level content validity indices (I-CVI & S-CVI). A total 120 patients with axSpA were assessed in the study. For construct validity, correlation between ASDAS with BASDAI, ESR, CRP, Maastricht enthesitis score, physician's global assessment and BASMI was assessed by Spearman's rank correlation coefficient. Internal consistency and test-retest reliability were assessed using Cronbach's alpha coefficient and intraclass correlation coefficient respectively. I-CVI for each item was 1 and S-CVI was 1. ASDAS-ESR and ASDAS-CRP showed strong correlation (Spearman's correlation coefficient >0.5) with BASDAI, ESR, MASES and physician global assessment of disease activity. The scale demonstrated excellent internal consistency (Crohnbach's alpha=0.703) and test-retest reliability (ICC=0.98). The adapted Bangla version of the ASDAS demonstrated acceptable psychometric properties (validity & reliability) in Bangladeshi patients with axSpA. Faridpur Med. Coll. J. Jul 2019;14(2): 62-66


2021 ◽  
Author(s):  
Siliang Man ◽  
Liang Zhang ◽  
Tao Bian ◽  
Hongchao Li ◽  
Zhuyi Ma ◽  
...  

Abstract Background. The aim is to test the reliability and validity of the Hip Inflammation MRI Scoring System (HIMRISS) in assessing hip involvement of AS patients at different stages of the bath ankylosing spondylitis radiology index (BASRI-hip) scoring system.Methods. Fifty-two outpatients with ankylosing spondylitis(AS) were included in this study. The subjects’ data includes demographics, clinical characteristics, disease activity score, and functional index. Based on the Harris hip scoring (HHS) of involved hip and BASRI-hip score, we devided these patients into no hip involvement group(HHS≥80 and BASRI≤1)(Group A), mild hip involvement subgroup (BASRI=2 or BASRI≤1 and HHS≤79) (Group B) and moderate to advanced hip involvement subgroup (BASRI≥3) (Group C). Data was analyzed statistically by SPSS software.Results. In total of 44 patients (88 hips), group A consisted of 21 hips, group B consisted of 42 hips and group C consisted of 25 hips. The test-retest intraclass correlation coefficients (ICCs) in four raters were 0.955~0.977 and interrater ICC was 0.993. HIMRISS correlated moderately with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (r=0.540, p<0.001), the Bath ankylosing spondylitis functional index (BASFI) (r=0.581, p<0.001), ASDAS-ESR (r=0.604, p<0.001) and Ankylosing Spondylitis Disease Activity Score(ASDAS)- C reactive protein (CRP) (r=0.575, p<0.001). HIMRISS in group B and C was significantly higher than that in group A: 29.38(17.00,40.94)vs 14.50(11.38,22.25), p=0.009; 38 (31.13,64.38)vs 14.50(11.38,22.25), p<0.001.Conclusions. HIMRISS applied to patients with AS demonstrated a satisfactory reliability, which means it is a reliable quantitive assessment tool for evaluating early hip involvement in patients with AS.


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Siliang Man ◽  
Liang Zhang ◽  
Tao Bian ◽  
Hongchao Li ◽  
Zhuyi Ma ◽  
...  

Abstract Background This study aimed to test the reliability and validity of the Hip Inflammation MRI Scoring System (HIMRISS) in assessing hip involvement of AS patients with AS at different stages of the bath ankylosing spondylitis radiology index (BASRI-hip) scoring system. Methods Fifty-two outpatients with ankylosing spondylitis (AS) were included in this study. The subjects’ data includes demographics, clinical characteristics, disease activity score, and functional index. Based on the Harris hip scoring (HHS) of involved hip and BASRI-hip score, we devided these patients into no hip involvement group((HHS ≥ 80 and BASRI ≤ 1) (Group A), mild hip involvement subgroup (BASRI = 2 or BASRI ≤ 1 and HHS ≤ 79) (Group B), and moderate to advanced hip involvement subgroup (BASRI ≥ 3) (Group C). Data was analyzed statistically by SPSS software. Results In total of 44 patients (88 hips), group A consisted of 21 hips, group B consisted of 42 hips and group C consisted of 25 hips. The test–retest intraclass correlation coefficients (ICCs) in four raters were 0.955 ~ 0.977 and interrater ICC was 0.993. HIMRISS correlated moderately with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (r = 0.540, p < 0.001), the Bath ankylosing spondylitis functional index (BASFI) (r = 0.540, p < 0.001), the Bath Ankylosing Spondylitis Functional Index (BASFI) (r = 0.581, p < 0.001), ASDAS-ESR (r = 0.604, p < 0.001), and Ankylosing Spondylitis Disease Activity Score (ASDAS)-C reactive protein (CRP) (r = 0.575, p < 0.001). HIMRISS in groups B and C was significantly higher than that in group A: 29.38 (17.00, 40.94) vs. 14.50 (11.38, 22.25), p = 0.009; 38 (31.13, 64.38) vs 14.50 (11.38, 22.25), p < 0.001. Conclusions HIMRISS applied to patients with AS demonstrated a satisfactory reliability, meaning it is a reliable quantitive assessment tool for evaluating early hip involvement in patients with AS.


2008 ◽  
Vol 68 (1) ◽  
pp. 18-24 ◽  
Author(s):  
C Lukas ◽  
R Landewé ◽  
J Sieper ◽  
M Dougados ◽  
J Davis ◽  
...  

Objectives:To develop a new index for disease activity in ankylosing spondylitis (ASDAS) that is truthful, discriminative and feasible, and includes domains/items that are considered relevant by patients and doctors.Methods:Eleven candidate variables covering six domains of disease activity, selected by ASAS experts in a Delphi exercise, were tested in a three-step approach, similar to the methodology used for the disease activity score in rheumatoid arthritis. Data on 708 patients included in ISSAS (International Study on Starting tumour necrosis factor blocking agents in Ankylosing Spondylitis) were used. Cross validation was carried out in the OASIS cohort (Outcome in Ankylosing Spondylitis International Study).Results:Principal component analysis disclosed three factors with eigenvalues >0.75: patient assessments, peripheral joint assessments and acute phase reactants. Discriminant function analysis resulted in a correct classification in ∼72% of the cases (prior probability ∼50%). Regression analysis resulted in an index with five variables (total back pain, patient global assessment, duration of morning stiffness, C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)). Three additional candidate indices were designed using similar methodology while omitting either ESR or CRP or patient global assessment. All four scores correlated with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI; r = 0.67–0.80), patient (0.58–0.75) and physician’s global assessment (0.41–0.48) of disease activity. All four candidate ASDAS indices performed better than BASDAI or single-item variables in discriminating between high and low disease activity state, according to doctors as well as patients in the OASIS cohort.Conclusion:The first steps in the development of a new assessment tool of disease activity in AS derived four candidate indices with good face and construct validity, and high discriminant capacity.


Medicina ◽  
2009 ◽  
Vol 45 (3) ◽  
pp. 177
Author(s):  
Lina Vencevičienė ◽  
Rita Rugienė ◽  
Algirdas Venalis ◽  
Irena Butrimienė

Original English questionnaires – Bath Ankylosing Spondylitis Functional Index, Bath Ankylosing Spondylitis Patient Global Score, and Bath Ankylosing Spondylitis Disease Activity Index – are designed to evaluate health, physical and psychical state of patients with spondyloarthropathies and to assess efficiency of the treatment. Objective. The objective of the study was to adapt Bath Ankylosing Spondylitis Functional Index, Bath Ankylosing Spondylitis Patient Global Score, Bath Ankylosing Spondylitis Disease Activity Index questionnaires to the Lithuanian context and examine their psychometric aspects: reliability and validity. Patients and methods. Validation and linguistic and cultural adaptation of Lithuanian questionnaires were performed according to the requirements for adaptation of the international questionnaires. Psychometric features of Lithuanian questionnaires were examined in 139 patients with spondyloarthropathies. The validity of questionnaires was tested by comparing these questionnaires with Health Assessment Questionnaire Modified for Spondyloarthropathies, metrology indices (tragus-to-wall distance, lateral flexion, modified Schober’s distance, intermalleolar distance), pain intensity, patient’s well-being, physician’s assessment of the disease activity, and total enthesis count. The reliability of questionnaires was assessed by determining internal consistency of scales and scale stability and by calculating the intraclass correlation coefficient. Results. The linguistic and cultural adaptation of these questionnaires was made during the study. Internal consistency was high for functional and disease activity index (Cronbach a³0.80) and moderate for the Bath Ankylosing Spondylitis Patient Global Score (Cronbach a=0.58). High stability in regard to time was characteristic of all three questionnaires (intraclass correlation coefficient >0.95). A significant association between the separate questions of examined instruments, their joint results and other factors reflecting patient’s health was established. Conclusions. Bath Ankylosing Spondylitis Functional Index, Bath Ankylosing Spondylitis Patient Global Score, and Bath Ankylosing Spondylitis Disease Activity Index questionnaires in Lithuanian fully correspond to psychometric requirements. They are appropriate and relevant in assessing the influence of spondyloarthropathies on a patient’s health.


2012 ◽  
Vol 39 (7) ◽  
pp. 1424-1432 ◽  
Author(s):  
CARLOS RODRÍGUEZ-LOZANO ◽  
MARÍA-ÁNGELES GANTES ◽  
BEATRIZ GONZÁLEZ ◽  
JOSÉ A. HERNÁNDEZ-BERIAIN ◽  
ANTONIO NARANJO ◽  
...  

Objective.We assessed the prevalence of patients with ankylosing spondylitis (AS), rating their state as acceptable (patient-acceptable symptom state; PASS), among 190 patients with AS seen in daily practice. Factors associated with PASS status and PASS thresholds for outcome measures were also analyzed.Methods.The characteristics of patients with affirmative and negative assignment to PASS were compared. Associated factors were estimated by logistic regression models and PASS thresholds by the 75th percentile and receiver-operating characteristic curve methods.Results.A total of 77% of patients rated their state as acceptable (95% CI 62–91). These patients were taking fewer nonsteroidal antiinflammatory drugs and corticosteroids, practiced more exercise, had less anxiety and depression, and had lower values of all patient-reported outcome measures, physicians’ assessment, AS Disease Activity Score (ASDAS) and C-reactive protein. Lower values of Bath AS Disease Activity Index and physician’s global assessment were independent factors associated with acceptable symptom state. High rates of anxiety and depression were found in patients not in PASS. The thresholds with the 75th percentile approach were 4.55 for the BASDAI and 2.84 for the ASDAS. Fifty-three percent of patients in PASS had a high or very high disease activity state according to ASDAS cutoff values.Conclusion.A high percentage of patients with AS in daily practice declared that their symptom state was acceptable. PASS status correlated with physician global assessment and BASDAI. PASS thresholds for common recommended outcome measures were relatively high and many patients in PASS had unacceptably high disease activity states according to ASDAS. Other factors such as psychological problems may influence a negative PASS state.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 743.1-744
Author(s):  
S. Azevedo ◽  
F. Guimarães ◽  
D. Almeida ◽  
D. Faria ◽  
J. Silva ◽  
...  

Background:Patient’s Global Assessment of Disease Activity (PtGA) and Physician’s Global Assessment of Disease Activity (PhGA) are important measures in the evaluation of patients with Spondyloarthritis (SpA), but often provide discordant results.1Both PtGA and PhGA are assessed as part of ankylosing spondylitis disease activity score (ASDAS), that is a measure of axial SpA disease activity endorsed by the Assessment of SpA International Society (ASAS) and Outcome Measures in Rheumatology.2,3In peripheral SpA, although there are no formally validated indexes, the American College of Rheumatology (ACR) and Disease Activity Score 28 (DAS 28) response criteria have shown reliable discriminant characteristics and both include PtGA and PhGA.3The lack of concordance between PtGA and PhGA may mislead treatment decisions, namely switches.Objectives:To assess the determinants of patient-physician discordance in SpA patients under biologic treatment.Methods:Cross-sectional study, including 72 with SpA according ASAS criteria. Physicians’ evaluation included comorbidities, parameters of inflammatory activity (erythrocyte sedimentation rate [ESR] and C-reactive protein [CRP], PhGA, ASDAS PCR and, DAS 28, and Participants completed patient-reported outcomes (PROs) and sociodemographic characteristics. For statistical analysis, SPSS was used and significance level was 2-sided p<0.05.Results:Clinical and laboratory characteristics of patients are shown in table 1. PtGA and PhGA were significantly different (34.8±21.2vs7.8±12.5 mm, respectively, p< .001) and patient-physician discordance (ΔPtGA - PhGA) was 27.5±14.3 mm.In peripheral SpA, patient-physician discordance had a correlation with patient age, Health Assessment Questionnaire (HAQ), Functional Assessment of Chronic Illness Therapy (FACIT), EuroQol-5 dimension (EQ5D), Short Form (36) Health Survey (SF-36), Hospital Anxiety and Depression scales (HADS), CRP, ESR, number of comorbidities and daily medication, and an association with employment status (employees had lesser discordance), anxiety/depression, fibromyalgia and osteoarthritis (OA). In multivariable analysis including employment status, SF-36, OA, number of comorbidities, and ESR (R2adjusted= .505), the main predictors of patient-physician discordance were lower SF36, higher number of comorbidities and employment status.In axial SpA, patient-physician discordance had a correlation with nocturnal back pain and total back pain VAS, FACIT, EQ5D, SF-36, HADS, Bath Ankylosing Spondylitis Functional Index (BASFI) and Bath Ankylosing Spondylitis Activity Index (BASDAI) scales, age, number of comorbidities and daily medication and an association with employment status (employees had lesser discordance), anxiety/depression and fibromyalgia. In multivariable analysis including employment status, SF-36, fibromyalgia, and number of comorbidities (R2adjusted= .738), the main predictors of patient-physician discordance were lower SF36, higher number of comorbidities and concomitant diagnosis of fibromyalgia.Neither for peripheral SpA nor for axial SpA an association with SpA subtype, HLA-B27 positivity, patient or physician gender, or patient education level was found.Conclusion:This study shows the variability implied in patient-physician discordance. We have demonstrated that comorbidities, employment status, and other factors not directly related to the disease are determinants for the patient-physician discordance.References:[1]Desthieux C, et al. 2016[2]Machado P et al. 2013[3]Mease PJ. 2011Disclosure of Interests:None declared


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