Responsiveness of histological disease activity indices in ulcerative colitis: a post hoc analysis using data from the TOUCHSTONE randomised controlled trial

Gut ◽  
2018 ◽  
Vol 68 (7) ◽  
pp. 1162-1168 ◽  
Author(s):  
Vipul Jairath ◽  
Laurent Peyrin-Biroulet ◽  
Guangyong Zou ◽  
Mahmoud Mosli ◽  
Niels Vande Casteele ◽  
...  
Keyword(s):  
Disease Activity ◽  
Effect Size ◽  
Controlled Trial ◽  
Intraclass Correlation ◽  
Correlation Coefficients ◽  
Treatment Assignment ◽  
Mayo Score ◽  
Histological Indices ◽  
Randomised Controlled ◽  
Activity Indices

ObjectiveWe evaluated the reliability and responsiveness of available but incompletely validated UC histological disease activity indices using standardised rules for centralised assessment.DesignDisease activity was assessed in biopsies collected in a phase II placebo-controlled ozanimod trial by four blinded pathologists using the Geboes (GS) and modified Riley (MRS) scores, the Robarts Histopathology (RHI) and Nancy Histological (NHI) indices and a Visual Analogue Scale. Reliability was assessed with intraclass correlation coefficients (ICCs). Index responsiveness was evaluated by assessing longitudinal validity (Pearson correlations of changes in index scores and other disease measures), and effect size estimates (standardised effect size (SES)) using two criteria for change (treatment assignment and >2 point decrease in total Mayo Clinic score). Area under the receiver operating characteristic (AUROC) curve estimates evaluated the probability of the indices to discriminate between treatment and placebo.ResultsInter-rater reliability of the histological indices was substantial to almost perfect (ICC>0.61), and responsiveness was moderate to large (SES estimates>0.5); 0.81 (0.52, 1.10), 0.87 (0.58, 1.17), 0.57 (0.30, 0.84) and 0.81 (0.52, 1.09) when treatment assignment was the criterion for change and 1.05 (0.80, 1.31), 1.13 (0.87, 1.39), 0.88 (0.64, 1.12) and 1.06 (0.80, 1.31) for the change in Mayo score criterion for the GS, MRS, RHI and NHI, respectively. The indices had similar drisciminative ability based on AUROC estimates (range 0.608–0.649).ConclusionAll four existing histological indices were similarly reliable and responsive based on this dataset.

scholarly journals Early and sustained efficacy with apremilast monotherapy in biological-naïve patients with psoriatic arthritis: a phase IIIB, randomised controlled trial (ACTIVE)

2018 ◽  
Vol 77 (5) ◽  
pp. 690-698 ◽  
Author(s):  
Peter Nash ◽  
Kamal Ohson ◽  
Jessica Walsh ◽  
Nikolay Delev ◽  
Dianne Nguyen ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Safety Profile ◽  
Controlled Trial ◽  
Health Assessment ◽  
Tender Joint ◽  
American College Of Rheumatology ◽  
Das 28 ◽  
Registration Number ◽  
Randomised Controlled

ObjectiveEvaluate apremilast efficacy across various psoriatic arthritis (PsA) manifestations beginning at week 2 in biological-naïve patients with PsA.MethodsPatients were randomised (1:1) to apremilast 30 mg twice daily or placebo. At week 16, patients whose swollen and tender joint counts had not improved by ≥10% were eligible for early escape. At week 24, all patients received apremilast through week 52.ResultsAmong 219 randomised patients (apremilast: n=110; placebo: n=109), a significantly greater American College of Rheumatology 20 response at week 16 (primary outcome) was observed with apremilast versus placebo (38.2% (42/110) vs 20.2% (22/109); P=0.004); response rates at week 2 (first assessment) were 16.4% (18/110) versus 6.4% (7/109) (P=0.025). Improvements in other efficacy outcomes, including 28-joint count Disease Activity Score (DAS-28) using C reactive protein (CRP), swollen joint count, Health Assessment Questionnaire-Disability Index (HAQ-DI), enthesitis and morning stiffness severity, were observed with apremilast at week 2. At week 16, apremilast significantly reduced PsA disease activity versus placebo, with changes in DAS-28 (CRP) (P<0.0001), HAQ-DI (P=0.023) and Gladman Enthesitis Index (P=0.001). Improvements were maintained with continued treatment through week 52. Over 52 weeks, apremilast’s safety profile was consistent with prior phase 3 studies in psoriasis and PsA. During weeks 0–24, the incidence of protocol-defined diarrhoea was 11.0% (apremilast) and 8.3% (placebo); serious adverse event rates were 2.8% (apremilast) and 4.6% (placebo).ConclusionsIn biological-naïve patients with PsA, onset of effect with apremilast was observed at week 2 and continued through week 52. The safety profile was consistent with previous reports.Trial registration numberNCT01925768; Results.

scholarly journals Physician’s Global Assessment in Psoriatic Arthritis: A Multicenter GRAPPA Study

2018 ◽  
Vol 45 (9) ◽  
pp. 1256-1262 ◽  
Author(s):  
Alberto Cauli ◽  
Dafna D. Gladman ◽  
Alessandro Mathieu ◽  
Ignazio Olivieri ◽  
Giovanni Porru ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Global Assessment ◽  
Intraclass Correlation ◽  
Correlation Coefficients ◽  
Major Effect ◽  
Self Evaluation ◽  
Dermatological Disease ◽  
Patient Assessments ◽  
Therapeutic Decision Making

Objective.Physician’s global assessment (PGA) of disease activity is a major determinant of therapeutic decision making. This study assesses the reliability of the PGA, measured by means of 0–100 mm visual analog scale (VAS), and the additional use of separate VAS scales for musculoskeletal (PhysMSK) and dermatologic (PhysSk) manifestations in patients with psoriatic arthritis (PsA).Methods.Sixteen centers from 8 countries enrolled 319 consecutive patients with PsA. PGA, PhysMSK, and PhysSk evaluation forms were administered at enrollment (W0) and after 1 week (W1). Detailed clinical data regarding musculoskeletal (MSK) manifestations, as well as dermatological assessment, were recorded.Results.Comparison of W0 and W1 scores showed no significant variation (intraclass correlation coefficients were PGA 0.87, PhysMSK 0.86, PhysSk 0.78), demonstrating the reliability of the instrument. PGA scores were dependent on PhysMSK and PhysSk (p < 0.0001) with a major effect of the MSK component (B = 0.69) compared to skin (B = 0.32). PhysMSK was correlated with the number of swollen joints, tender joints, and presence of dactylitis (p < 0.0001). PhysSk scores were correlated with the extent of skin psoriasis and by face, buttocks or intergluteal, and feet involvement (p < 0.0001). Finally, physician and patient assessments were compared showing frequent mismatch and a scattered dot plot: PGA versus patient’s global assessment (r = 0.36), PhysMSK versus patient MSK (r = 0.39), and PhysSk versus patient skin (r = 0.49).Conclusion.PGA assessed by means of VAS is a reliable tool to assess MSK and dermatological disease activity. PGA may diverge from patient self-evaluation. Because MSK and skin/nail disease activity may diverge, it is suggested that both PhysMSK and PhysSk are assessed.

scholarly journals How to calculate the ASDAS based on C-reactive protein without individual questions from the BASDAI: the BASDAI-based ASDAS formula

Rheumatology ◽  
2019 ◽  
Vol 59 (7) ◽  
pp. 1545-1549 ◽  
Author(s):  
I Concepcion Aranda-Valera ◽  
Juan L Garrido-Castro ◽  
Lourdes Ladehesa-Pineda ◽  
Janitzia Vazquez-Mellado ◽  
Pedro Zarco ◽  
...  
Keyword(s):  
Disease Activity ◽  
Strong Correlation ◽  
Validation Cohort ◽  
Linear Regression Analysis ◽  
Intraclass Correlation ◽  
Correlation Coefficients ◽  
National Registry ◽  
Derivation Cohort ◽  
The Mean ◽  
New Equation

Abstract Objectives To develop a new equation to calculate the Ankylosing Spondylitis Disease Activity Score based on CRP (ASDAS-CRP) using only the BASDAI total score and CRP. Methods Axial SpA (axSpA) patients from the Cordoba Spondyloarthritis Registry cohort were recruited as a derivation cohort, while a retrospective sample from the Spanish Rheumatology Society National Registry of Spondyloarthropathies and Ibero American Spondyloarhtritis Registry registers was used as a validation cohort. We built a new equation based only on the BASDAI and CRP, defining a new formula: the BASDAI-based ASDAS (BASDAS). Linear regression analysis was used to determine the coefficients of the equation in the derivation cohort and it was subsequently validated in the validation cohort. Results A total of 52 axSpA patients in the derivation cohort and 3359 patients in the validation cohort were included. In the derivation cohort, the mean BASDAS [2.24 (s.d. 0.90)] was very similar to the ASDAS-CRP [2.23 (s.d. 0.95)], with a very strong correlation (r = 0.96, P &lt; 0.001). In the validation cohort, the mean BASDAS was 3.31 (s.d. 1.37) and the ASDAS-CRP was 3.19 (s.d. 1.27), which also had a very strong correlation (r = 0.95, P &lt; 0.001). Intraclass correlation coefficients were excellent in both cohorts (0.963 and 0.947, respectively). Conclusion The BASDAS performs similarly to the ASDAS-CRP and can be calculated with only the BASDAI total score and CRP, allowing evaluation of disease activity in retrospective studies where the individual items of the BASDAI are not available.

Patient Global Assessment in Psoriatic Arthritis: A Multicenter GRAPPA and OMERACT Study

2011 ◽  
Vol 38 (5) ◽  
pp. 898-903 ◽  
Author(s):  
ALBERTO CAULI ◽  
DAFNA D. GLADMAN ◽  
ALESSANDRO MATHIEU ◽  
IGNAZIO OLIVIERI ◽  
GIOVANNI PORRU ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Skin Disease ◽  
Global Assessment ◽  
Intraclass Correlation ◽  
Depression Scale ◽  
Correlation Coefficients ◽  
Severity Index ◽  
Patient Global Assessment ◽  
Patient Anxiety

Objective.During OMERACT 8, delegates selected patient global assessment (PGA) of disease as a domain to be evaluated in randomized controlled trials in psoriatic arthritis (PsA). This study assessed the reliability of the PGA, measured by means of 0–100 mm visual analog scale (VAS), and the additional utility of separate VAS scales for joints (PJA) and skin (PSA).Methods.In total, 319 consecutive patients with PsA (186 men, 133 women, mean age 51 ± 13 yrs) were enrolled. PGA, PJA, and PSA were administered at enrolment (W0) and after 1 week (W1). Detailed clinical data, including ACR joint count, Psoriasis Area and Severity Index (PASI), and Hospital Anxiety and Depression Scale, were recorded.Results.Comparison of W0 and W1 scores showed no significant variations (intraclass correlation coefficients for PGA 0.87, PJA 0.86, PSA 0.78), demonstrating the reliability of the instrument. PGA scores were not influenced by patient anxiety or depression, but were dependent on PJA and PSA (p = 0.00001). PJA was dependent on the number of swollen and tender joints (p < 0.00001). PSA scores were influenced by the extent of skin psoriasis and by hand skin involvement (p = 0.00001). Joint and skin disease were found not to correlate in terms of disease activity as evidenced by the swollen joint count compared to PASI (r = 0.11) and by the PJA compared to PSA (r = 0.38).Conclusion.PGA assessed by means of VAS is a reliable tool related to joint and skin disease activity. Because joint and skin disease often diverge it is suggested that in some circumstances both PJA and PSA are also assessed.

Measuring Physical Activity in Juvenile Idiopathic Arthritis: Activity Diary Versus Accelerometer

2017 ◽  
Vol 44 (8) ◽  
pp. 1249-1256 ◽  
Author(s):  
Wineke Armbrust ◽  
G.J.F. Joyce Bos ◽  
Jan H.B. Geertzen ◽  
Pieter J.J. Sauer ◽  
Pieter U. Dijkstra ◽  
...  
Keyword(s):  
Physical Activity ◽  
Juvenile Idiopathic Arthritis ◽  
Effect Size ◽  
Convergent Validity ◽  
Intraclass Correlation ◽  
Correlation Coefficients ◽  
Accelerometer Data ◽  
Individual Level ◽  
Intraclass Correlation Coefficients ◽  
Activity Diary

Objective.(1) To determine convergent validity of an activity diary (AD) and accelerometer (Actical brand/Phillips-Respironics) in measuring physical activity (PA) in children with juvenile idiopathic arthritis (JIA). (2) To determine how many days give reliable results. (3) To analyze effects of correcting accelerometer data for non-wear.Methods.Patients with JIA (8–13 yrs) were recruited from 3 Dutch pediatric rheumatology centers. PA was assessed for 7 days with an AD and accelerometer, and was expressed as mean min/day of rest, light PA (LPA), moderate to vigorous PA (MVPA), and PA level (PAL). To analyze convergent validity, intraclass correlation coefficients (ICC) were calculated and paired sample Student t tests were performed. The required number of days to achieve reliable results was calculated using the Spearman-Brown prophecy formula.Results.Convergent validity between AD and accelerometer was moderate for rest and PAL (ICC 0.41). ICC for LPA and MVPA were < 0.24. AD overestimated PAL and MVPA compared with the accelerometer. Wearing the accelerometer 7–19 days gave reliable PA estimates on group and individual levels. For the AD, 13–36 days were needed. Adjusting accelerometer data for non-wear resulted in a clinically relevant higher mean number of min/day spent in LPA (effect size 1.12), but not in MVPA (effect size 0.44).Conclusion.Convergent validity between AD and accelerometer is moderate to poor. In children with JIA, 1-week assessment with an accelerometer is sufficient to measure PA (all levels) reliably. On an individual level and for clinical use, 3 weeks are required. Additional use of AD enables correction for non-wear of accelerometer data.

Development and Validation of MRI Sacroiliac Joint Scoring Methods for the Semiaxial Scan Plane Corresponding to the Berlin and SPARCC MRI Scoring Methods, and of a New Global MRI Sacroiliac Joint Method

2017 ◽  
Vol 45 (1) ◽  
pp. 70-77 ◽  
Author(s):  
Pernille Hededal ◽  
Mikkel Østergaard ◽  
Inge Juul Sørensen ◽  
Anne Gitte Loft ◽  
Jens S. Hindrup ◽  
...  
Keyword(s):  
Sacroiliac Joint ◽  
Controlled Trial ◽  
Linear Regression Analysis ◽  
Intraclass Correlation ◽  
Correlation Coefficients ◽  
Scoring Methods ◽  
Double Blind ◽  
Smallest Detectable Change ◽  
Observed Score ◽  
Very High

Objective.To develop semiaxial magnetic resonance imaging (MRI) scoring methods for assessment of sacroiliac joint (SIJ) bone marrow edema (BME) in patients with axial spondyloarthritis, and to compare the reliability with equivalent semicoronal scoring methods.Methods.Two semiaxial SIJ MRI scoring methods were developed based on the principles of the semicoronal Berlin and Spondyloarthritis Research Consortium of Canada (SPARCC) methods. A global quadrant-based method was also developed. Baseline and 12-week MRI of the SIJ from 51 patients participating in a randomized double-blind placebo-controlled trial of adalimumab 40 mg every other week versus placebo were scored by the semiaxial and the corresponding semicoronal methods. Results were compared by linear regression analysis. The reproducibility and sensitivity were evaluated by intraclass correlation coefficients (ICC) and smallest detectable change [SDC, absolute values and percentage of the highest observed score (SDC-HOS)].Results.Interreader and intrareader ICC were moderate to very high for semiaxial scoring methods (baseline 0.83–0.88 and 0.85–0.97; change 0.33–0.78), while high to very high for semicoronal scoring methods (baseline 0.90–0.92 and 0.93–0.97; change 0.77–0.89). Association between semiaxial and semicoronal scores were high for both the Berlin and SPARCC method (baseline: R2 = 0.93 and 0.88; change: R2 = 0.82 and 0.87, respectively), while lower for the global method (baseline: R2 = 0.79; change: R2 = 0.54). The SDC-HOS were 9.8–18.6% and 5.9–10.7% for the semiaxial and semicoronal methods, respectively.Conclusion.Detection of SIJ BME in the semiaxial scan plane is feasible and reproducible. However, a slightly lower reliability of all 3 semiaxial methods supports the general practice of using the coronal scan-plane in therapeutic studies.

scholarly journals Long-term Exercise After Pulmonary Rehabilitation (LEAP): a pilot randomised controlled trial of Tai Chi in COPD

2021 ◽  
pp. 00025-2021
Author(s):  
Marilyn L. Moy ◽  
Peter M. Wayne ◽  
Daniel Litrownik ◽  
Douglas Beach ◽  
Elizabeth S. Klings ◽  
...  
Keyword(s):  
Effect Size ◽  
Pulmonary Rehabilitation ◽  
Tai Chi ◽  
Controlled Trial ◽  
Controlled Study ◽  
Related Quality ◽  
Feasible Option ◽  
Health Related ◽  
Secondary Outcomes ◽  
Randomised Controlled

Mind-body modalities are promising strategies to maintain the benefits gained after completion of conventional pulmonary rehabilitation (PR) in persons with COPD.In this pilot randomised controlled study, we examined Tai Chi in persons with COPD after completing PR. Participants were randomised 2:2:1 to Tai Chi (TC), usual care (UC), or group walking (GW) for 24 weeks. We assessed feasibility; primary outcome was exercise capacity measured by 6-min walk test (6 MWT) distance at 24 weeks. Secondary outcomes included health-related quality of life measured by Chronic Respiratory Questionnaire (CRQ), dyspnea, mood, stress, social support, self-efficacy, physical activity, and exercise engagement. Effect size estimates and estimates from generalised estimating equations were calculated.Ninety-one persons (36 TC, 37 UC, 18 GW) were enrolled, with age 69±6 years, 59% male, and FEV1% predicted 48±19. There was no difference in adherence and adverse events between groups. There was a small between-group effect size (ES=0.25) in change in 6 MWT distance favoring TC compared to UC; 24-week comparison was nonsignificant (p=0.10). There were no differences in secondary outcomes. In exploratory analyses, there was a greater percentage of participants in TC who improved 6 MWT distance at 24 weeks, compared to UC, 64% versus 39%, p=0.05. There were higher percentages of participants in TC who improved CRQ Fatigue (59% versus 31%, p=0.02) and CRQ Mastery (47% versus 20%, p=0.01) domain scores, compared to UC. For GW, there were no differences compared with TC.Tai Chi may be a feasible option to maintain the benefits gained after completing conventional PR.

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