scholarly journals OP09 Patient reported outcomes reflect histologic disease activity in patients with Ulcerative Colitis: Interim analysis of the APOLLO study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S008-S009
Author(s):  
B Verstockt ◽  
C Jorissen ◽  
E Hoefkens ◽  
N Lembrechts ◽  
L Pouillon ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Disease Activity ◽  
Patient Reported Outcomes ◽  
Activity Index ◽  
Remission Rate ◽  
Stool Frequency ◽  
Patient Reported ◽  
Endoscopic Remission ◽  
Histological Remission ◽  
General Wellbeing

Abstract Background Treating beyond endoscopic remission, aiming for histological remission, has shown to reduce relapse and hospitalization rates in patients with ulcerative colitis (UC). However, very little is known on how histological remission associates with patient reported outcomes (PROMs). Methods PROMs (Simple clinical colitis activity index [SCCAI], IBD disk and Visual Analogue Scales [VAS]) were prospectively collected through a digital questionnaire in all patients with UC undergoing colonoscopy between July 21st 2020-Jan 21st 2021. Mayo endoscopic sub score and UCEIS were determined, as well as the Nancy histologic index (NHI) of the most affected area. Endoscopic remission was defined as Mayo endoscopic sub score 0 and UCEIS 0; histologic remission as NHI 0, absence of active inflammation as NHI ≤ 1. PRO2 remission was defined as stool frequency ≤ 1 (absolute stool frequency ≤ 3 OR 1–2 stools more than usual) and rectal bleeding score of 0. Results Fifty-six paired assessments were collected in 48 unique patients (Table 1), with a histologic, endoscopic and PRO-2 remission rate of 23.2%, 28.6% and 38.2% respectively. Patients with histologic remission or absence of histologic inflammation had a significantly lower overall IBD disability (p=0.007, p=0.003) and disease activity score (p=0.003, p<0.001), as compared to patients without. In line, NHI correlated with the overall IBD disk (r=0.40, p=0.002) and SCCAI score (r=0.50, p<0.001). Many individual components of both scores (abdominal pain, arthralgia, impact on education and work/interpersonal interactions/sexual function, regulation of defecation, blood loss, general wellbeing, joint pain, numbers of stools during night/day, urgency) differed significantly between patients with and without histologic remission. VAS scores assessing general wellbeing (r=0.33, p=0.01), impact on daily activities (r=0.41, p=0.002), UC-related symptoms (r=0.42, p=0.001) and worries (r=0.40, p=0.002) correlated with histology. Quartile analysis of the overall IBD disk and SCCAI scores confirmed the highest likelihood for histologic remission in patients with the lowest scores (Q1-Q2 vs Q3-Q4 39.3% vs 7.1%, p=0.01; 40.0% vs 9.7%, p=0.01) (Figure 1). Nevertheless, the overall accuracy of the IBD disk (0.75) or SCCAI score (0.76) for histologic remission is lower (p<0.05) than the accuracy of the Mayo endoscopic (0.90) or UCEIS (0.90) score. Table 1: Baseline features Abstract OP09 – Figure 1: Quartile analysis Conclusion In patients with UC, PROMs for disability and clinical disease activity reflect histologic disease activity and should therefore be further explored in (trial) endpoint discussions. However, they cannot fully replace endoscopic and histologic findings, and should be considered complementary.

scholarly journals P364 Patient reported outcomes, partial MAYO score and SCCAI are equally accurate in predicting mucosal healing in UC: final results form a prospective study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S381-S382
Author(s):  
P Golovics ◽  
L Gonczi ◽  
J Reinglass ◽  
C Verdon ◽  
S Pundir ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Disease Activity ◽  
Patient Reported Outcomes ◽  
Roc Analysis ◽  
Activity Index ◽  
Strong Association ◽  
Fecal Calprotectin ◽  
Mucosal Healing ◽  
Patient Reported ◽  
Assessment Of Disease Activity

Abstract Background Optimal management of patients with ulcerative colitis (UC) requires the accurate assessment of disease activity. Endoscopic evaluation is considered the gold standard approach, but it is invasive. We aimed to determine how strong patient reported outcomes, clinical scores and symptoms correlate with endoscopy for assessment of disease activity in UC patients. Methods 171 patients were included prospectively and consecutively (age: 49 (IQR: 38-61) years, duration 12 (4-19)years, 79 females (46.2%), 57.3% extensive disease, 42.7% on biologicals) at the time of the colonoscopy. The 2 item patient reported outcome (PRO), partial MAYO, Simple Clinical Colitis Activity Index (SCCAI), Mayo endoscopic subscore (MES), Baron and Ulcerative Colitis Endoscopic Index of Severity (UCEIS) scores were calculated. C reactive Protein (CRP) and fecal calprotectin (FCAL) was available in 83 and 45.6% of patients. 17.0% had clinical flare, treatment was escalated in 14.6% of patients. Sensitivity, specificity, PPV and NPV values were calculated, ROC analysis and K-statistics were performed. Results Rectal bleeding (RBS), stool frequency (SF) subscore of 0, or total PRO2 remission (RBS 0 and SF ≤1), partial MAYO (≤2) and SCCAI (≤2.5) remission were similarly associated to mucosal healing defined by MES (0 or ≤1) or Baron (0 or ≤1) scores (Table 1). PRO2 (AUCMES0/Baron0: 0.770/0.740, AUCMES0-1/Baron0-1: 0.868/0.858), SF (AUCMES0/Baron0:0.751/0.724, AUCMES0-1/Baron0-1:0842/0.820), RBS (AUCMES0/Baron0: 0.718/0.698, AUCMES0-1/Baron0-1: 0.814/0.845) partial Mayo (AUCMES0/Baron0: 0.823/0.788, AUCMES0-1/Baron0-1: 0.927/0.902) and SCCAI (AUCMES0/Baron0: 0.767/0.752, AUCMES0-1/Baron0-1:0.888/0.867) were similarly associated with mucosal healing in a ROC analysis. There was a strict association between MES 0 and Baron 0 (k=0.917) and UCEIS <4 and MES 0-1 (k=0.813), while moderate to fair agreement between UCEIS <4 and MES 0 (K=0.471) or Baron 0 (K=0.414)/Baron 0-1 (K=0.353), and between MES 0-1 and Baron 0-1 (K= 0.350) scores. Agreement between CRP and clinical remission or endoscopic healing (MES/Baron) was poor (K~0.2), while agreement between FCAL (>100 or >250) and RBS-PRO2 remission (K>100 or >250: 0.44-0.60) or pMAYO (K>100 or >250: 0.41-0.59) or MES/Baron 0 was moderate to good (K>100:0.53-0.52 and K>250:0.57-0.53). Conclusion We found no difference across accuracy of RBS, SF, PRO2, partial Mayo and SCCAI in predicting endoscopic healing. A strong association was found with high PPV for MES/Baron ≤1 and high NPV for MES/Baron 0. FCAL, but not CRP was associated to clinical and endoscopic remission.

scholarly journals P120 Prevalence of endoscopic improvement and endoscopic remission according to patient reported outcomes in ulcerative colitis

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S196-S196
Author(s):  
P Dulai ◽  
S Singh ◽  
V Jairath ◽  
C Ma ◽  
N Narula ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Rectal Bleeding ◽  
Patient Reported Outcomes ◽  
Stool Frequency ◽  
Post Induction ◽  
Mayo Score ◽  
Patient Reported ◽  
Endoscopic Remission ◽  
Prevalence Estimates ◽  
Individual Participant

Abstract Background We aimed to quantify the prevalence of endoscopic improvement (EI) and remission (ER) amongst ulcerative colitis patients with various permutations of patient reported outcomes (PRO) following treatment with biologic agents or tofacitinib. Methods Individual participant data from active intervention and placebo arms of clinical trials of infliximab, golimumab, vedolizumab, and tofacitinib were pooled to estimate the prevalence of EI (Mayo endoscopic sub-score [MES] 0 or 1) and ER (MES 0) scores with various permutations of the rectal bleeding sub-score (RBS) and stool frequency sub-score (SFS) of the Mayo score, following induction (6–8 weeks) and maintenance (30–54 weeks) therapy. Subgroup analyses were performed by year of publication and centrally read endoscopy scoring. Results Data from 2586 trial participants were analysed. Using locally scored endoscopy, the prevalence of EI and ER was highest among participants with a RBS 0 + SFS 0 post induction (EI: 81%, [95% CI 78–84]; ER: 29% [26–33]) and during maintenance (EI: 91% [87–93]; ER: 57% [52–62]). Prevalence estimates were lower for more recently performed trials (p < 0.01). In comparison to locally scored endoscopy, when using central endoscopy scoring the prevalence of EI and ER were lower post-induction (EI 57% [50–64], p < 0.001; ER 15% [11–21], p = 0.09) and during maintenance (EI 74% [67–81], p = 0.001; ER 31% [24–38], p = 0.001) for participants achieving a RBS 0 + SFS 0. Conclusion Approximately eight out of 10 patients with normalisation of rectal bleeding and stool frequency have improvement in endoscopic disease activity, whereas approximately only half of these patients have endoscopic remission.

P773 Patient reported outcomes, partial MAYO score and SCCAI are equally accurate in predicting mucosal healing in UC: Preliminary results from a prospective study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S613-S614
Author(s):  
P Golovics ◽  
L Gonczi ◽  
J Reinglass ◽  
C Verdon ◽  
W Afif ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Disease Activity ◽  
Patient Reported Outcomes ◽  
Roc Analysis ◽  
Activity Index ◽  
Strong Association ◽  
Fecal Calprotectin ◽  
Mucosal Healing ◽  
Patient Reported ◽  
Assessment Of Disease Activity

Abstract Background Optimal management of patients with ulcerative colitis (UC) requires the accurate assessment of disease activity. Endoscopic evaluation is considered the gold standard approach, but it is invasive. We aimed to determine how strong patient reported outcomes, clinical scores and symptoms correlate with endoscopy for assessment of disease activity in UC patients. Methods One hundred and thirty-six patients were included prospectively (age: 48 (IQR: 38–61) years, duration 12 (4–19) years, 63 females, 53.7% extensive disease, 40.4% on biologicals) at the time of the colonoscopy. The 2 item patient reported outcome (PRO), partial MAYO, Simple Clinical Colitis Activity Index (SCCAI), Mayo endoscopic subscore (MES), Baron and Ulcerative Colitis Endoscopic Index of Severity (UCEIS) scores were calculated. C reactive Protein (CRP) and fecal calprotectin (FCAL) was available in 58.1 and 33.8% of patients. 20.7% had clinical flare, treatment was escalated in 17.8% of patients. Sensitivity, specificity, PPV and NPV values were calculated, ROC analysis and K-statistics were performed. Results Rectal bleeding(RBS), stool frequency(SF) subscore of 0, or total PRO2 remission(RBS0 and SF≤1), partial MAYO(≤2) and SCCAI(≤2.5) remission were similarly associated to mucosal healing defined by MES(0 or ≤1) or Baron (0 or ≤1) scores (Table 1). PRO2 remission (AUCMES0/Baron0:0.747/0.715, AUCMES0-1/Baron0-1:0.867/0.863), SF AUCMES0/Baron0:0.731/0.703, AUCMES0-1/Baron0-1:0851/0.839), RBS(AUCMES0/Baron0:0.708/0.685, AUCMES0-1/Baron0-1:0.828/0.835) partial Mayo (AUCMES0/Baron0:0.792/0.755, AUCMES0-1/Baron0-1:0.917/0.903) and SCCAI (AUCMES0/Baron0:0.738/0.724, AUCMES0-1/Baron0-1:0.908/0.880) were similarly associated with mucosal healing in a ROC analysis. There was a string association between MES and Baron (k=0.798), while moderate agreement between UCEIS and MES (K=0.451) or Baron (K=0.499) scores. Agreement between CRP and clinical remission or endoscopic healing (MES/Baron) was poor (K~0.2), while agreement between FCAL (>100 or >250) and RBS-PRO2 remission (K>250:0.56–0.61) or MES/Baron 0 was moderate to good(K>100:0.54-0.53 and K>250:0.50–0.54) Conclusion We found no difference across accuracy of RBS, SF, PRO2, partial Mayo and SCCAI in predicting endoscopic healing. A strong association was found with high PPV for MES/Baron ≤1 and high NPV for MES/Baron 0. FCAL, but not CRP was associated to clinical and endoscopic remission.

scholarly journals Prevalence and risk factors of bowel symptoms in Korean patients with ulcerative colitis in endoscopic remission: a retrospective study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Kwangwoo Nam ◽  
Sang Hyoung Park ◽  
Jun Ho Oh ◽  
Ho-Su Lee ◽  
Soomin Noh ◽  
...  
Keyword(s):  
Risk Factors ◽  
Ulcerative Colitis ◽  
Patient Reported Outcomes ◽  
Significant Risk ◽  
Disease Extent ◽  
Korean Patients ◽  
Female Sex ◽  
Bowel Symptoms ◽  
Patient Reported ◽  
Endoscopic Remission

Abstract Background Many patients with ulcerative colitis (UC) in clinical remission frequently complain of bowel symptoms such as increased stool frequency (SF) and rectal bleeding (RB). However, studies on these patient-reported outcomes in patients with inactive UC are limited, especially in Korea. Therefore, we investigated the prevalence and risk factors of bowel symptoms in Korean patients with inactive UC. Methods We investigated the prevalence of bowel symptoms in patients with endoscopically quiescent UC between June 1989 and December 2016 using a well-characterized referral center-based cohort. The Mayo clinic score (MCS) was used to evaluate bowel symptoms at the most recent visit near the date of endoscopy. Clinical characteristics of the patients were compared based on the presence or absence of bowel symptoms. Results Overall, 741 patients with endoscopically quiescent UC were identified, of whom 222 (30%) and 48 (6.5%) had an SF and RB subscore of ≥ 1, respectively. Patients with bowel symptoms (SF + RB ≥ 1; n = 244 [32.9%]) had higher rates of left-sided colitis (E2) or extensive colitis (E3) than patients without bowel symptoms (SF + RB = 0; n = 497 [67.1%]; P = 0.002). Multivariate analysis revealed that female sex (odds ratio [OR]: 1.568; 95% confidence interval [CI]: 1.023–2.402; P = 0.039) and E2 or E3 (OR 1.411; 95% CI 1.020–1.951; P = 0.038) were the significant risk factors for increased SF. Conclusions This study revealed that one-third of patients with endoscopically quiescent UC reported increased SF. Female sex and disease extent may be associated with bowel symptoms.

scholarly journals Is Tightly Controlled Disease Activity Possible with Online Patient-reported Outcomes?

2014 ◽  
Vol 41 (4) ◽  
pp. 640-647 ◽  
Author(s):  
Margot J. Walter ◽  
S.H. Mohd Din ◽  
Johanna M. Hazes ◽  
E. Lesaffre ◽  
P.J. Barendregt ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Patient Reported Outcomes ◽  
Cross Validation ◽  
Activity Index ◽  
Joint Modeling ◽  
Joint Disease ◽  
Rheumatoid Arthritis Disease ◽  
Patient Reported ◽  
Over Time

Objective.To evaluate the performance of patient-reported outcomes (PRO) as primary indices for identification and prediction of a 28-joint Disease Activity Score (DAS28) > 3.2 among patients with rheumatoid arthritis (RA).Methods.Patients with RA completed monthly online PRO [Health Assessment Questionnaire (HAQ), Rheumatoid Arthritis Disease Activity Index (RADAI), visual analog scale (VAS) fatigue] and were clinically assessed every 3 months using the DAS28. Simple descriptive statistics, logistic regression, and the Bayesian joint modeling approach were used to analyze the data. The Bayesian joint model combines the scores and changes in the scores of 3 PRO to predict a DAS28 > 3.2 at the subsequent timepoint.Results.A group of 159 patients with RA participated. Stratified summaries of the PRO by DAS28 categories at baseline provided incremental values of the PRO for more active disease. However, on an individual level, the DAS28 and the PRO fluctuated over time. The prediction of subsequent DAS score by a single instrument at single timepoints resulted in moderate sensitivity and specificity. Using the intercept and slope of the combined PRO of the first 3 measurements to predict the DAS28 state at 3 months resulted in a sensitivity of 0.81 and a specificity of 0.92. After 10-fold cross validation, the model had a sensitivity of 0.61 and specificity of 0.75 to identify patients with a DAS28 > 3.2.Conclusion.PRO showed fluctuating levels of disease activity over time, while on a group level disease activity stayed the same. Using the changes in RADAI, HAQ, and VAS fatigue over time to predict future DAS28 > 3.2 resulted in moderate performance after the internal cross-validation of the model (sensitivity 0.61, specificity 0.75).

scholarly journals POS1460-HPR MYRA TOUCH FOR DISEASE ACTIVITY EVALUATION IN RHEUMATOID ARTHRITIS: A COMPARISON OF PATIENT-REPORTED OUTCOMES WITH PHYSICIAN’S ASSESSMENT

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1015.1-1015
Author(s):  
L. H. Eow ◽  
J. Yew ◽  
K. H. Lee ◽  
S. Selvadurai ◽  
S. M. Liau ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Inflammatory Markers ◽  
Patient Reported Outcomes ◽  
Activity Index ◽  
Disease Assessment ◽  
Activity Measurement ◽  
Patient Reported ◽  
Rheumatology Unit ◽  
High Level

Background:Patient-reported outcomes (PROs) have become an essential component of patients’ assessment in the management of Rheumatoid Arthritis(RA).They have been reported to be at least as informative if not more than physician assessed outcomes.MyRA Touch was pioneered by the Rheumatology Unit of Hospital Tuanku Jaa’far in Seremban Malaysia in March 2018,to engage and empower all RA patients on their own disease activity monitoring. It is an electronic platform, designed to enhanced the application of electronic patient reported outcomes (ePROs) among RA patients where they examine and record their own painful and/or swollen joints for DAS28 calculation and report their health assessment through Routine Assessment of Patient Index Data with 3 Measures (RAPID 3).MyRA Touch is an applications (App) that is user friendly and available in four major spoken languages (English, Chinese, Malay and Tamil) with an animated version for patients who are illiterate.Objectives:The objectives of this study are to determine the correlation between:I)Patient-reported and physician reported DAS28 ESR/CRPII)RAPID3 and Clinical Disease activity Index (CDAI)III)RAPID3 and DAS28 ESR/CRP assessed by physician and patientIV)RAPID3 and inflammatory markers ESR/CRP.Methods:This was a cross-sectional study carried out in the Rheumatology Unit of Hospital Tuanku Jaa’far. All data entered through MyRA Touch App from April 2018 till April 2020 was analysed.Results:There were a total of 562 patients who entered the data in the App, 87.9% were women. The ethnic compositions of the study subjects comprised of Indians (36.7%) followed by the Malays (34.7%),Chinese (26.3%) and other ethnics (2.3%). About half of patients (59.8%) were in the 51-70 age group whereas 22.9%,1.8% and 15.5% were in the 31-50,18-30 and above 70 age groups respectively. The majority of our patients (96%) were literate. A total of 54.3% of them received secondary education, 27% primary, 12.2% tertiary and 6.6% did not receive any formal education.There was a high level of correlation between DAS28 ESR/CRP performed by patient and DAS28 ESR/CRP assessed by physician, (r=0.808 for DAS28 ESR and r=0.804 for DAS28 CRP). RAPID3 also showed high level of correlation with CDAI and DAS28 CRP assessed by patient (r=0.700 and r=0.718 respectively). There was a moderate correlation between DAS28 ESR/CRP done by physician with RAPID3 (r=0.656 and r=0.696 respectively).RAPID3 demonstrated little correlation with inflammatory markers ESR and CRP (r=0.141 and r=0.171 respectively).Conclusion:PROs via DAS 28 (ESR/CRP) and RAPID3 showed moderate to high correlation with disease activity assessed by physician. We can empower patients to perform their own disease assessment by using the MyRA Touch App before seeing their physician and the information provided in the App, can help to reduced consultation time. During the COVID-19 pandemic, telemedicine is very much encouraged. By using the MyRA Touch, patients can assess their own tender and swollen joint count on a homunculus, evaluate their own physical function, health and pain using the RAPID3 parameters. The information obtained from the PROs in the MyRA touch App enables the physician to make a more comprehensive virtual assessment of the patient’s condition which helps in treatment decision making. In conclusion, MyRA Touch is an useful tool for disease activity measurement by patient.References:[1]Jenny AA, Diana BC, Omar JC, et al. Usefulness of Patients-Reported Outcomes in Rheumatoid Arthritis Focus Group. Hindawi Publishing Corporation Arthritis, vol 2012,Article ID935187.[2]Ana MO, Clifton OB. Patient Reported Outcomes in Rheumatoid Arthritis Clinical Trials. Curr Rheumato Rep.2015 April;17(4):501.Disclosure of Interests:None declared

scholarly journals Impact of assessing patient-reported outcomes with mobile apps on patient–provider interaction

RMD Open ◽  
2021 ◽  
Vol 7 (1) ◽  
pp. e001566
Author(s):  
Yomei Shaw ◽  
Delphine S Courvoisier ◽  
Almut Scherer ◽  
Adrian Ciurea ◽  
Thomas Lehmann ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Rheumatic Diseases ◽  
Patient Reported Outcomes ◽  
Activity Index ◽  
Mobile Apps ◽  
Disease Activity Index ◽  
Discussion Group ◽  
Patient Reported ◽  
Physician Awareness

ObjectiveTo explore the effect of apps measuring patient-reported outcomes (PROs) on patient–provider interaction in the rheumatic diseases in an observational setting.MethodsPatients in the Swiss Clinical Quality Management in Rheumatic Diseases Registry were offered mobile apps (iDialog and COmPASS) to track disease status between rheumatology visits using validated PROs (Rheumatoid Arthritis Disease Activity Index-5 score, Bath Ankylosing Spondylitis Disease Activity Index score, Routine Assessment of Patient Index Data-3 score and Visual Analogue Scale score for pain, disease activity and skin symptoms). We assessed two aspects of patient–provider interaction: shared decision making (SDM) and physician awareness of disease fluctuations. We used logistic regressions to compare outcomes among patients who (1) used an app and discussed app data with their physician (app+discussion group), (2) used an app without discussing the data (app-only group) or (3) did not use any app (non-app users).Results2111 patients were analysed, including 1799 non-app users, 150 app-only users and 162 app+discussion users (43% male; with 902 patients with rheumatoid arthritis, 766 patients with axial spondyloarthritis and 443 patients with psoriatic arthritis). App users were younger than non-app users (mean age of 47 vs 51 years, p<0.001). Compared with non-app users, the app+discussion group rated their rheumatologist more highly in SDM (OR 1.7, 95% CI 1.1 to 2.4) and physician awareness of disease fluctuations (OR 2.0, 95% CI 1.3 to 3.1). This improvement was absent in the app-only group.ConclusionApp users who discussed app data with their rheumatologist reported more favourably on patient–provider interactions than app users who did not and non-app users. Apps measuring PROs may contribute little to patient–provider interactions without integration of app data into care processes.

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