scholarly journals DOP18 UCEIS is associated with PRO2, partial Mayo and SCCAI remission in UC: Final results from a prospective study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S056-S057
Author(s):  
P Golovics ◽  
L Gonczi ◽  
J Reinglas ◽  
C Verdon ◽  
S Pundir ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Roc Analysis ◽  
Clinical Decision Making ◽  
Activity Index ◽  
Clinical Decision ◽  
Operating Characteristics ◽  
Patient Reported ◽  
Index Of Severity ◽  
Active Disease

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 the operating characteristics of the Ulcerative Colitis Endoscopic Index of Severity (UCEIS), to quantify the cut off most closely correlated with clinical remission or activity and determine agreement with the Mayo endoscopic subscore (MES), Baron score, clinical scores and biomarkers. 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. Ulcerative Colitis Endoscopic Index of Severity (UCEIS) Mayo endoscopic subscore (MES), Baron scores were calculated, as well as the 2 item patient reported outcome (PRO), partial MAYO, Simple Clinical Colitis Activity Index (SCCAI). 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 UCEIS was strongly associated to PRO2 SF (AUC:0.863), RBS (AUC:0.924), PRO2 combined (AUC:0.898), partial MAYO (AUC:0.945) and SCCAI (AUC:0.901) remission in a ROC analysis. A UCEIS of ≤3 was identified as the best cut-off to identify RBS subscore of 0, or total PRO2 remission (RBS 0 and SF ≤1), partial MAYO (≤2) and SCCAI (≤2.5) remission, while a UCEIS≥4 identified active disease frequently needing change in medical therapy. A moderate agreement was found between UCEIS <4 and MES 0 (K=0.471) or Baron 0 (K=0.414)/Baron 0–1 (K=0.353). Correlation between FCAL and UCEIS (coeff:0.701, p<0.0001) was strong, while modest only with CRP (coeff:0.248, p=0.01). Conclusion UCEIS was strongly associated with clinical remission defined as PRO2, SF, RBS, partial Mayo or SCCAI with best agreement with RBS and partial Mayo remission. A UCEIS of ≤3 was identified as a cut-off for quiescent disease, while a UCEIS≥4 identified active disease, which can support clinical decision-making based on endoscopic findings. Agreement between UCEIS and FCAL was strong, while agreement with UCEIS and MES/Baron scores was moderate.

scholarly journals P807 UCEIS is associated with PRO2, partial Mayo and SCCAI remission in UC: preliminary results from a prospective study

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S631-S631
Author(s):  
P A Golovics ◽  
L Gonczi ◽  
J Reinglass ◽  
C Verdon ◽  
W Afif ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Remission ◽  
Roc Analysis ◽  
Clinical Decision Making ◽  
Activity Index ◽  
Operating Characteristics ◽  
Faecal Calprotectin ◽  
Patient Reported ◽  
Index Of Severity ◽  
Active Disease

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 the operating characteristics of the Ulcerative Colitis Endoscopic Index of Severity (UCEIS), to quantify the cut off most closely correlated with clinical remission or activity and determine agreement with the Mayo endoscopic subscore (MES), Baron score, clinical scores and biomarkers. Methods 136 patients were included prospectively (age: 48 (IQR38-61) years, duration 12 (4–19)years, 63 females, 53.7% extensive disease, 40.4% on biologicals) at the time of the colonoscopy. Ulcerative Colitis Endoscopic Index of Severity (UCEIS) Mayo endoscopic subscore (MES), Baron scores were calculated, as well as the2 item patient reported outcome (PRO), partial MAYO, Simple Clinical Colitis Activity Index (SCCAI). CRP and faecal 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. ROC analysis and K-statistics were performed and Spearman’s correlation was calculated. Results UCEIS was strongly associated to PRO2 SF (AUC:0.866), RBS (AUC:0.921), PRO2 combined remission (AUC:0.905), partial MAYO (AUC:0.956) and SCCAI (AUC:0.907) remission in a ROC analysis. A UCEIS of ≤3 was identified as the best cut-off to identify RBS subscore of 0, or total PRO2 remission (RBS 0 and SF ≤1), partial MAYO (≤2) and SCCAI (≤2.5) remission, while a UCEIS≥4 identified active disease frequently needing change in medical therapy. A moderate agreement was found between UCEIS and MES (K=0.451) or Baron (K=0.499) scores. Correlation between FCAL and UCEIS (coeff:0.743, p < 0.0001) was strong, while modest only with CRP (coeff:0.333, p = 0.01). Conclusion A UCEIS was strongly associated with clinical remission defined as PRO2, SF, RBS, partial Mayo or SCCAI with best agreement with RBS and partial Mayo remission. A UCEIS of ≤3 was identified as a cut-off for quiescent disease, while a UCEIS≥4 identified active disease, which can support clinical decision-making based on endoscopic findings. Agreement between UCEIS and FCAL was strong, while agreement with UCEIS and MES/Baron scores was moderate.

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 Fecal Calprotectin and Clinical Disease Activity in Pediatric Ulcerative Colitis

2013 ◽  
Vol 2013 ◽  
pp. 1-5 ◽  
Author(s):  
Kaija-Leena Kolho ◽  
Dan Turner
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Outcome ◽  
Roc Curve ◽  
Clinical Remission ◽  
Activity Index ◽  
Fecal Calprotectin ◽  
Elisa Test ◽  
Clinical Activity ◽  
High Level ◽  
Active Disease

Objective. To explore fecal calprotectin levels in pediatric ulcerative colitis (UC) in relation with the validated clinical activity index PUCAI. Methods. This study included all 37 children (median age 14 years) with UC who had calprotectin measured (PhiCal ELISA Test) by the time of PUCAI assessment at the Children's Hospital of Helsinki in a total of 62 visits. Calprotectin values <100 μg/g of stool were considered as normal. The best cut-off value of each measure to predict 3-month clinical outcome was derived by maximizing sensitivity and specificity. Results. In clinically active disease (PUCAI ≥ 10), calprotectin was elevated in 29/32 patients (91% sensitivity). When in clinical remission, 26% (8/30) of the children had normal calprotectin but 7 (23%) had an exceedingly high level (>1000 μg/g). The best cut-off value for calprotectin for predicting poor outcome was 800 μg/g (sensitivity 73%, specificity 72%; area under the ROC curve being 0.71 (95%CI 0.57–0.85)) and for the PUCAI best cut-off values >10 (sensitivity 62%, specificity 64%; area under the ROC curve 0.714 (95%CI 0.58–0.85)). Conclusion. The clinical relevance of somewhat elevated calprotectin during clinical remission in pediatric UC is not known and, until further evidence accumulates, does not indicate therapy escalation.

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 (&gt;100 or &gt;250) and RBS-PRO2 remission (K&gt;250:0.56–0.61) or MES/Baron 0 was moderate to good(K&gt;100:0.54-0.53 and K&gt;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 Crohn’s disease and ulcerative colitis patient-reported outcomes signs and symptoms for the remote management of inflammatory bowel disease during the COVID-19 pandemic

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Sergio Pinto ◽  
Erica Loddo ◽  
Salvatore Paba ◽  
Agnese Favale ◽  
Fabio Chicco ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Crohn’S Disease ◽  
Bowel Disease ◽  
Patient Reported Outcomes ◽  
Signs And Symptoms ◽  
Patient Reported ◽  
Inflammatory Bowel ◽  
Active Patients ◽  
Active Disease

Abstract Background and aims The COVID-19 pandemic has led to a deep reorganization of hospital services including inflammatory bowel disease (IBD) units. In this situation, conversion of in-person routine follow-up visits into phone consultations might be necessary. Here we explored the feasibility of using the validated Crohn’s Disease (CD) or Ulcerative Colitis (UC) Patient-Reported Outcomes Signs and Symptoms (CD- and UC-PRO/SS) to collect data about abdominal symptoms (abdominal/S) and bowel signs and symptoms (bowel/SS) remotely. Methods CD- and UC-PRO/SS were collected during phone consultations and compared among patients with active and inactive disease. The effectiveness of therapeutic intervention in patients with active disease was assessed by PRO/SS variation. Results Twenty-one CD and 56 UC patients were evaluated by phone. Six (28.6%) CD and 15 (26.8%) UC patients were considered to have active disease. In CD the bowel/SS but not the abdominal/S module was significantly higher in active patients (mean bowel/SS 2.50 [SE ± 0.44] active vs 0.76 [SE ± 0.18] remission, p = 0.008, AUC 0.87; mean abdominal/S 1.11 [SE ± 0.38] active vs 0.24 [SE ± 0.13] remission, p = 0.066). UC-PRO/SS measures were significantly higher in active patients as compared to patients in remission (median bowel/SS 1.63 [SE ± 0.24] active vs 0.33 [SE ± 0.04] remission; p < 0.0001, AUC 0.91; mean abdominal/S 1.03 [SE ± 0.24] vs 0.37 [SE ± 0.12]; p = 0.009, AUC 0.71). Therapy was escalated in 12 patients (3 CD and 9 UC) due to disease relapse. Therapy escalation resulted in the reduction of PRO/SS as evaluated at the subsequent phone consultation. Conclusions PRO/SS might represent a feasible tool to evaluate disease activity and therapy outcome in IBD patients during periods of limited access to outpatient clinics.

Between a logic of disruption and a logic of continuation: Negotiating the legitimacy of algorithms used in automated clinical decision-making

2021 ◽  
pp. 136345932199674
Author(s):  
Rikke Torenholt ◽  
Henriette Langstrup
Keyword(s):  
Decision Making ◽  
Clinical Practice ◽  
Patient Reported Outcomes ◽  
Patient Involvement ◽  
Clinical Decision Making ◽  
Diagnostic Procedures ◽  
Clinical Decision ◽  
Patient Reported ◽  
Pro Tools

In both popular and academic discussions of the use of algorithms in clinical practice, narratives often draw on the decisive potentialities of algorithms and come with the belief that algorithms will substantially transform healthcare. We suggest that this approach is associated with a logic of disruption. However, we argue that in clinical practice alongside this logic, another and less recognised logic exists, namely that of continuation: here the use of algorithms constitutes part of an established practice. Applying these logics as our analytical framing, we set out to explore how algorithms for clinical decision-making are enacted by political stakeholders, healthcare professionals, and patients, and in doing so, study how the legitimacy of delegating to an algorithm is negotiated and obtained. Empirically we draw on ethnographic fieldwork carried out in relation to attempts in Denmark to develop and implement Patient Reported Outcomes (PRO) tools – involving algorithmic sorting – in clinical practice. We follow the work within two disease areas: heart rehabilitation and breast cancer follow-up care. We show how at the political level, algorithms constitute tools for disrupting inefficient work and unsystematic patient involvement, whereas closer to the clinical practice, algorithms constitute a continuation of standardised and evidence-based diagnostic procedures and a continuation of the physicians’ expertise and authority. We argue that the co-existence of the two logics have implications as both provide a push towards the use of algorithms and how a logic of continuation may divert attention away from new issues introduced with automated digital decision-support systems.

scholarly journals Call for action: how to improve use of patient-reported outcomes to guide clinical decision making in rheumatoid arthritis

2018 ◽  
Vol 38 (6) ◽  
pp. 935-947 ◽  
Author(s):  
Bruno Fautrel ◽  
Rieke Alten ◽  
Bruce Kirkham ◽  
Inmaculada de la Torre ◽  
Frederick Durand ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Decision Making ◽  
Patient Reported Outcomes ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Patient Reported

Novel Leucocyte/Thrombocyte Apheresis for Induction of Steroid-Free Remission in Ulcerative Colitis: A Controlled Randomized Pilot Study

2019 ◽  
Vol 13 (7) ◽  
pp. 949-953 ◽  
Author(s):  
Wolfgang Kruis ◽  
Phuong Nguyen ◽  
Julia Morgenstern ◽  
Wolfgang Ramlow ◽  
Axel Dignaß ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Pilot Study ◽  
Clinical Remission ◽  
Activity Index ◽  
Disease Activity Index ◽  
Oral Prednisolone ◽  
Serious Adverse Events ◽  
Symptomatic Infection ◽  
Reactive Protein ◽  
Group A

Abstract Background and Aims In active ulcerative colitis [UC] refractory to mesalazine, escalation to either steroids or immunosuppression is common practice. The efficacy and safety of alternative escalation therapy with a novel leukocyte apheresis device were studied. Methods This was a prospective, randomized, controlled multicentre pilot study comparing leukocyte apheresis with prednisolone in refractory UC (disease activity index [DAI] ≥ 4 and ≤8). Group A received weekly apheresis over five consecutive weeks. Group P received oral prednisolone 40 mg/day tapered to 0 mg at week 6. The primary end point was steroid-free clinical remission [DAI ≤ 2] at week 12. Clinical response was also analysed. Results Twenty-four patients were enrolled, 13 of whom were randomized into group A and 11 into group P. Clinical remission off steroids at week 12 was achieved in 3/12 patients [25.0%] with apheresis and 2/10 [20.0%] with prednisolone [p = 1.0]. The response rate after 12 weeks was 75.0% in group A and 50.0% in group P. Mean DAI scores improved in both treatment groups [p = 0.008]. C-reactive protein decreased from 6.0 ± 5.3 to 3.8 ± 3.7 mg/L at 12 weeks in group A and increased from 5.2 ± 6.0 to 6.3 ± 7.9 mg/mL in group P. Both treatments were well tolerated. No unexpected serious adverse events were seen in group A. In group P one symptomatic infection with Clostridium difficile occurred. Conclusions In patients with active UC refractory to mesalazine a novel leukocyte apheresis showed promising results. A comparison with prednisolone revealed similar therapeutic effectivity and excellent safety, providing the chance to escalate without systemic steroids.

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