SIBDQ Score Research Articles

Acceptability, feasibility, and impact of the MyGut digital health platform in the monitoring and management of inflammatory bowel disease

Abstract Background Digital health monitoring may help facilitate self-management strategies when caring for patients with inflammatory bowel disease (IBD). Aims This study investigated the feasibility of implementing the MyGut health application when caring for patients with IBD and evaluated whether its use improved health outcomes. Methods We conducted a prospective trial in 2 Canadian hospitals from 2020 to 2023. Patients with IBD were recruited from gastroenterology clinics, and the MyGut application was installed onto their mobile devices. Metrics such as acceptability, satisfaction, feasibility, quality-of-life scores (measured through the short IBD questionnaire [SIBDQ]), and resource utilization were collected throughout the 1-year follow-up period. Results Of the 84 patients enrolled, 58 patients (69%) continued to use the app until the study completion. At recruitment, all 84 patients (100%) were willing to use the MyGut application after a brief tutorial. There was a significant improvement in the SIBDQ scores after 1 year of MyGut use (mean = 56.0, SD 8.85 vs 52.0, SD 9.84) (P = .012). However, only 42.9% (21/49) of the patients were willing to continue using the application after 1 year, a significant decrease compared with the 71.4% (35/49) who were willing to continue after 2 months (P = .001). No differences were observed in the number of emergency room visits/hospitalizations (P = .78) before and after 1 year of MyGut use. Conclusions This study demonstrates that patients are willing to use digital health monitoring platforms and this may lead to improved quality of life. However, sustained efforts must be made to optimize its long-term feasibility.

Motivations behind complementary and alternative medicine use in patients with Crohn's disease and ulcerative colitis.

Complementary and alternative medicine (CAM) use is common in inflammatory bowel disease (IBD) patients and impacts compliance with conventional treatment. Gastroenterologists should understand the motivational factors of CAM use-factors that push patients away from standard therapy or pull towards CAM. Our study describes the motivations behind CAM use for IBD and evaluates differences between Crohn's disease (CD) and ulcerative colitis (UC) patients. Retrospective cohort survey of patients over 18 years old with IBD, evaluated by gastroenterologists at a tertiary care referral centre from January 1 to December 31, 2019. Only patients who reported CAM use were included. Chi-square and independent t-tests were performed and P-value <0.05 was significant. Of the 230 completed surveys, 193 reported CAM use (CD: 57.5% vs UC: 42.5%). Demographics, disease duration, and hospitalizations were similar, but CD patients had lower SIBDQ scores (CD: 48.1 vs UC: 53.5, P < 0.001). Both groups were largely influenced by their social network to use CAM (CD: 33% vs UC: 31.3%) and did not feel well informed about CAM (87.4%). CD and UC patients had similar push and pull factors. Push factors included lack of improvement (39%) and side effects (20%) with conventional treatment. Pull factors included the desire for a holistic approach (21%) and to improve mood (35%). UC patients wanted a natural approach to treat their IBD, which nearly reached significance (P = 0.049). Most patients hoped fatigue 62.7%, and diarrhoea 61.7% would improve with CAM, but more CD patients wanted to improve their appetite (P = 0.043). Despite differences in QoL, push and pull motivations for CAM use did not differ between CD and UC patients. Most users do not feel well informed of CAM and ongoing dialogue is important for patient-centred care.

Surgically-relevant quality of life thresholds for the Short Inflammatory Bowel Disease Questionnaire in Crohn’s disease

Background or PurposeDespite interest in patient-reported outcome measures to track progression in Crohn’s disease, frameworks to apply these questionnaires in the preoperative setting are lacking. Using the short inflammatory bowel disease questionnaire (sIBDQ), this study aimed to describe interpretable quality of life thresholds and examine potential associations with future bowel resection in Crohn’s disease. MethodsAdult Crohn’s disease patients completing an sIBDQ at a clinic visit between 2020-2022 were eligible. A stoplight framework was adopted for sIBDQ scores, including a ‘Resection Red zone’ suggesting poor quality of life that may benefit from discussions about surgery as well as a ‘Nonoperative Green’ zone. Thresholds were identified with both anchor- and distribution-based methods using receiver operating characteristic curve analysis and subgroup percentile scores, respectively. To quantify associations between sIBDQ scores and subsequent bowel resection, multivariable logistic regression models were fit with covariates of age, sex, body mass index, medications, disease pattern and location, resection history, and the Harvey Bradshaw Index. Incremental discriminatory value of the sIBDQ beyond clinical factors was assessed through area under the receiver operating characteristics curve (AUC) with an internal validation through bootstrap resampling. ResultsOf 2003 included patients, 102 underwent Crohn’s-related bowel resection. The sIBDQ Nonoperative Green zone threshold ranged from 61 to 64 and the Resection Red zone from 36 to 38. When adjusting for clinical covariates, a worse sIBDQ score was associated with greater odds of subsequent 90-day bowel resection when considered as a one-point (OR [95% CI], 1.05 [1.03-1.07]) or five-point change (OR [95% CI], 1.25 [1.13-1.40]). Inclusion of the sIBDQ modestly improved discriminative performance (AUC [95% CI] 0.85 [0.85 – 0.86]) relative to models that included only demographics (0.57 [0.57 – 0.58]) or demographics with clinical covariates (0.83 [0.83 – 0.84]). Discussion or ConclusionIn the decision-making process for bowel resection, disease-specific patient-reported outcome measures may be useful to identify Crohn’s disease patients with poor quality of life and promote shared understanding of personalized burden.

A239 MOTIVATIONS BEHIND CAM USE IN PATIENTS WITH CROHN'S DISEASE AND ULCERATIVE COLITIS

Abstract Background Complementary and alternative medicine (CAM) use is common in IBD patients and impacts compliance with conventional treatment. Gastroenterologists should understand the motivational factors of CAM use—factors that push patients away from standard therapy or pull towards CAM. Our study describes the motivations behind CAM use for IBD and evaluates differences between CD and UC patients. Aims To compare the motivations behind CAM use between CD and UC patients. Methods Retrospective cohort survey of patients over 18 years old with IBD, evaluated by gastroenterologists at a tertiary care referral centre from January 1 to December 31, 2019. Only patients that reported CAM use were included. Chi-square and independent t-tests were performed and p-value ampersand:003C0.05 was significant. Results Of the 230 completed surveys, 193 reported CAM use (CD:57.5% &amp; UC:42.5%). Demographics, disease duration and hospitalizations were similar, but CD patients had lower SIBDQ scores (CD:48.1 &amp; UC:53.5 pampersand:003C0.001). Both groups were largely influenced by their social network to use CAM (CD:33% &amp; UC:31.3%) and did not feel well informed of CAM (87.4%). CD and UC patients had similar push and pull factors. Push factors included lack of improvement (39%) and side effects (20%) with conventional treatment. Pull factors included the desire for a holistic approach (21%) and to improve mood (35%). Most patients hoped fatigue 62.7%, diarrhea 61.7% and abdominal pain 58.0% would improve with CAM. Conclusions Despite differences in QoL, push and pull motivations for CAM use do not differ between CD and UC patients. Most users do not feel well informed of CAM and ongoing dialogue is important for patient-centred care. Table 1: Characteristics of CAM use Funding Agencies None

Comprehensive assessment of nutritional and functional status of patients with ulcerative colitis and their impact on quality of life.

Patients with ulcerative colitis (UC) are likely to have poor nutritional intake and increased gut losses. This study was designed to study the prevalence and predictors of nutritional deficiencies in patients with UC and their impact on thequality of life (QOL). A prospective study was conducted among consenting patients with UC (cases) and healthy relatives of the cases (controls) visiting a university teaching hospital. They were assessed for clinical, demographic, endoscopic (Mayo score) and histological profile (Robart's score). They were assessed for thepresence of macronutrient and micronutrient deficiency, anthropometry, functional status (muscle strength by dynamometer and sit-to-stand test) and thequality of life (short inflammatory bowel disease questionnaire [SIBDQ]). A SIBDQ score of ≤ 50 was considered poor QOL. We studied 126 cases and 57 healthy controls (age [mean ± SD] 37.7 ± 13.2years vs. 34.40 ± 11.05years; [p = 0.10] females [38.1% vs. 38.7%]; p = 0.94). Cases more often were underweight (28% vs. 3.5%; p < 0.001), had low mid arm circumference (45% vs. 12%; p < 0.0001), lower functional status in the form of weaker hand grip strength (67% vs. 45.6%; p = 0.007) and weaker lower limb strength (80% vs. 42%; p < 0.0001). Cases more often hadthe evidence of macronutrient deficiencies: total serum protein deficiency (31% vs. 3.5%; p < 0.0001), serum albumin deficiency (25.4% vs. 0.00%; p < 0.0001) and cholesterol deficiency (63% vs. 28%; p < 0.0001). Micronutrient deficiencies were highly prevalent among cases: calcium (44%), phosphate (21%), magnesium (11%), zinc (76%), iron (87%), folate (16%), vitamin B12 (10%) and vitamin D (81%). Most cases had a poor quality of life (85/126; 67.5%). Factors associated with poor QOL were low hemoglobin, serum albumin, zinc and vitamin D levels and histologically active disease. On multi-variate analysis, low vitamin D levels (odds ratio [OR] = 6.1; 95%confidence interval [CI]: 1.9-19.7) and histologically active disease (OR = 4.0; 95%CI: 1.6-9.9) were identified as independent predictors of poor QOL. Macronutrient deficiency, micronutrient deficiency, lower functional status and poorer QOL are highly prevalent among patients with UC. The independent predictors of poor QOL were histologically active disease and low serum vitamin D levels. Identifying and correcting the deficiencies may help in improving the QOL of patients with UC.

P681 Preliminary data from the Biologic and Partial Enteral Nutrition in Crohn’s Disease Study (BIOPIC)

Abstract Background Biologics such as adalimumab (ADA) are used to induce clinical remission (CR) in individuals with active Crohn’s disease (CD) but around 50% of patients actually achieve clinical remission. Exclusive enteral nutrition is also an effective induction treatment, but tolerability limits its use, especially in adults. This study aimed to assess the efficacy and tolerability of partial enteral nutrition (PEN) in combination with ADA compared to ADA monotherapy. Methods In this multi-centre (n=8) RCT (NCT04859088), adults with active CD (Crohn’s Disease Activity Index, CDAI ≥ 150) due to start ADA as their first-line biologic were randomised to either continue their habitual unrestricted diet (UD) or to replace half of it with PEN during their first 6 weeks of induction treatment Primary outcome clinical efficacy (i.e., clinical response, CDAI baseline decrease of ≥ 70 or CR, CDAI score &amp;lt;150) was assessed after 12 weeks of ADA initiation. Secondary outcomes included changes in inflammatory markers (faecal calprotectin, (FCAL), CRP) and quality of life (SIBDQ), at 3 (only FCAL), 6 and 12 weeks. To calculate adherence to PEN, used/unused tins were returned and compared to number provided. Analysis was performed using intention-to-treat analysis. Results 32 participants (13 UD, 19 PEN) have completed the study; 29 (13 UD, 16 PEN) of whom completed the full 12 weeks of the study. Adherence rate to PEN was high (~96%). Clinical efficacy (response &amp; remission) was UD: 92% vs PEN: 84%, p=0.490 at 6 weeks and UD: 85% vs PEN: 58%, p=0.11 at week 12. FCAL data was available for 22 participants (9 UD, 13 PEN). FCAL (g/g) significantly decreased after 12 weeks in patients receiving PEN (mean difference 189, p=0.009) but this effect did not quite reach statistical significance (p=0.052) in the UD group (Fig 1). Proportionally more patients from the PEN group had FCAL &amp;lt;100 mg/kg compared to the UD group (3, 6, 12 weeks, PEN: 62%, 69%, 69% vs UD: 33%, 33%, 56%) during the study course. CRP (mg/L) significantly decreased at week 6 and 12 in patients receiving PEN (week 6 &amp; week 12, p&amp;lt;0.0001) and in patients continuing their UD (week 6, p=0.001, week 12, p=0.007). SIBDQ score increased in both groups (PEN, p=0.023 vs UD, p=0.008). Conclusion Preliminary data from the BIOPIC study suggests equivalence in clinical efficacy between the two groups but better responses to blood and gut inflammatory markers when ADA is combined with PEN. High tolerability of PEN suggests it can be a viable option for adult patients with active luminal CD.

Bowel Urgency in Patients with Ulcerative Colitis and Crohn's Disease: A Cross-Sectional Real-World Survey in Japan.

Bowel urgency (BU) is among the most disruptive of inflammatory bowel disease (IBD) symptoms. However, data on its prevalence and association with disease activity are limited. This real-world study of Japanese patients with IBD evaluated BU prevalence and compared clinical outcomes and health-related quality of life (HRQoL) between patients with and without BU. Data were drawn from the Adelphi IBD Disease Specific Programme™, a cross-sectional survey of physicians and their patients with ulcerative colitis (UC) and Crohn's disease (CD). Physicians reported demographic and clinical data, including disease activity measures (Mayo score and CD Activity Index [CDAI]), for consulting patients, who voluntarily completed a patient-reported questionnaire, including HRQoL measures (Short IBD Questionnaire [SIBDQ] and EQ-5D-5L). Outcomes were compared between patients with and without BU using t-, Fisher exact and Mann-Whitney U tests as appropriate. Of 120 UC patients, 27.5% (n = 33) self-reported BU; physicians were unaware of BU in 54.5% (n = 18) of these patients. Patients with BU had higher mean Mayo scores (p < 0.01) and lower mean SIBDQ scores (47.9 vs 56.6, p < 0.01) than patients without BU, with mean EQ-5D-5L scores 0.83 and 0.87, respectively (p = 0.06). Physicians were satisfied with treatment but believed better control could be achieved for 39.4% of patients with BU and 35.6% without. Of 114 CD patients, 17.5% (n = 20) self-reported BU; physicians were unaware of BU in 75.0% (n = 15) of these patients. Patients with BU had higher mean CDAI scores (p < 0.01) and lower mean SIBDQ (48.7 vs 56.2, p < 0.01) and EQ-5D-5L scores (0.81 vs 0.88, p < 0.01) than patients without BU. Physicians were satisfied but believed better control could be achieved for 40.0% of patients with BU vs 19.1% without. Patients with BU have worse clinical outcomes and HRQoL than patients without, underlining the need for improved physician-patient communication regarding BU and new IBD therapeutic options.

Real-World Endoscopic and Histologic Outcomes in Ulcerative Colitis Patients: A Retrospective Cohort Study.

Histologic activity has emerged as an aspirational therapeutic goal in ulcerative colitis management. It is not yet a formal treatment target in ulcerative colitis. However, it could be used as an adjunct to mucosal healing to represent a deeper level of healing. We investigated mucosal and histologic remission rates and potential predictors of these outcomes in a cohort of UC patients. We conducted a retrospective analysis of data collected from UC patients enrolled in an ongoing prospective cohort study. Mucosal healing was defined as Mayo endoscopic score = 0. A total of 131 patients with ulcerative colitis were enrolled in our study and were prospectively followed for a median length of 2 years (range 0-5 years), totaling 266 study visits. Mucosal healing was recorded for 27 patients at 70 (26%) different study visits. For patients with mucosal healing, histologic remission was achieved in 18/27 (66%) patients. On univariate analysis, sustained clinical remission, SIBDQ scores ≥ 5.5, CRP ≤ 5 mg/dL and absence of corticotherapy were associated with mucosal healing and SIBDQ scores ≥ 5.5 and CRP ≤ 5 mg/dL with histologic healing, respectively. After logistic regression analysis, none of the investigated factors were associated with mucosal and histologic healing. The number of CD8+ intraepithelial lymphocytes (IELs) was significantly greater than the number of CD4+ IELs in periods of disease activity, as well as during mucosal healing (p < 0.01 in both cases). Mucosal healing and histologic remission rates are low in real-life settings. The results of univariate analysis indicate that a good quality of life (SIBDQ score) and normal inflammatory markers (CRP) are associated with mucosal and histologic healing. However, frequently used patient- and disease-related factors, including mucosal healing, are not reliable predictors for histologic remission. Greater CD8+ lymphocyte involvement and higher CD8+/CD4+ distribution can have a meaningful impact on understanding the pathogenesis and natural history of ulcerative colitis, as well as future treatment options for lymphocyte-targeting medications.

P624 Investigating the symptom burden among European patients with moderate-to-severe Crohn’s disease using a real-world survey

Abstract Background Despite treatment, patients with Crohn’s disease (CD) experience symptoms that affect their health-related quality of life (HRQoL). Understanding how CD affects HRQoL reveals valuable insight into disease impact. We aimed to examine the disease burden in patients with moderate-to-severe CD in remission vs not in remission using real-world, gastroenterologist (GE)- and patient-reported data. Methods Data were drawn from the Adelphi Inflammatory Bowel Disease (IBD) Disease Specific Programme,1 a point-in-time survey conducted in France, Germany, Italy and Spain from October 2020 to March 2021. GEs collected data from the next 5–8 consecutive patients (≥18 years old, not involved in clinical trials) with a CD diagnosis who they saw in clinical practice. GEs reported patient demographics, clinical characteristics (including remission status) and treatment history. Patients completed questionnaires on their treatment satisfaction, symptoms and HRQoL (Short Inflammatory Bowel Disease Questionnaire [SIBDQ] and EQ-5D scores). Scores were compared among patients in remission vs not in remission using propensity score matching (PSM). Results Overall, 133 GEs reported on 538 patients with CD (Table 1). Overall, 66.0% of patients were employed, and of those not working, 24.3% were not working due to CD. Most patients (70.9%) had received ≥2 lines of treatment and 43.3% of patients were receiving a tumour necrosis factor (TNF) inhibitor. Of 427 patients from whom complete data were available and were therefore included in PSM analyses, 70.0% (n=299) were in remission. Although patients in remission were generally less likely than those not in remission to experience CD symptoms, they were still moderately likely to experience symptoms such as fatigue/tiredness and abdominal pain (Figure 1). Similarly, whilst patients in remission had better mean SIBDQ and EQ-5D scores than those not in remission, their scores still indicated diminished HRQoL (Figure 2). Of patients for whom symptom data were provided, 39.2% were either not satisfied with their current treatment or believed that better disease control could be achieved. A higher proportion of patients who were dissatisfied with their treatment reported residual symptoms than those who were satisfied, especially abdominal pain, non-bloody diarrhoea and fatigue/tiredness (Figure 3). Characteristics of patients in remission with mucosal healing were similar regardless of whether remission was confirmed by endoscopy. Conclusion A substantial proportion of patients with CD, even those in remission, experience high symptom burden and diminished HRQoL despite treatment. There is a need for therapies that provide more comprehensive disease control. 1. Anderson P et al. Curr Med Res Opin 2008:24;3063–72.

Validation of the German version of the Short Health Scale - a brief, valid and reliable instrument to assess health-related quality of life in German-speaking patients with inflammatory bowel diseases.

Health-related quality of life (hrQoL) may be the most important patient-reported outcome for patients with chronic disorders. The Short Health Scale (SHS) is a brief four-item instrument to assess hrQoL in patients with bowel disorders. This study examined the validity, reliability and sensitivity of the German translation of the SHS in a cohort of outpatients with inflammatory bowel diseases (IBD). The study was preregistered in April 2021 (https://doi.org/10.17605/OSF.IO/S82D9). Outpatients with IBD (n=225) in different stages of disease activity (as determined by the Harvey-Bradshaw index or partial Mayo score) completed the German SHS and the short Inflammatory Bowel Disease Questionnaire (sIBDQ) as an established measure of hrQoL to examine the convergent validity. To assess reliability, a subset of patients (n=30) in remission completed the same questionnaires after 4-8 weeks. Sensitivity to change was established from questionnaires of patients with either decreased (n=15) or increased (n=16) disease activity after 3-6 months. The internal consistency of the German SHS was high (Cronbach's α=0.860). SHS total scores correlated strongly with sIBDQ scores (ρ=-0.760, p<0.001) and disease activity (ρ=0.590, p<0.001). Retest reliability was high (ρ=0.695, p<0.001). Sensitivity to change was statistically significant for patients with decreased (p=0.013) but not increased (p=0.134) disease activity. The German version of the SHS is a valid and reliable tool to measure hrQoL in persons with IBD.

DOP68 CD-TREAT diet induces remission and improves quality of life in an open label trial in children and adults with active Crohn’s Disease

Abstract Background Exclusive enteral nutrition (EEN) is an established induction treatment for active Crohn’s disease (CD) with a proposed mechanism of action involving the gut microbiome. We have previously shown that CD-TREAT diet, a food-based diet with similar dietary profile to EEN, improves rat ileitis and replicates the effect of EEN on the gut microbiome of healthy volunteers and animal models. Here, we test the efficacy of CD-TREAT diet to induce clinical remission in active CD. Methods This is an open-label study in children (wPCDAI≥12.5) and adults (HBI≥5) with active CD. Primary outcome was clinical response (wPCDAI fall≥17.5; HBI fall≥3) or clinical remission (wPCDAI&amp;lt; 12.5; HBI&amp;lt;5) after 8 week treatment with CD-TREAT. Secondary outcomes included improvement of quality of life (QoL) and reduction in faecal calprotectin (FC) levels. Since CD-TREAT diet is gluten-free, adherence to treatment was assessed by the detection of the gluten immunogenic peptide (GIP) in faeces. Data are presented with median (IQR). Results 25 children, [age, 14.4 (12.5,15.7) years] and 32 adults, [age, 32.6 (24.2,43.9) years] were treated. 7 (12%) failed treatment and n=10 (18%) dropped out during the first 2 weeks of treatment due to palatability issues. In patients who completed 8 weeks of CD-TREAT course (n=40), 85% and 78% achieved clinical response and remission, respectively. CD-TREAT diet improved QoL in children [IMPACT-III score, baseline: 136 (122,143) vs 8weeks: 148 (133,153), p&amp;lt;0.01] and in adults [sIBDq score, baseline: 30 (26,45) vs 8weeks: 60 (48, 64), p&amp;lt;0.001]. Faecal GIP decreased during treatment [ng/g stool, baseline: 1250 (589, 1250), 4weeks: 0 (0,269), 8weeks: 0 (0,329), mg/mg, p&amp;lt;0.001 for both] showing adherence with the CD-TREAT diet. However, 33% and 40% of the patients had detectable faecal GIP at 4 and 8 weeks, respectively, revealing at least partial non-adherence. 30% of patients who completed CD-TREAT (n=12/40) experienced &amp;gt;50% FC reduction. Median FC levels decreased significantly? in the group of patients (n=22) who had undetectable GIP at 4 or 8 weeks [mg/kg FC, baseline: 1190 (361,1129); 8weeks: 534 (92,1230), p&amp;lt;0.01]. Conclusion CD-TREAT diet improved disease activity indices and QoL in the majority of patients who completed treatment and decreased FC in those who were most likely to be compliant. Future RCT should aim to compare CD-TREAT with other induction treatments and improve meal variety and palatability to improve compliance and reduce drop-out rates.

P315 High symptom burden and impact on health-related quality of life in patients with Crohn’s perianal fistulas: results from a global burden of illness study

Abstract Background Perianal fistulas (PAF) are a common complication in Crohn’s disease (CD) and can be associated with an increased burden of illness. A global study was conducted to assess the burden of illness in patients with Crohn’s perianal fistulas (CPF) compared with patients with CD without PAF (non-PAF CD). Here we present patient symptom burden and impact on HRQoL. Methods This cross-sectional study was conducted in seven countries (France, Germany, Spain, UK, Canada, Australia and Japan) in patients aged ≥21 and ≤90 years with self-reported physician-diagnosed CD. Patients were classified as having non-PAF CD (cohort, 1) or CPF without PAF-related surgery (cohort, 2) or CPF with PAF-related surgery (cohort, 3). Customised questions and validated general and disease-specific patient-reported outcome data were collected via a, 45-min IRB/EC-approved web-enabled questionnaire. Symptom burden and impact on HRQoL were evaluated using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ, scores, 1–7 [low–optimum] with, 2-week recall period) in all cohorts and Quality of Life in Patients with Anal Fistula (QoLAF, scores, 14–70 [low–high impact]) in cohorts, 2 and, 3. Data were analysed using descriptive statistics. Results Of, 929 patients recruited (cohort, 1, n=620; cohort, 2, n=174; cohort, 3, n=135), 58–69% were male and, 55–67% were aged, 21–40 years across all cohorts. Cohorts, 2 and, 3 experienced a significantly higher frequency of CD-related complications than cohort, 1 (mean [standard deviation, SD]:, 9.4 [4.5] and, 11.1 [5.2] vs, 6.0 [4.1], respectively; both p &amp;lt;0.05, Table, 1) and had a higher number of CD-related surgeries (other than PAF-related surgeries) in the past, 12 months (mean [SD]:, 1.8 [1.1], p =0.109 and, 2.2 [1.3], p &amp;lt;0.0001 vs, 1.5 [0.9], respectively). In patients with CPF, a smaller proportion in cohort, 2 had active PAF vs cohort, 3 (136 [78%] vs, 119 [88%], respectively; p =0.022) and a smaller proportion had experience with post-treatment PAF recurrence/persistence in cohort, 2 vs cohort, 3 (84 [48%] vs, 80 [59%], respectively; p =0.055). Overall SIBDQ scores were significantly lower (worse) in cohorts, 2 and, 3 than in cohort, 1 (3.8 and, 3.7 vs, 4.1 respectively; both p &amp;lt;0.001). In patients with CPF, total QoLAF scores were comparable between cohorts, 2 and, 3 (41 and, 42, respectively), although patients in cohort, 3 had a significantly higher (worse) score in the physical impact domain compared with cohort, 2 (21 vs, 19, respectively; p &amp;lt;0.05). Conclusion In this large global study, we observed that patients with CPF had incrementally higher symptom burden, owing to both CD and PAF, compared with patients with non-PAF CD. For patients with CPF, there was no difference in HRQoL irrespective of whether they had received PAF-related surgery or not.

P167 Sexual dysfunction and associated factors in young patients with Crohn’s disease

Abstract Background The prevalence of sexual dysfunction (SD) in general population has been estimated up to 30% in women and 5% in men, and 50% and 25% in IBD patients, respectively. We aimed to compare the rates of SD in young patients with Crohn’s disease (CD) with healthy controls (HC), as well as to identify SD associated factors in CD patients. Methods This was a cross-sectional, case-control, observational study, including CD out-patients, aged 18–40 years-old, and HC paired by gender and age. Sociodemographic and disease features were recorded. SD was measured by the Index of Female Sexual Function(IFSF) in women, and by International Index of Erectile Function(IIFE-15) in men. Psychological functioning was evaluated using the Hospital Anxiety and Depression Scale [HAD], and quality of life in IBD by SIBDQ-9. Differences between groups were statistically compared. Results A total of 122 subjects were included:73 men(48 CD, 25 HC) and 49 women(21 CD, 28 HC). Nineteen percent of CD women and 8.3% of men had active disease according to Harvey-Bradshaw Index. Nineteen percent of CD women and 6.3% of men were receiving steroids, 23.8% and 14.6% immunosuppressants, and 71.4% and 72.9% biologics, respectively. CD women had more sedentary lifestyle than HC(38.1% vs 3.6%, p=0.005). In women SD rates were 35% in CD vs 12% in HC(p &amp;lt; 0.08). Mean IFSF values were lower in CD women(27 CD vs 30 HC, p=0.02), as well as in the desire item(3.5 CD vs 4.3 HC, p=0.005). SD in men did not show significant difference between groups. Mean IIFE values differed between CD and HC(53.6 vs 67.2, p=0.001), as well as erectile disfunction, orgasm and global satisfaction(p&amp;lt; 0.05)(Table 1). Main factors associated with an abnormal SD in CD women were high fecal calprotectine, current use of steroids, lower SIBDQ score and higher depression score(p&amp;lt;0.05). Although disease features or current treatments did not correlate to SD in CD men, both perianal disease and surgery were associated with lower values of orgasm domain (p&amp;lt;0.05). Conclusion In our serie SD was numerically higher in CD patients compared to HS. SD in CD women, but not in men, was driven by disease activity, current steroid treatment and depression.

P341 Perceived risks and psychosocial burden during the COVID-19 pandemic in a large cohort of pediatric and adult patients with Inflammatory Bowel Disease

BackgroundThe COVID-19 pandemic induced restrictions in daily life and anxiety especially in vulnerable parts of the population. We investigated the psycho-social burden of the pandemic and self-perceived risk and harm in a large IBD cohort.MethodsIn this monocentric prospective observational study, pediatric (pIBD) and adult patients completed questionnaires related to their IBD (phenotype, disease activity, treatment), comorbidities, demographic and socioeconomic factors, validated tools on Perceived Stress (PSQ) and quality of life (sIBDQ). They judged perception of harm in case of acquiring COVID-19 using ratings from 1 to 7. We used number and type of established conditions for severe COVID-19 outcome to categorize patients in 5 risk groups. SARS-CoV2 antibodies were determined by Elecsys Roche anti-N pan-Ig. All comparisons were made by using t-test, Mann-Whitney-U-test or Chi-square-test where applicable with 2-sided significance levels of 5%. Univariate and multiple logistic regression was performed to determine associations between factors and perceived harm.ResultsBetween mid-July to mid-October, 504 (62%) of 820 invited IBD patients and 86 pIBD parents completed the survey. Age ranged from 6-85 years, 80% received mono- or combo-therapy with immunomodulator, biologic, JAK-inhibitor or corticosteroids. Remission, mild, moderate and severe disease activity were reported by 46, 39, 12 and 3%, respectively. High harm of potential COVID-19 (>3) was perceived by 75.4%, rates increased with age (p=0.0019). After adjusting for age and gender, high perceived harm was significantly associated with immunosuppressive drugs, number/type of comorbidities, sleep disturbance, unintended gain or loss of weight, higher PSQ and lower sIBDQ scores. PSQ scored lower in males >60 years vs age matched females or younger adults, and in patients in remission vs active disease. PIBD mothers’ total PSQ was similar with even higher subscores for demands (P=0.0004) as adults with moderate/severe disease. Compared to pre-pandemic, 58-93% of pIBD decreased physical activities (at home, sports, outdoor) with minor changes in adults. SARS-CoV-2 serology was positive in 0.4% of IBD patients compared to 2% of our city population. ConclusionPrior to 2nd infection wave, even IBD patients aged <40 years suffer from a high degree of worries, stress and perceived harm for potential COVID-19. Most elderly patients and those with comorbidities adequately estimate their risks. In pIBD, pandemic restrictions substantially impacted on physical activity. The low seropositivity rate indicates high adherence to social distancing or altered immune response due to IBD drugs. Results of the follow up survey in March 21 are underway.

Randomized Controlled Trial of Cognitive-Behavioral and Mindfulness-Based Stress Reduction on the Quality of Life of Patients With Crohn Disease.

Patients with Crohn disease have debilitating psychological symptoms, mental fatigue, and poor quality of life. Psychological intervention may improve these symptoms. We performed a randomized parallel-group physician-blinded trial of cognitive-behavioral and mindfulness-based stress reduction (COBMINDEX) on quality of life and psychological symptoms in adults with mild-moderate Crohn disease. COBMINDEX was taught by social workers in one-on-one video conferences over 3 months; quotidian home practice was mandated. Fifty-five COBMINDEX and 61 waitlist control patients completed the study; mean age was 33 years and 65% of participants were women. At 3 months, COBMINDEX patients had significantly reduced disease activity (per Harvey-Bradshaw Index score, C-reactive protein level, and calprotectin level), increased quality of life (Short Inflammatory Bowel Disease Questionnaire [SIBDQ] score increased from baseline 41 to 50; P < 0.001), decreased psychological symptoms (Global Severity Index [GSI], 0.98-0.70; P < 0.001), reduced fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue, 26-33; P < 0.001), and increased mindfulness disposition (Freiburg Mindfulness Inventory, 33-38; P < 0.001). Waitlist patients had a significant but small change in Harvey-Bradshaw Index, SIBDQ, and GSI scores, without improvement in fatigue or mindfulness. There were significant correlations (0.02 > P < 0.002) in COBMINDEX patients between baseline SIBDQ, GSI, Freiburg Mindfulness Inventory, and Functional Assessment of Chronic Illness Therapy-Fatigue scores with a relative change (baseline to 3 months) of the SIBDQ score, but none among waitlist patients. Predictors of relative change of the SIBDQ score in COBMINDEX patients included the GSI score (90% quantile; coefficient 0.52; P < 0.001), somatization (90%; 0.20; P = 0.001), depression (75%; 0.16; P = 0.03), and phobic anxiety (75%; 0.31; P = 0.008). COBMINDEX was effective in increasing patients' quality of life and reducing psychological symptoms and fatigue. Patients with severe baseline psychological symptoms benefited the most from COBMINDEX.

Real-life pilot study on the impact of the telemedicine platform EasyMICI–MaMICI® on quality of life and quality of care in patients with inflammatory bowel disease

Background Telemedicine has shown promising results in the follow up of patients with inflammatory bowel disease. This study compared quality of life and disease activity in patients with inflammatory bowel disease monitored using a telemedicine platform versus standard care. Methods In this prospective multicenter study, patients with active inflammatory bowel disease were randomized to EasyMICI–MaMICI® telemedicine platform or standard care. The main objective was to assess the efficacy of the software platform, as measured by quality of life and quality of care. Secondary outcomes were changes in the use of healthcare resources, and patient satisfaction in the MaMICI group. Results Fifty-four patients were enrolled (November 2017–June 2018); 59.3% had Crohn’s disease and 40.7% ulcerative colitis. Forty-two patients received biologics at inclusion. After 12 months, a significant improvement in quality of life was observed with MaMICI versus standard care, with mean (standard deviation) changes from baseline of 14.8 (11.8) vs 6.3 (9.7) in the SIBDQ scores and 18.5 (18.7) vs 2.4 (8.3) in the EuroQol 5 D-3L questionnaire scores (both p ≤ .02). Disease activity was similar in both treatment groups. Use of MaMICI slightly reduced healthcare utilization versus controls (mean gastroenterologist consultations 2.2 vs 4.1; p = .1308). Overall satisfaction with MaMICI was high (mean score 7/10), and 46.2% of remaining patients in the MaMICI group continued to use the platform until 12 months. Conclusion Significant improvement in quality of life and overall satisfaction with this telemedicine platform, indicates that further evaluation of EasyMICI–MaMICI in larger numbers of patients with inflammatory bowel disease is warranted.

The impact of clinical symptoms and endoscopic and histologic disease activity on health-related quality of life in patients with ulcerative colitis following treatment with multimatrix mesalazine

PurposeStudies of patients with ulcerative colitis (UC) report that reduced clinical symptoms and endoscopic activity predict better health-related quality of life (HRQoL). However, no study has examined the joint and unique associations of clinical and endoscopic activity with HRQoL, nor of histologic inflammation and HRQoL. These post hoc analyses evaluated whether reduced clinical, endoscopic, and histologic disease activity were uniquely associated with improved HRQoL for adults with active mild-to-moderate UC receiving once-daily 4.8 g/day multimatrix mesalazine for 8 weeks.MethodsAssessments at baseline and week 8 (i.e., treatment completion) included clinical and endoscopic activity (modified UC-Disease Activity Index), histology (Geboes scoring), and HRQoL (Short Inflammatory Bowel Disease Questionnaire [SIBDQ]; SF-12v2® Health Survey [SF-12v2]). Associations among each type of disease activity and HRQoL were examined by correlations and by mean changes in SIBDQ and SF-12v2 scores between disease activity subgroups (e.g., achievement of clinical remission; mucosal healing). Regression models estimated unique variance in HRQoL accounted by each type of disease activity.ResultsWithin the analysis sample (n = 717), patients with reduced clinical and endoscopic activity had significantly larger improvements in all HRQoL domains (p < 0.001), as did patients in both endoscopic and clinical remission compared to patients in endoscopic remission only (p < 0.05). Patients with histologic activity post-treatment scored significantly worse on all HRQoL domains than patients with no activity (p < 0.05). Correlations and regression models found that decreases in clinical and endoscopic activity were associated with improvements in HRQoL domain scores.ConclusionsClinical symptoms and mucosal health have separable, distinct impacts on UC patients’ HRQoL.

Impact of Digital Health Monitoring in the Management of Inflammatory Bowel Disease.

Technological advances now permit self-management strategies using mobile applications which could greatly benefit patient care. The purpose of this study was to investigate whether the use of the inflammatory bowel disease (IBD) digital health monitoring platform, HealthPROMISE, leads to better quality of care and improved health outcomes in IBD patients. IBD patients were recruited in gastroenterology clinics and asked to install the HealthPROMISE application onto their smartphones. Patient satisfaction, quality of care, quality of life, patient symptoms, and resource utilization metrics were collected throughout the study and sent directly to their healthcare teams. Patients with abnormal symptom/SIBDQ scores were flagged for their physicians to follow up. After one-year, patient outcome metrics were compared to baseline values. Overall, out of 59 patients enrolled in the study, 32 patients (54%) logged into the application at least once during the study period. The number of IBD-related ER visits/hospitalizations in the year of use compared to the prior year demonstrated a significant decrease from 25% of patients (8/32) to 3% (1/32) (p = 0.03). Patients also reported an increase in their understanding of the nature/causes of their condition after using the application (p = 0.026). No significant changes were observed in the number of quality indicators met (p = 0.67) or in SIBDQ scores (p = 0.48). Given the significant burden of IBD, there is a need to develop effective management strategies. This study demonstrated that digital health monitoring platforms may aid in reducing the number of ER visits and hospitalizations in IBD patients.Supplementary InformationThe online version contains supplementary material available at 10.1007/s10916-021-01706-x.

P006 AFTER-HOURS PATIENT PHONE CALLS TO GI FELLOWS WITHIN AN IBD MEDICAL HOME

Abstract Objective The Inflammatory Bowel Disease (IBD) Medical Home is a care delivery model that provides a comprehensive, patient-centered, coordinated care environment, previously shown to lead to an approximate 50% reduction in unplanned care. However, the frequency and nature of IBD medical home patient phone calls to gastroenterology (GI) fellows after-hours, and the contribution to unplanned care from these encounters, is unknown. Methods We included all patients that were seen in the IBD medical home between 7/1/2015 to 6/30/2016 (n = 293) and examined all phone call activity in the subsequent year: 7/1/2016 to 6/30/2017. After-hours phone calls were defined as documented calls that were routed to on-call GI fellows when the clinic is closed. The details of each after-hours encounter were reviewed, and were categorized by the reason for call, training year of the GI fellow, advice given to patient, and unplanned care outcomes. For comparison, we also tracked frequency of patient calls for symptoms during clinic hours. Demographic information, disease type, disease activity index, quality of life (QoL), and depression/anxiety scores documented most recently to the start of the observation period were included in the analysis. Comparisons were made using Chi-square, T-tests and non-parametric median tests. Results 259 of 293 patients (86.7%) had any documented phone interaction. Only 36 patients (12.3%) placed a total of 63 after-hours phone calls to GI fellows, with calls for symptoms representing the majority (71.4%). Among calls for symptoms (n = 45), patients were advised by GI fellows to present to the emergency department (ED) 44.4% of the time. There was no significant difference in ED recommendations by fellow training level (p = 0.17). Of the 20 ED encounters advised by fellows, 9 (45%) did not result in admission; and 2 patients had new cross-sectional imaging. Of the 11 admissions, 10 also had new cross-sectional imaging, with generation of 10 inpatient IBD consults, as well as 1 surgery for seton placement. After-hours callers were more likely to have Crohn’s disease and higher GAD-7 scores, with trends towards lower SIBDQ scores and higher PHQ-9 scores, but similar disease activity index scores, number of clinic visits, and demographics, compared to patients who called with symptoms during clinic hours (Table 1). Conclusions Among patients established within an IBD medical home model, a small population of patients called after hours resulting in frequent recommendation to present to the ED from GI fellows, however it is unknown if these encounters meaningfully changed their IBD care. Higher psychosocial complexity may influence this care behavior. Further studies of triage processes and educational initiatives aimed at GI fellows may help minimize unplanned ED and inpatient care in this patient population.

P523 Improvement of quality of life and continence in patients with distal ulcerative colitis treated by mesalazine: QUARTZ study

Abstract Background There is no robust data which analysed quality of life, functional disability and continence of patients with distal UC. QUARTZ is the first prospective study in this situation. Methods Observational, prospective and multicentric study involving public and private French gastroenterologist to recruit patients with mild to moderate (Mayo score ≥ 3 and ≤ 10) active proctitis or proctosigmoiditis (&amp;lt;20 cm) and under mesalazine for induction treatment. The patients followed for 12 months (±2 months). The primary objective was the quality of life evaluated by Short Inflammatory Bowel Disease (SIBDQ) at 8 weeks (±4 months). The functional disability and incontinence have been evaluated by IBD-Disability Index and Cleveland questionnaires. Results From December 2015 to November 2016, 117 patients were recruited. Data of 93 patients have been analysed and results are reported on Table 1. Among the 93 patients, 75 (81%) reached a clinical remission at week 8 with a SIBDQ score improvement of 6.7 ± 7.1 point (p &amp;lt; 0,001). Treatment adherence during the induction period was non-compliance for 76 patients (81%): 17 (18%) patients stopped treatment before W8 (all those patients received rectal formulation). After induction treatment, 72 (77%) patients received maintenance treatment. 11 (12%) patients reported adverse event not linked to the treatment. Conclusion For patients with distal ulcerative colitis treated by mesalazine, quality of life, functional disability and continence have been improved at 8 weeks of treatment despite a poor adherence.