Patient experiences in ulcerative colitis: conceptual model and review of patient-reported outcome measures.

PURPOSE: To identify symptoms and their impacts on daily functioning and health-related quality of life (HRQoL) experienced by adult patients with ulcerative colitis (UC) and evaluate patient-reported outcome (PRO) measures for UC clinical studies. METHODS: A conceptual model of symptoms and impacts of UC were developed from a literature review. PRO measures were identified from the literature, clinical trials databases, health technology assessment submissions, and regulatory label claims, and were selected for conceptual analysis based on disease specificity and use across information sources. PRO measures covering the most concepts when mapped against the conceptual model were assessed for gaps in psychometric properties using Food and Drug Administration (FDA) guidance and consensus-based standards for the selection of health measurement instruments (COSMIN) criteria. RESULTS: The conceptual model grouped the 52 symptom concepts and 72 proximal and distal impacts into eight, two, and five dimensions, respectively. Of 65 PRO measures identified, eight underwent conceptual analysis. Measures covering the most concepts and assessed for psychometric properties were the Inflammatory Bowel Disease Questionnaire, Symptoms and Impacts Questionnaire for UC, UC-PRO symptoms modules, UC-PRO impact modules, and Crohn's and UC Questionnaire; all had good or excellent support for content validity. The UC-PRO Signs and Symptoms fully met FDA guidance and COSMIN criteria for content validity and most psychometric properties. CONCLUSION: Existing PRO measures assess concepts relevant to patients with UC, but all PRO measures reviewed require further psychometric evaluation to demonstrate they are fit for purpose.

Psychological symptoms and quality of life in patients with inflammatory bowel disease in China: A multicenter study.

AIMS: To investigate the current situation of mental psychology and quality of life (QoL) in patients with inflammatory bowel disease (IBD) in China, and analyze the influencing factors. METHODS: A unified questionnaire was developed to collect clinical data on IBD patients from 42 hospitals in 22 provinces from September 2021 to May 2022. Multivariate Logistic regression analysis was conducted, and independent influencing factors were screened out to construct nomogram. The consistency index (C-index), receiver operating characteristic (ROC) curve, area under the ROC curve (AUC), calibration curve, and decision curve analysis (DCA) were used to evaluate the discrimination, accuracy, and clinical utility of the nomogram model. RESULTS: A total of 2478 IBD patients were surveyed, including 1371 patients with ulcerative colitis (UC) and 1107 patients with Crohn's disease (CD). Among them, 25.5%, 29.7%, 60.2%, and 37.7% of IBD patients had anxiety, depression, sleep disturbance and poor QoL, respectively. The proportion of anxiety, depression, and poor QoL in UC patients was significantly higher than that in CD patients (all p < 0.05), but there was no difference in sleep disturbance between them (p = 0.737). Female, higher disease activity and the first visit were independent risk factors for anxiety, depression and sleep disturbance in IBD patients (all p < 0.05). The first visit, higher disease activity, abdominal pain and diarrhea symptoms, anxiety, depression and sleep disturbance were independent risk factors for the poor QoL of patients (all p < 0.05). The AUC value of the nomogram prediction model for predicting poor QoL was 0.773 (95% CI: 0.754-0.792). The calibration diagram of the model showed that the calibration curve fit well with the ideal curve, and DCA showed that the nomogram model could bring clinical benefits. CONCLUSION: IBD patients have higher anxiety, depression, and sleep disturbance, which affect their QoL. The nomogram prediction model we constructed has high accuracy and performance when predicting QoL.

Impact of Inflammatory Bowel Disease on Patients' Caregivers: Results From a French Survey.

BACKGROUND: The impact of inflammatory bowel disease (IBD) on caregivers has rarely been investigated. Our work aims to explore the burden of IBD on the different aspects of caregivers' lives. METHODS: We conducted an online survey via the social network of the French IBD patient organization addressed to patients' caregivers who were asked to fill in a questionnaire covering the impact of the disease on different aspects of their lives. Impacts were measured by a visual analog scale (VAS). A VAS score ≥5 of 10 was considered significantly high. We then performed uni- and multivariate analyses of predictors of higher impact on parents and partners, separately. RESULTS: A total of 853 caregivers participated, predominantly women (77%). The mean age was 48.5 years. Their relationship with the patient was mainly parents in 57.1% and partners in 30.6%. The type of IBD was Crohn's disease in 63% and ulcerative colitis in 35%. The psychological burden was the highest among parents and was mainly correlated with a lack of knowledge about IBD and professional compromise (P < .05). The impact on leisure was the highest among partners and was affected by psychological, sexual, and professional burdens (P < .05). About 50% of partners experienced an absent sexual relationship for weeks/months and decreased libido regardless of IBD type. Professional impact was greater in parents compared with partners, and 36% of caregivers needed work arrangements. CONCLUSIONS: IBD has a high impact on different aspects of life of patients' caregivers. Therefore, interventions to reduce the disease burden in this population are needed.

Caregivers of patients with inflammatory bowel disease go through many psychological, social, and professional difficulties. Implementing adequate psychosocial interventions may improve their quality of life.

Association between inflammatory bowel disease and subsequent depression or anxiety disorders - A retrospective cohort study of 31,728 outpatients.

BACKGROUND: Crohn's disease (CD) and ulcerative colitis (UC) are characterized by chronic intestinal and systemic inflammation. The extraintestinal sequelae of inflammatory bowel disease (IBD) are major contributors to disease morbidity and significantly affect patients' quality of life. Here, we evaluated the association between IBD and subsequent depression or anxiety disorder in a large outpatient collective from Germany. METHODS: 15,864 individual IBD patients (CD: n = 6,791, UC: n = 9073) and 15,864 nearest neighbor propensity score matched patients without IBD were included from the Disease Analyzer database (IQVIA). Diagnoses of depression and anxiety disorders were compared between IBD and non-IBD patients during a five-year follow-up period using Kaplan-Meier estimators and Cox-regression models. RESULTS: After 5 years of follow-up, depression was diagnosed in 14.4% of CD patients versus 10.2% of matched pairs (p < 0.001) and in 13.1% of UC patients versus 10.1% of matched pairs (p < 0.001). In line, the incidence of anxiety order was significantly higher among CD (4.7% vs. 4.4%, p = 0.009) and UC patients (4.3% vs. 3.5%, p = 0.005). Regression analysis confirmed a significant association between IBD and both mental conditions (Hazard Ratio (HR)CD/depression: 1.40, HRUC/depression: 1.32, HRCD/anxiety disorder: 1.21, HRUC/anxiety disorder: 1.28). Subgroup analyses revealed a stronger association for CD and depression (HR: 1.51) and UC and depression (HR:1.49) among male patients as well as UC and anxiety disorders (HR: 1.51) among female patients. CONCLUSION: Our data argue for a significant association between IBD and mental diseases including depression and anxiety disorders. Although further pathophysiological research is warranted, we hypothesize that specific psychological screening measures in IBD patients could improve quality of life and outcome.

Psychological disorders and coping strategies in patients with inflammatory bowel disease. Their impact on health-related quality of life

Background and objectives: inflammatory bowel disease (IBD) has a major impact on psychological well-being. This condition is associated with a high level of anxiety and mood disorders, but stress prevalence and how an individual copes with IBD have not been sufficiently explored. The objective of this study was to assess the impact of the disease on psychological disorders and to identify coping strategies used by patients with IBD, as well as to analyze the relationship between these variables and sociodemographic and clinical variables. Methods: a cross-sectional prospective study was performed including 126 consecutive patients. Those with psychiatric conditions prior to the onset of the IBD were excluded. Independent variables were measured using a sociodemographic and clinical questionnaire. The patients completed the Hospital Anxiety and Depression Scale (HADS), the Perceived Stress Scale (PSS) and the BRIEF COPE questionnaire. Quality of life was measured using the nine-item IBD Quality of Life (IBDQ-9). Results: the final cohort comprised 100 patients (37 with ulcerative colitis and 63 with Crohn’s disease). The prevalence rates of the variables of stress, anxiety and depression were high (44 %, 24 % and 14 %, respectively). Stress and depression were higher in females (p < 0.05), without differences regarding other sociodemographic and clinical variables. Moreover, higher levels of anxiety and depression were found to be associated with stress and dysfunctional coping strategies (p < 0.01). Conclusions: patients with IBD, particularly women, have high rates of psychological disorders. Those with anxiety and depression presented more stress and used more dysfunctional strategies. These conditions must be considered for a multidisciplinary management. (AU)

Co-design and Consultation Ensure Consumer Needs Are Met: Building an eHealth Platform for Children with Inflammatory Bowel Disease.

BACKGROUND: Crohn's Colitis Care is an adult inflammatory bowel disease eHealth system. Crohn's Colitis Care required additional pediatric functionality to enable life-long records and mitigate transition inadequacies. AIM: This study describes and evaluates a consensus method developed to ensure consumer needs were met. METHODS: Pediatric-specific functionality and associated resources considered important for inclusion were developed by a clinician consensus group. This group was divided into thematic subgroups and underwent two voting rounds. The content validity index was used to determine items reaching consensus. Children with inflammatory bowel disease and their parents were later shown a descriptive list of non-clinical inclusion topics proposed by the consensus group, and asked to vote on whether topic-related functionality and resources should be included. RESULTS: The consensus process consulted 189 people in total (38 clinicians, 32 children with inflammatory bowel disease and 119 parents). There was agreement across all groups to incorporate functionality and resources pertaining to quality of life, mental health, self-management, and transition readiness; however, divergence was seen for general inflammatory bowel disease facts, your inflammatory bowel disease history, and satisfaction. Cost saw the greatest disparity, being less supported by consumers compared to clinicians. Over 75% of consumers agreed it would be okay for appointments to take longer for survey completion, and > 90% thought Crohn's Colitis Care should allow consumers to ask their treating team questions. CONCLUSIONS: Widespread consumer co-design and consultation were important in unveiling differing perspectives to ensure Crohn's Colitis Care was built to support both consumer and clinician perspectives. Consumers collaborate to create a list of functionality and resources to be included in software (left), influencing the final product build (right).

Health Care Disparities, Social Determinants of Health, and Emotional Impacts in Patients with Ulcerative Colitis: Results from a Global Ulcerative Colitis Narrative Patient Survey.

BACKGROUND: The Ulcerative Colitis (UC) Narrative global survey assessed aspects of living with UC. This analysis aimed to identify health care disparities, social determinants of health, and emotional impacts related to UC disease management, patient experience, and quality of life. METHODS: The survey was conducted by The Harris Poll from August 2017 to February 2018 among adults with UC. Responses from 1000 patients in the United States, Canada, Japan, France, and Finland were analyzed based on patient income, employment status, educational level, age, sex, and psychological comorbidities. Odds ratios (ORs) with significant P values (P < .05) from multivariate logistic regression models are reported. RESULTS: Low-income vs high-income patients were less likely to have participated in a peer mentoring (OR, 0.30) or UC education program (OR, 0.51). Patients not employed were less likely to report being in "good/excellent" health (OR, 0.58) than patients employed full time. Patients with low vs high educational levels were less likely to have reached out to patient associations/organizations (OR, 0.59). Patients aged younger than 50 years vs those aged 50 years and older were less likely to have visited an office within an inflammatory bowel disease center/clinic in the past 12 months (OR, 0.53). Males were less likely to be currently seeing their gastroenterologist than females (OR, 0.66). Patients with vs without depression were less likely to agree that UC had made them more resilient (OR, 0.51). CONCLUSIONS: Substantial differences in disease management and health care experience were identified, based on categories pertaining to patient demographics and psychological comorbidities, which may help health care providers better understand and advance health equity to improve patient care.

Patient-reported survey results revealed substantial differences in disease management and health care experience in patients with ulcerative colitis, based on categories pertaining to patient demographics and diagnosed psychological comorbidities, including income level, employment status, educational level, age, sex, depression, and anxiety.

Association of ulcerative colitis symptom severity and proctocolectomy with multidimensional patient-reported outcomes: a cross-sectional study.

BACKGROUND: The YOu and Ulcerative colitis: Registry and Social network (YOURS) is a large-scale, multicenter, patient-focused registry investigating the effects of lifestyle, psychological factors, and clinical practice patterns on patient-reported outcomes in patients with ulcerative colitis in Japan. In this initial cross-sectional baseline analysis, we comprehensively explored impacts of symptom severity or proctocolectomy on nine patient-reported outcomes. METHODS: Patients receiving tertiary care at medical institutions were consecutively enrolled in the YOURS registry. The patients completed validated questionnaires on lifestyle, psychosocial factors, and disease-related symptoms. Severity of symptoms was classified with self-graded stool frequency and rectal bleeding scores (categories: remission, active disease [mild, moderate, severe]). The effects of symptom severity or proctocolectomy on nine scales for quality of life, fatigue, anxiety/depression, work productivity, and sleep were assessed by comparing standardized mean differences of the patient-reported outcome scores. RESULTS: Of the 1971 survey responses analyzed, 1346 (68.3%) patients were in remission, 583 (29.6%) had active disease, and 42 (2.1%) had undergone proctocolectomy. A linear relationship between increasing symptom severity and worsening quality of life, fatigue, anxiety, depression, and work productivity was observed. Patients with even mild symptoms had worse scores than patients in remission. Patients who had undergone proctocolectomy also had worse scores than patients in remission. CONCLUSIONS: Ulcerative colitis was associated with reduced mood, quality of life, fatigue, and work productivity even in patients with mild symptoms, suggesting that management of active ulcerative colitis may improve patient-reported outcomes irrespective of disease severity. (UMIN Clinical Trials Registry: UMIN000031995, https://www.umin.ac.jp/ctr/index-j.htm ).

High Perceived Stress is Associated With Increased Risk of Ulcerative Colitis Clinical Flares.

BACKGROUND & AIMS: Although perceived stress (PS) has been associated with symptomatic flares in inflammatory bowel disease, clinical and physiological measures associated with perceived stress and flare are not known. The aim of this study was to identify physiological factors associated with perceived stress in ulcerative colitis (UC) subjects, and their relationship with flare. METHODS: Patients with UC in clinical remission (Simple Colitis Clinical Activity Index [SCCAI] score <5) underwent clinical and behavioral assessments, morning salivary cortisol measurements, autonomic nervous system activity testing (heart rate variability, electrodermal activity) at baseline with patient-reported SCCAI every 2 weeks over 1 to 2 years and fecal calprotectin at time of flare. Clinical flares (SCCAI ≥5) and biochemical flares (SCCAI ≥5 with fecal calprotectin ≥250 µg/g) were evaluated. RESULTS: One hundred ten patients with UC were enrolled, with mean follow-up of 65.6 weeks. Patients with UC with higher and lower PS were determined. Although the high PS group had 3.6 times higher odds of a clinical flare than the low PS group, no significant differences in biochemical flares were observed between the low and high PS groups. The high vs low PS group differed in tonic sympathetic arousal as indexed by significantly greater baseline electrodermal activity (4.3 vs 3.4 microsiemens; P = .026) in the high PS group, but not in terms of heart rate variability and morning cortisol levels. Increased fecal calprotectin was associated with cardioautonomic measures, suggesting lower parasympathetic activity. CONCLUSIONS: Increased PS assessed at baseline is associated with tonic sympathetic arousal and greater odds of clinical flares in patients with UC.

Improving Food-Related Quality of Life in Inflammatory Bowel Disease through a Novel Web Resource: A Feasibility Randomised Controlled Trial.

Food-related quality of life (FR-QoL) is impaired in inflammatory bowel disease (IBD) and education and support on food-related issues in IBD is needed. This feasibility trial aimed to investigate the effectiveness and acceptability of a web resource in enhancing FR-QoL in newly diagnosed IBD. Patients diagnosed with Crohn's disease or ulcerative colitis in the preceding 12 months, with an impaired FR-QoL, were recruited and randomised to either receive access to the web resource (covering IBD-specific diet concerns) or no access (control group) for 12 weeks, while receiving usual clinical care. FR-QoL, health-related quality of life, psychological outcomes, and clinical disease activity were assessed. Web resource usage was assessed, and patients' experiences of the web resource were investigated in semi-structured interviews. Of 81 patients screened, 50 participants were randomised, 30 to the web resource and 20 to control. FR-QoL increased more in the web resource (+11.7 SD 18.2) than control group (+1.4 SD 20.4) (p = 0.067), while IBD distress reduced in the web resource (-6.8 SD 26.6) and increased in the control group (+8.3 SD 25.5) (p = 0.052), albeit not statistically significantly. End of trial Crohn's disease clinical activity (PRO-2) was significantly lower in the web resource than control group (p = 0.046). Participants most frequently accessed web resource content discussing dietary management of gut symptoms and in semi-structured interviews, reported the website to contain relevant information. This feasibility study demonstrates potential effectiveness of the web resource on improving FR-QoL and psychological outcomes in IBD. An adequately powered effectiveness RCT is feasible to conduct and is now warranted. NCT03884686.

Mindfulness Intervention Decreases Frequency and Severity of Flares in Inactive Ulcerative Colitis Patients: Results of a Phase II, Randomized, Placebo-Controlled Trial.

BACKGROUND: Ulcerative Colitis (UC) is a chronic, inflammatory disease, characterized by symptomatic periods (flare) interspersed with asymptomatic periods (remission). Evidence suggests that psychological stress can trigger flare. Studies have shown that mindfulness interventions (MI) reduce stress, foster more adaptive coping, and improve quality of life, but have been minimally used for UC patients. The objective of this study was to determine whether participation in an MI results in improvements in UC disease course and inflammatory cascades, mindfulness, perceived stress, and other psychological outcomes in inactive UC patients with limited or no exposure to past MI. METHODS: Participants were randomized to an 8-week MI or control group. Biological and psychological assessments were performed at baseline, post 8-week course, and at 6- and 12-months. RESULTS: Forty-three participants enrolled. The MI increased the state of mindfulness and mindfulness skills, decreased perceived stress and stress response in patients with inactive UC. The MI intervention significantly decreased the incidence of flare over 12 months (P < .05). None of the UC patients in the MI flared during 12 months, while 5 of 23 (22%) control group participants flared during the same period. CONCLUSIONS: MIs could be considered as adjuvant treatment for a subset of UC patients with high perceived stress and low state of mindfulness.The trial was registered at clinicaltrials.gov as NCT01491997.

Inactive ulcerative colitis patients were randomized to a mindfulness intervention or control group. Biological and psychological assessments were performed over 12 months. The intervention significantly decreased the incidence of flares, increased the state of mindfulness and mindfulness skills, and decreased perceived stress and the stress response.

The Psychological Effects of COVID-19 Pandemic in Patients with Inflammatory Bowel Disease.

BACKGROUND: Coronavirus disease 2019 pandemic was expected to have traumatic effects and increase the anxiety levels of inflamma- tory bowel disease patients. METHODS: We aimed to investigate the psychosocial effects of the coronavirus disease 2019 pandemic on patients with inflammatory bowel disease by revealing the risk perception for present disease, coping strategies, follow-up characteristics, and treatment adher- ence. This is a cross-sectional, web-based survey study including 798 inflammatory bowel disease patients who were followed at our outpatient clinic and 303 volunteer who did not have any known chronic diseases and were not health professionals were included as the control group. RESULTS: In this study, 281 of the patients were diagnosed with Crohn's disease and 215 with ulcerative colitis. The mean age of patients with Crohn's disease, ulcerative colitis, and the control group were 40.9 ± 13.1, 42.3 ± 12.7, and 39.9 ± 11.6, respectively. Here, 119 (42%) of the Crohn's disease cases, 116 (54%) of the ulcerative colitis cases, and 170 (56%) of the control group were male. Among the 3 groups, coronavirus disease 2019-related post-traumatic stress disorder rates (Impact of Event Scale-Revised > 33) and State-Trait Anxiety Inventory of current status of anxiety-related anxiety rates were not statistically different while State-Trait Anxiety Inventory of anxiety tendency-related constant anxiety was higher in inflammatory bowel disease patients than the control group (P < .017). CONCLUSION: Inflammatory bowel disease patients with anxiety have a lower quality of life, and this may worsen the clinical course of the disease. Coronavirus disease 2019 is a major source of stress for such a vulnerable population. During the pandemic, psychological support and mental health awareness should be made accessible to all individuals.

Analysis of Factors Related to Spiritual Psychology and Quality of Life in Patients with Inflammatory Bowel Disease Based on Artificial Intelligence IBD Nursing Technology.

To investigate the characteristics of psychological symptoms in inflammatory bowel disease (IBD), to study the relationship between psychological symptoms and quality of life, and to provide some theoretical basis for the corresponding psychological treatment of IBD patients with psychiatric abnormalities. With the development of artificial intelligence (AI) and its gradual application to the medical field, it has brought new ideas to the medical development, and its research and application in IBD, including ulcerative colitis (UC) and Crohn's disease (CD), is increasing. Machine learning is used to select reasonable models and methods to help the prediction, diagnosis, treatment, and prognosis of IBD. In this study, we improved on the classical unidirectional LSTM model by adding backward and forward LSTM layers, designed a bidirectional LSTM model to improve the shortcomings of unidirectional LSTM with insufficient dependence on the posterior, introduced the contribution rate α to adjust the weight matrix of the forward LSTM layer and the backward LSTM layer, and experimentally verified the correctness and superiority of the proposed model. A total of 159 patients with IBD and 89 healthy people were collected and psychologically assessed using the general status questionnaire, the 90-item symptom checklist (SCL-90). Patients with IBD are prone to a combination of obsessive-compulsive, interpersonal, depressive, hostile, and other abnormal psychological symptoms, and their quality of life is significantly reduced; quality of life is mainly affected by disease condition, depression, interpersonal sensitivity, and paranoia, and patients in the active stage of the disease with heavy symptoms of depression, paranoia, and interpersonal sensitivity have low quality of life.

Identification of a choroid plexus vascular barrier closing during intestinal inflammation.

Up to 40% of patients with inflammatory bowel disease present with psychosocial disturbances. We previously identified a gut vascular barrier that controls the dissemination of bacteria from the intestine to the liver. Here, we describe a vascular barrier in the brain choroid plexus (PVB) that is modulated in response to intestinal inflammation through bacteria-derived lipopolysaccharide. The inflammatory response induces PVB closure after gut vascular barrier opening by the up-regulation of the wingless-type, catenin-beta 1 (Wnt/ß-catenin) signaling pathway, rendering it inaccessible to large molecules. In a model of genetically driven closure of choroid plexus endothelial cells, we observed a deficit in short-term memory and anxiety-like behavior, suggesting that PVB closure may correlate with mental deficits. Inflammatory bowel disease­related mental symptoms may thus be the consequence of a deregulated gut­brain vascular axis.

Correlation Between Sleep, Life, Mood, and Diet and Severity of Inflammatory Bowel Disease in China: A Retrospective Study.

BACKGROUND The aim of the present study was to assess the relationship between inflammatory bowel disease (IBD) and quality of sleep, quality of life (QoL), mental health, and dietary intake to identify potential risk factors for IBD. MATERIAL AND METHODS This was a retrospective analysis from September 2019 to August 2020. We enrolled 71 patients with IBD aged 14 to 69 years who completed the IBD-Life Habits Questionnaire, which included data on demographics, environmental factors, and dietary habits; the Pittsburgh Sleep Quality Index (PSQI); Patient Health Questionnaire (PHQ-9); Generalized Anxiety Disorder-7 (GAD-7); and the Inflammatory Bowel Disease Questionnaire (IBDQ). Of the patients, 46 had IBD that was in remission and in 25 the disease was active, based on scores used to assess clinical symptoms. The Crohn's Disease Activity Index (CDAI) and the Partial Mayo Score were used for Crohn disease (CD) and ulcerative colitis (UC), respectively. The patients were divided into 2 groups, based on disease status: remission (CDAI <150 or Mayo Score=0) and active (CDAI ≥150 or Mayo Score >0). Because sleep and dietary habits in the patients with UC and CD were not significantly different, the 2 groups of patients were eventually combined into a single IBD group. The IBD-Life Habits Questionnaire, except for IBDQ, was completed by 68 age- and sex-matched healthy controls. RESULTS Scores for PSQI (P=.001), PHQ-9 (P=.003), GAD-7 (P=.007), and IBDQ (P=.001) were significantly higher in the patients with active IBD. An IBDQ score >168.0 (PSQI score >7.5) indicates a clinically active state of IBD with a sensitivity of 84.8% (72.0%) and a specificity of 88.0% (82.6%). Diet composition was not related to disease activity. An analysis of patients and controls showed that lack of siblings could be a protective factor for onset of IBD (OR 0.300, 95% CI 0.119-0.785), while not being breastfed (OR 2.753, 95% CI 1.025-7.396) and consuming spicy foods could be risk factors for onset of IBD (OR 2.186, 95% CI 1.370-3.488). CONCLUSIONS In patients with IBD, poor sleep quality, poor QoL, depression, and anxiety were related to having active disease, whereas diet was not. Attempting to control dietary composition in patients with IBD may not be effective in preventing disease flare, but attention should be paid to intake of spicy foods.

Physician-patient communication affects patient satisfaction in treatment decision-making: a structural equation modelling analysis of a web-based survey in patients with ulcerative colitis.

BACKGROUND: The relationship of bidirectional sharing of information between physicians and patients to patient satisfaction with treatment decision-making for ulcerative colitis (UC) has not been examined. Here, we conducted a web-based survey to evaluate this relationship. METHODS: Patients aged ≥ 20 years with UC were recruited from the IBD Patient Panel and Japanese IBD Patient Association. Patients completed our web-based survey between 11 May and 1 June 2020. The main outcomes were patient satisfaction (assessed by the Decision Regret Scale) and patient trust in physicians (assessed by the Trust in Physician Scale). RESULTS: In this study (n = 457), a structural equation modelling analysis showed that physician-to-patient and patient-to-physician information significantly affected patient satisfaction with treatment decision-making (standardised path coefficient: 0.426 and 0.135, respectively) and patient trust in physicians (0.587 and 0.158, respectively). Notably, physician-to-patient information had a greater impact. For patient satisfaction with treatment decision-making and patient trust in physicians, information on "disease" (indirect effect: 0.342 and 0.471, respectively), "treatment" (0.335 and 0.461, respectively), and "endoscopy" (0.295 and 0.407, respectively) was particularly important, and the level of this information was adequate or almost adequate. Patient-to-physician information on "anxiety and distress" (0.116 and 0.136, respectively), "intention and desire for treatment" (0.113 and 0.132, respectively), and "future expectations of life" (0.104 and 0.121, respectively) were also important for patient satisfaction with treatment decision-making and patient trust in physicians, but these concerns were not adequately communicated. CONCLUSIONS: Adequate physician-patient communication, especially physician-to-patient information, enhanced patient satisfaction with treatment decision-making for UC.

Cross-Sectional Analysis of Quality of Life in Pediatric Patients with Inflammatory Bowel Disease in British Columbia, Canada.

OBJECTIVES: To evaluate quality of life (QoL) in a large cohort of pediatric patients with inflammatory bowel disease (IBD) and to identify the clinical factors that influence QoL. STUDY DESIGN: This cross-sectional study analyzes a quality improvement initiative in 351 pediatric patients with IBD in British Columbia, Canada using the self-reported Pediatric Quality of Life Inventory (PedsQL) 4.0 generic scale. The questionnaire was completed at outpatient clinic and biologic infusion appointments. Statistical analysis included the t test, ANOVA, and multilinear regressions to evaluate the relationships between clinical factors and QoL. RESULTS: Mean (SE) QoL scores (79.95 [0.84]) fell between previously described healthy and chronically ill populations. Disease activity was the most significant predictor of QoL, with patients in remission scoring similar (84.42 [0.87]) to well established healthy norms, and those with moderately or severely active disease having some of the lowest published PedsQL scores (63.13 [3.27]), lower than most other chronic pediatric conditions. Twenty-five patients with moderately or severely active disease at the time of survey completion had follow-up surveys identified 1 year later and had a significant improvement of both their disease activity (P < .005) and their PedsQL scores (follow-up survey mean 76.13 [3.11]). Additional clinical factors independently associated with poor QoL were school nonattendance (15.5% decrease in QoL, P < .001), immune-modulator selection (methotrexate conferring a 9.5% lower mean QoL score than azathioprine, P = .005), and female gender (P = .031). CONCLUSION: Pediatric patients with IBD experience a QoL significantly impacted by multiple clinical factors including current severity of IBD symptoms.

[Study of personality and anxiety in children and adolescents with inflammatory bowel disease]. / Estudio de personalidad y ansiedad en niños y adolescentes con enfermedad inflamatoria intestinal.

OBJECTIVE: to analyze the presence of common personality traits and anxiety states in children and adolescents with inflammatory bowel disease (IBD). PATIENTS AND METHOD: Longitudinal, prospecti ve, and analytical study by applying the questionnaires Children's Personality Questionnaire, High School Personality Questionnaire, State-Trait Anxiety Inventory for Children, and State-Trait Anxie ty Inventory for patients with IBD aged between 9 and 18 years seen at reference IBD units in Ara gon, Spain. The participants excluded were those with active disease, defined as a score > 10 on the Pediatric Crohn's Disease Activity Index (PCDAI Score) or > 10 on the Pediatric Ulcerative Colitis Activity Index (PUCAI Score). RESULTS: Twenty-six patients participated (73% male). 61.5% pre sented Crohn's disease (CD) and 38.5% ulcerative colitis (UC). No patient presented active disease. The personality profile as a group was characterized by being open, emotionally stable, calm, sober, sensible, enterprising, impressionable, dependent, serene, perfectionist, and relaxed. 50% of the CD patients were enterprising versus no UC patients (p < 0.05). There were no statistically significant di fferences when comparing the remaining personality factors based on IBD type, age, or sex. Patients with CD tended to be calmer (p = 0.0511) and patients with UC more introverted (p = 0.0549). The sample presented a state anxiety level (A/E) -1.1 ± 0.8 SD compared with the population average. The level of anxiety as a feature (A/R) was -0.6 ± 1 SD. Males had significantly lower levels than females in the case of A/E (p < 0.05). CONCLUSIONS: The presence of common personality traits in the pediatric population with IBD stands out but there was no greater anxiety than in the reference population.

Upadacitinib Treatment Improves Symptoms of Bowel Urgency and Abdominal Pain, and Correlates With Quality of Life Improvements in Patients With Moderate to Severe Ulcerative Colitis.

BACKGROUND AND AIMS: Bowel urgency and abdominal pain are impactful, yet under-appreciated ulcerative colitis symptoms and not commonly assessed in clinical trials. We evaluated how these symptoms may improve with upadacitinib treatment and correlate with clinical and health-related quality of life [HRQOL] outcomes in the phase 2b U-ACHIEVE study. METHODS: Patients aged 18-75 years, with moderately to severely active ulcerative colitis, were randomised to receive placebo or upadacitinib (7.5, 15, 30, or 45 mg once daily [QD]). Bowel urgency and abdominal pain were evaluated at baseline and Weeks 2, 4, 6, and 8. Week 8 correlations were evaluated between bowel urgency/abdominal pain with clinical [Mayo subscores and high-sensitivity C-reactive protein and faecal calprotectin measurements] and HRQOL outcomes [Inflammatory Bowel Disease Questionnaire and 36-Item Short Form Health Survey scores]. RESULTS: A greater proportion of patients [n = 250] reported no bowel urgency and less abdominal pain with upadacitinib treatment compared with placebo, with improvements observed as early as 2 weeks. At Week 8, patients receiving the 45-mg QD dose had the greatest improvements versus placebo, with 46% reporting no bowel urgency [vs 9%; p ≤ 0.001] and 38% reporting no abdominal pain [vs 13%; p = 0.015]. At Week 8, moderate correlations were found between bowel urgency or abdominal pain and most clinical and HRQOL outcomes. CONCLUSIONS: Induction treatment with upadacitinib demonstrated significant reductions in bowel urgency and abdominal pain compared with placebo. These symptoms also correlate to clinical and HRQOL outcomes, supporting their use to monitor disease severity and other treatment outcomes.

Efficacy and Safety of Tofacitinib Re-treatment for Ulcerative Colitis After Treatment Interruption: Results from the OCTAVE Clinical Trials.

BACKGROUND AND AIMS: Tofacitinib is an oral, small molecule Janus kinase inhibitor for the treatment of ulcerative colitis. Here, we evaluate the efficacy and safety of tofacitinib re-treatment following treatment interruption in patients with ulcerative colitis. METHODS: Here, patients with clinical response to tofacitinib 10 mg b.d. induction therapy were randomised to receive placebo in OCTAVE Sustain. Those experiencing treatment failure after Week 8 of OCTAVE Sustain entered OCTAVE Open and re-initiated tofacitinib 10 mg b.d. [re-treatment subpopulation]; efficacy and safety data are presented up to Month 36 of OCTAVE Open. RESULTS: Median time to treatment failure following interruption was 169 (95% confidence interval [CI], 94.0-179.0) and 123 [95% CI, 91.0-168.0] days for induction remitters, and induction responders but non-remitters, respectively. Following re-treatment with tofacitinib, rates (non-responder imputation after a patient discontinued; latest observation carried forward imputation after a patient advanced to a subsequent study [NRI-LOCF]) of clinical response, remission, and endoscopic improvement were 74.0%, 39.0%, and 55.0% at Month 2, and 48.5%, 37.4%, and 42.4% at Month 36, respectively. Among induction remitters and induction responders but non-remitters, clinical response rates at Month 36 were 60.6% and 42.4% [NRI-LOCF], respectively. Efficacy was recaptured regardless of prior tumour necrosis factor inhibitor failure status. The safety profile of tofacitinib 10 mg b.d. re-treatment was consistent with the overall cohort and demonstrated no new safety risks associated with exposure of ≤36 months. CONCLUSIONS: Median time to treatment failure was numerically higher in induction remitters versus induction responders but non-remitters. Following treatment interruption, efficacy was safely and successfully recaptured with tofacitinib 10 mg b.d. re-treatment in a substantial proportion of patients [ClinicalTrials.gov:NCT01458574;NCT01470612].