Does patient engagement affect IBD patients' health-related quality of life? Findings from a cross-sectional study among people with inflammatory bowel diseases.

BACKGROUND: Patients diagnosed with inflammatory bowel disease (IBD) are required to deal with the unpredictability of this clinical condition, which is associated with poorer health-related quality of life (HRQoL) compared to other clinical conditions. Patient engagement is currently demonstrated to relate with chronic patients' HRQoL, but few studies have been conducted among this population. METHODS: A cross-sectional study was conducted among 1176 IBD patients. Data were collected on participants' HRQoL (SIBD-Q) and patient engagement (PHE-s®). Regression analysis was used to examine the effects of patient engagement on HRQoL. RESULTS: About the half of the sample (47%) reported a low patient engagement level. 30% of the sample reported a low level of HRQoL. Psycho-emotional functioning resulted to be the aspect of HRQoL most impacted in the 37% of the sample. The regression model showed that PHE-s® is significantly related to the SIBD-Q total score (B = .585; p < .001; R squared = .343) and to the subscales' scores-systemic symptoms (B = .572; p < .001; R squared = .327), bowel symptoms (B = .482; p < .001; R squared = .232), social (B = .485; p < .001; R squared = .234) and psycho-emotional (B = .607; p < .001; R squared = .369) functioning. CONCLUSIONS: Patients who are engaged in their IBD care pathway are more likely to report higher level of HRQoL, thus offering clues to potential therapeutic approaches to ameliorating IBD patients' wellbeing. As this is a modifiable factor, screening for patient  health engagement levels, coupled with appropriate interventions, could improve care, and ultimately improve HRQoL outcomes among IBD patients.

Inadequate food literacy is related to the worst health status and limitations in daily life in subjects with inflammatory bowel disease.

PURPOSE: Diet affects Inflammatory Bowel Disease (IBD) patients' quality of life. An adequate Food Literacy (FL) level enables adequate food choices. Currently, there is a lack of knowledge on the FL degree in patients with IBD. To deepen this item, we measured for the first time the degree of FL in IBD patients and then we analyzed its correlation with health and socio-demographic variables. METHODS: This is an observational prospective study includingsubjects with IBD belonging to A.M.I.C.I. ONLUS association. We first measured the degree of FL through Literacy Survey (FLS-IT) questionnaire (containing the Newest Vital Sign (NVS)). In addition, we analyzed the relationship between FL individual level and health and sociodemographic variables, evaluating which of these aspects have a positive or negative correlation with FL level. In detail, continuous variables were analyzed by Mann Whitney test. Differences among proportions were assessed using the chi-square test. A Spearman's rank correlation analysis was performed to correlate the sociodemographic and health status variable with FL index and NVS. A stepwise linear regression analysis with backward selection was performed to identify possible predictor of good food literary skills in IBS patients. RESULTS: Overall, 450 IBD subjects completed the FLS-IT questionnaire. Among them, 69.78% (n = 314) showed an inadequate FL level. Concerning NVS test, 14.22% showed an insufficient ability to interpret food labels. In addition, higher FL level was associated to better subjective health conditions (r = 0.1513; p = 0.0013), less limitations in daily living activities (r = 0.1430; p = 0.0026), higher physical activity (r = 1200; p = 0.0110) and no alcohol consumption (p = 0.0020). Finally, higher NVS scores were shown by women (r = 0.1408; p = 0.0028) and by younger subjects (r = -0.1686; p = 0.0003). CONCLUSIONS: We showed that an inadequate level of FL, related to the worst health status and the presence of several limitations in daily life, is widespread among our Italian cohort of IBD patients, and health and social status influence the ability to make adequate food choices. For this reason, it is necessary to investigate the problem and identify effective intervention strategies that will improve the patient's nutritional awareness.

WE-CARE IBD SCORE: Assessing High-quality Care From the Perspective of Patients With Inflammatory Bowel Disease.

BACKGROUND AND AIMS: Patient-reported experience measures [PREMs] are today a core asset to orientate health care quality improvements. They are particularly relevant in clinical situations requiring frequent interactions between patients and the health care system, like inflammatory bowel disease [IBD]. Indeed, IBD chronic care requires continuous therapies, psychological interventions, and follow-ups. The characteristics of health care services play an important role in the life of these patients and in their satisfaction with the care received. The aim of this study was to develop and validate an IBD-specific questionnaire [WE-CARE IBD SCORE] able to capture IBD patients' needs and priorities for their own health care and based on patients' perspectives. METHODS: The WE-CARE IBD SCORE was developed and validated through a multistage process [qualitative and quantitative] and administered to 1176 patients with IBD. Psychometric evaluation included an assessment of internal consistency and factor analysis. RESULTS: The WE-CARE IBD SCORE is a short and self-administered questionnaire that includes six items assessing one unique dimension of 'IBD patient-reported high quality of care'. Psychometric evaluations demonstrate the reliability [Cronbach's alpha = 0.93] and validity [invariance to gender and diagnosis] of the questionnaire as an instrument able to detect and assess IBD patients' main psychosocial needs and priorities for receiving health care services. CONCLUSIONS: The WE-CARE IBD SCORE contributes to the panorama of existing quality of care patient-reported measures by providing a patient-based, psychosocial perspective in the evaluation of a key aspect for chronic-and particularly for IBD patients-care.

Psychological reaction to Covid-19 of Italian patients with IBD.

BACKGROUND: Patients with inflammatory bowel disease (IBD) may be particularly vulnerable to the effects of the novel coronavirus (Covid-19) on disease management and psychological status. This study explored psychological reactions to the Covid-19 emergency and IBD disease management in a sample of Italian patients. METHODS: An online questionnaire was designed to assess general concerns, psychological reaction, disease management, socio-demographics, and clinical information with validated scales and ad hoc items. A non-probabilistic purposive sample was selected, comprised patients with IBD who belonged to the Italian Association for patients with IBD (AMICI Onlus) completed the questionnaire in April 2020. Data obtained were analyzed using descriptive statistics, student's T-test for independent groups, and one-way ANOVA (Analysis of Variance). RESULTS: One thousand fourteen eligible questionnaires were analyzed. Italian patients with IBD appeared to be very worried about the Covid-19 emergency (60.7%) and concerned about the risks of infection (59%). Half of the sample reported medium to high-perceived stress, and 74% had low-medium coping self-efficacy levels. One third was in a state of psychological arousal. Twenty-nine percent of patients had canceled hospital appointments for fear of contracting the virus. The majority of responders believed that belonging to the Italian Association for Patients with IBD - AMICI Onlus - is useful. CONCLUSIONS: The results revealed that this sample of Italian patients with IBD lived with medium level of stress and with inadequate coping self-efficacy regarding disease management. Accordingly, Covid-19 may affect self-management behaviors. Therefore, national and regional associations for patients with IBD, should largely support these patients in this emergency.

Patient Engagement in Health Management as a Mediator Between Perceived Risk and COVID-19 Related Distress in Patients With IBD: A Structural Equation Model.

Objective: This study aimed to evaluate the impact of the COVID-19 emergency on patients with IBD's psychological distress, understanding the role of patient engagement as a mediator. Methods: An online questionnaire was created, measuring perceived risk susceptibility toward COVID-19, perceived stress, and patient engagement. The questionnaire was distributed to a purposive sample of IBD patients who belonged to the Italian Association for patients with IBD (AMICI Onlus) in April 2020. Structural equation models were implemented. Results: The effect of the perceived risk susceptibility toward COVID-19 contagion on the perceived stress is fully mediated by patient engagement (ß = 0.306, p < 0.001). Moreover, the patient engagement mitigates the perceived stress (ß = -0.748, p < 0.001) in our sample of IBD patients, and it is negatively influenced by the perceived risk susceptibility toward COVID-19 (ß = -0.410, p < 0.001). Conclusion: Patient engagement is the key factor that explains how the perceived risk susceptibility toward COVID-19 affects the perceived psychological distress in patients with IBD, underlining that the perceived risk of contagion increases their perceived level of stress through a decrease of patient engagement.

Promoting psycho-social wellbeing for engaging inflammatory bowel disease patients in their care: an Italian consensus statement.

BACKGROUND: Inflammatory bowel diseases (IBD) are remitting and relapsing diseases that mainly interest the gastrointestinal tract. IBD is associated with a condition of psycho-social discomfort that deeply compromises the quality of life and the competence of patient to be fully engaged in their self-management. As a consequence, effective care of IBD patients should include not only medical but also psychological support in order to improve patients' wellbeing. Although this, to date there is no standardized approach to promote psychological wellbeing of IBD patients in order to improve the perception of the quality of the care. To fill this gap, a consensus conference has been organized in order to define the psychosocial needs of IBD patients and to promote their engagement in daily clinical practice. This paper describes the process implemented and illustrates the recommendations deriving from it, which focus on the importance of a multidisciplinary approach in IBD management. RESULTS: The consensus conference has been organized in three phases: (1) literature review about life experiences, engagement, and psychosocial needs of IBD patients; (2) workshops with IBD experts and patients' representatives; (3) drafting of statements and voting. Seventy-three participants were involved in the consensus conference, and sixteen statements have been voted and approved during the consensus process. CONCLUSIONS: The main conclusion is the necessity of the early detection of - and, in case of need, intervention on- psycho-social needs of patients in order to achieve patient involvement in IBD care.

Biosimilars: The viewpoint of Italian patients with inflammatory bowel disease.

BACKGROUND: The viewpoint on biosimilars among patients with inflammatory bowel diseases (IBD) is largely unknown. AIMS: We aimed at exploring the confidence and opinion on biosimilars among Italian patients with IBD. METHODS: An anonymous, 20-item, questionnaire was sent via e-mail to all members of the Italian IBD patients' association (AMICI Onlus). Three sets of questions were formulated: 1: Characteristics of respondents; 2: The use of biologics and biosimilars in clinical practice; 3: General opinions on biologics and biosimilars. RESULTS: Of the 4,302 total surveys sent, there were 1,749 respondents (response rate: 40.6%). There was an equal distribution between males and females (48.3% and 51.7%, respectively), and between patients with Crohn's disease and ulcerative colitis (46.9% and 51.3%, respectively), while most of the patients were aged between 19 and 45 years and between 46 and 65 years (45.5% and 42.0%, respectively). Approximately 45% of the respondents declared to have never been informed about the existence of biosimilars. The great majority of patients (73.9%) did not know if originators and biosimilars could be considered equivalent, or if efficacy or safety of biosimilars could be lower than those of originators. Approximately half of the respondents (53.5%) had no idea that the use of low-cost biosimilars could be useful to increase the overall economic resources for the treatment of IBD. CONCLUSIONS: An extensive lack of knowledge and confidence in biosimilars exists among Italian patients with IBD. Efforts carried out by scientific societies and IBD patients' associations are required to overcome this issue.

Prevalence and incidence of inflammatory bowel disease in two Italian islands, Sicily and Sardinia: A report based on health information systems.

BACKGROUND: Few epidemiological data about inflammatory bowel disease (IBD) in Italy are available. AIMS: To estimate IBD prevalence and incidence in two Italian regions - Sicily and Sardinia - using regional health information systems. METHODS: Data from hospital discharges and disease-specific payment exemptions register were retrieved and underwent record-linkage procedures. Standardized prevalence and incidence were calculated as rates per 100,000 inhabitants. RESULTS: In Sicily, during the year 2013, the overall IBD incidence rate was 27 per 100,000 inhabitants, while the incidence rate of Crohn's disease (CD) was 16 for males and 13 for females, and the incidence of ulcerative colitis (UC) was 15 and 11 for males and females, respectively. At the date of December 31st, 2013, the standardized prevalence rate of IBD was estimated at 300 cases per 100,000 inhabitants. In Sardinia, during the period 2008-2010, the average IBD incidence rate per 100,000 was 15, with an incidence rate of 5 per 100,000 for CD, and 10 per 100,000 for UC, while the standardized prevalence rate of IBD was estimated at 187 cases per 100,000 inhabitants. CONCLUSIONS: The particularly high incidence of CD in Sicily, and the marked difference of IBD occurrence between the two islands deserve future investigations.