Multi-disciplinary Insights from the First European Forum on Visceral Myopathy 2022 Meeting.

Visceral myopathy is a rare, life-threatening disease linked to identified genetic mutations in 60% of cases. Mostly due to the dearth of knowledge regarding its pathogenesis, effective treatments are lacking. The disease is most commonly diagnosed in children with recurrent or persistent disabling episodes of functional intestinal obstruction, which can be life threatening, often requiring long-term parenteral or specialized enteral nutritional support. Although these interventions are undisputedly life-saving as they allow affected individuals to avoid malnutrition and related complications, they also seriously compromise their quality of life and can carry the risk of sepsis and thrombosis. Animal models for visceral myopathy, which could be crucial for advancing the scientific knowledge of this condition, are scarce. Clearly, a collaborative network is needed to develop research plans to clarify genotype-phenotype correlations and unravel molecular mechanisms to provide targeted therapeutic strategies. This paper represents a summary report of the first 'European Forum on Visceral Myopathy'. This forum was attended by an international interdisciplinary working group that met to better understand visceral myopathy and foster interaction among scientists actively involved in the field and clinicians who specialize in care of people with visceral myopathy.

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.

Baseline Data and Measurement Instruments Reported in Observational Studies in Inflammatory Bowel Disease: Results from a Systematic Review.

BACKGROUND: Heterogeneity in demographic and outcomes data with corresponding measurement instruments [MIs] creates barriers to data pooling and analysis. Several core outcome sets have been developed in inflammatory bowel disease [IBD] to homogenize outcomes data. A parallel Minimum Data Set [MDS] for baseline characteristics is lacking. We conducted a systematic review to develop the first MDS. METHODS: A systematic review was made of observational studies from three databases [2000-2021]. Titles and abstracts were screened, full-text articles were reviewed, and data were extracted by two reviewers. Baseline data were grouped into ten domains: demographics, clinical features, disease behaviour/complications, biomarkers, endoscopy, histology, radiology, healthcare utilization and patient-reported data. Frequency of baseline data and MIs within respective domains are reported. RESULTS: From 315 included studies [600 552 subjects], most originated from Europe [196; 62%] and North America [59; 19%], and were published between 2011 and 2021 [251; 80%]. The most frequent domains were demographics [311; 98.7%] and clinical [289; 91.7%]; 224 [71.1%] studies reported on the triad of sex [306; 97.1%], age [289; 91.7%], and disease phenotype [231; 73.3%]. Few included baseline data for radiology [19; 6%], healthcare utilization [19; 6%], and histology [17; 5.4%]. Ethnicity [19; 6%], race [17; 5.4%], and alcohol/drug consumption [6; 1.9%] were the least reported demographics. From 25 MIs for clinical disease activity, the Harvey-Bradshaw Index [n = 53] and Mayo score [n = 37] were most frequently used. CONCLUSIONS: Substantial variability exists in baseline population data reporting. These findings will inform a future consensus for MDS in IBD to enhance data harmonization and credibility of real-world evidence.

The sequential antifracturative treatment: a meta-analysis of randomized clinical trials.

Background: Subjects with a fragility fracture have an increased risk of a new fracture and should receive effective strategies to prevent new events. The medium-term to long-term strategy should be scheduled by considering the mechanisms of action in therapy and the estimated fracture risk. Objective: A systematic review was conducted to evaluate the sequential strategy in patients with or at risk of a fragility fracture in the context of the development of the Italian Guidelines. Design: Systematic review and meta-analysis. Data sources and methods: PubMed, Embase, and the Cochrane Library were investigated up to February 2021 to update the search of a recent systematic review. Randomized clinical trials (RCTs) that analyzed the sequential therapy of antiresorptive, anabolic treatment, or placebo in patients with or at risk of a fragility fracture were eligible. Three authors independently extracted data and appraised the risk of bias in the included studies. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation methodology. Effect sizes were pooled in a meta-analysis using fixed-effects models. The primary outcome was the risk of refracture, while the secondary outcome was the bone mineral density (BMD) change. Results: In all, 17 RCTs, ranging from low to high quality, met our inclusion criteria. A significantly reduced risk of fracture was detected at (i) 12 or 24 months after the switch from romosozumab to denosumab versus placebo to denosumab; (ii) 30 months from teriparatide to bisphosphonates versus placebo to bisphosphonates; and (iii) 12 months from romosozumab to alendronate versus the only alendronate therapy (specifically for vertebral fractures). In general, at 2 years after the switch from anabolic to antiresorptive drugs, a weighted BMD was increased at the lumbar spine, total hip, and femoral neck site. Conclusion: The Task Force formulated recommendations on sequential therapy, which is the first treatment with anabolic drugs or 'bone builders' in patients with very high or imminent risk of fracture.

A systematic review to evaluate the sequential therapy of antiresorptive (denosumab and bisphosphonate, such as alendronate, minodronate, risedronate, and etidronate), anabolic treatment (such as romosozumab, teriparatide), or placebo in patients with or at risk of a fragility fracture in the context of the development of the Italian Guidelines Subjects with previous fragility fractures should promptly receive effective strategies to prevent the risk of subsequent events. Indeed, patients with a fragility fracture have a doubled risk of a new fracture. For this reason, it is essential to provide adequate sequential therapy based on the mechanisms and the rapidity of action. A systematic review was performed to identify the sequential strategy in patients at high- or imminent-risk of (re)fracture and to support the Panel of the Italian Fragility Fracture Guideline in formulating recommendations. Our systematic review included seventeen studies mostly focused on women and enabled us to strongly recommend the anabolic drugs as first-line treatment. Specifically, for the sequential therapy from anabolic to antiresorptive treatment, there was a significant reduction in the risk of different types of fractures after the switch from romosozumab to denosumab versus placebo to denosumab. These findings were confirmed at 24 months after the switch. Considering the sequential treatment from antiresorptive to anabolic medications, there was a decreased risk of fracture 12 months after the switch from placebo to teriparatide versus bisphosphonate or antiresorptive to teriparatide. Moreover, a greater bone mineral density increase after the switch from anabolic to antiresorptive medications was shown in the lumbar spine, total hip, and femoral neck. The results of this systematic review and meta-analysis confirm that initial treatment with anabolic drugs produces substantial bone mineral density improvements, and the transition to antiresorptive drugs can preserve or even amplify the acquired benefit. These findings support the choice to treat very high-risk individuals with anabolic drugs first, followed by antiresorptive drugs.

Development of a Core Outcome Set for Real-world Data in Inflammatory Bowel Disease: A European Crohn's and Colitis Organisation [ECCO] Position Paper.

BACKGROUND AND AIMS: The utility of real-world data is dependent on the quality and homogeneity of reporting. We aimed to develop a core outcome set for real-world studies in adult patients with inflammatory bowel disease [IBD]. METHODS: Candidate outcomes and outcome measures were identified and categorised in a systematic review. An international panel including patients, dietitians, epidemiologists, gastroenterologists, nurses, pathologists, radiologists, and surgeons participated in a modified Delphi consensus process. A consensus meeting was held to ratify the final core outcome set. RESULTS: A total of 26 panellists from 13 countries participated in the consensus process. A total of 271 items [130 outcomes, 141 outcome measures] in nine study domains were included in the first-round survey. Panellists agreed that real-world studies on disease activity should report clinical, endoscopic, and biomarker disease activity. A disease-specific clinical index [Harvey-Bradshaw Index, Partial Mayo Score, Simple Clinical Colitis Activity Index] should be used, rather than physician global assessment. In ulcerative colitis [UC], either the UC Endoscopic Index of Severity or the Mayo Endoscopic Score can be used, but there was no consensus on an endoscopic index for Crohn's disease, nor was there consensus on the use of the presence of ulcers. There was consensus on using faecal calprotectin and C-reactive protein. There was no consensus on the use of histology in real-world studies. CONCLUSIONS: A core outcome set for real-world studies in IBD has been developed based on international multidisciplinary consensus. Its adoption will facilitate synthesis in the generation of real-world evidence.

Executive summary: Italian guidelines for diagnosis, risk stratification, and care continuity of fragility fractures 2021.

Background: Fragility fractures are a major public health concern owing to their worrying and growing burden and their onerous burden upon health systems. There is now a substantial body of evidence that individuals who have already suffered a fragility fracture are at a greater risk for further fractures, thus suggesting the potential for secondary prevention in this field. Purpose: This guideline aims to provide evidence-based recommendations for recognizing, stratifying the risk, treating, and managing patients with fragility fracture. This is a summary version of the full Italian guideline. Methods: The Italian Fragility Fracture Team appointed by the Italian National Health Institute was employed from January 2020 to February 2021 to (i) identify previously published systematic reviews and guidelines on the field, (ii) formulate relevant clinical questions, (iii) systematically review literature and summarize evidence, (iv) draft the Evidence to Decision Framework, and (v) formulate recommendations. Results: Overall, 351 original papers were included in our systematic review to answer six clinical questions. Recommendations were categorized into issues concerning (i) frailty recognition as the cause of bone fracture, (ii) (re)fracture risk assessment, for prioritizing interventions, and (iii) treatment and management of patients experiencing fragility fractures. Six recommendations were overall developed, of which one, four, and one were of high, moderate, and low quality, respectively. Conclusions: The current guidelines provide guidance to support individualized management of patients experiencing non-traumatic bone fracture to benefit from secondary prevention of (re)fracture. Although our recommendations are based on the best available evidence, questionable quality evidence is still available for some relevant clinical questions, so future research has the potential to reduce uncertainty about the effects of intervention and the reasons for doing so at a reasonable cost.

Medication holidays in osteoporosis: evidence-based recommendations from the Italian guidelines on 'Diagnosis, risk stratification, and continuity of care of fragility fractures' based on a systematic literature review.

Background: Noncommunicable, chronic diseases need pharmacological interventions for long periods or even throughout life. The temporary or permanent cessation of medication for a specific period, known as a 'medication holiday,' should be planned by healthcare professionals. Objectives: We evaluated the association between continuity (adherence or persistence) of treatment and several outcomes in patients with fragility fractures in the context of the development of the Italian Guidelines. Design: Systematic review. Data Sources and Methods: We systematically searched PubMed, Embase, and the Cochrane Library up to November 2020 for randomized clinical trials (RCTs) and observational studies that analyzed medication holidays in patients with fragility fracture. Three authors independently extracted data and appraised the risk of bias of the included studies. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation methodology. Effect sizes were pooled in a meta-analysis using random effects models. Primary outcomes were refracture and quality of life; secondary outcomes were mortality and treatment-related adverse events. Results: Six RCTs and nine observational studies met our inclusion criteria, ranging from very low to moderate quality. The adherence to antiosteoporotic drugs was associated with a lower risk of nonvertebral fracture [relative risk (RR) 0.42, 95% confidence interval (CI) 0.20-0.87; three studies] than nonadherence, whereas no difference was detected in the health-related quality of life. A reduction in refracture risk was observed when continuous treatment was compared to discontinuous therapy (RR 0.49, 95% CI 0.25-0.98; three studies). A lower mortality rate was detected for the adherence and persistence measures, while no significant differences were noted in gastrointestinal side effects in individuals undergoing continuous versus discontinuous treatment. Conclusion: Our findings suggest that clinicians should promote adherence and persistence to antiosteoporotic treatment in patients with fragility fractures unless serious adverse effects occur.

Food and Inflammatory Bowel Diseases: A scoping review on the impact of food on patients' psychosocial quality of life.

Growing bodies of literature show that a controlled diet is important in controlling the symptoms of Inflammatory Bowel Diseases (IBD). This leads patients to avoid foods considered potentially harmful. However, food is not just a nutrient but entails a series of hedonistic, cultural and social values. Thus, there is the concern that having to renounce certain foods might exert an impact on patients' psychosocial quality of life, particularly in younger patients. The aim of this paper is to review the existing literature to address which aspects of the patients' quality of life are affected by food restrictions. A scoping review was carried out. Five different databases were searched in January 2021. Retrieved papers were then screened to only include the relevant studies. Data were extracted and the main results of the studies were charted. A thematic analysis was carried out on the main results to identify the areas of psychosocial quality of life more often impacted by the food restrictions. From the initially identified 1967 unique entries, 14 studies were included. Results show that the perceived importance of food in controlling symptoms is confirmed by patients' accounts. The most common strategy adopted was, thus, the avoidance of trigger foods. The thematic analysis revealed three domains that are impacted by these restrictions: psychological quality of life, social life, family sphere. This study highlights the impact that food restrictions exert on IBD patients' quality of life, and warrants further studies to fill existing gaps, in particular regarding younger 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.

A Narrative Systematic Review and Categorisation of Outcomes in Inflammatory Bowel Disease to Inform a Core Outcome Set for Real-world Evidence.

BACKGROUND: Heterogeneity exists in reported outcomes and outcome measurement instruments [OMI] from observational studies. A core outcome set [COS] for observational and real-world evidence [RWE] in inflammatory bowel disease [IBD] will facilitate pooling large datasets. This systematic review describes and classifies clinical and patient-reported outcomes, for COS development. METHODS: The systematic review of MEDLINE, EMBASE, and CINAHL databases identified observational studies published between 2000 and 2021 using the population exposure outcome [PEO] framework. Studies meeting eligibility criteria were included. After titles and abstracts screening, full-text articles were extracted by two independent reviewers. Primary and secondary outcomes with corresponding OMI were extracted and categorised in accordance with OMERACT Filter 2.1 framework. The frequency of outcomes and OMIs are described. RESULTS: From 5854 studies, 315 were included: 129 [41%] Crohn's disease [CD], 60 [19%] ulcerative colitis [UC], and 126 [40%] inflammatory bowel disease [IBD] studies with 600 552 participants. Totals of 1632 outcomes and 1929 OMI were extracted mainly from medical therapy [181; 72%], surgical [34; 11%], and endoscopic [6; 2%] studies. Clinical and medical therapy-related safety were frequent outcome domains recorded in 194 and 100 studies. Medical therapy-related adverse events [n = 74] and need for surgery [n = 71] were the commonest outcomes. The most frequently reported OMI were patient or event numbers [n = 914], Harvey-Bradshaw Index [n = 45], and Montreal classification [n = 42]. CONCLUSIONS: There is substantial variability in outcomes reporting and OMI types. Categorised outcomes and OMI from this review will inform a Delphi consensus on a COS for future RWE in IBD. Data collection standardisation may enhance the quality of RWE applied to decision-making.

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.