Prevalence, Pathogenesis and Management of Anemia in Inflammatory Bowel Disease: An IG-IBD Multicenter, Prospective, and Observational Study.

BACKGROUND: Anemia is a common extraintestinal manifestation of inflammatory bowel disease (IBD), with a 6% to 74% prevalence and a negative impact on patient survival and quality of life, although the prevalence is apparently declining due to improved disease treatment. We aimed to investigate the prevalence, pathogenesis, and clinical correlates of anemia in Italian patients with IBD. METHODS: A multicenter, prospective, observational study, involving 28 Italian gastroenterology centers, was conducted to investigate the epidemiology and consequences of IBD-associated anemia. Clinical and laboratory data of anemic patients were obtained at study enrolment. RESULTS: Anemia was diagnosed in 737 of 5416 adult IBD outpatients (prevalence 13.6%); females were more commonly affected than males (odds ratio, 1.5; 95% confidence interval [CI], 1.2-1.7) and had more severe anemia. In the majority of cases, anemia was due to iron deficiency (62.5% of cases; 95% CI, 58.3%-66.6%), either isolated or in association with inflammation and/or vitamin deficiencies; anemia of inflammation accounted for only 8.3% of cases. More severe anemia was associated with increasing fatigue and worse quality of life. Only 68.9% of anemic patients with iron deficiency (95% CI, 63.4%-73.8%) and 34.6% of those with vitamin deficiencies (95% CI, 26.2%-44.2%) were properly treated with supplementation therapy. CONCLUSIONS: In Italy, the prevalence of IBD-associated anemia is lower than previously reported. Anemia of IBD is most commonly due to iron deficiency and contributes to fatigue and poor quality of life, but remains untreated in a large proportion of patients with iron and/or vitamin deficiencies. This study is registered at clinicaltrials.gov as NCT02872376.

The prevalence of inflammatory bowel disease­associated anemia is 13.6%. The prevalence is higher among females younger than 50. Anemia is usually due to iron deficiency and adversely affects fatigue and quality of life. Many patients with iron or vitamin deficiency (31% and 65%, respectively) remain untreated.

Activities related to inflammatory bowel disease management during and after the coronavirus disease 2019 lockdown in Italy: How to maintain standards of care.

BACKGROUND AND AIMS: Restructuring activities have been necessary during the lockdown phase of the coronavirus disease 2019 (COVID-19) pandemic. Few data are available on the post-lockdown phase in terms of health-care procedures in inflammatory bowel disease (IBD) care, and no data are available specifically from IBD units. We aimed to investigate how IBD management was restructured during the lockdown phase, the impact of the restructuring on standards of care and how Italian IBD units have managed post-lockdown activities. METHODS: A web-based online survey was conducted in two phases (April and June 2020) among the Italian Group for IBD affiliated units within the entire country. We investigated preventive measures, the possibility of continuing scheduled visits/procedures/therapies because of COVID-19 and how units resumed activities in the post-lockdown phase. RESULTS: Forty-two referral centres participated from all over Italy. During the COVID-19 lockdown, 36% of first visits and 7% of follow-up visits were regularly done, while >70% of follow-up scheduled visits and 5% of first visits were done virtually. About 25% of scheduled endoscopies and bowel ultrasound scans were done. More than 80% of biological therapies were done as scheduled. Compared to the pre-lockdown situation, 95% of centres modified management of outpatient activity, 93% of endoscopies, 59% of gastrointestinal ultrasounds and 33% of biological therapies. Resumption of activities after the lockdown phase may take three to six months to normalize. Virtual clinics, implementation of IBD pathways and facilities seem to be the main factors to improve care in the future. CONCLUSION: Italian IBD unit restructuring allowed quality standards of care during the COVID-19 pandemic to be maintained. A return to normal appears to be feasible and achievable relatively quickly. Some approaches, such as virtual clinics and identified IBD pathways, represent a valid starting point to improve IBD care in the post-COVID-19 era.

Use of corticosteroids and immunosuppressive drugs in inflammatory bowel disease: Clinical practice guidelines of the Italian Group for the Study of Inflammatory Bowel Disease.

The two main forms of intestinal bowel disease, namely ulcerative colitis and Crohn's disease, are not curable but can be controlled by various medical therapies. The Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD) has prepared clinical practice guidelines to help physicians prescribe corticosteroids and immunosuppressive drugs for these patients. The guidelines consider therapies that induce remission in patients with active disease as well as treatment regimens that maintain remission. These guidelines complement already existing guidelines from IG-IBD on the use of biological drugs in patients with inflammatory bowel diseases.

Training Programs on Endoscopic Scoring Systems for Inflammatory Bowel Disease Lead to a Significant Increase in Interobserver Agreement Among Community Gastroenterologists.

Background and Aims: Endoscopic outcomes are increasingly used in clinical trials and in routine practice for inflammatory bowel disease [IBD] in order to reach more objective patient evaluations than possible using only clinical features. However, reproducibility of endoscopic scoring systems used to categorize endoscopic activity has been reported to be suboptimal. The aim of this study was to analyse the inter-rated agreement of non-dedicated gastroenterologists on IBD endoscopic scoring systems, and to explore the effects of a dedicated training programme on agreement. Methods: A total of 237 physicians attended training courses on IBD endoscopic scoring systems, and they independently scored a set of IBD endoscopic videos for ulcerative colitis [with Mayo endoscopic subscore], post-operative Crohn's disease [with Rutgeerts score] and luminal Crohn's disease (with the Simple Endoscopic Score for Crohn's Disease [SESCD] and Crohn's Endoscopic Index of Severity [CDEIS]). A second round of scoring was collected after discussion about determinants of discrepancy. Interobserver agreement was measured by means of the Fleiss' kappa [kappa] or intraclass correlation coefficient [ICC] as appropriate. Results: The inter-rater agreement increased from kappa 0.51 (95% confidence interval [95% CI] 0.48-0.55) to 0.76 [95% CI 0.72-0.79] for the Mayo endoscopic subscore, and from 0.45 [95% CI 0.40-0.50] to 0.79 [0.74-0.83] for the Rutgeerts score before and after the training programme, respectively, and both differences were significant [P < 0.0001]. The ICC was 0.77 [95% CI 0.56-0.96] for SESCD and 0.76 [0.54- 0.96] for CDEIS, respectively, with only one measurement. Discussion: The basal inter-rater agreement of inexperienced gastroenterologists focused on IBD management is moderate; however, a dedicated training programme can significantly impact on inter-rater agreement, increasing it to levels expected among expert central reviewers.

Patient and physician views on the quality of care for inflammatory bowel disease after one-year follow-up: Results from SOLUTION-2, a prospective IG-IBD study.

BACKGROUND AND AIMS: Perception of quality of care is important in the management of patients with chronic diseases, particularly inflammatory bowel disease. AIMS AND METHODS: This longitudinal study aimed to investigate variations of the Quality of Care through the Patients' Eyes (QUOTE-IBD) questionnaire scores one year after the basal evaluation in the Studio Osservazionale quaLità cUre malatTIe crOniche intestiNali (SOLUTION-1) study. RESULTS: Of the cohort of 992 patients, 936 were evaluable. The QUOTE-IBD score overcame satisfactory levels of more than the 80%, overall and in all subdomains except for the "Continuity of Care" sub-dimension (mean, 8.3; standard deviation, 1.49), scored satisfactory only by 34% of the patients. No significant changes in satisfaction were recorded overall, or considering patients subgroups. Significant differences were found at the end of the follow-up between physicians' and patients' perceptions of quality of care, with the former over-rating their performance in "Continuity of Cares" and under-rating "Costs", "Competence", and "Accessibility" sub-domains of the score (p<0.05 for all). CONCLUSION: Perceived quality of care in a large cohort of Italian patients with inflammatory bowel disease remains unchanged after one-year follow-up and was not significantly affected by disease activity or therapeutic interventions. Differences between physicians' and patients' perceptions of quality of care should be taken into account.

Safety of treatments for inflammatory bowel disease: Clinical practice guidelines of the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD).

Inflammatory bowel diseases are chronic conditions of unknown etiology, showing a growing incidence and prevalence in several countries, including Italy. Although the etiology of Crohn's disease and ulcerative colitis is unknown, due to the current knowledge regarding their pathogenesis, effective treatment strategies have been developed. Several guidelines are available regarding the efficacy and safety of available drug treatments for inflammatory bowel diseases. Nevertheless, national guidelines provide additional information adapted to local feasibility, costs and legal issues related to the use of the same drugs. These observations prompted the Italian Group for the Study of Inflammatory Bowel Disease (IG-IBD) to establish Italian guidelines on the safety of currently available treatments for Crohn's disease and ulcerative colitis. These guidelines discuss the use of aminosalicylates, systemic and low bioavailability corticosteroids, antibiotics (metronidazole, ciprofloxacin, rifaximin), thiopurines, methotrexate, cyclosporine A, TNFα antagonists, vedolizumab, and combination therapies. These guidelines are based on current knowledge derived from evidence-based medicine coupled with clinical experience of a national working group.

Inter-observer agreement in endoscopic scoring systems: preliminary report of an ongoing study from the Italian Group for Inflammatory Bowel Disease (IG-IBD).

BACKGROUND: Endoscopic activity has become a therapeutic endpoint in inflammatory bowel disease. Aim of this study was to evaluate inter-observer agreement for endoscopic scores in a real-life setting. METHODS: 14 gastroenterologists with experience in inflammatory bowel disease care and endoscopic scoring reviewed videos of ulcerative colitis (n=13) and postoperative (n=10) and luminal (n=8) Crohn's disease. The Mayo subscore for ulcerative colitis, Rutgeerts score for postoperative Crohn's disease, Crohn's disease endoscopic index of severity (CDEIS), and the simple endoscopic score-Crohn's disease (SES-CD) for luminal Crohn's disease were calculated. A subset of five endoscopic clips were assessed by 30 general gastroenterologists without specific experience in endoscopic scores. Kappa statistics and intraclass correlation coefficients were used to measure agreement. RESULTS: Mayo subscore agreement was suboptimal: kappas were 0.53 (95% confidence interval 0.47-0.56) and 0.71 (0.67-0.76) for the two groups. Rutgeerts score agreement was fair: kappas were 0.57 (0.51-0.65) and 0.67 (0.60-0.72). Agreements for CDEIS and SES-CD were good: intraclass correlation coefficients for the two groups were 0.83 (0.54-1.00) and 0.67 (0.36-0.97) for CDEIS and 0.93 (0.76-1.00) and 0.68 (0.35-0.97) for SES-CD, respectively. CONCLUSION: The reproducibility of endoscopic scores in inflammatory bowel disease remains suboptimal, which could potentially have major effects on therapeutic choices.

Patient and physician views on the quality of care in inflammatory bowel disease: results from SOLUTION-1, a prospective IG-IBD study.

INTRODUCTION: Remarkable differences in quality of care (QoC) might be observed in different countries, affecting quality of life of inflammatory bowel disease (IBD) patients. The aim of this study was to assess patient and physician perceptions of the QoC in Italy. METHODS: A multicentre observational study on the quality of care in IBD (SOLUTION-1) was conducted in 36 IG-IBD (Italian Group for Inflammatory Bowel Disease) centres in Italy. The QUOTE-IBD (Quality of Care Through the Patient's Eyes) questionnaire was administered to IBD patients and to the attending physicians. The Quality Impact (QI) score summarises the QUOTE-IBD questionnaire, and a QI >9 is considered satisfactory. RESULTS: Nine-hundred-ninety-two patients and 75 physicians completed the QUOTE-IBD questionnaire. The patients scored the domains of competence (9.47 vs. 8.55) and costs (9.54 vs. 8.26) higher that the physicians, while information (9.31 vs. 9.43) and continuity of care (8.40 vs. 9.01) were scored lower. The QI score was rated worse by physicians with less experience (<12 years) with regard to competence (8.0 vs. 9.01), courtesy (8.12 vs. 10.0) and autonomy (8.97 vs. 10.0). Physicians considered the cost domain unsatisfactory. CONCLUSIONS: Healthcare was rated as satisfactory overall for Italian patients and physicians. The physicians underestimate their competence and consider the cost of medical management unsatisfactory. The patients are more critical regarding the continuity of care and information. Country-specific data on QoC allow local governments to allocate resources more effectively.