[ESTABLISHING A REGISTRY FOR INFLAMMATORY BOWEL DISEASE PATIENTS IN MACCABI HEALTHCARE SERVICES - JOINT PROJECT BETWEEN HOSPITALS, EPI-IIRN GROUP AND COMMUNITY MEDICINE].

INTRODUCTION: Inflammatory bowel diseases (IBD) are becoming a significant cause for chronic long term complex morbidity, particularly among adolescents and young adults. IBD patients require multidisciplinary management and considerable health resources. Recent advances and developments in the diagnostics and therapeutic options require identification and tight monitoring of these patients at both hospital and community level for better management and care. AIMS: To establish at Maccabi Healthcare Services (MHS) a dedicated registry for inflammatory bowel disease patients for long term monitoring in order to optimize care, better use of health resources and to promote high quality research. METHODS: A national project, initiated and headed by a team from Shaare Zedek Medical Center aimed to resolve the complexity in identifying IBD patients at the community setting. The project included data from all Israeli HMOs and major hospitals, that was incorporated into various algorithms to determine prevalence and incidence and to distinguish between Crohn's disease and ulcerative colitis diagnoses. Eventually, an algorithm that includes the number of diagnoses, number of purchases and duration of IBD-related medications showed the best results for separating those that suffer from IBD and those that do not. This algorithm was further validated by chart review. RESULTS: According to the established registry criteria there were 14488 IBD patients in MHS, 13000 active. Additionally we have established an ongoing platform for ongoing monitoring of clinical, therapeutic, laboratory and imaging information. DISCUSSION: Establishing an IBD registry in MHS was enabled by a national project that combined deep professional knowledge of the disease by leading academic centers together with advanced informatics and community large data. We now move on to operate the registry in real life, together with live monitoring of various parameters in order to promote excellent care, communication with patients, management and control and to enable prospective high quality research.

Development and validation of novel algorithms to identify patients with inflammatory bowel diseases in Israel: an epi-IIRN group study.

BACKGROUND: Before embarking on administrative research, validated case ascertainment algorithms must be developed. We aimed at developing algorithms for identifying inflammatory bowel disease (IBD) patients, date of disease onset, and IBD type (Crohn's disease [CD] vs ulcerative colitis [UC]) in the databases of the four Israeli Health Maintenance Organizations (HMOs) covering 98% of the population. METHODS: Algorithms were developed on 5,131 IBD patients and 2,072 controls, following independent chart review (60% CD and 39% UC). We reviewed 942 different combinations of clinical parameters aided by mathematical modeling. The algorithms were validated on an independent cohort of 160,000 random subjects. RESULTS: The combination of the following variables achieved the highest diagnostic accuracy: IBD-related codes, alone if more than five to six codes or combined with purchases of IBD-related medications (at least three purchases or ≥3 months from the first to last purchase) (sensitivity 89%, specificity 99%, positive predictive value [PPV] 92%, negative predictive value [NPV] 99%). A look-back period of 2-5 years (depending on the HMO) without IBD-related codes or medications best determined the date of diagnosis (sensitivity 83%, specificity 68%, PPV 82%, NPV 70%). IBD type was determined by the majority of CD/UC codes of the three recent contacts or the most recent when less than three contacts were recorded (sensitivity 92%, specificity 97%, PPV 97%, NPV 92%). Applying these algorithms, a total of 38,291 IBD patients were residing in Israel, corresponding to a prevalence rate of 459/100,000 (0.46%). CONCLUSION: The application of the validated algorithms to Israel's administrative databases will now create a large and accurate ongoing population-based cohort of IBD patients for future administrative studies.

Rapid Infliximab Infusion in Children: A Multicenter Retrospective Cohort Study.

Pediatric data on rapid infliximab infusion are scarce. We report our experience with a 1-hour rapid infusion protocol, prescribed in 3 pediatric inflammatory bowel disease units during 18 to 26 months. Children treated with infliximab for inflammatory bowel disease using a standard 2- to 3-hour infusion protocol were switched to a 1-hour protocol if they had received at least 4 standard duration infusions with no infusion reactions, there was no recent dose increase and no more than 10 weeks had elapsed since the previous infusion. A total of 102 children received infliximab infusions during the study period (85 Crohn disease; mean age 14.6 ±â€Š2.6 years) of whom 63 were switched to the rapid infusions. Seven patients on the rapid protocol (11%) and 6 patients on the standard protocol (15%) had infusion reactions (P = 0.55). Consistent with adult data, our study indicates that a 1-hour infliximab protocol in selected patients offers a safe alternative to the traditional 2- to 3-hour infusions.

Vedolizumab in Paediatric Inflammatory Bowel Disease: A Retrospective Multi-Centre Experience From the Paediatric IBD Porto Group of ESPGHAN.

Background: Vedolizumab, an anti-integrin antibody, has proven to be effective in adults with inflammatory bowel disease [IBD], but the data in paediatrics are limited. We describe the short-term effectiveness and safety of vedolizumab in a European multi-centre paediatric IBD cohort. Method: Retrospective review of children [aged 2-18 years] treated with vedolizumab from 19 centres affiliated with the Paediatric IBD Porto group of ESPGHAN. Primary outcome was Week 14 corticosteroid-free remission [CFR]. Results: In all, 64 children were included (32 [50%] male, mean age 14.5 ± 2.8 years, with a median follow-up 24 weeks [interquartile range 14-38; range 6-116]); 41 [64%] cases of ulcerative colitis/inflammatory bowel disease unclassified [UC/IBD-U] and 23 [36%] Crohn's disease [CD]. All were previously treated with anti-tumour necrosis factor [TNF] [28% primary failure, 53% secondary failure]. Week 14 CFR was 37% in UC, and 14% in CD [P = 0.06]. CFR by last follow-up was 39% in UC and 24% in CD [p = 0.24]. Ten [17%] children required surgery, six of whom had colectomy for UC. Concomitant immunomodulatory drugs did not affect remission rate [42% vs 35%; p = 0.35 at Week 22]. There were three minor drug-related adverse events. Only 3 of 16 children who underwent endoscopic evaluation had mucosal healing after treatment (19%). Conclusions: Vedolizumab was safe and effective in this cohort of paediatric refractory IBD. These data support previous findings of slow induction rate of vedolizumab in CD and a trend to be less effective compared with patients with UC.

Association between Cataract and Keratinocytic Skin Cancers or Melanoma: Speculating on the Common Role of Sun and Ultraviolet Radiation Exposures.

PURPOSE: Cataract and sun-related skin conditions are proxies to lifetime UV exposure. We examined the association between them using real-world data from an unselected Israeli population. METHODS: Computerized data was obtained from an Israeli health maintenance organization regarding cases of sun-related skin pathologies and cataract diagnosed between 2006 and 2011 in 686,260 members aged 40 or above. RESULTS: Sun-related skin disorders were found in 9.3% of the study population, more commonly among the elderly, and those who reside in areas of higher socioeconomic status. Cataract was diagnosed in 13.1% of the study population, with highest prevalence (47%) among squamous cell carcinoma patients, who were the oldest group. Multivariable analysis adjusting for age, sex, residential district, birth region, smoking, and chronic comorbidities showed no statistically significant association between melanoma and cataract (OR = 1.06; 95% CI: 0.91-1.22). Basal cell carcinoma, squamous cell carcinomas, and actinic keratosis were associated with increased likelihood of prevalent cataract with adjusted odds ratios (95% CI) of 1.14 (1.08-1.20), 1.11 (1.01-1.19), and 1.16 (1.13-1.19), respectively. When stratified by gender, the association between actinic keratosis and cataract was stronger in women than in men, particularly in patients under 65 years. CONCLUSIONS: The association between the prevalence of skin cancers and the prevalence of cataract enhances the conclusion that cataract is related to UVR exposure.

Epidemiology of hepatitis C virus infection in a large Israeli health maintenance organization.

Hepatitis C affects an estimated 130 million people worldwide and is a major cause of chronic liver disease. This retrospective database study aims to describe the epidemiology of HCV-infected patients in Maccabi Healthcare Services, a 2-million-member health maintenance organization in Israel. HCV was identified by cross-linking diagnoses, laboratory data, and dispensed HCV treatment (1993-2013). The point-prevalence of HCV in 2012 and annual incidence of newly-diagnosed HCV during 2003-2012 (index period) were calculated. The age-adjusted prevalence of HCV was 5.19/1,000 population (n = 10,648). The highest prevalence was found among males and in patients aged 35-54 years. Two thirds of HCV-infected patients were immigrants from the former Soviet Union (FSU). HCV genotype 1 was predominant (67%). A total of 6,150 patients were newly diagnosed with HCV infection during the index period. The age-standardized rate of newly-diagnosed HCV declined from over 50/100,000 (2003) to 15/100,000 (2012). This rate was highest in males from the FSU, particularly for birth cohorts in 1950-70. The study results suggest that the reported incidence of HCV infection in Israel is declining, while prevalence is particularly high among FSU immigrants and genotype 1 is predominant. As the HCV treatment landscape evolves, these estimates can inform future studies and health technology assessments.