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Inflammatory Bowel Disease (IBD) encompasses a cluster of chronic inflammatory disorders affecting the gastrointestinal tract. The primary objective of IBD treatment is the management of inflammation, symptom control, and the induction and sustenance of remission. Therapeutic interventions commonly encompass medications, dietary modifications, and, in certain instances, surgical procedures; however, a definitive cure remains elusive. While several nations have established national IBD registries, Romania has not. The responsibility of the implementation of such a registry was assumed by a non-profit organization, the "Clubul Român de Boală Crohn și Colită Ulcerativă", resulting in the creation of the registrul-ibd.ro platform. Given the absence of a curative remedy for IBD, it falls within the realm of personalized medicine. In light of this, the University of Medicine and Pharmacy of Craiova has developed a mobile application, IBDMonitor, intricately linked with the IBD registry. This innovative application empowers patients to meticulously record critical data, encompassing medication administration, symptomatology, lifestyle habits, as well as physiological, pathological, and daily occurrences. Medical professionals are granted real-time access to these patient-generated reports, enabling them to make prompt treatment adjustments. Following a successful pilot phase, various insights have emerged, notably revealing a relatively low long-term adherence rate to the application. Consequently, advocating for the widespread adoption of both the application and the registry on a national scale holds the potential to significantly enhance the utilization of these invaluable tools in the management of IBD. [ABSTRACT FROM AUTHOR]

Background: In response to the goal of the World Health Organisation to eliminate hepatitis C virus infections by 2030, Romania is striving for national elimination. An already successful micro-elimination project was expanded to test-and-treat specific populations and at-risk groups. The aim of this project was to identify the individuals with HCV infection in disadvantaged regions who do not have proper medical care access. Materials and Methods: Our two-arm interventional cross-sectional study used rapid anti-HCV antibody testing on two population groups from the Romanian southwestern region of Oltenia, approached between September 2020 and May 2021. The first group consisted of predominantly over 40 years old individuals, recruited through five family doctors from two medium-sized towns (community lot—CL). We approached a second group, aged 18–65, through 11 medical offices of five large factories in the same region (industry lot, IL). A 12-items questionnaire was given to each participant, to determine risk factors and record demographic data. Eligible patients initiated antiviral therapy using direct-acting antivirals (DAAs). Results: We enrolled 15,383 individuals between all 16 locations. The overall prevalence by antibody testing was 0.77% (119 cases). Of these, 57 subsequently received treatment with DAAs. We identified blood transfusions as a risk factor within the CL. Participants in the IL reported a relatively high risk for the following situations: sharing of personal hygiene belongings with another person, performing previous blood transfusions, dental interventions and previous surgery. Conclusions: In this global context, the use of micro-elimination allows interventions to be faster and more efficient. This is possible by targeting smaller and specific HCV risk groups. [ABSTRACT FROM AUTHOR]

Background & Aims: Real-world assessments of efficacy and safety of advanced therapies used for inflammatory bowel disease (IBD) patients are limited. We aimed to report safety, efficacy and treatment persistence of new molecules (infliximab, adalimumab, vedolizumab, tofacitinib, ustekinumab) in a retrospective multicentric national Romanian analysis. Methods: We conducted a nationwide, retrospective observational multicentric study. Data were collected retrospectively from electronic and paper files. Patients who started on one of the five investigated molecules during December 2019-December 2021 were included. The main outcome measures were clinical remission, endoscopic healing, persistence on treatment and safety data. Results: A total of 678 adult patients from 24 Romanian IBD centers with a diagnosis of ulcerative colitis or Crohn's disease were included. Participants had previously failure to one (268, 39.5%), two (108, 15%) or more treatment lines and only 38% (259) were biologic naïve. In the 24 months study period, most patients were started on vedolizumab (192, 28%), followed by adalimumab, infliximab, ustekinumab and tofacitinib. In biologic-naïve patients, most physicians (72%) preferred anti-TNF treatment as first line biologic (93 patients started on infliximab, 92 on adalimumab), followed by vedolizumab, ustekinumab and tofacitinib. During follow-up, 71% (470, p=0.05) of patients achieved clinical remission and 36% (134, p=0.03) achieved mucosal healing. The 6 months milestone for persistence was reached in 78% (530) of cases. Almost half of patients (47%, 316 patients) persisted on their current treatment for over 12 months. Overall, an adverse reaction was reported for 67 (10.4%) patients, with no lethal events. Conclusions: Population of biologic-experienced IBD patients in Romania is increasing and is becoming more difficult to achieve long-term disease control. Discontinuation rates for advanced therapies are high. [ABSTRACT FROM AUTHOR]

Despite all recent advances in the diagnosis and treatment of hepatitis C virus infection, the incidence remains high, motivating the present study to improve the prognosis of the disease through early diagnosis of asymptomatic patients with possible detectable risk factors. The aim of this study is to identify HCV infection in a disadvantaged population before the onset of symptoms and guide to specialized services for initiation of antiviral therapy, thus adhering to the WHO goal of elimination the infection. Materials and Methods: In the first two weeks after the start of the study, 320 patients with detectable risk factors for HCV were tested using rapid tests, in a southwestern city of Romania, Orșova, with the participation of four doctors, via Family Medicine Offices. Results: As a percentage, the amount of detection based on rapid tests was 2.5%, the positive results have apparently been achieved exclusively among female subjects. All patients have been informed about the result and included in the diagnostic trial, where they were fully evaluated to determine if they were eligible for therapy. Conclusions. Population screening contributes to the diagnosis and elimination of an underdiagnosed pathology, in a disadvantaged area with limited access to medical care. The positive feedback that has been received in just a few weeks after its beginning, once again has motivated to emphasis the population screening, with real considerations on the possibility of expanding this program on a large scale. [ABSTRACT FROM AUTHOR]

This observational study included all patients undergoing HCV treatment with direct-acting antiviral (DAA)-based therapy between May 2020 and September 2023 at the Dolj County Hospital, Romania. The aim was to investigate adherence to DAAs among HCV patients and the effect of this treatment on their health-related quality of life (HRQoL). Chronic HCV-infected patients were prospectively evaluated at baseline (T0), before the beginning of treatment, and 12 weeks after completing DAAs treatment (T1). The HCV-AD10 questionnaire was used to measure DAAs adherence, and HRQoL was assessed with the 15D instrument. The 15D questionnaire was administered at two time points: T0 and T1, during which the Sustained Virologic Response (SVR) was also measured. The primary outcome was DAAs adherence, with secondary outcomes including quality of life (QoL), and sustained virologic response (SVR). DAAs based therapy was initiated for 368 patients, all of whom were health insured. HRQoL and psychological state of HCV patients clinically improved. The DAAs adherence was very good (mean±SD, 91.51±8.34), being influenced by age (younger patients were much adherent, rho=-0.112, p-value=0.031) and the severity of the disease (patients with more severe hepatitis were less adherent, rho=-0.167, p-value=0.001). DAAs had a significant effect on improving HRQoL of HCV patients, but did not influence medication adherence. [ABSTRACT FROM AUTHOR]

Background & Aims: Colorectal cancer (CRC) is the third cause of cancer-related death worldwide. Screening programs can reduce CRC mortality rates by up to 60%. In line with the European Union recommendations, Romania started the first four regional pilot screening programs in 2020 (the ROCCAS II projects). This study reports the interim screening performance indicators. Methods: People aged 50 to 74 years were invited to the screening program. General practitioners (GPs) evaluated CRC risk based on a survey. High-risk or symptomatic individuals were referred directly to colonoscopy. The average risk participants received a fecal immunochemical test (FIT). Positive cases were invited to colonoscopy. Three regions were screened using the OC-SENSOR® (South-Muntenia, Bucharest-Ilfov, South-East) and one region (South-West) used the FOB GOLD®. The data was collected in the ROCCAS screening electronic registry. The following FIT parameters were evaluated: rates of return, invalidity, positivity, and colonoscopy acceptance rate according to age group, gender, region of provenience, and vulnerability status. Results: We included all cases screened between January 1, 2022 and September 30, 2023. In total, 168,958 people received the FIT test within the projects. The global FIT return rate was 90%. Factors associated with a higher return rate were female gender (90.77% vs 88.83%, p<0.0001), vulnerable status (91.23% vs 88.83%; p<0.00001), and rural residence (91.84% vs 88.42%, p<0.00001). The overall positivity rate was 5.75%. It was higher in males (7.64% vs 4.57% in females, p<0.00001) and progressively increased with the age group. The total invalid FIT rate was 5.87%, significantly lower for OC-SENSOR® (2.24%) than for the FOB GOLD® (13.6%). The overall acceptability rate for colonoscopy was 51.3%. Conclusions: According to our preliminary data, GP's participation in the pilot programs ensured adequate adherence to screening through FIT. The rate for FIT return and positivity were acceptable for both tests, while the invalid rate was much higher in FOB GOLD® compared to the OC-SENSOR®. Moreover, colonoscopy acceptance needs to be improved. Our preliminary analysis revealed the screening performance indicators meet the EU recommendations and fulfill the premises for national-level expansion of the program starting in 2024. [ABSTRACT FROM AUTHOR]

Background and Aim. Endoscopic therapy is the method of choice in the management of biliary strictures after orthotopic liver transplantation (OLT). Even though the mainstay approach for OLT stricture complications is represented by consecutive procedures of multiple plastic stents (MPS) insertion, a valuable alternative is the use of fully covered self-expandable metal stents (FCSEMS). The aim of the study was to compare MPS with FCSEMS used in the management of OLT biliary strictures, in terms of clinical outcomes and complications. Material and Methods. This is a retrospective, single-center study conducted between February 2014 and November 2019 in the Clinical Emergency Hospital of Bucharest, Romania. We enrolled all consecutive patients who developed biliary strictures after OLT and were treated by endoscopic retrograde cholangiopancreatography (ERCP) either with MPS or FCSEMS. Results. Thirty-six patients were included in the study, 27 patients had MPS and nine patients had FCSEMS. 106 ERCP procedures were performed and 159 stents were inserted. The mean number of ERCP procedures required per patient was significantly higher for MPS than for FCSEMS (3.34 ± 1.46 vs. 2.11 ± 0.33, p < 0.001). In the FCSEMS group only one patient had three procedures, due to stent migration. Difficult cannulation was encountered in 22 patients, 18 patients from MPS group and four patients from FCSEMS group. Dilation was performed in 20 (77%) MPS patients and in four FCSEMS patients (44%). Overall, we used 159 stents for stricture resolution, 149 plastic stents and 10 FCSEMS. Mean number of stents inserted was significantly lower in the FCSEMS group compared to MPS group (1.16 ± 0.40 vs. 5.73 ± 2.64, p < 0.001). Conclusions. Stricture resolution using FCSEMS is comparable to MPS and even has some advantages. In line with prior studies, FCSEMS are effective, with fewer complications and similar outcome compared to plastic stents. Other particular aspects should be further assessed, especially long-term follow up of FCSEMS and their cost efficiency. [ABSTRACT FROM AUTHOR]

Background & Aims: Identifying the risk factors for extraintestinal manifestations (EIMs) in inflammatory bowel diseases (IBD) may optimize the therapeutic decision. We aimed to assess the prevalence of EIMs in IBD patients in Romania and to determine the risk factors. Methods: We analyzed 2,626 patients registered in the Romanian IBD Prospect National Registry. We performed a descriptive cross-sectional study to assess the point prevalence of EIMs, calculating global prevalence and analyzing the different types of EIMs and their respective frequencies were carried out. Demographic and clinical risk factors were researched as possible predictors for EIMs development, based on the results of the univariate and multivariate logistic regression analysis. Results: The overall point prevalence of EIMs was 16.3%. A significantly higher frequency of EIMs in Crohn's disease (CD) was noted in comparison to ulcerative colitis (UC) and IBD unclassified (IBDU) (23.2% vs 11.3% and 16.3%, respectively, p<0.001). The most frequent type of EIM was peripheral arthropathy (8.3%), significantly associated with CD (p<0.001). Univariate analysis highlighted the significant independent common predictive risk factors for EIMs, in both CD and UC patients: female gender, patient's urban area of origin, anemia, hypoalbuminemia, and high level of C-reactive protein (CRP), while significant independent IBD phenotype-related risk factors were ileocolonic location and concomitant involvement of upper gastrointestinal tract for CD, non-smoker status and both moderate and severe disease activity for UC (p<0.05). Multivariate analysis determined that female CD patients with moderate or severe disease activity, with other than isolated ileal disease, and female UC patients with moderate or severe extensive colitis are the most likely to develop EIMs. Conclusions: IBD patients are experiencing EIMs in a large proportion, with higher rates for CD. As EIMs negatively affect patient outcomes, foreseeing the risk by identifying independent and associated predictive factors could be a first step to optimal work-up and treatment [ABSTRACT FROM AUTHOR]

The article focuses on the need for an excellence centers in Romania to provide quality of care to patients with inflammatory bowel diseases (IBDs). Topics include the adherence for expert physicians and guidelines to treat IBD patients, the implementation of certain measures and required criteria to address the widespread variations in the care of IBD patients, and the applicability of the measures into clinical practice in the country.

Background: The elimination of the Hepatitis C virus (HCV) will only be possible if rapid and efficient actions are taken. Artificial neural networks (ANNs) are computing systems based on the topology of the biological brain, containing connected artificial neurons that can be tasked with solving medical problems. Aim: We expanded the previously presented HCV micro-elimination project started in September 2020 that aimed to identify HCV infection through coordinated screening in asymptomatic populations and developed two ANN models able to identify at-risk subjects selected through a targeted questionnaire. Material and method: Our study included 14,042 screened participants from a southwestern region of Oltenia, Romania. Each participant completed a 12-item questionnaire along with anti-HCV antibody rapid testing. Hepatitis-C-positive subjects were linked to care and ultimately could receive antiviral treatment if they had detectable viremia. We built two ANNs, trained and tested on the dataset derived from the questionnaires and then used to identify patients in a similar, already existing dataset. Results: We found 114 HCV-positive patients (81 females), resulting in an overall prevalence of 0.81%. We identified sharing personal hygiene items, receiving blood transfusions, having dental work or surgery and re-using hypodermic needles as significant risk factors. When used on an existing dataset of 15,140 persons (119 HCV cases), the first ANN models correctly identified 97 (81.51%) HCV-positive subjects through 13,401 tests, while the second ANN model identified 81 (68.06%) patients through only 5192 tests. Conclusions: The use of ANNs in selecting screening candidates may improve resource allocation and prioritize cases more prone to severe disease. [ABSTRACT FROM AUTHOR]

This study aims to develop a new self-report tool (HCV-AD) measuring adherence factors, intentional or unintentional, during Hepatitis C Virus (HCV) treatment with direct-acting antivirals (DAA) aiming to achieve high efficacy, otherwise resulting in drug resistance and treatment failure. Two phases were conducted: in the first phase, items were generated based on an extensive literature review, and, in the second phase, a prospective cohort study was conducted using HCV patients from Gastroenterology Department from University County Hospital of Craiova, Romania (n = 222), to evaluate the validity and reliability of the questionnaire. A number of 19 items were generated following a systematic review and through expert opinion. The internal consistency reliability was evaluated using Cronbach's alpha. The construct validity was assessed using correlations with two other instruments: visual analog scale (VAS) and medication possession ratio (MPR). The final questionnaire (HCV-AD10) was derived through exploratory factor analysis, with 82% of total variance explained. This instrument appeared as a reliable and valid measure for medication adherence, with Cronbach's alpha (0.867) and significant high positive correlations between adherence scores calculated with HCV-AD10 and VAS (ρ = 0.61, p < 0.001) or with HCV-AD10 and MPR (ρ = 0.75, p < 0.001). This research would make a worthwhile contribution to HCV management. [ABSTRACT FROM AUTHOR]