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Background and Aims: Data on the outcomes after switching from adalimumab (ADA) originator to ADA biosimilar are limited. The aim was to compare the treatment persistence, clinical efficacy, and safety outcomes in inflammatory bowel disease patients who maintained ADA originator vs. those who switched to ADA biosimilar., Methods: Patients receiving ADA originator who were in clinical remission at standard dose of ADA originator were included. Patients who maintained ADA originator formed the non-switch cohort (NSC), and those who switched to different ADA biosimilars constituted the switch cohort (SC). Clinical remission was defined as a Harvey-Bradshaw index ≤4 in Crohn's disease and a partial Mayo score ≤2 in ulcerative colitis. To control possible confounding effects on treatment discontinuation, an inverse probability treatment weighted proportional hazard Cox regression was performed., Results: Five hundred and twenty-four patients were included: 211 in the SC and 313 in the NSC. The median follow-up was 13 months in the SC and 24 months in the NSC (p < 0.001). The incidence rate of ADA discontinuation was 8% and 7% per patient-year in the SC and in the NSC, respectively (p > 0.05). In the multivariate analysis, switching from ADA originator to ADA biosimilar was not associated with therapy discontinuation. The incidence rate of relapse was 8% per patient-year in the SC and 6% per patient-year in the NSC (p > 0.05). Six percent of the patients had adverse events in the SC vs. 5% in the NSC (p > 0.05)., Conclusion: Switching to ADA biosimilar did not impair patients' outcomes in comparison with maintaining on the originator., (© 2023 John Wiley & Sons Ltd.)

Effective vaccines against the SARS-CoV-2 are already available and offer a promising action to control the COVID-19 pandemic. IBD patients on biological agents accept the vaccine as well as an additional dose if recommended., Background: Vaccination against COVID-19 prevents its severe forms and associated mortality and offers a promising action to control this pandemic. In September 2021, an additional dose of vaccine was approved in patients with immunosuppression including IBD patients on biologic agents. We evaluated the vaccination rate and additional dose willingness in this group of at risk patients., Methods: A single-center, cross-sectional study was performed among IBD patients on biologic agents and eligible for an additional dose of the COVID-19 vaccine. IBD clinical characteristics and type of vaccine and date of administration were checked in medical records. Acceptance was evaluated after telephone or face-to-face surveys in IBD patients., Results: Out of a total of 344 patients, 269 patients (46.1% male; mean age 47±16 years; Crohn's disease 73.6%) were included. Only 15 (5.6%) patients refused the COVID-19 vaccine mainly (40%) for conviction (COVID-19 pandemic denial). 33.3% would re-consider after discussing with their doctor and/or receiving information on the adverse effects of the vaccine. Previous to the additional dose, the COVID-19 vaccination was present in 94.4% of patients (n=254). Adverse effects occurred in 53.9% of the cases, mainly pain in the arm (40%). Up to 94.1% of the patients agreed to an additional dose and 79.4% had already received the additional dose at the final time of the assessment., Conclusions: IBD patients on biological agents accept the vaccine as well as an additional dose if recommended. Physicians in charge of IBD units should provide information and confidence in the use of the vaccine in these IBD patients., (Copyright © 2022 Elsevier España, S.L.U. All rights reserved.)

Background and Aims: Artificial intelligence-based computer-aid detection (CADe) devices have been recently tested in colonoscopies, increasing the adenoma detection rate (ADR), mainly in Asian populations. However, evidence for the benefit of these devices in the occidental population is still low. We tested a new CADe device, namely, ENDO-AID (OIP-1) (Olympus, Tokyo, Japan), in clinical practice., Methods: This randomized controlled trial included 370 consecutive patients who were randomized 1:1 to CADe (n = 185) versus standard exploration (n = 185) from November 2021 to January 2022. The primary endpoint was the ADR. Advanced adenoma was defined as ≥10 mm, harboring high-grade dysplasia, or with a villous pattern. Otherwise, the adenoma was nonadvanced. ADR was assessed in both groups stratified by endoscopist ADR and colon cleansing., Results: In the intention-to-treat analysis, the ADR was 55.1% (102/185) in the CADe group and 43.8% (81/185) in the control group (P = .029). Nonadvanced ADRs (54.8% vs 40.8%, P = .01) and flat ADRs (39.4 vs 24.8, P = .006), polyp detection rate (67.1% vs 51%; P = .004), and number of adenomas per colonoscopy were significantly higher in the CADe group than in the control group (median [25th-75th percentile], 1 [0-2] vs 0 [0-1.5], respectively; P = .014). No significant differences were found in serrated ADR. After stratification by endoscopist and bowel cleansing, no statistically significant differences in ADR were found., Conclusions: Colonoscopy assisted by ENDO-AID (OIP-1) increases ADR and number of adenomas per colonoscopy, suggesting it may aid in the detection of colorectal neoplastic lesions, especially because of its detection of diminutive and flat adenomas. (Clinical trial registration number: NCT04945044.)., (Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)

Background: During the COVID-19 pandemic, ambulatory clinic visits were replaced by the implementation of telehealth modalities in most inflammatory bowel disease (IBD) units., Aims: The aim of this study was to assess the efficacy, efficiency, patient satisfaction, and acceptability of using telephone consultation in an IBD unit., Methods: A prospective cohort study was performed in IBD patients who underwent telephone consultation during COVID-19 lockdown (between 16th March and 13th April 2020). To assess the efficacy of this telephone consultation (lockdown visit), nonscheduled visits, emergency consultation, hospital admission, and surgery from lockdown visit to the next scheduled consultation (post-lockdown) were checked. To evaluate efficiency, the time between lockdown visit and post-lockdown consultation was compared with previous consultation (pre-lockdown), and the total number of visits 12 months before and after lockdown visit was checked. A telephone survey was designed to rate perception for a telephone consultation., Results: Out of a total of 274 patients, 220 patients (52.2% male; mean age 49 ± 16 years; Crohn's disease, n = 126; ulcerative colitis, n = 83; indeterminate colitis, n = 11) were included. Only one patient was consulted at the emergency department, 11 patients needed to rearrange the visit, and none patient underwent surgery before the scheduled post-lockdown visit. The interval to post-lockdown visit compared to pre-lockdown visit increased in 37.7% of patients. The satisfaction survey (n = 185) revealed that 94.6% perceived it was effective. However, 44.4% of patients rather prefer on-site consultation for follow-up., Conclusions: Telemedicine during the COVID-19 pandemic was shown to be effective and efficient to care for IBD patients. In addition, telephone consultation is well accepted by patients in non-extended follow-up periods., (© 2023 S. Karger AG, Basel.)

Background: During the coronavirus-19 disease (COVID-19) pandemic, gastroenterology guidelines recommended the suspension or reduction of non-urgent endoscopy. We aimed to assess the appropriateness and safety of endoscopic activity during the pandemic first wave lockdown using European Society of Gastrointestinal Endoscopy (ESGE) recommendations., Methods: We identified scheduled patients from the onset of the lockdown in Spain since March 16, 2020) to April 14, 2020. Daily hospital COVID-19-related burden was also registered. A similar cohort from a period immediately before the lockdown was studied (pre-lockdown cohort) to compare appropriateness., Results: 454 endoscopy procedures were performed during the studied period, comprising a 49.7% reduction compared to the pre-lockdown cohort (n = 913). There was a significant increase in ESGE high-priority indications (62.1% vs. 45.6%, p<0.001) associated with an increase in relevant endoscopic findings (p = 0.006), advanced neoplasia/cancer (p = 0.004) and cancer detection rate (p = 0.010). There were no differences in the rate of admissions or infection among scheduled patients in the lockdown cohort. None of the staff members tested positive for COVID-19 in the 7 days after the adoption of protective measures., Conclusion: A prioritized endoscopic activity is not associated with higher contagion after adopting protective measures. In addition, a triage of procedures that follow the ESGE criteria increases the rate of relevant endoscopic findings. These considerations may reduce the impact of the delays of diagnosis after the pandemic., Competing Interests: The authors have declared that no competing interests exist.

Introduction: Direct-acting antivirals (DAAs) are an opportunity for hepatitis C virus (HCV) elimination. Strategies are needed to diagnose new patients and to attract those diagnosed without evaluation. Patients with other chronic viral diseases who receive satisfactory treatment promote referral of other patients for evaluation. Our aim was to evaluate whether patients who have been treated with DAAs would recommend follow-up and treatment to other patients as well as the characteristics that influence this decision., Patients and Methods: Two-hundred and 2HCV-infected patients treated with DAAs were included. Patients were asked about whether they knew other infected people and their willingness to share their experience. A general satisfaction survey and a specific HCV satisfaction survey were carried out. Demographic, socioeconomic and HCV infection variables were recorded., Results: Despite the fact that 54.4% of the patients reported knowing others infected, 34.2% would not fully agree to share their experience. The analysis of general and specific satisfaction showed that patients who shared their experience mentioned a perception of greater care from the specialist (4.7±0.4 vs. 4.3±0.6, P=.001) and had more information on treatment expectations (4.6±0.5 vs. 4.0±0.7, P=.001) and social support (4.5±0.7 vs. 4.0±0.8, P=.001)., Conclusions: The perception by treated patients of general satisfaction with the healthcare process and information about benefits influences the degree of recommendation to other infected people. Knowledge about treatment and perception of improvement in health of treated patients should be enhanced as it can contribute to increasing referrals to specialized consultation., (Copyright © 2021 Elsevier España, S.L.U. All rights reserved.)

Competing Interests: M. Hernandez-Guerra has received research grants from AbbVie and Gilead and has participated in consultant advisories for Bayer and Intercept. The remaining authors declare that they have no conflict of interest.

Objective: We tested the hypothesis that an enhanced bowel preparation strategy (EBS) improves colonic cleansing in patients at high risk for inadequate bowel cleansing (HRI). Methods: This prospective randomized clinical trial included consecutive HRI patients referred for outpatient colonoscopy between February and October 2019. HRI was considered if patients scored >1.225 according to a previously validated bowel-cleansing predictive score. HRI patients were randomized (1:1) to a low-volume conventional bowel cleansing strategy (CBS) (1-day low residue diet (LRD) plus 2 L of polyethylene glycol (PEG) plus ascorbic acid) or to an EBS (3-day LRD plus 10 mg oral bisacodyl plus 4 L PEG). The Boston Bowel Preparation Scale (BBPS) was used to assess the quality of cleanliness. Intention-to-treat (ITT) and per protocol (PP) analyses were performed. A sample size of 130 patients per group was estimated to reach a 15% difference in favor of EBP. Results: A total of 253 HRI patients were included (mean age 69.8 ± 9.5 years, 51.8% women). No statistically significant differences were found in the BBPS scale between the two groups in the ITT analysis (CBS 76.8% vs. EBS 79.7%, P = 0.58) or PP analysis (CBS 78% vs. EBS 84.3%, P = 0.21), risk difference 2.9% (95% CI-7.26 to 39.16) in the ITT analysis, or risk difference 6.3% (95% CI-3.48 to 16.08) in PP analysis. No differences in preparation tolerance, compliance, adverse effects, or colonoscopy findings were found. Conclusion: EBS is not superior to CBS in hard-to-prepare patients. (EUDRACT: 2017-000787-15, NCT03830489). Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT03830489., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Gimeno-García, Hernández, Baute Dorta, Reygosa, de la Barreda, Hernandez-Bustabad, Amaral, Cedrés, del Castillo, Nicolás-Pérez, Jiménez, Alarcon-Fernández, Hernandez-Guerra, Romero, Alonso, González, Adrian, Hernandez, Ramos, Carrillo, Felipe, Hernández, Rodríguez-Jiménez and Quintero.)

Background: Recent evidence suggests that the number of low residue diet (LRD) days does not influence the bowel cleansing quality in non-selected patients. However, there are not data in the subgroup of patients with risk factors of inadequate bowel cleansing., Objective: The aim of this study was to assess whether a 3-day LRD improved the bowel cleansing quality in patients with risk factors of poor bowel cleansing., Patients and Methods: Post hoc analysis of a randomized controlled trial carried out between December 2017 and March 2018 in a tertiary care hospital. Patients with high risk of poor bowel cleansing were selected following a validated score. The patients were randomized to the 1-day LRD or 3-day LRD groups. All patients received a 2-L split-dose of polyethylene glycol plus ascorbic acid. Intention-to-treat (ITT) and per-protocol (PP) analyses were conducted for the main outcome., Results: 135 patients (1-day LRD group=67, 3-day LRD=68) were included. The rate of adequate cleansing quality was not significantly different between the groups in the ITT analysis: 76.1%, 95% CI: [64.6-84.8] vs. 79.4%, 95% CI: [68.2-87.4]; odds ratio (OR) 1.2, 95% CI [0.54-2.73]) or in the PP analysis: 77.3%, 95% CI: [65.7-85.8] vs. 80.3%, 95% CI: [69.0-88.3]; OR 1.2, 95% CI [0.52-2.77]). Compliance with the diet or cleansing solution, satisfaction or difficulties with the LRD and the polyp/adenoma detection rates were not significantly different., Conclusion: Our results suggest that 1-day LRD is not inferior to 3-day LRD in patients with risk factors of inadequate bowel cleansing., (Copyright © 2020 Elsevier España, S.L.U. All rights reserved.)

Introduction: Because hepatitis C virus (HCV) infection is curable in the majority of cases, the diagnosis of all infected patients has become a priority. In difficult-to-diagnose populations, simpler diagnostic methods are required such as the use of dried blood spots (DBS) as an alternative to blood drawn by venipuncture (VP). Before being able to include it as a HCV diagnostic detection method within the Spanish National Health System, the diagnostic accuracy of standard hospital equipment must be evaluated., Methodology: DBS samples were evaluated in vitro and in a field test after being processed in the Cobas 6800 system, establishing a correlation with the result by VP. Performance with different viral loads and intra-assay variability was compared., Results: In samples with a viral load of>3 log 10 IU/ml, viraemia was detected in all cases when at least two blood spot elutions were used (94 detections out of 95 spot elutions). The performance with 2 spots was lower in samples with<3 log 10 IU/ml (7/20). Correlation between VP and DBS viraemia was excellent (maximum with 2 spots, r 2 =0.906, P<.001) with a coefficient of variation of 0.05%. In routine clinical practice with specimens from screened subjects (n=61), excellent diagnostic accuracy was also observed., Conclusion: Viral load detection using DBS of at least two spots is a reliable method for HCV diagnosis. The standardisation of the method is feasible and our results support the incorporation of this diagnostic tool in Spain's Public Health System., (Copyright © 2019 Elsevier España, S.L.U. and Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.)

Background: The aim of this study was to assess whether a 3-day low-residue diet (LRD) improved bowel cleansing quality compared with a 1-day LRD regimen., Methods: Consecutive patients scheduled for outpatient colonoscopy were randomized to the 1-day LRD or 3-day LRD groups. All patients received a 2-L split-dose of polyethylene glycol plus ascorbic acid. The primary outcome was bowel cleansing quality as evaluated using the Boston Bowel Preparation Scale (BBPS) (adequate cleansing ≥ 2 points per segment). Secondary outcomes were adherence to and level of satisfaction with the LRD, difficulty following the dietary recommendations, and willingness to repeat the same LRD in the future. Intention-to-treat (ITT) and per-protocol (PP) analyses were conducted for the primary outcome. A superiority analysis was performed to demonstrate that a 3-day LRD regimen was superior to a 1-day LRD regimen with a margin of 10 %., Results: 390 patients (1-day LRD group = 196, 3-day LRD = 194) were included. The cleansing quality was not significantly different between the groups: ITT analysis 82.7 % (95 % confidence interval [CI] 77.4 to 88.0) vs. 85.6 % (95 %CI 80.7 to 90.5), with odds ratio (OR) 1.2 (95 %CI 0.72 to 2.15); PP analysis 85.0 % (95 %CI 79.9 to 90.1) vs. 88.6 % (95 %CI 84.0 to 93.2), with OR 1.4 (95 %CI 0.88 to 2.52). No differences were found regarding adherence to the diet or cleansing solution, satisfaction or difficulty with the LRD, and the polyp/adenoma detection rates., Conclusion: 3-day LRD did not offer advantages over 1-day LRD in preparation for colonoscopy., Competing Interests: None, (© Georg Thieme Verlag KG Stuttgart · New York.)