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Subrahmanyam, Bulusu, V. S. N. Murty i Sarah B. Hall. "Characteristics of Internal Tides from ECCO Salinity Estimates and Observations in the Bay of Bengal". Remote Sensing 15, nr 14 (10.07.2023): 3474. http://dx.doi.org/10.3390/rs15143474.
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Internal waves (IWs) are generated in all the oceans, and their amplitudes are large, especially in regions that receive a large amount of freshwater from nearby rivers, which promote highly stratified waters. When barotropic tides encounter regions of shallow bottom-topography, internal tides (known as IWs of the tidal period) are generated and propagated along the pycnocline due to halocline or thermocline. In the North Indian Ocean, the Bay of Bengal (BoB) and the Andaman Sea receive a large volume of freshwater from major rivers and net precipitation during the summer monsoon. This study addresses the characteristics of internal tides in the BoB and Andaman Sea using NASA’s Estimating the Circulation and Climate of the Ocean (ECCO) project’s high-resolution (1/48° and hourly) salinity estimates at 1 m depth (hereafter written as ECCO salinity) during September 2011–October 2012, time series of temperature, and salinity profiles from moored buoys. A comparison is made between ECCO salinity and NASA’s Soil Moisture Active Passive (SMAP) salinity and Aquarius salinity. The time series of ECCO salinity and observed salinity are subjected to bandpass filtering with an 11–14 h period and 22–26 h period to detect and estimate the characteristics of semi-diurnal and diurnal period internal tides. Our analysis reveals that the ECCO salinity captured well the surface imprints of diurnal period internal tide propagating through shallow pycnocline (~50 m depth) due to halocline, and the latter suppresses the impact of semi-diurnal period internal tide propagating at thermocline (~100 m depth) reaching the sea surface. The semi-diurnal (diurnal) period internal tides have their wavelengths and phase speeds increased (decreased) from the central Andaman Sea to the Sri Lanka coast. Propagation of diurnal period internal tide is dominant in the northern BoB and northern Andaman Sea.
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Wasmann, Karin A., Christianne J. Buskens, Willem A. Bemelman, Roel Hompes, Pieter J. Tanis, Geert R. A. M. D’Haens, Onur B. Dolmaci i in. "Complications While Waiting for IBD Surgery—Short Report". Journal of Crohn's and Colitis 14, nr 2 (12.08.2019): 277–80. http://dx.doi.org/10.1093/ecco-jcc/jjz143.
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Abstract Background and Aims While striving to meet the quality standards for oncological care, hospitals frequently prioritize oncological procedures, resulting in longer waiting times to surgery for benign diseases like inflammatory bowel disease [IBD]. The aim of this Short Report is to highlight the potential consequences of a longer interval to surgery for IBD patients. Methods The mean waiting times to elective surgery for IBD patients with active and inactive disease [e.g. pouch surgery after subtotal colectomy] at the Amsterdam UMC, location AMC, between 2013 and 2015 were compared with those for colorectal cancer surgery. Correlations between IBD waiting times and disease complications [e.g. >5% weight loss, abscess formation] and additional health-care consumption [e.g. telephone/outpatient clinic appointment, hospital admission] during these waiting times were assessed. Results The mean waiting was 10 weeks [SD 8] for patients with active disease [n = 173] and 15 weeks [SD 16] for those with inactive disease [n = 97], remarkably higher than that for colorectal cancer patients [5 weeks]. While awaiting surgery, 1 out of 8 patients had to undergo surgery in an acute or semi-acute setting. Additionally, 19% of patients with active disease had disease complications, and 44% needed additional health care. The rates were comparable for patients with inactive disease. Conclusions The current waiting time to surgery is not medically justified and creates a burden for health-care resources. This issue should be brought to the attention of policy makers, as it requires a structural solution. It is time to also set a maximally acceptable waiting time to surgery for IBD patients.
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Rees, F., A. Packham, A. Parmar, E. Hills, M. Smith i A. St. Clair Jones. "P528 Reducing intravenous monoclonal antibody observation times without compromising patient safety; a single-centre observational study". Journal of Crohn's and Colitis 15, Supplement_1 (1.05.2021): S503—S505. http://dx.doi.org/10.1093/ecco-jcc/jjab076.650.
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Abstract Background Monoclonal antibodies (MAbs) are integral to manage Inflammatory Bowel Disease (IBD). At Brighton & Sussex University Hospitals, intravenous MAbs, infliximab and vedolizumab, are administered in an outpatient setting. Licensing specifies post-infusion observation times of 1 to 2 hours. This affects waiting lists and capacity, particularly pertinent during the COVID-19 pandemic. Methods A single-centre observation study was conducted. Part 1 Retrospective data was collected for all infliximab and vedolizumab infusions from April to July 2019. Patients seen twice, were included once. For established infusion patients, historical reactions were recorded. Reaction incidence was established by observations, patient questioning and patient record review. To standardise the reactions, we used the cancer Common Terminology Criteria for Adverse Events; grade 3 is ‘severe’. Part 2 Observation time was removed from infusion 4 in April 2020. Prospective data was collected for all infliximab and vedolizumab infusions from April to December 2020. Multiple attendances were included. Results Part 1 130 infliximab patients (2607 infusions) and 69 vedolizumab patients (557 infusions) were reviewed. No severe reactions were recorded. All reactions occurred during induction dosing period. Analysis showed high levels of ‘no reactions observed’ after the first 4 infliximab infusions 97.7% (+1.6%, -4.7%), and the first 3 vedolizumab infusions 96.9% (+2.3%, -8.8%). 121 hours could be saved for infliximab and 64 hours for vedolizumab. Extrapolated this equates to 740 hours per year. Part 2 679 infliximab infusions were administered (including 12 new starters). 418 vedolizumab infusions were administered (16 new starters). No reactions were reported. Table key: Pt – patients, Inf – infusions, MAb – monoclonal antibody, Induct – Induction, Maint – maintenance, IV – intravenous, PO – oral, NC – not collected Conclusion All MAb infusion reactions occurred within 3 infusions, were non-severe and managed in clinic. By removing observation periods from infusion 4, capacity increased in concordance with COVID-19 social distancing, without affecting waiting times or patient safety. Patient experience was anecdotally improved. Further data from other centres are required to prove significance.
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Morão, B., S. Velho, L. Agostinho, J. Torres i M. Cravo. "P139 Body composition and Crohn’s disease behavior: Is adiposity the main game changer?" Journal of Crohn's and Colitis 16, Supplement_1 (1.01.2022): i222. http://dx.doi.org/10.1093/ecco-jcc/jjab232.267.
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Abstract Background Introduction: Visceral fat has been associated with unfavorable outcomes in Crohn’s disease (CD) patients. We investigated the association between body composition upon diagnosis and complicated phenotypes and time until surgery in patients with CD. Methods retrospective cohort study including patients with CD who had a computed tomography enterography (CT) or an entero magnetic resonance (MR) performed within 6 months of diagnosis. Skeletal muscle, visceral and subcutaneous adipose tissue cross-sectional areas were determined with CT or MR images at L3 vertebrae level, after being processed with Slice-o-Matic (Tomovison) and ABCS module (applicable only to CT scan images). Logistic regression was used to assess predictors of disease behaviourand time until abdominal urgery was modeled with proportional hazards Cox models. Results We included 63 patients: 33(52%) men with median age of 35 years. Disease location and behaviour according to Montreal classification was as follows: L1=28(44%), L2=13(21%), L3=18(28%), L1+L4=1(2%), L3+L4=3(5%); B1=39(62%), B2=11(17%), B3=13(21%); 20(32%) patients had perianal disease. At diagnosis, 17(27%) patients were treated with corticosteroids. Anti-TNF agents were started in 8(13%) patients, azathioprine in 23(36%), combination therapy in 15(24%); 17(27%) patients did not start any medical therapy. Visceral obesity was present in 12(19%) patients at diagnosis. Visceral obesity was associated with higher age of CD onset (median 60 vs 34 years, p=0.002) and complicated disease behaviour(B2/B3) at diagnosis (66.7% vs 31.7%, p=0.021), with an approximately 4 times higher risk of complicated behaviour(OR=4.37, 95%IC=1.19–18.44, p=0.03).After adjusting for age and perianal disease, total adipose tissue (visceral and subcutaneous fat) remained statistically significant and was associated with a 4% increase in the odds of complicated behaviourat diagnosis per 10 cm2of total adipose tissue (OR 1.004,95%CI 1.00–1.008, p=0.043). Median follow-up time was 3.35 years, during which 15 (24%) of patients underwent abdominal surgery. Visceral obesity was associated with a 5.10 times higher risk of abdominal surgery during follow-up (95%CI 1.52–17.09, p=0.008); after adjusting to disease behaviour, visceral obesity maintained a near significant association with a 2.90 times higher risk of surgery (95%CI 0.83–10.08, p=0.09). Conclusion In our cohort of patients with newly diagnosed CD, total fat upon diagnosis seems to be associated with B2 and B3 disease phenotypes. Furthermore, visceral obesity was associated with a 5.10 times higher risk of abdominal surgery during follow-up and with a shorter time until surgery.
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Muñoz-Villafranca, C., P. Arreba, M. Gomez, N. Ispizua Madariaga, L. Buendia, M. L. Lopez, A. Ugarte i in. "P595 Time of Therapeutic Drug Monitoring of infliximab during induction and its relationship with clinical remission in Inflammatory Bowel Disease". Journal of Crohn's and Colitis 17, Supplement_1 (30.01.2023): i723. http://dx.doi.org/10.1093/ecco-jcc/jjac190.0725.
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Abstract Background The usefulness of therapeutic drug monitoring(TDM) of infliximab during induction and its relationship with clinical outcome in patients with inflammatory bowel disease(IBD) is well established. However, the optimal time of monitoring in terms of clinical outcomes remains unclear. The aim is to evaluate the TDM at various times during induction and its association with clinical remission. Methods An observational, retrospective and single-centre study of patients with active disease ,Crohn’s disease (CD) or ulcerative colitis(UC), was performed. Induction treatment with infliximab 0, 2, 6 weeks was conducted and if there was response, maintenance therapy was provided. Antibody levels were measured in serum samples at week 2 and week 14 by using an enzyme-linked immunosorbent assay, within the therapeutic range(3-8 µg/ml). Patients were followed at least for one year or until loss of response. The clinical response was assessed in week 14 and week 52 by Harvey-Bradshaw Index in CD and Mayo Partial Index in UC. Results Out of 93 patients that were evaluated, 23 with UC(24.73%) and 70 with CD(75.27%,), 65 (69.89%) and 58 patients(62.37%) achieved remission at week 14 and week 52 respectively. Infliximab levels at week 14 but not at week 2 were significantly higher in patients who achieved clinical remission in both week 14 (5.8 vs 2.1 µg/ml; p=0.0002) as in week 52 (6.4 vs 1.9 µg/ml; p=0.0001). The levels at week 14, but not at week 2 had predictive value of remission, in both week 14 [OR 1,4 (CI 1.14-1.76) p=0.001] and week 52 [OR 1.4 (CI 1.15-1.87); p=0.001]. The patients with immunosuppressants at week 14 presented the highest rate of remission in week 52 (77.78 vs 52.63; p=0.014). The intensification of treatment was a negative factor to achieve remission both in week 14 and at week 52. Conclusion The levels of infliximab in week 14 are higher and have predictive value of clinical remission both in early (week 14) and long-term (week 52). Levels of infliximab in week 2 did not provide significant predictive value of clinical response. The use of immunosuppressants could be a favourable factor of clinical outcome.
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Dubinsky, M. C., T. Gibble, S. Travis, R. Panaccione, T. Hibi, A. P. Bleakman, T. Panni i in. "DOP70 Prevalence and severity of bowel urgency in Crohn’s Disease: Results from the Communicating Needs and Features of IBD Experience (CONFIDE) Survey". Journal of Crohn's and Colitis 18, Supplement_1 (1.01.2024): i201—i202. http://dx.doi.org/10.1093/ecco-jcc/jjad212.0110.
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Abstract Background Bowel urgency (BU) affects patients with Crohn’s disease (CD); however, its prevalence and severity are unclear. Here, data from Communicating Needs and Features of IBD Experiences (CONFIDE) study were used to understand the burden and impact of BU among patients with moderate-to-severe CD. Methods CONFIDE is an online, quantitative, cross-sectional survey exploring the experiences and impact of symptoms on patients with CD or ulcerative colitis in Europe (France, Germany, Italy, Spain, and UK), United States (US) and Japan. Criteria based on previous treatment, steroid use, and/or hospitalization defined moderate-to-severe CD. Patients were asked about bowel movement deferral time with response options ranging from able to wait ≥15 minutes (mins) to sometimes unable to make it to the bathroom in time. Patients currently experiencing BU (in last month) rated BU severity in the last 3 days using the Urgency Numeric Rating Scale (NRS, 0-10), a content-validated patient-reported instrument. CD data from Europe and US are presented here using descriptive statistics. Results Surveys were completed by 547 European (male [M]=55.4%, mean age 38 years) and 215 US (M=54.9%, mean age 40.9 years) patients with CD. Current BU (over the past month) was reported by 38% of patients in Europe and 42.3% in US. More than one-third of all patients in both Europe and US reported that over the last 3 days, they needed to get to the bathroom within 5 mins, and 1.8% European and 2.8% US patients were sometimes unable to make it to the bathroom in time. Among patients who reported currently experiencing BU, 46% reported the need to get to the bathroom within 5 mins and 3% reported sometimes being unable to make it to the bathroom in time in both Europe and US. Shorter deferral times were reported by those with higher mean Urgency NRS scores (Table). Mean (SD) Urgency NRS scores in patients with a deferral time <5 mins vs those with a deferral time >5 mins were 7.0 (1.7) vs 6.5 (2.1) among European and 7.3 (1.5) vs 6.7 (1.9) among the US patients. Most European and US patients reported experiencing BU, BU-related accidents, and/or wearing diaper/pad/other protection due to fear/anticipation of BU-related accidents at least once a month in past 3 months (Figure). Conclusion Patients with moderate-to-severe CD reported similar experiences of BU in the Europe and US, with most patients reporting currently experiencing BU and wearing diaper/pad/protection due to fear of BU-related accidents at least once a month. Patients currently experiencing BU had short deferral times, often having to reach the bathroom in ≤5 mins. Given the substantial burden and impact, BU should be considered when assessing patients with CD.
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Ramos Lopez, L., A. Hernández, M. Carrillo-Palau, A. Hernández-Camba, I. Alonso-Abreu, C. Reygosa, M. Vela i in. "P219 Impact of COVID-19 pandemic in patients with a first consultation for suspected inflammatory bowel disease". Journal of Crohn's and Colitis 16, Supplement_1 (1.01.2022): i271—i272. http://dx.doi.org/10.1093/ecco-jcc/jjab232.346.
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Abstract Background During the COVID-19 pandemic, outpatient activity and the performance of complementary tests have been limited in order to optimize health care resources in patients with SARS-CoV2 infection according to the incidence of cases in each time period. The aim of this study was to determine the impact of the measures implemented by the COVID-19 pandemic on the diagnosis, initiation of treatment, and follow-up of patients referred for suspected inflammatory bowel disease (IBD) at different times during the pandemic. Methods Retrospective multicenter study comparing three cohorts of patients who were referred for evaluation in IBD consultation during three time periods: pre-pandemic “pre-COVID19” (pC), from March to May 2019; during health alert “alert-COVID19” (aC), from March to May 2020; and during a recent post-pandemic alert period “post-COVID19 alert” (p-aC), from January 2021 to March 2021. All patients referred with suspected IBD (“first time” consultation) were included. Epidemiological and clinical variables were recorded from the onset of digestive symptoms and up to a follow-up of 6 months after consultation. Results A total of 114 first-time consultations were recorded: 47 in pC (age 45.3, SD 2.6 years; 63.83% female), 24 in aC (age 48.3, SD 3.3; male 54.2%) and 43 in p-aC (age 44.5, SD 2.4; male 53.4%). Significant differences were determined in terms of the reason for consultation between the periods (recent diagnosis of IBD: 25.5% pC vs 41.7% cD vs 53.5% a-pC; p= 0.03 and suspicion of IBD: 74.5% pC vs 58.3% aC vs 46.5% in p-aC; p = 0.03). The diagnosis of IBD was confirmed in 44.6% of patients in the pC period, 66.6% in aC and 67.4% in p-aC, (p=0.06). There were no significant differences between the three periods in terms of time from suspicion of the disease to evaluation at the first visit and time to completion of complementary tests. However, there were significant differences in the time between diagnosis and initiation of treatment among the pC group (mean 1.7, SD 1.05 months), in contrast to 4.36 months (SD 2.03) in aC and 3.82 months (SD 1.3) in p-aC (p= 0.05). There were also no differences in the management (treatment and request for complementary tests) of the sucessive consultation, except for the number of hospital admissions in the six months following the first consultation (5 cases in pC vs. no admissions in aC and p-aC,p=0.03). Conclusion During the COVID19 pandemic,the ability to diagnose patients with IBD has been maintained with no delays in the performance of complementary tests at participating centers. However, a delay in the initiation of treatment that could negatively impact the health of IBD patients is currently being maintained.
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Thoo, M., i E. Baynton. "P790 Examining mental health disease burden among Crohn’s Disease (CD) patients in Europe". Journal of Crohn's and Colitis 17, Supplement_1 (30.01.2023): i924. http://dx.doi.org/10.1093/ecco-jcc/jjac190.0920.
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Abstract Background Mental health is an overlooked aspect of inflammatory bowel disease (IBD) patient care and the most common psychological conditions in patients with IBD are anxiety and depression1. The objective of this study was to examine the possible factors that will impact mental health burden of CD patients in Europe. Methods A multi-centre online medical chart review study of patients with CD was conducted between Jul – Sep 2022 among UK, FR, DE, IT & ES gastroenterologists practicing across hospital and private practices. Physicians were screened for practice duration and patient volume. Charts of patients prescribed with advanced therapy were included in the analysis. Results 206 sampled physicians collectively reported 1178 CD patients. From the reported CD patients, 190 suffered mental health burden (depression or anxiety) and 988 CD patients did not suffered any mental health burden. Among CD patients suffered mental health burden, a higher proportion of CD patients are female vs those who did not suffered any (55% vs 46%). ‘Family history of IBD’ was the co-morbidity more likely to experience in reported CD patients suffered mental health burden vs those who did not (11% vs 7%). When looking at employment status between these two patient groups, reported CD patients suffer mental health burden was less likely to be in full-time employment vs those not suffered mental health burden. A higher proportion of reported CD patients suffered mental health burden were in part-time employment or housewife/househusband. CD patients with mental health burden had greater CRP level than patients without mental health burden (CRP mean: 16 vs 12). This aligns with reported CD patients with mental health burden had frequent surgery times vs without mental health burden (Mean surgery times: 2 vs 1) and had greater steroid usage (% reported patients currently on steroids – 18% vs 13%). Conclusion Comparisons in this study cohort highlight there are other factors could impact CD patients’ mental health burden other than IBD itself. This coincided with low full-time employment rate that attributed to financial stress may increase CD patients’ mental health burden. Also, higher rate of surgery and steroid usage in CD patients experienced mental health burden might suggest they had more severe or complications with their disease that will impact overall mental health. Further investigation using comparator cohort is warranted.
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Gutierrez Becker, B., E. Giuffrida, M. Mangia, F. Arcadu, V. Whitehill, D. Guaraglia, M. Schwartz i in. "P069 Artificial intelligence (AI)-filtered Videos for Accelerated Scoring of Colonoscopy Videos in Ulcerative Colitis Clinical Trials". Journal of Crohn's and Colitis 15, Supplement_1 (1.05.2021): S173—S174. http://dx.doi.org/10.1093/ecco-jcc/jjab076.198.
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Abstract Background Endoscopic assessment is a critical procedure to assess the improvement of mucosa and response to therapy, and therefore a pivotal component of clinical trial endpoints for IBD. Central scoring of endoscopic videos is challenging and time consuming. We evaluated the feasibility of using an Artificial Intelligence (AI) algorithm to automatically produce filtered videos where the non-readable portions of the video are removed, with the aim of accelerating the scoring of endoscopic videos. Methods The AI algorithm was based on a Convolutional Neural Network trained to perform a binary classification task. This task consisted of assigning the frames in a colonoscopy video to one of two classes: “readable” or “unreadable.” The algorithm was trained using annotations performed by two data scientists (BG, FA). The criteria to consider a frame “readable” were: i) the colon walls were within the field of view; ii) contrast and sharpness of the frame were sufficient to visually inspect the mucosa, and iii) no presence of artifacts completely obstructing the visibility of the mucosa. The frames were extracted randomly from 351 colonoscopy videos of the etrolizumab EUCALYPTUS (NCT01336465) Phase II ulcerative colitis clinical trial. Evaluation of the performance of the AI algorithm was performed on colonoscopy videos obtained as part of the etrolizumab HICKORY (NCT02100696) and LAUREL (NCT02165215) Phase III ulcerative colitis clinical trials. Each video was filtered using the AI algorithm, resulting in a shorter video where the sections considered unreadable by the AI algorithm were removed. Each of three annotators (EG, MM and MD) was randomly assigned an equal number of AI-filtered videos and raw videos. The gastroenterologist was tasked to score temporal segments of the video according to the Mayo Clinic Endoscopic Subscore (MCES). Annotations were performed by means of an online annotation platform (Virgo Surgical Video Solutions, Inc). Results We measured the time it took the annotators to score raw and AI-filtered videos. We observed a statistically significant reduction (Mann Whitney U test p-value=0.039) in the median time spent by the annotators scoring raw videos (10.59∓ 0.94 minutes) with respect to the time spent scoring AI-filtered videos (9.51 ∓ 0.92 minutes), with a substantial intra-rater agreement when evaluating highlight and raw videos (Cohen’s kappa 0.92 and 0.55 for experienced and junior gastroenterologists respectively). Conclusion Our analysis shows that AI can be used reliably as an assisting tool to automatically remove non-readable time segments from full colonoscopy videos. The use of our proposed algorithm can lead to reduced annotation times in the task of centrally reading colonoscopy videos.
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Gropp, R., H. Jodeleit, J. Caesar, C. Villarroel Aguilera, S. Sterz, L. Holdt, F. Beigel, S. Breiteneicher, J. Stallhofer i M. Siebeck. "DOP33 Stratification of patients for treatment with adalimumab by a combination of immune-profiling and in vivo efficacy studies in a novel mouse model of ulcerative colitis". Journal of Crohn's and Colitis 14, Supplement_1 (styczeń 2020): S071—S072. http://dx.doi.org/10.1093/ecco-jcc/jjz203.072.
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Abstract Background The Holy Grail in chronic inflammatory diseases is the identification of biological markers which might explain the heterogeneity of disease manifestations and predict responses to treatment. The aim of this study was to identify immunological subgroups of patients with UC and to test responsiveness to adalimumab in these subgroups in the mouse model of ulcerative colitis (UC), which is based on NOD/scid IL-2Rγ null (NSG) mice reconstituted with peripheral blood mononuclear cells (PBMCs; NSG-UC). Methods The immunological profiles of 40 UC patients and 16 non-UC donors were determined by flow cytometric analysis of PBMCs in a snapshot and longitudinal study and analysed by principal component (PCA), orthogonal partial least square discrimination (oPLS-DA)- and hierarchical clustering analysis. NSG mice were reconstituted five times at consecutive time points with PBMCs from a single donor and were analysed for frequencies of human leukocytes, histological phenotype and levels of calprotectin (CRP) and transforming growth factor (TGF)-β. The response to adalimumab was tested in the NSG-UC model reconstituted with PBMC from patients clustering in group I (n = 2) or II (n = 2). Readout were the clinical, colon and histological scores, serum levels of glutamic and aspartic acid and interleukin (IL)-6 and IL-1β. The response was analysed by PCA. Results Hierarchical clustering identified two major subgroups in UC patients. Group I was characterised by TH17 and M1 monocytes, group II by TH2/TH1 and switched B cells. O-PLS-DA revealed significant discrimination between the two groups. Patients analysed in longitudinal studies switched from one group to the other. Thus, these subgroups reflected the dynamics of inflammation in patients. Mice reconstituted five times at consecutive time points with PBMC from one donor achieved an immunological phenotype reflecting the one of the Patient at that time point. Like the patient, mice switched from a pro-inflammatory phenotype (group II) to an M1 monocyte driven inflammation (group I). In mice, group II was characterised by a severe influx of inflammatory cells and oedema whereas group I was signified by extensive fibrosis. This observation was corroborated by colonic CRP and TGFß levels. CRP levels were significantly higher in group II, whereas TGFβ levels were increased in group I. PCA analysis revealed that mice reconstituted with PBMC from group II responded better to treatment with adalimumab than mice from group I. Conclusion The combination of profiling and testing of therapeutics in the NSG-UC model may ultimately lead to individualised and phase-dependent therapies.
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Moret, I., E. Cerrillo, E. Saez-Gonzalez, D. Hervas, M. Iborra, L. Tortosa, P. Nos, J. Gadea i B. Beltran. "P096 Specific plasma micro-RNA profiles for prediction of recurrence in Crohn’s disease in pre-surgery and established recurrence scenarios". Journal of Crohn's and Colitis 14, Supplement_1 (styczeń 2020): S183—S184. http://dx.doi.org/10.1093/ecco-jcc/jjz203.225.
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Abstract Background Crohn’s disease (CD) patients who undergo ileocolonic resection are at high risk of postoperative recurrence (POR). Both environmental and genetic factors are known to influence CD pathogenesis. MicroRNAs (miRs) are important epigenetic regulators in CD, but their role in the progression to POR is still unknown. Thus, we aimed to identify differential miRs profiles and their potential use to predict POR in CD patients. Methods A cohort of 33 CD patients who underwent a resection was consecutively and prospectively followed for at least 1 year. Patients were classified according to the presence or absence of POR during the follow-up. POR was assessed by ileocolonoscopy (Rutgeerts’ index ≥ i2b) or MRI enterography within 6–12 months after surgery. Patients received postoperative therapy to prevent POR (thiopurines 47%; anti-TNFα 25%; mesalamine 9%; combination therapy 3%; none 16%). Peripheral blood samples were taken at fixed times. Total RNA was obtained from miRNeasy Serum/Plasma Advanced Kit (Qiagen) and run on the miRCURY LNAtm Universal RT microRNA PCR with a miRs panel selection (32) based on previous experiments. The predictive accuracy of the possible predictors was assessed by using receiver operating characteristic curves with the R software. Results MicroRNAs profiles were studied at two different times: presurgery (PS) and at the time of the morphological POR or, in those who remained in remission, 1 year after surgery (1 year). The miRs whose fluorescent signal did not differ from background noise were excluded from the analysis [8 in PS (25%); 5 in 1 year (16%)]. Using elastic net regression, five miRs (hsa.miR.191.5p, hsa.miR.15b.5p, hsa.miR.106b.5p, hsa.miR.451a and hsa.miR.93.5p) were selected for discriminating the two patient groups at the time pre-surgery. Seven miRs (hsa.miR.15b.5p, hsa.miR.126.3p, hsa.miR.451a, hsa.let.7b.5p, hsa.miR.93.5p, hsa.miR.423.5p and hsa.miR.125b.5p) were selected for discriminating the two patient groups at the time of 1 year. Using a predictive model with these miRs, an overall AUC of 0.86 (95% confidence interval, 0.75–0.97) was achieved for PS, and 0.96 (0.92–1.0) for 1 year. Conclusion This study shows that plasma microRNAs are useful biomarkers in the POR scenario. When recurrence is already established, a group of plasma miRs is also specifically expressed, thus assessing them could prevent patients from receiving and endoscopic procedure for POR evaluation. Furthermore, microRNA assessment PS could predict which patients will develop recurrence within 1 year of surgery. This could also have an impact on clinical management, selecting patients who can avoid immunosuppressive treatment and the ones who may need more intensive therapeutic strategies.
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Le, P. H., C. H. Chiu, C. T. Chiu, C. J. Kuo, P. J. Yeh, C. C. Chen i Y. B. Pan. "P452 Fecal Microbiota Transplantation Leads to Lower IBD Related Complications in Hospitalized Inflammatory Bowel Disease Patients with Clostridioides difficile Infection: A retrospective cohort study". Journal of Crohn's and Colitis 17, Supplement_1 (30.01.2023): i582. http://dx.doi.org/10.1093/ecco-jcc/jjac190.0582.
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Abstract Background Clostridioides difficile (C. difficile) infection (CDI) increases the risks of hospitalization, colectomy, and mortality in inflammatory bowel disease (IBD). There has been no study comprehensively evaluating the risk factors, clinical characteristics, and outcomes of CDI in IBD. Methods In this retrospective cohort study, we enrolled hospitalized IBD patients with toxin A/B results for C. difficile in a medical center between April 2007 and April 2021. They were divided into CDI group and control groups. The risk factors, clinical presentations and outcomes were analyzed. Results A total of 144 IBD inpatients (45 CDI group and 99 control group) were enrolled for analysis. The median follow-up duration was 15.5 months. The incidence of CDI in IBD inpatients was 31%. The risk factors of CDI included longer IBD duration, biological failure, and biological user. More patients presented as abdominal pain in CDI group (77.8% vs 55.6%, P=0.011). After antibiotics treatment and fecal microbiota transplantation, 83.3% patients had negative result, and 61.9% had improved clinical symptoms. Regarding clinical outcomes, CDI led to more hospitalizations (median 2 times (range 0-12 times) vs median 1 time (range 0-19 times), P=0.008), lower steroid free remission rate (46.7% vs 67.7%, P=0.017) and higher Mayo score (median 5 points (range 2-12 points) vs median 3 points (range 0-12 points)). Compared to antibiotics treatment, the patients receiving fecal microbiota transplantation (FMT) had less times of hospitalization and less IBD related complications during follow-up. Conclusion CDI led to more hospitalizations, lower steroid free remission rate and higher Mayo score in IBD inpatients. FMT should be considered in refractory or recurrent CDI in IBD to improve the clinical outcomes.
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Williams, P. J. S., G. O. L. Jones, J. R. Palmer i H. Rishbeth. "The association of polar mesosphere summer echo layers with tial modes". Annales Geophysicae 13, nr 4 (30.04.1995): 454–57. http://dx.doi.org/10.1007/s00585-995-0454-8.
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Abstract. The occurrence of PMSEs with time of day shows a semi-diurnal variation with minima at 8 and 20 h LT. PMSE layers observed for more than 30 min show an average rate of descent of 2 km h–1. These characteristics suggest the influence of tidal winds. When the observed steady wind and diurnal and semi-diurnal tides at EISCAT are added, the overall magnitude shows a time-variation which matches the occurrence of PMSEs, and the observed rate of descent, approximately 2 km h–1. Atmospheric gravity waves also contribute to the velocity of the neutral wind. When the wave reinforces the background wind, the PMSEs are stronger and descend more rapidly, but when the wave-related velocity opposes the background wind the PMSE is weaker and it descends more slowly.
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Sempere Robles, L., P. Bernabeu, J. I. Cameo Lorenzo, R. Laveda, M. F. García, M. Aguas, O. Belén i in. "P169 Delayed diagnosis of inflammatory bowel disease in women: Characterization and use of health resources". Journal of Crohn's and Colitis 16, Supplement_1 (1.01.2022): i239. http://dx.doi.org/10.1093/ecco-jcc/jjab232.297.
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Abstract Background Delayed diagnosis of IBD is associated with increased complications. Female gender is one of the factors most frequently associated with delayed diagnosis. Higher prevalence of functional gastrointestinal disorders in women probably hinders the diagnosis of IBD. The aim of this study is to explore delayed diagnosis of IBD and assess differences between women and men in healthcare access routes. Methods This multicentre prospective cohort study included 190 patients with newly diagnosed IBD. Data were collected on clinical and demographic characteristics, IBD activity and systematic reconstruction of the diagnostic process in a semi-structured interview together with a review of their medical record. Results Figure 1 shows clinical and demographic characteristics. In CD, patients’ symptoms were similar between both genders, except for a higher incidence of bowel incontinence, arthralgias, asthenia and other symptoms in women. In UC, there was no gender difference in clinical presentation. Overall, the median time from symptom onset to IBD diagnosis was 4.5(2.1–12.9) months, being significantly longer in women than in men, 7.8(3.3–18.9) vs. 3.8(1.7–7.8) p<0.001. In diagnostic process, the time from symptom onset to initial physician visit was 0.7(0.26–2) months with no statistically significant differences between women and men. While the time from initial physician visit to IBD diagnosis was 3.4(1.1–7.4) months with a longer time in women than in men 4.2(1.9–11.1) vs 2.2(0.82–5.1) p< 0.001. Figure 2 shows the different diagnostic times by sex in CD and UC. Misdiagnosis were reported in 61.6%, women had a higher percentage of misdiagnosis than men, 77.3% vs 48% (OR 3.6; 95% CI 1.9–6.9). These differences between women and men were maintained in CD 83% vs 55.3 (OR 3.9; 95% CI 1.5–9.9) and in UC 68.6% vs 41.8% (OR 3; 95% CI 1.2–7.4). Misdiagnosis were observed in 66/120 (55%) patients evaluated in Emergency Department, 89/166 (53.6%) in Primary Health Care, 25/122 (20.5%) in Gastroenterology Outpatient Clinics, 4/11(36.5) in another medical specialist, and 14/84 (16.7) in Hospital Admission. Women had a higher percentage of misdiagnosis, in Emergency Department 66.1%/44.3% (OR 2.4; 95% CI 1.1–5.1), Primary Health Care 65.1%/42.2% (OR 2.5; 95% CI 1.3–4.7), Gastroenterology Outpatient Clinics 29.5%/11.5% (OR 3.2; 95% CI 1.2–8.4) and Hospital Admission 25.6%/7.3% (OR 4.3; 95% CI 1.1–16.9). Figure 3 shows the distribution of the most frequently misdiagnosed pathologies prior to IBD diagnosis. Conclusion Delayed diagnosis of IBD in women affects both CD and CU, due to a longer delay in the diagnostic process since the patient consults for the first time. Gender biases in the misdiagnosis of IBD patients occur at all levels of health care.
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Rao, A., A. Bazarova, P. Mitra, S. Majumder, T. Parigi, S. Ghosh, M. Iacucci i U. Shivaji. "P190 Delayed IBD diagnosis leads to worse outcomes over years, with multiple implications on service delivery". Journal of Crohn's and Colitis 17, Supplement_1 (30.01.2023): i344—i345. http://dx.doi.org/10.1093/ecco-jcc/jjac190.0320.
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Abstract Background Delays in diagnosis can be patient and health-system related. Such delays have been reported to increase overall complications in Inflammatory Bowel Diseases (IBD). The aim of our study was to report on the impact of delays on IBD-related adverse outcomes (AOs), as hospitals currently face challenges with long waiting lists in the post-COVID-19 era. Methods New patients referred for suspected IBD to a single tertiary care centre between Jan 2013 to Dec 2017 were identified using EMR. A cut-off time was set for each delay-type based on best average hospital waiting times. Reasons for delays until start of treatment and data on pre-defined AOs (steroid & other rescue therapies, hospitalisations, surgery) were recorded for each patient until end of June 2021. Data was analysed using multiple Pearson correlations and Cox proportional Hazard model to determine if there was a difference in survival without AOs between patients with and without delay. Results 105 patients were identified using strict criteria (M=58; median age=32y) with a median follow-up of 55 months. The most frequent presenting complaints were abdominal pain (44, 41.9%), loose stools (40, 38.1%), bloody diarrhoea (37, 35.2%) and bleeding per-rectum (33, 31.4%). 65, 27 and 13 patients had a final diagnosis of Ulcerative colitis, Crohn’s disease and Unclassified colitis respectively, and were analysed jointly. The longest delay-types noted: patients seeking medical attention (median=4 months; range 1 to 84 months); arranging gastroenterology clinic review after GP referral (median=5 weeks; 1 to 30 weeks); and waiting for index endoscopy (median=3 weeks; 1 to 36 weeks). Patient stratification based on delay-type, using specific cut-off times for each showed a statistically significant difference in survival without AOs for all (when comparing delay vs no delay). - delay in seeking medical attention (cut-off=1m; p=0.004) (Fig 1A) - delay in GP referral to specialty review (cut-off=1w; p=0.048) - delay in index endoscopy (cut-off=4w; p=0.01) (Fig 1B) - delay in starting treatment (cut-off=4w; p=0.03) Fig 1A-Time to seek medical attention (survival without AOs; p=0.004) Fig 1B-Time from clinic review to index endoscopy (survival without AOs; p=0.01) Conclusion Several bottlenecks of delays increase AOs in IBD over the follow-up period. A delay as short as a week, between GP referral to specialty review, is significant in determining AOs, relevant for specialist IBD centres particularly in the post-Covid period. Endoscopy units should prioritise suspected IBD patients to reduce AOs, which is likely to have implications on service delivery and planning. Long delays observed in patients seeking medical attention highlights the need for better patient education in the community.
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Rao, A., A. Bazarova, P. Mitra, T. Parigi, S. Majumder, S. Ghosh, M. Iacucci i U. Shivaji. "P209 Delayed IBD diagnosis increases risk of requiring biologics in first 4-years - an Inception cohort study". Journal of Crohn's and Colitis 17, Supplement_1 (30.01.2023): i360—i361. http://dx.doi.org/10.1093/ecco-jcc/jjac190.0339.
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Abstract Background Delays in diagnosis can be due to patient and health-system related factors. The impact of such delays in Inflammatory Bowel Diseases (IBD), particularly on biological therapies, continues to be of interest. The aim of the study was to investigate if delays could predict need for biologics and report on related adverse outcomes (AOs). Methods New patients referred for suspected IBD to a single tertiary care centre between Jan 2013 to Dec 2017 were identified using EMR. For this study, delay-types and cut-off times for each type were set based on best average hospital waiting times. The reasons for delays until start of treatment were recorded; data on the start of biologics, duration, and reasons for switch (if required) were recorded. Data was analysed using multiple Pearson correlations and Cox proportional Hazard model to determine whether any delay-types could predict need for biologics and compare the risk between patients with or without delay. Results 105 patients were identified using stringent criteria (M=58; median age=32y) with a median follow-up of 55 months. 65, 27 and 13 patients had a final diagnosis of Ulcerative colitis, Crohn’s disease, and Unclassified colitis respectively, and were analysed collectively. A model that combined delay in seeking medical attention, and time taken from specialty review to index endoscopy exhibited the best predictive power with average AUROC of 0.67. When individual delay-types were analysed, it was noted that most delay-types increased the risk of biologic use: a) delay in seeking medical attention [OR-1.08(1.03 1.17)] b) delay from GP referral to specialty review [OR-1.10(1.0 1.23)] c) delay from specialty review to index endoscopy [OR-1.09(1.01 1.21)] On further analysis, there was a statistically significant increase noted in the risk of requiring biologics at any time during the follow-up period. Fig 1A illustrates survival without biologics when there is a delay of >2 weeks in seeking medical attention (p=0.042). Figure 1B illustrates survival without biologics when there is delay of >6 weeks from GP referral to index endoscopy (p=0.021). Figure 1A- Patient-related delay of >2weeks and risk of needing biologics (p=0.042) Figure 1B- Health-system related delay of >6weeks and risk of needing biologics (p=0.021) Conclusion The risk of requiring biologic therapy is higher in those patients who have faced any type of delay in their diagnosis of IBD. A patient-related delay of >2weeks and cumulative health-system related delay of >6weeks increase the risk of requiring biologic therapy at any time during their follow-up. Both primary and secondary care must work to reduce any delays as this has long-term implications for patients and economic implications for health care providers.
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Radford, S., C. Tench i G. Moran. "P260 Care pathway modelling and economic analysis of a single NHS IBD Service following introduction of Small bowel ultrasound". Journal of Crohn's and Colitis 17, Supplement_1 (30.01.2023): i407. http://dx.doi.org/10.1093/ecco-jcc/jjac190.0390.
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Abstract Background Small bowel ultrasound (SBUS) is an accurate, inexpensive and non-invasive method of diagnosing and monitoring IBD. The service delivery and economic implications of SBUS implementation on NHS IBD services have not previously been explored. Methods This study took the form of a service evaluation. Analysis of patient care episodes and flow through the established imaging (MRE and SBUS) and IBD care pathways was undertaken, data relating to patient flow, waiting times, resource use and healthcare engagement of patients were collected from care episodes between 01/01/2021 – 30/03/2022. Costs were calculated per care episode. Results Data from a service evaluation relating to 192 imaging referrals from IBD clinics for patients with Small bowel Crohn's disease (SBCD), and patient flow through the pathway were collected. Per scan, MRE was almost 5 times more costly than SBUS examinations (£305 versus £51 respectively). Patients from the SBUS pathway had fewer healthcare interactions across all three categories (Helpline, IBD Nurse or IBD Consultant appointments). Patients from the MRE pathway. Estimated costs per patient in the SBUS pathway were £81.72, and £379.58 per patient in the MRE pathway. Further to this the waiting times for MRE were significantly longer than those for SBUS. Conclusion The use of SBUS is a potential cost saving option when compared to MRE for adult patients with SBCD. There was a difference between the SBUS and MRE pathways in the waiting times for both the medical imaging scans, the reports of the scans and the initiation of an appropriate treatment plan. SBUS waiting times were shorter in all aspects except for the time between scanning report and the treatment initiation, indicating that it is the waiting times for the scans and the respective reporting that cause delays in treatment initiation. Future research in this area should attempt to consider the wider impact on cost effectiveness of the use of SBUS through investigation of costs including treatment costs, including the timing and use of biologic and immunomodulator treatments, impact of delays on service use and healthcare interactions of patients, work productivity and quality adjusted life years.
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Valdes, T., A. Vilches Arenas, B. Maldonado Perez, L. Castro Laria, V. Merino Bohorquez i F. Argüelles Arias. "P081 Therapeutic Drug Monitoring of infliximab in Crohn’s Disease: Cut-off points during maintenance therapy". Journal of Crohn's and Colitis 16, Supplement_1 (1.01.2022): i181—i182. http://dx.doi.org/10.1093/ecco-jcc/jjab232.210.
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Abstract Background Therapeutic drug monitoring of infliximab in Crohn’s disease is necessary to optimize treatments. However, infliximab serum levels are not well defined. The aim of the study was to find our cut-off of infliximab serum levels in Crohn’s disease patients in remission in clinical practice. Furthermore, we tried to identify other predictors of long-term benefit of infliximab therapy. Methods Observational, retrospective and single-center study of patients diagnosed with Crohn’s disease on maintenance therapy with infliximab from January 2019 to July 2020. Infliximab trough levels and antibodies to infliximab were measured at least three times, after 6 months of treatment. The tests were performed using enzyme linked immunosorbent assay. Clinical remission was defined using the Harvey Bradshaw index ≤4. The interpretation of data was by ROC analysis. Results 105 Crohn’s disease patients were included in the study, 57.1% men, with a median age at diagnosis of 26 years. The rest of the characteristics are in table 1. The best infliximab level cut-off point classifying patients in clinical remission was 4 μg/ml with an area under the curve of 0.801 (figure 1 and 2). Median infliximab trough levels were significantly higher when patients achieved clinical remission [4.8 (3–8) μg/ml] versus [0.59 (0.1–2.4) μg/ml]. In the multivariate analysis we observed that the variables age, time on infliximab treatment and time of disease evolution were associated with non-remission (table 2). Conclusion Infliximab levels are an objective parameter related to clinical remission in maintenance therapy in patients with Crohn’s disease. Our cut-off point associated with clinical remission was 4 μg/ml.
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Luber, R., R. O’Neill, S. Singh, Z. Arkir i P. Irving. "P485 Switching infliximab biosimilar: No adverse impact on inflammatory bowel disease control or drug levels with the first or second switch". Journal of Crohn's and Colitis 14, Supplement_1 (styczeń 2020): S426—S427. http://dx.doi.org/10.1093/ecco-jcc/jjz203.614.
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Abstract Background Biological medicines account for a significant cost to healthcare systems. With the advent of anti-tumour necrosis factor biosimilars, switching from originator to biosimilar has enabled cost saving in inflammatory bowel disease (IBD) without compromising disease control. However, with more biosimilars entering the market, the effect on IBD activity and pharmacokinetics (PK) of a second switch to another biosimilar is uncertain. This study aims to assess the effect on disease activity and drug levels associated with switching from infliximab (IFX) biosimilar Remsima® (Celltrion, Hungary) to another biosimilar, Flixabi® (Samsung Bioepis, The Netherlands), and to compare those switching for the first and second time. Methods All IBD patients on IFX biosimilar Remsima® were prospectively followed during their switch to Flixabi® in a single centre. Baseline data including C-reactive protein (CRP), trough IFX level, and clinical disease activity indices were collected; Harvey Bradshaw Index for Crohn’s disease (CD) and Simple Clinical Colitis Activity Index for ulcerative colitis (UC). These indices were repeated after at least two infusions of Flixabi®. Results 221 patients (179 CD, 42 UC) on stable IFX treatment were included in the study. 174 (79%) were on a concomitant immunomodulator. 5 (2%) patients ceased IFX prior to follow-up due to sustained remission, and 3 (1%) patients discontinued due to factors not directly related to drug or disease. 112 patients had PK analysis performed pre and post switch. An increase in IFX trough level was observed after switching IFX biosimilars; baseline median (IQR) trough level of 4.5µg/ml (2.9–6.3) compared with post switch of 5.1µg/ml (3.4–7.0) (p = 0.02). There was no difference in clinical scores or CRP post switch, and no new anti-IFX antibodies were detected. 107 patients (48%) were switching IFX agent for the second time, of which 51 had PK analysis performed. A similar increase in median IFX trough level was observed post switch in those switching for the first (4.7 vs. 6.1 µg/ml, p = 0.03) and second (4.0 vs. 4.5µg/ml, p = 0.05) times (Figure 1). No change in clinical disease activity or CRP occurred in either group. Concomitant immunomodulator and disease classification had no impact on change in IFX level (p = 0.72 and 0.37, respectively, on univariate analysis). Conclusion In a cohort of IBD patients switching to a new IFX biosimilar either for the first or second time, an increase in IFX level was observed with no impact on clinical and biochemical disease activity indices. Switching IFX biosimilars in IBD appears safe in the short term with respect to maintaining drug pharmacokinetic profile and disease control whether switching for the first or second time.
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Cervera Seco, L. M., M. Sánchez Mayor, A. M. Corraliza, A. Salas, J. Panés i U. M. Marigorta. "P897 Longitudinal multi-tissue transcriptomic study reveals patient-specific drug response determinants in Inflammatory Bowel Disease patients". Journal of Crohn's and Colitis 17, Supplement_1 (30.01.2023): i1011. http://dx.doi.org/10.1093/ecco-jcc/jjac190.1027.
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Abstract Background Despite the lack of understanding of Inflammatory Bowel Disease (IBD) pathogenesis, association studies have made inroads into the elucidation of the genetic component of disease diagnosis. The corresponding determinants of drug response, in turn, remain obscure. Primary response is low, secondary loss of response is prevalent and remission rates are low (30% of patients roughly). Along with the expanding repertoire of drugs, it is critical to develop a strategy to reveal the factors contibuting to drug response at the patient level. Our goal is to understand drug response in IBD looking to establish a precision medicine strategy to assign patients a specific treatment based on their transcriptomic profile. Methods We carried out a longitudinal follow-up of 147 IBD patients, from whom we sampled 264 intestinal biopsies and 119 blood extracts. Patients were exclusively treated with one of the three main available biologics: 248 with infliximab (anti-TNF), 47 with ustekinumab (anti-IL12/IL23) and 88 with vedolizumab (anti-α4β7). RNA-seq profiles were obtained at three different times (baseline, 14 weeks and 46 weeks after treatment initiation), resulting in 232, 92 and 59 samples, respectively. Differential expression analysis and pathway enrichment analysis were performed to get drug-specific genes and response signatures. Results The initial exploratory analysis confirms that tissue is the main determinant of expression variability among patients. As for longitudinal response, anti-TNF-specific features are quintessentially inflammatory, especially involved in translation and immune pathways, while response to ustekinumab is associated with extracellular recognition. Of note, vedolizumab-specific profiles strikingly differ between biopsy and blood samples. We also revealed that drug response is determined during first weeks of treatment, as up- and down-regulated genes are shared across time points. This may entail huge consequences in the clinic since the determination of response could be assessed earlier. Using clinical activity to define responders, we identified around 200 differentially expressed genes that could predict response to infliximab at time zero. We also improved our understanding regarding individual response by carrying out trend analyses based on connectivity scores that identify individual-specific regulated pathways. Conclusion While we identified common patterns across time in enriched pathways, we could discern specific drug response profiles. Besides providing a renewed understanding of the molecular effects of biological drugs, we propose that personalised models predicting response are feasible, and a promising venue to develop therapeutic guidelines of biologics in IBD.
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Bishara, M., R. Smith, R. Nice, C. Roberts, N. A. Kennedy, T. Ahmad i J. R. Goodhand. "P234 Online direct-to-public calprotectin testing in the UK: what is out there in 2023?" Journal of Crohn's and Colitis 18, Supplement_1 (1.01.2024): i575. http://dx.doi.org/10.1093/ecco-jcc/jjad212.0364.
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Abstract Background The longest component of the time-to-diagnosis is the interval between symptom onset and an individual seeking help. Recent reports in patients with sexually transmitted infections and hepatitis C, who also suffer health related stigma and a delay in diagnosis, suggest that this barrier may be overcome by the anonymity of direct-to-public testing. We sought to characterise the availability of online direct-to-public calprotectin testing in 2023 in the UK. Methods We undertook an online search using the Google search engine on May 25th, 2023, with the terms "buy" or "purchase" AND "calprotectin" AND "inflammatory bowel disease". Collection kits were procured, and stool samples tested to receive follow-up advice for known positive and negative stool samples. We recorded data regarding the assay, consumer information and the clinical advice offered on return of a positive and negative test. Results Overall, 54.5% (6/11) of available tests were home lateral flow tests, the remainder were home collection laboratory-based tests. Of the laboratory-based tests, three were conventional enzyme-linked immunosorbent assay (ELISA) assays and two were OC sensor tests. The lateral flow tests were considerably cheaper than the laboratory-based tests (median cost £14.20 [£7.85-21.00] vs £75.85 [£59-151], p<0.0001). The median turnaround time for the laboratory tests was 14 (1-23) days. All but one provider used a positivity threshold of 50ug/g. Eight of the eleven platforms (4 lateral flow tests and 4 laboratory-based tests) explicitly stipulated testing in the setting of gastrointestinal symptoms or suggested exclusion criteria. All tests included written and pictorial instructions with the testing kit. The median Flesch Kincaid readability score for the instructions and result reporting were 54.3 (43.9-73.7) and 51.8 (12.9-64.9): equivalent to a school reading grade of 9.2 (6.2-10.8) and 11.3 (7.2-15.8), respectively. Only two of the lateral flow tests provided written recommendations about follow up of positive results, whereas amongst the laboratory-based tests, all but one provider recommended onward discussion with a general practitioner or specialist. Two providers offered private referrals or consultations and six provided safety netting advice with regards to negative results. Conclusion In the UK online direct-to-public calprotectin testing is already readily available from multiple providers. Consumers can choose between home-based lateral flow tests or conventional laboratory testing. Further work is needed to redefine the diagnostic accuracy of calprotectin used in this way, however, the rapid turnaround times and anonymity suggest that direct-to-public calprotectin testing could be used to reduce the time to IBD diagnosis.
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Auger, Nathalie, Justin Côté-Daigneault, Marianne Bilodeau-Bertrand i Laura Arbour. "Inflammatory Bowel Disease and Risk of Birth Defects in Offspring". Journal of Crohn's and Colitis 14, nr 5 (7.01.2020): 588–94. http://dx.doi.org/10.1093/ecco-jcc/jjz211.
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Abstract Background and Aims The relationship between inflammatory bowel disease in pregnancy and birth defects is not understood. We evaluated whether Crohn’s disease and ulcerative colitis in pregnant women were associated with the risk of birth defects in the offspring. Methods We undertook a retrospective cohort study of 2 184 888 pregnancies in Quebec, Canada, between 1989 and 2016. We calculated risk ratios [RR] and 95% confidence intervals [CI] for the association between inflammatory bowel disease and the risk of birth defects, using generalised estimating equations adjusted for maternal characteristics. We assessed associations in the period before 2000, when immunosuppressive biologic therapy and folic acid food fortification were not yet available, compared with the period after 2000 when these interventions were more widespread. Results This study included 13 099 women with Crohn’s disease and 7798 with ulcerative colitis. Crohn’s disease was associated with 1.90 times [95% CI 1.10–3.28] the risk of abdominal wall defects [gastroschisis, omphalocoele, and diaphragmatic hernia] and ulcerative colitis was associated with 1.53 times [95% CI 1.02–2.30] the risk of central nervous system defects. The association of Crohn’s disease with abdominal wall defects was stronger before 2000 [RR 3.62, 95% CI 1.71–7.67] than after 2000 [RR 1.23, 95% CI 0.55–2.75]. Ulcerative colitis was associated with central nervous system defects regardless of time period. Conclusions These findings suggest that inflammatory bowel disease is associated with the risk of abdominal wall and central nervous system defects, and that introduction of immunobiologic medications is unlikely to be associated with added risk. Podcast This article has an associated podcast which can be accessed at https://academic.oup.com/ecco-jcc/pages/podcast
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Lehmann, A., G. Nandra, N. Power i J. O. Lindsay. "P707 Using urgent small bowel ultrasound (SBUS) as a tool for decision-making in patients with inflammatory bowel disease (IBD): retrospective analysis of United Kingdom (UK) patients' outcome". Journal of Crohn's and Colitis 17, Supplement_1 (30.01.2023): i838—i839. http://dx.doi.org/10.1093/ecco-jcc/jjac190.0837.
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Abstract Background In the UK, magnetic resonance enterography (MRE) and colonoscopy are the gold standard assessment for mucosal disease activity in IBD. Both techniques require bowel preparation, may be poorly tolerated and are often subject to delay due to capacity issues. In several European centres, ultrasound is used as an alternative tool for disease activity monitoring and clinical decision-making. Recent studies confirm excellent sensitivity, specificity, correlation with MRE / colonoscopy and robust inter-observer agreement. In the UK, a lack of US training in IBD physicians has hindered development of accessible SBUS. In view of issues with MRI capacity during the covid pandemic, a dedicated small bowel ultrasound list with a gastroenterology fellow and a specialist radiology consultant for urgent IBD patients was initiated. Methods Records of IBD patients undergoing SBUS between June 2022 and November 2022 were reviewed. SBUS assessed disease activity (vascularity, bowel wall thickness, mesenteric fat and lymphnodes), length of disease, presence of obstruction or fistulating disease. Patients were then retrospectively asked to rate their SBUS experience compared to previous MREs. Results 53 SBUS's (46 (86.7%) CD; 2 (3.7%) UC) were performed on a dedicated SBUS list by a gastroenterology fellow and specialist radiology consultant during the study. In 29 patients (54.7%), the area of interest was the terminal ileum. SBUS detected disease complications in 7 (2 (3.7%) patients with obstructive disease, and 5 (9.4%)) patients with penetrating disease. The average waiting time from the point of referral to SBUS was 4.7 weeks, compared to an average waiting time for MRE of 20 weeks. Treatment response was assessed in 18 patients (33.9%). We were able to make treatment decisions with 32 patients (60.3%) based on their SBUS results without further assessment. In 10 patients (18.8%), SBUS was used to confirm a diagnosis in addition to colonoscopy. 18/22 ( 81%) patients reported a preference for SBUS compared to MRE (preference score of 4.5 on scale of 1-5). Conclusion We developed an urgent SBUS service to aid timely clinical decision-making for IBD patients. In our practice, SBUS is an accurate tool to assess disease activity, significantly reduces patients waiting times and is the patient’s preferred investigation. There is a clear unmet need to train IBD doctors and radiologists in SBUS.
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Chen, B. C., M. T. Weng, C. H. Chang, L. Y. Huang i S. C. Wei. "P615 Does smoking really influence the development and the outcomes of Inflammatory Bowel Disease in Asian population? Results from the Taiwanese patients". Journal of Crohn's and Colitis 15, Supplement_1 (1.05.2021): S558—S559. http://dx.doi.org/10.1093/ecco-jcc/jjab076.736.
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Abstract Background Smoking has been reported to be associated with increased risk of Crohn’s disease (CD) and protect against ulcerative colitis (UC) from the Western population. However, the association are not well studied and there is no report about smoking and disease outcomes in the Asian population. This study is to clarify the influence of smoking in the development and disease outcomes of inflammatory bowel disease (IBD) in Asian population. Methods This case-controlled study was conducted by cross section chart review for smoking status as well as clinical characteristics of IBD patients at the National Taiwan University Hospital (NTUH). Age, sex, co-morbidities (hypertension, diabetes, and hyperlipidemia) matched non-IBD control were identified by using the database from the National Health Interview Survey of Taiwan, with 4 to 1 ratio for IBD patients. Clinical characteristics including disease phenotype, medication usage, times of admissions, times of emergency room (ER) visits, surgery, development of new cancer, survival status, endoscopic severity, laboratory data were retrieved and analyzed. Results A total of 700 IBD patients (UC: 412; CD: 378) diagnosed from January 1963 to 2020 were identified and analyzed for the influence of smoking to outcomes. The median follow-up time of UC and CD was 104 and 85 months, respectively. Among them, 575 patients (UC: 297, CD: 278) with complete information of comorbidities and aged from 12 to 64 years old were enrolled for smocking prevalence analysis. The prevalence of smoking was significantly lower in UC compared to the matched control (20.88% vs 30.39%, p = 0.0003), but there was no difference between CD and the matched control (19.78% vs 22.12%, p = 0.595). UC smokers were associated with less times of admission (1.56 vs. 2.46, p = 0.017), but higher rate of new cancer development (16% vs. 6.67%, p = 0.01), and mortality (16% vs. 4.91%, p = 0.001), when compared to the non-smokers. CD smokers tended to have disease located in terminal ileum (L1) and ileocolon (L3) (p = 0.0067), higher rate of stricturing (B2) and penetrating (B3) disease (p = 0.0328), higher risk of surgery (60.32% vs. 38.27%, p = 0.001) than the non-smokers, but no difference on mortality. Conclusion In Asian IBD population, smoking is a protective factor for UC occurrence and associated with lower hospitalization rate but more cancer and higher mortality. In contrast, smoking has no effect for CD occurrence and mortality but related to more aggressive behavior which resulted in higher surgical rate.
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Filip, R., P. Bar, D. Bartusik-Aebisher i D. Aebisher. "P010 Measurement of colonic mucosal content of biologics with the use of magnetic resonance imaging (MRI): A pilot study in patients with ulcerative colitis". Journal of Crohn's and Colitis 14, Supplement_1 (styczeń 2020): S134—S135. http://dx.doi.org/10.1093/ecco-jcc/jjz203.139.
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Abstract Background Anti-tumour necrosis factor antagonists (infliximab) as well as other molecules with different modes of action, including anti-integrin agents (vedolizumab), are currently used in patients with ulcerative colitis (UC Numerous studies have demonstrated a positive correlation between serum biologic drug concentrations and favourable therapeutic outcomes, whereas low or undetectable drug concentrations can lead to treatment failure. However, despite immunological issues, lack of and or loss of response may also be attributed to drug pharmacokinetics, of which penetration to the target tissue (colon wall) may play a crucial role Methods We used MRI to perform biochemical analyses of infliximab, adalimumab and vedolizumab concentrations testing the hypothesis that MRI relaxation time can be used to track antibodies in both mucosal biopsy samples and serum. All MR scans were performed with an Optima MR360 from General Electric Healthcare. To determine spin–lattice (T1) and spin–spin (T2) relaxation times, the Fast Spin Echo (FSE) sequence was used. Results The measured values of T1 relaxation times for infliximab, adalimumab, and vedolizumab were 2227 ± 35 ms, 2000 ± 22 ms and 1288 ± 15 ms, respectively. The obtained T2 relaxation times were 130 ± 11 ms, 90 ± 5, and 75 ± 10 ms, respectively. A decrease of both T1 and T2 values of 15 ± 3% are observed in serum from patients with ulcerative colitis. The values of infliximab and adalimumab were similar; the values of vedolizumab measurements in serum were about 50% lower. We find primary evidence that in T1 and T2 decreased in serum samples with ulcerative colitis and increase with the administration of infliximab, adalimumab and vedolizumab drugs. Samples of healthy tissue have T1 and T2 in the range of 2700 ± 5 ms and 150 ms ± 5 ms, respectively. A 30% decrease in T1 and T2 are observed for samples with ulcerative colitis. In this pilot study, we observed that values of T1 and T2 for tissues and serum that contain infliximab and adalimumab are similar, but vedolizumab shows a difference of about 30% when compared with infliximab and adalimumab. Conclusion MRI is an excellent method for quantitative and qualitative measurements of drug content in tissues and biological fluids. This is an innovative use of magnetic resonance imaging to develop a methodology for imaging of drugs that act as contrast agents via interaction with water in serum and tissue.
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Radford, S., P. Leighton, J. Coad i G. Moran. "N06 Assessing stakeholder identified barriers and enablers to Ultrasound implementation for assessment of Crohn’s Disease in the UK: A qualitative interview study". Journal of Crohn's and Colitis 16, Supplement_1 (1.01.2022): i619—i620. http://dx.doi.org/10.1093/ecco-jcc/jjab232.848.
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Abstract Background Data from the METRIC trial (PMID:29914843) has shown that small bowel ultrasound (US) has very good diagnostic accuracy for disease extent, presence and activity in Crohn’s Disease, is well tolerated by patients and is cheaper when compared to MRI. A recent survey (unpublished) undertaken by the authors via the British Society of Gastroenterology indicated that there is enthusiasm for the use of US in IBD care in the UK. However, uptake of US in the UK is limited, however it is unclear why this is the case. Methods A qualitative semi-structured interview study, utilising template analysis using the Normalisation Process Theory (NPT) codebook, was undertaken. NPT was used to guide the analysis framing the findings in relation to the implementation processes related to integrating US into daily IBD care. Interviews were undertaken utilising virtual meeting software. Results Fourteen participants were enrolled in the interview study (table #). Participants were enrolled between 02/06/2021-and 06/09/2021, with interviews taking place during the same time period. Enrolled were three patients living with CD (21.4%), two IBD Nurse specialists (14.3%), two IBD Nurse consultants (14.3%), one surgical IBD nurse specialist (7.1%), two consultant gastroenterologists (14.3%), two consultant radiologists (14.3%) and two gastroenterology service managers (14.3%). Participants reported that perceived barriers included reliance on MRI and established care pathways, reluctance to change, lack of trust in US in relation to perceived lack of precision when compared to MRI and the initial financial and time outlay in establishing a US service (buying equipment and training staff). Participants were enthusiastic for the uptake of US and discussed enablers to US uptake being the benefits to patients in terms of reduction in waiting times and earlier diagnosis and treatment allocation (leading to improved clinical outcomes), reduced hospital appointments, reduced costs to the NHS, patients having better understanding of their health and improvements in the therapeutic relationships between patients and healthcare professionals. Conclusion There is an enthusiasm to establish and utilise US in IBD care in the UK, however there are perceived barriers in achieving this. There is scant literature to effectively assess these reported barriers and enablers. Therefore there is further research required in the areas of the impact of the use of US on the confidence of clinical decision making of healthcare professionals and the relative cost effectiveness when compared to MRI use for the assessment of IBD in the UK.
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Drygiannakis, I., N. Tzenaki, E. Archontoulaki, E. Filidou, L. Kandilogiannakis, V. Valatas, G. Kolios i I. E. Koutroubakis. "P041 The upregulation of tissue factor in colonic mesenchymal cells in active ulcerative colitis is associated with severe and resistant to treatment disease, but tofacitinib has not effect on it". Journal of Crohn's and Colitis 17, Supplement_1 (30.01.2023): i207—i209. http://dx.doi.org/10.1093/ecco-jcc/jjac190.0171.
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Abstract Background Tissue factor (TF) plays an important role on blood clotting and the risk of thromboembolic events is increased in ulcerative colitis (UC). Tofacitinib, recently introduced in UC therapeutics, may further increase the risk. To delineate thrombosis pathophysiology in this context, TF expression in primary human colonic mesenchymal cells (PHCMC) of patients with active UC was correlated with clinical parameters, serum markers of inflammation and endoscopy. We then treated those PHCMC with tofacitinib with or without cytokines to better mimic the in vivo milieu they are exposed to. Methods PHCMC from endoscopic biopsies of the inflamed mucosa of 10 UC patients with an endoscopic Mayo score ≥2 were treated with all major T helper (Th)1 (TNF-α, IFN-γ), Th2 (IL-4, IL-13) or T regulatory (Treg; TGF-β, IL-10) cytokines with or without tofacitinib. Cells were lysed, RNA was isolated and reverse-transcribed to cDNA. TF and RPL4 (housekeeping) cDNAs were quantified with real-time PCR. Wilcoxon and Mann-Whitney U tests were used to compare TF ΔΔCT for paired or unpaired values, respectively, and Spearman’s rho to correlate TF ΔΔCT with scale clinical variables and continuous laboratory values. Results Increased TF mRNA abundance in PHCMC was correlated to increased partial Mayo score (Spearman's rho 0.661, p < 0.044), reduced serum albumin (Spearman's rho -0.723, p < 0.05) and to more severe endoscopic lesions: cells originating from UC patients of an endoscopic Mayo score 3 expressed 20 times more TF than those from an endoscopic Mayo score 2 (p < 0.017; Figure 1). Moreover, PHCMC from difficult-to-treat patients, defined as requiring >1 biologics, expressed 9 times more TF (Figure 2). On the other hand, treatment with tofacitinib did not upregulate TF (Figure 3). PHCMC expressed receptors and responded to treatment with all major Th1 (TNF-α, IFN-γ), Th2 (IL-4, IL-13) or Treg (TGF-β, IL-10) cytokines by further upregulating TF by 5.5-7.5 times (p 0.001-0.035). IL-13 had the maximal effect (Figure 4). Even when tofacitinib was added together with the aforementioned cytokines, it did not further upregulate TF; instead, it tended to partially inhibit their effects. For example, it decreased upregulation of TF by IL-13 by 40%. Conclusion The expression of TF mRNA in active UC is significantly associated with clinically and endoscopically severe disease and resistance to treatment. Tofacitinib per se does not increase TF. Instead, it may limit the upregulating effect of pro-inflammatory cytokines.
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Chahal, J., D. Sriranganathan, S. Poo, S. W. Lo, S. Kashkooli, M. Garg i J. P. Segal. "P642 Network meta-analysis: efficacy and safety of treatments for fistulising Crohn’s disease". Journal of Crohn's and Colitis 17, Supplement_1 (30.01.2023): i773—i774. http://dx.doi.org/10.1093/ecco-jcc/jjac190.0772.
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Abstract Background Fistulas are a debilitating complication of Crohn’s disease (CD) and treatment options remain limited, with sub-optimal efficacy. It is essential that other treatment options are considered, and there is a lack of head-to-head comparisons between them making positioning treatments challenging. To our knowledge this is the first network meta-analysis to help position all treatments for fistulising CD. Methods MEDLINE, EMBASE, EMBASE classic, the Cochrane central registry and Cochrane Specialised Trial Register were searched between 1978 and 2022 for randomised controlled trials (RCTs) reporting on treatments for fistulising CD. The primary outcomes were the efficacy of medical therapies at achieving fistula remission and maintenance of fistula closure. A network meta-analysis was performed using the frequentist model with pooled relative risks and P scores used to rank treatments, in accordance to PRISMA guidelines [Figure 1]. Results 964 studies were identified with the search criteria, with 28 RCTs after screening included for analysis with a total of 2,239 patients. At the 8 – 12 week end-point, none of the interventions were statistically significant, with tacrolimus ranked first at 4 times better than placebo (RR, 4.56; 95% CI, 0.76 – 27.30) at inducing remission of fistulas [Figure 2]. At the 16 – 24 week time point, infliximab produced the only statistically significant result with the 5mg/kg dose proving most effective (RR, 2.30; 95% CI, 1.40 – 3.77) [Figure 3]. At 44 weeks ustekinumab was found to be most superior with it being 2.38 times (RR, 2.38; 95% CI, 1.24 – 4.56) more superior to placebo, with adalimumab (RR, 2.06; 95% CI, 1.06 – 3.99) and infliximab 5mg/kg (RR, 1.68; 95% CI, 1.03 – 2.75) also producing a statistically significant result [Figure 4]. A limitation of this network meta-analysis is the significant heterogeneity between studies and variations in end-point definition, with certain small numbers in certain intervention groups limiting generalisability. Conclusion Despite infliximab being favoured in international guidelines for the treatment of perianal fistulising CD, other biologics such as ustekinumab and adalimumab may have a role. Future RCTs with standardised end-points are needed to further investigate biologics, especially ustekinumab and adalimumab, head-to-head against infliximab in the treatment of fistulising CD.
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Bokemeyer, B., N. Picker, T. Wilke, L. Rosin i H. Patel. "P377 Inadequate response with advanced therapies in real-world patients with Ulcerative Colitis – Results of a German claims database study". Journal of Crohn's and Colitis 15, Supplement_1 (1.05.2021): S392. http://dx.doi.org/10.1093/ecco-jcc/jjab076.501.
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Abstract Background Therapeutic management of Ulcerative Colitis (UC) is challenging, and clinicians are often obliged to attempt a variety of therapies in sequence until an adequate clinical response is achieved. However, real-world data regarding response rates in UC treatment are rare, particularly for later lines of therapy. Thus, this study aimed to investigate the incidence of inadequate response to advanced therapies in patients with UC. Methods This retrospective study was based on claims data from a regional German sickness fund covering the period from 01/2014-06/2019. Patients were included if they had at least two outpatient diagnoses in two different quarters or one inpatient diagnosis of UC (ICD-10: K51) and started a newly introduced advanced therapy (adalimumab, golimumab, infliximab, tofacitinib, vedolizumab) in 01/2015-06/2019. Patients were followed from treatment initiation (index date) until the end of the study period or loss to follow-up (median = 23.4 months). Proxies of inadequate response included: discontinuation (a supply gap of >60 days), switch, escalation (as dose increase exceeding 1.5 times the recommended maintenance dose), augmentation with 5-ASA, corticosteroid (CS) dependency (two CS prescriptions were observed starting more than 14 weeks after the index date), UC-related hospitalization, or UC-related surgery. CS dependency and treatment escalation were only assessed in the maintenance phase. Inadequate response in the analyzed sample was evaluated by means of Kaplan-Meier survival analysis. Results Among 574 UC patients (median age: 39 years; female: 53.5%), in whom an advanced therapy was initiated, 458 (79.8%) received an anti-TNF therapy, 113 (19.7%) vedolizumab and 3 (0.5%) tofacitinib. According to the available baseline period, 72 (12.4%) patients were identified as biologic-experienced. Most patients received CS (86.4%) and/or 5-aminosalicylic acids (81.7%) in the 12-month pre-index period. The median time to inadequate response to the initiated advanced therapy was 4.8 months (IQR: 2.6-11.9; Figure 1) with an inadequate response over 12 months in 75% (Figure 2). There was no significant difference in median time to inadequate response between biologic-naïve and biologic-experienced patients (4.9 vs. 4.7 months; p-value = 0.285). During the observable follow-up period, 172 (61%) patients switched from their index agent to another advanced therapy. Conclusion From the real-world settings in Germany, we found an inadequate response in UC-patients starting an advanced therapy in 75% of patients over 12 months. There is a need for more effective therapies among these patients.
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Karri, R., C. Grewal i N. Yassin. "P191 Robotic Surgery shows significant promise in delivering superior outcomes for patients with Inflammatory Bowel Disease". Journal of Crohn's and Colitis 17, Supplement_1 (30.01.2023): i345—i346. http://dx.doi.org/10.1093/ecco-jcc/jjac190.0321.
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Abstract Background Robotic surgery is a relatively novel surgical advancement in minimally invasive surgery for patients with Inflammatory Bowel Disease (IBD). The pathophysiology of the disease inherently makes these surgeries more complex with high complication rates. This study aimed to the evaluate the efficacy of robotic procedures for such patients and compare the short-term outcomes with laparoscopic surgery in patients with IBD. Methods A retrospective review was conducted of all patients who underwent robotic and laparoscopic surgery for IBD between November 2018 and April 2022 at a single institution. Demographics, peri-operative, intra-operative and post-operative data were analysed. Results 24 robotic cases were performed in the time period (75% Crohn’s) whilst 18 cases were performed laparoscopically (39% Crohn’s). Majority of the robotic patients had a Right Hemicolectomy (63%) with stoma formations in 38% of the procedures. 44% of the laparoscopic patients had a Total Colectomy and 39% had a Right Hemicolectomy with 78% of them having stomas. There was no significant difference in the patients age or BMI with a median age of 30 and BMI of 24.1 in the laparoscopic surgeries and a median age of 36 and BMI of 24.8 in the robotic group. The median operative time for the laparoscopic procedures was longer with 250 minutes versus 220 minutes in the robotic patients. The length of hospital stay for the patients was also greater for laparoscopic patients with a median of 9 compared to 6 days for robotic patients. 3 patients necessitated return to the ward within 30 days after laparoscopic surgery (17%) compared to only one robotic case (4%). However, 2 patients had a Clavin Dindo Grade 3 complication after robotic surgery compared to one in the laparoscopic set. In both sets of patients, one patient required surgery within 30 days: the robotic patient requiring laparotomy for adhesion-lysis and the laparoscopic patient for wound closure post wound dehiscence. Zero cases across all the patients necessitated conversion to open surgery and the mortality rate was 0%. Conclusion The results of this single centre study provide further support to studies demonstrating the feasibility and efficacy of robotic surgery in IBD patients. Patients operated robotically had a comparable safety profile with a similar complication rate whilst having whilst having shorter operating times and shorter length of hospital stay. Length of stay in hospital is a surrogate marker for early recovery post-surgery and carries significant benefit in the modern-day demand for hospital bed spaces. Therefore, robotic surgery offers a potentially superior alternative in minimally invasive surgery.
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Abreu, B., i G. Scott. "N43 The East Kent experience of switching from intravenous infliximab to subcutaneous, benefits to the patients, the service and financial implications". Journal of Crohn's and Colitis 18, Supplement_1 (1.01.2024): i2251. http://dx.doi.org/10.1093/ecco-jcc/jjad212.1415.
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Abstract Background This project started due to two main problematics, Medical Day Unit (MDU) capacity and costs savings. Infliximab is used to treat IBD, and is initially administered by infusion, arranged by MDU. Due to increased need of biologics, MDU capacity decreased and patients waited a minimum of 6 weeks for first treatment, which can cause flares and, consequently, need steroids or attendance to A&E. If patients were able to self-administer treatment, they would not need to attend MDU and those appointments could be used for new patients. Treatment costs savings have positive financial implications to the Trust. Another benefit is that patients have more independence and do not have to attend MDU for their infusions. Methods To organize this, we had regular meetings with our Homecare Pharmacy team so we could understand the implications to our service, Homecare availability for the increase of prescriptions and homecare company for stock requirements and availability of a nurse visit. Once all processes were clear, we visited MDU frequently for face-to-face discussion with patients at their appointment. During these conversations, we demonstrated what supplies the patient will receive and explained with demonstration pens. We noted that patients feel more reassured if they can be familiar with the injections and raise any concerns. During the days we could not attend MDU, we arranged letters for the patients, and had positive feedback as they contacted our helpline showing interest to switch. Another strategy is to discuss this process before starting treatment, so patients can have everything arranged while having their loading doses. Results Before organising this, we had 14 patients on infliximab subcutaneous injections. From April 2023 to 16/11/23 we have switched 58.4% of patients. Potential cost saving to the trust includes no VAT payment on homecare products, no nursing time cost, medical devices and disposable cost and MDU cost. From patient feedback it is shown that patients prefer subcutaneous injections as this reduces the time spent in MDU, cost of travel and better symptom control. This is work in progress and we will have further information on successes at the year end. Conclusion Our goal was to switch 40% of infliximab by the third quadrimester and have switched 58.4%. This is an ongoing process, patients are started on infliximab regularly so need to ensure they are aware of this option. This project has been very successful for both patients and the Trust. We only switched back 3 patients due to side effects and flares. We will continue with this initiative so we can promote patient independence, decrease waiting times for loading doses and to improve cost savings to the Trust.
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Georgieva, A. C., A. Atanassova i M. Mirchev. "P528 Response to biologic therapy in operated Crohn’s disease patients". Journal of Crohn's and Colitis 14, Supplement_1 (styczeń 2020): S454. http://dx.doi.org/10.1093/ecco-jcc/jjz203.656.
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Abstract Background About 70% of Crohn’s disease (CD) patients undergo surgery due to disease complication. According to the ECCO consensus, in such cases, the tumour necrosis factor-α (TNF-α) antagonists are a means of choice to prevent post-operative relapse. Methods The aim is to evaluate endoscopic, clinical and biochemical outcomes in CD patients, who have undergone surgery, in the course of the subsequent treatment with anti-TNFα mono/combination therapy—anti-TNFα + AZA. Among patients with CD who are undergoing biological treatment, we performed a retrospective analysis of the data of those who underwent surgical intervention associated with Crohn’s disease and subsequently started biological therapy. Results Of the 69 CD patients on biological therapy, surgical intervention was performed in 44.92% (n = 31) of cases prior to the initiation of the treatment. The prevalence of patients with right-sided hemicolectomy with subsequent ileotransverse anastomosis was 54.80%, followed by incision and abscess cavity drainage 22.6%, fistula excision 19.4% and left-sided hemicolectomy 3.2%. In 22 patients (71.0%) there was a clinical response (CDAI decline ≤ 100 points), with 66.66% of them achieving clinical remission (CDAI ≥ 150) (p = 0.001, strong correlation r = 0.596, p = 0.001). During the course of treatment, 23.80% lost clinical response after 18 months of treatment. We compared the mean value of the faecal calprotectin (FCP) before starting, and during the course of the biological treatment, we found that the FCP values decreased 1.5 times: 516.78 ± 273.93, (range 100 – 857)/330.46 ± 432.25, (range 5.32–1800). The activity of the disease measured by CDAI decreases twice during the course of the biological treatment: CDAI 378.00 ± 92.89 (range 258–695)/177.93 ± 116.38 (range 34–414) and CRP values decrease over four times: CRP 59.65 ± 64.52 (range 0.9–225)/13.14 ± 23.59 (range 0.13–116.10). During the course of the biological treatment, intestinal complications were observed in 33.33%, and 9.67% of the patients who had both progression and presence of intestinal complications had a subsequent surgery. In 33.33% of cases, the treatment was intensified. 16.70% of them had to switch to another biological drug. Perianal disease prior to biological treatment in operated patients is twice as common (x2 = 3.82, p = 0.050), which in turn appears to be a risk factor for surgical treatment (OR = 3.47 (0.953–12.685)). Conclusion In the follow up of the relationship between the occurrence of a clinical response and the onset of biological therapy, we found that the time interval was essential. The earlier the anti-TNFα therapy begins, the greater the likelihood of achieving a clinical and biochemical response (r = 0.326, p < 0.05).
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Hennlich, B., C. Madl i T. Pachofszky. "P345 Capsule endoscopy in the diagnostic process of suspected Crohn's Disease". Journal of Crohn's and Colitis 17, Supplement_1 (30.01.2023): i483. http://dx.doi.org/10.1093/ecco-jcc/jjac190.0475.
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Abstract Background Since more than 20 years, capsule endoscopy (CE) complements endoscopic and radiological examinations, to diagnose diseases of the small bowel (SB), for it allows the direct visualisation of the intestinal mucosa. Although nearly 30% of people suffering from Crohn’s Disease (CD) are affected by an inflammation solely in the SB, this minimally invasive approach is mostly used late in the diagnostic algorithm. Studies concerning indicators of quality of the CE system exist above all for the indication of obscure gastrointestinal bleeding (OGIB), therefore, the aim of this study is to analyse the detection, completion, and complication rate as well as visibility and passage times of the CE in a cohort with suspected CD. Additionally, the different CE models should be compared regarding these parameters and an assessment, which influence the intraobserver-variability exercises on the diagnostic accuracy should be conducted. Methods For this purpose, corresponding data out of written CE records from 430 patients in a tertiary hospital in the eastern part of Austria were retrospectively analysed. “Major Lesions” contained aphthoid, ulcerating and stenosing pathologies whereas “Minor Lesions” consisted of mucosal and villous abnormalities. In addition, the diagnose made after a follow-up period of six months was extracted from the individual medical records. Results 52,8% of the examinations were performed using the CapsoCam system, altogether there was a detection rate of 35,1%, the most frequent detected lesions being aphthoid abnormalities (76,8%). There was a completion rate of 95,4% and an average passage time of 266,94 ± 121,11 minutes. In 1,2% of the cases, a capsule retention occurred with a 1696 times higher chance in the presence of a stenosis. The visibility was rated “good” in 72,6% and the comparison between CapsoCam, PillCam, MiroCam and EndoCapsule showed, that only the completion rate has been associated with the choice of the CE model. After six months, CD has been diagnosed within 26,5% of the patients, resulting in a sensitivity of 70,2%, a specificity of 81,5% and a negative predictive value (NPW) of 84,2%. Conclusion Bearing in mind the increasing global incidence of CD and the association between an isolated inflammation in the SB with a poorer prognosis, CE can be highly contributing to an early diagnosis. The method is minimally invasive, patient-friendly, with a low complication rate due to a selective patient evaluation for the indication of suspected CD and the technology is constantly developing. The lack of standardized diagnostic criteria may be an important limitation, especially regarding the diagnostic accuracy, but special endoscopic indices are coming more and more into effect.
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Andres, M., A. Silvano, F. Straneo i D. R. Watts. "Icebergs and Sea Ice Detected with Inverted Echo Sounders". Journal of Atmospheric and Oceanic Technology 32, nr 5 (maj 2015): 1042–57. http://dx.doi.org/10.1175/jtech-d-14-00161.1.
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AbstractA 1-yr experiment using a pressure-sensor-equipped inverted echo sounder (PIES) was conducted in Sermilik Fjord in southeastern Greenland (66°N, 38°E) from August 2011 to September 2012. Based on these high-latitude data, the interpretation of PIESs’ acoustic travel-time records from regions that are periodically ice covered were refined. In addition, new methods using PIESs for detecting icebergs and sea ice and for estimating iceberg drafts and drift speeds were developed and tested. During winter months, the PIES in Sermilik Fjord logged about 300 iceberg detections and recorded a 2-week period in early March of land-fast ice cover over the instrument site, consistent with satellite synthetic aperture radar (SAR) imagery. The deepest icebergs in the fjord were found to have keel depths greater than approximately 350 m. Average and maximum iceberg speeds were approximately 0.2 and 0.5 m s−1, respectively. The maximum tidal range at the site was ±1.8 m and during neap tides the range was ±0.3 m, as shown by the PIES’s pressure record.
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Seeger, W. A., J. Thieringer, P. Esters, B. Allmendinger, H. Schulze i A. Dignass. "P363 Moderate endurance and muscle training are safe to perform for patients with quiescent or mild active Crohn’s disease and increases their strength". Journal of Crohn's and Colitis 14, Supplement_1 (styczeń 2020): S344—S345. http://dx.doi.org/10.1093/ecco-jcc/jjz203.492.
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Abstract Background The aim of this study was to examine the practicability and potential influence of moderate endurance and muscle training in patients with quiescent or mildly active Crohn’s disease (CD). Methods In this randomised controlled pilot trial 45 CD Patients with a CDAI below 220 were randomised to a control, an endurance or a muscle training group. Participants had to exercise individually for 3 months three times per week. Outcome parameters included disease activity (CDAI), inflammatory parameters and calprotectin, anthropometric data, general well-being (sIBDQ), physical activity (IPAQ), cardiorespiratory fitness as well as strength in the upper and lower extremities. Results Forty-five patients were randomised into an endurance (17), muscle (15) and control (13) group, respectively. In the endurance group, the dropout rate was 47% (8) vs. 13% (2) in the muscle group and 0 in the control group. Only one patient discontinued the study due to CD specific symptoms. One patient had to stop the study due to another concomitant disease. One patient in each intervention group was lost to follow-up. The most frequent reason for termination was lack of time and motivation: 37.5% (3) in the endurance group vs. 50% (1) in the muscle group. In both groups, the maximal and average force in the upper and lower extremity increased significantly (all p < 0.04). A statistically significant improvement of the quality of life could only be seen in the endurance group in the subclass ‘mood’ of the sIBDQ (p = 0.03). CDAI decreased in the muscle group in contrast to both other groups, statistical significance, however, was not reached. Conclusion This study shows that both endurance and muscle training can be safely performed in patients with mild-to-moderate CD. Muscle training seems to be more feasible for this patient group. Both forms of exercise have beneficial effects on strength and presumably on comorbidities, e.g. bone mineral density and thromboembolic complications. Further research in a larger population and also patients with higher disease activity is needed to examine the effects of moderate exercise on disease activity and immunological changes in CD patients.
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Carlson, S., S. McCartney i P. Harrow. "P356 A comparison of innovative strategies to promote engagement with an IBD patient portal". Journal of Crohn's and Colitis 15, Supplement_1 (1.05.2021): S376—S377. http://dx.doi.org/10.1093/ecco-jcc/jjab076.480.
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Abstract Background Patient portals are available on most major electronic health record (EHR) platforms and present many opportunities to improve patient engagement with services, the quality of data captured and therefore healthcare outcomes and patient satisfaction. Our centre looks after 5100 patients with IBD. We recently adopted the EPIC Systems patient portal MyChart which allows patients to view results, letters and complete patient reported outcomes (PRO). At baseline, few patients were registered for this platform. Our aim was to compare patient engagement with MyChart using a low and higher cost approach and to evaluate patient satisfaction with the platform. Methods 160 consecutive patients were invited to join MyChart between September and October 2020. The low-intensity intervention group were invited to join MyChart via a standardised email without further communication. Newly registered patients and active patients were sent a portal message with disease-specific PRO questionnaire 7 days prior to clinic (HBI, SCCAI and IBD Control). Patients in the high-intensity intervention group received a telephone reminder to encourage completion at each step, which took on average 2 minutes, in addition to email. Engagement with the platform was measured prospectively. After clinic a patient-experience questionnaire was sent to all patients who signed up to the platform. Results 72 patients were included in the low intensity group and 88 in the high intensity group. At baseline only 33% patients were already signed up to MyChart. Significantly more patients newly registered with the patient portal following the high intensity intervention compared to the low (75% vs. 30%, p <0.0001). Overall, patients in the high intensity group were significantly more likely to complete the PRO compared to the low (53% vs. 28%, p=0.002). Patients already registered were 5 times more likely to complete the PRO in the high intensity group compared to low (p=0.017). Platform engagement was not significantly impacted by gender or ethnicity. There was a trend toward lower engagement in patients over 65. 63 patients provided feedback. 87% found MyChart easy to use and 94% said they would complete the PRO questionnaires again. Conclusion In our patient cohort, a higher intensity strategy significantly increased patient registration and engagement with a new patient portal at a minimal cost of time and resource. Healthcare providers can facilitate patient engagement with patient portals and overcome barriers to adoption to unlock transformative opportunities for better quality IBD care, disease monitoring and population-based research.
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Mustonen, A., S. Asikainen, L. L. Hermansson i A. Jussila. "P161 Implementation of Outcome Measurement – Case Finnish IBD register". Journal of Crohn's and Colitis 16, Supplement_1 (1.01.2022): i235—i236. http://dx.doi.org/10.1093/ecco-jcc/jjab232.289.
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Abstract Background Inflammatory bowel diseases (IBD) are becoming increasingly common. In Finland, during 2020, in total of 54 000 patients were diagnosed with IBD, and over 2000 new diagnoses are made every year. The Finnish university hospitals in collaboration with BCB Medical Ltd have built disease-specific registers to support and monitor the quality and effectiveness of health care. The IBD register (IBDR) collects data on the effectiveness of IBD treatments and their follow-up, where e.g. disease severity, treatment and outcomes are profoundly monitored. As combination, IBDR, MyHealth service, and IBD Symptom Diary enables patients’ health, functional status, experience and QoL monitoring to reach the health care goals. The service supports patient treatment pathway and makes designing more personalized treatments for IBD possible. Methods The IBDR is a web-based system integrated with electronic health record (EHR) systems, through which patient data is captured. Nationally convergent register allows for peer review of treatment outcomes. To complement registers’ clinical data, PROMs are collected with online MyHealth service to enable automatic, recurring data collection directly from the patient. The first questionnaire is activated 14 days before the visit, whereas new questionnaire is sent to the patient two months after visit, and then at time points according to the disease activity index calculated from the questionnaire. The disease activity is reflecting the severity of the IBD symptoms[1]. Captured measures are immediately available for clinician review. Results MyHealth for IBD is actively used in four Finnish university hospitals and two central hospitals with some inter-regional variation. By November 2021, the questionnaires were answered 31 506 times since the beginning of the implementation in 2019. The response rate is yearly increasing (Figure 1). Distribution of disease activity index among IBD patients in Tampere University Hospital is shown in Figure 2. Conclusion IBDR enables the evaluation and comparison of patient care quality, which is not accessible through EHR systems alone. Our electronic data collection model brings out the patients’ voice and saves resources since cyclic questionnaires are automatically send to patients, and answers are immediately reached by clinician. In future, international comparison and monitoring of treatment outcomes will be emphasized. As MyHealth deployment proceeds across hospitals, the availability of the patient reported outcomes data will increase. International research and peer development will continue to be an essential part of our activities. Reference 1. Puolanne A-M et al. Dig Dis Sci (2017) 62:3123–3130.
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Marshall Mr, J., G. Rowse, S. Hollobone, S. Afhim i P. Oliver. "P105 Coping in Inflammatory Bowel Disease: insights from the Crohn’s and Colitis UK national survey". Journal of Crohn's and Colitis 15, Supplement_1 (1.05.2021): S199—S200. http://dx.doi.org/10.1093/ecco-jcc/jjab076.233.
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Abstract Background Inflammatory bowel disease (IBD) is a chronic condition that adversely affects quality of life (QoL) and well-being. Factors associated with coping in IBD include disease activity, the presence of arthropathy and illness perceptions such as personal control. The evidence in this field is, however, limited by small sample sizes. The aim of this study was to use data from a national survey to identify factors associated with coping in a large sample of IBD patients. Identification of factors associated with coping may help inform the development of targeted interventions to improve psychological well-being. Methods A national postal and online survey was conducted by the charity Crohn’s & Colitis UK of its members in 2018. Participants were asked to complete a questionnaire which was co-produced by the charity and University of Sheffield, following focus groups of key stakeholders. The survey collected demographic and disease-related information as well as Likert item responses to questions relating to well-being, including coping. The response rate was 22.2%. To examine factors associated with coping, ordinal regression analysis was performed. Results are presented as adjusted odds ratios (ORs). Results 8012 respondents were included in the analyses. The mean age of respondents was 45 years (SD =16 years) with 69% being female. The majority of respondents had a diagnosis of Crohn’s disease (78%) with 53% of participants self-reporting that they were in remission at the time of the survey. In multivariable analyses, the adjusted odds of females reporting difficulty in coping was 1.6 times higher than that for males (95% CI 1.43–1.79). The odds of those with active disease reporting more difficulty in coping were approximately twice that of those in remission (95% CI 2.38–2.93). Several well-being factors were found to be associated with coping, even after adjusting for personal and disease related characteristics (such as severity of symptoms and disease activity). Participants who had reported less understanding and felt they had less control of their IBD, had higher odds of difficulty in coping with their disease (95% CI 0.76–0.85 & 0.64–0.72 respectively). Participants who experienced disease-related stigma were also more likely to have difficulty in coping (95% CI for 1.99–2.26). Conclusion In this large survey of IBD patients, coping was associated with gender, disease characteristics and a number of psychological factors, which may be amenable to intervention to improve the QoL and well-being of patients with IBD. Efforts are required to improve public awareness of the impact of IBD in order to reduce stigma. Further research is required to understand these relationships and constructs through the use of validated measures.
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Van Erp, L. W., M. J. M. Groenen, W. Heida, J. Wisse, B. Roosenboom i P. J. Wahab. "P392 A mobile application to monitor Inflammatory Bowel Disease patients during intravenous biologic treatment: Results of a feasibility study". Journal of Crohn's and Colitis 15, Supplement_1 (1.05.2021): S402—S403. http://dx.doi.org/10.1093/ecco-jcc/jjab076.516.
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Abstract Background Active monitoring of IBD patients during intravenous (iv) biologic treatment is recommended but time-consuming and inconvenient for both patients and nurses. We developed a mobile application to promote self-management and monitor IBD patients cost-effectively during iv biologic treatment. We aimed to study the feasibility of the mobile application. Methods A prospective cohort study was performed in a secondary care centre with adult IBD patients treated with infliximab (iv) or vedolizumab (iv) for at least three months. The mobile application was used during four rounds of iv biologic treatment (figure 1). The application includes information modules and a personal interactive timeline with messages one week prior to iv biologic treatment (figure 1). Patients are asked to fill in a health check prior to each treatment to screen for contra-indications, such as respiratory infections or severe side-effects. Patients can also note any particularities or request contact with the IBD nurse. Blood tests are performed before every other infusion. Previously, patients were contacted by telephone prior to each biologic treatment by the IBD nurse. Using the application, patients are only personally contacted in case of abnormalities or upon request. Results Of 55 included patients, 52 patients completed the study. Mean age was 42 years (min 19 – max 68), 71% had Crohn’s disease, 76% had clinically quiescent disease, 85% used infliximab and 15% vedolizumab. Most patients used internet for over three years (98%) and their smartphone or tablet every day (98%). Compliance to health checks and blood tests was 67% during the 1st round of biologic treatment and 70%, 87% and 80% during the 2nd, 3rd and 4th round respectively. Patients used the application between median 6 (IQR 5 – 9) and 8 (IQR 5 – 11) times per round of biologic treatment. Patient satisfaction with the application was median 8 (VAS score, IQR 7 – 9). Prior to the 1st round of biologic treatment, all patients (100%) were contacted by telephone as in previous standard care. Using the application the number of patients requiring telephone contact decreased to 47%, 35% and 49% before the 2nd, 3rd and 4th round respectively. Patients remained equally satisfied with IBD care: median VAS score 8 (IQR 8 – 9) before and after implementation of the mobile application. The majority of patients (92%) wanted to continue using the application after the study ended. Figure 1: Study procedures Conclusion Monitoring of IBD patients treated with biologics using a mobile application is feasible. We saw a high compliance and satisfaction of patients, and reduction of health-care utilization. Almost all patients preferred using the application over previous standard care.
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Malhi, G., J. Chambers, G. Minhas, M. Mikail, R. Khanna i A. Wilson. "P620 Pivoting in a pandemic: The impact of COVID-19 on the provision of care for patients with Inflammatory Bowel Disease – A retrospective study". Journal of Crohn's and Colitis 15, Supplement_1 (1.05.2021): S560—S561. http://dx.doi.org/10.1093/ecco-jcc/jjab076.740.
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Abstract Background The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) outbreak, also known as COVID-19, initially began in a small cluster of patients in Wuhan, China and was declared a worldwide pandemic in March of 2020. Since the onset of the pandemic, the focus of many healthcare systems has shifted toward limiting non-essential visits to the hospital in order to prioritize and allocate resources toward treating those affected by COVID-19. While the effect of COVID-19 has been felt amongst many patient populations, those with Inflammatory Bowel Disease (IBD) have been particularly impacted. We aimed to determine how changes to the provision of IBD care due to the COVID-19 pandemic has affected IBD patients. Methods A retrospective cohort study was carried out in patients with an IBD diagnosis comparing patients admitted to two tertiary care centres affiliated with Western University in London, Canada between March 17 and August 31 2019 (2019 cohort or pre-pandemic), to patients admitted between March 17 and August 31 2020 (2020 cohort or pandemic). Patients were reviewed to assess any differences in care utilization and IBD-related outcomes such as hospitalization, need for surgery, length of stay in hospital and in-patient drug therapy during the defined time periods. Results A total of 863 patients were reviewed in 2019, and 554 in 2020. Of those, 184 (CD, n= 125; UC, n= 59) and 172 (CD, n= 109; UC, n= 62) encounters met the inclusion criteria for 2019 and 2020 respectively. Patient demographics were similar between 2019 and 2020 cohort with the exception of age (2019, mean age = 44.76 years ± 16.78; 2020, mean age=50.36 years ± 17.82, p=0.002). The length of stay in hospital was shorter in 2020 (6.88 days vs 9.63, p=0.045). Significantly fewer patients were initiated on Infliximab in hospital in 2020 (2020, 3.50 per month; 2019, 6.83 per month, p=0.001). Fewer in-patient surgeries were performed in 2020 (2019, 76; 2020, 57; p=0.112). Conclusion Preliminary data demonstrate during the COVID-19 pandemic there was a significant reduction in the length of stay for patients with IBD as well as fewer patients initiated on infliximab while in hospital. There was also a decrease in the number of surgeries performed in 2020. These differences may reflect an effort to minimize contact between patients and health care facilities as well as reduce the introduction of further immunosuppression. Further research will be to determine whether if more ER visits became hospitalizations and any delays in appointment times or endoscopies, or compliance issues with medications may have led to these aforementioned outcomes.
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Bjørlykke, K., J. Jahnsen, J. Brynskov, P. Molander, M. Eberhardson, L. G. Davidsdottir, T. Sipponen i in. "P467 Therapeutic drug monitoring of biologics in Inflammatory Bowel Disease: Nordic survey on implementation and barriers in clinical practice". Journal of Crohn's and Colitis 16, Supplement_1 (1.01.2022): i441. http://dx.doi.org/10.1093/ecco-jcc/jjab232.594.
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Abstract Background Therapeutic drug monitoring (TDM) is a useful tool to optimise biologic treatments of patients with inflammatory bowel disease (IBD). Albeit broadly recommended by gastrointestinal societies, it is, however, currently unknown how TDM has been adopted and is being used in everyday clinical practice. The aim of the study was to investigate how TDM has been taken up by physicians including barriers for implementation. Methods A web-based survey on TDM was distributed to all gastroenterology consultants in the Nordic countries via national gastroenterology- and IBD societies. Results Out of 377 physicians responding, 297 handled IBD patients on biologic therapies and were thus eligible for inclusion (NO 118 (40%), DK 86 (29%), SE 50 (17%), FI 33 (11%), IS 10 (3%)). The vast majority were consultant gastroenterologists (n=252, 85%), 152 (51%) were employed at university hospitals, 136 (46%) at community hospitals, and 9 (3%) in private practice. Overall, 257 (87%) used TDM during biologic therapies; 231 (90%) used reactive TDM and 163 (63%) proactive TDM. Common indications were to improve efficacy (70%), aid treatment decisions (62%), improve safety (36%), and improve cost-effectiveness (32%). Notably, Danish physicians used TDM to a significantly lesser extent than all others (58% vs 98%; odds ratio (OR) 0.03 [95%CI 0.01- 0.09], p<0.001); in particular outside the capital region (OR 0.15 [0.05–0.46], p=0.001). Reactive TDM was applied both at primary (74%) and secondary treatment failure (99%) and predominantly for TNF-inhibitors (90–98%) (vedolizumab 63%, ustekinumab 46%). Proactive TDM was used by 80% during maintenance therapy and 56% during induction, and mostly for TNF-inhibitors (79–97%) (vedolizumab 70%, ustekinumab 54%). Proactive TDM was more commonly used in NO, SE, and FI (p<0.001), and by physicians managing >10 IBD patients per week (OR 2.71 [1.34–5.48], p=0.005), but was not associated with employment at university hospital, size of hospital catchment area, or seniority. Main barriers to the use of TDM were lack of guidelines (51%), long response time from the laboratory (49%), lack of knowledge regarding how to use and interpret test results (42%), costs (38%), and currently available evidence (31%). Among physicians using TDM, only 66% reported awareness of TDM guidelines or recommendations. Conclusion TDM, and in particular reactive TDM of TNF-inhibitors, has been broadly adopted into clinical practice in the Nordic countries to improve efficacy and assist treatment decisions. Across the Nordic countries, IBD physicians call for improved test response times and, notably, TDM guidelines detailing indications for TDM and interpretation of test results.
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Laterza, L., L. Boldrini, H. E. Tran, C. Votta, L. Larosa, L. M. Minordi, F. Scaldaferri, A. Papa, A. Armuzzi i A. Gasbarrini. "P359 Radiomics could predict surgery at, 10 years in Crohn’s disease". Journal of Crohn's and Colitis 16, Supplement_1 (1.01.2022): i367—i368. http://dx.doi.org/10.1093/ecco-jcc/jjab232.486.
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Abstract Background Predicting clinical outcomes and defining the best time for elective surgery represents a major challenge in managing Crohn’s disease (CD) patients. Radiomics provides a method to extract quantitative features from medical images and may successfully predict clinical course. Although radiomics has been successfully used in oncology, its application in inflammatory bowel disease is still scarce. The aim of this pilot study is to evaluate the use of radiomics to predict the need for surgery in a cohort of CD patients with a long-term follow-up. Methods We retrospectively selected a cohort of, 30 CD patients undergone one or more CT scan enterographies between, 2009 and, 2011 for a total of, 44 CT scans. For each CT scan, typical lesions of CD were searched by an expert radiologist generating a region of interest (ROI) segmentation for each lesion., 93 lesions were lastly obtained for radiomic analysis., 217 radiomic features were extracted from each ROI using a dedicated institutional R library (Moddicom) validated within the Image Biomarker Standardization Initiative. Patients’ charts were reviewed to assess if patients underwent surgery in a, 10-year follow-up for a binary classification. The feature selection process included a univariate analysis with the Wilcoxon-Mann-Whitney test, the application of Boruta algorithm and the exclusion of highly correlated features. A logistic regression model was built with the selected features and evaluated by computing the area under the curve (AUC) of the receiver operating characteristic (ROC) curve. Accuracy, sensitivity, specificity, positive and negative predictive values (PPV, NPV) of the model were calculated using the best cut-off according to the Youden index method. A 3-fold cross-validation repeated, 5 times was used for internal validation. Results Two radiomic features were obtained from the feature selection process and resulted statistically significant in the fitted logistic regression model (p <, 0.0001) in predicting surgery: grey level histogram variance and grey level non-uniformity. This model presented an AUC (95% CI) of, 0.83 (0.73-0-91) in predicting surgery, confirmed by the cross-validation. Mean (standard deviation) values of the model performance metrics over the cross-validation iterations were: accuracy, 0.78 (0.02), sensitivity, 0.68 (0.14), specificity, 0.86 (0.07), PPV, 0.72 (0.12), NPV, 0.83 (0.09). Conclusion Radiomics could be a helpful tool to identify patients with high risk for surgery and needing a stricter monitoring or therapy intensification. Further studies are required to understand the possible corresponding histopathological features and to obtain larger and external validations of this model.
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Britschu, O., A. Meyer, J. E. Gottenberg, J. M. Reimund i B. Caron. "P559 Effect of vedolizumab and ustekinumab on articular manifestations in patients with inflammatory bowel disease refractory or intolerant to anti-TNF therapy: An observational prospective study". Journal of Crohn's and Colitis 14, Supplement_1 (styczeń 2020): S472—S473. http://dx.doi.org/10.1093/ecco-jcc/jjz203.687.
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Abstract Background The effectiveness of vedolizumab (VDZ), a monoclonal antibody targeting the α4β7 integrin, and ustekinumab (UST), an anti-interleukin-12/anti-interleukin-23 antibody, for the treatment of patients with inflammatory bowel disease (IBD) has been demonstrated. Nearly 50% of patients with IBD have extraintestinal manifestation(s) (EIM). The most frequent are rheumatologic. In contrast to the data available for infliximab (IFX), only retrospective or small studies with contradictory results have been published regarding the effect of VDZ or UST on IBD-associated articular manifestations. The aim of our study was to evaluate the effect of VDZ and UST used in the treatment of Crohn’s disease or ulcerative colitis on associated articular manifestations, compared with patients receiving IFX. Methods We conducted a single-centre observational prospective study. All consecutive patients diagnosed with IBD and treated with IFX, VDZ or UST were included and classified into two groups: group 1, not presenting articular manifestations at the baseline, and group 2, having articular manifestations at the inclusion. We evaluated the occurrence of articular manifestations assessed by the BASDAI score in group 1 and the evolution of articular manifestations according to the BASDAI score in group 2. EIM activity was assessed at months 0, 3, 6, 9 and 12. Improvement or worsening of joint manifestations was considered significant if the BASDAI decreased or increased by 10 mm or 20 % in relative value between its initial value and its last available value (M12 or earlier for patients with shorter follow-up times). Results From September 2017 to April 2019, 54 patients were included. Twenty-nine patients were analysed in group 1: 9 treated with IFX, 8 with VDZ and 12 with UST. During the follow-up period, 12 (41.4 %) patients in group 1 without EIM at baseline developed articular manifestations: 44.4 %, 50 % and 33.3 % respectively under IFX, VDZ and UST. The mean time from treatment initiation to the development of articular symptoms was 3.3, 3.8 and 2.6 months, respectively on IFX, VDZ and UST. Twenty-five patients were analysed in group 2, 6 treated with IFX, 7 with VDZ and 12 with UST. A significant improvement of the BASDAI score was observed in 50 % of patients treated with IFX, 71.4 % with VDZ and 41.7 % with UST. BASDAI scores were 31.2, 51.8 and 27.9 at M0 and 31.0, 44.7 and 27.5 on average over the entire follow-up for the following treatments respectively: IFX, VDZ and UST. Conclusion This prospective study suggests a potential beneficial effect of VDZ and UST on articular manifestations associated with IBD compared with IFX. However, these results need to be confirmed by larger prospective trials.
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Van Linschoten, R., N. van Leeuwen, J. A. Hazelzet, C. J. van der Woude, D. van Noord i R. L. West. "OP25 Prevalence of IBD in the Netherlands: development and validation of machine learning models for administrative data". Journal of Crohn's and Colitis 17, Supplement_1 (30.01.2023): i34—i35. http://dx.doi.org/10.1093/ecco-jcc/jjac190.0025.
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Abstract Background Treatment of IBD has improved with the introduction of biologics and small molecules, yet this has come with a considerable increase in healthcare costs. Due to the increasing cost burden, reliable nationwide epidemiological data on the prevalence of IBD is necessary to inform health policy makers, especially as the prevalence of IBD is forecasted to double between 2010 and 2030. We aimed to develop a model for identifying prevalent IBD cases in administrative data and to determine prevalence of IBD in the Netherlands. Methods Data on hospital care came from the Dutch National Hospital Care Basic Registration (Landelijke Basisregistratie Ziekenhuiszorg). This database contains data on all hospital admissions (since 1991), outpatient clinic visits (since 2017), and dispensations of biologics and small molecules (since 2015) of all hospitals in the Netherlands. Data on pathology reports were retrieved from the nationwide network and registry of histo- and cytopathology in the Netherlands (PALGA), this database contains coded pathology reports of all Dutch hospitals since 1991. These datasets were combined with a reference cohort with a verified IBD diagnosis (yes/no) and demographics for all patients. Models were trained to optimise the F-score and evaluated using five-times repeated ten-fold cross-validation. The best performing model from cross-validation was applied to assess IBD prevalence in the Netherlands. Results The reference cohort consisted of 10,155 patients, of which 3,381 were diagnosed with IBD. All models performed well in the cross-validation procedure, with F-scores of 0.870 and higher. The use of more flexible models led to improved performance, with gradient boosted trees performing best in the cross-validation procedure (Table 1). When applying the gradient boosted trees model to the general population, a prevalence of 691 per 100,000 was found for IBD in the Netherlands on 31-12-2020. Cases are unevenly distributed throughout the Netherlands (Figure 1), with the highest incidence in the south (Middle Limburg: 936 per 100,000 inhabitants) and the lowest in the northwest (Amsterdam: 545). Conclusion Prevalent IBD cases can be identified from administrative data using a gradient boosted trees model. Using this model, we have shown that prevalence of IBD in the Netherlands is increasing. However, while prior studies have predicted a growth in prevalence of 50% over the last 10 years, we found that IBD prevalence has only increased by 12% in that time range. The lower increase in prevalence may be predictive of a transition to the fourth epidemiological stage of IBD, aptly named Prevalence Equilibrium.
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Radia, C., R. George, S. Campbell, S. Abdel-Aziz, S. Plewa, S. Ratcliff, T. Blake i in. "P629 JAK inhibitor safety in Inflammatory Bowel Disease: real-world data comparing the effect of JAK inhibitors on blood parameters and their clinical significance". Journal of Crohn's and Colitis 18, Supplement_1 (1.01.2024): i1208—i1209. http://dx.doi.org/10.1093/ecco-jcc/jjad212.0759.
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Abstract Background Janus kinase inhibitors (JAKi) licensed for the treatment of inflammatory bowel disease (IBD) now include tofacitinib, upadacitinib and filgotinib. JAKi are known to cause abnormalities in a multitude of blood tests. However, whether there are differences in their effects in a ‘real-world’ setting is not known. Methods Blood test results for 118 patients treated with a JAKi were collected. A total of 13 parameters known to be affected were included. Percentage change at 12 and 24 weeks from baseline was calculated and compared amongst the different JAKi. The difference between the proportion of patients with abnormal results at each time-point was also reviewed. Results The JAKi breakdown included: tofacitinib-64, upadacitinib-35, filgotinib-18. JAKi treatment was associated with a significant rise in cholesterol, bilirubin, ALP and AST at 12 and 24 weeks (table 1), while rises in triglyceride and LDL cholesterol, and haemoglobin reduction were only apparent at 24 weeks. Other parameters showed transient or non-significant changes. Individual analysis of each parameter highlighted only two significant differences amongst JAKi: upadacitinib significantly reduced WCC (p=0.048) and neutrophil count (p=0.044) within the group at 24 weeks, and when directly compared to tofacitinib (p=0.047). However, no patients were neutropenic at 24 weeks and only 5 patients had a low WCC (upadacitinib: 3, tofacitinib: 2, filgotinib: 1). As per Common Terminology Criteria for Adverse Events (CTCAE), adverse events (AEs) in these parameters were low despite the significant percentage change in multiple variables. 1 patient (1.1%) was found to be anaemic (Hb <80g/L, at 12 weeks which resolved at 24 weeks), 1 (1.4%) was noted to be lymphopenic (lymphocyte count <0.5x109/L, at 24 weeks), and 1 (limited data) with CK >5 times upper limit of normal. No patients had a significant hepatic disorder as per CTCAE, though mild liver function changes above the upper limit of normal were seen in 9% of patients. On comparing the proportion of patients with abnormal results at 12 and 24 weeks to baseline, it was only cholesterol (p=0.027) and HDL-cholesterol (p=0.041) that had a significantly higher proportion of patients within the abnormal range at 12 weeks. This did not persist at 24 weeks (p=0.13 and p=0.37 respectively). Two patients were commenced on a statin during JAKi therapy. No abnormalities in these blood parameters caused drug withdrawal. Conclusion In this cohort the majority of changes in blood test parameters were transient and/or mild with no AE-related drug withdrawals during JAKi therapy. No clinically significant differences have been appreciated amongst the three JAKi.
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Bai, X., Z. Runing i Y. Hong. "P155 Evaluation the role of interleukin-22 in inflammation related intestinal fibrosis: its potential influence on gut microbiota or immune system". Journal of Crohn's and Colitis 18, Supplement_1 (1.01.2024): i460. http://dx.doi.org/10.1093/ecco-jcc/jjad212.0285.
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Abstract Background The role of interleukin-22 (IL-22) in inflammation-related intestinal fibrosis remains largely unknown. Previous studies considered it as a double-edged sword between anti-inflammation and fibro-genesis in a tissue-specific manner. Therefore, we aimed to investigate the role of IL-22 in colonic fibrosis formation under inflammation. Methods Paraffin-embedded specimens of the colon from patients with CD undergoing surgery were obtained for Masson staining and IL-22 immunohistochemistry. In vivo, male C57B6/J mice aged 8 weeks were divided into the DSS group, DSS+IL-22 group, and control group. The two DSS groups were fed with 2% DSS for 7 days and distilled water for 14 days, repeating three times. Mice were given rIL-22 (200 ng/mouse) or phosphate-buffered saline intraperitoneally at 0, 2, 4, and 6 days after DSS administration. Colonic bacterial 16S rRNA gene sequencing assay and RNA sequencing of colon tissue were performed. In vitro, the DLD-1 cells were stimulated by LPS and treated with different gradients of rIL-22 before the scratch wound-healing migration assay. Results A positive correlation between IL-22 expression and Masson staining area was observed in the surgical specimen from CD patients (R2=0.7473) and IL-22 expression was higher in CD patients with intestinal stricture. In animal experiments, the colonic fibrosis model was successfully created and confirmed by Masson’s staining. Notably, the DSS+IL-22 group exhibited a slightly shortened colon length, greater weight reduction, and higher histopathology score than the DSS group at sacrifice. The injection of rIL-22 restored colonic microbiota abundance, notably by reducing Clostridium-sensu-stricto-1 and increasing Lachnospiraceae_NK4A136 and Turicibacter. A total of 278 genes were differentially expressed in the DSS+rIL-22 vs DSS group. We figured out that the 48 upregulated genes were mainly enriched in extracellular function, muscle contraction, and biosynthesis. The 230 downregulated genes were mainly enriched in immune response and pathway response to pathogens. The further immunoinfiltration analysis showed increased aggregation of marginal zone B cells but less infiltrated innate lymphoid cell group 1, natural killer T cell, and effector memory T cell after DSS treatment. In vitro, with longer stimulation time, the higher dose of rIL-22 induced a greater percentage of wound healing under LPS-induced inflammation. Conclusion We primarily revealed the potential positive correlation between IL-22 and colonic fibrosis from several aspects. The underlying mechanisms may be related to the influence on microbiota abundance classical pro-inflammatory pathways like TNF pathway and NLR pathway, immune cells or pericytes.
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Yokoo, T., S. Yoshikawa, M. Tsutomu, S. Terauchi, H. Uchida, T. Nakao, K. Yamaoka i in. "P753 Early perianal abscess recurrence in patients with perianal Crohn's disease on biologic therapy predicts long-term permanent fecal diversion". Journal of Crohn's and Colitis 18, Supplement_1 (1.01.2024): i1406—i1407. http://dx.doi.org/10.1093/ecco-jcc/jjad212.0883.
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Abstract Background Generally, it’s difficult to estimate the efficacy of biologics (Bio) for perianal lesions of Crohn’s disease (CD) and lack of evidence. Sometimes, we experience the recurrence of perianal abscess and need to perform re-drainage even after starting 1st Bio. When the 1st bio fails, choosing an accurate 2nd Bio is difficult. The most severe result of this situation is rectal amputation. We wonder if any relationships between recurrence timing and long-term outcomes exist. We reviewed and aimed to know our institute’s perianal CD (pCD) treatment. Methods We retrospectively investigated patients' medical charts with pCD from 1988 to 2022 at Kenseikai Nara Coloproctology Center. We excluded the patients without using Bio or starting Bio after rectal amputation. The cases with missing values are excluded, too. We defined "early" as within two years and compared two cohorts, the early recurrence group (ER) and the no or late recurrence group (non-ER). We use the Kaplan-Meier method for calculating the time to fecal diversion. Results Eighty patients were recruited. The mean current age is 37.5 years old, and the onset of CD is 22.6 years old. The Perianal lesion’s onset is 24.5 years old. The male is 66, and 19 smokers are included. In this part, perianal lesion means only perianal abscess and fistula. Montreal Classification is shown in TABLE1. The Median follow-up duration was 142.5 months. We performed perianal surveillance (PS) for these patients, including EUA, Abscess Drainage, and seton placement, 3.1 times for each person. After the surgical interventions, we treat them with four Bio. After starting Bio, we experienced 33 early recurrences. We observed eight transient stoma creations, nine rectal amputations, and one anorectal cancer. Among them, we calculate the relationships between early recurrence and rectal amputation and find that early recurrence is a risk factor for permanent fecal diversion (HR 6.84 95%CI 1.48-31.7, p=0.0047 FIGURE1). We needed to switch the Bio for 31 patients during the observational period. To know which way of switching is effective for pCD, we calculate the relationships between the practice of switching and any treatment failure. Same class switching and changing MOA are not different for any treatment failure, which means re-abscess drainage and creation of any stoma (HR 0.40 95%CI 0.10-1.57 p=0.19). Conclusion Perianal abscess recurrence as we need to re-incision and drainage within two years after starting Bio treatment are related to permanent fecal diversion. We must pay attention to such kinds of patients, but the types of Bio we change didn’t affect any treatment failure. Further studies are needed in this field.
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Swadener, Beth Blue, Lacey Peters, Dana Frantz Bentley, Xiomara Diaz i Marianne Bloch. "Child care and COVID: Precarious communities in distanced times". Global Studies of Childhood 10, nr 4 (18.11.2020): 313–26. http://dx.doi.org/10.1177/2043610620970552.
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Drawing from an analysis of responses to COVID affecting the ECCE sector in the US, including the narratives of early childhood educators, we engage with several questions. These include: How is care work with children constructed and affected by COVID-19? How might current responses and policies be understood through the lens of social citizenship and the collective/the individual? How do these issues reflect the precarity of the ECCE sector? How are embodied and emotional aspects of care work manifesting in early educator/caregiver lives in the time of the pandemic? Who is caring for the caregivers and what care may be needed? How can we re-imagine the care of ourselves, and in relation to an ethics of care for the other?
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Martínez Ibeas, M. A., I. Bacelo Ruano, S. Rodríguez Manchón, M. Velasco Rodríguez-Belvís, J. F. Viada Bris, G. Domínguez Ortega i R. A. Muñoz Codoceo. "P709 Is azathioprine safe as long-term treatment in paediatric patients with inflammatory bowel disease?" Journal of Crohn's and Colitis 14, Supplement_1 (styczeń 2020): S573. http://dx.doi.org/10.1093/ecco-jcc/jjz203.837.
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Abstract Background The toxicity of azathioprine (AZA) includes myelosuppression, infections, pancreatitis, photosensitivity, and hepatotoxicity. The aim of this study was to describe the adverse effects profile of azathioprine as long-term treatment in paediatric inflammatory bowel disease (IBD). Methods An observational, descriptive and retrospective study was performed in the paediatric IBD Unit of a tertiary care hospital from September 2008 to December 2018. It was included patients under 18 diagnosed with IBD who were treated with AZA during their follow-up. We recorded epidemiological data, thiopurine methyltransferase (TPMT) enzyme activity, AZA side effects, and the dosage the patients were receiving when these effects took place. Bone marrow suppression (BMS) was defined as leukopenia, thrombocytopenia and/or anaemia. Acute pancreatitis (AP) induced by azathioprine was considered when two of these criteria (Atlanta 2012) were met: lipase increase (> 3 times normal value), congruent signs and symptoms and/or echographic findings, without other possible aetiology and with complete recovery after AZA withdrawal. Results We included 52 patients, being 31 men (59.6%). They were diagnosed with Crohn′s disease (CD) (73%), ulcerative colitis (UC) (21%) and IBD-unclassified (6%). The median TPMT activity was 17 U/ml (14.2–19.2). Up to 63.5% developed adverse effects by AZA with a median time from the beginning of treatment of 11.4 months (2.6–26.4) and a median dosage of 2 mg/kg/day (1.7–2.3). The most frequent side effect was BMS (52%). These patients had a median TPMT activity of 16.9 U/ml (14.2–18.9), the median duration of treatment was 14 months (3.9–27.7), and the median dosage was 2 mg/kg/d (1.8–2.5). BMS was more frequent in patients with UC (p 0.04) and longer treatment (p 0.08). No differences were found according to age, sex or TPMT activity. Up to 11.5% developed AP, the median duration of treatment until its appearance was 1.5 months (0.7–43.3) and the median dosage was 2 mg/kg/d (1.5–2.5). No differences were found related to age, sex, diagnosis or dosage. Other side effects were: 3 flu-like symptoms, 3 opportunistic infections, 2 hypertransaminasemia, and 1 patient with elevated pancreatic enzymes and hyperbilirubinemia. AZA was discontinued in 14 patients (43.8%): in 6 due to AP, in 4 due to severe lymphopenia, in 2 because of Epstein-Barr virus infection, in 1 due to flu-like symptoms and in 1 with several adverse effects. Conclusion More than half of the patients treated with AZA presented side effects, mainly BMS, although most of them were mild and temporary, and the withdrawal of the drug was not necessary. It seems that TPMT activity is not useful to predict BMS, but this adverse effect could be related to a longer treatment.
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NI DHALAIGH, D., G. Anna Marie i D. Farrell. "N06 Help-seeking behaviours for fatigue in inflammatory bowel disease". Journal of Crohn's and Colitis 14, Supplement_1 (styczeń 2020): S660. http://dx.doi.org/10.1093/ecco-jcc/jjz203.990.
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Abstract Background Fatigue is a common and burdensome symptom of inflammatory bowel disease (IBD). Although many symptoms of IBD can be debilitating, fatigue is reported by people with IBD as the most difficult symptom to live with. It is experienced by up to 86% of people in active disease and 41–48% of people with IBD in remission, and impacts greatly on all aspects of people’s lives. Fatigue is a complex and invisible symptom and therefore can often be overlooked by those caring for people with IBD. Since it is invisible, it can only be made known to healthcare professionals if patients seek help for it. The experience of people who seek help for IBD fatigue is unknown, as are the reasons some choose to seek help and others do not. This study aims to explore the determinants of help-seeking behaviour for fatigue in IBD and examine why some people with IBD fatigue are more likely to seek help than others. Methods An exploratory qualitative method was employed, underpinned by the Theory of Planned Behaviour. A voluntary sample of 12 people with a diagnosis of IBD was recruited from the Irish Society of Crohn’s and Colitis. The sample included people who had and who had not sought help for IBD fatigue in the past. Semi-structured interviews were conducted using an interview guide. Themes were uncovered using content analysis. Results Themes uncovered included symptom perception, impact of IBD fatigue and knowledge of and access to sources of help. Most commonly, people did not seek help if they could continue life with relative normalcy in spite of IBD fatigue. Access and availability of help was perceived as good. Barriers, such as time and cost, were identified as making help-seeking more difficult at times, however these did not prevent seeking help. Poor knowledge of the sources of help, IBD fatigue being regarded as an inferior symptom to other symptoms and the perceived lack of interventions to manage the complex symptom emerged as important factors influencing help-seeking behaviour. Conclusion The Theory of Planned Behaviour was found to be a useful framework to predict help-seeking behaviour for IBD fatigue. Symptom perception, impact of IBD fatigue and knowledge of and access to sources of help are the most influential aspects of help-seeking behaviour. IBD fatigue appears to lack the legitimacy of other IBD symptoms. Therefore, there is a need for healthcare professionals to fully acknowledge and routinely assess fatigue as part of the clinical management of IBD. Further research aimed at specifically managing fatigue as a major IBD burden is warranted, in particular multidimensional, holistic interventions to help people cope with the impact of IBD fatigue.