SummaryBackgroundInfliximab and ciclosporin are of similar efficacy in treating acute severe ulcerative colitis, but there has been no comparative evaluation of their relative clinical effectiveness and cost-effectiveness.MethodsIn this mixed methods, open-label, pragmatic randomised trial, we recruited consenting patients aged 18 years or older at 52 district general and teaching hospitals in England, Scotland, and Wales who had been admitted, unscheduled, with severe ulcerative colitis and failed to respond to intravenous hydrocortisone within about 5 days. Patients were randomly allocated (1:1) to receive either infliximab (5 mg/kg intravenous infusion given over 2 h at baseline, and again at 2 weeks and 6 weeks after the first infusion) or ciclosporin (2 mg/kg per day by continuous infusion for up to 7 days, followed by twice-daily tablets delivering 5·5 mg/kg per day for 12 weeks). Randomisation used a web-based password-protected site, with a dynamic algorithm to generate allocations on request, thus protecting against investigator preference or other subversion, while ensuring that each trial group was balanced by centre, which was the only stratification used. Local investigators and participants were aware of the treatment allocated, but the chief investigator and analysts were masked. Analysis was by treatment allocated. The primary outcome was quality-adjusted survival—ie, the area under the curve (AUC) of scores from the Crohn's and Ulcerative Colitis Questionnaire (CUCQ) completed by participants at baseline, 3 months, and 6 months, then every 6 months from 1 year to 3 years. This trial is registered with the ISRCTN Registry, number ISRCTN22663589.FindingsBetween June 17, 2010, and Feb 26, 2013, 270 patients were recruited. 135 patients were allocated to the infliximab group and 135 to the ciclosporin group. 121 (90%) patients in each group were included in the analysis of the primary outcome. There was no significant difference between groups in quality-adjusted survival (mean AUC 564·0 [SD 241·9] in the infliximab group vs 587·0 [226·2] in the ciclosporin group; mean adjusted difference 7·9 [95% CI −22·0 to 37·8]; p=0·603). Likewise, there were no significant differences between groups in the secondary outcomes of CUCQ scores, EQ-5D, or SF-6D scores; frequency of colectomy (55 [41%] of 135 patients in the infliximab group vs 65 [48%] of 135 patients in the ciclosporin group; p=0·223); or mean time to colectomy (811 [95% CI 707–912] days in the infliximab group vs 744 [638–850] days in the ciclosporin group; p=0·251). There were no differences in serious adverse reactions (16 reactions in 14 participants receiving infliximab vs ten in nine patients receiving ciclosporin); serious adverse events (21 in 16 patients vs 25 in 17 patients); or deaths (three in the infliximab group vs none in the ciclosporin group).InterpretationThere was no significant difference between ciclosporin and infliximab in clinical effectiveness.FundingNIHR Health Technology Assessment programme.
ObjectiveSymptoms and clinical course during inflammatory bowel disease (IBD) vary among individuals. Personalised care is therefore essential to effective management, delivered by a strong patient-centred multidisciplinary team, working within a well-designed service. This study aimed to fully rewrite the UK Standards for the healthcare of adults and children with IBD, and to develop an IBD Service Benchmarking Tool to support current and future personalised care models.DesignLed by IBD UK, a national multidisciplinary alliance of patients and nominated representatives from all major stakeholders in IBD care, Standards requirements were defined by survey data collated from 689 patients and 151 healthcare professionals. Standards were drafted and refined over three rounds of modified electronic-Delphi.ResultsConsensus was achieved for 59 Standards covering seven clinical domains; (1) design and delivery of the multidisciplinary IBD service; (2) prediagnostic referral pathways, protocols and timeframes; (3) holistic care of the newly diagnosed patient; (4) flare management to support patient empowerment, self-management and access to specialists where required; (5) surgery including appropriate expertise, preoperative information, psychological support and postoperative care; (6) inpatient medical care delivery (7) and ongoing long-term care in the outpatient department and primary care setting including shared care. Using these patient-centred Standards and informed by the IBD Quality Improvement Project (IBDQIP), this paper presents a national benchmarking framework.ConclusionsThe Standards and Benchmarking Tool provide a framework for healthcare providers and patients to rate the quality of their service. This will recognise excellent care, and promote quality improvement, audit and service development in IBD.
Summary Background : Steroid resistance represents a major clinical problem in the treatment of ulcerative colitis. In vitro, interleukin‐2 renders lymphocytes steroid resistant. Aim : To explore the therapeutic potential of interleukin‐2 receptor blockade in steroid‐resistant ulcerative colitis with both in vitro measures and a pilot in vivo study. Methods : Ten patients with steroid‐resistant ulcerative colitis received a single bolus of 40 mg of intravenous basiliximab plus steroid treatment in an open‐label, uncontrolled, 24‐week study. The outcome was assessed using the Ulcerative Colitis Symptom Score, rectal biopsy and Inflammatory Bowel Disease Questionnaire. Lymphocyte steroid sensitivity was measured in vitro in 39 subjects in the presence or absence of basiliximab. Results : Nine of the 10 patients achieved clinical remission within 8 weeks. At 24 weeks, seven patients were in clinical remission. Marked improvement in the Ulcerative Colitis Symptom Score was seen by 1 week (P = 0.004) and on rectal biopsy and Inflammatory Bowel Disease Questionnaire by 2 weeks (both P < 0.05). Improvements persisted to 24 weeks (Ulcerative Colitis Symptom Score, Inflammatory Bowel Disease Questionnaire, both P < 0.005). Eight of the nine responders relapsed (median, 9 weeks), but remission was re‐achieved with further corticosteroids and the addition of azathioprine. At 24 weeks, seven patients were in full clinical remission, five off all steroid therapy. In vitro measurement of lymphocyte steroid sensitivity demonstrated steroid resistance in 22% of subjects. All were rendered steroid sensitive in the presence of basiliximab. Conclusions : Basiliximab appears to be effective at inducing remission in steroid‐resistant ulcerative colitis. In vitro, basiliximab also produced a dramatic increase in lymphocyte steroid sensitivity in healthy subjects. Confirmation in randomized controlled studies is required.
Summary Background Most patients are prescribed Helicobacter pylori treatment without culture and antibiotic susceptibility testing, as current guidance recommends that patients with recurrent dyspepsia should be tested for H. pylori using a non‐invasive breath or faecal antigen test. Aims To determine the prevalence of H. pylori antibiotic resistance in patients attending endoscopy in England and Wales, and the feasibility of an antibiotic resistance surveillance programme testing. Methods We tested the antibiotic susceptibility of H. pylori isolates from biopsy specimens from 2063 of 7791 (26%) patients attending for endoscopy in Gloucester and Bangor, and 339 biopsy specimens sent to the Helicobacter Reference Unit (HRU) in London. Culture and susceptibility testing was undertaken in line with National and European methods. Results Helicobacter pylori were cultured in 6.4% of 2063 patients attending Gloucester and Bangor hospitals. Resistance to amoxicillin, tetracycline and rifampicin/rifabutin was below 3% at all centres. Clarithromycin, metronidazole and quinolone resistance was significantly higher in HRU (68%, 88%, 17%) and Bangor isolates (18%, 43%, 13%) than Gloucester (3%, 22%, 1%). Each previous course of these antibiotics is associated with an increase in the risk of antibiotic resistance to that agent [clarithromycin: RR = 1.5 (P = 0.12); metronidazole RR = 1.6 (P = 0.002); quinolone RR = 1.8 (P = 0.01)]. Conclusions Helicobacter pylori infection is now uncommon in dyspeptic patients at endoscopy. A surveillance system is feasible and necessary to inform dyspepsia management guidance. Clinicians should take a thorough antibiotic history before prescribing metronidazole, clarithromycin or levofloxacin for H. pylori.
Endoscopy is an important diagnostic and therapeutic procedure that demands high levels of cognitive and technical skill to perform effectively. Surprisingly little is known about how endoscopy is best taught and training is often inadequate. The aims of this study were to explore the learning experiences of endoscopy trainees to improve our understanding of current training. Following the use of an initial focus group to generate appropriate themes semi-structured interviews were performed on 10 trainees to assess their learning experiences. Many different components of the learning experience were identified; one-to-one supervised performance forms the basis for teaching but is often sub-optimal; endoscopy learners experience anxiety and find re-adopting the role of novice difficult; motivation, clear explanation and feedback are crucial to learning; breaking down endoscopy training into segments is seen as valuable and as learners progress a gradual withdrawal of supervision is appreciated. Several of the issues contributing to a positive learning experience relate closely to published evidence and theory relating to skills teaching from other fields. A model identifying the key elements of endoscopy learning is proposed. Further work to apply and test the findings from this study should lead to improved endoscopy training.
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