Minimising risk and improving the management of colonoscopic adverse events

Introduction Colonoscopy is the gold standard screening tool for colorectal cancer and is used as such in the English National Health Service Bowel Cancer Screening Programme (NHSBCSP). It does, however, carry a risk of adverse events that may compromise patient safety and the integrity of the screening programme. This thesis examined the colonoscopic adverse events perforation, post polypectomy bleeding (PPB) and post colonoscopy colorectal cancer (PCCRC) in the NHSBSCP. Aims & Methods 1. Determine the frequency of perforation, PPB and PCCRC in the NHSBCSP. 2. Determine the impact of perforation and PPB on patients and colonoscopists. 3. Identify risk factors for perforation so that its risk can be minimised. 4. Improve the management of perforation and PPB to improve patient outcomes. To achieve the aims of this thesis I used mixed methodology comprising both quantitative and qualitative health research methods. Results The frequency of the colonoscopic adverse events studied was 0.06% for perforation and 0.44% for post polypectomy bleeding. Perforation led to hospital admission in 98.7% of patients, with 53.9% of admissions having surgery and 26.1% of admissions leaving hospital with a stoma. Only perforations that had surgery developed post perforation morbidity and were admitted to intensive care. Perforation has a profound psychological impact on the colonoscopist involving four stages of reaction. Risk factors for perforation include time pressure, colonoscopist fatigue, a longer procedure than the colonoscopist expected and equipment failure. PPB led to hospital admission in 64.7% of patients studied with 27.9% of patients studied having a repeat endoscopic examination. 1.47% of the patients with PPB studied had surgery and 1.47% of the patients with PPB studied had radiological intervention. Conclusions 1. The rates of perforation and PPB in the NHSBCSP are in line with other similarly sized studies reported globally. The robust system for capturing details of perforation and PPB in the NHS BCSP suggest the rates reported in these studies accurately reflect their true rate. 2. Perforation leads to hospital admission in nearly all patients. Of those perforations admitted to hospital, surgery occurred in approximately a half, with stoma formation in approximately a quarter and post perforation morbidity in approximately one fifth. 3. PPB leads to hospital admission in approximately two thirds of patients. Over half of the Post Polypectomy Bleeds are of minor severity 4. Colonoscopists should be aware that time pressure, colonoscopist fatigue, a longer procedure than the colonoscopist expected and equipment failure may be associated with perforation

An exploration of the importance of trust in the post-acquisition integration context in high-technology industry

EThOS - Electronic Theses Online ServiceGBUnited Kingdo

***TEST SUBMISSION*** BMJ-15: Acceptance within last 3 months (01/03/2020); Online publication within 12 months (10/12/2020); Embargo (10/09/2021) less than 12 months from pub date; VoR

From UAT Test publisher via Jisc Publications RouterHistory: accepted 2020-03-01, epub 2020-12-10Article version: VoRPublication status: PublishedAbstract: TEST: THIS IS A PUBLICATIONS ROUTER TEST SUBMISSION. Objectives: To quantify post-colonoscopy colorectal cancer (PCCRC) rates in England by using recent World Endoscopy Organisation guidelines, compare incidence among colonoscopy providers, and explore associated factors that could benefit from quality improvement initiatives. Design: Population based cohort study. Setting: National Health Service in England between 2005 and 2013. Population: All people undergoing colonoscopy and subsequently diagnosed as having colorectal cancer up to three years after their investigation (PCCRC-3yr). Main outcome measures: National trends in incidence of PCCRC (within 6-36 months of colonoscopy), univariable and multivariable analyses to explore factors associated with occurrence, and funnel plots to measure variation among providers. Results: The overall unadjusted PCCRC-3yr rate was 7.4% (9317/126 152), which decreased from 9.0% in 2005 to 6.5% in 2013 (P<0.01). Rates were lower for colonoscopies performed under the NHS bowel cancer screening programme (593/16 640, 3.6%), while they were higher for those conducted by non-NHS providers (187/2009, 9.3%). Rates were higher in women, in older age groups, and in people with inflammatory bowel disease or diverticular disease, in those with higher comorbidity scores, and in people with previous cancers. Substantial variation in rates among colonoscopy providers remained after adjustment for case mix. Conclusions: Wide variation exists in PCCRC-3yr rates across NHS colonoscopy providers in England. The lowest incidence was seen in colonoscopies performed under the NHS bowel cancer screening programme. Quality improvement initiatives are needed to address this variation in rates and prevent colorectal cancer by enabling earlier diagnosis, removing premalignant polyps, and therefore improving outcomes

Efficacy and Safety of Elective Switching from Intravenous to Subcutaneous Infliximab [CT-P13]: A Multicentre Cohort Study

BackgroundIntravenous [IV] infliximab is a well-established therapy for inflammatory bowel diseases [IBD] patients. A subcutaneous [SC] formulation of infliximab [CT-P13] has recently been shown to be as effective as IV infliximab after two doses of IV induction in a randomised trial, but there are no data to support elective switching of patients on maintenance IV infliximab therapy. We aimed to assess the effectiveness of an elective switching programme to SC CT-P13 in patients treated with IV infliximab.MethodsPatients on established maintenance IV infliximab, who switched to SC CT-P13, were included in this retrospective multicentre cohort study. Disease activity was monitored serially with the Harvey-Bradshaw Index [HBI] for Crohn's disease [CD] and the Simple Clinical Colitis Activity Index [SCCAI] for ulcerative colitis (UC) for up to 12 months at months 3, 6, and 12. Faecal calprotectin [FC] and C-reactive protein [CRP] were recorded at baseline and follow-up, if available. Infliximab trough levels were measured prior to switch and at months 3, 6, and 12 following switch. The primary outcome measure was treatment persistence at latest follow-up. Secondary outcome measures included infliximab pharmacokinetics [PK], safety, need for corticosteroid rescue therapy, and need for surgery.ResultsWe included 181 patients, of whom 115 [63.5%] had CD. The majority [72.4%] were on 8-weekly dosing of intravenous infliximab prior to switching, and more than half [59.1%] were on concomitant immunomodulatory therapy. The majority of patients (CD: 106, 92.2%; UC: 46, 76.7%; and IBD unclassified [IBD-U]: 5, 83.3%) were in clinical remission. Treatment persistence rate was high [n = 167, 92.3%] and only 14 patients [7.7%] stopped treatment during the follow-up period. There was no significant difference between baseline and repeat measurements at 3, 6, or 12 months for HBI, SCCAI, CRP, or FC. Of the total cohort, 25 patients (13.8%) had perianal CD. Of these, only two patients [8%] had worsening of perianal CD and required antibiotic therapy and further examination under anaesthesia [EUA]. Both these patients also switched back to intravenous infliximab. Median infliximab level increased from a baseline of 8.9 µg/dl [range 0.4-16] to 16.0 µg/dl [range 2.3-16, p ConclusionsAmong patients on IV infliximab maintenance therapy switched to SC CT-P13, we observed high treatment persistence rates and low rates of immunogenicity, with no change in clinical disease activity indices or biomarkers. Infliximab levels increased after switch to SC CT-P13, and only ATI was associated with serum infliximab levels. Patient acceptance and satisfaction rates were high with SC CT-P13

Comparative effectiveness of antitumour necrosis factor agents and vedolizumab in ulcerative colitis.

INTRODUCTION:Antitumour necrosis factor (TNF) agents and vedolizumab are used to treat ulcerative colitis (UC) but the response is variable and there is little data on comparative effectiveness. Apart from previous exposure to anti-TNF agents, predictors of response have not been identified. We aimed to (i) compare the efficacy of anti-TNF agents and vedolizumab in UC and (ii) investigate the utility of clinical and biochemical parameters in predicting response. PATIENTS AND METHODS:Patients commencing any biological therapy for ambulant UC were included. Disease activity was monitored serially with the Simple Clinical Colitis Activity Index for up to 12 months. We compared the efficacy of anti-TNF agents and vedolizumab for induction and maintenance of response and remission on an intention-to-treat basis. We examined the utility of faecal calprotectin (FC) and early normalization of FC to predict response. RESULTS:Ninety-seven patients commencing anti-TNF and 42 commencing vedolizumab therapy were included. Vedolizumab-treated patients had significantly greater previous anti-TNF therapy exposure and a lower baseline FC. Response, remission and steroid-free remission rates were comparable between both groups at 6 weeks, 6 and 12 months. Clinical remission but not steroid-free remission at 12 months was higher in the vedolizumab group. There was a significant reduction in the Simple Clinical Colitis Activity Index and FC at 6 weeks, 6 and 12 months compared with baseline in both groups. Baseline FC and early normalization did not predict response at 6 and 12 months. CONCLUSION:The efficacy of anti-TNF and vedolizumab in UC appear comparable. We could not identify any predictors of response and remission