PCCRC rate is a key quality indicator of colonoscopy. The Word Endoscopy Organisation has reached consensus agreement to use one method for calculating 3 year PCCRC rates (termed PCCRC-3 y) to enable benchmarking of rates.1 This methodology, used previously by Morris et al.2, showed a PCCRC-3 y rate of 8.6% across the English National Health Service (NHS) from 2001–2007.2 with a rate of 7.3% in 2007. This study aimed to determine the rate of PCCRC-3 y in the English NHS Bowel Cancer Screening Programme (BCSP).
Methods
Data from each colonoscopy in the BCSP is entered into a national database, the Bowel Cancer Screening System. All colorectal adenocarcinomas, within and outside the BCSP, are validated and registered by the National Cancer Registration and Analysis Service. This retrospective observational study interrogated these databases to identify those BCSP colonoscopies detecting colorectal cancers within 6 months (true positive colonoscopies) and those BCSP colonoscopies in patients who subsequently developed a colorectal cancer 6 months – 3 years after the colonoscopy (false negatives) between 2006 and 2013.
Conclusions
The overall English NHS BCSP PCCRC–3 y rate from 2006–2010 is 3.1% – less than half the 7.3% PCCRC rate seen in the symptomatic English NHS for 2007, providing further evidence that high quality colonoscopy, such as that performed by screening–accredited colonoscopists in the BCSP, results in a lower rate of PCCRC.3 4 Despite the high quality of colonoscopy in the BCSP, PCCRCs still occur, showing the importance of vigilance during all colonoscopies. Diagnosis of >2000 colorectal cancers (true positive colonoscopies) each year indicates there is an adequate sample size for annual reporting of PCCRC–3 y rate within the BCSP and comparison with PCCRC–3 yr rates in symptomatic services.
References
1. Beintaris I, et al. United European Gastroenterology Journal 5(5_Suppl):PO436. 2. Morris EJA et al. Gut 2014;0:1–9. 3. Corley DA, et al. N Engl. J Med 2014;370:1298–306. 4. Kaminski MF, et al. N Engl. J Med 2010;362:1795–803.
Safety and the avoidance of adverse events are crucial in patient care. A number of explanatory variables for the serious adverse event of colonoscopic perforation have been identified; however, the context in which perforation occurs has largely been overlooked, as too has the subsequent impact on the colonoscopist. This study examined the human and environmental factors associated with colonoscopic perforations, along with colonoscopists' reactions to these, with a view to informing strategies for safer practice and clinician support. This qualitative study explored the experiences of colonoscopists who reported a previous colonoscopic perforation. Semi-structured interviews were undertaken with 11 colonoscopists, recruited through professional networks. Interviews were recorded and transcribed and analysed using a framework approach. Human and environmental factors contributing to perforation included colonoscopist fatigue, time pressure and equipment failure. Four distinct stages were identified in colonoscopists' reactions to perforation: 'The Perforation Realisation' comprising a range of strong and powerful emotions; 'The Consequences' involving feelings of personal responsibility, self-blame, fear of repercussion and vulnerability; 'Acceptance and Refocus' comprising a period of coming to terms with the perforation; and finally 'Reflection and Learning' where the colonoscopist reflected on the case and applied learning to their future practice. This study examines colonoscopists' personal experiences of perforations. It identifies the stages that colonoscopists experience after causing a perforation, and some of the broader contextual factors that can lead to these potentially preventable adverse events. The data suggest the need for greater emotional and pastoral support for endoscopists when such events occur.
Computed tomography colonography (CTC) is the gold standard radiological investigation for colorectal cancer screening. The Post-Imaging Colorectal Cancer (PICRC) rate (i.e. colorectal cancers that develop after a negative CTC) is a key quality indicator of CTC; however, PICRC rates have not been previously reported in a national programme. The Word Endoscopy Organisation has, through a consensus process, agreed a standard methodology for calculating PICRC rates to enable international benchmarking (1). This rate (which the WEO terms PICRC-3y) is calculated by dividing the PICRCs detected 6 months to 3 years after a negative CTC (false negatives) by the sum of the true positives (defined by CTCs with a cancer diagnosis within 6 months) and false negatives (PICRCs). This study aimed to determine the rate of PICRC-3y in the English National Health Service (NHS) Bowel Cancer Screening Programme (BCSP).
Methods
Data from each Bowel Cancer Screening Programme (BCSP) CTC is entered into a national database, the Bowel Cancer Screening System (BCSS). All colorectal adenocarcinomas, within and outside the BCSP, are validated and registered by the National Cancer Registration and Analysis Service (NCRAS). This retrospective observational study interrogated these databases to identify BCSP true positive and false negative CTCs. CTCs were included regardless of whether they were preceded or followed by a colonoscopy within a screening episode.
Results
Of the 8 PICRCs, 3 were detected at subsequent BCSP procedures, one at 1 year surveillance, and 2 following re-invitation for screening at 2 years. Five were detected outside the BCSP.
Conclusions
The PICRC–3y in the BCSP is higher than the rate in the published literature (4.4%)(2) and the corresponding rate for Post Colonoscopy Colorectal Cancer (PCCRC) over the same period (2.5%). CTC is commonly reserved for patients who are either deemed unsuitable for colonoscopy, or in whom colonoscopy has failed, meaning that there are likely to be substantial differences between the populations undergoing each examination. Because CTC and colonoscopy are performed in different populations, those having CTC more likely to be frailer with greater co–morbidity, the higher rate of PICRC when compared to PCCRC has to be interpreted with caution and may relate to the difficulty of investigating such patients, who may not be fit enough for, or refuse an intervention even if a lesion is found.
References
Beintaris I, et al. United European Gastroenterology Journal Vol 5 Issue 5_Suppl PO436 Obaro AE, et al. Lancet Gastroenterol Hepatol3(5) 32–36
Anti-tumour necrosis factor (TNF) agents and vedolizumab are used to treat UC but response is variable and there are little data on comparative efficacy of these agents. Apart from prior exposure to anti-TNF agents and concurrent immunomodulatory therapy, predictors of clinical response and remission to biologics have not been identified. We aimed to (i) compare the efficacy of anti-TNF agents and vedolizumab as induction and maintenance therapy in UC and (ii) investigate the utility of routinely used clinical and biochemical parameters in predicting clinical response and remission to biologics. Patients who were commenced on any biological agent for ambulant UC were included in this single-centre cohort study. Disease activity was monitored serially by calculation of Simple Clinical Colitis Activity Index (SCCAI) for up to 12 months. Faecal calprotectin (FC) at baseline and subsequent visits were recorded if available. Clinical response was defined as decrease in SCCAI ≥3 and remission by SCCAI ≥2. We compared the efficacy of anti-TNF agents and vedolizumab for induction and maintenance of response on an intention-to-treat basis. We also examined the utility of FC and early normalisation of FC to predict response and remission at 6 and 12 months. Ninety-seven patients commencing anti-TNF and 42 commencing vedolizumab therapy were included. Vedolizumab-treated patients had greater rate of prior anti-TNF therapy (69% vs. 11.3%, p = 0.001) and a lower baseline FC (median 577µg/g, IQR 72–210 vs. 955µg/g, IQR 116–2100 vs. p = 0.005). Clinical response, remission and steroid-free remission rates were broadly comparable between anti-TNF and vedolizumab-treated patients at 6 weeks, 6 and 12 months. Clinical remission at 12 months was higher in the vedolizumab group (51.4% vs. 27.8%, 27.8%, difference 95% CI 4.8–42.4) but no difference was noted in steroid-free remission at 12 months. There was a significant weekly reduction in SCCAI for vedolizumab (−0.06, 95% CI −0.09 to −0.04, p < 0.001) and anti-TNF agents (−0.06, 95% CI −0.07 to −0.04, p < 0.001). Similarly, the weekly calprotectin dropped significantly for vedolizumab (−7.64 µg/g, 95% CI −12.82 to −2.45, p = 0.004) and anti-TNF agents (−17.43 µg/g, 95% CI −23.79 to −11.08, p < 0.001). The colectomy rate (9.5% vedolizumab, 4.1% anti-TNF) and treatment persistence rate at 12 months (73% vedolizumab, 71% anti-TNF) were comparable between the two groups. None of the clinical and biochemical variables including baseline and early normalisation of FC predicted remission at 6 and 12 months. In a single-centre series of biologic-treated UC patients, the efficacy of anti-TNF and vedolizumab appear comparable. We could not identify any predictors of response and remission.
The success of bowelscope screening (population colorectal cancer screening aged 55 with a one off flexible sigmoidoscopy) in improving colorectal cancer outcomes is reliant on adenoma detection. The adenoma detection rate has been a concern within bowelscope screening (BoSS) and a national quality asssurance standard has been set at 6.7%. The use of Endocuff Vision has been shown to improve adenoma detection rate in colonoscopy both within the Bowel Cancer Screening Programme and symptomatic service. There is currently a randomized controlled trial underway (B-ADENOMA) to answer the question on the effectiveness of the use of Endocuff Vision in BoSS. This was a feasibility study to assess Endocuff Vision in BoSS.
Methods
Endocuff Vision was used during BoSS examinations at Liverpool & Wirral Bowel Cancer Screening Centre during a 3 month study period. A standardised proforma was completed after each examination by endoscopists, which included ratings of patients tolerability, endoscope handling, assistance in detecting pathology. Quality indicators were compared prior to and during the study.
Results
838 BoSS flexible sigmoidoscopies were performed prior to the study. Endocuff Vision was used in 133 procedures; 19.5% of all BoSS examinations during the study period. 4.5% were not successful. Endoscopists reported good or excellent patient tolerability in 83.5%, endoscope handling in 85.8% and assistance in detecting pathology in 68.8%. However, subjective narrative from endoscopists included more negative than positive comments on a ratio of 4:1. Comfort scores decreased significantly: 83.0% reporting no or minimal discomfort prior to the study to 78.7% during the study (p=0.03, OR 1.33 95% CI 1.02 – 1.71). Adenoma Detection Rate was 11.02% for the Endocuff Vision assisted examinations. Polyp Detection Rate increased from 18.5% prior to the study to 22.6% during the study period (p=0.05, OR 1.28 95% CI 1.00–1.65). Adenoma Detection Rate increased from 9.55% to 11.6% (79/681) (p=0.19, OR 1.24 95% 0.90–1.73).
Conclusions
This study illustrates that Endocuff Vision can be successfully used in Bowel Scope Screening. Endoscopists felt it aided the procedure and pathology detection. However, the discordance between the negative comments and ratings may suggest that more familiarity with the device is required. Patient comfort may be compromised but potential benefits include improved polyp and adenoma detection rates.
Abstract 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.
A new subcutaneous (SC) formulation of infliximab has recently been approved for the management of inflammatory bowel diseases (IBD). In the registration clinical trial, the efficacy of SC IFX was comparable to intravenous (IV) IFX (1) but specific data regarding the efficacy of SC IFX in perianal Crohn's disease (pCD) is lacking. We aimed to investigate the efficacy of SC IFX in patients with pCD who were switched from IV IFX.
Methods
We conducted a single centre observational, retrospective study of pCD patients who were maintained on IV IFX and switched to SC IFX. Elective switching was at the discretion of the treating physician. In patients with active pCD at treatment initiation, the success of SC IFX was defined by clinical success at 6 months assessed by the physician's judgment without additional medical or surgical treatment for pCD. In patients with inactive pCD, the pCD recurrence-free survival was calculated. Treatment persistence rates were calculated at the end of 6 months. Safety and adverse events of interest were recorded. Data was analysed using SPSS for Windows with p<0.05 being significant.
Results
We included 18 patients with a mean age of 36 (SD 12) and a M:F ratio of 5:4. Eleven (61%) patients were on concomitant thiopurines with a mean 6-thioguanine level of 258 (SD 155). The majority (n=13, 72%) had an inter-sphincteric fistula, 1 patient had a supra-sphincteric fistula (5.6%) and 2 patients (11.1%) each had trans-sphincteric and extra-sphincteric fistulae respectively. None of the patients had active, draining fistulae at the time of switching and 1 patient had an examination under anaesthesia (EUA) in the 6 weeks prior to switch. The mean IFX level at baseline was 9.9 μg/ml (SD 4.1). Two patients (11.1%) had recurrence of symptoms after switching to SC IFX and required further antibiotic therapy and EUA. These two patients also switched back to IV IFX after a median of 2.25 months. The mean IFX levels at 3 and 6 months after switch were 15.6 μg/ml (SD 0.2) and 15.5 μg/ml (SD 1.4) respectively (P<0.01). The treatment persistence rate at 6 months post-switch was 89% (16/18). There were no safety issues or adverse events of note.
Conclusions
Patients with pCD who were switched from IV to SC IFX had a high rate of symptom free survival and treatment persistence at 6 months. Treatment switch was associated with an increase in IFX levels. The efficacy of SC IFX at 6 months appears comparable to IV IFX for maintenance of remission in pCD (2).
References
Schreiber S, Ben-Horin S, Leszczyszyn J, Dudkowiak R, Lahat A, Gawdis-Wojnarska B, Pukitis A, Horynski M, Farkas K, Kierkus J, Kowalski M, Lee SJ, Kim SH, Suh JH, Kim MR, Lee SG, Ye BD, Reinisch W. Randomized Controlled Trial: Subcutaneous vs Intravenous Infliximab CT-P13 Maintenance in Inflammatory Bowel Disease. Gastroenterology. 2021 Mar 5:S0016-5085(21)00474-1. Sands BE, Anderson FH, Bernstein CN, Chey WY, Feagan BG, Fedorak RN, Kamm MA, Korzenik JR, Lashner BA, Onken JE, Rachmilewitz D, Rutgeerts P, Wild G, Wolf DC, Marsters PA, Travers SB, Blank MA, van Deventer SJ. Infliximab maintenance therapy for fistulizing Crohn's disease. N Engl J Med. 2004 Feb 26;350(9):876-85.
Ambulatory Management of Acute Severe Ulcerative Colitis: A Pandemic-driven Initiative Tristan Townsend, MBChB, Tristan Townsend, MBChB Gastroenterology Department, Royal Liverpool University Hospital, Liverpool University Foundation Trust, Liverpool, UK Search for other works by this author on: Oxford Academic PubMed Google Scholar Joseph Fiske, MBChB, Joseph Fiske, MBChB Gastroenterology Department, Royal Liverpool University Hospital, Liverpool University Foundation Trust, Liverpool, UK Search for other works by this author on: Oxford Academic PubMed Google Scholar Paul Collins, MD, Paul Collins, MD Gastroenterology Department, Royal Liverpool University Hospital, Liverpool University Foundation Trust, Liverpool, UK Search for other works by this author on: Oxford Academic PubMed Google Scholar Ashley Bond, MD, Ashley Bond, MD Gastroenterology Department, Royal Liverpool University Hospital, Liverpool University Foundation Trust, Liverpool, UK Search for other works by this author on: Oxford Academic PubMed Google Scholar Alan Steel, MD, Alan Steel, MD Gastroenterology Department, Royal Liverpool University Hospital, Liverpool University Foundation Trust, Liverpool, UK Search for other works by this author on: Oxford Academic PubMed Google Scholar Martyn Dibb, MD, Martyn Dibb, MD Gastroenterology Department, Royal Liverpool University Hospital, Liverpool University Foundation Trust, Liverpool, UK Search for other works by this author on: Oxford Academic PubMed Google Scholar Edmund Derbyshire, MD, Edmund Derbyshire, MD Gastroenterology Department, Royal Liverpool University Hospital, Liverpool University Foundation Trust, Liverpool, UK Search for other works by this author on: Oxford Academic PubMed Google Scholar Sreedhar Subramanian, MD Sreedhar Subramanian, MD Gastroenterology Department, Royal Liverpool University Hospital, Liverpool University Foundation Trust, Liverpool, UK Address correspondence to: Sreedhar Subramanian, Gastroenterology Department, Royal Liverpool University Hospital, Prescot Street, L7 8XP, Liverpool, UK. E-mail: sreedhar.subramanian@liverpoolft.nhs.uk. https://orcid.org/0000-0002-6483-1730 Search for other works by this author on: Oxford Academic PubMed Google Scholar Inflammatory Bowel Diseases, Volume 26, Issue 10, October 2020, Pages e112–e113, https://doi.org/10.1093/ibd/izaa231 Published: 19 August 2020
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.
Abstract Background A subcutaneous (SC) formulation of IFX has recently been shown to be as effective as intravenous (IV) IFX in a randomised trial but there are no real world data to support elective switching. We aimed to assess the effectiveness of an elective switching program from IV to SC IFX in patients with IBD. Methods Patients on maintenance IV IFX were included in this retrospective multi-centre cohort study across two sites. Disease activity was monitored serially with Harvey-Bradshaw Index (HBI) and simple clinical colitis activity index (SCCAI) at baseline, 3 and 6 months. Faecal calprotectin (FCP), C-reactive protein (CRP) and IFX levels were recorded at the same time points. Patients on 5mg/kg every 8 weeks were switched to SC IFX 120mg every other week (EOW), followed by those on 6 and 4 weekly IV IFX to either EOW or weekly SC IFX. A random selection of patients were surveyed for patient satisfaction using a likert scale. Criteria for switching were agreed within a standard operating procedure. Data was analysed using SPSS for Windows with p<0.05 being significant (ns, non-significant). Results 172 patients (109 CD, 57 UC, 6 IBD-U) were switched to SC IFX since April 2020 (97 male vs. 75 female; mean age 39.7 years and weight 78.6kg). 57.6% patients (n=99) were on concurrent immunomodulators. 152 patients were switched to EOW dosing. From baseline to 6 months post switch, HBI, SCCAI, FCP and CRP remained stable (p>0.05, ns), but mean IFX levels significantly increased from baseline (baseline = 9.8ug/mL vs. 3 month = 14.6ug/mL; p<0.0001) and then levels remained high between 3 and 6 month follow up (6 month = 15.0ug/mL; p>0.05, ns). 8 patients (4.65%) had self-limiting skin injection site reactions, 1 UC patient (0.58%) required corticosteroids, and 2 patients (1.16%) developed perianal symptoms requiring examination under anaesthesia (EUA). Overall 4 patients (2.36%) discontinued SC treatment due to adverse events (2 perianal disease patients, 1 flaring UC patient requiring oral steroids and 1 patient with neurological symptoms) and 1 (0.58%) planned discontinuation for a patient in the 3rd trimester of pregnancy. 85.2% (75/88) of patients agreed they were happier on SC IFX compared to IV IFX, 88.6% (78/88) feeling at least the same or better on SC IFX, and 92% (81/88) and 86.4% (76/88) agreeing that SC IFX was easy to use and felt safe using it, respectively. Conclusion SC IFX is effective at maintaining remission in IBD patients switched from IV to SC IFX with no evidence of inferiority at 6 month follow up. There is a significant increase in IFX levels from baseline to 3 months which is maintained to 6 months post switch. SC IFX appears to be safe with low rates of adverse events and is well tolerated by patients.
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