Impact on healthcare resources of switch from fecal occult blood test to fecal immunochemical test within the English Bowel Cancer Screening Program: a single-center study.

BACKGROUND AND AIMS: In July 2019, the fecal immunochemistry test (FIT) replaced the fecal occult blood test (FOBT) in England as the Bowel Cancer Screening Program (BCSP) screening tool. We aimed to assess the impact of this on healthcare resources at our BCSP center. METHODS: Two 6-month periods were initially analyzed for stool sample return and positivity rates. A subsequent comparative analysis of patient screening episodes assessed utilization of specialist screening practitioner (SSP) time, endoscopy, histology, radiology, surgical, and oncology service usage. RESULTS: A total of 42,234 patients received FOBT and 42,545 patients received FIT stool kits, with FIT showing higher return (61.8% vs 58.58%, FIT vs FOBT, P < .001) and sample positivity rates (2.41% vs 1.45%, FIT vs FOBT, P < .001). Four hundred patients commenced FOBT and 616 FIT screening episodes, a 54% increase. The FIT group had of a lower mean age (67.5 vs 69.5 years, FIT vs FOBT, P = .0001) with a lower nonattendance rate (.16% vs 1.5%, FIT vs FOBT, P = .01). With higher patient numbers, the FIT group required 69% more endoscopic procedures, 58% increased SSP time, 40% more radiologic tests, and 68% higher surgical procedures. FIT also led to a 109% increase in endoscopy-derived histology samples from an increase in the proportion of patients with polyps with FIT (54.8% vs 47.2%, P = .020) and a greater number of polyps per patient in whom polyps were found (3.00 vs 2.50 polyps, P = .017). This additional service burden equated to additional financial costs of approximately $558,000 per annum. CONCLUSIONS: The implementation of FIT led to notable increases in SSP time, endoscopy procedures, radiology tests, surgical procedures, and histopathology services, resulting in considerable ongoing financial implications on the organization. Findings can be used to aid workforce and service planning in National Health Service sites delivering BCSP and countries that have already adopted or are considering FIT within their national screening programs.

JAG consensus statements for training and certification in colonoscopy.

Introduction: In the UK, endoscopy certification is awarded when trainees attain minimum competency standards for independent practice. A national evidence-based review was undertaken to update and develop standards and recommendations for colonoscopy training and certification. Methods: Under the oversight of the Joint Advisory Group (JAG), a modified Delphi process was conducted between 2019 and 2020 with multisociety expert representation. Following literature review and Grading of Recommendations, Assessment, Development and Evaluations appraisal, recommendation statements on colonoscopy training and certification were formulated and subjected to anonymous voting to obtain consensus. Accepted statements were peer reviewed by JAG and relevant stakeholders for incorporation into the updated colonoscopy certification pathway. Results: In total, 45 recommendation statements were generated under the domains of: definition of competence (13), acquisition of competence (20), assessment of competence (8) and postcertification support (4). The consensus process led to revised criteria for colonoscopy certification, comprising: (1) achieving key performance indicators defined within British Society of Gastroenterology standards (ie, unassisted caecal intubation rate >90%, rectal retroversion >90%, polyp detection rate >15%+, polyp retrieval rate >90%, patient comfort <10% with moderate-severe discomfort); (2) minimum procedure count 280+; (3) performing 15+ procedures over the preceding 3 months; (4) attendance of the JAG Basic Skills in Colonoscopy course; (5) terminal ileal intubation rates of 60%+ in inflammatory bowel disease; (6) satisfying requirements for formative direct observation of procedure skills (DOPS) and direct observation of polypectomy skills (Size, Morphology, Site, Access (SMSA) level 2); (7) evidence of reflective practice as documented on the JAG Endoscopy Training System reflection tool; (8) successful performance in summative DOPS. Conclusion: The UK standards for training and certification in colonoscopy have been updated, culminating in a single-stage certification process with emphasis on polypectomy competency (SMSA Level 2+). These standards are intended to support training, improve standards of colonoscopy and polypectomy, and provide support to the newly independent practitioner.

JAG consensus statements for training and certification in flexible sigmoidoscopy.

Introduction: Joint Advisory Group (JAG) certification in endoscopy is awarded when trainees attain minimum competency standards for independent practice. A national evidence-based review was undertaken to update standards for training and certification in flexible sigmoidoscopy (FS). Methods: A modified Delphi process was conducted between 2019 and 2020 with multisociety representation from experts and trainees. Following literature review and Grading of Recommendations, Assessment, Development and Evaluations appraisal, recommendation statements on FS training and certification were formulated and subjected to anonymous voting to obtain consensus. Accepted statements were peer-reviewed by national stakeholders for incorporation into the JAG FS certification pathway. Results: In total, 41 recommendation statements were generated under the domains of: definition of competence (13), acquisition of competence (17), assessment of competence (7) and postcertification support (4). The consensus process led to revised criteria for colonoscopy certification, comprising: (A) achieving key performance indicators defined within British Society of Gastroenterology standards (ie, rectal retroversion >90%, polyp retrieval rate >90%, patient comfort <10% with moderate-severe discomfort); (B) minimum procedure count ≥175; (C) performing 15+ procedures over the preceding 3 months; (D) attendance of the JAG Basic Skills in Lower gastrointestinal Endoscopy course; (E) satisfying requirements for formative direct observation of procedural skill (DOPS) and direct observation of polypectomy skill (SMSA level 1); (F) evidence of reflective practice as documented on the JAG Endoscopy Training System reflection tool and (G) successful performance in summative DOPS. Conclusion: The UK standards for training and certification in FS have been updated to support training, uphold standards in FS and polypectomy, and provide support to the newly independent practitioner.

Development and validation of a novel method for assessing competency in polypectomy: direct observation of polypectomy skills.

BACKGROUND: Despite its ubiquitous use over the past 4 decades, there is no structured, formal method with which to assess polypectomy. OBJECTIVE: To develop and validate a new method with which to assess competency in polypectomy. DESIGN: Polypectomy underwent task deconstruction, and a structured checklist and global assessment scale were developed (direct observation of polypectomy skills [DOPyS]). Sixty bowel cancer screening polypectomy videos were randomly chosen for analysis and were scored independently by 7 expert assessors by using DOPyS. Each parameter and the global rating were scored from 1 to 4 (scores ≥3 = competency). The scores were analyzed by using generalizability theory (G theory). SETTING: Multicenter. RESULTS: Fifty-nine of the 60 videos were assessable and scored. The majority of the assessors agreed across the pass/fail divide for the global assessment scale in 58 of 59 (98%) polyps. For G-theory analysis, 47 of the 60 videos were analyzed. G-theory analysis suggested that DOPyS is a reliable assessment tool, provided that it is used by 2 assessors to score 5 polypectomy videos all performed by 1 endoscopist. DOPyS scores obtained in this format would reflect the endoscopist's competence. LIMITATIONS: Small sample and polyp size. CONCLUSIONS: This study is the first attempt to develop and validate a tool designed specifically for the assessment of technical skills in performing polypectomy. G-theory analysis suggests that DOPyS could reliably reflect an endoscopist's competence in performing polypectomy provided a requisite number of assessors and cases were used.

Variation in exposure to endoscopic haemostasis for acute upper gastrointestinal bleeding during UK gastroenterology training.

INTRODUCTION: Gastroenterologists are typically expected to be competent in endoscopic haemostasis for acute upper gastrointestinal bleeding (AUGIB), with the Certificate of Completion of Training (CCT) often heralding the onset of participation in on-call AUGIB rotas. We analysed the volume of haemostasis experience recorded by gastroenterology CCT holders on the Joint Advisory Group on Gastrointestinal Endoscopy Training System (JETS) e-portfolio, the UK electronic portfolio for endoscopy, and assessed for variations in exposure to haemostasis. METHODS: UK gastroenterologists awarded CCT between April 2014 and April 2017 were retrospectively identified from the specialist register. Credentials were cross-referenced with JETS to retrieve AUGIB haemostasis procedures prior to CCT. Procedures were collated according to variceal versus non-variceal therapies and compared across training deaneries. RESULTS: Over the 3-year study period, 241 gastroenterologists were awarded CCT. 232 JETS e-portfolio users were included for analysis. In total, 12 932 haemostasis procedures were recorded, corresponding to a median of 42 (IQR 21-71) per gastroenterologist. Exposure to non-variceal modalities (median 28, IQR 15-52) was more frequent than variceal therapies (median 11, IQR 5-22; p<0.001). By procedure, adrenaline injection (median 12, IQR 6-23) and variceal band ligation (median 10, IQR 5-20) were most commonly recorded, whereas sclerotherapy experience was rare (median 0, IQR 0-1). Exposure to haemostasis did not differ by year of CCT (p=0.130) but varied significantly by deanery (p<0.001), with median procedures ranging from 20-126. CONCLUSION: Exposure to AUGIB haemostasis during UK gastroenterology training varied across deaneries and procedural modalities which should prompt urgent locoregional review of access and delivery of training. Endoscopy departments should ensure the availability of supportive provisions in haemostasis (i.e. training/upskilling, supervision, mentorship) during the early post-CCT period.

Certification of UK gastrointestinal endoscopists and variations between trainee specialties: results from the JETS e-portfolio.

Introduction In the UK, endoscopy certification is administered by the Joint Advisory Group on Gastrointestinal Endoscopy (JAG). Since 2011, certification for upper and lower gastrointestinal endoscopy has been awarded via a national (JETS) e-portfolio to the main training specialties of: gastroenterology, gastrointestinal surgeons (GS) and non-medical endoscopists (NME). Trends in endoscopy certification and differences between trainee specialties were analyzed. Methods This prospective UK-wide observational study identified trainees awarded gastroscopy, sigmoidoscopy, colonoscopy (provisional and full) certification between June 2011 - 2017. Trends in certification, procedures and time-to-certification, and key performance indicators (KPIs) in the 3-month pre- and post-certification period were compared between the three main training specialties. Results Three thousand one hundred fifty-seven endoscopy-related certifications were awarded to 1928 trainees from gastroenterology (52.3 %), GS (28.4 %) and NME (16.5 â€Š%) specialties. During the study period, certification numbers increased for all modalities and specialties, particularly NME trainees. For gastroscopy and colonoscopy, procedures-to-certification were lowest for GS ( P  < 0.001), whereas time-to-certification was consistently shortest in NMEs ( P  < 0.001). A post-certification reduction in mean cecal intubation rate (95.2 % to 93.8 %, P  < 0.001) was observed in colonoscopy, and D2 intubation (97.6 % to 96.2 %, P  < 0.001) and J-maneuver (97.3 % to 95.8 %, P  < 0.001) in gastroscopy. Overall, average pre- and post-certification KPIs still exceeded national minimum standards. There was an increase in PDR for NMEs after provisional colonoscopy certification but a decrease in PDR for GS trainees after sigmoidoscopy and full colonoscopy certification. Conclusion Despite variations among trainee specialties, average pre- and post-certification KPIs for certified trainees met national standards, suggesting that JAG certification is a transparent benchmark which adequately safeguards competency in endoscopy training.

Impact and cost-effectiveness of formal gastroenterology outpatient referral Clinical Assessment Service.

OBJECTIVE: The aim was to assess the financial and operational impact of our new gastroenterology referral pathway model on our services. DESIGN: An electronic 'Clinical Assessment Service' (CAS) proforma and an information platform were developed, and all data were analysed retrospectively. SETTING: Royal Wolverhampton NHS Trust. PATIENTS: 14 245 general practitioner (GP) referrals were received during January 2014-December 2016 with 9773 of them being triaged via our CAS. MAIN OUTCOME MEASURES: We looked into patients' clinical outcome along with departmental performance and finances. RESULTS: A new outpatient appointment was offered to 60.1% (n=5873) of the CAS referred patients. Endoscopic or radiological investigations were requested for 29.2% (n=2854) of patients prior to deciding on further management plan. Out of those, 27% (n=765) went on to receive another gastroenterology (GI) clinic appointment. The remaining 21.3% (n=2089) of the CAS patients were discharged back to their GP following initial investigations. 5.5% (n=538) were discharged back to primary care with a letter of advice, whereas 5.2% (n=509) were deemed inappropriate for GI clinic and were redirected to other specialists. Overall, 32% (n=3127) of patients were managed without a face to face consultation in the GI clinic. This corresponds to 3136 less outpatient appointments with estimated reduced expenditure by the Clinical Commissioning Group (CCG) of £481K. The 18-week performance and waiting times remained stable despite the increasing referral population. The DNA rate dropped from 14% pre to 8.5%. CONCLUSIONS: Our clinical assessment model has, in addition to the clinical benefits, a considerable positive financial impact to the health economy.

Effect of faecal calprotectin assay variability on the management of inflammatory bowel disease and potential role of faecal S100A12.

AIMS: To prospectively evaluate whether between-assay variability of different faecal calprotectin (f-Cp) assays influences diagnostic accuracy for inflammatory bowel disease (IBD) in a cohort of patients with confirmed IBD and irritable bowel syndrome (IBS). To also evaluate the diagnostic accuracy of faecal S100A12 (f-S100A12) against f-Cp in the same patient cohort and assess whether f-S100A12 offers additional diagnostic value. METHODS: F-Cp using four commercially available f-Cp assays, f-S100A12 and blood biomarkers were measured in patients, recruited from the local IBD clinic, who had established IBS or active ulcerative colitis (UC) and Crohn's disease (CD). Diagnostic sensitivities and specificities for each assay and biomarker were calculated and compared. RESULTS: Median f-Cp levels in all assays were significantly higher in UC (347-884 µg/g; n=28) and CD (377-838 µg/g; n=15) compared with IBS (6-27 µg/g; n=17). Sensitivities and specificities at 50 µg/g were 94%-100% and 82%-100%, respectively. Median f-S100A12 levels were significantly higher in UC (81.0 µg/g; IQR 38.3-159.8) and CD (47.2 µg/g; IQR 5.3-108.9) compared with IBS (0.7 µg/g; IQR 0.5-0.8). At 2.8 µg/g, f-S100A12 had a sensitivity of 97% and specificity of 94%. The blood biomarkers demonstrated sensitivities and specificities of 44%-63% and 80%-92%, respectively. CONCLUSIONS: The diagnostic sensitivity of the calprotectin assays was similar despite inter-kit variability in absolute values. There is a need for f-Cp assay standardisation, but in its absence assay-specific cut-off values may optimise their diagnostic performance. F-S100A12 demonstrated comparable sensitivity and specificity to f-Cp and although a research tool at present, may have a future role to play in the diagnosis and management of these patients.

Ethnic variation in colorectal cancer risk following a positive faecal occult blood test in an English bowel cancer screening programme centre.

BACKGROUND AND AIMS: The literature on colorectal cancer (CRC) screening and ethnic diversity is dominated by studies from the USA. There are no such published data from the UK bowel cancer screening programme (BCSP) population. The Wolverhampton Bowel Cancer Screening Centre serves a population of 900,000 in the Black Country and South Staffordshire. South Asians (SA) comprise 9% of the population. We aimed to determine the effects of ethnicity and sex on the risk for cancer or adenoma detected by colonoscopy following a positive faecal occult blood test over a 5-year period (2007-2011). METHODS: Data were collected from the prospectively maintained BCSP cohort. South Asian patients were identified and compared with those of non-South Asian ethnicity, and colonoscopy outcomes were determined. RESULTS: A total of 3552 participants underwent BCSP colonoscopy (non-South Asian=3363; SA=189). There were 271 cancers (7.6%) detected within the non-South Asian group and seven cancers (0.2%) in the South Asian population (P<0.05). The probability of colon cancer is higher [odds ratio (OR)=3.84, P<0.05] in non-South Asians compared with South Asians. Patients in the 65-70-year age group have the highest risk (OR=1.60; P<0.05) for CRC. During the study 1313 adenomas were detected. A total of 771 high-risk and intermediate-risk adenomas were detected in the non-South Asian group, and 14 were detected in the South Asian group. The risk of adenoma in non-South Asians is six times higher than in South Asians (OR=5.99, P<0.001) following positive faecal occult blood testing. CONCLUSION: There are fewer colorectal cancers in South Asians compared with the non-South Asian population in this regional study. This is the first such study in the BCSP population.

Colonic tumour localization using an endoscope positioning device.

BACKGROUND AND STUDY AIM: Although colonoscopy is reliable in identifying colorectal cancer (CRC), studies have demonstrated incorrect tumour localization in 21-34% of colonoscopies when compared with surgical localization. The aim of this study was to determine our accuracy in determining the position of CRCs detected at colonoscopy with the aid of the ScopeGuide endoscope positioning device. PATIENTS AND METHODS: Cancers identified within the English National Bowel Cancer Screening Programme were studied. Retrospective analysis was undertaken of all patients diagnosed with CRC during the first screening round in Wolverhampton Bowel Cancer Screening Centre, England. ScopeGuide was used in all cases. Data from colonoscopy reports, computed tomography reports and surgical resection specimens were analysed. RESULTS: A total of 82 cancers were identified within the surgical resection specimen in 80 patients. Two proximal cancers were not identified at colonoscopy due to obstruction by the distal cancers. Colonoscopy with the aid of the endoscopy positioning device correctly identified the tumour location in 93.75% of cases in which the tumour could be reached endoscopically. Abdominopelvic computed tomography localized 82.5% of CRC. CONCLUSION: The ScopeGuide endoscopy positioning device enables accurate localization of cancers at colonoscopy. Tattooing of suspected cancer remains to be a best practice for localization during laparoscopic resection. The use of the endoscopic-positioning device may, however, result in greater confidence for localization of polypectomy sites, which have not been tattooed, in cases when cancer was not suspected but found histologically.

Expression and regulation of tissue inhibitor of metalloproteinase-1 and matrix metalloproteinases by intestinal myofibroblasts in inflammatory bowel disease.

Intestinal fibrosis and strictures frequently occur in Crohn's disease but not ulcerative colitis. We have recently shown that, compared to myofibroblasts obtained from normal and ulcerative colitis tissue, myofibroblasts isolated from fibrotic Crohn's disease mucosal samples express significantly lower amounts of transforming growth factor (TGF)-beta 3, but the expression of TGF-beta 2 was significantly greater. We now report that in myofibroblast cultures established from fibrotic Crohn's disease mucosal samples there is significantly higher constitutive expression of tissue inhibitor of metalloproteinase (TIMP)-1 compared to similar cells isolated from normal or ulcerative colitis tissue. Myofibroblasts derived from normal mucosa and from mucosa affected by ulcerative colitis or Crohn's disease also expressed matrix metalloproteinase (MMP)-1, MMP-2, and MMP-3 but did not express MMP-9. Recombinant (r) TGF-beta 1 and rTGF-beta 2, but not rTGF-beta 3, induced expression of TIMP-1 in normal intestinal myofibroblasts. These studies illustrate a potential mechanism by which differential expression of isoforms of TGF-beta may lead to excessive deposition of extracellular matrix and stricture formation via TIMP-1-mediated inhibition of MMP activity.

Pharmacology and gastrointestinal safety of lumiracoxib, a novel cyclooxygenase-2 selective inhibitor: An integrated study.

BACKGROUND AND AIMS: Lumiracoxib is a structurally novel, acidic selective inhibitor of cyclooxygenase (COX)-2. We coordinated existing methodologies in a single study to evaluate potency, selectivity, and effect on the human gastrointestinal tract. METHODS: Twenty four healthy subjects (aged 18-45 years, 12 female) received high dose lumiracoxib (800 mg every day), standard dose naproxen (500 mg twice a day), or placebo for 8 days in a double-blind randomized crossover study. At the start and end of each dosing period, COX-2 selectivity was assessed by ex vivo serum thromboxane B(2) (COX-1) and lipopolysaccharide stimulated prostaglandin (PG) E(2) (COX-2), mucosal injury by endoscopy, and small and large bowel permeability by 0- to 5-hour and 5- to 24-hour (51)Cr-EDTA absorption. Plasma lumiracoxib was measured 2 hours after dosing on day 8 and vortex-stimulated ex vivo gastric mucosal PGE(2) synthesis at the end of each treatment period by enzyme immunoassay. RESULTS: Lumiracoxib was well absorbed and demonstrated similar potency to naproxen as a COX-2 inhibitor (77% and 66% inhibition, respectively, vs. placebo), but it differed in being more selective (24% and 97% inhibition of thromboxane B(2) vs. placebo). Gastric PGE(2) was reduced by 69% by naproxen (P < 0.001 vs. placebo) and 29% by lumiracoxib (P < 0.01 vs. placebo and naproxen). No subjects developed gastroduodenal erosions on lumiracoxib (vs. 75% on naproxen and 12.5% on placebo). (51)Cr-EDTA absorption increased significantly with naproxen but not lumiracoxib. CONCLUSIONS: Lumiracoxib is a potent selective inhibitor of COX-2 that causes little or no endoscopically detected stomach or duodenal injury or changes in bowel permeability.