Safety and feasibility of same-day discharge after endoscopic submucosal dissection: a Western multicenter prospective cohort study.

BACKGROUND AND AIMS: Recent Western studies support the safety and efficacy of endoscopic submucosal dissection (ESD) for lesions throughout the GI tract. Although admission for observation after ESD is standard in Asia, a more selective approach may optimize resource utilization. We aimed to evaluate the safety and feasibility of same-day discharge (SDD) after ESD and factors associated with admission. METHODS: This was a post hoc analysis of a multicenter, prospective cohort of patients undergoing ESD (2016-2021). The primary end points were safety of SDD and factors associated with post-ESD admission. RESULTS: Of 831 patients (median age, 67 years; 57% male) undergoing 831 ESDs (240 performed in the esophagus, 126 in the stomach, and 465 in the colorectum; median lesion size, 44 mm), 588 (71%) were SDD versus 243 (29%) admissions. Delayed bleeding and perforation occurred in 12 (2%) and 4 (.7%) of SDD patients, respectively; only 1 (.2%) required surgery. Of the 243 admissions, 223 (92%) were discharged after ≤24 hours of observation. Interestingly, larger lesion size (>44 mm) was not associated with higher admission rate (odds ratio [OR], .5; 95% confidence interval [CI], .3-.8; P = .001). Lesions in the upper GI tract versus colon (OR, 1.7; 95% CI, 1.1-2.6; P = .01), invasive cancer (OR, 1.9; 95% CI, 1.2-3.1; P = .01), and adverse events (OR, 2.7; 95% CI, 1.5-4.8; P = .001) were independent factors for admission. Admissions were more likely performed by endoscopists with ESD volume <50 cases (OR, 2.1; 95% CI, 1.3-3.3; P = .001) with procedure time >75 minutes (OR, 13.5; 95% CI, 8.5-21.3; P < .0001). CONCLUSIONS: SDD after ESD can be safe and feasible. Patients with invasive cancer, lesions in the upper GI tract, longer procedure times, or procedures performed by low-volume ESD endoscopists are more likely to be admitted postprocedure. Risk stratification of patients for SDD after ESD should help optimize resource utilization and enhance ESD uptake in the West. (Clinical trial registration number: NCT02989818.).

The Bowel CLEANsing National Initiative: High-Volume Split-Dose Vs Low-Volume Split-Dose Polyethylene Glycol Preparations: A Randomized Controlled Trial.

BACKGROUND & AIMS: The aim of this study was to compare high-volume polyethylene glycol (PEG) with low-volume PEG with bisacodyl split-dosing regimens. METHODS: Adult outpatients in 10 Canadian tertiary hospitals were randomized, stratified by morning or afternoon colonoscopy, to high-volume split-dose PEG (2 L + 2 L) (High-SD) or low volume (1 L + 1 L) + bisacodyl (15 mg) PEG (Low-SD), with a second randomization to liquid or low-residue diets. The primary end point, using noninferiority hypothesis testing, was adequate bowel cleansing (Boston Bowel Preparation Scale total score of ≥6, with each of 3 colonic segments subscores ≥2). Secondary objectives were willingness to repeat the preparation, withdrawal time, cecal intubation, and polyp detection rates. RESULTS: Over 29 months, 2314 subjects were randomized to High-SD (N = 1157) or Low-SD (N = 1157) (mean age, 56.2 ± 13.4 y; 52.1% women). Colonoscopy indications were 38.2% diagnostic, 36.8% screening, and 25.0% surveillance, with no between-group imbalances in patient characteristics. Low-SD satisfied noninferiority criteria vs High-SD for adequate bowel cleanliness with only marginally inferior results (90.1% vs 88.1%; P = .02; difference, 2.0%; 95% CI [0.0%; 4.5%]). High-SD was associated with lower willingness to repeat (66.9% vs 91.9%; P < .01), was less well tolerated (7.3 ± 2.3 vs 8.1 ± 1.9; P < .01), causing more symptoms. No differences in procedural outcomes were noted except for more frequent cecal intubation rates after High-SD (97.4% vs 95.6%; P = .02). Among the High-SD group, adequate bowel preparation was greater after a clear liquid diet (93.6% vs 87.9%; P < .01), a finding not seen in the Low-SD group. CONCLUSIONS: Low-SD is noninferior to High-SD in providing adequate bowel preparation. Low-SD results in fewer symptoms, with greater willingness to repeat and tolerability. The overall impact of diet was modest.The study was approved by the research ethic boards from all sites and was registered at ClinicalTrials.gov (NCT02547571).

Endoscopic Submucosal Dissection in North America: A Large Prospective Multicenter Study.

BACKGROUND AND AIMS: Endoscopic submucosal dissection (ESD) in Asia has been shown to be superior to endoscopic mucosal resection (EMR) and surgery for the management of selected early gastrointestinal cancers. We aimed to evaluate technical outcomes of ESD in North America. METHODS: We conducted a multicenter prospective study on ESD across 10 centers in the United States and Canada between April 2016 and April 2020. End points included rates of en bloc resection, R0 resection, curative resection, adverse events, factors associated with failed resection, and recurrence post-R0 resection. RESULTS: Six hundred and ninety-two patients (median age, 66 years; 57.8% were men) underwent ESD (median lesion size, 40 mm; interquartile range, 25-52 mm) for lesions in the esophagus (n = 181), stomach (n = 101), duodenum (n = 11), colon (n = 211) and rectum (n = 188). En bloc, R0, and curative resection rates were 91.5%, 84.2%, and 78.3%, respectively. Bleeding and perforation were reported in 2.3% and 2.9% of the cases, respectively. Only 1 patient (0.14%) required surgery for adverse events. On multivariable analysis, severe submucosal fibrosis was associated with failed en bloc, R0, and curative resection and higher risk for adverse events. Overall recurrence was 5.8% (31 of 532) at a mean follow-up of 13.3 months (range, 1-60 months). CONCLUSIONS: In this large multicenter prospective North American experience, we demonstrate that ESD can be performed safely, effectively, and is associated with a low recurrence rate. The technical resection outcomes achieved in this study are in line with the current established consensus quality parameters and further support the implementation of ESD for the treatment of select gastrointestinal neoplasms; ClinicalTrials.gov, Number: NCT02989818.

Effect of endoscopic submucosal dissection on histologic diagnosis in Barrett's esophagus visible neoplasia.

BACKGROUND AND AIMS: Data are limited on the role of endoscopic submucosal dissection (ESD) as a potential diagnostic and staging tool in Barrett's esophagus (BE) neoplasia. We aimed to evaluate the frequency and factors associated with change of histologic diagnosis by ESD compared with pre-ESD histology. METHODS: This was a multicenter, prospective cohort study of patients who underwent ESD for BE visible neoplasia. A change in histologic diagnosis was defined as "upstaged" or "downstaged" if the ESD specimen had a higher or lower degree, respectively, of dysplasia or neoplasia when compared with pre-ESD specimens. RESULTS: Two hundred five patients (median age, 69 years; 81% men) with BE visible neoplasia underwent ESD from 2016 to 2021. Baseline histology was obtained using forceps (n = 182) or EMR (n = 23). ESD changed the histologic diagnosis in 55.1% of cases (113/205), of which 68.1% were upstaged and 31.9% downstaged. The frequency of change in diagnosis after ESD was similar whether baseline histology was obtained using forceps (55.5%) or EMR (52.2%) (P = .83). In aggregate, 23.9% of cases (49/205) were upstaged to invasive cancer on ESD histopathology. On multivariate analysis, lesions in the distal esophagus and gastroesophageal junction (odds ratio, 2.1; 95 confidence interval, 1.1-3.9; P = .02) and prior radiofrequency ablation (odds ratio, 2.5; 95% confidence interval, 1.2-5.5; P = .02) were predictors of change in histologic diagnosis. CONCLUSIONS: ESD led to a change of diagnosis in more than half of patients with BE visible neoplasia. Selective ESD can serve as a potential diagnostic and staging tool, particularly in those with suspected invasive disease. (Clinical trial registration number: NCT02989818.).

Association Between Time to Colonoscopy After Positive Fecal Testing and Colorectal Cancer Outcomes: A Systematic Review.

BACKGROUND & AIMS: Colonoscopy is required following a positive fecal screening test for colorectal cancer (CRC). It remains unclear to what extent time to colonoscopy is associated with CRC-related outcomes. We performed a systematic review to elucidate this relationship. METHODS: An electronic search was performed through April 2020 for studies reporting associations between time from positive fecal testing to colonoscopy and outcomes including CRC incidence (primary outcome), CRC stage at diagnosis, and/or CRC-specific mortality. Our primary objective was to quantify these relationships following positive fecal immunochemical testing (FIT). Two authors independently performed screening, abstraction, and risk of bias assessments. RESULTS: From 1,612 initial studies, 8 were included in the systematic review, with 5 reporting outcomes for FIT. Although meta-analysis was not possible, consistent trends between longer time delays and worse outcomes were apparent in all studies. Colonoscopy performed beyond 9 months from positive FIT compared to within 1 month was significantly associated with a higher incidence of CRC, with adjusted odds ratios (AORs) of 1.75 and 1.48 in the two largest studies. These studies also reported significant associations between colonoscopy performed beyond 9 months and higher incidence of advanced stage CRC (stage III or IV) at diagnosis, with AORs of 2.79 and 1.55, respectively. CONCLUSIONS: Colonoscopy for positive FIT should not be delayed beyond 9 months. Given the additional time required for urgent referrals and surgical planning for CRC, colonoscopy should ideally be performed well in advance of 9 months following a positive FIT.

Multivariable models for advanced colorectal neoplasms in screen-eligible individuals at low-to-moderate risk of colorectal cancer: towards improving colonoscopy prioritization.

BACKGROUND: Advanced colorectal neoplasms (ACNs), including colorectal cancers (CRC) and high-risk adenomas (HRA), are detected in less than 20% of persons aged 50 years or older who undergo colonoscopy. We sought to derive personalized predictive models of risk of harbouring ACNs to improve colonoscopy wait times for high-risk patients and allocation of colonoscopy resources. METHODS: We characterized colonoscopy indications, neoplasia risk factors and colonoscopy findings through chart review for consecutive individuals aged 50 years or older who underwent outpatient colonoscopy at The Ottawa Hospital (Ottawa, Canada) between April 1, 2008 and March 31, 2012 for non-life threatening indications. We linked patients to population-level health administrative datasets to ascertain additional historical predictor variables and derive multivariable logistic regression models for risk of harboring ACNs at colonoscopy. We assessed model discriminatory capacity and calibration and the ability of the models to improve colonoscopy specificity while maintaining excellent sensitivity for ACN capture. RESULTS: We modelled 17 candidate predictors in 11,724 individuals who met eligibility criteria. The final CRC model comprised 8 variables and had a c-statistic value of 0.957 and a goodness-of-fit p-value of 0.527. Application of the models to our cohort permitted 100% sensitivity for identifying persons with CRC and > 90% sensitivity for identifying persons with HRA, while improving colonoscopy specificity for ACNs by 23.8%. CONCLUSIONS: Our multivariable models show excellent discriminatory capacity for persons with ACNs and could significantly increase colonoscopy specificity without overly sacrificing sensitivity. If validated, these models could allow more efficient allocation of colonoscopy resources, potentially reducing wait times for those at higher risk while deferring unnecessary colonoscopies in low-risk individuals.

The Bowel CLEANsing National Initiative: A Low-Volume Same-Day Polyethylene Glycol (PEG) Preparation vs Low-Volume Split-Dose PEG With Bisacodyl or High-Volume Split-Dose PEG Preparations-A Randomized Controlled Trial.

INTRODUCTION: Bowel cleanliness has been shown to be superior with split-dose vs nonsplit preparations; we aimed to directly assess the poorly characterized comparative efficacies of split-dose vs same-day polyethylene glycol (PEG) regimens. METHODS: In this study, one of a series of randomized trials performed across 10 Canadian endoscopy units, patients undergoing colonoscopies between 10:30 and 16:30 were allocated to PEG low-volume same-day (15 mg bisacodyl the day before, 2 L the morning of the procedure), low-volume split-dose (15 mg bisacodyl the day before, 1 L + 1 L), or high-volume split-dose (2 L + 2 L). Coprimary endpoints were adequate bowel cleansing based on the Boston Bowel Preparation Scale using in turn different threshold cutoffs. RESULTS: Overall, 1,750 subjects were randomized equally across the 3 groups, with no differences in adequate bowel cleanliness rates (low-volume same-day, 90.5%; high-volume split-dose, 92.2%; P = 0.34; and low-volume split-dose, 87.9%; P = 0.17) for the Boston Bowel Preparation Scale ≥6 and 2 for each segment. Willingness to repeat the preparation was not significantly different between low-volume same-day (91.0%) and low-volume split-dose (92.5%; P = 0.40) but was greater than the high-volume split-dose (68.9%; P < 0.01). No significant differences were noted for withdrawal time, cecal intubation, or polyp detection rates. DISCUSSION: In this large randomized trial of PEG regimens, low-volume same-day resulted in similar bowel cleanliness compared with high-volume or low-volume split-dosing. Willingness to repeat and tolerability were superior with low-volume same-day compared with high-volume split-dose and similar to low-volume split-dose.

Associations between endoscopist feedback and improvements in colonoscopy quality indicators: a systematic review and meta-analysis.

BACKGROUND AND AIMS: Colonoscopy quality indicators such as adenoma detection rate (ADR) are surrogates for the effectiveness of screening-related colonoscopy. It is unclear whether endoscopist feedback on these indicators improves performance. We performed a meta-analysis to determine whether associations exist between endoscopist feedback and colonoscopy performance. METHODS: We conducted a search through May 2019 for studies reporting on endoscopist feedback and associations with ADR or other colonoscopy quality indicators. Pooled rate ratios (RRs) and weighted mean differences were calculated using DerSimonian and Laird random effects models. Subgroup, sensitivity, and meta-regression analyses were performed to assess for potential methodological or clinical factors associated with outcomes. RESULTS: From 1326 initial studies, 12 studies were included in the meta-analysis for ADR, representing 33,184 colonoscopies. Endoscopist feedback was associated with an improvement in ADR (RR, 1.21; 95% confidence interval [CI], 1.09-1.34). Low performers derived a greater benefit from feedback (RR, 1.62; 95% CI, 1.18-2.23) compared with moderate performers (RR, 1.19; 95% CI, 1.11-1.29), whereas high performers did not derive a significant benefit (RR, 1.06; 95% CI, 0.99-1.13). Feedback was not associated with increases in withdrawal time (weighted mean difference, +0.43 minutes; 95% CI, -0.50 to +1.36 minutes) or improvements in cecal intubation rate (RR, 1.00; 95% CI, 0.99-1.01). CONCLUSION: Endoscopist feedback is associated with modest improvements in ADR. The implementation of routine endoscopist audit and feedback should be considered alongside other quality improvement interventions in institutions dedicated to the provision of high-quality screening-related colonoscopy.

Defining and Applying Locally Relevant Benchmarks for the Adenoma Detection Rate.

INTRODUCTION: The adenoma detection rate (ADR) is the best validated colonoscopy performance quality indicator. The ASGE/ACG Task Force on Colonoscopy Quality set an ADR benchmark of ≥25% in a mixed male/female population. We propose a novel means for defining locally relevant ADR benchmarks using data from the population of interest and for applying ADR benchmarks using 95% confidence intervals (CIs) of an endoscopist's ADR. We further propose that ADR benchmarks should be raised to reflect what can be achieved by high-performing endoscopists. METHODS: We used endoscopists' performance in a baseline year to develop and apply benchmarks in an assessment year. We defined assessment year benchmarks (Minimally Acceptable, Standard of Care, and Aspirational) based on the average ADR of performance groups defined by baseline year ADR quartiles. We demonstrated the use of these benchmarks in endoscopists performing screening colonoscopies by determining if the upper bound of the 95% CI of the endoscopist's ADR included the ADR benchmark. RESULTS: The study included 8,492 colonoscopies (mean ADR 29%) in 2014 and 5,193 colonoscopies (mean ADR 32%) in 2015, completed at a regional screening center in Calgary, Canada. The Minimally Acceptable, Standard of Care, and Aspirational benchmarks for 2015 were 25%, 30%, and 39%, respectively. The 95% CI of the ADR of 1 (3%), 3 (10%), and 12 (39%) endoscopists did not include the benchmark. DISCUSSION: We have proposed methods for defining and applying benchmarks for ADR in average-risk patients that go beyond the "minimally acceptable" threshold currently recommended.

Temporal trends in postcolonoscopy colorectal cancer rates in 50- to 74-year-old persons: a population-based study.

BACKGROUND AND AIMS: Colorectal cancers (CRCs) diagnosed between 6 and 36 months after colonoscopy, termed postcolonoscopy CRCs (PCCRCs), arise primarily due to missed or inadequately treated neoplasms during colonoscopy. Introduction of multiple quality indicators and technological advances to colonoscopy practice should have reduced the PCCRC rate over time. We assessed temporal trends in the population rate of PCCRC as a measure of changing colonoscopy quality. METHODS: We conducted a population-based retrospective cohort study of persons aged 50 to 74 years without advanced risk factors for CRC who underwent complete colonoscopy in Ontario, Canada between 1996 and 2010. We defined the PCCRC rate as the proportion of individuals diagnosed with CRC within 36 months of colonoscopy that had PCCRC. We compared age-adjusted and sex-adjusted rates of PCCRC over time based on 3 periods (1996-2001, 2001-2006 and 2006-2010) and assessed the independent association between time period and PCCRC risk through multivariable regression, with respect to all PCCRCs, proximal PCCRC and distal PCCRC. RESULTS: There was a marked increase in colonoscopy volumes over the study period, particularly in younger age groups and non-hospital settings. Among 1,093,658 eligible persons the PCCRC rate remained stable at approximately 8% over the 15-year study period. The adjusted odds of PCCRC, distal PCCRC and proximal PCCRC, comparing the 2006 to 2010 period with the 1996 to 2001 period, were 1.14 (95% confidence interval [CI], 1.0-1.31), 1.11 (95% CI, 0.91-1.34), and 1.14 (95% CI, 0.94-1.38), respectively. Temporal trends in PCCRC risk did not differ by endoscopist specialty or institutional setting after covariate adjustment. CONCLUSION: The PCCRC rate in Ontario has remained consistently high over time. Widespread initiatives are needed to improve colonoscopy quality.

Variable Endoscopist performance in proximal and distal adenoma detection during colonoscopy: a retrospective cohort study.

BACKGROUND: Adenoma Detection Rate (ADR) is a validated colonoscopy quality indicator. In addition to overall ADR, Distal and Proximal Adenoma Detection Rates may provide important colonoscopy quality information. The goal of this study is to determine the association between distal and proximal adenoma detection (AD) and to identify factors contributing to overall, distal, and proximal AD. METHODS: This is a retrospective cohort study of patients with a noted family history of CRC or positive fecal occult blood test who underwent a screening colonoscopy at a regional colorectal cancer (CRC) screening center between May 2009 and December 2011. Data regarding patient demographics, procedure details, endoscopist characteristics and polyp histology were captured. The main outcomes measured were overall, distal, and proximal AD. RESULTS: 1907 patients were included. The median age was 60 years and 42% were male. Endoscopist median overall ADR was 25% (30% male, 21% female). Endoscopist distal ADR was only modestly associated with their proximal ADR (Spearman Rank: 0.51 p = 0.11). Highest overall ADR (29 to 45%) was found for endoscopists whose distal and proximal ADRs were above the group median. In multivariate analysis, factors associated with overall, distal, and proximal AD included age, sex, and endoscopist practicing experience. CONCLUSION: Inclusion of distal and proximal ADRs, in addition to overall ADR, in colonoscopy quality assessment provides the more accurate feedback on endoscopist performance.

Risk of colorectal cancer after a negative colonoscopy in low-to-moderate risk individuals: impact of a 10-year colonoscopy.

Background and study aims National societies recommend colorectal cancer (CRC) screening 10 years after a normal ("negative") colonoscopy in low-risk individuals. We studied the impact of a 10-year repeat colonoscopy on the risk of early incident CRC. Patients and methods We used health administrative data from Ontario, Canada, to conduct a population-based retrospective cohort study in 50 - 74-year-old individuals at low-to-moderate risk of CRC who had a negative colonoscopy between 1996 and 2001. We approximated exposure to repeat colonoscopy using an 8 - 12-year window. We excluded individuals who underwent lower endoscopy or colectomy, developed CRC, or were lost to follow-up between the baseline and repeat colonoscopies. We matched exposed individuals 1:1 to individuals who did not undergo lower endoscopy within 12 years for age, sex, and calendar year of baseline colonoscopy, and followed matched pairs for incident CRC. The primary analysis was multivariable hazards regression, adjusting for competing risks. Results A total of 13 350 matched pairs were observed for a median of 4.5 years (interquartile range 3.2 - 5.9 years). The cumulative probability of CRC following the matching date was 0.70 % (95 % confidence interval [CI] 0.42 % - 1.11 %) in individuals who underwent repeat colonoscopy and 0.77 % (95 %CI 0.48 % - 1.2 %) in individuals who did not undergo repeat colonoscopy. The adjusted hazard ratio for CRC was 0.91 (95 %CI 0.68 - 1.22). Conclusions We did not find an association between a second colonoscopy performed 10 years after a negative colonoscopy and early incident CRC. Our findings support the need for further studies on the utility of 10-year re-screening with colonoscopy in this setting.

Validated Scales for Colon Cleansing: A Systematic Review.

OBJECTIVES: Bowel cleanliness is a critical determinant of colonoscopy quality, mandating its standardized assessment, yet bowel preparation scales have been variably validated. The objective of this study was to assess validity and reliability of existing bowel preparation scales. METHODS: A systematic review of literature from January 1980 to January 2015 was performed. Main outcomes of this study are face, content, construct, and criterion validity, and inter- and intra-observer reliability measured by associations, interclass correlations (ICC) or κ-coefficients. RESULTS: Fourteen citations assessed seven scales. The Aronchick Scale, showed fair-to-substantial inter-observer reliability (ICC=0.31-0.76), and was the reference for subsequent validity testing. The Ottawa Bowel Preparation Quality Scale revealed superior inter-observer reliability (ICC=0.94). Five studies assessed the Boston Bowel Preparation Scale (BBPS). Increasing BBPS scores were associated with polyp detection (left colon: odds ratio (OR)=2.58 (1.34; 4.98), right colon: OR=1.6 (1.01; 2.55), less repeat colonoscopies (cutoff of 5, P<0.001), and shorter insertion/withdrawal times (P<0.001), while displaying substantial to excellent inter- and intra-observer reliability (ICC=0.74-0.91). Criterion validity of the Harefield Cleansing Scale (HCS) yielded slight-to-moderate expert-investigator agreement (ICC=0.15-0.46); HCS grades were not discriminant for adenoma detection. Inter- and intra-observer reliabilities were fair-to-moderate (ICC=0.46 (0.37; 0.54) and κ=0.28, respectively). The Chicago Bowel Preparation Scale displayed excellent inter-observer reliability (Pearson's r=0.84 (0.79; 0.88)), yet has been less studied. CONCLUSIONS: To conclude, all the published scales displayed limitations. The BBPS is the most thoroughly validated scale and should be used in a clinical setting. Between-scale comparisons for repeat colonoscopy time interval, ease, and pertinence of use for auditing are needed.

Defining Benchmarks for Adenoma Detection Rate and Adenomas Per Colonoscopy in Patients Undergoing Colonoscopy Due to a Positive Fecal Immunochemical Test.

OBJECTIVES: Although there is an accepted benchmark for adenoma detection rate (ADR) in average risk screening colonoscopy, a benchmark for ADR or the associated quality indicator, adenomas per colonoscopy (APC), for colonoscopies performed for a positive fecal immunochemical test (FIT+) has not been established. The purpose of this study was to propose methods for establishing a benchmark ADR and APC for FIT+ patients. METHODS: In this historical cohort study, we included 15,329 patients aged 50-74 years who underwent a colonoscopy at Alberta Health Services' Colon Cancer Screening Centre, Calgary, Canada, from 1 January 2014 to 30 June 2015 for either investigation of a positive FIT or average risk screening. Using meta-regression, we estimated for FIT+ patients the ADR and APC that corresponded to (Method #1: minimally acceptable) an ADR of 25% in average risk individuals, (Method #2: standard of care) the average ADR or APC in all FIT+ patients, and (Method #3: aspirational) the average FIT+ ADR or APC in colonoscopies performed by endoscopists with an ADR of ≥35% in average risk patients. RESULTS: At least one adenoma was detected in 30% of average risk patients and 58% of FIT+ patients. The calculated benchmark FIT+ ADRs for the three methods were 55, 60, and 65%, respectively. The calculated benchmarks for FIT+ APC were 1.2, 1.4, and 1.7, respectively. To account for expected random variation in individual endoscopists' ADR or APC, we propose using the upper bound of the 95% confidence interval of an endoscopist's ADR or APC to determine if they fall below a given benchmark. CONCLUSIONS: We have proposed methods of defining benchmarks for ADR and APC in FIT+ patients that go beyond the current "minimally acceptable" threshold currently recommended in average risk patients. These new thresholds represent results obtained by all peers and by a group of expert adenoma detectors defined in an independent patient cohort (average risk). Because the true adenoma burden in FIT+ patients could vary based on factors such as the threshold used to define a positive FIT, screening programs or endoscopy units may need to calculate their own benchmarks using local data.

The probiotic VSL#3 has anti-inflammatory effects and could reduce endoscopic recurrence after surgery for Crohn's disease.

BACKGROUND & AIMS: Probiotic formulations of single species of bacteria have not been effective in preventing the recurrence of Crohn's disease after surgery. We investigated the ability of VSL#3, a mixture of 8 different bacterial probiotic species, to prevent Crohn's disease recurrence after surgery in a multicenter, randomized, double-blind, placebo-controlled trial. METHODS: Within 30 days of ileocolonic resection and re-anastomosis, patients with Crohn's disease were randomly assigned to groups given 1 sachet of VSL#3 (900 billion viable bacteria, comprising 4 strains of Lactobacillus, 3 strains of Bifidobacterium, and 1 strain of Streptococcus salivarius subspecies thermophilus) (n = 59) or matching placebo (n = 60). Colonoscopy was performed at days 90 and 365 to evaluate the neoterminal ileum for disease recurrence and obtain mucosal biopsies for cytokine analysis. Patients from both groups with either no or mild endoscopic recurrence at day 90 received VSL#3 until day 365. The primary outcome was the proportion of patients with severe endoscopic recurrence at day 90. RESULTS: At day 90, the proportion of patients with severe endoscopic lesions did not differ significantly between VSL#3 (9.3%) and placebo (15.7%, P = .19). The proportions of patients with non-severe lesions at day 90 who had severe endoscopic recurrence at day 365 were 10.0% in the early VSL#3 group (given VSL#3 for the entire 365 days) and 26.7% in the late VSL#3 group (given VSL#3 from days 90 through 365) (P = .09). Aggregate rates of severe recurrence (on days 90 and 365) were not statistically different, 20.5% of subjects in the early VSL#3 group and 42.1% in the late VSL#3 group. Patients receiving VSL#3 had reduced mucosal inflammatory cytokine levels compared with placebo at day 90 (P < .05). Crohn's disease activity index and inflammatory bowel disease quality of life scores were similar in the 2 groups. CONCLUSIONS: There were no statistical differences in endoscopic recurrence rates at day 90 between patients who received VSL#3 and patients who received placebo. Lower mucosal levels of inflammatory cytokines and a lower rate of recurrence among patients who received early VSL#3 (for the entire 365 days) indicate that this probiotic should be further investigated for prevention of Crohn's disease recurrence. Clinical trials.gov number: NCT00175292.

The association of colonoscopy quality indicators with the detection of screen-relevant lesions, adverse events, and postcolonoscopy cancers in an asymptomatic Canadian colorectal cancer screening population.

BACKGROUND: Although several quality indicators of colonoscopy have been defined, quality assurance activities should be directed at the measurement of quality indicators that are predictive of key screening colonoscopy outcomes. OBJECTIVE: The goal of this study was to examine the association among established quality indicators and the detection of screen-relevant lesions (SRLs), adverse events, and postcolonoscopy cancers. DESIGN: Historical cohort study. SETTING: Canadian colorectal cancer screening center. PATIENTS: A total of 18,456 asymptomatic men and women ages 40 to 74, at either average risk or increased risk for colorectal cancer because of a family history, who underwent a screening colonoscopy from 2008 to 2010. MAIN OUTCOME MEASUREMENTS: Using univariate and multivariate analyses, we explored the association among procedural quality indicators and 3 colonoscopy outcomes: detection of SRLs, adverse events, and postcolonoscopy cancers. RESULTS: The crude rates of SRLs, adverse events, and postcolonoscopy cancers were 240, 6.44, and .54 per 1000 colonoscopies, respectively. Several indicators, including endoscopist withdrawal time (OR, 1.3; 95% CI, 1.2-1.4) and cecal intubation rate (OR, 13.9; 95% CI, 1.9-96.9), were associated with the detection of SRLs. No quality indicator was associated with the risk of adverse events. Endoscopist average withdrawal time over 6 minutes (OR, .12; 95% CI, .002-.85) and SRL detection rate over 20% (OR, .17; 95% CI, .03-.74) were associated with a reduced risk of postcolonoscopy cancers. LIMITATIONS: Single-center study. CONCLUSION: Quality assurance programs should prioritize the measurement of endoscopist average withdrawal time and adenoma (SRL) detection rate.

Development and validation of a nurse-assessed patient comfort score for colonoscopy.

BACKGROUND: Comfort during colonoscopy is a critical component of safety and quality. OBJECTIVE: To develop and validate the Nurse-Assessed Patient Comfort Score (NAPCOMS). DESIGN: Prospective scale validation. SETTING: Colorectal cancer screening centers in the United Kingdom and Canada. PATIENTS: A total of 300 consecutive patients undergoing colonoscopy at participating colorectal cancer screening centers. INTERVENTION: The NAPCOMS was developed by using a modified Delphi process. During colonoscopy, two endoscopy room nurses independently observed and rated patient comfort and tolerability by using NAPCOMS. In addition, endoscopists reported global comfort scores and patients' reported global comfort by using visual 4-point Likert and National Health Service-United Kingdom Global Rating Scales. MAIN OUTCOME MEASUREMENTS: Reliability and validity of NAPCOMS was measured by using intraclass correlations (ICC) between nurse ratings of colonoscopies and between NAPCOMS, endoscopist ratings, and patient ratings of global comfort. RESULTS: The ICC for the overall NAPCOMS was 0.84 (95% confidence interval [CI], 0.80-0.87). There was high agreement between the NAPCOMS and endoscopist ratings of comfort (ICC = 0.77; 95% CI, 0.72-0.81), moderate agreement between the NAPCOMS and patient ratings (ICC = 0.61; 95% CI, 0.53-0.67), and moderate agreement between the endoscopist and patient ratings (ICC = 0.52; 95% CI, 0.43-0.60). LIMITATIONS: NAPCOMS was validated in outpatients who received colonoscopy with minimal to moderate sedation as part of a screening and surveillance program, so performance among inpatients or those requiring deep sedation was not tested. CONCLUSION: NAPCOMS is a reliable and valid tool for assessing patient comfort in the setting of outpatient colonoscopy performed with minimal to moderate sedation.