Existing Bowel Preparation Quality Scales Are Reliable in the Setting of Centralized Endoscopy Reading.

BACKGROUND: Development of bowel preparation products has been based upon colon cleansing rating by a local endoscopist. It is unclear how bowel preparation scales perform when centrally evaluated. AIMS: To evaluate the reliability of bowel preparation quality scales when assessed by central readers. METHODS: Four central readers evaluated 52 videos in triplicate, 2 weeks apart, during the entire endoscopic procedure (insertion/withdrawal of the colonoscope) and exclusively on colonoscope withdrawal using the Boston Bowel Preparation Scale (BBPS), Chicago Bowel Preparation scale, Harefield Cleansing Scale, Ottawa Bowel Preparation Quality Scale (OBPQS), Aronchick score, a visual analogue scale, and additional items proposed in a modified Research and Development/University of California Los Angeles appropriateness process. Reliability was assessed with intraclass correlation coefficients. RESULTS: Intraclass correlation coefficients (95% confidence interval) for inter-rater reliability of the quality scales ranged from 0.51 to 0.65 (consistent with moderate to substantial inter-rater reliability) during the entire procedure. Corresponding intraclass correlation coefficients for intra-rater reliability ranged from 0.69 to 0.77 (consistent with substantial intra-rater reliability). Reliability was highest in the right colon and lowest in the left colon. No differences were observed in reliability when assessed for the procedure overall (insertion/withdrawal) relative to assessment on withdrawal alone. CONCLUSION: All five bowel preparation quality scales had moderate to substantial inter-rater reliability. Panelists considered the Aronchick score too simplistic for clinical trials and recognized that assessment of residual fluid in the Ottawa Bowel Preparation Quality Scale was not amenable to central assessment.

Management of Nonvariceal Upper Gastrointestinal Bleeding: Guideline Recommendations From the International Consensus Group.

Description: This update of the 2010 International Consensus Recommendations on the Management of Patients With Nonvariceal Upper Gastrointestinal Bleeding (UGIB) refines previous important statements and presents new clinically relevant recommendations. Methods: An international multidisciplinary group of experts developed the recommendations. Data sources included evidence summarized in previous recommendations, as well as systematic reviews and trials identified from a series of literature searches of several electronic bibliographic databases from inception to April 2018. Using an iterative process, group members formulated key questions. Two methodologists prepared evidence profiles and assessed quality (certainty) of evidence relevant to the key questions according to the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. Group members reviewed the evidence profiles and, using a consensus process, voted on recommendations and determined the strength of recommendations as strong or conditional. Recommendations: Preendoscopic management: The group suggests using a Glasgow Blatchford score of 1 or less to identify patients at very low risk for rebleeding, who may not require hospitalization. In patients without cardiovascular disease, the suggested hemoglobin threshold for blood transfusion is less than 80 g/L, with a higher threshold for those with cardiovascular disease. Endoscopic management: The group suggests that patients with acute UGIB undergo endoscopy within 24 hours of presentation. Thermocoagulation and sclerosant injection are recommended, and clips are suggested, for endoscopic therapy in patients with high-risk stigmata. Use of TC-325 (hemostatic powder) was suggested as temporizing therapy, but not as sole treatment, in patients with actively bleeding ulcers. Pharmacologic management: The group recommends that patients with bleeding ulcers with high-risk stigmata who have had successful endoscopic therapy receive high-dose proton-pump inhibitor (PPI) therapy (intravenous loading dose followed by continuous infusion) for 3 days. For these high-risk patients, continued oral PPI therapy is suggested twice daily through 14 days, then once daily for a total duration that depends on the nature of the bleeding lesion. Secondary prophylaxis: The group suggests PPI therapy for patients with previous ulcer bleeding who require antiplatelet or anticoagulant therapy for cardiovascular prophylaxis.

PANCREATIC SAFETY IN STUDIES OF THE GLUCAGON-LIKE PEPTIDE-1 RECEPTOR AGONIST ALBIGLUTIDE.

Objective: Albiglutide, a glucagon-like peptide-1 receptor agonist (GLP-1RA), reduces glycated hemoglobin with a low risk of hypoglycemia in patients with type 2 diabetes. The relationship between GLP-1RAs and risk of pancreatitis is unresolved. This independent, rigorous, expert review of the albiglutide HARMONY Phase III clinical program examined suspected cases of acute pancreatitis. Methods: An independent pancreatitis adjudication committee (PAC), composed of physicians with expertise in gastroenterology and pancreatic disease, was prospectively established to review cases of suspected acute pancreatitis in the HARMONY studies. Results: Patients treated in Phase III trials with albiglutide (n = 2,365), or active or placebo comparators (n = 2,530), averaged 56 years of age with a mean 8.3-year diabetes duration. Across the 8 studies, the PAC reviewed potential cases of treatment-emergent acute pancreatitis in 43 patients. Definite or probable acute pancreatitis was adjudicated for 11 patients (8 albiglutide; 3 active comparators). Most of these were considered by the PAC to be at least possibly related to study treatment (6 of 8 albiglutide cases and 2 of 3 active comparator cases). Both cases in the active comparator group adjudicated as definite or probable pancreatitis with at least a possible relationship to study treatment were in patients treated with a GLP-1RA. The frequency of pancreatitis was higher among patients treated with albiglutide (6/2,365, 0.3%) than with placebo (0/486, 0%) or active comparators (2/2,062, 0.08%). Conclusion: In the HARMONY Phase III program, adjudicated cases of acute pancreatitis were uncommon. However, within the limitations of available data, the incidence of acute pancreatitis with albiglutide appears to be within the range described for other studies of GLP-1RAs. Abbreviations: AE = adverse event; CI = confidence interval; DPP-4 = dipeptidyl peptidase-4; GLP-1 = glucagon-like peptide-1; GLP-1RA = glucagon-like peptide-1 receptor agonist; MH-OR = Mantel-Haenszel odds ratio; OR = odds ratio; PAC = pancreatitis adjudication committee; SAE = serious adverse event; ULN = upper limit of normal.

Clinical Practice Guidelines for the Use of Video Capsule Endoscopy.

BACKGROUND & AIMS: Video capsule endoscopy (CE) provides a noninvasive option to assess the small intestine, but its use with respect to endoscopic procedures and cross-sectional imaging varies widely. The aim of this consensus was to provide guidance on the appropriate use of CE in clinical practice. METHODS: A systematic literature search identified studies on the use of CE in patients with Crohn's disease, celiac disease, gastrointestinal bleeding, and anemia. The quality of evidence and strength of recommendations were rated using the Grading of Recommendation Assessment, Development, and Evaluation (GRADE) approach. RESULTS: The consensus includes 21 statements focused on the use of small-bowel CE and colon capsule endoscopy. CE was recommended for patients with suspected, known, or relapsed Crohn's disease when ileocolonoscopy and imaging studies were negative if it was imperative to know whether active Crohn's disease was present in the small bowel. It was not recommended in patients with chronic abdominal pain or diarrhea, in whom there was no evidence of abnormal biomarkers typically associated with Crohn's disease. CE was recommended to assess patients with celiac disease who have unexplained symptoms despite appropriate treatment, but not to make the diagnosis. In patients with overt gastrointestinal bleeding, and negative findings on esophagogastroduodenoscopy and colonoscopy, CE should be performed as soon as possible. CE was recommended only in selected patients with unexplained, mild, chronic iron-deficiency anemia. CE was suggested for surveillance in patients with polyposis syndromes or other small-bowel cancers, who required small-bowel studies. Colon capsule endoscopy should not be substituted routinely for colonoscopy. Patients should be made aware of the potential risks of CE including a failed procedure, capsule retention, or a missed lesion. Finally, standardized criteria for training and reporting in CE should be defined. CONCLUSIONS: CE generally should be considered a complementary test in patients with gastrointestinal bleeding, Crohn's disease, or celiac disease, who have had negative or inconclusive endoscopic or imaging studies.

Prospective Comparison of Standard- Versus Low-Radiation-Dose CT Enterography for the Quantitative Assessment of Crohn Disease.

OBJECTIVE: CT enterography (CTE) is sensitive and specific for active inflammatory changes of Crohn disease (CD), but its use has been limited by exposure to ionizing radiation. The objective of this study is to show the noninferiority of a model-based iterative reconstruction (MBIR) technique using lower radiation doses compared with standard-dose CTE in the assessment of CD. SUBJECTS AND METHODS: Patients referred to a hospital radiology department for CTE for the evaluation of CD underwent both a standard examination (used to generate filtered back-projection and adaptive statistical iterative reconstruction [ASIR] images) and low-dose MBIR CTE performed in a random sequence on the same day. Images were reviewed by two radiologists for signs of small-bowel CD. Radiologic findings obtained using ASIR and clinical assessments of disease activity served as the reference standard for comparison with low-dose CTE findings. RESULTS: A total of 163 patients, 92 (56.4%) of whom had active disease, underwent CTE. MBIR was found to be noninferior to the two standard-dose techniques, with no significant differences noted between the three types of images when compared with the clinical reference standard. As compared with the radiologic standard of ASIR, the very-low-dose scans had a high degree of accuracy, with sensitivity ranging from 0.85 to 0.94 and specificity ranging from 0.84 to 0.97 depending on the reader. A significant reduction in radiation exposure was noted with MBIR (mean [± SD] reduction, 3.30 ± 3.17 mSv) versus standard-dose imaging (7.16 ± 4.61 mSv; p < 0.001). CONCLUSION: Low-dose CTE using MBIR is sensitive and specific for the detection of active inflammatory changes of CD while utilizing radiation doses substantially lower than those associated with standard techniques.

Sham Feeding with Bacon Does Not Alter Transit Time or Complete Examination Rate During Small Bowel Capsule Endoscopy.

BACKGROUND: During capsule endoscopy (CE) studies, the complete examination rate (CER) can be increased by prolonging capsule battery life or reducing gastric transit time (GTT) and/or small bowel transit time (SBTT). However, despite enhanced battery life, 10% of studies remain incomplete. Previously studied interventions to reduce SBTT and enhance CER have produced conflicting results. We hypothesize that this may be a consequence of an insufficiently potent stimulus of small bowel motility. AIMS: To examine whether potent stimulation of the cephalic response of digestion during small bowel CE reduces GTT and/or SBTT and thus increases the CER. METHODS: A single-blind randomized trial was performed to evaluate the effect of bacon sham feeding on GTT, SBTT and CER. RESULTS: Baseline characteristics were similar between 63 sham fed patients and 59 controls. The median GTT was 17 min (9-65) in the bacon group and 25 min (14-55) in the control group. The median SBTT was 199 min (119-316) and 222 min (151-287), respectively. Cox proportional hazards model demonstrated no significant difference between groups for GTT (rate ratio 1.03, 95% CI 0.71-1.51, P = 0.87) or SBTT (rate ratio 1.02, 95% CI 0.70-1.49, P = 0.93). Although the taste of bacon was considered favorably by 72% of participants, taste did not correlate with GTT (ρ = 0.03, P = 0.83) or SBTT (ρ = - 0.115, P = 0.33). The CER was 91 and 95% in the bacon and control groups, respectively (P = 0.35). CONCLUSION: Bacon sham feeding has no effect on GTT, SBTT or CER and cannot be recommended in clinical practice.

ACG and CAG Clinical Guideline: Management of Dyspepsia.

We have updated both the American College of Gastroenterology (ACG) and the Canadian Association of Gastroenterology (CAG) guidelines on dyspepsia in a joint ACG/CAG dyspepsia guideline. We suggest that patients ≥60 years of age presenting with dyspepsia are investigated with upper gastrointestinal endoscopy to exclude organic pathology. This is a conditional recommendation and patients at higher risk of malignancy (such as spending their childhood in a high risk gastric cancer country or having a positive family history) could be offered an endoscopy at a younger age. Alarm features should not automatically precipitate endoscopy in younger patients but this should be considered on a case-by-case basis. We recommend patients <60 years of age have a non-invasive test Helicobacter pylori and treatment if positive. Those that are negative or do not respond to this approach should be given a trial of proton pump inhibitor (PPI) therapy. If these are ineffective tricyclic antidepressants (TCA) or prokinetic therapies can be tried. Patients that have an endoscopy where no pathology is found are defined as having functional dyspepsia (FD). H. pylori eradication should be offered in these patients if they are infected. We recommend PPI, TCA and prokinetic therapy (in that order) in those that fail therapy or are H. pylori negative. We do not recommend routine upper gastrointestinal (GI) motility testing but it may be useful in selected patients.

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.

Methotrexate in combination with infliximab is no more effective than infliximab alone in patients with Crohn's disease.

BACKGROUND & AIMS: Methotrexate and infliximab are effective therapies for Crohn's disease (CD). In the combination of maintenance methotrexate-infliximab trial, we evaluated the potential superiority of combination therapy over infliximab alone. METHODS: In a 50-week, double-blind, placebo-controlled trial, we compared methotrexate and infliximab with infliximab alone in 126 patients with CD who had initiated prednisone induction therapy (15-40 mg/day) within the preceding 6 weeks. Patients were assigned randomly to groups given methotrexate at an initial weekly dose of 10 mg, escalating to 25 mg/week (n = 63), or placebo (n = 63). Both groups received infliximab (5 mg/kg of body weight) at weeks 1, 3, 7, and 14, and every 8 weeks thereafter. Prednisone was tapered, beginning at week 1, and discontinued no later than week 14. The primary outcome was time to treatment failure, defined as a lack of prednisone-free remission (CD Activity Index, <150) at week 14 or failure to maintain remission through week 50. RESULTS: Patients' baseline characteristics were similar between groups. By week 50, the actuarial rate of treatment failure was 30.6% in the combination therapy group compared with 29.8% in the infliximab monotherapy group (P = .63; hazard ratio, 1.16; 95% confidence interval, 0.62-2.17). Prespecified subgroup analyses failed to show a benefit in patients with short disease duration or an increased level of C-reactive protein. No clinically meaningful differences were observed in secondary outcomes. Combination therapy was well tolerated. CONCLUSIONS: The combination of infliximab and methotrexate, although safe, was no more effective than infliximab alone in patients with CD receiving treatment with prednisone. ClincialTrials.gov number, NCT00132899.

When trainees reach competency in performing ERCP: a systematic review.

BACKGROUND AND AIMS: ERCP is an advanced endoscopic procedure that is technically more challenging and carries a higher risk of adverse events compared with standard endoscopy. A discrepancy currently exists among guidelines regarding the number of ERCPs that a trainee needs to complete before procedural competency should be assessed. Our aim was to assess the learning curve for performing ERCP. METHODS: Two authors independently searched MEDLINE (1946 to November 25, 2014) along with the gray literature to identify relevant citations. To warrant inclusion, citations were required to report successful trainee cannulation rate. Successful cannulation rate, set at a value of 80% or higher, was used as our baseline reference for competency. RESULTS: Nine studies, assessing 137 trainees and 17,100 ERCPs, were included in our analysis. Overall, competency was achieved among the included studies between 70 to 400 ERCPs. In the 2 studies that used pancreatic duct cannulation rate, competency was achieved by 70 to 160 ERCPs. Of the 5 studies that used selective duct cannulation rate, competency was achieved by 79 to 300 ERCPs. Finally, in the 4 studies that used common bile duct cannulation rate, 2 studies reached the reference competency threshold by 160 to 400 ERCPs. On further stratification, when assessing native papilla deep common bile duct cannulation, only 1 study reached the reference competency threshold by 350 to 400 ERCPs. CONCLUSIONS: Our findings suggest that as ERCP has evolved from a predominantly diagnostic to therapeutic procedure, procedural thresholds have risen well above North American training guidelines. Therefore, advanced endoscopy training programs need to reassess their current structure to ensure that procedural competency is being reached.

The effect of chewing gum on small-bowel transit time in capsule endoscopy: a prospective, randomized trial.

BACKGROUND: Approximately 1 in 6 capsule endoscopies (CEs) does not visualize the entire small bowel at completion of the examination because of limited battery life. OBJECTIVE: To determine whether chewing gum can reduce the small-bowel transit time and increase CE completion rates. DESIGN: Prospective, single-blind, randomized, controlled trial. SETTING: A tertiary university-affiliated hospital. PATIENTS: Consecutive patients 19 years of age and older undergoing outpatient small-bowel CE from October 2010 to July 2012 were assessed for eligibility. Those with previous gastric or small-bowel surgery or ileostomy, dysphagia prohibiting capsule ingestion, diabetes mellitus with evidence of end-organ damage, use of narcotics or prokinetics within 5 days before the procedure, clinical hyper-/hypothyroidism, and symptoms suggestive of acute bowel obstruction were excluded. INTERVENTION: Gum chewing for at least 20 minutes every 2 hours starting at the time of capsule ingestion. MAIN OUTCOME MEASUREMENTS: Small-bowel transit time, gastric transit time, and completion rate were measured. RESULTS: Chewing gum did not have any significant effect on gastric transit time (rate ratio 1.06; 95% CI, 0.73-1.55; P = .75), small-bowel transit time (rate ratio 0.91; 95% CI, 0.62-1.35; P = .65), or completion rate (91.67% chewing gum vs 88.71% control, P = .58) of CE. LIMITATION: Single-center study involving relatively healthy subjects. Procedures were done on an outpatient basis so participants were not monitored for adherence to protocol. CONCLUSIONS: Chewing gum does not speed up capsule transit or increase completion rate of CE in patients without risk factors for incomplete studies. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT01241825.).

2 L versus 4 L of PEG3350 + electrolytes for outpatient colonic preparation: a randomized, controlled trial.

BACKGROUND: Low-volume bowel preparations are ideal to ensure patient compliance, thus enabling high-quality examinations to be achieved. OBJECTIVES: To examine the bowel-cleansing efficacy and patient tolerability of split-dose 2 L PEG3350 + electrolytes (PEG3350e) with 15 mg bisacodyl versus split-dose 4 L PEG3350e. DESIGN: Single-blinded, noninferiority, randomized, controlled trial. SETTING: Single site, university-affiliated tertiary care center. PATIENTS: A total of 325 consecutive patients undergoing elective outpatient colonoscopy. INTERVENTION: 2 L of PEG3350e with 15 mg bisacodyl versus 4 L of PEG3350e, both given in a split-dose fashion. MAIN OUTCOME MEASUREMENTS: Efficacy and tolerability of a split dose of 2 L of PEG3350e with 15 mg bisacodyl. Efficacy was assessed by using the Boston Bowel Preparation Scale and Ottawa Bowel Preparation Scale. Patient satisfaction and tolerability were assessed by using a short survey. RESULTS: A total of 325 patients were included in the intention-to-treat analysis (51% male) with a mean ± standard deviation age of 56 ± 11.2 years. No statistically significant difference in cleanliness was found by using the Boston Bowel Preparation Scale (intention-to-treat, P = .381; per-protocol, P = .387) and the Ottawa Bowel Preparation Scale (intention-to-treat, P = .285; per-protocol, P = .334). Participants receiving 2 L of PEG3350e found the preparation easy to consume and were willing to repeat the procedure more often than the 4-L group (P < .001). LIMITATIONS: Single-center study looking at outpatient colonoscopies; unable to comment on adenoma detection rate. CONCLUSIONS: Bowel-cleansing efficacy was similar in both the 2-L and 4-L PEG3350e groups; however, patient tolerability and willingness to repeat preparation were statistically greater with the 2 L of PEG3350e with 15 mg bisacodyl regimen.

A randomized controlled trial assessing the effect of prescribed patient position changes during colonoscope withdrawal on adenoma detection.

BACKGROUND: High-quality colonoscope withdrawal technique is associated with a higher adenoma detection rate. Position change is routinely used in barium enema and CT colonography to facilitate adequate distension of the colon and promote movement of fluid from the segment of the colon being assessed. OBJECTIVE: To determine whether prescribed position changes during colonoscope withdrawal affect the adenoma detection rate compared with the usual care per endoscopist. DESIGN: Prospective, randomized, controlled trial. SETTING: Tertiary-care, university-affiliated hospital. PATIENTS: Patients referred for outpatient colonoscopy between July 2011 and July 2012 were evaluated for eligibility. Inclusion criteria were outpatient status and age ≥40 years. Exclusion criteria were (1) complete colonoscopy within 1 year before the procedure, (2) inability to provide informed consent, (3) incomplete colonoscopy to the cecum, (4) previous bowel resection, (5) inflammatory bowel disease, (6) colonic polyposis syndrome, (7) inadequate bowel preparation, and (8) musculoskeletal disorder or other mobility issues limiting effective patient position changes during colonoscopy. INTERVENTIONS: Prescribed position changes during colonoscope withdrawal. MAIN OUTCOME MEASUREMENTS: Polyp detection rate (PDR) and adenoma detection rate (ADR). RESULTS: A total of 776 patients were enrolled, with 388 in the dynamic group. There was no difference in PDR (odds ratio [OR] 0.99; P = .93) or ADR (OR 1.17; P = .28). Colonoscope withdrawal time was longer in the dynamic group (median time 466.5 vs 422.5 seconds; P < .0001). LIMITATIONS: Single-center study. Indication for procedure not controlled. Lack of standardized bowel preparation and blinding. CONCLUSION: Prescribed position changes during colonoscope withdrawal do not affect polyp/adenoma detection compared with the usual practice when the baseline ADR is above the recommended standard. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT01395173.).

Effectiveness of disseminating consensus management recommendations for ulcer bleeding: a cluster randomized trial.

BACKGROUND: International guidelines for the management of nonvariceal upper gastrointestinal bleeding have not been widely adopted in clinical practice. We sought to determine whether a national, multifaceted intervention could improve adherence to guidelines, especially for patients at high risk of nonvariceal upper gastrointestinal bleeding. METHODS: In this randomized trial, we stratified hospitals by region and size and allocated sites to either the control or experimental group. Health care workers in the experimental group were given published guidelines, generic algorithms, stratification scoring systems and written reminders and attended multidisciplinary guideline education groups and case-based workshops. These interventions were implemented over a 12-month period after randomization, with performance feedback and benchmarking. The primary outcome of adherence rates to key guidelines in endoscopic and pharmacologic management, determined by chart review, was adjusted according to site characteristics and possible within-site dependencies. We also report the rates of adherence to other recommendations. RESULTS: Forty-three sites were randomized to the experimental (n=21) or control (n=22) groups. In our primary analysis, we compared patients before (experimental group: n=402 patients; control group: n=424 patients) and after (experimental group: n=361 patients; control group: n=389 patients) intervention. Patient-level analysis revealed no significant difference in adherence rates to the guidelines after the intervention (experimental group: 9.8%; control group: 4.8%; p=0.99) after adjustment for the rate of adherence before the intervention (experimental group: 13.2%; control group: 7.1%). The adherence rates to other guidelines were similar and decreased over time, varying between 5% and 93%. INTERPRETATION: This national knowledge translation-based trial suggests poor adherence to guidelines on nonvariceal upper gastrointestinal bleeding. Adherence was not improved by an educational intervention, which highlights both the complexity and poor predictability of attempting to alter the behaviour of health care providers (Trial registration: ClinicalTrials.gov, no. MCT-88113).

Colorectal cancer surveillance after index colonoscopy: guidance from the Canadian Association of Gastroenterology.

BACKGROUND: Differences between American (United States [US]) and European guidelines for colonoscopy surveillance may create confusion for the practicing clinician. Under- or overutilization of surveillance colonoscopy can impact patient care. METHODS: The Canadian Association of Gastroenterology (CAG) convened a working group (CAG-WG) to review available guidelines and provide unified guidance to Canadian clinicians regarding appropriate follow-up for colorectal cancer (CRC) surveillance after index colonoscopy. A literature search was conducted for relevant data that postdated the published guidelines. RESULTS: The CAG-WG chose the 2012 US Multi-Society Task Force (MSTF) on Colorectal Cancer to serve as the basis for the Canadian position, primarily because the US approach was the simplest and comprehensively addressed the issue of serrated polyps. Aspects of other guidelines were incorporated where relevant. The CAG-WG recommendations differed from the US MSTF guidelines in three main areas: patients with negative index colonoscopy should be followed-up at 10 years using any of the appropriate screening tests, including colonoscopy, for average-risk individuals; among patients with >10 adenomas, a one-year interval for subsequent colonoscopy is recommended; and for long-term follow-up, patients with low-risk adenomas on both the index and first follow-up procedures can undergo second follow-up colonoscopy at an interval of five to 10 years. DISCUSSION: The CAG-WG adapted the US MSTF guidelines for colonoscopy surveillance to the Canadian health care environment with a few modifications. It is anticipated that the present article will provide unified guidance that will enhance physician acceptance and encourage appropriate utilization of recommended surveillance intervals.

Conflicts of interest ethics: silencing expertise in the development of international clinical practice guidelines.

BACKGROUND: It is unclear whether global experts with financial conflicts of interest (FCOIs) should be included in, be excluded from, or have a limited role in developing international clinical practice guidelines (CPGs). Optimal management of FCOIs to ensure independent, expert CPGs remains ethically contested. OBJECTIVE: To manage FCOIs and examine whether an ethics framework with discussion recusal by experts with FCOIs affects deliberations and voting on a CPG. DESIGN: Development of an ethics framework grounded on transparency and proportional management of COIs, including self-recusal, evaluation of the effect on COIs and CPG process by quantification of voting on recommendations, and qualitative assessment of experts' ethics dialogue. SETTING: International consensus meeting to formulate a CPG in gastroenterology. PARTICIPANTS: 34 experts from 15 countries. MEASUREMENTS: Counting the votes of experts with and without declared FCOIs and qualitative assessment of ethics discussions. RESULTS: 62% of experts reported at least 1 FCOI. Eight out of 21 recommendations presented potential FCOIs. Experts with conflicts recused themselves from discussing 6 of the 8 recommendations, leaving a majority of nonconflicted discussants (median, 22; range, 19 to 26) for the 6 recommendations. Recusals did not affect voting outcomes but may have diluted the richness of the discussions. Ethics dialogue revealed accord on transparency but underscored challenges to proportional management of COIs beyond basic disclosure. Concerns about bias, COI definitions, expertise, and integrity express important international ethics questions. LIMITATION: Small participant numbers and application of the framework to only 1 meeting of 1 CPG. CONCLUSION: An ethics framework may help to identify and manage COIs and catalyze both ethics dialogue and innovative COI standards that seek to balance impartiality and expertise for trusted CPGs. Optimal balancing remains contested. Recommendations include frameworks, interdisciplinary analysis, and international policy initiatives to better manage COIs in the CPG process. PRIMARY FUNDING SOURCE: Canadian Association of Gastroenterology; European Association for Gastroenterology and Endoscopy; Asian Pacific Society of Digestive Endoscopy; and Institute of Diabetes, Metabolism, and Nutrition of the Canadian Institutes of Health Research.

Survey of the Impact of COVID-19 on Chronic Liver Disease Patient Care Experiences and Outcomes.

Background: The COVID-19 pandemic has a secondary impact on the health of patients with chronic liver disease (CLD). Our objective was to study this impact on care provision, telemedicine, and health behaviours in CLD patients. Methods: CLD patients of an urban gastroenterology clinic who attended a telemedicine appointment between March 17, 2020 and September 17, 2020, completed an online survey on care delays, health behaviours, and experience with telemedicine. Chart review was conducted in 400 randomly selected patients: 200 charts from during the pandemic were compared to 200 charts the previous year. Data were extracted for clinicodemographic variables, laboratory investigations, and clinical outcomes. Results: Of 399 patients invited to participate, 135 (34%) completed the online survey. Fifty (39%) patients reported 83 care delays due to the COVID-19 pandemic, with the majority (71%) of delays persisting beyond 2 months. Ninety-five (75%) patients were satisfied with telemedicine appointments. There was a longer delay between lab work and appointments in patients seen during the pandemic compared to 2019 (P = 0.01). Compared to the year prior, during the COVID pandemic, there was a similar number of cases of cirrhosis decompensation (n = 26, 13% versus n = 22, 11%) and hospitalization (n = 12, 6% versus n = 5, 3%). Conclusion: The COVID-19 pandemic has led to care delays for CLD outpatients, with most delays on the scale of months. These patient-reported experiences and clinical observations can direct optimization of CLD care as effects from the pandemic evolve.

Factors associated with positive findings from capsule endoscopy in patients with obscure gastrointestinal bleeding.

BACKGROUND & AIMS: Capsule endoscopy (CE) is used most frequently to identify causes of obscure gastrointestinal bleeding (OGIB). Identifying factors associated with the detection of lesions by CE could improve resource utilization and thereby improve patient selection for CE examination. We sought to identify clinical factors associated with positive findings from CE in patients with OGIB. METHODS: We analyzed data from 698 CE procedures performed between December 2001 and April 2011 at St Paul's Hospital, Vancouver, Canada (50.3% of patients were female; mean age, 63.4 years). A positive finding was defined as a lesion that was believed to be the source of the bleeding (ulceration, mass lesion, vascular lesion, or visible blood). Univariate and multivariate logistic regression analyses were used to correlate demographic and clinical parameters with positive findings. RESULTS: A lesion believed to be the cause of bleeding was identified in 42% of cases. In univariate analysis, the number of esophagogastroduodenoscopies (EGDs), the presence of connective tissue disease or diabetes with end-organ damage, Charlson comorbidity index scores, and increasing transfusion requirements were significantly associated with identification of causative pathology from CE (all P < .027). In multivariate analysis, increasing number of EGDs (odds ratio [OR], 1.17; 95% confidence interval [CI], 1.00-1.37), increasing transfusion requirements (3-9 units: OR, 1.70; 95% CI, 1.08-2.66, and ≥10 units: OR, 2.72; 95% CI, 1.69-4.37), and connective tissue disease (OR, 2.24; 95% CI, 1.14-4.41) were all significantly associated with identification of positive findings by using CE (all P < .045). CONCLUSIONS: Patients with a higher number of precapsule EGDs or transfusions, or connective tissue disease, are superior candidates for analysis of OGIB by CE.