Quality indicators for capsule endoscopy and deep enteroscopy.

BACKGROUND AND AIMS: Capsule endoscopy (CE) and deep enteroscopy (DE) can be useful for diagnosing and treating suspected small-bowel disease. Guidelines and detailed recommendations exist for the use of CE/DE, but comprehensive quality indicators are lacking. The goal of this task force was to develop quality indicators for appropriate use of CE/DE by using a modified RAND/UCLA Appropriateness Method. METHODS: An expert panel of 7 gastroenterologists with diverse practice experience was assembled to identify quality indicators. A literature review was conducted to develop a list of proposed quality indicators applicable to preprocedure, intraprocedure, and postprocedure periods. The panelists reviewed the literature; identified and modified proposed quality indicators; rated them on the basis of scientific evidence, validity, and necessity; and determined proposed performance targets. Agreement and consensus with the proposed indicators were verified using the RAND/UCLA Appropriateness Method. RESULTS: The voting procedure to prioritize metrics emphasized selecting measures to improve quality and overall patient care. Panelists rated indicators on the perceived appropriateness and necessity for clinical practice. After voting and discussion, 2 quality indicators ranked as inappropriate or uncertain were excluded. Each quality indicator was categorized by measure type, performance target, and summary of evidence. The task force identified 13 quality indicators for CE and DE. CONCLUSIONS: Comprehensive quality indicators have not existed for CE or DE. The task force identified quality indicators that can be incorporated into clinical practice. The panel also addressed existing knowledge gaps and posed research questions to better inform future research and quality guidelines for these procedures.

Quality Indicators for Capsule Endoscopy and Deep Enteroscopy.

INTRODUCTION: Capsule endoscopy (CE) and deep enteroscopy (DE) can be useful for diagnosing and treating suspected small-bowel disease. Guidelines and detailed recommendations exist for the use of CE/DE, but comprehensive quality indicators are lacking. The goal of this task force was to develop quality indicators for appropriate use of CE/DE by using a modified RAND/UCLA Appropriateness Method. METHODS: An expert panel of 7 gastroenterologists with diverse practice experience was assembled to identify quality indicators. A literature review was conducted to develop a list of proposed quality indicators applicable to preprocedure, intraprocedure, and postprocedure periods. The panelists reviewed the literature; identified and modified proposed quality indicators; rated them on the basis of scientific evidence, validity, and necessity; and determined proposed performance targets. Agreement and consensus with the proposed indicators were verified using the RAND/UCLA Appropriateness Method. RESULTS: The voting procedure to prioritize metrics emphasized selecting measures to improve quality and overall patient care. Panelists rated indicators on the perceived appropriateness and necessity for clinical practice. After voting and discussion, 2 quality indicators ranked as inappropriate or uncertain were excluded. Each quality indicator was categorized by measure type, performance target, and summary of evidence. The task force identified 13 quality indicators for CE and DE. DISCUSSION: Comprehensive quality indicators have not existed for CE or DE. The task force identified quality indicators that can be incorporated into clinical practice. The panel also addressed existing knowledge gaps and posed research questions to better inform future research and quality guidelines for these procedures.

Long-Term Safety of a Coordinated Delivery Tablet of Enteric-Coated Aspirin 325 mg and Immediate-Release Omeprazole 40 mg for Secondary Cardiovascular Disease Prevention in Patients at GI Risk.

INTRODUCTION: In two, 6-month, randomized, double-blind Phase 3 trials, PA32540 (enteric-coated aspirin 325 mg and immediate-release omeprazole 40 mg) compared to aspirin alone was associated with fewer endoscopic gastric and duodenal ulcers in patients requiring aspirin therapy for secondary cardiovascular disease (CVD) prevention who were at risk for upper gastrointestinal (UGI) events. AIMS: In this 12-month, open-label, multicenter Phase 3 study, we evaluated the long-term cardiovascular and gastrointestinal safety of PA32540 in subjects who were taking aspirin 325 mg daily for ≥ 3 months for secondary CVD prevention and were at risk for aspirin-associated UGI events. Enrolled subjects received PA32540 once daily for up to 12 months and were assessed at baseline, month 1, month 6, and month 12. RESULTS: The overall safety population consisted of 379 subjects, and 290 subjects (76%) were on PA32540 for ≥ 348 days (12-month completers). Adverse events (AEs) caused study withdrawal in 13.5% of subjects, most commonly gastroesophageal reflux disease (1.1%). Treatment-emergent AEs occurred in 76% of the safety population (11% treatment-related) and 73% of 12-month completers (8% treatment-related). The most common treatment-related AE was dyspepsia (2%). One subject had a gastric ulcer observed on for-cause endoscopy. There were five cases of adjudicated nonfatal myocardial infarction, one nonfatal stroke, and one cardiovascular death, but none considered treatment-related. CONCLUSIONS: Long-term treatment with PA32540 once daily for up to 12 months in subjects at risk for aspirin-associated UGI events is not associated with any new or unexpected safety events.

PA32540 (a coordinated-delivery tablet of enteric-coated aspirin 325 mg and immediate-release omeprazole 40 mg) versus enteric-coated aspirin 325 mg alone in subjects at risk for aspirin-associated gastric ulcers: results of two 6-month, phase 3 studies.

BACKGROUND: Discontinuations and/or interruptions in aspirin therapy for secondary cardioprotection due to upper gastrointestinal (UGI) complications or symptoms have been shown to increase the risk for subsequent cardiovascular events. PA32540 is a coordinated-delivery, combination tablet consisting of enteric-coated aspirin (EC-ASA) 325 mg and immediate-release (IR) omeprazole 40 mg. METHODS: Two identically-designed, 6-month, randomized, double-blind trials evaluated PA32540 vs. EC-ASA 325 mg in a secondary cardiovascular disease prevention population taking aspirin 325 mg daily for ≥3 months and at risk for ASA-associated gastric ulcers (GUs). The combined study population was 1049 subjects (524 randomized to PA32540, 525 to EC-ASA 325 mg). The primary endpoint was the occurrence of endoscopically-determined gastric ulceration over 6 months. Safety outcomes included the rates of major adverse cardiovascular events (MACE) and UGI symptoms. RESULTS: Significantly fewer PA32540-treated subjects (3.2%) developed endoscopic GUs vs. EC-ASA 325 mg-treated subjects (8.6%) (P < .001). Overall occurrence of MACE was low (2.1%), with no significant differences between treatments in types or incidence of MACE. PA32540-treated subjects had significantly fewer UGI symptoms (P < .001) and significantly fewer discontinuations due to pre-specified UGI adverse events (1.5% vs. 8.2%, respectively; P < .001). CONCLUSIONS: PA32540 reduced the incidence of endoscopic GUs compared to EC-ASA 325 mg, but with a similar cardiovascular event profile. Due to fewer UGI symptoms, continuation on aspirin therapy was greater in the PA32540 treatment arm.

Race, ethnicity, and sex affect risk for polyps >9 mm in average-risk individuals.

BACKGROUND & AIMS: Colorectal cancer risk differs based on patient demographics. We aimed to measure the prevalence of significant colorectal polyps in average-risk individuals and to determine differences based on age, sex, race, or ethnicity. METHODS: In a prospective study, colonoscopy data were collected, using an endoscopic report generator, from 327,785 average-risk adults who underwent colorectal cancer screening at 84 gastrointestinal practice sites from 2000 to 2011. Demographic characteristics included age, sex, race, and ethnicity. The primary outcome was the presence of suspected malignancy or large polyp(s) >9 mm. The benchmark risk for age to initiate screening was based on white men, 50-54 years old. RESULTS: Risk of large polyps and tumors increased progressively in men and women with age. Women had lower risks than men in every age group, regardless of race. Blacks had higher risk than whites from ages 50 through 65 years and Hispanics had lower risk than whites from ages 50 through 80 years. The prevalence of large polyps was 6.2% in white men 50-54 years old. The risk was similar among the groups of white women 65-69 years old, black women 55-59 years old, black men 50-54 years old, Hispanic women 70-74 years old, and Hispanic men 55-59 years old. The risk of proximal large polyps increased with age, female sex, and black race. CONCLUSIONS: There are differences in the prevalence and location of large polyps and tumors in average-risk individuals based on age, sex, race, and ethnicity. These findings could be used to select ages at which specific groups should begin colorectal cancer screening.

Colonoscopy utilization and outcomes 2000 to 2011.

BACKGROUND: Understanding colonoscopy utilization and outcomes can help determine when the procedure is most effective. OBJECTIVE: To study trends in utilization and outcomes of colonoscopy in the United States from 2000 to 2011. DESIGN: Prospective collection of colonoscopy data. SETTING: A total of 84 adult diverse GI practices. PATIENTS: All adult patients receiving colonoscopy for any reason. INTERVENTION: Colonoscopy. MAIN OUTCOME MEASUREMENTS: Polyps >9 mm or suspected malignant tumor. RESULTS: We analyzed 1,372,838 reports. The most common reason for colonoscopy in patients aged <50 years is evaluation of symptoms such as irritable bowel syndrome (IBS) (28.7%) and bleeding or anemia (35.3%). In patients aged 50 to 74 years, colorectal cancer screening accounts for 42.9% of examinations. In patients aged >74 years, surveillance for cancer or polyps is the most common indication. The use of colonoscopy for average-risk screening increased nearly 3-fold during the study period. The prevalence of large polyps increases with age and is higher in men for every procedure indication. The prevalence of large polyps in patients with symptoms of IBS was lower than in those undergoing average-risk screening (odds ratio [OR] 0.85; 95% confidence interval [CI], 0.83-0.87). With increasing age, there was a shift from distal to proximal large polyps. The rate of proximal large polyps is higher in the black population compared with the white population (OR 1.19; 95% CI, 1.13-1.25). LIMITATIONS: In the absence of pathology data, use of surrogate as the main outcome. CONCLUSION: Colonoscopy utilization changed from 2000 to 2011, with an increase in primary screening. The proximal location of large polyps in the black population and with advancing age has implications for screening and surveillance.

Endoscopic hemostasis is rarely used for hematochezia: a population-based study from the Clinical Outcomes Research Initiative National Endoscopic Database.

BACKGROUND: Data on the use of endoscopic hemostasis performed during colonoscopy for hematochezia are primarily derived from expert opinion and case series from tertiary care settings. OBJECTIVES: To characterize patients with hematochezia who underwent in-patient colonoscopy and compare those who did and did not receive endoscopic hemostasis. DESIGN: Retrospective analysis. SETTING: Clinical Outcomes Research Initiative National Endoscopic Database, 2002 to 2008. PATIENTS: Adults with hematochezia. INTERVENTIONS: None. MAIN OUTCOME MEASUREMENTS: Demographics, comorbidities, practice setting, adverse events, and colonoscopy procedural characteristics and findings. RESULTS: We identified 3151 persons who underwent in-patient colonoscopy for hematochezia. Endoscopic hemostasis was performed in 144 patients (4.6%). Of those who received endoscopic hemostasis, the majority were male (60.3%), white (83.3%), and older (mean age 70.9 ± 12.3 years); had a low-risk American Society of Anesthesiologists classification (53.9%); and underwent colonoscopy in a community setting (67.4%). The hemostasis-receiving cohort was significantly more likely to be white (83.3% vs 71.0%, P = .02), have more comorbidities (classes 3 and 4, 46.2% vs 36.0%, P = .04), and have the cecum reached (95.8% vs 87.7%, P = .003). Those receiving hemostasis were significantly more likely to have an endoscopic diagnosis of arteriovenous malformations (32.6% vs 2.6%, P = .0001) or a solitary ulcer (8.3% vs 2.1%, P < .0001). LIMITATIONS: Retrospective database analysis. CONCLUSIONS: Less than 5% of persons presenting with hematochezia and undergoing inpatient colonoscopy received endoscopic hemostasis. These findings differ from published tertiary care setting data. These data provide new insights into in-patient colonoscopy performed primarily in a community practice setting for patients with hematochezia.

Is the American Society of Anesthesiologists classification useful in risk stratification for endoscopic procedures?

BACKGROUND: The American Society of Anesthesiologists (ASA) physical status classification is a measurement of comorbidity and a predictor of perioperative morbidity and mortality. OBJECTIVE: To assess the predictive ability of the ASA class for periendoscopic adverse events. DESIGN: Retrospective cohort analysis. SETTING: A total of 74 sites in the United States comprising academic, community/health maintenance organization, and Veterans Affairs/military practices affiliated with the Clinical Outcomes Research Initiative (CORI) database. PATIENTS: Patients who were 18 years or older who underwent an endoscopic procedure between 2000 and 2008. INTERVENTIONS: EGD, colonoscopy, flexible sigmoidoscopy, and ERCP. MAIN OUTCOME MEASUREMENTS: Immediate adverse event requiring an unplanned intervention. RESULTS: A total of 1,590,648 endoscopic procedures were performed on 1,318,495 individual patients. The majority of patients were designated as ASA class I or II (I: 27%, II: 63%). An immediate adverse event occurred in 0.35% of all endoscopic procedures (n = 5596) and was proportionally highest for ERCPs (1.84%). Increasing ASA class was associated with higher prevalence and a stepwise increase in the odds ratio of serious adverse events for EGD (II: 1.54 [95% confidence interval (CI), 1.31-1.82]; III: 3.90 [95% CI, 3.27-4.64]; IV/V: 12.02 [95% CI, 9.62-15.01]); and colonoscopy (II: 0.92 [95% CI, 0.85-1.01]; III: 1.66 [95% CI, 1.46-1.87]; IV/V: 4.93 [95% CI, 3.66-66.3]). This trend was not significant for flexible sigmoidoscopy and ERCP. LIMITATIONS: Retrospective; endpoint was a surrogate for periprocedure morbidity. CONCLUSIONS: ASA class is associated with increased risk of adverse events at endoscopy, particularly for EGD and colonoscopy. It is useful in endoscopic risk stratification and an important quality indicator for endoscopy.

The role of colonoscopy in evaluating hematochezia: a population-based study in a large consortium of endoscopy practices.

BACKGROUND: Data on the role of colonoscopy in hematochezia are almost exclusively derived from clinical experience in tertiary care practice. OBJECTIVE: To characterize the patient population who received colonoscopy for hematochezia in a consortium of diverse gastroenterology practices. DESIGN: Retrospective analysis. SETTING: Clinical Outcomes Research Initiative Database, 2002 to 2008. PATIENTS: Adults undergoing colonoscopy for the indication of hematochezia. MAIN OUTCOME MEASUREMENTS: Demographics, comorbidity, practice setting, adverse events, and colonoscopy procedure characteristics and findings. Age-stratified analyses and analyses of inpatient- versus outpatient-performed colonoscopies were also performed. RESULTS: A total of 966,536 colonoscopies were performed during the study period, 76,186 (7.9%) were performed for evaluation of hematochezia. The majority of patients were white non-Hispanic men younger than 60 years old who underwent colonoscopy at a community practice site (79.1%) and had a low-risk American Society of Anesthesiologists (ASA) score (81.5%), in whom colonoscopy reached the cecum (94.8%), and serious adverse events were rare. Colonoscopy findings were hemorrhoids (64.4%), diverticulosis (38.6%), and polyp or multiple polyps (38.8%). From the overall cohort, 38.3% were 60 years of age and older. The older age cohort had significantly more white non-Hispanic females, high-risk ASA scores, incomplete colonoscopies, and unplanned events. Colonoscopy findings demonstrated significantly higher rates of diverticulosis, polyp or multiple polyps, mucosal abnormality/colitis, tumor, and solitary ulcer (P < .0001). There were 3941 (5.2%) who underwent inpatient-performed colonoscopy. One third of this cohort (32.6%) was defined as having a high ASA score. LIMITATIONS: Retrospective database review. CONCLUSIONS: These results describe patient populations and characterize colonoscopy findings in individuals presenting with hematochezia primarily in a community practice setting.

Durability of radiofrequency ablation in Barrett's esophagus with dysplasia.

BACKGROUND & AIMS: Radiofrequency ablation (RFA) can eradicate dysplasia and intestinal metaplasia in patients with dysplastic Barrett's esophagus (BE), and reduce rates of esophageal adenocarcinoma. We assessed long-term rates of eradication, durability of neosquamous epithelium, disease progression, and safety of RFA in patients with dysplastic BE. METHODS: We performed a randomized trial of 127 subjects with dysplastic BE; after cross-over subjects were included, 119 received RFA. Subjects were followed for a mean time of 3.05 years; the study was extended to 5 years for patients with eradication of intestinal metaplasia at 2 years. Outcomes included eradication of dysplasia or intestinal metaplasia after 2 and 3 years, durability of response, disease progression, and adverse events. RESULTS: After 2 years, 101 of 106 patients had complete eradication of all dysplasia (95%) and 99 of 106 had eradication of intestinal metaplasia (93%). After 2 years, among subjects with initial low-grade dysplasia, all dysplasia was eradicated in 51 of 52 (98%) and intestinal metaplasia was eradicated in 51 of 52 (98%); among subjects with initial high-grade dysplasia, all dysplasia was eradicated in 50 of 54 (93%) and intestinal metaplasia was eradicated in 48 of 54 (89%). After 3 years, dysplasia was eradicated in 55 of 56 of subjects (98%) and intestinal metaplasia was eradicated in 51 of 56 (91%). Kaplan-Meier analysis showed that dysplasia remained eradicated in >85% of patients and intestinal metaplasia in >75%, without maintenance RFA. Serious adverse events occurred in 4 of 119 subjects (3.4%); the rate of stricture was 7.6%. The rate of esophageal adenocarcinoma was 1 per 181 patient-years (0.55%/patient-years); there was no cancer-related morbidity or mortality. The annual rate of any neoplastic progression was 1 per 73 patient-years (1.37%/patient-years). CONCLUSIONS: In subjects with dysplastic BE, RFA therapy has an acceptable safety profile, is durable, and is associated with a low rate of disease progression, for up to 3 years.

Adenoma detection rate increases with each decade of life after 50 years of age.

BACKGROUND: The adenoma detection rate (ADR) has recently been used as a quality measure for screening colonoscopy. We hypothesize that the ADR will increase with each decade of life after 50 years of age. OBJECTIVE: The aim of this study was to define age-based goals for the ADR and advanced neoplasia to improve the quality of colonoscopy. METHODS: Using the Clinical Outcomes Research Initiative database, we identified patients who underwent screening colonoscopy between 2005 and 2006. Pathology of polyp findings was reviewed, and the ADR and the prevalence of advanced neoplasia were calculated based on age and sex. RESULTS: A total of 7756 polypectomies (44.9%) were performed on 17,275 patients between 2005 and 2006. Of these polyps, 56.3% (4363) were adenomas or more advanced lesions. The ADR was higher in men than women and increased with age. The ADR in men younger than age 50 was 24.7 (95% CI, 18.2-31.2); for those 50 to 59 years of age, it was 27.8 (95% CI, 26.5-29.1); for those 60 to 69 years of age, it was 33.6 (95% CI, 31.7-35.4); for those 70 to 79 years of age, it was 34.3 (95% CI, 31.5-37.1); and for those older than 80 years of age, it was 40.0 (95% CI, 32.9-47.1). The ADR in women younger than 50 years old was 12.6 (95% CI, 6.8-18.4); in those 50 to 59 years of age, it was 17.0 (85% CI, 15.9-18.1); for those 60 to 69 years of age, it was 22.4 (95% CI, 20.8-24.0); for those 70 to 79 years of age, it was 26.1 (95% CI, 23.7-28.5); and for those older than 80 years of age, it was 26.9 (95% CI, 21.4-32.5). LIMITATIONS: The Clinical Outcomes Research Initiative database offers access to demographic information as well as endoscopy and pathology data, but there is limited clinical information about patients in the database. CONCLUSION: The ADR, and, importantly, the rate of advanced neoplasia increased with each decade of life after the age of 50 and are higher in men than women in each decade of life.

Factors that contribute to blood loss in patients with colonic angiodysplasia from a population-based study.

BACKGROUND & AIMS: Most studies of angiodysplasia are small and performed at a single center. We investigated the epidemiology and management of colonic angiodysplasia by using a national endoscopy database. METHODS: Colonoscopy reports (n = 229,727; generated from January 2000 to December 2002) from patients with documented angiodysplasia (n = 4159) were retrieved from the Clinical Outcomes Research Initiative. Predictors of occult or overt blood loss and endoscopic treatment were identified by using multivariate logistic regression. RESULTS: Most patients with documented angiodysplasia were older than 60 years (73%) or had right-sided lesions (62%). There was evidence of blood loss in 56% of patients with angiodysplasia. Predictors of blood loss included inpatient status (odds ratio [OR], 8.74; 95% confidence interval [CI], 5.42-14.10), 2-10 angiodysplasias (OR, 1.50; 95% CI, 1.29-1.75), more than 10 lesions (OR, 2.18; 95% CI, 1.69-2.80), black race (OR, 1.95; 95% CI, 1.46-2.62), severe illness (OR, 1.97; 95% CI, 1.62-2.41), Hispanic ethnicity (OR, 1.71; 95% CI, 1.32-2.22), and age older than 80 years (OR, 1.32; 95% CI, 1.06-1.63). Endoscopic therapy was given to 28% of patients with evidence of blood loss and in 68% with active bleeding. Endoscopic treatment increased among patients in a university practice setting (vs community setting, OR, 2.53; 95% CI, 1.96-3.27) and decreased in Northwest geographic locations (vs Southwest, OR, 0.60; 95% CI, 0.43-0.84). CONCLUSIONS: Predictors of blood loss in patients with colonic angiodysplasia include inpatient status, comorbidities, age, race/ethnicity, and lesion number. Endoscopic therapy for angiodysplasia varied according to practice setting and region.