Philip Schoenfeld

Quality Indicators for Colonoscopy

Colonoscopy is widely used for the diagnosis and treatment of colonic disorders. Properly performed, colonoscopy is generally safe, accurate, and well tolerated by most patients. Visualization of the mucosa of the entire large intestine and distal terminal ileum is usually possible at colonoscopy. In patients with chronic diarrhea, biopsy specimens can help diagnose the underlying condition. Polyps can be identified and removed during colonoscopy, thereby reducing the risk of colon cancer. Colonoscopy is the preferred method to evaluate the colon in most adult patients with bowel symptoms, iron deficiency anemia, abnormal radiographic studies of the colon, positive colorectal cancer screening tests, postpolypectomy and postcancer resection surveillance, surveillance in inflammatory bowel disease, and in those with suspected masses. The use of colonoscopy has become accepted as the most effective method of screening the colon for neoplasia in patients over the age of 50 years and in younger patients at increased risk (1). The effectiveness of colonoscopy in reducing colon cancer incidence depends on adequate visualization of the entire colon, diligence in examining the mucosa, and patient acceptance of the procedure. Preparation quality affects the ability to perform a complete examination, the duration the procedure, and the need to cancel or reschedule procedures (2, 3). Ineffective preparation is a major contributor to costs (4). Longer withdrawal times have been demonstrated to improve polyp detection rates, (5‐7) and conversely, rapid withdrawal may miss lesions and reduce the effectiveness of colon cancer prevention by colonoscopy. The miss rates of colonoscopy for large (≥1 cm) adenomas may be higher than previously thought (8, 9) Thus, careful examinations are necessary to optimize the effectiveness of recommended intervals between screening and surveillance examinations. Finally, technical expertise will help prevent complications that can offset any cost benefit ratio gained by removing neoplastic lesions. The following quality indicators have been selected to establish competence in performing colonoscopy and help define areas for continuous quality improvement. The levels of evidence supporting these quality indicators were graded according to Table 1. PREPROCEDURE The preprocedure period encompasses the time from first contact by the patient until administration of sedation or instrument insertion. The aspects of patient care addressed in prior documents apply here as well, including timely scheduling, patient preparation, identification, history and physical examination, appropriate choice of sedation and analgesia, evaluation of bleeding risk, etc. Because many examinations are currently being performed for colon cancer screening and are elective, care must be taken to be certain that all potential risks have been reduced to as low as practically achievable. The American Society for Gastrointestinal Endoscopy (ASGE) (10) and the U.S. Multi-Society Task Force on Colon Cancer have published appropriate indications for colonoscopy (11) (Tables 2 and 3).

An Evidence-Based Position Statement on the Management of Irritable Bowel Syndrome

IBS is characterized by abdominal discomfort associated with altered bowel function; structural and biochemical abnormalities are absent. e pathophysiology of IBS is multifactorial and of intense recent interest, largely because of the possibility of developing targeted therapies. As IBS is one of the most common disorders managed by gastroenterologists and primary care physicians, this monograph was developed to educate physicians about its epidemiology, diagnostic approach, and treatments. e American College of Gastroenterology (ACG) IBS Task Force updated the 2002 monograph because new evidence has emerged on the bene* t and risks of drugs used for IBS. Furthermore, new drugs also have been developed and the evidence for e+ cacy of these drugs needed to be assessed. To critically evaluate the rapidly expanding research about IBS, a series of systematic reviews were performed. Standard criteria for systematic reviews were met, including comprehensive literature searching, use of prespeci* ed study selection criteria, and use of a standardized and transparent process to extract and analyze data from studies. Evidence-based statements were developed from these data by the entire ACG IBS Task Force. Recommendations were graded using a formalized system that quanti* es the strength of evidence. Each recommendation was classi* ed as strong (grade 1) or weak (grade 2) and the strength of evidence classi* ed as strong (level A), moderate (level B), or weak (level C). Recommendations in this position statement may be crossreferenced with the supporting evidence in the accompanying article, “ An Evidenced Based Review on the Management of Irritable Bowel Syndrome ” .

The epidemiology of irritable bowel syndrome in North America: A systematic review

OBJECTIVE:The aim of this study was to systematically review published literature about the prevalence, incidence, and natural history of irritable bowel syndrome (IBS) in North America.METHODS:A computer-assisted search of MEDLINE, EMBASE, and Current Contents/Science Edition databases was performed independently by two investigators. Study selection criteria included: 1) North American population-based sample of adults; 2) objective diagnostic criteria for IBS (i.e., Rome or Manning criteria); and 3) publication in full manuscript form in English. Eligible articles were reviewed in a duplicate and independent manner. Data extracted were converted into individual tables and presented in descriptive form.RESULTS:The prevalence of IBS in North America ranges from 3% to 20%, with most prevalence estimates ranging from 10% to 15%. The prevalences of diarrhea-predominant and constipation-predominant IBS are both approximately 5%. Published prevalence estimates by gender range from 2:1 female predominance to a ratio of 1:1. Constipation-predominant IBS is more common in female individuals. The prevalence of IBS varies minimally with age. No true population-based incidence studies or natural history studies were found. In one cohort surveyed on two occasions 1 yr apart, 9% of subjects who were free of IBS at baseline reported IBS at follow-up producing an onset rate of 67 per 1000 person-years. In all, 38% of patients meeting criteria for IBS did not meet IBS criteria at 1-yr follow-up.CONCLUSION:Approximately 30 million people in North America meet the diagnostic criteria for IBS. However, data about the natural history of IBS is quite sparse and renewed efforts should be focused at developing appropriately designed trials of the epidemiology of IBS.

Efficacy of Antidepressants and Psychological Therapies in Irritable Bowel Syndrome: Systematic Review and Meta-analysis.

Objective: Irritable bowel syndrome (IBS) is a chronic functional gastrointestinal disorder. Evidence for treatment of the condition with antidepressants and psychological therapies is conflicting. Design: Systematic review and meta-analysis of randomised controlled trials (RCTs). MEDLINE, EMBASE and the Cochrane Controlled Trials Register were searched (up to May 2008). Setting: RCTs based in primary, secondary and tertiary care. Patients: Adults with IBS. Interventions: Antidepressants versus placebo, and psychological therapies versus control therapy or “usual management”. Main outcome measures: Dichotomous symptom data were pooled to obtain a relative risk (RR) of remaining symptomatic after therapy, with a 95% confidence interval (CI). The number needed to treat (NNT) was calculated from the reciprocal of the risk difference. Results: The search strategy identified 571 citations. Thirty-two RCTs were eligible for inclusion: 19 compared psychological therapies with control therapy or “usual management”, 12 compared antidepressants with placebo, and one compared both psychological therapy and antidepressants with placebo. Study quality was generally good for antidepressant but poor for psychological therapy trials. The RR of IBS symptoms persisting with antidepressants versus placebo was 0.66 (95% CI, 0.57 to 0.78), with similar treatment effects for both tricyclic antidepressants and selective serotonin reuptake inhibitors. The RR of symptoms persisting with psychological therapies was 0.67 (95% CI, 0.57 to 0.79). The NNT was 4 for both interventions. Conclusions: Antidepressants are effective in the treatment of IBS. There is less high-quality evidence for routine use of psychological therapies in IBS, but available data suggest these may be of comparable efficacy.

The epidemiology and natural history of Crohn's disease in population-based patient cohorts from North America: a systematic review.

To quantify, through systematic review, the epidemiology and natural history of Crohn’s disease in North America.

Nighttime heartburn is an under-appreciated clinical problem that impacts sleep and daytime function: the results of a Gallup survey conducted on behalf of the American Gastroenterological Association

OBJECTIVE:Although a large body of information exists about the prevalence of gastroesophageal reflux disease (GERD) in general, available data specifically addressing nocturnal reflux are limited. Because nocturnal acid reflux is reported to be associated with more severe injuries such as esophagitis and stricture, as well as adenocarcinoma of the esophagus, a better understanding of the prevalence and impact of nighttime heartburn as a sign of nocturnal acid reflux events can have significant potential management implications. The aims of this study were to determine the prevalence of nighttime heartburn and reflux-attributed supraesophageal symptoms among patients with GERD; and the impact of nighttime heartburn on sleep and several activities of daily living that could affect quality of life.METHODS:A nationwide telephone survey of 1000 adults experiencing heartburn at least once a week was conducted by the Gallup Organization on behalf of the American Gastroenterological Association.RESULTS:Altogether, 79% of respondents reported experiencing heartburn at night. Among those, 75% reported that symptoms affected their sleep, 63% believed that heartburn negatively affected their ability to sleep well, and 40% believed that nocturnal heartburn impaired their ability to function the following day. Of the 791 respondents with nighttime heartburn, 71% reported taking over-the-counter medicine for it, but only 29% of these rated this approach extremely effective. Forty-one percent reported trying prescription medicines, and 49% of these rated this approach extremely effective.CONCLUSIONS:Nighttime heartburn occurs in a large majority of adults with GERD, resulting in sleeping difficulties and impaired next-day function. The expected result from implemented therapy for heartburn is not achieved by a sizable percentage of patients.

The utility of probiotics in the treatment of irritable bowel syndrome: a systematic review.

OBJECTIVES:Irritable bowel syndrome (IBS) is a common disorder and available therapies have limited efficacy. Mucosal inflammation and alterations in gut microflora may contribute to the development of IBS symptoms, and researchers have hypothesized that probiotics might improve these symptoms. The aim of this study was to perform a systematic review of randomized controlled trials (RCTs) evaluating the efficacy, safety, and tolerability of probiotics in the treatment of IBS.METHODS:Comprehensive literature searches of multiple databases were performed. Study selection criteria were as follows: (i) RCTs, (ii) adults with IBS defined by Manning or Rome II criteria, (iii) single or combination probiotic vs. placebo, and (iv) improvement in IBS symptoms and/or decrease in frequency of adverse events reported. Data about study design and results were extracted in duplicate using standardized data extraction forms. Owing to variability in outcome measures, quantitative pooling of data was not feasible.RESULTS:A total of 16 RCTs met selection criteria. Of those, 11 studies showed suboptimal study design with inadequate blinding, inadequate trial length, inadequate sample size, and/or lack of intention-to-treat analysis. None of the studies provided quantifiable data about both tolerability and adverse events. Bifidobacterium infantis 35624 showed significant improvement in the composite score for abdominal pain/discomfort, bloating/distention, and/or bowel movement difficulty compared with placebo (P<0.05) in two appropriately designed studies. No other probiotic showed significant improvement in IBS symptoms in an appropriately designed study.CONCLUSIONS:B. infantis 35624 has shown efficacy for improvement of IBS symptoms. Most RCTs about the utility of probiotics in IBS have not used an appropriate study design and do not adequately report adverse events. Therefore, there is inadequate data to comment on the efficacy of other probiotics. Future probiotic studies should follow Rome II recommendations for appropriate design of an RCT.

Systematic Review on the Management of Chronic Constipation in North America

Systematic Review on the Management of Chronic Constipation in North America Lawrence J. Brandt, M.D., M.A.C.G., F.A.C.P., F.A.A.P.P.,1 Charlene M. Prather, M.D.,2 Eamonn M.M. Quigley, M.D., F.R.C.P., F.A.C.P., F.A.C.G., F.R.C.P.I.,3 Lawrence R. Schiller, M.D., F.A.C.P., F.A.C.G.,4 Philip Schoenfeld, M.D., M.S.Ed., M.Sc. (Epi),5 and Nicholas J. Talley, M.D., Ph.D.6 1Division of Gastroenterology, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY; 2Division of Gastroenterology, Saint Louis University School of Medicine, St. Louis, MO; 3Department of Medicine and Alimentary Pharmabiotic Center, National University of Ireland, Cork, Ireland; 4Division of Gastroenterology, Baylor University Medical Center, Dallas, TX; 5Division of Gastroenterology, University of Michigan School of Medicine, and Center for Excellence in Health Services Research, Veterans Affairs Medical Center, Ann Arbor, MI; 6Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, MN

A sustained viral response is associated with reduced liver-related morbidity and mortality in patients with hepatitis C virus.

BACKGROUND & AIMS The incidences of decompensated cirrhosis (defined by ascites, hepatic encephalopathy, or bleeding esophageal varices), hepatocellular carcinoma (HCC), and liver-related mortality among patients infected with hepatitis C virus (HCV) who achieve a sustained viral response (SVR), compared with patients who fail treatment (treatment failure), are unclear. We performed a meta-analysis to quantify the incidences of these outcomes. METHODS This meta-analysis included observational cohort studies that followed HCV treatment failure patients; data were collected regarding the incidence of decompensated cirrhosis, HCC, or liver-related mortality and stratified by SVR status. Two investigators independently extracted data on patient populations, study methods, and results by using standardized forms. The agreement between investigators in data extraction was greater than 95%. Data analysis was performed separately for studies that enrolled only HCV patients with advanced fibrosis. RESULTS We identified 26 appropriate studies for meta-analysis. Among treatment failure patients with advanced fibrosis, rates of liver-related mortality (2.73%/year; 95% confidence interval [CI], 1.38-4.080), HCC (3.22%/year, 95% CI, 2.02-4.42), and hepatic decompensation (2.92%/year; 95% CI, 1.61-4.22) were substantial. Patients with SVR are significantly less likely than patients who experienced treatment failure to develop liver-related mortality (relative risk [RR], 0.23; 95% CI, 0.10-0.52), HCC (RR, 0.21; 95% CI, 0.16-0.27), or hepatic decompensation (RR, 0.16; 95% CI, 0.04-0.59). CONCLUSIONS HCV patients with advanced fibrosis who do not undergo an SVR have substantial liver-related morbidity and mortality. Achieving SVR is associated with substantially lower liver-related morbidity and mortality.

Levofloxacin-Based Triple Therapy versus Bismuth-Based Quadruple Therapy for Persistent Helicobacter pylori Infection: A Meta-Analysis

BACKGROUND:Levofloxacin-based triple therapy has been suggested as an alternative salvage therapy to bismuth-based quadruple therapy for persistent Helicobacter pylori (H. pylori) infection.METHODS:A search of PUBMED, EMBASE, EBM Review databases and abstracts from recent Digestive Disease Week, United European Gastroenterology Week, and European Helicobacter Study Group conferences was performed. Randomized controlled trials (RCTs) comparing levofloxacin-based triple salvage therapy (levofloxacin + amoxicillin + PPI) to bismuth-based quadruple salvage therapy (bismuth + tetracycline + metronidazole + PPI) were selected for meta-analysis. Additionally, all prospective trials evaluating this levofloxacin-based triple therapy as salvage therapy were pooled to analyze optimal levofloxacin treatment duration and dosing. All selected trials confirmed prior treatment failure and post-salvage treatment eradication.RESULTS:Four RCTs compared a 10-day regimen of levofloxacin-based triple therapy to 7-day bismuth-based quadruple therapy (n = 391 patients). Levofloxacin-based triple therapy was superior to quadruple therapy (RR = 1.41 [95% CI: 1.25–1.59]). Levofloxacin-based triple therapy was better tolerated than quadruple therapy with a lower incidence of side effects (RR = 0.51 [95% CI: 0.34–0.75]) and side effects prompting discontinuation of therapy (RR = 0.30 [95% CI: 0.10–0.89]). Eleven trials (n = 547 patients) evaluating levofloxacin-based triple therapy demonstrated higher eradication rates with 10-day versus 7-day regimen (87%[95% CI: 82%-92%]vs 68%[95% CI: 62%-74%]) yet eight trials (n = 477 patients) demonstrated no difference with 500 mg daily versus 250 mg b.i.d. dosing of levofloxacin (81%[95% CI: 78%-89%]vs 84%[95% CI: 66%-97%]).CONCLUSIONS:A 10-day course levofloxacin triple therapy is more effective and better tolerated than 7-day bismuth-based quadruple therapy in the treatment of persistent H. pylori infection.