Safety and patient outcomes with lubiprostone for up to 52 weeks in patients with irritable bowel syndrome with constipation.

BACKGROUND: Irritable bowel syndrome with constipation (IBS-C) significantly decreases quality of life and the ability to perform daily living activities. AIM: To demonstrate the long-term safety, tolerability and patient outcomes of lubiprostone in patients with IBS-C. METHODS: This extension study enrolled 522 IBS-C patients who had completed one of two randomised phase 3 studies. All enrolled patients received open-label lubiprostone orally for 36-weeks (8 mcg, twice daily). The primary objective was the assessment of long-term safety and tolerability, monitored via adverse events (AEs), laboratory parameters and vital signs. Additional outcome endpoints included monthly responder rates and patient evaluations of IBS-C symptom severity and impact on quality of life. RESULTS: The evaluable safety population comprised of 520 patients; 476 of which had patient reported outcome data available. The overall safety profile of lubiprostone during this study was similar to that observed in the preceding phase 3 studies. The most common AEs were diarrhoea (11.0%), nausea (11.0%), urinary tract infection (9.0%), sinusitis (9.0%) and abdominal distention (5.8%). Diarrhoea and nausea were the most common treatment-related AEs. No serious AEs were considered treatment-related. Seventeen patients discontinued due to a treatment-related AE, of which diarrhoea and nausea accounted for six (1.2%) and three (0.6%) respectively. For responder rates and patient-evaluated parameters (n = 476), all groups experienced significant improvements from baseline, with initial improvements maintained throughout the study. CONCLUSION: In patients with irritable bowel syndrome with constipation, lubiprostone 8 mcg twice daily was found to be safe and well tolerated over 9-13 months of treatment.

Computer-assisted analysis of abrasive transepithelial brush biopsies increases the effectiveness of esophageal screening: a multicenter prospective clinical trial by the EndoCDx Collaborative Group.

BACKGROUND: The sensitivity of screening for Barrett's esophagus (BE) and esophageal dysplasia (ED) is hampered by the limited amount of tissue that can be sampled by forceps biopsy (FB). AIM: The aim of this study was to evaluate computer assisted analysis of an abrasive, transepithelial brush biopsy as an adjunct to FB to increase detection of BE and ED. METHODS: This was a multicenter prospective trial of patients being screened for BE and ED. Each patient had two brush biopsies (BB) and then random four-quadrant FB every 1-2 cm of the esophagus. All BB were examined with computer assistance by pathologists at CDx Laboratories (Suffern, NY), and all FB were examined by the investigators' local pathologists. RESULTS: Of 1,266 patients enrolled, 363 were diagnosed with BE by FB alone and 146 additional cases of BE were identified by adding BB. The addition of BB to FB increased the overall detection of BE by 39.8% (95% CI 32-48%). This added detection of BE in 11.5% of all patients tested with the BB (146/1266) resulted in a number of patients needed to test (NNT) to obtain each additional positive finding of Barrett's esophagus of 8.7. Among a subset of 848 patients with gastroesophageal reflux disease and no prior history of BE, the addition of BB to FB identified an additional 105 patients with BE increasing the overall detection of BE by 70.5% (95% CI 54-90%). Dysplasia was diagnosed in 16 patients by FB alone, with an additional 14 cases detected by adding BB. The addition of BB to FB thus increased the detection of ED by 87.5%. CONCLUSION: These results suggest that adjunctive computer-assisted analysis of an abrasive brush biopsy has the potential to substantially improve the detection of Barrett's esophagus and dysplasia in screening populations.

Clinical trial: the efficacy and tolerability of velusetrag, a selective 5-HT4 agonist with high intrinsic activity, in chronic idiopathic constipation - a 4-week, randomized, double-blind, placebo-controlled, dose-response study.

BACKGROUND: Velusetrag is an orally active 5-HT(4) receptor agonist of potential benefit in treating chronic idiopathic constipation. AIM: To evaluate the efficacy, safety and tolerability of velusetrag in chronic idiopathic constipation. METHODS: After a 2-week baseline period, patients [<3 spontaneous bowel movements (SBM)/week] received placebo or velusetrag (15, 30 or 50 mg) daily for 4 weeks in a randomized, double-blind design, followed by a 1-week follow-up period. The primary endpoint was the change from baseline in weekly SBM frequency averaged over the 4-week treatment period. RESULTS: Patients receiving velusetrag (15, 30 and 50 mg) achieved statistically and clinically significant increases in weekly SBM frequency relative to those receiving placebo. Mean increases were 3.6, 3.3 and 3.5 SBM/week respectively, compared with 1.4 SBM/week for placebo (P < 0.0001). Statistically significant increases in the weekly frequency of complete SBM (CSBM) were also reported (mean increases of 2.3, 1.8 and 2.3 for 15, 30 and 50 mg velusetrag respectively, compared with 0.6 for placebo). Common adverse events associated with velusetrag were diarrhoea, headache, nausea and vomiting, generally occurring during the initial days of dosing. CONCLUSION: Velusetrag was efficacious and well tolerated in patients with chronic idiopathic constipation (ClinicalTrials.gov identifier NCT00391820).

Clinical trial: lubiprostone in patients with constipation-associated irritable bowel syndrome--results of two randomized, placebo-controlled studies.

BACKGROUND: Effective treatments for irritable bowel syndrome with constipation (IBS-C) are lacking. AIM: To assess the efficacy and safety of lubiprostone in IBS-C. METHODS: A combined analysis was performed among 1171 patients with a Rome II diagnosis of IBS-C in two phase-3 randomized trials of lubiprostone 8 mcg vs. placebo twice daily for 12 weeks. Using a balanced seven-point Likert scale ranging from significantly relieved (+3), to significantly worse (-3), patients responded on their electronic diary to the question: 'How would you rate your relief of IBS symptoms over the past week compared to how you felt before you entered the study?'. The primary efficacy endpoint was the percentage of overall responders. RESULTS: Using an intent-to-treat analysis with last observation carried forward, a significantly higher percentage of lubiprostone-treated patients were considered overall responders compared with those treated with placebo (17.9% vs. 10.1%, P=0.001). Patients treated with lubiprostone reported a similar incidence of adverse events to those treated with placebo. CONCLUSIONS: The percentage of overall responders based on patient-rated assessments of IBS-C symptoms was significantly improved in patients treated with lubiprostone 8 mcg twice daily compared to those treated with placebo. Lubiprostone was well tolerated with a favourable safety profile.

Clinical trial: phase 2 study of lubiprostone for irritable bowel syndrome with constipation.

BACKGROUND: Analyses of a trial in constipated patients indicated that lubiprostone may be an effective treatment for irritable bowel syndrome with constipation. AIM: To assess the efficacy and safety of three lubiprostone doses for irritable bowel syndrome with constipation. METHODS: 195 irritable bowel syndrome with constipation patients received daily doses of 16 [8 microg twice daily (b.d.)], 32 (16 microg b.d.) or 48 microg (24 microg b.d.) lubiprostone or placebo b.d. for 3 months. Gastrointestinal parameters were recorded in diaries daily by patients. RESULTS: After 1 month, lubiprostone showed significantly greater improvements in mean abdominal discomfort/pain scores vs. placebo (P = 0.023). After 2 months, all lubiprostone groups showed significantly greater improvements in mean abdominal discomfort/pain scores (P < or = 0.039). After 3 months of treatment, the improvement in each lubiprostone arm was greater than placebo, but the test for trend was no longer significant. Treatment with lubiprostone showed significantly higher rates of gastrointestinal adverse events (P = 0.020), especially diarrhoea and nausea. CONCLUSION: Lubiprostone significantly improved gastrointestinal symptoms of irritable bowel syndrome with constipation at all doses. Higher doses of lubiprostone, especially the 48 microg/day group, were associated with more gastrointestinal adverse events. From these data, the 16 microg/day dose demonstrated the optimal combination of efficacy and safety. These results warrant further study of lubiprostone for treatment of irritable bowel syndrome with constipation patients.

Clinical trial: healing of NSAID-associated gastric ulcers in patients continuing NSAID therapy - a randomized study comparing ranitidine with esomeprazole.

BACKGROUND: The use of non-steroidal anti-inflammatory drugs (NSAID) is associated with an increased risk of gastric ulcer (GU) development. METHODS: This multicentre, randomized, double-blind, parallel-group trial compared endoscopic healing rates at 4 and 8 weeks after treatment with oral esomeprazole 40 or 20 mg once daily, or ranitidine 150 mg twice daily, in patients with 1 baseline GU > or = 5 mm but no GUs or duodenal ulcers >25 mm in diameter who received continued cyclooxygenase-2-selective or non-selective NSAID therapies. The primary outcome was the percentage of patients in each treatment group who had no GUs at week 8. RESULTS: Four hundred and forty patients were randomized to treatment. At week 8, GU healing rates (95% CI) with esomeprazole 40 mg, esomeprazole 20 mg and ranitidine were 85.7 (79.8-91.7)%, 84.8 (78.8-90.8)% and 76.3 (69.2-83.3)%, respectively; between-group differences were not statistically significant. Week-4 GU healing rates were 70.7 (62.9-78.4)% and 72.5 (65.0-79.9)% with esomeprazole 40 and 20 mg, respectively, and were significantly higher (P < 0.01 for both doses) than those with ranitidine [55.4 (47.1-63.7)%]. CONCLUSION: In patients who require continued NSAID therapy, GU healing rates at 8 weeks numerically favoured esomeprazole but were not significantly different from ranitidine.

Lubiprostone, a locally acting chloride channel activator, in adult patients with chronic constipation: a double-blind, placebo-controlled, dose-ranging study to evaluate efficacy and safety.

BACKGROUND: Lubiprostone, a locally acting type-2 chloride channel activator, induces intestinal fluid secretion. AIM: To assess efficacy and safety of oral lubiprostone at multiple doses for the treatment of chronic constipation. METHODS: A total of 129 patients with chronic constipation were randomized to receive lubiprostone (24, 48 or 72 mcg/day) or placebo for 3 weeks. Spontaneous bowel movement (SBM) frequency, rescue medication use, symptom assessments and adverse events (AEs) were tracked. RESULTS: Over the double-blinded period, mean SBM frequencies were higher for lubiprostone groups (5.1-6.1) vs. placebo (3.8) and the overall difference was statistically significant (P = 0.046). SBM frequencies at week 1 were significantly higher in patients taking lubiprostone 48 or 72 mcg/day (P < or = 0.003) and, at week 2, all three lubiprostone doses yielded significantly higher SBM rates vs. placebo (P < or = 0.020). Significantly larger proportions of patients taking lubiprostone 48 and 72 mcg/day also experienced a SBM on the first treatment day (P < or = 0.009). The most common AEs were nausea, headache and diarrhoea. CONCLUSIONS: Lubiprostone improved SBM rates in a dose-dependent manner. AEs were tolerable for most patients. Increased AE severity at 72 mcg/day did not provide a clear risk-to-benefit advantage compared with lubiprostone 48 mcg/day, the dose chosen for subsequent Phase 3 studies.

Chronic constipation: a survey of the patient perspective.

BACKGROUND: Constipation is a common, often chronic, gastrointestinal motility disorder characterized by such symptoms as straining, hard stool, and infrequent defecation. Published literature is limited regarding symptom prevalence, healthcare-seeking behaviour, and patient satisfaction with traditional therapies for chronic constipation. AIM: To assess the prevalence of chronic constipation among a random sample of Americans, to identify the frequency, severity and bothersomeness of their symptoms, and to assess satisfaction levels with traditional treatments. METHODS: All members (N = 37,004) of the Knowledge Networks Panel, representative of the US population, participated in a web-based survey. Eligibility was established using a six-question screener. RESULTS: Of the 24,090 panellists consenting to participate, 557 met eligibility requirements and took the 45-question survey. The most prevalent symptom was straining (79%). Hard stool and straining were the top two severe symptoms, and bloating, straining and hard stool were the top three bothersome symptoms. Symptoms affected quality of life of more than half (52%) the respondents. Among those who worked or went to school, 12% experienced reduced productivity and a mean of 2.4 days of absence in the month before the survey. Most respondents had used (96%) or were using (72%) constipation relief therapy; however, nearly half (47%) were not completely satisfied, mainly because of efficacy (82%) and safety (16%) concerns. CONCLUSIONS: Chronic constipation is common. Individual symptoms are often severe and bothersome, and many patients are dissatisfied with traditional treatment options, primarily because of lack of efficacy.

Meta-analysis of flavonoids for the treatment of haemorrhoids.

BACKGROUND: The aim of the study was to evaluate the impact of flavonoids on those symptoms important to patients with symptomatic haemorrhoids. METHODS: A comprehensive search strategy was used. All published and unpublished randomized controlled trials comparing any type of flavonoid to placebo or no therapy in patients with symptomatic haemorrhoids were included. Two reviewers independently screened studies for inclusion, retrieved all potentially relevant studies and extracted data. RESULTS: Fourteen eligible trials randomized 1514 patients. Studies were of moderate quality and showed variability in the results with potential publication bias. Meta-analyses using random-effects models suggested that flavonoids decrease the risk of not improving or persisting symptoms by 58 per cent (relative risk (RR) 0.42 (95 per cent confidence interval (c.i.) 0.28 to 0.61)) and showed an apparent reduction in the risk of bleeding (RR 0.33 (95 per cent c.i. 0.19 to 0.57)), persistent pain (RR 0.35 (95 per cent c.i. 0.18 to 0.69)), itching (RR 0.65 (95 per cent c.i. 0.44 to 0.97)) and recurrence (RR 0.53 (95 per cent c.i. 0.41 to 0.69)). CONCLUSION: Limitations in methodological quality, heterogeneity and potential publication bias raise questions about the apparent beneficial effects of flavonoids in the treatment of haemorrhoids.

Laxatives for the treatment of hemorrhoids.

BACKGROUND: Symptomatic hemorrhoids are a common medical condition, which increase in prevalence in women during pregnancy and postpartum. Although the evidence appears to be inconclusive, narrative reviews and clinical practice guidelines recommend the use of laxatives (and fiber) for the treatment of hemorrhoids and relief of symptoms. This is due to their safety and low cost. OBJECTIVES: To evaluate the impact of laxatives on a wide range of symptoms in people with symptomatic hemorrhoids. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2005), MEDLINE (1966 to 2005), EMBASE (1980 to 2005), CINAHL (1982 to 2005), BIOSIS, and AMED (Allied and Alternative Medicine Database), for eligible trials (including conference proceedings). We sought missing and additional information from authors, industry, and experts in the field. SELECTION CRITERIA: We selected all published and unpublished randomised controlled trials that compared any type of laxative to placebo or no therapy in any patient population. DATA COLLECTION AND ANALYSIS: Two authors independently screened studies for inclusion and retrieved all potentially relevant studies. Data were extracted from studies that met our selection criteria on study population, intervention used, pre-specified outcomes, and methodology. We extracted methodological information for the assessment of internal validity: existence and method of generation of the randomization schedule, and method of allocation concealment; blinding of caregivers and outcomes assessors; numbers of and reasons for participants lost to follow up; and use of validated outcome measures. MAIN RESULTS: Seven randomised trials enrolling a total of 378 participants to fiber or a non-fiber control were identified. Meta-analyses using random-effects models showed that laxatives in the form of fiber had a beneficial effect in the treatment of symptomatic hemorrhoids. The risk of not improving hemorrhoids and having persisting symptoms decreased by 53% in the fiber group (risk reduction (RR) 0.47, 95% CI 0.32 to 0.68). These results are compatible with large treatment effects regarding prolapse, pain, itching, although the pooled analyses showed a tendency toward no-effect for these parametres. The effect on bleeding showed a significant difference in favour of the fiber (RR 0.50, 95% CI 0.28 to 0.89). Studies including data on multiple follow ups (usually after six weeks and three months) showed consistent results over time. However, we have to stress two possible limitations of this review: the risk of publication bias, and only moderate study quality. AUTHORS' CONCLUSIONS: The use of fiber shows a consistent beneficial effect for relieving overall symptoms and bleeding in the treatment of symptomatic hemorrhoids.

Efficacy of esomeprazole 40 mg vs. lansoprazole 30 mg for healing moderate to severe erosive oesophagitis.

BACKGROUND: Secondary analyses from previous studies indicated that esomeprazole was more effective than lansoprazole and omeprazole in healing moderate or severe (Los Angeles grades C or D) erosive oesophagitis (EE). AIM: To compare prospectively healing rates with esomeprazole vs. lansoprazole in patients with moderate to severe EE. METHODS: In this multicentre, randomized, double-blind, parallel-group trial, adult patients with endoscopically confirmed moderate or severe EE received esomeprazole 40 mg (n = 498) or lansoprazole 30 mg (n = 501) once daily for up to 8 weeks. The primary end point was EE healing through week 8. Secondary assessments included investigator-assessed resolution of symptoms and safety and tolerability. RESULTS: Time to healing was significantly different (P = 0.007), favouring esomeprazole. Estimated healing rates at week 8 were 82.4% with esomeprazole 40 mg and 77.5% with lansoprazole 30 mg. Heartburn resolved at week 4 in 72% and 64% of patients who received esomeprazole and lansoprazole, respectively (P = 0.005). Control of other GERD symptoms was similar between treatments. Both treatments were well tolerated. CONCLUSIONS: With 8 weeks' treatment, esomeprazole 40 mg once daily heals moderate to severe EE faster and in more patients, and resolves heartburn in more patients after 4 weeks of treatment, than lansoprazole 30 mg once daily.

Options for patients with irritable bowel syndrome: contrasting traditional and novel serotonergic therapies.

This article reviews the efficacy and tolerability of traditional therapies for irritable bowel syndrome (IBS) and concludes that they are limited by both poor efficacy and adverse effects. Serotonin, a neurotransmitter found mainly in the gut, appears to represent a link in IBS pathophysiological processes -- altered gut motility, abnormal intestinal secretion and visceral hypersensitivity. Recently, available treatments for IBS have targeted serotonin receptors that are involved in motor, sensory and secretory functions of the gut. Serotonergic agents, such as alosetron (a 5-HT3 receptor antagonist) and tegaserod (a selective 5-HT4 receptor partial agonist), provide global relief of the multiple symptoms of IBS with diarrhoea and IBS with constipation, respectively, and represent important additions to the IBS treatment armamentarium.

Review article: tegaserod for chronic constipation.

Constipation is one of the most common gastrointestinal conditions with limited effective treatment options. Tegaserod, a 5-HT4 receptor agonist has demonstrated efficacy in relieving constipation-related symptoms in patients suffering from irritable bowel syndrome with constipation. This paper reviews two recent reports that have evaluated the efficacy and safety of tegaserod in patients with chronic constipation. Two double-blind, randomized, placebo-controlled trials have been reported; one in Europe and Asia (E2301) the other in North and South America (E2302). After a 2-week baseline period, patients were randomized to treatment with tegaserod 2 mg b.d., tegaserod 6 mg b.d. or placebo for 12 weeks. Two thousand, six hundred and twelve patients were randomized, the majority were white females. In both studies, responder rates during weeks 1-4 were significantly greater in the tegaserod groups compared with placebo. A similar trend was seen over weeks 1-12. Statistically significant improvements over placebo were seen across the majority of secondary efficacy variables. Tegaserod was safe with no consistent differences in the frequency of adverse events among the various groups. In conclusion, treatment of chronic constipation with tegaserod was associated with significant improvement in bowel frequency as well as other constipation symptoms. Tegaserod was also well tolerated in this patient population.

Risk factors for the severity of erosive esophagitis in Helicobacter pylori-negative patients with gastroesophageal reflux disease.

BACKGROUND: The risk factors for the varying grades of erosive esophagitis (EE) severity could be better understood. For that reason. we evaluated the risk factors associated with EE in patients with gastroesophageal reflux disease. METHOD: We determined the presence and severity of EE (using the Los Angeles Classification) in patients with negative serology Helicobacterpylori who underwent esophagogastroduodenoscopy as part of screening in four prospective, multicenter, randomized, double-blind comparative trials of once-daily esomeprazole and omeprazole for the acute healing of erosive esophagitis. We also examined the baseline characteristics of enrolled patients, and identified risk factors for severe disease using a multivariable logistic regression model. RESULTS: Erosive esophagitis was documented in 6709 patients of a total of 10,294 patients who underwent endoscopy: of these. 34% had grade A. 39% had grade B. 20% had grade C. and 7% had grade D disease. The majority of patients were male (61%) and Caucasian (93%) with a mean age of 46 years. In the regression model, the following were significant independent risk factors for severe (grades C and D) versus mild erosive esophagitis (grades A and B): severe heartburn (adjusted odds ratio 1.79); prolonged heartburn > 5 years in duration (1.16); obesity (1.21); the presence of hiatus hernia (2.13); male gender (1.97); and Caucasian ethnicity (1.53). CONCLUSION: In this large sample of patients with predominantly H. pylori-negative gastroesophageal reflux disease, risk factors for severe erosive esophagitis were the duration and severity of heartburn, and obesity.

Critical review of the epidemiology of gastroesophageal reflux disease with specific comparisons to asthma and breast cancer.

GERD is one of the most common GI disorders. Despite its frequent occurrence, the absence of a consistent definition and an easily used diagnostic gold standard make it difficult to ascertain the true epidemiology of this condition. Recent work to validate a short symptom questionnaire to reliably diagnose GERD will be a major methodological improvement facilitating the analysis of large populations to better define its epidemiology. When these methods are available, a number of questions need to be addressed (Table 4). These include elucidating the epidemiology of erosive and nonerosive reflux disease, defining the epidemiology of GERD among minority populations, determining the natural history of erosive and nonerosive reflux disease, and identifying potential risk factors contributing to the development of GERD. The answers to these questions should improve our understanding of GERD, allowing us to better identify and treat individuals and populations at risk with the ultimate goal of improving quality of life in addition to preventing the development of GERD complications such as adenocarcinoma.

Outcomes of acute esophageal food impaction: success of the push technique.

BACKGROUND: Acute esophageal food impaction (AEFI) is the most common form of esophageal impaction in adults. The current recommendation for management is extraction by using an overtube to protect the airway, which facilitates multiple passages of the endoscope and protects the esophageal mucosa. Typically, AEFI in our patients is treated with the push technique, a method found to be highly successful and without complications. METHODS: All patients with a diagnosis of AEFI from 1993 to 1998 were identified by computer search of ICD-9 diagnosis code 935.1 (foreign body of the esophagus). Patients were excluded if they were less than 18 years of age, had an acute esophageal foreign body other than food, or if the medical record was incomplete. RESULTS: The analysis included 189 patients: 114 men and 75 women. Of these, 77 (41%) had a Schatzki's ring, 61 (32%) had an esophageal stricture, and 4 (2%) had esophageal cancer. In 47 patients (25%) no obvious structural cause for AEFI was noted at endoscopy. In addition, 67 patients had breaks in the esophageal mucosa. The push technique resolved the food impaction in 184 of 189 (97%) of the patients. In no subgroup was there an instance of perforation, aspiration, or bleeding. Forty-five patients underwent dilation at the time of food disimpaction without complication. CONCLUSIONS: The push technique is both safe and effective in the treatment of AEFI. Dilation at the initial presentation of a patient with AEFI likewise appears to be safe. The push technique is recommended as the initial therapy of choice for AEFI. Dilation at the time of esophageal food disimpaction can be considered if there are no obvious contraindications.

Use of the Web for medical information by a gastroenterology clinic population.

CONTEXT: Surveys have shown that 60 million persons in the United States searched for health information online in 1998. However, lack of sampling from a clinic population limits the generalizability of these surveys to clinical practice. OBJECTIVES: To determine gastroenterology patients' access to and use of the Web as a medical information resource, to identify for what information patients search, and to determine how often physicians recommend that patients search the Web. DESIGN, SETTING, AND PARTICIPANTS: Cross-sectional survey of 1006 gastroenterology outpatients in Durham, NC, and Rockford, Ill, conducted in August 1999. MAIN OUTCOME MEASURES: Patient characteristics and education level, access to the Web, use of the Web as a medical information resource, search methods, and plans for future Web use. RESULTS: A total of 924 patients (92%) completed the questionnaire. Median age was 53 years, 41% were men, and the median education level was having completed some college. Fifty percent (462/924) reported having access to the Web. Of the 462 with access, 235 (51%) had searched the Web for medical information within the previous 12 months. Therefore, 25.5% of all patients surveyed had searched the Web for medical information within the previous year. Sixty percent of patients intended to use the Web as a medical information resource in the future. Only 35 (4%) of 825 had ever been referred to the Web by a physician. CONCLUSIONS: In this clinic setting, more than one quarter of gastroenterology outpatients reported having obtained medical information from the Web within the previous year. More than two thirds of patients stated they would use the Web as a medical information resource in the future. JAMA. 2000;284:1962-1964.

Epidemiology of esophageal and supraesophageal reflux injuries.

Gastroesophageal reflux disease (GERD) is a common gastrointestinal disorder. Despite its frequent occurrence, only a minority of patients seek medical attention, making it difficult to ascertain the true epidemiologic distribution of the disorder. A causal association between GERD and esophageal complications such as esophagitis, esophageal ulcer, and esophageal stricture is well accepted. Recent epidemiologic evidence suggests that GERD may likewise represent a risk factor for the development of supraesophageal conditions, such as asthma, chronic bronchitis, laryngitis, and even laryngeal cancer. Although epidemiologic associations do not establish a cause-and-effect relationship, they may indicate potential etiologic risk factors. Nevertheless, confirmation of the causal role of GERD in supraesophageal disorders awaits further investigation.

Characteristics of best gastroenterology practices.

OBJECTIVE: As health care costs continue to rise, competition among providers is increasing. Although this competition is currently based on price, quality of care will become an increasingly important issue. One popular method to assess quality is by comparing physicians' performance with that of a representative group of physicians, in a process called benchmarking. The purpose of this study was to survey private practice gastroenterologists to identify the practice characteristics, so-called "best practices," associated with high-quality health care delivery to provide data for use as benchmarks. METHODS: Three hundred randomly selected gastroenterology practices were surveyed regarding practice demographics, administration, financial management, and use of outcomes techniques by mail questionnaire. Analogous questionnaires were completed by representatives of the gastroenterology practices comprising the Gastroenterology Practice Management Group, LLC (GMPG). RESULTS: One hundred and eighty-two (61%) of the 300 eligible practices responded to the questionnaire. Increasing differences between survey and benchmark GPMG practices were observed as the complexity of quality measures increased. Among structure measures, the groups were similar. By contrast, significant differences were observed between survey and benchmark groups with regards to outcomes measures such as the use of practice guidelines, continuous quality improvement, and outcomes assessment. CONCLUSIONS: These results provide a snapshot of gastroenterology practices across the country and can be used as a benchmark for quality assessment purposes to compare with one's practice, suggesting areas for change or improvement. It seems clear that the defining characteristic of best gastroenterology practices is the demonstration of quality patient care. It also appears that many practices' efforts in this regard could be increased.

Importance of outcomes research in endoscopic practice.

The field of outcomes research has emerged in response to rising health care costs and the continued scarcity of resources. This field concerns itself with identifying the most effective and efficient use of finite resources and is a monitoring system to ensure that quality is maintained. This commitment to quality, however, must extend to the level of the individual endoscopist to ensure that patients' interests are maintained. If physicians are not actively involved in data collection and measurement to improve the quality and value of their work, someone else undoubtedly will. Because quality assessment and the accountability revolution in health care has public support, individual practitioners and entire specialties increasingly will need to provide routine outcomes data.