Fecal Microbiota Transplantation for the Treatment of Ulcerative Colitis: A Qualitative Assessment of Patient Perceptions and Experiences.

BACKGROUND: Fecal microbiota transplantation (FMT) is a promising experimental therapy for ulcerative colitis (UC), yet patient acceptance remains poorly understood. AIMS: The aim of this study was to explore perceptions and experiences of adult patients who received FMT for UC. METHODS: This study used a qualitative descriptive design with thematic content analysis. Patients who were approached for enrollment in a clinical trial (NCT02606032) were invited to participate in face-to-face semistructured interviews. Two groups were interviewed: those who chose to pursue FMT and those who declined FMT. Non-FMT patients were interviewed once; FMT patients were interviewed twice at pre- and post-treatment. RESULTS: Nine FMT patients (78% female, average age 46.7 years old) and eight non-FMT patients (50% female, average age 39.5 years old) were enrolled. Pretreatment themes included FMT as a natural therapy, external barriers to pursuing FMT, concerns with FMT and factors influencing the decision to pursue FMT. While both groups generally perceived FMT as a natural therapy, pre-FMT patients showed greater acceptance of alternative medicine. Both groups demonstrated poor understanding and similar initial concerns with product cleanliness. Pre-FMT patients were motivated to pursue FMT by feelings of last resort. Post-FMT themes included therapeutic impact of FMT and psychosocial impact of FMT. Post-FMT patients reported overall satisfaction and a unanimous preference for FMT over conventional medications. CONCLUSION: This is the first study to assess adult patient perceptions and real-life experiences with FMT for the treatment of UC. By improving patient education, we may achieve greater acceptance of FMT.

Esomeprazole and aspirin in Barrett's oesophagus (AspECT): a randomised factorial trial.

BACKGROUND: Oesophageal adenocarcinoma is the sixth most common cause of cancer death worldwide and Barrett's oesophagus is the biggest risk factor. We aimed to evaluate the efficacy of high-dose esomeprazole proton-pump inhibitor (PPI) and aspirin for improving outcomes in patients with Barrett's oesophagus. METHODS: The Aspirin and Esomeprazole Chemoprevention in Barrett's metaplasia Trial had a 2 × 2 factorial design and was done at 84 centres in the UK and one in Canada. Patients with Barrett's oesophagus of 1 cm or more were randomised 1:1:1:1 using a computer-generated schedule held in a central trials unit to receive high-dose (40 mg twice-daily) or low-dose (20 mg once-daily) PPI, with or without aspirin (300 mg per day in the UK, 325 mg per day in Canada) for at least 8 years, in an unblinded manner. Reporting pathologists were masked to treatment allocation. The primary composite endpoint was time to all-cause mortality, oesophageal adenocarcinoma, or high-grade dysplasia, which was analysed with accelerated failure time modelling adjusted for minimisation factors (age, Barrett's oesophagus length, intestinal metaplasia) in all patients in the intention-to-treat population. This trial is registered with EudraCT, number 2004-003836-77. FINDINGS: Between March 10, 2005, and March 1, 2009, 2557 patients were recruited. 705 patients were assigned to low-dose PPI and no aspirin, 704 to high-dose PPI and no aspirin, 571 to low-dose PPI and aspirin, and 577 to high-dose PPI and aspirin. Median follow-up and treatment duration was 8·9 years (IQR 8·2-9·8), and we collected 20 095 follow-up years and 99·9% of planned data. 313 primary events occurred. High-dose PPI (139 events in 1270 patients) was superior to low-dose PPI (174 events in 1265 patients; time ratio [TR] 1·27, 95% CI 1·01-1·58, p=0·038). Aspirin (127 events in 1138 patients) was not significantly better than no aspirin (154 events in 1142 patients; TR 1·24, 0·98-1·57, p=0·068). If patients using non-steroidal anti-inflammatory drugs were censored at the time of first use, aspirin was significantly better than no aspirin (TR 1·29, 1·01-1·66, p=0·043; n=2236). Combining high-dose PPI with aspirin had the strongest effect compared with low-dose PPI without aspirin (TR 1·59, 1·14-2·23, p=0·0068). The numbers needed to treat were 34 for PPI and 43 for aspirin. Only 28 (1%) participants reported study-treatment-related serious adverse events. INTERPRETATION: High-dose PPI and aspirin chemoprevention therapy, especially in combination, significantly and safely improved outcomes in patients with Barrett's oesophagus. FUNDING: Cancer Research UK, AstraZeneca, Wellcome Trust, and Health Technology Assessment.

Tax-deductible provisions for gluten-free diet in Canada compared with systems for gluten-free diet coverage available in various countries.

Celiac disease affects 1% of the North American population, with an estimated 350,000 Canadians diagnosed with this condition. The disease is triggered by the ingestion of gluten, and a lifelong, strict gluten-free diet (GFD) is the only currently available treatment. Compliance with a strict GFD is essential not only for intestinal mucosal recovery and alleviation of symptoms, but also for the prevention of complications such as anemia, osteoporotic fractures and small bowel lymphoma. However, a GFD is difficult to follow, socially inconvenient and expensive. Different approaches, such as tax reduction, cash transfer, food provision, prescription and subsidy, have been used to reduce the additional costs of the GFD to patients with celiac disease. The current review showed that the systems in place exhibit particular advantages and disadvantages in relation to promoting uptake and compliance with GFD. The tax offset system used in Canada for GFD coverage takes the form of a reimbursement of a cost previously incurred. Hence, the program does not help celiac patients meet the incremental cost of the GFD - it simply provides some future refund of that cost. An ideal balanced approach would involve subsidizing gluten-free products through controlled vouchers or direct food provision to those who most need it, independently of 'ability or willingness to pay'. Moreover, if the cost of such a program is inhibitive, the value of the benefits could be made taxable to ensure that any patient contribution, in terms of additional taxation, is directly related to ability to pay. The limited coverage of GFD in Canada is concerning. There is an unmet need for GFD among celiac patients in Canada. More efforts are required by the Canadian medical community and the Canadian Celiac Association to act as agents in identifying ways of improving resource allocation in celiac disease.

Barrett's Oesophagus Surveillance versus endoscopy at need Study (BOSS): protocol and analysis plan for a multicentre randomized controlled trial.

OBJECTIVES: The absolute annual risk of patients with Barrett's oesophagus (BO) developing oesophageal adenocarcinoma (OAC) is ≤ 0.5%. Screening BO patients for malignant progression using endoscopic surveillance is widely practised. To assess the efficacy and cost-effectiveness of this, we developed a protocol for a randomized controlled trial of surveillance versus 'at need' endoscopy. METHODS: In a multicentre trial, 3400 BO patients randomized to either 2-yearly endoscopic surveillance or 'at need' endoscopy will be followed up for 10 years. Urgent endoscopy will be offered to all patients who develop symptoms of dysphagia, unexplained weight loss > 7lb (3.2 kg), iron deficiency anaemia, recurrent vomiting, or worsening upper gastrointestinal symptoms. Participants must have endoscopically and histologically confirmed BO, with circumferential BO ≥ 1 cm or maximal tongue/island length ≥ 2 cm. Candidates with existing oesophageal high-grade dysplasia or cancer, or previous upper gastrointestinal cancer will be excluded. Primary outcome will be overall survival. Secondary outcomes will be cost effectiveness (cost per life year saved and quality adjusted life years); cancer-specific survival; time to OAC diagnosis and stage at diagnosis; morbidity and mortality related to any interventions; and frequency of endoscopy. CONCLUSIONS: This randomized trial will provide data to evaluate the efficacy and cost-effectiveness of screening BO patients for OAC.

British Society of Gastroenterology guidelines on the diagnosis and management of Barrett's oesophagus.

These guidelines provide a practical and evidence-based resource for the management of patients with Barrett's oesophagus and related early neoplasia. The Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument was followed to provide a methodological strategy for the guideline development. A systematic review of the literature was performed for English language articles published up until December 2012 in order to address controversial issues in Barrett's oesophagus including definition, screening and diagnosis, surveillance, pathological grading for dysplasia, management of dysplasia, and early cancer including training requirements. The rigour and quality of the studies was evaluated using the SIGN checklist system. Recommendations on each topic were scored by each author using a five-tier system (A+, strong agreement, to D+, strongly disagree). Statements that failed to reach substantial agreement among authors, defined as >80% agreement (A or A+), were revisited and modified until substantial agreement (>80%) was reached. In formulating these guidelines, we took into consideration benefits and risks for the population and national health system, as well as patient perspectives. For the first time, we have suggested stratification of patients according to their estimated cancer risk based on clinical and histopathological criteria. In order to improve communication between clinicians, we recommend the use of minimum datasets for reporting endoscopic and pathological findings. We advocate endoscopic therapy for high-grade dysplasia and early cancer, which should be performed in high-volume centres. We hope that these guidelines will standardise and improve management for patients with Barrett's oesophagus and related neoplasia.

Assessing the value of symptom relief for patients with gastroesophageal reflux disease treatment: willingness to pay using a discrete choice experiment.

OBJECTIVES: To assess patients' preferences and estimate willingness to pay (WTP) for gastroesophageal reflux disease (GERD) treatments. METHOD: Patients were randomly selected from a multicenter clinical study to participate in the discrete choice experiment (DCE) survey. Relevant treatment attributes were identified through literature review, clinical expert consultation, and focus groups. The DCE included 14 choice tasks composed of six attributes, three treatment profiles, and a "none"option considering orthogonality, D-efficiency, and level balance, while keeping patient response burden reasonable. Individual-level preferences and WTP were estimated by aggregate-level conditional logit and hierarchical Bayes analyses. RESULTS: Our sample of 361, drawn from a clinical trial, had a mean age of 57 years, were primarily women (53%), and rated their GERD symptoms as mild/moderate (31%) and moderately severe/severe (7%). Most important attributes of GERD treatment were (in order) as follows: avoiding side effects, sleeping discomfort, daytime discomfort, dietary changes, medication cost, and treatment frequency. Simulations found that patients are willing to pay an additional US $36 to reduce susceptibility to side effects from moderate to mild or to decrease the frequency of sleeping discomfort. Patients 65 years or older were willing to pay less for daytime discomfort relief, while women would pay more to avoid sleeping discomfort. CONCLUSIONS: Key factors concerning patients with GERD and their preference for treatment features to control GERD symptoms were confirmed. A DCE estimated WTP by GERD sufferers for relief from symptoms and avoidance of side effects using relevant treatment costs. These findings may help guide clinical treatment decisions for individual patients to improve GERD symptom control.

Functional Dyspepsia Treatment Trial (FDTT): a double-blind, randomized, placebo-controlled trial of antidepressants in functional dyspepsia, evaluating symptoms, psychopathology, pathophysiology and pharmacogenetics.

BACKGROUND: Functional dyspepsia (FD) is a common problem affecting up to 10-25% of individuals. FD accounts for significant health care costs and affects quality of life but has no definitive treatment. OBJECTIVES: The Functional Dyspepsia Treatment Trial (FDTT) aims to test whether treatment with an antidepressant (amitriptyline or escitalopram) leads to improvement of symptoms in patients with moderate to severe FD. DESIGN: The FDTT is an international multicenter, parallel group, randomized, double-blind, placebo-controlled trial to evaluate whether 12 weeks of treatment with escitalopram or amitriptyline improves FD symptoms compared to treatment with placebo. Secondly, it is hypothesized that acceleration of solid gastric emptying, reduction of postprandial satiation, and enhanced gastric volume change with a meal will be significant positive predictors of short- and long-term outcomes for those on antidepressants vs. placebo. The third aim is to examine whether polymorphisms of GNß3 and serotonin reuptake transporter influence treatment outcomes in FD patients receiving a tricyclic antidepressant, selective serotonin reuptake inhibitor therapy, or placebo. METHODS: The FDTT enrollment began in 2006 and is scheduled to randomize 400 patients by the end of 2012 to receive an antidepressant or placebo for 12 weeks, with a 6-month post-treatment follow-up. The study incorporates multiple validated questionnaires, physiological testing, and specific genetic evaluations. The protocol was approved by participating centers' Institutional Review Boards and an independent Data Safety Monitoring Board was established for monitoring to ensure patient safety and a single interim review of the data in December 2010 (ClinicalTrials.gov number NCT00248651).

The gain in quality-adjusted life months by switching to esomeprazole in those with continued reflux symptoms in primary care: EncomPASS--a cluster-randomized trial.

OBJECTIVES: Proton pump inhibitors (PPIs) are effective in gastroesophageal reflux disease (GERD), but their cost effectiveness is unknown. This is usually determined by cost/quality-adjusted life year (QALY) gained, but whether PPI therapy improves QALYs has not been assessed in a randomized trial. The PPI acid suppression symptom (PASS) test is a five-item questionnaire that identifies patients with persistent acid-related symptoms. We evaluated whether a PASS test-based management strategy of changing GERD therapy to esomeprazole in those with continued symptoms on another PPI or H(2) receptor antagonist therapy would be cost effective. We expressed the data in terms of cost per quality-adjusted life months (QALM), as this was a 4-week trial. METHODS: This is a multicenter, cluster-randomized, open-label study in primary care physician centers across Canada. Primary care physician centers were randomized to intervention or control arms. Patients on acid-suppressing medication were identified from primary care records and asked to complete the PASS test. PASS test failures at baseline assessment continued current therapy in control practices or switched to esomeprazole 20 or 40 mg daily (the dose was at the clinician's discretion) for 4 weeks in intervention practices. A planned secondary end point was QALM gain, measured using the validated Euroqol (EQ-5D) completed at baseline and 4 weeks. Medication use was also assessed by questionnaire. Canadian unit generic costs were applied to all GERD drugs, except to esomeprazole and lansoprazole, wherein proprietary costs were used (all costs in Canadian $). Data were analyzed using bootstrap sampling. RESULTS: A total of 1,564 patients were recruited from 134 intervention sites and 92 control sites. Data were evaluable for 808 intervention and 445 control patients. The mean (±standard deviation) QALM at 4 weeks in the intervention group was 0.885±0.164 compared with 0.814±0.179 in the control group, resulting in a mean 0.071 (95% CI=0.091-0.051) QALM gain (P<0.0001). Esomeprazole was cost effective for PASS test failures, with a mean cost of $763 (95% CI=456-1,414) per QALM gain. CONCLUSIONS: Esomeprazole was associated with a statistically significant gain in QALMs and was cost effective in primary care patients with persistent acid-related symptoms identified by the PASS test.

Empiric quadruple vs. triple therapy for primary treatment of Helicobacter pylori infection: Systematic review and meta-analysis of efficacy and tolerability.

OBJECTIVES: Recent treatment guidelines recommend two first-line therapies for Helicobacter pylori infection: proton pump inhibitor (PPI), bismuth, tetracycline, and metronidazole (quadruple therapy) or PPI, clarithromycin, and amoxicillin (triple therapy). We performed a systematic review and meta-analysis to compare the efficacy and tolerability of these regimens as first-line treatment of H. pylori. METHODS: A search of MEDLINE, EMBASE, Google Scholar, the Cochrane Central Register of Controlled Trials, ACP Journal Club, the Database of Abstracts of Reviews of Effectiveness, Cochrane Methodology Register, Health Technology Assessment Database, and abstracts from prominent gastrointestinal scientific meetings was carried out. Randomized controlled trials (RCTs) comparing bismuth quadruple therapy to clarithromycin triple therapy were selected for meta-analysis. Two independent reviewers extracted data, using standardized data forms. Meta-analysis was carried out with the metan command in Stata 10.1. Funnel plots and subgroup analyses were carried out. RESULTS: Nine RCTs (N=1,679) were included. Although dosing regimens of clarithromycin triple therapy were quite consistent between trials, dosing regimens varied considerably for bismuth quadruple therapy. Bismuth quadruple therapy achieved eradication in 78.3% of patients, whereas clarithromycin triple therapy achieved an eradication rate of 77.0% (risk ratio (RR)=1.002, 95% confidence interval (CI): 0.936-1.073). There was moderate heterogeneity and no evidence for significant publication bias. Subgroup analyses by study location, treatment duration, and study population did not account for the heterogeneity. There were no statistically significant differences in side effects yielded by quadruple vs. clarithromycin triple therapy (RR=1.04, 95% CI: 1.04-1.14). CONCLUSIONS: Quadruple and triple therapies yielded similar eradication rates as primary therapy for H. pylori infection. Both therapies yielded suboptimal eradication rates. Patient compliance and side effects are similar for quadruple and triple therapies.

Should we step-up or step-down in the treatment of new-onset dyspepsia in primary care?

Dyspepsia is common in the community, and the condition represents a considerable burden to the health service. Individuals over the age of 50 to 55 years consulting with new-onset dyspepsia and those with alarming features, such as dysphagia and weight loss, require urgent endoscopy to exclude gastro-esophageal malignancy. For younger individuals without alarm features prompt endoscopy and "test and scope" are not cost-effective initial management strategies. "Test and treat" or empirical acid suppression therapy should be preferred, depending on patient and physician choice, as well as local prevalence of Helicobacter pylori. If empirical acid suppression therapy is favored, a recent primary care-based trial from the Netherlands suggests the choice of initial acid suppressant (antacid or proton pump inhibitor [PPI]) has little effect on the likelihood of remaining symptomatic, and that stepping-up from antacid to PPI is more cost-effective than stepping-down from PPI, when current prices of branded drugs were considered.

Managing dyspepsia.

The prevalence of dyspepsia in the general population is as high as 40%, and its management represents a considerable financial burden to the health care system. Causes of dyspepsia amenable to medical therapy include peptic ulcer and functional dyspepsia, and testing for Helicobacter pylori and treating positive individuals is beneficial in both conditions. Individuals presenting for the first time with uninvestigated dyspepsia, age greater than 50 years, or alarm features require upper gastrointestinal (GI) endoscopy to exclude gastroesophageal malignancy. Upper GI endoscopy for younger individuals without alarm features is not cost-effective compared with the "test and treat" approach. Test and treat and empirical acid-suppression using a proton pump inhibitor (PPI) have similar costs and effects. Recent evidence suggests that empirical acid suppression commencing with antacids is as effective as PPI. Screening and treatment of H. pylori in PPI users and the community may reduce the costs of managing dyspepsia.

Economic reflections on proton pump inhibitor therapy for non-erosive reflux disease.

Proton pump inhibitor (PPI) therapy for gastroesophageal reflux disease is a good example of the evolution of economic analysis. Initial studies were simple models constructed on spreadsheets and described the most cost-effective therapy in terms of cost per cure of esophagitis. This tells a third-party payer what is the most efficient approach to healing esophagitis (technical efficiency) but does not give any indication of whether treating esophagitis is good value for money in the first place or whether health care dollars would be better spent in treating other diseases (allocative efficiency). As economic analyses became more sophisticated, more complex models were constructed. Outcomes were expressed in terms of cost per quality-adjusted life year gained or the question was framed in terms of the probability a strategy would be cost effective depending on willingness to pay for a month free from symptoms. These approaches answer the question of whether treating gastroesophageal reflux disease is good value for money. Models have traditionally evaluated treatment of esophagitis, but this does not address the most efficient therapy of non-erosive reflux disease. This article describes a simplified model (for illustrative purposes only) and suggests that PPI therapy is a cost-effective approach for the treatment of esophagitis whether generic or proprietary PPI costs are applied. PPI therapy is also likely to be a cost-effective strategy for non-erosive reflux disease at generic but not at proprietary prices.

Helicobacter pylori test and treat versus proton pump inhibitor in initial management of dyspepsia in primary care: multicentre randomised controlled trial (MRC-CUBE trial).

OBJECTIVE: To determine the cost effectiveness of Helicobacter pylori "test and treat" compared with empirical acid suppression in the initial management of patients with dyspepsia in primary care. DESIGN: Randomised controlled trial. SETTING: 80 general practices in the United Kingdom. PARTICIPANTS: 699 patients aged 18-65 who presented to their general practitioner with epigastric pain, heartburn, or both without "alarm symptoms" for malignancy. INTERVENTION: H pylori 13C urea breath test plus one week of eradication treatment if positive or proton pump inhibitor alone; subsequent management at general practitioner's discretion. MAIN OUTCOME MEASURES: Cost effectiveness in cost per quality adjusted life year (QALY) (EQ-5D) and effect on dyspeptic symptoms at one year measured with short form Leeds dyspepsia questionnaire. RESULTS: 343 patients were randomised to testing for H pylori, and 100 were positive. The successful eradication rate was 78%. 356 patients received proton pump inhibitor for 28 days. At 12 months no significant differences existed between the two groups in QALYs, costs, or dyspeptic symptoms. Minor reductions in costly resource use over the year in the test and treat group "paid back" the initial cost of the intervention. CONCLUSIONS: Test and treat and acid suppression are equally cost effective in the initial management of dyspepsia. Empirical acid suppression is an appropriate initial strategy. As costs are similar overall, general practitioners should discuss with patients at which point to consider H pylori testing. TRIAL REGISTRATION: Current Controlled Trials ISRCTN87644265.

A second-order simulation model of the cost-effectiveness of managing dyspepsia in the United States.

BACKGROUND: The "gold-standard'' evidence of effectiveness for a clinical practice guideline is the randomized controlled trial (RCT), although RCTs have a limited ability to explore potential management strategies for a chronic disease where these interact over time. Modeling can be used to fill this gap, and models have become increasingly complex, with both dynamic sampling and representation of second-order uncertainty to provide more precise estimates. However, both simulation modeling and probabilistic sensitivity analysis are rarely used together. The objective of this study was to explore uncertainty in controversial areas of the 2005 American Gastroenterology Association position statement on the management of dyspepsia. METHODS: Individual sampling model, incorporating a second-order probabilistic sensitivity analysis. POPULATION: US adult patients presenting in primary care with dyspepsia. Interventions compared: empirical acid suppression, test and treat for Helicobacter pylori, initial endoscopy, acid suppression then endoscopy, test and treat then proton pump inhibitor (PPI) then endoscopy. OUTCOMES: Cost-effectiveness, quality-adjusted life years, and costs in US dollars from a societal perspective, measured over a 5-year period. DATA SOURCES: mainly Cochrane meta-analyses. RESULTS: Endoscopy was dominated at all ages by other strategies. PPI therapy was the most cost-effective strategy in 30-year-olds with a low prevalence of H. pylori. In 60-year-olds, H. pylori test and treat was the most cost-effective option. CONCLUSIONS: Acid suppression alone was more cost-effective than either endoscopy or H. pylori test and treat in younger dyspepsia patients with a low prevalence of infection.

The health economics of Helicobacter pylori infection.

Economic considerations are becoming increasingly important as health care becomes more expensive. Evidence for effectiveness is usually gained from randomised controlled trials (RCTs) but often there is insufficient evidence of the costs of alternative strategies in trials. Often, therefore, economic models are needed to extrapolate data from a variety of sources to give an indication of which strategy is cost effective. Helicobacter pylori (H. pylori) testing and treating in a wide variety of upper gastrointestinal diseases is a good example of the application of economic analyses to health care interventions. H. pylori eradication in peptic ulcer disease is very effective with systematic reviews giving a number needed to treat of around two compared to no therapy. RCTs have also suggested that treating H. pylori is also more effective and less expensive than continuous H(2) receptor antagonist therapy and is therefore the dominant strategy in treating peptic ulcer disease. The impact of H. pylori eradication in infected patients with functional dyspepsia is less dramatic, with systematic reviews suggesting a number needed to treat of 14. Economic models suggest that in Europe H. pylori eradication is cost-effective compared to offering no treatment (e.g. in the UK we can be 95% certain this approach is cost effective if you are willing to pay $51/month free from dyspepsia). In the USA it is less certain that this is a cost-effective approach due to the higher cost of eradication therapy. H. pylori test and treat has been proposed as an alternative to early endoscopy in patients with uninvestigated dyspepsia. We have conducted an individual patient data meta-analysis of five RCTs that has addressed the cost effectiveness of this approach. Endoscopy was slightly more effective than H. pylori test and treat at relieving dyspepsia at one year but was not cost-effective as it cost $9000/dyspepsia cure at one year. Population H. pylori test and treat has been proposed as a strategy to prevent noncardia gastric cancer. RCTs have suggested this approach may be cost saving but more data are needed on whether H. pylori eradication will reduce gastric cancer mortality before this strategy can be recommended.

A community screening program for Helicobacter pylori saves money: 10-year follow-up of a randomized controlled trial.

BACKGROUND & AIMS: Population screening and treatment of Helicobacter pylori has been advocated as a means of reducing mortality from gastric cancer, as well as dyspepsia and dyspepsia-related resource use. Previous programs have failed to demonstrate a significant effect on mortality or resource use, but follow-up was only for 1 or 2 years. We aimed to determine the effect of screening for H pylori on dyspepsia and dyspepsia-related resource use over 10 years. METHODS: H pylori-positive individuals, aged 40-49 years, enrolled in a community screening program, randomized to eradication therapy or placebo in 1994, were sent a validated dyspepsia questionnaire by mail 10 years later, and primary care records were reexamined. Consultation, referral, prescribing, and investigation data related to dyspepsia were extracted. United Kingdom costs were applied to derive total cost per person (1 pound = 1.8 dollars). RESULTS: Of 2324 original participants, 1864 (80%) were traced and contacted. Of these, 1086 (47%) responded, and 919 (40%) agreed to a review of their primary care records. There was a 10-year mean saving in total dyspepsia-related costs of 117 dollars per person (95% confidence interval [CI] = 11 dollars-220 dollars, P = .03) with eradication therapy. Those symptomatic at baseline showed a nonsignificant trend toward resolution of symptoms at 10 years with eradication therapy (relative risk of remaining symptomatic, 0.89; 95% CI: 0.77-1.03). CONCLUSIONS: There were significant reductions in total dyspepsia-related health care costs. The savings made were greater than the initial cost of H pylori screening and treatment.

Ethnicity, gender, and socioeconomic status as risk factors for esophagitis and Barrett's esophagus.

Barrett's esophagus is thought to be a disease occurring predominantly in White Caucasian males of higher socioeconomic status. There are no published studies simultaneously examining risk of Barrett's esophagus according to ethnicity, gender, and socioeconomic status within a single data set. The authors conducted a retrospective case-control analysis within a cross-sectional study to determine risk of Barrett's esophagus in relation to sociodemographic variables in a large United Kingdom population. All patients undergoing upper gastrointestinal endoscopy at two clinical centers between January 2000 and January 2003 were evaluated. Data on ethnicity, age, gender, socioeconomic status, and the presence of Barrett's esophagus and esophagitis at endoscopy were collected. A total of 20,310 patients were analyzed. Barrett's esophagus was more common in White Caucasians (401/14,095 (2.8%)) than in South Asians (16/5,190 (0.3%)) (adjusted odds ratio (OR)=6.03, 95% confidence interval (CI): 3.56, 10.22), as was esophagitis (2,500/14,095 (17.7%) vs. 557/5,190 (10.7%); adjusted OR=1.76, 95% CI: 1.57, 1.97). Patients with Barrett's esophagus were also more likely to be male (adjusted OR=2.70, 95% CI: 2.18, 3.35) and of higher socioeconomic status (adjusted OR=1.58, 95% CI: 1.16, 2.15 (top tertile vs. bottom tertile)). White Caucasian ethnicity, male gender, and higher socioeconomic status are independent risk factors for Barrett's esophagus.

Helicobacter pylori "test and treat" or endoscopy for managing dyspepsia: an individual patient data meta-analysis.

BACKGROUND & AIMS: Helicobacter pylori "test and treat" has been recommended for the management of young dyspeptic patients without alarm symptoms, and trials have suggested that it is as effective as endoscopy. However, none of these trials have had sufficient sample size to confirm that "test and treat" costs less or to detect small differences in effect. A collaborative group has prospectively registered trials comparing prompt endoscopy with a "test and treat" approach, with the aim of performing an individual patient data meta-analysis of both effect and resource utilization data. METHODS: Researchers provided data for meta-analysis, pooling effects of interventions on individual dyspepsia symptoms. Standardized unit costs were applied to resource utilization, and net benefit was calculated at patient level. Effects, costs, and net benefit were then pooled at study level. RESULTS: Five trials were identified, containing 1924 patients (946 endoscopy [mean age, 40 years], 978 "test and treat" [mean age, 41 years]). The relative risk (RR) of remaining symptomatic after 1 year was reduced with endoscopy compared with "test and treat" (RR = 0.95; 95% confidence interval [CI]: 0.92-0.99). "Test and treat" cost 389 dollars less per patient (95% CI: 275-502 dollars). Using the net benefit approach, at no realistic level of willingness to pay per patient symptom-free did prompt endoscopy become cost-effective. CONCLUSIONS: Prompt endoscopy confers a small benefit in terms of cure of dyspepsia but costs more than "test and treat" and is not a cost-effective strategy for the initial management of dyspepsia.

Gambling with gastroesophageal reflux disease: should we worry about the QALY?

Gastroenterologists mainly deal with chronic organic and functional illnesses that are not life threatening but can be expensive to treat. How this compares with the management of other diseases that cause significant mortality is an important question to answer if health-care resources are to be allocated appropriately. Comparing health care in terms of cost per quality adjusted life year (QALY) gained is one approach to this problem although there are concerns about whose values should be elicited and how QALYs are measured.