BACKGROUND:Symptom diaries are potentially attractive but, because of concerns about patient compliance, they have had limited use in clinical trials. We assessed the validity and responsiveness of a symptom diary for patients with gastro-oesophageal reflux disease.METHODS:We included 215 patients with gastro-oesophageal reflux disease after starting treatment for 4 weeks with 40 mg esomeprazole once daily. Patients recorded whether they experienced night-time heartburn (yes/no), the severity of daytime heartburn on a scale from 1 (no heartburn) to 4 (severe heartburn) and their antacid use. Patients also completed a number of disease-specific and preference-based Health-related Quality of Life questionnaires at baseline and follow-up.RESULTS:Consistent with a priori predictions, daytime heartburn showed moderate to strong correlations with the Quality of Life in Reflux and Dyspepsia questionnaire (0.36-0.67) and four scales of symptom severity (0.36-0.70) for baseline, follow-up and change scores, but low correlations with the Standard Gamble. Responsiveness of the daytime heartburn item was excellent with a mean change from baseline to follow-up of -1.3 (95% CI -1.4 to -1.1) and a standardized response mean of 1.33 while responsiveness of the daily antacid use item was moderate (mean change scores -1.8 tablets taken, 95% CI -2.3 to -1.3 and standardized response mean of 0.64).CONCLUSIONS:The excellent psychometric properties of this simple gastro-oesophageal reflux disease diary make it an attractive measure for future trials.

BACKGROUND: Gastroesophageal reflux disease (GERD) is the most prevalent acid-related disorder in Canada and is associated with significant impairment of health-related quality of life. Since the last Canadian Consensus Conference in 1996, GERD management has evolved substantially.OBJECTIVE: To develop up-to-date evidence-based recommendations relevant to the needs of Canadian health care providers for the management of the esophageal manifestations of GERD.CONSENSUS PROCESS: A multidisciplinary group of 23 voting participants developed recommendation statements using a Delphi approach; after presentation of relevant data at the meeting, the quality of the evidence, strength of recommendation and level of consensus were graded by participants according to accepted principles.OUTCOMES: GERD applies to individuals who reflux gastric contents into the esophagus causing symptoms sufficient to reduce quality of life, injury or both; endoscopy-negative reflux disease applies to individuals who have GERD and a normal endoscopy. Uninvestigated heartburn-dominant dyspepsia -- characterised by heartburn or acid regurgitation - includes erosive esophagitis or endoscopy-negative reflux disease, and may be treated empirically as GERD without further investigation provided there are no alarm features. Lifestyle modifications are ineffective for frequent or severe GERD symptoms; over-the-counter antacids or histamine H2-receptor antagonists are effective for some patients with mild or infrequent GERD symptoms. Proton pump inhibitors are more effective for healing and symptom relief than histamine H2-receptor antagonists; their efficacy is proportional to their ability to reduce intragastric acidity. Response to initial therapy - a once-daily proton pump inhibitor unless symptoms are mild and infrequent (fewer than three times per week) - should be assessed at four to eight weeks. Maintenance medical therapy should be at the lowest dose and frequency necessary to maintain symptom relief; antireflux surgery is an alternative for a small proportion of selected patients. Routine testing for Helicobacter pylori infection is unnecessary before starting GERD therapy. GERD is associated with Barrett's epithelium and esophageal adenocarcinoma but the risk of malignancy is very low. Endoscopic screening for Barrett's epithelium may be considered in adults with GERD symptoms for more than 10 years; Barrett's epithelium and low-grade dysplasia generally warrant surveillance; endoscopic or surgical management should be considered for confirmed high-grade dysplasia or malignancy.CONCLUSION: Prospective studies are needed to investigate clinically relevant risk factors for the development of GERD and its complications; GERD progression, on and off therapy; optimal management strategies for typical GERD symptoms in primary care patients; and optimal management strategies for atypical GERD symptoms, Barrett's epithelium and esophageal adenocarcinoma.

BACKGROUND:There are few recent published consensus guidelines regarding nonvariceal upper gastrointestinal bleeding. In 2003, the Canadian Association of Gastroenterology sponsored a set of 20 recommendations.AIM:To compare current Canadian clinical practice patterns with these most recent guidelines.METHODS:Data obtained from the Canadian Registry of patients with Upper Gastrointestinal Bleeding and Endoscopy (RUGBE), complemented by a questionnaire sent out to the 18 participating RUGBE sites, were used to compare present practice with all 20 guidelines.RESULTS:Only three RUGBE sites had an explicit written protocol for nonvariceal upper gastrointestinal bleeding, and only 40% of the sites had support staff available after hours. The Blatchford prognostic scale was not used routinely, and only one site used the Rockall score for risk stratification. Most patients classified as low-risk according to the literature had endoscopy within 24 h and a median length of stay of two days compared with high-risk patients who underwent endoscopy approximately 4 h earlier, had a median length of stay of 4.3 days and displayed a higher mortality. Nineteen per cent of all patients had a routine second-look endoscopy. Proton pump inhibitors were frequently used in the acute setting. Thirteen per cent of all patients rebled and only 34% of these received a second endoscopy. One-half of all patients were tested for Helicobacter pylori while in hospital, mostly by histology, and one-third of those who tested positive received H pylori eradication during their hospitalization.CONCLUSION:Compared with recommendations put forward in the new guidelines, clinical practice before guideline publication was variable. The future level of guideline adherence and patient outcome data should be quantified and monitored as the guidelines are disseminated.

As an update to previously published recommendations for the management of Helicobacter pylori infection, an evidence-based appraisal of 14 topics was undertaken in a consensus conference sponsored by the Canadian Helicobacter Study Group. The goal was to update guidelines based on the best available evidence using an established and uniform methodology to address and formulate recommendations for each topic. The degree of consensus for each recommendation is also presented. The clinical issues addressed and recommendations made were: population-based screening for H. pylori in asymptomatic children to prevent gastric cancer is not warranted; testing for H. pylori in children should be considered if there is a family history of gastric cancer; the goal of diagnostic interventions should be to determine the cause of presenting gastrointestinal symptoms and not the presence of H. pylori infection; recurrent abdominal pain of childhood is not an indication to test for H. pylori infection; H. pylori testing is not required in patients with newly diagnosed gastroesophageal reflux disease; H. pylori testing may be considered before the use of long-term proton pump inhibitor therapy; testing for H. pylori infection should be considered in children with refractory iron deficiency anemia when no other cause has been found; when investigation of pediatric patients with persistent or severe upper abdominal symptoms is indicated, upper endoscopy with biopsy is the investigation of choice; the 13C-urea breath test is currently the best noninvasive diagnostic test for H. pylori infection in children; there is currently insufficient evidence to recommend stool antigen tests as acceptable diagnostic tools for H. pylori infection; serological antibody tests are not recommended as diagnostic tools for H. pylori infection in children; first-line therapy for H. pylori infection in children is a twice-daily, triple-drug regimen comprised of a proton pump inhibitor plus two antibiotics (clarithromycin plus amoxicillin or metronidazole); the optimal treatment period for H. pylori infection in children is 14 days; and H. pylori culture and antibiotic sensitivity testing should be made available to monitor population antibiotic resistance and manage treatment failures.

BACKGROUND:Active upper-GI bleeding (spurting or oozing) or a visible vessel at endoscopy are high-risk lesions that predict recurrence of bleeding. The aim of this study is to determine whether nasogastric aspirate predicts the presence of high-risk lesions.METHODS:The Canadian Registry of patients with Upper Gastrointestinal Bleeding undergoing Endoscopy was used to identify patients with upper-GI bleeding who underwent nasogastric aspiration and subsequent endoscopy. An association between nasogastric aspirate findings (bloody, "coffee ground," clear/bile) and high-risk lesions was sought.RESULTS:Of 1869 patients in the registry, 520 had documented nasogastric aspiration before endoscopy. Those who underwent aspiration did not differ from those who did not. A bloody nasogastric aspirate was significantly associated with high-risk lesions (odds ratio 4.82: 95% CI[2.3, 10.1] vs. clear/bile; and odds ratio 2.8: 95% CI[1.8, 4.3] vs. coffee ground). A bloody nasogastric aspirate had the highest specificity for high-risk lesions (75.8%: 95% CI[70.0, 80.0]) with a negative predictive value of 77.9%: 95% CI[73.2, 82.0], and raised the probability of having a high-risk lesions from 0.29 to 0.45. A clear nasogastric aspirate reduced the likelihood to 0.15. Nasogastric aspirate yielded the most useful information in hemodynamically stable patients without hematemesis.CONCLUSIONS:Nasogastric aspirate is useful in predicting high-risk lesions. Whether it can be used to determine which patients would benefit from earlier endoscopy deserves further study.

BACKGROUND:Recent data suggest a role for high-dose oral proton pump inhibition in ulcer bleeding.AIM:To compare the cost-effectiveness of oral high-dose proton pump inhibition to both high-dose intravenous proton pump inhibition and placebo administration.METHODS:The model adopted a 30-day time horizon, and focused on patients with ulcer haemorrhage initially treated endoscopically for high-risk stigmata. Re-bleeding rates were set a priori based on non-head-to-head data from the literature, and charges and lengths of stay from a national American database. Sensitivity analyses were carried across a broad range of clinically relevant assumptions.RESULTS:Re-bleeding rates for patients receiving intravenous, oral, or placebo therapies were 5.9%, 11.8%, and 27%, respectively. The mean lengths of stay and costs for admitted patients with and without re-bleeding were 4.7 and 3 days; $11,802, and $7993, respectively. High-dose intravenous proton pump inhibition was more effective and less costly (dominant) than high-dose oral proton pump inhibition with incremental savings of $136.40 per patient treated. The oral high-dose strategy in turn dominated placebo administration. Results remained robust according to one- and two-way sensitivity analyses.CONCLUSION:In patients undergoing endoscopic haemostasis, subsequent high-dose intravenous proton pump inhibition is more cost-effective than high-dose oral proton pump inhibition, which in turn dominates placebo. The results from this exploratory-type cost analysis require confirmation by head-to-head prospective trials performed in Western populations.

BACKGROUND:The role of Helicobacter pylori in gastro-oesophageal reflux disease (GERD) is controversial.AIM:To compare the severity of GERD in infected vs. non-infected patients, as part of an ongoing randomized controlled trial that examines the impact of H. pylori eradication on GERD-related outcomes.METHODS:Consecutive GERD patients underwent urea breath testing and completed validated GERD symptom severity, and quality of life questionnaires as well as, 24-h pH-metry. These parameters, as well as demographics and endoscopic findings were assessed in double-blinded fashion and compared between H. pylori-infected and non-infected subjects.RESULTS:Helicobacter pylori-infected GERD patients (n=50) were significantly older and less educated than non-infected patients (n=51). They also used proton pump inhibitors less often but had no difference in symptoms (as measured with both the Spechler's Activity Index and the Gastrointestinal Symptom Rating Scale), quality of life, endoscopic findings or 24-h pH-metry findings.CONCLUSION:This prospective, double-blind study demonstrates, using excellent GERD quantifying measures including validated symptom severity scores, endoscopy, and 24-h pH-metry, that there exist no clinically significant differences in clinical or laboratory-related GERD manifestations between H. pylori-infected and non-infected GERD patients.

SummaryBackground : The efficacy of high‐dose intravenous proton pump inhibition has recently been shown, yet its cost‐effectiveness remains poorly studied.Aim : To assess the cost‐effectiveness of this approach separately for American and Canadian health care settings.Methods : A validated decision model included patients with bleeding ulcers after successful endoscopic haemostasis. Probabilities were determined from the literature, and charges and lengths of stay from national databases. A third‐party payer perspective was adopted over a 30‐day time horizon.Results : Re‐bleeding rates were 5.9% for patients who received high‐dose intravenous proton pump inhibition and 22.9% for those who did not. Hospitalization costs for patients with and without re‐bleeding were US$11 802 and US$7993, and CAN$5220 and CAN$2696, respectively. High‐dose intravenous proton pump inhibition was more effective and less costly than the alternative of not administering it. The cost‐effectiveness ratios for high‐dose and no high‐dose intravenous proton pump inhibition were US$9112 and US$11 819 (CAN$3293 and CAN$4284 for the Canadian case), respectively. Sensitivity and threshold analyses showed that the results were robust across a wide range of clinically relevant assumptions.Conclusion : In the USA and Canada, administering high‐dose intravenous proton pump inhibition for 3 days is both more effective and less costly than not doing so for patients with bleeding ulcers after successful endoscopic haemostasis.

Purpose: There are few recent consensus guidelines on nonvariceal upper gastrointestinal bleeding (NVUGIB). In 2003, the Banff Conference produced a set of 20 guidelines. The aim of this study is to quantify the level of adherence to these guidelines in Canada prior to their publication. Methods: Data obtained between 1999–2002 from the Canadian Registry of patients with Upper Gastrointestinal Bleeding and Endoscopy (RUGBE) was used to assess adherence to guidelines, and was complemented by a questionnaire sent out to the 18 RUGBE sites. Results: Few RUGBE sites had an explicit written protocol for NVUGIB. Only 40% had support staff available after hours. The Blatchford prognostic scale was not used routinely, and only 1 site used the Rockall score for risk statification. Half of patients were tested for Helicobacter pylori mostly by histology, and only half of those who tested positive were treated while in hospital.Table: Outcomes in Low and High-Risk PatientsLow-Risk factors: hemoglobin > 90 g/L, platelets > 50 × 109 g/L, INR < 1.5, pulse < 100 beats/min, systolic blood pressure > 100 mmHg, no high-risk lesion on endoscopy High-Risk factors: absolute high-risk lesion on endoscopy, age ≫ 60, comorbidities factors of increased risk hemoglobin ≪ 90 g/L, platelet ≪ 50 × 109 g/L, INR ≫ 1.5, pulse ≫ 100 beats/min, systolic blood pressure ≪ 100 mmHgTable: Routine Second Look: not recommended by the guidelinesConclusions: Adequate dissemination of recent published guidelines should improve adherence to the statements, which will hopefully improve patient outcomes.

BACKGROUND: Sedation is not required to perform a technically adequate gastroscopy (EGDE), but does improve patient satisfaction, comfort, and willingness to repeat particularly in the elderly and those with decreased pharyngeal sensitivity. The comparative cost-efficacy of sedation versus no sedation remains poorly characterized.AIM: To compare the cost-efficacy of diagnostic EGDE with and without sedation in an adult ambulatory Canadian population.METHODS: A double-blind randomized controlled trial assigned patients to sedation versus placebo. "Successful endoscopy" was considered an EGDE rated 4/4 in technical adequacy (1 = inadequate to 4 = totally adequate), and 1-2/5 in patient self-reported comfort (1 = acceptable to 5 = unacceptable). Secondary outcomes included recovery room time, patient satisfaction alone, and willingness to repeat the procedure. Cost data were obtained using a published, institutional activity-based costing methodology. Analysis was intention to treat using standard univariate and multivariate methods.RESULTS: 419 patients (mean age 54.5, 48% male) were randomized (N = 210 active vs N = 209 placebo). Among patients randomized to active medication 76% of procedures were "successful" (placebo 46%), 79% were satisfied with their level of comfort (placebo 47%), and willingness to repeat was 81% (placebo 65%). We observed a 10% crossover rate from placebo to active medications. The use of sedation was the major determinant of successful endoscopy (OR = 3.8; 95% Cl: 2.5-5.7), but contributed to an increased recovery room time (29 vs 15 min; p < 0.0001). The expected cost of an additional successful endoscopy using sedation was $90.06 (CDN). In a planned subgroup analysis, among the elderly (>75; N = 53) unsedated endoscopy became the dominant approach. Indeed, in this population, a trend was observed favoring the effectiveness of placebo (63%) versus active medication (57%) (OR = 0.75; 95% Cl: 0.25-2.3) and was less costly resulting in $450 savings/unsedated EGDE.CONCLUSIONS: In the average Canadian ambulatory adult population, sedated diagnostic EGDE is more costly but remains an efficacious strategy by increasing the rate of successful endoscopies, patient satisfaction, and willingness to repeat. However, among the elderly (>75 yr), an unsedated strategy may be more cost-efficacious.

Background: Despite recommendations that patients rating their own health using utility and preference measures such as the feeling thermometer (FT) and standard gamble (SG) should also rate hypothetical marker states, little evidence supports marker state use. We evaluated whether the administration of marker states improves measurement properties of the FT and SG. Methods: We randomized 217 patients with gastroesophageal reflux disease to complete the FT (self-administered) and SG with marker states (FT+/SG+, n = 112) or without marker states (FT−/SG−, n = 105) before and after 4 weeks of treatment with a proton pump inhibitor, esomeprazole. Patients also completed other health-related quality of life instruments. Results: The use of marker states did not influence baseline utility scores (FT+ 0.66, FT− 0.68; SG+ 0.77, SG− 0.78, on a scale from 0 [dead] to 1.0 [full health]). Improvement after therapy was 0.21 in FT+ and 0.15 in FT− (both P < 0.001; difference between FT+ and FT− = 0.06, P = 0.02). Improvement in SG+ was 0.07 (P < 0.001) and 0.06 in SG− (P = 0.003) (difference between SG+ and SG− = 0.01, P = 0.63). Correlations with other health-related quality of life scores were generally stronger, with some statistically significant differences in correlations, for FT+ compared with FT−, but tended to be weaker for SG+ compared with SG−. Conclusion: The administration of marker states improved the responsiveness and validity of the FT but not of the SG. Decisions about administering marker states should depend on whether the FT and SG is of primary interest and the importance of optimal validity and responsiveness relative to competing objectives such as efficiency.

OBJECTIVES:From the Canadian Registry of patients with Upper Gastrointestinal Bleeding and Endoscopy (RUGBE), we determined clinical outcomes and explored the roles of endoscopic and pharmacologic therapies in a contemporary real-life setting. METHODS:Analysis of randomly selected patients endoscoped for nonvariceal upper gastrointestinal bleeding at 18 community and tertiary care institutions between 1999 and 2002. Covariates and outcomes were defined a priori and 30-day follow-up obtained. Logistic regression models identified predictors of outcomes. RESULTS:One thousand eight-hundred and sixty-nine patients were included (66 +/- 17 yr, 38% female, 2.5 +/- 1.6 comorbid conditions, hemoglobin, 96 +/- 27 g/L, 54% received a mean of 2.9 +/- 1.7 units of blood). Endoscopy was performed within 24 h in 76%, with ulcers (55%) most commonly noted. High-risk endoscopic stigmata and endoscopic therapy were reported in 37%. Rebleeding, surgery, and mortality rates were 14.1%, 6.5%, and 5.4%, respectively. Decreased rebleeding was significantly and independently associated with PPI use (85% of patients, mean daily dose 56 +/- 53 mg) in all patients regardless of endoscopic stigmata, (odds ratio (OR):0.53, 95% confidence interval, 95% CI:0.37-0.77) and endoscopic hemostasis in patients with high-risk stigmata (OR:0.39, 95% CI:0.25-0.61). PPI use (OR:0.18, 95% CI:0.04-0.80) and endoscopic therapy (OR:0.31, 95% CI:0.11-0.91) were also each independently associated with decreased mortality in patients with high-risk stigmata. CONCLUSIONS:These results appear to confirm the protective role of endoscopic therapy in patients with high-risk stigmata, and suggest that acute use of PPIs may be associated with a reduction of rebleeding in all patients, and lower mortality in patients with high-risk stigmata. Independent prospective validation of these observational findings is now required.

Background: Prior endoscopic studies evaluating conscious sedation have recruited only a small proportion of the patients actually approached. The generalizability of such results to an unselected adult ambulatory care population is thus questionable. The objectives of this study were to determine the characteristics of patients who refused inclusion in a randomized controlled trial of sedation and to compare these characteristics to those of patients who agreed to participate.Methods: Patients who refused participation in a randomized controlled trial of sedation completed standardized questionnaires addressing demographic data and possible confounding variables, and they also completed a validated anxiety questionnaire. Characteristics associated with refusal to participate in the randomized controlled trial were assessed by using uni- and multivariate analysis. Exploratory comparisons of outcomes between both groups included self-reported satisfaction with level of comfort and technical adequacy.Results: Of 302 patients screened, 203 refused to participate in the randomized controlled trial. The most common reason for refusal was the request for no sedation (135/203). A total of 163 were enrolled in this synchronous study. Patients who refused to participate exhibited 3 distinguishing characteristics: prior treatment for an anxiety disorder (risk difference 9.4%: 95% CI[3%,17%]), use of analgesic medication (risk difference 10.4%: 95% CI[2%, 19%]), and prior experience with EGD (risk difference 17.9: 95% CI[5%, 30%]). Only upper endoscopy experience was predictive of refusal to participate in the randomized controlled trial. No differences in outcomes existed between patients randomized to sedation and those refusing the randomized controlled trial who chose to receive sedative medication. Patients who refused participation in the randomized controlled trial and who underwent upper endoscopy without sedation were more satisfied than patients randomized to placebo (1.33 vs. 2.58; risk difference -1.25: 95% CI[-0.385 -2.1]). Moreover, the procedure in these patients was more adequate technically (4.86 vs. 4.18; risk difference 0.68: 95% CI[0.21, 1.13]).Conclusions: Characteristics of patients accepting and refusing randomization were highly similar, differing only with regard to upper endoscopy experience. An exploratory analysis of outcomes suggests that randomized controlled trial results may be biased in a direction that may underestimate the benefits of not administering sedative medication in a real-life setting.

Veldhuyzen van Zanten et al conducted a double-blind, randomized, multicentre study comparing triple therapy for Helicobacter pylori eradication to placebo for the treatment of nonulcer dyspepsia (NUD) symptoms in adult patients (1). Patients had moderate to severe epigastric pain on entry (rated at least a three on a five-point scale for at least three of the previous 14 days). The main outcome measure was the Mean Dyspepsia Summary Score (MDSS), which represents the mean severity of eight dyspepsia symptoms (epigastric pain, belching, heartburn, upper abdominal bloating, flatulence, sour taste, nausea and halitosis). Of the 1143 patients who were screened for this study in 27 centres across Canada, 157 were randomized. H pylori was eradicated in 82% of the active group compared with 6% in the placebo group. Symptoms improved in both groups over the 12-month study period, but there was no difference between the two groups in MDSS (2.34 in active and 2.30 in placebo groups at baseline, compared with 1.68 and 1.67, respectively, at the last visit). Nor were there differences in any of the individual symptoms, in the proportion of patients who achieved a certain MDSS score or in health care utilization, such as physician visits, need for additional prescriptions or days lost from work. The authors concluded that, compared with placebo, therapy for H pylori produced no sustained improvement of NUD symptoms.

SummaryBackground : The accuracy of physicians’ assessment of the severity of gastro‐oesophageal reflux disease is unclear.Aim : To correlate physician and patient assessment of gastro‐oesophageal reflux disease severity and its response to treatment.Methods : Adult uninvestigated gastro‐oesophageal reflux disease patients (n = 217) completed symptom and health‐related quality of life questionnaires at baseline and after treatment with esomeprazole 40 mg p.o. daily. Pearson coefficients quantified correlations between physician assessments and patient responses.Results : At baseline, the strongest correlations were heartburn severity (0.31), overall symptom severity (0.44) and a domain of the quality of life in reflux and dyspepsia questionnaire (0.31) (P < 0.001). Correlations of change with treatment were greater than baseline correlations: heartburn (0.39), overall symptoms (0.50) and global rate of change – stomach problems (0.72, all P < 0.001). The mean difference between the physicians’ assessment of change and the patients’ global rating of change was 0.20 (95% confidence intervals: 0.10–0.29) with physicians overestimating benefit.Conclusions : Correlations were often significant, although weak to moderate and better with symptom severity than with health‐related quality of life instruments as well as with change after therapy than at baseline. Increasing attention to health‐related quality of life may help physicians better understand patients’ experience. In clinical trials, treatment success should be assessed by the patient as well as the physician.

BACKGROUND:The role of endoscopic biopsies in the detection of Helicobacter pylori in patients with nonulcer dyspepsia is poorly defined. This study assesses the cost-effectiveness of performing routine biopsies for the detection of H pylori at upper endoscopy in these patients.METHODS:Clinical decision-making was modeled based on outcomes data from published articles and expert opinion. The target group was adults, less than 45 years of age, with nonulcer dyspepsia as defined by a normal endoscopy. Costs, expressed in Canadian dollars, were tabulated over a 1-year time horizon. The main outcome was relief of symptoms, defined as the absence of symptom persistence or recurrence over the 12 months. A strategy of performing a biopsy for the detection of H pylori with a rapid urease test during gastroscopy was compared with that of not performing a biopsy. In addition, as a secondary analysis, the cost-effectiveness of obtaining a biopsy specimen for histopathologic evaluation in patients after a negative rapid urease test was evaluated.RESULTS:A strategy of endoscopy with biopsy and rapid urease testing costs 3940 dollars per additional symptom-free patient as compared with endoscopy without biopsy. This result was sensitive to the difference in symptomatic recurrence rate at 1 year between patients in whom H pylori was successfully and unsuccessfully eradicated, which in this analysis, was set at 9.9%. Only when the difference in symptomatic recurrence in patients with successful versus unsuccessful eradication fell to less than 4% was endoscopy with biopsy over 10,000 dollars per cured patient greater than endoscopy without biopsy. The conclusions were otherwise robust when varying the values of other variables across clinically relevant ranges. There was little additional benefit associated with histopathologic assessment of biopsy specimens in patients with a negative rapid urease test and the cost per additional cure was 25,529 dollars.CONCLUSIONS:In adults with nonulcer dyspepsia under age 45 years undergoing endoscopy, routine procurement of a biopsy specimen for detection of H pylori was more costly yet more effective compared with not obtaining a specimen. The cost-effectiveness of a biopsy is dependent on the benefits of H pylori eradication in this patient population. The less likely a patient with nonulcer dyspepsia is to become asymptomatic after successful H pylori eradication, the more costly a strategy of routinely obtaining a specimen at endoscopy. The additional cost of sending a specimen for histopathologic analysis if the rapid urease test is negative does not appear warranted based on cost-effectiveness considerations.