Patient- versus physician-reported outcomes in rheumatoid arthritis patients treated with recombinant interleukin-1 receptor antagonist (anakinra) therapy.

OBJECTIVES: To determine whether patient-reported outcomes may differentiate treatment response better than physician-reported outcomes for rheumatoid arthritis (RA) patients being treated with anakinra. METHODS: A meta-analysis was conducted using data obtained from three separate randomized controlled clinical trials (RCTs) (n = 1007). Outcomes from 6-month assessments were grouped into four categories: American College of Rheumatology (ACR) response criteria, patient-reported measures (patient-reported pain, patient global assessment, and assessment of physical function using the Health Assessment Questionnaire), physician-reported measures (tender and swollen joint counts and physician global assessment), and laboratory tests (C-reactive protein and erythrocyte sedimentation rate). Effect sizes were calculated using changes from baseline and pooled standard deviations for each of these types of outcome. RESULTS: Active treatment with anakinra was superior to placebo by ACR(20) responses in all three RCTs. Effect sizes for patient-reported outcomes were greater than for physician-reported outcomes, and also greater than ACR(20) in three of five anakinra cohorts. Across the RCTs, placebo responses were greater with physician-reported than with patient-reported outcomes. In the two studies evaluating patients with longer-standing disease, differences between pooled effect sizes for patient-reported and physician-reported outcomes were even more pronounced. CONCLUSIONS: In three pivotal RCTs, active treatment with anakinra resulted in greater improvements in patient-reported than physician-reported outcomes compared with placebo. These observations confirm those previously reported from RCTs evaluating conventional DMARDs, demonstrating better discrimination of treatment effect with patient-reported outcomes.

The burden of illness of gastro-oesophageal reflux disease: impact on work productivity.

BACKGROUND: The impact of gastro-oesophageal reflux disease on work productivity has become increasingly important, as the symptoms of gastro-oesophageal reflux disease affect individuals in their productive years of life. AIMS: To assess the impact of gastro-oesophageal reflux disease on reduced work productivity and to identify the predictors of reduced productivity. METHODS: A sample of employed individuals reporting chronic heartburn was selected from US household mail survey respondents. Heartburn severity and frequency were recorded using a diary, and work productivity was assessed using the Work Productivity and Activity Impairment Questionnaire for Patients with Symptoms of Gastro-oesophageal Reflux Disease. Predictors of reduced productivity were evaluated. RESULTS: Over 30% of heartburn sufferers reported reduced productivity. Individuals with symptoms of gastro-oesophageal reflux disease (n = 1003) reported 6.0% reduced productivity attributable to symptoms. Over 48% of respondents with severe symptoms reported reduced productivity, compared with 40% and 12% of respondents with moderate and mild symptoms, respectively. Using logistic regression, severity, a younger age and nocturnal symptoms were associated with increased odds of reduced productivity. In those reporting nocturnal heartburn, medication use and sleep interference increased the odds of reduced productivity. CONCLUSIONS: Reduced work productivity is seen in a large proportion of subjects on prescription medication for gastro-oesophageal reflux disease. Symptom severity and nocturnal heartburn are significantly associated with reduced work productivity, particularly when nocturnal heartburn interferes with sleep.

The relation between gastroesophageal reflux disease and esophageal and head and neck cancers: a critical appraisal of epidemiologic literature.

The prevalence of esophageal adenocarcinoma has increased substantially in the United States. Studies demonstrate that certain preexisting conditions place persons at an increased risk for developing adenocarcinoma of the esophagus and of the head and neck. Such conditions include gastroesophageal reflux disease (GERD) and Barrett's esophagus (BE). The degree to which these conditions increase the risk is variable. This article critically evaluates data on the relationships between GERD and esophageal adenocarcinoma, between BE and esophageal adenocarcinoma, and between GERD and cancers of the head and neck.

Health-Related quality-of-life and quality-days incrementally gained in symptomatic nonerosive GERD patients treated with lansoprazole or ranitidine.

Eight-hundred forty-nine patients with symptomatic nonerosive GERD from two clinical trials of lansoprazole 15 mg daily (LAN 15) and lansoprazole 30 mg daily (LAN 30) vs ranitidine 150 mg twice a day (RAN 150) completed a health-related quality-of-life (HRQoL) questionnaire at baseline and four and eight weeks after treatment. The questionnaire included the Short-Form 12, GERD symptoms, eating symptoms, social restrictions, problems with sleep, work disability, treatment satisfaction, and associated importance weights items. Both LAN groups reported greater, although not significant, improvement from baseline to week 8 versus RAN 150 in the majority of HRQoL scales. Treatment satisfaction was significantly higher at week 8 in both LAN groups. Quality-days incrementally gained analysis showed that both LAN groups gained significantly more quality days than RAN 150. Patients taking lansoprazole 15 or 30 mg daily reported better outcomes than those receiving ranitidine 150 twice a day over the eight-week study.

Identifying patients with gastroesophageal reflux disease in a managed care organization.

The ability of various strategies to identify patients with gastroesophageal reflux disease (GERD) and the relative economic impact on disease management programs for GERD were studied. A telephone interview was conducted of a random sample of patients enrolled in any of three health plans in a 100,000-member managed care organization who had either a pharmacy claim or an encounter claim during 1997. The telephone interview identified patients with GERD and served as the standard by which the sensitivity, specificity, and predictive values of the following patient-identification strategies were compared: (1) telephone interview, (2) chart review, (3) use of encounter claims, (4) use of pharmacy claims, (5) use of both encounter claims, and pharmacy claims, and (6) use of encounter claims or pharmacy claims. Conservative estimates of costs and projected savings were then used to model the potential return on investment of the strategies. A total of 1186 patients completed the telephone interview, of whom 390 (33%) met the case definition of GERD. The most sensitive method for identifying patients with GERD was using either pharmacy or encounter claims (26%). The most specific strategy with the highest positive predictive value (PPV) (87%) was using both pharmacy and encounter claims, but this approach had a case-detection rate of only 3%. Encounter claims were significantly more sensitive than pharmacy claims and yielded a higher estimate of prevalence. The telephone interview identified the most subjects who could have benefited from a disease management program and cost 84% less than chart review. While use of administrative data (pharmacy and encounter claims) was the least costly strategy, it identified 74% fewer patients expected to benefit from disease management. The efficiency of disease management programs for GERD may depend on the method of patient identification, which in turn may depend on whether PPV or negative predictive value (NPV) should be maximized. If there is a need to identify all cases (i.e., sensitivity and NPV are most important), then telephone interview may provide the greatest opportunity for disease management with the greatest return on investment, but at the expense of enrolling many patients who may not benefit.

Endoscopy for acute nonvariceal upper gastrointestinal tract hemorrhage: is sooner better? A systematic review.

BACKGROUND: While the effectiveness of upper endoscopy has been established for acute nonvariceal upper gastrointestinal tract hemorrhage, its optimal timing has not been clearly defined. Early endoscopy has been advocated for its ability to achieve prompt diagnosis, risk stratification, and therapeutic hemostasis. OBJECTIVE: To determine whether early vs delayed endoscopy improves patient and economic outcomes for all risk groups with nonvariceal upper gastrointestinal tract hemorrhage. METHODS: A systematic review of 3 computerized databases (MEDLINE, HEALTHSTAR, and Cochrane Database of Systematic Reviews) was performed along with hand searching of published abstracts to identify English-language citations from 1980 to 2000. RESULTS: Twenty-three studies met explicit inclusion criteria. The highest-quality study examining outcomes in low-risk patients found no significant complications at 1-month follow-up for any outpatients managed with early endoscopy. The largest randomized trial of high-risk patients showed no mortality benefit but a significant decrease in transfusion requirements with early endoscopy. Seven of the 8 studies examining the effect of early endoscopy on length of stay as a measure of resource utilization demonstrated a significant reduction compared with that of delayed endoscopy. However, most included studies were found to suffer from 1 or more potentially significant methodologic shortcomings. CONCLUSIONS: The overwhelming majority of existing data suggest that early endoscopy is safe and effective for all risk groups. The clinical and economic outcomes of early endoscopy should be confirmed in additional well-designed randomized controlled trials. Given the strength of the evidence, efforts to develop a more standardized and time-sensitive approach to acute nonvariceal upper gastrointestinal tract hemorrhage should be undertaken.

Cost-effectiveness of proton-pump inhibitors for maintenance therapy of erosive reflux esophagitis.

The relative cost-effectiveness of proton-pump inhibitors (PPIs) in the maintenance therapy of erosive reflux esophagitis was studied. Decision analysis was used to model the cost-effectiveness of PPIs on the basis of clinical trial results. Management decisions in the model were based on published U.S. guidelines and recommendations. Probability estimates were derived from a systematic review of the literature. The model's base-case scenario compared rabeprazole, lansoprazole, and omeprazole for the prevention of symptom recurrence over one year. Meta-analyzed estimates of efficacy were derived from trials by using a generalized logistic regression model with random effects. Medical costs for hospitalization, procedures, and office visits reflected 2000 Medicare payment; drug costs were based on 2000 average wholesale prices. Average costs per patient were comparable among the PPIs (rabeprazole, $1414; lansoprazole, $1671; and omeprazole, $1599). Rabeprazole prevented symptom recurrence in 86% of rabeprazole recipients, versus 68% for lansoprazole and 81% for omeprazole, and yielded the lowest average cost-effectiveness ratio (rabeprazole, $1637 per recurrence prevented; lansoprazole, $2439; and omeprazole, $1968). The model was robust to changes in key variables. When evaluated by decision analysis over a wide range of assumptions, rabeprazole was comparable to other PPIs in terms of cost and offered improved effectiveness for maintenance therapy of erosive reflux esophagitis.

Clinical utility of serodiagnostic testing in suspected pediatric inflammatory bowel disease.

OBJECTIVES: Confronted with nonspecific symptoms, accurate screening tests would be useful to clinicians to distinguish between functional childhood disorders and inflammatory bowel disease (IBD), thus avoiding invasive diagnostic testing. Traditional ulcerative colitis-specific perinuclear antineutrophil cytoplasmic antibody (pANCA) and Crohn's disease-specific anti-Saccharomyces cerevisiae antibody (ASCA) serodiagnostic assays have recently been modified, with ELISA cut-off values recalculated to maximize sensitivity. The aim of this study was to determine whether the combination of these serodiagnostic tests could maximize diagnostic accuracy and minimize invasive investigations in pediatric patients presenting with nonspecific symptoms suggestive of IBD. METHODS: With investigators blinded to clinical diagnoses, ASCA, ANCA, and pANCA profiles were obtained prospectively from 128 patients undergoing complete diagnostic evaluation for IBD. In phase I, diagnostic accuracy and predictive values of the modified and traditional assays were compared for the IBD (n = 54) and non-IBD groups (n = 74). In phase II, the overall accuracy of a novel sequential diagnostic testing strategy was determined. Additionally, the potential number of invasive investigations avoided with the hypothetical application of this strategy to the cohort was determined. RESULTS: For phase I, the modified serodiagnostic assay was more sensitive (81 vs 69%), whereas the traditional assay had a higher specificity (96 vs 72%) for IBD (p < 0.05) For phase II, false-positive diagnoses would have been reduced by 81%, yielding an overall sequential testing strategy accuracy of 84%. CONCLUSIONS: The incorporation of sequential noninvasive testing into a diagnostic strategy may avoid unnecessary and costly evaluations and facilitate clinical decision making when the diagnosis of IBD in children is initially uncertain.

The quality of care in Barrett's esophagus: endoscopist and pathologist practices.

BACKGROUND: The diagnosis of Barrett's esophagus (BE) has important psychological and economic implications. Although accepted standards for endoscopic biopsy methods and pathological interpretation for BE exist, adherence to these standards as a measure of the quality of care in BE has not been evaluated. Our aim was to assess the quality of care in BE by evaluating the process of care and adherence to accepted standards of practice. METHODS: Explicit process-of-care criteria were developed using a systematic literature review and expert opinion in four domains of care: the quality of biopsy methods, the adequacy in identifying endoscopic landmarks, endoscopist-pathologist communication, and pathological interpretation and reporting. We reviewed all endoscopy and pathology reports of BE patients at two institutions from 1994-1997. An academic medical center (N = 237) with staff endoscopists and an academically affiliated community hospital (N = 100) with private-practice endoscopists were analyzed. RESULTS: Physicians showed the highest adherence to accepted standards of care in the "adequacy of identifying landmarks" and "endoscopist-pathologist communication" domains, with a > or =70% adherence rate in most criteria. Conversely, physicians demonstrated the poorest adherence with the "quality of biopsy methods" and "pathologist interpretation and reporting" domains, with adherence rates frequently <60%. Significantly, biopsies were taken in the presence of visible esophagitis 35% of the time. Performance on several of the quality indicators varied significantly by the practice setting. CONCLUSIONS: We have identified several opportunities for quality improvement efforts. In every domain, there is room for improvement, particularly in the quality of biopsy methods. As initiatives to screen the large population of gastroesophageal reflux disease patients for BE may be imminent, the time is now to define the critical process-of-care measures to minimize the risk of overdiagnosis and inadequate endoscopic surveillance.

Gastrointestinal toxicity associated with nonsteroidal anti-inflammatory drugs. Epidemiologic and economic issues.

The large body of literature on the gastrointestinal side effects of NSAIDs has shown consistently that populations can be identified that have a markedly elevated risk for these iatrogenic conditions. These groups include the elderly, persons with prior history of peptic ulcer disease and its complications, persons receiving anticoagulant and corticosteroid therapy, and persons who require long-term NSAID therapy, especially at high dose. It is possible that several comorbidities (e.g., rheumatoid arthritis) predispose patients to gastrointestinal complications caused by NSAIDs, but few studies have adjusted carefully for the possibility that concomitant medication use (e.g., oral anticoagulants, corticosteroids) or increased NSAID dose may account best for apparent association of comorbidities as a risk factor for serious gastrointestinal events. The role of H. pylori infection in affecting the risk of complicated ulcer disease among NSAID users remains to be fully elucidated. Low-dose aspirin for cardioprotective use is associated with an increased risk for PUBs; when used concomitantly with NSAIDs, this increases the risk of PUBs above that of the NSAID itself. Apart from the physical toll NSAID-related gastrotoxicity places on the patient, there are considerable economic consequences to patients, providers, and society. This cost presents a subject for research for those interested not only in improving the quality of patient care, but also in the prudent use of health care resources.

What have we learned from recent dyspepsia trials?

Dyspepsia is a common disorder and a frequent complaint of patients presenting for primary care. Understanding of the role of Helicobacter pylori has led to re-evaluation of management strategies for these patients. This article highlights results from clinical trials that have helped to clarify the role of empiric therapy, endoscopy, radiography, and H. pylori eradication in patients with nonulcer dyspepsia.

The economic impact of the diagnosis of dysplasia in Barrett's esophagus.

OBJECTIVE: Cost-effective strategies for identifying patients with Barrett's esophagus who are most likely to develop cancer have not been developed. Surveillance endoscopy is currently used, and we hypothesized that more frequent surveillance intervals would identify patients with "transient positive" diagnoses of dysplasia--dysplasia found on one examination but not on subsequent ones. Our aim was to explore the potential economic impact of transient positive diagnoses of dysplasia on alternative surveillance strategies over a 10-yr period. METHODS: Data were derived from a 2-yr randomized, prospective study comparing omeprazole to ranitidine in 95 patients with Barrett's esophagus. A transient positive diagnosis of dysplasia was defined as a patient who was diagnosed with dysplasia during the study period but whose 24-month biopsies revealed no dysplasia. We calculated the number of transient positive diagnoses of dysplasia and modeled the potential economic impact of a diagnosis of dysplasia over a 10-yr period. RESULTS: Thirty patients (31%) had at least one reading of dysplasia during the study period. Nineteen patients (20%) had a transient positive diagnosis of dysplasia. During the study period, no cancers were found. A surveillance strategy of every other year and every 6 months for dysplasia would result in 1072 endoscopies over a 10-yr period at a discounted cost of $1,587,184. A total of 61% of endoscopies would be because of transient positive diagnoses of dysplasia. A strategy of yearly surveillance and every 6 months for dysplasia would result in 1404 endoscopies at a discounted cost of $2,096,733, of which 28% would result from transient positive diagnoses of dysplasia. The discounted incremental costs of more frequent surveillance in this cohort of patients over 10 yr is $509,549. CONCLUSIONS: Based on current practice strategies, transient positive diagnoses of dysplasia account for 28-61% of endoscopies in Barrett's surveillance programs. This analysis suggests that the endoscopy workload and costs associated with surveillance could be substantially reduced if patients with transient positive diagnoses of dysplasia reverted to usual surveillance after two negative examinations.

The cost-effectiveness of diagnostic testing strategies for Helicobacter pylori.

OBJECTIVE: Several noninvasive methods are now available for diagnosing Helicobacter pylori infection. Because the prevalence of H. pylori infection is variable in patients requiring testing, the optimal testing strategies may vary under different conditions. The aim of this study was to evaluate the cost-effectiveness of competing diagnostic strategies for H. pylori in patients with varying H. pylori prevalence. METHODS: A decision analysis was performed comparing the costs per number of correct diagnoses achieved by alternative sequential testing strategies. Estimates of H. pylori prevalence and test characteristics were derived from a systematic review of the MEDLINE bibliographic database. Cost estimates were derived from the 2000 Medicare Fee Schedule. RESULTS: The enzyme-linked immunosorbent assay (ELISA) test had the lowest cost per correct diagnosis at low (30%), intermediate (60%), and high (90%) prevalence ($90-$95/correct diagnosis), but its diagnostic accuracy was low (80-84%). At low and intermediate prevalence the stool test was more accurate (93%), with an average cost of $126-$127 per correct diagnosis. Additional confirmatory testing of positive or negative tests increased the diagnostic accuracy of the stool test, but had high incremental costs. ELISA testing was preferable when prevalence rates were very high (90%), and using a confirmatory urea breath test for negative ELISA tests increased the diagnostic accuracy to 96%, with modest incremental costs. If the cost of the breath test was <$50 or if the cost of the stool test is >$82, breath testing became preferable to stool testing. If the cost of the stool test fell to <$20, it became preferable to ELISA. Similarly, if the cost of the ELISA serology was >$39 then stool testing became preferable at all prevalence rates. Fingerstick whole blood tests were not cost-effective. CONCLUSIONS: The choice of an initial test for H. pylori detection depends on the prevalence of H. pylori infection and the value placed on increased diagnostic accuracy. Although ELISA results in the lowest cost-effectiveness ratios, in patients at low-intermediate pretest probability of infection, the stool test provides increased accuracy, with modest incremental costs.

The omeprazole test is as sensitive as 24-h oesophageal pH monitoring in diagnosing gastro-oesophageal reflux disease in symptomatic patients with erosive oesophagitis.

BACKGROUND: Ambulatory 24-h oesophageal pH monitoring and a short course of high dose omeprazole can be used as diagnostic modalities for GERD. However, comparative studies of the diagnostic accuracy and reliability of both strategies have not been performed. AIM: To compare the omeprazole test to ambulatory 24-h oesophageal pH monitoring in diagnosing GERD in symptomatic patients using endoscopically proven erosive oesophagitis as a gold standard. METHODS: Patients with heartburn underwent an upper endoscopy. Only those with erosive oesophagitis were included in the study. Subsequently, patients underwent ambulatory 24-h oesophageal pH monitoring and an 'omeprazole test.' Daily symptoms were recorded during the first week (baseline) and repeated during the second week on therapy (omeprazole 40 mg in the morning and 20 mg in the evening). RESULTS: Thirty-five patients were included in the study. The omeprazole test was significantly more sensitive in diagnosing GERD than total acid contact time on 24-h oesophageal pH monitoring (83% vs. 60%; P < 0.03). However, the sensitivity of the pH test increased to 80% after adding patients with a positive symptom index, and patients with abnormal acid exposure in the supine or erect positions despite normal total acid contact time. Patients with a normal pH test were significantly younger (49 +/- 2.6 years) than those with abnormal test (59 +/- 1.8; P=0.002). CONCLUSIONS: In this study an omeprazole test was at least as sensitive as ambulatory 24-h oesophageal pH monitoring in diagnosing GERD in patients with erosive oesophagitis.

The quality of care for Medicare patients with peptic ulcer disease.

OBJECTIVE: The aim of this study was to examine quality of care for hospitalized Medicare beneficiaries with peptic ulcer disease. METHODS: Collaborating with five Peer Review Organizations, we used 1995 Medicare claim files to select samples of inpatients with a principal diagnosis of peptic ulcer disease. Quality of care indicators developed by content experts included percentages for ulcer patients tested for Helicobacter pylori (H. pylori); biopsied patients who received tissue tests; H. pylori-positive patients who received appropriate therapy; and ulcer patients screened for preadmission nonsteroidal anti-inflammatory drug (NSAID) use and counseled about risks. RESULTS: Of 2,644 patients eligible for medical record review, 56% were tested for H. pylori, and 73% of those testing positive were treated appropriately; 84% of patients with endoscopic biopsies received a tissue test for H. pylori; 74% of patients were screened for preadmission NSAID use, 24% had documented counseling of NSAID use, and only 2% had documented counseling on the ulcer risk of NSAID use. Statistically significant regional variation occurred in four of six quality indicators. Outpatient records were reviewed for 529 patients to document prior outpatient H. pylori in this population; only 2% (n = 12) were tested for H. pylori in the year before admission. CONCLUSIONS: Opportunities exist to improve quality of care by testing for and treating H. pylori in hospitalized Medicare beneficiaries with peptic ulcer disease and to improve screening for NSAIDs and counseling on ulcer risks.

Cost effectiveness of rabeprazole versus generic ranitidine for symptom resolution in patients with erosive esophagitis.

OBJECTIVE: To compare the cost effectiveness of rabeprazole (RAB) and ranitidine (RAN) in acute and maintenance therapy for erosive esophagitis using symptom response, rather than endoscopic healing, as the clinical outcome. STUDY DESIGN: Decision analysis was used to model the cost effectiveness of competing therapies based on the results of clinical trials of RAB versus RAN and estimates from the medical literature. METHODS: The model's base case scenario compared brand-name RAB (estimated average wholesale price) with generic RAN (25% of the average wholesale price of brand-name RAN). Medical costs for hospitalizations, procedures, and office visits reflected 1998 Medicare payments. The 1-year maintenance model accounted for drug-class switching and symptomatic, rather than endoscopic, recurrences. Effectiveness was reported as the percentage of patients in whom a symptomatic recurrence was prevented. The cost per symptomatic recurrence prevented was reported as an average and an incremental cost-effectiveness ratio. RESULTS: The per-patient cost of RAB therapy was higher than that of RAN therapy ($2020 vs $1917); RAB therapy, however, was more effective than RAN therapy in preventing symptomatic recurrences (74% vs 41%). The average cost-effectiveness ratio was lower for RAB therapy than for RAN therapy ($2748 per symptomatic recurrence prevented vs $4719 per symptomatic recurrence prevented). The cost of preventing one additional symptomatic recurrence with RAB rather than RAN was $313 (incremental cost-effectiveness ratio). Sensitivity analysis conducted on key clinical and cost variables supported the robustness of the decision model. CONCLUSION: This analysis demonstrates that management of esophagitis with RAB is more effective, and may be more cost effective, than management with generic RAN, despite RAB's higher per-unit cost.

Clinical and economic assessment of the omeprazole test in patients with symptoms suggestive of gastroesophageal reflux disease.

OBJECTIVE: To evaluate the diagnostic accuracy of a trial of a high-dose proton pump inhibitor (the omeprazole test) in detecting gastroesophageal reflux disease (GERD) in patients with heartburn symptoms. DESIGN: A randomized, double-blind, placebo-controlled, crossover trial. PATIENTS AND SETTING: Forty-three consecutive patients with symptoms suggestive of GERD were enrolled at a Veterans Affairs medical center. MAIN OUTCOME MEASURES: Symptom response to the omeprazole test vs placebo in GERD-positive and GERD-negative patients; sensitivity, specificity, and positive and negative predictive values of the omeprazole test; and cost per correct diagnosis achieved with the omeprazole test compared with traditional diagnostic strategies. RESULTS: Of 42 patients (98%) who completed the study, 35 (83%) were classified as GERD positive and 7 (17%) as GERD negative. Twenty-eight GERD-positive and 3 GERD-negative patients responded to the omeprazole test, providing a sensitivity of 80.0% (95% confidence interval, 66.7%-93.3%) and a specificity of 57.1% (95% confidence interval, 20.5%-93.8%). Economic analysis revealed that the omeprazole test saves $348 per average patient evaluated, and results in a 64% reduction in the number of upper endoscopies performed and a 53% reduction in the use of pH testing. CONCLUSIONS: The omeprazole test is sensitive and fairly specific for diagnosing GERD in patients with typical GERD symptoms. This strategy could result in significant cost savings and decreased use of invasive diagnostic tests.

The cost-effectiveness of the omeprazole test in patients with noncardiac chest pain.

PURPOSE: Recent evidence suggests that an empiric trial of omeprazole (the "omeprazole test") is sensitive and specific for diagnosing gastroesophageal reflux disease (GERD) as the cause of noncardiac chest pain. Our objective was to examine the clinical, economic, and policy implications of alternative diagnostic strategies for patients with noncardiac chest pain. METHODS: Decision analysis was used to evaluate the clinical and economic outcomes of two diagnostic strategies that begin with the omeprazole test (60 mg daily for 7 days) followed sequentially by invasive testing utilizing endoscopy, ambulatory 24-hour esophageal pH monitoring, and esophageal manometry as necessary, compared with two traditional strategies involving sequential invasive diagnostic tests. Cost estimates were based on Medicare reimbursement and the Red Book of average wholesale drug prices. Probability estimates were derived from a systematic review of the medical literature. RESULTS: The average cost per patient for the four diagnostic strategies varied from $1,859 to $2,313. Strategies utilizing the initial omeprazole test resulted in 84% of patients being symptom free at 1 year, compared with 73% to 74% for the strategies that began with invasive tests. The strategy of the omeprazole test, followed if necessary by ambulatory pH monitoring, then manometry, and then endoscopy, was both most effective and least expensive. It led to an 11% improvement in diagnostic accuracy and a 43% reduction in the use of invasive diagnostic tests, thus yielding an average cost savings of $454 per patient, compared with the strategy of beginning with endoscopy, then pH monitoring, and then manometry. CONCLUSIONS: Among patients with noncardiac chest pain, diagnostic strategies that begin with the omeprazole test result in reduced costs, improved diagnostic certainty, and a greater proportion of symptom-free patients at 1 year than do traditional strategies that begin with invasive diagnostic tests.

The effectiveness of endoscopy in the management of dyspepsia: a qualitative systematic review.

PURPOSE: Dyspepsia is a common primary care condition, yet its optimal management is poorly defined. We reviewed the literature to answer the following questions about patients with dyspepsia: 1) Does endoscopy result in improved patient outcomes? 2) Does endoscopy result in a reduction in the use of subsequent medical resources? 3) Does endoscopy result in improved medical decision making? 4) Is endoscopy cost effective? METHODS: We performed a systematic review of English-language articles in the MEDLINE, HEALTHSTAR, and EMBASE computerized bibliographic databases from January 1985 to July 1998. We included all studies, including decision analyses, with information about the effectiveness of endoscopy, as measured by its impact on patient outcomes, resource utilization, clinical decision making, or cost effectiveness. Two independent reviewers abstracted data from each study, and assessed its methodologic quality. RESULTS: Twenty-one studies met the inclusion criteria. For 3 of the 4 clinical questions, the weight of evidence does not support the effectiveness of endoscopy. The largest randomized clinical trial comparing endoscopy with empiric therapy demonstrates equivalent symptoms and quality of life at 1 year, with increased patient satisfaction and lower costs for initial endoscopy. Suboptimal study design, including lack of appropriate comparison groups, limit studies measuring the impact of endoscopy on resource utilization and decision-making. Decision analyses indicate that noninvasive H pylori testing followed by anti-H pylori therapy or empiric antisecretory therapy is more cost effective than initial endoscopy. CONCLUSIONS: With the exception of one randomized clinical trial, the preponderance of available data does not support the effectiveness of endoscopy in the management of dyspepsia. Prospective clinical trials that evaluate patient outcomes and resource utilization, and take H pylori status into account, are needed to determine the effectiveness of endoscopy in the management of dyspepsia.