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Endoscopic evaluation of patients with dyspepsia in a secondary referral hospital in Egypt. ALEXANDRIA JOURNAL OF MEDICINE 2015. [DOI: 10.1016/j.ajme.2013.10.001] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 10/26/2022] Open
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A one-year economic evaluation of six alternative strategies in the management of uninvestigated upper gastrointestinal symptoms in Canadian primary care. CANADIAN JOURNAL OF GASTROENTEROLOGY = JOURNAL CANADIEN DE GASTROENTEROLOGIE 2014; 24:489-98. [PMID: 20711528 DOI: 10.1155/2010/379583] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]
Abstract
BACKGROUND The cost-effectiveness of initial strategies in managing Canadian patients with uninvestigated upper gastrointestinalsymptoms remains controversial. OBJECTIVE To assess the cost-effectiveness of six management approaches to uninvestigated upper gastrointestinal symptoms in the Canadian setting. METHODS The present study analyzed data from four randomized trials assessing homogeneous and complementary populations of Canadian patients with uninvestigated upper gastrointestinal symptoms with comparable outcomes. Symptom-free months, qualityadjusted life-years (QALYs) and direct costs in Canadian dollars of two management approaches based on the Canadian Dyspepsia Working Group (CanDys) Clinical Management Tool, and four additional strategies (two empirical antisecretory agents, and two prompt endoscopy) were examined and compared. Prevalence data, probabilities, utilities and costs were included in a Markov model, while sensitivity analysis used Monte Carlo simulations. Incremental cost-effectiveness ratios and cost-effectiveness acceptability curves were determined. RESULTS Empirical omeprazole cost $226 per QALY ($49 per symptom-free month) per patient. CanDys omeprazole and endoscopy approaches were more effective than empirical omeprazole, but more costly. Alternatives using H2-receptor antagonists were less effective than those using a proton pump inhibitor. No significant differences were found for most incremental cost-effectiveness ratios. As willingness to pay (WTP) thresholds rose from $226 to $24,000 per QALY, empirical antisecretory approaches were less likely to be the most costeffective choice, with CanDys omeprazole progressively becoming a more likely option. For WTP values ranging from $24,000 to $70,000 per QALY, the most clinically relevant range, CanDys omeprazole was the most cost-effective strategy (32% to 46% of the time), with prompt endoscopy-proton pump inhibitor favoured at higher WTP values. CONCLUSIONS Although no strategy was the indisputable cost effective option, CanDys omeprazole may be the strategy of choiceover a clinically relevant range of WTP assumptions in the initial management of Canadian patients with uninvestigated dyspepsia.<p>
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Gisbert JP, Calvet X. Helicobacter Pylori "Test-and-Treat" Strategy for Management of Dyspepsia: A Comprehensive Review. Clin Transl Gastroenterol 2013; 4:e32. [PMID: 23535826 PMCID: PMC3616453 DOI: 10.1038/ctg.2013.3] [Citation(s) in RCA: 48] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/07/2023] Open
Abstract
OBJECTIVES: Deciding on whether the Helicobacter pylori test-and-treat strategy is an appropriate diagnostic–therapeutic approach for patients with dyspepsia invites a series of questions. The aim present article addresses the test-and-treat strategy and attempts to provide practical conclusions for the clinician who diagnoses and treats patients with dyspepsia. METHODS: Bibliographical searches were performed in MEDLINE using the keywords Helicobacter pylori, test-and-treat, and dyspepsia. We focused mainly on data from randomized controlled trials (RCTs), systematic reviews, meta-analyses, cost-effectiveness analyses, and decision analyses. RESULTS: Several prospective studies and decision analyses support the use of the test-and-treat strategy, although we must be cautious when extrapolating the results from one geographical area to another. Many factors determine whether this strategy is appropriate in each particular area. The test-and-treat strategy will cure most cases of underlying peptic ulcer disease, prevent most potential cases of gastroduodenal disease, and yield symptomatic benefit in a minority of patients with functional dyspepsia. Future studies should be able to stratify dyspeptic patients according to their likelihood of improving after treatment of infection by H. pylori. CONCLUSIONS: The test-and-treat strategy will cure most cases of underlying peptic ulcer disease and prevent most potential cases of gastroduodenal disease. In addition, a minority of infected patients with functional dyspepsia will gain symptomatic benefit. Several prospective studies and decision analyses support the use of the test-and-treat strategy. The test-and-treat strategy is being reinforced by the accumulating data that support the increasingly accepted idea that “the only good H. pylori is a dead H. pylori”.
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Affiliation(s)
- Javier P Gisbert
- Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IP) and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain
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Bozzani A, Sturkenboom MCJM, Sturkenboom MCJM, Ravasio R, Nicolosi A. Diagnostic work-up and management of young patients with ulcer-like dyspepsia: A cost-minimisation study. Eur J Gen Pract 2009. [DOI: 10.3109/13814780109094334] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/13/2022] Open
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Barton PM, Moayyedi P, Talley NJ, Vakil NB, Delaney BC. A second-order simulation model of the cost-effectiveness of managing dyspepsia in the United States. Med Decis Making 2007; 28:44-55. [PMID: 18057189 DOI: 10.1177/0272989x07309644] [Citation(s) in RCA: 21] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/10/2023]
Abstract
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.
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Kjeldsen HC, Bech M, Christensen B. Cost-effectiveness analysis of two management strategies for dyspepsia. Int J Technol Assess Health Care 2007; 23:376-84. [PMID: 17579942 DOI: 10.1017/s0266462307070420] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
OBJECTIVES To compare the cost-effectiveness of endoscopy and empirical proton pump inhibition (PPI) therapy for management of dyspepsia in primary care. METHODS A randomized controlled trial, including prospective collection of economic resource data, was conducted in general practice from June 2000 to August 2002, Aarhus County, Denmark. We randomly assigned 368 dyspeptic patients from thirty-two general practices to treatment with omeprazol 40 mg for 2 weeks (n=184) or endoscopy (n=184). The study adopted a societal perspective, and the year of costing was 2006. OUTCOME MEASURES days free of dyspeptic symptoms and proportion of patients with dyspepsia after 1 year based on patients' and general practitioners' (GPs) assessment. Costs were estimated from patient and GP questionnaires and from medical records. RESULTS The incremental cost-effectiveness (CE) ratio for 1 day free of dyspeptic symptoms using the endoscopy strategy was euro/day 154 compared with the PPI strategy. The incremental CE ratio for one person free of dyspeptic symptoms after 1 year using the endoscopy strategy was euro13,905 based on the patients' evaluation, and the incremental CE ratio for one person free of predominant symptoms after 1 year was euro5,990 according to the GPs' evaluation. The PPI strategy was both cheaper and more effective than the endoscopy strategy when reflux was the predominant symptom. CONCLUSIONS A strategy using empirical antisecretory PPI therapy should be recommended if the alternative is an endoscopy strategy for managing dyspeptic patients in general practice, especially if reflux was the predominant symptom.
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Affiliation(s)
- Hans C Kjeldsen
- Department and Research Unit of General Practice, University of Aarhus and Institute of Public Health, Denmark.
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Paterson WG, Depew WT, Paré P, Petrunia D, Switzer C, van Zanten SJV, Daniels S, for the Canadian Association of Gastroenterology Wait Time Consensus Group *. Canadian consensus on medically acceptable wait times for digestive health care. CANADIAN JOURNAL OF GASTROENTEROLOGY = JOURNAL CANADIEN DE GASTROENTEROLOGIE 2006; 20:411-23. [PMID: 16779459 PMCID: PMC2659924 DOI: 10.1155/2006/343686] [Citation(s) in RCA: 101] [Impact Index Per Article: 5.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 12/21/2022]
Abstract
BACKGROUND Delays in access to health care in Canada have been reported, but standardized systems to manage and monitor wait lists and wait times, and benchmarks for appropriate wait times, are lacking. The objective of the present consensus was to develop evidence- and expertise-based recommendations for medically appropriate maximal wait times for consultation and procedures by a digestive disease specialist. METHODS A steering committee drafted statements defining maximal wait times for specialist consultation and procedures based on the most common reasons for referral of adult patients to a digestive disease specialist. Statements were circulated in advance to a multidisciplinary group of 25 participants for comments and voting. At the consensus meeting, relevant data and the results of voting were presented and discussed; these formed the basis of the final wording and voting of statements. RESULTS Twenty-four statements were produced regarding maximal medically appropriate wait times for specialist consultation and procedures based on presenting signs and symptoms of referred patients. Statements covered the areas of gastrointestinal bleeding; cancer confirmation and screening and surveillance of colon cancer and colonic polyps; liver, biliary and pancreatic disorders; dysphagia and dyspepsia; abdominal pain and bowel dysfunction; and suspected inflammatory bowel disease. Maximal wait times could be stratified into four possible acuity categories of 24 h, two weeks, two months and six months. FUTURE DIRECTIONS Comparison of these benchmarks with actual wait times will identify limitations in access to digestive heath care in Canada. These recommendations should be considered targets for future health care improvements and are not clinical practice guidelines.
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Affiliation(s)
- William G Paterson
- Queen’s University, Hotel Dieu Hospital, Kingston, Ontario
- Correspondence: Dr William G Paterson, Queen’s University, 166 Brock Street, Kingston, Ontario K7L 5G2. Telephone 613-544-3400 ext 3376, fax 613-544-3114, e-mail
| | | | - Pierre Paré
- Université Laval, Hôpital du St-Sacrement, Québec City, Québec
| | | | - Connie Switzer
- University of Alberta, Grey Nuns Community Hospital, Edmonton, Alberta
| | | | - Sandra Daniels
- Canadian Association of Gastroenterology, Oakville, Ontario
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Jarbol DE, Bech M, Kragstrup J, Havelund T, Schaffalitzky de Muckadell OB. Economic evaluation of empirical antisecretory therapy versus Helicobacter pylori test for management of dyspepsia: a randomized trial in primary care. Int J Technol Assess Health Care 2006; 22:362-71. [PMID: 16984065 DOI: 10.1017/s0266462306051269] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
OBJECTIVES An economic evaluation was performed of empirical antisecretory therapy versus test for Helicobacter pylori in the management of dyspepsia patients presenting in primary care. METHODS A randomized trial in 106 general practices in the County of Funen, Denmark, was designed to include prospective collection of clinical outcome measures and resource utilization data. Dyspepsia patients (n = 722) presenting in general practice with more than 2 weeks of epigastric pain or discomfort were managed according to one of three initial management strategies: (i) empirical antisecretory therapy, (ii) testing for Helicobacter pylori, or (iii) empirical antisecretory therapy, followed by Helicobacter pylori testing if symptoms improved. Cost-effectiveness and incremental cost-effectiveness ratios of the strategies were determined. RESULTS The mean proportion of days without dyspeptic symptoms during the 1-year follow-up was 0.59 in the group treated with empirical antisecretory therapy, 0.57 in the H. pylori test-and-eradicate group, and 0.53 in the combination group. After 1 year, 23 percent, 26 percent, and 22 percent, respectively, were symptom-free. Applying the proportion of days without dyspeptic symptoms, the cost-effectiveness for empirical treatment, H. pylori test and the combination were 12,131 Danish kroner (DKK), 9,576 DKK, and 7,301 DKK, respectively. The incremental cost-effectiveness going from the combination strategy to empirical antisecretory treatment or H. pylori test alone was 54,783 DKK and 39,700 DKK per additional proportion of days without dyspeptic symptoms. CONCLUSIONS Empirical antisecretory therapy confers a small insignificant benefit but costs more than strategies based on test for H. pylori and is probably not a cost-effective strategy for the management of dyspepsia in primary care.
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Affiliation(s)
- Dorte Ejg Jarbol
- The Research Unit for General Practice, University of Southern Denmark, Odense.
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Hu WHC, Lam SK, Lam CLK, Wong WM, Lam KF, Lai KC, Wong YH, Wong BCY, Chan AOO, Chan CK, Leung GM, Hui WM. Comparison between empirical prokinetics, Helicobacter test-and-treat and empirical endoscopy in primary-care patients presenting with dyspepsia: A one-year study. World J Gastroenterol 2006; 12:5010-6. [PMID: 16937497 PMCID: PMC4087404 DOI: 10.3748/wjg.v12.i31.5010] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
AIM: To investigate the optimal strategy to treat dyspeptic patients in primary care.
METHODS: Dyspeptic patients presenting to primary care outpatient clinics were randomly assigned to: (1) empirical endoscopy, (2) H pylori test-and-treat, and (3) empirical prokinetic treatment with cisapride. Early endoscopy was arranged if patients remained symptomatic after 2 wk. Symptom severity, quality-of-life (SF-36) as well as patient preference and satisfaction were assessed. All patients underwent endoscopy by wk 6. Patients were followed up for one year.
RESULTS: Two hundred and thirty four patients were recruited (163 female, mean age 49). 46% were H pylori positive. 26% of H pylori tested and 25% of empirical prokinetic patients showed no improvement at wk 2 follow-up and needed early endoscopy. 15% of patients receiving empirical cisapride responded well to treatment but peptic ulcer was the final diagnosis. Symptom resolution and quality-of-life were similar among the groups. Costs for the three strategies were HK$4343, $1771 and $1750 per patient. 66% of the patients preferred to have early endoscopy.
CONCLUSION: The three strategies are equally effective. Empirical prokinetic treatment was the least expensive but peptic ulcers may be missed with this treatment. The H pylori test-and-treat was the most cost-effective option.
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Affiliation(s)
- Wayne H C Hu
- Department of Medicine, University of Hong Kong, China.
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Liebregts T, Adam B, Holtmann G. Funktionelle Dyspepsie – eine Verlegenheitsdiagnose? Internist (Berl) 2006; 47:568, 570-2, 574, passim. [PMID: 16767473 DOI: 10.1007/s00108-006-1624-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/24/2022]
Abstract
Dyspepsia comprises a broad spectrum of predominantly upper abdominal symptoms, such as pain, indigestion, nausea, early satiety and bloating. While these symptoms are highly prevalent, in less than 50% of patients presenting with dyspepsia, structural lesions or biochemical abnormalities are found that explain the symptoms when routine clinical tests are used. In patients without structural lesions the diagnosis of functional dyspepsia is justified. Exclusion of life-threatening disorders as the cause of symptoms and reassurance of the patient as well as proper explanation of the diagnosis and its underlying disease mechanisms (i.e. symptoms are due to a sensitive gut) is crucial and can be considered as an essential element of treatment. Since there is a remarkable comorbidity of anxiety and depression, psychosomatic interventions might be necessary in selected patients. Based on controlled clinical trials few drugs, such as proton pump inhibitors, prokinetics, tricyclic antidepressants, simethicone and selected herbal preparations have been found to be effective for treatment of functional dyspepsia. Effects of H. pylori eradication, even though strongly advocated, are most likely due to undiagnosed peptic ulcer disease in a very small group of patients. While there is currently no therapy that cures functional dyspepsia, the therapeutic target is to control symptoms.
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Affiliation(s)
- T Liebregts
- Department of Gastroenterology, Hepatology and General Medicine, Royal Adelaide Hospital, University of Adelaide, North Terrace, Adelaide, Australia
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O'Morain C. Role of Helicobacter pylori in functional dyspepsia. World J Gastroenterol 2006; 12:2677-2680. [PMID: 16718752 PMCID: PMC4130974 DOI: 10.3748/wjg.v12.i17.2677] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/03/2006] [Revised: 03/12/2006] [Accepted: 03/27/2006] [Indexed: 02/06/2023] Open
Abstract
The aetiology of dyspepsia is unknown in the majority of patients. Helicobacter pylori (H pylori) is the cause in a subset of patients. A non invasive test to assess the presence of H pylori is recommended in the management of patients under the age of 50 presenting to a family practitioner with dyspepsia. A urea breath test or a stool antigen test are the most reliable non invasive tests. Eradication of H pylori will reduce the risk to the patient with dyspepsia of developing a peptic ulcer, reduce the complication rate if prescribed non-steroid anti-inflammatory drugs and later reduce the risk of gastric cancer. The recommended treatment for non ulcer dyspepsia associated with a H pylori infection should be a 10-d course of treatment with a PPI and two antibiotics. Treatment efficacy should be assessed four weeks after completing treatment with a urea breath test or a stool antigen test.
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Affiliation(s)
- Colm O'Morain
- Trinity College Dublin, Adelaide and Meath Hospital, Tallaght, Dublin 24, Ireland.
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Klok RM, Arents NLA, de Vries R, Thijs JC, Brouwers JRBJ, Kleibeuker JH, Postma MJ. Economic evaluation of a randomized trial comparing Helicobacter pylori test-and-treat and prompt endoscopy strategies for managing dyspepsia in a primary-care setting. Clin Ther 2006; 27:1647-57. [PMID: 16330302 DOI: 10.1016/j.clinthera.2005.10.011] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 08/18/2005] [Indexed: 11/15/2022]
Abstract
BACKGROUND In western European countries, most dyspeptic patients are initially managed by their general practitioners (GPs), who use a range of strategies to manage dyspepsia. We performed an economic analysis of a Helicobacter pylori test-and-treat strategy versus a prompt endoscopy approach in a primary care setting. METHODS Data were used from the Strategy: Endoscopy versus Serology (SENSE) study, performed in The Netherlands from 1998 to 2001. Patients were randomized to a prompt endoscopy (n = 105) or test-and-treat (n = 118) group. Follow-up lasted 1 year. Adverse events were not recorded in the SENSE study. Health care costs were based on the total amount of dyspepsia-related drugs used, the number of dyspepsia-related GP visits, the number of diagnostic tests, and the number of dyspepsia-related referrals to specialists. The use of medical resources was calculated as standardized costs for 1999, recorded as euros. (On December 31, 1999, 1.00 Euro = 1.00 US dollar.) Quality of life was measured at inclusion and 1 year later, using the RAND-36 questionnaire. To calculate quality-adjusted life-years (QALYs), we transformed the individual scores of the RAND-36 into 1 overall score, the Health Utilities Index Mark 2, which introduced a limitation to the study. An incremental cost-effectiveness ratio (ICER) was calculated. The 95% confidence limits were calculated using a parametric bootstrap method with angular transformation. All cost data were analyzed from a third-party payer perspective. RESULTS The total costs per patient were 511 Euros, with 0.037 QALY gained per patient, in the test-and-treat group, and 748 Euros, with 0.032 QALY gained per patient, in the endoscopy group (between groups, P < 0.001 and P = NS, respectively). The point estimate of the ICER indicated that the test-and-treat strategy yielded cost savings and QALYs gained. Parametric bootstrap confidence limits indicated cost savings per QALY gained in 75.7% of the bootstrap simulations. CONCLUSION This analysis of data from the SENSE1026 study suggests that the H pylori test-and-treat strategy was more cost-effective than prompt endoscopy in the initial management of dyspepsia in general practice, from the perspective of a third-party payer.
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Affiliation(s)
- Rogier M Klok
- Groningen University Institute for Drug Exploration, Department of Social Pharmacy, Pharmacoepidemiology and Pharmacotherapy, The Netherlands.
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Talley NJ, Vakil NB, Moayyedi P. American gastroenterological association technical review on the evaluation of dyspepsia. Gastroenterology 2005; 129:1756-80. [PMID: 16285971 DOI: 10.1053/j.gastro.2005.09.020] [Citation(s) in RCA: 261] [Impact Index Per Article: 13.1] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/24/2022]
Affiliation(s)
- Nicholas J Talley
- Division of Gastroenterology and Hepatology and Internal Medicine, Mayo Clinic College of Medicine, Rochester, Minnesota
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Abstract
Dyspepsia is a chronic or recurrent pain or discomfort centered in the upper abdomen; patients with predominant or frequent (more than once a week) heartburn or acid regurgitation, should be considered to have gastroesophageal reflux disease (GERD) until proven otherwise. Dyspeptic patients over 55 yr of age, or those with alarm features should undergo prompt esophagogastroduodenoscopy (EGD). In all other patients, there are two approximately equivalent options: (i) test and treat for Helicobacter pylori (H. pylori) using a validated noninvasive test and a trial of acid suppression if eradication is successful but symptoms do not resolve or (ii) an empiric trial of acid suppression with a proton pump inhibitor (PPI) for 4-8 wk. The test-and-treat option is preferable in populations with a moderate to high prevalence of H. pylori infection (> or =10%); empirical PPI is an initial option in low prevalence situations. If initial acid suppression fails after 2-4 wk, it is reasonable to consider changing drug class or dosing. If the patient fails to respond or relapses rapidly on stopping antisecretory therapy, then the test-and-treat strategy is best applied before consideration of referral for EGD. Prokinetics are not currently recommended as first-line therapy for uninvestigated dyspepsia. EGD is not mandatory in those who remain symptomatic as the yield is low; the decision to endoscope or not must be based on clinical judgement. In patients who do respond to initial therapy, stop treatment after 4-8 wk; if symptoms recur, another course of the same treatment is justified. The management of functional dyspepsia is challenging when initial antisecretory therapy and H. pylori eradication fails. There are very limited data to support the use of low-dose tricyclic antidepressants or psychological treatments in functional dyspepsia.
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Affiliation(s)
- Nicholas J Talley
- Division of Gastroenterology and Hepatology, Mayo Clinic, Clinical Enteric Neuroscience Translational and Epidemiological Research Program, Mayo Clinic, Rochester, Minnesota 55905, USA
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Helfand M. Incorporating information about cost-effectiveness into evidence-based decision-making: the evidence-based practice center (EPC) model. Med Care 2005; 43:33-43. [PMID: 16056007 DOI: 10.1097/01.mlr.0000170037.73154.8b] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
RATIONALE There is a pressing need for guidance on how to incorporate economic information into evidence-based decision-making. Such guidance should take account of the quality and relevance of economic evaluations. OBJECTIVE To summarize lessons learned in integrating information from decision analyses and cost-effectiveness analyses. KEY ISSUES Several methods used by the Evidence-Based Practice Centers (EPCs) to conduct systematic reviews are applicable to assessing economic studies. We discuss methods to identify key questions for the review of economic studies. Reviews should assess how an economic model incorporates clinical logic and handles uncertainty about effectiveness. As is the case for metaanalysis of interventions, qualitative or quantitative synthesis of economic studies should explore heterogeneity to identify key uncertainties underlying divergent results as well as unsuspected sources of bias. CONCLUSIONS Applying EPC methods to synthesis of economic information can increase their relevance to clinicians and policymakers and inform decisions that require tradeoffs between effectiveness and harms of interventions.
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Affiliation(s)
- Mark Helfand
- Portland VA Medical Center and the Oregon Evidence-Based Practice Center, Oregon Health & Sciences University, Portland, Oregon 97239, USA.
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García-Altés A, Rota R, Barenys M, Abad A, Moreno V, Pons JMV, Piqué JM. Cost-effectiveness of a 'score and scope' strategy for the management of dyspepsia. Eur J Gastroenterol Hepatol 2005; 17:709-19. [PMID: 15947547 DOI: 10.1097/00042737-200507000-00004] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
OBJECTIVE It is important to identify the best initial work-up in patients with uninvestigated dyspepsia because of its epidemiological and economical relevance. The objective of the study was to assess systematically the effectiveness and cost-effectiveness of invasive and non-invasive strategies for the management of dyspepsia. METHODS A decision analysis was performed to compare prompt endoscopy, score and scope, test and scope, test and treat, and empirical antisecretory treatment. Published and local data on the prevalence of different diagnoses, rates of Helicobacter pylori infection, accuracy values of diagnostic tests, and effectiveness of drug treatments were used. The perspective of analysis was that of the public healthcare payer, and only direct costs were included, with a one-year post-therapy time horizon. The main outcome measure was cost per asymptomatic patient, valued in 2003 Euros. RESULTS Endoscopy was found to be the most effective strategy for the management of dyspepsia (38.4% asymptomatic patients), followed by test and scope (35.5%), test and treat (35.3%), score and scope (34.7%), and empirical treatment (28.5%). Incremental cost-effectiveness ratios showed that score and scope was the most cost-effective alternative (483.17 Euros per asymptomatic patient), followed by prompt endoscopy (1396.85 Euros). Sensitivity analyses showed variations when varying the values of prevalence of duodenal ulcer, and the values of healing of functional dyspepsia with antisecretory and eradication drugs. There were no changes when varying the prevalence of H. pylori in dyspepsia. CONCLUSIONS We would recommend stratifying patients by a score system, referring first to endoscopy those patients at higher risk of organic dyspepsia.
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Affiliation(s)
- Anna García-Altés
- Fundación Instituto de Investigación en Servicios de Salud, 08012 Barcelona, Spain.
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Ford AC, Qume M, Moayyedi P, Arents NLA, Lassen AT, Logan RFA, McColl KEL, Myres P, Delaney BC. Helicobacter pylori "test and treat" or endoscopy for managing dyspepsia: an individual patient data meta-analysis. Gastroenterology 2005; 128:1838-44. [PMID: 15940619 DOI: 10.1053/j.gastro.2005.03.004] [Citation(s) in RCA: 84] [Impact Index Per Article: 4.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/30/2022]
Abstract
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.
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Affiliation(s)
- Alexander C Ford
- Centre for Digestive Diseases, Leeds General Infirmary, United Kingdom
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Cuddihy MT, Locke GR, Wahner-Roedler D, Dierkhising R, Zinsmeister AR, Long KH, Talley NJ. Dyspepsia management in primary care: a management trial. Int J Clin Pract 2005; 59:194-201. [PMID: 15854196 DOI: 10.1111/j.1742-1241.2005.00372.x] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/29/2022] Open
Abstract
The aim was to evaluate the outcomes associated with four initial management strategies in new patients presenting to primary care physicians with dyspepsia. Patients with new symptoms (no alarm features) were randomised to empirical therapy (n = 11), Helicobacter pylori (HP) serology (n = 8), HP breath testing (n = 11) or oesophagogastroduodenoscopy (n = 13). Dyspepsia and health-related quality of life were assessed using standardised questionnaires at entry, 6 and 24 weeks post-trial enrollment. Outcomes were assessed by structured telephone interview every 6 weeks. In the initial HP testing arms, 21% were positive; 27% in the oesophagogastroduodenoscopy arm had inflammatory changes without ulcers at baseline. The majority (67%) received over the counter medication after initial management. Symptom-free status was similarly common in all groups (p = 0.49); only 20% pursued further evaluation. Total billed charges were higher in the oesophagogastroduodenoscopy group (US 2077 dollars) vs. empirical therapy (US 512 dollars), despite excluding the charge for initial oesophagogastroduodenoscopy, but overall, no effects on total medical charges were detected (p = 0.10). Regardless of initial management, most patients remained symptomatic, yet did not return for health care visits or undergo endoscopies. The cost of upfront endoscopy may not be the best choice for patients presenting with new dyspepsia.
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Affiliation(s)
- M T Cuddihy
- Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Boston, MA, USA
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Sreedharan A, Clough M, Hemingbrough E, Gatta L, Chalmers DM, Axon ATR, Moayyedi P. Cost-effectiveness and long-term impact of Helicobacter pylori 'test and treat' service in reducing open access endoscopy referrals. Eur J Gastroenterol Hepatol 2004; 16:981-6. [PMID: 15371920 DOI: 10.1097/00042737-200410000-00005] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/24/2022]
Abstract
INTRODUCTION We have shown that the introduction of a carbon urea breath test (13C-UBT) service for Helicobacter pylori screening and eradication is effective in reducing the rate of open access endoscopy referrals in patients aged < 40 years in the short term. This has been substantiated by several randomized controlled trials comparing a 'test and treat' strategy with early endoscopy in these patients. However, the long-term impact of such a strategy is not established. OBJECTIVE To ascertain the influence of 13C-UBT services on open access endoscopy referral rates in dyspeptic patients under the age of 40 years over a period of 5 years. METHODS Retrospective analysis of open access endoscopy referral rates between August 1990 and July 2000. Cost minimization analysis was performed with a Decision Analysis Model using Treeage Data 3.5. RESULTS The total number of open access referrals for endoscopy during 1990-1995 was between 765 and 1325 per year. The proportion of endoscopies performed in patients < 40 years ranged between 33.4% and 34.6%. The total number of endoscopy referrals during 1995-2000 after the introduction of the 13C-UBT services was between 1178 and 1321 per year. However, there was a sustained reduction in the proportion of patients aged < 40 years, ranging between 23.2% and 26.2% (Chi2 = 153.9, degrees of freedom = 9, P < 0.0001) during this period. CONCLUSIONS The H. pylori screening and treatment strategy using the 13C-UBT service results in a sustained reduction of the number of endoscopy referrals and is cost effective in dyspeptic patients under the age of 40 years, enabling better utilization of available resources.
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Affiliation(s)
- Aravamuthan Sreedharan
- Department of Gastroenterology, Centre for Digestive Diseases, The General Infirmary at Leeds, UK
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Evaluación de la eficacia diagnóstica de la consultoría entre internistas y médicos de familia para los pacientes con dispepsia. Med Clin (Barc) 2004; 123:374-80. [PMID: 15482701 DOI: 10.1016/s0025-7753(04)74522-4] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/26/2022]
Abstract
BACKGROUND AND OBJECTIVE Our goal was to evaluate the efficacy of internal medicine consulting (CIM) in primary care (PC) for the care of patients with dyspepsia. PATIENTS AND METHOD Prospective case-control study of a population of 87,016 inhabitants during a 2 years period. We included patients with dyspepsia (319) jointly attended by a family physician (FP) and consulting internists (CI). The CI went weekly to the primary care center (PCC) to attend patients who would have been referred to the hospital outpatient clinic for specialized care (SC). As control group, 775 patients with dyspepsia were randomly and simultaneously chosen among a total of 29,317 first medical referrals during the period of the study. RESULTS 5.36% of the consultations for SC were patients with dyspepsia (annual incidence of 183 patients/1,000 inhabitants). We observed a significant reduction in: mean time for SC (26.4 days; 22.4-30.4), mean number of tests per patient ordered by SC (0.77; 0.42-1.12), mean time for patient information on the tests ordered by SC (27.3 days; 18.7-35,9), mean time for the resolution of the process (27.3 days; 18.4-36.2) and rate of specialized follow-up visits (25.2%; 18.5-31.9); p < 0.005 in all cases. The resolution rate of the process (37.2%; 25.7-48.7) and the discharge rate (38.7%; 28.9-48.5) were significantly higher for CIM (p < 0.01 in both cases). The referral rate for SC showed a negative correlation (r = -0.97; p < 0.01) with the quality of the management; this rate related to the type of training, age and years of medical practice of the GPs. Satisfaction of patients with the CIM was very high. CONCLUSIONS The CIM with PC improves the efficacy of the specialized medical care of patients with dyspepsia.
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Abstract
The optimal diagnostic approach to the dyspeptic patient in primary care is still debated. Early endoscopy continues to be the diagnostic gold standard but competing non-invasive strategies challenge this. The most important approaches are empiric antisecretory treatment reserving endoscopy for unresponsive patients and patients with an early symptomatic relapse and helicobacter-based strategies reserving endoscopy for infected patients (test-and-scope) or for failures after eradication therapy (test-and-treat). Early endoscopy is recommended in patients with alarm features and should be considered in patients with new onset dyspepsia after age 50. In the remaining patients, early investigation can only be recommended in areas providing endoscopy at a low cost and with a short waiting list. The test-and-scope strategy may lead to a rise in the referral rates for endoscopy and cannot be recommended. The test-and-treat strategy is well documented in clinical trials as a safe and cost-effective approach. Helicobacter-based strategies are challenged by a decreasing prevalence of peptic ulcer disease and of the infection. In the near future, the empirical acid inhibition strategy will probably be cost-effective as gastro-oesophageal reflux becomes the predominant disorder in dyspeptic patients.
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Affiliation(s)
- Peter Bytzer
- Department of Medical Gastroenterology and Endoscopy, Glostrup University Hospital, DK-2600 Glostrup, Denmark.
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Talley NJ. What the physician needs to know for correct management of gastro-oesophageal reflux disease and dyspepsia. Aliment Pharmacol Ther 2004; 20 Suppl 2:23-30. [PMID: 15335410 DOI: 10.1111/j.1365-2036.2004.02043.x] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
Upper gastrointestinal symptoms are highly prevalent; usually those consulting have multiple symptoms, confounding management. Here, common clinically relevant management issues are considered based on the best available evidence. Regardless of the presenting symptoms, determine if there are any alarm features; these have a low positive predictive value for malignancy but all patients with them should be referred for prompt upper gastrointestinal endoscopy. Ask about medications; of most importance are the non-steroidal anti-inflammatory drugs (NSAIDs), both non-selective and COX-2 selective. Try to ascertain if the symptom pattern suggests gastro-oesophageal reflux disease (GERD) or not. Dominant heartburn, however, may be of limited value; if the background prevalence of GERD is 25% and the patient complains of dominant heartburn, then the likelihood that such a patient has GERD as identified by 24-h oesophageal pH testing is only just over 50%. If reflux disease is strongly suspected and there are no alarm features, give an empirical trial of a proton pump inhibitor (PPI). Symptoms cannot separate adequately functional from organic dyspepsia. Endoscopy in dyspepsia with no alarm features is more costly than an empirical management approach. H. pylori testing and treatment remains in most settings the preferable initial choice for managing dyspepsia without obvious GERD. However, a PPI trial may offer a similar outcome and may be preferable in low H. pylori prevalence areas; head-to-head management trials in primary care are lacking.
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Affiliation(s)
- N J Talley
- Center for Enteric Neurosciences and Translational Epidemiological Research, Mayo Clinic College of Medicine, Rochester, MN 55905, USA.
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Färkkilä M, Sarna S, Valtonen V, Sipponen P. Does the 'test-and-treat' strategy work in primary health care for management of uninvestigated dyspepsia? A prospective two-year follow-up study of 1552 patients. Scand J Gastroenterol 2004; 39:327-35. [PMID: 15125464 DOI: 10.1080/00365520310008674] [Citation(s) in RCA: 30] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/04/2023]
Abstract
BACKGROUND Although the 'test-and-treat' strategy is suggested as first-line therapy for uninvestigated dyspepsia, no large-scale studies in a real-life setting are available. METHODS 1552 dyspeptic patients aged between 25 and 60 with no alarm symptoms were recruited to the study. After screening with a 13C-urea breath test, they were randomized into three treatment arms: Helicobacter pylori-positive either to eradication therapy with OAM (omeprazole, amoxycillin and metronidazole) (Hp+/erad) or omeprazole 20 mg daily (Hp+/ome) for 10 days, whereas H. pylori-negative patients (Hp-/ome) were treated with 20 mg omeprazole for 10 days. Gastrointestinal symptoms were registered at baseline at 1 and 2 years on the Gastrointestinal Symptom Rating Scale (GSRS) and quality of life with the Psychological General Well-Being index (PGWB). Additional visits, referrals for and number of endoscopies and their findings were registered during the 2 years' follow-up. RESULTS Of the 1552 patients, 583 were H. pylori-positive (37.6%), and 288 of these were randomized for omeprazole and 295 to OAM. The Hp-/ome group had fewer general practitioner (GP) contacts (P<0.0001) than the H. pylori-positive groups. Eradication therapy significantly improved general well-being and reduced upper gastrointestinal symptoms: abdominal pain (P=0.0001), heartburn (P=0.0061), acid regurgitation (P=0.003), hunger pain (P=0.009), especially in Hp+/erad. Peptic ulcer was found in 6.2%, 1.0%, 0.2% in Hp+/ome, Hp-+/erad and Hp-/ome, respectively (P=0.0007). Only 3 patients (1.0%) developed peptic ulcers in Hp-+/erad, all eradication failures. CONCLUSIONS In uninvestigated dyspepsia, a negative test result for H. pylori reduces the number of GP contacts and endoscopy referrals compared to H. pylori-positive regardless of eradication therapy. Applied in real life, the test-and-treat strategy failed to reduce the number of endoscopies, but significantly reduced peptic ulcer disease and improved dyspeptic symptoms and quality of life.
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Affiliation(s)
- M Färkkilä
- Dept. of Medicine, Division of Gastroenterology, Helsinki University Central Hospital, Helsinki, Finland.
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Barenys M, Rota R, Moreno V, Villafafila R, García-Bayo I, Abad A, Pons JMV, Piqué JM. [Prospective validation of a clinical scoring system for the diagnosis of organic dyspepsia]. Med Clin (Barc) 2004; 121:766-71. [PMID: 14697161 DOI: 10.1016/s0025-7753(03)74093-7] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/13/2023]
Abstract
BACKGROUND AND OBJECTIVE Predictive symptomatic scoring models have been proposed to select patients with dyspepsia, who may be candidates to endoscopy. In a previous study performed by gastroentrologists from our group, we obtained three scales of symptoms to predict organic dyspepsia, peptic ulcer and esophagitis, respectively. Here we analyze the reproducibility of those scoring models of symptoms when used either by other gastroenterologists or general practitioners. PATIENTS AND METHOD It was a clinical prospective study of 230 patients from the Viladecans hospital area (120 from primary healthcare and 110 from the gastroenterologist's consultation). The three validation scales were performed in each patient. Then, we performed a diagnostic gastroscopy which allowed to classify patients into those with organic dyspepsia (ulcer, esophagitis, cancer) or those with functional dyspepsia. We calculated the overall predictive accuracy for the gastroenterologist and the general practitioner and for the three diagnoses (organic dyspepsia, ulcer or esophagitis) using the C statistic. RESULTS Discriminative capacities were 0.75 and 0.82 for organic dyspepsia, 0.78 and 0.86 for ulcer disease, and 0.78 and 0.82 for esophagitis, for the general practitioner and the gastroenterologist, respectively. In this validation study, the best cut-off value, namely the one combining good sensitivity and specificity, was found to be 7. CONCLUSIONS A correct predictive capacity of the symptomatic score models when used by other gastroenterologists or by primary healthcare practioners confirms its reproducibility and transferability. The use of predictive symptomatic score models in everyday clinical practice can allow to rationalize the referral for endoscopy in our local setting.
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Affiliation(s)
- Mercè Barenys
- Unitat de Digestiu. Hospital de Viladecans. Viladecans. Barcelona. Spain.
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Makris N, Crott R, Fallone CA, Bardou M, Barkun A. Cost-effectiveness of routine endoscopic biopsies for Helicobacter pylori detection in patients with non-ulcer dyspepsia. Gastrointest Endosc 2003; 58:14-22. [PMID: 12838214 DOI: 10.1067/mge.2003.295] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
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.
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Affiliation(s)
- Nicholaos Makris
- Division of Gastroenterology, McGill University Health Center and Department of Clinical Epidemiology, McGill University, Montréal, Québec, Canada
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Talley NJ. Yield of endoscopy in dyspepsia and concurrent treatment with proton pump inhibitors: the blind leading the blind? Gastrointest Endosc 2003; 58:89-92. [PMID: 12838227 DOI: 10.1067/mge.2003.302] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/10/2022]
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Smith T, Verzola E, Mertz H. Low yield of endoscopy in patients with persistent dyspepsia taking proton pump inhibitors. Gastrointest Endosc 2003; 58:9-13. [PMID: 12838213 DOI: 10.1067/mge.2003.308] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/12/2022]
Abstract
BACKGROUND Options for the evaluation of dyspepsia include a Helicobacter pylori test-and-treat strategy, empiric acid suppression, and initial endoscopy. The aim of this study was to determine the yield of endoscopy in patients in whom empiric therapy is unsuccessful compared with patients who received no empiric therapy and to identify factors associated with endoscopic findings. METHODS A total of 100 patients with dyspepsia referred for endoscopy completed a questionnaire that included a query concerning response to therapy. EGD findings were compared in patients taking an H2-receptor antagonist, patients taking a proton pump inhibitor, and those not receiving empiric therapy. RESULTS There were fewer endoscopic findings in patients being treated with a proton pump inhibitor compared with those taking an H2-receptor antagonist or those not receiving therapy (p < 0.01). Fewer proton pump inhibitor recipients had esophagitis or ulcer compared with patients in the no therapy group. Lack of symptom relief (<20%) by acid suppression was highly associated with a normal endoscopy (17/17). CONCLUSIONS Patients with persistent dyspepsia being treated with a proton pump inhibitor have fewer endoscopic abnormalities compared with patients with dyspepsia taking an H2-receptor antagonist and those receiving no therapy. For patients with partial symptom relief, proton pump inhibitor therapy may mask endoscopic findings, particularly esophagitis. Interruption of proton pump inhibitors before endoscopy may increase diagnostic yield. Endoscopy is unlikely to yield a positive finding in patients who experience no symptom relief while taking a proton pump inhibitor or H2-receptor antagonist.
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Affiliation(s)
- Terrence Smith
- Vanderbilt University, Department of Medicine, Division of Gastroenterology, Nashville, Tennessee 37232, USA
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Manes G, Menchise A, de Nucci C, Balzano A. Empirical prescribing for dyspepsia: randomised controlled trial of test and treat versus omeprazole treatment. BMJ 2003; 326:1118. [PMID: 12763982 PMCID: PMC156019 DOI: 10.1136/bmj.326.7399.1118] [Citation(s) in RCA: 52] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]
Abstract
OBJECTIVE To compare the efficacy of a "Helicobacter pylori test and treat" strategy with that of an empirical trial of omeprazole in the non-endoscopic management by empirical prescribing of young patients with dyspepsia. DESIGN Randomised controlled trial. SETTING Hospital gastroenterology unit. PARTICIPANTS 219 patients under 45 years old presenting with dyspepsia without alarm symptoms. INTERVENTION Patients received treatment with omeprazole 20 mg (group A) or with a urea breath test followed by an eradication treatment in case of H pylori infection or omeprazole alone in non-infected patients (group B). Lack of improvement or recurrence of symptoms prompted endoscopy. MAIN OUTCOME MEASURES Improvement in symptoms assessed by a dyspepsia severity score every two months; use of medical resources (endoscopic workload and medical consultation); clinical outcome. RESULTS 96/109 (88%) patients in group A and 61/110 (55%) in group B (P < 0.0001) had endoscopy: in 19 patients in group A and 32 in group B (20/67 infected and 12/43 non-infected) because of no improvement; in 77 further patients in group A and 29 in group B (7 infected and 22 non-infected) because of recurrence of symptoms during follow up. Endoscopy showed peptic ulcers only in group A; oesophagitis occurred significantly more often in group B than in group A. About 80% of examinations were normal in both groups, but nine duodenal scars occurred in group A. CONCLUSIONS Eradication treatment allows resolution of symptoms in a large number of patients with dyspepsia and reduces the endoscopic workload. After a trial of omeprazole, symptoms recur in nearly every patient. Such treatment is also likely to mask an appreciable number of peptic ulcers and cases of oesophagitis.
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Affiliation(s)
- Gianpiero Manes
- Department of Gastroenterology, Cardarelli Hospital, Via Solimena 101, 80129 Naples, Italy.
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Andriulli A, Grossi E, Buscema M, Festa V, Intraligi NM, Dominici P, Cerutti R, Perri F. Contribution of artificial neural networks to the classification and treatment of patients with uninvestigated dyspepsia. Dig Liver Dis 2003; 35:222-231. [PMID: 12801032 DOI: 10.1016/s1590-8658(03)00057-4] [Citation(s) in RCA: 17] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
OBJECTIVES To verify whether symptoms reported by patients with uninvestigated dyspepsia might be helpful in either classifying functional from organic dyspepsia (1st experiment), or recognising which Helicobacter pylori infected patients may benefit from eradication therapy (2nd experiment). METHODS We compared the performance of artificial neural networks and linear discriminant analysis in two experiments on a database including socio-demographic features, past medical history, alarming symptoms, and symptoms at presentation of 860 patients with uninvestigated dyspepsia enrolled in a large observational multi-centre Italian study. RESULTS In the 1st experiment, the best prediction for organic disease was given by the Sine Net model (specificity of 87.6% with 13 patients misclassified) and the best prediction for functional dyspepsia by the FF Bp model (sensitivity of 83.4% with 56 patients misclassified). The highest global accuracy of linear discriminant analysis was 65.1%, with 150 patients misclassified. In the 2nd experiment, the highest predictive performance was provided by the SelfDASn model: all infected patients who became symptom-free after successful eradicating treatment were correctly classified, whereas nine errors were made in forecasting patients who did not benefit from such a therapy. The highest global performance of linear discriminant analysis was 53.2%, with 37 patients misclassified. CONCLUSIONS In patients with uninvestigated dyspepsia, artificial neural networks might have potential for categorising those affected by either organic or functional dyspepsia, as well as for identifying all Helicobacter pylori infected dyspeptic patients who will benefit from eradication.
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Affiliation(s)
- A Andriulli
- Division of Gastroenterology, Casa Sollievo della Sofferenza Hospital, IRCCS, I-71013 San Giovanni Rotondo, Italy.
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Abstract
Nonulcer dyspepsia is a common condition in clinical practice. It is a heterogeneous disorder, and no single therapeutic agent is effective in all patients. The treatment of nonulcer dyspepsia is still dissatisfactory. Eradication of Helicobacter pylori organisms has a limited role and little effect. Antisecretory therapy has a modest effect in alleviating symptoms. Prokinetic agents may be effective, but selection bias in the trials performed to date may exaggerate their benefit. Partial 5-HT(4) agonists stimulate gastric emptying and may also affect gastric accommodation. They are promising but need further study. Data are limited on 5-HT(3) antagonists and hypnotherapy. New treatment approaches are necessary for this common and often chronic condition.
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Affiliation(s)
- Nimish Vakil
- Division of Gastroenterology, Department of Medicine, University of Wisconsin Medical School, Aurora Sinai Medical Center, Milwaukee, WI 53233, USA.
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Arents NLA, Thijs JC, Kleibeuker JH. A rational approach to uninvestigated dyspepsia in primary care: review of the literature. Postgrad Med J 2002; 78:707-16. [PMID: 12509687 PMCID: PMC1757932 DOI: 10.1136/pmj.78.926.707] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Abstract
In this paper the rationale and limitations of the four most important approach strategies to dyspepsia in primary care (empiric treatment, prompt endoscopy, "test-and-scope", and "test-and-treat") are analysed. It is concluded that in the absence of alarm symptoms, a "test-and-treat" approach is currently the most rational approach provided that three conditions are met: (1) a highly accurate test should be used, (2) the prevalence of Helicobacter pylori in the population should not be too low, and (3) an effective anti-H pylori regimen should be prescribed taking sufficient time to instruct and motivate the patient.
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Affiliation(s)
- N L A Arents
- Regional Public Health Laboratory, Groningen/Drenthe, The Netherlands
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Rabeneck L, Souchek J, Wristers K, Menke T, Ambriz E, Huang I, Wray N. A double blind, randomized, placebo-controlled trial of proton pump inhibitor therapy in patients with uninvestigated dyspepsia. Am J Gastroenterol 2002; 97:3045-51. [PMID: 12492188 DOI: 10.1111/j.1572-0241.2002.07123.x] [Citation(s) in RCA: 32] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
OBJECTIVES In patients with uninvestigated dyspepsia, a common initial management strategy in primary care is to prescribe a course of empiric antisecretory therapy and to refer those patients who do not respond for endoscopy. The objective of this research was to evaluate the effects of an empiric course of antisecretory therapy on dyspepsia-related health in patients with uninvestigated dyspepsia. METHODS We conducted a double blind, randomized, placebo-controlled trial in which patients with uninvestigated dyspepsia were randomized to a 6-wk course of omeprazole 20 mg p.o. b.id. versus placebo capsules p.o. bi.d. and followed over 1 yr. The patients were at least 18 yr old with at least a 1-wk history of dyspepsia without alarm features. Dyspepsia-related health was measured using the Severity of Dyspepsia Assessment (SODA), a valid, reliable, disease-specific outcome measure. The primary outcome was treatment failure, defined by a SODA Pain Intensity score > or = 29 (scores, 2-47) during follow-up. Patients who were treatment failures underwent endoscopy. RESULTS We enrolled 140 patients. The mean age was 51 yr, and seven (5%) were women. At 2 wk there were fewer treatment failures in the omeprazole group: 12 of 71 patients (17%) in the omeprazole group failed compared with 24 of 69 (35%) in the placebo group (p = 0.037, log rank test). Also, at 6 wk there were fewer failures in the omeprazole group: 21 of 71 patients (30%) in the omeprazole group failed compared with 31 of 69 (45%) in the placebo group in 0.067, log rank test). However, at the 1-yr follow-up, there was no significant difference in treatment failure rates in the two groups: 37 of 71 patients (52%) in the omeprazole group failed compared with 41 of 69 (59%) in the placebo group (p = 0.28, log rank test). CONCLUSIONS In patients with uninvestigated dyspepsia, as compared with a strategy that would entail prompt endoscopy for all patients, an initial 6-wk course of either placebo or omeprazole reduces the need for endoscopy over a 1-yr follow-up. Compared with placebo, an initial 6-wk course of omeprazole delays, but does not reduce, the need for endoscopy. For proton pump inhibitor therapy to reduce the need for endoscopy, it may need to be given continuously.
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Affiliation(s)
- Linda Rabeneck
- Department of Veterans Affairs Health Services Research and Development Center of Excellence and the Department of Medicine, Baylor College of Medicine, Houston, Texas, USA
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Ladabaum U, Fendrick AM, Glidden D, Scheiman JM. Helicobacter pylori test-and-treat intervention compared to usual care in primary care patients with suspected peptic ulcer disease in the United States. Am J Gastroenterol 2002; 97:3007-14. [PMID: 12492183 DOI: 10.1111/j.1572-0241.2002.07118.x] [Citation(s) in RCA: 21] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
OBJECTIVES [corrected] The Helicobacter pylori (H. pylori) "test-and-treat" strategy in uninvestigated dyspepsia is an effective alternative to prompt endoscopy. Our aims were to determine whether the combination of an educational session and availability of office-based H. pylori testing (test-and-treat intervention [TTI]) increases use of the test-and-treat strategy by primary care practitioners and whether it improves patient outcomes. METHODS We conducted a 1-yr prospective trial of patients with suspected peptic ulcer disease in six primary care centers, three with TTI and three designated as usual care controls (UCC). RESULTS H. pylori testing was performed in 81% of 54 TTI patients and in 49% of 39 UCC patients (p = 0.004). TTI and UCC patients had similar gastroenterology referral rates (24% vs 33%, p = 0.33), endoscopy or upper GI radiography rates (30% vs 31%, p = 0.91), and primary care visits per patient (3.1 +/- 2.8 vs 3.1 +/- 2.6, p = 0.92). TTI patients were less likely than UCC patients to receive repeated antisecretory medication prescriptions (35% vs 66%, p = 0.003). Symptomatic status at 1 yr and satisfaction with medical care did not differ between groups. Median (and interquartile range) annualized disease-related expenditures per patient were $454 ($162-932) for TTI and $576 ($327-1,435) for UCC patients (p = 0.17). CONCLUSIONS The combination of an educational session and availability of office-based H. pylori testing may increase acceptance of the test-and-treat strategy by primary care providers. It remains to be determined whether increased use of the test-and-treat strategy yields significant improvements in clinical and economic outcomes compared to usual care.
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Affiliation(s)
- Uri Ladabaum
- Department of Medicine, School of Public Health, Consortium for Health Outcomes, Innovation, and Cost-Effectiveness Studies (CHOICES), University of Michigan, Ann Arbor, USA
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Ladabaum U, Chey WD, Scheiman JM, Fendrick AM. Reappraisal of non-invasive management strategies for uninvestigated dyspepsia: a cost-minimization analysis. Aliment Pharmacol Ther 2002; 16:1491-501. [PMID: 12182749 DOI: 10.1046/j.1365-2036.2002.01306.x] [Citation(s) in RCA: 45] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/24/2022]
Abstract
BACKGROUND The benefits of the Helicobacter pylori test-and-treat strategy are attributable largely to the cure of peptic ulcer disease while limiting the use of endoscopy. AIM To reappraise the test-and-treat strategy and empirical proton pump inhibitor therapy for the management of uninvestigated dyspepsia in the light of the decreasing prevalence of H. pylori infection, peptic ulcer disease and peptic ulcer disease attributable to H. pylori. METHODS Using a decision analytical model, we estimated the cost per patient with uninvestigated dyspepsia managed with the test-and-treat strategy ($25/test; H.pylori treatment, $200) or proton pump inhibitor ($90/month). Endoscopy ($550) guided therapy for persistent or recurrent symptoms. RESULTS In the base case (25%H. pylori prevalence, 20% likelihood of peptic ulcer disease, 75% of ulcers due to H.pylori), the cost per patient is $545 with the test-and-treat strategy and $529 with proton pump inhibitor, and both strategies yield similar clinical outcomes at 1 year. H. pylori prevalence, the likelihood of peptic ulcer disease and the proportion of ulcers due to H.pylori are important determinants of the least costly strategy. At an H. pylori prevalence below 20%, proton pump inhibitor is consistently less costly than the test-and-treat strategy. CONCLUSIONS As the H. pylori prevalence, the likelihood of peptic ulcer disease and the proportion of ulcers due to H. pylori decrease, empirical proton pump inhibitor becomes less costly than the test-and-treat strategy for the management of uninvestigated dyspepsia. Given the modest cost differential between the strategies, the test-and-treat strategy may be favoured if patients without peptic ulcer disease derive long-term benefit from H.pylori eradication.
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Affiliation(s)
- U Ladabaum
- Division of Gastroenterology, Department of Medicine, University of California, San Francisco, Ca 94143-0538, USA.
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Abstract
Recent guidelines for dyspepsia, defined as pain or discomfort centred in the upper abdomen, emphasize that in younger patients with no alarm features and not taking nonsteroidal anti-inflammatory drugs, testing for Helicobacter pylori and treatment of the infection if present is a standard of care. If H. pylori is not present, empirical management (e.g. acid suppression) is often prescribed. It is further recommended that if patients relapse or fail to respond to treatment then upper endoscopy be undertaken. However, these guidelines have become controversial for a number of reasons. Firstly, the prevalence of H. pylori infection is falling as is the incidence of peptic ulcer disease due to the infection. Idiopathic peptic ulcer disease is also being increasingly recognized. Furthermore, the cost-effectiveness of endoscoping treatment failures has been questioned, as the yield is low and patient management is usually not altered. Finally, it remains controversial whether the treatment of H. pylori infection in functional dyspepsia is of value, and two recent high quality meta-analyses have reached diametrically opposite conclusions. Alternative strategies, such as initially treating with acid suppression and then considering H. pylori infection in those who fail have been suggested, as has in low H. pylori prevalent regions the abandonment of a test-and-treat strategy. However, appropriate management trials of these alternative strategies in primary care are lacking. The management of patients with functional dyspepsia who fail initial antisecretory therapy is now difficult; prokinetics have fallen into some disrepute. Tricyclic antidepressants (at a low dose) may be useful in a subset, but adequate trials are lacking.
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Affiliation(s)
- N J Talley
- Nepean Hospital, Penrith, NSW, Australia.
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Spiegel BMR, Vakil NB, Ofman JJ. Dyspepsia management in primary care: a decision analysis of competing strategies. Gastroenterology 2002; 122:1270-85. [PMID: 11984514 DOI: 10.1053/gast.2002.33019] [Citation(s) in RCA: 89] [Impact Index Per Article: 3.9] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/28/2022]
Affiliation(s)
- Brennan M R Spiegel
- Department of Medicine and Health Services Research, Cedars-Sinai Medical Center, Los Angeles, California, USA
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Abstract
OBJECTIVES Negative diagnostic tests are usually evaluated by their ability to advance a diagnostic search, or they are considered redundant expenditures in establishing a definitive diagnosis. It has remained difficult to assess their benefit in terms of their own merit and the reassurance that they provide to a patient. The aim of the present study is to develop a mathematical model for quantifying the impact of diagnostic tests on a patient's health-related quality of life (HRQL). METHODS An influence diagram is used to model how non-ulcer dyspepsia (NUD) and its medical care affect HRQL. Diagnostic tests and medical therapy benefit HRQL by alleviating fear of disease and NUD symptoms. Medical care can also adversely affect HRQL, lead to expenses in time and money, and compromise a patient's sense of autonomy. HRQL is modeled as the focal point of multiple influences detracting from its value. RESULTS Negative diagnostic tests can improve HRQL in NUD. The improvement of HRQL by diagnostic tests depends on a multitude of individual influences and the interactions between them, such as the severity of NUD symptoms andfear of disease, as well as the impact of medical care itself on HRQL. If a patient harbors a strong fear of serious disease or cancer, more extensive testing is likely to improve the patient's well-being and appears a worthwhile endeavor. Other patients, however, would be served perfectly well by empirical therapy only. For the vast majority of subjects with NUD who never seek medical advice, the unpleasantness of the disease itself does not outweigh the anticipated downside of obtaining medical care. CONCLUSION The analysis illustrates the applicability of the influence diagram in modeling disease behavior. This method helps to assess the benefit of negative tests beyond their means of generating information.
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Affiliation(s)
- Amnon Sonnenberg
- Department of Veterans Affairs Medical Center, Albuquerque, New Mexico 87108, USA.
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Abstract
Although dyspepsia is a very common disorder, the incidence of Helicobacter pylori infection in Western medical clinics is very low (20-35%). In cases where H. pylori is detected, elimination of it may be cost-effective in the long term, but even eradication is not a guarantee for long-term relief. Further studies to determine the connection between H. pylori and dyspepsia need to be completed before H. pylori eradication becomes the treatment of choice for that minority of patients. The majority of dyspeptic patients are not as simple to diagnose, and may need several empirical trials of therapy, or more specific diagnostic assessment.
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Affiliation(s)
- M B Fennerty
- Division of Gastroenterology, Oregon Health Sciences University, Portland, OR 97201-3098, USA.
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Bazzoli F, Bianchi Porro G, Bianchi MG, Molteni M, Pazzato P, Zagari RM. Treatment of Helicobacter pylori infection. Indications and regimens: an update. Dig Liver Dis 2002; 34:70-83. [PMID: 11926576 DOI: 10.1016/s1590-8658(02)80062-7] [Citation(s) in RCA: 23] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
The management of Helicobacter pylori infection is still surrounded by controversy and uncertainties. Indications and correct application of current regimens for Helicobacter pylori infection are still considered a matter of debate. Regarding indications, only peptic ulcer and mucosa associated lymphoid tissue lymphoma are considered clear indications for treatment. In other conditions, such as atrophic gastritis, post gastric cancer resection, first-degree relatives of gastric cancer patients, dyspeptic patients, patients with gastro-oesophageal reflux disease and non-steroidal anti-inflammatory drug users, the value of Helicobacter pylori eradication is still controversial. The regimens for first-line and second-line treatment of Helicobacter pylori infection have been recommended by the Maastricht 2 Consensus Report. Although all the treatments are considered to be effective, physicians still do not agree on what first-line regimen should be used. Furthermore, a consensus on the duration of the antibiotic treatment is still lacking, although Maastricht guidelines for treatment of Helicobacter pylori infection recommend a one-week therapy. Also regimens, as a third-line treatment, and methods to improve compliance and clinical outcome are still a matter of debate. All these points will be considered in the present review
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Affiliation(s)
- F Bazzoli
- Department of Internal Medicine and Gastroenterology, University of Bologna, Italy.
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Chen TS, Chang FY, Lee SD. Extending the reading time increases the accuracy of rapid whole blood test for diagnosis of Helicobacter pylori infection. J Gastroenterol Hepatol 2001; 16:1341-5. [PMID: 11851830 DOI: 10.1046/j.1440-1746.2001.02630.x] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/09/2022]
Abstract
BACKGROUND To evaluate the accuracy of two rapid whole blood tests (the BM-Test Helicobacter pylori and the QuikPac IV One Step H. pylori Whole Blood Test), and compare this to a conventional quantitative ELISA test (HEL-p TEST II). METHODS Helicobacter pylori status in dyspeptic patients was assessed by culture, histology, and rapid urease tests on biopsies from the antrum and corpus. The optimal cut-off value of the reading time for the rapid blood tests was determined by using the receiver characteristics operative (ROC) curves. RESULTS In the 141 patients examined, 89 were infected, 51 were not infected, and one was indeterminate (only positive in either urease test or histology). Areas under ROC curves were greater in the BM-Test compared with the QuikPac IV (0.948 vs 0.840, P < 0.01), with their most appropriate cut-off reading times at 360 and 395 min, respectively, rather than 10 min as suggested by the manufacturer. The sensitivity and specificity were 94.4% and 94.1% at 360 min, and 74.2 and 96.1% at 10 min for the BM-Test; 80.9, 76.5 at 395 min and 3.4 and 100% at 10 min for the QuikPac IV. The antibody titer of the quantitative ELISA test was negatively correlated with the reaction time of the two rapid blood tests in H. pylori-infected patients (P < 0.05, r=-0.3). CONCLUSIONS The BM-Test is an appropriate office-based test for diagnosing H. pylori infection in Chinese patients. Extending the reading time would facilitate the readability of rapid blood tests with a resultant increase in accuracy.
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Affiliation(s)
- T S Chen
- Division of Gastroenterology, Department of Medicine, Taipei Veterans General Hospital, and National Yang-Ming University, Taipei, Taiwan, Republic of China.
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Eisen GM, Dominitz JA, Faigel DO, Goldstein JA, Kalloo AN, Petersen BT, Raddawi HM, Ryan ME, Vargo JJ, Young HS, Fanelli RD, Hyman NH, Wheeler-Harbaugh J. The role of endoscopy in dyspepsia. Gastrointest Endosc 2001; 54:815-7. [PMID: 11726874 DOI: 10.1016/s0016-5107(01)70083-1] [Citation(s) in RCA: 17] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
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Gisbert JP, Cruzado AI, Benito LM, Carpio D, Perez-Poveda JJ, Gonzalez L, de Pedro A, Valbuena M, Prieto B, Cabrera MM, Cantero J, Pajares JM. Helicobacter pylori "test-and-scope" strategy for dyspeptic patients. Is it useful and safe? Dig Liver Dis 2001; 33:539-45. [PMID: 11816541 DOI: 10.1016/s1590-8658(01)80104-3] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
AIM To evaluate outcome of test-and-scope strategy using 13C-urea breath test, Helicobacter pylori IgG serology, and CagA serology. PATIENTS AND METHODS A series of 100 dyspeptic patients were studied. Biopsies were obtained for histology and rapid urease test (gold standard). Serum samples were obtained for Helicobacter pylori IgG and CagA serology, and 13C-urea breath test was carried out. RESULTS If endoscopy had not been performed in Helicobacter pylori patients based on 13C-urea breath test, <45 years, without alarm symptoms, and without non-steroidal anti-inflammatory drug use, 15% of endoscopies would have been saved, and one gastric ulcer and two oesophagitis would have been missed. Based on Helicobacter pylori IgG serology, 21% of endoscopies would have been saved. Finally, if endoscopy had been performed only in CagA+ patients, 31% of endoscopies would have been saved, missing one gastric ulcer and two cases of oesophagitis. CONCLUSIONS In our geographical area, the test-and-scope strategy based on 13C-urea breath test or Helicobacter pylori IgG serology would have saved only 15-20% of endoscopies. Although some relevant pathology would have been missed, it is not of a malignant type. 13C-urea breath test is the preferred non-invasive method to be used in this strategy, while Helicobacter pylori IgG serology is of limited value due to its low accuracy. With the use of CagA serology a larger number of unnecessary endoscopic examinations can be avoided.
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Affiliation(s)
- J P Gisbert
- Department of Gastroenterology, University Hospital of La Princesa, Madrid, Spain.
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Hasler WL. Augmented Visceral Perception. CURRENT TREATMENT OPTIONS IN GASTROENTEROLOGY 2001; 4:339-349. [PMID: 11469993 DOI: 10.1007/s11938-001-0060-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/29/2022]
Abstract
Disorders of augmented visceral perception include functional (or nonulcer) dyspepsia and irritable bowel syndrome (IBS). Enhancement of luminal perception can result from alterations in normal elastic gut wall properties or exaggerated responsiveness of visceral sensory nerve pathways. Standard therapies for functional dyspepsia are effective in subsets of patients and may act in part by compensating for gastric hypersensitivity (as with acid-suppressing drugs) or by enhancing gastric compliance (as with some motor-stimulating agents). Likewise, conventional treatments of patients with IBS reduce visceral perception via effects on sensory nerve function (fiber supplements) or luminal wall properties (antispasmodic drugs). Antidepressants are increasingly used in patients with functional dyspepsia or IBS. These drugs have several purported mechanisms, including 1) luminal relaxation, 2) blunting of visceral hypersensitivity, and 3) modulation of central nervous system pain processing pathways. The efficacy of available and investigational agents that act as visceral analgesics or luminal relaxants is an area of intense pharmaceutical research.
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Affiliation(s)
- William L. Hasler
- Division of Gastroenterology, Department of Internal Medicine, University of Michigan Medical Center, 3912 Taubman Center, Ann Arbor, MI 48109-0362, USA.
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Rabeneck L, Cook KF, Wristers K, Souchek J, Menke T, Wray NP. SODA (severity of dyspepsia assessment): a new effective outcome measure for dyspepsia-related health. J Clin Epidemiol 2001; 54:755-65. [PMID: 11470383 DOI: 10.1016/s0895-4356(00)00365-6] [Citation(s) in RCA: 54] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
The aim of this research was to develop and evaluate an instrument for measuring dyspepsia-related health to serve as the primary outcome measure for randomized clinical trials. Building on our previous work we developed SODA (Severity of Dyspepsia Assessment), a multidimensional dyspepsia measure. We evaluated SODA by administering it at enrollment and seven follow-up visits to 98 patients with dyspepsia who were randomized to a 6-week course of omeprazole versus placebo and followed over 1 year. The mean age was 53 years, and six patients (6%) were women. Median Cronbach's alpha reliability estimates over the eight visits for the SODA Pain Intensity, Non-Pain Symptoms, and Satisfaction scales were 0.97, 0.90, and 0.92, respectively. The mean change scores for all three scales discriminated between patients who reported they were improved versus those who were unchanged, providing evidence of validity. The effect sizes for the Pain Intensity (.98) and Satisfaction (.87) scales were large, providing evidence for responsiveness. The effect size for the Non-Pain Symptoms scale was small (.24), indicating lower responsiveness in this study sample. SODA is a new, effective instrument for measuring dyspepsia-related health. SODA is multidimensional and responsive to clinically meaningful change with demonstrated reliability and validity.
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Affiliation(s)
- L Rabeneck
- Department of Veterans Affairs (VA) Health Services Research and Development (HSR & D) Field Program, the VA Rehabilitation R&D Center, and Baylor College of Medicine, Houston, TX 77030, USA.
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Ladabaum U, Fendrick AM, Scheiman JM. Outcomes of initial noninvasive Helicobacter pylori testing in U.S. primary care patients with uninvestigated dyspepsia. Am J Gastroenterol 2001; 96:2051-7. [PMID: 11467631 DOI: 10.1111/j.1572-0241.2001.03938.x] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
OBJECTIVE Recent European trials demonstrate that testing and treatment for Helicobacter pylori (H. pylori) is an effective alternative to prompt endoscopy in uninvestigated dyspepsia. The eventual endoscopy rate after H. pylori testing, which is a key determinant of cost-effectiveness, is unknown in the United States. Our aim was to determine the endoscopy rate after H. pylori testing in primary care practice in the United States and to compare outcomes among seropositive and seronegative patients. METHODS We performed a retrospective review with mean 13 month follow-up of primary care patients with dyspeptic symptoms tested with office-based H. pylori serology. RESULTS Of 268 adults tested (37+/-11 yr, 58% women), 57 (21%) were seropositive and 49/57 (86%) received eradication therapy. Endoscopy or contrast radiography was performed on 19% of seropositive and 19% of seronegative patients (p = 0.97). Annualized median disease-related expenditures were similar among seropositive and seronegative patients ($228 [$93-$654] vs $366 [$107-$1268], p = 0.19). However, aggregate expenditures were substantially lower than the cost of endoscopy alone ($816 [$296-$970]). On follow-up, seropositive and seronegative patients had similar numbers of primary care visits (2.9+/-3.2 vs 3.5+/-3.6, p = 0.23), prolonged antisecretory medication use (25 vs 33%, p = 0.27), and specialist referrals (23 vs 24%, p = 0.83). CONCLUSION In a United States center, 81% of primary care patients tested for H. pylori did not undergo endoscopy, and patients incurred significantly lower median expenditures after noninvasive H. pylori testing than the cost of endoscopy alone. Seropositive and seronegative patients experienced comparable outcomes after H. pylori testing.
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Affiliation(s)
- U Ladabaum
- Department of Internal Medicine, University of Michigan, Ann Arbor, USA
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Griffiths RI, Rabeneck L, Guzman G, Cromwell DM, Strauss MJ, Robinson JW, Winston B, Li T, Graham DY. Costs of managing Helicobacter pylori-infected ulcer patients after initial therapy. Helicobacter 2001; 6:66-76. [PMID: 11328368 DOI: 10.1046/j.1523-5378.2001.00008.x] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/09/2022]
Abstract
BACKGROUND The objective of this research was to evaluate the outcomes and costs of alternative approaches to managing patients previously treated for peptic ulcer disease and Helicobacter pylori infection. MATERIALS AND METHODS A decision-analytic model was used to compare (1a) urease breath testing (UBT) for assessment of H. pylori status versus (1b) observation without further testing or treatment, among patients who were symptom-free following initial antimicrobial and antisecretory therapy for endoscopically demonstrated ulcer and H. pylori infection; and (2a) UBT versus (2b) repeat endoscopy with H. pylori testing, and versus (2c) repeat antimicrobial and antisecretory therapy without further testing, among patients who remained symptomatic following initial therapy. RESULTS Among patients who were symptom free after initial therapy, 6.1% receiving UBT had symptomatic ulcer at one year, compared to 18.2% of those simply observed. The expected first-year cost per symptom-free patient following initial therapy was $591 for UBT compared to $480 for observation. Among patients with persistent symptoms after initial therapy, 21% receiving repeat therapy had symptomatic ulcer at one year, compared to 23.8% receiving repeat endoscopy, and 23.3% receiving UBT. Corresponding medical costs per patient were, respectively, $766, $1787 and $1122. CONCLUSIONS The optimal approach to managing patients following initial treatment for ulcer and H. pylori infection depends on symptom status following initial therapy. For symptomatic patients, the preferred approach is to prescribe a repeat course of antimicrobial and antisecretory therapy. For patients without symptoms following initial therapy, UBT is the preferred approach because it is associated with a threefold lower risk of symptomatic ulcer at one year, although it costs an additional $110 per patient, compared with observation.
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Affiliation(s)
- R I Griffiths
- Project Hope Center for Health Affairs, Bethesda, MD, USA
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Westbrook JI, McIntosh JH, Duggan JM. Accuracy of provisional diagnoses of dyspepsia in patients undergoing first endoscopy. Gastrointest Endosc 2001; 53:283-8. [PMID: 11231384 DOI: 10.1016/s0016-5107(01)70399-9] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/08/2023]
Abstract
BACKGROUND This study assessed agreement between provisional and endoscopic diagnoses for patients with dyspepsia undergoing initial endoscopy, and examined variation between clinicians at 2 hospitals. METHODS This was a retrospective review of 423 consecutive patients. RESULTS Crude percentage agreement ranged from 55% to 97%. Kappa scores revealed poor agreement: peptic ulcers (0.11: 95% CI [0.05, 0.17]); gastroesophageal reflux disease (0.29: 95% CI [0.20, 0.38]); benign esophageal stricture (0.33: 95% CI [0.08, 0.58]); and cancer (0.12: 95% CI [-0.12, 0.36]). Positive and negative predictive values for cancer and benign esophageal stricture showed that agreement for a negative diagnosis was almost perfect, whereas agreement for a positive diagnosis was low. Only 17% of patients with cancer were given an accurate provisional diagnosis. Accuracy of diagnosis did not vary substantially between hospitals. CONCLUSIONS Crude percentage agreement is misleading. Emphasis should be placed on better prediction of cancer, benign esophageal stricture, and peptic ulcer disease. Accuracy of provisional diagnosis in everyday practice is no worse than that found in prospective studies in which clinicians knew a priori that diagnoses would be scrutinized. The difficulty of predicting diagnoses supports increased reliance on endoscopy.
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Affiliation(s)
- J I Westbrook
- School of Health Information Management, Faculty of Health Sciences, University of Sydney, and Princeton Medical Centre, Hamilton, Newcastle, Australia
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Groeneveld PW, Lieu TA, Fendrick AM, Hurley LB, Ackerson LM, Levin TR, Allison JE. Quality of life measurement clarifies the cost-effectiveness of Helicobacter pylori eradication in peptic ulcer disease and uninvestigated dyspepsia. Am J Gastroenterol 2001; 96:338-47. [PMID: 11232673 DOI: 10.1111/j.1572-0241.2001.03516.x] [Citation(s) in RCA: 38] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
OBJECTIVES Previous economic studies of Helicobacter pylori eradication in dyspepsia and peptic ulcer disease have not measured quality of life using utilities (preference probabilities), which are needed to compare the cost-effectiveness of such treatment to other health care interventions. The goals of this study were to measure quality of life in patients with dyspepsia or peptic ulcer and apply these measurements to published models of disease management to determine cost-effectiveness in dollars per quality-adjusted life year (QALY) gained. METHODS Utilities for dyspepsia and peptic ulcer disease were measured in adult patients (n = 73) on chronic acid suppression for peptic ulcer or ulcer-like dyspepsia. Median utility values were applied to the results of published cost-effectiveness analyses and a previously validated dyspepsia model. Cost-utility ratios for early H. pylori eradication in uninvestigated dyspepsia and peptic ulcer disease were then computed. RESULTS The total disutility, or lost quality of life, for an ulcer was 0.11 QALY, of which 0.09 QALY was attributed to dyspeptic symptoms. After these results were incorporated into published studies, cost-utility ratios for ulcer treatment varied from $3,100 to $12,500 per QALY gained, whereas estimates for uninvestigated dyspepsia management ranged from $26,800 to $59,400 per QALY. Sensitivity analyses indicated a range of $1,300 to $27,300 per QALY for management of duodenal ulcer and $15,000 to $129,700 per QALY for dyspepsia. CONCLUSIONS Strategies that emphasize early H. pylori eradication were cost-effective for patients with peptic ulcer and possibly cost-effective for patients with uninvestigated dyspepsia, relative to other medical interventions. Dyspeptic symptoms cause significant disutility that should be incorporated in future cost-effectiveness analyses of treatment strategies.
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Affiliation(s)
- P W Groeneveld
- Department of Veterans Affairs Medical Center and University of California, San Francisco, USA
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Delaney BC, Wilson S, Roalfe A, Roberts L, Redman V, Wearn A, Briggs A, Hobbs FD. Cost effectiveness of initial endoscopy for dyspepsia in patients over age 50 years: a randomised controlled trial in primary care. Lancet 2000; 356:1965-9. [PMID: 11130524 DOI: 10.1016/s0140-6736(00)03308-0] [Citation(s) in RCA: 91] [Impact Index Per Article: 3.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/06/2023]
Abstract
BACKGROUND Dyspepsia can be managed by initial endoscopy and treatment based on endoscopic findings, or by empirical prescribing. We aimed to determine the cost effectiveness of initial endoscopy compared with usual management in patients with dyspepsia over age 50 years presenting to their primary care physician. METHODS 422 patients were recruited and randomly assigned to initial endoscopy or usual management. Primary outcomes were effect of treatment on dyspepsia symptoms and cost effectiveness. Secondary outcomes were quality of life and patient satisfaction. Total costs were calculated from individual patient's use of resources with unit costs applied from national data. Statistical analysis of uncertainty on incremental cost-effectiveness ratio (ICER) was done along with a sensitivity analysis on unit costs with cost-effectiveness acceptability curves. FINDINGS In the 12 months following recruitment, 213 (84%) patients had an endoscopy compared with 75 (41%) controls. Initial endoscopy resulted in a significant improvement in symptom score (p=0.03), and quality of life pain dimension (p=0.03), and a 48% reduction in the use of proton pump inhibitors (p=0.005). The ICER was Pound Sterling1728 (UK Pound Sterling) per patient symptom-free at 12 months. The ICER was very sensitive to the cost of endoscopy, and could be reduced to Pound Sterling165 if the unit cost of this procedure fell from Pound Sterling246 to Pound Sterling100. INTERPRETATION Initial endoscopy in dyspeptic patients over age 50 might be a cost-effective intervention.
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Affiliation(s)
- B C Delaney
- Department of Primary Care and General Practice, University of Birmingham, Medical School, Edgbaston.
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