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Shah ED, Curley MA, Patel A, Lo WK, Chan WW. Heartburn Relief Is the Major Unmet Need for Drug Development in Gastroesophageal Reflux Disease: Threshold Value Analysis. Clin Gastroenterol Hepatol 2025; 23:263-271. [PMID: 38367746 PMCID: PMC11604002 DOI: 10.1016/j.cgh.2024.01.049] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/25/2023] [Revised: 01/29/2024] [Accepted: 01/31/2024] [Indexed: 02/19/2024]
Abstract
BACKGROUND AND AIMS Heartburn symptoms contribute to healthcare-seeking among patients with gastroesophageal reflux disease (GERD). Despite clinical guidance, management is often dictated by insurance restrictions. Several potassium-competitive acid blockers (PCABs) are under development as a new class of therapy. We performed economic analyses to align GERD drug development with the needs of gastroenterologists, insurers and patients in a value-based environment. METHODS A decision-analytic model was constructed to compare vonoprazan 20 mg daily (an example of a PCAB), common over-the-counter or prescription proton pump inhibitor regimens, and no treatment over a 1-year time horizon. Clinical responses were evaluated based on the proportions of heartburn-free days in a recent phase 3 multicenter trial. Healthcare utilization for persistent reflux symptoms was derived from national observational studies compared with healthy control subjects. Costs and quality-adjusted life years were reported. RESULTS Without insurance coverage for appropriate therapy, patients spend $4443 and insurers spend $3784 on average per year for inadequately treated GERD symptoms. Our model estimates that PCABs could save at least $3000 in annual costs to patients and insurers, could generate quality-adjusted life year gains (+0.06 per year), and could be cost-saving to insurers as a covered option at a price up to $8.57 per pill, if these drugs are able to demonstrate similar effectiveness to proton pump inhibitors in future trials evaluating heartburn relief and erosive esophagitis healing to regulators. Threshold prices reflect pricing after all pharmacy benefits manager rebates and discounts. DISCUSSION We demonstrate that aiming GERD-related drug development toward heartburn relief appears critical to align cost-effective incentives for industry and insurers with those of patients and gastroenterologists.
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Affiliation(s)
- Eric D Shah
- Division of Gastroenterology, Michigan Medicine, Ann Arbor, Michigan.
| | - Michael A Curley
- Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
| | - Amit Patel
- Division of Gastroenterology, Duke University School of Medicine, Durham, North Carolina; Division of Gastroenterology, Durham Veterans Affairs Medical Center, Durham, North Carolina
| | - Wai-Kit Lo
- Division of Gastroenterology, Durham Veterans Affairs Medical Center, Durham, North Carolina; Division of Gastroenterology, Brigham and Women's Hospital, Boston, Massachusetts
| | - Walter W Chan
- Division of Gastroenterology, Durham Veterans Affairs Medical Center, Durham, North Carolina; Division of Gastroenterology, Brigham and Women's Hospital, Boston, Massachusetts
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Hiramoto B, Muftah M, Flanagan R, Shah ED, Chan WW. Cost-Effectiveness Analysis of Current Treatment Options for Eosinophilic Esophagitis. Am J Gastroenterol 2025; 120:161-172. [PMID: 39344968 DOI: 10.14309/ajg.0000000000003104] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/12/2024] [Accepted: 09/18/2024] [Indexed: 10/01/2024]
Abstract
INTRODUCTION The management strategies for eosinophilic esophagitis include proton pump inhibitors (PPIs), swallowed topical corticosteroids (tCSs), elimination diets, and the biologic agent dupilumab, although there remains little guidance on the selection of initial treatment. We performed cost-effectiveness analyses to compare these approaches of first-line therapy. METHODS A Markov model was constructed from a payer perspective to evaluate the cost-effectiveness of first-line therapies for eosinophilic esophagitis, including PPI, tCS, and 6-food elimination diet (SFED), with crossover in treatments for primary and secondary nonresponse. The primary outcome was incremental cost-effectiveness ratio at 2 and 5-year time horizons. Secondary analyses included modeling from a societal perspective that also accounted for patient-specific costs, as well as a separate simplified model comparing dupilumab with tCS and PPI. RESULTS In the base-case scenario (5-year time horizon), the average costs were SFED: $15,296.81, PPI: $16,153.77, and tCS: $20,975.33 as initial therapy, with SFED being the dominant strategy (more effective/less costly), while PPI offered the lowest cost on a 2-year time horizon. From a societal perspective, PPI was the dominant initial strategy on both 2 and 5-year time horizons. Among pharmacologic therapies, PPI was the most cost-effective first-line option. Dupilumab was not cost-effective relative to tCS, unless the quarterly cost is reduced from $7,311 to $2,038.50 per price threshold analysis under permissive modeling conditions. DISCUSSION SFED was the most effective/least costly first-line therapy from the payer perspective while PPI was more cost-effective from the societal perspective. PPI is also the most cost-effective pharmacologic strategy. Dupilumab requires substantial cost reductions to be considered cost-effective first-line pharmacotherapy.
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Affiliation(s)
- Brent Hiramoto
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Boston, Massachusetts, USA
- Harvard Medical School, Boston, Massachusetts, USA
| | - Mayssan Muftah
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Boston, Massachusetts, USA
- Harvard Medical School, Boston, Massachusetts, USA
| | - Ryan Flanagan
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Boston, Massachusetts, USA
- Harvard Medical School, Boston, Massachusetts, USA
| | - Eric D Shah
- Division of Gastroenterology and Hepatology, Michigan Medicine, Ann Arbor, Michigan, USA
| | - Walter W Chan
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Boston, Massachusetts, USA
- Harvard Medical School, Boston, Massachusetts, USA
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Xie M, You JHS. Deprescribing of proton pump inhibitors in older patients: A cost-effectiveness analysis. PLoS One 2024; 19:e0311658. [PMID: 39374218 PMCID: PMC11458043 DOI: 10.1371/journal.pone.0311658] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/19/2024] [Accepted: 09/23/2024] [Indexed: 10/09/2024] Open
Abstract
Over-prescribing of proton-pump inhibitors (PPIs) is widely observed in older patients. Clinical findings have showed that deprescribing service significantly decreased inappropriate PPIs utilization. We aimed to examine the cost-effectiveness of PPI deprescribing service from the perspective of Hong Kong public healthcare provider. A decision-analytic model was constructed to examine the clinical and economic outcomes of PPI deprescribing service (deprescribing group) and usual care (UC group) in a hypothetical cohort of older PPI-users aged ≥65 years in the ambulatory care setting. The model inputs were retrieved from literature and public data. The model time-frame was one-year. Base-case analysis and sensitivity analysis were performed. Primary model outcomes were direct medical cost and quality-adjusted life-years (QALYs) loss. In base-case analysis, the deprescribing service (versus UC) reduced total direct medical cost by USD235 and saved 0.0249 QALY per PPI user evaluated. The base-case results were robust to variation of all model inputs in one-way sensitivity analysis. In probabilistic sensitivity analysis, the deprescribing group was accepted as cost-effective (versus the UC group) in 100% of the 10,000 Monte Carlo simulations. In conclusion, the PPI deprescribing service saved QALYs and reduced total direct medical cost in older PPIs users, and showed a high probability to be accepted as the cost-effective option from the perspective of public healthcare provider in Hong Kong.
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Affiliation(s)
- Mingxi Xie
- School of Pharmacy, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong SAR, China
| | - Joyce H. S. You
- School of Pharmacy, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong SAR, China
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Shah ED, Chan WW, Jodorkovsky D, Lee Lynch K, Patel A, Patel D, Yadlapati R. Optimizing the Management Algorithm for Heartburn in General Gastroenterology: Cost-Effectiveness and Cost-Minimization Analysis. Clin Gastroenterol Hepatol 2024; 22:2011-2022.e5. [PMID: 37683879 PMCID: PMC10918040 DOI: 10.1016/j.cgh.2023.08.026] [Citation(s) in RCA: 5] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/05/2023] [Revised: 08/08/2023] [Accepted: 08/16/2023] [Indexed: 09/10/2023]
Abstract
BACKGROUND AND AIMS Heartburn is the most common symptom seen in gastroenterology practice. We aimed to optimize cost-effective evaluation and management of heartburn. METHODS We developed a decision analytic model from insurer and patient perspectives comparing 4 strategies for patients failing empiric proton pump inhibitors (PPIs): (1) PPI optimization without testing, (2) endoscopy with PPI optimization for all patients, (3) endoscopy with PPI discontinuation when erosive findings are absent, and (4) endoscopy/ambulatory reflux monitoring with PPI discontinuation as appropriate for phenotypic management. Health outcomes were respectively defined on systematic reviews of clinical trials. Cost outcomes were defined on Centers for Medicare and Medicaid Services databases and commercial multipliers for direct healthcare costs, and national observational studies evaluating healthcare utilization. The time horizon was 1 year. All testing was performed off PPI. RESULTS PPI optimization without testing cost $3784/y to insurers and $3128 to patients due to lower work productivity and suboptimal symptom relief. Endoscopy with PPI optimization lowered insurer costs by $1020/y and added 11 healthy days/y by identifying erosive reflux disease. Endoscopy with PPI discontinuation added 11 additional healthy days/y by identifying patients without erosive reflux disease that did not need PPI. By optimizing phenotype-guided treatment, endoscopy/ambulatory reflux monitoring with a trial of PPI discontinuation was the most effective of all strategies (gaining 22 healthy days/y) and saved $2183 to insurers and $2396 to patients. CONCLUSIONS Among patients with heartburn, endoscopy with ambulatory reflux monitoring (off PPI) optimizes cost-effective management by matching treatment to phenotype. When erosive findings are absent, trialing PPI discontinuation is more cost-effective than optimizing PPI.
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Affiliation(s)
- Eric D Shah
- Division of Gastroenterology, Department of Internal Medicine, Michigan Medicine, Ann Arbor, Michigan.
| | - Walter W Chan
- Division of Gastroenterology, Department of Internal Medicine, Brigham and Women's Hospital, Boston, Massachusetts
| | - Daniela Jodorkovsky
- Division of Gastroenterology, Department of Internal Medicine, Icahn School of Medicine at Mount Sinai, New York, New York
| | - Kristle Lee Lynch
- Division of Gastroenterology, Department of Internal Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania
| | - Amit Patel
- Division of Gastroenterology, Department of Internal Medicine, Duke University School of Medicine and Durham Veterans Affairs Medical Center, Durham, North Carolina
| | - Dhyanesh Patel
- Division of Gastroenterology, Department of Internal Medicine, Vanderbilt University Medical Center, Nashville, Tennessee
| | - Rena Yadlapati
- Division of Gastroenterology, Department of Internal Medicine, University of California San Diego, San Diego, California
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van der Ende-van Loon MCM, Stoker A, Nieuwkerk PT, Curvers WL, Schoon EJ. How are we measuring health-related quality of life in patients with a Barrett Esophagus? A systematic review on patient-reported outcome measurements. Qual Life Res 2021; 31:1639-1656. [PMID: 34748137 PMCID: PMC9098608 DOI: 10.1007/s11136-021-03009-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 09/28/2021] [Indexed: 11/29/2022]
Abstract
Purpose Barrett esophagus (BE) is associated with a significant decrease of health-related quality of life (HRQoL). Too often, patient-reported outcome measures (PROMs) are applied without considering what they measure and for which purposes they are suitable. With this systematic review, we provide researchers and physicians with an overview of all the instruments previously used for measuring HRQoL in BE patients and which PROMs are most appropriate from the patient’s perspective. Methods A comprehensive search was performed to identify all PROMs used for measuring HRQoL in BE patients, to identify factors influencing HRQoL according to BE patients, and to evaluate each PROM from a patients’ perspective. Results Among the 27 studies, a total of 32 different HRQoL instruments were identified. None of these instruments were designed or validated for use in BE patients. Four qualitative studies were identified exploring factors influencing HRQoL in the perceptions of BE patients. These factors included fear of cancer, anxiety, trust in physician, sense of control, uncertainty, worry, burden of endoscopy, knowledge and understanding, gastrointestinal symptoms, sleeping difficulties, diet and lifestyle, use of medication, and support of family and friends. Conclusion None of the quantitative studies measuring HRQoL in BE patients sufficiently reflected the perceptions of HRQoL in BE patients. Only gastrointestinal symptoms and anxiety were addressed in the majority of the studies. For the selection of PROMs, we encourage physicians and researchers measuring HRQoL to choose their PROMs from a patient perspective and not strictly based on health professionals’ definitions of what is relevant.
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Affiliation(s)
| | - A Stoker
- Department of Gastroenterology and Hepatology, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands
| | - P T Nieuwkerk
- Department of Medical Psychology, Academic Medical Center, Amsterdam, The Netherlands
| | - W L Curvers
- Department of Gastroenterology and Hepatology, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands
| | - E J Schoon
- Department of Gastroenterology and Hepatology, Catharina Hospital, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands.,GROW: School of Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands
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Cotton CC, Erim D, Eluri S, Palmer SH, Green DJ, Wolf WA, Runge TM, Wheeler S, Shaheen NJ, Dellon ES. Cost Utility Analysis of Topical Steroids Compared With Dietary Elimination for Treatment of Eosinophilic Esophagitis. Clin Gastroenterol Hepatol 2017; 15:841-849.e1. [PMID: 27940272 PMCID: PMC5440206 DOI: 10.1016/j.cgh.2016.11.032] [Citation(s) in RCA: 37] [Impact Index Per Article: 4.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/31/2016] [Revised: 11/17/2016] [Accepted: 11/22/2016] [Indexed: 02/07/2023]
Abstract
BACKGROUND & AIMS Topical corticosteroids or dietary elimination are recommended as first-line therapies for eosinophilic esophagitis, but data to directly compare these therapies are scant. We performed a cost utility comparison of topical corticosteroids and the 6-food elimination diet (SFED) in treatment of eosinophilic esophagitis, from the payer perspective. METHODS We used a modified Markov model based on current clinical guidelines, in which transition between states depended on histologic response simulated at the individual cohort-member level. Simulation parameters were defined by systematic review and meta-analysis to determine the base-case estimates and bounds of uncertainty for sensitivity analysis. Meta-regression models included adjustment for differences in study and cohort characteristics. RESULTS In the base-case scenario, topical fluticasone was about as effective as SFED but more expensive at a 5-year time horizon ($9261.58 vs $5719.72 per person). SFED was more effective and less expensive than topical fluticasone and topical budesonide in the base-case scenario. Probabilistic sensitivity analysis revealed little uncertainty in relative treatment effectiveness. There was somewhat greater uncertainty in the relative cost of treatments; most simulations found SFED to be less expensive. CONCLUSIONS In a cost utility analysis comparing topical corticosteroids and SFED for first-line treatment of eosinophilic esophagitis, the therapies were similar in effectiveness. SFED was on average less expensive, and more cost effective in most simulations, than topical budesonide and topical fluticasone, from a payer perspective and not accounting for patient-level costs or quality of life.
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Affiliation(s)
- Cary C. Cotton
- University of North Carolina at Chapel Hill, Department of Medicine, Division of Gastroenterology and Hepatology, Center for Esophageal Diseases and Swallowing, Chapel Hill, NC, USA
| | - Daniel Erim
- University of North Carolina at Chapel Hill, Gillings School of Public Heath, Department of Health Policy and Management, Chapel Hill, NC, USA
| | - Swathi Eluri
- University of North Carolina at Chapel Hill, Department of Medicine, Division of Gastroenterology and Hepatology, Center for Esophageal Diseases and Swallowing, Chapel Hill, NC, USA
| | - Sarah H. Palmer
- University of North Carolina at Chapel Hill, Gillings School of Public Heath, Department of Health Policy and Management, Chapel Hill, NC, USA
| | - Daniel J. Green
- University of North Carolina at Chapel Hill, Department of Medicine, Division of Gastroenterology and Hepatology, Center for Esophageal Diseases and Swallowing, Chapel Hill, NC, USA
| | - W Asher Wolf
- University of North Carolina at Chapel Hill, Department of Medicine, Division of Gastroenterology and Hepatology, Center for Esophageal Diseases and Swallowing, Chapel Hill, NC, USA
| | - Thomas M. Runge
- University of North Carolina at Chapel Hill, Department of Medicine, Division of Gastroenterology and Hepatology, Center for Esophageal Diseases and Swallowing, Chapel Hill, NC, USA
| | - Stephanie Wheeler
- University of North Carolina at Chapel Hill, Gillings School of Public Heath, Department of Health Policy and Management, Chapel Hill, NC, USA
| | - Nicholas J. Shaheen
- University of North Carolina at Chapel Hill, Department of Medicine, Division of Gastroenterology and Hepatology, Center for Esophageal Diseases and Swallowing, Chapel Hill, NC, USA
| | - Evan S. Dellon
- University of North Carolina at Chapel Hill, Department of Medicine, Division of Gastroenterology and Hepatology, Center for Esophageal Diseases and Swallowing, Chapel Hill, NC, USA
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Stevanović J, de Jong LA, Kappelhoff BS, Dvortsin EP, Voorhaar M, Postma MJ. Dabigatran for the Treatment and Secondary Prevention of Venous Thromboembolism; A Cost-Effectiveness Analysis for the Netherlands. PLoS One 2016; 11:e0163550. [PMID: 27776137 PMCID: PMC5077099 DOI: 10.1371/journal.pone.0163550] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/07/2015] [Accepted: 09/11/2016] [Indexed: 01/31/2023] Open
Abstract
Background Dabigatran was proven to have similar effect on the prevention of recurrence of venous thromboembolism (VTE) and a lower risk of bleeding compared to vitamin K antagonists (VKA). The aim of this study is to assess the cost-effectiveness (CE) of dabigatran for the treatment and secondary prevention in patients with VTE compared to VKAs in the Dutch setting. Methods Previously published Markov model was modified and updated to assess the CE of dabigatran and VKAs for the treatment and secondary prevention in patients with VTE from a societal perspective in the base-case analysis. The model was populated with efficacy and safety data from major dabigatran trials (i.e. RE-COVER, RECOVER II, RE-MEDY and RE-SONATE), Dutch specific costs, and utilities derived from dabigatran trials or other published literature. Univariate, probabilistic sensitivity and a number of scenario analyses evaluating various decision-analytic settings (e.g. the perspective of analysis, use of anticoagulants only for treatment or only for secondary prevention, or comparison to no treatment) were tested on the incremental cost-effectiveness ratio (ICER). Results In the base-case scenario, patients on dabigatran gained an additional 0.034 quality adjusted life year (QALY) while saving €1,598. Results of univariate sensitivity analysis were quite robust. The probability that dabigatran is cost-effective at a willingness-to-pay threshold of €20,000/QALY was 98.1%. From the perspective of healthcare provider, extended anticoagulation with dabigatran compared to VKAs was estimated at €2,158 per QALY gained. The ICER for anticoagulation versus no treatment in patients with equipoise risk of recurrent VTE was estimated at €33,379 per QALY gained. Other scenarios showed dabigatran was cost-saving. Conclusion From a societal perspective, dabigatran is likely to be a cost-effective or even cost-saving strategy for treatment and secondary prevention of VTE compared to VKAs in the Netherlands.
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Affiliation(s)
- J. Stevanović
- Unit of PharmacoEpidemiology & PharmacoEconomics (PE2), University of Groningen, Groningen, the Netherlands
| | - L. A. de Jong
- Unit of PharmacoEpidemiology & PharmacoEconomics (PE2), University of Groningen, Groningen, the Netherlands
- * E-mail:
| | | | - E. P. Dvortsin
- Unit of PharmacoEpidemiology & PharmacoEconomics (PE2), University of Groningen, Groningen, the Netherlands
| | - M. Voorhaar
- Boehringer Ingelheim, Alkmaar, the Netherlands
| | - M. J. Postma
- Unit of PharmacoEpidemiology & PharmacoEconomics (PE2), University of Groningen, Groningen, the Netherlands
- Institute for Science in Healthy Aging & healthcaRE (SHARE), University Medical Center Groningen (UMCG), University of Groningen, Groningen, the Netherlands
- Department of Epidemiology, UMCG, University of Groningen, Groningen, the Netherlands
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Comparative Effectiveness of Esophagectomy Versus Endoscopic Treatment for Esophageal High-grade Dysplasia. Ann Surg 2016; 263:719-26. [PMID: 26672723 DOI: 10.1097/sla.0000000000001387] [Citation(s) in RCA: 26] [Impact Index Per Article: 2.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
Abstract
OBJECTIVE The purpose of this study is to determine the comparative effectiveness of esophagectomy versus endoscopic mucosal resection followed by radiofrequency ablation (EMR-RFA) for the treatment of Barrett esophagus with high-grade dysplasia (HGD). BACKGROUND HGD of the esophagus may be managed by surgical resection or EMR-RFA. National guidelines suggest that EMR-RFA is effective at eradicating HGD. The comparative effectiveness and cost-effectiveness of EMR-RFA versus esophagectomy for HGD remains unclear. METHODS A decision-analysis model was constructed to represent 3 management strategies for HGD: (1) esophagectomy, (2) EMR-RFA, and (3) endoscopic surveillance. Estimates for model variables were obtained from literature review, and costs were estimated from Medicare fee schedules. Costs and utilities were discounted at an annual rate of 3%. The baseline model was adjusted for alternative age groups and high-risk dysplastic variants. One-way and multivariable probabilistic sensitivity analyses were conducted. RESULTS For a 65-year-old patient, compared to esophagectomy, EMR-RFA yields equivalent utility (11.5 vs 11.4 discounted quality-adjusted life years) with lower total cost ($52.5K vs $74.3K) over the first 20 years. Dominance of EMR-RFA over esophagectomy persists for all age groups. Patients with diffuse or ulcerated HGD are more effectively treated with esophagectomy. Model outcomes are sensitive to estimated rates of disease progression and postintervention utility parameters. CONCLUSIONS Existing evidence supports EMR-RFA over esophagectomy for the treatment of esophageal HGD. Long-term outcomes and more definitive quality-of-life studies for both interventions are crucial to better inform decision-making.
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Yang JJ, Thanataveerat A, Green PHR, Lebwohl B. Cost Effectiveness of Routine Duodenal Biopsy Analysis for Celiac Disease During Endoscopy for Gastroesophageal Reflux. Clin Gastroenterol Hepatol 2015; 13:1437-43. [PMID: 25818076 PMCID: PMC4509941 DOI: 10.1016/j.cgh.2015.03.022] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/25/2015] [Accepted: 03/07/2015] [Indexed: 02/06/2023]
Abstract
BACKGROUND & AIMS Some patients with refractory gastroesophageal reflux disease (GERD) actually have undiagnosed celiac disease. These patients often undergo an esophagogastroduodenoscopy (EGD) to determine the etiology and severity of GERD. Performing routine duodenal biopsy analysis during an EGD could identify patients with celiac disease. We evaluated the cost effectiveness of this approach. METHODS We performed a systematic search of the MEDLINE database to identify publications through March 2014 on patients who underwent a duodenal biopsy analysis during an EGD for GERD. Data collected were used to construct a decision tree to calculate the cost effectiveness of an EGD with and without celiac disease tests. RESULTS Among 10,000 patients with refractory GERD who underwent an EGD, we predicted a biopsy strategy would detect 70% of patients with celiac disease if the prevalence of celiac disease was 1% in this cohort. Biopsy analysis at the start of the EGD procedure would increase the remaining quality-adjusted life years (QALYs) by 0.0032, and increase the lifetime cost by $389/patient. Compared with no biopsy, the biopsy strategy cost $55,692.86/case of celiac disease detected, and $121,875/QALY gained. The incremental cost-effectiveness ratio for the biopsy strategy met the threshold of less than $50,000/QALY when 1 of the following parameters was met: when the utility of living with GERD was less than 0.88, when the prevalence of celiac disease in patients with refractory GERD was greater than 1.8%, when biopsy analysis detected celiac disease with more than 98.1% specificity, when the cost of a gluten-free diet was less than $645.85/y, or if the cost of proton pump inhibitor therapy was more than $5874.01/y. CONCLUSIONS Based on base-case values, it is not cost effective to perform a biopsy analysis to detect celiac disease in patients undergoing an EGD for refractory GERD. However, the approach becomes cost effective when the prevalence of celiac disease in this population is 1.8% or greater.
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Affiliation(s)
- Janie J Yang
- Celiac Disease Center, Department of Medicine, Columbia University College of Physicians and Surgeons, New York, New York
| | - Anusorn Thanataveerat
- Department of Biostatistics, Columbia University Mailman School of Public Health, New York, New York
| | - Peter H R Green
- Celiac Disease Center, Department of Medicine, Columbia University College of Physicians and Surgeons, New York, New York
| | - Benjamin Lebwohl
- Celiac Disease Center, Department of Medicine, Columbia University College of Physicians and Surgeons, New York, New York.
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Abstract
Approximately 10% to 15% of the chronic gastroesophageal reflux disease population is at risk for the development of Barrett's esophagus, particularly in the setting of other risk factors, including male gender, Caucasian race, age more than 50, and central obesity. The risk of cancer progression for patients with nondysplastic BE has been estimated to be approximately 0.2% to 0.5% per year. Given these low progression rates and the high cost of endoscopic surveillance, cost-effectiveness analyses in this area are useful to determine appropriate resource allocation.
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11
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Hur C, Choi SE, Kong CY, Wang GQ, Xu H, Polydorides AD, Xue LY, Perzan KE, Tramontano AC, Richards-Kortum RR, Anandasabapathy S. High-resolution microendoscopy for esophageal cancer screening in China: A cost-effectiveness analysis. World J Gastroenterol 2015; 21:5513-23. [PMID: 25987774 PMCID: PMC4427673 DOI: 10.3748/wjg.v21.i18.5513] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/23/2014] [Revised: 09/03/2014] [Accepted: 11/08/2014] [Indexed: 02/06/2023] Open
Abstract
AIM To study the cost-effectiveness of high-resolution microendoscopy (HRME) in an esophageal squamous cell carcinoma (ESCC) screening program in China. METHODS A decision analytic Markov model of ESCC was developed. Separate model analyses were conducted for cohorts consisting of an average-risk population or a high-risk population in China. Hypothetical 50-year-old individuals were followed until age 80 or death. We compared three different strategies for both cohorts: (1) no screening; (2) standard endoscopic screening with Lugol's iodine staining; and (3) endoscopic screening with Lugol's iodine staining and an HRME. Model parameters were estimated from the literature as well as from GLOBOCAN, the Cancer Incidence and Mortality Worldwide cancer database. Health states in the model included non-neoplasia, mild dysplasia, moderate dysplasia, high-grade dysplasia, intramucosal carcinoma, operable cancer, inoperable cancer, and death. Separate ESCC incidence transition rates were generated for the average-risk and high-risk populations. Costs in Chinese currency were converted to international dollars (I$) and were adjusted to 2012 dollars using the Consumer Price Index. RESULTS The main outcome measurements for this study were quality-adjusted life years (QALYs) and incremental cost-effectiveness ratio (ICER). For the average-risk population, the HRME screening strategy produced 0.043 more QALYs than the no screening strategy at an additional cost of I$646, resulting in an ICER of I$11808 per QALY gained. Standard endoscopic screening was weakly dominated. Among the high-risk population, when the HRME screening strategy was compared with the standard screening strategy, the ICER was I$8173 per QALY. For both the high-risk and average-risk screening populations, the HRME screening strategy appeared to be the most cost-effective strategy, producing ICERs below the willingness-to-pay threshold, I$23500 per QALY. One-way sensitivity analysis showed that, for the average-risk population, higher specificity of Lugol's iodine (> 40%) and lower specificity of HRME (< 70%) could make Lugol's iodine screening cost-effective. For the high-risk population, the results of the model were not substantially affected by varying the follow-up rate after Lugol's iodine screening, Lugol's iodine test characteristics (sensitivity and specificity), or HRME specificity. CONCLUSION The incorporation of HRME into an ESCC screening program could be cost-effective in China. Larger studies of HRME performance are needed to confirm these findings.
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Choi SE, Perzan KE, Tramontano AC, Kong CY, Hur C. Statins and aspirin for chemoprevention in Barrett's esophagus: results of a cost-effectiveness analysis. Cancer Prev Res (Phila) 2013; 7:341-50. [PMID: 24380852 DOI: 10.1158/1940-6207.capr-13-0191-t] [Citation(s) in RCA: 25] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/17/2022]
Abstract
Data suggest that aspirin, statins, or a combination of the two drugs may lower the progression of Barrett's esophagus to esophageal adenocarcinoma. However, aspirin is associated with potential complications such as gastrointestinal bleeding and hemorrhagic stroke, and statins are associated with myopathy. We developed a simulation disease model to study the effectiveness and cost effectiveness of aspirin and statin chemoprevention against esophageal adenocarcinoma. A decision analytic Markov model was constructed to compare four strategies for Barrett's esophagus management; all regimens included standard endoscopic surveillance regimens: (i) endoscopic surveillance alone, (ii) aspirin therapy, (iii) statin therapy, and (iv) combination therapy of aspirin and statin. Endpoints evaluated were life expectancy, quality-adjusted life years (QALY), costs, and incremental cost-effectiveness ratios (ICER). Sensitivity analysis was performed to determine the impact of model input uncertainty on results. Assuming an annual progression rate of 0.33% per year from Barrett's esophagus to esophageal adenocarcinoma, aspirin therapy was more effective and cost less than (dominated) endoscopic surveillance alone. When combination therapy was compared with aspirin therapy, the ICER was $158,000/QALY, which was above our willingness-to-pay threshold of $100,000/QALY. Statin therapy was dominated by combination therapy. When higher annual cancer progression rates were assumed in the model (0.5% per year), combination therapy was cost-effective compared with aspirin therapy, producing an ICER of $96,000/QALY. In conclusion, aspirin chemoprevention was both more effective and cost less than endoscopic surveillance alone. Combination therapy using both aspirin and statin is expensive but could be cost-effective in patients at higher risk of progression to esophageal adenocarcinoma.
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Affiliation(s)
- Sung Eun Choi
- Massachusetts General Hospital, 101 Merrimac Street, 10th Floor, Boston, MA 02114.
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13
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Xie F, Gaebel K, Perampaladas K, Doble B, Pullenayegum E. Comparing EQ-5D valuation studies: a systematic review and methodological reporting checklist. Med Decis Making 2013; 34:8-20. [PMID: 23525701 DOI: 10.1177/0272989x13480852] [Citation(s) in RCA: 81] [Impact Index Per Article: 6.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/19/2023]
Abstract
BACKGROUND There has been a growing interest around the world in developing country-specific scoring algorithms for the EQ-5D. This study systematically reviews all existing EQ-5D valuation studies to highlight their strengths and limitations, explores heterogeneity in observed utilities using meta-regression, and proposes a methodological checklist for reporting EQ-5D valuation studies. METHODS . We searched Medline, EMBASE, the National Health Service Economic Evaluation Database (NHS EED) via Wiley's Cochrane Library, and Wiley's Health Economic Evaluation Database from inception through November 2012, as well as bibliographies of key papers and the EuroQol Plenary Meeting Proceedings from 1991 to 2012 for English-language reports of EQ-5D valuation studies. Two reviewers independently screened the titles and abstracts for relevance. Three reviewers performed data extraction and compared the characteristics and scoring algorithms developed in the included valuation studies. RESULTS . Of the 31 studies included in the review, 19 used the time trade-off (TTO) technique, 10 used the visual analogue scale (VAS) technique, and 2 used both TTO and VAS. Most studies included respondents from the general population selected by random or quota sampling and used face-to-face interviews or postal surveys. Studies valued between 7 and 198 total states, with 1-23 states valued per respondent. Different model specifications have been proposed for scoring. Some sample or demographic factors, including gender, education, percentage urban population, and national health care expenditure, were associated with differences in observed utilities for moderate or severe health states. CONCLUSIONS . EQ-5D valuation studies conducted to date have varied widely in their design and in the resulting scoring algorithms. Therefore, we propose the Checklist for Reporting Valuation Studies of the EQ-5D (CREATE) for those conducting valuation studies.
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Affiliation(s)
- Feng Xie
- Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada (FX, KP, BD, EP).,Programs for Assessment of Technologies in Health Research Institute, St. Joseph’s Healthcare Hamilton, Hamilton, Ontario, Canada (FX, KG, KP, BD)
| | - Kathryn Gaebel
- Programs for Assessment of Technologies in Health Research Institute, St. Joseph’s Healthcare Hamilton, Hamilton, Ontario, Canada (FX, KG, KP, BD)
| | - Kuhan Perampaladas
- Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada (FX, KP, BD, EP).,Programs for Assessment of Technologies in Health Research Institute, St. Joseph’s Healthcare Hamilton, Hamilton, Ontario, Canada (FX, KG, KP, BD)
| | - Brett Doble
- Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada (FX, KP, BD, EP).,Programs for Assessment of Technologies in Health Research Institute, St. Joseph’s Healthcare Hamilton, Hamilton, Ontario, Canada (FX, KG, KP, BD),Centre for Health Economics, Faculty of Business and Economics, Monash University, Clayton, Victoria, Australia (BD)
| | - Eleanor Pullenayegum
- Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, ON, Canada (FX, KP, BD, EP)
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14
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Hur C, Choi SE, Rubenstein JH, Kong CY, Nishioka NS, Provenzale DT, Inadomi JM. The cost effectiveness of radiofrequency ablation for Barrett's esophagus. Gastroenterology 2012; 143:567-575. [PMID: 22626608 PMCID: PMC3429791 DOI: 10.1053/j.gastro.2012.05.010] [Citation(s) in RCA: 124] [Impact Index Per Article: 9.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/08/2012] [Revised: 04/19/2012] [Accepted: 05/09/2012] [Indexed: 02/08/2023]
Abstract
BACKGROUND & AIMS Radiofrequency ablation (RFA) reduces the risk of esophageal adenocarcinoma (EAC) in patients with Barrett's esophagus (BE) with high-grade dysplasia (HGD), but its effects in patients without dysplasia are debatable. We analyzed the effectiveness and cost effectiveness of RFA for the management of BE. METHODS We constructed a decision analytic Markov model. We conducted separate analyses of hypothetical cohorts of patients with BE with dysplasia (HGD or low-grade [LGD]) and without dysplasia. In the analysis of the group with HGD, we compared results of initial RFA with endoscopic surveillance with surgery when cancer was detected. In analyzing the group with LGD or no dysplasia, we compared 3 strategies: endoscopic surveillance with surgery when cancer was detected (S1), endoscopic surveillance with RFA when HGD was detected (S2), and initial RFA followed by endoscopic surveillance (S3). RESULTS Among patients with HGD, initial RFA was more effective and less costly than endoscopic surveillance. Among patients with LGD, when S3 was compared with S2, the incremental cost-effectiveness ratio was $18,231/quality-adjusted life-year, assuming an annual rate of progression rate from LGD to EAC of 0.5%/year. For patients without dysplasia, S2 was more effective and less costly than S1. In a comparison of S3 with S2, the incremental cost-effectiveness ratios were $205,500, $124,796, and $118,338/quality-adjusted life-year using annual rates of progression of no dysplasia to EAC of 0.12%, 0.33%, or 0.5% per year, respectively. CONCLUSIONS By using updated data, initial RFA might not be cost effective for patients with BE without dysplasia, within the range of plausible rates of progression of BE to EAC, and be prohibitively expensive, from a policy perspective. RFA might be cost effective for confirmed and stable LGD. Initial RFA is more effective and less costly than endoscopic surveillance in HGD.
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Affiliation(s)
- Chin Hur
- Gastrointestinal Unit, Massachusetts General Hospital, Boston, Massachusetts; Institute for Technology Assessment, Massachusetts General Hospital, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts.
| | - Sung Eun Choi
- Institute for Technology Assessment, Massachusetts General Hospital, Boston, Massachusetts
| | - Joel H Rubenstein
- Division of Gastroenterology, University of Michigan Medical School, Ann Arbor, Michigan
| | - Chung Yin Kong
- Institute for Technology Assessment, Massachusetts General Hospital, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts
| | - Norman S Nishioka
- Gastrointestinal Unit, Massachusetts General Hospital, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts
| | - Dawn T Provenzale
- Durham VA Medical Center, Duke University Medical Center, Durham, North Carolina
| | - John M Inadomi
- Division of Gastroenterology, University of Washington School of Medicine, Seattle, Washington
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15
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Abstract
PURPOSE The purpose of the study is to evaluate the relationship between time trade off (TTO) and standard gamble (SG) estimates of health and vision utilities in a low vision patient sample. METHODS Telephone surveys were conducted on 74 low vision patients. All study participants were administered utility questionnaires that used the TTO and SG methods as they relate to health and vision. RESULTS There is high between-person variability in the relationship of TTO- to SG-estimated utilities for both vision and health. However, when transformed to logits, differences between TTO and SG utilities for health are equal to differences between TTO and SG utilities for vision. These differences are symmetrically distributed around the origin. The data were consistent with a model that includes both health or vision state and personal response criteria. The model explains between-person variability in the relationship of TTO to SG utilities as idiosyncratic differences within people between response criteria for making TTO and SG judgments. CONCLUSIONS The large between-person variability in the relation of utilities estimated from TTO to those estimated from SG can be explained by large between- and within-person variability in personal TTO and SG response criteria. However, within each person, the response criteria used to judge health state are the same as the response criteria used to judge vision state. This observation leads to the conclusion that health and vision states are in the same units when estimated from utilities. A meta-analysis of published studies that compared TTO with SG utilities for different health states confirms the conclusion of the model that average utilities across people are criterion-free estimates of average health-related states on a common logit scale.
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Caygill CPJ, Dvorak K, Triadafilopoulos G, Felix VN, Horwhat JD, Hwang JH, Upton MP, Li X, Nandurkar S, Gerson LB, Falk GW. Barrett's esophagus: surveillance and reversal. Ann N Y Acad Sci 2011; 1232:196-209. [PMID: 21950814 DOI: 10.1111/j.1749-6632.2011.06052.x] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/16/2023]
Abstract
The following on surveillance and reversal of Barrett's esophagus (BE) includes commentaries on criteria for surveillance even when squamous epithelium stains normally with a variety of biomarkers; the long-term follow-up of surgery versus endoscopic ablation of BE; the recommended surveillance intervals in patients without dysplasia; the sampling problems related to anatomic changes following fundoplication; the value of tissue spectroscopy and optical coherence tomography; the cost-effectiveness of biopsy protocols for surveillance; the quality of life of Barrett's patients; and risk stratification and surveillance strategies.
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Affiliation(s)
- Christine P J Caygill
- UK Barrett's Oesophagus Registry, UCL, Division of Surgery and Interventional Science, Royal Free and University College Medical School, London, United Kingdom
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17
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Gerson LB, Kahrilas PJ, Fass R. Insights into gastroesophageal reflux disease-associated dyspeptic symptoms. Clin Gastroenterol Hepatol 2011; 9:824-33. [PMID: 21699806 DOI: 10.1016/j.cgh.2011.05.015] [Citation(s) in RCA: 56] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/20/2011] [Revised: 04/28/2011] [Accepted: 05/11/2011] [Indexed: 12/13/2022]
Abstract
BACKGROUND & AIMS Patients with GERD frequently report dyspeptic-like symptoms, including nausea, vomiting, early satiety, bloating, and belching. The purpose of this review was to define the epidemiology and underlying mechanisms for dyspeptic symptoms in GERD patients. METHODS We performed a systematic literature review to identify the prevalence of dyspeptic symptoms in GERD patients. We identified 2057 studies, and 37 studies (2%) met the entry criteria, including 17 articles describing the prevalence of dyspeptic symptoms in GERD subjects, 7 studies describing mechanistic evaluation of dyspeptic symptoms in GERD, 7 studies describing questionnaires used to measure dyspeptic symptoms, and 6 studies assessing the role of proton pump inhibitor therapy for dyspeptic symptoms associated with GERD. We used an evidence-based approach to assess the literature. RESULTS The median (± standard deviation) prevalence of GERD in 30,384 subjects from 8 studies conducted in Western countries was 30% ± 8% (range, 20%-40%). Dyspeptic symptoms were present in 38% ± 14% (range, 21%-63%) and were more frequent in patients with frequent GERD symptoms, compared with patients with intermittent or no GERD symptoms [Evidence B]. Patients with nonerosive disease had a higher prevalence of dyspeptic symptoms [Evidence B] in addition to a lower response to proton pump inhibitor therapy [Evidence A], compared with patients with erosive esophagitis. Epigastic pain, belching, bloating, and early satiety demonstrated improvement on PPI therapy [Evidence A], compared with symptoms of nausea and vomiting that did not improve [Evidence A]. Patients with dyspepsia were at risk for a subsequent new diagnosis of GERD [Evidence B]. Dyspeptic symptoms contributed significantly to the decrement in health-related quality of life associated with GERD. CONCLUSIONS Dyspeptic symptoms are common in GERD patients and impact health-related quality of life.
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Affiliation(s)
- Lauren B Gerson
- Stanford University School of Medicine, Stanford, California, USA.
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18
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Endoscopy for upper GI cancer screening in the general population: a cost-utility analysis. Gastrointest Endosc 2011; 74:610-624.e2. [PMID: 21741639 DOI: 10.1016/j.gie.2011.05.001] [Citation(s) in RCA: 72] [Impact Index Per Article: 5.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/21/2011] [Accepted: 05/02/2011] [Indexed: 02/07/2023]
Abstract
BACKGROUND Colon cancer screening with colonoscopy is an accepted strategy; however, there are limited data regarding the cost-effectiveness of screening for upper GI cancers (esophageal adenocarcinoma with its premalignant precursor Barrett's esophagus, esophageal squamous cell cancer, gastric adenocarcinoma) in the United States. OBJECTIVE To evaluate the cost-effectiveness of screening the general population for upper GI cancers by performing an upper endoscopy at the time of screening colonoscopy. DESIGN Decision analysis. SETTING Third-party-payer perspective with a time horizon of 30 years or until death. PATIENTS This study involved 50-year-old patients already undergoing screening colonoscopy. INTERVENTION Comparison of two strategies: performing and not performing a screening upper endoscopy at the time of screening colonoscopy. MAIN OUTCOME MEASUREMENTS Incremental cost-effectiveness ratio (ICER). RESULTS One-time screening for the general population at the age of 50 for upper GI cancers required $115,664 per quality-adjusted life year (QALY) compared with no screening or surveillance. A strategy of screening and surveillance for Barrett's esophagus required only $95,559 per QALY saved. In 1-way sensitivity analyses, the prevalence rates of esophageal adenocarcinoma, esophageal squamous cell cancer, or gastric adenocarcinoma would have to increase by 654%, 1948%, and 337%, respectively, to generate an ICER of less than $50,000 per QALY. LIMITATIONS Omission of premalignant conditions for squamous cell cancer and gastric adenocarcinoma. CONCLUSION The ICER for screening the general population for upper GI cancers with endoscopy remains high, despite accounting for reduced endoscopy costs and the combined benefits of detecting early esophageal adenocarcinoma, esophageal squamous cell cancer, and gastric adenocarcinoma. However, the ICER compares favorably with commonly performed screening strategies for other cancers.
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19
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Miller SM, Goldstein JL, Gerson LB. Cost-effectiveness model of endoscopic biopsy for eosinophilic esophagitis in patients with refractory GERD. Am J Gastroenterol 2011; 106:1439-45. [PMID: 21448144 DOI: 10.1038/ajg.2011.94] [Citation(s) in RCA: 37] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
OBJECTIVES The population prevalence of eosinophilic esophagitis (EoE) is ~7% in adults. Current American Gastroenterology Association guidelines recommend endoscopic biopsy (Bx) in patients with symptoms of dysphagia. We conducted a cost-effectiveness model to determine if endoscopic Bx is cost effective in patients with refractory gastroesophageal reflux disease (GERD) without dysphagia. METHODS We designed a 5-year Markov model to compare costs and quality-adjusted life years for a cohort of 35-year-old patients with GERD refractory to proton pump inhibitor (PPI) therapy. We compared upper endoscopy (EGD) with and without Bx for EoE. We modeled that patients with EoE who did not undergo initial biopsy would wait 5 years until the diagnosis would be established via a second endoscopy with biopsy. RESULTS In patients with refractory GERD without dysphagia, endoscopic Bx for EoE was associated with an incremental cost-effectiveness ratio (ICER) of $51,420 per quality of life year (QALY). The upper endoscopy with biopsy arm cost $12,490 per patient and was associated with 4.080 QALYs, compared with EGD without Bx arm that cost $12,280 and was associated with 4.076 QALYs. The ICER was <$50,000 per QALY when the prevalence of EoE exceeded 8%, or the time of missed diagnosis was 6 years or greater. The biopsy arm was also cost effective if the QALY associated with symptomatic GERD was ≤0.93, cost of 3-month course of PPI therapy ≥$770 cost of fluticasone <$650, probability of EoE resolved on PPI ≤25%, symptom resolution on fluticasone ≥70%, cost endoscopy with biopsy ≤$520, or the cost of endoscopy without biopsy exceeded $300. CONCLUSIONS Upper endoscopy with Bx for EoE appears to be a cost-effective approach in patients when the prevalence of EoE is 8% or greater.
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Affiliation(s)
- Stephen M Miller
- Department of Medicine, Section of Digestive Diseases and Nutrition, University of Illinois at Chicago, Chicago, Illinois, USA
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20
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The gain in quality-adjusted life months by switching to esomeprazole in those with continued reflux symptoms in primary care: EncomPASS--a cluster-randomized trial. Am J Gastroenterol 2010; 105:2341-6. [PMID: 20842110 DOI: 10.1038/ajg.2010.368] [Citation(s) in RCA: 26] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
OBJECTIVES Proton pump inhibitors (PPIs) are effective in gastroesophageal reflux disease (GERD), but their cost effectiveness is unknown. This is usually determined by cost/quality-adjusted life year (QALY) gained, but whether PPI therapy improves QALYs has not been assessed in a randomized trial. The PPI acid suppression symptom (PASS) test is a five-item questionnaire that identifies patients with persistent acid-related symptoms. We evaluated whether a PASS test-based management strategy of changing GERD therapy to esomeprazole in those with continued symptoms on another PPI or H(2) receptor antagonist therapy would be cost effective. We expressed the data in terms of cost per quality-adjusted life months (QALM), as this was a 4-week trial. METHODS This is a multicenter, cluster-randomized, open-label study in primary care physician centers across Canada. Primary care physician centers were randomized to intervention or control arms. Patients on acid-suppressing medication were identified from primary care records and asked to complete the PASS test. PASS test failures at baseline assessment continued current therapy in control practices or switched to esomeprazole 20 or 40 mg daily (the dose was at the clinician's discretion) for 4 weeks in intervention practices. A planned secondary end point was QALM gain, measured using the validated Euroqol (EQ-5D) completed at baseline and 4 weeks. Medication use was also assessed by questionnaire. Canadian unit generic costs were applied to all GERD drugs, except to esomeprazole and lansoprazole, wherein proprietary costs were used (all costs in Canadian $). Data were analyzed using bootstrap sampling. RESULTS A total of 1,564 patients were recruited from 134 intervention sites and 92 control sites. Data were evaluable for 808 intervention and 445 control patients. The mean (±standard deviation) QALM at 4 weeks in the intervention group was 0.885±0.164 compared with 0.814±0.179 in the control group, resulting in a mean 0.071 (95% CI=0.091-0.051) QALM gain (P<0.0001). Esomeprazole was cost effective for PASS test failures, with a mean cost of $763 (95% CI=456-1,414) per QALM gain. CONCLUSIONS Esomeprazole was associated with a statistically significant gain in QALMs and was cost effective in primary care patients with persistent acid-related symptoms identified by the PASS test.
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21
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Barbiere JM, Lyratzopoulos G. Cost-effectiveness of endoscopic screening followed by surveillance for Barrett's esophagus: a review. Gastroenterology 2009; 137:1869-76. [PMID: 19840798 DOI: 10.1053/j.gastro.2009.10.011] [Citation(s) in RCA: 34] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/15/2023]
Abstract
Screening interventions for Barrett's esophagus (BE) are appealing, but there is little supporting evidence. We reviewed health economics studies about BE endoscopic screening followed by, as required, endoscopic surveillance ("screening and surveillance" hereafter) to help inform the design and conduct of future research. Health economics studies about BE screening and surveillance were identified using electronic database searches and personal contact with authors of identified studies. No studies examined general population screening. Five US studies published between 2003 and 2007 examined the cost effectiveness of screening and surveillance (against no intervention) in patients with chronic gastroesophageal reflux disease (GERD). There was no randomized trial evidence to inform model construction. Assumptions about prevalence and transition probabilities between BE histologic subtypes and about surveillance and treatment protocols varied substantially between studies. Parameters such as potential BE diagnosis-related reduction in quality of life or increase in health care use, diagnostic accuracy, and infrastructural costs (for quality assurance) were considered either "optimistically" or not at all. Only 2 studies considered endoscopic treatments. No study considered the recently introduced radiofrequency ablation technique, or the potential for biomarker-based risk stratification of surveillance interval or duration. Current health economics evidence is likely to have provided optimistic cost-effectiveness estimates and is not sufficient to support introduction of endoscopic BE screening programs among GERD patients. The evidence does not adequately incorporate novel (endoscopic) treatments and the potential for (clinical, endoscopic, or biomarker-based) risk stratification of surveillance. Future research should aim to encompass both these factors.
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Affiliation(s)
- Josephine M Barbiere
- Department of Public Health and Primary Care, School of Clinical Medicine, University of Cambridge, Cambridge, United Kingdom
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22
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Bytzer P. What makes individuals with gastroesophageal reflux disease dissatisfied with their treatment? Clin Gastroenterol Hepatol 2009; 7:816-22. [PMID: 19286478 DOI: 10.1016/j.cgh.2009.03.006] [Citation(s) in RCA: 26] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/02/2008] [Revised: 03/03/2009] [Accepted: 03/05/2009] [Indexed: 02/07/2023]
Abstract
BACKGROUND & AIMS Despite the efficacy of proton pump inhibitors (PPIs) as therapeutics for patients with gastroesophageal reflux disease (GERD) in randomized controlled trials, a number of studies have shown that a proportion of patients with GERD are not satisfied with their treatment. This article reviews the possible reasons why patients are dissatisfied with the way their disease is managed. METHODS Studies published between 1970 and 2007 were identified from PubMed, EMBASE, and the author's existing database. The 2708 publications were reviewed, and irrelevant ones were excluded. Eleven studies were found to be appropriate for use in this review. RESULTS Patients who are given prescriptions for PPIs tend to be more satisfied than those given H(2)-receptor antagonists. Partial responders are likely to be more dissatisfied than patients whose symptoms are fully resolved. A decrease in health-related quality of life is associated with greater dissatisfaction. Patients are more likely to be satisfied if they are taken seriously by their physician and if their symptoms are investigated. They are also more likely to be satisfied if the patient-physician consultation is interactive. CONCLUSIONS Patient satisfaction is a complex issue that depends on many factors. Patient satisfaction can be influenced by treatment regimen, general level of well-being, the bedside manner of the physician, and the quality of patient-physician communication. Improvements in recognition of GERD can improve management of the disease as well as patient satisfaction with their care and treatment.
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Affiliation(s)
- Peter Bytzer
- Department of Medical Gastroenterology, Køge University Hospital, University of Copenhagen, Copenhagen, Denmark
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Inadomi JM, Somsouk M, Madanick RD, Thomas JP, Shaheen NJ. A cost-utility analysis of ablative therapy for Barrett's esophagus. Gastroenterology 2009; 136:2101-2114.e1-6. [PMID: 19272389 PMCID: PMC2693449 DOI: 10.1053/j.gastro.2009.02.062] [Citation(s) in RCA: 143] [Impact Index Per Article: 8.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/13/2008] [Revised: 02/17/2009] [Accepted: 02/20/2009] [Indexed: 12/11/2022]
Abstract
BACKGROUND & AIMS Recommendations for patients with Barrett's esophagus (BE) include endoscopic surveillance with esophagectomy for early-stage cancer, although new technologies to ablate dysplasia and metaplasia are available. This study compares the cost utility of ablation with that of endoscopic surveillance strategies. METHODS A decision analysis model was created to examine a population of patients with BE (mean age 50), with separate analyses for patients with no dysplasia, low-grade dysplasia (LGD), or high-grade dysplasia (HGD). Strategies compared were no endoscopic surveillance; endoscopic surveillance with ablation for incident dysplasia; immediate ablation followed by endoscopic surveillance in all patients or limited to patients in whom metaplasia persisted; and esophagectomy. Ablation modalities modeled included radiofrequency, argon plasma coagulation, multipolar electrocoagulation, and photodynamic therapy. RESULTS Endoscopic ablation for patients with HGD could increase life expectancy by 3 quality-adjusted years at an incremental cost of <$6,000 compared with no intervention. Patients with LGD or no dysplasia can also be optimally managed with ablation, but continued surveillance after eradication of metaplasia is expensive. If ablation permanently eradicates >or=28% of LGD or 40% of nondysplastic metaplasia, ablation would be preferred to surveillance. CONCLUSIONS Endoscopic ablation could be the preferred strategy for managing patients with BE with HGD. Ablation might also be preferred in subjects with LGD or no dysplasia, but the cost effectiveness depends on the long-term effectiveness of ablation and whether surveillance endoscopy can be discontinued after successful ablation. As further postablation data become available, the optimal management strategy will be clarified.
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Affiliation(s)
- John M Inadomi
- Division of Gastroenterology, San Francisco General Hospital, San Francisco, California 94110, USA.
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24
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Crockett SD, Lippmann QK, Dellon ES, Shaheen NJ. Health-related quality of life in patients with Barrett's esophagus: a systematic review. Clin Gastroenterol Hepatol 2009; 7:613-23. [PMID: 19281858 PMCID: PMC2693470 DOI: 10.1016/j.cgh.2009.02.024] [Citation(s) in RCA: 52] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/12/2008] [Revised: 02/19/2009] [Accepted: 02/20/2009] [Indexed: 02/07/2023]
Abstract
BACKGROUND & AIMS Barrett's esophagus (BE) affects approximately 10% of patients with chronic gastroesophageal reflux disease (GERD). Patients with BE are at risk for reduced health-related quality of life (HRQoL) associated with GERD, in addition to the potential psychosocial stress of carrying a diagnosis of a premalignant condition with a risk of esophageal adenocarcinoma. We sought to systematically review the published literature on HRQoL of patients with BE. METHODS We searched PubMed, PsycINFO, and Cumulative Index to Nursing and Allied Health Literature for relevant clinical trials using a defined search strategy. We also manually searched relevant scientific meeting abstracts and related article bibliographies. Eligible articles were case series, cohort studies, or clinical trials that included one or more measures of HRQoL and/or quantitatively assessed burden of disease in patients with BE. Effect sizes were calculated when possible. RESULTS Our initial search identified 95 articles. After 2 physician reviews, 25 articles met inclusion criteria. Data show that BE is associated with a significant decrement in HRQoL as measured by both generic and disease-targeted instruments. In addition, patients with BE are at risk for psychological consequences such as depression, anxiety, and stress, which may be related to their increased risk of esophageal adenocarcinoma. Compared with subjects with GERD alone or the general population, a diagnosis of BE also leads to increased health care use and spending. CONCLUSIONS BE compromises multiple facets of patients' quality of life. Physicians and researchers should incorporate patient-reported outcomes data including HRQoL measures when treating or studying patients with BE.
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Affiliation(s)
- Seth D Crockett
- Center for Esophageal Diseases and Swallowing, Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina, Chapel Hill, Chapel Hill, North Carolina 27599-7080, USA.
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25
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Abstract
BACKGROUND Gastro-oesophageal reflux disease (GORD) is a common problem in the community, and many patients do not seek medical attention despite potential morbidity and the availability of effective therapeutic interventions. The factors which determine healthcare seeking in GORD are not well understood. AIM To examine the symptom experience and health and illness beliefs in people with GORD, who had either been diagnosed with the condition, or were dealing with the symptoms themselves. METHODS A total of 12 focus groups and 65 face-to-face interviews were conducted in the USA, UK, France and Germany, and involved 164 participants, who had either been diagnosed with GORD or were identified as having GORD in the community, using a random digit dialling telephone method. Transcripts of focus groups and interviews were analysed thematically, using a constant comparative approach, to identify key factors associated with healthcare seeking. RESULTS Patients' descriptions of GORD symptoms were often vivid, with the use of unexpected imagery and unusual beliefs about causality. We were able to identify four factors associated with healthcare seeking for GORD which were: the characteristics of symptoms (intensity and control), the perceived seriousness of symptoms, interference by symptoms with daily life and views about medicines and the medical profession. CONCLUSION Patients with GORD, using both self care and formal medical care, have a surprising range of ideas about the causes and best treatments of their symptoms. Physicians' awareness of these beliefs, coupled with an understanding of the factors associated with healthcare seeking for GORD, is likely to be important in enhancing clinical management and in patient and public education.
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Gonzalez JL, Sadowski DC, Mintchev MP. Friction-assisted magnetic holding of an ingestible capsule for esophageal pH and impedance monitoring. CONFERENCE PROCEEDINGS : ... ANNUAL INTERNATIONAL CONFERENCE OF THE IEEE ENGINEERING IN MEDICINE AND BIOLOGY SOCIETY. IEEE ENGINEERING IN MEDICINE AND BIOLOGY SOCIETY. ANNUAL CONFERENCE 2007; 2006:5944-7. [PMID: 17945922 DOI: 10.1109/iembs.2006.260543] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/09/2022]
Abstract
24-hour catheter-based ambulatory pH and impedance monitoring is an essential tool for diagnosing esophageal disorders. However, catheter-based monitoring systems are uncomfortable and interfere with normal activities of the patient. To overcome these disadvantages, different wireless monitoring systems have been proposed. However, efficient ways to position and hold wireless capsules are lacking. Currently there is a need to develop safe and reliable methods to hold an esophageal wireless monitoring system in position for 24 hours. Friction-assisted magnetic holding is proposed as an alternative to conventional holding techniques. Permanent magnet and electromagnet designs with the required characteristics to achieve this task were computer-designed and simulated. The size and power requirements of the magnets were considered. Simulation results were verified using laboratory experiments. Permanent neodymium magnets offered the best performance for the intended application. The obtained results show the feasibility of friction-assisted magnetic holding for esophageal monitoring. Improvements to the thread design, friction enhancing pins, magnetic shielding and encapsulation methods are necessary for in vivo testing.
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Kuppermann M, Learman LA, Schembri M, Gregorich S, Jacoby A, Jackson RA, Gates E, Wassel-Fyr C, Lewis J, Washington AE. Effect of Noncancerous Pelvic Problems on Health-Related Quality of Life and Sexual Functioning. Obstet Gynecol 2007; 110:633-42. [PMID: 17766611 DOI: 10.1097/01.aog.0000279153.56275.b5] [Citation(s) in RCA: 37] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
OBJECTIVE To assess the effect of abnormal uterine bleeding and pelvic pain and pressure on health-related quality of life and sexual functioning and assess treatment satisfaction. METHODS This is a cross-sectional study of 1,493 sociodemographically diverse women who were seeking care for noncancerous pelvic problems and who had not undergone hysterectomy. Participants were asked about symptoms, attitudes, health-related quality of life, sexual functioning, and treatment satisfaction. Preference for current health was measured using the time tradeoff metric, which asked respondents to estimate the number of years of life they would be willing to trade off to not have a uterine condition. Multivariable logistic regression was used to identify determinants of treatment satisfaction. RESULTS Most (82.7%) participants reported a complete lack of or only partial symptom resolution, and 42.3% reported that their pelvic problems interfered with their ability to have and enjoy sex. Mean Short Form-12 Physical (43-49) and Mental (41-44) Component Summary scores were substantially lower than population norms for women aged 40-49 years. Mean current health time tradeoff scores ranged from 0.78 to 0.88. Satisfaction with Western medicines ranged from 31.3% (progestin intrauterine device) to 58.2% (opiates) and with uterine-preserving surgery from 20.0% (dilation and curettage) to 51.0% (myomectomy); 27.7 % of the women who used acupuncture were satisfied. Participants with lower educational attainment, greater symptom resolution, and less interference of pelvic problems with sex were more likely to be satisfied. CONCLUSION Noncancerous pelvic problems are associated with serious decrements in health-related quality of life and sexual functioning and low rates of treatment satisfaction. LEVEL OF EVIDENCE II.
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Affiliation(s)
- Miriam Kuppermann
- Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco, California 94143-0856, USA.
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Abstract
Today, there are several modalities to treat gastroesophageal reflux disease (GERD) (medications, endoscopic therapies, surgery) and such therapies can be used either singly, or in tandem, or in combination with the others, aiming at "normalization" of the patient's GERD-related quality of life and, if possible, esophageal acid exposure. Several intermediate end points or clinically significant outcomes have not been reached by some therapeutic modalities and no single modality is or can be perfect. Statistically significant improvements in these intermediate end points have been shown in "some" but not all studies. Although healing of esophagitis can be accomplished with either medical or surgical therapy, there is inadequate data with endotherapies, because most patients treated with endotherapies have had prior trials of proton pump inhibitors (PPIs) and hence healed their esophagitis. Effective prevention of complications, such as esophageal adenocarcinoma, remains challenging for all modalities. Patients who have not normalized their GERD-related quality of life with once or twice daily PPI therapy should undergo functional esophageal evaluation with pH testing and esophageal motility study and they should be evaluated by both an endoscopist and a surgeon. The decision on how to proceed should be made on the basis of the criteria for endotherapy and surgery, availability of local endoscopic and surgical expertise and patients' preference. Such multimodality therapy model is in many ways similar to the long-term management of coronary artery disease where pharmacotherapy, angioplasty, and bypass surgery are frequently used in tandem or in combination. Multimodality therapy aiming at normalization of GERD-related quality of life is an option today, and should be available to all patients in need of therapy. The target population for GERD endotherapy currently consists of PPI-dependent GERD patients, who have a small (<2-cm-long) or no sliding hiatal hernia, and without severe esophagitis or Barrett esophagus. Thus far, only Stretta and the NDO plicator have been studied in sham-controlled trials. Registries of complications suggest that these techniques are relatively safe, but serious morbidity, including rare mortality have been reported (for a continuous update on complications related to endoscopic therapies see: http://www.fda.gov/cdrh/maude.html). All can be performed on an outpatient basis, under intravenous sedation and local pharyngeal anesthesia. Future comparative studies with predetermined clinically significant end points, validated outcome measures, prolonged follow-up, and complete complication registries will eventually determine the precise role of endoscopic procedures for the patients with GERD.
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Affiliation(s)
- George Triadafilopoulos
- Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Stanford, CA 94305-5187, USA.
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Dellon ES, Shaheen NJ. Barrett's esophagus and the costs of "doing something". Gastrointest Endosc 2007; 65:31-5. [PMID: 17185077 DOI: 10.1016/j.gie.2006.07.015] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/05/2006] [Accepted: 07/17/2006] [Indexed: 12/10/2022]
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Gerson LB, Ullah N, Hastie T, Goldstein MK. Does cancer risk affect health-related quality of life in patients with Barrett's esophagus? Gastrointest Endosc 2007; 65:16-25. [PMID: 17185075 DOI: 10.1016/j.gie.2006.05.018] [Citation(s) in RCA: 33] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/27/2005] [Accepted: 05/22/2006] [Indexed: 02/08/2023]
Abstract
BACKGROUND Health-related quality of life is decreased in patients with GERD and Barrett's esophagus (BE). OBJECTIVE To determine whether time-tradeoff (TTO) values would differ in patients with BE when patients were asked to trade away the potential risk of esophageal adenocarcinoma rather than chronic heartburn symptoms. DESIGN A prospective clinical trial. PATIENTS Subjects with biopsy-proven BE. INTERVENTIONS Custom-designed computer program to elicit health-state utility values, quality of life in reflux and dyspepsia (QOLRAD), and Medical Outcomes Survey short form-36 surveys. MAIN OUTCOME MEASUREMENTS TTO utility values for the annual cancer-risk-associated current health state and for hypothetical scenarios of dysplasia and esophageal cancer. RESULTS We studied 60 patients in the cancer-risk cohort (57 men, 92% veteran; mean age [standard deviation; SD], 65 years [11 years], mean GERD duration 17 years [12 years]). The heartburn cohort included 40 patients with GERD and BE with TTO values derived for GERD symptoms. The mean (SD) utility for nondysplastic BE was 0.91 (0.13) compared with 0.90 (0.12) for the heartburn cohort (P = .7). The mean utility values were significantly lower for scenarios of low-grade dysplasia (0.85 [0.12], P = .02) and high-grade dysplasia (0.77 [0.14], P < .005). The mean TTO was 0.67 (0.19) for the scenario of esophageal cancer. There was no correlation between the utility scores and the disease-specific survey scores. LIMITATIONS TTO values were hypothetical for states of dysplasia and cancer. CONCLUSIONS TTO utility values based on heartburn symptoms or annual risk of cancer in patients with nondysplastic BE are roughly equivalent. However, TTO utility values are significantly lower for health states with increasing cancer risks.
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Affiliation(s)
- Lauren B Gerson
- Division of Gastroenterology and Hepatology, Stanford University, Stanford, California 94305-5202, USA
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Stein K, Dyer M, Crabb T, Milne R, Round A, Ratcliffe J, Brazier J. A pilot Internet "value of health" panel: recruitment, participation and compliance. Health Qual Life Outcomes 2006; 4:90. [PMID: 17129380 PMCID: PMC1716763 DOI: 10.1186/1477-7525-4-90] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/04/2006] [Accepted: 11/27/2006] [Indexed: 11/10/2022] Open
Abstract
OBJECTIVES To pilot using a panel of members of the public to provide preference data via the Internet METHODS A stratified random sample of members of the general public was recruited and familiarized with the standard gamble procedure using an Internet based tool. Health states were periodically presented in "sets" corresponding to different conditions, during the study. The following were described: Recruitment (proportion of people approached who were trained); Participation (a) the proportion of people trained who provided any preferences and (b) the proportion of panel members who contributed to each "set" of values; and Compliance (the proportion, per participant, of preference tasks which were completed). The influence of covariates on these outcomes was investigated using univariate and multivariate analyses. RESULTS A panel of 112 people was recruited. 23% of those approached (n = 5,320) responded to the invitation, and 24% of respondents (n = 1,215) were willing to participate (net = 5.5%). However, eventual recruitment rates, following training, were low (2.1% of those approached). Recruitment from areas of high socioeconomic deprivation and among ethnic minority communities was low. Eighteen sets of health state descriptions were considered over 14 months. 74% of panel members carried out at least one valuation task. People from areas of higher socioeconomic deprivation and unmarried people were less likely to participate. An average of 41% of panel members expressed preferences on each set of descriptions. Compliance ranged from 3% to 100%. CONCLUSION It is feasible to establish a panel of members of the general public to express preferences on a wide range of health state descriptions using the Internet, although differential recruitment and attrition are important challenges. Particular attention to recruitment and retention in areas of high socioeconomic deprivation and among ethnic minority communities is necessary. Nevertheless, the panel approach to preference measurement using the Internet offers the potential to provide specific utility data in a responsive manner for use in economic evaluations and to address some of the outstanding methodological uncertainties in this field.
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Affiliation(s)
- Ken Stein
- Peninsula Technology Assessment Group, Peninsula Medical School, University of Exeter, Noy Scott House, Barrack Road, Exeter, EX2 5DW, UK
| | - Matthew Dyer
- Peninsula Technology Assessment Group, Peninsula Medical School, University of Exeter, Noy Scott House, Barrack Road, Exeter, EX2 5DW, UK
| | - Tania Crabb
- Peninsula Technology Assessment Group, Peninsula Medical School, University of Exeter, Noy Scott House, Barrack Road, Exeter, EX2 5DW, UK
| | - Ruairidh Milne
- National Coordinating Centre for Health Technology Assessment, University of Southampton, Boldrewood, Bassett Crescent East, Southampton, SO16 7PX, UK
| | - Alison Round
- Peninsula Technology Assessment Group, Peninsula Medical School, University of Exeter, Noy Scott House, Barrack Road, Exeter, EX2 5DW, UK
| | - Julie Ratcliffe
- Sheffield Health Economics Group, School of Health and Related Research (ScHARR), University of Sheffield, 30 Regent Court, Sheffield, S1 4DA, UK
| | - John Brazier
- Sheffield Health Economics Group, School of Health and Related Research (ScHARR), University of Sheffield, 30 Regent Court, Sheffield, S1 4DA, UK
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Hur C, Wittenberg E, Nishioka NS, Gazelle GS. Quality of life in patients with various Barrett's esophagus associated health states. Health Qual Life Outcomes 2006; 4:45. [PMID: 16884539 PMCID: PMC1559597 DOI: 10.1186/1477-7525-4-45] [Citation(s) in RCA: 17] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/01/2006] [Accepted: 08/02/2006] [Indexed: 02/07/2023] Open
Abstract
Background The management of Barrett's esophagus (BE), particularly high grade dysplasia (HGD), is an area of much debate and controversy. Surgical esophagectomy, intensive endoscopic surveillance and mucosal ablative techniques, especially photodynamic therapy (PDT), have been proposed as possible management strategies. The purpose of this study was to determine the health related quality of life associated with Barrett's esophagus and many of the pivotal health states associated with Barrett's HGD management. Methods 20 patients with Barrett's esophagus were enrolled in a pilot survey study at a large urban hospital. The utility of Barrett's esophagus without dysplasia (current health state) as well as various health states associated with HGD management (hypothetical states as the subject did not have HGD) were measured using a validated health utility instrument (Paper Standard Gamble). These specific health states were chosen for the study because they are considered pivotal in Barrett's HGD decision making. Information regarding Barrett's HGD was presented to the subject in a standardized format that was designed to be easily comprehendible. Results The average utility scores (0–1 with 0 = death and 1 = perfect health) for the various Barrett's esophagus associated states were: BE without dysplasia-0.95; Post-esophagectomy for HGD with dysphagia-0.92; Post-PDT for HGD with recurrence uncertainty-0.93; Post-PDT for HGD with recurrence uncertainty and dysphagia-0.91; Intensive endoscopic surveillance for HGD-0.90. Conclusion We present the scores for utilities associated with Barrett's esophagus as well as various states associated with the management of HGD. The results of our study may be useful in advising patients and providers regarding expected outcomes of the various HGD management strategies as well as providing utility scores for future cost-effectiveness analyses.
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Affiliation(s)
- Chin Hur
- Gastrointestinal Unit, Massachusetts General Hospital, Boston, MA, USA
- Institute for Technology Assessment, Massachusetts General Hospital, Boston, MA, USA
| | - Eve Wittenberg
- Institute for Technology Assessment, Massachusetts General Hospital, Boston, MA, USA
| | - Norman S Nishioka
- Gastrointestinal Unit, Massachusetts General Hospital, Boston, MA, USA
| | - G Scott Gazelle
- Institute for Technology Assessment, Massachusetts General Hospital, Boston, MA, USA
- Department of Health Policy and Management (GSG), Harvard School of Public Health, Boston, MA, USA
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34
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Abstract
BACKGROUND Diagnosing a potentially life-threatening disease may adversely affect patient quality of life (QOL) independent of biologic effects. It is unknown whether the mere diagnosis of Barrett's esophagus (BE) adversely impacts patients' preferences (health-state utility) sufficiently to impair the cost-effectiveness of endoscopic screening for esophageal adenocarcinoma. GOAL To calculate the threshold impact on utility incurred by diagnosing BE that would allow screening to remain cost-effective. STUDY A Markov model was developed to examine strategies of no screening, and screening with surveillance of BE. Patients were 50-year-old white men with symptoms of gastroesophageal reflux followed until 80 years of age or death. The primary outcomes were the threshold decrements in utility incurred by diagnosing BE based on willingness to pay (WTP) of dollar 50,000 and dollar 100,000 per quality-adjusted life-year (QALY) gained. RESULTS For a WTP of dollar 50,000/QALY, the decrement in utility could be as great as 9%, meaning that screening is cost-effective as long as diagnosing BE does not impair QOL by more than 9%. For a WTP of dollar 100,000, the decrement could be as great as 10.5%. CONCLUSIONS The decrement in utility caused by diagnosing BE may be substantial without compromising the cost-effectiveness of endoscopic screening.
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Affiliation(s)
- Joel H Rubenstein
- Division of Gastroenterology, University of Michigan Health System and Ann Arbor Veterans Affairs Medical Center, Ann Arbor, MI 48105, USA.
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Fajardo NR, Wise JL, Locke GR, Murray JA, Talley NJ. Esophageal perforation after placement of wireless Bravo pH probe. Gastrointest Endosc 2006; 63:184-5. [PMID: 16377347 DOI: 10.1016/j.gie.2005.07.035] [Citation(s) in RCA: 25] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/21/2005] [Accepted: 07/20/2005] [Indexed: 02/08/2023]
Affiliation(s)
- Noel R Fajardo
- Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, Minnesota 55905, USA
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36
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Abstract
Gastroenterologists mainly deal with chronic organic and functional illnesses that are not life threatening but can be expensive to treat. How this compares with the management of other diseases that cause significant mortality is an important question to answer if health-care resources are to be allocated appropriately. Comparing health care in terms of cost per quality adjusted life year (QALY) gained is one approach to this problem although there are concerns about whose values should be elicited and how QALYs are measured.
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