A Decision Analysis of Observation vs Immediate Reintervention for Asymptomatic Residual Fragments Less than 4 mm Following Ureteroscopic Lithotripsy
Michal UrsinyAlan YaghoubianMitchell R. HumphreysHilary BrotherhoodBenjamin ChewManoj MongaAmy E. KrambeckCameron CharchenkoAn Qi WangRoger L. SurNicole L. MillerTracy MarienYui-Hui H. ChangBodo E. KnudsenDirk LangeCourtney YongBrian R. MatlagaOjas ShahVernon M. PaisMichael E. LipkinBrian H. Eisner
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We performed a decision analysis model of the cost-effectiveness of observation vs intervention for asymptomatic residual fragments less than 4 mm in diameter following ureteroscopic holmium laser lithotripsy.Outcomes data from a retrospective analysis evaluating the natural history, complications and reintervention rates of asymptomatic residual stone fragments performed by the EDGE (Endourology Disease Group for Excellence) Research Consortium were used. A decision analysis model was constructed to compare the cost-effectiveness of initial observation of residual fragments to immediate intervention. Cost of observation included emergency room visits, hospitalizations and reinterventions. The cost analysis model extended to 3 years to account for delayed reintervention rates for fragments less than 4 mm. Costs of emergency department visits, readmissions and reinterventions were calculated based on published figures from the literature.Decision analysis modeling demonstrated that when comparing initial observation to immediate reintervention, the cost was $2,183 vs $4,424. The difference in cost was largely driven by the fact that over 3 years, approximately 55% of all patients remained asymptomatic and did not incur additional costs. This represents an approximate annual per patient savings of $747, and $2,241 over 3 years when observation is selected over immediate reintervention.Our decision analysis model demonstrates superior cost-effectiveness for observation over immediate reintervention for asymptomatic residual stones less than 4 mm following ureteroscopic lithotripsy. Based on these findings careful stratification and selection of patients may enable surgeons to improve cost-effectiveness of managing small, asymptomatic residual fragments following ureteroscopic lithotripsy.Keywords:
Watchful waiting
Economic evaluation in the form of reports of cost-effectiveness of the treatment and prevention of disease has only recently found widespread application in the visual sciences. While economic evaluation takes a number of forms: cost-minimization analysis, cost-benefit analysis, and cost-effectiveness analysis--it is the latter that is seen most often in the evaluation of vision-related health programs. Cost-effectiveness analysis is in particular seen most commonly in its very particular form of cost-utility analysis. Decision analysis is the analytic method most commonly used to perform cost-effectiveness analysis. In decision analysis, the expected cost and effectiveness of a health program are estimated in a rigorous fashion. In this report, we take the reader through the process of decision analysis including building the tree; populating the model with parameters for risk, cost and benefit; estimating expected cost and benefit; and deterministic and probabilistic sensitivity analysis. Examples employed include prominent studies of the cost-effectiveness of photodynamic therapy for treatment of neovascular macular degeneration and the treatment ocular hypertension to prevent glaucoma.
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This article is a call for increased use of real-world evidence in health technology assessment and related policy and decision making. There is currently a disconnect between evidence used to guide regulatory approval of therapies and evidence used to inform therapeutic coverage and reimbursement decisions. Public and private payers need to understand not only whether an intervention works but also whether it offers good value compared with licensed alternatives (not placebo) as they are used in the real-world practice and population (not in a controlled trial environment). Addressing such concerns requires evidence to be drawn from a wide range of study designs, but with consideration and weighting given to their relative strengths and weaknesses, as well as their position on the pragmatic-explanatory (i.e., effectiveness-efficacy) continuum. The potential impact of using different types of evidence to inform cost-effectiveness analysis (CEA) is discussed for omalizumab, comparing and contrasting a CEA model informed by an omalizumab efficacy trial to a CEA model drawing primarily on evidence from effectiveness observational studies of omalizumab. There was reasonable agreement between the two omalizumab CEA models, although the incremental cost-effectiveness ratio generated by the effectiveness observational study-driven model was more favorable for omalizumab. Health technology assessment bodies and payers must use their judgment to determine which components of efficacy-based and effectiveness-based CEA evidence are most closely aligned with their goals. For each CEA evidence component, perhaps the two E's form bounds of the truth as well as a fuller picture of the uncertainty surrounding the truth.
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Clinical decisions must be made, often under circumstances of uncertainty and limited resources. Decision analysis and cost-effectiveness analysis are methodologic tools that allow for quantitative analysis and the optimization of decision-making. These methods can be useful for decisions regarding individual patient evaluation and treatment options or in formulating healthcare policy. We overview the methodology of expected value decision analysis and of cost-effectiveness analysis, including cost-identification, cost-effectiveness, cost-benefit, and cost-utility analyses. Examples are provided of these methods and a user's guide to cost-effectiveness analysis is outlined.
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In this primer, the reader is introduced to the concepts governing decision analysis and cost-effectiveness analysis. The construction of decision trees and Markov models is presented to provide the necessary background to critique research articles in published literature. Specific sub-topics related to cost-effectiveness analysis are discussed including quality adjustment and utilities (patient preferences for health states), discounting, and sensitivity analysis including Monte Carlo simulation. Evidence based methods to critique decision and cost-effectiveness analysis are provided, and limitations to these analytic methods are examined. In summary, the major functions of decision analysis and cost-effectiveness analysis are to provide: (1) a quantitative summary of existing data, and (2) hypothesis generation for further research.
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Abstract Background In a stable, inotrope‐dependent pediatric patient with dilated cardiomyopathy, we evaluated the cost‐effectiveness of continuous‐flow VAD implantation compared to a watchful waiting approach using chronic inotropic therapy. Methods We used a state‐transition model to estimate the costs and outcomes of 14‐year‐old (INTERMACS profile 3) patients receiving either VAD or watchful waiting. We measured benefits in terms of lifetime QALYs gained. Model inputs were taken from the literature. We calculated the ICER, or the cost per additional QALY gained, of VADs and performed multiple sensitivity analyses to test how our assumptions influenced the results. Results Compared to watchful waiting, VADs produce 0.97 more QALYs for an additional $156 639, leading to an ICER of $162 123 per QALY gained from a healthcare perspective. VADs have 17% chance of being cost‐effective given a cost‐effectiveness threshold of $100 000 per QALY gained. Sensitivity analyses suggest that VADs can be cost‐effective if the costs of implantation decrease or if hospitalization costs or mortality among watchful waiting patients is higher. Conclusions As a bridge to transplant, VADs provide a health benefit to children who develop stable, inotrope‐dependent heart failure, but immediate implantation is not yet a cost‐effective strategy compared to watchful waiting based on commonly used cost‐effectiveness thresholds. Early VAD support can be cost‐effective in sicker patients and if device implantation is cheaper. In complex conditions such as pediatric heart failure, cost‐effectiveness should be just one of many factors that inform clinical decision‐making.
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ObjectiveTo compare costs and effectiveness of three strategies used against cervical cancer (CC) and genital warts: (i) Screening for CC; (ii) Bivalent Human Papillomavirus (HPV) 16/18 vaccine added to screening; (iii) Quadrivalent HPV 6/11/16/18 vaccine added to screening. MethodsA Markov model was designed in order to simulate the natural history of the disease from 12 years of age (vaccination) until death. Transition probabilities were selected or adjusted to match the HPV infection profile in Colombia. A systematic review was undertaken in order to derive efficacy values for the two vaccines as well as for the operational characteristics of the cytology test. The societal perspective was used. Effectiveness was measured in number of averted Disability Adjusted Life Years (DALYS). ResultsAt commercial prices reported for 2010 the two vaccines were shown to be non-cost-effective alternatives when compared with the existing screening strategy. Sensitivity analyses showed that results are affected by the cost of vaccines and their efficacy values, making it difficult to determine with certainty which of the two vaccines has the best cost-effectiveness profile. To be 'cost-effective' vaccines should cost between 141 and 147 USD (Unite States Dollars) per vaccinated girl at the most. But at lower prices such as those recommended by WHO or the price of other vaccines in Colombia, HPV vaccination could be considered very cost-effective. ConclusionsHPV vaccination could be a convenient alternative for the prevention of CC in Colombia. However, the price of the vaccine should be lower for this vaccination strategy to be cost-effective. It is also important to take into consideration the willingness to pay, budgetary impact, and program implications, in order to determine the relevance of a vaccination program in this country, as well as which vaccine should be selected for use in the program.
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The purpose of this study was to conduct a cost effectiveness analysis of strategies designed to improve national cervical cancer screening rates, along with a distributional cost effectiveness analysis that considers regional disparities.
Incremental cost-effectiveness ratio
Cancer screening
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