Ignoring study design heterogeneity in meta-analyses.
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Atrial Fibrillation↗
Biomedical subjects
J Jaime Caro
Publications and source records attributed to J Jaime Caro.
Cost-effectiveness of cardiac resynchronization therapy.
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Cardiac Pacing, Artificial↗
The time course of subsequent hospitalizations and associated costs in survivors of an ischemic stroke in Canada.
BACKGROUND: Documentation of the hospitalizations rates following a stroke provides the inputs required for planning health services and to evaluate the economic efficiency of any new therapies. METHODS: Hospitalization rates by cause were examined using administrative data on 18,695 patients diagnosed with ischemic stroke (first or subsequent, excluding transient ischemic attack) in Saskatchewan, Canada between 1990 and 1995. Medical history was available retrospectively to January 1980 and follow-up was complete to March 2000. Analyses evaluated the rate and timing of all-cause and cardiovascular hospitalizations within discrete periods in the five years following the index stroke. Cardiovascular hospitalizations included patients with a primary diagnosis of ischemic stroke, transient ischemic attack, myocardial infarction, stable or unstable angina, heart failure or peripheral arterial disease. RESULTS: One-third (36%) of patients were identified by a hospitalized stroke. Mean age was 70.5 years, 48.0% were male, half had a history of stroke or a transient ischemic attack at the time of their index stroke. Three-quarters of the patients (72.7%) were hospitalized at least once during a mean follow-up of 4.6 years, accruing CAD $24 million in the first year alone. Of all hospitalizations, 20.4% were related to cardiovascular disease and 1.6% to bleeds. In the month following index stroke, 12.5% were admitted, an average of 1.04 times per patient hospitalized. Strokes accounted for 33% of all hospitalizations in the first month. The rate diminished steadily throughout the year and stabilized in the second year when approximately one-third of patients required hospitalization, at a rate of about one hospitalization for every two patient-years. Mean lengths of stay ranged from nine days to nearly 40 days. Close-fitting Weibull functions allow highly specific probability estimates. Other cardiovascular risk factors significantly increased hospitalization rates. CONCLUSION: After stroke, there are frequent hospitalizations accounting for substantial additional costs. Though these rates drop after one year, they remain high over time. The number of other cardiovascular causes of hospitalization confirms that stroke is a manifestation of disseminated atherothrombotic disease.
Aged↗
Recommendations for evaluating compliance and persistence with hypertension therapy using retrospective data.
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Behavioral Research↗
Modelling the economic and health consequences of cardiac resynchronization therapy in the UK.
OBJECTIVE: Clinical evidence supports the use of cardiac resynchronization therapy (CRT) in advanced heart failure, but its cost-effectiveness is still unclear. This analysis assessed the economic and health consequences in the UK of implanting a CRT in patients with NYHA class III-IV heart failure. METHODS: A discrete event simulation of heart failure was used to compare the course over 5 years of 1000 identical pairs of patients -- one receiving both CRT and optimum pharmacologic treatment (OPT), the other OPT alone. All inputs were obtained from the data collected in the CArdiac REsynchronization in Heart Failure (CARE-HF) trial and a hospital in the UK. Direct medical costs (in 2004 pound) from the perspective of the National Health Service were considered. Both costs and benefits were discounted at 3.5%. Sensitivity analyses addressed all model inputs and multivariate analyses were performed by varying key parameters simultaneously. RESULTS: The model predicted 471 deaths and 2263 hospitalizations over 5 years with OPT alone and 348 deaths and 1764 hospitalizations with CRT, equivalent to a 26% reduction in mortality and 22% in hospitalizations, at a discounted cost of pound 11,423 per patient with CRT vs. pound 4,900 with OPT alone. CRT was predicted to increase quality-adjusted survival by 0.43 QALYs per patient, resulting in an incremental cost-effectiveness ratio of pound 15,247 per QALY gained (range: pound 12,531- pound 23,184). Sensitivity analyses revealed that this outcome was most sensitive to time horizon and cost of implantation. CONCLUSION: Based on these 5-year analyses, CRT is expected to yield substantial health benefits at a reasonable cost.
Cardiac Pacing, Artificial↗
Economic implications of growth hormone use in patients with short bowel syndrome.
OBJECTIVE: Short bowel syndrome is a rare, life-threatening condition that can result in nutritional malabsorption. Parenteral nutrition provides life-saving support but can lead to complications and affect quality of life. Recombinant human growth hormone, somatropin (rDNA origin), has been shown to significantly reduce dependence on nutritional support (p < 0.05). This study evaluates the economic impact of somatropin use in the management of short bowel syndrome. METHODS: A discrete event simulation (DES) model was developed to estimate the benefits and costs associated with somatropin use. Risks of treatment complications and of disease-related events were modeled in identical patient pairs--one receiving parenteral nutrition alone, the other receiving 4 weeks of somatropin--for 2 years following initiation of treatment. Life expectancy was assumed equivalent. Risk functions were estimated from the literature and one randomized clinical trial. Total and component costs associated with each strategy were determined. The distribution of patients reducing parenteral nutrition need and the final parenteral nutrition frequency were also estimated. Sensitivity analyses were completed for key inputs. Direct medical costs are reported in US 2004 dollars. RESULTS: The model predicted that 96.0% of patients receiving somatropin reduce or eliminate parenteral nutrition within 6 weeks: average use was reduced by 2.8 days and one-third weaned completely. Based on 1.9 L of parenteral nutrition per day, estimated costs were 118,098 dollars in year one and 132,935 dollars in year two. With somatropin, costs dropped to 84,309 dollars in year one--despite the 17,459 dollars cost of somatropin treatment--and 81,250 dollars in year two. Over 2 years savings totaled 85,474 dollars. LIMITATIONS: Insufficient data required that assumptions be made for some inputs. DES is new in pharmacoeconomics and may be perceived as a limitation. CONCLUSIONS: Somatropin use improves quality of life by reducing the need for parenteral nutrition and results in health care cost savings.
Cost of Illness↗
Budgetary impact of treating acute bipolar mania in hospitalized patients with quetiapine: an economic analysis of clinical trials.
OBJECTIVE: To present a tool that allows estimation of the budget impact of treatments for acute mania in bipolar I disorder from a US healthcare payer perspective. METHODS: Using discrete event simulation, the course of individuals is simulated beginning with hospitalization. Discharge depends on symptom level measured by the Young Mania Rating Scale (YMRS). The treatment effect is determined using time-dependent regression equations derived from trial data, and decision rules obtained from clinical experts. Outcomes include: time to response and symptom resolution; proportion of subjects reaching each outcome; number of adverse events. Costs were obtained from hospital discharge databases, the National Medicare Physician Fee Schedule and RedBook. Different scenarios are examined, each describing the proportion of subjects on the various treatments (lithium, divalproex sodium, olanzapine, risperidone, and quetiapine--monotherapy and in combination with lithium). Analyses are intention-to-treat over 100 days, corresponding to follow-up in mania trials. Despite its flexibility and structural adaptability, the model has some important limitations related to the characteristics of the clinical trials. These include focus on inpatient management of acute mania, use of the YMRS as the model driver, polypharmacy restricted to two-drug regimens, no explicit consideration of titration and dose changes, and relatively short time horizon. RESULTS: Scenarios with a greater proportion of quetiapine users (5% vs. 40% and 100%) result in a smaller impact on the healthcare budget (6912, 6277, and 5525 dollars per patient, respectively) and improvements in patient outcomes (e.g., 43%, 47%, and 54% responding at day 21; 74%, 77%, and 80% remitting by day 84). Sensitivity analyses showed that the budget impact is influenced by drug prices, discharge criteria and side-effect management. CONCLUSION: Results suggest that increased use of quetiapine for bipolar mania in the US is economically justified and improves health outcomes. In addition, this model illustrates that discrete event simulation is a useful and versatile tool for budget impact analyses.
Antipsychotic Agents↗
QALYs: are they helpful to decision makers?
The QALY is the product of life expectancy (estimated in years) and its quality over that time (estimated in utilities or QOL units). It theoretically enables direct comparison of the costs of obtaining different health outcomes through cost utility analysis (CUA). In this review, we argue that, at present, the problems related to the use of utilities preclude the use of cost per QALY as a major determinant of policy decisions on the acquisition and use of health technologies. Those who use CUA can be divided into (i) those who inform the process of decision making through CUA and (ii) those who make the decisions. The former have no direct budgetary responsibility for the decisions that are taken, while the decision makers must pay for those decisions from their budgets. Use of CUA rests on the assumption that all QALYs are of equivalent value in the eyes of society. However, the value accorded to them varies with circumstances. The utilities or QOL indices required to compute QALYs can be measured in different ways, which give different answers, and have been shown to be unreliable. Thus, the QALY is not sufficiently accurate or reliable to be used by decision makers as a basis for comparison of the costs of different technologies. Until the theoretical and practical problems of determining health preferences are resolved and the methods of their measurement are standardised, it is necessary to estimate the cost effectiveness of health interventions by relating their cost to their primary health outcomes.
Cost-Benefit Analysis↗
Assessment of compliance with osteoporosis treatment and its consequences in a managed care population.
OBJECTIVE: To evaluate non-compliance with osteoporosis medications as well as its implications for health and economic outcomes in actual practice. STUDY DESIGN: Data on demographics, prescription drug dispensing, physician services and hospitalizations were obtained from a US managed care database for women with osteoporosis who were dispensed an osteoporosis medication between 1997 and 2002. METHODS: Each subject's pattern of osteoporosis medication use was reconstructed using dispensing records. Subjects were considered compliant over a given period if their medication possession ratio (MPR) was >or=80% and gradients of compliance (<50% poor, 50-80% medium, 80-90% good, >90% excellent) were also examined. Using proportional hazards, the association between compliance over time and fracture rates was examined; Poisson regression was used for hospitalization and log-linear regression for medical costs. RESULTS: 38,120 women with osteoporosis were identified with a mean age of 66 years and an average follow-up of 1.7 years. Three quarters of them had an MPR below 80% when their entire follow-up was considered. Low compliance was associated with a 17% (95% CI 9-25%) increase in the fracture rate, adjusting for other known risk factors. Controlling for the specific drug regimen did not alter the association. Low compliance was also associated with a 37% (95% CI 32-43%) increase in the risk of all-cause hospitalization; and average monthly costs for all medical services combined were higher: 600 US dollars vs. 340 US dollars (P < 0.0001). Similar associations were observed when using the gradients of compliance. CONCLUSIONS: The desired goal of keeping patients with osteoporosis on chronic treatment is not being achieved adequately in actual practice and the potential social and economic implications of this behavior are substantial. Until compliance is improved, society will continue to fail in meeting an important public health goal.
Aged↗
Hospitalization for pertussis: profiles and case costs by age.
BACKGROUND: Pertussis, a highly contagious respiratory illness, affects people of all ages and can have serious clinical consequences. It has been reported that from 1997-2000, 20% of all pertussis cases required hospitalization in the US. This analysis examined demographics, case fatality rate, resource use and costs of hospital care related to pertussis by age. METHODS: ICD-9 codes (033.0, 033.9) were used to identify cases of pertussis in hospital discharge databases from roughly 1,000 US hospitals in 4 states (California, Florida, Maryland, Massachusetts). Data from 1996-1999 were examined by age group. Separate analyses were done for infants (< 1 year) and children (1-11 years); however, adolescent and adult cases were combined into one group (12+ years), due to the small number of cases. Databases were used to determine demographics, health service utilization and care costs. Cost estimates include accommodations, ancillary and physician services, reported in 2002 USD. RESULTS: Of the 2,518 cases identified, 90% were infants. The inpatient case fatality rate was < 1%. Of survivors, 99% were discharged home (6% with home health care); 1% required further sub-acute inpatient care. For the 2,266 infants, the mean LOS was 6 days at a cost of 9,586 dollars per stay. Children (n = 191) had a mean LOS of 3.7 and cost of 4,729 dollars; adolescents/adults (n = 61, mean age 40 years) stayed on average 3.4 days with a cost of 5,683 dollars per hospitalization. CONCLUSION: Infants are responsible for the bulk of hospitalizations and generate higher inpatient costs. Costly hospital care occurs, however, in patients with pertussis at all ages.
Adolescent↗
Potential strategies to reduce the burden of pertussis.
Pertussis continues to be a significant cause of morbidity and mortality among nonimmunized young infants. Although the inception of childhood pertussis immunization programs has significantly reduced the occurrence of the disease in children, waning vaccine-induced immunity permits the disease to affect adolescents and adults, who in turn transmit the disease to unimmunized or incompletely immunized infants. The Global Pertussis Initiative brought together experts from 17 countries around the world to evaluate strategies to improve disease control. Seven strategies were considered: (1) universal adult immunization; (2) selective immunization of mothers and close family contacts of newborns; (3) selective immunization of health care workers; (4) selective immunization of child care workers; (5) universal immunization of adolescents; (6) preschool booster at 4-6 years of age; and (7) reinforcement and/or improvement of current infant and toddler immunization strategies. Because immunization programs vary widely from country to country, no single strategy is likely to be appropriate for all. Moreover it would be helpful to have additional data to support the strategies and provide a better understanding of the disease so that new approaches can be monitored effectively. However, certain steps can be taken now to reduce the incidence of pertussis.
Adolescent↗
Pertussis immunization of adolescents in the United States: an economic evaluation.
The incidence of reported pertussis has increased during the past decade and poses a growing health and economic burden in developed countries, despite high rates of primary vaccination. Administration of a booster dose of acellular pertussis vaccine to adolescents may help reduce this burden, not only by reducing infections in vaccinated individuals but also by reducing transmission of Bordetella pertussis to other individuals, particularly infants. An epidemiologic model was created to assess the health and economic impact of implementing a program of routine acellular pertussis immunization in adolescents 11-18 years of age in the United States, considering both the reduction in cases in those vaccinated and among the unvaccinated population (due to herd immunity). Inputs for the base case were defined according to information derived from published literature and were supplemented by estimates provided by members of the Global Pertussis Initiative. Both direct and indirect costs were included (in 2002 US dollars) using U.S. data. Outcomes were evaluated over the lifetime of a cohort of potential adolescent vaccine candidates. Because of uncertainty in many of the inputs, extensive sensitivity analyses were conducted. With 80% vaccination coverage of adolescents and a 20% reduction of other cases because of herd immunity, >68,000 cases and 41 pertussis-related deaths would be avoided in the subsequent 10 years by routine administration of acellular pertussis boosters to a single cohort of adolescents in the United States. This strategy would be cost-effective, incurring from 6000 US dollars to 22,000 US dollars per life-year gained. The level of herd immunity attained and the true incidence of pertussis are critical determinants of cost effectiveness, as is the duration of immunity resulting from immunization. The cost of immunization and the discount rate also play a role. Although there is considerable uncertainty surrounding key inputs, the results indicate that the conditions required for adolescent immunization to be economically warranted are realistic.
Adolescent↗
Economic burden of pertussis and the impact of immunization.
Although routine use of vaccines has diminished the incidence of pertussis disease, it has not eliminated the pathogen. Epidemiologic data confirm that pertussis remains a significant health problem in all age groups. Disease burden is highest in infants, in whom pertussis disease frequently leads to severe complications and mortality, although it is also a significant health burden in adolescents and adults, in whom the reported incidence of pertussis is increasing. The Global Pertussis Initiative reviewed the literature to find data that express the economic impact of this health burden and to review economic evaluations of pertussis immunization. Although only limited data on the direct and indirect costs of pertussis are available, they suggest that it poses a significant economic burden and indicate that the direct medical costs of pertussis depend on the rate of hospitalization and the severity of complications, and are highest in infants. The indirect costs of pertussis also appear to be considerable, particularly among adults, in whom the disease reduces work productivity, because of either personal illness or child care responsibilities. Several health economic models on the cost effectiveness of childhood immunization strategies have been published, and although constrained by missing data, have generally found childhood immunization strategies to be cost-effective. Economic analyses of adolescent and adult immunization strategies have also been conducted, but the findings of these studies have been inconsistent. The most recent evaluations, using much higher estimates of incidence than reported previously, suggest that immunization of adolescents and specific adult subgroups may be cost-effective. The literature review confirmed that the economic burden of pertussis is substantial, but there are gaps in existing information. In the short term, further economic analyses are required, particularly of adolescent and adult immunization. More importantly, collection of primary epidemiologic and economic data should be undertaken in parallel. Despite the existing gaps in data, further research using the most current data should facilitate decisions on new vaccination strategies by describing conditions for favorable results and quantifying the margin of uncertainty.
Adolescent↗
Summary: health and economic burden of pertussis.
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Adolescent↗
Modeling the implications of changes in vascular calcification in patients on hemodialysis.
BACKGROUND: The Treat-to-Goal Study found that sevelamer slowed the progression of coronary calcification in patients on hemodialysis compared to calcium-based phosphate binders. To understand the implications of this effect for cardiovascular events, risk equations are needed. METHODS: Data on 179 patients on hemodialysis treated at one center in France included biochemical values during the year prior to study entry, patient characteristics, and cardiovascular events over an average of 4 years. As arterial calcification was evaluated ultrasonographically and quantified using a 0 to 4 score, an equation relating this to the electron-beam tomography (EBT)-based calcification score used in the trial was developed and applied to all patients. The estimated scores were then used in survival and Cox proportional hazards analyses of cardiovascular events in relation to the degree of calcification, controlling for other characteristics. RESULTS: Mean age at inclusion was 54 years, dialysis vintage 70 months, average follow-up 49 months; 32% suffered an event. The calcification score, diabetes, C-reactive protein (CRP), diastolic blood pressure, gender, smoking and hypertension are independent predictors of cardiovascular risk. The resulting equation indicates that, relative to a calcification score below 400, the risk of an initial event increases 44% for a score of 600, and more than doubles for a score of 1000. CONCLUSION: In the absence of long-term follow-up studies, these equations permit quantification of the expected long-term clinical consequences of the impact of various phosphate binders on vascular calcification. Together with resource use and cost information, these equations are key inputs for formal cost-effectiveness analyses.
Blood Pressure↗
Pharmacoeconomic analyses using discrete event simulation.
To date, decision trees and Markov models have been the most common methods used in pharmacoeconomic evaluations. Both of these techniques lack the flexibility required to appropriately represent clinical reality. In this paper an alternative, more natural, way to model clinical reality--discrete event simulation--is presented and its application is illustrated with a real world example.A discrete event simulation represents the course of disease very naturally, with few restrictions. Neither mutually exclusive branches nor states are required, nor is a fixed cycle. All relevant aspects can be incorporated explicitly and efficiently. Flexibility in handling perspectives and carrying out sensitivity analyses, including structural variations, is incorporated and the entire model can be presented very transparently. The main limitations are imposed by lack of data to fit realistic models. Discrete event simulation, though rarely employed in pharmacoeconomics today, should be strongly considered when carrying out economic evaluations, particularly those aimed at informing policy makers and at estimating the budget impact of a pharmaceutical intervention.
Computer Simulation↗
Costs and medical care consequences associated with the diagnosis of peripheral arterial disease.
BACKGROUND: Peripheral arterial disease (PAD) is increasingly recognised as an indicator of disseminated atherothrombosis, but its impact on use of healthcare resources is not well understood. OBJECTIVE: To provide a quantitative description of the resource utilisation and costs incurred following PAD. METHODS: Hospitalisations, physician visits and the corresponding direct medical costs were examined in 16,440 patients with a diagnosis of PAD (1985--1995) in Saskatchewan, Canada, and compared with 15,590 reference patients with a diagnosis of myocardial infarction (MI) [1990--1995]. Medical history and patient characteristics were available retrospectively to January 1980 and follow-up to December 2000. Rates and timing of all-cause and cardiovascular hospitalisations and physician visits within discrete periods in the 10 years following PAD diagnosis, and 5 years following MI, were evaluated, as were lengths of stay and predictors of hospitalisation. RESULTS: Average follow-up was 5.9 years among patients with PAD and 3.6 years for MI. Half (55%) of patients with PAD were male versus 64% of reference patients. The mean ages were 67.3 and 66.9 years, respectively. Patients with PAD were hospitalised most frequently soon after diagnosis, with rates subsequently decreasing to 0.14 per month. These rates were similar in the reference group except for the period immediately following MI. The average 5-year cost post-diagnosis (2002 Can dollars) per patient was 41,968 Can dollars vs 48,578 Can dollars for the reference population. CONCLUSIONS: A diagnosis of PAD not only imposes a severe burden on patients and their families, but it also significantly increases the use of healthcare resources and the associated costs. By the end of year 1, this burden is comparable with a diagnosis of MI.
Aged↗
Pharmacological management of overactive bladder : a systematic and critical review of published economic evaluations.
Overactive bladder is a common condition, with recent findings estimating the prevalence in adults at about 15%. Symptoms, including urinary urgency, high voiding frequency and urge incontinence, have been shown to decrease patients' quality of life. Given its high prevalence, the economic burden of overactive bladder is also substantial, with a recent estimate placing the annual cost in the US at 9.1 billion US dollars (year 2000 values). The objective of this review is to provide a critical appraisal of published economic evaluations of pharmacological and non-pharmacological treatments for overactive bladder. Published economic evaluations of treatments for overactive bladder have focused entirely on pharmacological treatments -- mainly on the two most commonly used drugs, oxybutynin and tolterodine, each of which is available in immediate- and extended-release formulations. Ten economic evaluations (more than half are cost-effectiveness studies) have been published. Modelling with decision trees or Markov models has been the predominant method. Evaluations comparing drug therapy with no treatment have concluded that drug therapy is cost effective. Analyses comparing the formulations of oxybutynin and tolterodine have produced highly inconsistent results, largely due to the sources of data employed for effectiveness and treatment discontinuation rates. There are no evaluations of drugs relative to non-pharmacological treatment, and there are other significant gaps in the economic evaluations of treatment to date. These include gaps resulting from a lack of reliable data on the performance of these drugs in real-world settings, particularly data on long-term persistence with treatment. A more definitive pharmacoeconomic comparison of oxybutynin and tolterodine formulations, incorporating all available clinical data, and other treatment options would help direct treatment.
Benzhydryl Compounds↗