Objectives: The objective of this study was to develop and implement a decision-making process for public funding of health services that links policy areas with health technology assessment and input from interested parties.

Methods: Health authorities, assessment organizations, and healthcare professionals were consulted as a follow-up to recommendations of an expert panel established by the Alberta government. The methods involved formulation of an eight-stage, collaborative process that incorporates identification through the health ministry of health technologies requiring review, assessment of the technologies using expert groups in Alberta, and consultation and formulation of advice within the ministry to inform ministerial funding decisions.

Results: All components of the decision process have been put in place and have collaborated to provide advice to inform policy on provincial health services. Of nineteen technologies selected for review, five have been completed and decisions made: laparoscopic adjustable gastric banding, fetal fibronectin assay for premature labor, newborn screening for cystic fibrosis, newborn screening for inborn errors of metabolism, and gastric electrical stimulation. A further six reviews are in progress, and reviews of the remaining technologies are planned for 2007.

Conclusions: Bridging the evidence-to-policy gap is more likely to succeed when the policy community is actively engaged and an explicit model is used to put health technology assessment into practice.

Objectives: Technologies in health care are evolving quickly, with new findings in the area of biotechnological and genetic research being published regularly. A health technology assessment (HTA) is often used to answer the question of whether the new technology should be implemented into clinical practice. International evidence confirms that the results of HTA research sometimes have limited impact on practical implementation and on coverage decisions; the study design is commonly based on the paradigm of stability of both the technology and the environment, which is often not the case. Constructive technology assessment (CTA) was first described in the 1980s. In addition to the traditional HTA elements, this approach also takes into account the technology dynamics by emphasizing sociodynamic processes. With a CTA approach, comprehensive assessment can be combined with an intentional influence in a favorable direction to improve quality.

Methods: In this study, the methodological aspects mainly concerning the diagnostic use of CTA are explained. The methodology will be illustrated using the controlled introduction of a new technology, called microarray analysis, into the clinical practice of breast cancer treatment as a case study. Attention is paid to the operationalization of the phases of development and implementation and the research methods most appropriate for CTA.

Conclusions: In addition to HTA, CTA can be used as a complementary approach, especially in technologies that are introduced in an early stage of development in a controlled way.

Objectives: After 4 years of deepening recession, Argentina's economy plummeted after default in 2002. This crisis critically affected health expenditures and triggered acute rationing. Our objective was to explore health decision-makers' knowledge and attitudes about economic evaluations (EE) and whether health technology assessment (HTA) were increasingly used for decision making.

Methods: A qualitative design based on semistructured interviews and focus groups was used to explore how decision makers belonging to different health sectors implement resource allocation decisions.

Results: Informants were mostly unaware of EE. The most important criteria mentioned to adopt a treatment were evidence of effectiveness, social/stakeholder demand, or resource availability. Despite general positive attitudes about EE, knowledge was rather limited. Although cost considerations were widely accepted by purchasers and managers, clinicians argued about these issues as interfering with the doctor–patient relationship. Other important perceived barriers to HTA use were lack of confidence in the transferability of studies conducted in developed countries and institutional fragmentation of the Argentine healthcare system. The new macroeconomic context was cited as a justification of implicit rationing measures. Although explicit priority setting was implemented by many purchasers and managers, HTA was not used to improve technical and/or allocative efficiency.

Conclusions: The crisis seems to be a strong incentive to extend the use of HTA in Argentina, provided decision makers are aware as well as involved in the generation of local studies.

Objectives: The Finnish Diabetes Prevention Study (DPS) was a randomized intervention program that evaluated the effect of intensive lifestyle modification on the development of diabetes mellitus type 2 in patients with impaired glucose tolerance. As such, a program is demanding in terms of resources; it is necessary to assess whether it would be money well spent. This determination was the purpose of this study.

Methods: We developed a simulation model to assess the economic consequences of an intervention like the one studied in DPS in a Swedish setting. The model used data from the trial itself to assess the effect of intervention on the risk of diabetes and on risk factors for cardiovascular disease. Results from the United Kingdom Prospective Diabetes Study were used to estimate the risk of cardiovascular disease and stroke. Cost data were derived from Swedish studies. The intervention was assumed to be applied to eligible patients from a population-based screening program of 60-year-olds in the County of Stockholm from which the baseline characteristics of the patients was used.

Results: The model predicted that implementing the program would be cost-saving from the healthcare payers' perspective. Furthermore, it was associated with an increase in estimated survival of .18 years. Taking into consideration the increased consumption by patients due to their longer survival, the predicted cost-effectiveness ratio was 2,363€ per quality-adjusted life-year gained.

Conclusions: Lifestyle intervention directed toward high-risk subjects would be cost-saving for the healthcare payer and highly cost-effective for society as a whole.

Objectives: The long-term cost-utility of a disease management program (DMP) for adults with asthma was assessed compared to usual care.

Methods: A DMP for patients with asthma has been developed and implemented in the region of Maastricht (The Netherlands). By integrating care, the program aims to continuously improve quality of care within existing budgets. A clinical trial was performed over a period of 15 months to collect data on costs and effects of the program and usual care. These data were used to inform a probabilistic decision-analytic model to estimate the 5-year impact of the program beyond follow-up. A societal perspective was adopted, with outcomes assessed in terms of costs per quality-adjusted life-year (QALY).

Results: The DMP is associated with a gain in QALYs compared to usual care (2.7±.2 versus 3.4±.8), at lower costs (€3,302±314 versus €2,973±304), thus leading to dominance. The probability that disease management is the more cost-effective strategy is 76 percent at a societal willingness to pay (WTP) for an additional QALY of €0, reaching 95 percent probability at a WTP of €1,000 per additional QALY.

Conclusions: Organizing health care according to the principles of disease management for adults with asthma has a high probability of being cost-effective and is associated with a gain in QALYs at lower costs.

Objectives: Congenital heart defects (CHD) are an important cause of death and morbidity in early childhood, but the effectiveness of alternative newborn screening strategies in preventing the collapse or death—before diagnosis—of infants with treatable but life-threatening defects is uncertain. We assessed their effectiveness and efficiency to inform policy and research priorities.

Methods: We compared the effectiveness of clinical examination alone and clinical examination with either pulse oximetry or screening echocardiography in making a timely diagnosis of life-threatening CHD or in diagnosing clinically significant CHD. We contrasted their cost-effectiveness, using a decision-analytic model based on 100,000 live births, and assessed future research priorities using value of information analysis.

Results: Clinical examination alone, pulse oximetry, and screening echocardiography achieved 34.0, 70.6, and 71.3 timely diagnoses per 100,000 live births, respectively. This finding represents an additional cost per additional timely diagnosis of £4,894 and £4,496,666 for pulse oximetry and for screening echocardiography. The equivalent costs for clinically significant CHD are £1,489 and £36,013, respectively. Key determinants of cost-effectiveness are detection rates and screening test costs. The false-positive rate is very high with screening echocardiography (5.4 percent), but lower with pulse oximetry (1.3 percent) or clinical examination alone (.5 percent).

Conclusions: Adding pulse oximetry to clinical examination is likely to be a cost-effective newborn screening strategy for CHD, but further research is required before this policy can be recommended. Screening echocardiography is unlikely to be cost-effective, unless the detection of all clinically significant CHD is considered beneficial and a 5 percent false-positive rate acceptable.

Objectives: A systematic review of the cost-effectiveness of abdominal aortic aneurysm (AAA) repair was conducted. Although open surgery has been considered the gold standard for prevention of AAA rupture, emerging less-invasive endovascular treatments have led to increased interest in evaluating the cost and cost-effectiveness of treatment options.

Methods: A systematic review of studies published in MEDLINE between 1999 and 2005 reporting the cost and/or cost-effectiveness of endovascular and/or open surgical repair of nonruptured AAAs was conducted. Case series studies with less than fifty patients per treatment were excluded.

Results: Of twenty eligible articles, three were randomized controlled trials, twelve case series, four Markov models, and one systematic review. Regardless of time frame, all studies found that endovascular repair costs more than open surgery. Although the high cost of the endovascular prosthesis was partially offset by reduced intensive care, hospital length of stay, operating time, blood transfusions, and perioperative complications, hospital costs were still greater for endovascular than open surgical repair. For patients medically fit for open surgery, mid-term costs were greater for endovascular repair with no difference in overall survival or quality of life. For patients medically unfit for open surgery, endovascular repair costs more than no intervention with no difference in survival.

Conclusions: Although conclusions regarding the cost-effectiveness of AAA treatment options are time dependent and vary by institutional perspective, from a societal perspective, endovascular repair is not currently cost-effective for patients with large AAA regardless of medical fitness.

Objectives: The University of Minnesota has maintained a home monitoring program for over 10 years for lung and heart–lung transplant patients. A cost analysis was completed to assess the impact of home monitoring on the cost of post-transplant medical care.

Methods: Clinical information gathered with the monitoring system includes spirometry, vital signs, and symptom data. To estimate the impact of this system on medical costs, we completed a retrospective analysis of the effects of home monitoring on the cost of post-lung transplant medical care. The cost analysis used multivariate linear regression with inpatient, outpatient, and total medical care costs as the dependent variables. The independent variables for the regression include home monitoring adherence, underlying disease, ambulatory diagnostic group mapping variables, transplant type, and patient demographics.

Results: The multivariate regression of the overall cost results predicts a 52.4 percent reduction in total costs with 100 percent patient adherence; this rate includes a 72.24 percent reduction in inpatient costs and a 46.6 percent increase in outpatient costs. The actual first year average patient adherence was 74 percent.

Conclusions: Adherence to home monitoring increases outpatient costs and reduces inpatient costs and provides an overall cost savings. The break-even point for patient adherence was 25.28 percent, where the net savings covered the cost of home monitoring. This is well within the actual first year adherence rates (74 percent) for subjects in the lung transplant home monitoring program, providing a net savings with adherence to home monitoring.

Objectives: This study investigated the direct medical resource use and cost, informal care cost, and indirect cost associated with breast cancer in different states of the disease in normal clinical practice.

Methods: A retrospective database analysis was used to estimate direct medical resource use and cost, and a patient questionnaire was used to evaluate informal care and work capacity in different states of breast cancer.

Results: For patients younger than 65 years of age, the first year after a primary diagnosis total cost amounted to 280,000 SEK ($39,000) and the first year after a local or contralateral recurrence total cost was 351,000 SEK ($48,900). The second and following years after primary breast cancer or recurrence had substantially lower total cost, amounting to 94,000 SEK ($13,000). For patients with metastatic disease, the annual total cost was estimated to 334,000 SEK ($46,500). For patients older than 65 years of age, the total cost for the first year after a primary diagnosis amounted to 80,000 SEK ($11,200) and the total cost for the first year after a local or contralateral recurrence was 92,000 SEK ($12,900). The total cost for the second and following years after primary breast cancer or recurrence was estimated to 18,000 SEK ($2,600), and the total annual cost for patients with metastatic was 122,000 SEK ($17,000).

Conclusions: Both direct medical costs and indirect cost vary substantially between disease states. For patients under 65 year of age, indirect costs accounted for more than 50 percent of the total cost.

Objectives: The aim of this study was to estimate the time and travel costs generated by women when attending for Papanicolaou (Pap) smear tests or colposcopy appointments in the United Kingdom, both absolutely and relative to the health service cost of the national cervical cancer screening programs.

Methods: Data were obtained from questionnaires completed by two samples of women participating in a three-center trial of management of low-grade abnormalities detected by screening (n = 1,106 for Pap smears and n = 1,203 for colposcopy appointments). Women were 20 to 59 years of age and resident in Grampian or Tayside, Scotland, or Nottingham, England. Questionnaire data were supplemented with sociodemographic information previously collected at the time of recruitment to the trial.

Results: The mean total time and travel costs per attendance at a smear test and at a colposcopy appointment were estimated to be £9.2 and £27.4, respectively, averaged across the three trial areas (valued at 2002 prices). Statistically significant intercenter disparities in time and travel costs were identified, particularly with respect to colposcopy appointments. For these, time and travel costs in Nottingham were substantially less than those in Grampian and Tayside (£22.9, £30.2, and £32.1, respectively). Time and travel costs amount to 26 and 33 percent, approximately, over and above the direct health service costs of the English and Scottish screening programs, respectively.

Conclusions: The time and travel costs associated with participation in the UK cervical cancer screening programs are substantial and are not spatially uniform across the country.

Objectives: This study was undertaken to understand how women view characteristics of tests for cervical dysplasia, because these characteristics can affect patient decision-making about screening and follow-up.

Methods: We recruited women who participated in a clinical trial of optical spectroscopy for the diagnosis of cervical dysplasia and used conjoint analysis to assess the women's preferences concerning test attributes. One group of women had a history of an abnormal Papanicolaou smear (diagnostic sample), while the other group did not (screening sample). Participants rated pairs of test scenarios that varied on characteristics such as test sensitivity and painfulness. Based on their responses, the relative importance of test sensitivity, specificity, timing of results feedback and treatment, and pain were calculated, and a cluster analysis was done to identify subgroups of participants with different preference patterns.

Results: In the overall sample, sensitivity was the most important attribute, followed by timing, specificity, and pain. Cluster analysis revealed four distinct groups who placed varying importance on each characteristic. The participants in the cluster for which pain was the most important attribute were more likely to be diagnostic patients, non-white, and have low education levels. They also reported more anxiety and pain during the examination than participants in other clusters.

Conclusions: To continue to reduce morbidity and mortality from cervical cancer, developers of new testing procedures should take into account test attributes such as these, which may affect adherence to screening and diagnostic follow-up to further minimize morbidity and mortality from cervical cancer.

Objectives: The impact of learning effects on the variability of costs of new health technologies in a prospective payment system (PPS) through the case of intensity modulated radiation therapy (IMRT) was studied.

Methods: A series of consecutive patients treated in nine medical centers was enrolled in a prospective study. Direct costs were assessed from the perspective of the healthcare providers. We used a two-level model to explain the variability of costs: patients nested within centers. Learning effects at the center level were considered through a fixed effect (the learning curve slope) and a random effect (the initial cost level). Covariates were introduced to explain the patterns of variation in terms of patient characteristics.

Results: The mean direct cost of IMRT was €5,962 (range, €2,414–€24,733). Manpower accounted for 53 percent of this cost. Learning effects explained 42 percent of the variance between centers (which was 88 percent of the total variance) and were associated with a substantial decrease in treatment costs. The mean initial treatment direct cost was €6,332 in centers with a previous experience of IMRT, whereas it was €14,192 in centers implementing IMRT for the first time. Including logistics costs and overhead, the full cost of IMRT was €10,916. Average reimbursement was €6,987.

Conclusions: Learning effects are a strong confounding factor in the analysis of costs of innovative health technologies involving learning effects. In a PPS, innovative health technology involving learning effects necessitates specific reimbursement mechanisms.

Objectives: The aim of this study was to assess whether a literature review of a technology can allow a learning curve to be quantified.

Methods: The literature for fiberoptic intubation was searched for studies reporting information relevant to the learning curve. The Cochrane Library, Medline, Embase, and Science Citation index were searched. Studies that reported a procedure time were included. Data were abstracted on the three features of learning: initial level, rate of learning, and asymptote level. Random effects meta-analysis was performed.

Results: Only twenty-one studies gave explicit information concerning the previous experience of the operator(s). There were thirty-two different definitions of procedure time. From four studies of fiberoptic nasotracheal intubation, the mean starting level and time for the 10th procedure was estimated to be 133 seconds (95 percent confidence interval, 113–153) and 71 seconds (95 percent confidence interval, 62–79), respectively.

Conclusions: The review approach allowed learning to be quantified for our example technology. Poor and insufficient reporting constrained formal statistical estimation. Standardized reporting of nondrug techniques with adequate learning curve details is needed to inform trial design and cost-effectiveness analysis.

Objectives: The clinical and cost-effectiveness of left ventricular assist devices as destination therapy for people with end-stage heart failure is assessed through a systematic review and economic evaluation.

Methods: Systematic review was performed of randomized controlled trials, quasiexperimental studies, case series, and case studies identified through searching eighteen electronic databases, bibliographies, and consultation with experts and manufacturers. Studies assessed survival, functional capacity, and quality of life. Cost-effectiveness was assessed through a 5-year decision analytic model to estimate the incremental cost-effectiveness ratio for using left ventricular assist devices compared with usual care.

Results: Six studies met the inclusion criteria, showing that left ventricular assist devices appear beneficial, improving survival and quality of life. Adverse events are a serious concern. The economic evaluation showed that left ventricular assist devices had a cost per quality adjusted life year of £170,616. Sensitivity analysis showed that the cost-effectiveness was not sensitive to changes in costs or utility.

Conclusions: Although left ventricular assist devices appear clinically effective as destination therapy, it is unlikely they will be cost-effective unless costs decrease or the benefits of their use increase.

Objectives: Ongoing developments in design have improved the outlook for left-ventricular assist device (LVAD) implantation as a therapy in end-stage heart failure. Nevertheless, early cost-effectiveness assessments, based on first-generation devices, have not been encouraging. Against this background, we set out (i) to examine the survival benefit that LVADs would need to generate before they could be deemed cost-effective; (ii) to provide insight into the likelihood that this benefit will be achieved; and (iii) from the perspective of a healthcare provider, to assess the value of discovering the actual size of this benefit by means of a Bayesian value of information analysis.

Methods: Cost-effectiveness assessments are made from the perspective of the healthcare provider, using current UK norms for the value of a quality-adjusted life-year (QALY). The treatment model is grounded in published analyses of the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial of first-generation LVADs, translated into a UK cost setting. The prospects for patient survival with second-generation devices is assessed using Bayesian prior distributions, elicited from a group of leading clinicians in the field.

Results: Using established thresholds, cost-effectiveness probabilities under these priors are found to be low (∼.2 percent) for devices costing as much as £60,000. Sensitivity of the conclusions to both device cost and QALY valuation is examined.

Conclusions: In the event that the price of the device in use would reduce to £40,000, the value of the survival information can readily justify investment in further trials.

Objectives: The aim of this article is to describe the diffusion of magnetic resonance imaging (MRI) in Iran, including regional variations during the period of 1990 to 2005 and international comparisons.

Methods: Data on the diffusion of MRI were obtained from the Medical Equipment Office of the Ministry of Health (MOH) and, using self-administered questionnaires, from forty-one universities specializing in medical sciences. Data were gathered from the year of first purchase up to mid-2005. Information for international comparisons was obtained from the Organization for Economic Cooperation and Development health data of 2006.

Results: Iran purchased its first MRI unit in 1990. Since then, the number of MRI units has increased remarkably. The diffusion curve of MRI in Iran follows an S-shaped curve with a very slow speed in the period of 1991–95. Accelerated adoption occurred later coinciding with a significant influence from the private sector, especially from 1999. Iran had ninety-three MRI units in 2005, and the number of MRI units per million in the population was 1.36.

Conclusions: The number of MRI units in provinces is not in direct proportion to the number of their inhabitants. Rational adoption and equitable diffusion of MRI may require the MOH and regulatory bodies to improve their ability in health technology assessment and integrate it into the policy making regarding adoption, diffusion, and utilization of health technologies.

Objectives: In April 1998, the Medical Services Advisory Committee (MSAC) was established by the Australian federal government. Since that time, all new medical procedures must be evaluated for safety, effectiveness, and cost-effectiveness as a condition of the surgeon receiving public funding by means of the Medicare Benefits Schedule (MBS). Over these first 8 years, a significant number of applications for the public funding of new procedures have been given negative recommendations by the MSAC based on insufficient clinical evidence or lack of cost-effectiveness. In August 2006, after almost 2 years of processing, the MSAC made the decision to fund the new procedure, laparoscopic remotely assisted radical prostatectomy (LRARP). However, they stated that there was still uncertainty about the comparative cost-effectiveness.

Methods: An observational study using provisional cost-utility data for LRARP based on a combination of costs taken from consecutive patients at the Epworth Hospital, Melbourne, Australia, and utilities from the prospectively collected data on all patients undergoing surgery for prostate cancer over a 4-year period at the Vattikuti Urology Institute, Michigan, United States.

Results: The incremental cost for LRARP compared with the open surgery alternative is A$2,264 or A$24,457 per quality-adjusted life-year, well below the range accepted by the Australian pharmaceutical equivalent of the MSAC (the PBAC) of A$42,000 and A$76,000. This figure does not take into account additional benefits such as reduced time away from employment, reduced blood loss, reduced possibility of infection, and reduced scarring.

Conclusions: This case study of LRARP demonstrates that there is sufficient crude evidence to show that this new procedure is likely to be superior to the existing procedure in terms of safety, effectiveness, and cost-effectiveness. The decision to allow MBS funding was correct and will allow for the collection of additional evidence, on both economic and clinical outcomes.

Objectives: The purpose of this study was to examine the diffusion patterns of new medical technologies in Korean hospitals. We also sought to identify critical factors leading to the decision to acquire capital-intensive medical technology. The rationale and timing of magnetic resonance imaging (MRI) acquisitions were retrospectively evaluated according to a “whether, when, and why” paradigm.

Methods: We analyzed data pertaining to 232 hospitals with active medical residency programs. Of these, 185 hospitals owned or leased an MRI unit, and 47 had not acquired units as of June 2004. Data were collected from the Ministry of Health and Welfare, Korean National Statistical Office, and Korean Hospital Association databases, and variables were identified and classified as predisposing, enabling, or reinforcing factors.

Results: The MRI diffusion rate curve was linear for two types of hospital but was S-shaped for tertiary hospitals, which were early adopters of MRI. Significant predictors for MRI adoption included the per capita number of regional physicians (+), total number of existing regional MRI units (−), percentage of the regional population over 65 years of age (+), private ownership of the hospital, presence of a radiology residency program, number of beds (+), and regional per capita taxable income (+).

Conclusions: Diffusion of MRI technology is occurring rapidly across Korean hospitals. The factors affecting MRI adoption in Korea are similar to the factors documented in other countries, namely regional population over age 65, regional income per capita, large hospitals, and teaching hospitals. This study provides baseline information for predicting diffusion patterns of other new and/or expensive medical technologies.