Objectives: Endobronchial ultrasound (EBUS), encompassing endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) and Endobronchial ultrasound transbronchial lung biopsy (EBUS-TBLB) has been proven to be a useful modality in the staging and diagnosis of lung cancer. However, there are limited publications on the cost-effectiveness of EBUS and no economic evaluations relevant to the Singapore setting. An economic evaluation using our hospital's data was used to assess the cost implications of EBUS substituting where clinically appropriate: transthoracic needle aspiration; (TTNA), fluoroscopy-guided transbronchial lung biopsy (TBLB), and mediastinoscopy in the diagnosis and staging of lung cancer.

Methods: Relationship between the clinical and economic implications of alternative modalities was modeled using data inputs that were relevant to the Singapore setting. Two decision analytic models were constructed to evaluate the cost of EBUS compared with TTNA, TBLB, and staging mediastinoscopy. Only direct costs were imputed.

Results: In the base–case analysis, TTNA was the most economical strategy (SGD3,335 = US$2,403) where clinically suitable for the diagnosis of lung cancer as compared to the other options: TBLB (SGD4,499) and EBUS-TBLB (SGD4,857). On the other hand, EBUS-TBNA resulted in expected cost savings of SGD1,214 per positive staging of lung cancer as compared to mediastinoscopy.

Conclusions: The use of EBUS-TBNA could result in cost savings of SGD1,214 per positive staging of lung cancer as compared to mediastinoscopy. Whereas TTNA was the most economical intervention for the diagnosis of lung cancer as compared to the other options, its main limitation lies in its suitability only for peripheral lung lesions and high complication rate.

Objectives: A recent study showed that estimates of cost-effectiveness submitted to National Institute for Health and Clinical Excellence (NICE) by manufacturers had significantly lower incremental cost-effectiveness ratios (ICERs) than those submitted by university-based Assessment Groups. This study extends that analysis.

Methods: Data were abstracted from relevant NICE documentation for thirty-two of eighty-two possible appraisals.

Results: The results from the analysis showed that sources of the difference in ICERs appear to be the effectiveness estimates relating to the comparator technology and the cost estimates relating to the technology under evaluation. That is, manufacturers estimated lower average benefits for the comparator technology and lower costs relating to the technology under evaluation compared with estimates submitted by the Assessment Groups.

Conclusions: These findings may be particularly important, given the introduction of the “Single Technology Appraisal.” Considerable difficulties were encountered when undertaking this study, highlighting, above all else, the complexity of explaining why results from economic evaluations purporting to answer the same question diverge.

Objectives: Several instruments for measuring health-related quality of life (HRQOL) have been developed, and others are under construction. The problem is whether the different HRQOL measures show comparable results. We first compared the functional relationship of the Nottingham Health Profile (NHP) and the 15-dimensional measure of HRQOL (15D) in hip and knee replacement patients. The hypothesis was that condition or intervention does not affect the functional relationship between NHP and 15D changes.

Methods: We assessed the agreement of the instruments by comparing observed changes in the 15D and its fitted values derived by regressing the 15D by the NHP dimensions. Patients (n = 452) were recruited consecutively from seven Finnish orthopedic departments during April 1991–May 1992. HRQOL was measured prior to surgery and 6, 12, and 24 months postoperatively.

Results: There was a different functional relationship between the HRQOL instruments in hip and knee patients; they agreed upon the direction of changes in HRQOL in 84% and showed opposite signs in 12%. The NHP showed significantly more improvement in quality of life than the 15D.

Conclusions: The two instruments were in slight but significant disagreement. Estimates of effectiveness can vary according to the instrument used. Comparisons of effectiveness in healthcare programs measured by differing instruments need information on the functional discrepancies between the instruments in the conditions and interventions in which they are applied.

The papers on the 16 European countries presented in this issue show their great diversity of health systems. Health technology assessment (HTA) has been institutionalized in a number of members of the European Union and has a growing impact on health policy. A remaining challenge is to see HTA visible and useful at the European level, which requires more active coordination of national and regional activities. A network of HTA programs and researchers has been established. The HTA-Europe Steering Committee has suggested a number of actions by the European Commission to promote further coordination. The most important conclusion of the HTA-Europe report is that a permanent coordinating structure is needed at the European level.

Objectives: Magnetic resonance imaging (MRI) and computerized tomography (CT) scanners are high-tech equipment with the highest utilizations and expenditures in Taiwan. This study investigates the factors that affect MRI and CT utilization, such as whether supply-side factors have more impact than demand-side factors, and the effect of utilization control policies.

Methods: This study used the nationwide CT and MRI claim data for the years 1998 to 2001 from the Bureau of National Health Insurance (BNHI) in Taiwan. Multiple regression analysis was the statistical method used to determine the relative factors that influence CT and MRI utilization.

Results: CT : population ratio, hospital-based physician : population ratio, female ratio, pediatric (≤14 years) : population ratio, and family income significantly influenced CT utilization. MRI : population ratio and hospital-based physician : population ratio, female ratio, and family income significantly influenced MRI utilization. However, the proportion of the aged (≥65 years of age) did not significantly influence CT or MRI utilization after controlling for other factors. The rates of CT and MRI utilization for the outpatient and inpatient settings and the repeated uses of CT or MRI have decreased significantly after a utilization review was implemented by BNHI, which suggests that CT and MRI have been overused.

Conclusions: Increases in supply-side factors significantly increase CT/MRI utilization, and supply-side factors impact CT/MRI utilization more than demand-side factors. The results show that the utilization instant report policy effectively decreases repeated uses of CT/MRI.

Italy has a national health service (SSN) dating to 1978. Italy's system of government is characterized by a rather high degree of decentralization of power, and the health system is likewise decentralized. Most of the responsibilities for health care have been ceded to the regions. The state retains only limited coordinating and supervisory powers. The state has a financial responsibility for the national health service, but state contributions are limited and expenditures in excess of this made by the region must be financed from other sources. Health reforms of 1992–93 aimed at making the regions more sensitive to the need to control aggregate expenditure and to monitor measures to promote efficiency, quality, and citizen-patient satisfaction. The diffusion of individual health technologies has been relatively uncontrolled in many regions in Italy, although tight central constraints on capital spending have contained diffusion of new technology. Regulation of placement of services is a planning function and is the responsibility of both the Ministry of Health and the regions. Health technology assessment (HTA) activities have been expanding since the early 1990s, but these activities tend to be untargeted, uncoordinated, and without priorities. Nonetheless, the principal actors in the SSN at national, regional, and local levels are becoming more sensitive to the need to apply criteria of clinical and cost-effectiveness and to be more rigorous in deciding what services to guarantee. There are reasons to be guardedly optimistic about the future of HTA in Italy.

Objectives: The aim of this study was to assess empirically the social and ethical risks associated with implantable radio-frequency identification (RFID) devices.

Methods: Qualitative research included observational studies in twenty-three U.S. hospitals that have implemented new patient identification systems and eighty semi-structured interviews about the social and ethical implications of new patient identification systems, including RFID implants.

Results: The study identified three primary social and ethical risks associated with RFID implants: (i) unfair prioritization of patients based on their participation in the system, (ii) diminished trust of patients by care providers, and (iii) endangerment of patients who misunderstand the capabilities of the systems.

Conclusions: RFID implants may aggravate inequalities in access to care without any clear health benefits. This research underscores the importance of critically evaluating new healthcare technologies from the perspective of both normative ethics and empirical ethics.

Objectives: The objective of this study was to develop a model to assess the cost-effectiveness of a new treatment for patients with depression.

Methods: A Markov simulation model was constructed to evaluate standard care for depression as performed in clinical practice compared with a new treatment for depression. Costs and effects were estimated for time horizons of 6 months to 5 years. A naturalistic longitudinal observational study provided data on costs, quality of life, and transition probabilities. Data on long-term consequences of depression and mortality risks were collected from the literature. Cost-effectiveness was quantified as quality-adjusted life-years (QALYs) gained from the new treatment compared with standard care, and the societal perspective was taken. Probabilistic analyses were conducted to present the uncertainty in the results, and sensitivity analyses were conducted on key parameters used in the model.

Results: Compared with standard care, the new hypothetical therapy was predicted to substantially decrease costs and was also associated with gains in QALYs. With an improved treatment effect of 50 percent on achieving full remission, the net cost savings were 20,000 Swedish kronor over a 5-year follow-up time, given equal costs of treatments. Patients gained .073 QALYs over 5 years. The results are sensitive to changes in assigned treatment effects.

Conclusions: The present study provides a new model for assessing the cost-effectiveness of treatments for depression by incorporating full remission as the treatment goal and QALYs as the primary outcome measure. Moreover, we show the usefulness of naturalistic real-life data on costs and quality of life and transition probabilities when modeling the disease over time.

Objectives: Although the importance of economic evaluations is recognized, research suggests the ways in which studies are summarized may not be optimal for a busy decision maker with little training in economics methodology. Therefore, the objective of this study was to seek decision makers' views on different summary formats, including a score, short summary, and structured abstracts of different degrees of detail.

Methods: We contacted 2,400 people, of which 84 decision makers volunteered and were presented, cumulatively, with different formats and asked whether these provided sufficient detail on the methodology and results of an economic study.

Results: From the fifty decision makers who responded to the questionnaire, it was found that the preferred combination was a very short summary, plus a more detailed structured abstract. It was also found that decision makers with economics training preferred the most detailed format, partly reflecting their reasons for consulting economic evaluations.

Conclusions: Decision makers require both an initial screen of study content, plus more detail should they find the study relevant or interesting.

Objectives: To calculate the costs of blood collection, testing, storage, and transfusion in Greece.

Methods: Costing information was collected from two large public hospitals, in Athens and Crete, that also act as blood banks. Given that private health care accounts for 40 percent of total health spending, the same costs were also considered in a private setting by collecting key reagent cost data from a leading private hospital in Athens. Mainly direct costs were considered (advertising campaigns, personnel, storage and maintenance, reagent costs, transportation costs from blood bank to end-use hospitals, and cross-matching and transfusion costs in receiving hospitals) and some indirect costs (opportunity cost of blood donorship).

Results: Captive donorship accounts for over 50 percent of the national blood supply. A unit of blood transfused would cost between €294.83 and €339.83 in public hospitals and could reach €413.93 in a private facility. This figure may be an underestimate, as it excludes opportunity costs of blood transfusion for patients and the healthcare system.

Conclusions: Blood has a significant cost to the health system. Policy makers and practitioners should encourage its rational use, build on current policies to further improve collection and distribution, encourage further volunteer donorship in Greece, and also consider alternatives to blood where the possibility exists.

Background: Healthcare use and costs are about 81% higher for morbidly obese individuals compared to non-obese persons, and 47% higher compared to the non-morbidly obese population. The benefits of bariatric surgery for health are well established, but its mid-term impact on healthcare use and costs remains controversial.

Methods: This study examines the trends in healthcare use and costs in a Brazilian cohort during a 4-year period before and after surgery. Healthcare use and direct costs related to inpatients and outpatients were retrieved from a healthcare insurance company database from which all cohort members were selected.

Results: Between 2004 and 2010, 4,006 individuals underwent bariatric surgery. Most patients were female (80%) with a mean age of 36.2 years and a mean body mass index of 42.8 kg/m2. Elevated blood pressure was present in 38% of cases and diabetes was found in 12.5% of subjects. Hospital admissions increased consistently after surgery, even after excluding hospitalizations for esthetic surgery and pregnancy-related care. The most prevalent conditions in this group were gastrointestinal diseases. Emergency department visits increased after bariatric procedures, in particular for genitourinary and hematologic problems. Adjusted costs were higher after surgery as assessed during a 4-year follow-up period.

Conclusion: Results indicate that costs and hospital admissions after bariatric surgery increase following this procedure, even when elective interventions are excluded. Healthcare providers and policy makers need to be aware that a decrease in obesity-related diseases following bariatric surgery does not reduce healthcare use and costs.

Objectives: Tackling ethical dilemmas faced by reimbursement decision makers requires deeper understanding of values on which health technology assessment (HTA) agencies are founded and how trade-offs are made. This was explored in this study including the case of rare disease.

Methods: Representatives from eight HTA explored values on which institutions are founded using a narrative approach and reflective multicriteria (developed from EVIDEM, criteria derived from ethical imperatives of health care). Trade-offs between criteria and the impact of incorporating defined priorities (including for rare diseases) were explored through a quantitative values elicitation exercise.

Results: Participants reported a diversity of substantive and procedural values with a common emphasis on scientific excellence, stakeholder involvement, independence, and transparency. Examining the ethical imperatives behind EVIDEM criteria was found to be useful to further explore substantive values. Most criteria were deemed to reflect institutions’ values, while 70 percent of the criteria were reported by at least half of participants to be considered formally by their institutions. The quantitative values elicitation highlighted the difficulty to balance imperatives of “alleviating or preventing patient suffering,” “serving the whole population equitably,” “upholding healthcare system sustainability,” and “making decisions informed by evidence and context” but may help share the ethical reasoning behind decisions. Incorporating “Priorities” (including for rare diseases) helped reveal trade-offs from other criteria and their underlying ethical imperatives.

Conclusions: Reflective multicriteria are useful to explore substantive values of HTAs, reflect how these values and their ethical underpinnings can be operationalized into criteria, and explore the ethical reasoning at the heart of the healthcare debate.

Objectives: Several studies have shown that a key determinant of successful health technology assessment (HTA) uptake is a clear, fair, and consistent decision-making process for the approval and introduction of health technologies. The aim of this study was to gauge healthcare providers' and managers' perceptions of local level decision making and determine whether these processes offer a conducive environment for HTA. An Area Health Service (AHS) aimed to use the results of this study to help design a new process of technology assessment and decision making.

Methods: An online survey was sent to all health service managers and healthcare providers working in one AHS in Sydney, Australia. Questions related to perceptions of current health technology decisions in participants' own institution/facility and opinions on key criteria for successful decision-making processes.

Results: Less than a third of participants agreed with the statements that local decision-making processes were appropriate, easy to understand, evidence-based, fair, or consistently applied. Decisions were reportedly largely influenced by total cost considerations as well as by the central state health departments and the Area executive.

Conclusions: Although there are renewed initiatives in HTA in Australia, there is a risk that such investments will not be productive unless policy makers also examine the decision-making contexts within which HTA can successfully be implemented. The results of this survey show that this is especially true at the local level and that any HTA initiative should be accompanied by efforts to improve decision-making processes.

The aim of this paper is to review the concept of patient-based evidence in health technology assessment (HTA), drawing on philosophical ideas of knowledge in order to judge whether current approaches to the use of evidence for HTA are complete. We draw on a number of key sources, including key papers and book chapters, discussion forums, agency reports, and conference presentations. We develop the potential dimensions of patient-based evidence, describe its key attributes, and consider its future development. Patient-based evidence has the potential to be a key concept in HTA, comprised of a series of related elements of importance to patients. We recognize that we raise more questions than can be answered, but as an emerging concept, recognition and understanding of patient-based evidence is still developing. The concepts and methods that support its application in HTA require urgent development. We conclude that clinical and economic forms of evidence are not enough for HTA. For HTA to be complete, we need to consider all relevant aspects of the phenomena, including patient-based evidence. There is now an urgent need for the global research and HTA community to work together to realize the full potential of patient-based evidence through conceptual and methodological development and wider recognition. We advocate that a task force be set up to address these urgent issues.

This article provides a comprehensive analysis of the social, cultural and economic factors which have led to the present pattern of technology utilization in Japan. It is divided into five sections. The first provides the historical framework; the second, an overview of the health care delivery context and its economic incentive structure; the third, an analysis of the various contenders involved in the process of resource allocation; the fourth, a description of the technology areas which have been emphasized in Japan; and the fifth, an examination of future issues.

Objective: To enhance the validity of a well-known expert panel process, we used data from patient surveys to identify and correct rating errors.

Methods: We used the two-round RAND/UCLA panel method to rate indications of harmful (presence of problems), hazardous (at risk for problems), and nonhazardous (no known risks) drinking in older adults. Results from the panel provided guidelines for classifying older individuals as harmful, hazardous, or nonhazardous drinkers, using a survey. The classifications yielded unexpectedly high numbers of harmful and hazardous drinkers. We hypothesized possible misclassifications of drinking risks and used the survey data to identify indications that may have led to invalid ratings. We modified problematic indications and asked three clinician panelists to evaluate the clinical usefulness of the modifications in a third panel round. We revised the indications based on panelist response and reexamined drinking classifications.

Results: Using the original indications, 48% of drinkers in the sample were classified as harmful, 31% as hazardous, and 21% as nonhazardous. A review of the indications revealed framing bias in the original rating task and vague definitions of certain symptoms and conditions. The modified indications resulted in classifications of 22% harmful, 47% hazardous, and 31% nonhazardous drinkers.

Conclusions: Analysis of survey data led to identification and correction of specific errors occurring during the panel-rating process. The validity of the RAND/UCLA method can be enhanced using data-driven modifications.

Until now, no systematic strategy for the prevention of major hemoglobinopathies has been implemented in southeastern France, in spite of frequencies of β-thalassemia trait and HbS trait as high as 2·5–8% in some ethnic populations. The purpose of the study was to help a group of experts, brought together by the Regional Center for Disease Control, to reach a consensus about screening for carriers of heterozygote hemoglobinopathies. A multicriteria decision-analysis model was used to take into account not only the costs and effectiveness of potential screening strategies, but also five other qualitative criteria: technical and practical feasibilities, ethical acceptability, information follow-up in time, and global impact on health education. Conclusions differ significatively from those of a pure costeffectiveness analysis, but a multicriteria approach seems best suited to medical experts' preferences.

According to the HTA-Europe report, health technology assessment (HTA) has the potential to influence health policy in the fields of research and development, regulation of pharmaceuticals, devices, and services, quality assurance, reimbursement, education and training of healthcare providers, and consumer education (1). To identify and bridge the gaps between HTA production and implementation, the goal of Working Group 6 was to approach the use of HTA in policy and practice on the aggregate policy level as well as in the local context, such as in hospitals. Members of Working Group 6 included both users (e.g., members of decision-making bodies) and producers (e.g., members of HTA agencies) of HTA reports. The aim of the working group was to identify three types of information on HTA implementation and impact. These included identifying successful examples of the implementation of HTA results, examples of structures that require HTA information as part of the decision-making process, and finally, identifying groups and persons who use HTA frequently and are willing to share their experiences with other HTA users and producers.

Objective: To analyze evolution of the health technology assessment (HTA) at the national level in South Korea.

Methods: Analysis of public documents, personal communication, and literative review.

Results: HTA in South Korea has been developed since 1990s, first introduced by academia and institutionalized within the National Health Insurance (NHI). Rapidly increasing expenditure had been a challenge of the NHI, which considered health technology management as a cost controlling measure. An amendment was made to the NHI Law in 2000, and provision was made to regulate the process of determining new insurance benefits including procedures, drugs, and equipment. This requirement made the NHI agencies to promote HTA approaches in connection with the government and professional organizations. Also the Healthcare Act was revised in October 2006 ruling that HTA focusing on safety and effectiveness be responsible for new health technologies. Currently, the HTA process is governed by a governmental committee comprising twenty members and technically supported by the HTA center created in the NHI structure.

Conclusions: Institutionalized HTA in Korea has been driven mainly by the requirements of the NHI and manifested strengths as well as weaknesses. The government is establishing a new organization for HTA, independent from the NHI.