Objectives: In cost-minimization studies, it is important to establish noninferiority in the clinical effect of the treatments under investigation. The relationship between the proportion of patients reaching the end point in a study, equivalence limit (δ), and power is investigated in the context of cost-minimization studies with dichotomous clinical end points. Two formulations of the null-hypothesis, absolute and relative formulations of δ, will be explored.

Methods: Sensitivity analysis was performed, in which the effect of the predicted proportions and δ on the power in a noninferiority setting was investigated. The patterns found are discussed in terms of the practical relevance within the cost-minimization framework.

Results: Sensitivity analyses show different patterns of results for both null-hypotheses. The differences in these results originate from the way δ is expressed. By expressing δ as absolute difference, power grows quite fast when sample proportions are smaller than expected. In the case of a proportional δ at small sample proportions, the power to establish noninferiority remains low.

Conclusions: To obtain valid results from a cost-minimization study, care has to be taken to adapt the correct methodology for noninferiority testing in clinical outcomes. Defining δ in terms of absolute differences between treatments can lead to obscured results. Although conservative, the expression of δ as a proportion of the effectiveness of the treatment as usual is found to be closer to clinical practice. The inflated δ, resulting from smaller clinical effects than expected when absolute formulation is applied, thus can be avoided.

Objectives: In the next decades, the number of stroke patients is expected to increase. Furthermore, organizational changes, such as stroke services, are expected to be implemented on a large scale. The purpose of this study is to estimate the future healthcare costs by taking into account the expected increase of stroke patients and a nationwide implementation of stroke services.

Methods: By means of a dynamic multistate life table, the total number of stroke patients can be projected. The model calculates the annual number of patients by age and gender. The total healthcare costs are calculated by multiplying the average healthcare costs specified by age, gender, and healthcare sector with the total number of stroke patients specified by age and gender.

Results: In the year 2000, the healthcare costs for stroke amounted to €1.62 billion. This amount is approximately 4.4 percent of the total national healthcare budget. Projections of the total costs of stroke based on current practice result in an increase of 28 percent (€2.08 billion) in the year 2020. A nationwide implementation of stroke services in 2020 would result in a substantial reduction of the costs of stroke (€1.81 billion: 13 percent cost reduction) compared with the regular care scenario.

Conclusions: A nationwide implementation of stroke services is a strong policy tool for cost containment of health care in an aging population like that in the Netherlands. Policy makers should optimize the organization of stroke care.

Objectives: The objective is to describe the principles for the design of the economic evaluation of COLOR II, a randomized, multi-country study comparing laparoscopic and open surgery for rectal cancer.

Methods: By using the experiences gained in a recent economic evaluation in colon cancer, where the same surgical techniques were compared, we could improve the method for identifying and measuring resource use items and also accommodate the use of data from the global study population.

Results: In the design of the study, the uncertainty in the resource-use variables was reduced by considering (i) what aspects drive each variable, (ii) what resource use is related to the intervention, (iii) how data from different countries affects the variable.

Conclusions: The aim was to refine the data collection so that the economic research question could be answered in the best possible way, given the circumstances in the clinical study. Thus, (i) some variables were treated as stochastic variables and others as deterministic variables, (ii) aggregate key cost-driving resource items were developed that corresponded to clinical events, and (iii) a surrogate variable was selected, instead of the “obvious variable”, to reduce the impact of confounding factors for one particular resource unit.

Abstract: The purpose of this study is to explain the rationale for the value of information approach to priority setting for research and to describe the methods intuitively for those familiar with basic decision analytical modeling. A policy-relevant case study is used to show the feasibility of the method and to illustrate the type of output that is generated and how these might be used to frame research recommendations. The case study relates to the use of glycoprotein IIb/IIIa antagonists for the treatment of patients with non-ST elevation acute coronary syndrome. This is an area that recently has been appraised by the National Institute for Health and Clinical Excellence.

Evaluations of telemedicine have sought to assess various measures of effectiveness (e.g., diagnostic accuracy), efficiency (e.g., cost), and engagement (e.g., patient satisfaction) to determine its success. Few studies, however, have looked at evaluating the organizational impact of telemedicine, which involves technology and process changes that affect the way that it is used and accepted by patients and clinicians alike. This study reviews and discusses the conceptual issues in telemedicine research and proposes a fresh approach for evaluating telemedicine. First, we advance a patient pathway perspective, as most of the existing studies view telemedicine as a support to a singular rather than multiple aspects of a health care process. Second, to conceptualize patient pathways and understand how telemedicine impacts upon them, we propose simulation as a tool to enhance understanding of the traditional and telemedicine patient pathway.

Objectives: There is a growing volume of literature on health economic evaluation, with this form of analysis becoming increasingly influential at the decision-making level worldwide. The purpose of this study was to review the current state of health economic evaluation in Greece, with a view to uncovering reasons why its use in this country is limited.

Methods: A search of the NHS Economic Evaluation Database was undertaken. The search included cost, cost-of-illness, cost-minimization, cost-effectiveness, cost-consequences, cost-utility, and cost-benefit analyses and was narrowed only to Greek authors undertaking solo or joint health economic evaluation in Greece.

Results: The search revealed that, in Greece, very little health economic evaluation has been undertaken. The main reason for the lack of interest is that the current chaotic healthcare system structure and financing does not provide the appropriate incentives to stimulate a powerful interest in this type of research. This condition is a result of the lack of a long-term national health policy and the hesitation of the present and past Greek governments to date to proceed to large-scale reforms because of political considerations. The Greek governments have also been content with the good health indicators being achieved.

Conclusions: Even if it is accepted that good health prevails in Greece, slower economic growth rates, an ageing population, and the continuous immigration will place increasing pressure on healthcare resources and will necessitate a more rational use of these resources. Health economic evaluation, by weighing benefits against costs, therefore, has an important role to play.

Objectives: In France, new guidelines for clinical practices concerning cystic fibrosis came out in 2002, underscoring the need for early and intensive management of this disease. Because no recent health economic studies on cystic fibrosis in France were available, we conducted a cost-analysis study before the new guidelines were put into practice, with a view to a later study on the medical and economic impact of these guidelines.

Methods: A cost-analysis study was performed of the inpatient and outpatient costs of patients with cystic fibrosis for the 2000–2001 period. The various direct costs were estimated on a sample of sixty-five adult and pediatric patients managed for cystic fibrosis in two reference medical centers. Data were obtained from medical records, and questionnaires were filled out by the patients. Analysis was made from the perspective of the French healthcare system.

Results: We studied sixty-five patients, 54 percent male patients and 72 percent children under 18 years of age. The total cost of cystic fibrosis care totaled 16,189 euros per year and per patient. Outpatient costs accounted for 88 percent of the total cost versus 12 percent for inpatient costs; medication costs were the highest with 21 percent of the total cost for home intravenous antibiotic treatments and 49 percent of the total cost for chronic medications.

Conclusions: The results show that outpatient costs were higher than inpatient costs, which could be related to the importance granted to home health care in France, notably for intravenous antibiotic treatments given for pulmonary complications.

Objectives: The mode of contact and response levels of authors who had been asked to provide missing or incomplete data for a systematic review on diet and exercise interventions for weight loss was examined.

Methods: We contacted authors by electronic mail, letter, or both. Survival analyses were performed with the Kaplan–Meier method to determine differences in the proportion of responders over time among the different modes of contact and to determine whether response rates differed between authors from the United States and those from other countries. Logistic regression was used to determine whether the number of items requested and publication date influenced the likelihood of response.

Results: Two hundred forty-one (39.9 percent) studies had missing or incomplete data (e.g., sample size, age, caloric restriction, exercise amount, and so on). We were unable to locate ninety-five authors (39.4 percent). Of the remaining authors, forty-six authors (31.5 percent) responded to information requests. Time to respond differed by contact method (p<.05): e-mail (3 ± 3 days), letter (27 ± 30 days), and both (13 ±12 days). Response rates from U.S. authors did not differ from those of other countries.

Conclusions: Our study suggests poor success in the acquisition of essential information. Given considerable time and resources, weight loss studies require improved reporting standards to minimize the relatively unsuccessful attempt to contact authors for important and necessary information.

Objectives: A cost-effectiveness analysis was conducted comparing diagnostic strategies for determining the HER2 status of invasive breast carcinomas, as an indication for trastuzumab at metastatic relapse.

Methods: A decision tree compared five strategies distinguished by (i) the use of immunohistochemical (IHC) and/or fluorescent in situ hybridization (FISH) techniques, and (ii) the test schedule (at initial diagnosis or metastatic relapse). Most cost and effectiveness data came from a French multicentric study of 2,045 patients from eight hospitals. We were not able to select final criteria for trastuzumab effectiveness, because published data rely on IHC techniques not used in France (i.e., HercepTest). We, therefore, selected two intermediate criteria for inappropriate treatment at relapse, that is, patients with HER2-amplified tumors not receiving trastuzumab (Criterion 1) and HER2-nonamplified tumors improperly treated with trastuzumab (Criterion 2). Sensitivity analyses were then performed to assess the robustness of the results to (i) discount rate, (ii) cost of FISH, and (iii) tissue fixation technique.

Results: The strategy using IHC at diagnosis was dominated by the four other strategies. Among these approaches, the only efficient strategy for both criteria was IHC used alone at metastatic relapse; strategies using FISH, or IHC followed by FISH on IHC2+ cases were efficient for Criterion 1, whereas IHC followed by FISH on IHC2+ and 3+ cases was efficient for Criterion 2.

Conclusions: Determining HER2 status at diagnosis, as an indication for trastuzumab at metastatic relapse, incurs substantial incremental costs, which do not appear to be justified. No other strategy can be excluded at first.

We should be careful when making claims that a given individual had a major impact on a given field. After all, much research is undertaken in teams and good ideas are quickly transferred and developed. There are, however, several reasons to suggest that Alan Williams made a major impact and that the field may have developed differently had he never become a health economist. I give five reasons below.

Objectives: The aim of this study was to evaluate utilization trends of the diagnostic imaging examinations during the past decade in a university hospital in Turkey.

Methods: Patient registries of a university hospital were used for the years 1995 and 2003. The data set consisted of patients' admissions, social security status, and diagnostic imaging tests.

Results: When compared with 1995 data, the total number of diagnostic imaging examinations and patient admissions increased 65.9 percent and 81.6 percent, respectively, in the year 2003. Although the total number of diagnostic imaging tests decreased 9.0 percent, there was a 145.4 percent increase in magnetic resonance imaging (MRI) examinations. Nevertheless, radiological diagnostic procedures consisted of 12.8 percent of the total hospital revenues in 1995 and 9.4 percent in 2003.

Conclusions: This study shows that approximately one third of inpatients underwent MRI and computed tomography examinations in 2003. The utilization rates of diagnostic imaging procedures, especially new technologies, need to be considered carefully with respect to appropriateness of procedures and planning of services.

Objectives: The objectives of this study were to analyze the current structure of the Turkish pharmaceuticals market to explain the latest developments and to offer some insight into the likely policy issues that this sector will face.

Methods: Systematic searches of the relevant Turkish and English research literature were made, using electronic databases in addition to written reports.

Results: The pharmaceutical industry in Turkey currently has eighty-seven manufacturing firms, eleven raw material manufacturers and thirty-eight importing firms. These add up to a total of 136 firms, 35 of which are driven by foreign capital, with 8 of these foreign-run firms having their own plants in Turkey. The industry employs approximately 19,000 personnel. In terms of growth, the value of pharmaceutical products in Turkey recently has exceeded that in Europe. In addition, per capita drug consumption levels are quite low compared with the Organisation for Economic Co-operation and Development and European Union countries. Major international players in the medical equipment and pharmaceutical products sector have also been opening offices in Turkey to reap the benefits of this rapidly evolving market.

Conclusions: The pharmaceutical industry in Turkey is quite advanced and diverse, with high quality, generic pharmaceutical products being manufactured as well as poor quality copies that have not been appropriately tested in terms of bioequivalence and bioavailability. The country faces a low level of drug consumption due to economic and cultural constraints compared with Western countries. Governmental control and regulations are key issues because the majority of drug purchases (70–80 percent) throughout the country are currently reimbursable through public sector agencies such as the Pension Fund and the Social Insurance Organization.

The Journal has lost a loyal friend and trusted advisor when former board member Bernard S. Bloom, PhD, died at his home in Society Hill, Pennsylvania. A gifted economist, Bernie's contribution to the healthcare field was immeasurable and left an indelible impression on students and peers alike.