Intrauterine growth retardation is associated with high risk of perinatal asphyxia. The neonatal mortality rate of small-for-gestational-age (SGA) infants (birthweight ≤ 2 SD) in Sweden decreased from 5.6% in 1973 to 2.0% in 1987. During the same period, the number SGA infants with postnatal asphyxia (5 min Apgar score <7) decreased from 10% to 5%. Based on antenatal diagnosis of fetal growth retardation, an optimal time of delivery reduces the risk of major neurological and developmental sequelae of the individual infant.

The basic aim of a drug policy is to ensure that effective and safe drugs of good quality are available to cover the health needs of a country. A national drug policy should be considered an integral part of any comprehensive health-care policy. The formulation of national drug policies varies even between similar countries because of conflicting interests and different political, economic, and social pressures. It is influenced by such factors as:

the health situation of the country;

the medical care system;

the education and training of health personnel;

the social security and health-insurance schemes;

drug research and development possibilities;

the domestic production of drugs;

the determination of the demand for drugs;

the system of drug distribution;

the possibilities for evaluation and control of drugs; and

international policies on medicinal products.

A widely held assumption today is that biomedicine is “scientific” and therefore “objective,” thus, “culture-free.” It epitomizes the objectivism falsely attributed to technology in general. Contemporary Japan is seen to epitomize non-Western modernity with its high development of industrialization and scientific technology. It follows then that biomedicine in Japan today should remain as such without cultural transformations. Yet, in post-industrial Japan today biomedicine takes an almost entirely different form and meaning from biomedicine practiced elsewhere, especially in Western societies such as the United States. The purpose of this paper is to describe the experience of hospitalization in contemporary Japan in order to demonstrate how Japanese culture and society have powerfully transformed the underlying concepts and practices of biomedicine, which was originally introduced from the West and has been highly acclaimed by the Japanese as the epitome of superior Western science and technology. Due to space limitations, however, it will not be possible to engage in an extensive discussion of theories about technological impact, or issues involved in the broader theoretical concern variously referred to as “modernization,” “industrialization,” “rationalization,” “secularization,” etc.

Objectives: Learning effects may have considerable influence on the performance of new health technologies, thereby on cost-effectiveness and ultimately on resource allocation. In the area of radiotherapy, equipment is becoming increasingly costly and the analysis of learning effects is complex given that sequential treatments are necessary, with multiple sessions for each patient. Our study aimed at analyzing learning effects in radiotherapy at an early stage of innovation.

Methods: We used multilevel analysis to separate out the different learning effects of the new technique. Statistical analysis of observational data collected in a French National prospective survey was performed using an individual growth model. Intrapatient learning was modeled at level 1, and two types of interpatient learning were considered at level 2, regarding possible influences of professional experience on (i) the duration of each patient's first session in a given setting and (ii) the rate of change of session duration over time for a given patient. Conventional radiotherapy was also considered for comparison.

Results: Our results demonstrate a substantial type-1 interpatient learning effect and an even higher intrapatient learning effect. No type-2 interpatient learning was at work: professional experience did not impact intrapatient learning. Moreover, some intrapatient learning was also reported with conventional radiotherapy and was not significantly modified by innovation. Session duration was in any case strongly influenced by disease.

Conclusions: Because professionals highly underestimated the learning phenomenon, assessment of learning cannot be based on professional statements and it requires careful analysis of observational data.

Objectives: The costs of comprehensive cardiac rehabilitation are established and compared to the corresponding costs of usual care. The effect on health-related quality of life is analyzed.

Methods: An unprecedented and very detailed cost assessment was carried out, as no guidelines existed for the situation at hand. Due to challenging circumstances, the cost assessment turned out to be ex-post and top-down.

Results: Cost per treatment sequence is estimated to be approximately €976, whereas the incremental cost (compared with usual care) is approximately €682. The cost estimate is uncertain and may be as high as €1.877.

Conclusions: Comprehensive cardiac rehabilitation is more costly than usual care, and the higher costs are not outweighed by a quality of life gain. Comprehensive cardiac rehabilitation is, therefore, not cost-effective.

The author argues that a “narrowing down” in the scope of HTA that occurred at the end of the 1970s was paralleled by developments in bioethics at the same time. Both disciplines responded to changes in the institutional and political field in which they operated. Over the past 20 years, decision making in the health field has changed again. To remain relevant, HTA must evolve further. Building in mechanisms for consultation with stakeholders will be an important element in this adjustment.

Positron emission tomography (PET) is a method of nuclear medicine imaging that uses short-lived radiopharmaceuticals to detect and quantify the metabolic abnormalities of disease processes. PET initially was developed in a research environment as a research tool; data from these research studies resulted in the gradual recognition that PET studies would be useful for various routine clinical applications. The diffusion of PET into clinical practice has been slow in comparison with other new imaging methods (e.g., magnetic resonance imaging). This slow diffusion is attributable to several factors, including the complexity and high cost of PET, the uncertain role of the U.S. Food and Drug Administration in regulating the radiopharmaceuticals that are produced and used on-site for PET studies, and the apparent slow pace at which the Health Care Financing Administration and other third-party payers are developing policies for reimbursing for PET.

Background: Despite a clear call for greater input from health technology assessment (HTA) in the areas of clinical practice and policy making, there are currently very few formal training programs. The objectives of our Consortium were to (i) develop a master's level program in HTA, (ii) test its content with a group of Canadian and European students, and (iii) evaluate the Program's strengths and weaknesses.

Objectives: This study presents the results of our evaluation of the first edition of the Master's Program (2001–2003).

Methods: The evaluation relied on (i) a self-administered student questionnaire for each course (n = 142), (ii) interviews with students (n = 10), and (iii) interviews with internship supervisors (n = 5).

Results: A vast majority of students were satisfied with the course content and particularly appreciated the exercises and materials presented in an intensive format. However, they needed more systematic feedback from faculty members and recommended increasing the methodology content. The six key characteristics of the program are (i) flexible format adapted to the needs of skilled professionals, (ii) continuous interaction between HTA users and producers, (iii) international academic and professional collaboration, (iv) partnership with HTA agencies, (v) global approach to evidence-based methods and practices, and (vi) multidisciplinary approach.

Conclusions: Despite the numerous organizational barriers inherent to creating an international program and several areas for improvement in the Program itself, the Ulysses Project was successful in attaining its objectives. Because there is a growing need for human resources with special training in HTA, further efforts need to be devoted to strengthening the international research capacity in HTA.

Emergency preparedness is a continuous quality improvement process through which roles and responsibilities are defined to effectively anticipate, respond to, and recover from the impact of emergencies. This process results in documented plans that provide a backbone structure for developing the core capacities to address health threats. Nevertheless, several barriers can impair an effective preparedness planning, as it needs a 360° perspective to address each component according to the best evidence and practice. Preparedness planning shares common principles with health technology assessment (HTA) as both encompass a multidisciplinary and multistakeholder approach, follow an iterative cycle, adopt a 360° perspective on the impact of intervention measures, and conclude with decision-making support. Our “Perspective” illustrates how each HTA domain can address different component(s) of a preparedness plan that can indeed be seen as a container of multiple HTAs, which can then be used to populate the entire plan itself. This approach can allow one to overcome preparedness barriers, providing an independent, systematic, and robust tool to address the components and ensuring a comprehensive evaluation of their value in the mitigation of the impact of emergencies.

The 1970s and early 1980s was the period in which high technology medicine became dominant. It had begun in the late 1950s with the introduction of effective artificial respiratory technology. This gave physicians, patients, and families the hope that the threats to fundamental life processes such as breathing could be countered by technology, and the dilemma of both meeting its costs and the ethical challenges of how to remove it when its use no longer produced benefits.

Objectives: The aim of this study was to assess incidence, time frame, and outcome of “Coverage with Evidence Development” (CED) decisions in the Swiss Basic Health Insurance scheme.

Methods: Analysis of all controversial medical technologies submitted to review by the Swiss Federal Office of Public Health (FOPH) from 1996 to 2012 with focus on decisions with constraints. Description of types of technology, type of initial decision, duration of evaluation period, final decision, and search for potential factors associated with changes over time.

Results: Forty-five (37.5 percent) of 120 controversial health technologies were classified as “yes, in evaluation, reimbursed” for a certain period of time and thirty-five (29.2 percent) as “no, in evaluation, not reimbursed” by the Federal Department of Home Affairs from 1996 to 2012. The rate of CED decisions ranged between zero and nine per year and was influenced by type of technology and calendar year. Forty-four of forty-five decisions were subject to further restrictions, to a “center or a specialist” (76 percent), “indications” (49 percent), “registry” (31 percent), or “other” (49 percent). The time to a final decision ranged from 1.5 to 11 years (median, 6 years). No factors associated with initial decision and final outcome could be identified.

Conclusions: CED as a reality in Switzerland might have enabled patients to obtain access to promising technologies early in their life cycle. CED might have acted as a trigger to a successful implementation of a comprehensive national registry. The lack of qualitative data stresses the urgent need for evaluation of the HTA decisions and their impact on patient outcome and costs.

Objectives: Recent introduction of a quadrivalent human papillomavirus (HPV) vaccine for girls in New Zealand is expected to decrease the incidence of HPV infection as well as resultant cytological abnormalities and cervical cancer. This may affect the cost-effectiveness of the national cervical screening program by reducing the incidence of lesions detected. This study investigates the cost-effectiveness of the current cervical screening policy with and without the HPV vaccine and compares these results with the cost-effectiveness of a range of other screening strategies.

Methods: A Markov state-transition model was built based on the natural history of HPV and cervical carcinogenesis. The model followed a hypothetical cohort of girls from 12 years to 85 years of age or death, through screening and treatment pathways. The model compared a “no vaccine and current screening” strategy with a selection of screening strategies with different age ranges and frequency intervals.

Results: The most cost-effective cervical screening strategy in the presence of the HPV vaccine would be screening women aged 30–60 every 5 years. Moving to this screening strategy from the base case of no vaccine and the current New Zealand strategy of screening women aged 20–69 every 3 years is predicted to have an incremental cost per quality-adjusted life-year gained of NZ$9,841 (€4,428).

Conclusions: Reducing screening intensity from 3 to 5 years as well as narrowing the screening age range for the vaccinated cohort once they reach mid-twenties is recommended. The importance of achieving a high vaccine uptake in New Zealand remains high.

Since the origin of technology assessment (TA) in the 1960s, including TAs of certain medical interventions, and formal recognition and institutionalization of health technology assessment (HTA) in the 1970s, the field of HTA has evolved in programs large and small in the public and private sectors. It has diffused into an increasing number of nations in a range of policy-making and decision-support contexts. Since its inception, the development and diffusion of HTA have been strongly characterized by international collaboration involving sharing of expertise and practical experience, and joint efforts to advance the state of the art. Also during that time, there have been periodic collaborations to identify or develop standard frameworks, good practices, guiding principles, checklists, and other normative, “how-to” documentation for the field. Recognizing the diversity and ongoing evolution of HTA, these efforts have generally sought to balance the appeal of standardization with that of flexibility to accommodate the ranges of HTA program remits and contexts.

Background: Timely provision of information on the cost-effectiveness of innovations in health care becomes more and more important, resulting in increasing pressure on researchers to provide proof of cost-effectiveness in a short time frame. However, most of these innovations require considerable time and effort to optimally implement leading to a biased “steady state” cost-effectiveness outcome. As decision makers in health care predominantly have a short-term focus, the discrepancy between short-term study outcomes and long-term cost-effectiveness may very well lead to misguided decisions about the adoption of innovations in health care.

Methods: Factors such as learning effects, capacity constraints, and delayed time to benefit are all related to a short-run timeframe and result in inefficiencies during the implementation of an innovation. These factors and the mechanisms by which they influence the cost-effectiveness outcome are explained for three different types of healthcare innovations.

Results: As standard cost-effectiveness analysis assumes costs and effects to behave constant and representative for an innovation's entire economic lifetime, resulting cost-effectiveness outcomes might give a biased, and often overly pessimistic, reflection of the actual cost-effectiveness of an innovation. This is further amplified by the fact that short-run inefficiencies are most prevalent and impactful during an innovation's earliest stage of operation.

Conclusions: This study advocates to carefully take into account the different factors contributing to lag-time bias in the design and analysis of cost-effectiveness studies, and to communicate potential biases due to short-run inefficiencies to all stakeholders involved in the decision making process.

It is well known that signs of respiratory distress or disease (RD), such as high breathing frequency, chest wall retractions, grunting, and cyanosis, are common in newborn infants. The signs may be very transient or develop into a potentially life-threatening condition. When they are first observed, they often have a very ambiguous prognostic significance.

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.

Objectives: We studied the cost-effectiveness of tenofovir and entecavir in e antigen positive (CHBe+) and negative (CHBe-) chronic hepatitis B.

Methods: Using a multicenter survey including 544 patients we measured patient quality of life and attributable costs by clinical disease stage. Natural disease progression was studied in 278 patients in a single center. A Markov model was constructed to follow hypothetical cohorts of treated and untreated 40-year-old CHBe+ and CHBe- patients and 50-year-old patients with compensated cirrhosis.

Results: We did not find an improvement in quality of life when viral load was reduced under treatment. Transition rates to liver cirrhosis were found to be age-dependent. Assuming equal effectiveness, tenofovir dominates the entecavir strategy because of its lower price in Belgium. The incremental cost-effectiveness ratio (ICER) of tenofovir after 20 years is more favorable for treating Caucasian cirrhotic patients (mean ICER €29,000/quality-adjusted life-year [QALY]) compared with treating non-cirrhotic patients (mean ICER €110,000 and 131,000/QALY for CHB e+ and e-, respectively). Within the non-cirrhotic patients the ICER decreases with increasing cohort starting age from 30 to 50 years.

Conclusions: Results of long-term models for tenofovir or entecavir treatment of CHB need to be interpreted with caution as long-term trials with hard end points are lacking. Especially the effect on HCC remains highly uncertain. Based on cost-effectiveness considerations such antiviral treatment should be targeted at patients with cirrhosis or at risk of rapid progression to this disease stage.

Objectives: Disinvestment of existing healthcare technologies that deliver low or no health benefit for their cost can be used as a tool to improve access to effective technologies, while ensuring the long-term sustainability of healthcare systems. The objective of this research was to identify disinvestment initiatives in Latin American countries (LAC).

Methods: First, a systematic literature review (SLR) was conducted. In February 2015, MEDLINE, MEDLINE In-Process, EMBASE, The Cochrane Library, and LILACS were searched for relevant journal articles, including terms related to “disinvestment,” “reallocation,” “obsolete technologies,” and “Latin America.” Additionally, a manual search of documents from Latin American health technology assessment agencies was performed. Second, an online questionnaire was sent to experts in LAC to assess whether unpublished real-life disinvestment initiatives exist. Questionnaire results were collected in September 2015.

Results: From the SLR, 350 records were selected for screening following de-duplication and eleven articles fulfilled inclusion criteria. Only two of these reported information on initiatives potentially identifiable as disinvestment-investment activities in Brazil and Peru. Nine respondents completed the questionnaire, and four reported that disinvestment initiatives had been conducted in their respective organizations in Argentina, Brazil, and Mexico. This lack of agreement between the SLR and the questionnaire responses shows that disinvestment initiatives are ongoing, despite being under reported.

Conclusions: Many challenges need to be overcome for a disinvestment initiative to be successful, and sharing particular experiences with the international community would increase the chances of positive outcomes. The present study highlights the need for publication of such experiences in LAC.